Q4 2023 Exelixis Inc Earnings Call

February 6, 2024

Michael M. Morrissey: We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis. And we're happy to now open the call. Thank you. Ladies and gentlemen, to ask a question, please press star 11 on your telephone and then wait to hear your name announced.

Operator: Good day, ladies and gentlemen, and welcome to the Exelixis 4th Quarter and Fiscal Year 2023 Financial Results Conference Call. My name is Tawanda, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Okay.

Operator: Good day, ladies and gentlemen, and welcome to the Exelixis's fourth quarter and fiscal year 2023 financial results conference call. My name is Tawanda, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host today, Miss Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Speaker Change: Good day, ladies and gentlemen, and welcome to the excellent fourth quarter and fiscal year 2023 financial results conference call.

Tomorrow: My name is tomorrow and I'll be your operator for today.

Operator: To withdraw your questions, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Tomorrow: As a reminder, this call is being recorded for replay purposes.

Operator: I would now like to turn the call over to your host today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed. Thank you, Twanda, and thank you all for joining us for the Exelixis fourth quarter and fiscal year 2023 financial results. Joining me on today's call are Mike Morrissey, our President and CEO, and Chris Senner, our Chief Financial Officer. We will review our progress for the fourth quarter and full year 2023 and to December 29th. E.J.

I would now like to turn the call over to your host today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Tomorrow: Now I'd like to turn the call over to your house today, Ms. Susan Hubbard Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Thank you, Twanda, and thank you all for joining us for the Exelixis Fourth Quarter and Fiscal year 2023 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO; and Chris Senner, our Chief Financial Officer. We will review our progress for the fourth quarter and full year 2023 ended December 29th 2023. P.J. Haley, our Executive Vice President of Commercial; Amy Peterson, our Chief Medical Officer, and Dana Aftab, our Chief Scientific Officer, are also on the call today and will participate in the question-and-answer portion of the call. the call today, we will refer to financial measures not calculated according to generally accepted... Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our guide

Susan Hubbard: Thank you, Twanda, and thank you all for joining us for the Exelixis Fourth Quarter and Fiscal year 2023 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO; and Chris Senner, our Chief Financial Officer. We will review our progress for the fourth quarter and full year 2023 ended December 29th 2023. P.J. Haley, our Executive Vice President of Commercial; Amy Peterson, our Chief Medical Officer, and Dana Aftab, our Chief Scientific Officer, are also on the call today and will participate in the question-and-answer portion of the call. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our GAAP results.

Amy: Hey guys, good afternoon. Thanks for taking my questions. I had a pipeline question, sort of thinking about the potential opportunity for Zanta-Litnip, perhaps sort of in context of some of the recent CABO phase three trial readouts, and specifically a question about the Stellar 305 study in head and neck cancer, which I thought interesting where you recently initiated a phase three trial and maybe just remind us what drives your confidence in Zanta's clinical profile in head and neck cancer and how should Yeah, thank you, Mike. This is Amy.

Hey guys, good afternoon. Thanks for taking my questions. I had a pipeline question, sort of thinking about the potential opportunity for Zanta-Litnip, perhaps sort of in context of some of the recent CABO phase three trial readouts, and specifically a question about the Stellar 305 study in head and neck cancer, which I thought interesting where you recently initiated a phase three trial and maybe just remind us what drives your confidence in Zanta's clinical profile in head and neck cancer and how should Yeah, thank you, Mike.

Susan Hubbard: Thank you, Tawanda, and thank you all for joining us for the Exelixis Q4 and fiscal year 2023 financial results conference call. Joining me on today's call are Michael Morrissey, our President and CEO, and Chris Centor, our Chief Financial Officer, who will review our progress for the Q4 and full year 2023, ended 29 December 2023. PJ Haley, our Executive Vice President of Commercial, Amy Peterson, our Chief Medical Officer, and Dana Aftab, our Chief Scientific Officer, are also on the call today and will participate in the question and answer portion of the call. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles.

Susan Hubbard: Thank you Wanda and thank you all for joining us for the <unk> fourth.

Susan Hubbard: <unk> fourth quarter and fiscal year 2023 financial results conference call joining.

Susan Hubbard: Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner.

Susan Hubbard: Our Chief Financial Officer, who will review our progress from the fourth quarter and full year 2023, and the December 2009 to 2023.

Susan Hubbard: Haley, our Executive Vice President of Commercial, Amy Peterson, our Chief Medical Officer, and Dana Aftab, our Chief Scientific Officer, are also on the call today. During the call today, we will refer to financial measures not calculated according to generally accepted... Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our guide

Speaker Change: P J Haley our executive Vice President of commercial any Peterson, our Chief Medical Officer, and Dana asked job our Chief Scientific Officer are also on the call today and will participate in the question and answer portion of the call during.

During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our GAAP results.

Speaker Change: During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles.

Susan Hubbard: Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures, as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters. Actual events or results could, of course, differ materially.

Speaker Change: Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results.

Susan Hubbard: During the course of this presentation, we will be making forward-looking statements regarding future events, and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the SEC, which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed in--by the company verbally, and in writing today, including, without limitation risks and uncertainties related to product commercial success, market competition, regulatory review, and approval processes conducting clinical trials, and compliance with applicable regulatory requirements are dependent on collaboration partners, and the level of cost associated with the discovery, product development, and business development and commercialization activities. With that, I will turn the call over to Mike.

During the course of this presentation, we will be making forward-looking statements regarding future events, and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the SEC, which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed in--by the company verbally, and in writing today, including, without limitation risks and uncertainties related to product commercial success, market competition, regulatory review, and approval processes conducting clinical trials, and compliance with applicable regulatory requirements are dependent on collaboration partners, and the level of cost associated with the discovery, product development, and business development and commercialization activities. And with that, I will turn the call over to Mike.

Speaker Change: During the course of this presentation, we will be making forward looking statements regarding future events and the future performance of the company does include statements about possible developments regarding discovery product development regulatory commercial financial and strategic matters actual events or results.

This is Amy...

Amy: Thanks for that question. So getting to the Stellar 303 study design and what gives us confidence, I think you might be referring to the recently reported failure of Pam Len in this setting. Here we actually believe that Stellar 305 is an example of a smart risk, not only because of the Phase II-III design that we've employed here, but also given what was observed with Cabo PEM, so dovetailing on your earlier question about leveraging Cabo data, here's an exact example of how we're doing that.

Speaker Change: Of course differ materially.

Susan Hubbard: We refer you to the documents we file from time to time with the SEC, which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed in by the company verbally and in writing today, including, without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of costs associated with the discovery, product development, business development, and commercialization activities. Then with that, I will turn the call over to Mike.

Speaker Change: Are you to the documents we file from time to time with the SEC, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed.

Speaker Change: By the company verbally and in writing today, including without limitation risks and uncertainties related to product commercial success market competition regulatory review and approval processes conducting clinical trials compliance with applicable regulatory requirements, our dependence on collaboration partners.

And with that, I will turn the call over to Mike.

Speaker Change: The level of costs associated with the discovery product development business development and commercialization activities and with that I will turn the call over to Mike Alright. Thank you Susan and thanks to everyone for joining us on the call today.

With that, I will turn the call over to Mike.

Michael M. Morrissey: All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis had a strong year in 2023, and we're already sprinting into 2024 after a busy January where we provided important updates across literally all components of our business. We're please to see continued growth of the CABOZANTINIB franchise in the U.S. and globally in 2023, which provides the foundation for our efforts to advance our drug discovery and development priorities that we outlined at our R&D Day in December. We reviewed important news to jump-start 2024 at our corporate update in January at the JPM Healthcare Conference. I won't reiterate everything here today but just focus on the top highlights, including first.

Michael M. Morrissey: All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis had a strong year in 2023, and we're already sprinting into 2024 after a busy January, where we provided important updates across literally all components of our business. We're please to see continued growth of the CABOZANTINIB franchise in the U.S. and globally in 2023, which provides the foundation for our efforts to advance our drug discovery and development priorities that we outlined at our R&D Day in December. We reviewed important news to jump-start 2024 at our corporate update in January at the JPM Healthcare Conference.

Amy: So in the multi-center phase two study that was recently published by Dr. Saba in Nature earlier this year and conducted in patients with inoperable recurrent metastatic head and neck cancer, that study of Fabo Pembroe demonstrated a 52% response rate, a 14.6 month median progression-free survival, and a 22.3 month median overall survival. It's a Phase II study, but it does benchmark well to monotherapy PEMBRO from the Keynote-048 study that had an ORR of 19%, and this 305 study is Zanza PEMBRO versus monotherapy PEMBRO. So we're looking at beating a response rate of around 19% with the doublet of Zanza PEMBRO. It also benchmarks well to the Phase 2 Lent-TEM study that demonstrated an ORR of 36% and a median progression-free survival of 8 months. We know that the LEAP study was negative, and obviously, we are going to review the data very carefully once it's public to assess what, if any, modifications need to be made in 305.

Michael M. Morrissey: All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis has had a strong year in 2023, and we're already sprinting into 2024 after a busy January, where we provided important updates across literally all components of our business. We're pleased to see continued growth of the cabozantinib franchise in the US and globally in 2023, which provides the foundation for our efforts to advance our drug discovery and development priorities that we outlined at our R&D Day in December. We reviewed important news to jumpstart 2024 at our corporate update in January at the JPM Healthcare Conference. I won't reiterate everything here today, but just focus on the top highlights, including, first, we saw a strong performance of the cabozantinib business in Q4 and full year 2023, with continued growth in demand and revenue.

Michael Morrissey: All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis has had a strong year in 2023, and we're already sprinting into 2024 after a busy January, where we provided important updates across literally all components of our business. We're pleased to see continued growth of the cabozantinib franchise in the US and globally in 2023, which provides the foundation for our efforts to advance our drug discovery and development priorities that we outlined at our R&D Day in December. We reviewed important news to jumpstart 2024 at our corporate update in January at the JPM Healthcare Conference. I won't reiterate everything here today, but just focus on the top highlights, including, first, we saw a strong performance of the cabozantinib business in Q4 and full year 2023, with continued growth in demand and revenue.

Michael M. Morrissey: That's what's has had a strong year in 2023, and we're already sprinting into 2024. After a busy January where we provided important updates across literally all components of our business.

Michael M. Morrissey: We're pleased to see continued growth of the Cabozantinib franchise in the U S and globally in 2023.

Michael M. Morrissey: Which provides the foundation for our efforts to advance our drug discovery and development priorities that we outlined at our R&D day in December.

We reviewed important news to jumpstart 2024 at our corporate update in January at the J P M Health care conference.

I won't reiterate everything here today, but just focus on the top highlights, including; first, we saw a strong performance of the CABOZANTINIB business in the Fourth Quarter and full year 2023, with continued growth in demand and revenue. CABOMETYX maintained its status as the leading TKI for RCC in both the first-line IO TKI market, and second-line monotherapy segment. Fourth quarter, CABO franchise net product revenues grew 14% year-over-year compared to the fourth Quarter 2022. CABO franchise net product revenues to 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global CABOZANTINIB franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion, in the Fourth Quarter and full year 2023. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half of 2024.

I won't reiterate everything here today, but just focus on the top highlights, including; first, we saw a strong performance of the CABOZANTINIB business in the Fourth Quarter and full year 2023, with continued growth in demand and revenue. CABOMETYX maintained its status as the leading TKI for RCC in both the first-line IO TKI market, and second-line monotherapy segment. Fourth Quarter, CABO franchise net product revenues grew 14% year-over-year compared to the Fourth Quarter 2022. CABO franchise net product revenues to 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global CABOZANTINIB franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion, in the Fourth Quarter and full year 2023 respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half of 2024. Obviously, this is a critical milestone for the company and the CABOZANTINIB franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to CABO and our other differentiated molecules that we pursue on behalf of patients with cancer.

Fourth quarter, CABO, franchise net product revenues grew 14% year-over-year compared to the fourth quarter 2022. CABO franchise net product revenues to 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI global CABOZANTINIB franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion in the fourth quarter and full year 2023 respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half.

significant progress in advancing the pipeline in 2023 that was highlighted in our R&D Day presentation in December.

Third, we made significant progress in advancing the pipeline in 2023 that was highlighted in our R&D Day presentation in December. Our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRPC. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly. Zanzibar development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XP-002 expansion cohorts is at a critical stage with a global network of sites now contributing to that. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris. Thanks, Mike. For the fourth quarter 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB Franchise Net Product Revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million, and included approximately $6 million in clinical trial sales. Gross net for the CABOZANTINIB franchise in the Fourth Quarter 2023 was 28.2%, which was in line with our expectations. Our CABOMETYX trade inventory increased by approximately 1,000 units when compared to the Third Quarter of 2023, to approximately 2.7 weeks on average. This increase in inventory was partially related to the timing of holidays at the end of 2023 and the beginning of 2024. Based on what we can see in the trade, some of this inventory has been utilized in the first weeks of 2024.

Christopher J. Senner: Thanks, Mike. For the fourth quarter of 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB franchise net product revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million, and included approximately $6 million in clinical trial sales. Gross to net for the CABOZANTINIB franchise in the fourth quarter 2023 was 28.2%, which was in line with our expectations.

Fourth quarter, CABO franchise net product revenues grew 14% year over year compared to the fourth quarter 2022. CABO franchise net product revenues to 16% for full year 2022. Highlighting its role as a worldwide leading TKI, global composant and franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion in the fourth quarter and full year 2023 respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October, and we expect a ruling in the first half.

Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October, and we expect a ruling in the first half of 2024.

Fourth quarter CABO franchise net product revenues grew 14% year over year compared to the fourth quarter 2022. CABO franchise net product revenues grew 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global CABOZANTINIB franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion in the fourth quarter and full year 2023 respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October, and we expect a ruling in the first half of 2024.

Fourth quarter CABO franchise net product revenues grew 14% year over year compared to the Fourth Quarter 2022. CABO franchise net product revenues grew 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global CABOZANTINIB franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion in the fourth quarter and full year 2023 respectively. Chris will review our 2024 financial guidance in his prepared remarks. Third, we made significant progress in advancing the pipeline in 2023 that was highlighted in our R&D Day presentation in December. Our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRPC. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly.

Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October, and we expect a ruling in the first half of 2024. Obviously, this is a critical milestone for the company and the CABOZANTINIB franchise. While we will not speak to any specifics today, I'm proud of the work that our team did in preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to COBO and our other differentiated molecules that we pursue on behalf of patients with cancer. we made significant progress in advancing the pipeline in 2023, which was highlighted in our R&D day presentation.

Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October, and we expect a ruling in the first half of 2024. Obviously,

this is a critical milestone for the company and the CABOZANTINIB franchise. While we will not speak to any specifics today, I'm proud of the work that our team did in preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to COBO and our other differentiated molecules that we pursue on behalf of patients with cancer. we made significant progress in advancing the pipeline in 2023, which was highlighted in our R&D day presentation.

Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October, and we expect a ruling in the first half of 2024.

Obviously, this is a critical milestone for the company and the CABOZANTINIB franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to CABO and our other differentiated molecules that we pursue on behalf of patients with cancer. Third, we made significant progress in advancing the pipeline in 2023, that was highlighted in our R&D Day presentation in December.

Third, we made significant progress in advancing the pipeline in 2023, that was highlighted in our R&D Day presentation in December. Our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRPC. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly. ZANZA development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB-002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB-002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

Third, we made significant progress in advancing the pipeline in 2023 that was highlighted in our R&D day presentation in December. our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRPC. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly. ZANZA development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB-002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our Fourth Quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

ZANZE development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB-002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our Fourth Quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter. Thanks, Mike. For the Fourth Quarter of 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB franchise net product revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million and included approximately $6 million in clinical trial sales. Gross net for the CABOZANTINIB franchise in the Fourth Quarter 2023 was 28.2%, which was in line with our expectations.

Thanks, Mike. For the fourth quarter of 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB franchise net product revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million and included approximately $6 million in clinical trial sales. Gross net for the CABOZANTINIB franchise in the Fourth Quarter 2023 was 28.2%, which was in line with our expectations....

Thanks, Mike. For the Fourth Quarter of 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB franchise net product revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million and included approximately $6 million in clinical trial sales. Gross net for the CABOZANTINIB franchise in the Fourth Quarter 2023 was 28.2%, which was in line with our expectations...

Fourth Quarter, CABO franchise net product revenues grew 14% year-over-year compared to the Fourth Quarter 2022. CABO franchise net product revenues to 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global CABOZANTINIB franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion, in the Fourth Quarter and full year 2023 respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half of 2024. Obviously, this is a critical milestone for the company and the CABOZANTINIB franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to CABO and our other differentiated molecules that we pursue on behalf of patients with cancer.

Michael M. Morrissey: Reiterate everything here today, but just focus on the top highlights including first.

Third, we made significant progress in advancing the pipeline in 2023 that was highlighted in our R&D Day presentation in December. Our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRPC. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly. ZANZA development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB-002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our Fourth Quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

ZANZA development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB-002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our Fourth Quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris. For the fourth quarter 2023, the company reported total revenues of approximately $480 million, which included Cabo Santon and Franchise Net Product Revenues of approximately $429 million. Kablametics net product revenues were $427.7 million and included approximately $6 million in clinical trials. Gross net for the Cabo Zante franchise in the fourth quarter 2023 was 28.2%, which was in line with our expectations.

Christopher Senner: Thanks, Mike. For the Fourth Quarter of 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB franchise net product revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million and included approximately $6 million in clinical trial sales. Gross net for the CABOZANTINIB franchise in the Fourth Quarter 2023 was 28.2%, which was in line with our expectations.

Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half of 2024. Obviously, this is a critical milestone for the company and the CABOZANTINIB franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to CABO and our other differentiated molecules that we pursue on behalf of patients with cancer. Third, we made significant progress in advancing the pipeline in 2023 that was highlighted in our R&D day presentation in December. Our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRPC. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly. Zanzibar development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XP-002 expansion cohorts is at a critical stage with a global network of sites now contributing to that. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

Michael M. Morrissey: We saw a strong performance of the Cabo Santa Net business in the fourth quarter and full year 2023, with continued growth in demand and revenue. Cabo Medics maintained its status as the leading TKI for RCC in both the first line IOTKI market and second line monotherapy. In the fourth quarter, CABO. Franchise net product revenues grew 14% year over year compared to the fourth. Cabo franchising their product revenues to 16% for full year 2020, highlighting its role as a worldwide leading TKI, global composant and franchise net product revenues generated by Exelixis and its partners were approximately $600 million in $2.3 billion, fourth quarter and full year 2023. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half.

Michael M. Morrissey: We saw a strong performance of the Cabozantinib business in the fourth quarter and full year 2023 with continued growth in demand and revenue Cabo.

Fourth quarter, CABO franchise net product revenues grew 14% year-over-year compared to the fourth Quarter 2022. CABO franchise net product revenues to 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global CABOZANTINIB franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion, in the Fourth Quarter and full year 2023. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half of 2024. Obviously, this is a critical milestone for the company and the CABOZANTINIB franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to CABO and our other differentiated molecules that we pursue on behalf of patients with cancer.

Michael M. Morrissey: CABOMETYX maintained its status as the leading TKI for RCC in both the first-line IO TKI market and second-line monotherapy segment. Q4, cabo franchise net product revenues grew 14% year-over-year compared to Q4 of 2022. Cabo franchise net product revenues grew 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global cabozantinib franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion in the Q4 and full year 2023, respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and a trial that took place in October, and we expect a ruling in the first half of 2024.

Michael Morrissey: CABOMETYX maintained its status as the leading TKI for RCC in both the first-line IO TKI market and second-line monotherapy segment. Q4, cabo franchise net product revenues grew 14% year-over-year compared to Q4 of 2022. Cabo franchise net product revenues grew 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global cabozantinib franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion in the Q4 and full year 2023, respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and a trial that took place in October, and we expect a ruling in the first half of 2024.

Michael M. Morrissey: <unk> maintained its status as the leading TGI for RCC.

Third, we made significant progress in advancing the pipeline in 2023 that was highlighted in our R&D day presentation in December. Our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRPC. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly. Zanzibar development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XP-002 expansion cohorts is at a critical stage with a global network of sites now contributing to that. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

Michael M. Morrissey: Both the first line Iot market in second line monotherapy segment.

With that please see our press release issued an hour ago for our Fourth Quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the Quarter. I'll now turn the call over to Chris. And I'll turn the call over to Mike. For the fourth quarter 2023, the company reported total revenues of approximately $480 million, which included Cabo Santon and Franchise Net Product Revenues of approximately $429 million. Kablametics net product revenues were $427.7 million and included approximately $6 million in clinical trials. Gross net for the Cabo Zante franchise in the fourth quarter 2023 was 28.2%, which was in line with our expectations.

Michael M. Morrissey: Fourth quarter Cabo franchise net product revenues grew 14% year over year compared to fourth quarter of 2022.

Fourth Quarter CABO franchise net product revenues grew 14% year-over-year compared to Fourth Quarter 2022. CABO franchise net product revenues grew 16% for full year 2023 compared to full year 2022. Highlighting its role as a worldwide leading TKI, global composant and franchise net product revenues generated by Exelixis and its partners were approximately $600 million and $2.3 billion, in the Fourth Quarter and full year 2023, respectively. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half.

Christopher Senner: Thanks, Mike. For the fourth quarter 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB franchise net Product Revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million and included approximately $6 million in clinical trials. Gross net for the CABOZANTINIB franchise in the Fourth Quarter 2023 was 28.2%, which was in line with our expectations.

Michael M. Morrissey: Cabo franchising their product revenues to 16% for full year 2020, highlighting its role as a worldwide leading TKI, global composant and franchise net product revenues generated by Exelixis and its partners were approximately $600 million in $2.3 billion, fourth quarter and full year 2023. Chris will review our 2024 financial guidance in his prepared remarks. Second, final reply briefs should be submitted in the next few weeks for the second MSN and the trial that took place in October. And we expect a ruling in the first half.

Michael M. Morrissey: Cabo franchise net product revenues grew 16% for full year 2023, compared to full year 2020 to highlight.

Michael M. Morrissey: Highlighting its role as a worldwide, leading PKI global Cabozantinib franchise net product revenues generated by <unk> and its partners were approximately $600 million and $2 3 billion.

Amy: But I think what we've also observed with the combination of PEM-LEN is the difficulty that physicians are having with regard to maintaining the dose density of LEN. So there are a lot of toxicities that require multiple dose reductions. And when you have enough dose reductions, that can actually interfere with the activity profile and could be a big reason why this doublet may not have succeeded but where Zanzipem could have succeeded. I'll also point out that Zanza has the same target profile as CABO in that it inhibits the TAM and MET families and results in a very similar immune permissive environment that CABO results in. However, the tolerability profile of Zanza is differentiated from that of CABO.

Michael M. Morrissey: In the fourth quarter and full year 2023, respectively.

Michael M. Morrissey: Chris will review, our 2024 financial guidance in his prepared remarks.

Michael M. Morrissey: Second final reply briefs should be submitted in the next few weeks for the second M. S N and a trial that took place in October and we expect a ruling in the first half of 2024.

Michael M. Morrissey: Obviously, this is a critical milestone for the company and the cabozantinib franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to cabo and our other differentiated molecules that we pursue on behalf of patients with cancer. Third, we made significant progress in advancing the pipeline in 2023 that was highlighted at our R&D Day presentation in December. Our top priority for 2024 is to advance potential new cabo indications for NET and metastatic CRPC. The recent Contact-02 presentation at ASCO GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly.

Michael Morrissey: Obviously, this is a critical milestone for the company and the cabozantinib franchise. While we will not speak to any specifics today, I'm proud of the work that our team did preparing and presenting this case. Exelixis has and will continue to vigorously protect our intellectual property rights with respect to cabo and our other differentiated molecules that we pursue on behalf of patients with cancer. Third, we made significant progress in advancing the pipeline in 2023 that was highlighted at our R&D Day presentation in December. Our top priority for 2024 is to advance potential new cabo indications for NET and metastatic CRPC. The recent Contact-02 presentation at ASCO GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session shortly.

Michael M. Morrissey: Obviously, this is a critical milestone for the company and the Cabo Zante franchise. While we will not speak to any specifics today, I'm proud of the work that our team did in preparing and presenting. Exelixis has and will continue to vigorously protect our intellectual property rights for Cabo and our other differentiated molecules that we pursue on behalf of Third, we made significant progress in advancing the pipeline in 2023, which was highlighted in our R&D day presentation.

Michael M. Morrissey: Obviously this is a critical milestone for the company and the Cabozantinib franchise.

Speaker Change: While we will not speak to any specifics today I'm proud of the work that our team did preparing and presenting this case.

Speaker Change: <unk> has and will continue to vigorously protect our intellectual property rights with respect to combo and our other differentiated molecules that we pursue on behalf of patients with cancer.

Speaker Change: Third we made significant progress in advancing the pipeline in 2023 that was highlighted at our R&D day presentation in December.

Michael M. Morrissey: Our top priority for 2024 is to advance potential new CABO indications for NET and metastatic CRT. The recent CONTACT-02 presentation at ASCO-GU generated a lot of buzz at the meeting that Amy is sure to address in the Q&A session. Zanzibar development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XP-002 expansion cohorts is at a critical stage with a global network of sites now contributing to that. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive With that, please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

Speaker Change: Top priority for 2020 for us to advance potential new Cabo indications for net and metastatic CRP C. <unk>.

Amy: Namely, we can start with full doses of Zanza in combination with IO, whereas in combination with CABO, we start at a reduced dose, and of course, with LEN, it starts at a reduced dose and reduces even further thereafter. So we'll keep our eyes on the data from the LEAP study in head and neck, but we are pretty confident that the combination that we're testing in head and neck with Zanza PEM represents a pretty high probability of success. It was awesome.

Speaker Change: The recent contact to presentation at ESMO Gi <unk> you generated a lot of buzz at the meeting that Amy assured to address in the Q&A session. Shortly.

ZANZA development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. And as you heard from Dana in December, our IND pipeline is full for the next few years with exciting new compounds that could address the range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing. please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter.

Michael M. Morrissey: Zanzalintinib development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. As you heard from Dana in December, our IND pipeline is full for the next few years, with exciting new compounds that could address a range of solid tumor indications, with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our Q4 and full year 2023 financial results, and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris.

Michael Morrissey: Zanzalintinib development continues to be a key priority for us in terms of both existing and new pivotal trials, and enrolling XB002 expansion cohorts is at a critical stage with a global network of sites now contributing to this effort. As you heard from Dana in December, our IND pipeline is full for the next few years, with exciting new compounds that could address a range of solid tumor indications, with potentially differentiating profiles based on extensive preclinical testing. With that, please see our press release issued an hour ago for our Q4 and full year 2023 financial results, and an extensive list of key corporate milestones achieved in the quarter. I'll now turn the call over to Chris.

Speaker Change: Xanthan development continues to be a key priority for us in terms of both existing and new pivotal trials and enrolling XP Oh two expansion cohorts is that a critical stage with a global network of sites now contributing to this effort.

Speaker Change: And as you heard from Dana in December our pipeline is full for the next few years with exciting new compounds that could address a range of solid tumor indications with potentially differentiating profiles based on extensive preclinical testing.

Amy: Thanks for the helpful contacts, that, Thank you. Please stand by for our next question. Our next question comes from the line of Jason Gerber with Bank of America. Your line is open.

With that please see our press release issued an hour ago for our Fourth Quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter. And I'll turn the call over to Mike. For the fourth quarter 2023, the company reported total revenues of approximately $480 million, which included Cabo Santon and Franchise Net Product Revenues of approximately $429 million. Kablametics net product revenues were $427.7 million and included approximately $6 million in clinical trials. Gross net for the Cabo Zante franchise in the fourth quarter 2023 was 28.2%, which was in line with our expectations.

Speaker Change: With that please see our press release issued an hour ago for our fourth quarter and full year 2023 financial results and an extensive list of key corporate milestones achieved in the quarter I'll now turn the call over to Chris.

Michael M. Morrissey: And I'll turn the call over to Mike. For the fourth quarter 2023, the company reported total revenues of approximately $480 million, which included Cabo Santon and Franchise Net Product Revenues of approximately $429 million. Kablametics net product revenues were $427.7 million and included approximately $6 million in clinical trials. Gross net for the Cabo Zante franchise in the fourth quarter 2023 was 28.2%, which was in line with our expectations.

Chris Senner: Thanks, Mike. For Q4 2023, the company reported total revenues of approximately $480 million, which included cabozantinib franchise net product revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million and included approximately $60 million in clinical trial sales. Gross to net for the cabozantinib franchise in Q4 2023 was 28.2%, which was in line with our expectations. Our CABOMETYX trade inventory increased by approximately 1,000 units when compared to Q3 2023 to approximately 2.7 weeks on hand. This increase in inventory was partially related to the timing of holidays at the end of 2023 and the beginning of 2024.

Amy: Hi, this is Chi Arm for Jason. Thanks for taking the time to ask me a question. Just one on prostate cancer, a two-part question. After the Ask OGU presentation, there was discussion around whether a second NHT or chemotherapy is the appropriate control arm. So I'm curious, on the regulatory side, do you have alignment with the FDA on the choice of control arm in contact O2? And on the commercial side, how do you see contact or to fit into the treatment algorithm relative to chemo and radio in the refractory setting? Thank you. Thanks, Chi. Let's have Amy start with the comparative question.

Christopher J. Senner: Thanks, Mike for the fourth quarter of 2023, the company reported total revenues of approximately $480 million, which included Cabozantinib franchise net product revenues of approximately $429 million.

Christopher Senner: Thanks, Mike. For the fourth quarter 2023, the company reported total revenues of approximately $480 million, which included CABOZANTINIB Franchise Net Product Revenues of approximately $429 million. CABOMETYX net product revenues were $427.7 million, and included approximately $6 million in clinical trial sales. Gross net for the CABOZANTINIB franchise in the Fourth Quarter 2023 was 28.2%, which was in line with our expectations.

Christopher J. Senner: <unk> net product revenues were $427 7 million and included approximately $6 million in clinical trial sales.

Christopher J. Senner: Gross to net for the Cabozantinib franchise in the fourth quarter 2023 was 28, 2%, which was in line with our expectations.

Christopher J. Senner: Our CABOMETYX trade inventory increased by approximately 1,000 units when compared to the Third Quarter of 2023, to approximately 2.7 weeks on average. This increase in inventory was partially related to the timing of holidays at the end of 2023 and the beginning of 2024. Based on what we can see in the trade, some of this inventory has been utilized in the first weeks of 2024. Additionally, we are estimating that our growth net for the full year 2024 will be approximately 30%. As we've seen in the past, growth net tends to be higher in the first quarter of a year, primarily due to higher Medicare Part D and copay assistance expenses. Finally, clinical trial sales have historically been choppy between quarters, and we expect this to continue in the future.

Our CABOMETYX trade inventory increased by approximately 1,000 units when compared to the Third Quarter of 2023, to approximately 2.7 weeks on average. This increase in inventory was partially related to the timing of holidays at the end of 2023 and the beginning of 2024. Based on what we can see in the trade, some of this inventory has been utilized in the first weeks of 2024.

Christopher J. Senner: Our cosmetics trade inventory increased by approximately 1000 units when compared to the third quarter, it's three to approximately $2 seven weeks on hand.

Christopher J. Senner: This increase in inventory was part two partially related to the timing of holidays at the end of 2023 and the beginning of 2024.

Chris Senner: Based on what we can see in the trade, some of this inventory has been utilized in the first weeks of 2024. Additionally, we are estimating that our gross to net for the full year 2024 will be approximately 30%. As we've seen in the past, gross to net tends to be higher in Q1 of a year, primarily due to higher Medicare Part D and co-pay assistance expenses. Finally, clinical trial sales have historically been choppy between quarters, and we expect this to continue in future quarters. Total revenues also included approximately $50.3 million in collaboration revenues, which includes approximately $40.7 million of royalties earned from our partners, Ipsen and Takeda, on their sales of cabozantinib.

Christopher J. Senner: Just on what we can see in the trade. Some of this inventory has been utilized in the first weeks of 2020.

Additionally, we are estimating that our gross to net for the full year 2024 will be approximately 30%. As we've seen in the past, gross to net tends to be higher in the first quarter of a year, primarily due to higher Medicare Part D and co-pay assistance expenses. Finally, clinical trial sales have historically been choppy between quarters, and we expect this to continue in the future quarters. Total revenues also included approximately $50.3 million in collaboration revenue, which included approximately $40.7 million of royalties earned from our partners, Ipsen and Takeda, on their sales of CABOZANTINIB. Our total operating expenses for the fourth quarter of 2023 were approximately $398 million, compared to $490 million in the Third Quarter of 2023. R&D expense was the primary driver of the decline in total operating expenses, which was primarily related to lower licensing expenses. Provision for income taxes for the fourth quarter of 2023 was approximately $17.5 million compared to a provision for income taxes of approximately $4.8 million for the third quarter of 2023. The company reported a net income of approximately $85.5 million, or $0.28 per share basic and $0.27 per share diluted for the fourth quarter.

Additionally, we are estimating that our gross to net for the full year 2024 will be approximately 30%. As we've seen in the past, gross to net tends to be higher in the first quarter of a year, primarily due to higher Medicare Part D and co-pay assistance expenses. Finally, clinical trial sales have historically been choppy between quarters, and we expect this to continue in the future quarters. Total revenues also included approximately $50.3 million in collaboration revenue, which included approximately $40.7 million of royalties earned from our partners, Ipsen and Takeda, on their sales of CABOZANTINIB. Our total operating expenses for the fourth quarter of 2023 were approximately $398 million, compared to $490 million in the Third Quarter of 2023. R&D expense was the primary driver of the decline in total operating expenses, which was primarily related to lower licensing expenses. Provision for income taxes for the fourth quarter of 2023 were approximately $17.5 million compared to a provision for income taxes of approximately $4.8 million for the Third Quarter of 2023. The company reported GAAP net income of approximately $85.5 million, or $0.28 per share basic, and $0.27 per share diluted for the Fourth Quarter of 2023. The company also reported a non-GAAP net income of approximately $104.2 million for $0.34 per share basic, and $0.33 per share diluted.

Christopher J. Senner: Additionally, we are estimating that our gross to net for the full year 2024 will be approximately 30% as we've seen in the past gross to that tends to be higher in the first quarter of the year, primarily due to higher Medicare part D and co pay assistance expenses.

Amy: Glad you asked that, and then PJ can wind up with the commercial stuff. Yeah, thanks, Chi. So I was also in the room for Dr. Chi's discussion. And let me just start out by saying not every phase 3 control arm is for every patient with that. We do work in collaboration with health authorities. KOLs are ultimately steering committee members to design a trial that maintains equipoise. And what do I mean by equipoise?

Total revenues also included approximately $50.3 million in collaboration revenue, which included approximately $40.7 million of royalties earned from our partners, Ipsen and Takeda, on their sales of CABOZANTINIB. Our total operating expenses for the fourth quarter of 2023 were approximately $398 million, compared to $490 million in the third quarter of 2023. R&D expense was the primary driver of the decline in total operating expenses, which was primarily related to lower licensing expenses. Provision for income taxes for the fourth quarter of 2023 were approximately $17.5 million compared to a provision for income taxes of approximately $4.8 million for the Third Quarter of 2023. The company reported GAAP net income of approximately $85.5 million, or $0.28 per share basic, and $0.27 per share diluted for the Fourth Quarter of 2023. The company also reported a non-GAAP net income of approximately $104.2 million for $0.34 per share basic, and $0.33 per share diluted.

Provision for income taxes for the fourth quarter of 2023 were approximately $17.5 million compared to a provision for income taxes of approximately $4.8 million for the third quarter of 2023. The company reported GAAP net income of approximately $85.5 million, or $0.28 per share basic, and $0.27 per share diluted for the fourth quarter of 2023. The company also reported a non-GAAP net income of approximately $104.2 million for $0.34 per share basic, and $0.33 per share diluted. Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense net of the related income tax. Cash and Investments for the year ended December 31, 2023 were approximately $1.7 billion. During the fourth quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97. This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2020

Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense net of the related income tax effect. Cash and Investments for the year ended December 31st, 2023 was approximately $1.7 billion. During the fourth quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97. This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, to pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2024.

Christopher J. Senner: Finally clinical trial sales have historically been choppy between quarters and we expect this to continue in future quarters.

This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, to pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2024. When combining the 2023 and 2024 share repurchase programs we'll return $1 billion to our shareholders by the end of 2024. And finally, turning to our financial guidance for the full year 2024. We announced our 2024 financial guidance at the J.P. Morgan Conference in January, and it is detailed on slide 14 of our earnings presentation. And with that, I'll turn the call back over to Mike.

Christopher J. Senner: Total revenues also included approximately $50.3 million in collaboration revenue, which included approximately $40.7 million of royalties earned from our partners, Ipsen and Takeda, on their sales of Kabuza. Our total operating expenses for the fourth quarter of 2023 were approximately $398 million, compared to $490 million in the third quarter of 2020. R&D expense was the primary driver of the decline in total operating expenses, which was primarily related to lower licensing expenses. Provision for income taxes for the fourth quarter of 2023 was approximately $17.5 million compared to a provision for income taxes of approximately $4.8 million for the third quarter of 2023. The company reported a net income of approximately $85.5 million, or $0.28 per share basic and $0.27 per share diluted for the fourth quarter.

Christopher J. Senner: Total revenues also included approximately $53 million in collaboration revenues.

Which includes approximately $47 million of royalties earned from our partners Ipsen and Takeda on their sales of Cabozantinib.

Chris Senner: Our total operating expenses for Q4 2023 were approximately $398 million, compared to $490 million in Q3 2023. R&D expense was the primary driver of the decline in total operating expenses, which was primarily related to lower licensing expenses. Provision for income taxes for Q4 2023 were approximately $17.5 million, compared to a provision for income taxes of approximately $4.8 million for Q3 2023. The company reported GAAP net income of approximately $85.5 million, or $0.28 per share basic and $0.27 per share diluted for Q4 2023.

Christopher J. Senner: Our total operating expenses for the fourth quarter of 2023 for approximately $398 million compared to $490 million in the third quarter of 2023.

Amy: When a patient is presented with the option to enroll in a study, it means that the treating physician has already determined that either treatment arm is reasonable for this patient. If the treating physician felt a different available treatment option was better suited for that patient, then we would not expect that patient to be presented with the option to enroll. We develop our inclusion and exclusion criteria, again, in discussions with health authorities and with KOLs to identify the most appropriate patient for our study. If an investigator felt his patient wasn't a candidate or her patient wasn't a candidate for second NHT, for example, as mentioned by Dr. Chi in his discussion at the GU Asco Symposium, high pain score, and high volume of disease, we expect that patient would be treated outside this clinical trial.

Provision for income taxes for the Fourth Quarter of 2023 were approximately $17.5 million compared to a provision for income taxes of approximately $4.8 million for the Third Quarter of 2023. The company reported GAAP net income of approximately $85.5 million, or $0.28 per share basic, and $0.27 per share diluted for the Fourth Quarter of 2023. The company also reported a non-GAAP net income of approximately $104.2 million for $0.34 per share basic, and $0.33 per share diluted. Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense net of the related income tax. Cash and Investments for the year ended December 31, 2023 were approximately $1.7 billion. During the fourth quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97. This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2020

Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense net of the related income tax effect. Cash and Investments for the year ended December 31st, 2023 were approximately $1.7 billion. During the fourth quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97. This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, to pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2024.

Christopher J. Senner: R&D expense was the primary driver of the decline in total operating expenses, which was primarily related to lower licensing expenses.

Christopher J. Senner: Provision for income taxes for the fourth quarter of 2023, or approximately $17 5 million compared to a provision for income taxes of approximately $4 8 million for the third quarter of 2023.

This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, to pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2024.---- And finally, turning to our financial guidance for the full year 2024. We announced our 2024 financial guidance at the J.P. Morgan Conference in January, and it is detailed on slide 14 of our earnings presentation. And with that, I'll turn the call back over to Mike.

Provision for income taxes for the fourth quarter of 2023 were approximately $17.5 million compared to a provision for income taxes of approximately $4.8 million for the Third Quarter of 2023. The company reported GAAP net income of approximately $85.5 million, or $0.28 per share basic, and $0.27 per share diluted for the Fourth Quarter of 2023. The company also reported a non-GAAP net income of approximately $104.2 million for $0.34 per share basic, and $0.33 per share diluted. Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense net of the related income tax. Cash and Investments for the year ended December 31, 2023 were approximately $1.7 billion. During the fourth quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97. This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2020

Christopher J. Senner: The company reported GAAP net income of approximately $85 5 million or 28 per share basic and <unk> 27 per share diluted for the fourth quarter 2023.

Chris Senner: The company also reported a non-GAAP net income of approximately $104.2 million, or $0.34 per share basic and $0.33 per share diluted. Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense, net of the related income tax effect. Cash and investments for the year ended December 31, 2023, was approximately $1.7 billion. During the fourth quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97.

Christopher J. Senner: The company also reported non-GAAP net income of approximately $104 2 million or <unk> 34 per share basic and <unk> 33 per share diluted.

Christopher J. Senner: The company also reported a non-GAAP net income of approximately $104.2 million for $0.34 per share basic and $0.33 per share. Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense net of the related income tax. Cash and Investments for the year ended December 31, 2023 were approximately $1.7 billion. During the fourth quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97. This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2020

Christopher J. Senner: non-GAAP net income excludes the impact of approximately $19 million in stock based compensation expense net of the related income tax effects.

Christopher J. Senner: Cash and investments for the year ended December 31, 2023 was approximately $1 7 billion during.

Non-GAAP net income excludes the impact of approximately $19 million of stock-based compensation expense net of the related income tax effect. Cash and Investments for the year ended December 31st, 2023 was approximately $1.7 billion. During the Fourth Quarter, we completed the $550 million share repurchase program we announced in March 2023. Since the commencement of this share repurchase program, we have repurchased approximately 26.2 million shares at an average price of $20.97. This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2020

Christopher J. Senner: During the fourth quarter, we completed the $550 million share repurchase program, we announced in March 2023 since.

Christopher J. Senner: Since the commencement of this share repurchase program, we have repurchased approximately $26 2 million shares at an average price of $20 97.

Amy: This is why we actually see heterogeneity in the patient demographics amongst contemporaneous studies conducted in similar settings. For example, look at the patient enrollment demographics between CONTACT and PSMA-4, both conducted in metastatic, castrate-resistant prostate cancer, both after having failed a first NHT. In CONTACT-02, 100% of our patients had measurable disease, versus 31% in PSMA-4. Additionally, approximately a quarter of our patients on contact received docetaxel in the metastatic setting versus zero in PSMA-4.

Chris Senner: This level of cash and investments, supported by our ongoing cash flow from operations, provides Exelixis with the flexibility to invest in internal R&D activities, to pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January 2024. When combining the 2023 and 2024 share repurchase programs, we will return $1 billion to our shareholders by the end of 2024. And finally, turning to our financial guidance for the full year 2024. We announced our 2024 financial guidance at the J.P. Morgan conference in January, and it is detailed on slide 14 of our earnings presentation. And with that, I'll turn the call back over to Mike.

Christopher J. Senner: This level of cash and investments supported by our ongoing cash flow from operations provides excellent for us with the flexibility to invest in internal R&D activities to pursue external business development opportunities to expand our pipeline and allows us to return capital to our shareholders through the $450 million share repurchase program, we announced in January 2024.

Christopher J. Senner: When combining the 2023 and 2024 share repurchase programs, we will return $1 billion to our shareholders by the end of 2024, and finally, turning to our financial guidance for the full year 2024, we announced our 2024 financial guidance at the Jpmorgan Conference in January and are detailed on slide 14 of our earnings.

This level of cash and investments, supported by our ongoing cash flow from operations provides Exelixis with the flexibility to invest in internal R&D activities, to pursue external business development opportunities to expand our pipeline, and allows us to return capital to our shareholders through the $450 million share repurchase program we announced in January of 2024. When combining the 2023 and 2024 share repurchase programs, we will return $1 billion to our shareholders by the end of 2024. And finally, turning to our financial guidance for the full year 2024. We announced our 2024 financial guidance at the J.P. Morgan Conference in January, and it is detailed on slide 14 of our earnings presentation. And with that, I'll turn the call back over to Mike.

Presentation, and with that I'll turn the call back over to Mike Alright, Thanks, Chris I'll wrap up here by thanking the entire <unk> team for their individual and collective efforts to support our range of discovery development and commercial activities. We had a great year in 2023, and 2024 is shaping up to be an inflection point for the business our science and the.

Michael M. Morrissey: All right, thanks, Chris. I'll wrap up here by thanking the entire Exelixis team for their individual and collective efforts to support our range of discovery, development, and commercial activities. We had a great year in 2023, and 2024 is shaping up to be an inflection point for the business, our science, and the patients we hope to serve on an ever-expanding basis. I want everyone to know that our team is highly motivated every single day to excel on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

Michael Morrissey: All right, thanks, Chris. I'll wrap up here by thanking the entire Exelixis team for their individual and collective efforts to support our range of discovery, development, and commercial activities. We had a great year in 2023, and 2024 is shaping up to be an inflection point for the business, our science, and the patients we hope to serve on an ever-expanding basis. I want everyone to know that our team is highly motivated every single day to excel on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

Christopher J. Senner: Combining the 2023 and 2024 share repurchase programs, we will return $1 billion to our shareholders by the end of 2020. And finally, turning to our financial guidance for the full year 2024. We announced our 2024 financial guidance at the J.P. Morgan Conference in January, and it is detailed on slide 14 of our earnings presentation. And with that, I'll turn the call back over to Mike.

Amy: 25% of our patients in contact had liver disease lost less than 5% on PSMA-4. And I'm going to even pull up some data on a meta-analysis conducted by Susan Palabi and in collaboration with Dr. Small, who is the ASCO-GU president, that did a meta-analysis of nine randomized phase 3 studies looking at docetaxel as the comparator arm. So thousands of patients. And when you look at the percent of patients in those randomized phase 3 studies on chemotherapy that actually had liver metastases, 9%. Contact O2 had 25% of patients with liver metastasis. All of these differences are due to the inclusion-exclusion criteria and situations where the treating physician and patient will look at either arm and say it is appropriate, or neither is appropriate.

We hope to serve in an ever expanding basis I want everyone to know that our team is highly motivated every single day to excel on our mission to help cancer patients recover stronger and live longer.

And finally, turning to our financial guidance for the full year 2024. We announced our 2024 financial guidance at the J.P. Morgan Conference in January, and is detailed on slide 14 of our earnings presentation. And with that, I'll turn the call back over to Mike.

Michael M. Morrissey: We look forward to updating you on our progress in the future. Thank you for your continued support and interest in <unk> and we're happy to now open the call for questions.

Operator: Thank you. Ladies and gentlemen, to ask a question, please press star one one on your telephone and then wait to hear your name announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen to ask a question. Please press star one on your telephone and then wait to hear your name announce to withdraw your question. Please press star one again please.

Michael M. Morrissey: All right. Thanks, Chris. I'll wrap up here by thanking the entire Exelixis team for their individual and collective efforts to support our range of discovery, development, and commercial activities. We had a great year in 2023, and 2024 shaping up to be an inflection point for the business, our science, and the patients we hope to serve at an ever-expanding basis. I want everyone to know that our team is highly motivated every single day to excel in our mission to help cancer patients. Cover Stronger.

Speaker Change: Please standby, while we compile the Q&A roster.

Speaker Change: Our first question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Michael Schmidt: Hey, guys, good afternoon. Thanks for taking my questions. I had a pipeline question. Sort of thinking about the potential opportunity for zanzalintinib, perhaps sort of in context of some of the recent CABO, phase three trial readouts. Specifically, a question on the STELLAR-305 study in head and neck cancer, which I thought interesting, where you recently initiated a phase three. And maybe just remind us what drives your confidence in zanzalintinib's, clinical profile in head and neck, and how should we think about, the success probability of the study?

Michael Schmidt: Hey, guys. Good afternoon. Thanks for taking my questions I had a pipeline question.

Michael Schmidt: Thinking about the.

Michael Schmidt: The potential opportunity for <unk> to Loopnet.

Michael Schmidt: Perhaps sort of in context of some of the recent Cabo phase III trial readout, specifically question on the stellar three or five study in head and neck cancer.

I want everyone to know that our team is highly motivated every single day to excel in our mission to help cancer patients rover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions. Thank you. Ladies and gentlemen, to ask a question, please press star 1-1 on your telephone and then wait to hear your name announced.

I want everyone to know that our team is highly motivated every single day to excel in our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions. [Operator Instructions]

I thought interesting, where you recently initiated a phase III and maybe just remind us what drives your confidence in <unk>.

PJ: And this is how we design ethical clinical trials in collaboration and agreement with health authorities, steering committees, the PIs, and the patients that enroll. I'll pass this over to P.J. Now to address the commotion. Great. Thanks, Amy. First of all, we're really excited about the data and presenting it. Metastatic castrate-resistant prostate cancer is a really big opportunity with over 75,000 patients across lines of therapy. You know, this remains a significant unmet medical need for patients and for the physicians who treat them. The five-year overall survival rate for this population is still only 15 percent.

Michael Schmidt: Michael profile in head and neck, and how should we think about that success probability.

Michael M. Morrissey: We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call. Thank you. Ladies and gentlemen, to ask a question, please press star 1-1 on your telephone and then wait to hear your name announced.

Amy Peterson: Yeah. Thank you, Mike. This is Amy. Thanks for that question. So getting to the STELLAR-303 study design and what gives us confidence, I think you might be referring to the recently reported failure of pemlen in this setting. Here we actually believe that STELLAR-305 is an example of a smart risk, not only because of the phase 2/3 design that we've employed here, but also given what was observed with CABO-Pem. So dovetailing on your earlier question about leveraging CABO data, here's an exact example of how we're doing that. So in the multicenter phase 2 study that was recently published by Dr.

Michael Schmidt: Yeah. Thank you Mike. This is Amy thanks for that question, so getting to the stellar 303 study design and what gives us confidence I think you might be referring to the.

Operator: [Operator Instructions] Our first question comes from the line of Michael Schmidt with Guggenheim.

Operator: Thank you. [Operator Instructions] Our first question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Speaker Change: The recently reported failure.

Amy: Len in this setting.

Amy: Here, we actually believe that stellar three of five is an example of a smart risk not only because of the phase three design that we have employee chair.

Amy: But also given what was observed with tableau Pam So dovetailing on your earlier question about leveraging Cabo data Here's an exact example of how we're doing that so in the multi center phase two study that was recently published by Dr. Saba nature earlier this year.

Andrew Peters: Hey guys, good afternoon. Thanks for taking my questions. I had a pipeline question, sort of thinking about the potential opportunity for ZANZALINTINIB, perhaps sort of in contact with some of the recent CABO Phase III trial readouts, specifically a question on the STELLAR-305 study in head and neck cancer, which I thought interesting, where you recently initiated a Phase III. And maybe just remind us what drives your confidence in ZANZA's clinical profile in head and neck and how we should think about the success probability? Yeah, thank you, Mike. This is Amy.

Michael Schmidt: Hey guys, good afternoon. Thanks for taking my questions. I had a pipeline question, sort of thinking about the potential opportunity for ZANZALINTINIB, perhaps sort of in contact with some of the recent CABO Phase III trial readouts, specifically a question on the STELLAR-305 study in head and neck cancer, which I thought interesting, where you recently initiated a Phase III. And maybe just remind us what drives your confidence in ZANZA's clinical profile in head and neck and how we should think about the success probability?

Amy Peterson: Published in Nature earlier this year, and conducted in patients with inoperable, recurrent metastatic head and neck cancer, that study of CABO-Pembro demonstrated a 52% response rate, a 14.6-month median progression-free survival, and a 22.3-month median overall survival. It's a phase 2, but it does benchmark well to monotherapy Pembro from the KEYNOTE-048 study that had an ORR of 19%, and this 305 study is Zanza-Pembro versus monotherapy Pembro. So we're looking at beating a response rate around 19% with the doublet of Zanza-Pembro. It also benchmarks well to the phase 2 Len-Pem study that demonstrated an ORR of 36% and a median progression-free survival of 8 months.

PJ: So, you know, when we think about the options that exist for them, there's obviously NHT, and I would point out that, you know, approximately 50 percent of patients have already received NHT before they get to the first-line castrate-resistant setting. And then, beyond that, really, all you've got is radioligand therapy and chemo. And both of these therapies obviously have limitations, you know, whether it's RLT with regard to, you know, logistics, you know, issues in terms of what that means for the patient with regard to being around family, et cetera. And we've seen repeatedly in market research and in discussions with physicians that, you know, many patients and physicians want to either delay or not receive chemo. So that said, we believe there's a significant place for this combination of Cabo Atenso should it be approved. Another thing I would point out here is that with only those two sort of classes of therapy available post-NHT, there's really a significant need and a great deal of excitement for new mechanisms of action. CRPC setting, and obviously, this regimen has two.

Amy: Conducted in patients with inoperable recurrent metastatic head and neck cancer.

That study.

Amy: <unk> demonstrated a 52% response rate of 14, six month median progression free survival and a 22.3 months median overall survival.

It's a phase two but it does benchmark well two monotherapy hambro from the keynote <unk> eight study that had an <unk> of 19% and this $3 five study.

Amy Peterson: Yes. Thank you, Mike. This is Amy. Thanks for that question. So getting to the STELLAR-303 study design and what gives us confidence, I think you might be referring to the recently reported failure of PEM/LEN in this setting. Here, we actually believe that STELLAR-305 is an example of a smart risk, not only because of the Phase II-III design that we've employed here, but also, given what was observed with CABO/PEM, so dovetailing on your earlier question about leveraging CABO data, here's an exact example of how we're doing that.

Andrew Peters: Thanks for that question. So getting to the Stellar 303 study design and what gives us confidence, I think you might be referring to the recently reported failure of Pam Len in this setting. Here, we actually believe that Stellar 305 is an example of a smart risk, not only because of the Phase II-III design that we've employed here, but also, given what was observed with CABO-PEM, so dovetailing on your earlier question about leveraging CABO data, here's an exact example of how we're doing that.

Zander hambro versus monotherapy <unk>. So we're looking at beating our response rate around 19% with the doublet of <unk>.

Amy: <unk>.

Amy: It also benchmarks well to the phase II learn some study that demonstrated in <unk> of 36%.

Amy: Median progression sorry, a median progression free survival of eight months, we know that the leap study was negative and obviously we are going to review the data very carefully once it's public to assess what if any modifications needed to be made.

Amy Peterson: We know that the Leap study was negative, and obviously, we are going to review the data very carefully once it's public, to assess what, if any, modifications need to be made in 305. But I think what we've also observed with the combination of PEM Len is the difficulty that physicians are having with regard to maintaining dose density of Len. So there's a lot of toxicities that require multiple dose reductions, and when you have enough dose reductions, that actually can interfere with the activity profile and could be a big reason why this doublet may not have succeeded, but where Xanza PEM could succeed. I'll also point out that Xanza has the same target profile as CABO, in that it inhibits the TAM and MET families and results in a very similar immune-permissive environment that CABO results in.

Amy: And $3 five but I think what we've also observed with the combination of mm. One is the difficulty that physicians are having with regard to maintaining dose density of Glenn. So there's a lot of toxicities that require multiple dose reductions.

Andrew Peters: So, in the multicenter Phase II study that was recently published by Dr. Saba in Nature earlier this year, and conducted in patients with inoperable recurrent metastatic head and neck cancer, that study of CABO/PEMRO demonstrated a 52% response rate, a 14.6 month median progression-free survival, and a 22.3 month median overall survival. It's a Phase II, but it does benchmark well to monotherapy PEMBRO from the KEYNOTE-048 study that had an ORR of 19%, and this 305 study is ZANZA/PEMBRO versus monotherapy PEMBRO. So we're looking at beating a response rate of around 19% with the doublet of ZANZ/ PEMBRO. It also benchmarks well to the Phase 2 Lentem study that demonstrated an ORR of 36% and a median progression-free survival of 8 months. We know that the LEAP study was negative, and obviously, we are going to review the data very carefully once it's public to assess what, if any, modifications need to be made in 305.

So, in the multicenter Phase II study that was recently published by Dr. Saba in Nature earlier this year, and conducted in patients with inoperable recurrent metastatic head and neck cancer, that study of CABO/PEMRO demonstrated a 52% response rate, a 14.6 month median progression-free survival, and a 22.3 month median overall survival. It's a Phase II, but it does benchmark well to monotherapy PEMBRO from the KEYNOTE-048 study that had an ORR of 19%, and this 305 study is ZANZA/PEMBRO versus monotherapy PEMBRO. So we're looking at beating a response rate of around 19% with the doublet of ZANZ/ PEMBRO.

Amy: When you have enough dose reductions that act that actually can interfere with the activity profile and could be a big reason why this doublet may not have succeeded but where zander Pam could succeed I'll also point out that <unk> has the same target profiles.

PJ: So a TKI as well as immunotherapy, and certainly there's a lot of potential excitement for immunotherapy in prostate cancer. So we're excited about the opportunity. You know, when we think about the broader treating population of community oncology, these are physicians who are very comfortable, obviously, with checkpoint inhibitors, as well as Cabo's antigen. We look forward to the.

Amy: Though in that it inhibits the Tam and that families and results in a very similar immune permissive environment that Cabo results and however, the tolerability profile of Zander is differentiated from Cabo.

It also benchmarks well to the Phase II LEN/PEM study that demonstrated an ORR of 36% and a median progression-free survival of 8 months. We know that the LEAP study was negative, and obviously, we are going to review the data very carefully once it's public to assess what, if any, modifications need to be made in 305. But I think what we've also observed with the combination of PEM/LEN is the difficulty that physicians are having with regard to maintaining the dose density of LEN. So there's a lot of toxicities that require multiple dose reductions, and when you have enough dose reductions, that actually can interfere with the activity profile, and could be a big reason why this doublet may not have succeeded but where ZANZA/PEM could have succeed. I'll also point out that ZANZA has the same target profile as CABO in that it inhibits the TAM and MET families and results in a very similar immune permissive environment that CABO results in, however, the tolerability profile of ZANZA is differentiated from CABO.

Amy Peterson: However, the tolerability profile of Zanza is differentiated from CABO. Namely, we can start with full doses of Zanza in combination with IO, whereas in combination with CABO, we start at a reduced dose, and of course, with Len, it starts at a reduced dose and reduces even further thereafter. So we'll keep our eyes on the data from the LEAP study in head and neck, but we are pretty confident that the combination that we're testing in head and neck with Zanza PEM represent a pretty high probability of success.

Amy: We can start with full doses of <unk> in combination with IL, whereas in combination with Cabo we started at a reduced dose and of course with land. It starts at a reduced dose and reduces even further thereafter, so we'll keep our eyes on the data from the leap.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Gregory Renzo with RBC Capital Markets. Your line is open. Hi guys, it's Nishant for Gregg.

Michael M. Morrissey: Congratulations on the progress this quarter and thanks for taking my questions. Just on the current patent litigation with MSN, I know you can't speak to the details of the case itself, but just thinking ahead on potential outcomes in the presence of Cabo's exclusivity, could you share how you're framing the best case and worst case outcomes of the MSN 2 case in relation to Cabo's exclusivity? And then just quickly on Zanza, can we expect any updates on Stellar 002 this year? Congratulations again and thanks so much.

Andrew Peters: But I think what we've also observed with the combination of PEM-LEN is the difficulty that physicians are having with regard to maintaining the dose density of LEN. So there are a lot of toxicities that require multiple dose reductions. And when you have enough dose reductions, that can actually interfere with the activity profile and could be a big reason why this doublet may not have succeeded but where Zanzipem could have succeeded. I'll also point out that Zanza has the same target profile as CABO in that it inhibits the TAM and MET families and results in a very similar immune permissive environment that CABO results in. However, the tolerability profile of Zanza is differentiated from that of CABO.

Amy: Study in head and neck, but we are pretty confident that the combination that we're testing in head and neck with zander Pam represent a pretty high probability of success.

So there's a lot of toxicities that require multiple dose reductions, and when you have enough dose reductions, that actually can interfere with the activity profile, and could be a big reason why this doublet may not have succeeded but where ZANZA/PEM could have succeed. I'll also point out that ZANZA has the same target profile as CABO in that it inhibits the TAM and MET families and results in a very similar immune permissive environment that CABO results in, however, the tolerability profile of ZANZA is differentiated from CABO.

Dana Aftab: Awesome. Thanks for the helpful context.

Michael Schmidt: Awesome. Thanks for the helpful context.

Speaker Change: Alright, thanks for the outflow context.

Amy Peterson: You bet, Michael, thank you.

Speaker Change: You bet Michael Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Jason Gerberry with Bank of America. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Jason Burberry with Bank of America. Your line is open.

Geoff Meacham: Hi, this is Chi Arm for Jason. Thanks for taking our question. Just one on prostate, a two-part question. After the ASCO GU presentation, there was a discussion around whether a second NHT or chemotherapy is the appropriate control arm. So I'm curious, on the regulatory side, do you have alignment with the FDA on the choice of control arm in Contact-02? And on the commercial side, how do you see, you know, Contact-02 fit into the treatment algorithm relative to chemo and radio in a refractory setting? Thank you.

Chi Fong: Hi, this is Chi Arm for Jason. Thanks for taking our question. Just one on prostate, a two-part question. After the ASCO GU presentation, there was a discussion around whether a second NHT or chemotherapy is the appropriate control arm. So I'm curious, on the regulatory side, do you have alignment with the FDA on the choice of control arm in Contact-02? And on the commercial side, how do you see, you know, Contact-02 fit into the treatment algorithm relative to chemo and radio in a refractory setting? Thank you.

Chi: Hi, This is chi on for Jason.

Michael M. Morrissey: Yeah, thanks for the question. I'll take the answer question and then pass it over to Amy. Yeah, so again, we're not talking about specifics relative to the trial for obvious reasons, and I really don't want to speculate on potential outcome scenarios in those. We are excited about the opportunity to move the company forward. We always do the right thing by patients and shareholders, and that will continue. Sure. Thanks, Nish, for the question on STELLAR-002. So that is a multi-arm study that is evaluating Zanza in combination with IO, but not just monotherapy IO like PD-1 or PD-L1, but additionally bringing other agents to the table. So, for example, CTLA-4 or LAG-3. Many of the cohorts that we're enrolling are in earlier lines of therapy. And so it's going to take some time for the data to mature, but we are really looking forward to sharing that as it does mature. So stay tuned for what we might be able to show in 2020.

Jason Burberry: Thanks for taking our question.

Chi: Just one on prostate two part question after the <unk> presentation, there was the discussion to wrong.

Chi: With our second an HP or chemotherapy is the appropriate control arm. So I'm curious.

Andrew Peters: Namely, we can start with full doses of ZANZA in combination with IO, whereas in combination with CABO, we start at a reduced dose, and of course, with LEN, it starts at a reduced dose and reduces even further thereafter. So we'll keep our eyes on the data from the LEAP study in head and neck, but we are pretty confident that the combination that we're testing in head and neck with ZANZA/PEM represents a pretty high probability of success. It was awesome.

Namely, we can start with full doses of ZANZA in combination with IO, whereas in combination with CABO, we start at a reduced dose, and of course, with LEN, it starts at a reduced dose and reduces even further thereafter. So we'll keep our eyes on the data from the LEAP study in head and neck, but we are pretty confident that the combination that we're testing in head and neck with ZANZA/PEM represents a pretty high probability of success.

Speaker Change: On the regulatory side, you have alignment with the FDA on the choice of the control arm and contact all materials and on the rack on the commercial side, how do you see.

Speaker Change: Contact at true fit into the treatment algorithm relative to chemo and radio in a refractory setting. Thank you.

Michael Schmidt: Awesome. Thanks for the helpful context.

Operator: Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Your line is open.

Dana Aftab: Thanks, Chi. Let's have Amy start with the comparative question. Glad you asked that, and then PJ can wind up with the commercial stuff.

Michael Morrissey: Thanks, Chi. Let's have Amy start with the comparative question. Glad you asked that, and then PJ can wind up with the commercial stuff.

Speaker Change: Thanks, Gee lets have Amy start with the.

Amy: Comparative question glad you asked that and then P. J cannot windup with the commercial stuff yeah. Thanks Chi. So I was also in the room for the discussion by Doctor Chi and let me just start out with not every phase three control arm is for every patient with that disease.

Amy Peterson: Yeah. Thanks, Chi. So I was also in the room for the discussion by Dr. Chi. And let me just start out with not every phase 3 control arm is for every patient with that disease. We do work in collaboration with health authorities, with KOLs, ultimately, our steering committee members, to design a trial that maintains equipoise. And what do I mean by equipoise? When a patient is presented the option to enroll in a study, it means that the treating physician has already determined that either treatment arm are reasonable for this patient. If the treating physician felt a different available treatment option were better suited for that patient, then we would not expect that patient to be presented with the option to enroll.

Chi Meng Fong: Hi, this is Chi on for Jason. Thanks for taking a question. Just one on prostate cancer, a two-part question. After the ASCO-GU presentation, there was a discussion around whether a second NHT or chemotherapy is the appropriate control arm. So I'm curious, on the regulatory side, do you have alignment with the FDA on the choice of control arm in CONTACT-02? And on the commercial side, how do you see CONTACT-O2 fit into the treatment algorithm relative to chemo and radio in the refractory setting? Thank you.

P. J: We do work in collaboration with health authorities with Kols ultimately our steering committee members to design a trial that maintains excellent poised and what do I mean by equipoise.

Amy: Thank you. Please stand by for our next question. Our next question comes from the line of Jay Olson with OPCO. Your line is open.

P. J: When a patient is presented the option to enroll in the study it means that the treating physician has already determined that I either treatment arm are reasonable for this patient.

Operator: Hi, this is Chung on the line for today. Thanks for taking the question and congratulations on the progress. And also, thanks for the caller on contact 02. I have two questions actually regarding some other data presented at ASCOGU and would love to hear your thoughts. So, first question, I'm curious about your thinking on the potential launch of a step Q formulation of OptiVol and if that actually may create some additional momentum for the uptake of Cabo Nevo compared to other regimens given the pretty favorable data we saw with Checkmate 67T and also potentially more attractive pricing with a step Q formulation, which would obviously have easier administration. And second question, just with QnO 534 now showing OS benefits in Thank you so much. Yeah, thanks for the question. I think PJ can handle both of them.

Operator: you know, contact O2 to fit into the treatment algorithm relative to chemo and radio in the refractory setting. Thank you. Thanks, Chi. Let's have Amy start with the comparative question.

you know, contact O2 to fit into the treatment algorithm relative to chemo and radio in the refractory setting. Thank you.

P. J: The treating physician felt a different available treatment option were better suited for that patient then we would not expect that patient.

Thanks, Chi. Let's have Amy start with the comparative question. Glad you asked that. And then P.J. can wind up with the commercial stuff. Yeah, thanks, Chi. So I was also in the room for Dr. Chi's discussion. And let me just start out by saying that not every phase 3 control arm is for every patient with that disease. We do work in collaboration with health authorities. KOLs are ultimately steering committee members to design a trial that maintains equipoise. And what do I mean by equipoise?

Michael M. Morrissey: Thanks, Chi. Let's have Amy start with the comparative question. Glad you asked that. And then P.J. can wind up with the commercial stuff.

Andrew Peters: Glad you asked that, and then PJ can wind up with the commercial stuff. Yeah, thanks, Chi. So I was also in the room for Dr. Chi's discussion. And let me just start out by saying that not every phase 3 control arm is for every patient with that disease. We do work in collaboration with health authorities. KOLs are ultimately steering committee members to design a trial that maintains equipoise. And what do I mean by equipoise?

P. J: Centered with the option to enroll.

Amy Peterson: We develop our inclusion and exclusion criteria, again, in discussions with health authorities and with KOLs to identify the most appropriate patient for our study. If an investigator felt his patient wasn't a candidate or her patient wasn't a candidate for second NHT, for example, as mentioned by Dr. Chi in his discussion at the ASCO GU Symposium, high pain score, high volume of disease, we expect that patient would be treated outside this clinical trial. This is why we actually see heterogeneity in the patient demographics amongst contemporaneous studies conducted in similar settings. For example, look at the patient enrollment demographics between Contact-02 and PSMA four, both conducted in metastatic, castrate-resistant prostate cancer, both after having failed a first NHT. In Contact-02, 100% of our patients had measurable disease versus 31% in PSMA four.

P. J: We develop our inclusion and exclusion criteria again and discussions with health authorities and with Kols to identify the most appropriate patients for our study.

Amy Peterson: Yes. Thanks, Chi. So I was also in the room for the discussion by Dr. Chi. And let me just start out with not every Phase III control arm is for every patient with that disease. We do work in collaboration with health authorities, with KOLs, ultimately steering committee members to design a trial that maintains equipoise. And what do I mean by equipoise? When a patient is presented with the option to enroll in a study, it means that the treating physician has already determined that either treatment arm are reasonable for this patient. If the treating physician felt a different available treatment option were better suited for that patient, then we would not expect that patient to be presented with the option to enroll.

P. J: If an investigator felt this patient wasn't a candidate or her patient wasn't a candidate for a second NH tea for example, as mentioned by Dr. Chi in his discussion at the <unk> Symposium I pain score high volume of disease, we expect that patient would be treated outside this clinical trial.

Andrew Peters: When a patient is presented with the option to enroll in a study, it means that the treating physician has already determined that either treatment arm are reasonable for this patient. If the treating physician felt a different available treatment option were better suited for that patient, then we would not expect that patient to be presented with the option to enroll. We develop our inclusion and exclusion criteria again in discussions with health authorities and with KOLs to identify the most appropriate patient for our study. If an investigator felt his patient wasn't a candidate or her patient wasn't a candidate for second NHT, for example, as mentioned by Dr. Chi in his discussion at the GU Asco Symposium, high pain score, and high volume of disease, we expect that patient would be treated outside this clinical trial.

When a patient is presented with the option to enroll in a study, it means that the treating physician has already determined that either treatment arm are reasonable for this patient. If the treating physician felt a different available treatment option were better suited for that patient, then we would not expect that patient to be presented with the option to enroll.

P. J: This is why we actually see heterogeneity in the patient demographics amongst contemporaneous study is conducted in similar settings.

P. J: For example look at the patient enrollment demographics between contact MTS Ami for both conducted in metastatic castrate resistant prostate cancer. Both after having failed a first N H T and contact O two 100% of our patients.

We develop our inclusion and exclusion criteria again in discussions with health authorities and with KOLs to identify the most appropriate patient for our study. If an investigator felt his patient wasn't a candidate or her patient wasn't a candidate for second NHT, for example, as mentioned by Dr. Chi in his discussion at the GU ASCO symposium, high pain score, high volume of disease, we expect that patient would be treated outside this clinical trial.

Had measurable disease.

P. J: 31% and PSM for.

Amy Peterson: Approximately a quarter of our patients on Contact-02 received docetaxel in the metastatic setting versus 0 on PSMAfore. 25% of our patients in Contact-02 had liver disease versus less than 5% on PSMAfore. I'm going to even pull up some data on a meta-analysis conducted by Sumanta Pal and in collaboration with Dr. Small, who is the ASCO GU president, that did a meta-analysis of nine randomized Phase 3 studies looking at docetaxel as the comparator arm, so thousands of patients. When you look at the percent of patients in those randomized Phase 3 studies on chemotherapy that actually had liver metastases, 9%. Contact-02 had 25% patients with liver metastases.

P. J: Approximately a quarter of our patients on contact received docetaxel in the metastatic setting versus zero on <unk> for <unk>.

PJ: So take it away. Yeah, thanks for the question. You know, with regard to the subcute formulation, I think if there are more options for physicians and ultimately their patients, that's a positive thing. And if there's more convenience for the overall regimen of Cabo in combination with Novolumab for first-line RCC, that's certainly a good thing. It could provide momentum, but at the end of the day, you know, we'll have to wait and see how that plays out.

Andrew Peters: This is why we actually see heterogeneity in the patient demographics amongst contemporaneous studies conducted in similar settings. For example, look at the patient enrollment demographics between CONTACT and PSMAfore, both conducted in metastatic castrate-resistant prostate cancer, both after having failed a first NHT. In CONTACT-02, 100% of our patients had measurable disease, versus 31% in PSMAfore. Approximately 1/4 of our patients on CONTACT received DOCETAXEL in the metastatic setting versus 0 on PSMAfore. 25% of our patients in CONTACT had liver disease versus less than 5% on PSMAfore.

P. J: 25% of our patients in contact had liver disease.

P. J: It is less than 5% on PSM, four and I'm going to even pull up some data on a meta analysis conducted by citizens a lobby and in collaboration with Dr. Small who is the <unk> precedent.

P. J: That did a meta analysis of nine randomized phase three phase III studies looking at Docetaxel as the comparator arm.

P. J: Thousands of patients and when you look at the percent of patients in those randomized phase III studies on chemotherapy that actually had liver metastases.

PJ: With regard to the Pembro adjuvant data, certainly impressive data on overall survival, and I think, you know, the way I talked about this a bit before and the way we've thought about it is, you know, really impressive data, great for patients, obviously good to see an OS benefit for them there. With regard to impact in the metastatic first-line setting, the population that's eligible for adjuvant therapy among those who have nephrectomy is relatively small. So, you know, that said, there will be some impact over time in the first line setting, but it will take some time, we believe, to play out. Certainly for patients who are quickly recurring, either while on or shortly after the adjuvant treatment. What we've heard from physicians about KOLs is they'll think about them, you know, in a different fashion, which could provide incremental potential or, you know, another therapeutic option. Obviously, the main other one would be, you know, good news for patients. And, you know, I think it'll take time to play out in the first line, but certainly, you know, nothing but potential for copyright.

P. J: 9%.

P. J: Contact <unk> had 25% patients with liver metastases.

Andrew Peters: 25% of our patients in CONTACT had liver disease versus less than 5% on PSMAfore. And I'm going to even pull up some data on a meta-analysis conducted by Susan Pahlavi and in collaboration with Dr. Small, who is the ASCO-GU president, that did a meta-analysis of nine randomized phase three studies looking at docetaxel as the comparator arm. So thousands of patients. And when you look at the percent of patients in those randomized phase 3 studies on chemotherapy that actually had liver metastases, 9%. Contact O2 had 25% of patients with liver metastasis. All of these differences are due to the inclusion and exclusion criteria and situations where the treating physician and patient will look at either arm and say it is appropriate or neither is appropriate, and this is how we design ethical clinical trials in collaboration and agreement with health authorities steering committees, the PIs, and the patients that enroll. Subtitles by the Amara.org community. I'll pass it over to PJ now to address the commercial.

25% of our patients in CONTACT had liver disease versus less than 5% on PSMAfore.

Amy Peterson: All of these differences are due to the inclusion/exclusion criteria and situations where the treating physician and patient will look at either arm and say it is appropriate or neither is appropriate. And this is how we design ethical clinical trials in collaboration and agreement with health authorities, steering committees, the PIs, and the patients that enroll. I'll pass it over to PJ now to address the commercial landscape.

P. J: All of these differences are due to the inclusion exclusion criteria and situations, where the treating physician and patient we will look at either arm and say it is appropriate or neither is appropriate and this is how we design ethical clinical trials in.

And I'm going to even pull up some data on a meta-analysis conducted by Susan Halabi and in collaboration with Dr. Small, who is the ASCO-GU President, that did a meta-analysis of 9 randomized Phase III studies looking at DOCETAXEL as the comparator arm, so thousands of patients. And when you look at the percent of patients in those randomized Phase III studies on chemotherapy that actually had liver metastases, 9%. CONTACT-O2 had 25% of patients with liver metastasis. All of these differences are due to the inclusion and exclusion criteria and situations where the treating physician and patient will look at either arm and say it is appropriate or neither is appropriate, and this is how we design ethical clinical trials in collaboration and agreement with health authorities steering committees, the PIs, and the patients that enroll. Subtitles by the Amara.org community. I'll pass it over to PJ now to address the commercial.

P. J: <unk> and agreement with health authorities.

P. J: <unk> committees, the pis and the patients that enroll.

P. J: Pass it over to P. J now to address the commercial landscape great.

P.J. Haley: Great. Thanks, Amy. First of all, we're really excited about the data and presenting it. Metastatic castration-resistant prostate cancer is a really large opportunity with over 75,000 patients across lines of therapy. You know, this remains a significant unmet medical need for patients and for the physicians who treat them. The five-year overall survival rate for this population is still only 15%. So, you know, when we think about the options that exist for them, there's obviously NHT. And I would point out that, you know, approximately 50% of patients have already received NHT before they get to the first-line castration-resistant setting. Then beyond that, really, all you've got is radioligand therapy and chemo. And both of these therapies obviously have limitations.

P. J: Great. Thanks, Amy first of all we're really excited about the data and presenting it.

P. J: Metastatic castrate resistant prostate cancer is a really large opportunity.

All of these differences are due to the inclusion, exclusion criteria and situations where the treating physician and patient will look at either arm, and say it is appropriate or neither is appropriate. And this is how we design ethical clinical trials in collaboration and agreement with health authorities steering committees, the PIs, and the patients that enroll. I'll pass it over to P.J. now to address the commercial landscape.

P. J: With over 75000 patients across lines of therapy.

Speaker Change: This remains a significant unmet medical need.

P. J: For patients and for the physicians, who treat them the five year overall survival rate for this population is still only 15%.

P. J: So when we think about the options that exist for them, because obviously NH T.

P. J: I would point out that approximately 50% of patients who have already received NIH.

P. J: Before they get to the first line castrate resistant setting than beyond that really all you've got is radio ligand therapy or chemo. Both of these therapies, obviously have limitations, whether its RFP with regards to.

P.J. Haley: Great. Thanks, Amy. First of all, we're really excited about the data and presenting it. Metastatic castrate-resistant prostate cancer is a really large opportunity with over 75,000 patients across lines of therapy. This remains a significant unmet medical need for patients and for the physicians who treat them. The 5-year overall survival rate for this population is still only 15%.

P.J. Haley: You know, whether it's RLP with regards to logistics, you know, issues in terms of what that means for the patient, with regards to being around family, et cetera. And we've seen repeatedly in market research and in discussions with physicians that, you know, many patients and physicians want to either delay or not receive chemo. So that said, you know, we believe there's a significant place for this combination of cabozantinib-atezolizumab, should it be approved. Another thing I would point out here is that with only those two sort of classes of therapy available post-NHT, there's really a significant need and a great deal of excitement for new mechanisms of action in the CRPC setting.

PJ: Got it. Thank you so much. Yeah. Thank you. Will you stand by for our next question? Our next question comes from the line of Asthika Goonewardene with Truist. Your line is open.

P. J: Logistics.

P. J: Issues in terms of what that means for the patient.

P. J: With regards to being around family et cetera.

P. J: And we've seen repeatedly in market research and discussions with physicians that many patients and physicians want to either delay or not receive chemo.

Operator: Hey, guys, thanks for taking my question. And I appreciate you guys being super, super efficient today and giving one of the quickest prepared remarks that we've had in a long while. And I'd like to talk a little bit about contact O2, please. When you look at the subsequent therapy, there was a bit of an imbalance where patients on the control arm got more chemo than patients on the cargo arm. Maybe Amy and Michael just wanted to comment on that.

PJ: So, you know, when we think about the options that exist for them, there's obviously NHT, and I would point out that approximately 50% of patients have already received NHT before they get to the first-line castrate-resistant setting. And then beyond that, really all you've got is radioligand therapy and chemo. And both of these therapies obviously have limitations, whether it's RLP with regard to logistics issues in terms of what that means for the patient with regards to being around family, et cetera.

P. J: So that said, we believe theres a significant place for this combination of Cabo with tensor should it be prudent.

P. J: Another thing I would point out here is that with only those.

P. J: Sort of classes of therapy available post MH.

P. J: There's really significant need it a great deal of excitement for new mechanisms of action in the <unk> setting.

P.J. Haley: Obviously, this regimen has two, so a TKI as well as immunotherapy, and certainly, there's a lot of potential excitement for immunotherapy in prostate cancer. So we're excited about the opportunity. You know, when we think about the broader treating population of community oncology, these are physicians who are very comfortable, obviously, with checkpoint inhibitors as well as cabozantinib across the board. So we look forward to the potential in this space.

P. J: And obviously this regimen has too so it <unk> as well as immunotherapy and certainly.

P. J: There's a lot of potential excitement immunotherapy.

P. J: In prostate cancer. So we're excited about the opportunity.

PJ: And we've seen repeatedly in market research and in discussions with physicians that many patients and physicians want to either delay or not receive chemo. So that said, we believe there's a significant place for this combination of CABO/ATEZO should it be approved. Another thing I would point out here is that with only those two sort of classes of therapy available post-NHT, there's really a significant need and a great deal of excitement for new mechanisms of action in a CRPC setting. And obviously, this regimen has two, so it is a TKI as well as immunotherapy. And certainly, there's a lot of potential excitement for immunotherapy in prostate cancer, so we're excited about the opportunity. When we think about the broader treating population of community oncology, these are physicians who are very comfortable, obviously, with checkpoint inhibitors, as well as CABA's antidote across. We look forward to the potential. Great, thank you. You're welcome.

And we've seen repeatedly in market research and in discussions with physicians that many patients and physicians want to either delay or not receive chemo. So that said, we believe there's a significant place for this combination of CABO/ATEZO should it be approved.

P. J: When we think about the broader treating population of community oncology. These are physicians, who are very comfortable obviously with.

Amy: Now, we already saw that the codes separate, but how confident do you feel that this OS benefit will still carry forward despite this imbalance? And then can I relate to that? Can you maybe give us a little bit of color on when we could expect that next OS work on contact O2? Yeah, so, Asthika, I'll take those questions. There are a couple that are embedded in there.

P. J: Checkpoint inhibitors as well as cabozantinib across the board. So we look forward to the potential in this space.

Dana Aftab: Great. Thank you.

Chi Fong: Great. Thank you.

Speaker Change: Great. Thank you.

Another thing I would point out here is that with only those 2 sort of classes of therapy available post-NHT, there's really a significant need and a great deal of excitement for new mechanisms of action in CRPC setting. And obviously, this regimen has 2, so a TKI as well as immunotherapy, and certainly, there's a lot of potential excitement for immunotherapy in prostate cancer. So we're excited about the opportunity. When we think about the broader treating population of community oncology, these are physicians who are very comfortable, obviously, with checkpoint inhibitors, as well as CABOZANTINIB across the board. So we look forward to the potential in this space. Great, thank you. You're welcome.

Amy Peterson: You're welcome, Qi.

Speaker Change: Youre welcome Chee.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Gregory <unk> with RBC capital markets. Your line is open.

Gregory Renza: Hi, guys. It's Nishant for Greg. Congrats on the progress this quarter, and thanks for taking my questions. Just on the current patent litigation with MSN, I know you can't speak to the details of the case itself, but just thinking ahead on potential outcomes and the presence for Cabo's exclusivity, could you share how you're framing the best-case and worst-case outcomes of the MSN 2 case in relation to Cabo's exclusivity? And then just quickly on zanzalintinib, can we expect any updates on STELLAR-002 this year? Congrats again, and thanks so much.

Anish Nikhanj: Hi, guys. It's Nishant for Greg. Congrats on the progress this quarter, and thanks for taking my questions. Just on the current patent litigation with MSN, I know you can't speak to the details of the case itself, but just thinking ahead on potential outcomes and the presence for Cabo's exclusivity, could you share how you're framing the best-case and worst-case outcomes of the MSN 2 case in relation to Cabo's exclusivity? And then just quickly on zanzalintinib, can we expect any updates on STELLAR-002 this year? Congrats again, and thanks so much.

Gregory: Hi, guys. Its me shrunk for Greg Congrats on the progress this quarter and thanks for taking my questions. Just on the current patent litigation with MSN I know you can't speak to the details of the case itself, but just thinking ahead on potential outcomes in the presence for Cabos exclusivity could you share how you're framing the best case and worst case outcomes of the <unk>.

Amy: So, first, with regard to subsequent therapy. Remember what we showed at ASCO-GU. We had 19 percent of patients getting chemotherapy in the cabo-eczema arm compared to 28 percent getting chemotherapy in the second NHT arm. And this is important because one of the outcomes that we actually measured in terms of patient benefit was time to subsequent chemotherapy. And the time to subsequent chemotherapy was delayed with Cabo Atizo versus second NHT, which we actually believe to be a good thing, given especially what you heard from PJ, knowing what we know about the patients who get chemotherapy, who want chemotherapy, who are eligible to receive chemotherapy. It's about 30% of the patient population overall. And so delaying time to chemotherapy is not a bad thing. When we look at the OS and the confidence of the OS benefit, and what do we think we are going to see? I mean, I can't speculate on what we're going to see.

Gregory: In relation to Cabos exclusivity and then just quickly on <unk> can we expect any updates on stellar or two this year, congrats again and thanks so much.

Michael M. Morrissey: Yeah, thanks for the question. I'll take the anti-question and then pass it over to Amy. Yeah, so again, we're not talking about specifics relative to the trial for obvious reasons, and I really don't want to speculate on potential outcome scenarios and those kinds of things. You know, we're excited about the opportunity to move the company forward. We always do the right thing by patients and shareholders, and that will continue going forward. Amy?

Michael Morrissey: Yeah, thanks for the question. I'll take the anti-question and then pass it over to Amy. Yeah, so again, we're not talking about specifics relative to the trial for obvious reasons, and I really don't want to speculate on potential outcome scenarios and those kinds of things. You know, we're excited about the opportunity to move the company forward. We always do the right thing by patients and shareholders, and that will continue going forward. Amy?

Yes, thanks for the question I'll take the.

Gregory: And the question then pass it over to Amy.

Amy: Yeah. So again, we're not talking about specifics relative to the trial for obvious reasons and I really don't want to speculate on potential outcome scenarios and those kinds of things.

Great, thank you. You're welcome.

Chi Meng Fong: Great, thank you.

Amy Peterson: You're welcome, Chi.

PJ: Thank you. Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is open. Hi guys, it's Nishant on behalf of Greg.

Operator: Thank you. Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is open.

We're excited about the opportunity to move the company forward.

Amy: You always do the right thing by patients and shareholders and that will continue going forward.

Anish Nikhanj: Hi, guys. It's Anish on behalf of Greg. Congratulations on the progress this quarter, and thanks for taking my questions. Just on the current patent litigation with MSN, I know you can't speak to the details of the case itself, but just thinking ahead on potential outcomes in the presence for CABO's exclusivity, could you share how you're framing the best-case and worst-case outcomes of the MSN N-2 case in relation to CABO's exclusivity? And then just quickly on ZANZA, can we expect any updates on STELLAR-002 this year? Congratulations again, and thanks so much.

Amy Peterson: Sure. Thanks, Nish, for the question on STELLAR-002. So that is a multi-arm study. It is evaluating zanza in combination with IO, but not just monotherapy IO, like a PD-1, PD-L1, but it additionally bringing other agents to the table. So for example, CTLA-4 or LAG-3, many of the cohorts that we're enrolling are in earlier lines of therapy, and so it's going to take some time for the data to mature, but we are really looking forward to sharing that as it does mature. So stay tuned for what we might be able to show in 2024.

Operator: Congratulations on the progress this quarter and thanks for taking my questions. Just on the current patent litigation with MSN, I know you can't speak to the details of the case itself, but just thinking ahead on potential outcomes in the presence of Cabo's exclusivity, could you share how you're framing the best case and worst case outcomes of the MSN 2 case in relation to Cabo's exclusivity? And then just quickly on Zanza, can we expect any updates on Stellar 002 this year? Congratulations again, and thanks so much.

Speaker Change: Sure. Thanks. Thanks for the question on stellar 002, so that is a multi arm study that has it is it is evaluating zander in combination with I O, but not just monotherapy Io like a PD one PDL, one, but an additionally, bringing other agents to the table. So for example, <unk>.

Speaker Change: La four or leg three many of the cohorts that we're enrolling are in earlier lines of therapy, and so it's going to take some time for the data to mature, but we are really looking forward to sharing that as it does mature so stay tuned for what we might be able to show in 2024.

Michael M. Morrissey: Yes, thanks for the question. I'll take the ANDA question and then pass it over to Amy. Yes. So again, we're not talking about specifics relative to the trial for obvious reasons, and I really don't want to speculate on potential outcome scenarios and those kinds of things. You know, we're excited about the opportunity to move the company forward. We always do the right thing by patients and shareholders, and that will continue going forward. Amy?

Amy: However, what I can say is that at the time of the analysis that we did for the interim OS analysis, we did only 49% of the target number of events, and we conducted that analysis while we were still enrolling patients. So we conducted that analysis in 507 patients out of 575 that had yet to be enrolled. With that said, at this early analysis, we did see a trend that favors Cabo Atizo, i.e., there is no decrement to survival with a hazard ratio of 0.79 and medians of 14.6 for second NHT and 16.7 for Cabo Atizo, which is different from what we've seen with other studies conducted in this space that have reported their data contemporaneously with ours. Now, whether or not we will hit the final OS is unknown.

Gregory Renza: Thank you.

Anish Nikhanj: Thank you.

Amy Peterson: You're welcome.

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Jay Olson with Opco. Your line is open.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Jay Olson with Opco. Your line is open.

P.J. Haley: Hey, this is Chung on the line for Jay. Thanks for taking the question, and congrats on the progress. Also, thanks for the color on Contact-02. I have two questions actually regarding to some other data presented at ASCO GU and love to hear your thoughts. So first question, I'm curious about your thinking on the potential launch of a subq formulation of Opdivo, and if that actually may create some additional momentum to the uptake of Cabometyx compared to other regimens, given the pretty favorable data we saw with CheckMate-67T, and also potentially more attractive pricing with a subcu formulation, of course, the easier administration. Second question, just with KEYNOTE-564 now showing OS benefits in the adjuvant setting, how would you expect the impact on the market size and potential treatment paradigm in the advanced setting, moving forward?

Cheng Li: Hey, this is Chung on the line for Jay. Thanks for taking the question, and congrats on the progress. Also, thanks for the color on Contact-02. I have two questions actually regarding to some other data presented at ASCO GU and love to hear your thoughts. So first question, I'm curious about your thinking on the potential launch of a subq formulation of Opdivo, and if that actually may create some additional momentum to the uptake of Cabometyx compared to other regimens, given the pretty favorable data we saw with CheckMate-67T, and also potentially more attractive pricing with a subcu formulation, of course, the easier administration. Second question, just with KEYNOTE-564 now showing OS benefits in the adjuvant setting, how would you expect the impact on the market size and potential treatment paradigm in the advanced setting, moving forward?

Jay Olson: Hi, This is shown on the line for Jade. Thanks for taking the question and congrats on the progress.

Jay Olson: Thanks for the color on contact go too.

Jay Olson: I have two questions actually regarding to some other data presented to.

Amy Peterson: Sure. Thanks, Nish, for the question on STELLAR-002. So that is a multi-arm study that has--it is evaluating ZANZA in combination with IO, but not just monotherapy IO like PD-1, PD-L1, but additionally bringing other agents to the table. So, for example, CTLA-4 or LAG-3; many of the cohorts that we're enrolling are in earlier lines of therapy. And so it's going to take some time for the data to mature, but we are really looking forward to sharing that as it does mature. So stay tuned for what we might be able to show in 2024.

Jay Olson: And love to hear your thoughts. So first question I'm curious about your thinking on the potential launch opus sub Q formulation of Opdivo.

Jade: If that actually may create some additional momentum to the uptick up capital knievel compared to other regimens given the pretty favorable data. What you saw with checkmate 670, and also potentially more attractive pricing with the sub Q formulation that will of course.

Andrew Peters: Thank you. Our next question comes from the line of Jay Olson with OPCO. Your line is open. Hey, this is Chung on the line for today.

Operator: Thank you. Our next question comes from the line of Jay Olson with OPCO. Your line is open.

Jade: Administration.

Speaker Change: Second question.

Speaker Change: Thats it for now showing.

Hi, this is Cheng on the line for Jay. Thanks for taking the question and congrats on the progress. And also, thanks for the color on CONTACT-02. I have 2 questions actually regarding to some other data presented at ASCO GU and would love to hear your thoughts. So first question, I'm curious about your thinking on the potential launch of a Sub-Q formulation of OPDIVO and if that actually may create some additional momentum for the uptake of CABO/NIVO compared to other regimens given the pretty favorable data we saw with CHECKMATE 67T and also potentially more attractive pricing with the Sub-Q formulation, of course, the easier administration. And second question, just with Q&O 5-4 now showing OS benefits in the adj How would you expect the impact on the market size and potential treatment paradigm in the advanced setting moving forward? Thank you so much. Yeah, thanks for the question. I think PJ can handle both.

Cheng Li: Hi, this is Cheng on the line for Jay. Thanks for taking the question and congrats on the progress. And also, thanks for the color on CONTACT-02. I have 2 questions actually regarding to some other data presented at ASCO GU and would love to hear your thoughts. So first question, I'm curious about your thinking on the potential launch of a Sub-Q formulation of OPDIVO and if that actually may create some additional momentum for the uptake of CABO/NIVO compared to other regimens given the pretty favorable data we saw with CHECKMATE 67T and also potentially more attractive pricing with the Sub-Q formulation, of course, the easier administration. And second question, just with KEYNOTE-564 now showing OS benefit in the adjuvant setting, how would you expect the impact on the market size and potential treatment paradigm in advanced setting moving forward?

Speaker Change: Benefits in the adjuvant setting.

Operator: Thanks for taking the question and congrats on the progress. And also, thanks for the color on contact go to. I have two questions actually regarding some other data presented at ASCOGU and would love to hear your thoughts. So first question, I'm curious about your thinking on the potential launch of a step Q formulation of Opdivo and if that actually may create some additional momentum for the uptake of Cabonevo compared to other regimens given the pretty favorable data we saw with checkmate 67T and also potentially more attractive pricing with a step Q formulation, of course, the easier administration. And second question, just with Q&O 5-4 now showing OS benefits in the adj How would you expect the impact on the market size and potential treatment paradigm in the advanced setting moving forward? Thank you so much. Yeah, thanks for the question. I think PJ can handle both.

Speaker Change: How would you expect the impact on the market size and potential.

Speaker Change: Treatment paradigm.

Speaker Change: Setting moving forward. Thank you so much.

Amy: We're looking forward to hopefully seeing that data in 2024. What I'll say is that we did achieve the primary endpoint of radiographic regression-free survival. We believe what we demonstrated and showed at ASCO-GU is clinical benefit, and it's clinically meaningful. It was statistically significant. In the ITT population, it was significant across subgroups of patients. It was consistent no matter how we sliced or diced the analysis in the ITT population or whether or not we applied PCWG working group re-criteria to the analysis.

P.J. Haley: Thank you so much.

Cheng Li: Thank you so much.

Michael M. Morrissey: Yeah, thanks for the question. I think PJ can handle those both, so take it away.

Michael Morrissey: Yeah, thanks for the question. I think PJ can handle those both, so take it away.

Speaker Change: Yes. Thanks for the question I think P. J can handle those boats taken away. Yes. Thanks for the question with regards to the sub Q formulation I think if there is.

P.J. Haley: Yeah, thanks for the question. You know, with regards to the subcu formulation, I think if there's more options for physicians and ultimately their patients, that's a positive thing. And if there's more convenience for the overall regimen of CABO in combination with nivolumab for first-line RCC, that's certainly a good thing. It could provide momentum, but at the end of the day, you know, we'll have to wait and see how that plays out. With regards to the pembro adjuvant data, certainly impressive data in overall survival. And I think, you know, the way I talked about this a bit before and the way we've thought about it is, you know, really impressive data, great for patients. Obviously, good to see an OS benefit for them there.

P. J: More options for physicians.

And ultimately their patients that's a positive thing and if theres more convenience for the.

And second question, just with KEYNOTE-564 now showing OS benefit in the adjuvant setting, how would you expect the impact on the market size and potential treatment paradigm in advanced setting moving forward? Thank you so much.

P. J: The overall regimen of Cabo.

P. J: In combination with <unk> for first line RCC that that's certainly a good thing and could provide momentum but at the end of the day.

And second question, just with KEYNOTE-564 now showing OS benefits in the adjuvant setting. How would you expect the impact on the market size and potential treatment paradigm in the advanced setting moving forward? Thank you so much. Yeah, thanks for the question. I think PJ can handle both.

P. J: We will have to wait and see how that plays out.

P. J: With regards to the <unk> adjuvant data.

P. J: Certainly impressive data.

Yes. Thanks for the question. I think P.J. can handle those both. So take it away. Yeah, thanks for the question. You know, with regard to the subcute formulation, I think if there are more options for physicians and ultimately their patients, that's a positive thing. And if there's more convenience for the overall regimen of Cabo in combination with Novolumab for first-line RCC, that's certainly a good thing. It could provide momentum, but at the end of the day, you know, we'll have to wait and see how that plays out.

Michael Morrissey: Yes. Thanks for the question. I think P.J. can handle those both. So take it away.

P. J: Overall survival and I think the way I talked about this a bit before the way we thought about it is.

P.J. Haley: Yes. Thanks for the question. With regard to the Sub-Q formulation, I think if there are more options for physicians and ultimately their patients, that's a positive thing. And if there's more convenience for the overall regimen of CABO in combination with NIVOLUMAB for first-line RCC, that's certainly a good thing. It could provide momentum, but at the end of the day, we'll have to wait and see how that plays out.

P. J: Really impressive data great for patients obviously, good to see that benefit for them there.

Amy: And so we believe that regardless of what the final OS shows, there are reasons to support this novel TKI-IO combination for approval in all patients who meet the eligibility criteria for contact O2. So that's patients with visceral disease, extra-pelvic adenopathy, and we believe the risk-benefit profile is sufficient enough, and the totality of the risk-benefit profile is sufficient enough to have a conversation with the regulators and look to see whether or not we can actually proceed with an approval, knowing that our job is to bring options to patients. We focus on getting the drugs approved. The physicians focus on treating the patients with the right therapy that is approved.

P.J. Haley: With regards to impact in the metastatic first-line setting, it's the population that's eligible for adjuvant therapy among those getting nephrectomy is relatively small. So you know, that said, there will be some impact over time in the first-line setting, but it will take some time, we believe, to play out. Certainly for patients who are quickly recurring, either while on or shortly after the adjuvant treatment, what we've heard from physicians, from KOLs, is they'll think about them, you know, in a different fashion, which could provide incremental potential for, you know, another therapeutic option. Obviously, the main other one being TKI there. But you know, good news for patients.

With regards to impact in the in the metastatic first line setting.

P. J: The population that's eligible for adjuvant therapy, among those nephrectomy is relatively small.

P. J: So that said there.

P. J: There'll be some impact over time in the first line setting.

P. J: But it will take some time, we believed to play out.

PJ: With regards to the Pembro Adjuvant data, certainly impressive data on overall survival. And I think the way I talked about this a bit before and the way we've thought about it is really impressive data, great for patients. Obviously, good to see an OS benefit for them there. With regard to impact in the metastatic first-line setting... The population that's eligible for adjuvant therapy among those who have nephrectomy is relatively small.

Yes. Thanks for the question. I think P.J. can handle those both, so take it away. With regards to the Pembro Adjuvant data, certainly impressive data on overall survival. And I think the way I talked about this a bit before and the way we've thought about it is really impressive data, great for patients. Obviously, good to see an OS benefit for them there.

Michael M. Morrissey: Yes. Thanks for the question. I think P.J. can handle those both, so take it away.

P. J: Certainly for patients who are.

Yes. Thanks for the question. With regards to Sub-Q formulation, I think if there's more options for physicians and ultimately their patients, that's a positive thing. And if there's more convenience for the overall regimen of CABO in combination with NIVOLUMAB for first-line RCC, that's certainly a good thing. It could provide a momentum. But at the end of the day, we'll have to wait and see how that plays out. And With regards to the Pembro Adjuvant data, certainly impressive data on overall survival. And I think the way I talked about this a bit before and the way we've thought about it is really impressive data, great for patients. Obviously, good to see an OS benefit for them there.

P.J. Haley: Yes. Thanks for the question. With regards to Sub-Q formulation, I think if there's more options for physicians and ultimately their patients, that's a positive thing. And if there's more convenience for the overall regimen of CABO in combination with NIVOLUMAB for first-line RCC, that's certainly a good thing. It could provide a momentum. But at the end of the day, we'll have to wait and see how that plays out.

P. J: Quickly recurring either well honor shortly after the adjuvant treatment, what we've heard from physicians from Kols, who still.

With regards to the Pembro Adjuvant data, certainly impressive data In overall survival. And I think the way I talked about this a bit before and the way we've thought about it is really impressive data, great for patients. Obviously, good to see an OS benefit for them there.

P. J: Think about them.

P. J: In a different fashion, which could provide incremental potential.

P. J: Potential or.

With regards to impact in the metastatic first-line setting it's-- the population that's eligible for adjuvant therapy among those who have nephrectomy is relatively small. So, that said, there will be some impact over time in the first-line setting, but it will take some time, we believe, to play out. Certainly for patients who are quickly recurring, either while on or shortly after the adjuvant treatment, what we've heard from physicians from KOLs is they'll think about them in a different fashion, which could provide incremental potential or another therapeutic option, obviously, the main other one being TKI there. But good news for patients, and I think it'll take time to play out in the first-line, but certainly, nothing but potential for CABO.

P. J: Another therapeutic option, obviously the main other one teekay either but all good news for patients.

P.J. Haley: And, you know, I think it'll take time to play out in the first line, but certainly, you know, I think nothing but potential for CABO.

P. J: And I think it will take time to play out in the first line but.

PJ: So, you know, that said, there will be some impact over time in the first line setting, but it will take some time, we believe, to play out. Certainly for patients who are quickly recurring, either while on or shortly after the adjuvant treatment. What we've heard from physicians at KOLs is they'll think about them, you know, in a different fashion, which could provide incremental potential or, you know, another therapeutic option. Obviously, the main other one being TK, which is good news for patients. And, you know, I think it'll take time to play out in the first line, but certainly, you know, nothing but potential for copyright.

P. J: Certainly.

P. J: I think nothing but potential for Cabo.

Dana Aftab: Got it. Thank you so much.

Cheng Li: Got it. Thank you so much.

Speaker Change: Got it thank you so much.

Amy Peterson: Yeah. Thank you, Chung.

Speaker Change: Yes. Thank you Chang thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Atika Gumwardani with Truist. Your line is open.

Speaker Change: Please standby for our next question.

Ethical Go: Our next question comes from the line of Ethical Go award winning with Truth. Your line is open.

Amy: And I sort of mentioned that in my earlier comments when you look at the differing patient populations that exist even in studies conducted in the same space. The combination of Cabo Atizo is a novel potential treatment option for all those patients that meet the criteria for contact O2. It's not a study that moves an already approved agent into an earlier line. It's not a study that is testing a different radiolabeled PSMA-4 agent. It is not a different chemotherapy agent in a different line. It is not a different androgen access targeted agent.

Asthika Goonewardene: Hey, guys. Thanks for taking my question, and I appreciate you guys being super, super efficient today and being one of the quickest prepared remarks that we've had in a long while. I'd like to talk a little bit about Contact-02, please. When you looked at the subsequent therapy, there was a bit of an imbalance where patients on the control arm got more chemo than patients on the CABO arm. Maybe Amy and Mike, I just wanted you to comment on this. And we already saw the curves separate, but how confident do you feel that this OS benefit will still carry forward despite this imbalance?

Ethical Go: Hey, guys. Thanks for taking my question.

Ethical Go: Appreciate you guys being super Super efficient and being one of the quickest.

Ethical Go: <unk> remarks that we've had in a long while.

Ethical Go: I'd like to talk a little bit about contact those two please.

Ethical Go: When you look at the subsequent therapy that was a bit of an imbalance.

PJ: Got it. Thank you so much. Yeah, thank you. Thank you. Will you stand by for our next question? Our next question comes from the line of Asthika Goonewardene with Truist. Your line is open.

Cheng Li: Got it. Thank you so much.

Ethical Go: We have patients on the control arm.

Operator: Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is open.

Ethical Go: More chemo Ben.

Ethical Go: Patients on the on the travel.

Speaker Change: Maybe Amy and Michael just wondering if you could comment on this and we already saw that.

Asthika Goonewardene: Hi guys, thanks for taking my question, and I appreciate you guys being super, super efficient today, and being one of the quickest prepared remarks that we've had in a long while. I'd like to talk a little bit about CONTACT-O2, please. When you look at the subsequent therapy, there was a bit of an imbalance where patients on the control arm got more chemo than patients on the CABO arm. Maybe, Amy and Michael, just wondered if you could comment on this?

Speaker Change: <unk> separate but how confident do you feel that.

Speaker Change: This.

Speaker Change: OS benefit will still carryforward. Despite this imbalance.

Amy: Cabo Atizo is the first TKI-IO combination to demonstrate positive results, representing a unique treatment option for patients, and we believe that it is our imperative to bring it to these patients. Not only do we believe this, but many of the KOLs that we interacted with at GU-ASCO believe this, and the patient advocacy groups that we interacted with believe this. Patients want alternative treatment options. And approval doesn't mean that everyone is now going to be treated with the therapy. However, if the therapy is not approved, no one, not even those who seem to benefit most from this combination, will be able to receive it. Thanks, Amy. That is really helpful. And also, my congratulations on this data and for your restraint from not getting up and saying something to Dr. G during his podium comments. Maybe I can squeeze one more in.

Asthika Goonewardene: And then, related to that, can you maybe give us a little bit of color on when we could expect that next OS look on Contact-02?

Speaker Change: And then can I related to that can you maybe give us a little bit of color on when we could expect that Mexico Westwood can contact them too.

Amy Peterson: Yeah. So, Ashik, I'll take those questions. There are a couple that are embedded in there. So first, with regard to subsequent therapy, remember what we showed at ASCO GU. We had 19% of patients getting chemotherapy in the CABO-atezo arm, compared to 28% getting chemotherapy in the second NHT arm. And this is important because one of the outcomes that we actually measured in terms of patient benefit was time to subsequent chemotherapy, and the time to subsequent chemotherapy was delayed with CABO-atezo versus second NHT, which we actually believe to be a good thing, given especially what you heard from PJ. Knowing what we know about the patients who get chemotherapy, who want chemotherapy, who are eligible to receive chemotherapy, it's about 30% of the patient population overall.

Speaker Change: Yeah. So.

Speaker Change: I'll take those questions. There are a couple that are.

Speaker Change: Embedded in there so first with regard to subsequent therapy.

Andrew Peters: Now, we already saw that the curves separate, but how confident do you feel that this OS benefit will still carry forward despite this imbalance? And then can I relate to that? Can you maybe give us a little bit of color on when we could expect that next OS work on contact O2? Yeah, so, Asthika, I'll take those questions. There are a couple that are embedded in there.

We already saw that the curves separate, but how confident do you feel that this OS benefit will still carry forward despite this imbalance? And then can I-- related to that, can you maybe give us a little bit of color on when we could expect that next OS work on CONTACT-O2?

Speaker Change: Remember, what we showed at <unk>, we had 19% of patients getting chemotherapy and the Cabo arm compared to 28% getting chemotherapy in the second NH TR.

Speaker Change: And this is important because one of the outcomes that we actually measured in terms of patient benefit was time to subsequent chemotherapy and the time to subsequent chemotherapy was delayed with Cabo at T, though versus second and Ht, which we actually believe too.

Yes. So Asthika, I'll take those questions. There are a couple that are embedded in there. So first, with regard to subsequent therapy, remember what we showed at ASCO-GU; we had 19% of patients getting chemotherapy in the CABO/ATEZO arm, compared to 28% getting chemotherapy in the second NHT arm. And this is important because one of the outcomes that we actually measured in terms of patient benefit was time to subsequent chemotherapy. And the time to subsequent chemotherapy was delayed with CABO/ATEZO versus second NHT, which we actually believe is a good thing, given especially what you heard from P.J. knowing what we know about the patients who get chemotherapy, who want chemotherapy, who are eligible to receive chemotherapy, it's about 30% of the patient population overall. And so delaying time to chemotherapy is not a bad thing. When we look at the OS and the confidence of OS benefit and what we think we are going to see, I mean, I can't speculate on what we're going to see

Amy Peterson: Yes. So Asthika, I'll take those questions. There are a couple that are embedded in there. So first, with regard to subsequent therapy, remember what we showed at ASCO-GU; we had 19% of patients getting chemotherapy in the CABO/ATEZO arm, compared to 28% getting chemotherapy in the second NHT arm. And this is important because one of the outcomes that we actually measured in terms of patient benefit was time to subsequent chemotherapy. And the time to subsequent chemotherapy was delayed with CABO/ATEZO versus second NHT, which we actually believe is a good thing, given especially what you heard from P.J. knowing what we know about the patients who get chemotherapy, who want chemotherapy, who are eligible to receive chemotherapy, it's about 30% of the patient population overall. And so delaying time to chemotherapy is not a bad thing.

Andrew Peters: So first, with regard to subsequent therapy, remember what we showed at ASCO-GU; we had 19% of patients getting chemotherapy in the CABO-ACESO arm, compared to 28% getting chemotherapy in the second NHT arm. And this is important because one of the outcomes that we actually measured in terms of patient benefit was time to subsequent chemotherapy. And the time to subsequent chemotherapy was delayed with Cabo Atizo versus second NHT, which we actually believe is a good thing, given especially what you heard from PJ, knowing what we know about the patients who get chemotherapy, who want chemotherapy, who are eligible to receive chemotherapy. It's about 30% of the patient population overall. And so delaying time to chemotherapy is not a bad thing. When we look at the OS and the confidence of OS benefit and what we think we are going to see, I mean, I can't speculate on what we're going to see.

Speaker Change: A good thing given especially what you heard from P. J, knowing what we know about the patients who get chemotherapy, who want chemotherapy, who are eligible to receive chemotherapy, it's about 30% of the patient population overall.

Amy: There was a previous question on OO2. Can you please, I know it's stay tuned for updates. Could you maybe give us a little color and tell us which of the cohorts have completed recruitment? So I'm not able to give that to you at this point in time. Again, we have multiple cohorts, and just because they've completed treatment doesn't necessarily mean that they are the first to read out. Remember, we have to follow for the duration of therapy. We have to follow for progression-free survival. And we have to follow for OS. And even if the cohort is completed, it doesn't mean that we will have data in the coming months. I got it.

Amy Peterson: So delaying time to chemotherapy is not a bad thing. When we look at the OS and the confidence of OS benefit, and what do we think we are going to see, I mean, I can't speculate on what we're going to see. However, what I can say is that at the time of the analysis that we did for the interim OS analysis, we did only 49% of the target number of events, and we conducted that analysis while we were still enrolling the study. So we conducted that analysis in 507 patients of 575 that had yet to be enrolled.

Speaker Change: And so delaying time to chemotherapy.

Speaker Change: Not a bad thing when we look at that.

Speaker Change: Oh absolute confidence.

Speaker Change: OS benefit and what do we think we are going to see I mean, I I can't speculate on what we're going to see however, what I can say is that at the time of the analysis that we did at the end.

When we look at the OS and the confidence of OS benefit and what we think we are going to see, I mean, I can't speculate on what we're going to see, however, what I can say is that at the time of the analysis that we did for the interim OS analysis, we did only 49% of the target number of events, and we conducted that analysis while we were still enrolling the study. So we conducted that analysis in 507 patients out of 575 that had yet to be enrolled. With that said, at this early analysis, we did see a trend that favors CABO/ATEZO, i.e., there is no decrement to survival with a hazard ratio of 0.79 and medians of 14.6 for second NHT and 16.7 for CABO/ ATEZO, which is different from what we've seen with other studies conducted in this space that have reported their data contemporaneously with ours. Now, whether or not we will hit the final OS is unknown.

Andrew Peters: However, what I can say is that at the time of the analysis that we did for the interim OS analysis, we did only 49% of the target number of events, and we conducted that analysis while we were still enrolling patients. So we conducted that analysis in 507 patients out of 575 that had yet to be enrolled. With that said, at this early analysis, we did see a trend that favors Cabo Atizo, i.e., there is no decrement to survival with a hazard ratio of 0.79 and medians of 14.6 for second NHT and 16.7 for Cabo Atizo, which is different from what we've seen with other studies conducted in this space that have reported their data contemporaneously with ours. Now, whether or not we will hit the final OS is unknown.

Speaker Change: OS analysis, we did only 49% of the target number although that.

Speaker Change: And we conducted that analysis why we while we were still enrolling the study. So we conducted that analysis and 507 patients.

Speaker Change: 575 that had yet to be involved.

Amy Peterson: With that said, at this early analysis, we did see a trend that favors CABO-atezo, i.e., there is no decrement to survival, with a hazard ratio of 0.79 and medians of 14.6 for second NHT and 16.7 for CABO-atezo. Which is different from what we've seen with other studies conducted in this space that have reported their data in contemporaneously with ours. Now, whether or not we will hit final OS is unknown. We're looking forward to hopefully seeing that data in 2024. What I'll say is that we did achieve the primary endpoint of radiographic progression-free survival. We believe what we demonstrated and showed at ASCO GU is clinical benefit, and it's clinically meaningful. It was statistically significant in the ITT population. It was significant across subgroups of patients. It was consistent...

Speaker Change: With that said at this early analysis, we did see a trend that favors Pablo Piso I E. There is no decrement to survival with a hazard ratio of 0.79 and medians of $14 six per second NH T and 16, 7% for Cabo a T cell.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Andy Hsieh with Will Blair. Your line is open.

Operator: Thank you. Thank you. Thank you. Great.

Speaker Change: Which.

Speaker Change: It is different from what we've seen with other studies conducted in this space that have reported their data in contemporaneously with ours.

Operator: Thanks for taking our questions and congratulations on achievements, both in the clinical and financial fronts. Also, it's really nice to see Cabo's profound activity in the ventral metastasis subgroup and inside, again, in the prostate cancer space. I want to ask specifically about the PFS delta.

Now, whether or not we will hit the final OS is unknown. We're looking forward to hopefully seeing that data in 2024. What I'll say is that we did achieve the primary endpoint of radiographic progression-free survival. We believe what we demonstrated and showed at ASCO-GU is clinical benefit, and it's clinically meaningful. It was statistically significant in the ITT population, it was significant across subgroups of patients. It was consistent no matter how we sliced or diced the analysis in the ITT population, or whether or not we applied PCWG Working Group 3 criteria to the analysis.

Speaker Change: Now whether or not we will hit final OS.

Andrew Peters: We're looking forward to hopefully seeing that data in 2024. What I'll say is that we did achieve the primary endpoint of radiographic regression-free survival. We believe what we demonstrated and showed at ASCO-GU is clinical benefit, and it's clinically meaningful. It was statistically significant.

Speaker Change: It's unknown, where we're looking to we're looking forward to hopefully seeing that data in 2024, what I'll say is that we did achieve the primary endpoint of radiographic progression free survival. We believe what we demonstrated in showed at <unk> is clinical.

Amy: That was discussed during the discussion at ASCO-GU coinciding with the scanning interval. I'm just curious, have you done or planning to conduct analysis to rule that scenario out? And separately, regarding the Arthas collaboration, combining Xanza with HIP-2, looking at the previous Cabo plus Belzut-Xan combination, it appears that Cabo is doing most of the heavy lifting on the efficacy front. So do you expect differentiation from this novel combination? Okay, so can I just get a clarification on the question regarding the PFS rule out scenarios. I heard a couple in there, so Cabo in the subgroups or, sorry Cabo from, comment in the subgroups and the data that we showed at ASCO and subgroups. The PFS rule out scenarios, were you talking about the censoring? Can you repeat that question?

Benefit and it's clinically meaningful it was statistically significant.

Andrew Peters: In the ITT population, it was significant across subgroups of patients; it was consistent no matter how we sliced or diced the analysis in the ITT population or whether or not we applied PCWG working group re-criteria to the analysis. And so, regardless of what the final OS shows, there are reasons to support this novel TKI-IO combination for approval in all patients who met the eligibility criteria for contact O2. So that's patients with visceral disease, extrapelvic adenopathy, and we believe the risk-benefit profile is sufficient enough, and the totality of the risk-benefit profile is sufficient enough to have a conversation with the regulators and look to see whether or not we can actually proceed with an approval. It's important to know that our job is to bring options to patients. We focus on getting the drugs approved, and physicians focus on treating the patients with the right therapy that is approved.

In the ITT population, it was significant across subgroups of patients; it was consistent no matter how we sliced or diced the analysis in the ITT population or whether or not we applied PCWG working group re-criteria to the analysis.

Speaker Change: In the ITT population it was significant across subgroups of patients. It was consistent no matter, how we slice or dice. The analysis in the ITT population or whether or not we applied PC WG working group Rede criteria to the analysis.

Amy Peterson: No matter how we sliced or diced the analysis in the ITT population, or whether or not we applied PCWG working group criteria to the analysis. So we believe that regardless of what the final OS shows, there's reasons to support this novel TKI/IO combination for an approval in all patients who met the eligibility criteria for Contact-02. That's patients with visceral disease, extra pelvic adenopathy, and we believe the risk-benefit profile is sufficient enough, and the totality of the risk-benefit profile is sufficient enough to have a conversation with the regulators and look to see whether or not we can actually proceed with an approval. It's important to know that our job is to bring options to patients. We focus on getting the drugs approved.

And so we believe that regardless of what the final OS shows, there are reasons to support this novel TKI-IO combination for approval in all patients who met the eligibility criteria for CONTACT-02. So that's patients with visceral disease, extrapelvic adenopathy, and we believe the risk-benefit profile is sufficient enough, and the totality of the risk-benefit profile is sufficient enough to have a conversation with the regulators and look to see whether or not we can actually proceed with an approval. It's important to know that our job is to bring options to patients. We focus on getting the drugs approved. The physicians focus on treating the patients with the right therapy that is approved.

Now whether or not we will hit final OS is unknown. We're looking to-- we're looking forward to hopefully seeing that data in 2024. What I'll say is that we did achieve the primary end point of radiographic progression-free survival. We believe what we demonstrated and showed at ASCO GU is clinical benefit, an it's clinically meaningful. It was statistically significant in the ITT population.It was significant across subgroups of patients. It was consistent no matter how we sliced or diced the analysis in the ITT population or whether or not we apply PCWG Working Group 3 criteria to the analysis. so we believe that regardless of what the final OS shows, there are reasons to support this novel TKI-IO combination for approval in all patients who met the eligibility criteria for CONTACT-02. So that's patients with visceral disease, extrapelvic adenopathy, and we believe the risk-benefit profile is sufficient enough, and the totality of the risk-benefit profile is sufficient enough to have a conversation with the regulators and look to see whether or not we can actually proceed with an approval.

Speaker Change: And so we believe that regardless of what the final OS shows.

Speaker Change: There is reasons to support this novel Teekay I Io combination for an approval in all patients who met the eligibility criteria for contact <unk>, so that patients with visceral disease extra pao that adenopathy.

Speaker Change: And we believe the risk benefit profile is sufficient enough and the totality of the risk benefit profile is sufficient enough to have a conversation with the regulators and look to see whether or not we can actually proceed with an approval it's important.

Amy: Yeah, yeah, certainly. Yeah, yes. If you want to comment on the censoring, yeah, we have questions on that too. But I guess my question was specifically about the PFS delta, right? So between the experimental arm and the control arm, really close to the scanning interval of nine weeks. And that was kind of brought up, you know, during the discussion. And I'm just curious about, you know, if you can rule that out, basically, the delta of the PFS could potentially be an artifact at the scanning interval.

It's important to know that our job is to bring options to patients. We focus on getting the drugs approved. The physicians focus on treating the patients with the right therapy that is approved. And I sort of mentioned that in my earlier comments when you look at the different patient populations that exist even in studies conducted in the same space. The combination of CABO/ATEZO is a novel potential treatment option that could meet all those patients that met the criteria for contact O2. It's not a study that moves an already approved agent into an earlier line. It's not a study that is testing a different radio-labelled PSMA-4 agent.

Speaker Change: To know that.

Speaker Change: But our job is to bring option to.

Speaker Change: Two patients.

Speaker Change: We focus on getting the drugs approved but physicians focus on treating the patient with the right therapy that is approved and I sort of mentioned that in my earlier comments. When you look at the different patient populations that exist even in studies conducted in the same space.

Amy Peterson: The physicians focus on treating the patients with the right therapy that is approved, and I sort of mentioned that in my earlier comments when you look at the differing patient populations that exist, even in studies conducted in the same space. The combination of CABOMETYX; it's a novel potential treatment options that meet for all those patients that met the criteria for Contact-02. It's not a study that moves an already approved agent into an earlier line. It is not a different radiolabeled PSMA-4 agent. It is not a different chemotherapy agent in a different line. It is not a different androgen axis-targeted agent. CABOMETYX is the first TKI/IO combination to demonstrate positive results, representing a unique treatment option for patients, and we believe that it is our imperative to bring it to these patients.

Andrew Peters: And I sort of mentioned that in my earlier comments when you look at the differing patient populations that exist even in studies conducted in the same space. The combination of Cabo Atizo is a novel potential treatment option that could meet all those patients that met the criteria for contact O2. It's not a study that moves an already approved agent into an earlier line. It's not a study that is testing a different radio-labelled PSMA-4 agent.

The combination of CABO/ATEZO is a novel potential treatment option that meet-- for all those patients that met the criteria for CONTACT-O2. It's not a study that moves an already approved agent into an earlier line. It's not a study that is testing a different radio-labeled PSMA-fore agent. It is not a different chemotherapy agent in a different line. It is not a different androgen access targeted agent.

Speaker Change: The combination of Cabo to you, though it's a novel potential treatment options that neat.

Speaker Change: For all those patients that met the criteria.

Speaker Change: Our contact out too it's not a study that moves an already approved agent into an earlier line not a study that is testing a different radio labeled semi for agent. It is not a different chemotherapy agent in a different line. It is not a different androgen access targeted agent.

Andrew Peters: It is not a different chemotherapy agent in a different line. It is not a different androgen access targeted agent. Cabo Atizo is the first TKI-IO combination to demonstrate positive results representing a unique treatment option for patients, and we believe that it is our imperative to bring it to these patients. Not only do we believe this, but many of the KOLs that we interacted with at GU-ASCO believe this, and the patient advocacy groups that we interacted with believe this. Patients want alternative treatment options, and approval doesn't mean that everyone is now going to be treated with the therapy. However, if the therapy is not approved, no one, not even those who seem to benefit most from this combination, will be able to receive it. Thanks, Amy. That is really helpful.

It is not a different chemotherapy agent in a different line. It is not a different androgen access targeted agent.

Amy: Okay, now I understand your question much better. Thank you. Thank you. So with regard to the PFS delta, one thing: take a step back, and we do look at many parameters of clinical benefit, not just an improvement at a single point in time. In general, the optimal way to view the treatment effect is really based on the hazard ratio, which looks at the difference between the experimental and control arms across the entire PFS analysis, not at one point estimate, i.e.

CABO/ATEZO is the first TKI-IO combination to demonstrate positive results representing a unique treatment option for patients, and we believe that it is our imperative to bring it to these patients. Not only do we believe this, but many of the KOLs that we interacted with at GU-ASCO believe this, and the patient advocacy groups that we interacted with believe this. Patients want alternative treatment options, and approval doesn't mean that everyone is now going to be treated with the therapy. However, if the therapy is not approved, no one, not even those who seem to benefit most from this combination, will be able to receive it. Thanks, Amy. That is really helpful.

Speaker Change: <unk> is the first TK I O combination to demonstrate positive results, representing a unique treatment option for patients.

Speaker Change: And we believe that it is our imperative to bring it to these patients not only do we believe this but many of the kols that we interacted with at <unk> believe this and the patient advocacy groups that we interacted with believe that patients want alternative treatment options.

Amy Peterson: Not only do we believe this, but many of the KOLs that we interacted with at GU ASCO believe this, and the patient advocacy groups that we interacted with believe this. Patients want alternative treatment options, and approval doesn't mean that everyone is now going to be treated with the therapy. However, if the therapy is not approved, no one, not even those who seem to benefit most from this combination, will be able to receive it.

Speaker Change: And approval doesn't mean that everyone is now going to be treated with the therapy. However, if the therapy is not approved no one not even those who seem to benefit most from this combination will be able to receive it.

Amy: The median here that you're referring to. There are multiple examples of no benefit at the median, but a positive hazard ratio resulting in approval going all the way back to ipilimumab in melanoma and really, most recently, felzutafan in RCC, where the curves separate after the median, yet clinical benefit was identified, and the drugs have been approved. Going into what we have observed in our study, we have very robust PFS findings seen across all subgroups, similar in the IPT population, and according to the PCWG working group criteria. We believe that these are clinically meaningful PFS benefits, especially in this patient population in contact, which represents overall a worse prognosis than other studies conducted in this space. We have a lot of this; one hundred percent of patients had measurable disease, and 40% had visceral disease.

Asthika Goonewardene: Thanks, Amy. That is really helpful. And also, my congratulations on this data. And we have restraint from not getting up and saying something to Dr. Chi at this podium comment. Maybe if I could squeeze one more in. There was a previous question on OO2. Can you-- I know it's stay tuned for updates. Could you maybe give us a little color and tell us which of the cohorts have completed recruitment?

Asthika Goonewardene: Thanks, Amy. That is really helpful. And also, my congratulations on this data and for your restraint from not getting up and saying something to Dr. Chi at his podium comments. Maybe if I could squeeze one more in. Can we... There was a previous question on 002. Can you, I know it's stay tuned for updates. Could you maybe give us a little color and tell us which of the cohorts have completed recruitment?

Speaker Change: Thanks, Amy that is really helpful. And also my congratulations on this data and we have a strength from not getting up and saying something deducted yes.

Andrew Peters: And also, my congratulations on this data. And we have restraint from not getting up and saying something to Dr. G at this podium comment. Maybe if I could squeeze one more in.

Speaker Change: Protium comments.

Speaker Change: Maybe if I can squeeze one more in.

Andrew Peters: There was a previous question on OO2. Can you please, I know it's stay tuned for updates. Could you maybe give us a little color and tell us which of the cohorts have completed recruitment? So I'm not able to give that to you at this point in time. Again, we have multiple cohorts, and just because they've completed treatment doesn't necessarily mean that they are the first to read out. Remember, we have to follow for the duration of therapy. We have to follow for progression-free survival. And we have to follow for OS. And even if the cohort is completed, it doesn't mean that we will have data in the coming months. I got it.

There was a previous question on OO2. Can you please, I know it's stay tuned for updates. Could you maybe give us a little color and tell us which of the cohorts have completed recruitment?

Speaker Change: There was a previous question on <unk> can you I know.

Speaker Change: Stay tuned for updates could you maybe give us a little color and tell us.

Speaker Change: Which of the cohorts have completed recruitment.

So I'm not able to give that to you at this point in time. Again, we have multiple cohorts, and just because they've completed treatment doesn't necessarily mean that they are the first to read out. Remember, we have to follow for the duration of therapy. We have to follow for progression-free survival. And we have to follow for OS. And even if the cohort is completed, it doesn't mean that we will have data in the coming months. I got it.

Amy Peterson: So I'm not able to give that to you at this point in time. Again, we have multiple cohorts, and just because they've completed treatment doesn't necessarily mean that they are the first to read out. Remember, we have to follow for duration of therapy. We have to follow for progression-free survival. And we have to follow for OS. And even if the cohort is completed, it doesn't mean that we will have data in the coming months.

Amy Peterson: I'm not able to give that to you at this point in time. Again, we have multiple cohorts, and just because they've completed treatment doesn't necessarily mean that they are the first to read out. Remember, we have to follow for duration of therapy. We have to follow for progression-free survival, and we have to follow for OS. Even if the cohort is completed, it doesn't mean that we will have data in the coming months.

Protium: So I'm not able to give that to you at this point in time again, we have multiple cohorts and just because they've completed treatment doesn't necessarily mean that they are the first to read out remember we have to follow for duration of therapy, we have to follow for progression free.

Protium: Viable and we have to follow for our apps and even if the cohort is completed it doesn't mean that we will have data in the coming months.

Asthika Goonewardene: Got it. Okay, well, I'll stay tuned. Thanks so much for taking my questions.

Asthika Goonewardene: Got it. Okay, well, I'll stay tuned. Thanks so much for taking my questions, guys.

Andrew Peters: Okay, well, I'll stay tuned. Thanks so much for taking my questions, guys. The Bulletproof Executive 2013, Thank you.

Okay, well, I'll stay tuned. Thanks so much for taking my questions, guys. The Bulletproof Executive 2013, Thank

Speaker Change: Got it okay, well I will stay tuned thanks, so much for taking my questions guys.

Amy Peterson: You bet, Asad.

Speaker Change: You bet. Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Andy Shay with William Blair. Your line is open.

Operator: Please stand by for our next question. Our next question comes from the line of Andy Hsieh with Will Blair. Your line is open. Thank you. Thank you. Thank you.

Thank you. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open. Thank you. Thank you. Thank you.

Operator: Thank you. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Andy Shay with William Blair. Your line is open.

Amy: In the ITP, a hazard ratio of 0.65 translates to a 50% improvement over the control arm, which is exactly what we saw at the median, 4.2 versus 6.3 months. In the liver met subgroup, the hazard ratio of 0.43 translates to a more than doubled improvement over the control arm. And, in fact, at the median, we observed a trebling of the effect from 2.1 to 6.2 months

Thanks for taking our questions and congratulations on achievements, both in the clinical and financial fronts. Also, it's really nice to see CABO's profound activity in the visceral metastases subgroup and the side, again, in the prostate cancer space. I want to ask specifically about the PFS delta. It was discussed during the discussion at ASCO-GU coinciding with the scanning interval. I'm just curious, have you done or are planning to conduct analysis to roll that scenario out? Um, and separately, regarding the Arthas collaboration, combining Zanza with HIP-2, uh, looking at previous Cabo plus Belzucca band combination, it appears that Cabo is doing most of the heavy lifting on the efficacy front. So, do you expect, um, differentiation from this novel combination? Thank you. Okay, so can I just get a clarification on the question with regard to, I heard a couple in there, so Cabo in the subgroups, sorry, Cabo from, Comment in the subgroups, and the data that we showed at ASCO and subgroups. The PFS rule-out scenarios: were you talking about censoring? Can you repeat that question?

Tsan-Yu Hsieh: Thanks for taking our questions and congratulations on achievements, both in the clinical and financial fronts. Also, it's really nice to see CABO's profound activity in the visceral metastases subgroup and the side, again, in the prostate cancer space. I want to ask specifically about the PFS delta. It was discussed during the discussion at ASCO-GU coinciding with the scanning interval. I'm just curious, have you done or are planning to conduct analysis to roll that scenario out? And Separately, regarding to Arcus collaboration, combining ZANZA with HIF-2. Looking at previous CABO plus BELZUTIFAN combination, it appears that CABO is doing most of the heavy lifting on the efficacy front. So do you expect differentiation from this novel combination?

Andy Hsieh: Great, thanks for taking our questions, and congratulations on achievements both in the clinical and financial fronts. Also, really nice to see CABO's profound activity in the visceral metastases, you know, subgroup and again, in the prostate cancer space. I want to ask specifically about the PFS delta that was discussed during the discussion at ASCO GU, coinciding with the scanning interval. I'm just curious: have you done or planning to conduct analysis to rule that scenario out? And separately, regarding the Arcus collaboration, combining Xofigo with the HIF-2α, looking at previous CABO plus belzutifan combination, it appears that CABO is doing most of the heavy lifting on the efficacy front. So do you expect differentiation from this novel combination? Thank you.

Andy Shay: Great. Thanks for taking our questions and congratulations on achieving both in the clinical and financial fronts.

Andy Shay: Also really nice to see cabos profound activity in the visceral metastases.

Andy Shay: Subgroup and inside began in the prostate cancer space.

Andy Shay: I wanted to ask specifically about the PFS Delta.

And Separately, regarding to Arcus collaboration, combining ZANZA with HIF-2. Looking at previous CABO plus BELZUTIFAN combination, it appears that CABO is doing most of the heavy lifting on the efficacy front. So do you expect differentiation from this novel combination?

Operator: I was discussed during the discussion at ASCO-GU coinciding with the scanning interval. I'm just curious, have you done or are planning to conduct analysis to rule that scenario out? Um, and separately, regarding the Arthas collaboration, combining Zanza with HIP-2, uh, looking at previous Cabo plus Belzucca band combination, it appears that Cabo is doing most of the heavy lifting on the efficacy front. So, do you expect, um, differentiation from this novel combination? Thank you. Okay, so can I just get a clarification on the question with regard to, I heard a couple in there, so Cabo in the subgroups, sorry, Cabo from, Comment in the subgroups, and the data that we showed at ASCO and subgroups. The PFS rule-out scenarios: were you talking about censoring? Can you repeat that question?

Andy Shay: I was discussed during the discussion of <unk>, coinciding with the standing interval and I'm. Just curious have you done or are planning to conduct the analysis to rule that scenario out.

Amy: In the patients with prior doses of Taxol, the hazard ratio was 0.57, which translates to a 75% improvement over the control arm, and in that median, we saw a doubling of median PFS from 4.1 to 8.8 months. So, this is part of the totality of data, but it is not all of the totality of data. And in contact O2, we have to also consider the patients that were enrolled and how they are unique and distinct from other studies that have evaluated drugs against second NHT. We have to consider the unmet need that is existent in this space and other important outcomes that we looked at. For example, I mentioned time to chemotherapy. We delayed time to chemotherapy with Cabo Atizo. We actually found that Cabo Atizo resulted in an increase in time to symptomatic skeletal events.

Um, and separately, regarding the Arthas collaboration, combining Zanza with HIP-2, uh, looking at previous Cabo plus Belzucca band combination, it appears that Cabo is doing most of the heavy lifting on the efficacy front. So, do you expect, um, differentiation from this novel combination? Thank you. Okay, so can I just get a clarification on the question with regard to, I heard a couple in there, so Cabo in the subgroups, sorry, Cabo from, Comment in the subgroups, and the data that we showed at ASCO and subgroups. The PFS rule-out scenarios: were you talking about censoring? Can you repeat that question?

Andy Shay:

Andy Shay: And then separately regarding the RFS collaboration combining the handset with the hip too.

Andy Shay: Looking at previous causal plus <unk> combination it appears that.

Andy Shay: Cabo is doing most of the heavy lifting on the efficacy front. So do you expect differentiation from this novel combination. Thank you.

Amy Peterson: Okay. So can I just get a clarification on the question with regard... I heard a couple in there. So CABO in the subgroups, or sorry, CABO plus Cabometyx in the subgroups and the data that we showed at ASCO in subgroups. The PFS rule-out scenarios, were you talking about the censoring? What – Can you repeat that question?

Speaker Change: Okay. So so can I just get a clarification on the question with regard to I heard a couple of them there so cabo in the subgroups or sorry, <unk> from <unk>.

Speaker Change: Comment in the subgroups and the data that we showed at <unk> subgroup.

Speaker Change: The PFS rule out scenarios, where you're just talking about the censoring.

Speaker Change: Can you repeat that question.

Operator: Ok. Can I get a clarification on the question with regard--I heard a couple in there. So CABO in the subgroups--sorry, CABO from comment in the subgroups and the data that we showed at ASCO and subgroups. The PFS rule-out scenarios, were you talking about the censoring? Can you repeat that question? If you want to comment on the censoring, yeah, we have questions about that too. But I guess my question was specifically talking about the PFS delta, right? So between the experimental arm and the control arm, really close to the scanning interval of nine weeks. And that was kind of brought up, you know, in the discussion. And I'm just curious about, you know, if you can rule that out, basically, you know, the delta of the PFS and potentially be an artifact at the scanning interval.

Amy Peterson: Ok. Can I get a clarification on the question with regard--I heard a couple in there. So CABO in the subgroups--sorry, CABO from comment in the subgroups and the data that we showed at ASCO and subgroups. The PFS rule-out scenarios, were you talking about the censoring? Can you repeat that question?

Andy Hsieh: Yeah, yeah, certainly. Yeah, yes. Well, if you want to comment on, on the censoring, yeah, we, we have, you know, questions on that too. But I guess my question was specifically talking about the PFS delta, right? So between the experimental arm and the control arm, really close to the scanning interval of nine weeks. And that was kind of brought up, you know, at the, at, at a discussion.

Speaker Change: Yeah, Yeah certainly.

Speaker Change: Yes.

Speaker Change: You want to comment on accessories.

Speaker Change: We have questions on that too, but I guess my question was specifically talking about the PFS Delta right. So between the experimental arm and the control arm.

Tsan-Yu Hsieh: Yes, yes, centainly, if you want to comment on the censoring, yes, we have questions about that too. But I guess my question was specifically talking about the PFS delta, right? So between the experimental arm and the control arm, really close to the scanning interval of 9 weeks. And that was kind of brought up at the discussion. And I'm just curious about if you can rule that out, basically, the delta of the PFS could potentially be an artifact at the scanning interval.

Speaker Change: Really close to the scanning interval at nine weeks and that was kind of brought up.

Amy: These are painful events for patients, so there are other outcomes that we look at. And what we also look at is the adverse event profile. And the adverse event profile that we showed was Cabo Atizo versus second NHT. These are patients who enrolled in the study having tolerated their first NHT quite well. The median time on prior NHT was 12 months, so these are patients who know the toxicities of NHT and they tolerate them. And so when you juxtapose the toxicity of Cabo Atizo against that, it looks different.

Speaker Change: At the end of discussion.

Amy Peterson: Okay.

Andy Hsieh: And I'm just curious about, you know, if you can rule that out. Basically, you know, the delta of the PFS could potentially be an artifact at the scanning interval.

Speaker Change: I'm just curious about.

Speaker Change: If you can't rule that out basically.

Speaker Change: The delta of the PFS.

Speaker Change: So it would be an artifact that the scan intervals.

Amy Peterson: ... Okay, now I understand your question much better. Thank you. Thank you. So, so with regard to the PFS delta, one thing is take a step back, and we do look at many parameters of clinical benefit, not just an improvement in a single point in time. In general, the optimal way to view the treatment effect is really based on the hazard ratio, which looks at the difference between experimental and control arm across the entire PFS analysis, not at one point estimate, i.e., the median here that you're referring to. There are multiple examples of no benefit at the median, but a positive hazard ratio resulting in approval, going all the way back to ipilimumab in melanoma, and really most recently, belzutifan in RCC, where the curves separate after the median, yet clinical benefit was identified and the drugs have been approved.

Amy Peterson: Okay. Now I understand your question much better. Thank you, thank you. So with regard to the PFS delta, one thing, take a step back, and we do look at many parameters of clinical benefit, not just an improvement in a single point in time. In general, the optimal way to view the treatment effect is really based on the hazard ratio, which looks at the difference between the experimental and control arms across the entire PFS analysis, not at one point estimate, i.e. the median here that you're referring to.

Speaker Change: Okay now I understand your question much better. Thank you. Thank you so.

Speaker Change: With regard to the PFS dealt that one things take a step back and we do look at many parameters of clinical benefit not just an improvement in a single point in time.

Speaker Change: In general the optimal way to view the treatment effect is really based on the hazard ratio, which looks at the difference between experimental and control arm across the entire PFS analysis not at one point estimate I E. The median here that you're referring to.

Amy: I'll grant you that. But when you compare that to the toxicity profile of chemotherapy, it's very differentiated. We do not have cytopenias. We do not have febrile neutropenia. We do not have alopecia.

Operator: The median here that you're referring to, there are multiple examples of no benefit at the median, but a positive hazard ratio resulting in approval going all the way back to ipilimumab in melanoma. And really, most recently, felzutafan in RCC, where the curve separates after the median, yet clinical benefit was identified, and the drugs have been approved. Going into what we have observed in our study, we have very robust PFS findings seen across all subgroups, similar in the IPT population, and according to the PCWG working group criteria. We believe that these are clinically meaningful PFS benefits, especially in this patient population in contact, which represents overall a worse prognosis than other studies conducted in this space. We have a lot of this; one hundred percent of patients had measurable disease. 40% of them had visceral disease.

The median here that you're referring

There are multiple examples of no benefit at the median, but a positive hazard ratio resulting in approval going all the way back to IPILIMUMAB in melanoma. And really, most recently, BELZUTIFAN in RCC, where the curve separates after the median, yet clinical benefit was identified, and the drugs have been approved. Going into what we have observed in our study, we have very robust PFS findings seen across all subgroups, similar in the IPT population, and according to the PCWG Working Group criteria. We believe that these are clinically meaningful PFS benefits, especially in this patient population in CONTACT, which represents overall a worse prognosis than other studies conducted in this space. We have a lot of --this-- 100% of patients had measurable disease. 40% had visceral disease.

Speaker Change: There are multiple examples of no benefit at the median but a positive hazard ratio, resulting in approval going all the way back to Bloom, a mab in melanoma and really most recently <unk> in RCC, where the curves separate aster the median yacht clinical benefit.

Amy: And we do not have peripheral neuropathy, so it's a differentiated toxicity profile from other available therapies to this patient. And furthermore, when you look at this toxicity profile and compare it to Cabo I.O. in other diseases where this doublet is used, like kidney cancer, by the same oncologists that treat prostate cancer, the toxicity profile is nearly identical. So going back to what I said at the beginning, when we talk about clinical benefit, we really need to consider a variety of parameters that we believe here have met and support a robust and clinically meaningful benefit in a very unique patient population. Now I'll go on to the Zanza Arcus question, okay? I know I went a long time there, but okay.

Speaker Change: It was identified in the drugs have been approved.

Amy Peterson: Going into what we have observed in our study, we have very robust PFS findings seen across all subgroups, similar in the ITT population and according to the PCWG working group criteria. We believe that these are clinically meaningful PFS benefits, especially in this patient population in Contact, which represents overall a worse prognosis than other studies conducted in this space. A hundred percent of patients had measurable disease, 40% had visceral disease. In the ITT, a hazard ratio of 0.65 translates to a 50% improvement over the control arm, which is exactly what we saw at the median, 4.2 versus 6.3 months. In the liver met subgroup, the hazard ratio, 0.43, translates to a more than doubling the improvement over control arm.

Speaker Change: Going into what we have observed in our study we have very robust PFS findings seen across all subgroups similar in the ITT population and according to the PC WG working group criteria. We believe that these are clinically meaningful PFS benefits, especially in this patient population.

We believe that these are clinically meaningful PFS benefits, especially in this patient population in CONTACT, which represents overall a worse prognosis than other studies conducted in this space. We have a lot of --this-- 100% of patients had measurable disease. 40% had visceral disease. In the ITT, a hazard ratio of 0.65 translates to a 50% improvement over the control arm, which is exactly what we saw at the median 4.2 versus 6.3 months.

Speaker Change: Relation in contact which represents overall a worst prognosis than other studies conducted in this space. We have a lot of this at 100% of patients had measurable disease.

Speaker Change: 40% I had visceral disease.

Operator: In the ITT, a hazard ratio of 0.65 translates to a 50% improvement over the control arm, which is exactly what we saw at the median, 4.2 versus 6.3 months. In the LiverMet subgroup, the hazard ratio of 0.43 translates to more than doubling the improvement over the control arm. And, in fact, at the median, we observed a trebling of the effect from 2.1 to 6.2 months

In the ITT, a hazard ratio of 0.65 translates to a 50% improvement over the control arm, which is exactly what we saw at the median, 4.2 versus 6.3 months.

Speaker Change: In the ITC.

Speaker Change: Hazard ratio of <unk> 65 translates to a 50% improvement over the control arm, which is exactly what we thought the median or two versus six three months.

In the Liver MET subgroup, the hazard ratio of 0.43 translates to a more than doubling the improvement over the control arm. And, in fact, at the median, we observed a trebling of the effect from 2.1 to 6.2 months. In the patients with prior DOCETAXEL, the hazard ratio was 0.57, which translates to a 75% improvement over the control arm, and in that median, we saw a doubling of median PFS from 4.1 to 8.8 months. So, this is part of the totality of data, but it is not all of the totality of data. And in CONTACT-O2, we have to also consider the patients that were enrolled and how they are unique and distinct from other studies that have evaluated drugs against second NHT. We have to consider the unmet need that is existent in this space and other important outcomes that we looked at. For example, I mentioned time to chemotherapy. We delayed time to chemotherapy with CABO/ATEZO. We actually--CABO/ATEZO resulted in an increase in time to symptomatic skeletal events. This are attainable events for patients.

Speaker Change: In the liver Mets subgroup, the hazard ratio of <unk> four three translates to a more than doubling the improvement over control arm and in fact that the median we observed a trebling of the effect from 2.1 to $6 two months.

Amy: So you asked about Zanza HIF given the data with Cabo Bells and not being real clear that Bell Zutophan might be bringing anything to the table. Let me just take a step back and remind everybody what we're talking about with Zanza is what we believe to be a best-in-class VEGF-RTKI drug.

Amy Peterson: And in fact, at the median, we observed a trebling of the effect from 2.1 to 6.2 months. In the patients with prior docetaxel, the hazard ratio was 0.57, which translates to a 75% improvement over the control arm, and in that median, we saw a doubling of median PFS from 4.1 to 8.8 months. So this is part of the totality of data, but it is not all of the totality of data. And in Contact-02, we have to also consider the patients that were enrolled and how they are unique and distinct from other studies that have evaluated drugs against second NHT. We have to consider the unmet need that is existent in this space and other important outcomes that we looked at. For example, I mentioned time to chemotherapy.

Operator: In the patients with prior doses of Taxol, the hazard ratio was 0.57, which translates to a 75% improvement over the control arm, and in that median, we saw a doubling of median PFS from 4.1 to 8.8 months. So, this is part of the totality of data, but it is not all of the totality of data. And in contact O2, we have to also consider the patients that were enrolled and how they are unique and distinct from other studies that have evaluated drugs against second NHT. We have to consider the unmet need that is existent in this space and other important outcomes that we looked at. For example, I mentioned time to chemotherapy. We delayed time to chemotherapy with Cabo Atizo. We actually resulted Cabo Atizo resulted in an increase in time to symptomatic skeletal events, which are painful events for patients.

Speaker Change: In the patients with prior Docetaxel the hazard ratio was <unk>, five seven which translates to a 75% improvement over the control arm and that median we saw a doubling of median PFS from four one to eight eight months.

So, this is part of the totality of data, but it is not all of the totality of data. And in CONTACT-O2, we have to also consider the patients that were enrolled and how they are unique and distinct from other studies that have evaluated drugs against second NHT. We have to consider the unmet need that is existent in this space and other important outcomes that we looked at. For example, I mentioned time to chemotherapy. We delayed time to chemotherapy with CABO/ATEZO. We actually--CABO/ATEZO resulted in an increase in time to symptomatic skeletal events. This are attainable events for patients. So there are other outcomes that we look at. And what we also look at is the adverse event profile. And the adverse event profile that we showed was CABO/ATEZO versus second NHT. These are patients who enrolled in this study having tolerated their first NHT quite well. Median time on prior NHT was 12 months.

Amy: It has a similar target profile to CABO, but the tolerability profile is differentiated. Monty Child went through this at R&D Day, and we presented at IKCS, patients that actually responded to Zanza who progressed on CABO. So it's different.

Speaker Change: So.

Speaker Change: This is part of the totality of data, but it is not all of the totality of data.

Speaker Change: And then contract.

Speaker Change: We have to also consider the patients that were enrolled and how they are unique and distinct from other studies that have evaluated drugs again second and each team.

Amy: We think we have an opportunity for a best in class. ARCUS is evaluating monotherapy AB521. We'll see whether or not that emerges as a best in class agent.

Speaker Change: We have to consider the unmet need that is.

Speaker Change: Existing <unk> in this space and other important outcomes, but we looked at for example, I mentioned time to chemotherapy we delayed.

Amy: But there's a reason to bring two potentially active agents together in this disease, and we're really excited about Stellar-009. It's co-funded by ARCUS and us, and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward. And Andy, I know you had a multi-part question, but we've got a long queue, so we're gonna need to move on. Please stand by for our next question. Our next question comes from the line of Yaron Werber with TD Cohen. Your line is open. Hey, guys. This is Joyce on for your own.

Amy Peterson: We delayed time to chemotherapy with CABO-ATEZO. We actually, CABO-ATEZO resulted in an increase in time to symptomatic skeletal events. These are painful events for patients, so there are other outcomes that we look at. And what we also look at is the adverse event profile, and the adverse event profile that we showed with CABO-ATEZO versus second NHT. Now, these are patients who enrolled in this study, having tolerated their first NHT quite well. Median time on prior NHT was 12 months. All right? So these are patients who know the toxicities of NHT, and they tolerate them. And so when you juxtapose the toxicities of CABO-ATEZO against that, it looks different. I'll grant you that. But when you look at that compared to the toxicity profile of chemotherapy, it's very differentiated.

Speaker Change: Time to chemotherapy with Cabo at T. Though we actually result, Cabo if she has a resulted in a D and an increase in time to symptomatic scolino events. These are <unk>.

Operator: So there are other outcomes that we look at, and what we also look at is the adverse event profile. And the adverse event profile that we showed was Cabo Atizo versus second NHT. These are patients who enrolled in this study having tolerated their first NHT quite well. Median time on prior NHT was 12 months.

Speaker Change: Full events for patients. So there are other outcomes that we look at.

Speaker Change: And what we also look at is the adverse event profile and the adverse event profile that we showed with Pablo piso versus second and HP.

These are patients who enrolled in this study having tolerated their first NHT quite well. Median time on prior NHT was 12 months. So these are patients who know the toxicities of NHT and they tolerate them. And so when you juxtapose the toxicity of CABO/ATEZO against that, it looks different. I'll grant you that. But when you look at that compared to the toxicity profile of chemotherapy, it's very differentiated. We do not have cytopenias. We do not have febrile neutropenia. We do not have alopecia, and we do not have peripheral neuropathy. So it's a differentiated toxicity profile from otherwise other available therapies to this patient.

Speaker Change: These are patients who enrolled in the study have any tolerated there first in each key quite well median time on prior NH T was 12 months alright. So these are patients who know the toxicities of NH tea and they tolerate them and so when you juxtapose the toxicity.

Operator: Sorry. Thanks for taking our question. And thanks for all of the color on contact 02.

Operator: So these are patients who know the toxicities of NHT and they tolerate them. And so when you juxtapose the toxicity of Cabo Atizo against that, it looks different. I'll grant you that. But when you look at it compared to the toxicity profile of chemotherapy, it's very different. We do not have cytopenias. We do not have febrile neutropenia. We do not have alopecia.

Operator: Um, maybe just one more on that. Could you clarify, since the study seems to have enrolled both second-line patients as well as, as you noted, up to 25% of patients who had previously received docetaxel. How broad of a label you guys are aiming for here, whether it's second line post-first NHT but pre-chemo, or whether you're also looking to get approval in post-first NHT and post-chemo. Yeah, thanks for the question. I'm not at liberty to really predict what might be the ultimate label. But again, I'll go back to the first principles of clinical trial design. When we design the study, we do pay special attention to the inclusion and exclusion criteria.

Speaker Change: Although it seems though against that it looks different.

Speaker Change: I'll Grant you that but when you look at that compared to the toxicity profile of <unk>.

Speaker Change: No therapy, it's very differentiated we do not have cytopenia as we do not have febrile neutropenia, we do not have alopecia and we do not have peripheral neuropathy. So its a differentiated toxicity profile from otherwise other available therapies.

Amy Peterson: We do not have cytopenias, we do not have febrile neutropenia, we do not have alopecia, and we do not have peripheral neuropathy. So it's a differentiated toxicity profile from otherwise other available therapies to this patient. And furthermore, when you look at this toxicity profile and compare it to CABO-Io in other diseases where this doublet is used, like kidney cancer, by the same oncologists that treat prostate cancer, the toxicity profile is nearly identical. So going back to what I said at the beginning, when we talk about clinical benefit, we really need to consider a variety of parameters that we believe here we've met and support a robust and clinically meaningful benefit in a very unique patient population. Now, I'll go on to the Xofigo, Arcus, question. Okay? I know I went long there, but okay.

Operator: And we do not have peripheral neuropathy, so it's a differentiated toxicity profile from other available therapies to this patient. And furthermore, when you look at this toxicity profile and compare it to Cabo I.O. in other diseases where this doublet is used, like kidney cancer, by the same oncologists that treat prostate cancer, the toxicity profile is nearly identical. So going back to what I said at the beginning, when we talk about clinical benefit, we really need to consider a variety of parameters that we believe here have met and support a robust and clinically meaningful benefit in a very unique patient population. Now I'll go on to the Zanza Arcus question, okay? I know I went a long time there, but okay.

And we do not have peripheral neuropathy, so it's a differentiated toxicity profile from other available therapies to this patient.

And furthermore, when you look at this toxicity profile and compare it to CABO IO in other diseases where this doublet is used, like kidney cancer, by the same oncologists that treat prostate cancer, the toxicity profile is nearly identical. So going back to what I said at the beginning, when we talk about clinical benefit, we really need to consider a variety of parameters that we believe here we've met and support a robust and clinically meaningful benefit in a very unique patient population. Now I'll go on to the ZANZA/ARCUS question, Okay? I know I went longthere, but-- Okay.

Speaker Change: To this patient and Furthermore, when you look at the toxicity profile.

Speaker Change: Garrett to cobble, I O and other diseases, where this doublet.

Speaker Change: Used like kidney cancer via the same oncologists that treat prostate cancer.

Amy: All of that is being discussed with the regulators, and I would state that what we believe we have is a positive study in the ITT patient population and that this is the first positive global phase 3 study of a TTI-IO combination in metastatic castration-resistant prostate cancer patients who have progressed on at least one NHT in both pre- and post-chemo settings.

Speaker Change: The profile is nearly identical.

Speaker Change: Going back to what I see.

Speaker Change: Got it.

Speaker Change: When we talk about clinical benefit we really need to consider a variety of parameters that we believed here, we've mapped and support our robust and clinically meaningful benefit in a very unique patient population.

Speaker Change: Now I'll go onto the Vanda Arca.

Now I'll go on to the ZANZA/ARCUS question, Okay? I know I went longthere, but-- Okay. So you asked about ZANZA HIF given the data with CABO/BEL and not being real clear that BELZUTIFAN might be bringing anything to the table. Let me just take a step back and remind everybody what we're talking about with ZANZA is what we believe to be a best-in-class VEGFR TKI drug. It has a similar target profile to CABO, but the tolerability profile is differentiated. MONTY PAL went through at R&D Day--we presented at IKCS, patients that actually responded to ZANZA to progress on CABO. So it's different.

Amy: Got it, thank you. If I could just squeeze in a follow-up, looking at Vanda. Joyce, I've got to be honest, we have a super long list of people to get to, so we're happy to follow up with you afterward. No worries.

Speaker Change: Question Okay.

Speaker Change: What went wrong, there, but okay.

Amy Peterson: So you asked about zanzalintinib, has given the data with cabozantinib and not being real clear that belzutifan might be bringing in anything to the table. Let me just take a step back and remind everybody what we're talking about with zanzalintinib is what we believe to be a best-in-class VEGF-RTKI drug. It has a similar target profile to CABO, but the tolerability profile is differentiated. Monty Pyle went through at R&D Day, and we presented at IKDX.

Operator: So you asked about Zanza HIF given the data with Cabo Bells and not being real clear that Bell Zutaphan might be bringing anything to the table. Let me just take a step back and remind everybody what we're talking about with Zanza is what we believe to be a best-in-class VEGF-RTKI drug.

Speaker Change: You asked about Zander have given the data with Cabo bells, and not being real clear that cell.

Speaker Change: <unk> Zeta found might be bringing anything to the table. Let me just take a step back and remind everybody. What we're talking about with Zander is what we believe to be a best in class.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Prakash Tewari with Jeffrey. Your line is open. Hey, thanks so much.

Speaker Change: That Jeff our T K I.

Operator: It has a similar target profile to CABO, but the tolerability profile is differentiated. Monty Pyle went through this at R&D Day, and we presented at IKCS, patients that actually responded to Zanza who progressed on CABO. So it's different.

Speaker Change: It has a similar target profile to coddle, but the Tolerability profile is differentiated Monte Kyle went through at R&D day, we presented at KFC up patients.

Operator: So of the kind of $950 million in R&D expenses for next year, how much is specifically Zanza related? And the reason I ask is that, if you look at Cobbler's development program, you were able to share some of the development costs with Ipsen, Takeda, and Bristol. And is there an opportunity to potentially do that with Zanza's development here?

[Company Representative] (Exelixis): ... patients that actually responded to zanza who progressed on CABO. So it's different. We think we have an opportunity for a best-in-class. Arcus is evaluating monotherapy AB521. We'll see whether or not that emerges as a best-in-class agent. But there's a reason to bring two potentially active agents together in this disease, and we're really excited about STELLAR-009. We are, it's co-funded by Arcus and us, and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward.

Amy Peterson: ... patients that actually responded to zanza who progressed on CABO. So it's different. We think we have an opportunity for a best-in-class. Arcus is evaluating monotherapy AB521. We'll see whether or not that emerges as a best-in-class agent. But there's a reason to bring two potentially active agents together in this disease, and we're really excited about STELLAR-009. We are, it's co-funded by Arcus and us, and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward.

Speaker Change: Patients that actually responded the vans up keeps progressing on Cabo. So it's different and we think we have the opportunity for a best in class ARCUS evaluating monotherapy 85 to one we'll see whether or not that emerges as a best in class agent, but there's a reason to bring.

Operator: We think we have an opportunity for a best-in-class. Arcus is evaluating monotherapy AB521. We'll see whether or not that emerges as a best-in-class agent. But there's a reason to bring 2 potentially active agents together in this disease, and we're really excited about STELLAR-009. It's co-funded by Arcus and us, and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward. Thank you, Andy. I know you had a multi-part question, but we've got a long queue, so we're going to need to move on to the next question. Please stand by for our next question, which comes from the line of Yaron Werber with TD Cohen. Your line is open. Hey guys. This is Joyce on for your own.

We think we have an opportunity for a best-in-class. Arcus is evaluating monotherapy AB521. We'll see whether or not that emerges as a best-in-class agent. But there's a reason to bring 2 potentially active agents together in this disease, and we're really excited about STELLAR-009. It's co-funded by Arcus and us, and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward.

Operator: But there's a reason to bring two potentially active agents together in this disease, and we're really excited about Stellar-009. It's co-funded by Arcus and us, and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward. Thank you, Andy. I know you had a multi-part question, but we've got a long queue, so we're going to need to move on to the next question. Please stand by for our next question, which comes from the line of Yaron Werber with TD Cohen. Your line is open. Hey guys. This is Joyce on for your own.

<unk> to potentially active agents together in this disease and we're really excited about stellar O nine we are.

Operator: So how aggressively will the company be looking in terms of collaborating on Zanza? And then, number two, roughly how much of that spending for 2024 is Zanza related? And then maybe just stepping back, for the Merck studies, which are looking at, you know, HIF-2 Alpha and Pembro versus TKI Pembro in a first-line setting, you know, obviously, if that hits, it would have a pretty significant impact on the market. I'd love to get your take on whether HIF-2 Alpha would be able to show a benefit on top of, you know, HIF-2 Alpha Pembro would actually be able to show a benefit versus a TKI-based regimen.

Speaker Change: It's co funded by ARCUS and us and in that study, we will test the combination in patients with RCC to figure out whether and how we might move this combination forward.

Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open. Hey guys. This is Joyce on for your own.

Operator: Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.

[Company Representative] (Exelixis): Great, Andy, I know you had a multi-part question, but we've got a long queue, so we're going to need to move on to the next question. Operator?

Susan Hubbard: Great, Andy, I know you had a multi-part question, but we've got a long queue, so we're going to need to move on to the next question. Operator?

Speaker Change: Great Andy I know you had a multipart question, but we've got a long queue. So we're going to need to move on to the next question operator.

Operator: Please stand by for our next question. Our next question comes from the line of Yaron Weber with TD Cowen. Your line is open.

Speaker Change: Please standby for our next question.

Speaker Change: Yeah.

Speaker Change: Okay.

Hi guys. This is Joyce on for Yaron. Sorry. Thanks for taking our question. And thanks for all of the color on CONTACT-02. Maybe just one more on that. Could you clarify, since the study seems to have enrolled both second-line patients as well as, as you noted, about--up to 25% of patients who had previously received DOCETAXEL, how broad of a label you guys are aiming for here, whether it's second-line post-first NHT but pre-chemo, or whether you're also looking to get approval in post-first NHT and post-chemo? Yeah, thank you guys for the question. I'm not at liberty to really predict what might be the ultimate label, but again, I'll go back to the first principles of clinical trial design. When we design a study, we do pay special attention to the inclusion and exclusion criteria.

Joyce Zhou: Hi guys. This is Joyce on for Yaron. Sorry. Thanks for taking our question. And thanks for all of the color on CONTACT-02. Maybe just one more on that. Could you clarify, since the study seems to have enrolled both second-line patients as well as, as you noted, about--up to 25% of patients who had previously received DOCETAXEL, how broad of a label you guys are aiming for here, whether it's second-line post-first NHT but pre-chemo, or whether you're also looking to get approval in post-first NHT and post-chemo?

Speaker Change: Our next question comes from the line of Yamana Whopper with TD Cowen Your line is open.

Operator: Hey, guys, this is Joyce on for Yaron. Sorry, thanks for taking our question. And thanks for all of the color on Contact-02. Maybe just one more on that. Could you clarify, since the study seems to have enrolled both, second-line patients as well as, as you noted, about, or up to 25% of patients, who had previously received docetaxel, how broad of a label you guys are aiming for here, whether it's second-line post first NHT, but pre-chemo, or whether you're also looking to get approval in post first NHT and post-chemo? Thanks.

Joyce Zhou: Hey, guys, this is Joyce on for Yaron. Sorry, thanks for taking our question. And thanks for all of the color on Contact-02. Maybe just one more on that. Could you clarify, since the study seems to have enrolled both, second-line patients as well as, as you noted, about, or up to 25% of patients, who had previously received docetaxel, how broad of a label you guys are aiming for here, whether it's second-line post first NHT, but pre-chemo, or whether you're also looking to get approval in post first NHT and post-chemo? Thanks.

Yamana Whopper: Hey, guys. This is joey on for your own.

Operator: Sorry. Thanks for taking our question. And thanks for all of the color on contact 02.

Joey: Sorry, Thanks for taking our question.

Yamana Whopper: And thanks for all the color on contact O two.

Operator: Um, maybe just one more on that. Could you clarify, since the study seems to have enrolled both second-line patients as well as, as you noted, about... up to 25% of patients who had previously received Dosataxel. How broad of a label you guys are aiming for here, whether it's second-line post-first NHT but pre-chemo, or whether you're also looking to get approval in post-first NHT and post-chemo? Yeah, thank you guys for the question. I'm not at liberty to really predict what might be the ultimate label, but again, I'll go back to the first principles of clinical trial design. When we design a study, we do pay special attention to the inclusion and exclusion criteria.

Joey: Maybe just one more on that.

Joey: Could you clarify since the study seems to have enrolled the second.

Joey: Second line patients as well as as you noted about.

Joey: Our up to 25% of patients.

Joey: Who had previously received docetaxel.

Joey: How broad of a label that you guys are aiming for here, whether it's second line post first in hte, but pre chemo.

Joey: We're also looking to get approval in poster with an H T and post chemo. Thanks.

Amy Peterson: Yes. Thanks, Joyce for the question. I'm not at liberty to really predict what might be the ultimate label, but again, I'll go back to the first principles of clinical trial design, when we design the study, we do pay special attention to the inclusion/exclusion criteria. All of that will be discussed with the regulators. And I would state that what we believe we have is a positive study in the ITT patient population and that this is the first, positive global Phase III study of a TKI-IO combination in metastatic castration-resistant prostate cancer patients who have progressed on at least one NHT in both pre-and post-chemo settings.

[Company Representative] (Exelixis): Yeah, thanks, Joyce, for the question. I'm not at liberty to really predict what might be the ultimate label, but again, I'll go back to first principles of clinical trial design. When we design the study, we do pay special attention to the inclusion/exclusion criteria. All of that is discussed with the regulators, and I would state that what we believe we have is a positive study in the ITT patient population, and that this is the first positive global Phase 3 study of a TKI IO combination in metastatic castration-resistant prostate cancer patients who have progressed on at least one NHT in both pre and post-chemo setting.

Amy Peterson: Yeah, thanks, Joyce, for the question. I'm not at liberty to really predict what might be the ultimate label, but again, I'll go back to first principles of clinical trial design. When we design the study, we do pay special attention to the inclusion/exclusion criteria. All of that is discussed with the regulators, and I would state that what we believe we have is a positive study in the ITT patient population, and that this is the first positive global Phase 3 study of a TKI IO combination in metastatic castration-resistant prostate cancer patients who have progressed on at least one NHT in both pre and post-chemo setting.

Speaker Change: Yes, that's right for the question I I I'm not at Liberty to really.

Operator: And, you know, to bounce off that last question, where do you see this combo of Zanza and HIF-2 Alpha really playing a role in the market? Thank you. Wow, there's a lot there.

Speaker Change: Predict what might be the ultimate label, but again I'll go back to first principles of clinical trial design. When we design the study we do.

Speaker Change: Pay special attention to the inclusion exclusion criteria all of that is discussed with the regulators and I would state that what we believe we have as a positive study in me I T T patient population and that this is the first.

Operator: All of that will be discussed with the regulators, and I would state that what we believe we have is a positive study in the ITT patient population and that this is the first, positive global phase 3 study of a TKI-IO combination in metastatic castration-resistant prostate cancer patients who have progressed on at least one NHT in both pre- and post-chemo settings.

Michael M. Morrissey: Yeah, so let me work backwards real fast. You asked, I think, three or four questions there. I certainly don't want to comment on a competitor's study and the probability of success there, but I would refer you back to all the published data of TKIs combined with HIF-2 inhibitors compared to contemporaneous, say, single-agent TKI data like Cabo from Contact 03.

Speaker Change: Positive global Phase III study of a teekay Io combination in metastatic castration resistant prostate cancer patients who have progressed on at least one and H T in both pre and post chemo setting.

Operator: Got it. Thank you. If I could just squeeze in a follow-up, looking at zanzalintinib

Joyce Zhou: Got it. Thank you. If I could just squeeze in a follow-up, looking at zanzalintinib

Operator: Got it. Thank you. If I could just squeeze in a follow-up. Looking at ZANZA... Joyce, I've got to be honest, we have a super long list of people to get to, so we're happy to follow up with you after this call. No worries.

Joyce Zhou: Got it. Thank you. If I could just squeeze in a follow-up. Looking at ZANZA...

Got it. Thank you if I could just squeeze in a follow up I'm looking at Jay.

Michael M. Morrissey: And you can, I think, draw some conclusions there. And, you know, obviously, we want to see data. Data drives the process.

Joyce, I've got to be honest, we have a super long list of people to get to, so we're happy to follow up with you after this call. No worries.

Susan Hubbard: Joyce, I've got to be honest, we have a super long list of people to get to, so we're happy to follow up with you after this call.

[Company Representative] (Exelixis): Joyce, I've got to be honest, we have a super long list of people to get to, so we're happy-

Amy Peterson: Joyce, I've got to be honest, we have a super long list of people to get to, so we're happy-

Speaker Change: Be honest, we haven't Super long list of people to get too. So we're happy with you as well.

Operator: Okay.

Joyce Zhou: Okay.

[Company Representative] (Exelixis): To follow up with you after the call, but we're getting out of time.

Amy Peterson: To follow up with you after the call, but we're getting out of time.

Operator: No worry.

Joyce Zhou: No worry.

Operator: Our next question comes from the line of Akash Tewari with Jefferies. Your line is open. Hey, thanks so much.

Joyce Zhou: No worries. Thank you.

Operator: Our next question comes from the line of Akash Tewari with Jefferies. Your line is open.

[Company Representative] (Exelixis): Thank you, Joyce.

Amy Peterson: Thank you, Joyce.

Operator: No worry. Thank you.

Joyce Zhou: No worry. Thank you.

Speaker Change: Thank you.

Operator: Please stand by for our next question. Our next question comes from the line of Akash Tewari with Jefferies. Your line is open.

Speaker Change: Please standby for our next question.

Speaker Change: Okay.

Michael M. Morrissey: And we'll see how that data looks, but I would really refer you back to some of the published data relative to what we're seeing with contemporary TKI data.

Speaker Change: Our next question comes from the lineup of cost to war with Jefferies. Your line is open.

Akash Tewari: Hi, thanks so much. So of the kind of $950 million in R&D expenses for next year, how much is specifically ZANZA-related? And kind of the reason I ask is, if you look at CABO's development program, you were able to share some of the development costs with Ipsen, Takeda, and Bristol. And is there an opportunity to potentially do that with ZANZA's development here? So how aggressively will the company be looking in terms of collaborating on ZANZA? And then, number two, roughly how much of that spend for 2024 is ZANZA-related?

Michael Yee: Hey, thanks so much. So of the kind of $950 million in R&D expenses for next year, how much is specifically zanza related? And kind of the reason I ask is, if you look at CABO's development program, you were able to share some of the development costs with Ipsen, Takeda, Bristol. And is there an opportunity to potentially do that with zanza's development here? So how aggressively will the company be looking in terms of collaborating on zanza? And then number two, roughly how much of that spend for 2024 is zanza related? And then maybe just stepping back, for the Merck studies, which are looking at, you know, HIF-2α and pembro versus TKI pembro in a first-line setting. You know, obviously, if that hits, it would have a pretty significant impact on the market.

Akash Tewari: Hey, thanks so much. So of the kind of $950 million in R&D expenses for next year, how much is specifically zanza related? And kind of the reason I ask is, if you look at CABO's development program, you were able to share some of the development costs with Ipsen, Takeda, Bristol. And is there an opportunity to potentially do that with zanza's development here? So how aggressively will the company be looking in terms of collaborating on zanza? And then number two, roughly how much of that spend for 2024 is zanza related? And then maybe just stepping back, for the Merck studies, which are looking at, you know, HIF-2α and pembro versus TKI pembro in a first-line setting. You know, obviously, if that hits, it would have a pretty significant impact on the market.

Operator: So of the kind of $950 million in R&D expenses for next year, how much is specifically Zanza-related? And the reason I ask is that, if you look at Kaaba's development program, you were able to share some of the development costs with Ipsen, Takeda, and Bristol. And is there an opportunity to potentially do that with Zanza's development here?

Costa War: Hey, thanks, so much so of the kind of $950 million in R&D expenses for next year, how much is specific lease danza related and kind of the reason I ask is if you look at Cabos development program, you were able to share some of the development costs with Ipsen, Takeda Bristol and <unk>.

Michael M. Morrissey: In terms of... Clinical collaborations. Yeah, we spoke to this at length at the J.P. Morgan update as well as at the R&D Day presentation. We're super proud of all the work that we've done in collaboration with our commercial partners and our clinical partners on CABO.

Costa War: Is there an opportunity to potentially do that with the Vantiv development here. So how aggressively will the company be booking in terms of collaborating on Dan's up and then number two roughly how much of that spend.

Operator: So how aggressively will the company be looking in terms of collaborating on Zanza? And then, number two, roughly how much of that spend for 2024 is Zanza-related? And then maybe just stepping back, for the Merck studies, which are looking at, you know, HIF-2 Alpha and Pembro versus TKI Pembro in a first-line setting, you know, obviously, if that hits, it would have a pretty significant impact on the market. I'd love to get your take on whether HIF-2 Alpha would be able to show a benefit on top of, you know, HIF-2 Alpha, and Pembro would actually be able to show a benefit versus a TKI-based regimen.

So how aggressively will the company be looking in terms of collaborating on Zanza? And then, number two, roughly how much of that spend for 2024 is Zanza-related?

Michael M. Morrissey: We think that was a really appropriate way to go relative to basically expanding the opportunities clinically by working with various partners to be able to run a variety of trials, 90R, the contacts, et cetera, where we had the opportunity to co-fund. As we talked about at J.P. Morgan in January, that's a priority for us with Zanza. The first few that we started by ourselves to get the ball rolling, and we're certainly having lots of discussions now around the possibility of combining Zanza with other checkpoints in a collaborative and potentially co-funding manner, but we don't want to get ahead of that.

Costa War: For 2024 is that is it related and then maybe just stepping back for the Merck studies, which are looking at hip.

And then maybe just stepping back, for the Merck studies, which are looking at HIF-2 ALPHA and PEMBRO versus TKI PEMBRO in a first-line setting, obviously, if that hits, it would have a pretty significant impact on the market. I'd love to get your take on whether HIF-2 Alpha would be able to show a benefit on top of-- HIF-2 ALPHA PEMBRO would actually be able to show a benefit versus a TKI-based regimen. And to bounce off that last question, where do you see this combo of ZANZA and HIF-2 ALPHA really playing a role in the market? Thank you.

Costa War: <unk> two alpha.

Costa War: And Pembroke versus TK IPM row in a first line setting obviously, if that hits that would have a pretty significant impact on the market I'd love to get your take on whether <unk> alpha would be able to show a benefit.

Michael Yee: I'd love to get your take on whether HIF-2α would be able to show a benefit, on top of, you know, the HIF-2α pembro would actually be able to show a benefit versus a TKI-based regimen. And, you know, to bounce off that last question, where do you see this combo of, you know, zanzalintinib and a HIF-2α really playing a role in the market? Thank you.

Akash Tewari: I'd love to get your take on whether HIF-2α would be able to show a benefit, on top of, you know, the HIF-2α pembro would actually be able to show a benefit versus a TKI-based regimen. And, you know, to bounce off that last question, where do you see this combo of, you know, zanzalintinib and a HIF-2α really playing a role in the market? Thank you.

Costa War: On top of that.

Costa War: I have two alpha Pembroke would actually be able to show a benefit versus a <unk> based regimen and.

Operator: And, you know, to bounce off that last question, where do you see this combo of Zanza and HIF-2 Alpha really playing a role in the market? Thank you. Wow, there's a lot there.

And, you know, to bounce off that last question, where do you see this combo of Zanza and HIF-2 Alpha really playing a role in the market? Thank you.

Costa War: Bounce up that last question, where do you see this combo.

Costa War: Vanda and hip.

Michael M. Morrissey: When we have something to say that's definitive, we'll be sure to share that with you. But thanks again for your questions, and we should move on now because time is up. Thank you. Ladies and gentlemen, due to the interest in time, we ask that you limit yourself to one question. Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with JMP Securities. Your line is open.

Two alpha really playing a role in the market. Thank you.

[Company Representative] (Exelixis): Wow, there's a lot there.

Michael Morrissey: Wow, there's a lot there.

Michael M. Morrissey: Wow, there's a lot there. So let me work backwards real fast. You asked, I think 3 or 4 questions there. I certainly don't want to comment on a competitor's study and the probability of success there, but I would refer you back to all the published data of TKIs combined with HIF-2 inhibitors compared to contemporaneous, say single-agent TKI data like CABO from CONTACT-03. And you can, I think, draw some conclusions there. And obviously, we want to see data. Data drives the process, and we'll see how that data looks, but I would really refer you back to some of the published data relative to what we're seeing with contemporaneous TKI data.

Speaker Change: Well Theres a lot there.

[Company Representative] (Exelixis): There's a lot to unpack there.

Amy Peterson: There's a lot to unpack there.

Operator: Yeah, so let me work backwards real fast. You asked, I think, three or four questions there. I certainly don't want to comment on a competitor's study and the probability of success there, but I would refer you back to all the published data of TKIs combined with HIF-2 inhibitors compared to contemporaneous, say single-agent TKI data like Cabo from Contact 03.

[Company Representative] (Exelixis): Yeah. So let me work backwards real fast. You asked, I think, three or four questions there. Certainly don't want to comment on a competitor's study and the probability of success there. I would refer you back to all the published data of TKIs combined with HIF-2 inhibitors compared to contemporaneous, say, single-agent TKI data like CABO from Contact-03, and you can, I think, draw some of the conclusions there. And, you know, obviously, we want to see data. Data, data, data drives the process, and we'll see how that data looks. But I would really refer you back to some of the published data relative to what we're seeing with contemporaneous TKI data.

Michael Morrissey: Yeah. So let me work backwards real fast. You asked, I think, three or four questions there. Certainly don't want to comment on a competitor's study and the probability of success there. I would refer you back to all the published data of TKIs combined with HIF-2 inhibitors compared to contemporaneous, say, single-agent TKI data like CABO from Contact-03, and you can, I think, draw some of the conclusions there. And, you know, obviously, we want to see data. Data, data, data drives the process, and we'll see how that data looks. But I would really refer you back to some of the published data relative to what we're seeing with contemporaneous TKI data.

Speaker Change: Yeah. So let me let me work backwards real fast you asked I think three or four questions there.

Speaker Change: Certainly don't want to comment on our competitors.

Speaker Change: Competitor study and the probability of success there I would refer you back to all the published data of.

Speaker Change: T J is.

Speaker Change: Bind with.

Speaker Change: <unk> two inhibitors.

Speaker Change: Compared to <unk>.

PJ: Thank you for taking my questions and congratulations on my quarter. I have a question about CAVO as an oral plus checkpoint inhibitor in prostate cancer. And, you know, absent a label and filing, even just how do you view the community setting versus the academic setting for prostate cancer playing out and also with respect to, you know, the potential lack of radioisotopes in the community setting and how do you see a path forward there based on the data that we've already seen, especially with eyes in the community setting where this may be the earlier choice for. Thank you. Yeah, great. PJ? Yeah, thanks for the question, Silvan. I think you kind of hit on some of the salient themes there.

Speaker Change: Contemporaneous.

Operator: And you can, I think, draw some conclusions there. And obviously, we want to see data. Data drives the process.

Speaker Change: Say single agent Teekay I data like Cabo from from contact three and you can I think draw some of the conclusions there and you know.

Speaker Change: Obviously, we want to see data data data data drives the process and we'll see how that data looks and but I would really refer you back to some of the published data relative to what we're seeing with contemporaneous.

Operator: And we'll see how that data looks, but I would really refer you back to some of the published data relative to what we're seeing with contemporaneous TKI data. In terms of clinical collaborations, yeah, we spoke to this at length at the J.P. Morgan update as well as the R&D Day presentation. We're super proud of all the work that we've done in collaboration with our commercial partners and our clinical partners on CABO. We think that was a really appropriate way to go relative to, you know, basically expanding the opportunities clinically by working with various partners to be able to run a variety of trials, 90R, the contacts, et cetera, where we had the opportunity to co-fund. As we talked about at J.P. Morgan in January, that's a priority for us with Zanza. The first few that we started by ourselves to get the ball rolling, and we're certainly having lots of discussions now around the possibility of combining Zanza with other checkpoints in a collaborative and potentially co-funding manner, but we don't want to get ahead of that.

And we'll see how that data looks, but I would really refer you back to some of the published data relative to what we're seeing with contemporaneous TKI data.

[Company Representative] (Exelixis): In terms of clinical collaborations, yeah, we, we spoke to this at length at the J.P. Morgan update, as well as the R&D Day presentation. We're super proud of all the work that we've done in collaboration with our commercial partners and our clinical partners on CABO. We think that was a really appropriate way to go relative to you know, basically expanding the opportunities clinically by working with various partners to be able to run a variety of trials, NET, the Contacts, et cetera, where we had we had the opportunity to co-fund. As we talked about at J.P. Morgan in January, that's a priority for us with zanza.

Michael Morrissey: In terms of clinical collaborations, yeah, we, we spoke to this at length at the J.P. Morgan update, as well as the R&D Day presentation. We're super proud of all the work that we've done in collaboration with our commercial partners and our clinical partners on CABO. We think that was a really appropriate way to go relative to you know, basically expanding the opportunities clinically by working with various partners to be able to run a variety of trials, NET, the Contacts, et cetera, where we had we had the opportunity to co-fund. As we talked about at J.P. Morgan in January, that's a priority for us with zanza.

Speaker Change: TK I data in terms of.

In terms of clinical collaborations, yes, we spoke to this at length at the J.P. Morgan update as well as the R&D Day presentation. We're super proud of all the work that we've done in collaboration with our commercial partners and our clinical partners on CABO. We think that was a really appropriate way to go relative to basically expanding the opportunities clinically by working with various partners to be able to run a variety of trials, 9ER, the CONTACTS, et cetera, where we had the opportunity to co-fund. As we talked about at J.P. Morgan in January, that's a priority for us with Zanza. The first few that we started by ourselves to get the ball rolling, and we're certainly having lots of discussions now around the possibility of combining Zanza with other checkpoints in a collaborative and potentially co-funding manner, but we don't want to get ahead of that.

Speaker Change: Our co clinical collaborations yes, we spoke to this at length at the at the Jpmorgan.

Speaker Change: Date, as well as the R&D day presentation, where super.

Speaker Change: Proud of all the work that we've done in collaboration with our commercial partners.

Speaker Change: And our clinical partners on Cabo, we think that was a really appropriate way to go relative to.

Speaker Change: Basically expanding the opportunities clinically by working with various partners to be able to run a variety of trials 90, or the contacts et cetera, where we had we had the opportunity to co fund as we talked about at JP Morgan in January that's a priority for us with Samsung the first few of them.

As we talked about at J.P. Morgan in January, that's a priority for us with ZANZA. The first few that we started by ourselves to get the ball rolling, and we're certainly having lots of discussions now around the possibility for combining ZANZA with other checkpoints in a collaborative and potentially co-funding manner, but we don't want to get ahead of that.

PJ: Obviously, in the community oncology setting, it's a bit different. Access to radioligand therapy is not as ubiquitous there. And, you know, when you talk to physicians, clinicians, and offices, it can potentially mean losing the patient and some opportunity there. So I think that's a consideration. As I mentioned previously, you know, I think what we know, our performance for Cabo in really all aspects, combination and monotherapy, is very strong in the community. So we know it's effective, I should say, a really large amount of physicians there have substantial experience with Cabo at this point, which is, which is great, clearly community oncologists who treat. A variety of malignancies have, you know, significant experience with, you know, various checkpoint inhibitors. So, I think that certainly could be a nice opportunity for us. Thank you. Operator.

Michael M. Morrissey: ... the first few that we started by ourselves to get the ball rolling, and we're certainly having lots of discussions now around the possibility for, combining zanzalintinib with other checkpoints, in a collaborative and potentially co-funding manner. But don't want to get ahead of that. When we have something to say that's definitive, we'll be sure to share that with you. But thanks again for your questions, and we should move on now because time is tight.

Michael Morrissey: ... the first few that we started by ourselves to get the ball rolling, and we're certainly having lots of discussions now around the possibility for, combining zanzalintinib with other checkpoints, in a collaborative and potentially co-funding manner. But don't want to get ahead of that. When we have something to say that's definitive, we'll be sure to share that with you. But thanks again for your questions, and we should move on now because time is tight.

Speaker Change: We started by ourselves to get the ball rolling and we're certainly having lots of discussions now around the possibility for combining <unk> with other checkpoints.

Speaker Change: In a collaborative and potentially co funding manner, but don't want to get ahead of that when we have something to say that's the credit it will be sure to share that with you, but thanks again for your questions and we should move on now because time is tight.

Operator: As we talked about at J.P. Morgan in January, that's priority for us with ZANZA, the first view that we started by ourselves to get the ball rolling. And we're certainly having lots of discussions now around the possibility for combining ZANZA with other checkpoints in a collaborative and potentially co-funding manner. But don't want to get ahead of that. When we have something to say that's definitive, we'll be sure to share that with you. But thanks again for your questions, and we should move on now, because time is running out. Thank you. Ladies and gentlemen, due to the interest in time, we ask that you limit yourself to one question. Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with JMP Securities. Your line is open.

As we talked about at J.P. Morgan in January, that's priority for us with ZANZA, the first view that we started by ourselves to get the ball rolling. And we're certainly having lots of discussions now around the possibility for combining ZANZA with other checkpoints in a collaborative and potentially co-funding manner. But don't want to get ahead of that. When we have something to say that's definitive, we'll be sure to share that with you. But thanks again for your questions, and we should move on now, because time is tight.

Operator: Thank you. Ladies and gentlemen, due to the interest of time, we ask that you limit yourself to one question. Please stand by for our next question. Our next question comes from the line of Sylvan Terkin with JMP Securities. Your line is open.

Akash Tewari: Thank you.

Operator: Ladies and gentlemen, due to the interest of time, we ask that you limit yourself to one question. Please stand by for our next question. Our next question comes from the line of Sylvan Terkin with JMP Securities. Your line is open.

Speaker Change: Thank you.

Ladies and gentlemen, due to the interest of time, we ask that you limit yourself to one question.

Speaker Change: Please standby for around next question.

Operator: [Operator Instructions] Our next question comes from the line of Silvan Tuerkcan with JMP Securities. Your line is open.

Speaker Change: Our next question comes from the line of Silvan <unk> with JMP Securities. Your line is open.

Operator: Thank you for taking my question, and congrats on the quarter. I have a question about CABO as an oral plus checkpoint inhibitor in prostate cancer, and as in the label and filing, even, just how do you view the community setting versus the academic setting for prostate cancer play out, also with respect to the potential lack of radioisotopes in the community setting? And how do you see a path forward, therefore based on the data that we've already seen, especially with eyes in the community setting, where this may be the earlier choice for patients? Thank you. Yeah, great. PJ? Yeah, thanks for the question, Silvan. I think you kind of hit on some of the salient themes there.

Silvan Tuerkcan: Thank you for taking my question, and congrats on the quarter. I have a question about CABO as an oral plus checkpoint inhibitor in prostate cancer, and as in the label and filing, even, just how do you view the community setting versus the academic setting for prostate cancer play out, also with respect to the potential lack of radioisotopes in the community setting? And how do you see a path forward, therefore based on the data that we've already seen, especially with eyes in the community setting, where this may be the earlier choice for patients? Thank you.

[Analyst] (JMP Securities): Yeah, thank you for taking my questions, and congrats on the quarter. I have a question about CABO as an oral plus checkpoint inhibitor in prostate cancer and, you know, asking the label and, and filing even, just how do you view the community setting versus the academic setting for prostate cancer play out? Also with respect to, you know, potential lack of radioisotopes in the community setting, and, and how do you, you know, see a path forward therefore, based on the data that we've already seen, especially with IOs in the community setting, where this may be the earlier choice for patients? Thank you.

Silvan Türkcan: Yeah, thank you for taking my questions, and congrats on the quarter. I have a question about CABO as an oral plus checkpoint inhibitor in prostate cancer and, you know, asking the label and, and filing even, just how do you view the community setting versus the academic setting for prostate cancer play out? Also with respect to, you know, potential lack of radioisotopes in the community setting, and, and how do you, you know, see a path forward therefore, based on the data that we've already seen, especially with IOs in the community setting, where this may be the earlier choice for patients? Thank you.

Silvan: And thank you for taking my question and congrats on the quarter.

Silvan: A question about <unk>.

Silvan: Cabo as an oral <unk> plus checkpoint inhibitor.

Silvan: Prostate cancer and asthma label and finally, given just how do you view the community setting versus the academic setting.

Silvan: For prostate cancer play out also with respect to potential lack of radioisotopes in the community setting.

Speaker Change: How are you.

Speaker Change: See a path forward therefore based on the data that we've already seen especially with high as in the community setting where this may be the earlier choice for patients. Thank you.

Michael M. Morrissey: Yeah, great. PJ?

Michael Morrissey: Yeah, great. PJ?

Yes. Great. P.J.? Yeah, thanks for the question, Silvan. I think you kind of hit on some of the salient themes there. Obviously, the community oncology setting is a bit different. Access to radioligand therapy is not as ubiquitous there. And, you know, when you talk to physicians, clinicians, and offices, it can potentially mean losing the patient and some opportunity there. So I think that's a consideration. As I mentioned previously, you know, I think what we know, our performance for Cabo in really all aspects, combination and monotherapy, is very strong in the community. So we know it's effective, I should say, you know, a really large amount of physicians there have substantial experience with CABO at this point, which is great, and are clearly community oncologists who treat. A variety of malignancies have significant experience with various checkpoint inhibitors.

Michael M. Morrissey: Yes. Great. P.J.?

Yes. Thanks for the question, Silvan. I think you kind of hit on some of the salient themes there. Obviously, the community oncology setting is a bit different. Access to radioligand therapy is not as ubiquitous there. And, you know, when you talk to physicians, clinicians, and offices, it can potentially mean losing the patient and some opportunity there. So I think that's a consideration. As I mentioned previously, I think what we know, our performance for CABO in really all aspects, combination and monotherapy, is very strong in the community-- I should say a really large amount of physicians there have substantial experience with CABO at this point, which is great,. And clearly, community oncologists who treat a variety of malignancies have significant experience with various checkpoint inhibitors.

J.P. Haley: Yes. Thanks for the question, Silvan. I think you kind of hit on some of the salient themes there. Obviously, the community oncology setting is a bit different. Access to radioligand therapy is not as ubiquitous there. And, you know, when you talk to physicians, clinicians, and offices, it can potentially mean losing the patient and some opportunity there. So I think that's a consideration.

P.J. Haley: Yeah, thanks for the question, Sylvan. I think you, you kind of hit on some, you know, some of the salient themes there. Obviously, the community oncology setting, it's a bit different. Access to radioligand therapy is not as ubiquitous there. And, you know, when you talk to physicians, clinicians, offices, it can potentially mean, you know, losing the patient, and some opportunity there. So I think that's a consideration. As I mentioned, previously, you know, I think what we know, our, our performance for CABO in really all aspects, combination and monotherapy, in the, is very strong in the community. So we know a strong, or I should say, you know, a really large amount of physicians there have substantial experience with CABO at this point, which is, which is great.

Speaker Change: Yes, great P. J, yes. Thanks for the question Silvan. Thank you you've kind of hit on some.

Operator: Please stand by for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open. Hi, this is Michael Riad on behalf of Jeff Hung.

Speaker Change: Some of the salient themes there obviously the community.

PJ: Obviously, the community oncology setting is a bit different. Access to radioligand therapy is not as ubiquitous there. And, you know, when you talk to physicians, clinicians, and offices, it can potentially mean losing the patient and some opportunity there. So I think that's a consideration. As I mentioned previously, you know, I think what we know, our performance for Cabo in really all aspects, combination and monotherapy, is very strong in the community. So we know it's effective, I should say, you know, a really large amount of physicians there have substantial experience with CABO at this point, which is great, and are clearly community oncologists who treat. A variety of malignancies have significant experience with various checkpoint inhibitors.

Speaker Change: My apologies setting it is a bit different.

Speaker Change: Access to radio like <unk> therapy is not as ubiquitous there and when you talk to physicians clinicians offices it can potentially mean.

Operator: Thank you for taking our question. Is there any impact on the development path for XP010 or 371 following the recent deal for Catalan? More specifically, are there any ADC capabilities lost, like on linker payload design or site conjugation? And if so, how could the company address these?

Speaker Change: Losing the patient.

Speaker Change: Some opportunity there.

Speaker Change: So I think that's a consideration.

Speaker Change: As I mentioned.

As I mentioned previously, I think what we know, our performance for CABO in really all aspects, combination and monotherapy, is very strong in the community-- I should say a really large amount of physicians there have substantial experience with CABO at this point, which is great,. And clearly, community oncologists who treat a variety of malignancies have significant experience with various checkpoint inhibitors. So I think that certainly could be a nice opportunity for us, should we be approved. Thank you.

Speaker Change: Previously I think what we know our performance for <unk>.

Speaker Change: Cabo and really all aspects combination and monotherapy.

Speaker Change: <unk> is very strong in the community.

Operator: Thanks so much. Thanks, Michael. This is Dana.

Speaker Change: So we know a strong or I should say really large amount of physicians that have substantial experience with cabo at this point, which is which is great.

Dana: I'll take that question. Yeah, so when we learned the news about Catalan, we immediately reached out to their leadership and had some very productive discussions. And at this point, I can say we're confident in their continuing support of our programs, and we don't anticipate any. Thank you. Please stand by for our next question. Our next question comes from Ilana Etzer Darout with BMO Capital Markets. Ilana, go.

P.J. Haley: Clearly, community oncologists who treat a variety of malignancies have, you know, significant experience with, you know, various checkpoint inhibitors. So I think that certainly could be a nice opportunity for us, should we be approved.

Speaker Change: And clearly community oncologists, who treat.

Speaker Change: A variety of malignancies have.

Speaker Change: If I can experience.

PJ: So I think that certainly could be a nice opportunity for us, should we? Thank you. Operator.

Speaker Change: Various checkpoint inhibitors, so I think that that certainly could be.

Speaker Change: A nice opportunity for us.

Speaker Change: Uh huh.

Speaker Change: Should we be approved.

Amy Peterson: Great.

[Analyst] (JMP Securities): Thank you.

Silvan Türkcan: Thank you.

Amy Peterson: Thank you, PJ. Operator, next question, please.

Susan Hubbard: Thank you, PJ. Operator, next question, please.

Speaker Change: Great. Thank you Jay.

Thank you. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open. Hi, this is Michael Riad on behalf of Jeff Hung.

Operator: Thank you. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open.

Operator: Please stand by for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open. Hi, this is Michael Riad on behalf of Jeff Hung.

Speaker Change: Operator next question. Please please standby borrow next question.

Operator: Please stand by for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open.

Hi, this is Michael Riad on for Jeff Hung. Thank you for taking our question. Is there any impact on the development path for XB010 or 371 following the recent deal for Catalent? More specifically, are there any ADC capabilities loss, like on linker payload design or site conjugation? And if so, how could the company address these? Thanks so much. Thanks, Michael. This is Dana.

Michael Riad: Hi, this is Michael Riad on for Jeff Hung. Thank you for taking our question. Is there any impact on the development path for XB010 or 371 following the recent deal for Catalent? More specifically, are there any ADC capabilities loss, like on linker payload design or site conjugation? And if so, how could the company address these? Thanks so much.

Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open.

[Analyst] (Morgan Stanley): Hi, this is Michael Riad on for Jeff Hung. Thank you for taking our question. Is there any impact on the development path for XB010 or XB371 following the recent deal for Catalent? More specifically, are there any ADC capabilities lost, like on linker payload design or site conjugation? And if so, how could the company address these? Thanks so much.

Michael Riad: Hi, this is Michael Riad on for Jeff Hung. Thank you for taking our question. Is there any impact on the development path for XB010 or XB371 following the recent deal for Catalent? More specifically, are there any ADC capabilities lost, like on linker payload design or site conjugation? And if so, how could the company address these? Thanks so much.

Operator: Great. Thanks for taking the time to answer the question. Just on the COBO label expansion, if you're able to provide any more color on the comment around sort of plan data-driven regulatory filings for NET and prostate cancer, and also whether or not the regulatory strategy for these two indications outside of the U.S. would be the same as it is here in the U.S., thank you. Yeah, I wouldn't want to comment on ex-U.S. regulatory strategies. That's in the hands of our partners. But Amy and or PJ can say a few words on the others.

Speaker Change: Hi, This is Michael Rehaut on for Jeff hung. Thank you for taking my question is there any impact on the development path for <unk> zero zero or $3 seven one following the recent deal for <unk> more specifically are there any ADC capabilities loss like linker payload designers site conjugation.

Operator: And if so, how could the company address these? Thanks so much. Thanks, Michael. This is Dana.

And if so, how could the company address these? Thanks so much. Thanks, Michael. This is Dana.

Speaker Change: So how could the company address these thanks so much.

Thanks so much. Thanks, Michael. This is Dana.

Thanks, Michael. This is Dana. I'll take that question. Yes. So when we learned the news about Catalent, we immediately reached out to their leadership and had some very productive discussions. And at this point, I can say we're confident in their continuing support of our programs, and we don't anticipate any change. Thank you. Please stand by for our next question. Our next question comes from Ilana Petzer-Durrell with BMO Capital Markets. Ilana, go.

Dana T. Aftab: Thanks, Michael. This is Dana. I'll take that question. Yes. So when we learned the news about Catalent, we immediately reached out to their leadership and had some very productive discussions. And at this point, I can say we're confident in their continuing support of our programs, and we don't anticipate any change.

Dana Aftab: Thanks, Michael. This is Dan, and I'll take that question. Yeah, so when we learned the news with Catalent, we immediately reached out to their leadership and had some very productive discussions. At this point, I can say we're, we're confident in their continuing support of our programs, and we don't anticipate any change.

Yeah. Thanks, Michael This is Dan I'll take that question.

Dan: Yes, so when we learned the news with Cadillac, we immediately reached out to their leadership and head.

Dan: Some very productive discussions and at this point I can say were confident and their continuing support of our programs and we don't anticipate any change.

[Analyst] (Morgan Stanley): Thank you so much.

Michael Riad: Thank you so much.

Speaker Change: Thank you so much.

Amy Peterson: Thanks, Michael.

Susan Hubbard: Thanks, Michael.

Speaker Change: Thanks, Michael.

Operator: Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is open.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Etzer Deraut with BMO Capital Markets. Your line is open.

Speaker Change: Thank you please standby for our next question.

Pets: Our next question comes from the line of pets. The route with BMO capital markets. Your line is open.

[Analyst] (BMO Capital Markets): Great, thanks for taking the question. Just on the CABO label expansion, if you're able to provide any more color on the comment around sort of planned data-driven regulatory filings for NET in prostate cancer, and also whether or not the regulatory strategy for these two indications outside of the US would be the same as it is here in the US. Thank you.

Operator: Great, thanks for taking the question. Just on the CABO label expansion, if you're able to provide any more color on the comment around sort of planned data-driven regulatory filings for NET in prostate cancer, and also whether or not the regulatory strategy for these two indications outside of the US would be the same as it is here in the US. Thank you.

Operator: Great. Thanks for taking the question. Just on the CABO label expansion, if you're able to provide any more color on the comment around sort of plan data-driven regulatory filings for NET and prostate cancer, and also whether or not the regulatory strategy for these two indications outside of the U.S. would be the same as it is here in the U.S.? Thank you. Yeah, I wouldn't want to comment on ex-U.S. regulatory strategies. That's in the hands of our partners. But Amy and or PJ can say a few words on the others. So, sure. So with regard to Cabinet, we had some really exciting data. I think most people are familiar with it.

Etzer Darout: Great. Thanks for taking the question. Just on the CABO label expansion, if you're able to provide any more color on the comment around sort of plan data-driven regulatory filings for NET and prostate cancer, and also whether or not the regulatory strategy for these two indications outside of the U.S. would be the same as it is here in the U.S.? Thank you.

Pets: Great. Thanks for taking my question just on the couple of label expansion. If you are able to provide any more color on the comment around sort of planned data driven regulatory filings for <unk> in prostate cancer, and also whether or not the regulatory strategy for these two indications outside of the U S would be the same as it is here in the U S. Thank you.

Operator: So, sure. So with regard to Cabinet, we had some really exciting data. I think most people are familiar with it.

Amy: We have a patient population that has a very poor prognosis, which was observed in the median time to progression on placebo of three months changed to eight point three and eleven point four months depending on whether or not you had peanuts or eat peanuts. We are in very close collaboration with the Alliance, and we're working hard to get the complete locked database transferred to us. It's hard to comment on the timelines, but we have some advantages with Cabinet that we didn't have, for example, with Cabo Sun, most notably that a blinded independent central radiology review was already incorporated into the study. And we do have a strong partnership with the Alliance.

Yeah, I wouldn't want to comment on ex-U.S. regulatory strategies. That's in the hands of our partners. But Amy and or PJ can say a few words on the others. So, sure. So with regard to Cabinet, we had some really exciting data. I think most people are familiar with it. We have a patient population that has a very poor prognosis, which was observed in the median time to progression on placebo of three months changed to eight point three and eleven point four months depending on whether or not you had peanuts or eat peanuts. We are in very close collaboration with the Alliance, and we're working hard to get the complete locked database transferred to us. It's hard to comment on the timelines, but we have some advantages with Cabinet that we didn't have, for example, with Cabo Sun, most notably that a blinded independent central radiology review was already incorporated into the study. And we do have a strong partnership with the Alliance.

Michael M. Morrissey: Yeah, I wouldn't want to comment on ex-U.S. regulatory strategies. That's in the arms of our partners, but Amy and/or P.J. can say a few words on the others.

Michael M. Morrissey: Yeah. I wouldn't want to comment on ex-US regulatory strategies. That's in the arms of our partners, but Amy can, and/or PJ can say a few words on the others, so.

Michael Morrissey: Yeah. I wouldn't want to comment on ex-US regulatory strategies. That's in the arms of our partners, but Amy can, and/or PJ can say a few words on the others, so.

Speaker Change: Yes, I wouldn't want to comment on ex U S regulatory strategy, that's in the arms of our partners, but Amy can.

Amy: P. J can say a few words on the others. So sure so with regard to cabinet, we had some really exciting data.

Operator: So, sure. So with regard to Cabinet, we had some really exciting data. I think most people are familiar with it.

Amy Peterson: Sure. So with regard to CABINET, we had some really exciting data. I think most people are familiar with it. We have a patient population that has a very poor prognosis that was observed in the median time to progression on placebo of 3 months, changed to 8.3 and 11.4 months in, depending on whether or not you had pNET or epNET. We are in very close collaboration with the Alliance, and we're working hard to get the complete locked database transferred to us. It's hard to opine on the timelines, but we have some advantages with CABINET that we didn't have, for example, with CABOSUN, most notably, BI, Blinded Independent Central Radiology Review was already incorporated into the study.

Sure. So with regard to CABINET, we had some really exciting data. I think most people are familiar with it. We have a patient population that has a very poor prognosis, which was observed in the median time to progression on placebo of 3 months changed to 8.3 and 11.4 months depending on whether or not you had pNET or epNET. We are in very close collaboration with the Alliance, and we're working hard to get the complete locked database transferred to us. It's hard to opine on the timelines, but we have some advantages with CABINET that we didn't have, for example, with CABOSUN, most notably blinded independent central radiology review was already incorporated into the study. And we do have a strong partnership with the Alliance.

Amy: I think most people are familiar with it we have a patient population that has a very poor prognosis that was observed in the median time to progression on placebo of three months.

Andrew Peters: We have a patient population that has a very poor prognosis, which was observed in the median time to progression on placebo of three months changed to eight point three and eleven point four months depending on whether or not you had peanuts or eat peanuts. We are in very close collaboration with the Alliance, and we're working hard to get the complete locked database transferred to us. It's hard to comment on the timelines, but we have some advantages with Cabinet that we didn't have, for example, with Cabo Sun, most notably that a blinded independent central radiology review was already incorporated into the study. And we do have a strong partnership with the Alliance.

<unk> to $8, three and 11, four months and depending on whether or not you had peanuts or not.

Amy: We are in very close collaboration with the alliance and they're working hard to get the complete locked database transferred to US it's hard to opine on the timelines, but we have some advantages with cabinet that we didn't have for example, with Cabo San most notably a.

It's hard to opine on the timelines, but we have some advantages with CABINET that we didn't have, for example, with CABOSUN, most notably blinded independent central radiology review was already incorporated into the study. And we do have a strong partnership with the Alliance. And so we're looking forward to having discussions with the agency in 2024. That's about all I can say with regard to CABINET. And when it comes to CONTACT-O2, I think I've already mentioned, and we are anticipating final OS results sometime in 2024. However, we believe that the data that we presented at ASCO G.U. represents a data package that sufficiently supports the totality of clinical benefit in the ITT patient population.

Amy: Blinded independent Central Radiology review was already incorporated into the study and when you do have a strong partnership with the alliance and so we're looking forward to having discussions with the agency in 2020 for it that's about all I can say with regard to cabinet and when it comes to.

Amy Peterson: We do have a strong partnership with the Alliance, and so we're looking forward to having discussions with the agency in 2024. That's about all I can say with regard to CABINET. When it comes to Contact-02, I think I've already mentioned, you know, we are anticipating final OS results sometime in 2024. However, we believe that the data that we presented at ASCO GU represents a data package that sufficiently supports the totality of clinical benefit in the ITT patient population, and we'll have ongoing discussions with the agency on how best to bring that in front of them.

Andrew Peters: And so we're looking forward to having discussions with the agency in twenty twenty four. That's about all I can say with regard to Cabinet. And when it comes to contact O2, I think I've already mentioned, and we are anticipating final O.S. results sometime in twenty twenty four. However, we believe that the data that we presented at ASCO G.U. represents a data package that sufficiently supports the totality of clinical benefit in the ITT patient population.

Amy: And so we're looking forward to having discussions with the agency in twenty twenty four. That's about all I can say with regard to Cabinet. And when it comes to contact O2, I think I've already mentioned, and we are anticipating final O.S. results sometime in twenty twenty four.

Amy: Contact O. Two I think I've already mentioned, we are anticipating final OS results sometime in 2024. However, we believe that the data that we presented at <unk> G. You represents a data package that sufficiently supports the totality of clinical benefit in the ITT patient.

And when it comes to CONTACT-O2, I think I've already mentioned, and we are anticipating final OS results sometime in 2024. However, we believe that the data that we presented at ASCO G.U. represents a data package that sufficiently supports the totality of clinical benefit in the ITT patient population. We'll have ongoing discussions with the agency on how best to bring that in front of them.

Amy: However, we believe that the data that we presented at ASCO G.U. represents a data package that sufficiently supports the totality of clinical benefit in the ITT patient population. We'll have ongoing discussions with the agency on how best to bring that to the attention of. Thank you. You're welcome. Operator.

Andrew Peters: And we'll have ongoing discussions with the agency on how best to bring that in front of. All right, thank you. You're welcome. Operator, next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

And we'll have ongoing discussions with the agency on how best to bring that in front of.

Amy: Population will have ongoing discussions with the agency on how best to bring that in front of them.

[Analyst] (BMO Capital Markets): All right. Thank you.

Etzer Darout: All right. Thank you.

All right, thank you. You're welcome. Operator, next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

All right, thank you. You're welcome.

Etzer Darout: All right, thank you.

Speaker Change: Okay. Thank you.

Amy Peterson: You're welcome. Operator, next question, please?

Susan Hubbard: You're welcome. Operator, next question, please?

Operator, next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

You're welcome. Operator, next question.

Operator, next question.

Speaker Change: Youre welcome Operator next question please.

Operator: Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Operator: Our next question comes from the line of Peter Lawson with Barclays. Your line is open. Question around guidance. Thoughts on pricing and volume in 2024, especially in light of IRA and any kind of seasonality that we should be thinking about for revenues through 2024. Yeah, hi Peter. It's PJ.

Operator: Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Speaker Change: Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Operator: Great, thank you. Just a question around guidance, thoughts on pricing and volume in 2024, especially in light of IRA and any kind of seasonality that we should be thinking about for revenues through '24? Yeah, Peter, it's PJ.

Peter Lawson: Great, thank you. Just a question around guidance, thoughts on pricing and volume in 2024, especially in light of IRA and any kind of seasonality that we should be thinking about for revenues through '24?

Peter Lawson: Great. Thank you. Just a question around guidance. Your thoughts on pricing and volume in 2024, especially in light of IRA and any kind of seasonality that we should be thinking about for revenues through 2024?

Peter Lamb: Great. Thank you.

Peter Lamb: Question.

Peter Lamb: Question around guidance.

Peter Lamb: Pricing and volume.

Peter Lamb: In 2024, especially in life.

Peter Lamb: Any kind of seasonality that we should be thinking about for revenues through 'twenty four.

Yes. Hi, Peter, it's PJ. Thanks for the question. The IRA is clearly now in play this year. What that means specifically is our price increase was 2.2%, as we certainly didn't want to incur any inflation related penalties there with regards to our revenue. The real good news for patients there in terms of Medicare is that the patient's out-of-pocket will be limited this year to approximately $3,300. Next year that will be $2,500, and it's really early days from what we're observing there, but obviously good news for patients with the potential to have those lower out-of-pocket costs. So we're keeping a close eye on it, and yes, we'll track it and update it as available. Good. And anything else we should think about as it goes to seasonality for the year?

P.J. Haley: Yes. Hi, Peter, it's PJ. Thanks for the question. The IRA is clearly now in play this year. What that means specifically is our price increase was 2.2%, as we certainly didn't want to incur any inflation related penalties there with regards to our revenue. The real good news for patients there in terms of Medicare is that the patient's out-of-pocket will be limited this year to approximately $3,300. Next year that will be $2,500, and it's really early days from what we're observing there, but obviously good news for patients with the potential to have those lower out-of-pocket costs. So we're keeping a close eye on it, and yes, we'll track it and update it as available.

P.J. Haley: Yeah. Hi, Peter, it's PJ. Thanks for the question. You know, the IRA is clearly, you know, now in play this year. You know, what that means specifically is our price increase was 2.2%, as we certainly didn't want to incur any inflation-related penalties there with regards to our revenue. The real good news for patients there in terms of Medicare is that the patient out-of-pocket will be limited this year to approximately $3,300. Next year, that'll be $2,500. And it's really early days from what we're observing there, but obviously, good news for patients with the potential to have those lower out-of-pocket costs. So we're keeping a close eye on it, and yeah, we'll track it and update as available.

Peter Lamb: Yeah, Hi, Peter It's P. J thanks for the question.

PJ: Thanks for the question. The IRA is clearly, you know, now in play this year. What that means specifically is our price increase was 2.2%, as we certainly didn't want to incur any inflation.

P. J: The Iras clearly.

P. J: Now in play this year.

P. J: What that means specifically is our price increase was two 2%.

P. J: As we certainly didn't want to incur any inflation.

PJ: The real good news for patients there in terms of Medicare is that the patient's out-of-pocket cost will be limited this year to approximately $3,300. Next year that will be $2,500, and it's really early days from what we're observing there, but obviously good news for patients with the potential to have those lower out-of-pocket costs. So we're keeping a close eye on it. Yeah, we'll track it and update it as available. Good. And anything else we should think about as it goes to seasonality for the year?

PJ: The real good news for patients there in terms of Medicare is that the patient's out-of-pocket cost will be limited this year to approximately $3,300. Next year that will be $2,500, and it's really early days from what we're observing there, but obviously good news for patients with the potential to have those lower out-of-pocket costs, so we're keeping a close eye on it. Yeah, we'll track it and update it as available. Great. And is there anything else we should think about as it goes to seasonality for the year?

P. J: Related penalties there with regards to our revenue.

P. J: The real good news for patients who are in terms of Medicare is that the patient out of pocket.

P. J: We will be limited this year to approximately $3300 next year that'll be 2500.

P. J: And it's really early days from what we're observing there, but obviously good news for patients with the potential to have those lower out of pocket costs. So we're keeping a close eye on it and.

Speaker Change #101: Yes, we'll track it and update is available.

Peter Lawson: Great. And anything else we should think about as regards to seasonality for the year?

Peter Lawson: Great. And anything we should think about as regards to seasonality, for the year?

Speaker Change #102: Great and anything we should think about as it goes to seasonality.

PJ: Yes, nothing we would comment on here, Peter. Operator, can we have the next question, please? We're getting close to the top of the hour. Thank you. Please stand by for our next question. Our next question comes from Yolanda Cavalier-Pullman with BTIG. Yolanda, it's open. Yeah, good evening. Congratulations on the progress. And thanks for taking my question. Regarding the phase 2, 3 head and neck cancer trial for Zanza and Keytruda, is it mostly to replace Keytruda monotherapy that is used in patients with lower tumor burdens, or do you also expect it to work better than Keytruda and chemocombination for Bugsy disease? Yeah, sorry, very, very quickly. This is a study that is just the ends of PEMBRO versus PEMBRO. There is no chemotherapy containing arm.

Michael M. Morrissey: Yes, nothing we would comment on here, Peter.

PJ: You had nothing we would comment on. Thanks, Peter. Operator, do we have the next question? close to the top of the hour.

Speaker Change #102: For the year.

Our next question comes from the line of Kaveri Pohlman with BTIG. Yolanda, it's open. Yeah, good evening. Congratulations on the progress. And thanks for taking my question. Regarding the phase 2, 3 head and neck cancer trial for Zanza and Keytruda, is it mostly to replace Keytruda monotherapy that is used in patients with lower tumor burdens, or do you also expect it to work better than Keytruda and chemocombination for Bugsy disease? Yeah, sorry, very, very quickly. This is a study that is just the ends of PEMBRO versus PEMBRO. There is no chemotherapy containing arm.

Operator: Our next question comes from the line of Kaveri Pohlman with BTIG. Your line is open.

P.J. Haley: Yeah, nothing we would comment on here, Peter.

Speaker Change #103: Yes, nothing we would comment on here Peter.

[Company Representative] (Exelixis): Thanks, Peter. Operator, can we have the next question, please? We're getting close to the top of the hour.

Susan Hubbard: Thanks, Peter. Operator, can we have the next question, please? We're getting close to the top of the hour.

Good evening, and congrats on the progress. And thanks for taking my question. Regarding the Phase II/III head and neck cancer trial for ZANZA and KEYTRUDA, is it mostly to replace KEYTRUDA monotherapy that is used in patients with lower tumor burdens? Or do you also expect it to work better than KEYTRUDA and chemo combination for bulky disease? Yeah, sorry, very, very quickly. This is a study that is just the ends of PEMBRO versus PEMBRO. There is no chemotherapy containing arm.

Kaveri Pohlman: Good evening, and congrats on the progress. And thanks for taking my question. Regarding the Phase II/III head and neck cancer trial for ZANZA and KEYTRUDA, is it mostly to replace KEYTRUDA monotherapy that is used in patients with lower tumor burdens? Or do you also expect it to work better than KEYTRUDA and chemo combination for bulky disease?

Speaker Change #104: Thanks, Peter Operator could we have next question. Please for getting close to the top of the hour. Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from Yolanda Cavalier-Pullman with BTIG. Yolanda, it's open.

Operator: Thank you. Please stand by for our next question. Our next question comes from Ilana Cabarillo-Pullman with BTIG. Your line is open.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Kaveri Pullman with BTIG. Your line is open.

Please standby for our next question.

Pullman: Our next question comes from along the cavalry of Pullman with P. T.

Andrew Peters: Yeah, good evening. Congratulations on the progress. And thanks for taking my question. Regarding the phase 2, 3 head and neck cancer trial for Zanza and Keytruda, is it mostly to replace Keytruda monotherapy that is used in patients with lower tumor burdens, or do you also expect it to work better than Keytruda and chemocombination for Bugsy disease? Yeah, sorry, very, very quickly. This is a study that is just the ends of PEMBRO versus PEMBRO. There is no chemotherapy containing arm.

Amy: Yeah, good evening. Congratulations on the progress. And thanks for taking my question. Regarding the phase 2, 3 head and neck cancer trial for Zanza and Keytruda, is it mostly to replace Keytruda monotherapy that is used in patients with lower tumor burdens, or do you also expect it to work better than Keytruda and chemocombination for bulky disease? Yeah, hi.

Pullman: T I G. Your line is open.

Kaveri Pohlman: Yeah, good evening. Congrats on the progress, and thanks for taking my question. Regarding the phase 2/3 head and neck cancer trial for zanzalintinib and Keytruda, is it mostly to replace Keytruda monotherapy that is used in patients with lower tumor burden, or do you also expect it to work better than Keytruda in chemo combination for bulky disease?

Operator: Yeah, good evening. Congrats on the progress, and thanks for taking my question. Regarding the phase 2/3 head and neck cancer trial for zanzalintinib and Keytruda, is it mostly to replace Keytruda monotherapy that is used in patients with lower tumor burden, or do you also expect it to work better than Keytruda in chemo combination for bulky disease?

Yeah. Good evening, congrats on the progress and thanks for taking my question regarding the phase two three head and neck cancer trial for example, and Keytruda is it mostly to replace Keytruda monotherapy that is used in patients with lower tumor burden or you also expect it to work rather than Keytruda chemo combo.

Yes, sorry, Kaveri. Very quickly, this is a study that is ZANZA/PEMBRO versus PEMBRO. There is no chemotherapy-containing arms. So the former, not the latter, right, replacing monotherapy with KEYTRUDA. Yes, I just kind of want to know that, you know, Keytruda monotherapy is mostly used in lower tumor burden patients. Is that what you will be focusing on in your trial as well? Heeding back to some of the comments I made earlier, the study has inclusion and exclusion criteria. Some of the inclusion criteria require that, for example, the tumor has to express a CPS score greater than one percent.

Amy Peterson: Yes, sorry, Kaveri. Very quickly, this is a study that is ZANZA/PEMBRO versus PEMBRO. There is no chemotherapy-containing arms. So the former, not the latter, right, replacing monotherapy KEYTRUDA.

Pullman: In Asia for bulky disease.

Amy Peterson: Yeah, hi. Sorry, Kaveri. Very quickly, this is a study that is just zanzalintinib pembro versus pembro. There is no chemotherapy-containing arm, so, the former, not the latter, right? Replacing monotherapy Keytruda.

Yes, hi.

Amy: Sorry, very, very quickly. This is a study that is just the ends of PEMBRO versus PEMBRO. There are no chemotherapy arms.

Speaker Change #106: Sorry can vary very quickly. This is a study that is just stands at Pembroke versus pan-broil. It there is no chemotherapy containing harm so.

Andrew Peters: So the former, not the latter, right, replacing monotherapy with Keytruda. Yes, I just kind of want to know that, you know, Keytruda monotherapy is mostly used in lower tumor burden patients. Is that what you will be focusing on in your trial as well? Heeding back to some of the comments I made earlier, the study has inclusion and exclusion criteria. Some of the inclusion criteria require that, for example, the tumor has to express a CPS score greater than one percent.

Yes, I just kind of want to know that KEYTRUDA monotherapy is mostly used in lower tumor burden patients. Is that what you will be focusing on in your trial as well? Heeding back to some of the comments I made earlier, the study has inclusion and exclusion criteria. Some of the inclusion criteria require that, for example, the tumor has to express a CPS score greater than one percent.

Kaveri Pohlman: Yes, I just kind of want to know that KEYTRUDA monotherapy is mostly used in lower tumor burden patients. Is that what you will be focusing on in your trial as well?

Amy: So the former, not the latter, right? Replacing monotherapy. Yes, I just kind of want to know that, you know, Keytruda Monotherapy is mostly used in lower tumor burden patients. Is that what you will be focusing on in your trial as well? So hearkening back to some of the comments I made earlier, the study has inclusion and exclusion criteria. Some of the inclusion criteria require that, for example, the tumor has to express a CPS score greater than 1%.

Speaker Change #107: The former not the latter right, replacing monotherapy keytruda.

Kaveri Pohlman: Yeah. Yes, I just kind of, like, wanted to know that, you know, Keytruda monotherapy, it is mostly used in lower tumor burden patients. Is that what you will be focusing on in your trial as well?

Speaker Change #107: Yeah.

Speaker Change #108: Yes, I just kind of like wanted to know that Keytruda monotherapy is mostly used.

Amy Peterson: So harkening back to some of the comments I made earlier, the study has inclusion and exclusion criteria. Some of the inclusion criteria require that, for example, the tumor has to express the CPS score greater than 1%. There's not necessarily a limit on tumor burden. So, again, we go to equipoise, what study and-- treatment arm, either treatment arm reasonable for the patient sitting in front of the physician, in order to randomize. I can't speak to what burden of disease they would enroll in the study.

Speaker Change #108: Used in lower tumor burden in patients is that what you will be focusing on in your trial as well.

Amy Peterson: So, harkening back to some of the comments I made earlier, the study has inclusion and exclusion criteria. Some of the inclusion criteria require that, for example, the tumor has to express the CPS score greater than 1%. There's not necessarily a limit on tumor burden. So again, we go to equipoise. What is the treatment arm, either treatment arm, reasonable for the patient sitting in front of the physician in order to randomize? I can't speak to what burden of disease they would enroll in the study.

Speaker Change #109: So harkening back some of the comments I made earlier the study has inclusion and exclusion criteria. Some of the inclusion criteria require that the for example, the tumor has to express the Cps score of greater than 1%, there's not necessarily a limit on tumor burden. So again, we go to <unk>.

Andrew Peters: There's not necessarily a limit to tumor burden. So, again, we go to equipoise what study and treatment is the treatment arm, either treatment arm reasonable for the patient sitting in front of the physician. In order to randomize, I can't speak to what burden of disease they would enroll on.

Amy: There's not necessarily a limit to tumor burden. So again, we go to equipoise. What study is the treatment arm, or any treatment arm, reasonable for the patient sitting in front of the physician in order to randomize? I can't speak to what burden of disease they would enroll in.

Speaker Change #108: Boyds what.

Speaker Change #110: Study in treatment is the treatment arm either treatment arm reasonable for the patient sitting in front of the physician in order to randomize I can't speak to what burden of disease. They wouldn't wrong study great. Thank you Amy and operator, let's take our final question. Please.

Andrew Peters: Our final question comes from the line of Christopher Liu with Leerink Partners. Your line is open.

Amy: Thank you, Amy. Thank you. Our final question comes from the line of Christopher Liu with LeRink Partners. Your line is open.

[Company Representative] (Exelixis): Great. Thank you, Amy. Operator, let's take our final question, please.

Susan Hubbard: Great. Thank you, Amy. Operator, let's take our final question, please.

Operator: Thank you. Our final question comes from the line of Christopher Lu with Liberate Partners. Your line is open.

Speaker Change #111: Thank you.

Speaker Change #111: Final question comes from the line of Christopher <unk> with Leerink Partners. Your line is open.

Operator: Thanks for the question. On CONTACT-02, you guys had a median duration of treatment exposure of 4 months and a median progression-free survival of 6 months. I was just wondering what the key driver of that difference was. And then just a quick second one. You guys have a few ADCs in the pipeline? Just wondering what the technology is driving that. Is it still ZYMEWORKS? So I'll take the treatment exposure question. I think we actually presented at ASCO-GU that we had dose intensity of 94% with CABO and 83% with Atezo. The median duration of therapy being disconnected from the PFS can be for a variety of reasons. Patients take chemotherapy breaks, they restart, they get dose reductions, they restart. So it's not anything that I can elaborate on at this point in time. Good. Dana, final answer? Sure. Yeah, so for the newer ADCs in the pipeline, we're not using Zyme Works. That is primarily through the Smart Tag technology with Catalyst.

Christopher Liu: Thanks for the question. On CONTACT-02, you guys had a median duration of treatment exposure of 4 months and a median progression-free survival of 6 months. I was just wondering what the key driver of that difference was. And then just a quick second one. You guys have a few ADCs in the pipeline? Just wondering what the technology is driving that. Is it still ZYMEWORKS?

Operator: Thanks for the question. On CONTACT-02, you guys had a median duration of treatment exposure of four months and a median progression-free survival of six months. Just wondering what the key driver of that difference was, and then just a quick second one. You guys have a few ADCs in the pipeline. Just wondering what the technology is driving that.

[Analyst] (Liberate Partners): Thanks for the question. On Contact-02, you guys had a median duration of treatment exposure of four months and a median progression-free survival of six months. Just wondering what the key driver of that difference was? And then just a quick second one: you guys have a few ADCs in the pipeline. Just wondering what the technology is driving that. Is it still Zymeworks?

Operator: Thanks for the question. On Contact-02, you guys had a median duration of treatment exposure of four months and a median progression-free survival of six months. Just wondering what the key driver of that difference was? And then just a quick second one: you guys have a few ADCs in the pipeline. Just wondering what the technology is driving that. Is it still Zymeworks?

Christopher: Thanks for the question.

Christopher: On contact owed to you guys had a median duration of treatment exposure for months and median progression free survival of six months just wondering what the key driver of that difference was and then just a quick second one if you can.

Operator: And then just a quick second one. You guys have a few ADCs in the pipeline. Just wondering what the technology is driving that.

Christopher: I have a few a b season the pipeline just wondering what the technology is driving that is it still zimmer.

Operator: Is it still Zymark? So I'll take the treatment exposure question. I think we actually presented at ASCO-GU that we had dose intensity of 94% with CABO and 83% with Atezo. The median duration of therapy being disconnected from the PFS can be for a variety of reasons. Patients take chemotherapy breaks, they restart, they get dose reductions, they restart. So it's not anything that I can elaborate on at this point in time. Good. Dana, final answer? Sure. Yeah, so for the newer ADCs in the pipeline, we're not using Zyme Works. That is primarily through the Smart Tag technology with Catalyst.

Amy: Is it still Zymark? So I'll take the treatment exposure question. I think we actually presented at ASCO-GU that we had dose intensity of 94% with CABO and 83% with Atezo. The median duration of therapy being disconnected from the PFS can be for a variety of reasons. Patients take chemotherapy breaks, they restart, they get dose reductions, they restart.

Amy Peterson: So I'll take the treatment exposure question. I think, you know, we actually presented at ASCO GU that we had dose intensity of 94% with cabo and 83% with atezo. The median duration of therapy being disconnected with the PFS can be for a variety of reasons. Patients take chemotherapy breaks, they restart, they get dose reductions, they restart. So you know, it's not anything that I can elaborate on at this point in time.

Speaker Change #113: So I'll take the treatment exposure question I think we actually presented at <unk> that we had dose intensity of 94% with Cabo and <unk> 83.

So I'll take the treatment exposure question. I think we actually presented at ASCO-GU that we had dose intensity of 94% with CABO and 83% with ATEZO. The median duration of therapy being disconnected with the PFS can be for a variety of reasons. Patients take chemotherapy breaks, they restart, they get dose reductions, they restart. So it's not anything that I can elaborate on at this point in time. Good. Dana, final answer? Sure. Yeah, so for the newer ADCs in the pipeline, we're not using Zyme Works. That is primarily through the Smart Tag technology with Catalyst.

Amy Peterson: So I'll take the treatment exposure question. I think we actually presented at ASCO-GU that we had dose intensity of 94% with CABO and 83% with ATEZO. The median duration of therapy being disconnected with the PFS can be for a variety of reasons. Patients take chemotherapy breaks, they restart, they get dose reductions, they restart. So it's not anything that I can elaborate on at this point in time.

Speaker Change #114: Percent with a T. Though the median duration of therapy being disconnected with the PFS can be for a variety of reasons patients take chemotherapy breaks they restart they get dose reductions they restart so yeah. It is it's it's not anything that I can elaborate on that at this point in time.

Operator: So it's not anything that I can elaborate on at this point in time. Good. Dana, final answer? Sure. Yeah, so for the newer ADCs in the pipeline, we're not using Zyme Works. That is primarily through the Smart Tag technology with Catalyst.

Amy: So it's not anything that I can elaborate on at this point in time. Good. Dana, final answer?

P.J. Haley: Good. Dana, final answer?

Michael Morrissey: Good. Dana, final answer?

Good. Dana, final answer? Sure. Yeah, so for the newer ADCs in the pipeline, we're not using Zyme Works. That is primarily through the Smart Tag technology with Catalyst.

Michael M. Morrissey: Good. Dana, final answer?

Dana: Sure. Yeah, so for the newer ADCs in the pipeline, we're not using ZymWorks. That is primarily through the Smart Tag technology with Catalyst.

Dana Aftab: Sure. Yeah, so for the newer ADCs in the pipeline, we're not using Zymeworks. That is primarily through the SmartTag technology with Catalent.

Speaker Change #114: Dana final answer sure, yes, so for the newer adcs in the pipeline, we're not using some works that is primarily through the smart tag technology with Catlin.

Sure. Yes. So for the newer ADCs in the pipeline, we're not using ZYMEWORKS. That is primarily through the SMARTag technology with Catalent. Yeah, I'd recommend if you're interested in the details that we had a pretty fulsome discussion around all that information at the R&D day in December. So take a look at the webcast, and I think you'll have a very deep understanding of how broad we have the platform built around both linkers and warheads with various. Thank you, Mike. And with that, we'll thank everybody for joining us. I'll throw the call today for your attention, for your questions, and we're certainly available to take any follow-up. Have a great rest of your day. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Dana T. Aftab: Sure. Yes. So for the newer ADCs in the pipeline, we're not using ZYMEWORKS. That is primarily through the SMARTag technology with Catalent.

Yes, I'd recommend, if you're interested in the details, we had a pretty fulsome discussion around all that information at the R&D Day in December. So take a look at the webcast, and I think you'll have a very deep understanding of how broad we have the platform built around both linkers and warheads with various ADCs. Thank you, Mike. And with that, we'll thank everybody for joining us. I'll throw the call today for your attention, for your questions, and we're certainly available to take any follow-up. Have a great rest of your day. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Michael M. Morrissey: Yes, I'd recommend, if you're interested in the details, we had a pretty fulsome discussion around all that information at the R&D Day in December. So take a look at the webcast, and I think you'll have a very deep understanding of how broad we have the platform built around both linkers and warheads with various ADCs.

Michael M. Morrissey: Yeah, I'd recommend if you're interested in the details that we had a pretty fulsome discussion around all that information at the R&D day in December. So take a look at the webcast, and I think you'll have a very deep understanding of how extensive we have it. This is a platform built around both linkers and warheads with various...

P.J. Haley: Yeah, I'd recommend if you're interested in the details that we had a pretty fulsome discussion around all that information at the R&D Day in December. So take a look at the webcast, and I think you'll have a very deep understanding of how broad we have the platform built around both linkers and warheads with various ADCs.

Michael Morrissey: Yeah, I'd recommend if you're interested in the details that we had a pretty fulsome discussion around all that information at the R&D Day in December. So take a look at the webcast, and I think you'll have a very deep understanding of how broad we have the platform built around both linkers and warheads with various ADCs.

Dana: Yeah, I'd recommend if you're interested in the details that we had a pretty fulsome discussion around all that information at the R&D day in December. So take a look at the webcast, and I think you'll have a very deep understanding of how broad we have the platform built around both linkers and warheads with various. Thank you, Mike. And with that, we'll thank everybody for joining us. I'll throw the call today for your attention, for your questions, and we're certainly available to take any follow-up. Have a great rest of your day. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Dana: I would recommend if you're interested in the details, let's say, we had a pretty fulsome discussion around all of that information at the R&D day in December so take a look at the webcast and I think you'll have.

Dana: <unk> deep understanding of how broad we have the platform built around both lingers and warheads with various agencies.

Great. Thank you, Mike. And with that, we'll thank everybody for joining us for the call today, for your attention, for your questions, and we're certainly available to take any follow-up you may have. Have a great rest of your day. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Susan Hubbard: Great. Thank you, Mike. And with that, we'll thank everybody for joining us for the call today, for your attention, for your questions, and we're certainly available to take any follow-up you may have. Have a great rest of your day.

Operator: Thank you, Mike. And with that, we'll thank everybody for joining us. Let's go to the call today for your questions. Available to take any follow-up, Have a great rest of your day. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

[Company Representative] (Exelixis): Great. Thank you, Mike. And with that, we'll thank everybody for joining us throughout the call today, for your attention, for your questions, and we're certainly available to take any follow-up you may have. Have a great rest of your day.

Susan Hubbard: Great. Thank you, Mike. And with that, we'll thank everybody for joining us throughout the call today, for your attention, for your questions, and we're certainly available to take any follow-up you may have. Have a great rest of your day.

Speaker Change #116: Great. Thank you, Mike and with that we'll thank everybody for joining us on the call today for your attention for your questions and we're certainly available to take any follow up you may have a great rest of your day.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker Change #117: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Speaker Change #117: Okay.

Speaker Change #117: [music].

Speaker Change #117: Okay.

Speaker Change #117: [music].

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