Q1 2024 Exelixis Inc Earnings Call

April 30, 2024

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Operator: Good morning ladies and gentlemen, and welcome to the Exelixis' first quarter 2024 financial results conference call. My name is Tawanda and I'll be your operator today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Mr. Varant Shirvanian, Director of Investor Relations. Please proceed.

Speaker Change: Good day, ladies and gentlemen, and welcome to <unk> first quarter 2024, and that's results conference call.

Wanda: My name is to Wanda and I'll be your operator today.

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

Wanda: I would now like to turn the call over to your host for today, Mr. Robert Sherbondy Director of Investor Relations. Please proceed.

Varant Shirvanian: Thank you, Tawanda, and thank you all for joining us for the Exelixis' Q1 2024 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO; Chris Senner, our Chief Financial Officer; PJ Haley, our Executive Vice President of Commercial; Amy Peterson, our Chief Medical Officer; and Dana Aftab, our Chief Scientific Officer, who together will review our progress for the Q1 2024 ended 31 March 2024. 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. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company.

Varant Shirvanian: Thank you, Tawanda, and thank you all for joining us for the Exelixis first quarter 2024 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, P.J Haley, our Executive Vice President of Commercial, Amy Peterson, our Chief Medical Officer, and Dana Aftab, our Chief Scientific Officer, who together, will review our progress for the first quarter of 2024, which ended March 31st, 2024.

Robert Sherbondy: Thank you for Honda and thank you all for joining us for the <unk> first quarter 2024 financial results Conference call.

Robert Sherbondy: Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner, Our Chief Financial Officer P. J Haley, our executive Vice President of commercial Amy Peterson, Our Chief Medical Officer, and Deanna Aftab, Our Chief Scientific Officer, who together will review our progress for the first quarter 2024 and at March 31.

Robert Sherbondy: <unk> thousand 24.

Varant Shirvanian: 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. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company.

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

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

Robert Sherbondy: During the course of this presentation, we will be making forward looking statements regarding future events and the future performance of the company.

Varant Shirvanian: 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 Securities and Exchange Commission, which under the heading Risk Factors identify important factors that could cause actual results to differ materially from those expressed 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 discovery, product development, business development, and commercialization activities. With that, I'll turn the call over to Mike.

Varant Shirvanian: 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 Securities and Exchange Commission, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed 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 discovery, product development, business development and commercialization activities. With that, I'll turn the call over to Mike.

Robert Sherbondy: This includes statements about possible developments regarding discovery product development regulatory commercial financial and strategic matters.

Robert Sherbondy: Fuel events or results could of course differ materially we refer you to the documents we file from time to time with the Securities and Exchange Commission, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation risks and.

Robert Sherbondy: Fees 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 discovery product development business development and commercialization activities with that I will.

Michael M. Morrissey: All right. Thanks, Varant, and thanks to everyone for joining us on the call today. Exelixis is off to a strong start in 2024 and had a productive first quarter across all components of our business. We're pleased to see both revenue and demand growth for the ComboZanza franchise in the US and globally. Top priority is to move the needle for patients and shareholders by advancing ComboZanza and the rest of our exciting pipeline to improve the standard of care for patients with cancer. We have a lot to cover today, so let's jump right into it with the key highlights for the quarter, including, first. We saw a strong performance of the ComboZanza business in the first quarter of 2024, with continued growth in demand and revenue year-over-year compared to first quarter 2023.

Michael M. Morrissey: Alright, thanks Varant, and thanks to everyone for joining us on the call today. Exelixis is off to a strong start in 2024 and had a productive first quarter across all components of our business. We're pleased to see both revenue and demand growth for the [inaudible] franchise in the U.S. and globally. Our top priority is to move the needle for patients and shareholders by advancing Cabo, Zanza and the rest of our exciting pipeline to improve the standard of care for patients with cancer.

Turn the call over to Mike Alright, Thanks, Brian and thanks to everyone for joining us on the call today <unk> is off to a strong start in 2024 and had a productive first quarter across all components of our business. We're pleased to see both revenue and demand growth for the Cabozantinib franchise in the U S and globally.

Speaker Change: Our priority is to move the needle for patients and shareholders by advancing Cabo exams, and the rest of our exciting pipeline to improve the standard of care for patients with cancer.

Michael M. Morrissey: We have a lot to cover today so let's jump right into it with the key highlights for the quarter, including first, we saw a strong performance of the Cabo business in the first quarter of 2024, with continued growth in demand and revenue year over year, compared to first quarter 2023. Even with typical seasonal headwinds that were further magnified by the implementation of the IRA, Cabo Medics maintained its status as the leading TKI for RCC in both the first line IOTKI market and the second line monotherapy segment. First quarter 2024, Cabo franchise net product revenues grew 4% year over year compared to first quarter 2023, highlighting its role as a worldwide leading TKI, global Cabo [inaudible] and franchise net product revenues generated by Exelixis and its partners grew approximately 9% year over year in the first quarter of 2024 compared to first quarter 2023.

Michael M. Morrissey: You want to cover today, so let's jump right into it with the key highlights for the quarter, including first.

We saw strong performance of the Cabozantinib biggest business in the first quarter of 2024 with continued growth in demand and revenue year over year compared to first quarter 2023.

Michael M. Morrissey: Even with typical seasonal headwinds that were further magnified by the implementation of the IRA, CABOMETYX maintained its status as the leading TKI for RCC in both the first-line IO TKI market and the second-line monotherapy segment. Q1 2024, CABOMETYX franchise net product revenues grew 4% year-over-year compared to Q1 2023. Highlighting its role as a worldwide leading TKI, global CABOMETYX zanzalintinib franchise net product revenues generated by Exelixis and its partners grew approximately 9% year-over-year in Q1 2024 compared to Q1 2023. As discussed previously, we're excited about the potential for additional CABOMETYX growth, with the new indications on the horizon that PJ and Amy will discuss shortly. Chris will review our full Q1 2024 financial results in his prepared remarks. Second, we continue to advance our industry-leading pipeline across all stages of preclinical and clinical development.

Michael M. Morrissey: Even with typical seasonal headwinds that were further magnified by the implementation of the Iowa rate Teva medics maintained its status as the leading Teekay I for RCC.

Michael M. Morrissey: The first line <unk> market. The second line monotherapy segment's first quarter 2020 for Cabo franchise net product revenues grew 4% year over year compared to first quarter 2023 highlights.

Michael M. Morrissey: Highlighting its role as a worldwide, leading teekay I global Cabozantinib franchise net product revenues generated by <unk> and its partners grew approximately 9% year over year in the first quarter 2024, compared to first quarter 2023 as.

Michael M. Morrissey: As discussed previously, we're excited about the potential for additional Cabo growth with the new indications on the horizon that PJ and Amy will discuss shortly. Chris will review our full first quarter 2024 financial results in his prepared remarks.

Michael M. Morrissey: As discussed previously we are excited about the potential for additional cargo growth with the new indications on the horizon that P J and Amy will discuss shortly.

Michael M. Morrissey: Chris will review, our full first quarter 2024 financial results in his prepared remarks second we continued to advance our industry, leading pipeline across all stages of preclinical and clinical development.

Michael M. Morrissey: Second, we continued to advance our industry-leading pipeline across all stages of preclinical and clinical development. Our top priorities for 2024 are to advance potential new combo indications for NET and metastatic CRPC and expedite Zanza's clinical development with both existing and new pivotal trials as well as potential new combination strategies. XB002 cohort expansion remains a clear focus for us, and XL309 continues to generate exciting momentum in the synthetic lethality space. Finally, we're thrilled with our progress in advancing new candidates in discovery and preclinical development, targeting a range of solid tumor indications that comprise an IND pipeline of both small molecules and biotherapeutics, which we expect to evolve quickly over the next several years.

Michael M. Morrissey: Our top priorities for 2024 are to advance potential new cabo indications for NET and metastatic CRPC and expedite zanza clinical development with both existing and new pivotal trials, as well as potential new combination strategies. XB002 cohort expansion remains a clear focus for us, and XL309 continues to generate exciting momentum in the synthetic lethality space. Finally, we're thrilled with our progress in advancing new candidates in discovery and preclinical development, targeting a range of solid tumor indications that comprise an IND pipeline of both small molecules and biotherapeutics, which we expect to evolve quickly over the next several years. Third, final reply briefs for the second MSN and the trial were submitted in February, and we continue to expect a ruling in the first half of 2024. While we will not speak to any specifics today, this remains a critical milestone for the company and the cabo-zanza franchise.

Michael M. Morrissey: Our top priority for 2024 are to advance potential new Cabo indications for net and metastatic CRP C and expedite the <unk> clinical development with both existing and new pivotal trials as well as potential new combination strategies XP <unk> cohort expansion remains a clear focus for us.

Michael M. Morrissey: And X L 309 continues to generate exciting momentum in the synthetic metallurgy space. Finally, we're thrilled with our progress in advancing new candidates in discovery and preclinical development targeting a range of solid tumor indications that comprise an IND pipeline at both small molecules and bio therapeutics.

Michael M. Morrissey: Which we expect to evolve quickly over the next several years.

Michael M. Morrissey: Third, final reply briefs for the second MSN and the trial were submitted in February, and we continue to expect a ruling in the first half of 2024. While we will not speak to any specifics today, this remains a critical milestone for the company and the Cabos [inaudible] Franchise. Exelixis will continue to vigorously protect our intellectual property rights with respect to Cabo and our other differentiated molecules we pursue on behalf of patients with cancer. Finally, fourth, we expect business development activities to ramp up significantly as we gain clarity on the outcome of the patent litigation.

Third, final reply briefs for the second MSN and the trial were submitted in February, and we continue to expect a ruling in the first half of 2024. While we will not speak to any specifics today, this remains a critical milestone for the company and the Cabos [inaudible] Franchise. Exelixis will continue to vigorously protect our intellectual property rights with respect to Cabo and our other differentiated molecules we pursue on behalf of patients with cancer.

Michael M. Morrissey: Third final reply briefs for the second M. S N and the trial were submitted in February and we continue to expect a ruling in the first half of 2024, while we will not speak to any specifics today. This remains a critical milestone for the company and the Cabozantinib franchise excellence will continue to vigorous.

Michael M. Morrissey: Exelixis will continue to vigorously protect our intellectual property rights with respect to Combo and our other differentiated molecules we pursue on behalf of patients with cancer. Finally, fourth, we expect business development activities to ramp up significantly as we gain clarity on the outcome of the patent litigation. Fortunately, we're exploring options to collaborate with other organizations in cost and compound sharing arrangements in a manner similar to our prior ComboZanza checkpoint combination endeavors. In addition, we are carefully reviewing the competitive landscape on an enterprise-wide level to identify additional later-stage assets that we believe, through our unique ComboZanza lens, fit into our GU and GI oncology-focused drug development and commercialization platform. So with that, please see our press release issued an hour ago for our Q1 2024 financial results and an extensive list of key corporate milestones achieved in the quarter.

Michael M. Morrissey: We protect our intellectual property rights with respect to Cabo and our other differentiated molecules, we pursue on behalf of patients with cancer.

Finally, fourth, we expect business development activities to ramp up significantly as we gain clarity on the outcome of the patent litigation. And finally, we're exploring options to collaborate with other organizations in cost and compound sharing arrangements in a manner similar to our prior Cabozantinib checkpoint combination endeavors. In addition, we are carefully reviewing the competitive landscape on an enterprise-wide level to identify additional later-stage assets that we believe, through our unique Cabozantinib lens, fit into our GU and GI oncology focused drug development and commercialization platform. So with that, please see our press release issued an hour ago for our first quarter 2024 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: Finally, fourth we expect business development activities to ramp up significantly as we gain clarity on the outcome of the patent litigation. Fortunately, we're exploring options to collaborate with other organizations and cost and compounds sharing arrangements in a manner similar to our prior cabozantinib checkpoint.

Michael M. Morrissey: And finally, we're exploring options to collaborate with other organizations in cost and compound sharing arrangements in a manner similar to our prior Cabozantinib checkpoint combination endeavors. In addition, we are carefully reviewing the competitive landscape on an enterprise-wide level to identify additional later-stage assets that we believe, through our unique Cabozantinib lens, fit into our GU and GI oncology focused drug development and commercialization platform. So with that, please see our press release issued an hour ago for our first quarter 2024 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: Asian endeavors.

Michael M. Morrissey: <unk>, we are carefully reviewing the competitive landscape on an enterprise wide level to identify additional later stage assets that we believe through our unique cabozantinib lens.

Michael M. Morrissey: Get into our <unk> and Gi oncology focused drug development and commercialization platform.

Michael M. Morrissey: With that please see our press release issued an hour an hour ago for our first quarter 2024 financial results and an extensive list of key corporate milestones achieved in the quarter I'll now turn the call over to Chris. Thanks.

Michael M. Morrissey: I'll now turn the call over to Chris.

Christopher J. Senner: Thanks, Mike. For the first quarter 2024, the company reported total revenues of approximately $425 million, which included ComboZanza franchise net product revenues of $378.5 million, ComboMedics net product revenues were $376.4 million, and included approximately $6 million in clinical trial sales. Gross to net for the ComboZanza franchise in the first quarter 2024 was 32.9%, which is higher than the gross to net we experienced in the fourth quarter 2023, but overall in line with our expectations. This increase in gross to net deductions in the first quarter 2024 is primarily related to higher Medicare Part D and PHS expenses. Historically, we have experienced higher Medicare Part D expenses in the first quarter of the year due to many Part D patients moving through the donor hole at the start of the calendar year.

Christopher J. Senner: Thanks, Mike. For the first quarter of 2024, the company reported total revenues of approximately $425 million, which included Cabozantinib franchise net product revenues of $378.5 million. Cabo Medics net product revenues were $376.4 million and included approximately $6 million in clinical trials. Gross to net for the Cabozantinib franchise for the first quarter of 2024 was 32.9%, which is higher than the gross to net we experienced in the fourth quarter of 2023, but overall, in line with our expectations. This increase in gross to net deductions in the first quarter of 2024 is primarily related to higher Medicare Part D and PHS expenses.

Christopher J. Senner: Thanks, Mike for the first quarter of 2024, the company reported total revenues of approximately $425 million.

Christopher J. Senner: Which included Cabozantinib franchise net product revenues of $378 5 billion.

Christopher J. Senner: <unk> net product revenues were $376 4 million and included approximately $6 million in clinical trial sales.

Christopher J. Senner: Most of that for the Cabozantinib franchise in the first quarter 2024 was 32, 9%, which is higher than the gross to net we experienced in the fourth quarter of 2023, but overall in line with our expectations.

Christopher J. Senner: This increase in gross to net deductions in the first quarter of 2024 is primarily related to higher Medicare Part D and PHS expenses. Historically, we have experienced higher Medicare Part D expenses in the first quarter of the year due to many Part D patients moving through the donor hole at the start of the calendar year.

This increase in gross to net deductions in the first quarter of 2024 is primarily related to higher Medicare Part D and PHS expenses.

Christopher J. Senner: This increase in gross to net deductions in the first quarter of 2024 is primarily related to higher Medicare part D and Phs expenses.

Historically, we have experienced higher Medicare Part D expenses in the first quarter of the year due to many Part D patients moving through the donor hole at the start of the calendar year.

Christopher J. Senner: Historically, we have experienced higher Medicare part D expenses in the first quarter of the year due to many part D patients moving through the donut hole at the start of the calendar year.

Christopher J. Senner: Our Cabometyx trade inventory decreased by approximately 350 units when compared to Q4 2023, with approximately 2.4 weeks on hand. As I mentioned on our Q4 earnings conference call, we experienced a trade inventory build in Q4 2023 of approximately 1,000 units, in that we had observed an inventory drawdown in January. As discussed previously, Exelixis took a 2.2% price increase on 1 January 2024. This price increase is more than offset by the higher gross to net deductions during Q1 2024. Also, while we don't provide quarterly revenue guidance, we do see some seasonality in net product revenue trends, where Q1 net product revenues have historically been lower than the following quarters in a year.

Christopher J. Senner: Our CABOMETYX trade inventory decreased by approximately 350 units when compared to the fourth quarter of 2023 to approximately 2.4 weeks on hand. As I mentioned on our fourth quarter earnings conference call, we experienced a trade inventory build in the fourth quarter of 2023 of approximately 1,000 units, and that we had observed an inventory drawdown in January. As discussed previously, Exelixis took a 2.2% price increase on January 1, 2023. This price increase is more than offset by the higher gross to net deductions during the first quarter of 2024.

Christopher J. Senner: Our cosmetics trade inventory decreased by approximately 350 units when compared to the fourth quarter of 2023, approximately two four weeks on hand.

Christopher J. Senner: As I mentioned on our fourth quarter earnings conference call, we experienced a trade inventory build in the fourth quarter of 2023 of approximately 1000 units and that we had observed an inventory drawdown in January as discussed previously <unk> took a two 2% price increase on January one 2020 for.

Christopher J. Senner: This price increase is more than offset by the higher gross to net deductions during the first quarter of 2024. Also, while we don't provide quarterly revenue guidance, we do see some seasonality in net product revenue trends, where first quarter net product revenues have historically been lower than the following quarters in a year. If you analyze the last seven years of first-quarter net product revenue and compare them to the reported annual net product revenues of the same year, in many of those years, the first-quarter net product revenues are in the range of 21 to 23% of our annual net product revenues.

This price increase is more than offset by the higher gross to net deductions during the first quarter of 2024.

Christopher J. Senner: This price increases more than offset by the higher gross to net deductions. During the first quarter of 2024 also while we don't provide quarterly revenue guidance, we do see some seasonality in net product revenue trends, our first quarter net product revenues have historically been lower than the following quarters in a year. If you analyze the last seven years.

Also, while we don't provide quarterly revenue guidance, we do see some seasonality in net product revenue trends, where first quarter net product revenues have historically been lower than the following quarters in a year. If you analyze the last seven years of first-quarter net product revenue and compare them to the reported annual net product revenues of the same year, in many of those years, the first-quarter net product revenues are in the range of 21 to 23% of our annual net product revenues.

Christopher J. Senner: If you analyze the last seven years of the first quarter net product revenue and compare them to the reported annual net product revenues of the same year, in many of those years, the first quarter net product revenues are in the range of 21% to 23% of our annual net product revenues. We took this seasonality impact into account when preparing our annual net product revenue guidance of $1.65 to $1.75 billion, which we are reiterating on today's call. As a reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue in future quarters. Total revenues also included approximately $47 million in collaboration revenues, including approximately $40 million of royalty earned from Ipsen on their sales of cabozantinib in their territories.

Christopher J. Senner: First quarter net product revenue and compare them to the reported annual net product revenues of the same year and many of those years. The first quarter net product revenues are in the range of 21% to 23% of our annual net product revenues. We took this seasonality impact into account when preparing our annual net product revenue guidance of $1 65 to $1 75.

Christopher J. Senner: We took this seasonality impact into account when preparing our annual net product revenue guidance of $1.65 to $1.75 billion, which we are reiterating on today's call. As a reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue in future quarters.

Christopher J. Senner: <unk>.

Christopher J. Senner: Which we are reiterating on today's call.

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

Christopher J. Senner: Total revenues also included approximately $47 million in collaboration revenues, including approximately $40 million of royalty earned from Ibsen and Takeda on their sales of Cabozantinib in their territories. Our total operating expenses, excluding restructuring charges, for the first quarter of 2024 were approximately $363 million, compared to $398 million in the fourth quarter of 2023. The sequential decrease in these operating expenses was primarily driven by lower drug discovery in general and administrative expenses in the first quarter of 2024.

Christopher J. Senner: Total revenues also included approximately $47 million in collaboration revenues, including approximately $40 million of royalties earned from Ipsen and Takeda on their sales of Cabozantinib in their territories.

Christopher J. Senner: Our total operating expenses, excluding restructuring charges for Q1 2024, were approximately $363 million compared to $398 million in Q4 2023. The sequential decrease in these operating expenses was primarily driven by lower drug discovery and general and administrative expenses in Q1 2024. In January 2024, we announced a restructuring of our business, which included a headcount reduction of 174 FTEs. The total costs of this restructuring in Q1 2024 were approximately $33 million, which includes severance and employee-related costs, asset impairment, and contract termination costs. Provision for income taxes for Q1 2024 was approximately $12 million compared to provision for income taxes approximately $18 million for Q4 2023.

Christopher J. Senner: Our total operating expenses, excluding restructuring charges for the first quarter 2024, or approximately $363 million compared to $398 million in the fourth quarter of 2023.

Christopher J. Senner: The sequential decrease in these operating expenses was primarily driven by lower drug discovery and general and administrative expenses in the first quarter of 2024.

Christopher J. Senner: In January 2024, we announced the restructuring of our business, which included a headcount reduction of 174 FTEs. The total cost of this restructuring in the first quarter of 2024 was approximately $33 million, which includes severance and employee-related costs, asset impairment, and contract termination costs. Provision for income taxes for the first quarter of 2024 was approximately $12 million, compared to provision for income taxes of approximately $18 million for the fourth quarter of 2023.

Christopher J. Senner: In January 2024, we announced the restructuring of our business, which included a head count reduction of 174 Ftes.

Christopher J. Senner: The total cost of this restructuring in the first quarter 2024, or approximately $33 million, which we include which includes severance and employee related costs asset impairment and contract termination costs for.

Christopher J. Senner: Provision for income taxes for the first quarter of 2024 was approximately $12 million compared to a provision for income taxes of approximately $18 million for the fourth quarter of 2023.

Christopher J. Senner: The company reported GAAP net income of approximately $37 million or 12 cents per share on a fully diluted basis for Q1 2024. The company also reported non-GAAP net income of approximately $52 million or 17 cents per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $15 million of stock-based compensation expense net of the related income tax effect. Cash and investments for the quarter ended 31 March 2024 was approximately $1.6 billion. During the first quarter of 2024, we repurchased approximately $191 million of Exelixis shares at an average price of $22.08. We remain committed to fully executing on the $450 million share repurchase program we announced in January 2024. Combining the 2023 and 2024 share repurchase program, we will return $1 billion to our shareholders by the end of 2024.

Christopher J. Senner: The company reported gap net income of approximately $37 million or $0.12 per share on a fully diluted basis for the first quarter of 2024. The company also reported non-gap net income of approximately $52 million or $0.17 per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $15 million of stock-based compensation expense net of the related income tax effect.

Christopher J. Senner: The company reported GAAP net income of approximately $37 million or <unk> 12 per share on a fully diluted basis for the first quarter 2024. The company also reported non-GAAP net income of approximately $52 million or <unk> 17 per share on a fully diluted basis.

Christopher J. Senner: Cash and investments for the quarter ended March 31, 2024 were approximately $1.6 billion. During the first quarter of 2024, we repurchased approximately $191 million of Exelixis' shares at an average price of $22.08. We remain committed to fully executing on the $450 million share repurchase program we announced in January 2024. Combining the 2023 and 2024 share repurchase programs, we will return $1 billion to our shareholders by the end of 2024. 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 our $450 million share repurchase program. And finally, we are reiterating our full year 2024 financial guidance, which is detailed on slide 14 of our earnings presentation. And with that, I'll turn the call over to PJ.

Christopher J. Senner: non-GAAP net income excludes the impact of approximately $15 million of stock based compensation expense net of the related income tax effect cash and investments for the quarter ended March 31, 2024 was approximately $1 6 billion.

Christopher J. Senner: During the first quarter of 2024, we repurchased approximately $191 million of <unk> shares at an average price of $22 eight.

Christopher J. Senner: We remain committed to fully executing on the $450 million share repurchase program, we announced in January 2024.

Christopher J. Senner: Combining the 2023 and 2024 share repurchase program, we will return $1 billion to our shareholders by the end of 2024.

Christopher J. 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 our $450 million share repurchase program. Finally, we are reiterating our full year 2024 financial guidance, which is detailed on Slide 14 of our earnings presentation. With that, I'll turn the call over to PJ. Thank you, Chris. In Q1 2024, the team continued to execute at a high level, which has resulted in CABOMETYX continuing to be the number one prescribed TKI in RCC and second-line HCC. Additionally, CABOMETYX, in combination with nivolumab, remains the number one TKI plus IO combination in first-line renal cell carcinoma.

Christopher J. Senner: This level of cash and investments supported by our ongoing cash flow from operations provides <unk> with the flexibility to invest in internal R&D activities to pursue.

Christopher J. Senner: External business development opportunities to expand our pipeline and allows us to return capital to our shareholders through our $450 million share repurchase program.

Speaker Change: And finally, we are reiterating our full year 2024 financial guidance, which is detailed on slide 14 of our earnings presentation and with that I'll turn the call over to P. J. Thank.

P.J. Haley: In the first quarter of 2024, the team continued to execute at a high level, which resulted in CABOMETYX continuing to be the number one prescribed TKI in RCC and second line HCC. Additionally, CABOMETYX, in combination with Novolumab, remains the number one TKI plus IO combination in first-line renal cell carcinoma. With regard to prescriptions, CABOMETYX's TRX volume grew 4% year over year in Q1 2024 relative to Q1 2023. However, in the same period, the TKI market basket was flat.

P. J.: Thank you, Chris and the first quarter of 2024 team continued to execute at a high level, which has resulted in Kabul mix continuing to be the number one prescribed <unk> in RCC and second line HCC.

P. J.: Additionally, <unk> in combination with pneumonia map remains the number one <unk> plus Io combination in first line renal cell carcinoma.

Christopher J. Senner: With regards to prescriptions, CABOMETYX TRx volume grew 4% year-over-year in Q1 2024 relative to Q1 2023. In the same period, the TKI market basket was flat. Furthermore, the business remains strong both in terms of demand, and new patient starts. CABOMETYX continued to perform well in the first quarter from both a marketplace, and competitive perspective. CABOMETYX again led the TKI market basket in TRx share at 40%. As we have discussed previously, the first-line RCC market is extremely competitive, and Q1 was the sixth full quarter in which CABOMETYX plus nivolumab remained the number one prescribed TKI plus IO combination in first-line RCC. Furthermore, long-term data from the CheckMate-9ER study, now with a minimum of four years follow-up, was presented at ASCO GU this year and continues to reinforce the leadership position that CABOMETYX has in the RCC marketplace.

P. J.: With regards to prescriptions <unk> T. Rx volume grew 4% year over year in Q1 2024 relative to Q1 2023.

P. J.: In the same period, the <unk> market basket was flat.

Patrick J. Haley: Furthermore, the business remains strong, both in terms of demand and new patients starts. CABOMETYX continued to perform well in the first quarter from both a marketplace and competitive perspective. CABOMETYX again led the TKI market basket in TRX share at 40%. As we have discussed previously, the first-line RCC market is extremely competitive. Q1 was the sixth full quarter in which CABOMETYX plus Novolumab remained the number one prescribed TKI plus IO combination in first-line RCC.

P. J.: Furthermore, the business remained strong both in terms of demand and new patient starts.

P. J.: <unk> continued to perform well in the first quarter from both a marketplace and competitive perspective.

P. J.: <unk> again led the tpa market basket in Trs share at 40%.

P. J.: As we have discussed previously the first line RCC market is extremely competitive.

P. J.: Q1 was the sixth full quarter in which <unk> plus Nevada Mab remained the number one prescribed <unk> plus Io combination in first line RCC.

Patrick J. Haley: Furthermore, long-term data from the Checkmate 9ER study, now with a minimum of four years of follow-up, was presented at ASCO-GU this year and continues to reinforce the leadership position that CABOMETYX has in the RCC market. Looking forward, the commercial team is excited about the positive results from the Cabinet trial in neuroendocrine tumors as well as the CONTACT-2 trial in metastatic castration-resistant prostate cancer, which Amy will discuss in some detail. Neuroendocrine tumors comprise a large and heterogeneous patient population.

Furthermore, long-term data from the Checkmate 9ER study, now with a minimum of four years of follow-up, was presented at ASCO-GU this year and continues to reinforce the leadership position that CABOMETYX has in the RCC market. Looking forward, the commercial team is excited about the positive results from the Cabinet trial in neuroendocrine tumors as well as the CONTACT-2 trial in metastatic castration-resistant prostate cancer, which Amy will discuss in some detail.

P. J.: Furthermore, long term data from the Checkmate <unk> study now with a minimum of four years follow up was presented at <unk>. This year and continues to reinforce the leadership position <unk> has in the RCC marketplace.

Christopher J. Senner: Looking forward, the commercial team is excited about the positive results from the CABINET trial in neuroendocrine tumors as well as the CONTACT-02 trial in metastatic castration-resistant prostate cancer, which Amy will discuss in some detail. Neuroendocrine tumors comprise a large and heterogeneous patient population. If patients become metastatic and progress, treatment options become limited. The only oral therapy options are sunitinib and everolimus, and there has not been an approval in the US for an oral agent in NET since 2016. There is a strong unmet need for new options for patients who have progressed on systemic therapy. There are approximately 8,000 incident second-line plus drug-treatable patients annually in the US. Approximately 20% of these patients are SSTR negative, and in lung NETs, that percentage is higher, with 40% to 60% being SSTR negative.

P. J.: Looking forward our commercial team is excited about the positive results from the cabinet trial.

P. J.: So Andrew <unk> tumors as well as the contact to trial in metastatic castration resistant prostate cancer, which Amy will discuss in some detail.

P. J.: Neuroendocrine tumors comprise a large and heterogeneous patient population.

Neuroendocrine tumors comprise a large and heterogeneous patient population. As patients become metastatic and progress, treatment options become limited. The only oral therapy options are sunitinib and everolimus. There has not been an approval in the U.S. for an oral agent in NET since 2016. There is a strong unmet need for new options for patients who have progressed on systemic therapy. There are approximately 8,000 incident second-line plus drug-treatable patients annually in the US. Approximately 20% of these patients are SSTR negative, and in lung cancer, that percentage is higher, with 40 to 60 percent being SSTR negative.

Patrick J. Haley: As patients become metastatic and progress, treatment options become limited. The only oral therapy options are sunitinib and everolimus. There has not been an approval in the U.S. for an oral agent in NET since 2016.

P. J.: The patients become metastatic and progress.

P. J.: Treatment options become limited.

P. J.: The only oral therapy options are sunitinib and ever alignments and there has not been an approval in the U S for an oral agent in net <unk>.

P. J.: 2016.

Patrick J. Haley: There is a strong unmet need for new options for patients who have progressed on systemic therapy. There are approximately 8,000 incident second-line plus drug-treatable patients annually in the US. Approximately 20% of these patients are SSTR negative, and in lung cancer, that percentage is higher, with 40 to 60 percent being SSTR negative.

P. J.: There is a strong unmet need for new options for patients who have progressed on systemic therapy.

P. J.: There are approximately 8000 incident second line plus drug treatable patients annually in the U S.

P. J.: Approximately 20% of these patients are <unk> T are negative.

P. J.: And in lung Mets that percentage is higher 40% to 60% being S STR negative.

Christopher J. Senner: Most NET patients will receive many lines of therapy, in part due to the more indolent nature of the disease relative to other solid tumors. We have conducted preliminary market research, which reveals that oral therapies account for approximately 50% of the utilization in this market in the second-line plus setting. The CABINET study had a diverse population, including pancreatic, extrapancreatic, and lung NET patients, SSTR positive or negative patients, as well as previously treated with Lutathera. Regulatory approval for CABINET would potentially position Combo to help a broad range of NET patients. Metastatic castration-resistant prostate cancer is a large market with significant unmet medical need, where the primary therapeutic options remain novel hormonal therapy, chemotherapy, and radioligand therapy. There is a significant unmet need in this patient population, particularly for patients progressing on an NHT and who wish to delay chemotherapy.

Patrick J. Haley: Most NET patients will receive many lines of therapy, in part due to the more indolent nature of the disease relative to other solid tumors. We have conducted preliminary market research, which reveals that oral therapies account for approximately 50% of the utilization in this market in the second line plus setting. The Cabinet study had a diverse population, including pancreatic, extra pancreatic, and lung net patients, SSTR positive or negative patients as well as patients previously treated with Lutathera.

P. J.: Most net patients will receive many lines of therapy.

P. J.: In part due to the more indolent nature of the disease relative to other solid tumors.

P. J.: We have conducted preliminary market research, which reveals that oral therapies account for approximately 50% of the utilization in this market in the second line plus setting.

P. J.: The cabinet study had a diverse population, including pancreatic extra pancreatic and lung net patients.

P. J.: SSD are positive or negative patients as well as previously treated with <unk>.

Patrick J. Haley: Regulatory approval for Cabinet would potentially position CABO to help a broad range of NET patients. Metastatic castration-resistant prostate cancer is a large market with significant unmet medical needs, where the primary therapeutic options remain novel hormonal therapy, chemotherapy, and radioligand therapy. There is a significant unmet need in this patient population, particularly for patients progressing on an NHT and who wish to delay chemotherapy. Many patients receive an NHT before they become metastatic and castrate resistant.

P. J.: Regulatory approval for cabinet with potentially positioning Cabo to help a broad range of net patients.

P. J.: Metastatic castration resistant prostate cancer is a large market with significant unmet medical need where the primary therapeutic options remain novel hormonal therapy.

P. J.: <unk> and.

P. J.: And radio ligand therapy.

P. J.: There is a significant unmet need in this patient population, particularly for patients progressing on an NHS and who wish to delay chemotherapy.

Christopher J. Senner: Many patients receive an NHT before they become metastatic and castrate-resistant. Cabo plus atezo represents a potential option for many of these patients with novel mechanisms of action and convenient administration in the metastatic CRPC setting. Furthermore, the commercial organization would be well-positioned to leverage the RCC team infrastructure to achieve synergy in a new GU oncology indication. In summary, regulatory approval in these additional indications with significant unmet need would provide the opportunity for continued growth for Cabometyx in the coming years. I would also add that the commercial team is extremely excited about the progress in the pipeline, particularly zanzalintinib, as we look forward to having another product to help patients with cancer. With that, I will turn the call over to Amy.

P. J.: Many patients receive and NH T before they become metastatic castrate resistant.

Patrick J. Haley: CABO plus Attezo represents a potential option for many of these patients with novel mechanisms of action and convenient administration in the metastatic CRPC setting. Furthermore, the commercial organization would be well positioned to leverage the RCC team infrastructure to achieve synergy in a new GU oncology indication. In summary, regulatory approval and these additional indications of significant unmet need would provide the opportunity for continued growth for CABOMETYX in the coming years.

P. J.: Cabo plus <unk> represents a potential option for many of these patients with novel mechanisms of action and convenient administration in the metastatic <unk> setting.

P. J.: Furthermore, the commercial organization would be well positioned to leverage the RCC team infrastructure to achieve synergy and a new GE you oncology indication.

P. J.: In summary, regulatory approval in these additional indications with significant unmet need would provide the opportunity for continued growth for <unk> in the coming years.

Patrick J. Haley: I would also add that the commercial team is extremely excited about the progress in the pipeline, particularly Zanzalitinib, as we look forward to having another product to help patients with cancer. With that, I will turn the call over to Amy.

P. J.: I would also add that the commercial team is extremely excited about the progress in the pipeline, particularly Zamzam Whitman as we look forward to having another product to help patients with cancer.

P. J.: With that I will turn the call over to Amy <unk>.

Patrick J. Haley: Thanks, PJ. Today, I'll provide a high-level update on our clinical stage pipeline. The team is continuing the momentum across all of the programs we highlighted during our R&D day last December, with laser focus on execution for the ComboZanza franchise as well as for our clinical pipeline. Our pipeline is broad, both in terms of modalities and targets, representing a variety of development opportunities which, combined with our robust translational and clinical development capabilities, provide an exciting and high-potential platform for growth. Today, I'll share the progress we are making towards executing on our clinical trials across the development pipeline and on our potential regulatory submissions for ComboZanza. So let's start with ComboZanza and CABINET, which was a Phase III study that evaluated Combo versus matched placebo in patients with previously treated advanced or metastatic pancreatic or extrapancreatic neuroendocrine tumors, which I'll refer to as pNET or epNET, respectively.

Amy Peterson: Thanks, PJ. Today, I'll provide a high-level update on our clinical stage pipeline. The team is continuing the momentum across all of the programs we highlighted during our R&D day last December, with laser focus on execution for the ComboZanza franchise as well as for our clinical pipeline. Our pipeline is broad, both in terms of modalities and targets, representing a variety of development opportunities which, combined with our robust translational and clinical development capabilities, provide an exciting and high-potential platform for growth. Today, I'll share the progress we are making towards executing on our clinical trials across the development pipeline and on our potential regulatory submissions for ComboZanza. So let's start with ComboZanza and CABINET, which was a Phase III study that evaluated Combo versus matched placebo in patients with previously treated advanced or metastatic pancreatic or extrapancreatic neuroendocrine tumors, which I'll refer to as pNET or epNET, respectively.

Amy Peterson: Thanks, PJ. Today, I'll provide a high-level update on our clinical stage pipeline. The team is continuing the momentum across all of the programs we highlighted during our R&D Day last December with laser focus on execution for the Cabozantinib franchise as well as for our clinical pipeline. Our pipeline is broad, both in terms of modalities and targets, representing a variety of development opportunities which, combined with our robust translational and clinical development capabilities, provide an exciting and high-potential platform for growth. Today, I'll share the progress we are making towards executing on our clinical trials across the development pipeline and on our potential regulatory submissions for Cabozantinib. So let's start with Cabozantinib and Cabinet.

Amy Peterson: Thanks P J.

Amy Peterson: I'll provide a high level update on our clinical stage pipeline. The team is continuing the momentum across all of the programs. We highlighted during our R&D day last December with laser focus on execution for the Cabozantinib franchise as well as for our clinical pipeline. Our pipeline is broad in terms of them.

Amy Peterson: Modalities and targets, representing a variety of development opportunities, which combined with our robust translational and clinical development capabilities provide an exciting and high potential platform for growth today I'll share. The progress we are making towards executing on our clinical trials across the development pipe.

Amy Peterson: Blind and on our potential regulatory submissions for Cabozantinib.

Amy Peterson: Lets start with Cabozantinib and cabinet.

Amy Peterson: This is a phase III study that evaluated CABO versus MATCH placebo in patients with previously treated advanced or metastatic pancreatic or extra pancreatic neuroendocrine tumors, which I'll refer to as PNET or EPNET respectively. The study was conducted by the Alliance for Clinical Trials in Oncology, and data was presented by Dr. Jennifer Chan at ESMO 2023. The study had two independently powered cohorts, one for PNET and the other for EPNET. Notably, the PFS hazard ratio for each cohort strongly favored CABO, with hazard rates of 0.27 and 0.45 in the PNET and EPNET populations respectively.

Amy Peterson: This is a phase III study that evaluated cabo versus placebo in patients with previously treated advanced or metastatic pancreatic or extra pancreatic neuroendocrine tumors, which I'll refer to as peanuts or <unk>, respectively.

Patrick J. Haley: The study was conducted by the Alliance for Clinical Trials in Oncology, and data was presented by Dr. Jennifer Chan at ESMO 2023. The study had two independently powered cohorts, one for pNET and the other for epNET. Notably, the PFS hazard ratio for each cohort strongly favored Combo, with hazard rates of 0.27 and 0.45 in the pNET and epNET populations, respectively. The safety profile of monotherapy Combo was consistent with its known profile, and no new safety signals were identified. This initial analysis was based on local assessments with limited data available from the Blinded Independent Radiology Committee, or BIRC. The compelling results triggered an IDMC recommendation and Alliance decision to stop enrollment, unblind the study, and allow patients to cross over from placebo to cabozantinib.

Amy Peterson: The study was conducted by the Alliance for Clinical Trials in Oncology, and data was presented by Dr. Jennifer Chan at ESMO 2023. The study had two independently powered cohorts, one for pNET and the other for epNET. Notably, the PFS hazard ratio for each cohort strongly favored Combo, with hazard rates of 0.27 and 0.45 in the pNET and epNET populations, respectively. The safety profile of monotherapy Combo was consistent with its known profile, and no new safety signals were identified. This initial analysis was based on local assessments with limited data available from the Blinded Independent Radiology Committee, or BIRC. The compelling results triggered an IDMC recommendation and Alliance decision to stop enrollment, unblind the study, and allow patients to cross over from placebo to cabozantinib.

Amy Peterson: The study was conducted by the alliance for clinical trials in oncology and data was presented by Dr. Jennifer Chan at ESMO 2023. The study had two independently powered cohorts one for peanuts and the other for <unk>.

Amy Peterson: Notably the PFS hazard ratio for each cohort strongly favored cabo with hazard rates.

Amy Peterson: 0.27, and 0.45, and the E and the peanut and EP net populations respectively.

Amy Peterson: The safety profile of monotherapy CABO was consistent with its known profile, and no new safety signals were identified. This initial analysis was based on local assessments with limited data available from the Blinded Independent Radiology Committee, or BIRC. The compelling results triggered an IDMC recommendation and alliance decision to stop enrollment, unblind the study, and allow patients to cross over from placebo to Cabozantinib. The final analysis by Burke will be shared at a conference later this year and support our intention to file in the coming months.

Amy Peterson: Safety profile as monotherapy Cabo with consistent with its known profile and no new safety signals were identified.

Amy Peterson: This initial analysis was based on local assessments with limited data available from the blinded independent Radiology Committee are berke, the compelling results triggered an <unk> recommendation and alliance decision to stop enrollment Unblinded study and allow patients to cross over from placebo to Cabozantinib.

Patrick J. Haley: The final analysis by BIRC will be shared at a conference later this year and support our intention to file in the coming months. As PJ mentioned in his section, we are very excited about the potential to bring ComboZanza to patients with neuroendocrine tumors. The CABINET data are quite impressive and robust, and if approved, support Combo as a potential new standard of care in a population that is in dire need of effective treatment options. Turning now to CONTACT-02, our randomized open-label phase III study of Combo plus atezolizumab versus second-line novel hormonal therapy, or NHT, in patients with castration-resistant prostate cancer and measurable extrapelvic soft tissue disease. We believe the data from this study support a favorable risk-benefit to patients and our intent to file.

Amy Peterson: The final analysis by BIRC will be shared at a conference later this year and support our intention to file in the coming months. As PJ mentioned in his section, we are very excited about the potential to bring ComboZanza to patients with neuroendocrine tumors. The CABINET data are quite impressive and robust, and if approved, support Combo as a potential new standard of care in a population that is in dire need of effective treatment options. Turning now to CONTACT-02, our randomized open-label phase III study of Combo plus atezolizumab versus second-line novel hormonal therapy, or NHT, in patients with castration-resistant prostate cancer and measurable extrapelvic soft tissue disease. We believe the data from this study support a favorable risk-benefit to patients and our intent to file.

Amy Peterson: The final analysis by Barrick will be shared at a conference later this year and support our intention to file in the coming months.

Amy Peterson: As PJ mentioned in his section, we are very excited about the potential to bring Cabozantinib to patients with neuroendocrine tumors. The Cabinet data are quite impressive and robust, and if approved, support CABO as a potential new standard of care in a population that is in dire need of effective treatment options. Turning now to CONTACT-02, our randomized open-label phase III study of CABO plus atezolizumab versus second novel hormonal therapy, or NHT in patients with castration-resistant prostate cancer and measurable extrapelvic soft tissue disease.

Amy Peterson: As P. J mentioned in his section we are very excited about the potential sprain cabozantinib to patients with neuroendocrine tumors and <unk>.

Amy Peterson: Cabinet data are quite impressive and robust and if approved support Cabo as a potential new standard of care in a population that is in dire need of effective treatment options.

Amy Peterson: Turning now to contact out to a randomized open label Phase III study of parallel plus a teaser lithium app versus second novel hormonal therapy or <unk> in patients with castration resistant prostate cancer and measurable extra pelvic soft tissue disease. We believe the data from this study support.

Amy Peterson: We believe the data from this study support a favorable risk-benefit to patients and our intent to file. Remember, this is a unique study population, given the requirement for measurable disease, which we deliberately chose to ensure a robust assessment of PFS by birth. Contact had dual primary endpoints of PFS by BERC and OS. We anticipate having the final OS analysis in the coming month. So what does a dual primary endpoint mean?

We believe the data from this study support a favorable risk-benefit to patients and our intent to file. Remember, this is a unique study population, given the requirement for measurable disease, which we deliberately chose to ensure a robust assessment of PFS by birth. Contact had dual primary endpoints of PFS by BERC and OS. We anticipate having the final OS analysis in the coming month.

Amy Peterson: A favorable risk benefit to patients and our intent to file.

Patrick J. Haley: Remember, this is a unique study population, given the requirement for measurable disease, which we deliberately chose to ensure a robust assessment of PFS by BIRC. CONTACT had dual primary endpoints of PFS by BIRC and OS. We anticipate having the final OS analysis in the coming months. So what does a dual primary endpoint mean? It means that for a study to be considered positive from a statistical standpoint, we only have to hit on one of the endpoints. Dr. Niraj Agarwal presented the significant and robust PFS results at ASCO GU. The PFS hazard rate in the pre-specified PFS population was 0.65, with a p-value equal to 0.0007, so statistically significant, hence a positive study. The PFS hazard rates, medians, and Kaplan-Meier curves in the ITT population by BIRC were nearly identical to that in the PFS population.

Amy Peterson: Remember, this is a unique study population, given the requirement for measurable disease, which we deliberately chose to ensure a robust assessment of PFS by BIRC. CONTACT had dual primary endpoints of PFS by BIRC and OS. We anticipate having the final OS analysis in the coming months. So what does a dual primary endpoint mean? It means that for a study to be considered positive from a statistical standpoint, we only have to hit on one of the endpoints. Dr. Niraj Agarwal presented the significant and robust PFS results at ASCO GU. The PFS hazard rate in the pre-specified PFS population was 0.65, with a p-value equal to 0.0007, so statistically significant, hence a positive study. The PFS hazard rates, medians, and Kaplan-Meier curves in the ITT population by BIRC were nearly identical to that in the PFS population.

Amy Peterson: Remember this is a unique study population.

Amy Peterson: The requirement for measurable disease, which we deliberately chose to ensure a robust assessment of PFS Piper.

Amy Peterson: Contact had dual primary endpoints of PFS by Burke and OS we anticipate having the final OS analysis in the coming months.

So what does a dual primary endpoint mean? It means that for a study to be considered positive from a statistical standpoint, we only have to hit on one of the endpoints. Dr. Neeraj Agarwal presented the significant and robust PFS results at ASCO-GU. The PFS hazard rate in the pre-specified PFS population was 0.65, with a p-value equal to 0.0007, so it was statistically significant, hence a positive study. The PFS hazard rates, medians, and Kaplan-Meier curves in the ITT population by Burke were nearly identical to that in the PFS population.

Amy Peterson: It means that for a study to be considered positive from a statistical standpoint, we only have to hit on one of the endpoints. Dr. Neeraj Agarwal presented the significant and robust PFS results at ASCO-GU. The PFS hazard rate in the pre-specified PFS population was 0.65, with a p-value equal to 0.0007, so it was statistically significant, hence a positive study. The PFS hazard rates, medians, and Kaplan-Meier curves in the ITT population by Burke were nearly identical to that in the PFS population.

Amy Peterson: So what does a dual primary endpoint mean, it means that for a study to be considered positive from a statistical standpoint, we only have to hit on one of the endpoints.

Amy Peterson: Dr. <unk> <unk> presented a significant and robust PFS results at <unk> Gilles the PFS hazard rate and the Prespecified PFS population with 0.65 with a P value equal to 0.0007 so.

Amy Peterson: Statistically significant.

The PFS hazard rates, medians, and Kaplan-Meier curves in the ITT population by Burke were nearly identical to that in the PFS population. This was also true for PFS according to the PCWG 3 criteria, which includes bone imaging also assessed by Burke. A PFS benefit was observed in all subgroups, notably in those with the poorest outcomes, that is, in patients with liver metastases and in patients who've already received both an NHT and docetaxel. In this analysis, OS demonstrated a trend favoring CABO-ATIZA.

Amy Peterson: Positive study.

Amy Peterson: The PFS hazard grades medians and Kaplan Meier curves in the ITT population by Burke were nearly identical to that in the PFS population.

Patrick J. Haley: This was also true for PFS according to the PCWG3 criteria, which includes bone imaging, also assessed by BIRC. A PFS benefit was observed in all subgroups, notably in those with the poorest outcomes, that is, in patients with liver metastases and in patients who've already received both an NHT and docetaxel. At this analysis, OS demonstrated a trend favoring Combo atezo. CONTACT02 enrolled a uniquely aggressive clinical subset of mCRPC, one that is typically highlighted for having the worst prognosis, which is reflected by the limited activity with second NHT. The toxicities reported with Combo plus atezo were higher than those with second NHT, and this is not surprising, given NHTs are very well tolerated, especially in those who've already demonstrated good tolerance to prior NHT. And remember, the median duration of prior NHT was one year in CONTACT02.

Amy Peterson: This was also true for PFS according to the PCWG3 criteria, which includes bone imaging, also assessed by BIRC. A PFS benefit was observed in all subgroups, notably in those with the poorest outcomes, that is, in patients with liver metastases and in patients who've already received both an NHT and docetaxel. At this analysis, OS demonstrated a trend favoring Combo atezo. CONTACT02 enrolled a uniquely aggressive clinical subset of mCRPC, one that is typically highlighted for having the worst prognosis, which is reflected by the limited activity with second NHT. The toxicities reported with Combo plus atezo were higher than those with second NHT, and this is not surprising, given NHTs are very well tolerated, especially in those who've already demonstrated good tolerance to prior NHT. And remember, the median duration of prior NHT was one year in CONTACT02.

Amy Peterson: This was also true for PFS according to the PCWG 3 criteria, which includes bone imaging also assessed by Burke. A PFS benefit was observed in all subgroups, notably in those with the poorest outcomes, that is, in patients with liver metastases and in patients who've already received both an NHT and docetaxel. In this analysis, OS demonstrated a trend favoring Cabo [inaudible].

Amy Peterson: This was also true for PFS. According to the PC WG three criteria, which includes bone imaging also assessed by Burke.

Amy Peterson: The PFS benefit was observed in all subgroups, notably in those with the poorest outcome that is in patients with liver metastases and in patients who've already received both on an H T and docetaxel.

Amy Peterson: At this analysis <unk> demonstrated a trend favoring cabo at T cell.

Amy Peterson: CONTACT-O2 enrolled a uniquely aggressive clinical subset of MCRPC, one that is typically highlighted for having the worst prognosis, which is reflected by the limited activity with second NHT. The toxicities reported with CABO plus ATIZA were higher than those with second NHT. And this is not surprising, given NHTs are very well tolerated, especially in those who've already demonstrated good tolerance to prior NHTs. And remember, the median duration of prior NHT was one year in CONTACT-02.

Amy Peterson: Contact <unk> enrolled a uniquely aggressive clinical subset.

Amy Peterson: CRP C. One that is typically highlighted for having the worst prognosis, which is reflected by the limited activity was second in each state.

Amy Peterson: The toxicity is reported with Cabo plus cities that were higher than those with second and HTM. This is not surprising given an HTS are very well tolerated.

Amy Peterson: Especially in those who have already demonstrated good tolerance to prior NH tea and remember the median duration of prior NH T was one year and contact hotel.

Patrick J. Haley: The tolerability profile Combo atezo was consistent with the known tolerability profile of each monotherapy agent and with the doublet from other studies, as well as with other approved IO TKI combinations. Putting this together and based on the input we've received from many in the GU oncology community, from patient advocacy groups, and patients, we firmly believe these findings represent an acceptable risk-benefit profile, and we are committed to filing this year. So there's quite a lot of excitement with Combo in 2024, but I'm going to turn now to zanzalintinib, where our excitement continues to grow. Our phase I studies have multiple expansion cohorts in a variety of tumors and combinations. Data generated from these cohorts has and will continue to support our expanded development for Zanza. At the IKCS conference in R&D day last year, Dr.

Amy Peterson: The tolerability profile Combo atezo was consistent with the known tolerability profile of each monotherapy agent and with the doublet from other studies, as well as with other approved IO TKI combinations. Putting this together and based on the input we've received from many in the GU oncology community, from patient advocacy groups, and patients, we firmly believe these findings represent an acceptable risk-benefit profile, and we are committed to filing this year. So there's quite a lot of excitement with Combo in 2024, but I'm going to turn now to zanzalintinib, where our excitement continues to grow. Our phase I studies have multiple expansion cohorts in a variety of tumors and combinations. Data generated from these cohorts has and will continue to support our expanded development for Zanza. At the IKCS conference in R&D day last year, Dr.

Amy Peterson: The tolerability profile of CABO-ATIZA was consistent with the known tolerability profile of each monotherapy agent and with the doublet from other studies, as well as with other approved IOTKI combinations. Putting this together, and based on the input we've received from many in the GU Oncology community, from patient advocacy groups, and patients, we firmly believe these findings represent an acceptable risk-benefit profile, and we are committed to filing this year. So there's quite a lot of excitement about CABO in 2024, but I'm going to turn now to Zanzalitnib, where our excitement continues to grow.

Amy Peterson: The Tolerability profile Cabo accuser was consistent with the known Tolerability profile of each monotherapy agent.

Amy Peterson: And with the doublet from other studies as well as with other approved Iot Kei combinations.

Amy Peterson: Putting this together and based on the endpoint we've received from many in the oncology community from patient advocacy groups and patient. We firmly believe these findings represent an acceptable risk benefit profile and we are committed to filing this year. So there's quite a lot of excitement with Cabo in 2024, but im going.

Amy Peterson: Turn now to <unk>, where our excitement continues to grow.

Amy Peterson: Our phase I studies have multiple expansion cohorts and a variety of tumors and combinations. Data generated from these cohorts has and will continue to support our expanded development for Zanza. At the IKCF conference on R&D Day last year, Dr. Monty Powell presented promising data with Zanza monotherapy, where compelling and durable responses were observed in 32 patients with treatment-refractory clear cell kidney cancer, all of whom had received prior IO, and the majority of whom, or 81%, had received prior VEGFR TKIs, including 51% who had previously received CABO.

Amy Peterson: Our phase one studies of multiple expansion cohorts in a variety of tumors and combinations.

Amy Peterson: Data generated from these cohorts has and will continue to support our expanded development for Zander.

Amy Peterson: The Ik CF conference in R&D day last year, Dr. Monte power presented promising data with <unk> monotherapy were compelling and durable responses were observed in 32 patients with treatment refractory clear cell kidney cancer, all of whom had received prior IL and the majority of whom are 81% had received.

Patrick J. Haley: Monty Powell presented promising data with Zanza monotherapy, where compelling and durable responses were observed in 32 patients with treatment-refractory clear-cell kidney cancer, all of whom had received prior IO, and the majority of whom, or 81%, had received prior VEGFR TKIs, including 51% who previously received Combo. The ORRs of 38% in the ITT and of 24% in patients who had received prior Combo are very encouraging, especially given that Zanza shares the target kinase profile of Combo but a shorter half-life, which you will hear about in more detail from Dana, and which seems to result in differential partitioning into tissues, including tumor tissue, potentially explaining the emerging differentiated activity and tolerability profile. We're not the only ones excited about Zanza's potential. The GU community was very receptive to the data presented at IKCS, and discussions around collaboration opportunities are ongoing.

Amy Peterson: Monty Powell presented promising data with Zanza monotherapy, where compelling and durable responses were observed in 32 patients with treatment-refractory clear-cell kidney cancer, all of whom had received prior IO, and the majority of whom, or 81%, had received prior VEGFR TKIs, including 51% who previously received Combo. The ORRs of 38% in the ITT and of 24% in patients who had received prior Combo are very encouraging, especially given that Zanza shares the target kinase profile of Combo but a shorter half-life, which you will hear about in more detail from Dana, and which seems to result in differential partitioning into tissues, including tumor tissue, potentially explaining the emerging differentiated activity and tolerability profile. We're not the only ones excited about Zanza's potential. The GU community was very receptive to the data presented at IKCS, and discussions around collaboration opportunities are ongoing.

Amy Peterson: Prior VEGF, RT chaos, including 51%, who previously received Cabo.

Amy Peterson: The ORRs of 38% in the ITT and of 24% in patients who had received prior CABO are very encouraging, especially given that Zanza shares the target kinase profile of CABO but a shorter half-life, which you will hear about in more detail from Dana and which seems to result in differential partitioning into tissues, including tumor tissue, potentially explaining the emerging differentiated activity and tolerability profile. We're not the only ones excited about Zanza's potential.

The ORRs of 38% in the ITT and of 24% in patients who had received prior CABO are very encouraging, especially given that Zanza shares the target kinase profile of CABO but a shorter half-life, which you will hear about in more detail from Dana and which seems to result in differential partitioning into tissues, including tumor tissue, potentially explaining the emerging differentiated activity and tolerability profile.

Amy Peterson: <unk> of 38% in the ITT and a 24% in patients who had received prior cabo are very encouraging, especially given that zander shares the target kinase profile Cabo, but a shorter half life, which you will hear about in more detail from Dana in which seems to result in differential partitioning.

Amy Peterson: <unk> into tissues, including tumor tissue potentially explaining the emerging differentiated activity and tolerability profile.

We're not the only ones excited about Zanza's potential. The GU community was very receptive to the data presented at IKCS, and discussions around collaboration opportunities are ongoing.

Amy Peterson: We're not the only ones excited about Kansas potential, but Gilles community was very receptive to the data presented at <unk> and discussions around collaboration opportunities are ongoing.

Amy Peterson: The GU community was very receptive to the data presented at IKCS, and discussions around collaboration opportunities are ongoing. Turning now to our pivotal studies, we currently have three phase three studies with Zanza, and we're evaluating additional pivotal studies, including opportunities for collaboration with other companies. Our most mature study is STELLAR-303.

The GU community was very receptive to the data presented at IKCS, and discussions around collaboration opportunities are ongoing.

Patrick J. Haley: Turning now to our pivotal studies, we currently have three phase III studies with Zanza, and we're evaluating additional pivotal studies, including opportunities for collaboration with other companies. Our most mature study is STELLAR-303. This study will evaluate the combination of Zanza plus atezolizumab versus regorafenib in patients with non-MSI-high, non-dMMR metastatic and refractory colorectal cancer. The primary endpoint is OS in the population of patients without liver mets, or NLM, followed by an evaluation of OS in the ITT population. Should OS in the NLM population be statistically significant? This is not a dual primary endpoint. The sample size for both NLM and LM patients is capped to ensure an adequate number of events in each of these analyses.

Amy Peterson: Turning now to our pivotal studies, we currently have three phase III studies with Zanza, and we're evaluating additional pivotal studies, including opportunities for collaboration with other companies. Our most mature study is STELLAR-303. This study will evaluate the combination of Zanza plus atezolizumab versus regorafenib in patients with non-MSI-high, non-dMMR metastatic and refractory colorectal cancer. The primary endpoint is OS in the population of patients without liver mets, or NLM, followed by an evaluation of OS in the ITT population. Should OS in the NLM population be statistically significant? This is not a dual primary endpoint. The sample size for both NLM and LM patients is capped to ensure an adequate number of events in each of these analyses.

Turning now to our pivotal studies, we currently have three phase three studies with Zanza, and we're evaluating additional pivotal studies, including opportunities for collaboration with other companies. Our most mature study is STELLAR-303.

Amy Peterson: Turning now to our pivotal studies, we currently have three phase III studies, Louisiana, and we're evaluating additional pivotal studies, including opportunities for collaboration with other companies.

Amy Peterson: Our most mature study is stellar three out of three.

Amy Peterson: This study will evaluate the combination of Zanza plus ateazolizumab versus regorafenib in patients with non-MSI high, non-DMMR metastatic and refractory colorectal cancer. The primary endpoint is OS in the population of patients without liver mets or NLM, followed by an evaluation of OS in the ITT population should OS in the NLM population be statistically significant so this is not a dual primary endpoint.

Amy Peterson: This study will evaluate the combination of <unk> plus cities Iliza mab versus regular RAF inhibitor in patients with non MSI high non DMR metastatic and refractory colorectal cancer.

Amy Peterson: The primary endpoint is OS in the population of patients without liver Mets or an L. M followed by an evaluation of OS in the ITT population showed OS in the MLM population be statistically significant. So this is not a dual primary end point.

Amy Peterson: The sample size for both NLM and LM patients is capped to ensure an adequate number of events in each of these analyses. PI excitement about the potential of this combination, especially in patients without liver mets, has resulted in a rapid uptick in enrollment, and enrollment to the liver met cohort is basically complete. Enrollment to the NLM cohort should be complete in the coming months.

Amy Peterson: The sample size for both N O Lemon L. M patients is tapped to ensure adequate number of events in each of these analyses PAA excitement about the potential of this combination, especially in patients without liver Mets has resulted in rapid uptick in enrollment and enrollment to deliver mad cohort is basically complete.

Patrick J. Haley: PI excitement about the potential of this combination, especially in patients without liver mets, has resulted in rapid uptick in enrollment, and enrollment to the liver met cohort is basically complete. Enrollment to the NLM cohort should be complete in the coming months. STELLAR-304 is our phase 3 trial, which compares the combination of zanzalintinib plus nivolumab to sunitinib in patients with previously untreated metastatic non-clear cell kidney cancer. This has dual primary endpoints of progression-free survival and overall response rate. OS is a secondary endpoint. The probability of success of a study is a key strategic lever when we consider how to prioritize our portfolio.

Amy Peterson: PI excitement about the potential of this combination, especially in patients without liver mets, has resulted in rapid uptick in enrollment, and enrollment to the liver met cohort is basically complete. Enrollment to the NLM cohort should be complete in the coming months. STELLAR-304 is our phase 3 trial, which compares the combination of zanzalintinib plus nivolumab to sunitinib in patients with previously untreated metastatic non-clear cell kidney cancer. This has dual primary endpoints of progression-free survival and overall response rate. OS is a secondary endpoint. The probability of success of a study is a key strategic lever when we consider how to prioritize our portfolio.

Amy Peterson: Enrollment to the MLM cohort should be complete in the coming months.

Amy Peterson: Stellar 304 is our phase III trial that compares the combination of Zanza plus Nivolumab to Sunitinib in patients with previously untreated metastatic non-clear cell kidney cancer. This has dual primary endpoints of progression-free survival and overall response rate, while OS is a secondary endpoint.

Amy Peterson: Stellar three or four is our phase III trial, which compares the combination of <unk> plus mobile in App to sunitinib in patients with previously untreated metastatic non clear cell kidney cancer.

Amy Peterson: It has dual primary endpoints of progression free survival and overall response rate.

Amy Peterson: As a secondary endpoint.

Amy Peterson: The probability of success of a study is a key strategic lever when we consider how to prioritize our portfolio. Given that VEGFR-TKIs work in non-clear cell kidney cancer, that TKI-IO combos work in non-clear cell kidney cancer, that CABO monotherapy beats SUTENT in kidney cancer, and that ZANZA has best-in-class potential as a VEGFR-TKI, we believe this study has a reasonably high TKI. Investigators are also excited about this combination, and enrollment is ongoing in multiple countries.

Amy Peterson: The probability of success of our study is a key strategic lever when we consider how to prioritize our portfolio.

Patrick J. Haley: Given that VEGFR TKIs work in non-clear-cell kidney cancer, that TKI IO combos work in non-clear-cell kidney cancer, that Combo monotherapy beats Sutent in kidney cancer, and that zanzalintinib has the best-in-class potential for a VEGFR TKI, we believe this study has a reasonably high PTS. Investigators are also excited about this combination, and enrollment is ongoing in multiple countries. STELLAR-305 is our phase 2/3 trial, which will evaluate zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with untreated PD-L1 expressing advanced or metastatic squamous cell carcinoma of the head and neck. This study was activated late last year, and we are full steam ahead in site activation mode.

Amy Peterson: Given that VEGFR TKIs work in non-clear-cell kidney cancer, that TKI IO combos work in non-clear-cell kidney cancer, that Combo monotherapy beats Sutent in kidney cancer, and that zanzalintinib has the best-in-class potential for a VEGFR TKI, we believe this study has a reasonably high PTS. Investigators are also excited about this combination, and enrollment is ongoing in multiple countries. STELLAR-305 is our phase 2/3 trial, which will evaluate zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with untreated PD-L1 expressing advanced or metastatic squamous cell carcinoma of the head and neck. This study was activated late last year, and we are full steam ahead in site activation mode.

Amy Peterson: Even that veg F. RT <unk> work in non clear cell kidney cancer that Teekay I O combos work in non clear cell kidney cancer that Cabo monotherapy beat <unk> in kidney cancer and that Zander has a best in class potential for <unk>. We believe this study has a reasonably high Pts.

Amy Peterson: Investigators are also excited about this combination and enrollment is ongoing in multiple countries.

Amy Peterson: Stellar 305 is our Phase II/III trial that will evaluate Zanzalitinib in combination with Pembrolizumab versus Pembrolizumab alone in patients with untreated PD-L1 expressing advanced or metastatic squamous cell carcinoma of the head and neck. This study was activated late last year, and we are full steam ahead into site activation mode. Given the emerging favorable activity and tolerability profile of Zanza and its mechanism of action that results in an immune permissive environment, we believe this combination of Zanza plus Pembro could result in improved outcomes versus single-agent Pembro and has the potential to offer patients a chemo-free option. Of course, we are intrigued by the LEAP 010 data, and just as we did with Stellar 310, we'll make necessary our appropriate modifications to Stellar 305 to increase the probability of success.

Amy Peterson: Stellar 305 is our phase two three trial, which will evaluate <unk> in combination with <unk> versus <unk> alone in patients with untreated PD L. One expressing advanced or metastatic squamous cell carcinoma of the head and neck.

Amy Peterson: This study was activated late last year and we are full steam ahead in the site activation mode, given the emerging favorable activity and tolerability profile of <unk> and its mechanism of action that results in an immune permissive environment. We believe this combination of <unk> plus Pembroke could result in improved.

Patrick J. Haley: Given the emerging favorable activity and tolerability profile of Zanza and its mechanism of action that results in an immune permissive environment, we believe this combination of Zanza plus pembro could result in improved outcomes versus single-agent pembro and has the potential to offer patients a chemo-free option. Of course, we are intrigued by the LEAP010 data, and just as we did with STELLAR310, we'll make necessary or appropriate modifications to STELLAR305 to increase the probability of success. We are always evaluating data from Zanza and Combo studies, emerging data from our competitors, and the evolving treatment landscape to inform the design and initiation of the next pivotal studies for Zanza, an asset that we believe has potential for best-in-class as a VEGFR TKI with commensurate improved activity in patients that ultimately transfer into value for our shareholders.

Amy Peterson: Given the emerging favorable activity and tolerability profile of Zanza and its mechanism of action that results in an immune permissive environment, we believe this combination of Zanza plus pembro could result in improved outcomes versus single-agent pembro and has the potential to offer patients a chemo-free option. Of course, we are intrigued by the LEAP010 data, and just as we did with STELLAR310, we'll make necessary or appropriate modifications to STELLAR305 to increase the probability of success. We are always evaluating data from Zanza and Combo studies, emerging data from our competitors, and the evolving treatment landscape to inform the design and initiation of the next pivotal studies for Zanza, an asset that we believe has potential for best-in-class as a VEGFR TKI with commensurate improved activity in patients that ultimately transfer into value for our shareholders.

Amy Peterson: Outcomes versus single agent <unk> and has the potential to offer patients a chemo free option.

Amy Peterson: Of course, we are intrigued by the leap <unk> data and just as we did with stellar 310 will make necessary or appropriate modifications to stellar 305 to increase the probability of success.

Amy Peterson: We are always evaluating data from Zanza and CABO studies, emerging data from our competitors, and the evolving treatment landscape to inform the design and initiation of the next pivotal studies for Zanza, an asset that we believe has potential to be best-in-class as a VEGFR TKI with commensurate improved activity in patients that ultimately transfers into value for our shareholders. I'll now briefly touch on our early clinical pipeline assets, XB002 and XL309, before passing the call over to Dana.

Amy Peterson: We are always evaluating data data from Zander and combo studies emerging data from our competitors and the evolving treatment landscape to inform the design and initiation of the next pivotal studies for Zander and assets that we believe has potential for best in classes of <unk> with commensurate improved activity in patients that.

Amy Peterson: Ultimately transfer into value for our shareholders.

Patrick J. Haley: I'll now briefly touch on our early clinical pipeline assets, XB002 and XL309, before passing the call over to Dana. XB002 is our tissue factor-directed antibody-drug conjugate, incorporating a modified auristatin as a payload. Enrollment into the cohort expansions in the JUUL 101 study is robust, and as the data matures, will allow us to understand the initial benefit-risk profile. We will provide updates when we have data maturity. Finally, last and certainly not least, is XL309, which we are very excited about. Dana will talk more on why we remain optimistic about this particular USP1 inhibitor. So in the interest of time, I'll just state that dose escalation cohorts are enrolling, and we hope to open combination cohorts with PARP inhibition a little later this year.

Amy Peterson: I'll now briefly touch on our early clinical pipeline assets, XB002 and XL309, before passing the call over to Dana. XB002 is our tissue factor-directed antibody-drug conjugate, incorporating a modified auristatin as a payload. Enrollment into the cohort expansions in the JUUL 101 study is robust, and as the data matures, will allow us to understand the initial benefit-risk profile. We will provide updates when we have data maturity. Finally, last and certainly not least, is XL309, which we are very excited about. Dana will talk more on why we remain optimistic about this particular USP1 inhibitor. So in the interest of time, I'll just state that dose escalation cohorts are enrolling, and we hope to open combination cohorts with PARP inhibition a little later this year.

Amy Peterson: I'll now briefly touch on our early clinical pipeline assets <unk> hundred nine before passing the call over to Dana X P. O two as our tissue factor directed antibody drug conjugate incorporating a modified or a statin has a payload enrolled.

Amy Peterson: XB002 is our tissue factor directed antibody conjugate, incorporating a modified or a statin as a payload. Enrollment into the cohort expansions in the JUUL 101 study is robust, and as the data matures, it will allow us to understand the initial benefit risk profile. We will provide updates when we have data maturity. Finally, last but certainly not least, is XL309, which we are very excited about. Dana will talk more about why we remain optimistic about this particular USP1 inhibitor. So, in the interest of time, I'll just state that dose escalation cohorts are enrolling, and we hope to open combination cohorts with PARP inhibition a little later this year.

Amy Peterson: Enrollment into the cohort expansion and then you all one on one study is robust and as the data matures. It will allow us to understand the initial benefit risk profile, we will provide updates when we have data maturity.

Amy Peterson: Finally last and certainly not least is <unk> 309, which we are very excited about Dana we will talk more on why we remain optimistic about this particular USD one inhibitor. So in the interest of time I'll just state that dose escalation cohorts are enrolling and we hope to open combination cohorts with PARP inhibition a little later this.

Amy Peterson: So, in the interest of time, I'll just state that dose escalation cohorts are enrolling, and we hope to open combination cohorts with PARP inhibition a little later this year. In summary, we're advancing a robust pipeline of clinical stage molecules while maximizing the potential benefit to patients from our flagship asset, Cabozantinib, in high unmet medical needs indications. We remain very optimistic about what we can do for patients who, despite significant advances, still need better treatment options. And with that, I'll turn the call over to Dave.

So, in the interest of time, I'll just state that dose escalation cohorts are enrolling, and we hope to open combination cohorts with PARP inhibition a little later this year.

Patrick J. Haley: In summary, we're advancing a robust pipeline of clinical stage molecules while maximizing the potential benefit to patients from our flagship asset, cabozantinib, in high unmet medical need indications. We remain very optimistic about what we can do for patients who, despite significant advances, still need better treatment options. And with that, I'll turn the call over to Dana. Thanks, Amy, and good afternoon, everyone. Today, I'm giving a brief update on our progress in Q1 2024 toward our goals for preparing for IND filings and for advancing new compounds to development candidate status. And then I'll wrap up with some preclinical updates on our USP1 inhibitor, XL309, and our next-generation VEGF receptor tyrosine kinase inhibitor, zanzalintinib. On the IND front, we are making good progress on all of our pre-IND programs and are on track to file up to three this year.

Amy Peterson: In summary, we're advancing a robust pipeline of clinical stage molecules while maximizing the potential benefit to patients from our flagship asset, cabozantinib, in high unmet medical need indications. We remain very optimistic about what we can do for patients who, despite significant advances, still need better treatment options. And with that, I'll turn the call over to Dana.

Amy Peterson: Yeah.

In summary, we're advancing a robust pipeline of clinical stage molecules while maximizing the potential benefit to patients from our flagship asset, Cabozantinib, in high unmet medical needs indications. We remain very optimistic about what we can do for patients who, despite significant advances, still need better treatment options. And with that, I'll turn the call over to Dana.

Amy Peterson: In summary, we are advancing a robust pipeline of clinical stage molecules, while maximizing the potential benefit to patients from our flagship asset Cabozantinib and high unmet medical need indications, we remain very optimistic about what we can do for patients who despite significant advances still need better treatment options.

Dana Aftab: Thanks, Amy, and good afternoon, everyone. Today, I'm giving a brief update on our progress in Q1 2024 toward our goals for preparing for IND filings and for advancing new compounds to development candidate status. And then I'll wrap up with some preclinical updates on our USP1 inhibitor, XL309, and our next-generation VEGF receptor tyrosine kinase inhibitor, zanzalintinib. On the IND front, we are making good progress on all of our pre-IND programs and are on track to file up to three this year.

Amy Peterson: With that I'll turn the call over to Dana.

Dana Aftab: Thanks, Amy, and good afternoon everyone. Today, I'm giving a brief update on our progress in the first quarter of 2024 toward our goals for preparing for IND filings and for advancing new compounds to development candidate status. And then I'll wrap up with some preclinical updates on our USP1 inhibitor, XL309, and our next generation VEGF receptor tyrosine kinase inhibitor, Zanzalitinib. On the IND front, we are making good progress on all of our pre-IND programs and are on track to file up to three this year.

Dana: Thanks, Amy and good afternoon, everyone today, I'm, giving a brief update on our progress in the first quarter of 2024 toward our goals for preparing for IND filings and for advancing new compounds to development candidate status.

Dana: And then I'll wrap up with some preclinical updates on our USP one inhibitor <unk> 309 in our next generation <unk> receptor tyrosine kinase inhibitor, it's Angela.

Dana Aftab: On the IND front, we are making good progress on all of our pre-IND programs and are on track to file up to three this year.

Dana: On the R&D front, we are making good progress on all of our pre IND programs and are on track to file up to three this year the.

Patrick J. Haley: The first one we expect to file this year is for XB010, our 5T4 targeted antibody-drug conjugate that carries the cytotoxic antitubulin payload MMAE. IND preparation is wrapping up soon, so we expect that one to file around mid-year. The second IND we expect to file this year is for XL495, which is a small molecule inhibitor of PKMYT1 that shows synthetic lethality in the context of increased cyclin E levels, which occurs across a wide range of tumors. IND preparation is progressing, and we are on track to also file this one around mid-2024. The third IND we expect to file this year will be for XB628, our bispecific antibody that targets PD-L1 along with NKG2A and displays NK cell engager activity in preclinical models.

Dana Aftab: The first one we expect to file this year is for XB010, our 5T4 targeted antibody-drug conjugate that carries the cytotoxic antitubulin payload MMAE. IND preparation is wrapping up soon, so we expect that one to file around mid-year. The second IND we expect to file this year is for XL495, which is a small molecule inhibitor of PKMYT1 that shows synthetic lethality in the context of increased cyclin E levels, which occurs across a wide range of tumors. IND preparation is progressing, and we are on track to also file this one around mid-2024. The third IND we expect to file this year will be for XB628, our bispecific antibody that targets PD-L1 along with NKG2A and displays NK cell engager activity in preclinical models.

Dana T. Aftab: The first one we expect to file this year is for XB010, our 5T4-targeted antibody drug conjugate that carries the cytotoxic antitubulant payload MMAE. IND preparation is wrapping up soon, so we expect that one to file around mid-year. The second IND we expect to file this year is for XL495, which is a small molecule inhibitor of PKMIT1 that shows synthetic lethality in the context of increased cyclin E levels, which occurs across a wide range of tumors. IND preparation is progressing and we are on track to also file this one around mid-2024.

The first one we expect to file this year is for XB010, our 5T4-targeted antibody drug conjugate that carries the cytotoxic antitubulant payload MMAE. IND preparation is wrapping up soon, so we expect that one to file around mid-year.

Dana: The first one we expect to file this year is for XP 010, or <unk> four targeted antibody drug conjugate the carriers the cytotoxic anti tubular payload MMA.

Dana: Andy preparation is wrapping up soon so we expect that one to file around mid year.

The second IND we expect to file this year is for XL495, which is a small molecule inhibitor of PKMIT1 that shows synthetic lethality in the context of increased cyclin E levels, which occurs across a wide range of tumors. IND preparation is progressing and we are on track to also file this one around mid-2024.

Dana: Second we expect to file this year is for XL for 95, which is a small molecule inhibitor of PK met one that showed synthetically salary in the context of increased cyclin E levels, which occurred across a wide range of tumors.

Dana: R&D preparation is progressing and we are on track to also file this one around mid 2024.

Dana T. Aftab: The third IND we expect to file this year will be for XB628, our bispecific antibody that targets PDL-1 along with NKG2A and displays NK cell engager activity in preclinical models. The GLP tox study for XB628 is now complete, and manufacturing and other activities have us on track for an IND filing in the fourth quarter of 2024. Each one of these programs has a solid rationale for generating differentiating data in the clinic, so we're excited to get these INDs filed and to get the trials up and enrolling quickly.

Dana: The third R&D, we expect to file this year will be for XP six to eight or by specific antibody that targets PDL, one along with <unk> and displays NK cell engage your activity in preclinical models.

Patrick J. Haley: The GLP tox study for XB628 is now complete, and manufacturing and other activities have us on track for IND filing in Q4 2024. Each one of these programs has a solid rationale for generating differentiating data in the clinic, so we're excited to get these INDs filed and to get the trials up and enrolling quickly. In terms of new development candidates this year, we are currently on track to achieve our goals of at least two this year with some exciting new programs, including a small molecule inhibitor targeting PLK4, which is synthetically lethal in cells with amplified TRIM37, and a novel antibody-drug conjugate program. Both of these programs represent first or best-in-class approaches with potential to generate differentiating results in the clinic, so we're certainly pleased that we remain on track for putting these additional assets into the preclinical pipeline this year.

Dana Aftab: The GLP tox study for XB628 is now complete, and manufacturing and other activities have us on track for IND filing in Q4 2024. Each one of these programs has a solid rationale for generating differentiating data in the clinic, so we're excited to get these INDs filed and to get the trials up and enrolling quickly. In terms of new development candidates this year, we are currently on track to achieve our goals of at least two this year with some exciting new programs, including a small molecule inhibitor targeting PLK4, which is synthetically lethal in cells with amplified TRIM37, and a novel antibody-drug conjugate program. Both of these programs represent first or best-in-class approaches with potential to generate differentiating results in the clinic, so we're certainly pleased that we remain on track for putting these additional assets into the preclinical pipeline this year.

Dana: The GOP Tox study for <unk> six to eight is now complete and manufacturing and other activities have us on track for IND filing in the fourth quarter of 2024.

Dana: Each one of these programs has a solid rationale for generating differentiating data in the clinic. So we're excited to get these <unk> filed and to get the trials up and enrolling quickly.

Dana T. Aftab: In terms of new development candidates this year, we are currently on track to achieve our goals of at least two this year, with some exciting new programs, including a small molecule inhibitor targeting PLK4, which is synthetically lethal in cells with amplified TRIM37, and a novel antibody drug conjugate program. Both of these programs represent first or best-in-class approaches with potential to generate differentiating results in the clinic, so we're certainly pleased that we remain on track to put these additional assets into the preclinical pipeline this year.

Dana: In terms of new development candidates. This year. We are currently on track to achieve our goals of at least two this year with some exciting new programs, including a small molecule inhibitor targeting <unk>, four which is synthetically lethal and sales of amplified trimmed <unk> 37, and a novel antibody drug conjugate program.

Dana: Both of these programs represent first or best in class approaches with potential to generate differentiating results in the clinic. So we're certainly pleased that we remain on track for putting these additional assets into the preclinical pipeline this year.

Patrick J. Haley: Today, I'd like to shift gears a bit and describe some exciting preclinical data we generated for two of our small molecules in the clinical pipeline. I'll start first with a brief update on XL309 and then describe some preclinical data we've generated comparing zanzalintinib and cabozantinib. We recently tested the combination of XL309 with the selective PARP1 inhibitor, saruparib, in the preclinical breast cancer xenograft model, MDA-MB436, in which the BRCA1 gene is mutated. The data we generated with the combination showed that at doses of both compounds that alone showed minimal tumor growth delay, when given in combination, resulted in very strong tumor regression that persisted for at least a month after dosing had ceased.

Dana Aftab: Today, I'd like to shift gears a bit and describe some exciting preclinical data we generated for two of our small molecules in the clinical pipeline. I'll start first with a brief update on XL309 and then describe some preclinical data we've generated comparing zanzalintinib and cabozantinib. We recently tested the combination of XL309 with the selective PARP1 inhibitor, saruparib, in the preclinical breast cancer xenograft model, MDA-MB436, in which the BRCA1 gene is mutated. The data we generated with the combination showed that at doses of both compounds that alone showed minimal tumor growth delay, when given in combination, resulted in very strong tumor regression that persisted for at least a month after dosing had ceased.

Dana T. Aftab: So now I'd like to shift gears a bit and describe some exciting preclinical data we generated for two of our small molecules in the clinical pipeline. I'll start with a brief update on XL309 and then describe some preclinical data we've generated comparing Zanzalitinib and Cabozantinib. We recently tested the combination of XL309 in the selective part with the selective part one inhibitor seruperib in the preclinical breast cancer xenograft model MDA-MB436, in which the BRCA1 gene is mutated.

Dana: So now I'd like to shift gears, a bit and describe some exciting preclinical data we generated for two of our small molecules and the clinical pipeline I'll start first with a brief update on XL 309, and then describe some preclinical data we've generated comparing <unk> and cabozantinib.

Dana: We recently tested the combination of XL 309, and the selective PARP with the selective PARP, one inhibitor <unk> and the preclinical breast cancer Xenograft model MDA MB 436 in which the <unk> gene is mutated the data we generated with the combination showed that at doses of both <unk>.

Dana: Pounds that alone showed minimal tumor growth delay when given in combination resulted in very strong tumor regression that persisted for at least a month after dosing had ceased.

Patrick J. Haley: The other data I'm sharing with you today, I think, will help to shed more light on the underlying basis for an emerging benefit-risk profile for zanzalintinib that appears to be improved compared to cabozantinib. You may recall that zanzalintinib retains the target kinase profile of cabozantinib, but with a PK profile that's more optimal for dose adjusting to manage tolerability. And as you just heard from Amy, we're seeing what appears to be an overall improved benefit-risk profile with Zanza, with responses in some patients who progressed on Combo and lower rates of certain AEs with Zanza, such as hand-foot syndrome, diarrhea, and fatigue. We now have some preclinical data, which we think help to explain these differences between the two molecules.

Dana Aftab: The other data I'm sharing with you today, I think, will help to shed more light on the underlying basis for an emerging benefit-risk profile for zanzalintinib that appears to be improved compared to cabozantinib. You may recall that zanzalintinib retains the target kinase profile of cabozantinib, but with a PK profile that's more optimal for dose adjusting to manage tolerability. And as you just heard from Amy, we're seeing what appears to be an overall improved benefit-risk profile with Zanza, with responses in some patients who progressed on Combo and lower rates of certain AEs with Zanza, such as hand-foot syndrome, diarrhea, and fatigue. We now have some preclinical data, which we think help to explain these differences between the two molecules.

Dana T. Aftab: The data we generated with the combination showed that at doses of both compounds that alone showed minimal tumor growth delay, when given in combination, resulted in very strong tumor regression that persisted for at least a month after dosing had ceased. The other data I'm sharing with you today, I think will help to shed more light on the underlying basis for an emerging benefit-risk profile for Zanzalitinib that appears to be improved compared to Cabozantinib.

Dana: The other data I'm sharing with you today I think will help to shed more light on the underlying basis for an emerging benefit risk profile for <unk> that appears to be improved compared to cabozantinib.

Dana T. Aftab: You may recall that Zanzalitinib retains the target kinase profile of Cabozantinib but with a PK profile that's more optimal for dose adjusting to manage tolerability. And as you just heard from Amy, we're seeing what appears to be an overall improved benefit-risk profile with Zanza, with responses in some patients who progressed on Cabo and lower rates of certain AEs with Zanza, such as hand-foot syndrome, diarrhea, and fatigue.

Dana: You may recall that <unk> retains the target kinase profile of Cabozantinib, but with a PK profile thats more optimal for dose adjusting to manage tolerability and as you just heard from Amy we're seeing what appears to be an overall improved benefit risk profile of sansa with responses in some patients who progressed on Cabo and <unk>.

Dana: Lower rates of certain aes with danza, such as hand foot syndrome, diarrhea and fatigue.

Dana T. Aftab: We now have some preclinical data which we think help to explain these differences between the two molecules. First, we've continued to explore potential differences in the biological target profiles of the compounds, and both were recently run side-by-side in the same experiment on the PRISM screen at the Broad Institute. This is a large-scale, diverse cancer cell line screen that determines the effects of compounds on cell viability across approximately 900 distinct cell lines, representing over 45 cancer subtypes.

Dana: We now have some preclinical data, which we think help to explain these differences between the two molecules.

Patrick J. Haley: First, we've continued to explore potential differences in the biological target profiles of the compounds, and both were recently run side by side in the same experiment in a prism screen at the Broad Institute. This is a large-scale, diverse cancer cell line screen that determines the effects of compounds on cell viability across approximately 900 distinct cell lines representing over 45 cancer subtypes. The results we got back from the screen showed the compounds were remarkably similar in terms of their ability to impact cell viability, which largely confirms the hypothesis that the key biological target profiles of Combo and Zanza are essentially the same. Given the similar target profiles, we hypothesized that a potential rationale for the improved profile we were seeing in the clinic with Zanza might be related to differences in tissue drug concentrations between tumors and normal healthy tissue when compared to Combo.

Dana Aftab: First, we've continued to explore potential differences in the biological target profiles of the compounds, and both were recently run side by side in the same experiment in a prism screen at the Broad Institute. This is a large-scale, diverse cancer cell line screen that determines the effects of compounds on cell viability across approximately 900 distinct cell lines representing over 45 cancer subtypes. The results we got back from the screen showed the compounds were remarkably similar in terms of their ability to impact cell viability, which largely confirms the hypothesis that the key biological target profiles of Combo and Zanza are essentially the same. Given the similar target profiles, we hypothesized that a potential rationale for the improved profile we were seeing in the clinic with Zanza might be related to differences in tissue drug concentrations between tumors and normal healthy tissue when compared to Combo.

Dana: First we have continued to explore potential differences in the biological target profiles of the compounds and both who have recently run side by side in the same experiment in a prison screening at the broad Institute.

Dana: This is a large scale diverse cancer cell lines screen that determines the effects of compounds on cell viability across approximately 900 distinct cell lines, representing over 45 cancer subtypes.

Dana T. Aftab: The results we got back from the screen showed that the compounds were remarkably similar in terms of their ability to impact cell viability, which largely confirms the hypothesis that the key biological target profiles of CABO and Zanza are essentially the same. Given the similar target profiles, we hypothesize that a potential rationale for the improved profile we are seeing in the clinic with Zanza might be related to differences in tissue drug concentrations between tumors and normal healthy tissue when compared to CABO.

Dana: The results we got back from the screen showed the compounds were remarkably similar in terms of their ability to impact cell viability, which largely confirms the hypothesis that the key biological target profiles of Cabo and <unk>.

Dana: Are essentially the same.

Dana: Given the similar target profiles, we hypothesize that a potential rationale for the improved profile, we're seeing in the clinic with zander might be related to differences in tissue drug concentrations between tumors and normal healthy tissue when compared to combo.

Patrick J. Haley: Therefore, we conducted tissue distribution studies in both rats and mice and observed that compared to cabozantinib, zanzalintinib showed higher free drug concentrations in tumors and lower free drug concentrations in normal tissues. This translated to more potent on-target activity for inhibition of MET in tumors by Zanza. These results were a bit surprising, as we had not expected such differentials in tissue partitioning between these two molecules. But the results certainly are consistent with, and I think, help explain the apparently improved benefit-risk profile that's emerging with Zanza in the clinic. So with that, I'll turn the call back over to Mike. All right, thanks, Dana. I'll close by highlighting that two longstanding Exelixis executives are retiring after serving at a company for nearly two decades.

Dana Aftab: Therefore, we conducted tissue distribution studies in both rats and mice and observed that compared to cabozantinib, zanzalintinib showed higher free drug concentrations in tumors and lower free drug concentrations in normal tissues. This translated to more potent on-target activity for inhibition of MET in tumors by Zanza. These results were a bit surprising, as we had not expected such differentials in tissue partitioning between these two molecules. But the results certainly are consistent with, and I think, help explain the apparently improved benefit-risk profile that's emerging with Zanza in the clinic. So with that, I'll turn the call back over to Mike.

Dana T. Aftab: Therefore, we conducted tissue distribution studies in both rats and mice and observed that, compared to Cabozantinib, Zanzalitinib showed higher free drug concentrations in tumors and lower free drug concentrations in normal tissue. This translated to more potent on-target activity for inhibition of MET in tumors by Zanza. These results were a bit surprising, as we had not expected such differentials in tissue partitioning between these two molecules, but the results certainly are consistent with, and I think help explain, the apparently improved benefit-risk profile that's emerging with Zanza in the clinic. So with that, I'll turn the call back over to Mike.

Dana: Therefore, we conducted tissue distribution studies in both rats, and mice and observe that compared to Cabozantinib Lanza Linton of showed higher free drug concentrations in tumors and lower free drug concentrations in normal tissues. This.

Dana: This translated to more potent on target activity for inhibition of met in tumors by Zander. These.

Dana: These results were a bit surprising as we had not expected such differentials in tissue partitioning between these two molecules, but the results certainly are consistent with and I think help explain the apparently improved benefit risk profile, that's emerging with vans in the clinic.

Michael M. Morrissey: All right, thanks, Dana. I'll close by highlighting that two longstanding Exelixis executives are retiring after serving at a company for nearly two decades.

Dana: So with that I'll turn the call back over to Mike Alright, Thanks, Dana I will I'll close by highlighting that two longstanding <unk> executives are retiring after serving our company for nearly two decades first Peter Lamb EVP of scientific strategy was with <unk> for nearly 25 years.

Michael M. Morrissey: Alright, thanks Dana. I will close by highlighting that two long-standing Exelixis executives are retiring after serving our company for nearly two decades. First, Peter Lamb, EVP of Scientific Strategy, has been with Exelixis for nearly 25 years, and as you all know, he has made an outsized impact on our drug discovery efforts during his tenure at the organization. Additionally, Laura Dillard, our EVP of Human Resources, has spent nearly 20 years leading our HR efforts to ensure we are keeping pace with the evolution and growth of the company.

Patrick J. Haley: First, Peter Lamb, EVP of Scientific Strategy, was with Exelixis for nearly 25 years and, as you all know, made an outsized impact on our drug discovery efforts during his tenure at the organization. Additionally, Laura Dillard, our EVP of Human Resources, spent nearly 20 years leading our HR efforts to ensure we are keeping pace with the evolution and growth of the company. On behalf of the entire Exelixis team, I'd like to thank both Peter and Laura for their friendship, dedication to Exelixis, and most importantly, commitment to cancer patients on a global level. We wish them all the best as they start their retirement. So with that, I want to thank the entire XL team for their efforts to support our discovery, development, and commercial activities.

Michael M. Morrissey: First, Peter Lamb, EVP of Scientific Strategy, was with Exelixis for nearly 25 years and, as you all know, made an outsized impact on our drug discovery efforts during his tenure at the organization. Additionally, Laura Dillard, our EVP of Human Resources, spent nearly 20 years leading our HR efforts to ensure we are keeping pace with the evolution and growth of the company. On behalf of the entire Exelixis team, I'd like to thank both Peter and Laura for their friendship, dedication to Exelixis, and most importantly, commitment to cancer patients on a global level. We wish them all the best as they start their retirement. So with that, I want to thank the entire XL team for their efforts to support our discovery, development, and commercial activities.

Michael M. Morrissey: As you all know made an outsized impact on our drug discovery efforts during his tenure at the organization.

Michael M. Morrissey: Additionally, Lauren Dillard, our EVP of human resources spent nearly 20 years, leading our HR efforts to ensure we are keeping pace with the evolution and growth of the company.

Michael M. Morrissey: On behalf of the entire Exelixis team, I'd like to thank both Peter and Laura for their friendship, dedication to Exelixis, and most importantly, their commitment to cancer patients on a global level. We wish them all the best as they start their retirement. So, with that, I want to thank the entire Exelixis team for their efforts to support our discovery, development, and commercial activities. We're off to a great start in 2024 and expect this year to be critical for our science and the patients we hope to serve in the future.

On behalf of the entire Exelixis team, I'd like to thank both Peter and Laura for their friendship, dedication to Exelixis, and most importantly, their commitment to cancer patients on a global level. We wish them all the best as they start their retirement.

Dana: Behalf of the entire <unk> team I'd like to thank both Peter and Lora for their friendship dedication to <unk> and most importantly commitment to cancer patients on a global level, we wish them all the best as they start their retirement.

So, with that, I want to thank the entire Exelixis team for their efforts to support our discovery, development, and commercial activities. We're off to a great start in 2024 and expect this year to be critical for our science and the patients we hope to serve in the future.

Dana: So with that I want to thank the entire <unk> team for their efforts to support our discovery development and commercial activities. We're off to a great start in 2024 and expect this year to be critical for our science and the patients we hope to serve in the future. We built and are constantly fortifying <unk> as a big small company with all of them.

Patrick J. Haley: We're off to a great start in 2024 and expect this year to be critical for our science and the patients we hope to serve in the future. We've built and are constantly fortifying Exelixis as a big, small company with all that we do every hour of every day. The Exelixis team is highly motivated to exceed expectations in our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future, and thank you for your continued support and interest in Exelixis. We're happy to now open the call for questions. Thank you. Ladies and gentlemen, if you'd like to ask a question, please press star 11 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 11 again.

Michael M. Morrissey: We're off to a great start in 2024 and expect this year to be critical for our science and the patients we hope to serve in the future. We've built and are constantly fortifying Exelixis as a big, small company with all that we do every hour of every day. The Exelixis team is highly motivated to exceed expectations in our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future, and thank you for your continued support and interest in Exelixis. We're happy to now open the call for questions.

Michael M. Morrissey: We built and are constantly fortifying Exelixis as a big, small company with all that we do every hour of every day. The Exelixis team is highly motivated to exceed expectations and our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future, and thank you for your continued support and interest in Exelixis. We're happy to now open the call for questions.

Dana: We do every hour of every day <unk>. His team is having motivated to exceed expectations and our mission to help cancer patients recover stronger and live longer.

Speaker Change: We look forward to updating you on our progress in the future and 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, if you'd like to ask a question, please press star 11 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 11 again. In the interest of time, we ask that you limit yourself to one question only. Please stand by while we compile the Q&A roster. Our first question comes from the line of Joe Catanzaro with Piper Sandler. Your line is open.

Speaker Change: Thank you.

Operator: 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. To withdraw your question, please press star 1, 1 again. In the interest of time, we ask that you limit yourself to one question only. Please stand by while we compile the Q&A roster. Our first question comes from the line of Joe Catanzaro with Piper Sandler. Your line is open. Yeah, hi, thanks for taking my questions and appreciate you taking the time here. So I wonder if you could elaborate a bit on your earlier comment in the event of a positive outcome with regard to MSM [inaudible] litigation and is there an interest in looking for later stage assets in [inaudible]? I guess, how would you define later stage? Is it sort of modality agnostic and what size deal do you think you could execute with the balance sheet and clarity around CABO revenue? Thanks.

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

Speaker Change: To withdraw your question. Please press star one again.

Patrick J. Haley: In the interest of time, we ask that you limit yourself to one question only. Please stand by while we compile the Q&A roster. Our first question comes from the line of Joe Catanzaro with Piper Sandler. Your line is open. Yeah, hi. Thanks for taking my questions, and appreciate you taking the time here. So I'm wondering if you could elaborate a bit on your earlier comments and the events of a positive outcome with regards to MSN patent litigation and sort of interest in looking for later stage assets in GU/GI oncology. I guess, how would you define later stage? Is this sort of modality agnostic? And what size deal do you think you could execute with the balance sheet and clarity around the Combo revenue tail? Thanks. Yeah, Joe, it's Mike. Thanks for the question. Yeah, this isn't really a new approach.

Joe Catanzaro: Yeah, hi, thanks for taking my questions and appreciate you taking the time here. So I wonder if you could elaborate a bit on your earlier comment in the event of a positive outcome with regard to MSM [inaudible] litigation and is there an interest in looking for later stage assets in [inaudible]? I guess, how would you define later stage? Is it sort of modality agnostic and what size deal do you think you could execute with the balance sheet and clarity around CABO revenue? Thanks.

Speaker Change: In the interest of time, we ask that you limit yourself to one question only please.

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

Speaker Change: Okay.

Michael M. Morrissey: Yeah, Joe, it's Mike. Thanks for the question. Yeah, this isn't really a new approach. We talked about this earlier in the year, as we were implementing the restructuring, focusing our BD efforts on later stage assets, in terms of new modalities that are either in or entering pivotal trials, as well as their focus on helping us find collaborations with Zanza and other molecules in our pipeline to collaborate on in terms of cost and or compound sharing arrangements.

Speaker Change: Our first question comes from the line of Joe Catanzaro with Piper Sandler Your line is open.

Joseph Catanzaro: Yeah, hi. Thanks for taking my questions, and appreciate you taking the time here. So I'm wondering if you could elaborate a bit on your earlier comments and the events of a positive outcome with regards to MSN patent litigation and sort of interest in looking for later stage assets in GU/GI oncology. I guess, how would you define later stage? Is this sort of modality agnostic? And what size deal do you think you could execute with the balance sheet and clarity around the Combo revenue tail?

Joseph Michael Catanzaro: Yeah, Hi, Thanks for taking my questions then.

Joseph Michael Catanzaro: Youre, taking the time here so I'm wondering if you could.

Joseph Michael Catanzaro: Elaborate a bit on your earlier comments in the event of a positive outcome with regards to the MSN patent litigation.

Joseph Michael Catanzaro: And sort of interest in looking for later stage assets in <unk> Gi oncology I guess, how would you define later stage as this sort of modality agnostic and what size of deal do you think you could execute with the balance sheet and clarity around the Cabo revenue too. Thanks.

Michael M. Morrissey: Thanks. Yeah, Joe, it's Mike. Thanks for the question. Yeah, this isn't really a new approach. We talked about this earlier in the year as we were implementing the restructuring, focusing our BD efforts on later-stage assets in terms of new modalities that are either in or entering pivotal trials, as well as their focus on helping us find collaborations with zanzalintinib and other molecules in our pipeline to collaborate on in terms of cost and/or compound sharing arrangements.

Joseph Michael Catanzaro: Yes, Joe it's Mike. Thanks for the question Yeah. This isn't really a new new.

Patrick J. Haley: We talked about this earlier in the year as we were implementing the restructuring, focusing our BD efforts on later-stage assets in terms of new modalities that are either in or entering pivotal trials, as well as their focus on helping us find collaborations with zanzalintinib and other molecules in our pipeline to collaborate on in terms of cost and/or compound sharing arrangements. So look, we're very interested in building a pipeline. We've got a great discovery, development, and commercial organization, and late-stage assets fit well into that overall approach. Whether they be already in pivotal trials or about to enter, we think we can add a lot of value as we go forward. So wouldn't want to comment on size, wouldn't want to comment, and certainly on individual targets. We're modality agnostic in terms of small molecules and biologics.

Michael M. Morrissey: <unk> approach, we talked about this earlier in the year as we were implementing the restructuring focusing our BD efforts on later stage assets in terms of new modalities that are either in or entering pivotal trials as well as their focus on helping us find our collaborations with vans and other molecules.

Joseph Michael Catanzaro: And our pipeline to collaborate on in terms of cost <unk> compounds sharing arrangement. So look we're very interested in building a pipeline and we've got a great discovery development and commercial organization and late stage assets fit well into that overall approach whether they'd be already in pivotal trials are about to enter we think we can.

Michael M. Morrissey: So look, we're very interested in building a pipeline. We've got a great discovery, development, and commercial organization, and late-stage assets fit well into that overall approach. Whether they be already in pivotal trials or about to enter, we think we can add a lot of value as we go forward. So wouldn't want to comment on size, wouldn't want to comment, and certainly on individual targets. We're modality agnostic in terms of small molecules and biologics.

Michael M. Morrissey: So, look, we're very interested in building a pipeline. We've got a great discovery, development, and commercial organization, and late stage assets fit well into that overall approach whether they are already in pivotal trials or about to enter, we think we can add a lot of value as we go forward. So, I wouldn't want to comment on size, wouldn't want to comment, and certainly on individual targets where modality agnostic in terms of small molecules and biologics. We have, I think, a very, very good eye for good data and good compounds. Again, the CABO lens, if you will, really informs that. We talked about that at R&D Day back in December. So, we're all in in terms of finding potential assets to be able to bring into our pipeline, and that will continue as we go forward.

Joseph Michael Catanzaro: Add a lot of value as we go forward so wouldn't want to comment on size wouldn't want to comment on certainly on.

Tawanda: We talked about that at R&D Day back in December. So, we're all in in terms of finding potential assets to be able to bring into our pipeline, and that will continue as we go forward. 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. Hey guys, thanks for taking my questions. So I just wanted to follow up on the commercial opportunity slide. Just curious how you guys think an indication like that could ramp the second line incidence. It's a decent size number, I'm just wondering about the availability of an established AI which wasn't studied head to head. I guess, does that create a barrier at all or might slow the launch, the launch for our [inaudible] just given the need to retrain physicians or educate them about your data. Thanks. Hi, Jason. This is PJ, thanks for the question. I'd say we're really excited about the data Amy went into a little more detail on. As I mentioned, it's a preliminary market research. We certainly had some advisory boards. I guess what I'd say at a high level is there's a lot of enthusiasm for the data. I don't think there'll be anything significantly different than prior launches. You mentioned [inaudible] and kind of trajectory or uptake or retraining physicians per se. I think they're very comfortable obviously with TKI and even in this setting. So we think this is a really nice opportunity potentially should we receive approval. For CABO, as I spoke to the broad population that was studies with regards to pancreatic, extra pancreatic, site of origin tumors including the lung which is a little bit different from some of the other agents which we had studied broadly as well as the fact that we studied whether it was TR positive or negative as well as kind of having a modern data set which included a lot of patients treated with Lutathera. The study really give us the potential to be broad and I think in a sense very user friendly for oncologists so really looking for something [inaudible].

We talked about that at R&D Day back in December. So, we're all in in terms of finding potential assets to be able to bring into our pipeline, and that will continue as we go forward. 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. Hey guys, thanks for taking my questions. So I just wanted to follow up on the commercial opportunity slide. Just curious how you guys think an indication like that could ramp the second line incidence. It's a decent size number, I'm just wondering about the availability of an established AI which wasn't studied head to head. I guess, does that create a barrier at all or might slow the launch, the launch for our [inaudible] just given the need to retrain physicians or educate them about your data. Thanks.

We talked about that at R&D Day back in December. So, we're all in in terms of finding potential assets to be able to bring into our pipeline, and that will continue as we go forward.

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. Hey guys, thanks for taking my questions. So I just wanted to follow up on the commercial opportunity slide. Just curious how you guys think an indication like that could ramp the second line incidence. It's a decent size number, I'm just wondering about the availability of an established AI which wasn't studied head to head. I guess, does that create a barrier at all or might slow the launch, the launch for our [inaudible] just given the need to retrain physicians or educate them about your data. Thanks.

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.

Jason Gerberry: Hey guys, thanks for taking my questions. So I just wanted to follow up on the commercial opportunity slide. Just curious how you guys think an indication like that could ramp the second line incidence. It's a decent size number, I'm just wondering about the availability of an established AI which wasn't studied head to head. I guess, does that create a barrier at all or might slow the launch, the launch for our [inaudible] just given the need to retrain physicians or educate them about your data. Thanks.

Joseph Michael Catanzaro: Individual targets, where modality agnostic in terms of small molecules and biologics.

Patrick J. Haley: We have, I think, a very good eye for good data and good compounds. Again, the Combo lens, if you will, really informs that. We talked about that at R&D Day back in December. We're all in in terms of finding potential assets to be able to bring into our pipeline, and that will continue as we go forward. 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. Hey, guys. Thanks for taking my question. So mine, I just wanted to follow up on the NET commercial opportunity slide. I'm just curious how you guys think an indication like that could ramp the second-line incidence. It's a decent-sized number.

Michael M. Morrissey: We have, I think, a very good eye for good data and good compounds. Again, the Combo lens, if you will, really informs that. We talked about that at R&D Day back in December. We're all in in terms of finding potential assets to be able to bring into our pipeline, and that will continue as we go f

Joseph Michael Catanzaro: We have I think a very very good eye for good data and good compounds again, the Cabo lens. If you will really informs that and talked about that at R&D day.

P.J. Haley: Hi, Jason. This is PJ, thanks for the question. I'd say we're really excited about the data Amy went into a little more detail on. As I mentioned, it's a preliminary market research. We certainly had some advisory boards. I guess what I'd say at a high level is there's a lot of enthusiasm for the data. I don't think there'll be anything significantly different than prior launches. You mentioned [inaudible] and kind of trajectory or uptake or retraining physicians per se. I think they're very comfortable obviously with TKI and even in this setting. So we think this is a really nice opportunity potentially should we receive approval. For CABO, as I spoke to the broad population that was studies with regards to pancreatic, extra pancreatic, site of origin tumors including the lung which is a little bit different from some of the other agents which we had studied broadly as well as the fact that we studied whether it was TR positive or negative as well as kind of having a modern data set which included a lot of patients treated with Lutathera. The study really give us the potential to be broad and I think in a sense very user friendly for oncologists so really looking for something new in this setting.

Joseph Michael Catanzaro: Back in December so we're all in in terms of finding potential assets to be able to bring into our pipeline and that will continue as we go forward.

Operator: orward. 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.

Operator: Please stand by for our next question. Our next question comes from the line of Jason Gerberry with Banks for Miracle. Your line is open. Hey guys, thanks for taking my question. So my question, I just wanted to follow up on. create the barrier at all, or might slow the launch.

Speaker Change: Thank you.

Speaker Change: Please standby for around next question.

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

Jason Gerberry: Hey, guys. Thanks for taking my question. So mine, I just wanted to follow up on the NET commercial opportunity slide. I'm just curious how you guys think an indication like that could ramp the second-line incidence. It's a decent-sized number.

Jason: Hey, guys. Thanks for taking my question.

Jason: So in my mind I, just wanted to follow up on the.

Jason: Any key commercial opportunity slide I'm, just curious how you guys think an indication like that could ramp.

Speaker Change: That line incidents.

Patrick J. Haley: I just wonder about the availability of an established oral TKI, which wasn't studied head-to-head against, if that creates a barrier at all or might slow the launch versus the launches we're accustomed to seeing, like TechMate 90R, just given the need to potentially retrain physicians or educate them about your data. Thanks. Yeah. Hi, Jason. This is PJ. Thanks for the question. I'd say we're really excited about the data that Amy went into a little more detail on. As I mentioned, we've kind of conducted some preliminary market research. We've certainly had some advisory boards. I guess what I'd say at a high level is there's a lot of enthusiasm for the data. I don't think there'll be anything significantly different than prior launches. You mentioned 90R in terms of kind of trajectory or uptake or sort of retraining physicians, per se.

Jason Gerberry: I just wonder about the availability of an established oral TKI, which wasn't studied head-to-head against, if that creates a barrier at all or might slow the launch versus the launches we're accustomed to seeing, like TechMate 90R, just given the need to potentially retrain physicians or educate them about your data.

Speaker Change: <unk> number.

Speaker Change: I just wonder about the availability of an established oral PKI, which wasn't studied head to head against that.

Tawanda: create the barrier at all, or might slow the launch.

Speaker Change: Creates a barrier at all or might flow the launch versus the launches we're accustomed to seeing like checkmate 90 or.

Speaker Change: Just given the need potentially retraining physicians or educate them about your data. Thanks.

Patrick J. Haley: Thanks. Yeah. Hi, Jason. This is PJ. Thanks for the question. I'd say we're really excited about the data that Amy went into a little more detail on. As I mentioned, we've kind of conducted some preliminary market research. We've certainly had some advisory boards. I guess what I'd say at a high level is there's a lot of enthusiasm for the data. I don't think there'll be anything significantly different than prior launches. You mentioned 90R in terms of kind of trajectory or uptake or sort of retraining physicians, per se.

Patrick J. Haley: Yeah, hi Jason, this is PJ. Thanks for the question. You know, I'd say we're really excited about the data that Amy went into a little more detail on. As I mentioned, we've kind of conducted some preliminary market research, we've certainly had some advisory boards, and I guess what I'd say at a high level is that there's a lot of enthusiasm for the data. So, you know, I don't think there'll be anything significantly different from prior launches.

Speaker Change: Yes, Hi, Jason This is P. J thanks for the question.

P. J: I'd say, we're really excited about the data.

P. J: Amy went into a little more detail on.

P. J: As I mentioned, we've kind of conducted some preliminary market research has certainly had some advisory boards and I guess, what I'd say at a high level is there.

P. J: There is a lot of enthusiasm for the data.

P. J: I don't think there'll be.

P. J: Anything significantly different than prior launches you mentioned 90 90 or in terms of kind of.

Tawanda: You mentioned 9ER in terms of kind of... Trajectory or uptake or sort of retraining physicians per se, I think they're very comfortable, obviously, with TKIs and, you know, even in this setting. So, you know, we think this is a really nice opportunity, potentially, should we receive approval. For CABO, you know, as I spoke to, I think the broad population that was studied with regards to pancreatic, extra pancreatic, site of origin tumors, including lung, which is a little bit different from some of the other agents which weren't studied as broadly, as well as the fact that, you know, we're studied in SSTR positive, negative, as well as kind of having a modern data set, which included a lot of patients treated with Lutatherapy before the study really gives us, you know, the potential to be broad and I think, in a sense, very user friendly for oncologists who are really looking for something new in this setting.

P. J: Trajectory of uptake or sort of retraining physicians per se I think they are very comfortable obviously with teekay eyes.

Patrick J. Haley: I think they're very comfortable, obviously, with TKIs and even in this setting. So we think this is a really nice opportunity, potentially, should we receive approval. For Combo, as I spoke to, I think the broad population that was studied with regards to pancreatic, extrapancreatic, site of origin tumors, including lung, which is a little bit different from some of the other agents, which weren't studied as broadly, as well as the fact that we're studied in SSTR positive and negative, as well as kind of having a modern dataset, which included a lot of patients treated with Lutathera before the study, really gives us the potential to be broad and, I think, in a sense, very user-friendly for oncologists who are really looking for something new in this setting. Thank you. Please stand by for our next question.

P. J: Even in this setting.

P. J: So we think this is a really nice opportunity potentially should we receive approval for Cabo.

P. J: As I spoke to I think the broad.

P. J: A population that was studied with regards to pancreatic extra pancreatic site of origin.

P. J: Tumors, including lung, which is a little bit different from.

P. J: Some of the other agents were toward studied as broadly as well as the fact that <unk>.

P. J: Studied in <unk> positive negative as.

P. J: As well as kind of having a modern data set which included a lot of patients.

P. J: <unk> treated with <unk> before the study really gives us.

P. J: The potential to be broad and I think in a sense very user friendly.

P. J: For oncologists, who are really looking for something new in this setting.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Speaker Change: Thank you.

Operator: Please stand by for our next question. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.

Speaker Change: Please standby for our next question.

Patrick J. Haley: Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open. Hey, guys. Thanks for taking my questions. I had one for Amy on STELLAR-305. And so just wondering how the enrollment criteria in the study compare to that from KEYNOTE-048 or LEAP-010, to what degree you feel like you may need to adjust the trial based on the LEAP-010 data that was presented recently, and what your confidence level is in demonstrating a positive overall survival trend, which was obviously not the case in LEAP-010. Thanks so much. Yeah, thanks for the question, Michael.

Michael Schmidt: Hey guys, thanks for taking my questions. I had one for Amy on Stellar 305. And so, just wondering how the enrollment criteria in the study compare to that [inaudible] and to what degree do you feel like you may need to adjust the trial based on the LEAP-10 data that was presented recently and what [inaudible]. Thanks so much.

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

Michael Schmidt: Hey, guys. Thanks for taking my questions. I had one for Amy on STELLAR-305. And so just wondering how the enrollment criteria in the study compare to that from KEYNOTE-048 or LEAP-010, to what degree you feel like you may need to adjust the trial based on the LEAP-010 data that was presented recently, and what your confidence level is in demonstrating a positive overall survival trend, which was obviously not the case in LEAP-010. Thanks so much.

Michael Schmidt: Hey, guys. Thanks for taking my questions I had one for Amy on stellar three or five and so just wondering.

Michael Schmidt: How the enrollment criteria in the study compared to that from Keno at all for eight or 10.

Michael Schmidt: To what degree you feel like you may need to adjust the trial based on the 10 data that was presented recently and what your confidence level is and demonstrating a positive overall survival trend, which was obviously not the case and like Ted Thanks, So much.

Michael Schmidt: Yeah, thanks for the question, Michael. It was very interesting to actually get a chance to see the results from the presentation earlier this year in terms of LEAP10, notably an ORR and a PFS that favored Len/PEM, but an OS that didn't, and an interesting duration of response with monotherapy/PEM favored over the doublet. So this is a different population, frontline head and neck, a little bit more frail than other patient populations. And we're interested in trying to uncover as much as we can around the dose of Len, the dose reductions, and how much that may have abrogated a patient's ability to receive full PEM/BRO dose. So we are busy, deeply, trying to understand that and, if need be, make a change to the 305 study with regard to dose in the context of a frailer patient population, if you will.

Amy Peterson: Yeah, thanks for the question, Michael. It was very interesting to actually get a chance to see the final results from the presentation earlier this year in terms of LEAP-10, notably an ORR and a PFS that favored LEN-PEM, but an OS that didn't, and an interesting duration of response with monotherapy PEM favored over the doublet. So, you know, this is a different population, frontline head and neck, a little bit more frail than other patient populations.

Speaker Change: Yeah. Thanks for the question Mike.

Patrick J. Haley: It was very interesting to actually get a chance to see the results from the presentation earlier this year in terms of LEAP10, notably an ORR and a PFS that favored Len/PEM, but an OS that didn't, and an interesting duration of response with monotherapy/PEM favored over the doublet. So this is a different population, frontline head and neck, a little bit more frail than other patient populations. And we're interested in trying to uncover as much as we can around the dose of Len, the dose reductions, and how much that may have abrogated a patient's ability to receive full PEM/BRO dose. So we are busy, deeply, trying to understand that and, if need be, make a change to the 305 study with regard to dose in the context of a frailer patient population, if you will.

Ted: It was very interesting to actually get a chance to see the final results from the presentation earlier this year in terms of <unk> 10.

Ted: Notably <unk> and PFS that favored a lan tam, but in Oss that didn't.

Ted: And an interesting duration of response with monotherapy Pam favored over at the doublet.

Ted: This is a different population frontline head and neck, a little bit more frail than other patient populations and we're interested in trying to uncover as much as we can around the dose of land the dose reductions and how much.

Amy Peterson: And, you know, we're interested in trying to uncover as much as we can around the dose of LEN, the dose reductions, and how much that may have abrogated a patient's ability to receive the full PEMBRO dose. So we are busy, deeply trying to understand that, and, if need be, make a change to the 305 study with regard to dose in the context of a very, a frailer patient population I think that there is a differentiation between ZANZA and LEN in that ZANZA does inhibit the TAM kinase family, which is implicated, if you will, in favoring an immune permissive environment.

Ted: That may have aggregated a patient's ability to receive full pembroke dose.

Ted: So we are busy deeply trying to understand that and.

Ted: Need be make a change to the 305 study with regard to dose in the context of a very.

Ted: A frail or patient population.

Patrick J. Haley: I think that there's a differentiation between Zanza and Len in that Zanza does inhibit the TAM kinase family, which is implicated, if you will, in favoring an immune-permissive environment. So the mechanism of action of Zanza is different from Len, and because of that, could very likely have a differential outcome, and we believe it will. So we'll see what ultimately needs to be changed, and we'll keep you posted on those changes as they're made. Right now, the eligibility criteria, for the most part, are posted on ClinicalTrials.gov. And where we need to make an update, we will. 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. Great. Good afternoon, Mike and team. Thanks for the updates, and thanks for taking the question.

Amy Peterson: I think that there's a differentiation between Zanza and Len in that Zanza does inhibit the TAM kinase family, which is implicated, if you will, in favoring an immune-permissive environment. So the mechanism of action of Zanza is different from Len, and because of that, could very likely have a differential outcome, and we believe it will. So we'll see what ultimately needs to be changed, and we'll keep you posted on those changes as they're made. Right now, the eligibility criteria, for the most part, are posted on ClinicalTrials.gov. And where we need to make an update, we will.

Ted: Well I think that there's a differentiation between zander and learn and that zander doesn't inhibit the Tam kinase family.

Ted: Which is.

Ted: Implicated if you will and favoring an immune permissive environment. So the mechanism of action of <unk> is different from Atlanta, and because of that could very likely have a differential outcome and we believe it will so we'll see.

Amy Peterson: So the mechanism of action of ZANZA is different from LEN and because of that, could very likely have a differential outcome, and we believe it will. So we'll see how what ultimately needs to be changed, and we'll keep you posted on those changes as they're made. Right now, the eligibility criteria are, for the most part, posted on clinicaltrials.gov, and where we need to make an update, we will.

Ted: What what ultimately needs to be changed and we'll keep you posted on those changes as as they're made right now the eligibility criteria for the most part are posted on clinical trials Gov.

Ted: And where we need to make an update.

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.

Ted: Well.

Speaker Change: Thank you.

Operator: 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. Good afternoon Mike and team. Thanks for the update, thanks for taking my question. I'll just ask a little bit building on the neuro [inaudible] tumor opportunity, certainly in contact with respect to CABO, but as you think about Zanza and the combo optionality there and the white space that you have, I'm wondering if you could just comment on a bit on Zanza and this indication. What is the opportunity and what is the potential development path as you think about [inaudible] with Zanza and the therapy as something to explore? Thanks again.

Operator: 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: Please standby for our next question.

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

Gregory Renza: Great. Good afternoon, Mike and team. Thanks for the updates, and thanks for taking the question. Mike, maybe just to ask a little bit, building on the neuroendocrine tumor opportunity, certainly nicely in context with respect to Combo. But as you do think about Zanza and the Combo optionality there and the white space that you have, I'm wondering if you could just comment a bit about Zanza in this indication. Is there opportunity, and what are the potential development paths? If you think about Combos, would potentially Zanza and Lutathera be something to explore?

Gregory Renza: Good afternoon Mike and team. Thanks for the update, thanks for taking my question. I'll just ask a little bit building on the neuro [inaudible] tumor opportunity, certainly in contact with respect to CABO, but as you think about Zanza and the combo optionality there and the white space that you have, I'm wondering if you could just comment on a bit on Zanza and this indication. What is the opportunity and what is the potential development path as you think about [inaudible] with Zanza and the therapy as something to explore? Thanks again.

Gregory James Renza: Great Good afternoon, Mike and team thanks for the update and thanks for taking the question.

Patrick J. Haley: Mike, maybe just to ask a little bit, building on the neuroendocrine tumor opportunity, certainly nicely in context with respect to Combo. But as you do think about Zanza and the Combo optionality there and the white space that you have, I'm wondering if you could just comment a bit about Zanza in this indication. Is there opportunity, and what are the potential development paths? If you think about Combos, would potentially Zanza and Lutathera be something to explore? Thanks again. Yeah, Greg, thanks for the question. It's a great one. I can punt over to Amy and PJ to opine upon. Amy? Yeah, sure. As I mentioned during the call, we're always assessing what is the next best thing to think about for zanzalintinib. We look at all things that are strategic in our assessment. So I talked about the probability of technical success.

Gregory James Renza: Mike maybe just to ask a little bit building on the neuroendocrine tumor opportunity certainly nicely in context with respect to combo, but as you think about the Santa Ana the combo Optionality, there and the white space that you have I'm wondering if you could just comment a bit about zander since in this indication is there opportunity and what are the potential.

Gregory James Renza: <unk> passed as you think about combos would potentially is that then with the therapy would be something to explore thanks again.

Michael M. Morrissey: Thanks again. Yeah, Greg, thanks for the question. It's a great one. I can punt over to Amy and PJ to opine upon. Amy?

Michael M. Morrissey: Yeah, Greg, thanks for the question. That's a great one. I can punt it over to Amy and PJ to opine upon. Amy?

Michael M. Morrissey: Yes, Greg Thanks for the question, that's a great when I can punt over to Amy and Pega to opine upon Amy.

Amy Peterson: Yeah, sure. As I mentioned during the call, we're always assessing what is the next best thing to think about for zanzalintinib. We look at all things that are strategic in our assessment. So I talked about the probability of technical success. That's a big one for us to consider, as well as the time it takes to conduct the study and the competitive and evolving landscape and the value proposition. And I would say that neuroendocrine tumor is high on the list for Zanza, and we are very interested in it. I'll let PJ comment a little bit on the commercial.

Amy Peterson: Yeah, sure. As I mentioned during the call, we're always assessing what is the next best thing to think about for Zanzalitnib. We look at all things that are strategic in our assessment. So I talked about the probability of technical success, that's a big one for us to consider, as well as the time it takes to conduct the study and the competitive and evolving landscape and the value proposition. And I would say that neuroendocrine tumor is high on the list for Zanza, and we are very interested in it. I'll let PJ comment a little bit on the commercial.

Amy Peterson: Yes, sure as I mentioned during the call. We're always assessing what is the next best thing to think about for Zander, Let know we look at all.

Amy Peterson: That's a big one for us to consider, as well as the time it takes to conduct the study and the competitive and evolving landscape and the value proposition. And I would say that neuroendocrine tumor is high on the list for Zanza, and we are very interested in it. I'll let PJ comment a little bit on the commercial.

Amy Peterson: <unk> that are strategic and and our associates.

Amy Peterson: <unk>, so I talked about the probability of technical success, that's a big one for us to consider as well as the time it takes to conduct the study in the competitive and evolving landscape and the value proposition.

Patrick J. Haley: That's a big one for us to consider, as well as the time it takes to conduct the study and the competitive and evolving landscape and the value proposition. And I would say that neuroendocrine tumor is high on the list for Zanza, and we are very interested in it. I'll let PJ comment a little bit on the commercial. Yeah, I mean, I think just at a high level, if I go back to kind of the opportunity here, certainly a large unmet medical need, as I mentioned, with not many new therapies, really any oral therapies being approved since 2016. So I think there's a lot of room to maneuver in this tumor type in particular. The orals, as I mentioned in my remarks and on the slide, account for approximately 50% of the second-line plus population.

Amy Peterson: And I would say that neuroendocrine tumor is high on the list four for Zander.

Amy Peterson: And we are very interested in it.

Amy Peterson: Let TJ comment a little bit on the commercial yeah, I mean, I think just at a high level.

Patrick J. Haley: Yeah, I mean, I think just at a high level, if I go back to kind of the opportunity here, certainly a large unmet medical need, as I mentioned, with not many new therapies, really any oral therapies being approved since 2016. So I think there's a lot of room to maneuver in this tumor type in particular. The orals, as I mentioned in my remarks and on the slide, account for approximately 50% of the second-line plus population.

P.J. Haley: Yeah, I mean, just at a high level, if I go back to kind of the opportunity here, certainly a large unmet medical need, as I mentioned, with not many new therapies, really any oral therapies being approved since 2016, so I think there's a lot of room to maneuver in this tumor type, in particular. The orals, as I mentioned in my remarks, and on the slide, account for approximately 50% of the second line plus population. So if you think about Lutathera, for example, which is doing over $400 million in revenue annually, basically in a second line plus population, they have the NETR2 data. They had ASCO GI this year, but those revenues kind of predate that so that's a pretty significant opportunity in less than 50% of that market so I think its a big space that really there's a high appetite for new therapies, for new trials and opportunity for this market to grow over time so I see this as very exciting.

TJ: If I go back to kind of the opportunity here.

TJ: Certainly a large unmet medical need as I mentioned with not many new therapies really any oral therapy is being approved.

TJ: Since 2016, so I think theres a lot of room to maneuver.

TJ: In this in this tumor type in particular.

TJ: The oral is as I mentioned.

TJ: In my remarks, and on the slide account for approximately 50% of the second line plus population.

Patrick J. Haley: So if you think about Lutathera, for example, which is doing over $400 million in revenue annually, basically a second-line plus population, they have the NETR2 data at ASCO GI this year, but those revenue kind of predate that. So that's a pretty significant opportunity in less than 50% of that market. So I think this is a big space that's really there's a high appetite for new therapies, for new trials, and really an opportunity for this market to grow over time. So I see it as very exciting. Yeah, that's great, PJ. I would just add, I think the way we talk about NET here, and we're really excited about certainly the CABINET data and the opportunities to go forward with Zanza, we think NET is similar to what we saw with RCC back in the 2014, 2015, 2016 time.

Patrick J. Haley: So if you think about Lutathera, for example, which is doing over $400 million in revenue annually, basically in a second line plus population, they have the NETR2 data. They had ASCO GI this year, but those revenues kind of predate that. So that's a pretty significant opportunity.

TJ: So if you think about <unk> for example.

TJ: Which is doing over $400 million in revenue annually.

TJ: Basically our second line plus population they have the network to data at.

TJ: At <unk> this year, but those revenue kind of predate that so that's a pretty significant opportunity and less than 50% of that market. So I think this is a big space.

TJ: Thats really there is a high appetite for for.

TJ: New therapies for new trials.

TJ: And really an opportunity for this market to grow over time, so I see it as very exciting yes, that's great P. J I would just I would just add I think the way we talk about next year and we're really excited about certainly the cabinet data and the opportunities to go forward with <unk>. We think we think net is similar to what we saw with RCC back from that.

Michael M. Morrissey: Yeah, that's great, PJ. I would just add, I think the way we talk about NET here, and we're really excited about certainly the CABINET data and the opportunities to go forward with Zanza, we think NET is similar to what we saw with RCC back in the 2014, 2015, 2016 time. There's lots of similarities between the two, even though they're obviously very different indications. So we're excited about this. We hope to invest more as we go forward. Lots of opportunities with Zanza and other potential combinations. Stay tuned. As that evolves, we'll keep you in the loop.

Michael M. Morrissey: Yeah, that's great, PJ. I would just add: I think the way we talked about that here and we're really excited about certainly the [inaudible] data and the opportunities to go forward with Zanza, we think NET is similar to what we saw at RCC back in the 2014, 2015, 2016 time and there's a lot of similarities between the two even though they are obviously different indications. So we're excited about this, we hope to invest more as we go forward. Lots of opportunities with Zanza and other potential combinations so stay tuned. As that evolves, we'll keep you in the loop.

Speaker Change: 2014, 2015, 2016 time and Theres lots of lots of similarities between the two even though there are obviously different very different indications. So we are excited about this we hope to invest more as we go forward lots of opportunities with <unk> and other potential combinations. So stay tuned as that as that evolves, we'll keep you in the loop.

Patrick J. Haley: There's lots of similarities between the two, even though they're obviously very different indications. So we're excited about this. We hope to invest more as we go forward. Lots of opportunities with Zanza and other potential combinations. Stay tuned. As that evolves, we'll keep you in the loop. Thank you. Please stand by for our next question. Our next question comes from the line of Yaraan Webber with TD Cowen. Your line is open. Hey, guys. This is Joy Assan for Yaraan. Thanks for taking the question. Maybe just another follow-up on the NET market opportunity. I think you guys have previously said that the prevalent population is about five times the size of the second-line plus incident population or about 40,000 patients. Just wondering how much of that market you think you can capture or pull into this opportunity with Combo and/or Zanza. Thank you. Yeah.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Yaraan Webber with TD Cowen. Your line is open.

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Yaron Werber with T.D. Cowen. Your line is open. Hi, this is Joyce on for Yaron. Thanks for taking the question. Maybe just another follow up on the market opportunity, I think you guys have [inaudible] population is about five times the size of the second line plus incident population or about 40,000 patients. Just wondering if you can comment on that market you think you can capture or pull into this opportunity with CABO and or Zanza.

Speaker Change: Please standby for our next question.

Speaker Change: Yes.

Speaker Change: Our next question comes from the line of Youre wrong Weber with T. D. Cohen Your line is open.

Joy Assan: Hey, guys. This is Joy Assan for Yaraan. Thanks for taking the question. Maybe just another follow-up on the NET market opportunity. I think you guys have previously said that the prevalent population is about five times the size of the second-line plus incident population or about 40,000 patients. Just wondering how much of that market you think you can capture or pull into this opportunity with Combo and/or Zanza. Thank you. Yeah.

Speaker Change: This is joey on for Aaron Thanks for taking my question.

Joey: Maybe just another follow up on the any key market opportunity.

Joey: Thank you guys have previously said that the prevalent population is about five times the size of the second line plus incident population or about.

Joey: About 40000 patients.

Joey: Wondering how much of that market you think you can capture or pull into this opportunity with Cabo <unk> and Beth Thank you.

Patrick J. Haley: Hi, Joyce. This is PJ. Thanks for the question. I think, as I mentioned, the 8,000 patients, those are kind of new incident patients in a given year. And as you mentioned, the prevalent population is much larger. I think I wouldn't want to speculate before we get to a label on the potential upside or where it might play out in the marketplace. But I think when we think about the 8,000 patients, etc., that's kind of the baseline. And there certainly could be many more patients, given that this is an indolent disease where patients receive many lines of therapy that might be kind of out there. But again, I think we need to wait till we get in the market to really get a good sense of that.

P.J. Haley: Yeah, hi Joyce, this is P.J. Thanks for the question. I think as I mentioned, the 8,000 patients, those kind of new incident patients in a given year. And as you mentioned, the prevalent population is much larger. I wouldn't want to speculate before we get to a label on the potential upside or where it might play out in the marketplace, but I think when we think about the 8-K patients, etc., that's kind of the baseline and there certainly could be many more patients, given that this is an indolent disease where patients receive many lines of therapy that might be kind of out there. But again, I think we need to wait till we get in the market to really get a good sense of that but we're very confident and comfortable with the 8,000 patients as it is being a really significant potential opportunity for CABO.

Joey: Yeah, Hi, Joyce this is P. J. Thanks for the question I think.

Patrick J. Haley: Thanks for the question. I think you know, as I mentioned, the 8000 patients are those kind of new incident patients in a given year. And as you mentioned, the prevalent population is much larger. I think, you know, I wouldn't want to speculate before we get to a label on the potential upside or where it might play out in the marketplace. But I think, you know, when we think about the 8K patients, etc., that's kind of the baseline.

P. J.: You know as I mentioned, the 8000 patients or those are kind of new incident patients in a given year and as you mentioned the prevalent population is.

P. J.: Is much larger I think.

P. J.: I wouldn't want to speculate.

P. J.: Before we get to a label on the potential upside or where it might play out in.

Joey: In the marketplace, but I think when you.

Joey: Think about the 8-K patients et cetera, that's kind of the baseline and there certainly could.

Patrick J. Haley: And there certainly could be many more patients, given that this is an indolent disease where patients receive many lines of therapy that might be kind of out there. But again, I think we need to wait till we get in the market to really get a good sense of that. But we're very confident and comfortable in the 8,000 patients as it is being a really significant potential opportunity for Combo.

Joey: It could be many more patients given that this is an indolent disease.

Joey: Where patients received many lines of therapy.

Joey: It might be kind of out there, but again I think we need to.

Joey: To wait until we get in the market to really get a good sense of that but we're very confident and comfortable in the 8000 patients as it is being a really significant potential opportunity for Cabo.

Patrick J. Haley: But we're very confident and comfortable in the 8,000 patients as it is being a really significant potential opportunity for Combo. Thank you. Please stand by for our next question. Our next question comes from the line of Andy Sea with Wim Blair. Your line is open. Oh, great. Thanks for taking our questions. 2 quick ones if you don't mind. 1, financial, 1, scientific. In terms of Medicare D exposure, Chris, do you mind reminding us your exposure there for the Combo franchise? Several companies, including Gilead, kind of called out the potential impact next year stemming from the Medicare Part D redesign. So that's part 1. Part 2, very provocative differential partitioning data of Combo versus Zanza. I am curious, 1, how was that determined? Was it based on kind of radio labeling experiments?

Patrick J. Haley: and there certainly could be many more patients, given that this is an indolent disease where patients receive many lines of therapy that might be kind of out there. But again, I think we need to wait till we get in the market to really get a good sense of that but we're very confident and comfortable with the 8,000 patients as it is being a really significant potential opportunity for CABO.

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

Speaker Change: Thank you.

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

Joey: Please standby for our next question.

Joey: Yeah.

Unknown: Oh, great. Thanks for taking our questions. Two quick ones, if you don't mind, one financial and one scientific. In terms of Medicare D exposure, Chris, do you mind reminding us your exposure there for the CABO franchise? Several companies, including Gilead, kind of called out the potential impact next year stemming from the Medicare Part D redesign, so that's part one. Part two, very [inaudible] partitioning data of CABO versus Zanza. I am curious, one, how was that determined? Was it based on kind of radio labeling experiments? And then, perhaps, from a hypothesis perspective, do you have any sort of initial work in terms of why that is? Is that kind of a difference in passive diffusion, or maybe transporters are involved? So, those are the two questions. Thank you.

Joey: Our next question comes from the line of Andy <unk> with William Blair. Your line is open.

Andy Shea: Oh, great. Thanks for taking our questions. 2 quick ones if you don't mind. 1, financial, 1, scientific. In terms of Medicare D exposure, Chris, do you mind reminding us your exposure there for the Combo franchise? Several companies, including Gilead, kind of called out the potential impact next year stemming from the Medicare Part D redesign. So that's part 1. Part 2, very provocative differential partitioning data of Combo versus Zanza. I am curious, 1, how was that determined? Was it based on kind of radio labeling experiments?

Tawanda: One financial, one scientific. In terms of Medicare D exposure, Chris, do you mind reminding us your exposure there for the CABA franchise? Several companies, including Gilead, kind of called out the potential impact next year stemming from the, you know, the Medicare Part D redesign. So that's part one. Part two, very, Partitioning data of Cabo versus Zanza.

Andy: Okay. Thanks for taking our questions.

Andy: Two quick one if you don't mind.

Andy: One financial Walnut scientific.

Andy: In terms of Medicare exposure, Chris do you mind reminding us your your exposure there for the Cabo franchise.

Andy: Several companies, including Gilead kind of called out the potential impact next year.

Andy: Steadily from the.

Andy: The Medicare part D redesign so that's part one part two very provocative differential.

Michael M. Morrissey: I am curious, one, how was that determined? Was it based on kind of radio labeling experiments? And then, perhaps, from a hypothesis perspective, do you have any sort of, you know, initial work in terms of why that is? You know, is that kind of a difference in passive diffusion, or maybe transporters are involved? So, those are the two questions. Thank you.

Christopher J. Senner: Partitioning data cabos versus via the I am curious one how was that determined.

Patrick J. Haley: And then perhaps from a hypothesis perspective, do you have any sort of initial working in terms of why that is? Is that kind of a difference in passive diffusion, or maybe transporters are involved? So those are the two questions. Thank you. Yeah, thanks, Andy. It's Mike. Dana, why don't you take that second question first, and then we'll punt over to PJ for the Medicare Part D question. Sure. Okay. Thanks for the question, Andy. Yeah. So in terms of the partitioning, we generated data in rats. And this is really data for preparing for the mass balance studies in humans. That was the first sort of view into differential partitioning into normal tissues that we got. So that was using radio-labeled drug. So, of course, that measures everything, metabolites, and anything else that's attached to the radioactive tracer.

Andy Shea: And then perhaps from a hypothesis perspective, do you have any sort of initial working in terms of why that is? Is that kind of a difference in passive diffusion, or maybe transporters are involved? So those are the two questions. Thank you.

Christopher J. Senner: Based on kind of radio labeling experiments and then.

Christopher J. Senner: Perhaps from a hypothesis.

Christopher J. Senner: Perspective, do you have any sort of.

Christopher J. Senner: Initial working in terms of why that is.

Christopher J. Senner: Is that kind of a difference it pass or defeat here, maybe transporters are involved.

Christopher J. Senner:

Michael M. Morrissey: Yeah, thanks, Andy. It's Mike. Dana, why don't you take that second question first, and then we'll punt over to PJ for the Medicare Part D question.

Speaker Change: So those are the two questions. Thank you.

Michael M. Morrissey: Yeah, thanks Andy, it's Mike. Dana, why don't you take that second question first, and then we'll punt over to P.J for the Medicare Part D question.

Mike Dana: Yeah. Thanks, Andy It's Mike Dana I want to take that second question first and then we'll pass over to PJ for the Medicare part D question sure. Okay. Thanks for the question Andy Yes, so in terms of the partitioning.

Patrick J. Haley: Sure. Okay. Thanks for the question, Andy. Yeah. So in terms of the partitioning, we generated data in rats. And this is really data for preparing for the mass balance studies in humans. That was the first sort of view into differential partitioning into normal tissues that we got. So that was using radio-labeled drug. So, of course, that measures everything, metabolites, and anything else that's attached to the radioactive tracer.

Dana Aftab: Sure, okay, thanks for the question, Andy. Yeah, so in terms of the partitioning, we generated data in rats, and this is really data for preparing for the mass balance studies in humans. That was the first sort of view into differential partitioning into normal tissues that we got, so that was using radiolabeled drugs. So, of course, that measures everything, metabolites, and anything else that's attached to the radioactive tracer. In terms of the tumors, and actually, the data that I showed on the slide came from sort of a side-by-side experiment in mice where we were determining the compound concentrations by mass spectrometry

Michael M. Morrissey: We generated data in rats, and this is really data for preparing for.

Mike: The mass balance studies in humans.

Mike: That was the first sort of a view into differential partitioning into normal tissues that we got so that was using radio labeled drug.

Mike: So of course that means that that measure is everything metabolites and anything else.

Dana Aftab: In terms of the tumors, and actually, the data that I showed on the slide came from sort of a side-by-side experiment in mice where we were determining the compound concentrations by mass spectrometry and at doses that generated similar free drug concentrations in the plasma, which again were determined by doing protein binding experiments, et cetera, we saw those free drug concentrations in normal tissues and tumors. And that was just one of several representative normal tissues.

Mike: That's attached to the radioactive tracer.

Patrick J. Haley: In terms of the tumors, and actually, the data that I showed on the slide came from sort of a side-by-side experiment in mice where we were determining the compound concentrations by mass spectrometry. And at doses that generated similar free drug concentrations in the plasma, which, again, were determined by doing protein binding experiments, etc., we saw those free drug concentrations in normal tissues and tumors. And that was just one of several representative normal tissues. So we're still generating a lot of data. There's obviously a lot of different components that go into how drugs distribute within a living animal or person, including things like protein binding, tissue binding, which involves other components other than protein, membranes, lipids, and whatnot, transporter effects, pH-dependent effects. There's so many different pieces of the puzzle that go into understanding how this happens.

Mike: In terms of the tumor and actually the data that I showed on the slide.

Mike: Came from sort of a side by side experiment in mice, where we were determining the compound concentrations by mass spectrometry.

Dana T. Aftab: and at doses that generated similar free drug concentrations in the plasma, which again were determined by doing protein binding experiments, et cetera, we saw those free drug concentrations in normal tissues and tumors. And that was just one of several representative normal tissues. So we're still generating a lot of data. There are obviously a lot of different components that go into how drugs distribute within a living animal or person, including things like protein binding, tissue binding, which involves other components other than protein, membranes, lipids, and whatnot, transporter effects, and pH-dependent effects.

and at doses that generated similar free drug concentrations in the plasma, which again were determined by doing protein binding experiments, et cetera, we saw those free drug concentrations in normal tissues and tumors. And that was just one of several representative normal tissues.

Mike: And.

Mike: At doses that generated.

Mike: A similar free drug concentrations in the plasma.

Mike: Which again were determined by doing protein binding experiments et cetera, we saw those free drug concentrations in normal tissues and tumors and that was just one of several representative on normal tissues.

Mike: So we're still generating a lot of data there is obviously a lot of different components that go into how drugs distribute within living animal or.

Mike: Our person including.

So we're still generating a lot of data. There are obviously a lot of different components that go into how drugs distribute within a living animal or person, including things like protein binding, tissue binding, which involves other components other than protein, membranes, lipids, and whatnot, transporter effects, and pH-dependent effects. There are so many different pieces of the puzzle that go into understanding how this happens, so we're still gathering data to try to understand the full model that's driving these differences. And what I would just say is stay tuned as we generate more data and publish those data, that will hopefully lay out the full mechanism of how this happens. But I must say that it was a surprise to us to see this happen. We had not anticipated or predicted that this would happen with these drugs a priori.

Mike: Things like protein binding tissue binding, which which involves other components other than protein membrane lipids and whatnot transporter effects.

Mike: Ph dependent effects, there's so many different pieces of the puzzle that go into understanding how this happened. So we're still gathering data to try to understand the full model. That's driving these differences in what I would just say is stay tuned as we generate more data and publish those data.

Patrick J. Haley: So we're still gathering data to try to understand the full model that's driving these differences. And what I would just say is stay tuned as we generate more data and publish those data that will hopefully lay out the full mechanism of how this happens. But I must say that it was a surprise to us to see this happen. We had not anticipated or predicted that this would happen with these drugs a priori. Great. Thanks, Dana. PJ? Yeah. So, hi, Andy. Our Medicare Part D accounts for approximately 40% of the business. And as you know, with regards to the IRA, that'll continue to evolve in 2025. So the out-of-pocket cap for patients will be even lower next year, around $2,000. And also, it'll be spread out over a monthly basis. So the thinking is that could potentially reduce the burden on patients even further. Thank you.

Mike: That will hopefully lay out the full mechanism of how this happens, but I must say that it was it was a surprise to us to see this happen we had not anticipated or predicted that this would happen with these drugs a priori.

Dana T. Aftab: There are so many different pieces of the puzzle that go into understanding how this happens, so we're still gathering data to try to understand the full model that's driving these differences. And what I would just say is stay tuned as we generate more data and publish those data, that will hopefully lay out the full mechanism of how this happens. But I must say that it was a surprise to us to see this happen. We had not anticipated or predicted that this would happen with these drugs a priori. Great. Thanks Dana. PJ?

There are so many different pieces of the puzzle that go into understanding how this happens, so we're still gathering data to try to understand the full model that's driving these differences. And what I would just say is stay tuned as we generate more data and publish those data, that will hopefully lay out the full mechanism of how this happens. But I must say that it was a surprise to us to see this happen. We had not anticipated or predicted that this would happen with these drugs a priori.

Michael M. Morrissey: Great. Thanks, Dana. PJ?

P.J. Haley: Hi Andy. Our Medicare Part D accounts for approximately 40% of the business. And as you know, with regard to the IRA, that'll continue to evolve in 2025, so the out-of-pocket cap for patients will be even lower next year, around $2,000, and also it'll be spread out over a monthly basis. So the thinking is that could potentially reduce the burden on patients.

Michael M. Morrissey: Great. Thanks Dana. PJ?

Michael M. Morrissey: Great. Thanks, Dana. PJ? Yeah. So, hi, Andy.

Dana Aftab: Yeah. So, hi, Andy. Our Medicare Part D accounts for approximately 40% of the business. And as you know, with regards to the IRA, that'll continue to evolve in 2025. So the out-of-pocket cap for patients will be even lower next year, around $2,000. And also, it'll be spread out over a monthly basis. So the thinking is that could potentially reduce the burden on patients even further.

Speaker Change: Thanks, Dana P J, yes, so hi, Andy.

Speaker Change: Our part D.

Dana: Medicare part D accounts for approximately 40% of the business and as you know.

Dana: With regards to the IRS that'll continue to evolve in 2025, so the out of pocket.

Dana: Cap for patients will be even lower next year.

Dana: Around $2000 and also it will be spread out over a monthly basis. So.

Dana: The thinking is that could potentially.

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

Dana: Reduce the burden on patients even further.

Patrick J. Haley: Please stand by for our next question. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open. Oh, hey. Thank you for providing this comprehensive update and for taking our question. For Zanza, can you talk about when we should expect to see some combination data? And Bristol recently mentioned initial clinical proof of concept for Opduolag and non-small cell lung cancer. What's your thinking and interest level in the combination of Zanza with Opduolag and STELLAR-302? Thank you. Sure. Thanks for the question. I'll take that. This is Amy. So you saw on the slides, we do have a variety of cohorts that we are expanding in both STELLAR-001 and STELLAR-002. And in combination with PD-1, in addition to other IO agents, including CTLA-4 and LAG-3, we will present the data when it is mature.

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 Oppenheimer. Your line is open. Hey, thank you for providing this comprehensive update and for taking our questions. For Zanza, can you talk about when we should expect to see some combination data? And [inaudible] recently mentioned the initial clinical proof of concept for OPDUALAG in small cell lung cancer, what's your thinking and interest level in the combination of Zanza with OPDUALAG [inaudible]? Thank you.

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

Jay Olsen: Hey, thank you for providing this comprehensive update and for taking our questions. For Zanza, can you talk about when we should expect to see some combination data? And [inaudible] recently mentioned the initial clinical proof of concept for OPDUALAG in small cell lung cancer, what's your thinking and interest level in the combination of Zanza with OPDUALAG in Stellar-002? Thank you.

Speaker Change: Please standby for our next question.

Amy Peterson: Sure, thanks for the question. I'll take that. This is Amy. So, as you saw on the slides, we do have a variety of cohorts that we are expanding in both Stellar-001 and Stellar-002 and in combination with PD-1, in addition to other IO agents, including CTLA-4 and Leg-3. We will present the data when it is mature. Some of these are early-line cohorts, it just takes a while because you want to get ORR, you want to get DOR, you want to get PFS. Some of them actually also have OS. They're event-driven, and we just have to wait for those events before we can report on that.

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

Jay Olson: Oh, hey. Thank you for providing this comprehensive update and for taking our question. For Zanza, can you talk about when we should expect to see some combination data? And Bristol recently mentioned initial clinical proof of concept for Opduolag and non-small cell lung cancer. What's your thinking and interest level in the combination of Zanza with Opduolag and STELLAR-302? Thank you.

Jay Olson: Oh, Hey, thank you for providing this comprehensive update and for taking our question.

Jay Olson: For <unk> can you talk about when we should expect to see some combination data and Bristol recently mentioned initial clinical proof of concept for opt to a lag in non small cell lung cancer, what's your thinking in interest level and the combination of <unk> with Opdivo Laggan stellar Oh two thank you.

Amy Peterson: Sure. Thanks for the question. I'll take that. This is Amy. So you saw on the slides, we do have a variety of cohorts that we are expanding in both STELLAR-001 and STELLAR-002. And in combination with PD-1, in addition to other IO agents, including CTLA-4 and LAG-3, we will present the data when it is mature.

Amy Peterson: So, as you saw on the slides, we do have a variety of cohorts that we are expanding in both Stellar-001 and Stellar-002. And in combination with PD-1, in addition to other IO agents, including CTLA-4 and Leg-3, we will present the data when it is mature. Some of these are early-line cohorts. It just takes a while because you want to get ORR, you want to get DOR, you want to get PFS. Some of them actually also have OS.

Jay Olson: Sure. Thanks for the question I'll take that this is Amy.

Amy Peterson: So you saw on the slides, we do have a variety of cohorts that we are expanding in.

Amy Peterson: Both stellar <unk> and stellar <unk> and in combination with PD. One in addition to other IL agents, including <unk> four and lag three.

Amy Peterson: We will present the data when it is mature some of these are early line cohorts. It just takes a while because you want to get or are you wanting to get DLR you Wanna get PFS. Some of them actually also have O S. They're event driven.

Patrick J. Haley: Some of these are early-line cohorts. It just takes a while because you want to get ORR. You want to get DOR. You want to get PFS. Some of them actually also have OS. They're event-driven. We just have to wait for those events before we can report on that. When it comes to interest with combination partners, I also presented the various combinations that we're doing, not only IO, IO, IO, but also we have the collaboration with HIF2-ALPHA, and we're looking at other combinations. So I would say that we're data-driven, and we'll go where the combinations tell us we should go. But we remain open. I think that what we're continuing to identify and uncover is that the ability for Zanza to combine with all of these other agents is actually rather straightforward. That's reasonably well tolerated at full doses.

Amy Peterson: Some of these are early-line cohorts. It just takes a while because you want to get ORR. You want to get DOR. You want to get PFS. Some of them actually also have OS. They're event-driven. We just have to wait for those events before we can report on that. When it comes to interest with combination partners, I also presented the various combinations that we're doing, not only IO, IO, IO, but also we have the collaboration with HIF2-ALPHA, and we're looking at other combinations. So I would say that we're data-driven, and we'll go where the combinations tell us we should go. But we remain open. I think that what we're continuing to identify and uncover is that the ability for Zanza to combine with all of these other agents is actually rather straightforward. That's reasonably well tolerated at full doses.

Amy Peterson: And we just have to wait for those events before we can report on that when it comes to interest with combination partners that you know that.

Amy Peterson: They're event-driven, and we just have to wait for those events before we can report on that. When it comes to interest from combination partners, I also presented the various combinations that we're doing, not only IO-IO-IO, but also, we have the collaboration with HIF-2Alpha, and we're looking at other combinations. So I would say that we're data-driven, and we'll go where the combinations tell us we should go but we remain open.

They're event-driven, and we just have to wait for those events before we can report on that.

Amy Peterson: I also presented the various combinations that we're doing not only <unk>, but also.

When it comes to interest from combination partners, I also presented the various combinations that we're doing, not only IO-IO-IO, but also, we have the collaboration with HIF-2Alpha, and we're looking at other combinations. So I would say that we're data-driven, and we'll go where the combinations tell us we should go but we remain open.

Amy Peterson: We have the collaboration with Hep to layout Alpha and we're looking at other combination. So I would say that we're data driven and we'll go where the combinations tell us we should go but we are we remain open and I think that the.

Amy Peterson: What we're continuing to identify and uncover is that.

Amy Peterson: The ability for zens combined with all of these other agents this is actually.

Amy Peterson: I think that what we're continuing to identify and uncover is that the ability for Zanza to combine with all of these other agents is actually rather straightforward. It's reasonably well-tolerated at full doses, and so we don't think that there's an issue in terms of Zanza's ability to combine with any of these agents. The decision to move forward into additional studies just has to be made upon the data that we see as it matures in the 001 and 002 cohorts.

Amy Peterson: Rather straightforward.

Amy Peterson: Reasonably well tolerated.

Patrick J. Haley: So we don't think that there's an issue in terms of Zanza's ability to combine with any of these agents. It just has to be the decision to move forward into additional studies just has to be made upon the data that we see as it matures in the 001 and 002 cohorts. Thank you. Please stand by for our next question. Our next question comes from the line of Akash Tawari with Jefferies. Your line is open. Hi. This is Kathy on for Akash. I just wanted to follow up on the Medicare Part D question that was asked earlier, and specifically on how will the restructure of the catastrophic coverage component impact Combo in the coming years, and also how does Exelixis specifically plan to mitigate these pricing impacts? Thank you. Thanks for the question. This is Mike.

Amy Peterson: So we don't think that there's an issue in terms of Zanza's ability to combine with any of these agents. It just has to be the decision to move forward into additional studies just has to be made upon the data that we see as it matures in the 001 and 002 cohorts.

Amy Peterson: At full doses and so we don't think that there is.

Amy Peterson: Issue in terms of <unk> ability to combine with any of these agents that just has to be.

Amy Peterson: The decision to move forward into additional studies just has to be made upon the data that we see as it matures and the old one and O two cohorts.

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

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Akash Tewari with Jeffries. Your line is open. Hi, this is Kathy on for Akash. I just wanted to follow up on the Medicare Part D question that was asked earlier and specifically on how will the restructure of the [inaudible] component impact CABO in the coming years and also how Exelixis plans to mitigate these pricing impacts. Thank you.

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

Speaker Change: Please standby for our next question.

Costa Worry: Our next question comes from the line of our cost to worry with Jefferies. Your line is open.

[Company Representative] (Jefferies): Hi. This is Kathy on for Akash. I just wanted to follow up on the Medicare Part D question that was asked earlier, and specifically on how will the restructure of the catastrophic coverage component impact Combo in the coming years, and also how does Exelixis specifically plan to mitigate these pricing impacts? Thank you.

Unknown: Hi, this is Kathy on for Akash. I just wanted to follow up on the Medicare Part D question that was asked earlier and specifically on how will the restructure of the [inaudible] component impact CABO in the coming years and also how Exelixis plans to mitigate these pricing impacts. Thank you.

Speaker Change: Hi, This is Kathy on for our cause I just wanted to follow up on the Medicare part D question that was asked earlier and specifically on how all of the restructure of the catastrophic coverage component impact Cabo in the coming years and also how does X lexis, specifically plan to me.

Michael M. Morrissey: Thanks for the question. This is Mike. Yeah, I certainly wouldn't want to comment on what's going to happen in the years ahead. We have a pretty good idea about what to expect relative to 2025 and beyond. So again, I wouldn't want to opine beyond what's happening in 2024. We have a high degree of confidence that we've got that really good sense of where that's going and how to navigate those different changes. So we'll see them ahead. When we get to 2025 and beyond, we'll talk about those changes then. Okay? Thank you.

Speaker Change: Beef prices will impact thank you.

Michael M. Morrissey: Thanks for the question. This is Mike. Yeah, I certainly wouldn't want to comment on what's going to happen in the years ahead, but we have a pretty good idea about what to expect relative to '25 and beyond. So again, I wouldn't want to comment beyond what's happening in 2024, and we have a high degree of confidence that we've got that really good sense of where that's going and how to navigate those different changes. So, moving full steam ahead, and when we get to '25 and beyond, we'll talk about those changes then. Okay, thank you.

Patrick J. Haley: Yeah, I certainly wouldn't want to comment on what's going to happen in the years ahead. We have a pretty good idea about what to expect relative to 2025 and beyond. So again, I wouldn't want to opine beyond what's happening in 2024. We have a high degree of confidence that we've got that really good sense of where that's going and how to navigate those different changes. So we'll see them ahead. When we get to 2025 and beyond, we'll talk about those changes then. Okay? Thank you. Thank you. Please stand by for our next question. Our next question comes from the line of Chris Shabritani with Goldman Sachs. Your line is open. Great. Thank you very much. Perhaps you could help us understand your prioritization of capital allocation between the share of purchases and the business development activity.

Speaker Change: Thanks for the question. This is Mike, Yes, I, certainly wouldn't want to comment on kind of what's going to happen in the years ahead.

Michael M. Morrissey: Yeah, I certainly wouldn't want to comment on what's going to happen in the years ahead. But we have a pretty good idea about what to expect relative to 25 and beyond. So again, I wouldn't want to comment beyond what's happening in 2024, and we have a high degree of confidence that we've got that really good sense of where that's going and how to navigate those different changes. So, moving full steam ahead, and when we get to 25 and beyond, we'll talk about those changes then. Okay. Thank you.

Mike: We have a pretty good idea about what to expect relative to 25 and beyond.

Mike: So again I wouldn't want to opine beyond what's happening in 2024, and we have a high degree of confidence that we've got that really good sense of where that's going and how to navigate those different different changes so move.

Mike: Our full steam ahead ends and when you get the 25 and beyond we'll talk about those changes that okay. Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Chris Shabritani with Goldman Sachs. Your line is open.

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Chris Shibutani with Goldman Sachs. Your line is open.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Chris Shabby tiny with Goldman Sachs. Your line is open.

Chris Shibutani: Great. Thank you very much. Perhaps you could help us understand your prioritization of capital allocation between the share of purchases and the business development activity.

Chris Shibutani: Great, thank you very much. Perhaps you could help us understand your prioritization of capital allocation between the share of purchases and the business development activity. I think Joe had tried to ask earlier and recognize that you aren't necessarily thinking of sharing specifics, but it sounded as if it was contingent upon the outcome of the MSM IP decision for you to perhaps lean in more intentionally on the BD front. I just wanted to make sure I understood, because you also include in your release that you plan on completing the share of purchase allocation that the board approved for the full year 2024. Thank you.

Speaker Change: Great. Thank you very much.

Speaker Change: Perhaps you can help us understand your prioritization of capital allocation between share repurchases and the business development activity I think Joe had tried to ask earlier and recognizing that you aren't necessarily thinking of sharing specifics, but it sounded as if it was.

Patrick J. Haley: I think Joe had tried to ask earlier, and recognizing that you aren't necessarily thinking of sharing specifics, that it sounded as if it was contingent upon the outcome of the MSN IP decision for you to perhaps lean in more intentionally on the BD front. I just wanted to make sure I understood because you also include in your release that you plan on completing the share repurchase authorization that the board approved for the full year 2024. Thank you. Yeah. Thanks for the question, Chris. Yeah, I would not certainly assume those two activities are mutually exclusive. We have plenty of cash. We're generating free cash every quarter. We've been profitable for years. I think we have the appetite to do both, as Chris and others we've all talked about previously. The share buyback between last year and this year will be $1 billion.

Chris Shibutani: I think Joe had tried to ask earlier, and recognizing that you aren't necessarily thinking of sharing specifics, that it sounded as if it was contingent upon the outcome of the MSN IP decision for you to perhaps lean in more intentionally on the BD front. I just wanted to make sure I understood because you also include in your release that you plan on completing the share repurchase authorization that the board approved for the full year 2024. Thank you. Yeah.

Contingent upon the outcome of the MSM IP decision for you to perhaps lean in more intentionally on the BD front I just wanted to make sure I understood. Because you also include in your release that you plan on completing the share repurchase allocation at the border.

Speaker Change: For the full year 2024, thank you.

Michael M. Morrissey: Thanks for the question, Chris. Yeah, I would not certainly assume those two activities are mutually exclusive. We have plenty of cash. We're generating free cash every quarter. We've been profitable for years. I think we have the appetite to do both, as Chris and others we've all talked about previously. The share buyback between last year and this year will be $1 billion.

Michael M. Morrissey: Yeah, thanks for the question, Chris. Yeah, I would not certainly assume that those two activities are mutually exclusive. We have plenty of cash. We're generating free cash every quarter. We've been profitable for years. I think we have the appetite to do both, as Chris and others we've all talked about previously, the shared buyback between last year and this year will be a billion dollars. The idea that we want to add additional late-stage assets to our portfolio certainly makes sense in the context of growing the business in terms of both top line and bottom line growth by having a diversified offering of products that we can use in the context of our development and commercialization platform to move the needle for patients and shareholders.

Speaker Change: Yes. Thanks for the question, Chris, Yes, I would not certainly assume those those two activities are mutually exclusive we have we have plenty of cash we're generating free cash every quarter. We've been profitable for three years I think we have the appetite to do both as a as Kristin.

Michael M. Morrissey: I think we have the appetite to do both, as, as Chris and others we've all talked about previously, the shared buyback between last year and this year will be a billion dollars. You know, the idea that we want to add additional late-stage assets to our portfolio certainly makes sense in the context of growing the business in terms of both top line and bottom line growth by having a diversified offering of products that we can use in the context of our development and commercialization platform to move the needle for patients and shareholders.

Speaker Change: Others, we've all talked about previously the share buyback between last year and this year will be a $1 billion.

Patrick J. Haley: The idea that we want to add additional late-stage assets to our portfolio certainly makes sense in the context of growing the business in terms of both top-line and bottom-line growth by having a diversified offering of products that we can use in the context of our development and commercialization platform to move the needle for patients and shareholders. So we are certainly very excited about the options we have ahead of us. Getting beyond getting certainty with the ANDA is the first priority. Once we have that in place, then I think the next steps are relatively straightforward with how we want to maneuver the business. So thanks for the question, and happy to follow up at a later time if you want. Thank you. Please stand by for our next question. Our next question comes from the line of Derek Ochela with Wells Fargo. Your line is open.

Michael M. Morrissey: The idea that we want to add additional late-stage assets to our portfolio certainly makes sense in the context of growing the business in terms of both top-line and bottom-line growth by having a diversified offering of products that we can use in the context of our development and commercialization platform to move the needle for patients and shareholders. So we are certainly very excited about the options we have ahead of us. Getting beyond getting certainty with the ANDA is the first priority. Once we have that in place, then I think the next steps are relatively straightforward with how we want to maneuver the business. So thanks for the question, and happy to follow up at a later time if you want.

Speaker Change: The idea that we want to add additional late stage assets.

Speaker Change: Two our portfolio certainly makes sense in the context of growing the business in terms of both topline and bottomline growth by having a diversified offering of products that we can use in the context of our development and commercialization platform to move the needle for patients and shareholders. So we are certainly.

Michael M. Morrissey: So we are certainly very excited about the options we have ahead of us. Getting beyond, getting certainty with the ANDA is the first priority. Once we have that in place, then I think the next steps are relatively straightforward with how we want to maneuver the business. So thanks for the question and I'll be happy to follow up at a later time if you want.

Speaker Change: Very excited about the options. We have ahead of us getting beyond getting certainty with the <unk> is the first priority. Once we have that in place then I think the next steps are relatively straightforward with how we want to maneuver the business. So thanks.

Speaker Change: Thanks for the question and happy to follow up at a later time, if you want.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Derek Ochela with Wells Fargo. Your line is open.

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Derek Archula with Wells Fargo. Your line is open. Hey guys, thanks for taking the question. So I guess just one from us, how do you envision the CABO approvals in both prostate and neuro tumors? How does that change the volume growth profile of CABO relative to today? How much acceleration could we potentially see?

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Derek Archula with Wells Fargo. Your line is open.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Derek <unk> with Wells Fargo. Your line is open.

Patrick J. Haley: Hey, guys. Thanks for taking the question. So just, I guess, one from us. How do you envision the Combo approvals in both prostate and neuroendocrine tumors? How does that change the volume growth profile of Combo relative today? How much acceleration could we potentially see in the future? Thanks. Yeah. Hi, Derek. This is PJ. So certainly wouldn't want to give guidance beyond this year, specifically on revenue or volume. I guess I'd kind of reiterate some of my earlier comments with regards to NET, obviously, and CRPC for that matter, both significant areas of unmet medical need. As I mentioned, NET is 8,000 patients in the second-line plus setting. And we have the potential to really have a broad opportunity in that marketplace.

[Company Representative] (Wells Fargo): Hey, guys. Thanks for taking the question. So just, I guess, one from us. How do you envision the Combo approvals in both prostate and neuroendocrine tumors? How does that change the volume growth profile of Combo relative today? How much acceleration could we potentially see in the future? Thanks. Yeah.

Derek Archula: Hey guys, thanks for taking the question. So I guess just one from us, how do you envision the CABO approvals in both prostate and neuro tumors? How does that change the volume growth profile of CABO relative to today? How much acceleration could we potentially see?

Derek: Hey, guys. Thanks for taking the question. So just I guess, one for Mark how do you envision the combo approvals in both prostate and neuroendocrine tumors, how does that change the volume growth profile of <unk> relative today, how much acceleration could we potentially see in the future. Thanks.

Patrick J. Haley: Hi, Derek. This is PJ. So certainly wouldn't want to give guidance beyond this year, specifically on revenue or volume. I guess I'd kind of reiterate some of my earlier comments with regards to NET, obviously, and CRPC for that matter, both significant areas of unmet medical need. As I mentioned, NET is 8,000 patients in the second-line plus setting. And we have the potential to really have a broad opportunity in that marketplace.

P.J. Haley: Yeah, hi Derek, this is PJ. I certainly wouldn't want to give guidance beyond this year, specifically on revenue or volume. I guess I'd kind of reiterate some of my earlier comments with regard to net, obviously, and CRPC, for that matter, both significant areas of unmet medical need. As I mentioned, net is 8,000 patients in the second line plus setting, and more broadly, we have the potential to really have a broad opportunity in that marketplace. CRPC, obviously, a really large market, again, ultimately, with limited treatment options with regard to primary treatment options being chemo, NHT, and radioligand therapy, but you're talking about tens of thousands of patients. So we're very excited about the opportunities, and should we have the opportunity to bring them to market and help patients, we think they'll be a really significant opportunity for growth.

Derek: Yes, Hi, Derek this is P. J, so certainly wouldn't want to.

P. J: Give guidance beyond this year, specifically on revenue or volume.

P. J: I guess Ed.

P. J: Kind of reiterate some of my earlier comments.

P. J: With regards to net obviously.

P. J: And CRP C for that matter are both significant.

Patrick J. Haley: CRPC, obviously, a really large market, again, ultimately, with limited treatment options with regard to primary treatment options being chemo, NHT, and radioligand therapy, but you're talking about tens of thousands of patients. You know, so we're very excited about the opportunities, and, should we have the opportunity to bring them to market and help patients, we think they'll be a really significant opportunity for growth.

P. J: Areas of unmet medical need.

P. J: As I mentioned net is 8000 patients in the second line plus setting and more broadly.

P. J: The potential to be really have a broad opportunity in that marketplace.

Patrick J. Haley: CRPC, obviously, a really large market, again, ultimately with limited treatment options with regards to primary treatment options being chemo, NHT, and radioligand therapy, but you're talking about tens of thousands of patients. So we're very excited about the opportunities. And should we have the opportunity to bring them to market and help patients, we think there'll be a really significant opportunity for growth. Thank you. Please stand by for our next question. Our next question comes from the line of Sylvain Turkin with Citizens JMP. Your line is open. Yeah. Thank you. Congrats on the quarter, and thanks for taking my question. I just want to ask about the overlap in sales force and call points between RCC and a potential sales force for prostate cancer.

P. J: <unk>, obviously, a really large.

P. J: Market.

P. J: Again.

P. J: Ultimately with limited treatment options with regards to.

P. J: Primary treatment options being chemo NHTSA radio <unk> therapy, but youre talking about tens of thousands of patients.

P. J: So we're very excited about the opportunities and should we have the opportunity to bring them to market and help patients. We think there'll be a really significant opportunity.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Sylvain Turkin with Citizens JMP. Your line is open.

P. J: Opportunity for growth.

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with Citizens J&P. Your line is open. Thank you. Congrats on the quarter and thanks for taking my question. I just want to ask about the overlap in sales between RCC and a potential salesforce for [inaudible] which is what I'm trying to get to. What are the incremental costs for potentially launching that [inaudible]?

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with Citizens J&P. Your line is open.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Sylvan Chicken with citizens JMP. Your line is open.

[Company Representative] (Citizens JPM): Yeah. Thank you. Congrats on the quarter, and thanks for taking my question. I just want to ask about the overlap in sales force and call points between RCC and a potential sales force for prostate cancer.

Sylvan Chicken: Yeah. Thank you congrats on the quarter and thanks for taking my question I just wanted to ask you about the overlap and Salesforce and call points between RCC and a potential sales force for prostate cancer, and then basically what I'm trying to get through this.

Silvan Tuerkcan: Thank you. Congrats on the quarter and thanks for taking my question. I just want to ask about the overlap in sales between RCC and a potential salesforce for [inaudible] which is what I'm trying to get to. What are the incremental costs for potentially launching that [inaudible]?

Patrick J. Haley: Basically, what I'm trying to get to is, can you tell us what's kind of the incremental cost for potentially launching NET in prostate cancer? Yeah. Sylvain, thanks for the question. PJ, why don't you address both in terms of prostate, RCC, and then on the GI side, NET and HCC? Yeah. Happy to, Mike. Thanks for the question, Sylvain. So I'll start with RCC. We see really significant overlap in terms of GU oncologists, right? So whether it's in the community setting or even in academia in particular, GU oncologists focus are really treating the majority of these GU indications. So again, significant overlap there, which is potentially great for a number of reasons. One, as I mentioned in my prepared remarks, we can leverage our existing RCC infrastructure without having to invest significantly to build that for a potential prostate cancer launch.

Sylvan Chicken: Can you tell us what.

What kind of incremental cost for potentially launching method and prostate cancer.

Michael M. Morrissey: Yeah, Silvan, thanks for the question. PJ, why don't you address both in terms of prostate RCC and then on the GI side, NET and HCC?

P. J: Yeah. So Matt Thanks for the question P. J why don't you address both in terms of prostate RCC and then on the GI side net and HCC, Yes happy to Mike. Thanks for the question Silvan, So I'll start with RCC, we see really significant overlap.

P.J. Haley: Yeah, happy to Mike. Thanks for the question, Silvan. So I'll start with RCC. We see really significant overlap in terms of GU oncologists, right? So whether it's in the community setting or even in academia, in particular, GU on focus really treating the majority of these GU indications. So, again, significant overlap there, which is, potentially great for a number of reasons. One, we can really, as I mentioned in my prepared remarks, we can leverage our existing RCC infrastructure. So, without having to invest significantly to build that for a potential prostate cancer launch.

P. J: In terms of Zhou oncologists right, so whether it's in the community setting or even in academia.

P. J: In particular <unk>.

Speaker Change: Our focus are really treating the majority of these.

<unk> indications, so again significant overlap there, which is potentially great for a number of reasons. One we really as I mentioned in my prepared remarks, we can leverage our existing RCC infrastructure.

Patrick J. Haley: So, without having to invest significantly to build that for a potential prostate cancer launch. And two, these are physicians who are very familiar with Cabozantinib in RCC, managing side effects, etc. so that could be certainly something that would be in our favor as well. With regard to NET, a lot of these, 50% plus, really 60% plus are GI related. We have another sort of sleeve of our team, if you will, that is GI focused, and there's a heavy overlap there as well with our call points, both in the community as well as, again, in academia, who are physicians who are treating NET, as well as those GI tumors.

So, without having to invest significantly to build that for a potential prostate cancer launch.

Speaker Change: So without having to invest significantly too.

Speaker Change: To build that for a potential prostate cancer launch.

And two, these are physicians who are very familiar with Cabozantinib in RCC, managing side effects, etc. so that could be certainly something that would be in our favor as well. With regard to NET, a lot of these, 50% plus, really 60% plus are GI related. We have another sort of sleeve of our team, if you will, that is GI focused, and there's a heavy overlap there as well with our call points, both in the community as well as, again, in academia, who are physicians who are treating NET, as well as those GI tumors.

Patrick J. Haley: And two, these are physicians who are very familiar with cabozantinib in RCC, managing side effects, etc. So that could be certainly something that would be in our favor as well. With regards to NETs, a lot of these, as 50%+, really 60%+, are GI-related. We have another sort of sleeve of our team, if you will, is GI-focused. And there's a heavy overlap there as well with our call points, both in the community as well as, again, in academia, physicians who are treating NET as well as those GI tumors.

Two these are physicians, who are very familiar.

With Cabozantinib in RCC, managing side effects et cetera, so that could be.

Speaker Change: Certainly something.

Speaker Change: That would be in our favor as well with regards to net a lot of these.

Speaker Change: Is 50% plus.

Speaker Change: It really 60% plus our Gi related.

We have another sort of sleeve of our team if you will is Gi.

Speaker Change: Focused and.

Speaker Change: There's a heavy overlap there as well with our call points, both in the community as well as again in academia.

Speaker Change: Who are physicians, who are treating net as.

Patrick J. Haley: So again, it's a really nice potential for us to leverage our existing infrastructure as well as launch into a market where a lot of the prescribers have existing comfort and familiarity and, frankly, positive experiences according to all our market research: tumors, whether it's HCC, thyroid cancer, DTC, or in many different settings in renal cell carcinoma. So that's certainly something we look forward to. Thank you. Please stand by for our next question. Our next question comes from the line of David Lebowitz with Citi. Your line is open. Thank you very much for taking my question. When you discuss the strategy, Zanza versus Cabo going forward, it seems it's clearly an effort to focus on different overall indications. Does that strategy evolve in the event of an unfavorable MSN2 ruling? Yeah, David, thanks for the question.

Speaker Change: As well as those Gi tumors. So again, it's a really nice.

Patrick J. Haley: So again, it's a really nice potential for us to leverage our existing infrastructure, as well as launch into a market where a lot of prescribers have existing comfort and familiarity and, frankly, positive experiences according to all our market research tumors, whether it's HCC, thyroid cancer, DTC, or, in many different settings in renal cell carcinoma. So that's certainly something we look forward to.

Speaker Change: Potential for us to leverage our existing infrastructure.

Speaker Change: As well as launch into a market, where a lot of the prescribers have existing comfort and familiarity and frankly positive experiences according to our market.

Michael M. Morrissey: tumors, whether it's HCC, thyroid cancer, DTC, or, you know, in many different settings in renal cell carcinoma. So that's certainly something we look forward to.

So tumors, whether its HCC thyroid cancer DTC or.

Speaker Change: And many different settings in renal cell carcinoma, so thats certainly something we look forward to.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of David Lebowitz with Citi. Your line is open.

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of David Lebowitz with Citi. Your line is open.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of David Lebowitz with Citi. Your line is open.

David Lebowitz: Thank you very much for taking my question. When you discuss the strategy, Zanza versus Cabo going forward, it seems it's clearly an effort to focus on different overall indications. Does that strategy evolve in the event of an unfavorable MSN2 ruling?

David Lebowitz: Thank you very much for taking my question. When you discuss the strategy Zanza versus CABO going forward, it seems it's clearly an effort to focus on different overall indications. Does that strategy evolve in the event of an unfavorable MSM2 ruling?

David Lebowitz: Thank you very much for taking my question.

David Lebowitz: When you discuss the strategy <unk> carve out going forward. It seems it's clearly an effort to focus on different overall indications.

David Lebowitz: Does that strategy evolved.

David Lebowitz: In the event of an unfavorable MSR to Lilly.

Michael M. Morrissey: Yeah, David, thanks for the question. Yeah, I wouldn't want to, and we wouldn't want to speculate on that right now. So I think we've made the commitment to evolve the overall approach in terms of how we're developing TKIs, VEGFR-targeting TKIs over to Zanza. And that's still the plan going forward. We think we have what looks like to be an emerging improvement in overall activity and safety, the totality of data. It's still early. Would suggest that. So we're all in on Zanza, and there's a lot of excitement there in the community. And we're having, I think, a lot of very interesting, productive discussions about how we might combine with Zanza. So lots of opportunity, lots to do there. So stay tuned.

Michael M. Morrissey: Yeah, David, thanks for the question. Yeah, we wouldn't want to speculate on that right now. I think we've made the commitment to evolve the overall approach in terms of how we're developing TKIs [inaudible] our targeting TKIs over to Zanza and that's still the plan going forward. We think we have what looks like to be an emerging improvement in overall activity and safety, the totality of data is still early. So we're all in on Zanza, and there's a lot of excitement there in the community. And we're having, I think, a lot of very interesting, productive discussions about how we might combine with Zanza. So lots of opportunity, lots to do there so stay tuned.

Patrick J. Haley: Yeah, I wouldn't want to, and we wouldn't want to speculate on that right now. So I think we've made the commitment to evolve the overall approach in terms of how we're developing TKIs, VEGFR-targeting TKIs over to Zanza. And that's still the plan going forward. We think we have what looks like to be an emerging improvement in overall activity and safety, the totality of data. It's still early. Would suggest that. So we're all in on Zanza, and there's a lot of excitement there in the community. And we're having, I think, a lot of very interesting, productive discussions about how we might combine with Zanza. So lots of opportunity, lots to do there. So stay tuned. Thank you. Please stand by for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open.

David Lebowitz: Yes, David Thanks for the question, Yeah, I wouldn't want to we wouldn't want to speculate on that right now so.

Speaker Change: We've made the commitment to evolve.

Speaker Change: The overall approach in terms of how we are developing teekay is bad Jeff are targeting Teekay is overdue zamzam.

Tawanda: So, you know, we've made the commitment to evolve the overall approach in terms of how we're developing TKIs, and veering up our targeting TKIs over to Zanza. And that's, that's still the plan going forward. We think we have what looks like to be an emerging improvement in overall activity and safety that, you know, the totality of data is still early, would suggest. So we're all in on Zanza, and there's a lot of excitement there in the community. And we're having, I think, a lot of very interesting, productive discussions about how we might combine with Zanza. So lots of opportunity, lots to do there. So stay tuned.

Speaker Change: And that's still the plan going forward, we think we have what looks like to be an emerging improvement in overall activity and safety of the totality of data is still early.

It would suggest that so we're all in on <unk> and Theres a lot of excitement there in the community.

Speaker Change: And we're having I think a lot of very interesting productive discussions about how we might combine with <unk>. So lots of opportunity lots to do there so stay tuned.

Michael M. Morrissey: Thank you. Please stand by for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open.

Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Jeff Hung with Morgan Stanley. Your line is open. Thanks for taking my question. Following up on the neuorendocrine population, given the heterogeneity of tumors, are you planning to stratify the current population to focus on specific subgroups initially? Appreciate any details you can provide. Thanks.

Please standby for our next question.

Speaker Change: Yes.

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

Patrick J. Haley: Thanks for taking my question. Following up on the neuroendocrine tumor prevalent population, given heterogeneity of tumors, are you planning to stratify the prevalent population to focus on specific subgroups initially? Appreciate any details you can provide. Thanks. Yeah, Jeff, this is PJ. Thanks for the question. Generally, what I would say is as we focus coming out of the gate, given that, as I mentioned, we kind of really have broad inclusion criteria in our study of whether that's site of origin, SSTR receptor status, what patients have been previously treated with. We really believe we have the opportunity to go right out of the gates should we be approved and launch this very broadly.

Jeff Hung: Thanks for taking my question. Following up on the neuroendocrine tumor prevalent population, given heterogeneity of tumors, are you planning to stratify the prevalent population to focus on specific subgroups initially? Appreciate any details you can provide.

Jeff Hung: Thanks for taking my question following up on the neuroendocrine tumor prevalent population.

Jeff Hung: Given heterogeneity of tumors are you planning to stratify the prevalent population to focus on specific subgroups initially.

Patrick J. Haley: Thanks. Yeah, Jeff, this is PJ. Thanks for the question. Generally, what I would say is as we focus coming out of the gate, given that, as I mentioned, we kind of really have broad inclusion criteria in our study of whether that's site of origin, SSTR receptor status, what patients have been previously treated with. We really believe we have the opportunity to go right out of the gates should we be approved and launch this very broadly.

Jeff Hung: Appreciate any details you can provide thanks.

P.J. Haley: Yeah, Jeff, this is PJ. Thanks for the question. Generally, what I would say is, as we focus on coming out of the gate, given that, as I mentioned, we kind of really have broad inclusion criteria in our study of whether that's site of origin, SSTR receptor status, what patients have been previously treated with, we really believe we have the opportunity to go right out of the gate should we be approved and launch this very broadly. And I think that will be what we're hearing in ad boards, et cetera, very much appreciated and adopted well from a physician community perspective because they need new options for really all of these patients. And in some cases, like right now, for patients who have been on a variety of therapies. So I think it would be a broad opportunity, and we would certainly position it as such.

Jeff Hung: Yes, Jeff This is P. J thanks for the question.

P. J: Generally what I would say is as we focus.

P. J: Coming out of the gate given that as I mentioned, we kind of really have broad.

P. J: <unk>.

P. J: Inclusion criteria in our study of whether that site of origin.

P. J: S S GR receptor status.

P. J: What patients have been previously treated with.

P. J: We really believe we have the opportunity to to.

P. J: Go right out of the gates.

P. J: Should we be approved and launched this very broadly and I think that would be.

Patrick J. Haley: And I think that will be, in what we're hearing in ad boards, etc., very much appreciated and adopted well from a physician community perspective because they need new options for really all of these patients. And in some cases, like right now, for patients who have been on a variety of therapies. So I think it would be a broad opportunity, and we would certainly position it as such. Thank you. Please stand by for our next question. Our next question comes from the line of Edsel Durout with BMO Capital Markets. Your line is open. Hi. This is Luke Chamillon for Edsel. Thanks for taking my question. For the prostate and NET filings, what are the key factors that are going to influence the timing of those filings? What are you waiting on for those?

Patrick J. Haley: And I think that will be what we're hearing in ad boards, et cetera, very much appreciated and adopted well from a physician community perspective because they need new options for really all of these patients. And in some cases, like right now, for patients who have been on a variety of therapies. So I think it would be a broad opportunity, and we would certainly position it as such.

P. J: What we're hearing and outboards et cetera very much.

P. J: Appreciated and adopted well from a physician community perspective, because they need new options for really all of these patients.

P. J: And in some cases.

P. J: Yeah.

P. J: Right now for patients who have been on a variety of therapies. So I think it would be a broad opportunity and we would certainly.

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

P. J: <unk> two as.

As such.

Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is open. Hi, this is Lucas on for Etzer. Thanks for taking my question. For the prostate and NET filings, what are the key factors that are going to influence the timing of those filings? And are there only going to be US filings or are we going to also look for ex-US and are there any other [inaudible] factors for filing those?

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Ed <unk> with BMO capital markets.

Operator: Hi. This is Luke Chamillon for Edsel. Thanks for taking my question. For the prostate and NET filings, what are the key factors that are going to influence the timing of those filings? What are you waiting on for those? Are those only going to be US filings, or are you also looking for ex-US, and are there any other timing factors for filing those?

Your line is open.

Speaker Change: Hi, This is Luke on for Ed. Thanks for taking my question for the prostate and Keith filings what are the key factors that are going to influence the timing of the refinery what are you waiting on for those.

Patrick J. Haley: Are those only going to be US filings, or are you also looking for ex-US, and are there any other timing factors for filing those? Thanks, Lucas. This is Amy. I'll take that question. So I can't comment on what our partners are going to be doing with regard to ex-US filing. Cabo is in collaboration under a collaboration agreement with Ipsen for non-US, non-Japan, and with Takeda for Japan. What we're focused on, and what I mentioned in the call, is that we needed the data by year-end in order to complete the dossier for a filing. We have the data, and we're in discussions, and we really are hoping to be able to submit in the coming months for the CABINET study. For CONTACT, I also mentioned we have final OS, which we're anticipating in the coming months. The study was a positive study.

Luke: Are there is only going to be U S filings are we also looking for ex U S and are there any other gating factors for filing those.

Amy Peterson: Thanks, Lucas. This is Amy. I'll take that question. So I can't comment on what our partners are going to be doing with regard to ex-US filing. Cabo is in collaboration under a collaboration agreement with Ipsen for non-US, non-Japan, and with Takeda for Japan. What we're focused on, and what I mentioned in the call, is that we needed the data by year-end in order to complete the dossier for a filing. We have the data, and we're in discussions, and we really are hoping to be able to submit in the coming months for the CABINET study. For CONTACT, I also mentioned we have final OS, which we're anticipating in the coming months. The study was a positive study.

Luke: Okay.

Amy Peterson: Thanks, Lucas. This is Amy. I'll take that question. So I can't comment on what our partners are going to be doing with regard to ex-U.S. filing. CABO is in collaboration under a collaboration agreement with Ipsen for non-U.S., non-Japan, and with Takeda for Japan. What we're focused on, and what I mentioned in the call, is that we needed the data from Burke in order to complete the dossier for a filing. And we have the data, and we're in discussions, and we really are hoping to be able to submit it in the coming months for the cabinet study. For context, I also mentioned we have final OS, which we're anticipating in the coming months. The study was a positive study. Statisticaly significant OS is not required in order for the study to be positive. We showed a really nice trend favoring CABO-ATIZA which I will point out, given what else is going on in prostate cancer in terms of radioligand to PSMA-4 assets, where initially hazard ratios for OS were above one, Novartis just announced that there's less than one, probably very close to one. The fact that we had a nice trend, I think, is also supportive of a risk-benefit profile that favors patients. So stay tuned, we'll let you know how the conversations and filings progress with the agency.

Luke: Thanks, Lucas this is Amy I'll I'll I'll take that question.

Amy Peterson: So I can't comment on what our partners are going to be doing with regard to ex U S. Filing Cabo is in collaboration under our collaboration agreement with Ipsen for non U S non Japan and with Takeda for Japan.

Amy Peterson: I'll take that question. So I can't comment on what our partners are going to be doing with regard to ex-U.S. filing. CABO is in collaboration under a collaboration agreement with Ipsen for non-U.S., non-Japan, and with Takeda for Japan. What we're focused on, and what I mentioned in the call, is that we needed the data from Burke in order to complete the dossier for a filing. And we have the data, and we're in discussions, and we really are hoping to be able to submit it in the coming months for the cabinet study. Boatizo, which I will point out, given what else is going on in prostate cancer in terms of radioligand PSMA-4 assets, where initially hazard ratios for OS were above one, Novartis just announced that there's less than one, probably very close to one. The fact that we had a nice trend, I think, is also supportive of a risk-benefit profile that favors patients. Stay tuned. We'll let you know how the conversations and filings progress with the agency.

Amy Peterson: What we're focused on and what I mentioned in the call is that we needed that data by Bert.

Amy Peterson: In order to complete the dossier for a filing and we have the data in and we're in discussions and we really are hoping to be able to submit in the coming months for the cabinet study.

Amy Peterson: For contact.

Amy Peterson: As I mentioned, we have final Oss, which we're anticipating in the coming months.

Amy Peterson: For context, I also mentioned we have final OS, which we're anticipating in the coming months. The study was a positive study. Statisticaly significant OS is not required in order for the study to be positive. We showed a really nice trend favoring CABO-ATIZA which I will point out, given what else is going on in prostate cancer in terms of radioligand to PSMA-4 assets, where initially hazard ratios for OS were above one, Novartis just announced that there's less than one, probably very close to one. The fact that we had a nice trend, I think, is also supportive of a risk-benefit profile that favors patients. So stay tuned, we'll let you know how the conversations and filings progress with the agency.

Amy Peterson: The study was a positive study statistically significant OS has not required in order for the study to be positive. We showed a really nice trend favoring <unk>, which I will point out given the what what else is going on in prostate cancer in terms of radio lag.

Patrick J. Haley: Statistically significant OS is not required. In order for the study to be positive, we showed a really nice trend favoring cabo-atezo, which I will point out, given what else is going on in prostate cancer in terms of radioligand to PSMA-targeted assets, where initially hazard ratios for OS were above one. Novartis just announced there's less than one, probably very close to one. The fact that we had a nice trend, I think, is also supportive of a risk-benefit profile that favors the patients. And so stay tuned. We'll let you know how conversations and filings progress with the agency. Thank you. Please stand by for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open. Thanks for taking the questions.

Amy Peterson: Statistically significant OS is not required. In order for the study to be positive, we showed a really nice trend favoring cabo-atezo, which I will point out, given what else is going on in prostate cancer in terms of radioligand to PSMA-targeted assets, where initially hazard ratios for OS were above one. Novartis just announced there's less than one, probably very close to one. The fact that we had a nice trend, I think, is also supportive of a risk-benefit profile that favors the patients. And so stay tuned. We'll let you know how conversations and filings progress with the agency.

Amy Peterson: Boatizo, which I will point out, given what else is going on in prostate cancer in terms of radioligand PSMA-4 assets, where initially hazard ratios for OS were above one, Novartis just announced that there's less than one, probably very close to one. The fact that we had a nice trend, I think, is also supportive of a risk-benefit profile that favors patients. Stay tuned. We'll let you know how the conversations and filings progress with the agency.

Amy Peterson: And P. SMA four assets were initially hazard ratios for OS were above one novartis just announced their says.

Amy Peterson: Less than one probably very close to one the fact that we had a nice trend I think is also supportive of a risk benefit profile that is that favors the patients.

Amy Peterson: So.

Speaker Change: Stay tuned well, we'll let you know.

Speaker Change: How conversations and filings progressed with the agency.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open. Thanks for taking the questions.

Speaker Change: Thank you.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open. Thanks for taking these questions. Chris, just a question on the share buyback, are you focused on expanding that, especially if there's a negative outcome around IP, would that be something that you'd expand or accelerate?

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Speaker Change: Please standby for our next question.

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

Peter Lawson: Thanks for taking these questions. Chris, just a question on the share buyback, are you focused on expanding that, especially if there's a negative outcome around IP, would that be something that you'd expand or accelerate?

Patrick J. Haley: Chris, just a question on the share buyback and thoughts on expanding that, especially if there's a negative outcome around IP. Would that be something you'd expand or accelerate? Hey, Peter. Thanks for the questions. Chris, yeah, I'm not going to speculate on what we're going to do depending on the different variables around outcomes on the MSN trial. As I mentioned in our prepared remarks, we're committed to executing on the $450 million. We did $191 million in Q1, and we're committed to getting the rest done this year. Thank you. At this time, there are no further questions. So I would now like to turn the call back over to your host, Varant, for closing remarks. Thank you, Tawanda, and thank you all for joining us today.

Peter Lawson: Chris, just a question on the share buyback and thoughts on expanding that, especially if there's a negative outcome around IP. Would that be something you'd expand or accelerate?

Peter Lawson: Thanks for taking the questions.

Peter Lawson: Chris just a question on the share buyback and thoughts on expanding that especially if there's a negative outcome around IP would that be something you would expand or accelerate.

Christopher J. Senner: Hey, Peter. Thanks for the questions. Chris, yeah, I'm not going to speculate on what we're going to do depending on the different variables around outcomes on the MSN trial. As I mentioned in our prepared remarks, we're committed to executing on the $450 million. We did $191 million in Q1, and we're committed to getting the rest done this year.

Christopher J. Senner: Hey Peter, thanks for the questions, Chris. Yeah, I'm not going to speculate on what we're going to do, depending on the different variables around outcomes in the MSN trial. But as I mentioned in our prepared remarks, we're committed to executing on the $450 million and we did $191 million in the first quarter, and we're committed to getting the rest done this year.

Peter Lawson: Hey, Peter Thanks for the questions, Chris, Yes, Im not going to speculate on what we're going to do it depending on the different variables around outcomes on the MSN trial.

Peter: As I mentioned in our prepared remarks, we're committed to executing on the $450 million and we did $191 million in the first quarter and we're committed to getting the rest of this year.

Operator: Thank you. At this time, there are no further questions. So I would now like to turn the call back over to your host, Varant, for closing remarks.

Speaker Change: Thank you.

Operator: Thank you. At this time, there are no further questions, and so I would now like to turn the call back over to your host, Varant, for closing remarks.

At this time there are no further questions and so I would now like to turn the call back over to your host for closing remarks.

Varant Shirvanian: Thank you, Tawanda, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call. Thank you.

Speaker Change: Thank you to Wanda and thank you all for joining US today, we welcome your follow up calls with any additional questions.

Patrick J. Haley: We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker Change: You may have that we were unable to address during today's call. Thank you.

Patrick J. Haley: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.

Speaker Change: Okay.

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Q1 2024 Exelixis Inc Earnings Call

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EXEL

Exelixis

Earnings