Q2 2024 Exelixis Inc Earnings Call

August 6, 2024

Operator: Good day, ladies and gentlemen, and welcome to the Exelixis second quarter 2024 financial results conference call. My name is Tawanda, and I'll be your operator for today, as a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations, you may begin.

Susan Hubbard: Thank you, Tawanda, and thank you all for joining us for the Exelixis Second 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, 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 Second Quarter 2024, and to June 30th 2024. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles.

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

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

During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic value. However, actual events or results could, of course, differ materially.

Susan Hubbard: We refer you to the documents we file from time to time with the FCC, 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 comercialization activities. And with that, I will turn the call over to Mike. All right. Thank you, Susan.

Susan Hubbard: We refer you to the documents we file from time to time with the SEC, which, under the heading risk factors, identify important factors that could cause actual results to differ materially from those expressed 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. And with that, I will turn the call over to Mike.

Any 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 red.

Tori requirements, our dependence on collaboration partners and the level of costs associated with discovery product development business development and commercialization activities and with that I will turn the call over to Mike Alright. Thank you Susan and thanks to everyone for joining us on the call today.

Michael M. Morrissey: All right ,thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis had a very busy and productive second quarter across literally all components of our business, especially in commercial, regulatory, and development. And we're thrilled with our momentum that's driving us into the second half of 2024. We continue to execute on key priorities for important future value drivers in discovery, development, and commercial and remain steadfast in our focus to improve the standard of care for patients with cancer. We have a lot to cover today.

Michael M. Morrissey: Alright ,thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis had a very busy and productive second quarter across literally all components of our business, especially in commercial, regulatory, and development. And we're thrilled with our momentum that's driving us into the second half of 2024. We continue to execute on key priorities for important future value drivers in discovery, development, and commercial and remain steadfast in our focus to improve the standard of care for patients with cancer.

Michael Morrissey: And thanks to everyone for joining us on the call today. Exelixis had a very busy and productive second quarter across literally all components of our business, especially in commercial, regulatory, and development. And we're thrilled with our momentum that's driving us into the second half of 2024. We continue to execute on key priorities for important future value drivers in discovery, development, and commercial and remain steadfast in our focus to improve the standard of care for patients with cancer. We have a lot to cover today.

Mike: We had a very busy and productive second quarter across literally all components of our business, especially in commercial regulatory and development and we're thrilled with our momentum that's driving us into the second half of 2024.

Speaker Change: We continue to execute on key priorities for important future value drivers in discovery development and commercial and remain steadfast in our focus 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 key highlights for the quarter, including first, strong financial performance with top and bottom line growth, driven by the strength of the CABOZANTINIB franchise globally. Momentum in the CABOZANTINIB business continued in the second quarter of 2024, with growth in demand and revenue, both quarter over quarter and year over year. CABOMETYX maintained it's status as the leading TKI for RCC in the US, with second quarter 2024 CABO franchise net product revenue is growing 16% quarter over quarter compared to first quarter 2024 and 7% year over year compared to second quarter 2023.

Michael Morrissey: So let's jump right into it with key highlights for the quarter, including first, strong financial performance with top and bottom line growth, driven by the strength of the Cabo Santos franchise globally. Momentum in the compost antenna business continued in the second quarter of 2024, with growth in demand and revenue, both quarter over quarter and year over year. Cabo Medics maintained its status as the leading TKI for RCC in the US, with second quarter 2024 Cabo franchise net product revenue growing 16% quarter over quarter compared to first quarter 2024 and 7% year over year compared to second quarter 2023.

We have a lot to cover today, so let's jump right into it with key highlights for the quarter, including first strong financial performance with top and bottom line growth driven by the strength of the Cabozantinib franchise globally.

Michael M. Morrissey: Global CABOZANTINIB franchise's Net Product Revenues generated by Exelixis and it's partners grew to $618 million dollars in the second quarter of 2024. The $150 million dollars commercial milestone we earned from Ipsen in the second quarter is emblematic of the continued strength of the CABO franchise on a worldwide basis. The robust net product revenue and total revenue for the quarter, along with continued expense discipline, drove our net income growth as well. As Chris will highlight later in the call, we had a very good second quarter and look forward to continuing the momentum in the second half of the year.

Michael M. Morrissey: Second, building off the strength of CABOS's leadership position in RCC, we're excited about the opportunity for new indications like NET to drive future Cabo growth and believe it could be another area where Exelixis has the potential to grow into a market leader. Our CABO sNDA submission based on the cabinet data was accepted with standard review, and a PDUFA date in early April 2025. Exel's top priority is to advance the NET indication from a clinical and regulatory perspective and launch it as soon as possible pending approval.

Unknown Executive: The Archivo SNDA submission based on the cabinet data was accepted with standard review and a PDUFA date in early April 2025. Excel's top priority is to advance the net indication from a clinical and regulatory perspective and launch as soon as possible pending approval.

Michael M. Morrissey: As you'll hear from Amy, Phase III of ZANZA and NET underscores our commitment to establish a leadership position in this underserved population, and provides another therapeutic opportunity to improve the standard of care for patients with NET. PJ will also highlight recent market research, which helps frame our excitement for this indication. Third, we continue to advance our industry-leading pipeline with a focus on generating differentiating clinical data that will improve the standard of care for patients with cancer. Our success in building the Cabo franchise provides a roadmap to maximize clinical and commercial success for molecules in our pipeline.

Michael M. Morrissey: Third, we continue to advance our industry-leading pipeline with a focus on generating differentiating clinical data that will improve the standard of care for patients with cancer. Our success in building the Cabo franchise provides a roadmap to maximize clinical and commercial success for molecules in our pipeline.

Michael Morrissey: Third, we continue to advance our industry-leading pipeline with a focus on generating differentiating clinical data that will improve the standard of care for patients with cancer. Our success in building the Cabo franchise provides a roadmap to maximize clinical and commercial success for molecules in our pipeline. Advancing potential new CABO indications and expediting ZANSA clinical development with both existing and new pivotal trials remains our top focus. We continuously evaluate our pipeline to ensure we are disciplined in our investments and that they align with emerging data and the evolving treatment landscape.

Third, we continue to advance our industry-leading pipeline with a focus on generating differentiating clinical data that will improve the standard of care for patients with cancer. Our success in building the Cabo franchise provides a roadmap to maximize clinical and commercial success for molecules in our pipeline.

Michael M. Morrissey: Advancing potential new CABO indications and expediting ZANZA clinical development with both existing and new pivotal trials remains our top focus. We continuously evaluate our pipeline to ensure we are disciplined in our investments and that they align with emerging data and the evolving treatment landscape. In that context, we've decided to discontinue XB002, and it is unlikely to improve upon the tissue factor targeting ADCs already approved or in the clinic. We believe there are higher value and, therefore, higher priority opportunities with ZAMZA and NET, and potentially other GU indications that drive us to reallocate resources to support these activities. A CABO lens sets a high bar for clinical differentiation and ultimate commercial success, and we're mindful that investments in programs that are unlikely to improve the standard of care do little to create value for patients or shareholders.

Michael M. Morrissey: In that context, we've decided to discontinue XB002, and it is unlikely to improve upon the tissue factor targeting ADCs already approved or in the clinic. We believe there are higher value and, therefore, higher priority opportunities with ZAMZA and NET, and potentially other GU indications that drive us to reallocate resources to support these activities.

Michael Morrissey: In that context, we've decided to discontinue XB002, and it is unlikely to improve upon the tissue factor targeting ADCs already approved or in the clinic. We believe there are higher value and, therefore, higher priority opportunities with ZAMHSA and NET and potentially other GU indications that drive us to reallocate resources to support these activities. Cabo Lens sets a high bar for clinical differentiation and ultimate commercial success, and we're mindful that investments in programs that are unlikely to improve the standard of care do little to create value for patients or shareholders.

Michael M. Morrissey: A CABO lens sets a high bar for clinical differentiation and ultimate commercial success, and we're mindful that investments in programs that are unlikely to improve standard of care, does little to create value for patients or shareholders. We're optimistic in our progress with XL309, XB010, and new candidates in our pipeline, which we expect to advance quickly. Fourth, the strong financial performance this quarter, and our continued financial and pipeline discipline allows us to be both strategic and opportunistic in capital deployment. While we expect business development and clinical collaboration and discussions to continue throughout 2024, our strong financial performance this quarter, with record levels of net product revenues and total revenues, allows us to pursue another $500 million share repurchase program on top of the billion dollars of shares we've bought over the last 15 months. Thank you. Finally, there's nothing new to report on the CABO ANDA litigation. As in the past, we will not speak to any specifics today. And it's a statement of the obvious that the upcoming ANDA ruling remains a critical milestone for the company and CABO's antitrust 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.

Unknown Executive: Cabo Lens sets a high bar for clinical differentiation and ultimate commercial success, and we're mindful that investments in programs that are unlikely to improve standards of care do little to create value for patients or shareholders. We're optimistic in our progress with XL309, XB010, and new candidates in our pipeline, which we expect to advance.

Michael Morrissey: We're optimistic about our progress with XL309, XB010, and new candidates in our pipeline, which we expect to advance. Fourth, the strong financial performance this quarter and our continued financial and pipeline discipline allows us to be both strategic and opportunistic in capital deployment. While we expect business development and clinical collaboration and discussions to continue throughout 2024, our strong financial performance this quarter, with record levels of net product revenues and total revenues, allows us to pursue another $500 million share repurchase program on top of the billion dollars of shares we've bought over the last year.

Michael M. Morrissey: Fourth, the strong financial performance this quarter, and our continued financial and pipeline discipline allows us to be both strategic and opportunistic in capital deployment. While we expect business development and clinical collaboration and discussions to continue throughout 2024, our strong financial performance this quarter, with record levels of net product revenues and total revenues, allows us to pursue another $500 million share repurchase program on top of the billion dollars of shares we've bought over the last 15 months. Finally, there's nothing new to report on the CABO ANDA litigation, as in the past, we will not speak to any specifics today, and it's a statement of the obvious that the upcoming ANDA ruling remains a critical milestone for the company and CABOZANTINIB franchise.

Michael M. Morrissey: While we expect business development and clinical collaboration and discussions to continue throughout 2024, our strong financial performance this quarter, with record levels of net product revenues and total revenues, allows us to pursue another $500 million share repurchase program on top of the billion dollars of shares we've bought over the last 15 months. Finally, there's nothing new to report on the CABO ANDA litigation, as in the past, we will not speak to any specifics today, and it's a statement of the obvious that the upcoming ANDA ruling remains a critical milestone for the company and CABOZANTINIB 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 Morrissey: Thank you. Finally, there's nothing new to report on the CABO ANDA litigation. As in the past, we will not speak to any specifics today. And it's a statement of the obvious that the upcoming ANDA ruling remains a critical milestone for the company and CABO's antitrust 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: Finally, there's nothing new to report on the CABO ANDA litigation, as in the past, we will not speak to any specifics today, and it's a statement of the obvious that the upcoming ANDA ruling remains a critical milestone for the company and CABOZANTINIB franchise.

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

Mike: Cabo and our other differentiated molecules, we pursue on behalf of patients with cancer.

Michael Morrissey: So with that, please see our press release issued an hour ago for our second quarter of 2024 financial results and an extensive list of key corporate milestones achieved in the quarter. And I'll now turn the call over to Mike.

Mike: So with that please see our press release issued an hour ago for our second quarter 2024 financial results and an extensive list of key corporate milestones achieved in the quarter and I'll now turn the call over to Chris. Thanks, Mike for the second quarter of 2024. The company reported total revenues of approximately $637 2 million.

Christopher J. Senner: Thanks, Mike. For the second quarter of 2024, the company reported total revenues of approximately $637.2 million dollars, which included CABOZANTINIB Franchise Net Product Revenues of $437.6 million dollars. CABOMETYX net product revenues were $433.3 million dollars, and included approximately $6.6 million dollars in clinical trial sales. Gross net for the CABOZANTINIB franchise in the second quarter of 2024 was 27.6%, which is lower than the gross net we experienced in the first quarter of 2024, and is generally in line with our expectations. This decrease in gross net deductions in second quarter 2024 is primarily related to lower Medicare Part D, copay assistance, and 340B expenses.

Chris: Which included Cabozantinib franchise net product revenues of $437 6 million.

Speaker Change: <unk> net product revenues were $433 3 million and included approximately $6 $6 million in clinical trial sales.

Speaker Change: Gross to net for the Cabozantinib franchise in the second quarter of 2024 was 27, 6%, which is lower than the gross to net we experienced in the first quarter of 2024 and is generally in line with our expectations. This decrease in gross to net deductions in the second quarter 2024 is primarily related to lower Medicare part D Copay assistance and $3 40.

Christopher J. Senner: This decrease in gross net deductions in second quarter 2024 is primarily related to lower Medicare Part D, copay assistance, and 340B expenses. Our CABOMETYX trade inventory decreased by approximately 300 units when compared to the first quarter 2024 to approximately two point weeks on. As a reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue in the future. Total revenues also included approximately $195 million of licensed revenues for the second quarter of 2024. The largest contributor to our licensed revenues is the $150 million commercial sales milestone we recognized in the second quarter as a result of Ipsen's achievement of $600 million in cumulative net sales of Cabo Zantanib in its related licensed territory over four consecutive quarters.

Christopher J. Senner: This decrease in gross net deductions in second quarter 2024 is primarily related to lower Medicare Part D, copay assistance, and 340B expenses.

Christopher J. Senner: Our CABOMETYX trade inventory decreased by approximately 300 units when compared to the first quarter 2024 to approximately two point weeks on hand. 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 $195 million dollars of licensed revenues for the second quarter of 2024, the largest contributor to our licensed revenues is the $150 million dollars commercial sales milestone we recognized in the second quarter as a result of Ipsen's achievement of $600 million dollars in cumulative net sales of CABOZANTINIB in it's related licensed territory over four consecutive quarters.

<unk> expenses are.

Mike: <unk> trade inventory decreased by approximately 300 units when compared to the first quarter 2024 to approximately two point weeks on hand.

Christopher Senner: As a reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue in the future. Total revenues also included approximately $195 million of licensed revenues for the second quarter of 2024. The largest contributor to our licensed revenues is the $150 million commercial sales milestone we recognized in the second quarter as a result of Ipsen's achievement of $600 million in cumulative net sales of Cabo Zantanib in its related licensed territory over four consecutive quarters.

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

Christopher J. Senner: Total revenues also included approximately $195 million dollars of licensed revenues for the second quarter of 2024, the largest contributor to our licensed revenues is the $150 million dollars commercial sales milestone we recognized in the second quarter as a result of Ipsen's achievement of $600 million dollars in cumulative net sales of CABOZANTINIB in it's related licensed territory over four consecutive quarters.

Speaker Change: Total revenues also included approximately $195 million of license revenues for the second quarter 2024, the largest contributor to our license revenues is the $150 million commercial sales milestone, which we recognized in the second quarter. As a result of absence achievement of $600 million cumulative net sales of Cabozantinib and its related license territory.

Chris: Over four consecutive quarters.

Christopher J. Senner: Additionally, we recognize approximately $41 million dollars of licensed revenues from the royalties we earned from Ipsen and Takeda on their sales of CABOZANTINIB in their territories. Our total operating expenses, excluding restructuring charges for the second quarter of 2024, were approximately $361 million dollars, compared to $363 million dollars in the first quarter of 2024. The sequential decrease in these operating expenses was primarily driven by lower licensing and clinical trial costs, offset by higher commercial and general and administrative expenses in the second quarter of 2024. Provision for income taxes for the second quarter of 2024 was approximately $67 million dollars compared to a provision for income taxes of approximately $12 million dollars for the first quarter of 2024.

Christopher J. Senner: Provision for income taxes for the second quarter of 2024 was approximately $67 million dollars compared to a provision for income taxes of approximately $12 million dollars for the first quarter of 2024. The company reported GAAP net income of approximately $226.1 million, or 70 cents, 77 cents per share on a fully diluted basis for the second quarter of 2024. The company also reported non-GAAP net income of approximately $246 million dollars, or 84 cents per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $20 million dollars of stock-based compensation expense, net of the related income tax effect.

Unknown Executive: Provision for income taxes for the second quarter of 2024 was approximately $67 million compared to a provision for income taxes of approximately $12 million for the first quarter of 2020. Non-GAAP net income excludes the impact of approximately $20 million of stock-based compensation expense, net of the related income tax effect.

Christopher Senner: The company reported GAAP net income of approximately $226.1 million, or 70 cents, 77 cents per share on a fully diluted basis for the second quarter of 2020. The company also reported non-GAAP net income of approximately $246 million, or $0.84 per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $20 million of stock-based compensation expense, net of the related income tax effect.

Christopher J. Senner: The company also reported non-GAAP net income of approximately $246 million dollars, or 84 cents per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $20 million dollars of stock-based compensation expense, net of the related income tax effect.

Unknown Executive: Cash and investments as of June 30, 2024, were approximately $1.4 billion. During the second quarter of 2024, we repurchased approximately $259 million of Exelixis shares at an average price of $22.23. Additionally, Exelixis announced today that the company's board of directors has authorized the repurchase of up to $500 million of the company's common stock through the end of 2025. And finally, turning to our financial guidance for the full year, we're increasing our total revenue guidance and SG&A expense guidance. We're increasing our total revenue guidance due to the recognition of the $150 million commercial sales milestone from Ipsen in the second quarter.

Christopher J. Senner: Cash and investments as of June 30, 2024 were approximately $1.4 billion dollars. During the second quarter of 2024, we repurchased approximately $259 million of Exelixis shares at an average price of $22.23, completing the $450 million dollars share repurchase program authorized earlier this year. Through this $450 million dollars program, we retired 20.3 million shares at an average price of $22.17. When combining the March 2023 $550 million dollars share repurchase program, and the January 2024 $450 million dollars share repurchase program, we repurchased and retired approximately 46.5 million shares.

Christopher J. Senner: Additionally, Exelixis announced today that the company's board of directors has authorized the repurchase of up to $500 million dollars of the company's common stock through the end of 2025, this is our third share repurchase program authorized since March 2023. And finally, turning to our financial guidance for the full year, we're increasing our total revenue guidance and SG&A expense guidance, we're increasing our total revenue guidance due to the recognition of the $150 million dollars commercial sales milestone from Ipsen in the second quarter.

Christopher J. Senner: And finally, turning to our financial guidance for the full year, we're increasing our total revenue guidance and SG&A expense guidance, we're increasing our total revenue guidance due to the recognition of the $150 million dollars commercial sales milestone from Ipsen in the second quarter.

Christopher J. Senner: Additionally, we are increasing our SG&A guidance due to the pre-launch costs associated with preparing the commercial organization to launch the potential net indication. Please see slide 14 of our Q2 earnings presentation for further details. With that, I'll turn the call over to Amy.

Amy Peterson: Thanks Chris, I'm happy to share our progress across our pipeline with you all today, starting with CABOZANTINIB and an exciting status update on our filing activities with the Phase 3 Cabinet Study in Neuroendocrine Tumors, or NET. As Mike mentioned, we are pleased to report that Exelixis is filing for a supplementary NDA for CABOZANTINIB in pancreatic or extra pancreatic neuroendocrine tumors, and has been accepted by the FDA with a target PDUFA date of April 3, 2025. The FDA also granted orphan drug designation to CABOZANTINIB in pancreatic NET. As a reminder, the phase three cabinet study evaluated capazantinib 60 milligrams daily versus placebo in patients with previously treated advanced or metastatic pancreatic or extra pancreatic neuroendocrine tumors, which I will refer to as PNUT or EPNUT, respectively. By way of background, NETs, sometimes referred to as carcinoid tumors, are a diverse group of malignancies that arise from neuroendocrine cells in various organs. While previously thought to be fairly uncommon, there has been a marked increase in the incidence over the past 20 years.

Amy Peterson: The FDA also granted orphan drug designation to cabizantinib in pancreatic NET. As a reminder, the phase three cabinet study evaluated capazantinib 60 milligrams daily versus placebo in patients with previously treated advanced or metastatic pancreatic or extra pancreatic neuroendocrine tumors, which I will refer to as PNUT or EPNUT, respectively. By way of background, NETs, sometimes referred to as carcinoid tumors, are a diverse group of malignancies that arise from neuroendocrine cells in various organs. While previously thought to be fairly uncommon, there has been a marked increase in the incidence over the past 20 years.

Amy Peterson: As a reminder, the phase three CABINET study evaluated CABOZANTINIB 60 milligrams daily versus placebo in patients with previously treated advanced or metastatic pancreatic or extra pancreatic neuroendocrine tumors, which I will refer to as pNET or epNET, respectively. By way of background, NETs, sometimes referred to as carcinoid tumors, are a diverse group of malignancies that arise from neuroendocrine cells in various organs. While previously thought to be fairly uncommon, there has been a marked increase in the incidence over the past 20 years, and in 2024, approximately 15,000 people in the US will be diagnosed with this tumor type. Well differentiated neuroendocrine tumors develop most commonly about 55% of the time in the GI tract, followed by lung at approximately 25%, and pancreas just under 10%. They may also arise from other tissues like the prostate, breast, thymus, and skin. To date, FDA-approved therapies have been directed at stimulating somatostatin receptors and inhibiting angiogenesis. Somatostatin analogs were first approved for the treatment of symptoms related to functional tumors and subsequently to delay disease progression. More recently, somatostatin analogs have been used to deliver radioligand or radionuclide therapy to somatostatin receptor-expressing tumor cells.

Amy Peterson: And in 2024, approximately 15,000 people in the US will be diagnosed with this tumor type. Well differentiated neuroendocrine tumors develop most commonly about 55% of the time in the GI tract, followed by lung at approximately 25%, and pancreas just under 10%. They may also arise from other tissues like the prostate, breast, thymus, and skin. To date, FDA-approved therapies have been directed at stimulating somatostatin receptors and inhibiting angiogenesis. Somatostatin analogs were first approved for the treatment of symptoms related to functional tumors and subsequently to delay disease progression. More recently, somatostatin analogs have been used to deliver radioligand or radionuclide therapy to somatostatin receptor-expressing tumor cells.

Amy Peterson: Well differentiated neuroendocrine tumors develop most commonly about 55% of the time in the GI tract, followed by lung at approximately 25%, and pancreas just under 10%. They may also arise from other tissues like the prostate, breast, thymus, and skin. To date, FDA-approved therapies have been directed at stimulating somatostatin receptors and inhibiting angiogenesis. SOMATOSTATIN analogs were first approved for the treatment of symptoms related to functional tumors and subsequently to delay disease progression. More recently, SOMATOSTATIN analogs have been used to deliver radioligand or radionuclide therapy to SOMATOSTATIN receptor-expressing tumor cells.

Unknown Executive: They may also arise from other tissues like the prostate, breast, thymus, and skin. To date, FDA-approved therapies have been directed at stimulating somatostatin receptors and inhibiting angiogenesis. Advanced or metastatic NSCLC carry a poor prognosis, and this was reflected in the relatively short investigator-assessed progression-free survival of approximately three months on placebo in either the P-Net or E-P-Net cohorts from the cabinet study. Again, as presented by Dr. Channot, ESMO in 2023. We look forward to presenting these final data, including key subgroups, at a future medical meeting and intend to submit an SNDA to the FDA later this year. At final analysis, the experimental arm did not demonstrate an OS benefit over the control arm, a key secondary endpoint.

Amy Peterson: LUTETIUM Lu-177 dotatate or LUTATHERA is an SSTR targeting beta-emitting radioligand indicated for use in somatostatin-expressing gastroenteropancreatic NETs, that is, tumors of the foregut, which includes the pancreas, the midgut, and the hindgut. NET is considered a highly vascular tumor, and angiogenesis inhibitors have proved useful in it's treatment, SUNITINIB is indicated for use in pNET. EVEROLIMUS is indicated for use in pNET and in non-functioning GI and lung NET. Putting these indications together, there are a number of neuroendocrine tumors that are not covered by these labels, for example, not all patients with a neuroendocrine tumor are candidates for LUTATHERA because their tumors may not express sufficient levels of SSTR to be eligible.

Amy Peterson: For example, not all patients with a neuroendocrine tumor are candidates for Lutathera because their tumors may not express sufficient levels of SSTR to be eligible. Furthermore, Lutathera is not approved in patients with LungNet, a population representing nearly a quarter of all Nets and, importantly, a population that was included in Cabinet. As presented by Dr. Jennifer Chan of the Dana-Farber Cancer Institute at ESMA last year, one out of five of the patients enrolled into Cabinet with EP-Net had LungNet.

For example, not all patients with a neuroendocrine tumor are candidates for Lutathera because their tumors may not express sufficient levels of SSTR to be eligible.

Amy Peterson: Furthermore, LUTATHERA is not approved in patients with LungNET, a population representing nearly a quarter of all NETs and, importantly, a population that was included in CABINET. As presented by Dr. Jennifer Chan of the Dana-Farber Cancer Institute at ESMA last year, one out of five of the patients enrolled into CABINET with epNET had Lung NET. NETs can be functional or non-functional, and EVEROLIMUS is not indicated in functional carcinoid tumors, patients with functional NETs were included in the CABINET trial, representing 32% of epNET and 16% of pNET patients. Functional NETs secrete bioactive molecules leading to symptoms like flushing, bronchospasm, diarrhea, and blood pressure fluctuations that can cause significant morbidity and reduced quality of life.

Amy Peterson: Nets can be functional or non-functional, and everolimus is not indicated in functional carcinoid tumors. Patients with functional nets were included in the cabinet trial, representing 32% of EP net and 16% of P net patients. Functional nets secrete bioactive molecules leading to symptoms like flushing, bronchospasm, diarrhea, and blood pressure fluctuations that can cause significant morbidity and reduced quality of life.

Amy Peterson: Functional NETs secrete bioactive molecules leading to symptoms like flushing, bronchospasm, diarrhea, and blood pressure fluctuations that can cause significant morbidity and reduced quality of life. Advanced or metastatic NETs carry a poor prognosis, this was reflected in the relatively short investigator-assessed progression-free survival of approximately three months on placebo in either the pNET or epNET cohorts from the CABINET study, again, as presented by Dr. Chan at ESMO in 2023. We're excited to announce that the final PFS results by Blinded Independent Central Radiology Review, the primary endpoint of the Cabinet study, will be presented during an oral paper session at the ESMO 2024 Congress in Barcelona next month. One last thing to point out about Cabinet is that this Phase 3 was designed and executed by the NCI-funded Alliance for Clinical Trials in Oncology. That is, Cabinet was not an Exelixis-sponsored trial but rather was conducted under a Collaborative Research and Development Agreement, or CRADA, with the NCI. Studies like Cabinet underscore the importance of building strong relationships with the academic community.

Speaker Change: I'm not secrete bioactive molecules, leading to symptoms like Flushing, bronchospasm, diarrhea, and blood pressure fluctuations that can cause significant morbidity and reduced quality of life.

Amy Peterson: Advanced or metastatic NETs carry a poor prognosis, this was reflected in the relatively short investigator-assessed progression-free survival of approximately three months on placebo in either the pNET or epNET cohorts from the CABINET study, again, as presented by Dr. Chan at ESMO in 2023.

Speaker Change: Advanced or metastatic nets carry a poor prognosis. This was reflected in the relatively short investigator assessed progression free survival of approximately three months on placebo in either the peanut or EP neck cohorts from the cabinet study again as presented by Dr. Chan at ESMO in 2023.

Amy Peterson: We're excited to announce that the final PFS results by Blinded Independent Central Radiology Review, the primary endpoint of the CABINET study, will be presented during an oral paper session at the ESMO 2024 Congress in Barcelona next month. One last thing to point out about CABINET is that this Phase 3 was designed and executed by the NCI-funded Alliance for Clinical Trials in Oncology. That is, CABINET was not an Exelixis-sponsored trial, but rather was conducted under a Collaborative Research and Development Agreement, or CRADA, with the NCI. Studies like CABINET underscore the importance of building strong relationships with the academic community.

Amy Peterson: We're excited to announce that the final PFS results by Blinded Independent Central Radiology Review, the primary endpoint of the Cabinet study, will be presented during an oral paper session at the ESMO 2024 Congress in Barcelona next month. One last thing to point out about Cabinet is that this Phase 3 was designed and executed by the NCI-funded Alliance for Clinical Trials in Oncology. That is, Cabinet was not an Exelixis-sponsored trial but rather was conducted under a Collaborative Research and Development Agreement, or CRADA, with the NCI. Studies like Cabinet underscore the importance of building strong relationships with the academic community.

Speaker Change: We're excited to announce that the final PFS results by blinded independent Central Radiology review. The primary end point of the cabinet study will be presented during an oral proffered papers session at ESMO 2020 for Congress in Barcelona next month.

Speaker Change: One last thing to point out about cabinet is that this phase III was designed and executed by the NCI funded alliance for clinical trials in oncology that is cabinet was not an <unk> sponsored trial, but rather was conducted under a collaborative research and development agreement or creator with.

Speaker Change: The NCI.

Speaker Change: Studies like cabinet underscore the importance of building strong relationships with the academic community.

Amy Peterson: Such studies, at a maximum, can support labels and new indications and, at a minimum, can provide meaningful information to inform further development. The NET KOL community recognized the need for additional effective therapies and understood the potential for CABOZANTINIB to realize that need. The data from CABINET provides important information to ensure that as many patients with NET, either based on site of origin, or on functional or non-functional status, and regardless of SSTR expression, could potentially gain access to an effective therapy. The data should also support approvals outside the US, and we're pleased that our partner Ipsen has already indicated interest in filing cabinet in their territory.

Speaker Change: Such studies at a maximum can support labels in new indications and at a minimum can provide meaningful information to inform further development.

Speaker Change: The net kols community recognize the need for additional effective therapies and understood the potential for cabozantinib to realize that need.

Speaker Change: The data from cabinet provides important information to ensure that as many patients with net either based on site of origin or in functional or nonfunctional status and regardless of S. STR expression to potentially gain access to an effective therapy.

Speaker Change: The data should also support approvals outside the U S and we're pleased that our partner Ipsen has already indicated interest in filing cabinet in their territories.

Amy Peterson: So, as you can infer, we're very excited about the data generated from CABINET, and we'll work closely with the agency towards an approval. The next study I'd like to discuss is CONTACT-02, a randomized, open-label Phase III study evaluating CABO+ATEZOLIZUMAB versus a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer, who have measurable extrapelvic soft tissue disease. In January 2024 at ASCO GU, Dr. Neeraj Agarwal of the Huntsman Cancer Institute, presented results from CONTACT-02, showing a significant improvement in progression-free survival, meeting one of the dual primary efficacy endpoints of the trial.

Speaker Change: So as you can infer we're very excited about the data generated from cabinet and will work closely with the agency towards an approval.

Speaker Change: The next study I'd like to discuss is contact owe to a randomized open label Phase III study evaluating Cabo plus cities Iliza Mab versus a second novel hormonal therapy in patients with metastatic castration resistant prostate cancer, who have measurable extra pelvic soft tissue disease.

Dr. Agarwal: In January 2024 at <unk>, Dr. <unk> Agarwal of the Huntsman Cancer Institute presented results from contact O two showing a significant improvement in progression free survival meeting one of the dual primary efficacy endpoints of the trial.

Amy Peterson: The safety profile of the combination reflected the known safety profile of each individual agent and was consistent with the tolerability profile of approved IOTKI combinations. The final overall survival analysis for the study has been completed, all OS and the ITT continued to favor the combination of CABO+ATEZO, it did not reach statistical significance. We look forward to presenting these final data, including key subgroups, at a future medical meeting and intend to submit an sNDA to the FDA later this year. Finally, for CABO, I'll briefly cover COSMIC-313, our Phase III trial evaluating the triplet of CABO, NIVO, and IPI versus NEVO-IPI in frontline intermediate or poor risk renal cell carcinoma. We previously reported the primary endpoint of PFS by the Blinded Independent Radiology Committee, which showed a hazard ratio of 0.73 and a p-value of 0.01, favoring the triplet. At final analysis, the experimental arm did not demonstrate an OS benefit over the control arm, a key secondary endpoint.

Speaker Change: The safety profile of the combination reflected the known safety profile of each single agent and was consistent with the Tolerability profile of approved Iot K I combinations.

Speaker Change: The final overall survival analysis for the study has been completed.

Speaker Change: While OS in the ITT continued to favor the combination of Cabo plus a T. Though it did not reach statistical significance.

Amy Peterson: We look forward to presenting these final data, including key subgroups, at a future medical meeting and intend to submit an SNDA to the FDA later this year. Finally, for CABO, I'll briefly cover COSMIC-313, our Phase 3 trial evaluating the triplet of CABO, NEVO, and IPPE versus NEVO-IPPE in frontline intermediate or poor risk renal cell carcinoma. We previously reported the primary endpoint of PFS by the Blinded Independent Radiology Committee, which showed a hazard ratio of 0.73 and a p-value of 0.01, favoring the triplet. However, at final analysis, the experimental arm did not demonstrate an OS benefit over the control arm, a key secondary endpoint.

Speaker Change: We look forward to presenting these final data, including key subgroups at a future medical meeting and intend to submit an NDA to the FDA later this year.

Speaker Change: Finally for Cabo I'll briefly cover cosmic 313, our phase III trial evaluating the triplet of Cabo Nemo and EP versus knievel, it'd be in frontline intermediate or poor risk renal cell carcinoma.

Amy Peterson: We previously reported the primary endpoint of PFS by the Blinded Independent Radiology Committee, which showed a hazard ratio of 0.73 and a p-value of 0.01, favoring the triplet. At final analysis, the experimental arm did not demonstrate an OS benefit over the control arm, a key secondary endpoint. Based on this OS result and the evolution of the first-line RCC treatment landscape since the study was initiated in May 2019, we have no plans to file this study for label extension. Data from this study will be disclosed at a future time. I'll now discuss our development stage assets, starting with ZANZALINTINIB.

Speaker Change: We previously reported the primary endpoint of PFS by blinded Independent Radiology Committee, which showed a hazard ratio of 0.73 and a P value of 0.01 favoring the triplet.

Speaker Change: At the final analysis, the experimental arm did not demonstrate an OS benefit over the control arm a key secondary endpoint.

Amy Peterson: Based on this OS result and the evolution of the first-line RCC treatment landscape since the study was initiated in May 2019, we have no plans to file this study for label extension. Data from this study will be disclosed at a future time. I'll now discuss our development stage assets, starting with Anzalitna.

Speaker Change: Based on this OS result, and the evolution of first line RCC treatment landscape. Since the study was initiated in May 2019, we have no plans to file this study for label extension.

Speaker Change: Data from this study will be disclosed at a future time.

Unknown Executive: I'll now discuss our development stage assets, starting with Anzalitna, taking into account that survival in NLM patients is longer than it is in those with liver mets. This study was initiated late last year, and the team has made substantial progress with site activation and patient enrollment. The progress we are seeing reflects the external excitement about the potential for this regimen to offer patients a chemo-free treatment option. We know that this type of tumor is sensitive to both IO and VEGF inhibitors like xanthelitinib.

Speaker Change: I'll now discuss our development stage assets starting with <unk>.

Amy Peterson: First, I'm pleased to announce that we have completed enrollment in STELLAR-303, our pivotal Phase 3 study evaluating the combination of ZANZA+ATEZOLIZUMAB versus regorafenib in patients with non-MSI-HIGH, non-DMMR, metastatic, and refractory colorectal cancer. The primary endpoint in this study is overall survival in the non-liver met or NLM patient population. If positive we will then evaluate survival in the ITT population, that includes patients with and without liver NET. The sample size for both NLM and liver MET patients was capped to ensure adequate numbers of events in each of these analyses. The survival analysis is event-driven, and we are currently estimating the study should read out in 2025, taking into account that survival in NLM patients is longer than it is in those with liver mets. Steller-304, our phase 3 trial evaluating the combination of Zanza plus nivolumab versus sunitinib in frontline non-clear cell kidney cancer, has dual primary endpoints of progression-free survival and objective For this study, we are on track to complete enrollment by mid-2025.

Speaker Change: First I am pleased to announce that we have completed enrollment in just stellar 303, our pivotal phase III study evaluating the combination of zandra plus cities Iliza mab versus regular wrapping them in patients with non MSI high na.

Speaker Change: D M M R metastatic and refractory colorectal cancer.

Speaker Change: The primary endpoint in this study is overall survival in the non liver met or N L M patient population.

Speaker Change: If positive we will then evaluate survival in the ITT population that includes patients with and without liver Mets.

Speaker Change: Sample size for both N L M and liver met patients was capped to ensure adequate numbers of events in each of these analyses.

Speaker Change: The survival analysis is event driven and we are currently estimating the study should read out in 2025.

Amy Peterson: The survival analysis is event-driven, and we are currently estimating the study should read out in 2025, taking into account that survival in NLM patients is longer than it is in those with liver NETs. Stellar-304, our Phase III trial evaluating the combination of ZANZA+NIVOLUMAB versus SUNITINIB in frontline non-clear cell kidney cancer. Has dual primary endpoints of progression-free survival and objective response rate, both as assessed by a blinded independent radiology review, for this study, we are on track to complete enrollment by mid-2025. Stellar 303 is our regist- sorry, Stellar-305 is our registrational trial evaluating 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 initiated late last year, and the team has made substantial progress with site activation and patient enrollment. The progress we are seeing reflects the external excitement about the potential for this regimen to offer patients a chemo-free treatment option. We know that this type of tumor is sensitive to both IO and VEGF inhibitors like ZANZALINTINIB.

Speaker Change: Taking into account that survival in <unk> patients is longer than it is in those with liver Mets.

Speaker Change: Stellar three or four our phase III trial evaluating the combination of Zander, plus new valla mab versus sunitinib in frontline non clear cell kidney cancer has dual primary endpoints of progression free survival and objective response rate both as assessed by a blinded independent radiology review.

Speaker Change: For this study we are on track to complete enrollment by mid 2025.

Amy Peterson: Stellar 303 is our regist- sorry, Stellar-305 is our registrational trial evaluating 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 initiated late last year, and the team has made substantial progress with site activation and patient enrollment. The progress we are seeing reflects the external excitement about the potential for this regimen to offer patients a chemo-free treatment option. We know that this type of tumor is sensitive to both IO and VEGF inhibitors like ZANZALINTINIB.

Amy Peterson: Stellar 305 is our registrational trial evaluating 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 initiated late last year, and the team has made substantial progress with site activation and patient enrollment. The progress we are seeing reflects the external excitement about the potential for this regimen to offer patients a chemo-free treatment option. We know that this type of tumor is sensitive to both IO and VEGF inhibitors like xanthelitinib.

Speaker Change: Stellar three or three as a registry sorry, stellar three or five as a registrational trial evaluating <unk> in combination with <unk> versus <unk> alone in patients with untreated PD lone expressing advanced or metastatic squamous cell carcinoma of the head and neck.

Amy Peterson: This study was initiated late last year, and the team has made substantial progress with site activation and patient enrollment. The progress we are seeing reflects the external excitement about the potential for this regimen to offer patients a chemo-free treatment option. We know that this type of tumor is sensitive to both IO and VEGF inhibitors like ZANZALINTINIB.

Speaker Change: This study was initiated late last year and the team has made substantial progress with site activation and patient enrollment.

Speaker Change: The progress we are seeing reflects the external excitement about the potential for this regimen to offer patients a chemo free treatment option. We know that this type of tumor is sensitive to both Io and VEGF inhibitors like zions letting them and even in light of the recent failure of <unk> plus <unk> that we have.

Unknown Executive: And even in light of the recent failure of linvatinib plus pembrolizumab, we remain confident that combining the right TKI with IO could improve patient outcomes, and we believe in xanthelitinib's differentiated profile to accomplish that. 2025 will be an important and exciting year for ZAMHSA with data readouts across key programs, including maturing data in the expansion cohorts of Stellar 001 and 002. Therefore, we are stopping further development and will proceed with study closeout of Joule 101.

Amy Peterson: And even in light of the recent failure of linvatinib plus pembrolizumab, we remain confident that combining the right TKI with IO could improve patient outcomes, and we believe in ZANZALINTINIB's differentiated profile to accomplish as much. As for future additional studies with ZANZA, our immediate priority is to launch a new pivotal study, Stellar-311, evaluating ZANZALINTINIB versus EVEROLIMUS in patients with advanced neuroendocrine tumors whose disease has progressed on a somatostatin analog. The study design leverages the comprehensive body of data generated by CABOZANTINIB in this disease setting, as well as important feedback from our network of investigators looking to bring additional effective therapies to their patients in an earlier setting.

Speaker Change: We remain confident that combining the right teekay I with Io could improve patient outcomes and we believe <unk> differentiated profile to accomplish as much.

Speaker Change: As for future additional studies with Zander, our immediate priority is to launch a new pivotal study stellar 311, evaluating <unk> versus everolimus in patients with advanced neuro endocrine tumors, whose disease has progressed on a somatostatin analog the.

Speaker Change: The study design Leverages the comprehensive body of data generated by Cabozantinib in this disease setting as well as important feedback from our network of investigators looking to bring additional effective therapies to their patients and in earlier settings.

Amy Peterson: Exelixis has built a strong footing in RCC with CABOZANTINIB, and we intend to extend that leadership into the NET's space, first with the filing of CABINET, and now with this initial study of ZANZALINTINIB. The NET space is reminiscent of where we started in RCC years ago when the METEOR and CABOSUN studies read out. Our assessment of the market, which you'll hear more about from PJ, leads us to believe there is similar potential for ZANZA and NET, to that which we realized for CABO in RCC. We intend to initiate the study early next year with the goal of establishing ZANZA as the preferred first oral therapy in advanced neuroendocrine tumors. The enthusiasm we have received from investigators on this trial design strengthens our conviction of the potential for ZANZA to offer a meaningful advance to this ever-increasing patient population.

Speaker Change: <unk> has built a strong footing in RCC with Cabozantinib and we intend to extend that leadership into the net space first with the filing of the cabinet and now with this initial study of Sandra letting them.

Speaker Change: The net space is reminiscent of where we started in RCC years ago, when the Meteor and <unk> studies read out RF.

Amy Peterson: Our assessment of the market, which you'll hear more about from PJ, leads us to believe there is similar potential for Zanza and NET to that which we realized for Cabo in RCC. We intend to initiate the study early next year with the goal of establishing Zanza as the preferred first oral therapy in advanced neuroendocrine tumors. The enthusiasm we have received from investigators on this trial design strengthens our conviction of the potential for Zanzibar to offer a meaningful advance to this ever-increasing patient population.

Speaker Change: Our assessment of the market, which you'll hear more about from T. J leads us to believe there are similar potential for zander in that to that which we realize for Cabo in RCC.

Speaker Change: We intend to initiate this study early next year with the goal of establishing <unk> as the preferred first oral therapy and advanced neuroendocrine tumors.

Amy Peterson: We intend to initiate the study early next year with the goal of establishing ZANZA as the preferred first oral therapy in advanced neuroendocrine tumors. The enthusiasm we have received from investigators on this trial design strengthens our conviction of the potential for ZANZA to offer a meaningful advance to this ever-increasing patient population. Taken together, we've demonstrated a calculated yet diverse development program for ZANZALINTINIB that has the potential to grow it's value proposition across a variety of disease settings. 2025 will be an important and exciting year for ZANZA with data readouts across key programs, including maturing data in the expansion cohorts in Stellar-001 and 002. We are constantly assessing other development opportunities for ZANZALITINIB, and we'll update you on those plans as we make progress.

Speaker Change: The enthusiasm we have received from investigators on this trial design strengthens our conviction of the potential for zander to offer a meaningful advance to this ever increasing patient population.

Amy Peterson: The enthusiasm we have received from investigators on this trial design strengthens our conviction of the potential for ZANZA to offer a meaningful advance to this ever-increasing patient population.

Amy Peterson: Taken together, we've demonstrated a calculated yet diverse development program for Zanzalytinib that has the potential to grow its value proposition across a variety of disease settings. 2025 will be an important and exciting year for ZAMHSA with data readouts across key programs, including maturing data in the expansion cohorts in Stellar 001 and 002. We are constantly assessing other development opportunities for Zanzibar, and we'll update you on those plans as we make progress.

Speaker Change: Taken together, we've demonstrated a calculated yet diverse development program for <unk> that has the potential to grow its value proposition across a variety of disease settings.

Speaker Change: 2025 will be an important and exciting year for <unk> with data readouts across key programs, including maturing data in the expansion cohorts and stellar or <unk> and <unk>.

Amy Peterson: We are constantly assessing other development opportunities for ZANZALITINIB, and we'll update you on those plans as we make progress. I'll now provide a quick update on our XB002 and XL309 programs. XB002 is our tissue factor targeting ADC that carries the modified aerostatin payload, XB002 is being evaluated in the Phase I JEWEL-101 study across various tumor types as a single agent and in combination with NIVOLUMAB. Based on available data, we have come to the conclusion that XB002 is unlikely to improve upon TISOTUMAB VEDOTIN, or other competitor tissue factor targeting ADCs currently in development, therefore, we are stopping further development and will proceed with study closeout of JEWEL-101. Data from the study will be disclosed at a future time.

Speaker Change: We are constantly assessing other development opportunities for <unk> and we will update you on those plans as we make progress.

Amy Peterson: I'll now provide a quick update on our XB002 and XL309 programs. XB002 is our tissue factor targeting ADC that carries the modified aerostatin payload. XB002 is being evaluated in the Phase I Juul 101 study across various tumor types as a single agent and in combination with nivolumab. Based on available data, we have come to the conclusion that XB002 is unlikely to improve upon Tazatomab, Vidotin, or other competitor tissue factor targeting ADCs currently in development. Therefore, we are stopping further development and will proceed with study closeout of Joule 101.

Speaker Change: I'll now provide a quick update on our <unk> and <unk> programs.

Speaker Change: That's b 002, as our tissue factor targeting ADC that carries a modified or statin payload <unk> is being evaluated in the phase one dual 101 study across various tumor types as a single agent and in combination with <unk>.

Speaker Change: Based on available data, we have come to the conclusion that X P. O. Two is unlikely to improve upon <unk> or other competitor tissue factor targeting ADC is currently in development.

Amy Peterson: Based on available data, we have come to the conclusion that XB002 is unlikely to improve upon TISOTUMAB VEDOTIN, or other competitor tissue factor targeting ADCs currently in development, therefore, we are stopping further development and will proceed with study closeout of JEWEL-101. Data from the study will be disclosed at a future time.

Speaker Change: Therefore, we are stopping further development and we will proceed with study closeout of dual 101 data from the study will be disclosed at a future time.

Unknown Executive: Data from the study will be disclosed at a future time. XL309 is our small molecule USP-1 inhibitor currently being evaluated in advanced solid tumors in a Phase I study as a single agent and in combination with Olaparib, a PARP-12 inhibitor. The mechanism of action of XL309 and its potential to combine with PARP inhibitors provides optionality for a robust development program in a variety of solid tumors, not necessarily restricted to tumors that harbor BRCA1-2 mutations.

Dana Aftab: Data from the study will be disclosed at a future time. XL309 is our small molecule USP1 inhibitor currently being evaluated in advanced solid tumors in a phase one study as a single agent and in combination with Olaparib, a PARP1-2 inhibitor. The mechanism of action of XL309 and its potential to combine with PARP inhibitors provides optionality for a robust development program in a variety of solid tumors, not necessarily restricted to tumors that harbor BRCA1-2 mutations.

Data from the study will be disclosed at a future time.

Speaker Change: <unk> hundred nine is our small molecule USB one inhibitor currently being evaluated in advanced solid tumors and a phase one study as a single agent and in combination with <unk> a PARP one two inhibitor the.

Amy Peterson: XL309 is our small molecule USP1 inhibitor, currently being evaluated in advanced solid tumors in a Phase I study as a single agent and in combination with Olaparib, a PARP-1/2 inhibitor. The mechanism of action of XL309 and it's potential to combine with PARP inhibitors provides optionality for a robust development program in a variety of solid tumors, not necessarily restricted to tumors that harbor BRCA1-2 mutations. And the team is making great progress with enrollment, including patients into the combination cohort, we're actively assessing how we might prioritize expanded development of this particular compound. As I approach my one year anniversary later this month, I have to say I'm proud of the progress the teams have made in advancing our diverse clinical programs. We are well poised to continue providing physicians and patients new and important therapeutic options, I look forward to sharing additional updates with you as we move through the second half of this year. I'll now turn the call over to Dana. Thanks, Amy, and good afternoon, everyone.

Speaker Change: The mechanism of action of <unk> 309, and potential to combined with PARP inhibitors provides optionality for a robust development program in a variety of solid tumors not necessarily restricted to tumors that harbor Bronco <unk> two mutations.

Amy Peterson: And the team is making great progress with enrollment, including patients into the combination cohort. We're actively assessing how we might prioritize expanded development of this particular compound. As I approach my one year anniversary later this month, I have to say I'm proud of the progress the teams have made in advancing our diverse clinical programs. We are well poised to continue providing physicians and patients with new and important therapeutic options. I look forward to sharing additional updates with you as we move through the second half of this year. I'll now turn the call over to Dana. Thanks, Amy, and good afternoon, everyone.

Speaker Change: And the team is making great progress with enrollment including patients into the combination cohorts.

Unknown Executive: We're actively assessing how we might prioritize expanded development of this particular compound. As I approach my one year anniversary later this month, I have to say I'm proud of the progress the teams have made in advancing our diverse clinical programs. We are well poised to continue providing physicians and patients with new and important therapeutic options.

Speaker Change: We're actively assessing how we might prioritize expanded development of this particular compound.

Amy Peterson: As I approach my one year anniversary later this month, I have to say I'm proud of the progress the teams have made in advancing our diverse clinical programs. We are well poised to continue providing physicians and patients new and important therapeutic options, I look forward to sharing additional updates with you as we move through the second half of this year. I'll now turn the call over to Dana.

Speaker Change: As I approach my one year anniversary later this month I have to say I'm proud of the progress. The teams have made in advancing our diverse clinical programs. We are well poised to continue providing physicians and patients new and important therapeutic options I look forward to sharing additional updates with you as.

Amy Peterson: I'll now turn the call over to Dana. Thanks, Amy, and good afternoon, everyone.

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

Speaker Change: As we move through the second half of this year.

Amy Peterson: Thanks, Amy, and good afternoon, everyone.

Speaker Change: I'll now turn the call over to Dana.

Dana T. Aftab: Thanks, Amy, and good afternoon, everyone. Today, I'm giving a brief update on our progress in the second quarter of 2024 toward our goals for preparing for IND filings and for advancing new compounds to develop into candidate status. On the IND front, we've continued to make good progress on all of our pre-IND programs, and we remain on track to file up to three this year. As you saw in the press release, we filed the IND for XB010 in the second quarter, and the Phase I trial is now underway.

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

Dana: On the R&D front, we've continued to make good progress on all of our pre R&D programs and we remain on track to file up to three this year.

Speaker Change: As you saw in the press release, we filed the IND for <unk> zero ones Euro in the second quarter and the phase one trial is now underway XP.

Dana Aftab: XB010 is a 5T4-targeted antibody drug conjugate that carries the cytotoxic antitubulin payload monomethyl auristatin E, and uses SMARTag linker-payload technology, which results in a more stable and homogeneous ADC compared to earlier generation technologies. XB010 is the first custom ADC that our internal teams designed and built, with participation by our collaboration partners, and brought to the clinic. And the principal investigators of the Phase 1 study are quite enthusiastic about the potential for this molecule to address significant unmet needs for patients with tumors that express 5T4, so we look forward to efficient execution of this study.

Speaker Change: <unk> 010 is a five four targeted antibody drug conjugate that carries the cytotoxic anti tubular payload <unk> E and uses smart tag linker payload technology, which results in a more stable and homogeneous ADC compared to earlier generation technologies.

Speaker Change: <unk> 010 is the first custom ADC, but our internal teams designed and built with participation by our collaboration partners and brought to the clinic and the principal investigators of the phase. One study are quite enthusiastic about the potential for this molecule to address significant unmet need for patients with tumors that express <unk> four.

Speaker Change: So we look forward to efficient execution of this study.

Dana Aftab: So we look forward to efficient execution of this study. The second INDATA file this year is for XL495, our small molecule inhibitor of PKMET1. Inhibition of PKMET1 is synthetically lethal in the context of increased cyclin E levels, which occurs across a wide range of tumors.

So we look forward to efficient execution of this study.

Unknown Executive: The second INDATA file this year is for XL495, our small molecule inhibitor of PKMIT1. Inhibition of PKMET1 is synthetically lethal in the context of increased cyclin E levels, which occurs across a wide range of tumors. We continue to be enthusiastic about the potential for XB371 to differentiate from Tizodimab and Thodotin in the clinic, primarily because of the topoisomerase inhibitor payload, which is a completely different mechanism of action and could give us reach into indications like colorectal cancer that express tissue factor but are typically insensitive to microtubule inhibitors. GLP talks and other IND enabling activities for XB371 are well underway, and we expect to file the IND in 2025.

Dana: The second item to file this year is <unk> 95, or small molecule inhibitor of P came at one <unk>.

Dana T. Aftab: The second IND to file this year is for XL495, our small molecule inhibitor of PKMYT1. Inhibition of PKMYT1 is synthetically lethal in the context of increased cyclin E levels, which occurs across a wide range of tumors. We're progressing toward IND filing and acceptance by the FDA for XL495 in the very near future, so we look forward to getting that Phase I study underway soon. 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. Our IND enabling activities for XB628 are progressing on schedule to support filing the IND later this year. I'm also pleased to give a brief update on XB371, our tissue factor targeting ADC that utilizes smart tag technology to conjugate a topoisomerase inhibitor payload to the antibody. We continue to be enthusiastic about the potential for XB371 to differentiate from Tizodimab and Thodotin in the clinic, primarily because of the topoisomerase inhibitor payload, which is a completely different mechanism of action and could give us reach into indications like colorectal cancer that express tissue factor but are typically insensitive to microtubule inhibitors.

Dana: Inhibition of he came at one is synthetically lethal in the context of increased cycling the levels, which occurs across a wide range of tumors, we're progressing towards IND filing and acceptance by the FDA for the XO four XL for nine five in the very near future. So we look forward to getting that phase one study underway as soon.

Dana Aftab: We're progressing toward IND filing and acceptance by the FDA for XL495 in the very near future, so we look forward to getting that phase one study underway soon. 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 and gauger activity in preclinical models. Our IND enabling activities for XB628 are progressing on schedule to support filing the IND later this year.

Speaker Change: The third IMT, we expect to file this year will be for xb six to eight or by specific antibody that targets PDL, one along with <unk> and displays NK cell engagement activity in preclinical models.

Dana: Our IMD, enabling activities for <unk> are progressing on schedule to support filing the IND later this year.

Dana Aftab: I'm also pleased to give a brief update on XB371, our tissue factor targeting ADC that utilizes smart tag technology to conjugate a topoisomerase inhibitor payload to the antibody. We continue to be enthusiastic about the potential for XB371 to differentiate from Tizodimab and Thodotin in the clinic, primarily because of the topoisomerase inhibitor payload, which is a completely different mechanism of action and could give us reach into indications like colorectal cancer that express tissue factor but are typically insensitive to microtubule inhibitors.

Dana T. Aftab: I'm also pleased to give a brief update on XB371, our tissue factor targeting ADC that utilizes SMARTag technology to conjugate a TOPOisomerase inhibitor payload to the antibody. We continue to be enthusiastic about the potential for XB371 to differentiate from TISOTUMAB VEDOTIN in the clinic, primarily because of the TOPOisomerase inhibitor payload, which is a completely different mechanism of action, and could give us reach into indications like colorectal cancer that express tissue factor but are typically insensitive to microtubule inhibitors. GLP talks and other IND enabling activities for XB371 are well underway, and we expect to file the IND in 2025. In terms of new development candidates, we expect to achieve our goal of at least two this year with some exciting new programs, including a small molecule inhibitor targeting PLK4 and a novel antibody drug conjugate program. And with that, I'll turn the call over to PJ.

Dana: I'm also pleased to give a brief update on SB 371, our tissue factor targeting ADC that utilizes smart tag technology to conjugate a tallboy summaries inhibitor payload to the antibody.

Dana: We continue to be enthusiastic about the potential for SB 307, one to differentiate from <unk> in the clinic, primarily because of the top where summaries inhibitor payload, which is a completely different mechanism of action and could give us reach into indications like colorectal cancer that express tissue factor, but are typically insensitive.

Dana: Two microtubule inhibitors.

Dana Aftab: GLP talks and other IND enabling activities for XB371 are well underway, and we expect to file the IND in 2025. In terms of new development candidates, we expect to achieve our goal of at least two this year with some exciting new programs, including a small molecule inhibitor targeting PLK4 and a novel antibody drug conjugate program. And with that, I'll turn the call over to PJ.

Dana: GOP talks and other IND, enabling activities for <unk> hundred 71 are well underway and we expect to file the IND in 2025.

Dana T. Aftab: In terms of new development candidates, we expect to achieve our goal of at least two this year with some exciting new programs, including a small molecule inhibitor targeting PLK4 and a novel antibody drug conjugate program. And with that, I'll turn the call over to PJ.

Dana: In terms of new development candidates, we expect to achieve our goal of at least two this year with some exciting new programs, including a small molecule inhibitor targeting <unk> four and a novel antibody drug conjugate program.

Dana: And with that I'll turn the call over to P. J.

P.J. Haley: Thank you Dana. The second quarter of 2024 was a strong quarter as the team continued to execute at a high level, which has resulted in CABOMETYX continuing to be the number one prescribed TKI in RCC. Additionally, CABOMETYX, in combination with NIVOLUMAB, has achieved it's highest market share to date and remains the number one TKI+IO combination and first-line renal cell carcinogen. With regard to prescriptions, CABOMETYX TRX volume grew 6% year over year in Q2 2024, relative to Q2 2023. Furthermore, the business remains strong both in terms of demand and new patient starts, both of which were at an all-time high for CABOMETYX in the second quarter. CABOMETYX continued to perform well from both a marketplace and competitive perspective. Problematics again led the TKI market basket, with TRX share to increasing to 41%. As we have discussed previously,

P. J.: Thank you Dana.

P. J.: Quarter of 2024 was a strong quarter as the team continued to execute at a high level, which has resulted in <unk> continuing to be the number one prescribed <unk> in RCC.

Unknown Executive: Additionally, Cabo Medix, in combination with Novolumab, has achieved its highest market share to date and remains the number one TKI-IO combination and first-line renal cell carcinogen. Cabo Medix TRX volume grew 6% year over year in Q2 2024 relative to Q2 2023. Furthermore, the business remains strong both in terms of demand and new patient starts, both of which were at an all-time high for Cabo Medics in the second quarter. This share increase drove higher new patient starts and demand for ComboMed.

P. J.: Additionally, <unk> in combination with the Volvo has achieved its highest market share to date and remains the number one <unk> Io combination in first line renal cell carcinoma.

P. J.: With regards to prescriptions cob.

PJ Haley: Cabo Medics TRX volume grew 6% year over year in Q2 2024 relative to Q2 2023. Furthermore, the business remains strong both in terms of demand and new patient starts, both of which were at an all-time high for Cabo Medics in the second quarter. Albumetics continued to perform well from both a marketplace and competitive perspective. Problematics again led the TKI market basket, with TRX share increasing to 41%. As we have discussed previously,

P. J.: <unk> volume grew 6% year over year in Q2, 2024 relative to Q2 2023.

P.J. Haley: Furthermore, the business remains strong both in terms of demand and new patient starts, both of which were at an all-time high for CABOMETYX in the second quarter. CABOMETYX continued to perform well from both a marketplace and competitive perspective. Problematics again led the TKI market basket, with TRX share to increasing to 41%. As we have discussed previously, the first-line RCC market is extremely competitive. And Q2 was the seventh full quarter in which CABOMETYX+NIVOLUMAB remained the number one prescribed TKI+IO combination in first-line RCC. In Q2, CABOMETYX+NIVOLUMAB reached it's highest share ever in first-line RCC, this share increase drove higher new patient starts and demand for CABOMETYX, in particular, we are seeing strong growth in community oncology setting. Furthermore, long-term data from the Checkmate 9ER Study, now at the minimum, 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. Beyond Firstline RCC.

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

P. J.: Of which were at an all time high for capo metrics in the second quarter.

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

P. J.: <unk> again led the TK I market basket with Trs share increasing to 41%.

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

PJ Haley: The first-line RCC market is extremely competitive. Q2 was the seventh full quarter in which Cabo Medix plus Novolumab remained the number one prescribed TKI plus IO combination in first-line RCCs. In Q2, Cabo Medix plus Novolumab reached its highest share ever in first-line RCC. This share increase drove higher new patient starts and demand for ComboMed. In particular, we are seeing strong growth in community oncology. Furthermore, long-term data from the Checkmate 90-Hour Study. Now at the minimum, four years of follow-up was presented at ASCO-GU this year and continues to reinforce the leadership position that Cabo Medics has in the RCC market, beyond Firstline RCC.

P. J.: In Q2, seven full quarter in which <unk> plus <unk> remained the number one prescribed teekay I plus Io combination in first line RCC.

P.J. Haley: In Q2, CABOMETYX+NIVOLUMAB reached it's highest share ever in first-line RCC, this share increase drove higher new patient starts and demand for CABOMETYX, in particular, we are seeing strong growth in community oncology setting. Furthermore, long-term data from the Checkmate 9ER Study, now at the minimum, 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. Beyond Firstline RCC. Cabo Medics is performing well in other segments, including second line RCC, second line HCC, and second line DTC. Looking forward, the commercial team is excited about the positive results from the cabinet trial in neuroendocrine tumors, particularly now that we have a PDUFA date. Neuroendocrine tumors comprise a large and heterogeneous patient population.

P.J. Haley: In Q2, CABOMETYX+NIVOLUMAB reached it's highest share ever in first-line RCC, this share increase drove higher new patient starts and demand for CABOMETYX, in particular, we are seeing strong growth in community oncology setting. Furthermore, long-term data from the Checkmate 9ER Study, now at the minimum, 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. Beyond Firstline RCC, CABOMETYX is performing well in other segments, including second line RCC, second line HCC, and second line DTC.

P. J.: In Q2, <unk> plus of old map reached its highest share ever at.

P. J.: First line RCC.

P. J.: This share increase drove higher new patient starts and demand for cargo mix.

Unknown Executive: In particular, we are seeing strong growth in community oncology. Now at the minimum, four years of follow-up was presented at ASCO-GU this year and continues to reinforce the leadership position that Cabo Medics has in the RCC market. Patients become metastatic and progress; for an oral agent in net since 2016, there will be approximately 9000 second-line plus drug treated patients in the United States. There is a lack of optimal sequencing data in this setting.

P. J.: In particular, we're seeing strong growth in the community oncology setting.

P. J.: Furthermore, long term data from the Checkmate <unk> study.

P. J.: Now with a minimum four years follow up.

P. J.: As presented at <unk>. This year it continues to reinforce the leadership position.

P. J.: <unk> has in the RCC marketplace.

P.J. Haley: Beyond Firstline RCC.

P. J.: Beyond first line RCC combo medics is performing well in other segments, including second line RCC second line HCC in second line DTC.

PJ Haley: Cabo Medics is performing well in other segments, including second line RCC, second line HCC, and second line DTC. Looking forward, the commercial team is excited about the positive results from the cabinet trial in neuroendocrine tumors, particularly now that we have a PDUFA date. Neuroendocrine tumors comprise a large and heterogeneous patient population.

P.J. Haley: Looking forward, the commercial team is excited about the positive results from the CABINET trial in neuroendocrine tumors, particularly now that we have a PDUFA date. Neuroendocrine tumors comprise a large and heterogeneous patient population, patients become metastatic and progress, treatment options become limited. The only oral targeted therapy options are SUNITINIB and EVEROLIMUS, and 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, in 2025, there will be approximately 9000 second-line plus drug-treated patients in the United States. Approximately 80% of patients are SSTR positive, and in lung NETs, that percentage is much lower, with approximately 44% being SSTR positive.

P. J.: Looking forward commercial team is excited about the positive results from the cabinet trial in neuroendocrine tumors, particularly now that we have with <unk>.

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

PJ Haley: Patients become metastatic and progress. Treatment options become limited. The only oral targeted therapy options are Sinitinib and Everolimus, and there has not been an approval in the U.S. for an oral agent in net since 2016.

P. J.: These patients become metastatic and progress treatment options become limited.

P. J.: The only oral targeted therapy options are sunitinib.

P. J.: Our wireless and there has not been an approval in the U S for oral agent and net since 2016.

PJ Haley: There is a strong unmet need for new options for patients who have progressed on systemic therapy. In 2025, there will be approximately 9000 second-line plus drug-treated patients in the United States. Approximately 80% of patients are SSTR positive. And in lung nets, that percentage is much lower, with approximately 44% being SSTR positive.

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

P. J.: In 2025.

P. J.: There will be approximately 9002nd line plus drug treated patients in the United States.

P. J.: Approximately 80% of patients are S. S GR positive and in lung Mets that percentage is much lower.

P.J. Haley: Approximately 80% of patients are SSTR positive, and in lung NETs, that percentage is much lower, with approximately 44% being SSTR positive, most NET patients will receive multiple lines of therapy, in part due to the more indolent nature of the disease relative to other solid tumors. We've conducted preliminary market research, which reveals that oral therapies account for approximately 50% of the utilization in this market in the second and third line plus settings. The currently available options do not have broad evidence across all disease characteristics, including site of origin, grade, SSTR status, and functional status. Also, in market research, physicians do not view the toxicity profile of these agents in a favorable manner.

P. J.: Proximately, 44% being assessed GR positive.

PJ Haley: Most NET patients will receive multiple lines of therapy, part due to the more indolent nature of the disease relative to other solid tumors. We've conducted preliminary market research, which reveals that oral therapies account for approximately 50% of the utilization in this market in the second and third line plus set. The currently available options do not have broad evidence across all disease characteristics, including site of origin, grade, SSTR status, and functional status. Also, in market research, physicians do not view the toxicity profile of these agents in a favorable manner.

P. J.: Most net patients or received multiple lines of therapy in part due to the more indirect nature of the disease relative to other solid tumors.

Speaker Change: We have conducted preliminary market research, which reveals that oral therapies account for approximately 50% of the utilization in this market in the second and third line plus six.

P. J.: The currently available options do not have broad evidence across all disease characteristics, including site of origin grade S. S. T R status and functional status.

P. J.: Also in market research physicians do not view the toxicity profile of these agents in a favorable manner.

P.J. Haley: Furthermore, as I mentioned previously, the majority of NET patients will receive many lines of therapy sequenced throughout their treatment course. There is a lack of optimal sequencing data in the setting, particularly in patients previously treated with LUTATHERA. All of this taken together underscores the significant need for a contemporary data set that is broad in it's applicability to address the unmet medical need for this heterogeneous patient population. Turning to the CABINET trial, the study had a broad and diverse population that included patients regardless of site of disease origin, tumor grade, prior LUTATHERA, SSTR status, or functional status of the tumors, we conduct market research and hear from KOLs about the cabinet data, we are pleased with the feedback that we are receiving. Physicians cite the study design as positive, that it covers a broad range of NET patients that they see in their practice, as well as the fact that it is a contemporary data set and is inclusive of patients who have received LUTATHERA. In market research, the efficacy data on CABINET is viewed favorably by prescribers in terms of progression-free survival, overall response rate, and disease control-rate.

P. J.: Furthermore, as I mentioned previously the majority of net patients will receive many lines of therapy sequenced throughout their treatment course.

P. J.: There was a lack of optimal sequencing data in this setting, particularly in patients previously treated with <unk>.

Unknown Executive: All of this taken together underscores the significant need for a contemporary data set that is broad in its applicability to address the unmet medical need for this heterogeneous patient population. In market research, the efficacy data on Cabinet are viewed favorably by prescribers in terms of progression-free survival. Overall response rate and disease control rate. Most physicians in the research have experience with CABO in RCC, HCC, or DTC. The potential opportunity in neuroendocrine tumors fits very well with Exelixis's existing commercial infrastructure and capability. Synergies also exist across other commercial functions, such as marketing, market access, and commercial operations.

P. J.: All of this taken together underscores the significant need for contemporary data set that is broad in its applicability to address the unmet medical need for this heterogeneous patient population.

P.J. Haley: Turning to the CABINET trial, the study had a broad and diverse population that included patients regardless of site of disease origin, tumor grade, prior LUTATHERA, SSTR status, or functional status of the tumors, we conduct market research and hear from KOLs about the cabinet data, we are pleased with the feedback that we are receiving. Physicians cite the study design as positive, that it covers a broad range of NET patients that they see in their practice, as well as the fact that it is a contemporary data set and is inclusive of patients who have received LUTATHERA. In market research, the efficacy data on CABINET is viewed favorably by prescribers in terms of progression-free survival, overall response rate, and disease control-rate.

Speaker Change: Turning to the cabinet trial.

PJ Haley: The study had a broad and diverse population that included patients regardless of site of disease origin, tumor grade, prior lutethera, SSTR status, or functional status of the tumors. We conduct market research and hear from KOLs about the cabinet data. We are pleased with the feedback that we are receiving. Physicians cite the study design as positive, that it covers a broad range of NET patients that they see in their practice, as well as the fact that it is a contemporary data set and is inclusive of patients who have received Lunatherapy. In market research, the efficacy data on Cabinet are viewed favorably by prescribers in terms of progression-free survival, overall response rate, and disease control rate.

P. J.: The study had a broad and diverse population that included patients regardless of site of disease origin tumor grade.

P. J.: <unk> S S T R status or functional status of the tumors.

Speaker Change: As we conduct market research and hear from Kols about the cabinet data, we're pleased with the feedback that we're receiving.

P.J. Haley: Physicians cite the study design as positive, that it covers a broad range of NET patients that they see in their practice, as well as the fact that it is a contemporary data set and is inclusive of patients who have received LUTATHERA. In market research, the efficacy data on CABINET is viewed favorably by prescribers in terms of progression-free survival, overall response rate, and disease control-rate.

Speaker Change: Physicians cite the study design is positive.

Speaker Change: <unk> has a broad range of net patients that they see in their practice as well as the fact that it is a contemporary datasets and is inclusive of patients who have received <unk>.

P. J.: In market research efficacy data cabinet is viewed favorably by prescribers in terms of progression free survival overall response rate and disease control rate.

P.J. Haley: In market research, the efficacy data on CABINET is viewed favorably by prescribers in terms of progression-free survival, overall response rate, and disease control-rate. Most physicians in the research have experience with CABO in RCC, HCC, or DTC. These oncologists cite their experience with CABOMETYX in other tumors as positive, particularly when it comes to comfort with dose modification and toxicity management. The feedback and research clearly demonstrate that a regulatory approval for CABOMETYX based on the CABINET study would have the potential to help a broad range of NET patients and address the unmet medical need. The potential opportunity in neuroendocrine tumors fits very well with Exelixis's existing commercial infrastructure and capabilities.

PJ Haley: Most physicians involved in the research have experience with CABO in RCC, HCC, or DTC. These oncologists cite their experience with carbametics in other tumors as positive, particularly when it comes to comfort with dose modification and toxicity management. The feedback and research clearly demonstrate that a regulatory approval for problematics based on the cabinet study would have the potential to help a broad range of NET patients and address an unmet medical need. The potential opportunity in neuroendocrine tumors fits very well with Exelixis's existing commercial infrastructure and capability.

P. J.: Most physicians in the research have experience with Cabo in RCC HCC or DTC.

P. J.: These oncologists site their experience with <unk> in other tumors as well.

Speaker Change: Positive, particularly when it comes to comfort with dose modification and toxicity management.

P. J.: The feedback and research clearly demonstrates that a regulatory approval for <unk> based on the cabinet study would have the potential to help a broad range of net patients and address an unmet medical need.

P. J.: The potential opportunity in neuroendocrine tumors fits very well <unk> existing commercial infrastructure and capabilities.

P.J. Haley: The potential opportunity in neuroendocrine tumors fits very well Exelixis's existing commercial infrastructure and capabilities. Oncologists are the primary treaters of advanced neuroendocrine tumors, and our analysis indicates that the majority of NET treaters have prior experience using CABINET and are already being called on by our sales force for our labeled indications. Synergies also exist across other commercial functions, such as marketing, market access, and commercial operations, hence, potential launch of CABO in NET would not require significant incremental investment. Launch planning and preparation for the opportunity in neuroendocrine tumors is well underway, and our team is excited by this endeavor. CABO franchise is entering the second half of 2024 with significant momentum in our currently improved indications, and a potential regulatory approval of CABOMETYX in NET would provide the opportunity to continue the growth and momentum in the coming years.

PJ Haley: Oncologists are the primary treaters of advanced neuroendocrine tumors, and our analysis indicates that the majority of NET treaters have prior experience using coblematics and are already being called on by our sales force for our labeled indication. Synergies also exist across other commercial functions, such as marketing, market access, and commercial operations.

P. J.: Oncologists are the primary treaters of advanced neuroendocrine tumors and our analysis indicates that the majority of net treaters have prior experience using <unk>.

P. J.: And are already being called on by our sales force for our labeled indications.

P. J.: Synergies also exist across other commercial functions, such as marketing market access and commercial operations.

PJ Haley: Hence, potential launch of Cabo and NET would not require significant incremental investment. Launch planning and preparation for the opportunity in neuroendocrine tumors is well underway, and our team is excited by this endeavor. Cabo franchise is entering the second half of 2024 with significant momentum in our currently improved indications, and a potential regulatory approval of Cabo medics and net would provide the opportunity to continue the growth and momentum in the coming year.

P. J.: Hence potential launch of Cabo and that would not require significant incremental investment.

P.J. Haley: Launch planning and preparation for the opportunity in neuroendocrine tumors is well underway, and our team is excited by this endeavor. CABO franchise is entering the second half of 2024 with significant momentum in our currently improved indications, and a potential regulatory approval of CABOMETYX in NET would provide the opportunity to continue the growth and momentum in the coming years. Furthermore, the commercial team is enthusiastic about the progress in the pipeline, particularly with ZANZALINTINIB, as 2025 is coming into focus as an important year for the compound, as you heard from Amy. We are motivated to expand the CABO franchise to a kinase inhibitor franchise, with ZANZA having the potential to help patients in tumors where CABO has demonstrated activity, such as NETs and RCC, as well as new tumors, such as colorectal cancer, so we can continue to help more patients with cancer. With that, I will turn the call back over to Mike.

P. J.: Launch planning and preparation for the opportunity and neuroendocrine tumors is well underway and our team is excited by this endeavor.

P. J.: Tableau franchise is entering the second half of 2024 with significant momentum in our currently approved indications and a potential regulatory approval of <unk> in net will provide the opportunity to continue the growth and momentum in the coming years.

PJ Haley: Furthermore, the commercial team is enthusiastic about the progress in the pipeline, particularly with Zanzalitlib, as 2025 is coming into focus as an important year for the compound, as you heard from Amy. We are motivated to expand the CABO franchise to a kinase inhibitor franchise, with Zanza having the potential to help patients in tumors where CABO has demonstrated activity, such as NETs and RCC, as well as new tumors, such as colorectal, so we can continue to help more patients with cancer. With that, I will turn the call back over to Mike.

P. J.: Furthermore, the commercial team is enthusiastic about the progress in the pipeline, particularly.

P. J.: As 2025 is coming into focus as an important year for the compound as you heard from me.

P.J. Haley: We are motivated to expand the CABO franchise to a kinase inhibitor franchise, with ZANZA having the potential to help patients in tumors where CABO has demonstrated activity, such as NETs and RCC, as well as new tumors, such as colorectal cancer, so we can continue to help more patients with cancer. With that, I will turn the call back over to Mike.

P. J.: We are motivated to expand the Cabo franchise to a kinase inhibitor franchise with <unk>, having the potential to help patients in tumors, where Cabo has demonstrated activities such as nuts in RCC as well as new tumors, such as colorectal cancer. So we can continue to help more patients with cancer.

P. J.: With that I will turn the call back over to Mike Alright. Thanks, P. J I'd like to close our call today by reflecting on an event. We recently held it serves as an important reminder, about why we are dedicated to the work we're doing at <unk> every single day.

Michael M. Morrissey: All right. Thanks, PJ. I'd like to close our call today by reflecting on an event we recently held that serves as an important reminder about why we are dedicated to the work we do at Exelixis every single day. We had the honor of hosting kidney cancer patients and advocates Laura Esseler and Katie Coleman for a special panel discussion where they shared insights about their kidney cancer journey and the significant ripple effect the connections and information shared from peer to peer support and advocacy can have on people impacted by a devastating cancer diagnosis.

Speaker Change: We have the honor of hosting kidney cancer patients and advocates Laura as stellar and Katie Coleman for a special panel discussion, where they shared insights about their kidney cancer journey and the significant ripple effect the connections and information shared with computer pure supporting efficacy can have on people impacted by a devastating.

P. J.: Cancer diagnosis.

Michael M. Morrissey: Their powerful stories of hardship, resiliency, and an unwavering dedication to advocate for fellow patients reinforce our individual and collective commitment to the patients we serve and reminds all of us that together, we can make a meaningful difference in the lives of people affected by cancer. So with that, I want to thank the entire Exelixis team for their efforts to support our discovery, development, and commercial activities. We had a very strong first half of 2024 and are on track for this year to be a critical one for our science and the patients we strive to serve now and in the future.

Speaker Change: They're powerful stories of hardship resiliency and an unwavering dedication to advocate for fellow patients reinforces our individual and collective commitment to the patients we serve and reminds all of us that together, we can make a meaningful difference in the lives of people affected by cancer.

Michael M. Morrissey: So with that, I want to thank the entire Exelixis team for their efforts to support our discovery, development, and commercial activities. We had a very strong first half of 2024 and are on track for this year to be a critical one for our science and the patients we strive to serve now and in the future.

Speaker Change: So with that I want to thank the entire <unk> team for their efforts to support our discovery development and commercial activities. We had a very strong first half of 2024 and are on track for this year to be a critical one for our science and the patients we strive to serve now and in the future. The exel team is highly motivated to exceed expectations.

Unknown Executive: We had a very strong first half of 2024 and are on track for this year to be a critical one for our science and the patients we strive to serve now and in the future. The Excel team is highly motivated to exceed expectations and our mission to help cancer patients recover stronger and live longer.

Michael M. Morrissey: The Exel 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, thank you for your continued support and interest in Exelixis. And we're now happy to open the call for questions.

Mike: Yeah, thanks for the question. It's Mike.

P. J.: Our mission to help cancer patients recover stronger and live longer.

P. J.: Look forward to updating you on our progress in the future.

Speaker Change: You for your continued support and interest in <unk> and we're now happy to open the call for questions.

Speaker Change: Thank you.

Operator: Thank you, ladies and gentlemen, 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, 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 Michael Schmidt with Guggenheim Securities. Your line is open. Hi, this is Paul.

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, 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 Michael Schmidt with Guggenheim Securities. Your line is open.

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

P. J.: To withdraw your question. Please press star one again.

Speaker Change: We ask that you limit yourself to one question only.

P. J.: Please standby, while we compile the Q&A roster.

P. J.: Our first question comes from the line of Michael Schmidt with Guggenheim Securities. Your line is open.

P. J.: Hi, This is Paul on for Michael Thanks for taking my question.

Speaker Change: Just for Cabo and thinking about expectations for possible labeling and net.

Speaker Change: Looking at the cabinet study patients thats been around two to three median line, including somatostatin analogs from other treatment how are you.

Speaker Change: Thinking about how the label might reflect prior lines of therapy in terms of second line versus third line plus.

Speaker Change: Just thoughts about the label that you could share would be super helpful. Thank you.

Michael Schmidt: Hi, this is Paul on for Michael Thanks for taking our question. Just for CABO and thinking about expectations for possible labeling in NET. You know, looking at the CABINET study, patient that's been around two to three, you know, medium lines including a [inaudible] and other treatments. How are you thinking about how the label might reflect prior lines of therapy, in terms of second line versus third line+? And any other thoughts about the label that you could share would be super helpful. Thank you. an't really share much in terms of the label. We're deep in the response to the agency. We're very excited about the fact that they've accepted the filing and are marching towards an approval date of April 3rd, 2025. We think that the study allows a fairly broad label for NET, pancreatic, extra pancreatic, prior FSTR, yes or no, functional yes or no. How that actually pans out in terms of words will remain to be seen.

Michael Morrissey: Thanks, Paul, for the question. I can't really share much in terms of the label. We're deep in the response to the agency. We're very excited about the fact that they've accepted the filing and are marching towards an approval date of April 3rd, 2025. We think that the study allows a fairly broad label for NET, pancreatic, extra pancreatic, prior FSTR, yes or no, functional yes or no. How that actually pans out in terms of words will remain to be seen.

P. J.: Thanks, Paul for the question.

Speaker Change: I can't really share much in terms of the label we're deep in the <unk>.

Speaker Change: We are in the response to the agency. We're very excited about the fact that they have accepted the filing and our marching towards an approval date of April.

Speaker Change: Third in 2025.

Amy Peterson: Thanks Paul for the question, I can't really share much in terms of the label, we're deep in the response to the agency ,we're very excited about the fact that they've accepted the filing and are marching towards an approval date of April 3rd, 2025. We think that the study allows a fairly broad label for NET, pancreatic, extra pancreatic, prior FSTR, yes or no, functional yes or no. How that actually pans out in terms of words will remain to be seen.

P. J.: We think that the study allows a fairly broad.

Speaker Change: <unk> four nuts pancreatic extra pancreatic prior S. S T R, yes, or no functional yes or no.

Speaker Change: How that actually pans out in words will remain to be seen.

P. J.: Thank you.

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

Speaker Change: Please standby for our next question.

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

support: Hi, This is support on for Greg.

Speaker Change: On the business development opportunities and collaborations.

Speaker Change: That extra emphasis is exploring does that include potential.

Speaker Change: Potential acquisition of late stage assets that fit with the <unk> portfolio that was indicated in the previous quarter and any color on the calibration would be would be helpful. Thank you.

Unknown Executive: Yeah, look, we're, as we mentioned last quarter, very interested in looking at late-stage assets in the GUGI space. Obviously, I can't go into details right now about that. But it's certainly a prime area of focus for us. Anything we can do to add late-stage compounds to our portfolio would be, I think, a real benefit for potentially patients, shareholders, and the company. So that's where our focus is right now, and stay tuned as things evolve throughout the second half of the year.

Michael Morrissey: Hi this is [inaudible] on for Greg, on the business development opportunities and collaborations that Exelixis is exploring, does that include a potential acquisition of late-stage asset that fit with the DUGI portfolio that was indicated in the previous quarter? Any color on the collaboration would be helpful, thank you. that Yeah, thanks for the question. It's Mike.

Gregory Renza: Hi this is [inaudible] on for Greg, on the business development opportunities and collaborations that Exelixis is exploring, does that include a potential acquisition of late-stage asset that fit with the GUGI portfolio that was indicated in the previous quarter? Any color on the collaboration would be helpful,

Mike: Yeah. Thanks for the question, it's Mike Yeah look we're as we mentioned last quarter, we're very interested in looking at late stage assets in the <unk> space, Obviously I can't go into details right now about that but it's certainly a prime area of focus for us and anything we can do to add late stage compounds.

Speaker Change: Two our portfolio would be I think that will benefit for potentially patients shareholders and the company. So that's where our focus is right now and stay tuned as things evolve throughout the second half of the year.

Michael M. Morrissey: Yeah, thanks for the question. It's Mike. Yeah, look, we're, as we mentioned last quarter, we're very interested in looking at late-stage assets in the GUGI space, obviously, I can't go into details right now about that, but it's certainly a prime area of focus for us. Anything we can do to add late-stage compounds to our portfolio would be, I think, a real benefit for potentially patients, shareholders, and the company. So that's where our focus is right now, and stay tuned as things evolve throughout the second half of the year.

Michael Morrissey: Yeah, look, we're, as we mentioned last quarter, very interested in looking at late-stage assets in the GUGI space. Obviously, I can't go into details right now about that. But it's certainly a prime area of focus for us. Anything we can do to add late-stage compounds to our portfolio would be, I think, a real benefit for potentially patients, shareholders, and the company. So that's where our focus is right now, and stay tuned as things evolve throughout the second half of the year.

P. J.: Thank you.

Operator: Thank you, please stand by for our next question. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is open.

Speaker Change: What do you say by far our next question.

Unknown Executive: Our next question comes from the line of Axteca Gunawarden with Truist. Your line is open.

Speaker Change: Our next question comes from the line of extra color going awarding with truth. Your line is open.

Asthika Goonewardene: Hey, guys, thanks for taking my question. I just want to say congrats on the progress and the lead on CABO sales this quarter. So I have another question for you. It's unfortunate [inaudible] did not hit on OS, we're hopeful it still gets approved, and if it does, what is the level of confidence that not having OS will not be detrimental to uptake? And if I can squeeze a quick one, a quick side question in here, can you just give us a little bit more color on the update on recruitment to STELLAR-305? I know you said side activation is going well, but there's just quite a lot of other clinical trials underway in this setting, and I just want to get a little bit more color from you if you can provide on how patient enrollment is going? Thanks.

Unknown Executive: Hey, guys, thanks for taking my question. I just wanted to say congrats on the progress and the lead in the travel sales quarter. So Amy, I have a question for you.

Speaker Change: Hey, guys. Thanks for taking my question.

Speaker Change: Congrats on the progress.

Speaker Change: <unk> global sales quota.

Speaker Change: So and then another question here.

Speaker Change: It's unfortunate our contractors or did not hit on Oss, where hopefully still gets approved and if it does what is the level of confidence that not having a risk we will not be detrimental to uptake if I can squeeze a quick one.

PJ Haley: It's unfortunate a contractor who did not hit on O.S., but hopefully, it still gets approved. And if it does, what is the level of confidence that not having O.S. will not be detrimental to uptake? And if I can squeeze a quick one, a quick side question in here.

Speaker Change: A quick side question in here can you just give us a little bit more color on the update on the recruitment to sell a three or five and then you said site activation is going well.

Unknown Executive: It's unfortunate a contractor did not hit on O.S., but hopefully, it still gets approved. And if it does, what is the level of confidence that not having O.S. gives you? Will it not be detrimental to uptake? And if we can squeeze a quick one, a quick side question in here, can you just give us a little bit more color on the update on the recruitment to cell 305? I know you said site activation is going well, but there are just quite a lot of other clinical trials underway in this setting, and I just want to get a little bit more color from you on how patient enrollment is going. Thanks.

Speaker Change: But theres still quite a lot of other clinical trials underway in this setting I just wanted to get a little bit more color from you. If you can provide on how patient enrollment is going.

Unknown Executive: Yeah, thanks Estacote. Can you take that first question on how about a commercial for prostate cancer?

TJ: Yeah. Thanks, Aster color TJ take that first question on <unk>.

Speaker Change: How about commercial for prostate potentially yeah.

Asthika Goonewardene: And if I can squeeze a quick one, a quick side question in here, can you just give us a little bit more color on the update on recruitment to STELLAR-305? I know you said side activation is going well, but there's just quite a lot of other clinical trials underway in this setting, and I just want to get a little bit more color from you if you can provide on how patient enrollment is going? Thanks.

Unknown Executive: Yeah, thanks for the question. You know, we're really excited about the data. And, you know, I think there's a significant unmet need out there. As we've talked about previously, we certainly wouldn't want to get ahead of ourselves and talk about potential uptake in the market, etc. But, you know, like I said, we're excited about that data right now. As I mentioned in my remarks, we're really excited about and focused on the near-term neuroendocrine tumor launch, which is really our top priority, in addition to maintaining our current inline business. So our focus is on that at the moment.

Speaker Change: So the question, we're really excited about about the data.

Speaker Change: And you don't think there is a significant unmet need out there.

Speaker Change: As we've talked about previously.

Speaker Change: Certainly wouldn't want to get ahead of ourselves and talking about potential uptake.

Speaker Change: In the market et cetera, but.

Speaker Change: Like I said, we're excited about that data right now.

P. J.: As I mentioned in my remarks were really excited about and focused on the near term neuroendocrine.

Speaker Change: Tumor launch, which is really our top priority. In addition to maintaining our current inline business. So our focus is there.

Amy Peterson: Can you just give us a little bit more color on the update on recruitment to cell 305? I know you said side activation is going well, but there's just quite a lot of other clinical trials underway in this setting, and I just want to get a little bit more color from you on how patient enrollment is going. Thanks.

Speaker Change: At the moment.

Speaker Change: Sure. Thanks for the question at the parallel I'll answer first a little bit more high color on contact O. Two very excited that the study was positive we hit on PFS, we hit no matter of different ways that you assess PFS and subgroups.

Speaker Change: That has been the basis of approval even in this setting in prostate cancer there is precedent.

PJ Haley: Yeah thanks Asthika, PJ take that first question and CABO comercial for prostateCan you take that first question and [inaudible] commercial for prostate potentially? Yeah.

Michael M. Morrissey: Yeah thanks Asthika, PJ take that first question and CABO commercial for prostate, can you take that first question on [inaudible] commercial for prostate potentially?

Speaker Change: We believe that what this offers us something to patients who really have high unmet need for example patients with liver Mets when we presented the subgroup that <unk>. These patients really don't have much in terms of available effective therapies to them when we pulse the external community.

Speaker Change: On their excitement about the data they actually are very excited to potentially have something that they can reach four relatively easily it's not chemo the tolerability profile of Cabo a tease out there.

P.J. Haley: Yeah, thanks for the question. You know, we're really excited about the data, and, you know, I think there's a significant unmet need out there as we've talked about previously, we certainly wouldn't want to get ahead of ourselves and talk about potential uptake in the market, etc. But, you know, like I said, we're excited about that data right now, as I mentioned in my remarks, we're really excited about and focused on the near-term neuroendocrine tumor launch, which is really our top priority, in addition to maintaining our current inline business, so our focus is there at the moment.

PJ Haley: Yeah, thanks for the question. You know, we're really excited about the data. And, you know, I think there's a significant unmet need out there. As we've talked about previously, we certainly wouldn't want to get ahead of ourselves and talk about potential uptake in the market, etc. But, you know, like I said, we're excited about that data right now. As I mentioned in my remarks, we're really excited about and focused on the near-term neuroendocrine tumor launch, which is really our top priority, in addition to maintaining our current inline business. So our focus is there at the moment. Great.

Speaker Change: We're comparing it to chemo knocked in second <unk> and they are actually very excited about the potential to have this in their armamentarium.

Speaker Change: We'll see how things go with regard to our filing as far as an update on three of five we're aware of the lead.

Speaker Change: But you know I can't really say much more than that.

Speaker Change: Thank you.

Amy Peterson: Great. Amy? Sure. Thanks for the question, Ethica.

Michael M. Morrissey: Great. Amy?

Unknown Executive: Stand by for our next question. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open.

Amy Peterson: Sure, thanks for the question, Asthika. I'll answer first, a little bit more high color on contact O2. Very excited, the study was positive, we hit on PFS, we hit in no matter the different ways that you assess PFS and subgroups. PFS has been the basis of approval, even in this setting of prostate cancer, there's precedent. We believe that what this offers is something to patients who really have high unmet need, for example, patients with liver mets, and we presented this subgroup at ASCO-GU. These patients really don't have much in terms of available effective therapies to them, when we pulse the external community on their excitement about the data, they are actually very excited to potentially have something that they can reach for, relatively easily, it's not chemo.

Speaker Change: Please standby for our next question.

Amy Peterson: I'll answer first. A little bit more high color on contact O2. Very excited. The study was positive. We hit on PFS. We hit no matter the different ways that you assess PFS and subgroups.

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

Amy Peterson: PFS has been the basis of approval. Even in the setting of prostate cancer, there's precedent. We believe that what this offers is something to patients who really have high unmet need, for example, patients with liver mets, and we presented this subgroup at ASCO-GU. These patients really don't have much in terms of available effective therapies. When we pulse the external community on their excitement about the data, they are actually very excited to potentially have something that they can reach for relatively easily. It's not chemo.

Jay Olson: Oh, Hey, thank you for providing the update and congrats on all the progress for the New 311 study of <unk> and first line net can you talk about how you're weighing the use of single agent <unk> versus combination approach and would you consider running.

Speaker Change: Head to head trial of <unk> versus Cabo. Thank you.

Unknown Executive: Thanks, Jay. Great questions. So at this point in time, we're focusing on Zanza head-to-head versus Everolimus, which we think is a reasonable therapy to offer patients in this line. We have to maintain equipoise whenever we design a study so that the doctor is okay talking about each option that they have. We are interested in combinations. However, at this point in time, it's a little bit early days. We would have to assess the safety and tolerability of any combination before we could initiate a Phase III study. We believe that this is probably the first of multiple trials that will run in this space. So stay tuned. We'll look at combinations as well.

Speaker Change: Thanks, Jay Great questions. So at this point in time, we're focusing on are the zander head to head versus Everolimus, which we think is a reasonable therapy to offer patients. In this line we have to maintain equipoise whenever we design a study so that the physician is okay.

Amy Peterson: These patients really don't have much in terms of available effective therapies to them, when we pulse the external community on their excitement about the data, they are actually very excited to potentially have something that they can reach for, relatively easily, it's not chemo. The tolerability profile of Cabo [inaudible], they're comparing it to chemo, not to second NHT, and they're actually very excited about the potential to have this in their armamentarium. We'll see how things go with regard to our filing, as far as an update on 305, we're aware of the lead, but I can't really say much more than that. Thank you. 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 the update.

Speaker Change: Talking about each option.

Speaker Change: That they have we are interested in combination however.

Speaker Change: At this point in time, it's a little bit early days, we would have to assess the safety tolerability of any combination before we could initiate a phase III study. We believe that this is the first probably multiple trials that will run in the space. So.

Speaker Change: Stay tuned we will look at combinations as well.

Amy Peterson: 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. Oh, hey, thank you for providing the update.

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.

Speaker Change: Thank you.

Unknown Executive: Will you stand by for questions?

Amy Peterson: The tolerability profile of Cabo Atizo, they're comparing it to chemo, not to second NHT, and they're actually very excited about the potential to have this in their arsenal. We'll see how things go with regard to our filing. As far as an update on 305, we're aware of the lead, but I can't really say much more than that. Thank you. 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 the update.

Speaker Change: Please standby for questions.

Jay Olson: Oh, hey, thank you for providing the update and congrats on all the progress. For the new 311 study of ZANZA in first-line NET, can you talk about how you're weighing the use of single agent ZANZA versus a combination approach? And would you consider running a head to head trial of ZANZA vs CABO? Thank you. Thanks Jay, great question, so at this point in time we're focusing on the ZANZA head to head vs EVEROLIMUS, which we think is a reasonable therapy to offer patients in this line, we have to maintain [inaudible] whenever we design a study so that the physician is ok talking about each option that they have. W are interested in combination, however at this point in time is a little bit early stage, we would have to asses the safety tolerability of any combination before we could initiate a Phase III study. We believe this is the first of probabloy multiple trials that we'll run in this space so stay tunes, we'll look at combinations as well.

Michael M. Morrissey: Thanks Jay, great question, so at this point in time we're focusing on the ZANZA head to head vs EVEROLIMUS, which we think is a reasonable therapy to offer patients in this line, we have to maintain [inaudible] whenever we design a study so that the physician is ok talking about each option that they have. We are interested in combination, however at this point in time is a little bit early stage, we would have to asses the safety tolerability of any combination before we could initiate a Phase III study. We believe this is the first of probabloy multiple trials that we'll run in this space so stay tunes, we'll look at combinations as well.

Jay Olson: We are interested in combination, however at this point in time is a little bit early stage, we would have to asses the safety tolerability of any combination before we could initiate a Phase III study. We believe this is the first of probabloy multiple trials that we'll run in this space so stay tunes, we'll look at combinations as well.

Operator: Please stand by for our next question. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open. Thanks, Jay. Great questions. So at this point in time, we're focusing on Zanza head to head versus Everolimus, which we think is a reasonable therapy to offer patients in this line. We have to maintain equipoise whenever we design a study so that the physician is okay talking about each option that they have. We are interested in combinations. However, you know, at this point in time, it's a little bit early days; we would have to assess We believe that this is probably the first of multiple trials that will run in this space. So stay tuned; we'll look at combinations as well.

Speaker Change: Our next question comes from the lineup Yamana Weber with keeping Cowen Your line is open.

Yamana Weber: Hey, guys I'm curious on pay around thanks for taking our question.

Yamana Weber: But there too I was just wondering if you will be performing subgroup analyses in patients by high risk factors similar to what you did for PFS for example in liver Mets patients.

Speaker Change: And whether you hope to learn from anything there on the O S separation and what drove the overall O as to not be statistically significant.

Amy Peterson: Thanks, Jay. Great questions. So at this point in time, we're focusing on Zanza head to head versus Everolimus, which we think is a reasonable therapy to offer patients in this line. We have to maintain equipoise whenever we design a study so that the physician is okay talking about each option that they have. We are interested in combinations. However, you know, at this point in time, it's a little bit early days; we would have to assess We believe that this is probably the first of multiple trials that will run in this space. So stay tuned; we'll look at combinations as well.

Speaker Change: Yeah, Hi, Thanks for the question. So we're looking forward to sharing the data we did provide subgroup analyses that <unk>, both according to PFS and according to <unk>, which we would.

Speaker Change: We would intend to update we're very interested in what subgroups may benefit. The most from this combination as well as potential subgroups that may not have as much benefit right. It's all about risk benefit when a physician is deciding who to treat and so you know well we look forward to providing an update stay tuned for when.

Speaker Change: It happens and I'm looking forward to have more discussion on this in the future.

Speaker Change: Thank you.

Operator: Will you stand by for questions? Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open. Hey guys, this is [inaudible] on for Yaron, thanks for taking our question. On [inaudible]I was just wondering if you would be performing sub-group analysis and patients by high risk factors, similar to what you did for PFS, for example in liver NET patients. And whether you hope to learn from anything there on the OS separation and what drove the overall OS to not be statistically significant? thanks.

Operator: Will you stand by for questions? Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.

Yaron Werber: Hey guys, this is [inaudible] on for Yaron, thanks for taking our question. On [inaudible]I was just wondering if you would be performing sub-group analysis and patients by high risk factors, similar to what you did for PFS, for example in liver NET patients. And whether you hope to learn from anything there on the OS separation and what drove the overall OS to not be statistically significant? thanks.

Amy Peterson: Yeah, hi, thanks for the question. So, you know, we're looking forward to sharing the data; we did provide subgroup analyses at GU-ASCO, both according to PFS and according to OS, which we would, we would intend to, update. We're very interested in what subgroups may benefit the most from this combination, as well as potential subgroups that may not have as much benefit, right? It's all about risk vs. benefit when a physician is deciding who to treat. And so, you know, we'll look forward to providing an update, stay tuned for when that happens, and look forward to having more discussion on this in the future.

Speaker Change: What are your standby for our next question.

Operator: Will you stand by for our next question? Our next question comes from the line of Andy Hsieh of William Blair, your line is open.

Speaker Change: Our next question comes from the line of Annie Xu William Blair. Your line is open.

Andy Hsieh: Great, thanks for taking our questions. So maybe a quick one for me, just curious about your reaction to the standard review? I was shocked about the FDA's decision to not give you breakthrough when I read the press release. Secondarily, I'm curious about the kind of overlap and potential for cannibalization, just looking at the STELLAR-311 study and also the CABINET study population, there's an example before with NETR1 that the FDA gave them a really broad label. I'm just curious about that broad label and it's potential implications for the STELLAR-311 study? Thank you.

Annie Xu: Oh, great. Thanks for taking our questions. So maybe a quick one for me just curious about your reaction on the standard review I was shocked about the Fda's decision to not give you breakthrough.

Speaker Change: When I read the press release.

Speaker Change: Secondarily I'm.

Speaker Change: I am curious about kind of the overlap and potential for cannibalization.

Annie Xu: Just looking at the stellar 311 study and also the cabinet a study population there as an example, before with net or one that the FDA gave them a really broad label I'm just curious about the broad label and its potential application to the stellar three you want one study. Thank you.

Michael M. Morrissey: Hey, Andy, it's Mike, I'll take those. So look, we're thrilled to have, as always, any sNDA or NDA accepted and a PDUFA date out there, it allows us to focus the team in terms of both the review and then any kind of, you know, additional launch readiness that we have to do, so I think both Amy and PJ did a great job of framing that. So we're thrilled to be where we are right now with CABO and NETS and certainly very excited about moving ZANZA forward in that direction, too.

Mike: Hi, Andy it's Mike.

Mike: I'll take those so look we are.

Speaker Change: We're thrilled to have.

Speaker Change: Always any SMB or NDA accepted.

Michael Morrissey: So look, we're thrilled to have, as always, any SNDA or NDA accepted and a PDUFA date out there. It allows us to focus the team in terms of both the review and then any kind of, you know, additional launch readiness that we have to do. So I think both Amy and PJ did a great job of framing that. So we're thrilled to be where we are right now with CAVO and NETS and certainly very excited about moving ZANTA forward in that direction, too.

Speaker Change: The Paducah date out there it allows us to focus the team in terms of both the review and then any kind of Adil.

Mike: Additional launch readiness that we have to do so I think both Amy and Puget did a great job of framing that so we're thrilled to be where we're at right now with Cabo and <unk> and certainly very excited about moving as the.

Hans: Hans afford in that direction too.

Michael M. Morrissey: You know, in terms of, you know, future markets, when 311 reads out, if that's positive, we're very confident we can navigate the opportunities we have there, you know, obviously, a lot depends on data and labels and those kinds of things that we just don't have right now. So, you know, stay tuned, obviously, as things go forward, we'll be able to talk about that more, but we're kind of at the starting block right now with our ability to start navigating, you know, NETS, and we think, as everyone talked about today, this is a really, really important area for us to dive into. And, you know, we've been successful in Renal, and I think with the right level of focus and discipline, and hard work, we can hopefully make the same thing happen with NETs too.

Speaker Change: Terms of future markets. When you have 311 reads out if that's positive.

Mike: And we're very confident we can we can navigate the opportunities we have there.

Hans: Obviously, a lot depends on data and labels and those kinds of things that we just don't have right now. So so stay tuned obviously as things go forward, we'll be able to talk about that more but we're kind of at the at the starting block right now with with our ability to start navigating nets and we think is as everyone talks about today. This is a <unk>.

Michael Morrissey: And we think, as everyone talked about today, this is a really, really important area for us to dive into. And, you know, we've been successful in Reno, and I think with the right level of focus, discipline, and hard work, we can hopefully make the same thing happen with NETS.

Hans: Really really important area for us to dive into and we've been successful in renal and I think with the right level of focus and discipline and hard work. We can hopefully make the same thing happened with nets too.

Michael M. Morrissey: And, you know, we've been successful in Renal, and I think with the right level of focus and discipline, and hard work, we can hopefully make the same thing happen with NETs too.

Speaker Change: Thank you.

Unknown Executive: Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with Citizens JMP. Your line is open.

Speaker Change: Please standby for our next question.

Operator: Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with Citizens JNP. Your line is open.

Salim Sunderji: Our next question comes from the line of sale than Turkey, which citizens JMP. Your line is open.

Silvan Tuerkcan: Good afternoon, and congrats on the top line being here, and thanks for taking my question. My first question is more strategic, can you just speak on your, the M&A strategy and maybe the urgency versus the new $500 million dollars stock buyback that you just authorized? Just how do you think about the two? Does that mean the M&A strategy is maybe more long-term, or you don't have something to cross here as of this very moment? And then my second question is just about the discontinuation of XB002, if you could just remind me that that has no real cross whatsoever to your other ADCs, right? Because they are completely different toxins, constructs, and from a different collaboration. Thank you.

Salim Sunderji: Hey, good afternoon, and congrats on the on the top line beat here and thanks for taking my question.

Salim Sunderji: My first question is more strategic I mean can you just speak on Europe.

Speaker Change: The M&A strategy and maybe the urgency versus the new $500 million stock buyback that you just authorized just how do you think about it too.

Unknown Executive: How do you think about the two? Does that mean the M&A strategy is maybe more long-term, or you don't have anything that crosses your crosshairs as of this very moment? And then my second question is just about the discontinuation of Xb02. If you could just remind me that that has no real cross-talk whatsoever with your other ADCs, right? Because they are completely different toxins, constructs, and from a different collaboration.

Speaker Change: Does that mean, the M&A strategies, maybe more long term on it.

Speaker Change: You don't have something the crosshairs as this very moment.

Michael Morrissey: And then my second question is just about the discontinuation of XD-002, if you could just remind me that that has no real cross-reactivity whatsoever to your other ADCs, right? Because they are completely different toxins, constructs, and from a different collaboration.

Silvan Tuerkcan: And then my second question is just about the discontinuation of XB002, if you could just remind me that that has no real cross whatsoever to your other ADCs, right? Because they are completely different toxins, constructs, and from a different collaboration. Thank you.

Speaker Change: And then my second question is just about the discontinuation of X T O two.

If you could just remind me that has no read across whatsoever to your other adcs right because they are it could be different toxins constructed from a different collaboration. Thank you.

Michael Morrissey: Thank you.

Michael M. Morrissey: Yeah, thanks for the question, I think I'll take them both just to keep things kind of straightforward here. So, look, in terms of BD, you know, we're focused on finding assets that we have a high degree of conviction in, relative to, again, the way we view things through the CABO lens in terms of, you know, development, regulatory, commercial, what it means to be successful clinically and commercially, so, the conviction that we have in late-stage assets is the most important thing. We have, obviously, a very successful molecule in CABO, we're generating lots of free cash, we think we can do both in terms of having the dry powder to keep buying back shares, as we've announced today, and doing the appropriate level of BD if we have the conviction in the asset. So what's rate-limiting is that conviction it's not really how we're going to pay for it, OK? So it's a very important part of our story. We're not desperate, we're not going to go out and do a silly deal.

Unknown Executive: Thank you. Yeah, thanks for the question. I think I'll take them both, just to keep things kind of straightforward here.

Speaker Change: Yeah. Thanks.

Speaker Change: Thanks for the question.

Speaker Change: On the I'll take them, both just to keep things kind of straightforward here. So look in terms of BD.

Speaker Change: We're focused on finding.

Hans: Assets that we have a high degree of conviction in relative to again the way we view things through the Cabo lens in terms of development regulatory commercial what it means to be successful clinically and commercially so that the conviction that we have in our in.

Michael Morrissey: So, look, in terms of BD, you know, we're focused on finding assets that we have a high degree of conviction in relative to, again, the way we view things through the CABO lens in terms of, you know, development, regulatory, commercial, what it means to be successful clinically and commercially. So, the conviction that we have in late-stage assets is the most important. We have, obviously, a very successful molecule in Cab

Unknown Executive: So, look, in terms of BD, you know, we're focused on finding assets that we have a high degree of conviction in, relative to, again, the way we view things through the CABO lens in terms of, you know, development, regulatory, commercial, what it means to be successful, clinically and commercially. So, the conviction that we have in late-stage assets is the most important thing. You know, we obviously have a very successful molecule in CABO.

Michael M. Morrissey: We have, obviously, a very successful molecule in CABO, we're generating lots of free cash, we think we can do both in terms of having the dry powder to keep buying back shares, as we've announced today, and doing the appropriate level of BD if we have the conviction in the asset. So what's rate-limiting is that conviction it's not really how we're going to pay for it, OK? So it's a very important part of our story. We're not desperate, we're not going to go out and do a silly deal. We have to have that fundamental belief that whatever we do in terms of transactions will lead to value for patients and shareholders. That's the main driver. In terms of XB-002, yes, as you said, and Dana, I think, referred to this really well, 371 continues as well as XB-010, which just entered the clinic, and other assets in that class of molecules. So we're excited about our ADC approaches. We've got a lot of different irons in the fire, and, you know, data drives the process. So we've always said that, we've always behaved that way, and that will continue.

Hans: The late stage assets is the most important thing.

Speaker Change: We have obviously, a very successful molecule in Cabo, we're generating lots of free cash. We think we can we can do both in terms of having the dry powder to keep buying back shares as we've announced today and doing the appropriate level of BD. If we have the conviction in the asset so whats.

Michael Morrissey: We're generating lots of free cash. We think we can do both in terms of having the dry powder to keep buying back shares, as we've announced today, and doing the appropriate level of BD if we have the conviction in the asset. So what's rate-limiting is that conviction.

Unknown Executive: We're generating lots of free cash. We think we can do both, in terms of having the dry powder to keep buying back shares, as we've announced today, and doing the appropriate level of BD if we have the conviction in the asset. So, what's rate-limiting is that conviction. It's not really how we're going to pay for it, okay?

Unknown Executive: So, it's a very important part of our story. We're not desperate. We're not going to go out and do a silly deal.

Hans: Whats rate limiting is that conviction, it's not really how we're going to pay for it. Okay. So so it's very important part of our story, we're not desperate we're not going to go out and do a silly deal we have to have that that fundamental belief that wherever we do in terms of transactions will lead to value for patients and shareholders. That's the main driver.

Michael Morrissey: It's not really how we're going to pay for it, OK? So it's a very important part of our story. We're not desperate. We're not going to go out and do a silly deal.

Michael Morrissey: We have to have that fundamental belief that whatever we do in terms of transactions will lead to value for patients and shareholders. That's the main driver. In terms of XB-002, yes, as you said, and Dana, I think, referred to this really well, 371 continues as well as XB-010, which just entered the clinic, and other assets in that class of molecules. So we're excited about our ADC approaches. We've got a lot of different irons in the fire, and, you know, data drives the process. So we've always said that, we've always behaved that way, and that will continue.

Michael M. Morrissey: We have to have that fundamental belief that whatever we do in terms of transactions will lead to value for patients and shareholders, that's the main driver. In terms of XB002, yes, as you said, and Dana, I think, referred to this really well, 371 continues as well as XB-010, which just entered the clinic, and other assets in that class of molecules. So we're excited about our ADC approaches. We've got a lot of different irons in the fire, and, you know, data drives the process. So we've always said that, we've always behaved that way, and that will continue.

Michael M. Morrissey: We have to have that fundamental belief that whatever we do in terms of transactions will lead to value for patients and shareholders, that's the main driver.

Unknown Executive: We have to have that fundamental belief that whatever we do, in terms of transactions, will lead to value for patients and shareholders. That's the main driver. In terms of XB002, yes, as you said, and Dana, I think, referred to this really well, 371 continues, as well as XB010, which just entered the clinic, and other assets in that class of molecules. So, we're excited about our ADC approaches. We've got a lot of different irons in the fire, and, you know, data drives the process. So, that's, we've always been, we've always said that. We've always behaved that way, and that will continue going forward.

Michael M. Morrissey: That's the main driver. In terms of XB-002, yes, as you said, and Dana, I think, referred to this really well, 371 continues as well as XB-010, which just entered the clinic, and other assets in that class of molecules. So we're excited about our ADC approaches. We've got a lot of different irons in the fire, and, you know, data drives the process. So we've always said that, we've always behaved that way, and that will continue.

Speaker Change: In terms of <unk>, Yes, as you said and Dana I think refer to this really well.

Michael M. Morrissey: In terms of XB002, yes, as you said, and Dana, I think, referred to this really well, 371 continues as well as XB010, which just entered the clinic, and other assets in that class of molecules. So we're excited about our ADC approaches, we've got a lot of different irons in the fire, and, you know, data drives the process, so we've always said that, we've always behaved that way, and that will continue going forward.

Speaker Change: Seven one continues as well as <unk>, which just entered into the clinic and other assets in there and that.

Hans: That class of molecules. So we're excited about our ADC approaches we've got a lot of different irons in the fire and data drives the process. So that's we've always been we've always said that we've always behave that way and that will continue going forward.

Speaker Change: Thank you.

Unknown Executive: Please stand by for our next question. Our next question comes from the line of David Lebowitz with Citi. Your line is open. Check to see if you are on mute, David. David Lebowitz, your line is open.

Operator: Thank you, please stand by for our next question, which comes from the line of David Lebowitz with Citi. Your line is open. Check to see if you are on mute, David. David Lebowitz, your line is open. Sorry about that.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of.

Operator: David Lebowitz with Citi. Your line is open. Check to see if you are on mute, David. David Lebowitz, your line is open. Sorry about that.

Hans: David Lebowitz with Citi. Your line is open.

Speaker Change: Check to see if you're on mute David.

David Lebowitz your line is open sorry.

David Lebowitz: Sorry about that.

David Lebowitz: Thank you for taking my question could you could you speak to launch preparedness for treating neuroendocrine tumors.

Speaker Change: Given that it's not overlapping as much with renal.

Speaker Change: How much of an extra electric does this represent for the team.

David Lebowitz: Sorry about that, thank you for taking my question. Could you speak to the launch preparedness for treating neuroendocrine tumors, given that it's not overlapping as much with renal, how much of [inaudible] does this represents for the team?

Unknown Executive: Yeah, David, thanks for that question. We covered that pretty extensively on the call. PJ, I want to give you the one minute summary real fast.

Michael M. Morrissey: Yeah, David, thanks for that question, we covered that pretty extensively on the call. PJ, you want to give you the one minute summary real fast?

Speaker Change: Yes, David Thanks for that question, we covered that pretty extensively on the call P. J I wanted to give the one minute summary, real fast yeah. Thanks, David.

Unknown Executive: Yeah, thanks, David. You know, I think we've got a good handle on this. You know, it's not much of a significant lift.

P.J. Haley: Yeah, thanks, David. You know, I think we've got a good handle on this, you know, it's not much of a significant lift, it's more or less incremental, as we've said, from a resourcing perspective. We see a strong overlap in NET treating physicians with our current customer universe that we call on, because, you know, we're calling on GI specialists already with HCC. And then we're, you know; we have a very strong presence in community oncology. So, you know, I think there are a couple things there, one is that, you know, it's not a significant incremental resourcing request, and the others were well positioned to take advantage of it. Okay, thanks.

Speaker Change: We've got a good handle on this.

Speaker Change: It's not much of a significant lift it's more or less incremental as we said from a resourcing perspective.

Unknown Executive: It's more or less incremental, as we said, from a resourcing perspective. We see a strong overlap in net treating physicians with our current customer universe that we call on because, you know, we're calling on GI specialists already with HCC. And then we're, you know; we have a very strong presence in community oncology. So, you know, I think there are a couple things there. One is that, you know, it's not a significant incremental resourcing request, and the others were well positioned to take advantage of it. Okay, thanks.

PJ Haley: It's more or less incremental, as we've said, from a resourcing perspective. We see a strong overlap in net treating physicians with our current customer universe that we call on because, you know, we're calling on GI specialists already with HCC. And then we're, you know; we have a very strong presence in community oncology. So, you know, I think there are a couple things there. One is that, you know, it's not a significant incremental resourcing request, and the others were well positioned to take advantage of it. Okay, thanks.

Speaker Change: We see a strong overlap in <unk>.

Speaker Change: Net treating physicians.

Speaker Change: With our current customer universe that we call on because we're calling on Gi.

Speaker Change: <unk> specialists already with HCC and then.

Speaker Change: We have a very strong presence in community oncology, So I think theres a couple of things there.

Speaker Change: One is that it is.

Speaker Change: Not a significant incremental.

Speaker Change: Resourcing requests and the others were well positioned to take advantage of it.

Peter: Thanks Peter.

Andy Hsieh: Okay, thanks P.J.

Peter: Thank you.

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

Operator: Thank you, please stand by for our next question. Our next question comes from the line of Jeffrey Hung with Morgan Stanley. Your line is open.

Speaker Change: Please standby for our next question.

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

Michael Rehaut: Hi, This is Michael Rehaut on for Jeff hung. Thank you for taking my question I'm, sorry cabinet and their end consumers you noted that five year survival rates turned down when going from Gi to long to pancreatic.

Speaker Change: Given that but also given the cabinet was stopped early due to the compelling efficacy how long into the treatment course do you want to go into with stellar 311 to see sort of the competitive landscape. Thanks. So much.

Unknown Executive: Hi Michael. Yeah, thanks for the question. I think, you know, we're still refining the study. We hope that ZANDA, if the study ultimately is positive, would effectively be the preferred first oral treatment in patients who have advanced or metastatic neuroendocrine tumors. So, in that sense, it's looking pretty early on. In the treatment setting, we know that median progression-free survival in this setting can be up to 22 months, as observed with Lutathera. So, you know, we're hoping that we'll beat Everolimus and that we can establish ZANDA as the preferred treatment.

Jeff Hung: Hi this is Michael [inaudible] on for Jeff Hung, thank you for taking our question. For CABINET and [inaudible] you noted that five years survival rates trend down when going from GI, to lung, to pancreatic, given that, but also given the CABINET was stopped earlier due to compelling efficacy. How long into the treatment course do you want to go into qith STELLAR-311 to see sort of the competitive landscape? thank you so much. thanks for the question. I think we're still refining the study. We hope that ZANDA, if the study ultimately is positive, would effectively be the preferred first oral treatment in patients who have advanced or metastatic neuroendocrine tumors. So, in that sense, it's looking pretty early on. In the treatment setting, we know that median progression-free survival in this setting can be up to 22 months, as observed with Lutathera. So, you know, we're hoping that we'll beat Everolimus and that we can establish ZANDA as the preferred treatment.

Jeff Hung: Hi this is Michael [inaudible] on for Jeff Hung, thank you for taking our question. For CABINET and [inaudible] you noted that five years survival rates trend down when going from GI, to lung, to pancreatic, given that, but also given the CABINET was stopped earlier due to compelling efficacy. How long into the treatment course do you want to go into qith STELLAR-311 to see sort of the competitive landscape? thank you so much. Hi Michael, yeah thanks for the question. I think we're still refining the study, we hope that ZANZA, if the study ultimately is positive, would effectively be the preferred first oral treatment in patients who have advanced or metastatic neuroendocrine tumors, ao, in that sense, it's looking pretty early on. In the treatment setting, we know that median progression-free survival in this setting can be up to 22 months, as observed with LUTATHERA. So, you know, we're hoping that we'll beat EVEROLIMUS and that we can establish ZANDA as the preferred.

Speaker Change: Yeah, Michael Thanks for the question I think we're still refining the the study we hope that Zander. If the study ultimately is positive would be what it is.

Speaker Change: Actively be the preferred first oral treatment in patients who have advanced or metastatic neuroendocrine tumor. So in that sense. It's looking pretty early on in the treatment setting. We know that median progression free survival. In this setting can be up to 22 months since observed with leader Tara.

Amy Peterson: Hi Michael, yeah thanks for the question. I think we're still refining the study, we hope that ZANZA, if the study ultimately is positive, would effectively be the preferred first oral treatment in patients who have advanced or metastatic neuroendocrine tumors, ao, in that sense, it's looking pretty early on. In the treatment setting, we know that median progression-free survival in this setting can be up to 22 months, as observed with LUTATHERA. So, you know, we're hoping that we'll beat EVEROLIMUS and that we can establish ZANDA as the preferred.

Jeff Hung: Hi Michael, yeah thanks for the question. I think we're still refining the study, we hope that ZANZA, if the study ultimately is positive, would effectively be the preferred first oral treatment in patients who have advanced or metastatic neuroendocrine tumors, ao, in that sense, it's looking pretty early on. In the treatment setting, we know that median progression-free survival in this setting can be up to 22 months, as observed with LUTATHERA. So, you know, we're hoping that we'll beat EVEROLIMUS and that we can establish ZANDA as the preferred.

Peter: So.

Peter: I I I hope.

Peter: Hoping that we'll beat our realignment and that we can establish that the preferred.

Speaker Change: Thank you.

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

Speaker Change: Please standby for our next question.

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

Unknown Executive: Okay, guys, thank you for taking my questions. I think you largely answered them.

Jason Gerberry: Okay, guys, thank you for taking my questions, I think you largely answered it. But as I was thinking about NET and the opportunity with CABO and how it differs, ultimately, with ZANZA. It sounds like with CABO, you're kind of in that third-fourth line of treatment absent some of those segments you highlighted, like NET lung, but it's really with the second, third line study that you have with ZANZA, where you can really open up the market opportunity, and see a dynamic like in RCC, where you can get some patient stacking. And I know you mentioned 22 months PFS with Luda, what would be your expectation for Alimus in this setting, just to try to get some sense of how long these patients are staying on therapy in sort of the second, third line setting.

Speaker Change: Oh, Hey, guys. Thank you for taking my questions I think you're largely answered it but if I was thinking about net and and the opportunity with Cabo and how it differs ultimately.

Peter: Zander it sounds like with Cabo you're kind of in that third fourth line.

Speaker Change: Of treatment absent some of those segments, you highlighted like that long, but its really with the second and third line study that you have with Vanguard, where you can really open up the market opportunity and see a dynamic like in RCC, where you can get some patient stacking and I know you mentioned 22 months PFS with Luna what would be your.

Michael Morrissey: And I know you mentioned 22 months PFS with Luda, what would be your expectation for Alimus in this setting, just to try to get some sense of how long these patients are staying on therapy in sort of the second, third line setting.

Jason Gerberry: And I know you mentioned 22 months PFS with LUTA, what would be your expectation for what EVEROLIMUS would do in this setting? Just to to get some sense of how long these patients are staying on therapy in sort of the second, third line setting things?

Speaker Change: Patient for like whatever alignments will do in this setting just to try to get some sense of of how long. These patients are staying on therapy and toward the second and third line setting. Thanks.

Mike: But as I was thinking about NET and the opportunity with Cabo and how it differs, ultimately, with Zanza, it sounds like with Cabo, you're kind of in that third, fourth line of treatment absent some of those segments you highlighted, like NET long, but it's really with the second, third line study that you have with Zanza where you can really open up the market opportunity and see a dynamic like in RCC where you can And I know you mentioned 22 months of PFS with Luda.

Michael M. Morrissey: Yeah, Jason, it's Mike, thanks for the question. You know, I guess I would challenge your assumptions about where you think CABO will land, it's clearly, the patient population that was studied in CABINET, is a broad population. I won't go into all the details again now just for the sake of time, but let's see the kind of label we get, and let's use that to benchmark kind of where CABO goes relative to our initial foray into the net population, so stay tuned on that. I guess, in terms of Zanza, I think the challenge there and the opportunity there is to go head-to-head against an active control. And I think that's the, in our view, that's the main focus of what we're hoping to do with Steltman 311, in analogy to what we did with Meteor, back with CABA and RCC against Everolimus as well, or even CABA's son with Samitnib. So think about it from that point of view. Obviously, if you fast forward, that leaves out the positive. We just kind of go to the first small molecule oral therapy.

Speaker Change: Yeah, Jason it's Mike. Thanks for the question I guess I would I would challenge your assumptions about where you think Cabo will land.

Speaker Change: It's.

Mike: What would be your expectation for Alimus in this setting just to try to get some sense of how long these patients are staying on therapy in sort of the second, third line setting thing?

Speaker Change: Clearly the patient population that we studied in Canada is up because a broad population.

Mike: Yeah, Jason, it's Mike. Thanks for the question. You know, I guess I would challenge your assumptions about where you think Cabo will land. Clearly, the patient population that was studied in cabinet is a broad population.

Speaker Change: We'll go into all the details again now just for sake of time, but you know, let's let's see the kind of label, we get and lets use that to benchmark kind of where Cabo goes relative to.

Mike: I won't go into all the details again now just for the sake of time, but, you know, let's see the kind of label we get, and let's use that to benchmark kind of where CABA goes relative to, you know, the initial, our initial foray into the net population. So stay tuned on that. I guess in terms of Zanza, I think the challenge there and the opportunity there is to go head to head against an active control.

Speaker Change: The initial our initial foray into the net population so stay tuned on that I guess in terms of the <unk> I think the challenge there and the opportunity. There is to go head to head against an active control and I think that's the in our view that's the main focus of what we're.

Michael Morrissey: So stay tuned on that. I guess, in terms of Zanza, I think the challenge there and the opportunity there is to go head-to-head against an active control. And I think that's the, in our view, that's the main focus of what we're hoping to do with Steltman 311, in analogy to what we did with Meteor, back with CABA and RCC against Everolimus as well, or even CABA's son with Samitnib. So think about it from that point of view. Obviously, if you fast forward, that leaves out the positive. We just kind of go to the first small molecule oral therapy.

Michael M. Morrissey: I guess, in terms of ZANZA, I think the challenge there, and the opportunity there is to go head-to-head against an active control, and I think that's the, in our view, that's the main focus of what we're hoping to do with STELLAR-311, in analogy is what we did with METEOR, back with CABO and RCC against EVEROLIMUS as well, or even CABO's son with SUNITINIB. So think about it from that point of view, obviously, if you fast forward, that leaves out the positive. We just kind of go to the first small molecule oral therapy, it puts us in a very different position than what CABO could have based upon the CABINET label.

Michael M. Morrissey: guess, in terms of Zanza, I think the challenge there and the opportunity there is to go head-to-head against an active control. And I think that's the, in our view, that's the main focus of what we're hoping to do with Steltman 311, in analogy to what we did with Meteor, back with CABA and RCC against Everolimus as well, or even CABA's son with Samitnib. So think about it from that point of view. Obviously, if you fast forward, that leaves out the positive. We just kind of go to the first small molecule oral therapy.

Mike: And I think that's the, in our view, that's the main focus of what we're hoping to do with Stelma 311, in analogy to what we did with Meteor, back with CABA and RCC against Everolimus as well, or even CABA's son with Sinitinib. So think about it from that point of view. Obviously, if you fast forward, that reads out positive.

Peter: Looking to do with stellar 311 and are now in an analogy to what we do with meteor back with Cabo in RCC against against Everolimus, as well or even combo sun with Sunitinib. So think about it from that point of view, obviously, if you're if you fast forward that reads out positive with just kind of go.

Mike: We've just beat the kind of go-to, you know, first small molecule oral therapy. It puts us in a very different position than what CABA could have based upon the cabinet label. So lots of moving pieces. Don't want to speculate. You could see how this might evolve.

Peter: Two.

Peter: First.

Peter: Small molecule oral therapy, it puts us in a very different position than what Cabo could have based upon the cabinet level. So lots of moving pieces don't want to speculate you can see how this might evolve let's get the cabinets.

Michael Morrissey: It puts us in a very different position than what CABA could have based upon the cabinet label. So, lots of moving pieces. I don't want to speculate. You can see how this might evolve. Let's get the cabinet CABA label first, and then we'll get Stellar 311 going with, again, high priority, really pleased with the progress that the development team has made over the last year and be able to kind of streamline processes, a sense of urgency and focus.

It puts us in a very different position than what CABA could have based upon the cabinet label.

Michael M. Morrissey: So, lots of moving pieces, I don't want to speculate, you can see how this might evolve, let's get the CABINET, CABO label first, and then we'll get Stellar-311 going with, again, high priority, really pleased with the progress that the development team has made over the last year, and be able to kind of streamline processes, a sense of urgency and focus, kudos to Amy and her team for kind of getting us back to where we were in the past. And we'll address all these issues with more data and time as we go forward. Thank you.

Mike: So let's get the cabinet, you know, CABA label first, and then, you know, we'll get Stelma 311 going with, again, high priority, really pleased with the progress that the development team has made over the last year and be able to kind of streamline processes, a sense of urgency and focus. Kudos to Amy and her team for kind of getting us back to where we've been in the past. And we'll, we'll, you know, address all these issues with more data and time as we go forward. Thank you. Thank you.

Peter: Kabul label first and then.

Peter: We will get we will get stellar 311 going with again high priority really pleased with the progress that the development team has made over the last year and be able to kind of streamline processes, a sense of urgency and focus kudos to Amy and her team for kind of getting us back to where we've been in the past and will.

Michael Morrissey: Kudos to Amy and her team for kind of getting us back to where we were in the past. And we'll address all these issues with more data and time as we go forward. Thank you.

Peter: Address all of these issues with more data in time as we go forward. Thank you.

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

Operator: Thank you, please stand by for our next question. Our next question comes from the line of Akash Tewari with Jefferies. Your line is open. Hey this is Amy on for Akash, thank you so much for taking our question. So in terms of the NET opportunity, do yo think this can get to 1 billion over time? And how are you thinking about the size of the NET market relative to RCC long term?

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

Peter: Thank you.

Peter: Please standby for our next question.

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

Akash Tewari: Hey this is Amy on for Akash, thank you so much for taking our question. So in terms of the NET opportunity, do yo think this can get to 1 billion over time? And how are you thinking about the size of the NET market relative to RCC long term?

Amy: Hey, this is Amy I'm, sorry costs. Thanks, so much for taking a question. So in terms of the net opportunity do you think this can get to 1 billion over time and how are you thinking about the size of the next market relative to RCC long term.

Unknown Executive: Yeah, Amy, thanks for the question. I mean, that's the key question. Obviously, we're not going to answer that today. We need to see the label and how that looks. I think it's safe to say, and we're all talking about that in different contexts today, that we think that is underserved. We think the opportunity, in terms of the incident patient population, the prevalent patient population, the long time these patients kind of factor or kind of go from one therapy to another, this could be a real opportunity to help those patients longitudinally with combo, with Zanza, and potential other combinations as we go forward.

Akash Tewari: Yeah, Amy, thanks for the question, I mean, that's the key question. Obviously, we're not going to answer that today, we need to see the label and how that looks. I think it's safe to say, and we're all talking about that in different contexts today, that we think that is underserved. We think the opportunity, in terms of the incident patient population, the prevalent patient population, the long time these patients kind of factor or kind of go from one therapy to another. This could be a real opportunity to help those patients longitudinally with CABO, with ZANZA, and potential other combinations as we go forward. So, we're excited about this, we're not going to give numbers today, certainly, as things go forward, we see the label, we have a better sense of being able to frame the initial market opportunity, and maybe more importantly, the bigger opportunity as we go forward over the next few years could be really interesting. So stay tuned.

Michael M. Morrissey: Yeah, Amy, thanks for the question, I mean, that's the key question. Obviously, we're not going to answer that today, we need to see the label and how that looks. I think it's safe to say, and we're all talking about that in different contexts today, that we think that is underserved. We think the opportunity, in terms of the incident patient population, the prevalent patient population, the long time these patients kind of factor or kind of go from one therapy to another. This could be a real opportunity to help those patients longitudinally with CABO, with ZANZA, and potential other combinations as we go forward.

Speaker Change: Yeah, Jamie Thanks for the question I mean, that's the that's the key question, obviously, we're not going to answer that today.

Speaker Change: We need to see the label and how that looks.

Speaker Change: I think it's safe to say, we're all talking about that in different different context is today that we think net is underserved we think the opportunity in terms of the incident patient population. The prevalent patient population long time, these patients kind of factor or kind of go from one therapy to another this could.

Speaker Change: Would be a real opportunity to help those patients longitudinally with Cabo was anza potential other combinations as we go forward. So so we're excited about this.

So, so we're excited about this. We're not going to give numbers today. Certainly, as things go forward, we see the label. We have a better sense of being able to frame the initial market opportunity and maybe more importantly, the bigger opportunity as we go forward over the next few years could be really interesting. So stay tuned. Great question.

Michael Morrissey: So, we're excited about this. We're not going to give numbers today. Certainly, as things go forward, we see the label. We have a better sense of being able to frame the initial market opportunity, and maybe more importantly, the bigger opportunity as we go forward over the next few years could be really interesting. So stay tuned.

Akash Tewari: So, we're excited about this, we're not going to give numbers today, certainly, as things go forward, we see the label, we have a better sense of being able to frame the initial market opportunity, and maybe more importantly, the bigger opportunity as we go forward over the next few years could be really interesting. So stay tuned, great question, come back in a few months or quarters once we get approval, and we'll be happy to talk about that. Okay. Thank you.

Michael M. Morrissey: So, we're excited about this, we're not going to give numbers today, certainly, as things go forward, we see the label, we have a better sense of being able to frame the initial market opportunity, and maybe more importantly, the bigger opportunity as we go forward over the next few years could be really interesting. So stay tuned, great question, come back in a few months or quarters once we get approval, and we'll be happy to talk about that. Okay.

Speaker Change: Not going to give numbers today, but certainly as things go forward, we see the label, we have a better sense of being able to frame. The the initial market opportunity and maybe more importantly, the bigger opportunity as we go forward over the next few years.

Speaker Change: It could be really interesting so stay tuned great question come back in a few.

Operator: Come back in a few months or quarters once we get approval, and we'll be happy to talk about that. Okay. Thank you. Our next question comes from the line of Alex Bullock with Barclays. Your line is open. Hey, good afternoon.

Come back in a few months or quarters once we get approval, and we'll be happy to talk about that. Okay. Thank you.

Speaker Change: A few months or quarters, once we get approval and we'll be happy to talk about that.

Operator: Thank you, please stand by for our next question. Our next question comes from the line of Alex Bullocks with Barclays. Your line is open. Hey good afternoon, this is Alex on for Peter Lawson with Barclays, thanks for taking our question. I just had a quick one on the USP1 program, I was wondering if you had any comments on development from competing programs, we've had some discontinuations in this space, and also some data at ASCO. I'm curious if any of these developments impact in any way your clinical development strategy with this asset, Thank you.

Operator: Thank you, please stand by for our next question. Our next question comes from the line of Alex Bullocks with Barclays. Your line is open.

Our next question comes from the line of Alex Bullock with Barclays. Your line is open. Hey, good afternoon.

Speaker Change: Thank you.

Operator: Please stand by for our next question. Our next question comes from the line of Alex Bullocks with Barclays. Your line is open.

Peter: Please standby for our next question.

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

Peter Lawson: Hey good afternoon, this is Alex on for Peter Lawson with Barclays, thanks for taking our question. I just had a quick one on the USP1 program, I was wondering if you had any comments on development from competing programs, we've had some discontinuations in this space, and also some data at ASCO. I'm curious if any of these developments impact in any way your clinical development strategy with this asset, Thank you.

Alex: Hey, Good afternoon. This is Alex on for Peter Lawson with Barclays. Thanks for taking our question I just had a quick one on the U S. P. One program I was wondering if you had any comments on.

Speaker Change: Development from competing programs, we've had some discontinuation in this space and also.

Some data ESCO.

Dan: I'm curious if any of these developments impact in any way your clinical development strategy with this asset. Thank you yeah. Yeah. Thanks for the question Dan I want to cover that one sure yes. Thanks for the question Alex.

Dana Aftab: Thank you. Yeah. Yeah. Thanks for the question, Dan. I want to cover that one. Sure. Yeah. Thanks for the question, Alec.

Thank you.

Yeah, yeah, thanks for the question, Dana want to cover that one? Sure. Yeah. Thanks for the question, Alec.

Michael M. Morrissey: Yeah, yeah, thanks for the question, Dana want to cover that one?

Dana T. Aftab: Sure, yeah, thanks for the question, Alex. Yeah, we obviously were very attentive to the data presented on the KSQ Roche molecule at ASCO, as well as to the discontinuation of the Tango molecule. So, you know, first of all, we remain extremely enthusiastic about XL309, it has a unique scaffold, it is a different compound than either the KSQ or the Tango molecule. And as we noted previously at the R&D Day event last December, we presented a lot of data showing how our molecule differentiates from the KSQ compound. What was shown at ASCO with that compound was primarily a PK limitation, and that is exactly what we predicted from our preclinical data, given their poor solubility and some other issues with their compounds. So we believe that our compound is differentiated from that in the preclinical data, and we're very eager to share the first clinical data when they're available to hopefully show that we aren't, in fact, differentiating from that compound. But we remain very enthusiastic about our compound to differentiate it from anything that's been out there so far.

Dana Aftab: Sure. Yeah, thanks for the question, Alex. Yeah, we obviously were very attentive to the data presented on the KSQ Roche molecule at ASCO as well as to the discontinuation of the Tango molecule. But, you know, first of all, we remain extremely enthusiastic about XL309. It has a unique scaffold, so it is a different compound than either the KSQ or the Tango molecule. And as we noted previously at the R&D Day event last December, we presented a lot of data showing how our molecule differentiates from the KSQ compound.

Speaker Change: Yes, we obviously.

Speaker Change: We're very attentive to the data.

Presented on the Ks Q Roche.

Speaker Change: Roche molecule at a at <unk> as well as to the discontinuation of the Tango molecule. So first of all we remain extremely enthusiastic about <unk> 309.

It has a unique scaffold it has a different compound than either the Ks Q or the tango molecule.

Speaker Change: And as we noted previously at the R&D day event last December we presented a lot of data showing how our molecule differentiates from the <unk> compound what was shown at <unk> was primarily with that compound is primarily a PK limitation.

Dana T. Aftab: What was shown at ASCO with that compound was primarily a PK limitation, and that is exactly what we predicted from our preclinical data, given their poor solubility and some other issues with their compounds. So we believe that our compound is differentiated from that in the preclinical data, and we're very eager to share the first clinical data when they're available to hopefully show that we aren't, in fact, differentiating from that compound. But we remain very enthusiastic about our compound to differentiate it from anything that's been out there so far.

Dana Aftab: What was shown at ASCO with that compound was primarily a PK limitation, and that is exactly what we predicted from our preclinical data, given their poor solubility and some other issues with their compounds. So we believe that our compound is differentiated from that in the preclinical data, and we're very eager to share the first clinical data when they're available to hopefully show that we aren't, in fact, differentiating from that compound But we remain very enthusiastic about our compound to differentiate it from anything that's been out there so far.

Speaker Change: And that is exactly what we predicted from our preclinical data given their poor solubility and some other issues with their compound. So we believe that our compound is differentiated from that in the preclinical.

Speaker Change: Data and we're very eager to share the first clinical data when they're available.

Peter: To hopefully show that we arent impact differentiating from that compound, but we remain very enthusiastic about our compound to differentiate from anything thats been out there so far.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Operator: Please stand by for our next question. Our next question comes from the line of Sudan Loganathan with Stephens, your line is open. Hi everyone, thank you in advance for taking my question and congrats on the strong CABO quarter and all the pipeline progress. In reference to COSMIC-313, you know, what that program kind of consists the last opportunity to really further tap into the first line RCC [inaudible] and [inaudible] 50 to 60% market penetration by taking share away with another strategy? And then, what would be a marketing strategy here to kind of show growth in the near term for CABOMETYX and first time RCC?

Operator: Please stand by for our next question. Our next question comes from the line of Sudan Loganathan with Stephens, your line is open.

Our next question comes from the line of student Logan Nathan with Stephens. Your line is open.

Logan Nathan: Hi, everyone. Thank you in advance for taking my question and congrats on the strong <unk> quarter and all the pipeline progress in regards to cosmic 313 with that program kind of considered the last opportunity to really further tap into the first line RCC population and then is there a path to exceeding 50% to 60% market penetration by taking share away from them.

Sudan Loganathan: Hi everyone, thank you in advance for taking my question and congrats on the strong CABO quarter and all the pipeline progress. In reference to COSMIC-313, you know, would that program kind of consists the last opportunity to really further tap into the first line RCC population?? And then is there a path exceeding 50 to 60% market penetration by taking share away with another strategy? And then, what would be a marketing strategy here to kind of show growth in the near term for CABOMETYX in first time RCC?

Speaker Change: With another strategy and then what would be a marketing strategy to kind of show growth in the near term for a couple of medicine.

Speaker Change: Your line RCC.

PJ Haley: Yeah, PJ, why not take that one? Yeah, thanks for the question.

Mich: Yeah, PJ, why not take that one?

P.J. Haley: Yeah, thanks for the question. You know, I would say, you know, 313, we certainly did significant market research on it, but you know, we just didn't see a risk-benefit profile going forward that was really going to raise the bar relative to the current combinations. You know, in particular, CABO+NIVO, as I mentioned, the leading first line IO+TKI combination for seven quarters, and our market share has continued to grow. And, in fact, as I mentioned in my prepared remarks, reached the highest point thus far in this quarter. So we're pleased about that, our data resonates very well with customers, and our team is executing at a high level, so, you know, we're optimistic that we could potentially drive further market share growth there with CABO+NIVO.

Speaker Change: Yeah P J I want to take that one yeah. Thanks for the question.

PJ Haley: You know, in particular, Cabo Nevo, as I mentioned, has been the leading first line IOTKI combination for seven quarters, and our market share has continued to grow. And, in fact, as I mentioned in my prepared remarks, reached the highest point thus far this quarter. So we're pleased about that. Our data resonates very well with customers, and our team is executing at a high level. So, you know, we're optimistic that we could potentially drive further market share growth there with Cabo Nevo.

PJ Haley: Yeah, thanks for the question. You know, I would say, you know, 3013, we certainly did significant market research on it. But we just didn't see a risk benefit profile going forward that was really going to raise the bar relative to the current combinations.

I would say.

Speaker Change: 301, three which certainly did significant market research on it.

Speaker Change: We just didn't see a risk benefit profile going forward that was really going to raise the bar.

Speaker Change: Relative to the current combinations.

Particular, Cabo NEVA NEVA as I mentioned.

A leading <unk>.

Speaker Change: First one Iot <unk> combination now for seven quarters and our market share.

Speaker Change: Has continued to grow and in fact as I mentioned in my prepared remarks reached the highest point.

Thus far in this quarter. So we're pleased about that our data resonates.

Speaker Change: Well with customers and our team is executing at a high level. So.

We're optimistic that we could potentially drive further market share growth there with colonial.

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.

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, I appreciate the opportunity, there have been a lot of detailed questions about the pipeline, if I could just throw in two bigger picture questions. Broadly speaking, the pharmaceutical industry is going to be faced with the Inflation Reduction Act (IRA-related adaptations to commercial models and Medicare). Everyone is trying to understand the impact on 2025 from the Medicare Part D redesign, and obviously, I believe you guys have the small company exemption. Can you just give us a sense for how you see Exelixis's exposure and impact, including in 2025? And then secondly, Michael, the board has included several new faces over the last 18 months, which is healthy and good to see, just curious to know in what way those new voices may have been shaping some of the strategies going forward? It certainly seems as if execution has been very consistent, but if you can provide us with any hints about this broadened board and if there are actually ways that that is affecting your thinking strategically? Thank you.

Speaker Change: Great. Thank you very much.

Speaker Change: I appreciate the opportunity there's been a lot of detailed questions about the pipeline if I could just throw in two bigger picture questions.

Broadly speaking.

Speaker Change: The pharmaceutical industry is going to be faced with D.

Speaker Change: Inflation reduction Act IRA related I got patients to commercial models and Medicare everyone is trying to understand the impact on 2025 from Medicare part D redesign and obviously I believe you guys had a small company exemption can you just give us a sense for how you see <unk>.

Michael Morrissey: Can you just give us a sense for how you see Exelixis's exposure and impact, including in 2025? And then, Michael, the board has included several new faces over the last 18 months, which is healthy and good to see. Just curious to know in what way those new voices may have been shaping some of the strategies going forward. It certainly seems as if execution has been very consistent, but if you can provide us with any hints about this broadened board and the ways that that is affecting your thinking strategically. Thank you.

Chris Shibutani: And then secondly, Michael, the board has included several new faces over the last 18 months, which is healthy and good to see, just curious to know in what way those new voices may have been shaping some of the strategies going forward? It certainly seems as if execution has been very consistent, but if you can provide us with any hints about this broadened board and if there are actually ways that that is affecting your thinking strategically? Thank you.

Exposure and impact, including in 2025, and then secondly, Michael The Board has included several new faces over the last 18 months, which is healthy and good to see just curious to know in what way those new voices may have been shaping some of the strategies going forward certainly seems.

This execution has been very consistent but if you can provide us with any hints about this brought on board and Directionally wafer that is influencing your thinking strategically thank you.

Michael M. Morrissey: Chris, thanks for the questions, as you as you mentioned, we, you know, we have been successful in securing in terms of the IRA, the small biotech exemption in terms of price negotiations. So we've got that covered, and we're also, as you mentioned, being able to secure the small manufacturer phase on the Medicare Part D. So 25 should be relatively minor relative to the way that phase in works for companies that qualify for the small manufacturer phase in. So it's going to have a relatively small, almost innocuous impact on our gross net, but we'll get into that next year, I don't want to give guidance now, but, you know, we're certainly in that ballpark where we've got that covered. And kudos to our government affairs team and our legal team to help us get over the, you know, navigate all those issues as we've gone forward. In terms of the board, look, we are ecstatic about the board.

Speaker Change: Chris Thanks for the questions as you as you mentioned.

We have been successful in securing in terms of the <unk>.

The small biotech exemption in terms of price negotiations. So we've got that covered and we're also as you mentioned.

Able to secure the small manufacturer facing on the Medicare part D. So 25 should be relatively minor relative to the wave that phase and works for companies that qualify for the small manufacturer fees and so.

Michael M. Morrissey: So it's going to have a relatively small, almost innocuous impact on our gross net, but we'll get into that next year, I don't want to give guidance now, but, you know, we're certainly in that ballpark where we've got that covered. And kudos to our government affairs team and our legal team to help us get over the, you know, navigate all those issues as we've gone forward. In terms of the board, look, we are ecstatic about the board, it's just been a great collaboration, as we've always had with the board relative to both strategic issues, operational issues, alignment issues around how we navigate. You know, with a pretty hard business in terms of, you know, doing the right science, being able to navigate a lot of really important issues on the commercial side, on the clinical side, making it through COVID, and kind of coming out the back end as strong as possible. So, a very, very strong board.

Michael Morrissey: It's going to have a relatively small, almost innocuous impact on our gross net, but we'll get into that next year. I don't want to give guidance now, but, you know, we're certainly in that ballpark where we've got that covered, and kudos to our government affairs team and our legal team to help us get over the, you know, navigate all those issues as we've gone forward in terms of Look, we are ecstatic about the board.

It's going to be a relatively small.

I will almost innocuous.

Speaker Change: Impact on our gross to net but we'll get into that next year I don't want to give guidance now, but we're certainly in that ballpark, where we've got that covered and kudos to our government affairs team and our legal team to help us get over that.

Michael M. Morrissey: And kudos to our government affairs team and our legal team to help us get over the, you know, navigate all those issues as we've gone forward. In terms of the board, look, we are ecstatic about the board.

Over the and navigate all those issues as we've gone forward.

Speaker Change: The board look we are static about the board.

Michael Morrissey: It's just been a great collaboration, as we've always had with the board relative to both strategic issues, operational issues, alignment issues around how we navigate this pretty hard business in terms of, you know, doing the right science, being able to navigate a lot of really important issues on the commercial side, on the clinical side, making it through COVID, and kind of coming out the back end as strong as possible. So, a very, very strong board.

Speaker Change: <unk> been a great collaboration as we've always had with the board relative to both strategic issues operational issues alignment issues around how we navigate.

Michael M. Morrissey: know, with a pretty hard business in terms of, you know, doing the right science, being able to navigate a lot of really important issues on the commercial side, on the clinical side, making it through COVID, and kind of coming out the back end as strong as possible. So, a very, very strong board, we've always had a strong board, and that continues to be the case. You're right, different faces, different voices, different perspectives are valuable to have, and I think everybody on the management team is really excited to be able to work with this board very, very closely.

What's a pretty hard business in terms of.

Doing the right science being able to navigate a lot of really important issues on the commercial side on the clinical side, you know, making it through COVID-19 and kind of coming out the backend as strong as possible. So very very strong board. We've always had a strong board that continues to be the case, you're right different faces.

Michael Morrissey: We've always had a strong board, and that continues to be the case. You're right. Different faces, different voices, different perspectives are valuable to have. And I think everybody on the management team is really excited to be able to work with this board very, very closely.

Different voices different perspectives are valuable to have and I think everybody on the management team is really excited to be able to work with this board very very closely.

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 today's host, Susan Hubbard. Ms. Hubbard?

Speaker Change: At this time there are no further questions and so I would now like to turn the call back over to today's host Susan Hubbard Ms Hubbard.

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

Susan Hubbard: Yeah. Thank you Anna and thank you all for joining us today and we certainly welcome your follow up calls with any additional questions. You may have that when we were unable to address during today's call. Thank you.

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

Ladies and gentlemen that concludes today's conference call. Thank you for your participation you may now disconnect.

Okay.

Speaker Change: [music].

Yes.

[music].

Q2 2024 Exelixis Inc Earnings Call

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