Exelixis Q4 2025 Exelixis Inc Earnings Call | AllMind AI Earnings | AllMind AI
Q4 2025 Exelixis Inc Earnings Call
Speaker #1: The day . Ladies and gentlemen , and welcome to the EXELIXIS, INC. fourth quarter and fiscal year 2025 for natural results conference call .
Speaker #1: My name is Tawanda and I'll be your today operator for . As a reminder , this call is being recorded for replay purposes .
Speaker #1: I would now like to turn the call over to your host for today, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations.
Andrew Peters: Thank you, Tawanda, and thank you all for joining us for the Exelixis Q4 and fiscal year 2025 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, Dana Aftab, our Executive Vice President of Research and Development, and P.J. Haley, our Executive Vice President of Commercial, who will review our progress for the Q4 and fiscal year 2025 ended December 31, 2025. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company.
Andrew Peters: Thank you, Tawanda, and thank you all for joining us for the Exelixis Q4 and fiscal year 2025 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, Dana Aftab, our Executive Vice President of Research and Development, and P.J. Haley, our Executive Vice President of Commercial, who will review our progress for the Q4 and fiscal year 2025 ended December 31, 2025. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company.
Speaker #1: Please proceed .
Speaker #2: Thank you , Tawanda , and thank you all for joining us for the fourth quarter and fiscal year 2025 financial results conference call .
Speaker #2: Joining me on today's call are Mike Morrissey , our . president and CEO Center , our chief financial officer , Dana Aftab . Our executive Vice president of research and development .
Speaker #2: And P.J. Haley, our Executive Vice President of Commercial, who will review our progress for the fourth quarter and fiscal year 2025, ended December 31, 2025.
Speaker #2: During the call today , we will refer to financial measures not calculated according to generally accepted accounting principles . Please refer to today's press release , which is posted on our website for an explanation of our reasons for using such non-GAAP measures , as well as tables deriving these measures from our GAAP results .
Speaker #2: During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company.
Andrew Peters: This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters, potential growth opportunities, and government drug pricing policies and initiatives. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which, under the heading "Risk Factors," identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation, risk, and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of costs associated with discovery, product development, business development, and commercialization activities. With that, I'll turn the call over to Mike.
Andrew Peters: This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters, potential growth opportunities, and government drug pricing policies and initiatives. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which, under the heading "Risk Factors," identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation, risk, and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of costs associated with discovery, product development, business development, and commercialization activities. With that, I'll turn the call over to Mike.
Speaker #2: This includes statements about possible developments regarding discovery , product development , regulatory , commercial , financial and strategic matters . Potential growth , and pricing opportunities government policies and Actual events or initiatives .
Speaker #2: results could , of course , differ materially . We refer you to the documents we file from time to with time the Securities and Exchange Commission , which , under the heading Risk Factors , identify important factors that could cause actual results to differ materially from those expressed by the company .
Speaker #2: Verbally and in writing today , including , without limitation , risk and uncertainties related to product , commercial success , market competition , regulatory review and approval processes .
Speaker #2: 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 .
Michael M. Morrissey: All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. 2025 was a transformational year for Exelixis, with strong growth across all components of our business. We expect to build on this momentum in 2026 and have already made significant progress during a very busy January. Critically, and we'll emphasize this here and throughout the call, Exelixis has a singular focus to build a multi-franchise business in solid tumor oncology based on the foundation of cabozantinib, the potential of zanzalintinib, and the depth of our early-stage pipeline. As outlined at our December R&D Day, our strategy to build a pipeline of franchises in solid tumor oncology covers three critical dimensions: products, tumor indications, and modalities, and is based on current Exelixis leadership in GU oncology and our aspirational goal to expand our leadership into GI indications with equal intensity and potential upside.
Michael M. Morrissey: All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. 2025 was a transformational year for Exelixis, with strong growth across all components of our business. We expect to build on this momentum in 2026 and have already made significant progress during a very busy January. Critically, and we'll emphasize this here and throughout the call, Exelixis has a singular focus to build a multi-franchise business in solid tumor oncology based on the foundation of cabozantinib, the potential of zanzalintinib, and the depth of our early-stage pipeline. As outlined at our December R&D Day, our strategy to build a pipeline of franchises in solid tumor oncology covers three critical dimensions: products, tumor indications, and modalities, and is based on current Exelixis leadership in GU oncology and our aspirational goal to expand our leadership into GI indications with equal intensity and potential upside.
Speaker #2: With that , I'll turn the call over to Mike .
Speaker #3: All right . Thank you , Andrew , and thanks to everyone for joining us on the call today . 2025 was a transformational year for with Exelixis growth strong across all components of our business We .
Speaker #3: build on this momentum in 2026 and have already made significant progress during a very busy January critically and emphasize will this here and throughout the call .
Speaker #3: EXELIXIS, INC. has a singular focus to build a multi franchise business in solid tumor oncology based on the foundation of Cabozantinib , the potential of Tinib and our and the depth of our early stage pipeline .
Speaker #3: As outlined at our December R&D Day, our strategy to build a pipeline of franchises in solid tumor oncology covers three critical dimensions.
Speaker #3: Products . Tumor indications , and modalities , and is based on current leadership in GU oncology and our aspirational goal to expand our leadership into GI indications with equal intensity and potential The upside .
Michael M. Morrissey: The Exelixis strategy for product, tumor, and modality franchises provides the framework to drive both the growth of any overall market we choose to pursue and the potential to capture a greater share of the commercial opportunity with multiple entry points. Our operational model to establish, expand, and entrench any given franchise highlights the potential value for all our stakeholders. Importantly, the progress we have made over the last 12 months, as well as our expectations for 2026 and beyond, are well aligned with this franchise-focused approach. With that context in place, we outlined important news and priorities to kick off 2026 and our corporate update in January at the JPMorgan Healthcare Conference. I won't reiterate everything here today, but just focus on the top highlights, including: First, we saw continued strong performance of the cabozantinib business in the Q4 and full year 2025.
Michael M. Morrissey: The Exelixis strategy for product, tumor, and modality franchises provides the framework to drive both the growth of any overall market we choose to pursue and the potential to capture a greater share of the commercial opportunity with multiple entry points. Our operational model to establish, expand, and entrench any given franchise highlights the potential value for all our stakeholders. Importantly, the progress we have made over the last 12 months, as well as our expectations for 2026 and beyond, are well aligned with this franchise-focused approach. With that context in place, we outlined important news and priorities to kick off 2026 and our corporate update in January at the JPMorgan Healthcare Conference. I won't reiterate everything here today, but just focus on the top highlights, including: First, we saw continued strong performance of the cabozantinib business in the Q4 and full year 2025.
Speaker #3: strategy for product , tumor and modality franchises provides the framework to drive both the growth of any overall market we choose to pursue and the potential to capture a greater share of the commercial opportunity with multiple entry points .
Speaker #3: Our operational model to establish , expand and entrench any given franchise highlights the potential value for all our stakeholders . Importantly , the progress we have made over the last 12 months , as well as our expectations for 2026 and beyond , are well aligned this with franchise focused approach .
Speaker #3: With that context , in place , we outlined important news and priorities to kick off 2026 and our corporate update in January . At the JP Morgan Healthcare Conference .
Speaker #3: I won't reiterate everything here today , but just focus on the top highlights , including . First , we saw continued strong performance of the Cabozantinib business in the fourth quarter and full year 2025 .
Michael M. Morrissey: CABOMETYX maintained its position as the leading TKI for RCC and the market leader for neuroendocrine tumors in the oral second-line plus segment. Full year 2025, US CABO franchise net product revenues grew 17% to approximately $2.12 billion compared to full year 2024. Q4 2025, US CABO franchise net product revenues grew 6% year over year to $547 million compared to Q4. Continuing its role as a worldwide leading TKI, global CABO franchise net product revenues generated by Exelixis and its partners were approximately $754 million and $2.89 billion in Q4 and full year 2025, respectively. Importantly, CABO's US net product revenues exceeded $100 million for the neuroendocrine tumor indication in 2025.
Michael M. Morrissey: CABOMETYX maintained its position as the leading TKI for RCC and the market leader for neuroendocrine tumors in the oral second-line plus segment. Full year 2025, US CABO franchise net product revenues grew 17% to approximately $2.12 billion compared to full year 2024. Q4 2025, US CABO franchise net product revenues grew 6% year over year to $547 million compared to Q4. Continuing its role as a worldwide leading TKI, global CABO franchise net product revenues generated by Exelixis and its partners were approximately $754 million and $2.89 billion in Q4 and full year 2025, respectively. Importantly, CABO's US net product revenues exceeded $100 million for the neuroendocrine tumor indication in 2025.
Speaker #3: Cabometyx maintained its position as the leading TKI for RCC and the market leader for neuroendocrine tumors in the oral second line , plus segment .
Speaker #3: Full year 2025 US Cabo franchise net product revenues grew 17% to approximately $2.12 billion , compared to full year 2024 . Fourth quarter 2025 US Cabo franchise product revenues grew 6% year over year to $547 million , compared to the fourth quarter of 20 .
Speaker #3: Continuing its role as a worldwide leading TKI Global Cabo franchise , net product revenues generated by Exelixis and its partners were approximately $754 million in $2.89 billion in fourth full year 2025 , respectively .
Speaker #3: Importantly , US Cabos net product revenues exceeded $100 million for the neuroendocrine tumor indication in 2025 . Second , we're excited to accelerate Zanza as our next potential oncology franchise opportunity in 2026 with the recently announced acceptance of our NDA for the Zanza Atezo combination in third line CRC .
Michael M. Morrissey: Second, we're excited to accelerate zanzalintinib as our next potential oncology franchise opportunity in 2026 with the recently announced acceptance of our NDA for the zanzalintinib atezolizumab combination in third-line+ CRC based upon the STELLAR-303 data. The entire organization is rallying around this important 2026 milestone, and we've taken decisive steps to fortify our commercial footprints to maximize the impact of potentially launching two drugs in different indications in successive years. Notably, we've expedited the buildup of our GI sales team in January with the focus to accelerate the growth of the CABOMETYX neuroendocrine tumor opportunity before zanzalintinib could come online for CRC later in the year. We think this enhancement could be an important component of our growth narrative in the near term and speaks to the confidence we have in both Cabo and zanzalintinib as we move into 2026.
Michael M. Morrissey: Second, we're excited to accelerate zanzalintinib as our next potential oncology franchise opportunity in 2026 with the recently announced acceptance of our NDA for the zanzalintinib atezolizumab combination in third-line+ CRC based upon the STELLAR-303 data. The entire organization is rallying around this important 2026 milestone, and we've taken decisive steps to fortify our commercial footprints to maximize the impact of potentially launching two drugs in different indications in successive years. Notably, we've expedited the buildup of our GI sales team in January with the focus to accelerate the growth of the CABOMETYX neuroendocrine tumor opportunity before zanzalintinib could come online for CRC later in the year. We think this enhancement could be an important component of our growth narrative in the near term and speaks to the confidence we have in both Cabo and zanzalintinib as we move into 2026.
Speaker #3: Based upon the stellar 303 data , the entire organization is rallying around this important 2026 milestone , and we've taken decisive steps to fortify our commercial footprint to maximize the impact of potentially launching two drugs in different indications in successive years .
Speaker #3: Notably , we've expedited the buildout of our GI sales team in January with the focus to accelerate the growth of the Carbomedics neuroendocrine tumor opportunity .
Speaker #3: Before Zanza could come online for CRC later in the year . We think this enhancement could be an component of our important growth narrative in the near term , to the and speaks have confidence we in both Cabo and as move we into 2026 .
Michael M. Morrissey: Third, zanzalintinib is rapidly advancing as our next franchise opportunity with seven ongoing and soon-to-start pivotal trials, along with a variety of important trial concepts under consideration as a potential next wave of pivotal trials. We continue to prioritize Xanza both as a monotherapy and in combinations for existing and new indications as an expeditious path to a second Exelixis oncology franchise. Importantly, we're excited by the level of interest in new clinical collaborations for Xanza from the JPM meeting that could expand the breadth and depth of our Xanza pivotal trial efforts to potentially define new standards of care for patients with cancer. Fourth, as we highlighted at our R&D Day in December, our Exelixis IND pipeline is full for the next several years, with potential first-in-class and/or best-in-class molecules demonstrating differentiating activity based on extensive preclinical testing.
Michael M. Morrissey: Third, zanzalintinib is rapidly advancing as our next franchise opportunity with seven ongoing and soon-to-start pivotal trials, along with a variety of important trial concepts under consideration as a potential next wave of pivotal trials. We continue to prioritize Xanza both as a monotherapy and in combinations for existing and new indications as an expeditious path to a second Exelixis oncology franchise. Importantly, we're excited by the level of interest in new clinical collaborations for Xanza from the JPM meeting that could expand the breadth and depth of our Xanza pivotal trial efforts to potentially define new standards of care for patients with cancer. Fourth, as we highlighted at our R&D Day in December, our Exelixis IND pipeline is full for the next several years, with potential first-in-class and/or best-in-class molecules demonstrating differentiating activity based on extensive preclinical testing.
Speaker #3: Third , Zanza is rapidly advancing as our next franchise opportunity , with seven ongoing and soon to start pivotal trials , along with a variety of important trial concepts under consideration as potential as a potential next wave of pivotal trials , we continue to prioritize Zanza both as a monotherapy and in combinations for existing and new indications .
Speaker #3: As an expeditious path to a second Exelixis oncology franchise. Importantly, we're excited by the level of interest in new clinical collaborations for Zanza from the JPM meeting that could expand the breadth and depth of our Zanza pivotal trial efforts to potentially define new standards of care for patients with cancer.
Speaker #3: Fourth , highlighted at our R&D Day in December , our exelixis IND is pipeline full for the next several years with potential first in class and or best in class molecules , demonstrating differentiating activity based on extensive preclinical testing .
Michael M. Morrissey: All our efforts are focused on identifying the next clinical asset we can move into full development as another potential Exelixis franchise opportunity. Dana will summarize our status today at a high level, and I refer you back to the replay of our R&D Day to dive into the details for Xanza and the rest of our pipeline. Finally, business development activities continue to focus on late-stage assets in the GU and GI space. We're pursuing backend-loaded pay-for-success transactions that fit into our oncology franchise framework as a top priority. In terms of capital allocation, we're confident we have the balance sheet and expected free cash flows to advance our pipeline priorities, access new molecules from external sources when appropriate, and continue our share repurchase program when we believe our shares are undervalued.
Michael M. Morrissey: All our efforts are focused on identifying the next clinical asset we can move into full development as another potential Exelixis franchise opportunity. Dana will summarize our status today at a high level, and I refer you back to the replay of our R&D Day to dive into the details for Xanza and the rest of our pipeline. Finally, business development activities continue to focus on late-stage assets in the GU and GI space. We're pursuing backend-loaded pay-for-success transactions that fit into our oncology franchise framework as a top priority. In terms of capital allocation, we're confident we have the balance sheet and expected free cash flows to advance our pipeline priorities, access new molecules from external sources when appropriate, and continue our share repurchase program when we believe our shares are undervalued.
Speaker #3: All our efforts are focused on identifying the next clinical asset . We can move into full development as another potential franchise opportunity . Daniel will summarize our status today at a high level , and I refer you back to the replay of our R&D day to dive into the details for Zanza and the rest of our pipeline .
Speaker #3: Finally , business development activities continue to focus on late stage assets in the GU and GI space . We're pursuing back end loaded pay for success transactions that fit into our oncology franchise framework as a top priority in terms of capital allocation .
Speaker #3: We're confident we have the balance sheet and expected free cash flows to advance our pipeline priorities . Access new molecules from external sources when appropriate , and continue our share repurchase we program believe our shares are undervalued .
Michael M. Morrissey: With that, please see our press release issued an hour ago for our Q4 and full year 2025 financial results and an extensive list of key corporate milestones achieved in Q4. I'll now turn the call over to Chris.
Michael M. Morrissey: With that, please see our press release issued an hour ago for our Q4 and full year 2025 financial results and an extensive list of key corporate milestones achieved in Q4. I'll now turn the call over to Chris.
Speaker #3: With that, please see our press release issued an hour ago for our fourth quarter and full year 2025 financial results, and an extensive list of key corporate milestones achieved. In order, I'll now turn the call over to Chris.
Christopher Senner: Thanks, Mike. For the Q4 2025, the company reported total revenues of approximately $599 million, which included Cabozantinib franchise net product revenues of $546.6 million. CABOMETYX net product revenues were $544.7 million. Gross to net for the Cabozantinib franchise in the Q4 2025 was 28.5%, which is lower than the gross to net we experienced in the Q4 2025. This decrease in gross to net deductions in the Q4 2025 is primarily related to lower PHS and 340B volume when compared to the Q4 2025. Additionally, we estimate that our gross to net for the full year 2026 will be between 31% and 32%. As previously disclosed, Exelixis has been designated a specified small manufacturer, which requires Exelixis to pay a 2% discount in 2026 on all Medicare Part D sales and is included in our gross to net estimate for the year.
Christopher Senner: Thanks, Mike. For the Q4 2025, the company reported total revenues of approximately $599 million, which included Cabozantinib franchise net product revenues of $546.6 million. CABOMETYX net product revenues were $544.7 million. Gross to net for the Cabozantinib franchise in the Q4 2025 was 28.5%, which is lower than the gross to net we experienced in the Q4 2025. This decrease in gross to net deductions in the Q4 2025 is primarily related to lower PHS and 340B volume when compared to the Q4 2025. Additionally, we estimate that our gross to net for the full year 2026 will be between 31% and 32%. As previously disclosed, Exelixis has been designated a specified small manufacturer, which requires Exelixis to pay a 2% discount in 2026 on all Medicare Part D sales and is included in our gross to net estimate for the year.
Speaker #3: Thanks , Mike , for the fourth quarter 2025 . The company reported .
Speaker #2: Total revenues of approximately approximately $599 million , which included Cabozantinib franchise net product revenues of $546.6 million . Cabometyx net product revenues were $544.7 million .
Speaker #2: Gross to net Cabozantinib for the franchise in the fourth quarter of 2025 was 28.5%, which is lower than the gross to net that we experienced in the third quarter of 2025.
Speaker #2: This decrease in gross to net deductions in the fourth quarter of 2025 is primarily related to lower pH and P-40b volume when compared to the third quarter of 2025 .
Speaker #2: Additionally , we estimate that our gross to net for the full year be 2026 will between 31% and 32% . As previously disclosed , Exelixis has been designated as specified small manufacturer , which requires Exelixis to pay a 2% discount in 2026 on all Part D Medicare sales and is included in our gross and net estimate for the year .
Christopher Senner: Our CABOMETYX trade inventory was slightly higher at 2.2 weeks on hand at the end of the year when compared to the Q4 2025. Total revenues in the Q4 2025 also include approximately $52.8 million in royalties earned from our partners, Ipsen and Takeda, on their sales of cabozantinib. Our total operating expenses, excluding restructuring expenses for the Q4 2025, were approximately $363 million compared to $341 million in the Q4 2025. The sequential increase in these operating expenses was primarily driven by higher manufacturing costs for drug development candidates, NDA filing fees, personnel expenses, and higher marketing expenses, offset by lower stock-based compensation in the Q4 2025. Provision for income taxes for the Q4 2025 was approximately $8.2 million compared to a provision for income taxes of approximately $58.8 million for the Q4 2025.
Christopher Senner: Our CABOMETYX trade inventory was slightly higher at 2.2 weeks on hand at the end of the year when compared to the Q4 2025. Total revenues in the Q4 2025 also include approximately $52.8 million in royalties earned from our partners, Ipsen and Takeda, on their sales of cabozantinib. Our total operating expenses, excluding restructuring expenses for the Q4 2025, were approximately $363 million compared to $341 million in the Q4 2025. The sequential increase in these operating expenses was primarily driven by higher manufacturing costs for drug development candidates, NDA filing fees, personnel expenses, and higher marketing expenses, offset by lower stock-based compensation in the Q4 2025. Provision for income taxes for the Q4 2025 was approximately $8.2 million compared to a provision for income taxes of approximately $58.8 million for the Q4 2025.
Speaker #2: Our trade inventory was slightly higher at 2.2 weeks on hand . At the end of the year . When compared to the third quarter of 2025 .
Speaker #2: Total revenues in the fourth quarter of 2025 also includes approximately $52.8 million in royalties earned from our partners . It's an indicator on their sales of Cabozantinib , our total operating expenses , excluding restructuring expenses , for the fourth quarter of 2025 , were approximately $363 million , compared to $341 million in the third quarter of 2025 .
Speaker #2: The the sequential increase in these operating expenses was primarily driven by higher manufacturing costs for drug development candidates . NDA filing fees , personnel expenses , and higher expenses , marketing by lower offset stock based compensation .
Speaker #2: In the fourth quarter of 2025 , provision for income taxes for the fourth quarter of 2025 was approximately $8.2 million , compared to a provision for income taxes of approximately $58.8 million for the third quarter of 2025 .
Christopher Senner: This decrease in tax provisions was related to items that were recognized in the Q4 2025. The company reported GAAP net income of approximately $244.5 million or $0.92 per share basic, and $0.88 per share diluted for the Q4 2025. The company also reported a non-GAAP net income of approximately $259.5 million or $0.97 per share basic, and $0.94 per share diluted. Non-GAAP net income excludes the impact of approximately $15 million of stock-based compensation expense net of the related income tax effect. Cash and marketable securities for the year ended 31 December 2025, was approximately $1.66 billion. During fiscal year 2025, we repurchased $954 million of the company's outstanding common stock, resulting in the retirement of approximately 24 million shares of the company's outstanding common stock at an average price per share of $39.61.
Christopher Senner: This decrease in tax provisions was related to items that were recognized in the Q4 2025. The company reported GAAP net income of approximately $244.5 million or $0.92 per share basic, and $0.88 per share diluted for the Q4 2025. The company also reported a non-GAAP net income of approximately $259.5 million or $0.97 per share basic, and $0.94 per share diluted. Non-GAAP net income excludes the impact of approximately $15 million of stock-based compensation expense net of the related income tax effect. Cash and marketable securities for the year ended 31 December 2025, was approximately $1.66 billion. During fiscal year 2025, we repurchased $954 million of the company's outstanding common stock, resulting in the retirement of approximately 24 million shares of the company's outstanding common stock at an average price per share of $39.61.
Speaker #2: This decrease in tax provisions was related to items that were recognized in the fourth quarter of 2025 , the company reported GAAP net income of approximately $244.5 million , or $0.92 per share .
Speaker #2: Basic , and $0.88 per share diluted for the fourth quarter of 2025 . The company also reported a non-GAAP net income of approximately $259.5 million , or $0.97 per share .
Speaker #2: Basic , and $0.94 per share diluted non-GAAP net income excludes the impact of approximately $15 million of stock based , stock based compensation expense , net of the related income tax effect .
Speaker #2: Cash and marketable securities for the year ended December 31st , 2025 was approximately $1.66 billion during fiscal 2025 , we year repurchased $954 million of the company's common stock , resulting in the retirement of approximately 24 million shares of the company's outstanding common stock at an average price per share of $39.61 .
Christopher Senner: As of the end of fiscal year 2025, we had approximately $590 million remaining under the $750 million stock repurchase plan authorized by the company's board in October 2025. Finally, turning to our financial guidance for the full year 2026, we announced our 2026 financial guidance during the JPMorgan Conference in January, which is detailed on slide 19 of our earnings presentation. With that, I'll turn the call over to P.J.
Christopher Senner: As of the end of fiscal year 2025, we had approximately $590 million remaining under the $750 million stock repurchase plan authorized by the company's board in October 2025. Finally, turning to our financial guidance for the full year 2026, we announced our 2026 financial guidance during the JPMorgan Conference in January, which is detailed on slide 19 of our earnings presentation. With that, I'll turn the call over to P.J.
Speaker #2: As of the end of fiscal year 2025 , we had approximately $590 million remaining under the $750 million stock repurchase plan authorized by the company's board in October 2025 , and finally , turning to our financial guidance for the full year 2026 , we announced our 2026 financial guidance during the J.P.
Speaker #2: Morgan Conference in January, which is detailed on slide 19 of our earnings presentation. And with that, I'll turn the call over to P.J.
Patrick Haley: Thank you, Chris. CABOMETYX business remains strong in the Q4 of 2025. The team continued to execute at an extremely high level, CABOMETYX continuing to be the number one prescribed TKI in renal cell carcinoma, the number one TKI plus IO combination in first-line RCC, and the number one oral agent in second-line plus neuroendocrine tumors. This is an exciting time for the team with zanzalintinib on the horizon as we prepare to launch our next franchise molecule, which would also expand the Exelixis GI franchise. The prescription data in the oral TKI market basket of Cabo, lenvatinib, axitinib, sunitinib, and pazopanib convey the strength of Cabo relative to the competition. Looking at the TRX comparison for Q4 2024 to Q4 2025, CABOMETYX grew 3 share points from 43% to 46%.
Patrick Haley: Thank you, Chris. CABOMETYX business remains strong in the Q4 of 2025. The team continued to execute at an extremely high level, CABOMETYX continuing to be the number one prescribed TKI in renal cell carcinoma, the number one TKI plus IO combination in first-line RCC, and the number one oral agent in second-line plus neuroendocrine tumors. This is an exciting time for the team with zanzalintinib on the horizon as we prepare to launch our next franchise molecule, which would also expand the Exelixis GI franchise. The prescription data in the oral TKI market basket of Cabo, lenvatinib, axitinib, sunitinib, and pazopanib convey the strength of Cabo relative to the competition. Looking at the TRX comparison for Q4 2024 to Q4 2025, CABOMETYX grew 3 share points from 43% to 46%.
Speaker #2: . Thank you , Chris Carbomedics ,
Speaker #4: Business remains strong in the fourth quarter of 2025. The team continued to execute at an extremely high level. Carbomedics continues to be the number one prescribed TKI in renal cell carcinoma.
Speaker #4: The number one TKI plus IO combination . In first line RCC and the number one oral agent . Second line plus neuroendocrine . This tumors is an exciting time for the team with on the horizon .
Speaker #4: As we prepare to launch our next franchise , molecule should also expand the Exelixis GI franchise . The prescription data in the oral TKI market basket of Cabo Lenvatinib Axitinib , sunitinib and Pazopanib convey the strength of Cabo relative to the competition .
Speaker #4: Looking at the TRX comparison , the Q4 2024 to Q4 2025 Cabometyx grew three Sharepoint's from 43% to 46% . And importantly , Cabometyx TRX volume grew 15% in Q4 2025 compared to Q4 outpacing the 2024 , growth rate of the market basket , which was 7% for the same period .
Patrick Haley: And importantly, CABOMETYX TRX volume grew 15% in Q4 2025 compared to Q4 2024, outpacing the growth rate of the market basket, which was 7% for the same period. Physicians are responding positively to the broad net label and the contemporary trial design and perceive the efficacy and tolerability of Cabo as favorable relative to other small molecule therapies in the space. Prescribers are using Cabo broadly across patient and tumor characteristics, including patients with neuroendocrine tumors arising in the pancreas, GI tract, and lung, across all tumor grades, functional, and SSTR status, and those who have received prior treatment with LUTATHERA. Turning to new patient market share for second-line plus neuroendocrine tumors in Q4, we're pleased that CABOMETYX remains the market leader in the oral therapy segment. And additionally, our research indicates that there is opportunity to continue to grow market share, particularly in the community.
Patrick Haley: And importantly, CABOMETYX TRX volume grew 15% in Q4 2025 compared to Q4 2024, outpacing the growth rate of the market basket, which was 7% for the same period. Physicians are responding positively to the broad net label and the contemporary trial design and perceive the efficacy and tolerability of Cabo as favorable relative to other small molecule therapies in the space. Prescribers are using Cabo broadly across patient and tumor characteristics, including patients with neuroendocrine tumors arising in the pancreas, GI tract, and lung, across all tumor grades, functional, and SSTR status, and those who have received prior treatment with LUTATHERA. Turning to new patient market share for second-line plus neuroendocrine tumors in Q4, we're pleased that CABOMETYX remains the market leader in the oral therapy segment. And additionally, our research indicates that there is opportunity to continue to grow market share, particularly in the community.
Speaker #4: responding Physicians are positively to the broad net label and the contemporary trial design , and perceive the efficacy and tolerability of Cabo as favorable relative to other small molecule therapies in the space .
Speaker #4: are Drivers using Cabo broadly across patient and tumor characteristics , including patients with neuroendocrine tumors arising in the pancreas , GI tract , and lung across all tumor grades .
Speaker #4: Functional and SSR status , and those who have received prior treatment with Lutathera . Turning to new patient market share for second line plus neuroendocrine tumors in Q4 , we're pleased that Cabometyx remains the market leader in the oral therapy segment in .
Speaker #4: Additionally , our research indicates that there is opportunity to continue to grow market share , particularly in the community . My highlighted Cabo revenue in 2025 neuroendocrine tumors team The is fully exceeded $100 million .
Patrick Haley: As Mike highlighted, CABOMETYX 2025 revenue in neuroendocrine tumors exceeded $100 million, and the team is fully engaged on driving growth in this indication in 2026 with a strong focus on the community setting. For that reason, we are pleased that we have completed the expansion of our GI sales team, which will yield greater reach into the community in order to continue to grow net market share for CABOMETYX. Our new representatives join us with significant oncology sales experience, particularly in colorectal cancer and GI oncology. We are excited to have them hit the ground running. Importantly, the expanded team will be able to gain valuable experience selling CABOMETYX before we turn our focus to the potential launch of zanzalintinib in colorectal cancer. We were thinking about building on and expanding our GI franchise.
Patrick Haley: As Mike highlighted, CABOMETYX 2025 revenue in neuroendocrine tumors exceeded $100 million, and the team is fully engaged on driving growth in this indication in 2026 with a strong focus on the community setting. For that reason, we are pleased that we have completed the expansion of our GI sales team, which will yield greater reach into the community in order to continue to grow net market share for CABOMETYX. Our new representatives join us with significant oncology sales experience, particularly in colorectal cancer and GI oncology. We are excited to have them hit the ground running. Importantly, the expanded team will be able to gain valuable experience selling CABOMETYX before we turn our focus to the potential launch of zanzalintinib in colorectal cancer. We were thinking about building on and expanding our GI franchise.
Speaker #4: engaged on driving growth in this indication . In 2026 , with a strong focus on the community setting . For that reason , we are pleased that we have completed the expansion of our GI sales team , which will yield greater reach into the community .
Speaker #4: In order to continue to grow net market share for Cabometyx , our new representatives join us with significant oncology sales experience , particularly in colorectal cancer and GI oncology .
Speaker #4: We are excited to have them hit the ground running. Importantly, the expanded team will be able to gain valuable experience selling Carbo before we turn our focus to the potential launch in colorectal cancer. We are thinking about building on and expanding our GI franchise.
Patrick Haley: We are thrilled with the results of STELLAR-303 and a PDUFA date set for later this year. Pending regulatory approval, we believe that these data would provide Exelixis with a compelling commercial opportunity in one of the Big Four tumors. Our market research and advisory boards demonstrate positive feedback and excitement for the STELLAR-303 data. Physicians reiterate the significant unmet medical need for patients in the third-line plus CRC setting and are excited for the potential to have an ICI option available for the broader population of CRC patients. In closing, we are pleased with the growth of the Cabo business both in RCC and NETs. In neuroendocrine tumors, prescribers see CABOMETYX as a more favorable choice versus other previously approved generic small molecule therapies. Simultaneously, our internal team is in full launch preparation for zanzalintinib, and the excitement around these efforts is palpable.
Patrick Haley: We are thrilled with the results of STELLAR-303 and a PDUFA date set for later this year. Pending regulatory approval, we believe that these data would provide Exelixis with a compelling commercial opportunity in one of the Big Four tumors. Our market research and advisory boards demonstrate positive feedback and excitement for the STELLAR-303 data. Physicians reiterate the significant unmet medical need for patients in the third-line plus CRC setting and are excited for the potential to have an ICI option available for the broader population of CRC patients. In closing, we are pleased with the growth of the Cabo business both in RCC and NETs. In neuroendocrine tumors, prescribers see CABOMETYX as a more favorable choice versus other previously approved generic small molecule therapies. Simultaneously, our internal team is in full launch preparation for zanzalintinib, and the excitement around these efforts is palpable.
Speaker #4: We are thrilled with the results of stellar 303 at a date set for later this year regulatory , pending approval , we believe that these data would provide excellence with a compelling commercial opportunity in one of the Big Four tumors , our market research and advisory boards demonstrate positive feedback and excitement for the stellar 303 data physicians reiterate the significant unmet medical need for patients in the third line , plus CRC setting , and are excited for the potential to have an ICI option available for the broader population of CRC patients .
Speaker #4: In closing, we're pleased with the growth of the Cabo business, both in RCC and NETs in neuroendocrine tumors. Prescribers seek Cabo medics.
Speaker #4: The more favorable choice versus other previously approved generic small molecule therapies . Simultaneously , our internal team is in full launch preparation for Zanza and the excitement around these efforts is palpable .
Patrick Haley: We look forward to the opportunity to launch the next Exelixis franchise later in the year to be able to help appropriate patients with colorectal cancer. Beyond STELLAR-303, we are enthusiastic about the significant development plan for Xanza, which could position the Xanza franchise to far exceed Cabo in terms of the number of patients that could be impacted across tumor types and settings. With that, I will turn the call over to Dana.
Patrick Haley: We look forward to the opportunity to launch the next Exelixis franchise later in the year to be able to help appropriate patients with colorectal cancer. Beyond STELLAR-303, we are enthusiastic about the significant development plan for Xanza, which could position the Xanza franchise to far exceed Cabo in terms of the number of patients that could be impacted across tumor types and settings. With that, I will turn the call over to Dana.
Speaker #4: forward to the Look opportunity to launch the next Exelixis franchise later in the be able year . To to help appropriate patients with colorectal cancer beyond stellar 303 , we're enthusiastic about the significant development plan for Zanza , which could position the Zanza franchise to far exceed Cabo in terms of the number of patients that could be impacted across tumor types and settings .
Dana Aftab: Thanks, PJ. Our strategy in R&D is on building franchises in key solid tumor indications, and we continue to be focused on maximizing our productivity with disciplined investment in high-value opportunities for our portfolio. Zanzalintinib is clearly our next big franchise opportunity with seven ongoing or planned pivotal studies, so my update today will be focused mostly on zanzalintinib, but I'll also touch on our earlier stage pipeline of small molecules and biotherapeutics. As Mike mentioned earlier, the FDA accepted our new drug application submission for zanzalintinib with a PDUFA target action date of December 3rd this year. The NDA is based on the results from the STELLAR-303 trial comparing the combination of zanzalintinib plus atezolizumab versus regorafenib in patients with microsatellite instability-high colorectal cancer who had received multiple prior therapies.
Dana Aftab: Thanks, PJ. Our strategy in R&D is on building franchises in key solid tumor indications, and we continue to be focused on maximizing our productivity with disciplined investment in high-value opportunities for our portfolio. Zanzalintinib is clearly our next big franchise opportunity with seven ongoing or planned pivotal studies, so my update today will be focused mostly on zanzalintinib, but I'll also touch on our earlier stage pipeline of small molecules and biotherapeutics. As Mike mentioned earlier, the FDA accepted our new drug application submission for zanzalintinib with a PDUFA target action date of December 3rd this year. The NDA is based on the results from the STELLAR-303 trial comparing the combination of zanzalintinib plus atezolizumab versus regorafenib in patients with microsatellite instability-high colorectal cancer who had received multiple prior therapies.
Speaker #4: And with that , I will turn the call over to Dana . Thanks , PJ .
Speaker #3: Our strategy and .
Speaker #2: is on R&D building franchises in key solid tumor indications . And we continue to be focused on maximizing our productivity with disciplined investment in high value opportunities for our portfolio .
Speaker #2: Zanza is clearly our next big franchise opportunity , with seven ongoing or planned pivotal studies . So my update today will be focused mostly on Zanza , but I'll also touch on our earlier stage pipeline of small molecules and biotherapeutics .
Speaker #2: Mike As mentioned earlier , the FDA accepted our new drug Application submission for a Zanza with target date of action December 3rd this year NDA is based on .
Speaker #2: the The results from the stellar 303 trial . Comparing the combination of Zanza plus atezolizumab versus Regorafenib in patients with non microsatellite instability , high colorectal cancer who had received multiple prior therapies .
Dana Aftab: As a quick reminder, the trial has dual primary endpoints designed to assess survival outcomes, more specifically in the population of patients without liver metastases, which we refer to as the NLM patients or population, and more broadly in the intention to treat or ITT population, which includes patients both with and without liver metastases. The study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the broader ITT population at the final analysis, while data pertaining to the other dual primary endpoint of overall survival in the NLM population showed a trend in overall survival favoring the combination. The NLM data were immature at the data cutoff, and the trial has been proceeding to the planned final analysis for this endpoint, and we expect to have those top-line results around the middle of this year.
Dana Aftab: As a quick reminder, the trial has dual primary endpoints designed to assess survival outcomes, more specifically in the population of patients without liver metastases, which we refer to as the NLM patients or population, and more broadly in the intention to treat or ITT population, which includes patients both with and without liver metastases. The study met one of its dual primary endpoints, demonstrating a 20% reduction in the risk of death with the combination in the broader ITT population at the final analysis, while data pertaining to the other dual primary endpoint of overall survival in the NLM population showed a trend in overall survival favoring the combination. The NLM data were immature at the data cutoff, and the trial has been proceeding to the planned final analysis for this endpoint, and we expect to have those top-line results around the middle of this year.
Speaker #2: As a quick reminder, the trial has dual primary endpoints designed to assess survival outcomes. More specifically, in the population of patients without liver metastases, which we refer to as the NLM patients or population.
Speaker #2: And more broadly , in the intention to treat or ITT population , which includes patients both with and without liver metastases . The study met one of its dual primary endpoints , demonstrating a 20% reduction in the risk of death with the combination in the broader ITT population at the final analysis .
Speaker #2: While data pertaining to the other dual primary endpoint of overall survival in the NLM a trend population showed in overall survival combination , favoring the the NLM data were immature at the data cutoff , and the been trial has proceeding to the planned final analysis for this endpoint , and we expect to have those top line results around the middle of this year .
Dana Aftab: Needless to say, we are very excited about engaging with regulators on this first NDA for Xanza in combination with Atezo, which, if approved, could potentially become a new standard of care for CRC patients who have received multiple prior therapies. We believe that the STELLAR-303 results demonstrate clear clinical differentiation of Xanza from other TKIs and IO combination partners investigated in this space, and that Xanza's differentiated mechanism of action, including inhibition of the TAM kinases and MET, is a key factor in this clinical differentiation and underscores Xanza's franchise potential. As a next step toward realizing that potential, our team is highly focused on investigating Xanza in an earlier setting in patients with colorectal cancer. To that end, we're planning to initiate the STELLAR-316 trial this year in patients with colorectal cancer who are positive for molecular residual disease or MRD after completing definitive therapy.
Dana Aftab: Needless to say, we are very excited about engaging with regulators on this first NDA for Xanza in combination with Atezo, which, if approved, could potentially become a new standard of care for CRC patients who have received multiple prior therapies. We believe that the STELLAR-303 results demonstrate clear clinical differentiation of Xanza from other TKIs and IO combination partners investigated in this space, and that Xanza's differentiated mechanism of action, including inhibition of the TAM kinases and MET, is a key factor in this clinical differentiation and underscores Xanza's franchise potential. As a next step toward realizing that potential, our team is highly focused on investigating Xanza in an earlier setting in patients with colorectal cancer. To that end, we're planning to initiate the STELLAR-316 trial this year in patients with colorectal cancer who are positive for molecular residual disease or MRD after completing definitive therapy.
Speaker #2: Needless to say , we are very excited about engaging with regulators on this first NDA for Zanza in combination with Atezo , which , if approved , could potentially become a new standard of care for CRC patients who have received multiple prior therapies .
Speaker #2: We believe that this stellar 303 results demonstrate clear clinical differentiation of zanza from other tkis and IO combination partners investigated in this space , and that zanza differentiated mechanism of action , including inhibition of the Tam kinases and Met is a key factor in this clinical differentiation and underscores Zaza's franchise potential as a next step toward realizing that potential , team is our highly focused on zanza investigating in an earlier setting in patients with colorectal cancer .
Speaker #2: To that end , we're planning to initiate the stellar 31 trial year in this patients with colorectal cancer or a positive for molecular residual disease or MRD .
Dana Aftab: By definitive therapy, we mean rectal cancer patients who have been treated with total neoadjuvant therapy followed by surgery or colon cancer patients who had surgery followed by adjuvant chemotherapy. About 20% of patients are MRD positive following definitive therapy, and these patients typically have a poor prognosis with median disease-free survival times in the 6- to 8-month time frame. Critically, these patients have no therapeutic options that have been shown in a phase 3 trial to prevent or delay metastatic progression of their disease. Thus, this represents a significant opportunity in the colorectal cancer landscape. In STELLAR-316, MRD will be determined with the Signatera circulating tumor DNA test, and we are very excited to be working with Natera as our diagnostic partner in this endeavor.
Dana Aftab: By definitive therapy, we mean rectal cancer patients who have been treated with total neoadjuvant therapy followed by surgery or colon cancer patients who had surgery followed by adjuvant chemotherapy. About 20% of patients are MRD positive following definitive therapy, and these patients typically have a poor prognosis with median disease-free survival times in the 6- to 8-month time frame. Critically, these patients have no therapeutic options that have been shown in a phase 3 trial to prevent or delay metastatic progression of their disease. Thus, this represents a significant opportunity in the colorectal cancer landscape. In STELLAR-316, MRD will be determined with the Signatera circulating tumor DNA test, and we are very excited to be working with Natera as our diagnostic partner in this endeavor.
Speaker #2: After completing definitive therapy by definitive therapy , we mean . Rectal cancer patients who have been treated with total neoadjuvant therapy , followed by surgery or colon cancer patients who had surgery followed by adjuvant chemotherapy .
Speaker #2: About 20% of patients are MRD positive following definitive therapy, and these patients typically have a poor prognosis, with median disease-free survival times in the 6 to 8 month time frame.
Speaker #2: Critically, these patients have no therapeutic options that have been shown in a phase 3 trial to prevent or delay metastatic progression of their disease.
Speaker #2: Thus, this represents a significant opportunity in the colorectal cancer landscape. Enstilar 306 will be determined with the Signatera circulating tumor DNA test, and we are very excited to be working with Natera as our diagnostic partner in this endeavor.
Dana Aftab: Their commercial test is very extensively utilized in this setting, and their database built from testing thousands of patients each year gives us incredible insight and clarity regarding patient demographics and outcomes. Some of the primary hurdles in phase 3 trial execution are around site performance and patient recruitment, but we now have information from our partner that should help us focus on prioritizing activation of clinical trial sites that are already known to have the highest cadence of testing and the highest numbers of eligible patients. Thus, once STELLAR-316 is initiated around mid-year, we expect enrollment to be quite brisk. Moving on to other trials, STELLAR-201 is a SignalArm phase 2 trial designed to evaluate Xanza in patients with recurrent meningioma, and we expect that trial to initiate around the middle of this year.
Dana Aftab: Their commercial test is very extensively utilized in this setting, and their database built from testing thousands of patients each year gives us incredible insight and clarity regarding patient demographics and outcomes. Some of the primary hurdles in phase 3 trial execution are around site performance and patient recruitment, but we now have information from our partner that should help us focus on prioritizing activation of clinical trial sites that are already known to have the highest cadence of testing and the highest numbers of eligible patients. Thus, once STELLAR-316 is initiated around mid-year, we expect enrollment to be quite brisk. Moving on to other trials, STELLAR-201 is a SignalArm phase 2 trial designed to evaluate Xanza in patients with recurrent meningioma, and we expect that trial to initiate around the middle of this year.
Speaker #2: Their commercial test is very extensively utilized in this setting , and their database built from testing thousands of patients each year , gives us incredible insight and clarity patient regarding demographics and outcomes .
Speaker #2: Some of the primary hurdles in phase three trial execution are around site performance and patient recruitment , but we now have information from our partner that should help us focus on prioritizing activation of clinical trial sites that are already known to have highest cadence of testing , and the highest of eligible patients .
Speaker #2: Thus , once stellar 306 is initiated around mid-year , we expect enrollment to be quite brisk . Moving on to other trials , stellar 201 is a single phase two trial to evaluate zanza in arm patients with recurrent expect meningioma , and we that trial to initiate around this the middle of year Stellar .
Dana Aftab: STELLAR-311 is our phase 3 trial evaluating zanzalintinib compared to everolimus as an initial oral therapy in patients with neuroendocrine tumors. That study was initiated last year and is proceeding on schedule. STELLAR-304 is our pivotal trial evaluating the combination of zanzalintinib plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma. We expect top-line results from STELLAR-304 around mid-year, and if positive, those results could lead to our second NDA filing for zanzalintinib. Finally, progress continues with regard to the phase 2 umbrella study being conducted by Merck, in which the combination of zanzalintinib plus belzutifan is being evaluated in patients with previously treated metastatic RCC, and two pivotal studies that Merck is running in clear cell RCC evaluating zanzalintinib in combination with belzutifan.
Dana Aftab: STELLAR-311 is our phase 3 trial evaluating zanzalintinib compared to everolimus as an initial oral therapy in patients with neuroendocrine tumors. That study was initiated last year and is proceeding on schedule. STELLAR-304 is our pivotal trial evaluating the combination of zanzalintinib plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma. We expect top-line results from STELLAR-304 around mid-year, and if positive, those results could lead to our second NDA filing for zanzalintinib. Finally, progress continues with regard to the phase 2 umbrella study being conducted by Merck, in which the combination of zanzalintinib plus belzutifan is being evaluated in patients with previously treated metastatic RCC, and two pivotal studies that Merck is running in clear cell RCC evaluating zanzalintinib in combination with belzutifan.
Speaker #2: 311 is our phase three trial evaluating Zanza compared to everolimus as an initial oral therapy in patients with neuroendocrine tumors. That study was initiated last year and is proceeding on schedule, and Stellar 304 is our pivotal trial.
Speaker #2: Evaluating the combination of zanzalintinib plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma. We expect top-line results from STELLAR-304 around mid-year.
Speaker #2: And if positive , those results could lead to second NDA our filing for Zanza . Finally , progress continues with regard to the phase two umbrella study being conducted by Merck , in which the combination of Zanza plus Belzutifan is being evaluated in patients with previously treated metastatic RCC and two pivotal studies that Merck is running in clear cell RCC evaluating in combination bells with .
Dana Aftab: One of those pivotal studies is LITESPARK-033, which is comparing zanzalintinib plus belzutifan versus cabozantinib as front-line therapy for patients who received anti-PD-1 or anti-PD-L1 therapy in the adjuvant setting. And that study initiated in December last year. We'll update you on the details of the other phase 3 study as they become available. Given the demonstrated clinical differentiation we've seen with zanzalintinib and its potential to be the TKI of choice for combinations with immunotherapies and other mechanisms of action, we're continuing to assess the landscape of additional opportunities for zanzalintinib development. To that end, we've engaged in discussions with potential collaborators on some exciting new combinations, and we look forward to sharing more details of these opportunities as we get closer to launching the trials.
Dana Aftab: One of those pivotal studies is LITESPARK-033, which is comparing zanzalintinib plus belzutifan versus cabozantinib as front-line therapy for patients who received anti-PD-1 or anti-PD-L1 therapy in the adjuvant setting. And that study initiated in December last year. We'll update you on the details of the other phase 3 study as they become available. Given the demonstrated clinical differentiation we've seen with zanzalintinib and its potential to be the TKI of choice for combinations with immunotherapies and other mechanisms of action, we're continuing to assess the landscape of additional opportunities for zanzalintinib development. To that end, we've engaged in discussions with potential collaborators on some exciting new combinations, and we look forward to sharing more details of these opportunities as we get closer to launching the trials.
Speaker #2: One of those pivotal studies is light Spark 033 , which is comparing zanza plus bells versus carbo as frontline therapy for patients who received anti-PD-1 or Anti-pd-l1 therapy in the adjuvant setting , and that study , initiated in December last year .
Speaker #2: We'll update you on the details of the other phase three study as they become available . Given the demonstrated clinical differentiation we've seen with Zanza and its potential to be TKI the of choice for combinations with immunotherapies and other mechanisms of action , we're continuing to assess the landscape of additional opportunities for zanza development .
Speaker #2: To that end , we've engaged in discussions with potential collaborators on some exciting new combinations , and we look forward to sharing more details of these opportunities as we get closer to launching the trials .
Dana Aftab: Now shifting to our early clinical pipeline, we have four molecules in this space that are currently in clinical development, namely XL309, XB010, XB628, and XB371. The phase 1 studies for these early molecules are progressing well. In terms of earlier stage development candidates, we are continuing to advance exciting new small molecule and ADC programs, and I look forward to sharing more details as these early pipeline programs advance. Our strategy with the early pipeline is focused on identifying the next potential franchise molecules beyond Cabo and Xanza. We will continue our approach of getting to go, no-go decisions quickly and efficiently, leveraging our expertise to pick the winners and ultimately maximize impact for patients. With that, I'll turn the call back over to Mike.
Dana Aftab: Now shifting to our early clinical pipeline, we have four molecules in this space that are currently in clinical development, namely XL309, XB010, XB628, and XB371. The phase 1 studies for these early molecules are progressing well. In terms of earlier stage development candidates, we are continuing to advance exciting new small molecule and ADC programs, and I look forward to sharing more details as these early pipeline programs advance. Our strategy with the early pipeline is focused on identifying the next potential franchise molecules beyond Cabo and Xanza. We will continue our approach of getting to go, no-go decisions quickly and efficiently, leveraging our expertise to pick the winners and ultimately maximize impact for patients. With that, I'll turn the call back over to Mike.
Speaker #2: Now , shifting to early clinical pipeline , we have four molecules in this space that are currently in clinical namely development , XL 309 010 , XB 628 , and XB 371 , and the phase one studies for these early molecules are progressing well in terms of earlier stage development , candidates , we are continuing to advance exciting new small molecule and ADC programs , and I look forward to sharing more details as these early pipeline programs advance our strategy with early the pipeline is focused on identifying the next potential franchise molecules beyond Cabo and Zanza .
Speaker #2: So, we will continue our approach of getting to go/no-go decisions quickly and efficiently, leveraging our expertise to pick the winners, and ultimately maximize impact for patients.
Michael M. Morrissey: All right. Thanks, Dana. I'll wrap up here by thanking the entire Exelixis team for their outstanding efforts in 2025. As we reflect on the substantial progress we've made over the last 12 months, we importantly look forward to 2026 as a potentially transformational year for the company. We will continue to execute in all cylinders with cabozantinib while also preparing for what could be a second potential franchise with zanzalintinib, all while we continue to advance our early stage pipeline. As always, I want to commend everyone at Exelixis for their individual and collective efforts, urgency, and focus as we strive to excel on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.
Michael M. Morrissey: All right. Thanks, Dana. I'll wrap up here by thanking the entire Exelixis team for their outstanding efforts in 2025. As we reflect on the substantial progress we've made over the last 12 months, we importantly look forward to 2026 as a potentially transformational year for the company. We will continue to execute in all cylinders with cabozantinib while also preparing for what could be a second potential franchise with zanzalintinib, all while we continue to advance our early stage pipeline. As always, I want to commend everyone at Exelixis for their individual and collective efforts, urgency, and focus as we strive to excel on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.
Speaker #2: So with that , I'll turn the call back over to Mike .
Speaker #3: All right. Thanks, Dana. I'll wrap up here by thanking the entire team for their outstanding efforts in 2025. As we reflect on the substantial progress we've made over the last 12 months, we look forward to 2026 as a potentially transformational year for the company.
Speaker #3: continue We will to execute on all cylinders with Cabozantinib while also preparing for what could be a second potential franchise with NIB , all while we continue to advance our early stage pipeline .
Speaker #3: As always, I want to commend everyone at Exelixis, Inc. for their individual and collective efforts, urgency, and focus as we strive to excel in our mission to help cancer patients recover stronger and live longer.
Speaker #3: We look forward to updating you on our progress in the future . Thank you for your continued support and interest in Exelixis , and we're happy to now open the call for questions .
Operator: Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 11 on your telephone, then wait for your name to be 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 Asthika Goonewardene with Truist. Your line is open.
Operator: Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 11 on your telephone, then wait for your name to be 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 Asthika Goonewardene with Truist. Your line is open.
Speaker #1: Thank you . Ladies and gentlemen . As a reminder to ask the question , please press star one one on your telephone . Then wait for your name to be announced to withdraw your question , please press star one one again .
Speaker #1: We ask that you limit yourself to one question only . stand Please by while we compile the Q&A roster . first question comes from the Our line of Azteca Gordini with Truist .
[Analyst] (various): Hey, guys. Thanks for taking my questions. So just a technical question here on as you launch Xanza, how long will you be able to benefit from the small manufacturer discount? And if I can sneak a quick second one in, it's nice to see the share repurchases step up in Q4. Just wondering if you can give any comments on the cadence of repurchases so far for the six weeks of the new year. Thank you.
Asthika Goonewardene: Hey, guys. Thanks for taking my questions. So just a technical question here on as you launch Xanza, how long will you be able to benefit from the small manufacturer discount? And if I can sneak a quick second one in, it's nice to see the share repurchases step up in Q4. Just wondering if you can give any comments on the cadence of repurchases so far for the six weeks of the new year. Thank you.
Speaker #1: Your line is open .
Speaker #5: Hey guys , thanks for taking my questions . So just a technical question here on as you launch Zanza . How long will it will you be able to benefit from the small manufacturer discount and if you can sneak a quick second one in , it's nice to see the share repurchases step up in Q4 .
Speaker #5: Just wondering if you can give any comments on the cadence of repurchases so far ? The after the six weeks of the new year ?
Michael M. Morrissey: Yeah. After CEO Mike, I will take the first question, and maybe Chris can take the second one. Again, don't want to get too far ahead of ourselves with Xanza. We're early in the review cycle for the process. Obviously, the small manufacturer exemptions that we have are tied to having a single product that has the majority of our revenue, and we would think that would be the case for the foreseeable future. I think the cutoff is around 20% for a second product to come into play. So I think we're okay there for a while. Obviously, it's all about the kinetics of any subsequent launch. So stay tuned on that. Still very early days. Don't want to speculate on the timing for when that could be an issue. Okay? Chris?
Michael M. Morrissey: Yeah. After CEO Mike, I will take the first question, and maybe Chris can take the second one. Again, don't want to get too far ahead of ourselves with Xanza. We're early in the review cycle for the process. Obviously, the small manufacturer exemptions that we have are tied to having a single product that has the majority of our revenue, and we would think that would be the case for the foreseeable future. I think the cutoff is around 20% for a second product to come into play. So I think we're okay there for a while. Obviously, it's all about the kinetics of any subsequent launch. So stay tuned on that. Still very early days. Don't want to speculate on the timing for when that could be an issue. Okay? Chris?
Speaker #5: .
Speaker #3: Yeah , Mike , I will take the first question and maybe Chris can take the second one . You know , again , don't want to get too far ahead of ourselves with Zanza .
Speaker #3: We're early in the review cycle for the process . Obviously , the small manufacturer exemptions that have we are tied to having a single product that has the majority of our and we revenue , would think that be the case for the foreseeable future .
Speaker #3: I think the cutoff is around 20% . For a second product to come into play . So I think we're okay there for a while .
Speaker #3: Obviously , it's all about the kinetics of of any subsequent launch . So stay tuned on that . Still very early days . Don't want to speculate on the timing for when that could be an issue .
Patrick Haley: Yeah. Thanks, Mike. So Asthika, from a share repurchase perspective, as Mike mentioned in his prepared remarks, we're going to continue to do share repurchases as long as we feel like we're undervalued, and that continues today. We have $590 million left over on the most recent authorization, $750 million authorization from the board, and our commitment is to complete that this year.
Patrick Haley: Yeah. Thanks, Mike. So Asthika, from a share repurchase perspective, as Mike mentioned in his prepared remarks, we're going to continue to do share repurchases as long as we feel like we're undervalued, and that continues today. We have $590 million left over on the most recent authorization, $750 million authorization from the board, and our commitment is to complete that this year.
Speaker #3: Okay , Chris .
Speaker #2: Thanks , Mike . So , from a from a share repurchase .
Speaker #3: Perspective .
Speaker #2: You know , as Mike mentioned in his prepared remarks , you know , we're going to continue to do share repurchases as long as we feel like we're undervalued and that that continues today .
Speaker #2: You know, we have $590 million left over on the most recent authorization, the $750 million authorization from the board. And our commitment is to complete that this year.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.
Speaker #1: Thank you. Please stand by for our next question. Our next question comes from the line of Paul Choi with Goldman Sachs.
Paul Choi: Hi. Thank you. Good afternoon, and thanks for taking our question. My question is just on: can you comment on recent 340B purchasing behavior and whether you expect that channel to increase, and along with the Part D redesign, just sort of your views on how that could potentially also impact zanzalintinib as you commercialize that in 2027? Thank you very much for taking our question.
Paul Choi: Hi. Thank you. Good afternoon, and thanks for taking our question. My question is just on: can you comment on recent 340B purchasing behavior and whether you expect that channel to increase, and along with the Part D redesign, just sort of your views on how that could potentially also impact zanzalintinib as you commercialize that in 2027? Thank you very much for taking our question.
Speaker #1: Your line is open
Speaker #6: Thank you . Good
Speaker #6: afternoon , and . Hi . our question . My question is just on . Can you comment on recent 340 b purchasing behavior and whether you expect that channel to to increase and along with , with part the part D redesign just sort of your your views on how that could potentially also impact Zanza as you commercialize that in 27 .
Patrick Haley: Yeah. Chris?
Patrick Haley: Yeah. Chris?
Christopher Senner: Yeah. So thanks, Paul. It's Chris. From a 340B perspective, we've seen variability throughout 2025, and we're expecting variability throughout 2026, and that could have an impact on the gross to net just based on the fact that it's a heavily discounted segment of the business. And the second question was.
Christopher Senner: Yeah. So thanks, Paul. It's Chris. From a 340B perspective, we've seen variability throughout 2025, and we're expecting variability throughout 2026, and that could have an impact on the gross to net just based on the fact that it's a heavily discounted segment of the business. And the second question was.
Speaker #6: Thank you very much for taking our question .
Speaker #3: Yeah , Chris .
Speaker #2: So thanks , Paul . It's Chris , you know , from a 340 perspective , we've seen variability throughout 2025 . And you expecting know , we're variability throughout 2026 .
Speaker #2: You know, and that could have an impact on the gross to net, just based on the fact that it's a heavily discounted segment of the business. And the second question—
Michael M. Morrissey: Yeah. On the Part D redesign, P.J., you want to address that?
Michael M. Morrissey: Yeah. On the Part D redesign, P.J., you want to address that?
Christopher Senner: Yeah. Well, I'm sorry. Was it zanzalintinib? In terms of zanzalintinib, I think we'll obviously be designing our channel to optimize results going forward there, having all the experience we have from Cabo and being in the market for a decade. So we'll obviously look to customize that for sort of the current state of the business in the markets.
Christopher Senner: Yeah. Well, I'm sorry. Was it zanzalintinib? In terms of zanzalintinib, I think we'll obviously be designing our channel to optimize results going forward there, having all the experience we have from Cabo and being in the market for a decade. So we'll obviously look to customize that for sort of the current state of the business in the markets.
Speaker #3: Was on the part D redesign , PJ , you want to address that .
Speaker #4: Yeah . Well I'm sorry , was it Zanza in terms of , you know terms of in , Zanza I will think how you know ?
Speaker #4: Obviously we'll be designing our channel to optimize results going forward . There . You know , having all the experience we have from Cabo and being in the market for a decade .
Speaker #4: So , you know , we'll obviously look to to customize that for sort of , you know , the current state of the business in the markets .
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with Citizens. Your line is open.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Tuerkcan with Citizens. Your line is open.
Speaker #1: Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Cherkin with Citizens. Your line is open.
Silvan Tuerkcan: Yeah. Thank you, and thanks for taking my questions. Thank you for the details on STELLAR-316. I just have a big picture question here. How big do you think this population is since it's so early in colorectal cancer? And what's a rough timeline for readout here? And additionally, are there any reference trials? I know this design is very popular with immunotherapy, but for targeted therapies, I've not seen that yet. Thank you.
Silvan Tuerkcan: Yeah. Thank you, and thanks for taking my questions. Thank you for the details on STELLAR-316. I just have a big picture question here. How big do you think this population is since it's so early in colorectal cancer? And what's a rough timeline for readout here? And additionally, are there any reference trials? I know this design is very popular with immunotherapy, but for targeted therapies, I've not seen that yet. Thank you.
Speaker #5: Thank you . Yeah . And thanks for taking my questions . Thank you for the details on Stellar 316 . I just have a big picture question here .
Speaker #5: How big do you think this population is, since it's so early in colorectal cancer? And what's a rough timeline for readout here?
Speaker #5: And additionally , are there any reference trials ? I know this this this design is very popular with immunotherapy , but for for therapies , I've not targeted seen that yet .
Patrick Haley: Sure. Thanks, Silvan. This is Dana. I'll take the question. So with STELLAR-316, the population we're calculating is based on approximately 20% of the patients who've completed definitive therapy and are positive based on the ctDNA test from Natera. The data that they have and that we've gleaned from public sources and presentations indicates an opportunity of 20,000 to 25,000 or so in that range.
Patrick Haley: Sure. Thanks, Silvan. This is Dana. I'll take the question. So with STELLAR-316, the population we're calculating is based on approximately 20% of the patients who've completed definitive therapy and are positive based on the ctDNA test from Natera. The data that they have and that we've gleaned from public sources and presentations indicates an opportunity of 20,000 to 25,000 or so in that range.
Speaker #5: you Thank .
Speaker #2: Thanks , Sure . Silvan . This is Dana . I'll take the question . So with stellar 316 , you know the population were calculating is based on approximately 20% of the patients who have completed definitive therapy .
Speaker #2: And are positive based on the ctDNA test from Natera , the the data that they have and that we've gleaned from public sources and presentations and indicates an opportunity of 20 to 25,000 or so in that range .
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.
Speaker #7: Thank you .
Speaker #1: Please stand by for our next question. Our next question comes from the line of Yaron Werber with TD Cowen. Your line is open.
Ashwani Verma: Great. Thanks so much for taking my question. Maybe a quick question on NET. It sounds like revenues were over $100 million for the year. Kind of in the past, we've thought the opportunity can reach even $500 to 600 million, and it was sort of more than 50% of the quarter-over-quarter growth in Q2. Can you maybe just help frame what is it going to take? Do you need to move it up to get a higher share, or sort of what's the dynamic on the market? And then secondly, just any update on when Merck will start the next study in combination with zanzalintinib. Thank you.
Ashwani Verma: Great. Thanks so much for taking my question. Maybe a quick question on NET. It sounds like revenues were over $100 million for the year. Kind of in the past, we've thought the opportunity can reach even $500 to 600 million, and it was sort of more than 50% of the quarter-over-quarter growth in Q2. Can you maybe just help frame what is it going to take? Do you need to move it up to get a higher share, or sort of what's the dynamic on the market? And then secondly, just any update on when Merck will start the next study in combination with zanzalintinib. Thank you.
Speaker #8: Great . Thanks so much for taking my question . Maybe a quick on question on , it sounds like revenues net were were over 100 million for the year we kind of in the .
Speaker #8: You know , past we've thought the opportunity can reach even , you know , 500 to 600 . And and it was sort of than more 50% of the quarter over quarter growth in Q2 .
Speaker #8: Can you maybe just help frame what is it going to take ? Do you need to move it up to get a higher share or sort of what's the dynamic on the market ?
Michael M. Morrissey: Yeah. P.J., Patrick, take the next question.
Michael M. Morrissey: Yeah. P.J., Patrick, take the next question.
Speaker #8: And then secondly, just any update on when Merck will start the next study in combination with Zanza? Thank you.
Patrick Haley: Yeah. Thanks for the question, Yaron. With regards to NET, we're really pleased with the start to the launch year, which, I'll remind you, approval was just kind of the very end of March there at the end of Q1. So as you mentioned, we're very happy to achieve the $100 million in net revenue in 2025. It's still very early days in terms of the launch. We're very pleased that we've become the number one oral therapy in the second-line plus neuroendocrine tumor segment. But our market research, as I mentioned, indicates that there's still plenty of room to grow there. And really, as we look at it, that's primarily in the community setting. Our uptake has been broad across all sort of clinical features of NET, which is great.
Patrick Haley: Yeah. Thanks for the question, Yaron. With regards to NET, we're really pleased with the start to the launch year, which, I'll remind you, approval was just kind of the very end of March there at the end of Q1. So as you mentioned, we're very happy to achieve the $100 million in net revenue in 2025. It's still very early days in terms of the launch. We're very pleased that we've become the number one oral therapy in the second-line plus neuroendocrine tumor segment. But our market research, as I mentioned, indicates that there's still plenty of room to grow there. And really, as we look at it, that's primarily in the community setting. Our uptake has been broad across all sort of clinical features of NET, which is great.
Speaker #3: Yeah . PJ take that . Take the next question .
Speaker #4: Yeah . Thanks for the question . Your own you know , with regards to net , we're really pleased with the start to the launch here , which I'll remind you , you know , approval was just kind of the very end of March there at the end of Q1 .
Speaker #4: So as you mentioned , we're very happy to achieve the 100 million in in net revenue 2025 . And in very early still , you days in terms of the launch , you know , we're very pleased that we've become the number one oral therapy in the second line .
Speaker #4: Plus neuroendocrine tumor segment . But our market research , as I mentioned , indicates that there's still plenty of room to grow there .
Speaker #4: And really , as we look at it , that's primarily in the community setting . You know , our uptake has been broad across all sort of clinical features of net , which is great .
Patrick Haley: But what's exciting about having opportunity in the community setting is the fact that we've expedited and really now completed our expansion of our GI sales team to really put it on par with the size of our GU team. It gives us the ability to reach much farther into the community and really do what we need to do to change behavior more broadly. Because what we see is physicians responding very favorably to the data and having positive experiences with the drug. So we just need to be in front of them so that they have the opportunity to use Cabo for appropriate patients. So we're looking forward to that.
Patrick Haley: But what's exciting about having opportunity in the community setting is the fact that we've expedited and really now completed our expansion of our GI sales team to really put it on par with the size of our GU team. It gives us the ability to reach much farther into the community and really do what we need to do to change behavior more broadly. Because what we see is physicians responding very favorably to the data and having positive experiences with the drug. So we just need to be in front of them so that they have the opportunity to use Cabo for appropriate patients. So we're looking forward to that.
Speaker #4: But what's about having exciting opportunity in the community setting is the fact that we've expedited and really now completed our expansion of our GI sales team to really put it , you know , on par with the size of our GU team gives us the ability to reach much farther into the community .
Speaker #4: And , you know , really need to do do what we to change behavior more broadly , because what we see is physicians responding very favorably to the data and having positive experiences with the drug .
Speaker #4: So we just need to be in front of them have the opportunity to use so that they Cabo for appropriate patients . So we're looking forward to that .
Operator: Thank you. Our next question comes from the line of Akash Tewari with Jefferies. Your line is open.
Operator: Thank you. Our next question comes from the line of Akash Tewari with Jefferies. Your line is open.
Speaker #1: you Thank . Our next question comes from of Acosta Wurie with Jefferies . Your line is open .
[Analyst] (various): Hey. Thanks so much. Can you talk about why you and Merck chose to kind of run a trial like LITESPARK-033 in this post-adjuvant first-line RCC setting versus what your team did with CheckMate 9ER when you went after PD-1 naive patients? And kind of what I'm trying to understand is really what percent of first-line RCC patients now are actually getting a PD-1 in an adjuvant setting, and how do you think that figure will really evolve as we approach the end of the decade? And maybe just lastly, what profile do you think zanzalintinib plus belzutifan will need to show in a second-line plus setting to support running a trial in the same population as LITESPARK-001? Thank you.
Asthika Goonewardene: Hey. Thanks so much. Can you talk about why you and Merck chose to kind of run a trial like LITESPARK-033 in this post-adjuvant first-line RCC setting versus what your team did with CheckMate 9ER when you went after PD-1 naive patients? And kind of what I'm trying to understand is really what percent of first-line RCC patients now are actually getting a PD-1 in an adjuvant setting, and how do you think that figure will really evolve as we approach the end of the decade? And maybe just lastly, what profile do you think zanzalintinib plus belzutifan will need to show in a second-line plus setting to support running a trial in the same population as LITESPARK-001? Thank you.
Speaker #2: Hey, thanks so much. Can you talk about why you and Merck chose to kind of run a trial like LIGHTS OE33 in this post?
Speaker #2: Adjuvant first line RCC setting versus what your team did with checkmate nine er when you went after PD one naive patients and kind of what I'm trying to understand is really what percent of first line RCC patients now are actually getting a PD one in an adjuvant setting .
Speaker #2: How do you—and do you think that figure will really evolve as we approach the end of the decade? And maybe just lastly, what profile do you think Zanza plus belzutifan will need to show in a second line?
Michael M. Morrissey: Yeah. Akash, let me start, and I can pass it on to P.J. and/or Dana to provide color commentary. So again, I think the way we look at the problem, and I would advise that you look at the problem, is not so much on what's happening today, but what's going to be happening in the future. Think early to mid-30s, 2030s, where we're really targeting having Xanza be a standard of care for RCC, right? If you look at the Cabo story, we have a dominant standard of care TKI for RCC in the '20s, right, based upon all the data we've generated. And we aspire to do the same thing for Xanza, but fast-forwarding years ahead to be able to understand how standard of care will evolve between now and then so that Xanza can be a great player there.
Michael M. Morrissey: Yeah. Akash, let me start, and I can pass it on to P.J. and/or Dana to provide color commentary. So again, I think the way we look at the problem, and I would advise that you look at the problem, is not so much on what's happening today, but what's going to be happening in the future. Think early to mid-30s, 2030s, where we're really targeting having Xanza be a standard of care for RCC, right? If you look at the Cabo story, we have a dominant standard of care TKI for RCC in the '20s, right, based upon all the data we've generated. And we aspire to do the same thing for Xanza, but fast-forwarding years ahead to be able to understand how standard of care will evolve between now and then so that Xanza can be a great player there.
Speaker #2: Setting to support running a trial in the same population as LIGHTS? Oh, one, thank you.
Speaker #3: Yeah , let me let me start and I can pass it on to P.J. and or or Dana to provide color commentary . So again , I think the way we look at the problem and advise that you look at the I would problem is not so much on what's happening today , but what's going to be happening in the in the future .
Speaker #3: I think early to mid 30s , 2030s , where we're really targeting , you know , having zanza be a standard of care for RCC , right ?
Speaker #3: If you look at the Cabo story , you know , we have a dominant , you know , standard of care . TKI for RCC in the 20s , right .
Speaker #3: Based upon all the data we've generated and we aspire to do the same thing for Zanza . But fast forwarding , you know , years ahead .
Michael M. Morrissey: So again, we've got three ongoing or planned pivotal trials so far with RCC. We're having a lot of very important discussions with other potential combination partners that I'll frame as having orthogonal MOAs that could, again, give us a lot more bang for the buck also in RCC that we're really excited about. So I would look at and I certainly look at, and I would recommend you look at it as this is the non-clear-cell trial. The two Merck trials are really just the beginnings of building a franchise for RCC where we can have a dominant position with zanzalintinib in the 2030s.
Michael M. Morrissey: So again, we've got three ongoing or planned pivotal trials so far with RCC. We're having a lot of very important discussions with other potential combination partners that I'll frame as having orthogonal MOAs that could, again, give us a lot more bang for the buck also in RCC that we're really excited about. So I would look at and I certainly look at, and I would recommend you look at it as this is the non-clear-cell trial. The two Merck trials are really just the beginnings of building a franchise for RCC where we can have a dominant position with zanzalintinib in the 2030s.
Speaker #3: To be able to understand how standard of care will evolve between now and then . So that Zanza can be a great player .
Speaker #3: There . So again , we've got three ongoing or planned pivotal trials . So far with RCC . We're having a lot of important very discussions with other combination potential partners that I'll frame as having orthogonal Moas that know , could , you again , give us a lot more bang for the buck .
Speaker #3: Also in RCC that we're really excited about . So so I would look at and I certainly look at it and I would recommend you look at it as you know , the , the Non-clear cell trial , the two Merck trials are really just the beginnings of building a franchise for RCC , where we can have a dominant position with Zanza in the 2030s .
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open.
Speaker #1: Thank you . Please stand by for our next question . My next question comes from the line of Andy Shi with William Blair .
[Analyst] (various): Thanks for taking our questions. So kind of going back to the previous question, maybe for PJ, do you see an increased utility of Cabo monotherapy in the first-line setting, just driven by the evolving dynamics in the IO usage, mostly in the adjuvant setting?
Asthika Goonewardene: Thanks for taking our questions. So kind of going back to the previous question, maybe for PJ, do you see an increased utility of Cabo monotherapy in the first-line setting, just driven by the evolving dynamics in the IO usage, mostly in the adjuvant setting?
Speaker #1: Your line is open .
Speaker #9: I think our questions so kind of going back to the previous question , maybe for P.J. , do you see an increased utility of carbo monotherapy in the first line setting ?
Speaker #9: Just driven by the evolving dynamics in the IO usage, mostly in the adjuvant setting?
Patrick Haley: Yeah. Thanks for the question, Andy. What I'd say is we've always had a very reasonable utilization of Cabo monotherapy in the first-line setting. If you kind of think back to the Cabo Sun study, which we did, it was a cooperative group study that we got an indication based on in sort of single-agent first-line utilization. So there's always been a role and a place for Cabo in the first-line setting, and that really continues to be the case, particularly in terms of the monotherapy segment of that population.
Patrick Haley: Yeah. Thanks for the question, Andy. What I'd say is we've always had a very reasonable utilization of Cabo monotherapy in the first-line setting. If you kind of think back to the Cabo Sun study, which we did, it was a cooperative group study that we got an indication based on in sort of single-agent first-line utilization. So there's always been a role and a place for Cabo in the first-line setting, and that really continues to be the case, particularly in terms of the monotherapy segment of that population.
Speaker #4: Yeah . Thanks for the question , Andy . You know , what I'd say is we've always had a very reasonable utilization of carbo monotherapy in the first line setting .
Speaker #4: If you kind of think back to the the cabosun study , which we did , it was a cooperative group study that we got an indication based on in sort of single agent first line utilization .
Speaker #4: So there's always been a role and a place for Carbo in the first line setting . And that really continues to be the the case , particularly in terms of , you know , the monotherapy segment of that population .
Operator: Thank you. Our next question comes from the line of Sean Laaman with Morgan Stanley. Your line is open.
Operator: Thank you. Our next question comes from the line of Sean Laaman with Morgan Stanley. Your line is open.
Speaker #7: Thank you .
Patrick Haley: Hi, Mike and team. Hope everyone's well. Thanks for taking my question. Just maybe some updated thoughts ahead of the non-liver mets OS final analysis in mid-2026, Mike, how do you anticipate positive data impacting your commercial strategy or communication with physicians?
Patrick Haley: Hi, Mike and team. Hope everyone's well. Thanks for taking my question. Just maybe some updated thoughts ahead of the non-liver mets OS final analysis in mid-2026, Mike, how do you anticipate positive data impacting your commercial strategy or communication with physicians?
Speaker #1: next question Our comes from the line of Sean Lohman with Morgan Stanley . Your line is open .
Speaker #10: Mike . And team hope Hi , everyone's well . And thanks for taking my question . Just maybe some updated thoughts . You know , ahead of the Nonliver final OS Mets analysis mid 26 , in Mike , do you how anticipate positive data impacting your commercial strategy or communication with physicians ?
Michael M. Morrissey: Thanks for the question, Sean. That's a great one for P.J. to answer. Over to you, P.J.
Michael M. Morrissey: Thanks for the question, Sean. That's a great one for P.J. to answer. Over to you, P.J.
Patrick Haley: Yeah. No. Thanks for the question, Sean. I'd say first and foremost, obviously, the non-liver mets is a subset of the overall ITT population where we've been positive. So as we think about that, that's a big deal. And the liver mets patients, in a sense, were kind of the harder-to-treat segment. So we're really excited about the data we have in hand in the sense that that's really going to help us move the needle pending approval for those patients, as I mentioned, that we see from our research, our advisory boards, where there's a significant unmet medical need and where the STELLAR-303 data really being received positively. Obviously, we'll see what the non-liver mets data show when that comes. And I think the way we think about it, that's just more opportunity to help us elucidate the benefit across the board in advanced third-line plus CRC.
Patrick Haley: Yeah. No. Thanks for the question, Sean. I'd say first and foremost, obviously, the non-liver mets is a subset of the overall ITT population where we've been positive. So as we think about that, that's a big deal. And the liver mets patients, in a sense, were kind of the harder-to-treat segment. So we're really excited about the data we have in hand in the sense that that's really going to help us move the needle pending approval for those patients, as I mentioned, that we see from our research, our advisory boards, where there's a significant unmet medical need and where the STELLAR-303 data really being received positively. Obviously, we'll see what the non-liver mets data show when that comes. And I think the way we think about it, that's just more opportunity to help us elucidate the benefit across the board in advanced third-line plus CRC.
Speaker #3: Thanks for the question , Sean . That's a great one for PJ to answer . What were you PJ .
Speaker #4: question , Sean . , thanks for your You know , I'd say first and foremost , you know , obviously the Nonliver Mets is a subset of the overall ITT population where we've been positive .
Speaker #4: So , you know , as we think about that , that's a big And the liver Mets patients in a sense were kind of the harder to treat segment .
Speaker #4: So we're really excited about the data we have in hand in the sense that that's really going to help us move the needle .
Speaker #4: know , pending You approval for those patients . As I mentioned , that we see , you know , from our research , our advisory boards , where there's a significant unmet medical need and where the stellar 303 data really being received positively .
Speaker #4: You know , obviously , we'll see what the Nonliver Mets data data show . And that and , you know , I think the way we think about it , just more opportunity for us to help us elucidate the benefit , you know , across the board in in advance , third line plus CRC .
Patrick Haley: We've just heard a lot of positives in terms of the data, particularly when we think about the mechanism of action of the combination as well as the potential to have an immune checkpoint inhibitor available to a broader population outside of the MSI high population. That's really something we're hearing across the board from oncologists, is important. And in fact, what we hear from them is literally almost all their patients are asking for an immune checkpoint inhibitor. So we think this will be really important for the treating physicians and their patients.
Patrick Haley: We've just heard a lot of positives in terms of the data, particularly when we think about the mechanism of action of the combination as well as the potential to have an immune checkpoint inhibitor available to a broader population outside of the MSI high population. That's really something we're hearing across the board from oncologists, is important. And in fact, what we hear from them is literally almost all their patients are asking for an immune checkpoint inhibitor. So we think this will be really important for the treating physicians and their patients.
Speaker #4: You know , we've just heard a lot of positives in terms of of the data . You know , particularly when we think about the mechanism of action of the combination as well as the potential to have an immune checkpoint inhibitor available to broader population outside MSI high That's population .
Speaker #4: really something we're hearing across the board from oncologists is important . And in fact , what we hear from them is literally almost all their patients are asking for an immune checkpoint inhibitor .
Operator: Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.
Operator: Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is open.
Speaker #4: So we think this will be really important treatment for the physicians and their patients.
Speaker #7: Thank you .
Michael M. Morrissey: Hey, guys. This is Rose Li from Michael. Thanks for taking our questions. I guess just first of all, I guess as we look ahead to the 25 December date for STELLAR-303, can you just comment on the nature of your interactions with the FDA to date and whether you currently anticipate an advisory committee as part of the review process? And then secondly, regarding your earlier stage pipeline, how are you thinking about the cadence of initial data disclosures? And can you provide some color on how you're evaluating those early signals when making the no-go decision on advancing programs? Thank you.
Michael M. Morrissey: Hey, guys. This is Rose Li from Michael. Thanks for taking our questions. I guess just first of all, I guess as we look ahead to the 25 December date for STELLAR-303, can you just comment on the nature of your interactions with the FDA to date and whether you currently anticipate an advisory committee as part of the review process? And then secondly, regarding your earlier stage pipeline, how are you thinking about the cadence of initial data disclosures? And can you provide some color on how you're evaluating those early signals when making the no-go decision on advancing programs? Thank you.Sure. Thanks for the question, Rose. This is Dana. So regarding the STELLAR-303 NDA and interactions with the agency, I'll just reiterate, we're super excited about the acceptance of the NDA, and we're very actively engaging with the agency on the filing, as is the norm in these types of activities. So regarding the non-liver mets data, those data are due in the middle of the year. Those data, as well as any other data, including the 120-day safety update, additional analyses, or data cuts that the agency asked for, will be shared with the agency as part of the normal process. So all of that is going according to plan, and we're quite excited about our interactions. We're very positive on how things are proceeding, and we're working with the agency very actively. So we're happy.
Speaker #1: Our next question comes from the line of Michael Schmidt with Guggenheim . Your line is open .
Speaker #11: guys , this is Hey , Roseann for Michael . taking Thanks for our questions . I guess just first of all , as we look ahead to the December first , 303 , can you just comment on the nature of your interactions with the FDA to date and whether you currently anticipate an advisory committee as part of the review process ?
Speaker #11: And then secondly , regarding your earlier stage pipeline , how are you thinking about the cadence of initial data disclosures and can you provide some color on how evaluating those early when signals making the no no go decision on advancing programs ?
Patrick Haley: Sure. Thanks for the question, Rose. This is Dana. So regarding the STELLAR-303 NDA and interactions with the agency, I'll just reiterate, we're super excited about the acceptance of the NDA, and we're very actively engaging with the agency on the filing, as is the norm in these types of activities. So regarding the non-liver mets data, those data are due in the middle of the year. Those data, as well as any other data, including the 120-day safety update, additional analyses, or data cuts that the agency asked for, will be shared with the agency as part of the normal process. So all of that is going according to plan, and we're quite excited about our interactions. We're very positive on how things are proceeding, and we're working with the agency very actively. So we're happy.
Speaker #11: Thank you .
Speaker #12: Thanks for the question , Roseanne . This is Dana . So regarding the stellar 303 NDA and interactions with the agency , I'll just reiterate we're super excited about the acceptance of the NDA .
Speaker #12: And we're we're very actively engaging with the the agency on the filing , as is the norm in these types of activities . So , you know , we're we're regarding the non liver Mets data .
Speaker #12: You know , those data are due in the middle of the year . Those data as well as any other data , including like the 120 day safety update .
Speaker #12: Additional analyses or data cut to the agency asked for will be shared with the agency as part of the normal process . So all of that is going according to plan .
Speaker #12: And we're we're quite excited about our interactions . The the , you know , we're very positive on on how things are proceeding and we're working with the agency very actively .
Operator: Thank you. Our next question comes from the line of Sudan Loganathan with Stephens. Your line is open.
Operator: Thank you. Our next question comes from the line of Sudan Loganathan with Stephens. Your line is open.
Speaker #12: So we're we're happy .
Speaker #7: Thank you .
[Analyst] (various): Hi, everyone. Thanks for taking my question. First, I wanted to ask, can you comment on any trials ongoing and potentially reading out this year that could challenge Cabo in the second-line plus RCC setting? And then secondly, how do trials such as that LITESPARK-033 and even the combo trial Arcus is running with Cabo in the post-IO setting could help retain the lead share in RCC as we look into the remainder of 2026?
Asthika Goonewardene: Hi, everyone. Thanks for taking my question. First, I wanted to ask, can you comment on any trials ongoing and potentially reading out this year that could challenge Cabo in the second-line plus RCC setting? And then secondly, how do trials such as that LITESPARK-033 and even the combo trial Arcus is running with Cabo in the post-IO setting could help retain the lead share in RCC as we look into the remainder of 2026?
Speaker #1: Our next question comes from the line of Logan Nathan with Stephens . Your line is open .
Speaker #12: Hi, everyone. Thanks for taking my question.
Speaker #2: First , I wanted to ask , can you comment on any trials ongoing and potentially reading year that could challenge Carbo ? And the second line plus RCC setting ?
Speaker #2: And then secondly , how do as that trials such light spark oe33 and even the combo trial Arcus is running with carbo in the post IO setting could help retain the lead share in RCC .
Michael M. Morrissey: Okay, Sudan. Thanks for the question. P.J., want to take that one on?
Michael M. Morrissey: Okay, Sudan. Thanks for the question. P.J., want to take that one on?
Speaker #2: As we look into the remainder of 2026.
Speaker #2: As we look into the remainder of 2026.
Patrick Haley: Yeah. Thanks for the question. With regards to ongoing trials, obviously, we're aware that there's data reading out at the upcoming GU ASCO meeting. We're following that very closely. I guess the press release should have said it's positive for PFS. I would just remind you, and we heard this sort of very clearly from our KOL in our R&D Day event and sort of broadly across the board from KOLs and research, that to really raise the bar and the standard of care in RCC at this point, overall survival is really critical to do that. So we'll see what the data are. Anytime you add more drugs into the mix, there's incremental toxicity, and you have to kind of see what the overall profile of the product is. But we're confident in Cabo, in our position in the marketplace, in our team, and in the data.
Patrick Haley: Yeah. Thanks for the question. With regards to ongoing trials, obviously, we're aware that there's data reading out at the upcoming GU ASCO meeting. We're following that very closely. I guess the press release should have said it's positive for PFS. I would just remind you, and we heard this sort of very clearly from our KOL in our R&D Day event and sort of broadly across the board from KOLs and research, that to really raise the bar and the standard of care in RCC at this point, overall survival is really critical to do that. So we'll see what the data are. Anytime you add more drugs into the mix, there's incremental toxicity, and you have to kind of see what the overall profile of the product is. But we're confident in Cabo, in our position in the marketplace, in our team, and in the data.
Speaker #3: Susan , thanks for the question . Okay PJ . Want to take that one on ?
Speaker #4: Yeah , thanks for the question . You know , with regards to to ongoing trials , obviously we're we're aware that there's , you know , data reading out at the upcoming Asco meeting .
Speaker #4: We're following that very closely . You know , I guess the press release , you know , says it's positive for PFS . I would just remind you and we heard this sort of very clearly from our coal in our R&D day event .
Speaker #4: And sort of broadly across the board from , from Kols and research that to really raise the bar in the standard of care in RCC at this point , overall survival is really critical to do that .
Speaker #4: So , know , you we'll see data are . Anytime you add more drugs into the mix , there's incremental toxicity and you have to kind of see what the , the , the overall profile of the product is .
Patrick Haley: The data has ripened well as we've seen data such as CONTACT-03 from Cabo. So we're confident in our position in RCC.
Patrick Haley: The data has ripened well as we've seen data such as CONTACT-03 from Cabo. So we're confident in our position in RCC.
Speaker #4: you know , we're But , confident in Cabo in our position in the marketplace , in our team , in the data . The data is ripe .
Speaker #4: And well , as we've seen , you know , data such as contact three from Cabo . So , you know , we're confident in our position in RCC .
Operator: Thank you. Our next question comes from the line of Leonid Timashev with RBC. Your line is open.
Operator: Thank you. Our next question comes from the line of Leonid Timashev with RBC. Your line is open.
Speaker #7: Thank you .
[Analyst] (various): Thanks, guys. Thanks for taking my question. I just wanted to follow up on some of the RCC questions from today and then your own. I guess with growth to net looking better than expected, the net launch being stronger than expected, I guess how much growth are we expecting from RCC in 2026? And I guess is that coming from new patient starts? Are there still segments of the population that are underutilizing Cabo and RCC, or is it maybe more playing defense, and maintaining share in 2026 is the strategy across some of the academic centers? Can you just maybe talk about that? Thanks.
Asthika Goonewardene: Thanks, guys. Thanks for taking my question. I just wanted to follow up on some of the RCC questions from today and then your own. I guess with growth to net looking better than expected, the net launch being stronger than expected, I guess how much growth are we expecting from RCC in 2026? And I guess is that coming from new patient starts? Are there still segments of the population that are underutilizing Cabo and RCC, or is it maybe more playing defense, and maintaining share in 2026 is the strategy across some of the academic centers? Can you just maybe talk about that? Thanks.
Speaker #1: Our next question comes from the line of Leonid Timashev with RBC. Your line is open.
Speaker #13: Thanks , guys . Thanks for taking my question . I just wanted to follow up on RCC some of the questions from Sudan in your own .
Speaker #13: I guess with gross to net looking better than expected, the net launch being stronger than expected. I guess, how much growth are we expecting from RCC coming in 2026?
Speaker #13: in from And I guess that new patient starts , are segments of still there the population that are Underutilizing , Cabo and RCC ?
Speaker #13: Or is it more maybe more , you defense and maintaining share in 2026 ? Is the strategy across some of the academic centers .
Michael M. Morrissey: Yeah. Sure. P.J., I want to take that, and I'll provide some color commentary too.
Michael M. Morrissey: Yeah. Sure. P.J., I want to take that, and I'll provide some color commentary too.
Patrick Haley: Yeah. Thanks for the question, Leonid. As I mentioned, kind of we're very pleased with our position and the year we had in 2025 with significant growth in both RCC and, obviously, from the NET launch. So as we look forward, you obviously see from our guidance that we have significant growth we're expecting in 2026. And we really do see that coming from really both aspects of the franchise in terms of neuroendocrine tumors as well as RCC as we continue to compete in that space. We're doing so very well. And the first-line market is very much our focus. And we believe we can continue to get growth coming from those patients in the first-line setting.
Patrick Haley: Yeah. Thanks for the question, Leonid. As I mentioned, kind of we're very pleased with our position and the year we had in 2025 with significant growth in both RCC and, obviously, from the NET launch. So as we look forward, you obviously see from our guidance that we have significant growth we're expecting in 2026. And we really do see that coming from really both aspects of the franchise in terms of neuroendocrine tumors as well as RCC as we continue to compete in that space. We're doing so very well. And the first-line market is very much our focus. And we believe we can continue to get growth coming from those patients in the first-line setting.
Speaker #13: Can you just maybe talk about that? Thanks.
Speaker #3: Yeah , sure . PJ , I want to take that and I'll provide some color to . commentary
Speaker #4: Yeah , thanks for the question , Leonid . You know , we're as I mentioned , kind of we're very pleased with our position and the year we had in 2025 with a significant growth in both RCC and obviously from from the net launch .
Speaker #4: So, as we look forward, you know, you obviously see from our guidance that we have significant growth we're expecting in 2026.
Speaker #4: And we really do see that coming from both aspects of the franchise, in terms of neuroendocrine tumors as well as RCC.
Speaker #4: As we continue to compete in that space , we're doing so very well . And , you know , the first line market is very much our focus .
Speaker #4: And we believe we can continue to get get from those growth coming patients . In the first line setting .
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.
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 #7: Thank you .
Speaker #1: For our next 'Please stand by' question, our next question comes from the line of Jason Gerberry with Bank of America. Your line is open.
[Analyst] (various): Hey, guys. Thank you for taking my question. Mike, my question's more of just a conceptual one because I know you can't really comment on potential zanzalintinib pricing. But as you kind of observe what we're seeing as maybe a trend in higher launch pricing in the last 12 months for cancer therapies, I'm just wondering maybe if you can speak to that as a trend. It seems like perhaps maybe sponsors are factoring in things like IRA and compensating for that. And investors have taken notice as well of these higher launch prices. So I wonder if you can just comment at all in terms of what you're seeing from a trend perspective. Thanks.
Asthika Goonewardene: Hey, guys. Thank you for taking my question. Mike, my question's more of just a conceptual one because I know you can't really comment on potential zanzalintinib pricing. But as you kind of observe what we're seeing as maybe a trend in higher launch pricing in the last 12 months for cancer therapies, I'm just wondering maybe if you can speak to that as a trend. It seems like perhaps maybe sponsors are factoring in things like IRA and compensating for that. And investors have taken notice as well of these higher launch prices. So I wonder if you can just comment at all in terms of what you're seeing from a trend perspective. Thanks.
Speaker #14: Hey , guys . Thank you for taking my question , Mike . My question is more of just a conceptual one because I know you can't really comment on potential pricing , but as you kind of observe what we're seeing is maybe a trend in higher launch pricing in the last 12 months for cancer therapies .
Speaker #14: I'm just wondering, maybe, if you can speak to that as a trend. It seems like, perhaps, maybe sponsors are factoring in things like IRA and compensating for that.
Speaker #14: And investors have taken notice as well of these higher launch prices. So I wonder if you can just comment at all in terms of what you're seeing from a trend perspective.
Michael M. Morrissey: Yeah. Thanks, Jason. Well, I think you actually covered it pretty well in terms of the data and the facts out there. I wouldn't want to speculate why people are behaving a certain way, but you certainly can, and you did, which is fine. We'll certainly keep potential pricing opportunities for Exelixis's drugs, certainly zanzalintinib, under our hat until the appropriate time. But I'm really glad that you highlighted some of the trends as they're going forward, which I think the way you frame it is probably a reasonable way to kind of put things in perspective. So thanks for doing that.
Michael M. Morrissey: Yeah. Thanks, Jason. Well, I think you actually covered it pretty well in terms of the data and the facts out there. I wouldn't want to speculate why people are behaving a certain way, but you certainly can, and you did, which is fine. We'll certainly keep potential pricing opportunities for Exelixis's drugs, certainly zanzalintinib, under our hat until the appropriate time. But I'm really glad that you highlighted some of the trends as they're going forward, which I think the way you frame it is probably a reasonable way to kind of put things in perspective. So thanks for doing that.
Speaker #14: Thanks .
Speaker #3: Yeah . Thanks , Jason . I think you actually covered it pretty well in terms of the the data and the facts out there .
Speaker #3: I wouldn't You know , want to people speculate why are behaving a certain way . But , you know , you certainly can .
Speaker #3: So and you did , which is fine . You know , we'll we'll certainly keep potential pricing opportunities for EXELIXIS, INC. Certainly drugs .
Speaker #3: under our hat until the appropriate time . But I'm really glad that you highlighted some of the , some of the trends as they're going forward , which , you know , I think the the way you frame it is probably a reasonable way to , you know , kind of put things in perspective .
Operator: Thank you. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is open.
Operator: Thank you. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is open.
Speaker #3: So, thanks for doing that.
Speaker #7: Thank you .
Paul Choi: Hi. This is Lucas. Thanks for taking my question. For non-clear-cell, can you give some color around what you expect the market size to be and what your expectations around outcomes relative to standard of care is? And in your R&D slides, you list sunitinib or Cabo Nivo or pembrolizumab as standard of care. Do you have any visibility as to what proportion of patients get those three regimens? And with that, do you have any ideas to how much Cabo revenue is currently attributable to non-clear-cell?
Paul Choi: Hi. This is Lucas. Thanks for taking my question. For non-clear-cell, can you give some color around what you expect the market size to be and what your expectations around outcomes relative to standard of care is? And in your R&D slides, you list sunitinib or Cabo Nivo or pembrolizumab as standard of care. Do you have any visibility as to what proportion of patients get those three regimens? And with that, do you have any ideas to how much Cabo revenue is currently attributable to non-clear-cell?
Speaker #1: next Our question comes from the line of with Barclays . Your line is open .
Speaker #15: Hi , this is Luca . Thanks for taking my question for Non-clear cell . Can you give some can you give some color around what you expect the market size to be and what your expectations are on outcomes relative to standard of care is ?
Speaker #15: And in your R&D slides , you list , you know , sunitinib or Cabo Nivo or Pembro Lin as standard of care . Do you have any visibility as to , you know , what proportion patients of those three regimens and like with that , do you have any any idea as to how much Cabo revenue is currently attributable to Non-clear cell ?
Michael M. Morrissey: PJ?
Michael M. Morrissey: PJ?
Patrick Haley: Yeah. Thanks for the question, Lucas. I guess to start with, as we've said before, non-clear-cell RCC is approximately 20% of renal cell carcinoma. I guess a little perspective on the non-clear-cell portion of RCC today, just like sort of the entire market of renal cell carcinoma, it's very competitive. You mentioned a number of regimens, therapies that can be used there and are used there. Just like there's hotly contested sort of the broader RCC, non-clear-cell is the same. So we believe that that sets us up really well in terms of 304 should we have a positive outcome there because this is very much an underserved and understudied part of the population in terms of these non-clear-cell patients. 304 is really the first pivotal registrational phase 3 study looking at this population.
Patrick Haley: Yeah. Thanks for the question, Lucas. I guess to start with, as we've said before, non-clear-cell RCC is approximately 20% of renal cell carcinoma. I guess a little perspective on the non-clear-cell portion of RCC today, just like sort of the entire market of renal cell carcinoma, it's very competitive. You mentioned a number of regimens, therapies that can be used there and are used there. Just like there's hotly contested sort of the broader RCC, non-clear-cell is the same. So we believe that that sets us up really well in terms of 304 should we have a positive outcome there because this is very much an underserved and understudied part of the population in terms of these non-clear-cell patients. 304 is really the first pivotal registrational phase 3 study looking at this population.
Speaker #4: PJ yeah , thanks for the question , Lucas . You know , I guess to start with , you know , as we've said before , Non-clear cell RCC is approximately 20% of renal cell carcinoma .
Speaker #4: And , you know , I guess a little perspective on the non-clear cell portion of RCC today , just like sort of the entire market of renal cell carcinoma .
Speaker #4: It's very competitive . You know , mentioned a you number of regimens , therapies that can be used there and are used there .
Speaker #4: And just like there's there's , you know , hotly contested sort of the broader RCC non-clear cell is the same . So , you know , we believe that that sets us really well in terms of 3 or 4 .
Speaker #4: Should we have a positive outcome there, because, you know, this is very much an underserved and understudied part of the population in terms of these non-clear cell patients.
Patrick Haley: So as you think about that, that becomes very significant in terms of the ability to really identify those patients and a specific benefit in that population. So what we hear from KOLs is that'll be very important in terms of the potential benefit for those patients and elucidating it. And furthermore, it's really exciting to us to have a potential entry point, obviously, for zanzalintinib into RCC. This is obviously our major franchise in terms of Cabo and something we look forward to expanding on. And as Mike kind of alluded to earlier, we view this as just the beginning for zanzalintinib and RCC. We've got the Merck studies. And as has been mentioned here today, many other potential opportunities we're looking at in combination partners.
Patrick Haley: So as you think about that, that becomes very significant in terms of the ability to really identify those patients and a specific benefit in that population. So what we hear from KOLs is that'll be very important in terms of the potential benefit for those patients and elucidating it. And furthermore, it's really exciting to us to have a potential entry point, obviously, for zanzalintinib into RCC. This is obviously our major franchise in terms of Cabo and something we look forward to expanding on. And as Mike kind of alluded to earlier, we view this as just the beginning for zanzalintinib and RCC. We've got the Merck studies. And as has been mentioned here today, many other potential opportunities we're looking at in combination partners.
Speaker #4: And 3 or 4 is really the first pivotal Registrational phase three study looking at this population . So , you know , as you think about that , that becomes very significant in terms of , you know , the ability to really identify those patients in a specific benefit in that population , you know , so what we hear from Kohl's is that'll be very important in terms of of of the potential benefit for those patients .
Speaker #4: And elucidating it . And furthermore , you know , it's really exciting to us to have a potential entry point . Obviously , Zanza for into RCC .
Speaker #4: You know, this is obviously our major franchise in terms of, we look forward to something Cabo and expanding on, kind of alluded to.
Speaker #4: as Mike , And , you earlier , we view this as just the beginning for Zanza and RCC . We've got , you know , the Merc studies .
Patrick Haley: So, kind of like we did in Cabo and covering the landscape with multiple clinical trial data readouts to really become the standard there, that's our view and approach for Xanza and RCC as well.
Patrick Haley: So, kind of like we did in Cabo and covering the landscape with multiple clinical trial data readouts to really become the standard there, that's our view and approach for Xanza and RCC as well.
Speaker #4: And as has been mentioned here today , you many other potential opportunities we're looking at and combination partners . So like we did in Cabo , Cabo and covering the landscape with multiple clinical trial data readouts to really become the standard there .
Operator: Thank you. Our next question comes from the line of Stephen Willey with Stifel. Your line is open.
Operator: Thank you. Our next question comes from the line of Stephen Willey with Stifel. Your line is open.
Speaker #4: That's our view, and approach for Zanza in RCC as well.
[Analyst] (various): Yeah. Good afternoon. Thanks for taking the question. I think you've previously intimated that you're conducting some additional work on zanzalintinib dose optimization. Just curious if this data is going to be used to inform a starting zanzalintinib dose for STELLAR-316 and whether you would potentially expect to submit any of this additional dose optimization data as part of the ongoing NDA review. Thanks.
Asthika Goonewardene: Yeah. Good afternoon. Thanks for taking the question. I think you've previously intimated that you're conducting some additional work on zanzalintinib dose optimization. Just curious if this data is going to be used to inform a starting zanzalintinib dose for STELLAR-316 and whether you would potentially expect to submit any of this additional dose optimization data as part of the ongoing NDA review. Thanks.
Speaker #7: Thank you .
Speaker #1: Our next question comes from the line of Steven Willi with Stifel. Your line is open.
Speaker #16: Yeah, good afternoon. Thanks for taking the question. I think you've previously intimated that you're conducting some additional work on Zanza dose optimization.
Speaker #16: And just curious if this data is going to be used to inform a starting dose for stellar 316 , and whether you would expect to submit potentially any of this additional dose optimization data part of the ongoing NDA review .
Patrick Haley: Sure. This is Dana Aftab. Thanks for the question. So yeah, our approach is always to use the optimal dose in any pivotal study that's appropriate to each individual setting, which might be influenced by a number of factors, including stage of disease, potential combination partner, expected duration of treatment, etc. So we take that approach with every study, and we'll continue to do so for the foreseeable future, certainly for STELLAR-316. With STELLAR-303, as we mentioned, I think during an event at ESMO, we do have data that we feel are quite strong supporting contribution components. I've shared those data with the agency as part of the review.
Patrick Haley: Sure. This is Dana Aftab. Thanks for the question. So yeah, our approach is always to use the optimal dose in any pivotal study that's appropriate to each individual setting, which might be influenced by a number of factors, including stage of disease, potential combination partner, expected duration of treatment, etc. So we take that approach with every study, and we'll continue to do so for the foreseeable future, certainly for STELLAR-316. With STELLAR-303, as we mentioned, I think during an event at ESMO, we do have data that we feel are quite strong supporting contribution components. I've shared those data with the agency as part of the review.
Speaker #16: as Thanks .
Speaker #12: Sure . This is Dana . Steven , thanks for the question . So yeah , we you know , approach our is always to use the optimal dose in any pivotal study that's appropriate to each individual setting , which , you know , might be influenced by a number of factors , including stage of disease , potential combination partner , expected duration of treatment , etc.
Speaker #12: . So we take that approach with every study , and we'll continue to do so for the foreseeable future . Certainly for stellar 316 with stellar 303 , mentioned , as we I think during an event at SFO , we do have data that we feel are quite strong supporting contribution components and share those data with the agency as part of the review .
Operator: Thank you. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open.
Operator: Thank you. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open.
Speaker #7: Thank you .
Speaker #1: Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open.
Christopher Senner: Oh, hey, guys. Thanks for taking the question. As you plan for the commercialization of Xanza, since this would be the first approval, how should we think about the launch trajectory in CRC? And since it's also a new indication for Atezo, is there any work that Roche is doing that you're aware of to ensure a rapid uptake for this innovative combination regimen? Thank you.
Christopher Senner: Oh, hey, guys. Thanks for taking the question. As you plan for the commercialization of Xanza, since this would be the first approval, how should we think about the launch trajectory in CRC? And since it's also a new indication for Atezo, is there any work that Roche is doing that you're aware of to ensure a rapid uptake for this innovative combination regimen? Thank you.
Speaker #5: Oh hey .
Speaker #17: thanks for Guys , taking the question . As you plan for the commercialization of Zanza , since be the this would first approval , how should we think about the launch trajectory in Ccrcc ?
Speaker #17: And since it's also a new indication for Atezo, is there any work that Roche is doing that you're aware of to ensure a rapid uptake for this innovative combination regimen?
Patrick Haley: Yeah. Yeah. Thanks for the question, Jay. What I'd say is in terms of what we're expecting in the marketplace, as I mentioned, we see a significant unmet medical need here. And it's very exciting to launch a new product and a new combination in the marketplace. As I mentioned, our team here, we've been working very hard on it, and folks are very excited about that. I don't want to sort of get ahead of any specific forecasts or guidance with regards to that. But what I would say is that the market here is fragmented. We've talked about that before. You see in the third-line plus CRC market, you see approximately 1/3 TKIs. You see about 1/3 LONSURF BEV in terms of the sunitinib regimen. And the remaining 1/3 is either chemo or sort of targeted therapies directed at specific biomarker-driven populations.
Patrick Haley: Yeah. Yeah. Thanks for the question, Jay. What I'd say is in terms of what we're expecting in the marketplace, as I mentioned, we see a significant unmet medical need here. And it's very exciting to launch a new product and a new combination in the marketplace. As I mentioned, our team here, we've been working very hard on it, and folks are very excited about that. I don't want to sort of get ahead of any specific forecasts or guidance with regards to that. But what I would say is that the market here is fragmented. We've talked about that before. You see in the third-line plus CRC market, you see approximately 1/3 TKIs. You see about 1/3 LONSURF BEV in terms of the sunitinib regimen. And the remaining 1/3 is either chemo or sort of targeted therapies directed at specific biomarker-driven populations.
Speaker #17: Thank you .
Speaker #4: Yeah , yeah , thanks for the question , Jay . You know what I'd is in terms we're what we're expecting in the marketplace , as I mentioned , you know , we see a significant unmet medical need here .
Speaker #4: And it's very exciting to launch a new product and a new combination in the marketplace. As I mentioned, our team here, we've been working very hard on it.
Speaker #4: And folks are very excited about that. You don't want to, I sort of don't want to get ahead of any specific forecasts or guidance with regards to that.
Speaker #4: But what I would is that , market say is you know , the fragmented . We've talked about that before . You see , line , in the third plus CRC market , you see approximately third tkis .
Speaker #4: a You see about a third Lonsurf . Bev , in terms of the sunlight regimen , and the remaining third is either chemo or sort of targeted therapies directed at specific , you know , biomarker driven populations .
Patrick Haley: So when you see a fragmented market like that, there's certainly really opportunity to have a significant impact. So that's certainly exciting. And as I mentioned previously, significant overall survival benefit over an active standard of care as well as the opportunity to have immunotherapy for this broader patient population have been resonating really well with prescribers in our market research. So we're excited to get there. We are devoting every sort of appropriate resource to this. So we're fully ready to go on the first day of a potential launch.
Patrick Haley: So when you see a fragmented market like that, there's certainly really opportunity to have a significant impact. So that's certainly exciting. And as I mentioned previously, significant overall survival benefit over an active standard of care as well as the opportunity to have immunotherapy for this broader patient population have been resonating really well with prescribers in our market research. So we're excited to get there. We are devoting every sort of appropriate resource to this. So we're fully ready to go on the first day of a potential launch.
Speaker #4: So when you see a fragmented market like that, there's certainly real opportunity to have a significant impact. So that's certainly exciting.
Speaker #4: And as I previously mentioned, you know, significant overall survival benefit over an active standard of care, as well as the opportunity to have immunotherapy for this broader patient population, have been resonating really well with prescribers in our market research.
Speaker #4: So we're excited to get there. You know, we are devoting every sort of appropriate resource to this. So we're fully ready to go on the first day of a potential launch.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Tiago Fauth with Wells Fargo Securities. Your line is open.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Tiago Fauth with Wells Fargo Securities. Your line is open.
Speaker #4: .
Speaker #7: you Thank .
Speaker #1: Please stand by next for our question. Our next question comes from the line of Eva Fortier, Vertigo with Wells Fargo. Your line is open.
Silvan Tuerkcan: Good afternoon. Thanks for taking our question. Two quick from Wans. I think the first one on STELLAR-304 readout, should we be expecting kind of similar to what we saw last year with STELLAR-303 where we get a press release with limited data and then followed up at a medical meeting with the full data release? If that's the case, what would be a good target meeting? Is this a second-half 2026 event? And then the second question, just within the ASCO GU topic, should we expect any significant updates from zanzalintinib? We see a few titles in the program, but perhaps you could comment on these. Thanks.
Silvan Tuerkcan: Good afternoon. Thanks for taking our question. Two quick from Wans. I think the first one on STELLAR-304 readout, should we be expecting kind of similar to what we saw last year with STELLAR-303 where we get a press release with limited data and then followed up at a medical meeting with the full data release? If that's the case, what would be a good target meeting? Is this a second-half 2026 event? And then the second question, just within the ASCO GU topic, should we expect any significant updates from zanzalintinib? We see a few titles in the program, but perhaps you could comment on these. Thanks.
Speaker #5: Good afternoon . Thanks for taking our question . Two quick . from one , I think the first .
Speaker #11: One on .
Speaker #5: Stellar 304 readout . Should we be expecting kind of like similar to what we saw last year with 303 , where we get a press release with limited data and then like followed up at a medical meeting with the full data release .
Speaker #5: If that's the case , what would be like a good target meeting ? Is this like a second half , 2026 event ? second question just within Asco two topic , should we expect any significant updates from Samsa ?
Speaker #5: We see a few titles in the program, but perhaps you could comment on these. Thanks.
Michael M. Morrissey: Yeah. Thanks for the question, Eva. It's Mike. Let me take that. So in terms of 304 top-line results, how we'll communicate that, stay tuned on that. We look at every opportunity as a separate opportunity based upon what's happening, the data, the timing, other meetings, etc. So as we get closer to having top-line results, we'll figure that out and then obviously communicate that to you guys in a very compliant fashion. Second question I missed.
Michael M. Morrissey: Yeah. Thanks for the question, Eva. It's Mike. Let me take that. So in terms of 304 top-line results, how we'll communicate that, stay tuned on that. We look at every opportunity as a separate opportunity based upon what's happening, the data, the timing, other meetings, etc. So as we get closer to having top-line results, we'll figure that out and then obviously communicate that to you guys in a very compliant fashion. Second question I missed.
Speaker #3: Yeah . Thanks for the question Eva . It's Mike . Let me let me take that . in terms So of 304 , you know , results , top line communicate that .
Speaker #3: hollow Stay tuned on that . You know we look at every every opportunity as a separate opportunity based upon you know , what's happening .
Speaker #3: The data . The timing . Other meetings etc. . So as we get as we get closer to having top line results , we'll figure that out .
Speaker #3: And then obviously communicate that to you guys in a very compliant fashion . Second question , I missed oh Asco GU . Yeah I don't I'm not sure we have a lot to offer on that right now .
Patrick Haley: ASCOGUE.
Patrick Haley: ASCOGUE.
Michael M. Morrissey: Oh, ASCO GU. Yeah. I'm not sure we have a lot to offer on that right now. The titles are out. So I would look at those carefully, and we'll see you there for sure.
Michael M. Morrissey: Oh, ASCO GU. Yeah. I'm not sure we have a lot to offer on that right now. The titles are out. So I would look at those carefully, and we'll see you there for sure.
Operator: Thank you. Our next question comes from the line of Ashwani Verma with UBS. Your line is open.
Operator: Thank you. Our next question comes from the line of Ashwani Verma with UBS. Your line is open.
Speaker #3: The titles are out, so I would look at those carefully, and we'll see you there for sure.
Speaker #7: Thank you .
Ashwani Verma: Oh, hi. Thanks for taking my question. So just on Q4, looking at the strong net growth that you saw and also some growth on net improvement quarter-over-quarter as well, did RCC grow for Cabo? So that's the first question. And then secondly, for this upcoming LITESPARK-011 data at the end of February, yeah, so OS is still maturing. We know that, right? But in terms of median PFS, what type of delta versus the Cabo prior 10 months can have a near-term impact on your RCC sales? Thanks.
Ashwani Verma: Oh, hi. Thanks for taking my question. So just on Q4, looking at the strong net growth that you saw and also some growth on net improvement quarter-over-quarter as well, did RCC grow for Cabo? So that's the first question. And then secondly, for this upcoming LITESPARK-011 data at the end of February, yeah, so OS is still maturing. We know that, right? But in terms of median PFS, what type of delta versus the Cabo prior 10 months can have a near-term impact on your RCC sales? Thanks.
Speaker #1: Our next question comes from the line of Verma with UBS. Your line is open, Ash.
Speaker #18: thanks thanks for I taking my question . So just on looking at the four Q net strong that you saw and also some gross net improvement over quarter quarter as well , did RCC grow for carbo ?
Speaker #18: So that's the first question . And then secondly for this upcoming like Sparc 011 data at the end of February . Yeah . So OS is still maturing .
Speaker #18: We know that right . But in terms of median PFS , like what type of delta versus the carbo prior ten months can have an impact on your RCC sales .
Michael M. Morrissey: DJ?
Michael M. Morrissey: DJ?
Patrick Haley: Yeah. Thanks for the question. As I mentioned in my prepared remarks, we're really pleased with the business and the momentum. As we looked at the quarter, we had strong growth in terms of 15% TRX growth year-over-year, which we're very pleased with. And that clearly was driven both by RCC and NET. So again, we're excited about that. As I alluded to earlier, we expect to continue to grow both of the franchises this year as is indicated by our guidance.
Patrick Haley: Yeah. Thanks for the question. As I mentioned in my prepared remarks, we're really pleased with the business and the momentum. As we looked at the quarter, we had strong growth in terms of 15% TRX growth year-over-year, which we're very pleased with. And that clearly was driven both by RCC and NET. So again, we're excited about that. As I alluded to earlier, we expect to continue to grow both of the franchises this year as is indicated by our guidance.
Speaker #18: Thanks .
Speaker #3: Vijay .
Speaker #4: Yeah , thanks for the question . You know , as I mentioned in my prepared remarks , you know , we're really pleased with the business and the momentum .
Speaker #4: You know , as we looked at at at the quarter , we had strong growth in terms of 15% TRH growth year over year , which we're very pleased with .
Speaker #4: And that's , you know , clearly was driven both by RCC and Net . So again , we're excited As I alluded to about that .
Speaker #4: earlier , we expect to continue to grow both of the franchises this year , as is indicated by our guidance .
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Kalpit Patel with Wolfe Research. Your line is open.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Kalpit Patel with Wolfe Research. Your line is open.
Speaker #7: Thank you .
Speaker #1: Please stand by for our next question. Our next question comes from the line of Kyle Pitt Patel with Wolfe Your Line Research.
Christopher Senner: Hey. Good afternoon, and thanks for taking the question. For STELLAR-304, I know you have overall survival as a secondary endpoint. But with the recent FDA draft guidance on using OS when it seems most reasonable, do you anticipate the need to show a benefit in OS to receive a full approval? And then also for that same trial, you have Sunitinib as the control arm. But do you think, at least on a cross-trial basis, you need to look better than what Cabo Plus Nivo delivers historically in this setting?
Christopher Senner: Hey. Good afternoon, and thanks for taking the question. For STELLAR-304, I know you have overall survival as a secondary endpoint. But with the recent FDA draft guidance on using OS when it seems most reasonable, do you anticipate the need to show a benefit in OS to receive a full approval? And then also for that same trial, you have Sunitinib as the control arm. But do you think, at least on a cross-trial basis, you need to look better than what Cabo Plus Nivo delivers historically in this setting?
Speaker #1: is open .
Speaker #19: Hey , good afternoon and thanks for taking the question for stellar 3 or 4 . I know you have overall survival as a secondary endpoint , but with the recent FDA draft guidance on using OS when it seems most reasonable , do you anticipate the need to show a benefit in OS to receive a full approval ?
Speaker #19: And then also for that same trial , you have sunitinib as the control arm , but do you think , at least on a cross-trial cross-trial basis , you need to look better than what carbo plus nivo delivers historically in this setting ?
Michael M. Morrissey: P.J., can you take a shot at that?
Michael M. Morrissey: P.J., can you take a shot at that?
Patrick Haley: Yeah. Well, I'll talk about what we need to see in the marketplace. In terms of, I think, as I mentioned earlier, it's competitive in terms of non-clear-cell just as it is in the overall RCC market. Again, though, as we dial into the specific patient population of non-clear-cell RCC, that's obviously a separate and distinct population from the broader phase 3 studies for all the regimens on the market today, including Cabo Nivo. So we'll have to be very careful not to sort of mix the data in terms of very different patient populations. So that said, as I mentioned earlier, we are certainly excited about a specific phase 3 trial, which is the only one studying this underserved and understudied population in terms of non-clear-cell RCC. And having positive results here, we believe, will be very impactful for the marketplace.
Patrick Haley: Yeah. Well, I'll talk about what we need to see in the marketplace. In terms of, I think, as I mentioned earlier, it's competitive in terms of non-clear-cell just as it is in the overall RCC market. Again, though, as we dial into the specific patient population of non-clear-cell RCC, that's obviously a separate and distinct population from the broader phase 3 studies for all the regimens on the market today, including Cabo Nivo. So we'll have to be very careful not to sort of mix the data in terms of very different patient populations. So that said, as I mentioned earlier, we are certainly excited about a specific phase 3 trial, which is the only one studying this underserved and understudied population in terms of non-clear-cell RCC. And having positive results here, we believe, will be very impactful for the marketplace.
Speaker #3: PJ, I'd take a shot at that.
Speaker #4: , well Yeah , I'll talk about , you know , what we need to see in the marketplace in terms of , you know , I think as I mentioned earlier , it's it's competitive in terms of non-clear cell , just as it is in the overall RCC market .
Speaker #4: You know , again , though , as we dial into the the specific patient population of Non-clear cell RCC , you know , that's obviously a separate and distinct population from the broader phase three studies for all the regimens on the market today , including Cabo Nivo .
Speaker #4: So we'll have to be very careful not to, you know, sort of, sort of mix the data in terms of very different patient populations.
Speaker #4: So that said , as as I mentioned earlier , we are certainly excited about a phase specific three trial , is the which only studying one this underserved and understudied population in terms of non-clear cell , RCC and having , you know , positive results we believe there , will be very impactful for the marketplace .
Operator: Thank you. Ladies and gentlemen, at this time, there are no further questions. And so I would turn the call over to today's host, Andrew Peters. Mr. Peters?
Operator: Thank you. Ladies and gentlemen, at this time, there are no further questions. And so I would turn the call over to today's host, Andrew Peters. Mr. Peters?
Speaker #7: Thank you . .
Speaker #1: Ladies and gentlemen . At this time , there are no further questions . And so I will turn the call over to today's host , Andrew Peters .
Michael M. Morrissey: Thank you, Tawanda, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call. Have a great rest of the week, everyone.
Michael M. Morrissey: Thank you, Tawanda, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call. Have a great rest of the week, everyone.
Speaker #1: Mr. Peters ,
Speaker #3: Thank .
Speaker #12: You , and thank you all for joining us today . We welcome your follow up calls with any additional questions . You may have that we were unable to address during today's call .
Operator: Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.
Operator: Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect.
Speaker #12: Have a great rest of the week, everyone.
