Q1 2025 Exelixis Inc Earnings Call

May 13, 2025

Yeah.

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

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

Speaker Change: Thank you Wanda and thank you all for joining us for the <unk> first quarter 2025 financial results Conference call.

Dana Aftab: Our IND enabling activities for XB064 are progressing on schedule to support filing an IND later this year. In terms of new development candidates, we have some exciting new programs progressing toward DC nomination, including some innovative small molecules and antibody drug conjugates.

Speaker Change: Joining me on today's call are Mike Morrissey, our president and CEO, Chris Senner, Our Chief Financial Officer P. J Haley, our executive Vice President of commercial Amy Peterson, Our Chief Medical Officer, and Dana Aftab, Our Chief Scientific Officer, who will review our progress for the first quarter 2025 ended March 31, 2000 and.

Dana Aftab: And I look forward to sharing more details about those programs at the R&D Day event we're planning for later this year.

Dana Aftab: And finally, we've decided to discontinue the development program for Excel 495. Following enrollment in several cohorts in the dose-escalation phase of the Phase 1 study, we encountered drug-related toxicities which we believe are due to on-target, off-tumor effects of the drug inhibiting PKMint1 in normal tissue. A clear signal to us that the therapeutic index is too low to support further development of the compound. We're in a high attrition business and this decision enables us to refocus our resources on advancing our next wave of promising development candidates into and through clinical studies.

Speaker Change: 25 during the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results.

Speaker Change: During the course of this presentation, we will be making forward looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery product development regulatory commercial financial and strategic matters and government drug pricing policies and initiatives actual events or results could differ.

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

Michael Morrissey: And with that, I'll turn the call back over to Mike. All right. Thanks, Dana.

Michael Morrissey: I'll wrap up here by thanking the entire Exelixis team for our strong start in the first quarter of 2025. I want to commend everyone for their individual and collective urgency and resilience as we advance our discovery, development, and commercial priorities. 2025 is already shaping up to be another important year for the business and the patients we hope to serve. We're never satisfied or content with the status quo, and we look to make every hour count as we 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.

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

Mike Morrissey: Development business development, and commercialization activities and with that I'd like to turn the call over to Mike Alright. Thank you Susan and thanks to everyone for joining us on the call today.

Michael Morrissey: Thank you for your continued support and interest in Exelixis.

Speaker Change: We had a strong first quarter highlighted by significant progress and momentum across all components of our business. We continue to execute on our strategy to build a multi compound multi franchise oncology enterprise.

Tawanda: And we're happy to now open the call for questions. Thank you.

Tawanda: Ladies and gentlemen, to ask a 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.

Speaker Change: For 2025 to be a very busy and highly productive time for the company I think it's safe to say that we have reached another critical inflection point in recent XY axes history, and we're energized to take things to the next level as we move forward into the second quarter and beyond.

Tawanda: Please stand by while we compile the Q&A roster.

Speaker Change: Product development business development, and commercialization activities and with that I'd like to turn the call over to Mike Alright. Thank you Susan and thanks to everyone for joining us on the call today.

Mike Schmidt: Our first question comes from the line of Mike Schmidt with Guggenheim. Your line is open. Hey, guys, good afternoon. Thanks for taking our questions and congrats on a great first quarter result here. So 1Q sales were obviously very strong in terms of growth over last year.

As we've discussed previously we have a singular focus on improving the standard of care for patients with cancer, our future success in achieving this goal will enable <unk> to help many more cancer patients and ultimately solidify our leadership position through innovation and execution.

Mike Alright: So lots of we had a strong first quarter highlighted by significant progress and momentum across all components of our business. We continue to execute on our strategy to build a multi compound bulky franchise oncology enterprise.

Mike Schmidt: Could you just help us understand a little bit better what's been driving capital growth at this point? And obviously, Neuroendocrine was approved at the end of 1Q. Did you see some contribution from that prior to approval already?

Speaker Change: We're pleased to see accelerating growth of the U S. Cabo franchise in the first quarter, both in terms of absolute revenue and relative growth compared to the competition.

Mike Alright: We expect 2025 to be a very busy and highly productive time for the company.

Mike Alright: It's safe to say that we have reached another critical inflection point in our recent X, what's the history and we're energized to take things to the next level as we move forward into the second quarter and beyond.

Speaker Change: Which reflects cabo status as the leading Teekay I for RCC.

P.J. Haley: And secondly, could you just provide some more color about the launch in Neuroendocrine tumors and expectations for the early trajectory there throughout the rest of the year? Thanks so much. All right. Thanks, Michael.

Speaker Change: We anticipate seeing additional upside with new indications in neuroendocrine tumors, where we secured regulatory approval at the end of March.

Mike Alright: As we've discussed previously we have a singular focus on improving the standard of care for patients with cancer, our future success in achieving this goal will enable <unk> to help many more cancer patients and ultimately solidify our leadership position through innovation and execution.

Speaker Change: Key highlights for the first quarter include first.

Speaker Change: We saw strong performance of the Cabozantinib U S business with continued growth in demand new starts and revenue.

P.J. Haley: PJ, why don't you start, and then Chris and I can provide some color commentary afterwards as needed. Go ahead. Okay. Thanks for the question, Michael. Yeah, as you mentioned, we had a strong quarter of results. We're very pleased with the progress we've made. As you look at the business, in terms of demand and TRX, we grew significantly in terms of market share from 40% to 44%. And on an absolute level, the volume grew 18% year over year. Similarly, NRX, we grew share from 38%. to 43% in terms of new prescription share in our TKI market basket and even had a more substantial growth on absolute terms of 27% and both of those were the only product to grow share so you know performing really well relative to the competition.

Speaker Change: First quarter 2025 U S. Cabo franchise net product revenues grew 36% year over year to $513 million compared to $378 million in the first quarter 2024, Global Cabo franchise net product revenues generated by <unk> and its partners were approximately <unk> <unk>.

Mike Alright: We're pleased to see accelerating growth of the U S. Cabo franchise in the first quarter, both in terms of absolute revenue and relative growth compared with the competition, which reflects cabo status as the leading teekay I for RCC.

Mike Alright: We anticipate seeing additional upside with new indications in neuroendocrine tumors, where we secured regulatory approval at the end of March.

Speaker Change: $680 million in the first quarter 2025, compared to $559 million in the first quarter of 2024, given the strong momentum of Cabo and <unk> in the first quarter, we're increasing our 2025 full year financial guidance for net product revenues and total revenues by $100 million.

Mike Alright: Key highlights for the first quarter include first.

Mike Alright: Strong performance at the Cabozantinib U S business with continued growth in demand you starts and revenue.

Mike Alright: First quarter 2025 U S. Cabo franchise net product revenues grew 36% year over year to $513 million compared to $378 million in the first quarter 2024, Global Cabo franchise net product revenues generated by extra lets us as partners were approximately.

Speaker Change: Second on top of our strong financial and commercial performance. The highlight of the quarter was the U S regulatory approval of Cabo medics and both Peanuts peanut ahead of our assigned producer date of April 3rd 2025, our commercial team was ready to execute our detailed launch plan and we were out in the field with.

P.J. Haley: In terms of our business the majority of this is being driven by RCC and in particular frontline RCC in terms of the combination of you know HABO with NEBO. As I mentioned in my prepared remarks we had updated data presented at GU-ASCO in terms of checkmate 9 ER and the five-year follow-up data that's been resonating really well with physicians and really continues to position us in a way that differentiates us from the competition which we're pleased with.

Mike Alright: $680 million in the first quarter of 2025 compared to $559 million in the first quarter of 2020 for keeping the strong momentum of Cabo and <unk> in the first quarter, we're increasing our 2025 full year financial guidance for net product revenues and total revenues by $100 million.

Speaker Change: In hours of approval.

Speaker Change: P. J, we'll provide more information and commentary about our first quarter commercial dynamics and the net launch in his prepared remarks, we plan to evaluate further updates to our 2025 financial guidance as we build momentum on the net launch and gained further clarity on additional revenue opportunities for 2025.

Mike Alright: Second on top of our strong financial and commercial performance. The highlight of the quarter was the U S regulatory approval of Cabo medics and both Peanuts peanut ahead of our assigned producer date of April 32025, our commercial team was ready to execute our detailed launch plan and we were out in the field with.

P.J. Haley: So now a little bit in terms of NET what I'll say is we only promote on label you know there was a little bit of NET utilization we saw prior to approval but you know as I mentioned the approval came or approvals came on March 26th so very early days in terms of the launch but what I can tell you is that the feedback you know we're getting is really positive from prescribers the team was literally sprinting out of the gate across all tactics and really all channels so we're really pleased with the momentum there in NET and we think as I mentioned it's a really substantial opportunity but obviously really early days here and you know we'll be excited to continue to report updates on that as the launch progresses and we get throughout the Thank you.

Speaker Change: Third it is mission critical for us to advance new molecules from our pipeline into full development and ultimately onto the market to excel in our mission to help cancer patients recover stronger and live longer.

Speaker Change: We're excited to advance Zanzibar to the center stage in 2025 is our next oncology franchise opportunity.

Mike Alright: Hours of approval.

Speaker Change: Important anticipated zander data milestones from pivotal trials in the second half of 2025 include topline results from stellar three or three and colorectal cancer cell or three or four in non clear cell RCC and a decision to advance the phase III portion of stellar 305 in head and neck cancer all of <unk>.

Third is mission critical for us to advance new molecules from our pipeline into full development and ultimately onto the market to excel in our mission to help cancer patients recover stronger and live longer.

Speaker Change: The best rates for each trial.

Speaker Change: In addition, we expect to initiate the study with 311 trial of <unk> in the first half of 2025 and anticipate Mercury will initiate two RCC study is evaluating <unk> plus close to defend this year.

Speaker Change: Excited to advance Zanzibar to the center stage in 2025 is our next oncology franchise opportunity.

Speaker Change: Important anticipated zander data milestones from pivotal trials in the second half of 2025 include top line results from stellar three or three and colorectal cancer cell or three or four in non clear cell RCC and a decision to advance the phase III portion of stellar 305 in head and neck cancer all.

Asthika Goonewardene: Please stand by for our next question. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is open.

Speaker Change: Fourth as we highlighted recently, our <unk> pipeline is coming into focus with a range of new and potential we have differentiated molecules heading into and through early clinical evaluation. The goal of these efforts isn't to build a big pipeline, it's the carefully and quickly evaluate new clinical assets.

Asthika Goonewardene: Hey guys, thanks for taking my questions and I'll echo the congratulations on some pretty rock star performance in Q1 here on the guidance race. I want to add on to Michael's question just to get a little bit more dynamics on the NET launch. Did you guys see a bolus effect or are you guys anticipating a bolus effect here in the early days of launch at NET? And if so, when do you kind of expect it to stabilize to give you a more accurate run rate in terms of acceleration and uptake?

Speaker Change: The debt rates for each trial.

Speaker Change: And identify the winners for advancement into full development is top investment priorities.

Speaker Change: In addition, we expect to initiate to start with 311 trial of <unk> in the first half of 2025 and anticipate Merck will initiate two RCC study is evaluating <unk> plus cost to defend this year.

Speaker Change: Early development of <unk> hundred nine continues to be our main focus as both a monotherapy and in combination with PARP inhibitors to deepen and prolonged responses.

Speaker Change: Fourth as we highlighted recently, our <unk> pipeline is coming into focus with a range of new and potentially differentiated molecules heading into and through early clinical evaluation golar.

Speaker Change: Dose escalation with <unk> continues to advance quickly, we're making good progress on our goal to file up to three new <unk> in 2025 X be six to eight recently entered the clinic and we remain on track for IND submissions for <unk>, four and <unk> 371 this year.

Asthika Goonewardene: And then second, if I may, when you modify the statistical analysis for STELR 303 to do it instead of doing it sequentially from non-Livermed to IDD and do it more as a dual primary endpoint for both those groups, does that help in any way with the alpha spend or maybe the hazard ratio you need to meet statistical significance? Thanks. All right.

Speaker Change: All of these efforts is to build a big pipeline, it's the carefully and quickly evaluate new clinical assets and identified the winners for advancement into full development as top investment priorities.

Speaker Change: Finally in regard to capital allocation, we're excited about the trajectory of our business and have the balance sheet and expect the cash flow to advance our pipeline priorities access new high conviction assets and continue to repurchase shares when we believe they are undervalued.

Speaker Change: Early development of <unk> 309 continues to be our main focus as both a monotherapy and in combination with PARP inhibitors to deepen and prolonged responses.

P.J. Haley: Thanks, Asthika. P.J., real quick on NETs, and then we'll go over to AIDS 303. Yeah. Thanks for the question, Asthika. You know, what I'll say is, obviously, very early days in the NET launch, as I mentioned, we're very excited about it. You know, we'll continue to see the trends as we move forward. I mean, these patients are advanced in their disease with neuroendocrine tumors, so we're necessarily expecting to see a bolus there. You know, as I mentioned, you know, great prescriber excitement about the drug. We're seeing new prescriptions, you know, out of the gate and just looking forward to tracking that going forward.

Speaker Change: Business development activities to continue in earnest and our focus on late stage assets in the <unk> space.

Speaker Change: Escalation with X P. O N. L continues to advance quickly are making good progress on our goal to file up to three new <unk> in 2025, XD six to eight recently entered the clinic and we remain on track for IND submissions for <unk>, four and <unk> 371 this year.

Speaker Change: Back end loaded pay for success transactions that tucked nicely into our existing and potential future oncology franchise remain a top priority as always we're focused on doing the right deals for the right assets at the right valuations.

Speaker Change: Finally in regard to capital allocation, we're excited about the trajectory of our business and have the balance sheet and expected cash flow to advance our pipeline priorities access new high conviction assets and continued to repurchase shares when we believe they are undervalued.

Chris Senner: So with that I'm. Please see our press release issued an hour ago for our first quarter 2025 financial results and an extensive list of key corporate milestones achieved in the quarter and I'll now turn the call over to Chris.

Amy Peterson: Amy? Sure, thanks, Ashika. So just quickly, with regard to changing the endpoint, just to reset for a second, STELLAR-303 is a very large global clinical phase three pivotal study. And the trial was designed to allow us to assess outcomes in the population of patients without liver mats, referred to as NLM, and in the ITT population. As you know, we completed enrollment about a year ago, and Mike has said many times, we're in the business of generating P-values and positive outcomes for patients. And we continuously evaluate our studies and make modifications necessary to ensure we achieve the maximum success for those patients.

Chris Senner: Thanks, Mike for the first quarter of 2025, the company reported total revenues of approximately $555 million, which included Cabozantinib franchise net product revenues of $513 $3 million.

Speaker Change: Business development activities continue in earnest and our focus on late stage assets in the <unk> space backend loaded pay for success transactions that tucked nicely into our existing and potential future oncology franchise remain a top priority as always we're focused on doing the right deals for the right assets.

Chris Senner: <unk> net product revenues were $510 9 million and included approximately $12 million in clinical trial sales.

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

Speaker Change: The right valuations so with that please see our press release issued an hour ago for our first quarter 2025 financial results and an extensive list of key corporate milestones achieved in the quarter and I'll now turn the call over to Chris. Thanks, Mike for the first quarter 2025, the company reported total revenues of approximately 555.

Chris Senner: Gross to net for the Cabozantinib franchise in the first quarter of 2025 was 28, 9%, which is higher than the gross to net we experienced in the fourth quarter of 2024.

Chris Senner: This increase in gross to net deductions in the first quarter of 2025 is primarily related to higher DHS and 340 <unk> volumes in the quarter.

Amy Peterson: So given that we completed enrollment about a year ago, then the relative maturity of events in the liver mat population really suggested to us that it's best to move the ITT analysis from sequential to dual because of the really significant potential value as a positive outcome would help a much larger patient population. So it really wasn't about P-values or hazard ratios. or Alpha. Thank you.

Speaker Change: $5 million, which.

Speaker Change: <unk> Cabozantinib franchise net product revenues of $513 3 billion.

Chris Senner: As previously disclosed excellent. This is qualified as a specified small manufacturer with a phase in period, which requires excellence is to pay a 1% discount in 2025 on all Medicare part D sales.

Speaker Change: <unk> net product revenues were $510 9 million and included approximately $12 million in clinical trial sales.

Speaker Change: As a continued reminder, clinical trial sales have historically been choppy between quarters and we expect this to continue into the future.

Chris Senner: And is included in our gross to net estimates for the year.

Inventory at the end of the first quarter of 2025 was approximately two weeks on hand, which was down slightly when compared to the fourth quarter of 2024.

Speaker Change: So it's not for the Cabozantinib franchise in the first quarter of 2025 was 28, 9%, which is higher than the gross to net we experienced in the fourth quarter of 2024.

Chris Senner: Does it as relatively flat inventory dynamic between the fourth quarter of 2024 and first quarter 2025.

Sean Laaman: Please stand by for our next question. Our next question comes from the line of Sean Laaman with Morgan Stanley. Your line is open. Good afternoon, Mike and team. Great set of results.

Speaker Change: This increase in gross to net deductions in the first quarter 2025 is primarily related to higher EHS and 340 <unk> volumes in the quarter.

Chris Senner: We experienced a little inventory destocking in the first quarter of 2025.

Total revenues also included approximately $42 million in collaboration revenues, which includes approximately $36 $7 million of royalties earned from our partners Ipsen and Takeda on their sales of cabozantinib in their respective territories.

Speaker Change: As previously disclosed excellent. This is qualified as a specified small manufacturer for the <unk>.

Chris Senner: Maybe just sort of contextualise what seasonality we can expect for Carbo for the year. I think the beat on street was around $50 million on revenue and the raise is about $100 million on revenue. Maybe just to give us some context around that, please. Sure.

Speaker Change: Phase in period, which requires <unk> to pay a 1% discount in 2025 on all Medicare part D sales.

Chris Senner: Total operating expenses for the first quarter of 2025 were approximately $369 million compared to $404 million in the fourth quarter.

And is included in our gross to net estimates for the year.

Speaker Change: Inventory at the end of the first quarter 2025 was approximately two weeks on hand, which was down slightly when compared to the fourth quarter 2024.

Chris Senner: Chris, do you want to start with that and I'll do the color commentary? Thanks, Sean. So, I mean, the seasonality, I think that we've seen in the past where we saw higher gross net in the first quarter and lower gross net progressing throughout the year is gone because of our specified small manufacturer designation. So, the 1% is across all Medicare patients throughout the year. So, that creates some stability in the gross net. We're still projecting gross net to be in the 29 to 30% range like I talked about last quarter. And so, and this year, we also didn't have an inventory dynamic like we've had in past years where we had higher inventory coming in a Q4 and a destocking in Q1.

Chris Senner: Sure.

Chris Senner: The sequential decline in this operating in these operating expenses was primarily driven by lower clinical trial costs and manufacturing costs for drug development candidates and licensing costs.

Speaker Change: Does it as relatively flat inventory dynamic between the fourth quarter 2024, and first quarter of 2025.

Speaker Change: We experienced little inventory destocking in the first quarter of 2025.

Chris Senner: These lower R&D costs were offset by higher general and administrative costs in the first quarter of 2025 provision.

Speaker Change: Total revenues also included approximately $42 million in collaboration revenues, which includes approximately $36 $7 million of royalties earned from our partners Ipsen and Takeda on their sales of cabozantinib in their respective territories.

Chris Senner: Provision for income taxes for the first quarter of 2025 was approximately $46 $1 million compared to a provision for income taxes of approximately $44 $9 million for the fourth quarter of 2024.

Speaker Change: Total operating expenses for the first quarter 2025 were approximately $369 million compared to $404 million in the fourth quarter.

Chris Senner: The company reported GAAP net income of approximately $159 6 million or <unk> 57 per share basic and <unk> 55 per share diluted for the first quarter of 2025.

Speaker Change: Sure.

Speaker Change: The sequential decline in this operating in these operating expenses was primarily driven by lower clinical trial costs manufacturing costs for drug development candidates and licensing costs.

Chris Senner: The company also reported a non-GAAP net income of approximately $179 6 million or <unk> 64 per share basic and <unk> 62 per share diluted.

Chris Senner: So, we didn't see that either. You know, from a gross to net perspective, we see some stability there in that 29 to 30% range, and we didn't have the inventory dynamics that we've seen in the past. Thank you.

Speaker Change: Yeah.

Speaker Change: These lower R&D costs were offset by higher general and administrative costs in the first quarter 2025 provision.

Chris Senner: non-GAAP net income excludes the impact of approximately $20 million of stock based compensation expense net of the related income tax effect.

Speaker Change: Provision for income taxes for the first quarter of 2025 was approximately $46 1 million compared to a provision for income taxes of approximately $44 $9 million for the fourth quarter of 2020.

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

Chris Senner: Cash and marketable securities for the quarter ended March 31, 2025 was approximately $1 $65 billion.

During the first quarter of 2025, we repurchased approximately $289 million of the company's shares.

Gregory Renza: Hi, thanks so much for taking our question. This is for on for Greg. Um, just a quick questions on on the school years, 25 guidance. Could you confirm if the hundred million dollars increase in terms of where does that come from? And how much of the contribution of that amount come from net and and related questions? When do you anticipate having a clarity on the potential of net to include into the full year 25 guidance?

Speaker Change: The company reported GAAP net income of approximately $159 6 million or <unk> 57 per share basic and <unk> 55 per share diluted for the first quarter of 2025.

<unk> and the retirement of approximately $8 million of the company's shares at an average price per share of $35 83.

Speaker Change: The company also reported a non-GAAP net income of approximately $179 6 million or <unk> 64 per share basic and <unk> 62 per share diluted.

As of the end of the first quarter of 2025, we had approximately $5 $5 million remaining under the $500 million stock repurchase plan authorized by the company's board in August 2024.

Speaker Change: non-GAAP net income excludes the impact of approximately $20 million of stock based compensation expense net of the related income tax effect.

Chris Senner: In 2000 and February 2025, the board authorized an additional $500 million stock repurchase plan that expires at the end of 2025.

Speaker Change: Cash and marketable securities for the quarter ended March 31, 2025 was approximately $1 65 billion.

Chris Senner: Thanks so much. Yeah, thanks for the question. Yeah, just talking about the the guidance raised. I think it's safe to say the biggest part of that is in the RCC-based business. It's a little bit of net in there, but the majority of it is based on the strength of the base business in the first quarter. You know, we're tracking net very closely, obviously, as well as for the whole business, because that's what we do. And as we feel like we've, you know, got momentum there, certainly coming out of the launch and great performance so far.

Chris Senner: We have been purchasing shares under the February 2025 plan during the second quarter.

During the first quarter of 2025, we repurchased approximately $289 million of the company's shares.

Chris Senner: Now turning to our net product revenue and total revenue financial guidance for the full year 2025.

Speaker Change: In the retirement of approximately $8 million of the company's shares at an average price per share of $35.83.

Chris Senner: We're increasing our net product and total revenue guidance given <unk> strong performance in the first quarter and our expectations of continued strong performance throughout 2025, we're increasing our net product revenue guidance to 2.05 billion to $2, one 5 billion, which increases the midpoint of our net product revenue guidance range by $100 million when compared to our <unk>.

Speaker Change: As of the end of the first quarter of 2025, we had approximately $5 $5 million remaining under the $500 million stock repurchase plan authorized by the company's board in August 2024.

Speaker Change: In 2020 in February 2025, the board authorized an additional $500 million stock repurchase plan that expires at the end of 2025.

Chris Senner: So don't wanna give you guidance on giving you a different guidance later, but we're tracking that closely. And when we think it's the right time with the right level of confidence, we will talk about that in the future.

Obviously provided net product revenue guidance.

Chris Senner: We're also making a corresponding increase to our total revenue guidance, which is now 225 billion to $2 $35 billion.

Speaker Change: We have been purchasing shares under the February 2025 plan during the second quarter.

Speaker Change: Now turning to our net product revenue and total revenue financial guidance for the full year 2025.

Chris Senner: Finally regarding the impact of tariffs on our business as we've said previously our IP for both Cabozantinib and <unk> is domiciled in the U S.

Tawanda: Thank you. Please stand by for our next question.

Silvan Tuerkcan: Our next question comes from the line of Silvan Tuerkcan with Citizens. The line is open. Thank you so much for taking my question and congrats on this stellar quarter. I just wanted to ask a more general question on your BD appetite. Can you just maybe talk about specifically the scenario for Exelixis and maybe by extrapolation to some of your peers, how does the current environment influence your BD plans? Are you currently on hold? Are you looking? Are there certain roadblocks that need to get away for you to pull the trigger here? Thank you. Yeah, thanks for the question.

Speaker Change: We're increasing our net product and total revenue guidance given <unk> strong performance in the first quarter and our expectations of continued strong performance throughout 2025.

Chris Senner: And as of now we are projecting minimal exposure on our U S. Cabozantinib business our cost of goods sold is approximately 4% of net product revenue and three of those four percentage points as royalty owed to a third party.

Speaker Change: Increasing our net product revenue guidance to 2.05 billion to $2, one 5 billion, which increases the midpoint of our net product revenue guidance range by $100 million when compared to our previously provided net product revenue guidance.

Speaker Change: The vast majority of Cabozantinib finished product for U S distribution is manufacturing in Canada, and any potential tariff impact on the remaining 1% would be de minimis to the overall business and with that I'll turn the call over to P. J.

Speaker Change: We're also making a corresponding increase to our total revenue guidance, which is now 2.25 billion to $2 $35 billion.

Mike Morrissey: Chris This is Mike highlighted the Cabo <unk> business was very strong in the first quarter of 2025, and importantly, <unk> received approvals in neuroendocrine tumors on March 26.

Speaker Change: Finally regarding the impact of tariffs on our business as we've said previously our IP for both Cabozantinib and <unk> is domiciled in the U S.

Michael Morrissey: As I said in my prepared remarks, you know, we are, we're definitely open for business on the BD side. We're focused on high conviction assets that fit into our franchise framework within GU and GI oncology, where we believe we have the opportunity to convert differentiating clinical data into commercial success. That's the Cabo story. That's the lens with which we look at all opportunities internally and externally. So that, quite frankly, isn't, is the same, hasn't changed, and will continue to be the same going forward. We're not looking to buy on the cheap, right? We're not looking to buy assets that we have, or we see as being very risky, but they're cheap.

Speaker Change: And as of now we are projecting minimal exposure on our U S. Cabozantinib business our cost of goods sold is approximately 4% of net product revenue and three of those four percentage points as royalty owed to a third party.

Mike Morrissey: Although grew in terms of revenue demand and new patient starts and notably warm.

Speaker Change: Well relative to the competition.

Speaker Change: Team continued to execute at an extremely high level and this has resulted in <unk> continuing to be the number one prescribed teekay I in renal cell carcinoma as well as the number one <unk> plus <unk> combination in first line RCC.

P. J.: Thank you, Chris as Mike highlighted the Cabo <unk> business was very strong in the first quarter of 2025 importantly, <unk> received approvals neuroendocrine tumors on March 26.

Speaker Change: The commercial team is executing the launch in nets with great urgency.

Speaker Change: And with the goal to rapidly establish carbo mix is the small molecule market leader in that space.

Speaker Change: Although groups in terms of revenue demand and new patient starts and notably one.

Speaker Change: We are pleased that prescribers are responding positively to the data and are excited to have a new therapy to address the unmet need in neuroendocrine tumors as we look to build on the strong momentum of the <unk> business.

Michael Morrissey: So it might make sense. That's not how we look at it. We're a high science. We want to make sure we can move the needle for patients. And the dynamic that we've observed and learned and been able to be successful with Cabo is that if you can move the needle for patients, if you can improve standard of care, you can commercialize that asset very, very productively. So that's the goal. So, as I said, previous calls, we've burned many a haystack. We've got a few, a few needles that we're looking at right now. We're hoping to transact.

Speaker Change: Well relative to the competition.

Speaker Change: The team continued to execute at an extremely high level and this has resulted in <unk> continuing to be the number one prescribed teekay I in renal cell carcinoma as well as the number one <unk> plus <unk> combination in first line RCC.

Speaker Change: The prescription data in the TK I market basket of Cabo with that new exiting it.

Speaker Change: <unk> and <unk>.

Speaker Change: Our commercial team is executing the launch in nets with great urgency.

Speaker Change: They use the strength of Cabo relative to the competition.

Speaker Change: And with the goal to rapidly establish <unk> as the small molecule market leader in the space.

Speaker Change: Looking at the Trs comparison, Q1, 2024 to Q1 2025.

Michael Morrissey: Maybe we do. Maybe we don't.

Michael Morrissey: It's all about the right asset at the right time and the right valuation, but we've got a great team across the BD and financial sectors within legal, within commercial, within discovery and development. So we've got a full court press here to be able to figure out what makes the most sense for us and then really how to do that in a practical way that can build value for patients and for shareholders. Thank you.

Speaker Change: <unk> grew four share points from 40% to $44.

Importantly, Cabo is the only product in the market basket to grow market share.

<unk> volume grew 18% in this time period outpacing the growth rate of the market.

Speaker Change: The prescription data in the TK high market basket of Cabo when that nib exiting it.

Speaker Change: 10 percentage points, which was the only product that grew at a rate greater than the market.

Speaker Change: They've been <unk>.

Yaron Werber: Please stand by for our next question. Our next question comes from the line of Yaron Werber with T.D. Cohen. Your line is open. Great. Congratulations again. It's really a terrific showing. So I have maybe two interrelated questions. One is just a little housekeeping.

Speaker Change: They use the strength of Cabo relative to the competition.

Speaker Change: The checkmate 90 or five year follow up data presented at <unk> in February has been resonating very well with prescribers in the RCC space.

Speaker Change: Looking at the Trs comparison, Q1, 2024 to Q1 2025.

<unk> grew four share points from 40% to $44.

These data help our team continued to drive differentiation from the competition in the first line RCC market.

Chris Senner: If you can just remind us, Part D redesign, how much of an impact did it have this quarter, if any? And what percentage of your business is Medicare facing versus commercial?

Speaker Change: Importantly, Cabo is the only product in the market basket to grow market share.

Speaker Change: Turning to new prescriptions or <unk>.

Speaker Change: <unk> volume grew 18% in this time period outpacing the growth rate of the market.

P.J. Haley: And then sort of the more meaty question is, it's clearly, Mike, it sounds like you're waiting for the uptake in net and you're saying it's a first line versus second or third line for small molecules. I mean, it sounds like you're aiming and you're intending and you should probably raise guidance again. Thank you.

Speaker Change: <unk> hadn't even had even stronger data trends.

Speaker Change: <unk> and Rx share and the TK our market basket went from 38% in Q1 2024.

Speaker Change: 10 percentage points and so the only product that grew at a rate.

Speaker Change: Greater than the market.

Speaker Change: A 43% in Q1 2025.

Speaker Change: The checkmate 90 or five year follow up data presented at <unk> in February has been resonating very well with prescribers in the RCC space.

Speaker Change: This share gain is even more impressive as every other product in the market basket lost share in the same time period.

P.J. Haley: Yeah, so Chris, why don't you take care of the housekeeping and then PJ can address some of the kind of overall market dynamics for NET as we see it currently. Go ahead, Chris. All right, you're rolling this, Chris. So from a Medicare Part D redesign perspective, you know, if you look at a quarter Q4 versus Q1, we didn't see a big dynamic there, big change in the amount of Medicare. Reimbursements we had to make. If you look at it versus Q1 last year, there was a larger, there's a bigger difference there. We had some benefit towards us in the Q1 this year.

Speaker Change: These data help our team continued to drive differentiation from the competition in the first line RCC market.

Speaker Change: And Rx volume for <unk> grew 27% year over year.

Speaker Change: We believe this strength in new prescriptions, which outpaces the total prescription growth of 18%.

Speaker Change: Turning to new prescriptions or N Rx.

Speaker Change: <unk> hadn't even had even stronger data trends.

Speaker Change: Is an indicator that the business is well positioned to continue the strong momentum going forward.

Speaker Change: <unk> and Rx share and the TK our market basket went from 38% in Q1 2024.

Speaker Change: Furthermore, the new indications in nets will add to the current momentum of the business.

Speaker Change: A 43% in Q1 2025.

Speaker Change: We are thrilled that <unk> is approved for appropriate patients and then in neuroendocrine tumors.

Speaker Change: This share gain is even more impressive as every other product in the market basket lost share in the same time period.

Speaker Change: As we have discussed previously we see this as a compelling commercial opportunity for <unk> and the <unk> brand.

Speaker Change: And Rx volume for <unk> grew 27% year over year.

Chris Senner: Now, from a split between commercial and Commercial Business and Medicare Part D business is about equal when you look at the two compared to one another from a patient and payer mixed perspective.

Speaker Change: Based upon market research, we believe that there will be approximately 9000 drug treated patients in the second and third lines in the U S. In 2025, and this is expected to grow to approximately 11000 by 2030.

Speaker Change: We believe this strength in new prescriptions, which outpaces the total prescription growth of 18%.

P.J. Haley: Yeah, and as far as net goes, like, like I mentioned, you know, view this as a substantial opportunity. You know, the billion dollars is across all lines of therapy. That said, in terms of second and third line, that is where small molecules, you know, make up the majority of utilization. You know, and we think there's substantial opportunity there. Even looking at, you know, other, another therapy in the market, for example, if you look at Lutathera's recent revenue, if you look at their last quarter's revenue, given it a run rate, that's at $560 million annualized. So, you know, again, we're very excited by this opportunity.

Speaker Change: He is an indicator that the business is well positioned to continue the strong momentum going forward.

Speaker Change: Furthermore, the new indications in nets will add to the current momentum of the business.

Speaker Change: Our research also indicates that the majority of the second and third line patients received oral small molecules as their standard of care.

Speaker Change: We are thrilled that <unk> is approved for appropriate patients and then in neuroendocrine tumors.

Speaker Change: Furthermore, as we have previously discussed the oral market opportunity in 2025 is forecasted to be approximately $1 billion in the U S.

Speaker Change: As we have discussed previously we see this as a compelling commercial opportunity for <unk> and the <unk> brand.

Speaker Change: Recall that the target net physician universe has significant overlap with legacy <unk> prescribers.

Speaker Change: We believe that this overlap coupled with our sales teams' deep relationships would accelerate access and promotional opportunities.

P.J. Haley: When it comes to the small molecule market, we're the only, you know, branded molecule out there with, you know, a substantial and experienced team behind this. And we're really excited about the ability to help patients and move the business Thank you.

Speaker Change: Our research also indicates that the majority of the second and third line patients received oral small molecules as their standard of care.

Speaker Change: We were pleased to see this come to fruition is our team called on more than 70% of the 3500 net prescriber net physician targets in the first three weeks post approval.

Speaker Change: Furthermore, as we have previously discussed the oral market opportunity in 2025 is forecasted to be approximately $1 billion in the U S.

Speaker Change: As we have previously discussed the cabinet study uniquely positions <unk> across patient and tumor characteristics, including patients with neuroendocrine tumors arising in the pancreas Gi tract and lung across all tumor grades from one to three <unk>.

Speaker Change: Recall that the target net physician universe has significant overlap with legacy <unk> prescribers.

Chi Fong: Our next question comes from the line of Chi Fong with Bank of America Securities. Your line is open. Hey guys, this is Chi for Jason. Thanks for taking our questions. We have a question on capital allocation.

Speaker Change: We believe that this overlap coupled with our sales teams' deep relationships would accelerate access and promotional opportunities and we're pleased to see this come to fruition as our team called on more than 70% of the 3500 net prescriber net physician targets in the first three weeks post approval.

Speaker Change: Functional status.

Michael Morrissey: Mike, I've asked you this question early in the year before, and I'm going to ask you again. I'm curious about your philosophy in terms of the buyback program. And lastly, what's your philosophy on investing capital into R&D or business development? Thanks so much. Yeah, thank you for the question. Look, I again, as we talked about, previously reiterated in prepared remarks today, you know, with our balance sheet, and, you know, effective free cash flows, we think we can allocate capital effectively around investing in the internal pipeline, doing the appropriate thoughtful and pragmatic BD, and still buying back shares when we think the shares are undervalued relative to where we think it can go.

Speaker Change: TR status and those who have received prior treatment with <unk> therapy.

Speaker Change: The unique study population led to strong and broad NCC and guideline recommendations for <unk> as a preferred a recommended option regardless of site origin or tumor grade for patients who received prior therapy.

Speaker Change: <unk>.

Speaker Change: We are pleased with the <unk> label, which will allow physicians to prescribe <unk> to a wide range of net patients who have received prior therapy and importantly, this approval makes <unk>. The first and only systemic treatment that is FDA approved for previously treated net regardless of site of origin or patients functional.

Speaker Change: Functional status.

Speaker Change: TR status and those who have received prior treatment with <unk> therapy.

Speaker Change: Status.

Speaker Change: The unique study population led to strong and broad <unk> guideline recommendations for <unk> as a preferred a recommended option regardless of site origin or tumor grade for patients who received prior therapy.

Speaker Change: <unk> had been launch ready for some time prior to approval and literally hit the ground sprinting with Cabo received a net indications.

Speaker Change: The <unk> data.

Speaker Change: Messages are resonating well and prescriber reception has been extremely positive and confirmatory of the unmet medical need in the neuro endocrine tumors space.

Speaker Change: We are pleased with the <unk> label, which will allow physicians to prescribe <unk> to a wide range of net patients who have received prior therapy and importantly, this approval makes cabo medics, the first and only systemic treatment that is FDA approved for previously treated net regardless of site of origin or patients functional.

Speaker Change: Our core promotional assets were deployed within days, if not hours of approval, including personal promotional pieces. The website targeted non personal digital and social media tactics peer to peer education, as well as patient and Allied health care professional educational materials.

Michael Morrissey: So, so I think that's the right approach. How we do that, how we emphasize one over the other will be situationally dependent. You know, I think by my math, we bought back about 19, 20% of our outstanding float over the last couple of years. We've done that at significantly lower prices than where the stock is trading at today. So that's a good move from an investment point of view. You know, we like investing in ourselves, right? Again, in the in the context of how we view quality, how we view assets that can move the needle, the needle for patients and shareholders, we think Exelixis is a great place to put that money.

Speaker Change: Status.

Speaker Change: <unk> had been launch ready for some time prior to approval and literally hit the ground sprinting when Cabo received a net indications.

Speaker Change: Team has mobilized and are already working to quickly established <unk> as a new standard of care for second and third line net patients.

Speaker Change: The <unk> data.

Speaker Change: Messages are resonating well and prescriber reception has been extremely positive and confirmatory of the unmet medical need in the neuro endocrine tumors space.

Speaker Change: We are also pleased that the indication is providing us great access to customers. So we're able to discuss both the cabinet data as well as the RCC Checkmate 90, or five year follow up data for relevant physicians.

Speaker Change: We are excited by this opportunity to serve net patients and our enthusiasm is matched by physicians excitement to have a new and effective option for their patients.

Michael Morrissey: So, so that's how we're going to continue to operate, you know, We're data dependent. We're data driven. So we'll see how that goes in the future, but again, having the cash flows that we've got and the balance sheet that we have gives us the ultimate optionality, and we like that going forward.

Speaker Change: In general prescribers to use <unk> as a more favorable choice versus current small molecule therapies.

Speaker Change: Team has mobilized and are already working to quickly established <unk> as a new standard of care for second and third line net patients.

Tawanda: Thank you. Please stand by for our next question.

Speaker Change: Additionally, the competition in the oral segment of the net market are all generic therapies, which puts <unk> in a significant advantage with a full commercial organization in support of the launch.

Speaker Change: We're also pleased that the indication is providing us great access to customers. So we're able to discuss both the cabinet data as well as the RCC Checkmate 90, or five year follow up data for relevant physicians.

Akash Tewari: Our next question comes from the line of Akash Tewari with Jeffrey. The line is open. Hey, thanks so much. So it sounds like you're going to have a do or no go decision on your head and neck study with Merck at the end of the year. What do you want to see on event rates to justify moving forward with that trial? And then also, when we think about the PD-1 VEGF bi-specific class, there's a lot of similarities to kind of the pitch on Zanzib. You know, you hate VEGF, but you have a wider therapeutic window.

Amy Peterson: All of this taken together drives our conviction that the net market will be a substantial opportunity for the <unk> business with that I will turn the call over to Amy.

Speaker Change: We are excited by this opportunity to serve net patients and our enthusiasm is matched by physicians excitement to have a new and effective option for their patients.

Thank you P. J, everyone that excellent chairs you our excitement around the recent approval of cabozantinib in patients with either pancreatic or extra pancreatic neuroendocrine tumors.

Speaker Change: In general prescribers sees <unk> as a more favorable choice versus current small molecule therapies.

Michael Morrissey: Have you thought about acquiring one of those assets for RCC and head and neck, given your partner Merck already has the Lenovo asset?

Speaker Change: This approval came approximately one week prior to the <unk> date, thanks to the team interacting seamlessly with the FDA and the Alliance Cooperative group.

Speaker Change: Additionally, the competition in the oral segment of the net market are all generic therapies.

Amy Peterson: Thank Okay, so why don't you, Amy, take the head and neck question, and I'll come back on the BD Cycle Fest. Okay, yeah, thanks, Akash, for the question. So I did mention in the prepared remarks that we are anticipating to have sufficient number of events in order for the IDMC to review and enable a GoNoGo to Phase 3. We don't typically talk about what those events are, and so I'm just waiting for the data to mature so that we can have the call and get the decision, but that's about really all I can say.

Speaker Change: Puts cabo mix at a significant advantage.

Speaker Change: With this major accomplishment now behind US the cabinet team is able to shift focus towards helping our partner Epson obtained ex U S approvals.

Speaker Change: Full commercial organization in support of the launch.

Speaker Change: All of this taken together drives our conviction that the net market will be a substantial opportunity for the <unk> business.

Speaker Change: As a reminder, this application was chosen for project Orbis, an FDA initiatives that can facilitate approvals and participating countries around the globe.

Amy: I will turn the call over to Amy.

Speaker Change: Thank you P J, everyone that excellent shares your excitement around the recent approval of cabozantinib in patients with either pancreatic or extra pancreatic neuroendocrine tumors.

Speaker Change: Looking ahead 2025 is shaping up to be a very big year, not just for Cabozantinib, but also for example that given the breadth of data Readouts and pivotal trial initiations anticipated.

Speaker Change: This approval came approximately one week prior to the Paducah date, thanks to the team interacting seamlessly with the FDA and the Alliance Cooperative group.

Michael Morrissey: Okay, thank you. Yeah, on the BD side, look, we're, you know, we look at everything with a pretty careful eye. We really like being in the bi-specific space, and certainly 6-2-8 is a good example of that, that we think the potential combination with Zanza gives us really good coverage on the PD-L1 side, on the VEGF side, and then bringing in NK cells as well. So, you know, how you slice and dice those opportunities, you have to be really thoughtful and really careful. Obviously, there's a lot of PD-L1 VEGF targeting bi-specifics right now. We don't see a lot of differentiation in that area, and certainly there's key data waiting to be disclosed around, certainly, say, the survival data in the non-small cell lung cancer trials.

Speaker Change: First I want to remind you of why we are optimistic about <unk> potential to become a best in class <unk>.

Speaker Change: With this major accomplishment now behind US the cabinet team is able to shift focus towards helping our partner Epson obtained ex U S approvals.

Speaker Change: <unk> target profile is similar to Cabos its half life is much shorter enabling faster recovery from treatment related adverse events with dose modifications and possibly favoring tumor accumulation over plasma concentration as was observed in non clinical models and presented at ACR last year.

Speaker Change: As a reminder, this application was chosen for project Orbis, an FDA initiative that can facilitate approvals and participating countries around the globe.

Speaker Change: Either of these qualities could result in an improved therapeutic index presented to letting them.

Speaker Change: In terms of pivotal data Readouts. The first trial, we anticipate data from his stellar three of three.

Speaker Change: First I want to remind you of why we are optimistic about <unk> potential to become a best in class <unk>.

Speaker Change: This phase III study compares the combination of <unk> plus a diesel is a map <unk> in patients who have received multiple prior therapies for their advanced colorectal cancer.

Speaker Change: While the enzyme target profile is similar to cabos. Its half life is much shorter enabling faster recovery from treatment related adverse events with dose modifications and possibly favoring tumor accumulation of a plasma concentration as was observed in non clinical models and presented at ACR last year.

Michael Morrissey: So we're looking at everything. We consider everything. Again, we have a, I think, unique perspective on how to build value, and we're going to continue to execute on that as we go forward.

Speaker Change: The trial is designed to assess outcomes in the population of patients without liver metastases referred to as <unk>.

Michael Morrissey: Thank you.

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

Speaker Change: And in the intent to treat or ITT population.

Speaker Change: Either of these qualities could result in an improved therapeutic index presented to letting them.

Speaker Change: At <unk> Gi in January of this year, we presented encouraging clinical data from the stellar O. One expansion colorectal cohorts evaluating zander with or without a tease out.

Amy Peterson: Hi, this is Yvonne. For Derek, thanks for taking our question, and congrats on the quarter. A quick one from us, can you help set expectations a bit on the non-clear cell renal cell carcinoma study, and what have we seen here from SUNY Tunisia in this patient population? Thanks.

Speaker Change: In terms of pivotal data Readouts. The first trial, we anticipate data from stellar three of three this phase III study compares the combination of <unk> plus <unk> <unk> in patients who have received multiple prior therapies for their advanced colorectal cancer.

Speaker Change: As seen in stellar all one and frankly in all other colorectal trials patients without liver metastases tend to live longer than those with liver metastases, regardless of treatment intervention.

Amy Peterson: Amy, you want to take that? Yeah, sure. So, with regard to setting expectations, this is, I think, a very exciting study for us. One, it is a study in kidney cancer. It's the first phase three that's ever been run in the smaller population in kidney cancer. And so, having a positive outcome, we think, would really benefit patients who have been otherwise lumped into the category of clear cell kidney cancer. The best benchmark that we have is probably with Sutent. That's what we're going up against. So, this is a study that is looking at nivolumab plus xanthelitinib versus sunitinib.

Speaker Change: The trial is designed to assess outcomes in the population of patients without liver metastases referred to as <unk>.

Speaker Change: We announced completion of enrollment in stellar 303 in the second quarter of last year.

Speaker Change: And in the intent to treat or ITT population.

Speaker Change: Given the maturity of follow up time, and the intent to treat population, we anticipate being able to perform the overall survival analysis in the ITT simultaneous with the overall survival analysis in the non liver map population.

Speaker Change: At <unk> Gi in January of this year, we presented encouraging clinical data from the stellar O. One expansion colorectal cohorts evaluating zander with or without a tease out as.

We have amended the statistical analysis plan to dual primary endpoints and N L M and ITT.

Speaker Change: And topline data remains on track for the second half of 2025 events pending.

Speaker Change: We announced completion of enrollment in stellar 303 in the second quarter of last year.

Stellar three or four is our pivotal study evaluating the combination of <unk>, plus Nevada mab versus Sunitinib in patients who have not yet received systemic therapy for their locally advanced or metastatic non clear cell renal cell carcinoma.

Amy Peterson: We know that CABO has beaten sunitinib in a head-to-head. CABO-NIVO beat sunitinib. And we think that Xans is better than CABO. And so CABO-NIVO against sunitinib, we think has a very high probability of success here. The PFS that is most commonly quoted for sunitinib in non-clear cell space is about five to six months. Thank you.

Speaker Change: The primary endpoints in this study are progression free survival as assessed by blinded independent central radiology and objective response rates by robust we expect to wrap up enrollment this quarter and anticipate data in the second half of 2025 again.

Speaker Change: I'm, Mary endpoints and N L M and ITT.

Tawanda: Will you stand by for our next question?

Speaker Change: And topline data remains on track for the second half of 2025 events pending.

Speaker Change: Pending.

Sean Laaman: Our next question comes from the line of Andy Hsieh with Wembley Air. Your line is open. Thanks for taking our questions. Congratulations on the beat and raise.

Speaker Change: Also in the second half of 2025, we expect the phase III go no go decision for stellar 305, our phase two three study comparing <unk> plus timberlands, a map to placebo plus <unk> in patients who have not yet receive systemic therapy for their advanced PD lone expressing squamous.

Speaker Change: Stellar three or four is our pivotal study evaluating the combination of <unk>, plus Nevada mab versus Sunitinib in patients who have not yet received systemic therapy for their locally advanced or metastatic non clear cell renal cell carcinoma.

Andy Hsieh: Two quick ones for us, just going back to the 303 statistical analysis change. I'm curious about the definition. So dual versus co-primary endpoints, can you declare victory with just win in either endpoint? So that's part one. Part two, so the alpha spend, so do you need 0.025 end for success on just one of the two endpoints if that's the scenario?

The primary endpoints in this study are progression free survival as assessed by blinded independent central radiology and objective response rates by robust we expect to wrap up enrollment this quarter and anticipate data in the second half of 2025 again that's pending.

Speaker Change: Ms cell carcinoma of the head and neck.

Speaker Change: Merck is supplying <unk> for this trial as part of our collaboration agreement.

Speaker Change: As for New trial starts seller 311, our pivotal study comparing <unk> nerve to ever alignment as the first oral therapy in patients with neuroendocrine tumors is on track to initiate this quarter.

Dana Aftab: And I was captivated by Dana's commentary about the induced proximity mechanism for 628. I saw several of the presentations looking at kind of dual, kind of bi-specific ADCs and dual payloads. Curious about your thoughts on expanding on your toolkits to explore that opportunity. Thank you.

Speaker Change: And Merck is making steady progress with their phase II and phase III studies in clear cell renal cell carcinoma with anticipated start in the second half of 2025.

Speaker Change: Finally, we are proud to have numerous presentations at <unk> 2025, including three involving sansa.

Speaker Change: Cell carcinoma of the head and neck.

Speaker Change: Merck is supplying <unk> for this trial as part of our collaboration agreement.

Dana Aftab: Thanks, Andy.

Speaker Change: As you can imagine we're excited about <unk> potential and expect 2025 can be a very data rich year.

Dana Aftab: You know, we've addressed the 303 question several times, so let's start with Dana on the 628 and the kind of strategy there, and then we'll go to Amy real fast for a wrap-up on 303. Go ahead. Sure. So just to reiterate, XB628 presentation at ACR was our first sort of data dump on that compound at a scientific conference, and we showed quite a few data points, but I think that the key one that you're referencing, Andy, is the one showing the ability of the molecule to co-localize NK cells with tumor cells, and then, critically, that translated to a much higher sort of level of NK-mediated cytotoxicity against those tumor cells in an in vitro assay compared to monospecific antibodies hitting each checkpoint individually.

Speaker Change: As for new trial starts selling 311, our pivotal study comparing zander, let enough to ever alignment as the first oral therapy and patients with neuro endocrine tumors is on track to initiate this quarter.

Dana Aftab: Leave you with that and turn the call over to Dana.

Dana Aftab: Thanks, Amy and good afternoon, everyone.

Dana Aftab: Today, I'm, giving a brief update on our recent progress towards IND filings and advancing new compounds to development candidate status and I'll close with an update on the <unk> five program.

Speaker Change: And Merck is making steady progress with their phase II and phase III studies in clear cell renal cell carcinoma with anticipated start in the second half of 2025.

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

Speaker Change: Finally, we are proud to have numerous presentations at <unk> 2025, including three involving Zander.

Dana Aftab: As you saw in the press release, we filed the IND for <unk> six to eight in the first quarter of this year and the phase one trial is now open and recruiting SB.

Speaker Change: As you can imagine we're excited about <unk> potential and expect 2025 to be a very data rich year.

Dana: Leave you with that and turn the call over to Dana.

<unk> is a bi specific antibody that targets <unk> and PDL, one two separate immune checkpoint proteins, the tumors used to overcome innate and adaptive anti tumor immune responses.

Dana: Thanks, Amy and good afternoon, everyone.

Speaker Change: Today, I'm, giving a brief update on our recent progress towards IND filings and advancing new compounds to development candidate status and I'll close with an update on the <unk> 495 program.

Dana Aftab: So, yeah, I mean, obviously, we're very excited about this molecule based on its ability to potentially impact or address unmet need across all of our key therapeutic areas, including GU and GI oncology and in colorectal cancer in combination with drugs like Zanzalitinib and other drugs.

Dana Aftab: And because PD lone is expressed on tumor cells. While <unk> is expressed on that natural killer or NK cells <unk> potentially can also act as an NK cell engaged or for tumors.

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

As you saw in the press release, we filed the IND for <unk> six to eight in the first quarter of this year and the phase one trial is now open and recruiting SB.

Speaker Change: As we demonstrated in our presentation last month at ACR in preclinical models <unk> causes tumor cells and NK cells to co localized.

Dana Aftab: When it comes to other types of technologies that you kind of hinted at in terms of multi-payloads and things like that, we're, of course, very interested in those types of technologies, and what I would just say at this point is stay tuned for more information that we plan to kind of bring out from behind the curtain at the R&D Day event later this year, where we're planning to really go into a lot more of our strategy. Awesome. Thank you.

Speaker Change: <unk> is a bi specific antibody that targets <unk> and PDL, one two separate immune checkpoint proteins that tumors used to overcome innate and adaptive anti tumor immune responses.

Speaker Change: Resulting in tumor cell kill that is substantially higher than that seen with a combination of two monoclonal that separately target <unk> and PDL one.

Speaker Change: As a first in class molecule with an innovative mechanism of action <unk> has created a lot of excitement with the principal investigators of the phase one trial. So we're looking forward to efficient execution of this study.

And because PD lone is expressed on tumor cells. While <unk> is expressed on that natural killer or NK cells <unk> potentially and also act as an NK cell engagement for tumors.

Speaker Change: The second IND, we expect to file this year is for XP $3 seven one our tissue factor targeting ADC that carries a tow quest summaries inhibitor payload.

Speaker Change: As we demonstrated in our presentation last month at ACR in preclinical models <unk> causes tumor cells and NK cells to co localized.

Amy Peterson: Amy? Yeah, just real quickly, so you are right, Andy, in that a co-primary requires both be positive in order for the study to be positive. Dual primary means either one can be positive for the study to be positive. However, it does not necessitate equal split of alpha. Thank you. Please stand by for our next question.

Speaker Change: Resulting in tumor cell kill that is substantially higher than that seen with a combination of two monoclonal that separately target <unk> and PDL one.

Speaker Change: Our presentation last month at ACR showed some very compelling preclinical data demonstrating deep and durable regression of human colorectal lung and pancreatic xenograft tumors in mice. After a single dose of <unk> hundred 71, underscoring the significant potential for this molecule to address unmet need.

Andrew Berens: Our next question comes from the line of Andrew Berens with Leroy Partners. Your line is open. Hi, good afternoon.

Speaker Change: Our IND, enabling activities for <unk> 371, we'll wrap up soon and we expect to file the IND and initiate the phase one study later this year.

Andrew Berens: This is the E-Synon for Andy. Congrats on the quarter and thanks for taking our question. Just two quick ones.

Speaker Change: The second IND, we expect to file this year is for SB 371, our tissue factor targeting ADC that carries a tobey Sommer ace inhibitor payload.

Speaker Change: The third R&D, we expect to file this year will be for XP 064, our monoclonal antibody that targets Iot to.

Andrew Berens: On 303, can you remind us what Zanza Tezo has demonstrated in the ITT and how do you expect the control arm to perform? Then maybe on 304, will we get an interim OS as part of the second half update? And just curious, you know, do you anticipate needing OS data in order to file? Thank you. Yeah, sure. So thanks for the question. I'll remind everybody of the data that we presented in STELLAR-001, which was Zanza plus atezolizumab in patients with colorectal cancer. The eligibility criteria were pretty similar to that for 303, with the exception that everybody had to be RAS-WILD type on STELLAR-001.

Speaker Change: Our IND, enabling activities for <unk> are progressing on schedule to support filing an IND later this year.

Speaker Change: In terms of new development candidates, we have some exciting new programs progressing toward DC nomination, including some innovative small molecules and antibody drug conjugates and I look forward to sharing more details about those programs at the R&D day event. We're planning for later this year.

Speaker Change: Our IND, enabling activities for <unk> hundred seven one we'll wrap up soon and we expect to file the IND and initiate the phase one study later this year.

Speaker Change: And finally, we've decided to discontinue the development program for <unk> hundred 95.

The third R&D, we expect to file this year will be for X P 064, our monoclonal antibody that targets <unk>.

Amy Peterson: But there what we saw was median OS with Zanza atezo of 11.7 months in the ITT population, and it was 18.5 months in the non-liver mat patient population. And of course, that study is still ongoing with additional follow-up, and we'll update those as possible. That bodes well when you consider in non—these are cross-trial comparisons—the benchmark of regorafenib that we know from the RCAD database, from the Phase III studies, and other comparators is really in the ITT patient population somewhere between six to eight months. Thank you.

Speaker Change: Following enrollment in several cohorts in the dose escalation phase of the phase one study, we encountered drug related toxicities, which we believe are due to on target off tumor effects of the drug inhibiting PK meant one in normal tissues.

Speaker Change: IND, enabling activities for <unk> zero explore are progressing on schedule to support filing an IND later this year.

Speaker Change: A clear signal to us that the therapeutic index is too low to support further development of the compound.

Speaker Change: We're in a high attrition business and this decision enables us to refocus our resources on advancing our next wave of promising development candidates into and through clinical studies.

Speaker Change: And finally, we've decided to discontinue the development program for XL for 95.

Speaker Change: And with that I'll turn the call back over to Mike Alright, Thanks, Dana I'll wrap up here by thanking the entire <unk> team for a strong start in the first quarter of 2025, I want to commend everyone for their individual and collective urgency and resilience as we advance our discovery development and commercial priorities.

Tawanda: Please stand by for our next question.

Sean Laaman: Our next question comes from the line of Jay Olson with OPCO, your line is open. Oh, hi.

Sean Laaman: This is Sean on the line for Jay. Thanks for taking the question, and congrats on the quarter. Maybe two questions from us.

Speaker Change: <unk> signaled to us that the therapeutic index is too low to support further development of the compound.

Speaker Change: 225 is already shaping up to be another important year for the business and the patients we hope to serve now and in the future.

P.J. Haley: First, going back to the early launch of CABOE and NET, I'm wondering if we can maybe describe the characteristics of those early adopters, for example, like the number of prior line of therapy and also their tumor location.

Speaker Change: Never satisfied our content with the status quo and we look to make every hour counts as we excel on our mission to help cancer patients recover stronger and live longer.

Mike Alright: And with that I'll turn the call back over to Mike Alright, Thanks, Dana I'll wrap up here by thanking the entire <unk> team for a strong start in the first quarter of 2025, I want to commend everyone for their individual and collective urgency and resilience as we advance our discovery development and commercial priorities.

Amy Peterson: And secondly, on 309, I'm wondering if you can provide some color on the data to be presented this year, whether that will include both single agent and also combination data. Thank you.

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

Speaker Change: Thank you.

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

P.J. Haley: Yeah, PJ, why don't you start with with Annette? I'm not sure we can answer that question effectively, but go ahead. Yeah, I mean, I guess what I can say is qualitatively, you know, similar to the data set of cabinet and in the label being very broad, you know, what we're hearing generally is, you know, It's safe to say that in the commercial setting we don't get a lot of details on the that are getting the job done. Unlike in the trial itself. Correct. Yeah, I just call it.

Mike Alright: 225 was already shaping up to be another important year for the business and the patients we hope to serve.

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

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

Mike Alright: And in the future.

Speaker Change: Please stand by while we compile the Q&A roster.

Mike Alright: We're never satisfied our content with the status quo and we look to make every hour counts as we excel on our mission to help cancer patients recover stronger and live longer we.

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

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

Mike Smith: Hey, guys. Good afternoon, thanks for taking our questions and congrats on a great first quarter with solid here.

Speaker Change: So <unk> sales were obviously very strong in terms of growth over last year could you just help us understand a little bit better what's been driving Cabo growth at this point and obviously.

Mike Alright: Thank you.

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

To withdraw your question. Please press star one again.

Speaker Change: Neuroendocrine was approved at the end of <unk> TTC, some contribution from that prior to approval already and.

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

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

Amy Peterson: Okay, 309 real fast, Amy? Yeah, sure, Jay. Really excited about XL309. This is our small molecule USP1 inhibitor. We are in dose escalation, both as monotherapy and in combination with PERP inhibition. You know, we will be happy to share the data publicly once we have a complete data set. Thank you.

Speaker Change: Secondly, could you just provide some more color about the the the launch and Orlando consumers and expectation.

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

Mike Schmidt: Hey, guys. Good afternoon, thanks for taking our questions and congrats on a great first quarter as solid here.

Speaker Change: Expectations for the early trajectory of that throughout the rest of the year. Thanks, so much.

J: Alright, Thanks, Michael P. J why don't you start and then Chris and I can provide some color commentary afterwards as needed to go ahead. Okay. Thanks for the question Michael as.

Tawanda: Please stand by for our next question.

Speaker Change: As you mentioned.

Speaker Change: We had a strong quarter of results, we're very pleased with the progress we've made.

Ash Verma: Our next question comes from the line of Ash Verma with UBS, your line is open. Hi, thanks for taking my question. So I wanted to understand the net launch dynamic a little bit. If you can elaborate on where do you expect the uptake to come from? Is it from the EPNET or the PNET setting? And is there any difference between this being used before or after AWS or Sutent, or should we think about the competition with Luta Thera?

Speaker Change: Neuroendocrine was approved at the end of <unk> DTC, some contribution from that prior to approval already and.

As you look at the business in terms of demand and T. Rx we grew.

Speaker Change: Secondly, could you just provide some more color about the.

Speaker Change: Significantly in terms of market share from 40% to 44%.

Speaker Change: Launch in neuroendocrine tumors and.

Speaker Change: And on the absolute level the.

Speaker Change: Volume grew 18% year over year Similarly.

Speaker Change: Expectations for the early trajectory there throughout the rest of the year. Thanks, so much.

Speaker Change: In Rx, we grew share from 38%.

Mike: Alright, Thanks, Michael P. J why don't you start and then Chris and I can provide some color commentary afterwards as needed to go ahead okay.

Speaker Change: 243% in terms of new prescription share in our <unk> market basket and even had a more substantial growth.

Speaker Change: For the question Michael.

Speaker Change: As you mentioned we are we.

P.J. Haley: Yeah, again, I would just say, you know, early days in terms of the launch setting and our expectation. And what we're kind of hearing from customers is that given the data are broad, and this data set is unique in that sense, and utilized across sites of origin, you know, lines of therapy, etc. You know, that's what we're hearing, as well as, you know, that's the fact that our expectation is that it will be broadly Yeah. utilized across that and we're aiming to be the small molecule leader in the space within our indication.

Speaker Change: In absolute terms of 27% in both of those were the only product to grow share so performing really well relative.

Speaker Change: We had a strong quarter of results, we're very pleased with the progress we've made.

Speaker Change: As you look at the business in terms of demand in <unk>, we grew.

Speaker Change: Relative to the competition in terms of our business. The majority of this is being driven by RCC and.

Speaker Change: <unk> in terms of market share from 40% to 44%.

Speaker Change: And in particular frontline RCC in terms of the combination of.

Speaker Change: And on an absolute level the.

Speaker Change: Carbo with Nemo.

Speaker Change: Volume grew 18% year over year Similarly.

Speaker Change: As I mentioned in my prepared remarks, we had updated data presented at <unk>.

Speaker Change: Forex, we grew share from 38%.

Speaker Change: In terms of checkmate <unk> and the five year follow up data that's been.

Speaker Change: 243% in terms of new prescription share in our <unk> market basket and even had a more substantial growth.

Speaker Change: Resonating really well.

Speaker Change: With physicians and really continues to position us in a way that differentiates us from the competition.

In absolute terms of 27% in both of those were the only product to grow share so performing really well.

P.J. Haley: Thank you.

Peter Lawson: Please stand by for our next question.

Speaker Change: Which we're pleased with.

Speaker Change: Now a little bit in terms of net.

Chris Senner: Our next question comes from the line of Peter Lawson with Barclays. Your line is open. Great, thank you so much. Thank you very much and congratulations.

Speaker Change: Relative to the competition in terms of our business. The majority of this is being driven by RCC.

Speaker Change: What I'll say is that we only promote on label.

Speaker Change: There was a little bit of net utilization, we saw prior to approval.

Speaker Change: And in particular frontline RCC in terms of the combination of.

Chris Senner: I don't think you mentioned about clinical trial sales. but that and then How are you going to think about pricing power?

Speaker Change: Carver, which nemo.

Speaker Change: But as I mentioned the approval came.

Speaker Change: As I mentioned in my prepared remarks, we had updated data presented at <unk>.

Speaker Change: Our approvals came on March 26th so very early days in terms of the launch, but what I can tell you is that the feedback.

Speaker Change: In terms of checkmate <unk> and the five year follow up data that's been.

Speaker Change: We're getting is really positive from prescribers. The team was literally sprinting out of the gate across all tactics.

Chris Senner: Chris, go ahead. Yeah, Peter, we did talk about clinical trial sales in the prepared remarks section. We had about $12 million in the quarter. Okay, thank you.

Speaker Change: Resonating really well.

Speaker Change: With physicians and really continues to position us in a way that differentiates us from the competition.

Speaker Change: And really all channels. So we're really pleased with the momentum there and we think as I mentioned, it's a really substantial opportunity, but obviously really early days here and we'll be excited to continue to report updates on that as the launch progresses and we get throughout the year.

Speaker Change: We're pleased with.

Speaker Change: Now a little bit in terms of net.

Sudan Loganathan: Please stand by for our next question. Our next question comes from the line of Sudan Loganathan with Stevens. The line is open.

What I'll say is that we only promote on label.

Speaker Change: There was a little bit of net utilization, we saw prior to approval.

Dana Aftab: Hi, this is Felix Ampuma for Sudan Loganathan. Congrats on the quota. I have a quick question regarding STELR 311 in the next indication that will be initiated by first half 2025. Given the approval of CABO for the same indication, how does that change the bar for success for the STELR 3 next trial? Thanks, Felix. I'll try and answer this quickly. This is a study that is going up against Everolimus. This will be Zanzalitinib versus Everolimus as a first oral therapy in patients who have progressed on their SFA. So it's a slightly different space. All of the KOLs, we have a global steering committee, and we've been talking globally with thought leaders around the world.

Speaker Change: But as I mentioned the approval came.

Speaker Change: <unk> came on March 26th so very early days in terms of the launch, but what I can tell you is that the feedback.

Speaker Change: Thank you.

Speaker Change: Okay.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Aster cargo Warden with choice Youre line is open.

Speaker Change: We're getting is really positive from prescribers. The team was literally spinning out of the gate across all tactics.

Speaker Change: Hey, guys. Thanks for taking my questions and I'll Echo the congratulations on some pretty rock star performance in Q1 here.

Speaker Change: And really all channels. So we're really pleased with the momentum there net and we think as I mentioned, it's a really substantial opportunity, but obviously really early days here and we'll be excited to continue to report updates on that as the launch progresses and we get throughout the year.

Speaker Change: <unk> I wanted to add on to Michael's question, just to get a little bit more of the dynamics on the net launch.

Speaker Change: Did you guys see a bolus effect or do you guys have.

Speaker Change: Anticipating a bolus effect here in the early days of launch at net and then when do you and if so when you kind of expect it to kind of stabilize to give you a more accurate run rate in terms of.

Speaker Change: Thank you.

Speaker Change: Of course.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Gordon with choice Youre line is open.

Speaker Change: In terms of.

Speaker Change: Acceleration in uptake and then second if I may.

Dana Aftab: They're all very excited about this option and the trial. So at this point in time, we're not that concerned about competing with CABA. Thank you.

Gordon: Hey, guys. Thanks for taking my questions and I'll Echo the congratulations on.

Speaker Change: Can you modify the statistical analysis for stellar three or three to do it from instead of doing sequentially from non liver met to ITG and do it more as a dual primary end point for both those groups does that help in any way with the alpha spend or maybe D.

Speaker Change: On some pretty rock star performance in Q1 here.

Speaker Change: <unk> I wanted to add on to Michael's question, just to get a little bit more on the dynamics.

Tawanda: Ladies and gentlemen, I'm showing no further questions in the queue.

Speaker Change: The net launch.

Susan Hubbard: I would now like to turn the call back over to your host, Ms. Susan Hubbard. Thank you, Tawanda, and thank you all for joining us today. We certainly welcome your follow-up calls with any additional questions you may have.

Speaker Change: Do you guys see a bolus effect.

Speaker Change: Anticipating a bolus effect here in the early days of launch at net and then when do you and if so when do you kind of expect it to kind of stabilize to give you a more accurate run rate in terms of.

Speaker Change: The hazard ratio you'd need to meet statistical significance.

Speaker Change: Yeah.

Speaker Change: Alright, Thanks, Aster cab PGA real quick on Nets, and then we'll go over to the 303, yes. Thanks for the question <unk>.

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

Speaker Change: In terms of the acceleration.

What I'll say is obviously very early days and the net launch as I mentioned, we're very excited about it.

Speaker Change: Acceleration in uptake and then second if I may.

Speaker Change: Modify the statistical analysis for <unk> III to do it from considering sequentially from non liver met too.

Speaker Change: We will continue to see the trends as we move forward I mean, these patients are advanced in their disease with neuroendocrine tumors or <unk>.

Speaker Change: ITG and do it more as a dual primary end point for both those groups.

Speaker Change: Necessarily expecting to see a bolus there.

Speaker Change: Scott help in any way with the alpha spend or maybe D.

Speaker Change: As I mentioned.

Speaker Change: Great prescriber excitement about the drug we're seeing new prescriptions out of the gate and just looking forward to tracking that going forward great. Amy sure. Thanks, <unk>. So just quickly with regard to changing the endpoint just to.

Speaker Change: The hazard ratio you'd need to meet statistical significance.

Speaker Change: Alright, Thanks, Aster PGA real quick on net and then we'll go over to <unk> for 303, yes. Thanks for the question Africa.

Speaker Change: What I'll say is obviously very early days and the net launch as I mentioned, we're very excited about it.

Speaker Change: Reset for a second stellar 303 is a very large global clinical phase III pivotal study.

Speaker Change: We will continue to see the trends as we move forward I mean these these patients are advanced in their disease with there are under consumer so are.

Speaker Change: And the trial is designed to allow us to assess outcomes in the population of patients without liver mats referred to as an alignment in the ITT population.

Speaker Change: Necessarily expecting to see a bolus there.

Speaker Change: As you know, we completed enrollment about a year ago and Mike has said many times, we are in the business and generating P values and positive outcomes for patients and we continuously evaluate our studies and make modifications necessary to ensure we achieve the maximum success for those patients. So given that we completed enrollment about a year.

As I mentioned.

Speaker Change: <unk> for a second stellar 303 is a very large global clinical phase III pivotal study.

Speaker Change: Ago.

Speaker Change: And then the relative maturity of advance and deliver Matt population really suggested to us that it's best to move the ITT analysis from sequential to dual.

Speaker Change: And the trial is designed to allow us to assess outcomes in the population of patients without remember, Matt referred to as an alignment in the ITT population.

Speaker Change: Because of the really significant potential value as a positive outcome would help a much larger patient population. So it really wasn't about P values are or hazard ratios.

Speaker Change: Our alpha.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Sean <unk> with Morgan Stanley. Your line is open.

Good afternoon, my contained a great set of results.

Speaker Change: <unk>.

Speaker Change: And then the.

Speaker Change: The relative maturity of advance and deliver Matt population really suggested to us that it's best to move the ITT analysis from sequential to do well.

Speaker Change: Maybe just sort of contextualize what seasonality, we can expect for Cabo for the year I think the debate on straight was around $50 million on revenue and the rise is about $100 million on revenue and maybe just to give us some context around that place.

Speaker Change: Because of the really significant potential value as a positive outcome would help a much larger patient population. So it really wasn't about P values or hazard ratios.

Speaker Change: Sure, Chris you want to start with that and I'm sure color commentary. Thanks, Sean So I mean, the seasonality I think that we've seen in the past, where we saw higher gross debt in the first quarter and lower gross to net progressing throughout the year has gone because of the specified.

Speaker Change: Our alpha.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Sean <unk> with Morgan Stanley. Your line is open.

Speaker Change: Good afternoon, my contained a great set of results.

Speaker Change: Maybe just sort of contextualize what seasonality, we can expect for Cabo for the year I think the debate on straight was around $50 million on revenue and.

Speaker Change: While manufacturer designation, so the 1% across all Medicare patients throughout the year. So that creates some stability in the gross to net were still projecting gross to net to be in the 29% to 30% range like I talked about last quarter and so and this year. We also didn't have a.

Speaker Change: The raise is about $100 million in revenue, maybe just to give us some context around that place.

Speaker Change: Inventory dynamic like we've had in past years, where we had higher inventory coming out of Q4 and lower.

Speaker Change: Sure, Chris you want to start with that and I'm sure our color commentary. Thanks, Sean So I mean, the seasonality I think that we've seen in the past, where we saw higher gross debt in the first quarter and lower gross to net progressing throughout the year is gone because of our specify.

Speaker Change: And the Destocking in Q1, so we didn't see that either so.

Speaker Change: From a gross to net perspective, we see some stability there in that 20% to 30% range and we didn't have the inventory dynamics that we've seen in the past.

Speaker Change: While manufacturer designation, so the 1% across all Medicare patients throughout the year, so that creates some stability in the gross to net.

Thank you.

Speaker Change: Please standby for our next question.

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

Speaker Change: Still projected gross to net to be in the 29% to 30% range like I talked about last quarter and so and this year. We also didn't have.

Scott: Alright. Thanks, so much for taking our question. This is Scott on for Greg.

Scott: Just quick questions on on the full year is 25 guidance.

Speaker Change: Inventory dynamic like we've had in past years, where we had higher inventory coming out of Q4 and lower.

Scott: Could you confirm if.

Speaker Change: And the Destocking in Q1, so we didn't see that either so.

Scott: The $100 million increase.

Speaker Change: From a gross to net perspective, we see some stability there in that 20% to 30% range and we didn't have the inventory dynamics that we've seen in the past.

Scott: In terms of where does that come from and how much of the contribution.

Scott: Oh that ammo come from net and and related questions. When do you anticipate having a clarity on the push into your potential of net to include in the Intuit a full year 25 guidance. Thanks, so much.

Speaker Change: Thank you.

Please standby for our next question.

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

Speaker Change: Yeah. Thanks for the question, Yes, just talking about the guidance raise.

Speaker Change: Alright. Thanks, so much for taking our question. This is Scott on for Greg.

Speaker Change: Just quick questions on on the full year is 25 guidance.

Speaker Change: I think it's safe to say the biggest part of that is in the RCC based business, so a little bit of netting there, but the majority of it is based on the strength of the base business in the first quarter.

Speaker Change: Could you confirm if.

Speaker Change: The $100 million increase.

In terms of where does that come from and how much of that contribution.

Speaker Change: We're tracking net very closely obviously as well as for the whole business because that's what we do and as we feel like we've got momentum there certainly coming out of the launch and great performance. So far so don't want to give you guidance on giving you a different guidance later, but we're tracking that closely and when we think it's the right time with the right level.

Of that amount come from net and and related questions. When do you anticipate having a clarity on <unk> for potential net to include in the Intuit a full year 25 guidance. Thanks, so much.

Speaker Change: Yeah. Thanks for the question, Yes, just talking about the guidance raise.

Speaker Change: We have confidence we will talk about that in the future.

Speaker Change: Thank you.

Speaker Change: I think it's safe to say the biggest part of that is in the RCC based business. So a little bit of net in there, but the majority of it is based on the strength of the base business in the first quarter.

Speaker Change: Please standby power on Nick's question.

Speaker Change: Our next question comes from on Sylvan checking with citizens.

Speaker Change: Line is open.

Speaker Change: Thank you so much for taking my question.

Speaker Change: We're tracking that very closely obviously as well as for the whole business because that's what we do and as we feel like we've got momentum there certainly coming out of the launch and great performance. So far so don't want to give you guidance on giving you a different guidance later, but we're tracking that closely and when we think it's the right time with the right level.

Speaker Change: Congrats on a stellar quarter I just wanted to ask a more general question on your BD appetite can you just maybe talk about specifics.

Speaker Change: <unk>, maybe by extrapolation to some of your peers.

Speaker Change: How does the current environment.

Speaker Change: Influence your BD plans. How are you currently on hold are you looking are there certain roadblocks that need.

Speaker Change: The confidence we will talk about that in the future.

Speaker Change: Thank you.

Speaker Change: When you took it away for you to pull the trigger here. Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Our next question comes from the line of Sylvan chicken with citizens.

Speaker Change: Yeah. Thanks for the question as I said in my prepared remarks, we are.

Speaker Change: Line is open.

Speaker Change: We're definitely open for business on the BD side.

Speaker Change: Thank you so much for taking my question.

Speaker Change: Congrats on a stellar quarter.

Speaker Change: We're focused on high conviction assets that fit into our franchise framework within GE you in Gi oncology.

Speaker Change: To ask a more general question on your BD appetite can you just maybe talk about specifics.

Speaker Change: <unk> and maybe by extrapolation to some of your peers.

Speaker Change: We believe we have the opportunity to convert.

Speaker Change: Differentiating clinical data into commercial success, that's the Cabo story, that's the lens with which we look at all opportunities internally and externally. So that quite frankly isn't is the same hasnt changed and we will continue to be the same going forward, we're not looking to buy on the cheap right.

Speaker Change: How does the current environment.

Speaker Change: Influence your BD plans. How are you currently on hold are you looking are there certain roadblocks that need.

Speaker Change: When you took it away for you to pull the trigger here. Thank you.

Speaker Change: Yeah. Thanks for the question as I said in my prepared remarks, we are we are.

Speaker Change: Definitely open for business on the BD side.

Speaker Change: Not looking to buy assets that we have or we see as being very risky, but they are cheap so it might make sense that that's not how we look at it where high science, we wanted to make sure. We can move the needle for patients and the dynamic that we've that we've observed and learned and been able to be successful successful with Cabo is that if you can.

Speaker Change: We're focused on high conviction assets that fit into our franchise framework within GE, <unk> and Gi oncology, where we believe we have the opportunity to convert.

Speaker Change: <unk> differentiated clinical data into commercial success, that's the Cabo story, that's the lens with which we look at all opportunities internally and externally so that quite frankly isn't.

Speaker Change: If you can move the needle for patients. If you can improve standard of care you can commercialize that asset very very productively. So thats the goal so.

Speaker Change: Is the same hasnt changed and will continue to be the same going forward, we're not looking to buy on the cheap we're not looking to buy assets that we have or we see as being very risky, but theyre cheap so it might make sense that that's not how we look at it we're a high science, we wanted to make sure we can move the needle for patients and the <unk>.

Speaker Change: As I have said on previous calls we've burned maybe a haystack. We've got a few few needles that we're looking at right now we are hoping to transact maybe we do maybe we don't it's all about the right assets at the right time, and the right valuation, but we've got a great team across the BD and financial sectors within legal within commercial.

Speaker Change: Dynamic that we've that we've observed and learned and been able to be successful successful with Cabo is that if you can if you can move the needle for patients. If you can improve standard of care you can commercialize that asset very very productively. So thats the goal so.

Speaker Change: Within discovery and development. So we've got a full court press here to be able to figure out what makes the most sense for us and then really how to do that in a practical way that can build value for patients and for shareholders.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: As I've said on previous calls we've burned maybe a haystack. We've got a few few needles that we're looking at right now.

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

Speaker Change: Great.

Speaker Change: Gratulation again, it's really a terrific showing.

Speaker Change: We're hoping to transact maybe we do maybe we don't it's all about the right assets at the right time, and the right valuation, but we've got a great team across the BD and financial sectors within legal within commercial within discovery and development. So we've got a full court press here to be able to figure out what makes the most sense for us and then really how to do that.

So I have maybe two interrelated questions. One is just a little housekeeping.

Speaker Change: If you could just remind us part D redesign how much of an impact did they have this quarters.

Speaker Change: And what percentage of your business is Medicare facing versus commercial and then sort of the more immediate question is.

Speaker Change: In a practical way that can build value for patients and for shareholders.

Speaker Change: <unk>.

Speaker Change: Clearly Mike It sounds like you are waiting for the uptick in net and you're saying, it's a $1 billion opportunity how much of that $1 billion is sort of first line versus second or third line for small molecules I mean, it sounds like you are aiming and youre, intending and you should probably raised guidance again. Thank you.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

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

Speaker Change: Great.

Speaker Change: Congratulations again, it's really a terrific showing.

Speaker Change: So I have maybe two two interrelated question one is just a little housekeeping.

Speaker Change: Yes, so Chris why don't you take care of the housekeeping and then P. J can address some of the kind of overall market dynamics for net.

Speaker Change: If you can just remind us part D redesign how much of an impact that they have this quarter, if any and what percentage of your business is Medicare facing versus commercial and then sort of the more meaty question is.

Speaker Change: As we see it currently go ahead, Chris on your own as Chris.

Speaker Change: So from a Medicare part D redesign perspective, if you look at it quarter Q4 versus Q1, we didn't see a big dynamic there big change in the amount of Medicare.

Speaker Change: It's clearly Mike It sounds like you are waiting for the uptick in net and you're saying that it's $1 billion opportunity how much of that $1 billion is sort of first line versus second or third line for small molecules I mean, it sounds like youre, aiming and Youre, intending and you should probably raised guidance again. Thank you.

Speaker Change: Reimbursements, we had to make if you look at it versus Q1 last year. There was there was a larger.

Speaker Change: There's a bigger difference there we had some benefit towards towards US. This in Q1. This year now from a split between commercial and.

Speaker Change: Yes, so Chris why don't you take care of the housekeeping and then P. J can address some of the kind of overall market dynamics for nets as we see it currently go ahead, Chris your own as Chris.

Speaker Change: <unk>.

Speaker Change: Commercial business of Medicare part D business, it's about equal.

Speaker Change: When you look at the two compared to one another from a patient and payer mix perspective.

Speaker Change: From a Medicare part D redesign perspective, if you look at our quarter Q4 versus Q1, we didn't see a big dynamic they're big change in the amount of Medicare.

Speaker Change: Yeah, and as far as net goes like like I mentioned.

Speaker Change: We view this as a substantial opportunity.

Speaker Change: The $1 billion is across all lines of therapy.

Speaker Change: Reimbursements, we had to make if you look at it versus Q1 last year. There was there was a larger.

Speaker Change: That said in terms of second and third line that is where small molecules.

Speaker Change: There's a bigger difference there we had some benefit towards towards us.

Speaker Change: You know make up the majority of utilization.

Speaker Change: Q1, this year now from a split between commercial and <unk>.

Speaker Change: And we think there's substantial opportunity there even looking at it.

Speaker Change: The other another therapy in the market for example, if you look at.

Speaker Change: Commercial business of Medicare part D business, it's about equal when.

Speaker Change: <unk> is a recent revenue.

Speaker Change: When you look at the two compared to one another from a patient and payer mix perspective.

If you look at their last quarters revenue given it a runway run rate, that's a $560 million.

Speaker Change: Yeah, and as far as net goes like like I mentioned.

Speaker Change: We view this as a substantial opportunity.

Annualized so again, we're very excited by this opportunity.

Speaker Change: The $1 billion is across all lines of therapy.

Speaker Change: When it comes to the small molecule market, we're the only.

Speaker Change: That said in terms of second and third line that is where small molecules.

Speaker Change: Branded molecule out there with.

Speaker Change: Substantial and experienced team behind this and we're really excited about the ability to help patients and move the business forward.

Speaker Change: The majority of utilization.

Speaker Change: And we think there's substantial opportunity there even looking at it.

Speaker Change: Thank you.

Speaker Change: The other another therapy in the market for example, if you look at.

Speaker Change: Our next question comes from the line of Chi Fong with Banc of America Securities. Your line is open.

Speaker Change: <unk> recent revenue.

Speaker Change: If you look at their last quarters revenue given it a runway run rate that's at $560 million.

Speaker Change: Hey, guys. This is chi on for Jason.

Speaker Change: Thanks for taking our question what's the.

Speaker Change: A question on capital allocation, Mike I've asked you. This question early in the year before and I'm going to ask you I can I'm curious about your philosophy in terms of the buyback program. Obviously you guys have consistently.

Speaker Change: Annualized so again, we're very excited by this opportunity.

Speaker Change: When it comes to the small molecule market, we're the only.

Speaker Change: Branded molecule out there with.

Substantial and experienced team behind this and we're really excited about the ability to help patients and move the business forward.

Speaker Change: That's just going to keep buying back for 2023, I think roughly high single digit percentage of outstanding shares if I count correctly.

Speaker Change: Thank you.

Chi Fong: Our next question comes from the line of Chi Fong with Banc of America Securities. Your line is open.

Speaker Change: And it will be about $500 million give or take so I'm just curious if share price remain current and existing level or even if cabo itself Oh Kris what's your philosophy on share buyback first says where you're investing capital into R&D or.

Speaker Change: Hey, guys. This is chi on for Jason.

Chi Fong: Thanks for taking our question a quick.

Chi Fong: A question on capital allocation, Mike I've asked you. This question early in the year before and I'm going to ask you I can I'm curious about your philosophy in terms of the buyback program. Obviously you guys have consistently.

Speaker Change: Development. Thanks, so much.

Speaker Change: Yeah. Thank you for the question look I again, as we talked about previously reiterated in prepared remarks today with our balance sheets and.

Chi Fong: Francisco to keep buying back for 2023, I think roughly high single digit percentage of outstanding shares if I count correctly.

Speaker Change: As expected free cash flows we think we can allocate capital effectively around investing in the internal pipeline and doing the appropriate thoughtful and pragmatic BD and still buying back shares. When we think the shares are undervalued relative to where we think it can go. So so I think that's the right approach how we do that.

Chi Fong: Annual maybe like $500 million of at least give or take so I'm. Just curious if share price remain current and existing level or even if cabo itself increase what's your philosophy on share buyback first says, we invest the capital into R&D or.

Speaker Change: How we emphasize one over the other will be situationally dependent.

Development. Thanks, so much.

Speaker Change: I think by my math, we bought back about 19%, 20% of our outstanding float over the last couple of years.

Chi Fong: Yes. Thank you for the question look I again, as we talked about previously reiterated in prepared remarks today with our balance sheets and.

Speaker Change: We've done that at significantly lower prices than where the stock is trading at today. So that's I think a good move from an investment point of view.

Chi Fong: As expected free cash flows we think we can allocate capital effectively around investing in the internal pipeline and doing the appropriate thoughtful and pragmatic BD and still buying back shares. When we think the shares are undervalued relative to where we think it can go. So so I think thats the right approach, how we do that.

Speaker Change: We like investing in ourselves right again.

Speaker Change: In the context of how we view quality, how we view assets that can move the needle the needle for patients and shareholders. We think <unk> is a great place to put that money. So.

Chi Fong: How we emphasize one over the other will be situationally dependent.

Speaker Change: So that's how we're going to continue to operate.

Speaker Change: With data dependent with data driven so we'll see how that goes in the future, but again, having the cash flows that we've got in the balance sheet that we have gives us the ultimate optionality and we like that going forward.

Chi Fong: I think by my math, we bought back about 19%, 20% of our outstanding float over the last couple of years.

Chi Fong: We've done that at significantly lower prices than where the stock is trading at today. So thats a good move from an investment point of view.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

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

Chi Fong: We like investing in ourselves right again.

Speaker Change: Cost to worry with Jefferies. Your line is open.

Chi Fong: In the context of how we view quality, how we view assets that can move the needle the needle for patients and shareholders. We think <unk> is a great place to put that money. So.

Speaker Change: Hey, Thanks, so much I think it sounds like youre going to have a dog or a no go decision on your head and neck study with Merck at the end of the year, what do you want to see on event rates to justify moving forward with that trial and then also when we think about the PD one VEGF Bispecific class Theres a lot of similarity to kind of pick on Zander, you hit that Jeff, but you'll have a wider therapeutic window.

Chi Fong: So that's how we're going to continue to operate.

Chi Fong: With data dependent with data driven so we'll see how that goes in the future, but again, having the cash flows that we've got in the balance sheet that we have gives us the ultimate optionality and we like that going forward.

Speaker Change: Have you thought about acquiring one of those assets for RCC in head and neck and given your partner Merck already has the window of asset. Thank you.

Chi Fong: Thank you.

Speaker Change: Please standby for our next question.

Amy Peterson: Okay. So why not use Amy take the head and neck question and I'll come back on the BD cycle first okay. Yes. Thanks for the question. So I did mention in the prepared remarks that we are anticipating to have sufficient number of events in order for the IBM Z to review and enable a go no go to phase III.

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

Speaker Change: Hey, thanks, so much.

Speaker Change: Sounds like Youre going to have a dog or no go decision on your head and neck study with America at the end of the year, what do you want to see on event rates to justify moving forward with that trial and then also when we think about the PD one bedroom Bispecific class Theres a lot of similarity to kind of pick on vans.

We don't typically talk about what those events are and so I'm just waiting for the data to mature. So that we can have the com and get the decision, but that's about really all I can say okay. Thank you yeah on the BD side look where we look at everything with a pretty careful eye.

Speaker Change: But you have a wider therapeutic window have you thought about acquiring one of those assets for RCC. It had neck given your partner Merck already hassled to Nova asset. Thank you.

Speaker Change: Okay. So why not use Amy take the head and neck question and I'll come back on the BD cycle first okay. Yes. Thanks for the question. So I did mention in the prepared remarks that we are anticipating to have sufficient number of events in order for the IBM Z to review and enable a go no go to phase II.

Amy Peterson: We really like being in the Bispecific space and certainly <unk> is a good example of that that we think the <unk>.

Amy Peterson: Potential combination with <unk> gives us really good coverage on the on the PDL one side on the <unk> side, and then bringing in bringing in NK cells.

Speaker Change: Hi.

Speaker Change: We don't typically talk about what those events are.

Amy Peterson: Sales as well so you know how you slice and dice those opportunities you have to be really thoughtful and really careful obviously theres a lot of.

Speaker Change: And so on.

Speaker Change: I'm just waiting for the data to mature so that we can have the com and get the decision, but that's about really all I can say okay. Thank you, yes on the BD side look where we look at everything with us pretty careful eye.

Amy Peterson: PDL, one VEGF targeting bi specifics right now we don't see a line of differentiation in that in that area and certainly there is key data waiting to be disclosed around certainly say the survival data in the in the non small cell lung cancer trials. So so we're looking at everything.

Speaker Change: We really like being in the Bispecific space and certainly <unk> is a good example of that that we think the potential combination with <unk> gives us really good coverage on the on the PDL one side on the VEGF side, and then bringing in bringing in NK cells.

Amy Peterson: Consider everything again, we have a I think unique perspective on how to build value and continue to execute on that as we go forward.

Speaker Change: Sales as well so how you slice and dice those opportunities you have to be really thoughtful and really careful obviously theres a lot of.

Amy Peterson: Thank you.

Speaker Change: Please standby for our next question.

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

Speaker Change: PDL, one VEGF targeting bi specifics right now we don't see a lot of differentiation in that in that area and certainly there is key data waiting to be disclosed around certainly say the survival data in the in the non small cell lung cancer trials. So so we're looking at everything.

Speaker Change: Hi, This is <unk> on for Derik. Thanks for taking my question and congrats on the quarter a quick one from us.

Speaker Change: Can you help set expectations a bit on the non clear cell renal cell carcinoma study.

Speaker Change: What we've seen here from <unk> in this patient population.

Speaker Change: Consider everything again, we have a I think unique perspective on how to build value and continue to execute on that as we go forward.

Speaker Change: Maybe you want to take that yeah sure. So.

Speaker Change: With regard to setting expectations. This is a I think a very exciting study for US won it is a study in kidney cancer. Its first phase III that's ever been run.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

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

In the smaller population in kidney cancer, and so having a positive outcome, we think would really benefit patients who have been otherwise lumped into the category of clear cell kidney cancer.

Speaker Change: Hi, This is <unk> on for Derik, Thanks for taking our questions and congrats on the quarter a quick one from us can you.

Speaker Change: Expectations a bit on the non clear cell renal cell carcinoma study and what we've seen here from <unk> in this patient population.

Speaker Change: The best benchmark that we have is probably with <unk>. That's what we're going up against that this is a study that is looking at Nevada.

Speaker Change: Maybe you want to take that yeah sure. So.

Speaker Change: US <unk> versus Sunitinib.

Speaker Change: With regard to setting expectations. This is a I think a very exciting study for US won it is a study in kidney cancer. Its first phase III that's ever been run.

Speaker Change: <unk>.

Speaker Change: We know that Cabo has beaten Senate nobody had to had a cabo knievel beat Sunitinib and we think that sands is better than Cabo and so Cabo Nemo against Sunitinib. We think has a very high probability of success here.

In the smaller population in kidney cancer, and so having a positive outcome, we think would really benefit patients who have been otherwise lumped into the category of clear cell kidney cancer.

Speaker Change: The PFS that is most commonly quoted for sunitinib in non clear cell space is about five to six months.

Speaker Change: The best benchmark that we have is probably with <unk>. That's what we're going up against that this is a study that is looking at Nevada.

Speaker Change: Thank you.

Speaker Change: Please standby for her next question.

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

Speaker Change: Zander, let NAV versus Sunitinib.

Speaker Change: Yes.

Speaker Change: Yeah.

Speaker Change: We know that Cabo has beaten.

Speaker Change: Yeah.

Speaker Change: Thanks for taking my questions. Congratulations on the beat and raise two quick ones for US just going back to the 303 statistical analysis change.

Speaker Change: Nobody had to had a cabo knievel beat Sunitinib and we think that zions is better than Cabo and so Cabo Nemo against Sunitinib. We think has a very high probability of success here.

Speaker Change: Curious about the definition so dual versus co primary endpoints can you declare victory with just win in either endpoint.

Speaker Change: The PFS that is most commonly quoted for sunitinib in non clear cell space is about five to six months.

Speaker Change: So that's part one part two so the alpha spend so do you need 0.025 and four four for success.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Just wanted to end point, if that's the scenario.

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

Speaker Change: And that was captivated by Dana his commentary about the induced proximity mechanism for four 628.

Yes.

Andy Chu: Thanks for taking my questions. Congratulations on the beat and raise two quick ones for US just going back to the 303 statistical analysis change.

Speaker Change: Several of the presentation is looking at.

Speaker Change: Dual.

Speaker Change: Got a bispecific adcs dual payloads curious about your thoughts on expanding on on your tool kits to explore that opportunity. Thank you.

Andy Chu: Curious about the definition so dual versus co primary endpoints can you declare victory with just win in either endpoint.

Andy Chu: So that's part one part two so the alpha spend so do you need 0.25 and four for success.

Alright, Thanks, Andy we've addressed the three or three question several times, so let's start with Dana on the six two weeks in the kind of strategy. There and then we'll go to Amy real fast for a wrap up on three of III got sure. So just to reiterate.

Andy Chu: Just wanted to end point, if that's the scenario.

Speaker Change: And that was captivated by Dana his commentary about the induced proximity mechanism for $6 28.

Speaker Change: <unk> presentation at ACR.

Speaker Change: It was our first.

Speaker Change: Several of the presentation is looking at.

Speaker Change: Sure.

Speaker Change: Data dump on that compound at a scientific conference and we showed quite a few data points, but I think that the key one that you're referencing Andy is the one showing the ability of the molecule to co localize NK cells or tumor cells, and then critically that translated to a <unk>.

Speaker Change: Dual.

Speaker Change: Kind of Bispecific Adcs dual payloads curious about your thoughts on expanding on on your tool kits to explore that opportunity. Thank you.

Speaker Change: Alright, Thanks, Andy we've addressed three of three question several times, so let's start with Dana on the six two weeks in the kind of strategy. There and then we'll go to Amy real fast for a wrap up on three of III got sure. So just to reiterate.

A much higher sort of level of NK mediated cytotoxicity against those tumor cells in vitro assay compared to mono specific antibodies hitting each.

Speaker Change: <unk> presentation at ACR.

Speaker Change: Checkpoint individually.

Speaker Change: It was our first sort of.

Speaker Change: So yes, I mean, obviously, we're very excited about this molecule based on its ability to potentially impact.

Speaker Change: Or address unmet need across all of our key therapeutic areas, including <unk> and Gi oncology and in colorectal cancer and <unk>.

Speaker Change: Combination with drugs like <unk> and other drugs.

Speaker Change: To a much higher sort of level of NK mediated cytotoxicity against those tumor cells in an in vitro assay compared to mono specific antibodies hitting each.

Speaker Change: <unk> point individually.

And what I would just say at this point is stay tuned for more information that we plan to kind of bring out from behind the curtain at the R&D day event later this year, where we're planning to really.

Speaker Change: So yes, I mean, obviously, we're very excited about this molecule based on its ability to potentially impact.

Speaker Change: Or address unmet need across all of our key therapeutic areas, including <unk> and Gi oncology and in colorectal cancer.

Speaker Change: Go into a lot more of our strategy for the future of our discovery pipeline awesome. Thank you yeah. Just real quickly. So you are right Andy and that are co primary requires both be positive in order for the study to be positive dual primary means either one can be positive for the study to be positive.

Speaker Change: Combination with drugs like <unk> and other drugs.

Speaker Change: When it comes to other types of technologies that you kind of hinted at in terms of multi payloads and things like that we're of course very interested in those types of technologies and what I would just say at this point is stay tuned for more information that we plan to kind of bring.

Speaker Change: However, it does not necessitate equal split of Alpha.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Out from behind the curtain at the R&D day event later this year, where we're planning to really.

Speaker Change: Our next question comes from the line of Andrew Burns with Leerink Partners. Your line is open.

Go into a lot more of our strategy for the future of our discovery pipeline awesome. Thank you Amy just real quickly. So you are right Andy and that are co primary requires both be positive in order for the study to be positive dual primary means either one can be positive for the study to be positive.

Speaker Change: Hi, Good afternoon. This is <unk>.

Speaker Change: On for Andy Congrats on the quarter and thanks for taking our question.

Speaker Change: Just two quick ones on 303 can you remind us what <unk> has demonstrated in the ITT and how do you expect the control arm to perform and then maybe on three or four when we get an interim OS that is part of the second half update and just curious.

Speaker Change: However, it does not necessitate equal split of Alpha.

Speaker Change: We need do you anticipate needing OS data in order to file thank you.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: Yeah sure. So thanks for the question.

Speaker Change: Our next question comes from the line of Andrew Burns with Leerink Partners. Your line is open.

Speaker Change: I'll I'll remind everybody of the data that we presented in stellar Oh, one which was <unk> plus <unk> in patients with colorectal cancer. The eligibility criteria were pretty similar to that for 303 with the exception that everybody had to be Ras wild type and stellar.

Speaker Change: Hi, Good afternoon. This is <unk>.

Speaker Change: <unk> on for Andy Congrats on the quarter and thanks for taking my question.

But there what we saw was the median OS with Zander achieves a 11 seven months in the ITT population.

Speaker Change: And it was 18 five months in the non liver Mac patient population and of course that study is still ongoing with additional follow up and we will update those as possible that bodes well when you consider and non crop. These are cross trial comparisons the benchmark of <unk> that.

Speaker Change: Yeah sure. So thanks for the question.

That we know from the archived database from the Phase III studies in other competitors is really in the ITT patient population somewhere between six to eight months.

Speaker Change: But there what we saw was the median OS with Zander achieves a 11 seven months in the ITT population and it was 18 five months in the non liver Mac patient population and of course that study is still ongoing with additional follow up and we'll update that.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

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

Jay Olson: Oh, Hi, this is shown in our lives a J. Thanks for taking the question and congrats on the quarter.

Speaker Change: As possible that bodes well when you consider and non crop. These are cross trial comparisons the benchmark of <unk>.

Speaker Change: Maybe two questions from us first going back to the early launch of Cabo in that I'm wondering if again.

Speaker Change: Maybe describe the characteristics of those early adopters for example, like the number of prior Lyle therapy and also their tumor location.

Speaker Change: That we know from the archive database from the Phase III studies in other competitors is really in the ITT patient population somewhere between six to eight months.

Speaker Change: Yes, definitely else real life I'm wondering if you can provide some color on the data.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Speaker Change: To be presented this year, whether that will include both single agent and also combination data. Thank you.

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

R. J.: Oh, Hi, this is shown on the lines R. J. Thanks for taking the question congrats on the quarter.

Speaker Change: Yeah P. J why don't you start with with the net I'm not sure. We can answer that question effectively but go ahead, yeah, I mean, I guess, what I can say is qualitatively similar to the dataset.

Speaker Change: Maybe two questions from us first going back to the early launch of Cabo and match.

R. J.: I'm wondering if.

R. J.: Maybe describe the characteristics of those early adopters for example.

Of cabinet in the label being very broad what we're hearing generally as you know our excitement to utilize the drug in utilization in a very broad manner, regardless of sort of tumor location.

R. J.: Number one prior line of therapy and also their children location.

R. J.: Yes, it's definitely all thrilled I am wondering if you can provide some color on the data to.

Speaker Change: Patient grade line of therapy et cetera, So I think.

R. J.: To be presented.

R. J.: Whether that will include both single agent and also a combination data. Thank you.

Speaker Change: Just a lot of excitement to have a drug that physicians can use kind of broadly across the neuroendocrine tumor space, but it is safe to say that in the commercial setting we don't get a lot of details on the patient center there.

Speaker Change: Getting the drug.

Speaker Change: Unlike in the <unk>.

Speaker Change: Of cabinet and the label being very broad what we're hearing generally as you know.

Speaker Change: Trial itself correct, yes, just quality.

Speaker Change: Okay, and I know fast yeah sure a J it really excited about <unk> 309. This is our small molecule <unk>. One inhibitor. We are in dose escalation, both as monotherapy and in combination with PARP inhibition.

Speaker Change: Excitement to utilize the drug in utilization and a very broad manner, regardless of sort of tumor location.

Speaker Change: Patient grade line of therapy et cetera, So I think.

Speaker Change: We will be happy to share the data.

Speaker Change: Once we have a complete dataset.

Speaker Change: Thank you.

Speaker Change: Standby for our next question.

Speaker Change: Our next question comes from the line of Ash Birla with UBS. Your line is open.

Speaker Change: Getting the drug.

Speaker Change: Unlike in the group.

Speaker Change: Hey, Thanks for taking my questions I wanted to understand like the net launch down to make a little bit. If you can elaborate on where you expect the uptake to come from is it from the Ethernet the peanuts hitting and is there any distinction between like.

Speaker Change: Trial itself correct.

Speaker Change: Quality.

Speaker Change: And I know fast any yes, sure a J it really excited about XL three online. This is our small molecule <unk> one inhibitor.

Speaker Change: Are in dose escalation, both as monotherapy and in combination with PARP inhibition.

Speaker Change: This being used before or after a willingness or Sudan.

Speaker Change: We will be happy to share the data.

Speaker Change: How should we think about the competition with youth apparel.

Publicly once we have a complete dataset.

Speaker Change: Thank you.

Speaker Change: Thanks.

Speaker Change: Please standby for our next question.

Speaker Change: Yeah again, I would just say early days in terms of the launch setting and.

Speaker Change: Our next question comes from the line of Ash Verma with UBS. Your line is open.

Speaker Change: Our expectation and what we're kind of hearing from customers is that given the data or abroad.

Ash Verma: Hey, Thanks for taking my questions I wanted to understand like the net large down to make a little bit.

Speaker Change: This data set is unique in that sense and utilized.

Speaker Change: He can elaborate on where do you expect the uptake to come from is it from the Ethernet the peanuts setting and is there any difference between like this being used before or after I will really miss or Sudan.

Speaker Change: Cross sites of origin lines.

Speaker Change: All lines of therapy et cetera.

Speaker Change: That's what we're hearing.

Speaker Change: As well as you know Thats. The fact that our expectation is that it will be broadly.

Speaker Change: Utilized across.

Speaker Change: How should we think about the competition with yoga apparel.

Speaker Change: Offsetting where we're aiming to be the small molecule leader in the space within our indication.

Thanks.

Speaker Change: Yeah again, I would just say early days in terms of the launch setting and.

Speaker Change: Thank you Lee.

Speaker Change: Our expectation and what we're kind of hearing from customers is that given the data or abroad.

Speaker Change: Please standby for our next question.

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

Speaker Change: This data set is unique in that sense and utilized.

Peter Lawson: Great. Thank you so much thanks for taking the question congratulations on the quarter.

Speaker Change: Across sites of origin.

Peter Lawson: Just quoted I didn't think you mentioned about clinical trial sales.

Speaker Change: Lines of therapy et cetera.

That's what we're hearing.

Peter Lawson: It took about that and then.

Speaker Change: As well as that's the fact that our expectation is that it will be broadly.

Peter Lawson: How are you kind of think about pricing power considering here.

Peter Lawson: Positioning OCC.

Speaker Change: Utilized across.

Thank you.

Speaker Change: There are certain where we're aiming to be the small molecule leader in the space within our indication.

Chris Senner: Chris Go ahead, yeah, you're right. We did talk about clinical trial sales in the prepared remarks section, we had about $12 million in the quarter.

Speaker Change: Thank you.

Speaker Change: Please standby for our next question.

Chris Senner: Okay.

Chris Senner: You.

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

Chris Senner: Please standby for our next question.

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

Peter Lawson: Great. Thank you so much thanks for taking my question congratulations on the quarter.

Speaker Change: Just on the quarter.

Speaker Change: Hi, This is CLEC complement for <unk>.

Speaker Change: I don't think you mentioned about clinical trial sales.

Speaker Change: Sudan, Nathan congrats on the quota.

Peter Lawson: Talk about that and then.

Peter Lawson: How are you kind of think about pricing power.

Speaker Change: I have a quick question regarding.

Speaker Change: There are 311.

Peter Lawson: <unk>.

Peter Lawson: We are positioning OCC.

Speaker Change: Net indication that will be initiated by.

Peter Lawson: <unk>.

Peter Lawson: Chris Go ahead, Peter we did talk about clinical trial cells in the prepared remarks section, we had about $12 million in the quarter.

Speaker Change: 2025, given the approval of Cabo, but the same indication.

Speaker Change: Does that change the.

Speaker Change: <unk> for the military.

Speaker Change: Okay. Thank you.

Speaker Change: Xtra.

Peter Lawson: Please standby for our next question.

Speaker Change: Thanks, Dave I'll try and answer this quickly.

Speaker Change: Our next question comes from the line of Sudan, Logan Nathan with Stephens. Your line is open.

Speaker Change: This is a study that is going up against ever alignment. This will be <unk> versus everolimus as a first oral therapy and patients who have progressed on their FSA. So it's a slightly a slightly different space all of the Kols, we have a global steering committee and we've been talking globally with thought leaders around.

Speaker Change: Hi, This is Phil.

Speaker Change: Sudan Nathan.

Speaker Change: Brad on the quota.

Speaker Change: A quick question regarding.

Speaker Change: <unk> III 11.

Speaker Change: Net indication that will be initiated by.

Speaker Change: The world, they're all very excited about this option.

Speaker Change: 2025, given the approval of Cabo, but the same indication.

Speaker Change: And the trial. So at this point in time, we're not that concerned about competing with Cabo.

Speaker Change: Does that change the.

Speaker Change: <unk> for the stellar three.

Speaker Change: Next trial.

Speaker Change: Thank you.

Speaker Change: Thanks, Pete likes I'll try and answer this quickly.

Speaker Change: Ladies and gentlemen, I'm showing no further questions in the queue.

Speaker Change: The study that is going up against ever align us this will be zander, let NAV versus everolimus as a first oral therapy and patients who have progressed on their FSA. So it's a slightly a slightly different space all of the Kols. We are a global steering committee and we've been talking globally with thought leaders around the.

Speaker Change: I would now like to turn the call back over to your host Ms. Susan Hubbard.

Thank you I wanted to thank you all for joining US today, we certainly welcome your follow up calls with any additional questions you may have.

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

Speaker Change: The world, they're all very excited.

Speaker Change: This option.

Speaker Change: And the trial. So at this point in time, we're not that concerned about competing with Cabo.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen, I'm showing no further questions in the queue.

I'd now like to turn the call back over to your host Ms. Susan Hubbard.

Speaker Change: Thank you I wanted to thank you all for joining US today, we certainly welcome your follow up calls with any additional questions you may have.

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

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Uh huh.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: Sure.

Speaker Change: [music].

Speaker Change: Yes.

Speaker Change: [music].

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