Exelixis, Inc. (EXEL) Earnings Call Transcript

Good day, ladies and gentlemen, and welcome to the Exelixis Third Quarter 2026 Financial Results Conference Call. My name is Tolanda, and I will be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Mr. Andrew Peters, Senior Vice President of Strategy and Investor Relations. Please proceed.

Thank you, Towanda, and thank you all for joining us for the Exelixis Third Quarter 2026 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO; Chris Senner, our Chief Financial Officer; Dana Aftab, our Executive Vice President of Research and Development; and P.J. Haley, our Executive Vice President of Commercial, who will review our progress for the third quarter 2026 ended September 30, 2026. The -- during the call today, we will refer to financial not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results. During the course of the 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 recovery, product development, regulatory, commercial, financial and strategic matters, potential growth opportunities and government drug pricing policies and initiatives. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which under the heading Risk Factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitation, 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 cost associated with discovery, product development, business development and commercialization activities. With that, I'll turn the call over to Mike.

All right. Thank you, Andrew, and thanks to everyone for joining us on the call today. Exelixis had a strong third quarter and continues to advance the key components of our business. The company is well positioned to deliver on our strategic objectives and tactical goals for 2026 and beyond. As we aspire to become a company with a diverse pipeline of potential oncology franchise assets and opportunities. Most importantly, zanzolintinib is positioned to drive the next phase of growth for Exelixis as our second franchise molecule, potentially first with the third line plus CRC opportunity. . Followed by several waves of pivotal trials that we'll highlight today. Cabo's strong third quarter performance reinforces our confidence in its long-term revenue growth trajectory. We saw solid year-over-year growth in both the RCC and net indications in Q3 and are excited with the potential of the cabo net indication, which serves as the foundation of our future expanded net franchise with [ Xansa ] and other molecules in our pipeline. The bottom line today is that we remain laser-focused to advance XL to the next level with numerous opportunities as we build new oncology franchises through discovery, development, commercial and business development activities, while we reinforced our existing cabo franchise. Key highlights for the third quarter 2026 include: first, Xansa is in the spotlight as our next potential franchise opportunity. Xansa remains our #1 R&D priority, and we are advancing key objectives across the program. Beyond our current pivotal trials, we are actively advancing a second wave of potential pivotal trials that could further expand the scope, reach and long-term value of [ Zama ] in GU, GI and other indications. Our goal is to build a durable franchise with stacking capabilities that could drive growth for years to come. Second, we continue to see substantial growth from the cabozantinib franchise. Cabo remains the leading TKI for RCC and and the market leader for the oral second line plus net segment. Third quarter 2026, U.S. combo franchise net product revenues grew approximately 11% year-over-year to $605 million. continuing its role as the worldwide leading TKI global cabo franchise net product revenues generated by Exelixis and its partners grew approximately 11% year-over-year to $818 million in the third quarter 2026. Third, our commitment to rigorous expense management and capital allocation is unwavering as we invest in our mission-critical R&D priorities while returning cash to shareholders with our share repurchase program. We believe our expense management and capital allocation strategy is an important corporate differentiator and positions us to create both short-term and long-term shareholder value while maintaining strategic flexibility. Third quarter and year-to-date progress underscores the strength of our oncology franchise strategy as we advance [ Anza ] towards becoming a major franchise, develop our broad portfolio, 1 of the cabozantinib business. and maintain disciplined capital allocation. So with that, please see our press release issued an hour ago for our quarterly financial results and a comprehensive summary of key corporate milestones achieved during the period. And with that, I'll turn the call over to Chris.

Thanks, Mike. For the third quarter, 2026, the company reported total revenues of approximately $659 million, which included cabozantinib franchise, U.S. net product revenues of $605 million. CABOMETYX net product revenues were $603 million and included no clinical trial sales. As a continued reminder, clinical trial sales have historically been choppy between quarters, and we expect this to continue into the future. Gross to net for the cabozantinib franchise in the third quarter was approximately 29%, which is lower than the gross to net we experienced in the second quarter. This decrease in gross to net deductions in the third quarter is primarily due to lower 340B discounts when compared to the second quarter. Additionally, we are updating our estimate for full year 2026 gross to net deductions, and we're now projecting that will be approximately 30%. Our CABOMETYX trade inventory was down at 1.8 weeks on hand at the end of the third quarter when compared to the second quarter. Total revenues in the third quarter in -- also include approximately $52 million in royalties earned from our partners, Ipsen and Takeda, on their sales of [ Cabot. ] Our total operating expenses for the third quarter of 2026 were approximately $390 million compared to $380 million in the second quarter. The sequential increase in these operating expenses was primarily driven by higher legal and advisory fees, marketing expenses and higher cost of goods sold, which were offset by lower license and other collaboration costs. Provision for income taxes for the third quarter of 2026 was approximately $64.7 million compared to approximately $50.6 million for the second quarter of 2026. The company reported GAAP net income of approximately $218 million or $0.88 per share basic and $0.85 per share diluted for the third quarter 2026. Company also reported non-GAAP net income of approximately $240 million or $0.97 per share basic and $0.94 per share diluted. Non-GAAP net income excludes the impact of approximately $22 million of stock-based compensation expense net of the related income tax effect. Cash and marketable securities for the quarter ended September 30, 2026, were approximately $1.4 billion. During the third quarter of 2026, we repurchased approximately $250 million of the company's outstanding common stock, resulting in the retirement of approximately 4.5 million shares of the company's outstanding common stock at an average price per share of $55.77. As of the end of the third quarter of 2026, we had approximately $348 million remaining under the $750 million stock repurchase plan authorized for the company's Board in May 2026. And finally, we're updating the full year 2026 financial guidance, reflecting changes to our cost of goods sold and our tax rate estimates, which are detailed on Slide 13 of our earnings presentation. And with that, I'll turn the call over to Dana.

Thanks, Chris. Our unified strategy in R&D is focused on developing multiple franchise molecules in oncology. Therefore, we continue to be focused on maximizing our productivity with disciplined investment in high-value opportunities for [ Xansa ] as well as the rest of our portfolio. Our strategy is based on our experience with cabo or 14 completed pivotal trials and aid approvals firmly cemented its franchise status and brought tremendous value to patients across a spectrum of different cancers. We're taking a similar approach to Zanza where we now have 7 ongoing trials that are potentially label-enabling which we refer to as Wave 1. Those trials address just a subset of the potential opportunities for Xansa and we are now well underway on planning and executing our Wave 2 pivotal studies for [ ZaZa. ] All of these activities are aligned with our strategy, which prioritizes development of Xansa as a multidimensional solid tumor oncology franchise molecule. The STELLAR 316 trial is a key component of this strategy. and is designed to entrench Sansa in the GI franchise. This is a pivotal Phase III trial investigating Zaza with and without subcutaneous pembro in patients with resected Stage II or III colorectal cancer [indiscernible] who following definitive therapy have tested positive for molecular residual disease and have no radiographic evidence of disease. I'm happy to say that sites in this trial are now activated and enrolling participants. We are particularly excited about this trial, not only because of its potential to improve outcomes in CRC patients at an earlier stage of disease that was addressed in the CELLAR-303 trial but also because it utilizes the Signatera test to select patients with the greatest need. Regarding the NDA based on STELLAR 303, our updated PDUFA action date is March 3, 2027. We -- in the neuroendocrine tumor indication, STELLAR 311 is our global Phase III trial evaluating Xansa compared to everolimus as an initial oral therapy in patients with pancreatic or extrapancreatic neuroendocrine tumors. STELLAR 311 positions Zaza to potentially become the first and only small molecule to be randomized against an active control in a pivotal trial in this indication, which, depending on the data, could potentially position Zaza to broadly displace other oral agents in the frontline setting. Thus, we are very enthusiastic about STELLAR-311, and that sentiment is also shared by investigators and patients based on the continued robust enrollment we've observed in the trial since its activation. In the GU tumor franchise, STELLAR-304 is our first pivotal trial for Zama in kidney cancer, evaluating the combination of Xansa plus nivolumab versus sunitinib in patients with non-clear cell renal cell carcinoma. We completed enrollment in STELLAR-304 last year, and we now expect top line results from the study to be available in the first quarter next year. If positive, those results could lead to our second NDA filing for Zaza in clear cell RCC, progress continues with regard to the 2 pivotal Phase III studies that Merck is running to evaluate Sansa in combination with [indiscernible] with LITESPARK-033 investigating the combination in the frontline setting and LITESPARK-034 in the second-line plus setting. Finally, for our Wave 1 trial updates, STELLAR-201 is our Phase II trial evaluating Zanza in patients with recurrent minigeona who are no longer responsive to or eligible for local therapies, and enrollment in the trial continues to exceed our initial projections. This indication represents a very high unmet need in neuro-oncology, which we believe is a factor in the robust enrollment we've observed pending favorable results and given the absence of any approved systemic therapies in this setting, the STELLAR-201 trial could be an important opportunity for Xansa to become the first systemic therapy that could improve outcomes for these patients. We're excited to see these 7 ongoing Wave 1 trials continuing to move forward. And we believe that Zanza's differentiated profile has the potential to translate into a meaningful benefit for patients in other tumor settings and/or combinations with additional molecules and mechanisms of action. To realize that potential, we are actively pursuing the next wave of potential pivotal trials or Wave 2 for Zanza. A primary focus for Wave 2 is to continue investigating XanZa combined with established immunotherapies, given the demonstrated clinical differentiation we've observed with Zanza paired with atezo in CRC and with nivo and RCC, which we believe strongly supports Sansa's potential to be the TKI of choice for combinations with immune checkpoint inhibitors. A clear fit within this strategy is STELLAR-202, our Phase II trial in squamous non-small cell lung cancer as investigating the addition of ZaNational Funza to pembro in the maintenance phase after induction with pembro plus chemotherapy. I'm happy to announce that STELLAR-002 is now initiated and enrolling participants. In addition to STELLAR-002 in lung cancer, we're also planning combinations with established checkpoint inhibitors in other tumor types in wave 2, including bladder cancer. We are especially interested in and planning for a potential trial for bladder cancer patients previously treated with enfortumab vedotin plus a PD-1 immune checkpoint inhibitor. Our cohort in STELLAR-002 evaluating Xansa in this setting has enrolled extremely quickly affirming the substantial unmet need in this setting. Beyond established IO molecules, the mechanism of action of Sansa clearly supports combinations with newer generations of IO-based therapy as well. To that end, we've begun enrolling a cohort combining our novel bispecific immunotherapy XP 628 with zanza in our [ XB628 ] Phase I trial. The primary focus of this cohort is safety and patients across a range of cancers are being enrolled. We expect to begin enrolling expansion cohort soon to focus on our key tumor franchises, including GU and GI. We've also been engaged in discussions with potential collaborators to plan studies combining zanza with their novel molecules and mechanisms of action to address unmet needs across a spectrum of cancers, primarily focused in GU and GI indications and we plan to give further updates on these activities as we get closer to launching the trials. Beyond immunotherapies, we're also exploring the combination of zanza with chemotherapy, specifically docetaxel in patients with metastatic castration-resistant prostate cancer who have measurable disease. This combination is being investigated in an expansion cohort in STELLAR-002, which is actively enrolling patients. The rationale for this cohort is based on data with cabo, where a small Phase II study showed favorable outcomes when cabo is combined with docetaxel in patients with metastatic CRPC. If zanza combination with docetaxel is shown to be safe and active, that could open up a number of opportunities across a range of solid tumors, where docetaxel, other chemotherapies or ADCs carrying cytotoxic payloads remain the standard of care, such as second-line non-small cell lung cancer and CRC. Accordingly, other studies combining zanza with cytotoxic modalities to be potentially included in wave 2 are in the planning stage to allow us to move quickly depending on the data that emerged. Finally, our early clinical pipeline continues to progress, and we're also advancing new small molecule and ADC programs toward IND filings and development candidate nominations. In this regard, I'm happy to announce that we have a new development candidate in our pipeline, XL 558, a selective somatostatin receptor 2 agonist, which has recently been nominated and for which we plan to submit an IND later this year. I look forward to sharing more details on this and other pipeline programs as they advance. And with that, I'll turn the call over to P.J.

Thank you, Dana. The CABOMETYX franchise continues to show strength after more than a decade since its initial launch. The 7 indications predominantly in the GU and GI solid tumor space, CABOMETYX is a best-in-class TKI across these therapeutic franchises. Exelixis is built and refined significant commercial capabilities throughout this time, including a foundation of success in the community setting. As Dana detailed, the vanzolitinib franchise is positioned to build on the foundation of CABOMETYX in both GU and GI oncology and beyond with its extensive development program with what we believe to be a superior molecule. We are excited about the potential approval of zanza in colorectal cancer as our first indication in a large tumor type significant unmet medical need. CRC is largely treated in the community, provides an opportunity to leverage the strength of our capabilities in that set. We are thrilled with the results of STELLAR-303, pending regulatory approval we believe that these data would provide Exelixis with a compelling commercial opportunity in 1 of the big 4 tumors. The third line plus CRC setting consists of approximately 23,000 patients in the U.S. and represents an overall market opportunity of approximately $1.5 billion in terms of contemporary pricing. Our market research and advisory boards demonstrate positive feedback and excitement for the STELLAR-303 data. Physicians reiterate the significant unmet medical need for patients in the third-line setting and are excited for the potential to have a regimen that includes an immune checkpoint inhibitor available for the broader population of CRC patients. The analysis of CRC prescribers demonstrates a significant overlap with CABOMETYX prescribers at approximately 70%. We -- and when including co-location of addresses, the overlap increases to 90%. This overlap and the fact that the majority of CRC is treated in the community position us well for the potential launch of zanza. Turning to CABOMETYX. Net product revenue grew 12% year-over-year for Q3 2026 compared to Q3 2025 and while showing strength across all facets of the business. RCC continues to grow as we have a strong promotional focus on our first line 9ER data, we maintain a high market share as the #1 TKI plus IO combination, in addition to being the #1 prescribed TKI in renal cell carcinoma. The net business continues to grow as CABOMETYX continues to be the #1 prescribed oral therapy in the second line plus say. The prescription data in the oral TKI market basket of cabo ovatinibcitinib, sunitinib and pazopanib, convey the strength of cabo relative to the competition. Looking at the TRx comparison of Q3 2025 and to Q3 2026, CABOMETYX grew 3 share points from 46% to 49%. Additionally, ABOMETYX TRx volume grew 13% in Q3 2026 and compared to Q3 2025, outpacing the growth rate of the market basket, which was 6% for the same period. In RCC, CABOMETYX continues to show strength with demand growth and first-line combination market share, where CABOMETYX plus nivolumab is the #1 TKI Casio combination. The CheckMate 9ER data continue to resonate with prescribers across the various clinical characteristics of RCC patients. CABOMETYX business showed continued strength in the community setting, which is reflective of oncologists' comfort and experience with cabo. With regard to net, we are pleased that demand continues to grow, and we see further penetration into the community setting. CABOMETYX second-line plus new patient oral market share continued to increase and is now greater than 50%, extending the brand's leadership position in the space. We continue to see the benefit of more patients on therapy as refills are driving more demand and given the higher new patient market share, we expect Regal to continue to increase going forward. Our expanded GI sales team has now been deployed in the field for a second full quarter, providing greater reach into the community. In addition to driving continued momentum and new patient market share, in the team is increasing the breadth of prescribers with now over 1,000 unique net prescribers activated since launch. The CABOMETYX business remains strong, with growth being driven by both RCC and net as our team's sole focus is maximizing the impact of our promotional efforts for all customers and tactics. Cabo remains well positioned as the #1 TKI and TKI plus IO combination in RCC as well as the #1 oral therapy in the second line plus net market. Looking forward to zanza, our internal team is in full launch preparation and the excitement around these efforts is palpable. We look forward to the opportunity to launch the next Exelixis franchise to be able to help appropriate patients with colorectal cancer. Beyond STELLAR-303, we are enthusiastic about the significant development plan for Sansa, which could position the zanza franchise to far exceed cabo in terms of the number of patients to be impacted a seller types and settings. And with that, I will turn the call back over to Mike.

All right. Thanks, P.J. I'll close by thanking the entire Exelixis team for a strong first 9 months of 2026. As we finish the year and look ahead to 2027, we're proud of our progress and focused on achieving more. It's a potentially transformational time for Exelixis with zanza taking center stage in development and commercial planning. We're proud to be part of 1 team united in improving outcomes for cancer patients and building value for shareholders. . Advancing zanza as our second potential franchise remains our top priority, supported by revenues from cabo's growing business as we invest in our pipeline and return value to shareholders through our share repurchase program. I want to thank everyone at Exelixis for their great focus and unwavering teamwork as we work together to advance our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

[Operator Instructions] Our first question comes from the line of Andy Shay with William Blair.

Great. Great performance overall across all the different business units. So congratulations on all the progress there. 1 bigger picture question, if you don't mind. Can you comment on the 340B program? It seems like there is some evolution there and just how that would impact the obviously, the existing copper franchise and also the Lanza going forward.

Yes, Andy, it's Mike. Yes, there's a lot going on in the 340B world. It has, to our knowledge, very little impact. So we continue to have our integrity agreement in place to make sure that we can track claims and reduce essentially double counting when it comes to other programs. But we're really on top of that and our market access team is obviously very engaged there in doing the full court press across the board. But we're seeing that stabilize in the business, which is great to see, and we continue to, again, make it a focus as we go forward. .

Our next question comes from the line of Johan Werber with TD Colin. Our next question comes from the line of Asthika on Warden with Leerink Partners.

Good to speak to from the new platform. Just want to talk about the Zenda FDA discussions that are underway right now. Have you reached a labeling discussion stage of the interactions with the FDA?

Thanks for the question and great to hear from you again. Dan, do you want to take that one?

Sure. Yes. Beyond what I said in the prepared remarks around our PDUFA date, now being in March next year, I -- for obvious reasons, I'm not going to speculate further on thing, especially regarding our interactions with the agency during an ongoing review. .

Our next question comes from the line of Akash Tewari with Jefferies. .

This is Manoj on for Akash. Just 2 from our end are the overall and a specific adverse-related dropout rates in STELLAR-304 tracking in line with your original design assumptions? And also you previously mentioned about 5 to 8 months median PFS in the control arm. Is that still unchanged given the the readout? .

Yes. We had a hard time hearing you. I think the first question was around rates and then the control arm estimates. Dana, I want to

Yes. Yes. So thanks for the question. So first of all, excited about the 304 study, it represents the first Phase III global randomized controlled trial for patients in this setting. So it really has the potential to not only establish a Level 1 evidence-based standard of care for patients, but also to set new standards because all of the data right now that exist are from small single-arm studies, regionally restricted studies. So just regarding our announcement today about the top line results being available in Q1. We're not going to get into details around enrollment or event rates or anything like that other than to say that based on the events coming in, we're now close to a clinical cutoff date, and that's driving our expectations around Q1 for the top line results

Our next question comes from the line of Sean Laaman with Morgan Stanley.

Hope everyone's well and congrats on us. Just on 304, so there's been a bit of a delay there. But how large could non-clear cell RCC ultimately become within the broader zanza franchise relative to? .

Sean, thanks for that question. Great to hear from you. P.J., you want to take that one? .

Yes. Thanks for the question, Sean. David mentioned, we're really excited about the 304 study particularly since it's the first randomized Phase II to really look at this patient population, this population is about 20% of the renal cell carcinoma population. So we're excited about it, but I think it's important to note that when we think about all of our XAN studies, Dana talked about in Wave 1. This is actually the smallest of those. So our excitement for the program is really great. And I think the other thing we think about with regards to 4, it's really just our first study in kidney cancer, which is obviously something we're very focused on. We have the 2 light spark studies with Merck ongoing. And I think we're very focused on other combinations with zanza as Dana referred to, with orthogonal MOAs. If you look at the [ LITESPARK-022 ] study being negative, which was reported at ESMO that leaves an opportunity in the first-line setting. So we're very much looking at that as a potential opportunity going forward. And we've been very successful as I referred to in my remarks, with CABOMETYX, with our market share, et cetera, being the market leader in the '20s. And our vision and our goal is to make zanza the market leader in the 30s. And I think with the renal program, the GI program we're working on Wave 1 and now the trials we're working on in Wave 2 and beyond set us up very well to do that.

Our next question comes from the line of Michael Schmidt with Guggenheim.

I had another 1 on Wave 1 Zante opportunity. This 1 in clear-cell RCC. And just trying to understand the size of the light Spark 34 opportunity, which could be the first study to read out perhaps relative to Merck's LITESPARK-022, which is similar in some ways and then also on LITESPARK-033, the other study. Curious how you think about the recent adjuvant busulfan approval and how that might impact that patient population? . Thanks, Michael. PJ, you want to take a shot at that? .

Yes. Thanks for the question, Michael. As I was just referring to are really excited about the zanza program broadly. ESMO, lots of excitement and engagement with KOLs there about it, generally speaking. With regards to those light Spark studies 3 and 4 LITESPARK-033 is in the front line, in the post-adjuvant setting. So more and more patients are receiving adjuvant therapy. As far as the LITESPARK-022 study, we'll have to see how those data evolve with further follow-up and see what the impact of that is on the adjuvant setting. But I think, generally speaking, with more options, you can only have more patients treated. And then certainly, we're excited about LITESPARK-034, where the design of that is adding zanza to Belzudafan. So I think in that sense, it's a bit differentiated from some of the other studies out there and can really -- has the potential to have some good data and be impactful in the second line plus population in kidney cancer, which we've proven before with Media and beyond that we can have a very substantial business in that setting.

Our next question comes from Silvan Tuerkcan with Citizens.

Congrats on the great quarter with Cabo here, I just want to ask maybe if you can give us your ESMO 2026 kind of overview here, kind of what you thought was exciting for maybe the cabo franchise and RCC and your learnings that you might have had from the sale light studies there. And maybe anetumab the bispecific here that that's coming late line? And then also, have you learned anything as more for zenda and colorectal, where we had that CMA ADC data from AbbVie in late line as well? Any color would be helpful.

Silvan, thanks for the question. Great question, actually. So let's P.J , Dana, why don't you guys acting that 1 why don't you start?

Yes. Thanks for the question, Silvan. Certainly, I was referring to it earlier, ESMO was a great meeting for us, really busy lots of discussions with KOLs, with investigators, both on the GE and the GI side, which is always rewarding as we've kind of continued to build these relationships the feedback we're hearing generally about the Vans program, the excitement about it is is really a lot of excitement and very palpable as these studies are enrolled quickly. and as we move closer to potentially to market with STELLAR-303. Overall, from the data presented, I think there wasn't really a lot new there. in terms of impacting cabo today. I think significantly, we did see the data from LITESPARK-022, which we knew was negative, as I referred to earlier, which I think is providing basically the fact that there's an opportunity now in the broad first-line population with those triplet failing to have the potential to to have a regimen raise the standard of care beyond doublets in first-line RCC. So that's something we're very interested in and thinking a lot about in terms of our development plan.

Great. Dana?

Yes. So Silvan, thanks for that question. We were obviously at ESMO and tracking all the developments there very closely. And we feel that all the data coming out, especially on sort of some of the newer IO mechanisms, all of these are mechanisms that are orthogonal to anlotinib those -- it feeds right into our strategy for developing Zaza as the TKI of choice to really become the backbone of any IO combination across the spectrum of GU and GI and even in some indications outside of those key franchises. . So from a development perspective, we're really focused on that aspect of evaluating any potential combination partner with vanzolitinib and especially in Wave 2. We're considering lots of potential combinations there. So I'd say stay tuned, but we were certainly looking at those data.

Our next question comes from the line of Jason Gerberry with Bank of America Securities.

Just 1 on STELLAR-304 and just a question on the protocol, which says I think I got right that patients who drop out will continue to be followed for OS. And so I'm just trying to get a better sense of whether those patients would be censored or not for OS. If a lot of patients on Sutent discontinue randomization if they want to get on a PD-1 TKI. I'm just wondering if that would at all be a factor compounding the OS analysis. So just wondering if you could comment on that protocol point.

Yes. So thanks for the question, Jason. This is Dana. So regarding STELLAR-304, as I mentioned, we're excited about this because the opportunity to deliver the first Level 1 evidence for these patients and patients with high unmet need without any type of study like this to generate that type of evidence for a new therapy. Regarding the specifics of the trial, I don't want to get into details there, and I don't want to speculate on the potential for drop out or anything else like that. As I mentioned, we're close to data cutoff now, which is what's driving our Q1 top line results expectations.