Exelixis, Inc. (EXEL) Earnings Call Transcript & Summary

Good day, ladies and gentlemen, and welcome to the Exelixis Second Quarter 2026 Financial Results Conference Call. My name is Kathleen, 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, Kathleen, and thank you all for joining us for the Exelixis Second Quarter 2026 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President; and 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 second quarter 2026 ended June 30, 2026. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial and strategic matters, potential growth opportunities and government drug pricing policies and initiatives. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the Securities and Exchange Commission, which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitation, 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 the 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 continues to execute across the key elements of our business, positioning the company to deliver on our strategic objectives for 2026 and beyond. We are in the early innings of our next phase of growth as we deliver on our strategy to evolve from a single compound company to one with a pipeline of potential oncology franchise opportunities. Zanzalintinib is poised to transform Exelixis as our next franchise molecule, potentially first with a third-line plus CRC filing that's currently under review, followed by accelerating progress on the next 6 pivotal trials that we've highlighted recently. Importantly, a second wave of trials is lining up nicely to initiate potentially as early as 2027. Our confidence in cabo's long-term revenue growth trajectory remains unchanged. The updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the NET indication, which reflects the unique characteristics of the NET patient population and histology. We remain confident in the long-term potential of the cabo NET indication and view the NET franchise as an important growth driver for cabo, zanza and other molecules in our pipeline. We continue to see meaningful opportunities to expand our impact for patients, strengthen our commercial position and create value for shareholders. Our strategy to build a multi-franchise oncology business contains 5 key elements, including: first, execution. Zanza is leading the pack as our next potential franchise opportunity and our highest R&D priority. The EXEL team continues to execute on key objectives across the program, including the STELLAR-303 regulatory review, pivotal trial data readouts, expediting clinical trial enrollment and new study initiations. The second is expansion. We are building the foundation for the next wave of growth opportunities for zanza. Beyond our current pivotal trials, we are actively evaluating new development opportunities that could further expand the scope, reach and long-term value of zanza 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. Third key element is commercial performance. We continue to see substantial growth from the cabozantinib franchise. Cabo remains the leading TKI for RCC, the market leader for the oral second-line plus NET segment and a key player in the treatment of patients with liver and thyroid cancers. Second quarter 2026 U.S. cabo franchise net product revenues grew approximately 10% year-over-year to $573 million. Continuing its role as a worldwide leading TKI, global cabo franchise net product revenues generated by Exelixis and its partners grew approximately 13% year-over-year to $806 million in the second quarter 2026. Fourth is preparation. We continue to prioritize our commercial readiness with the potential launch of zanza in third-line plus CRC, pending a positive regulatory review later this year. We believe the CRC opportunity represents an important first step towards establishing zanza as our second oncology franchise and a significant driver of future growth. We see this element of our strategy as especially timely as we pursue new GU and GI indications, specifically in tandem early and late-stage opportunities in CRC with STELLAR-303 and STELLAR-316. Fifth and finally, discipline. We remain committed to rigorous expense management and capital allocation, as can be seen by trimming expense guidance while we invest in our mission-critical R&D priorities and keeping our projected free cash flow essentially unchanged. We believe this balanced approach remains an important differentiator and positions us to create long-term value while maintaining strategic flexibility. Taken together, these 5 strategic elements working in tandem, underscore the strength of our strategy and the progress we are making across the business. We believe we are well positioned to advance zanza towards becoming a major oncology franchise, expand our development portfolio, drive continued growth to the cabozantinib franchise and deploy capital in a disciplined manner to maximize shareholder value. 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 second quarter of 2026, the company reported total revenues of approximately $629 million, which included cabozantinib franchise net product revenues of $573 million. CABOMETYX net product revenues were $571 million and included approximately $2.7 million in 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 second quarter 2026 was 29.5%, which is lower than the gross to net we experienced in the first quarter of 2026. This decrease in gross to net deductions in the second quarter of 2026 is primarily due to lower co-pay assistance for commercial patients, which is partially offset by a modest increase in 340B utilization when compared to the first quarter of 2026. Additionally, we're updating our estimate for full year 2026 gross to net deductions, and we are now projecting that it will be between 30% and 31%. Our CABOMETYX trade inventory was flat at 2.1 weeks on hand at the end of the second quarter 2026 when compared to the first quarter of 2026. Total revenues in the second quarter of 2026 also includes approximately $53 million in royalties earned from our partners, Ipsen and Takeda on their sales of cabozantinib. Our total operating expenses for the second quarter 2026 were approximately $380 million compared to $359 million in the first quarter of 2026. The sequential increase in these operating expenses was primarily driven by higher clinical trial costs, marketing expenses and stock-based compensation. Provision for income taxes for the second quarter of 2026 was approximately $50.6 million compared to a provision for income taxes of approximately $57.2 million for the first quarter of 2026. The company reported GAAP net income of approximately $212 million or $0.85 per share basic and $0.82 per share diluted for the second quarter of 2026. The company also reported GAAP (sic) [ non-GAAP ] net income of approximately $237 million or $0.95 per share basic and $0.91 per share fully diluted. Non-GAAP net income excludes the impact of approximately $25 million of stock-based compensation, net of the related income tax effect. Cash and marketable securities for the quarter ended June 30, 2026, were approximately $1.4 billion. During the second quarter of 2026, we repurchased approximately $312 million of the company's outstanding common stock, resulting in the retirement of approximately 6.5 million shares of the company's outstanding common stock at an average price per share of $47.85. During the second quarter, we completed the October 2025 stock repurchase program. As of the end of the second quarter 2026, we had approximately $598 million remaining under the $750 million stock repurchase plan authorized by the company's Board in May of 2026. And finally, we're updating our full year 2026 financial guidance. We are lowering and narrowing our total revenues and net product revenue guidance, which lowers the midpoint by $50 million when compared to our previous guidance. This updated financial guidance reflects modestly slower growth in 2026 due to a more gradual ramp for the NET indication than the original projection. Additionally, we are reducing R&D expense guidance, lowering the midpoint of our R&D expense guidance range by $50 million when compared to the previous guidance. Details of our full year guidance can be found on Slide 14 of our earnings presentation. And with that, I'll turn the call over to P.J.

Thank you, Chris. CABOMETYX net product revenue grew 10% year-over-year for Q2 2026 relative to Q2 2025. The revenue growth for the first half of 2026 was modestly slower than we had anticipated due to a more gradual ramp in the growth of NET in the second-line plus setting due to patient kinetics. Importantly, we are pleased that cabo has achieved second-line plus oral class new patient market share greater than 45%, and we believe this is a leading indicator for future growth of the net business. The RCC business continues to grow as we have a strong promotional focus on our first-line 9ER data, where 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 prescription data in the oral TKI market basket of cabo, lenvatinib, axitinib, sunitinib and pazopanib convey the strength of cabo relative to the competition. Looking at the TRx comparison of Q2 2025 to Q2 2026, CABOMETYX grew 2 share points from 45% to 47%. Additionally, CABOMETYX TRx volume grew 12% in Q2 2026 compared to Q2 2025, outpacing the growth rate of the market basket, which was 6% for the same period. CABOMETYX was approved for NET about a year ago, and we have many learnings regarding this unique tumor type. NET is heterogeneous and generally more indolent than many more aggressive solid tumor malignancies. As we have been in the market speaking with physicians and conducting advisory boards, we have learned that this may lead to differences in management of these patients. Sometimes NET patients are scanned less frequently than a standard 3-month interval and often a patient's disease may be relatively slow growing. Furthermore, the initiation of subsequent therapy could be less urgent for some patients, resulting in attenuation of a current treatment or sometimes a treatment break. Hence, the patient kinetics of NET in the second-line plus setting can be more gradual than other solid tumors. That said, we continue to be pleased with the market dynamics as the CABOMETYX second-line plus oral new patient market share grew substantially in the second quarter to over 45%, extending the brand's leadership position in the space. We have begun to see the benefit of more patients on therapy as refills are driving more demand and given the increased new patient market share, we expect refills to continue to increase going forward. Market research indicates that there is opportunity to continue to grow market share, particularly in the community setting. Our expanded GI sales team was in the field, providing greater reach into the community in Q2, and we believe this contributed to an increase in our second-line plus NET market share. We have also acquired and implemented more granular utilization data that gives us greater resolution on the net business at the prescriber level for certain segments of the market. These data are giving us the ability to optimize our promotional efforts through refined targeting. The data highlight the potential for cabo growth in NET, and we remain confident that as patients seek treatment after progression, CABOMETYX will be the leading choice, which will translate into a robust long-term opportunity. Our new representatives joined us with significant oncology sales experience, particularly in colorectal cancer and GI oncology. The expanded sales team will gain valuable experience selling cabo before we turn our focus to the potential launch of zanzalintinib in colorectal cancer. As we are thinking about building on and expanding our GI franchise, we are thrilled with the results of STELLAR-303 and a PDUFA date set for later this year. Pending regulatory approval, we believe that these data would provide Exelixis with a compelling commercial opportunity in 1 of the big 4 tumors. Third-line plus CRC setting consists of approximately 23,000 patients in the U.S. and represents an overall opportunity of $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 need for patients in the third-line CRC 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. 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 across 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 second-line plus NET. 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 later in the year to be able to help appropriate patients with colorectal cancer. Beyond STELLAR-303, we are enthusiastic about the significant development plan for zanza, which could position the zanza franchise to far exceed cabo in terms of the number of patients that could be impacted across tumor types and settings. And with that, I will turn the call over to Dana.

Thanks, P.J. My update today will be focused mostly on the 7 ongoing or imminent pivotal trials for zanza as well as some updates on additional exploratory studies and plans to continue driving the breadth of development of zanza, all of which is aligned with our strategy in R&D, which prioritizes developing zanza as a multidimensional solid tumor oncology franchise molecule. Starting with our NDA for zanza plus atezo in colorectal cancer, which is based on the results from the STELLAR-303 trial. This continues to be our top priority as we work toward the PDUFA date in early December. Our team continues to focus on the ongoing review and is fully engaged in launch preparations. Alongside those activities, we've also been steadily moving forward on our strategy to realize zanza's franchise potential by continuing to drive the breadth of development of zanza in key tumor landscapes and indications. In the early colorectal space, our team has been highly focused on launching the STELLAR-316 trial, which will investigate zanza with and without subcutaneous pembro in patients with resected Stage II or III CRC who following definitive therapy, have tested positive for molecular residual disease or MRD and have no radiographic evidence of disease. The unmet need is high for these patients, and we've gotten a lot of positive feedback on the study from KOLs in the GI oncology community. Activation of the first site in this trial is imminent with many more lined up behind it, and we anticipate patient screening to begin this month. With Natera as our collaborator, we've been able to select sites based on actual test metrics, prioritizing those with the highest numbers of MRD-positive patients. So we're confident this approach will translate to a steep enrollment curve, especially since there are no other ongoing Phase III trials competing for these patients. In the neuroendocrine tumors indication, STELLAR-311 is our global Phase III trial evaluating zanza compared to everolimus as an initial oral therapy in patients with pancreatic or extra-pancreatic neuroendocrine tumors. That study was initiated last year, and we continue to see robust enrollment that is months ahead of projections, reflecting both investigator and patient enthusiasm for the study. Moving on to genitourinary tumors and kidney cancer specifically. STELLAR-304 is our first pivotal trial for zanza in kidney cancer, evaluating the combination of zanza plus nivolumab versus sunitinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma. I'd like to emphasize that the non-clear cell RCC space is underserved with no positive readouts from a Phase III study specifically focused on these patients despite them representing approximately 20% of all RCC cases. A handful of Phase II studies, the majority of which are single-arm, non-randomized trials have shown activity with a range of treatments in this setting with wide variations in response rates and durations of PFS for sunitinib and other agents that are currently used for these patients. Such variations are to be expected when comparing data across trials, especially when those trials are small and geographically restricted. Given the fact that STELLAR-304 is the first large, randomized controlled Phase III trial for these patients and is also enrolling globally, we expect that, if positive, the trial could establish the first ever Level 1 evidence for benefit and a new standard of care for these patients. We completed enrollment in STELLAR-304 last year. And given current event rates, we continue to expect top line results from the study in the second half of 2026. If positive, those results could lead to our second NDA filing for zanza. Pivoting now to clear cell RCC, progress continues with regard to the 2 pivotal Phase III studies that Merck is running to evaluate zanzalintinib in combination with belzutifan. The LITESPARK-033 trial is comparing zanza plus belz versus cabo in the frontline setting for patients who received adjuvant treatment with anti-PD-1 or anti-PD-L1 therapy. And LITESPARK-034 is comparing zanza plus belz versus belz plus placebo in the second-line plus setting after both anti-PD-1 or L1 and VEGFR-TKI therapies. We're excited to see these Phase III studies in clear cell RCC moving forward and we believe there are other important opportunities to explore in this space, pairing zanza with other modalities and orthogonal mechanisms in first-line RCC, especially immunotherapies given the demonstrated clinical differentiation we've observed with zanza and its potential to be the TKI of choice for combinations with immunotherapies as well as other mechanisms of action. Our discussions with potential collaborators have been advancing well, and we plan to give further updates on these activities as we get closer to launching the trials. Moving on now to other indications in the GU space, we're excited to advance an expansion cohort in the ongoing STELLAR-002 study to evaluate zanza in patients with metastatic bladder cancer who have progressed on the combination of enfortumab vedotin or EV plus pembro. The rationale for this cohort is based on a significant body of data generated with cabo showing encouraging activity in bladder cancer. Bladder was not prioritized for pivotal development with cabo due to the rapidly changing landscape at that time. What's changed since then is the approval of the combination of EV plus pembro in multiple settings, including in the frontline for patients with metastatic disease. This resulted in an important new standard of care for these patients, but very quickly, a new unmet need emerged with essentially no established standard of care for patients after they progress on the combination. We're enrolling a cohort in STELLAR-002, evaluating zanza as a single agent in patients who progressed on EV plus pembro, and we're already seeing encouraging signs of clinical activity. It's early days, but if the data continue to develop in this way, we plan to move quickly toward launching a pivotal study in this indication. Another expansion cohort for zanza in the STELLAR-002 study is in combination with docetaxel in patients with metastatic castration-resistant prostate cancer or CRPC, who have measurable disease. The rationale for this cohort is based on data with cabo, where a small Phase II study showed favorable outcomes when cabo was combined with docetaxel in patients with metastatic CRPC. We're particularly excited about this cohort because if zanza in 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 in second-line non-small cell lung cancer. Sites for this expansion cohort in STELLAR-002 are now activated and open for enrollment. Moving on now to STELLAR-201. This is our Phase II trial evaluating zanza in patients with recurrent meningioma who are no longer responsive to or eligible for local therapies. The primary endpoint of this trial is objective response rate with secondary efficacy endpoints, including duration of response, progression-free survival and overall survival. The trial will enroll up to 100 patients and our enrollment in this trial so far is exceeding our initial projections, which we believe reflects the high level of interest and enthusiasm for the trial among neuro-oncologists. One factor driving excitement for this study is the fact that there are no approved systemic therapies for meningioma that's refractory to local therapies. So this indication represents a very high unmet need in neuro-oncology. 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 zanza to become the first systemic therapy that could improve outcomes for these patients. Lastly, we've been making steady progress toward initiation of STELLAR-202, our planned Phase II trial in squamous non-small cell lung cancer that will explore the addition of [ zanza ] in the maintenance phase after induction with pembro plus chemotherapy. The rationale for this trial is partly based on data from the CONTACT-01 trial, where the subgroup of non-small cell lung cancer patients with squamous histology appear to derive substantial benefit from the combination of cabo plus atezo compared to chemo. This is an important opportunity given the relatively short PFS in the maintenance setting and the lack of any new approvals in frontline squamous non-small cell lung cancer since KEYNOTE-407 established the current standard of care with pembro plus chemo. We expect to initiate STELLAR-202 in the second half of this year. Now shifting to our early clinical pipeline. Our 4 molecules currently in clinical development, namely XL309, XB010, XB628 and XB371 continue to progress, and we are also continuing to move new small molecule and ADC programs toward IND filings and development candidate nominations. And I look forward to sharing more details as these programs advance. So with that, I'll turn the call back over to Mike.

All right. Thanks, Dana. To close today's call, I'll start by thanking the entire Exelixis team for their great efforts during the first half of the year. 2026 continues to be a potentially transformational year for the company, and everyone at Exelixis is working together as one team with a single focus to improve outcomes for cancer patients and build value for all our shareholders. Advancing zanza as our second potential franchise opportunity remains our top priority while we use the revenues from cabo's growing business to invest in the pipeline while returning value to shareholders through our share repurchase program. I want to thank everyone at Exelixis for their individual and collective efforts, incredible focus, and hard work as we work day in and day out on our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

[Operator Instructions] And our first question comes from the line of Paul Choi of Goldman Sachs.

I want to ask on STELLAR-304 and timing. Do you think this is something that might be able to make a major medical meeting this year? And just any sort of updated precision on data timing that you could offer would be great.

Dana, go ahead, please.

Sure. Thanks for the question, Paul. So as I said in my prior remarks, we are expecting to achieve the planned number of events in the second half of this year. Beyond that, it wouldn't really be appropriate for me to speculate on when exactly that's going to happen or even when the data will be available at a medical meeting. What I can say is that we will message on that at the appropriate time.

And your next question comes from the line of Akash Tewari of Jefferies.

This is Anastasia on for Akash. So I wanted to ask about your first-line post-adjuvant study. Specifically, I think you guys have made a comment about maybe like a 15,000 patient population. I'm wondering if that changes at all based on the LITESPARK-022 study, the one that had improved PFS. Do you anticipate patients will start switching to an already existing like the pembro plus HIF-2 alpha. And if you do, does that reduce your patient population? How are you viewing that data?

Yes. Thanks for the question, Anastasia. This is P.J. I think, obviously, very early days for the LITESPARK-022 combination just getting approved with belz in the adjuvant setting. I think what we see in the first-line setting in terms of patients overall coming off of previously treated adjuvant therapy is in that kind of a 20% to 25% range of first-line patients. I wouldn't want to speculate with regards to how much utilization the combination will be used in the adjuvant setting. But I will say, historically, that setting is one that's very sensitive to toxicity. This is, I think, a reason that agents with positive studies such as sunitinib really didn't get uptake in that in the past. And I think with the overall survival bar that pembro monotherapy has set there, it's a very high bar to beat. So I think physicians will think very carefully as to whether or not they want to add toxicity in terms of another agent in this setting.

And your next question comes from the line of Andy Hsieh of William Blair.

Sorry about the background noise. I'm just curious about your take on the ongoing STELLAR-311 study against the backdrop of the guidance lowering, whether there's a chance that it's cannibalizing cabo sales, resulting in a more gradual ramp?

Yes. P.J., please?

Yes. Andy, thanks for the question. As Dana said, we're really excited, first and foremost, about the STELLAR-311 study. I've had the opportunity to speak to a lot of KOLs, obviously, in the NET space. And I'll just say they're very excited about that study. And as Dana said, it's progressing well. So I think to your point, any time you do have a study that is recruiting, it does draw potential patients from the commercial patient pool, so to speak. And it can be a bit exacerbated in a smaller tumor type, for example. So we think that could be having a small impact. But I'd say certainly, what I mentioned in terms of patient kinetics in terms of just patients taking a bit more time to go from therapy in subsequent settings is really the driving factor as it is a more indolent tumor type. And fortunately, these patients, many of them may have the luxury of a little more time before going on to that therapy. That said, I think it's really important just to reiterate that I remain really excited about the opportunity in NET. We're not really changing the outlook at all. As you mentioned, it's just kind of the ramp is a little more gradual, but we're excited that we achieved a new patient market share over 45% this quarter. And I think I'm sure you'll recall that we always talked about the TAM in this setting as being about $1 billion for the oral therapy market in the second-line plus setting. So we're excited about that market share. And eventually, those patients, we believe when they do have a therapy selection, it will be cabo in most of those cases. So we're excited about that going forward.

And your next question comes from the line of Sean Laaman of Morgan Stanley.

Just with the CRC PDUFA date coming up later this year, what label language would be the most commercially meaningful? And what label limitations, if any, around liver mets prior therapy or subgroup interpretation do you think could be real that may constrain uptake?

Yes. Thanks, Sean. Dana, do you want to take that one?

Yes, sure. So as I mentioned, Sean, earlier, the -- this is an ongoing review. Our team is highly focused and extremely excited, in fact, about what this can mean for the company, especially given the fact that if approved, this would be the first immunotherapy containing regimen for the vast majority of patients with this disease. And also, it would be the first launch of our next franchise molecule. So it means a lot for patients and for the company. So there's a lot of excitement around this. Beyond that, we really can't comment on an ongoing review and especially on label that is really up to discussions with the agency.

And your next question comes from the line of Silvan Tuerkcan of Citizens Bank.

This is Josh on for Sylvan. Congrats on the update. At the beginning of maybe it was 2025, Exelixis shared their vision for $5 billion in revenue for zanza by 2033. Now I guess, 1.5 years from that point, can you highlight the progress made towards that goal? And if how the makeup of that projection has evolved since then?

Yes, Josh, thanks for the question. Yes, that number was given, I would say, late '24 around our view on what success -- aspirational view on what success could look like relative to our second franchise molecule. The fact that we have launched or are about to launch or one is imminent of the 7 pivotal trials with the next wave on the way, I think, speaks to the depth and breadth of the opportunity going forward. Super excited about what's already in the oven, if you will. And then the next wave, as you heard Dana talk about today, potentially involving other GU and GI indications, we think, is potentially super valuable for patients as well as driving value for shareholders. So obviously, we have a lot of work to do. We're in the execution business, but we're committed to making this second franchise as valuable for patients and for shareholders as possible.

And your next question comes from the line of Kalpit Patel of Wolfe Research.

Just one on the ANDA's tentative approval. We've been feeling in questions on that. And my question is, if they do get the conversion or they get the full approval, does that in any sense, accelerate the timing of the generic developers, the agreements that you have in place before the 2031 timelines?

Yes, Andrew?

Kalpit, thanks for the question. I can't really get into the specifics of the agreements that we've had with the other true ANDA generic filers. But I would note that the sort of scenario that you're describing isn't particularly common in these sorts of agreements. And so I wouldn't think it's something to expect.

And your next question comes from the line of Yaron Werber of TD Cowen.