Thank you for standing by, and welcome to Revolution Medicines' corporate update call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1 1 on your telephone. If your question has been answered and you would like to remove yourself from the queue, simply press star 1 1 again. We ask that you please limit yourself to one question and one follow-up. Now I would like to introduce your host for today's program, Ryan Asay, Senior Vice President, Corporate Affairs. Please go ahead, sir. Hello, everyone. Thank you for joining Revolution Medicines webcast to discuss the FDA approval of daraxonrasib, now approved under the brand name RASONQUE. We have issued a press release announcing the approval and posted the presentation that accompanies today's remarks on the investors section of our website. Before we begin, I would like to remind everyone that today's discussion will include forward-looking statements regarding our business, commercialization plans, clinical development programs, and other future events. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those described. Please refer to our SEC filings for a discussion of these risks. Joining me today are Dr. Mark Goldsmith, our Chairman and Chief Executive Officer, Dr. Alan Sandler, our Chief Development Officer, and Anthony Mancini, our Chief Global Commercialization Officer. Dr. Wei Lin, our Chief Medical Officer, and Jack Anders, our Chief Financial Officer, will join us for the Q&A portion of today's call. With that, I will turn the call over to our Chief Executive Officer, Dr. Mark Goldsmith. Mark? Thank you, Ryan. Today marks an historic step forward for patients living with metastatic pancreatic cancer. Eligible patients now have a new treatment option that directly addresses the main cause of their disease. I am gratified to share that the US Food and Drug Administration has approved RASONQUE for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multi-agent systemic therapy. This approval validates more than a decade of work aimed at pancreatic cancer, a primarily RAS driven disease and one of the most difficult challenges in medicine, cancer biology, and drug discovery. RASONQUE, known generically as daraxonrasib, is an oral, once daily, RAS(ON) multi-selective inhibitor targeting RAS proteins. This groundbreaking medicine is supported by compelling clinical evidence in this aggressive cancer that has been characterized by a high symptom burden, bleak prognosis, and few meaningful therapeutic advances. This approval confirms the potential for bold scientific innovation to fundamentally change how RAS-driven cancers are treated. At Revolution Medicines, we invested our full resources and capabilities into one of the most important challenges in oncology, discovering and developing oral medicines capable of directly inhibiting multiple common cancer-causing forms of RAS, a disease target that had frustrated scientists for decades. Meeting this ambition requires scientific innovation while standing on the shoulders of others, boldly challenging dogma, deep collaboration and perseverance across our organization, and close partnership with investigators worldwide. Today, that collective effort has resulted in RASONQUE, the first FDA-approved targeted medicine in pancreatic cancer that defies its main cause, RAS. Before going further, I want to thank every patient in the RASolute 302 clinical program and their families, the investigators, research nurses, study coordinators, and site personnel who made the results possible, the advocacy organizations that support this community, and the entire Revolution Medicines team. We are profoundly grateful for the trust patients place in us by generously participating in clinical trials even before a medicine is validated. With RASONQUE now approved, let me highlight four messages that frame what today means for patients and for Revolution Medicines. First, the approval is grounded in the unprecedented overall survival benefit demonstrated in the registrational phase III RASolute 302 trial, which we believe is one of the most meaningful treatment advances achieved in metastatic pancreatic cancer. Second, today's approval positions RASONQUE to becoming a practice-changing new standard of care for patients with previously treated metastatic pancreatic cancer and for those who are not candidates for multi-agent systemic therapy. We believe it has the potential to change expectations for patients across these settings. Third, Revolution Medicines is launch-ready and fully operational in the U.S. Our commercialization organization, manufacturing and supply network, market access capabilities, and patient support infrastructure enable us to begin serving patients immediately. Finally, beyond marking the successful development of a single pioneering medicine, this approval provides the first definitive proof point for our bold RAS(ON) strategy, advancing both multi-selective and mutant-selective inhibitors enabled by our proprietary tri-complex platform across multiple RAS-addicted cancers. It is an important step toward building a leading global oncology company serving patients with RAS-addicted cancers. We view today not as a finish line, but as a beginning of a much larger opportunity to improve outcomes for patients. Before we review the clinical data, I want to highlight what this image represents. For decades, RAS was viewed as being beyond the reach of direct inhibition, while meaningful treatment advances in metastatic pancreatic cancer, a disease primarily caused by RAS, remains limited. Today, RASONQUE represents a transformative step toward changing that. For patients, it represents the possibility of living longer than with chemotherapy and having more time before pain worsens or quality of life declines. For physicians, it represents having a new targeted medicine to offer eligible patients and with it, renewed hope in a setting where meaningful advances have been limited. For investigators, it reflects years of scientific innovation, collaboration, and clinical excellence. And for the Revolution Medicines team, it marks the moment we have pursued tirelessly for years, delivering to patients a highly innovative and impactful medicine that we discovered and developed. I will now turn it over to Alan, who will put the historical treatment landscape in context, explain how the early clinical evidence informed our phase III development strategy, and then walk us through the pivotal phase III RASolute 302 result that supported today's approval. Alan? Thank you, Mark. Historically, metastatic pancreatic cancer has been one of the most devastating and difficult to treat cancers. Despite being predominantly driven by RAS, targeted therapies have been available only to a very small number of patients whose tumors carry rare, actionable non-RAS mutations. Published epidemiology and treatment pattern analyses indicate that approximately 55,000 patients are diagnosed each year in the U.S. with metastatic pancreatic cancer, including both new diagnoses and patients who progress from a pre-metastatic stage of disease. In the RASONQUE era, approximately 74% of these patients, or 41,000 per year, received first-line treatment with cytotoxic chemotherapy, while approximately 26% received no systemic therapy. Of those who received first-line treatment, fewer than half, approximately 19,000 patients, went on to receive second-line treatment. Intravenous chemotherapy regimens based on either 5-FU or gemcitabine have been widely used across all lines of treatment for metastatic disease, typically requiring regular visits to a hospital or infusion center. These patterns illustrate both the aggressive nature of metastatic pancreatic cancer and the substantial attrition across lines of therapy that characterize the treatment landscape. Against that backdrop, we look for evidence that directly inhibiting active RAS could produce meaningful clinical activity across RAS-driven cancers. Across separate phase I studies, RASONQUE, as a single agent, demonstrated encouraging and differentiated anti-tumor activity in previously treated and first-line metastatic pancreatic cancer, as well as in other tumor types, including previously treated RAS mutant non-small cell lung cancer. The strong signals of clinical activity in single-arm studies across multiple tumor types and in different lines of treatment supported our decision to initiate a wide-ranging phase III program, which is still underway, to rigorously evaluate RASONQUE in these settings. This progression from early clinical evidence to broad registrational development is reflected in a first set of five randomized phase III trials with RASONQUE shown here. More than 2,000 patients have now been treated with RASONQUE in a wide set of early and late-stage clinical studies in multiple tumor types and treatment settings, providing a substantial and growing body of clinical experience. So far, the phase III program includes four trials in pancreatic cancer, spanning previously treated metastatic disease, first-line metastatic disease, and the adjuvant setting for resectable disease, as well as a fifth trial in previously treated RAS mutant non-small cell lung cancer. RASolute 302, a global study comparing RASONQUE monotherapy to standard of care cytotoxic chemotherapy in patients with previously treated metastatic pancreatic cancer, is complete and led to today's approval of RASONQUE. This approval provides a significant element of phase III validation for our RAS(ON) inhibitor approach to RAS-addicted cancers. The other phase III studies are in progress, and uses beyond the approved indication remain investigational. I will now summarize the RASolute 302 data supporting today's approval, followed by key elements of the approved label. The results of RASolute 302 were presented in the plenary session at the 2026 ASCO Congress in May and published simultaneously in the New England Journal of Medicine. RASONQUE demonstrated an unprecedented overall survival benefit, reducing the risk of death by 60% and nearly doubling median overall survival versus chemotherapy with a manageable safety profile. As a medical oncologist, the most important point to me is straightforward: patients treated with RASONQUE lived significantly longer. As shown in the intent-to-treat population, which included patients with and without an identified tumor RAS mutation, RASONQUE produced a statistically significant and clinically meaningful improvement in overall survival versus standard chemotherapy. The overall survival benefit was also consistent across clinically relevant predefined patient subgroups. As with any subgroup analyses, these results should be interpreted with appropriate caution. Nonetheless, considered in aggregate, this consistency supports confidence in the robustness of the overall results. RASONQUE also demonstrated a statistically significant improvement in progression-free survival, as assessed by blinded independent central review. The alignment of the overall survival and progression-free survival findings further strengthens the evidence supporting approval. The patient-reported outcomes contribute an important patient-centered dimension to the RASolute 302 results. Compared with chemotherapy, RASONQUE significantly delayed deterioration in patient-reported measures of both pain and overall quality of life. For patients with metastatic pancreatic cancer, delaying worsening of pain and preserving quality of life are essential treatment goals, making these findings meaningful alongside the survival benefit. Turning to safety, we did not identify any new safety signals in the profile observed in RASolute 302 compared to earlier studies. Treatment-emergent adverse events were generally manageable with established management and dose modification strategies, and treatment discontinuations due to adverse events were substantially less frequent than with chemotherapy. Together with the efficacy findings, these results support a compelling benefit/risk profile for RASONQUE. The U.S. prescribing information reflects the strength of the evidence supporting this approval. RASONQUE is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy. Importantly, the indication is not restricted by tumor RAS mutation status, and no companion diagnostic is required. RASONQUE is administered orally once daily. The prescribing information includes detailed guidance on dosage and administration, prophylaxis, management of key adverse reactions, and relevant drug interactions. Physicians should review the full prescribing information before prescribing. The label enables physicians to begin prescribing RASONQUE immediately for eligible patients, translating years of clinical research into patient benefit. RASONQUE is available beginning today. With that, I will hand it over to Anthony Mancini. Thanks, Alan. Today's approval is grounded in the unprecedented overall survival benefit and broader clinical evidence demonstrated in RASolute 302. It marks an important advance for people living with metastatic pancreatic cancer. From the outset, our commercialization strategy has been focused on the patient. We will ensure that eligible patients can access RASONQUE quickly, and we will support them throughout their treatment journey. With RASONQUE now approved, our focus shifts from preparation to execution. Our launch strategy is anchored in three priorities. First, enable healthcare providers and eligible patients with the resources needed for an optimal treatment experience. Through education, patient services, and field support, we aim to enable rapid adoption and to help patients remain on therapy. Second, establish RASONQUE as the new standard of care for eligible patients with metastatic pancreatic cancer. The phase III RASolute 302 results that Alan just described, including the near doubling of median overall survival, a statistically significant improvement in progression-free survival, meaningful improvements in patient-reported outcomes, and a manageable safety profile, position RASONQUE as a truly practice-changing therapy. Third, ensure broad coverage and seamless patient access from day one. Our market access organization and patient services capabilities are fully operational and engaged. This remains a setting of profound unmet medical need where patients have historically had limited treatment options and poor outcomes. We believe RASONQUE can meaningfully change the treatment outlook for eligible patients. A successful oncology launch requires more than a strong clinical profile. It requires reaching every stakeholder involved in the care of pancreatic cancer patients. Approximately 40% of patients are treated at academic centers where many investigators and opinion leaders are already familiar with the RASONQUE clinical program, which we believe will help drive early adoption. The remaining 60% of patients receive care in community oncology practices, making broad community education and practice-level engagement equally important. We've built a world-class commercialization organization with deep experience in oncology, oral oncolytics, gastrointestinal cancer, and new product launches. Our U.S. medical science liaisons have been active for over a year, engaging clinical experts through scientific exchange. Our thought leader liaison team has been engaging appropriately with opinion leaders to gather perspectives on the treatment landscape and potential implementation needs. Those insights have helped shape our launch readiness. To date, our field-based market access teams have engaged key integrated delivery networks and large community accounts, as well as payers representing more than 80% of covered lives through pre-approval information exchange. Our sales team is set to engage with the broader oncology healthcare provider community. Overall, our field-based teams are deployed to enable a coordinated launch by advancing clinical understanding, preparing the breadth of accounts, addressing access barriers, and helping eligible patients benefit from RASONQUE. Central launch priority is helping eligible patients begin therapy promptly and remain supported throughout treatment. RASONQUE is now commercially available in the United States at a wholesale acquisition cost of $39,800 for a 30-day supply based on the recommended daily dose. We believe the price reflects the unprecedented overall survival benefit and broader clinical value demonstrated in RASolute 302. Our market access and patient services infrastructure is fully operational to support broad patient access across channels. Our comprehensive patient services program, (ON)Path, provides integrated support from prescription through ongoing treatment. The program includes coverage navigation, financial support, adherence support, and educational resources for patients, caregivers, and healthcare teams. Importantly, our team will also be focused on ensuring continuity of care for patients who have been receiving RASONQUE through the expanded access program, supporting a smooth and seamless transition to commercial supply and applicable insurance coverage. Eligible commercially insured patients may qualify for co-pay assistance as low as $0. Dedicated support teams will work with providers and specialty pharmacies to navigate coverage and coordinate access. Our goal is simple: help remove barriers to access so physicians can focus on treatment and patients can focus on their care. In the United States, our launch is now underway, with commercial supply, distribution, patient services, and each of our field teams fully operational. Internationally, we have established teams in Europe and Japan and are rapidly expanding our capabilities in preparation for future potential partners. The European Medicines Agency's phased review of daraxonrasib is underway. We intend to address the broader international opportunity in phases, market by market. I should note that outside the United States, daraxonrasib is investigational and has not yet been approved by any regulatory authorities. We will, however, be able to respond to unsolicited requests from healthcare providers who have decided to prescribe daraxonrasib to suitable patients in countries where it has not yet received regulatory approval on a paid basis through global named patient access. This process will vary from country to country depending on local laws, regulatory, and access requirements. Additional information about global named patient access is available on our website. Together, these capabilities provide the foundation for a successful U.S. launch and position us for future global expansion as additional approvals are obtained. With that, I'll hand the call back to Mark. Thank you, Anthony. As you've heard today, this approval represents more than the successful development of one pioneering medicine. It validates a strategy Revolution Medicines has long pursued. By combining deep biological insight, innovative chemistry, and bold but disciplined clinical development, we set out to create and validate new targeted medicines that transform outcomes for patients with RAS-driven cancers. Today, RASONQUE makes that vision a reality and begins our next chapter. Our immediate priority is clear: deliver RASONQUE to eligible patients across the United States and establish it as a practice-changing new standard of care. In parallel with the U.S. launch, we are advancing launch readiness in Europe and Japan and expect to address additional international markets in phases subject to regulatory approvals. The RASONQUE NDA is included in the FDA's Project Orbis initiative, which provides a framework for concurrent review of oncology applications by participating international health authorities. Today's U.S. approval provides a foundation for our ambition to build the leading global pancreatic cancer franchise. Our development strategy extends well beyond today's indication. Four additional global phase III registrational programs are underway in pancreatic cancer, spanning first-line metastatic and resectable disease, and using complementary monotherapy and combination strategies involving RASONQUE and zoldonrasib, our RAS(ON) G12D selective covalent inhibitor. These programs are designed to address diverse patient needs across the treatment continuum. Our ambition is not simply to participate in pancreatic cancer care, but to improve patient outcomes by redefining treatment across a wide range of cancer types caused by RAS. That ambition extends across our broader portfolio. RASONQUE is the first approved targeted medicine to emerge from our broad and differentiated pipeline of oral RAS(ON) inhibitors, spanning multiple RAS mutations, tumor types, and treatment settings. The experience of successfully discovering, developing, and now delivering RASONQUE strengthens every part of our organization. It deepens our understanding of patients, expands our relationships with physicians and treatment centers, reinforces our commercial capabilities, and creates scientific and medical insights that can accelerate the development of future medicines. Discover, develop, and deliver are more than words on a slide. Together, they describe an integrated strategy for fulfilling our mission. Discovery fuels development. Development creates opportunities to deliver innovative medicines. Commercialization, in turn, generates scientific and clinical insights that inform the next generation of discovery and development. With RASONQUE now approved and entering clinical practice, that virtuous cycle can operate in a fundamentally new way for Revolution Medicines. For the first time, our research scientists, development teams, and commercial organization are connected through an improved medicine in everyday clinical use, which will enable us to incorporate feedback from an even broader patient and prescriber universe as we continue driving innovation on behalf of patients. This new phase provides a robust foundation for building an industry-leading global targeted medicines franchise. RASONQUE is the first approval proof point for this strategy, and our mission is to translate the breadth of our science and pipeline into multiple transformative medicines that improve outcomes for patients with RAS-addicted cancers. Today's approval is a compelling and exciting step toward realizing that vision. Before we open the call for questions, I want to close where I began, with patients. Behind every data point is a person and a family facing an extraordinarily difficult diagnosis. Bringing RASONQUE to these patients is central to our mission. To the patients and families, investigators, employees, collaborators, and shareholders who helped make today possible, thank you. We also recognize the creative vision of Gregg Verdine and the pioneering scientists at Warp Drive Bio. Their early work established both the initial technology foundation that became part of Revolution Medicines eight years ago and a new paradigm that inspired our discovery work, leading to this consequential milestone. We are honored by today's approval, committed to bringing RASONQUE to patients, and energized by what comes next as the revolution continues. With that, I'll turn the call over to the operator for the Q&A portion of the call. Certainly. As a reminder, ladies and gentlemen, if you do have a question at this time, please press star one one on your telephone. We do ask that you please limit yourself to one question and one follow-up. Our first question comes from the line of Michael Schmidt from Guggenheim. Your question, please. Thanks, and yeah, congratulations on this great accomplishment. It is clearly a great day for patients. Mark, as we think about the potential launch ramp here, just remind us of the patients that are already on the early access program. What are the logistics and timing for those to potentially roll over to becoming commercial patients? What is the expectation longer term, how fast you can reach patients in the community as well beyond academic centers? Thanks so much. Yeah. Thank you for your questions, Michael. Anthony Mancini can comment on both of those. Yeah. Thanks, Michael, for the question. The patients on the EAP following the U.S. approval will be transitioning within a few months. I think it is important to note that (ON)Path, our patient support program, will be available to assist all patients who have been prescribed RASONQUE, including those in the EAP program and new patients. For U.S. patients who are already receiving daraxonrasib in the EAP, we will work very closely with treating physicians at all sites to support transition to commercially available treatment as clinically appropriate. Those who are pending medical review or who had been medically approved but not yet shipped product at the time of approval will need to access RASONQUE through commercial channels. So the EAP portal will be closing today but available for a limited transition period. Our intent is really to support continuity of care for eligible patients and work very closely with all of the key centers to ensure this happens as quickly as possible. We estimate that will take a couple of months. Thank you. Our next question comes from the line of Brian Cheng from JP Morgan. Your question, please. Hey, guys. Truly congrats on the approval, and thanks for taking our question here. As we think about the launch here, what kind of metrics could we get during your upcoming earnings call to track the launch over time? We have a quick follow-up. Thank you. Thanks, Brian. You're giving Anthony more opportunity to speak than in any prior meeting. Yeah. Thanks, Brian. Look, we're going to evaluate launch progress across a range of different indicators, including physician adoption, patient access, treatment continuity, and of course, financial performance. We'll provide appropriate context on launch progress based on the indicators we believe are most relevant at each stage of the launch. These will include things like net sales, some patient adoption metrics, prescriber adoption, and coverage. That information, of course, may evolve over time as the launch matures and as we gain additional experience in the market. Great. Then, just on the RASONQUE's potential usage in locally advanced settings, I'm just wondering if there's any potential for NCCN guideline to enable usage there. Because we do see some usage for other therapies enabling usage off-label for locally advanced. I'm curious if there's any potential there. Thank you. Thanks for that question. I think Dr. Sandler can comment on that. Yeah. Again, thanks for the question. In terms of locally advanced, that is an area certainly of interest that we're going to be looking to pursue specifically in the future. The label itself is based specifically, of course, on 302 on the previously treated population and then those patients not a candidate for multi-agent systemic therapy. Dr. Wei, do you want to add something to that? Historically, the NCCN guideline does provide guidance based on the metastatic standard of care and extrapolation of data for use in locally advanced. However, to date, I think that's going to be a decision that's going to be weighed by the physician and their patient. Great. Congrats on the approval again. Thank you. Thank you. Thank you. Our next question comes from the line of Tyler Van Buren from TD Cowen. Your question, please. Hey there. Thanks so much for the question. Mark, congratulations on this transformative approval and milestone for patients. I understand that RASONQUE is now available by prescription, but for the new non-EAP commercial patients, how long will it take for them to get commercial or paid drug in hands? Could this be faster than the EAP, and do you expect it to be a matter of days or weeks? Perhaps as a follow-up, how do you expect coverage to progress? Thank you, Tyler. Nice to hear from you. Back to Anthony. Yeah, thanks, Tyler, for the question. I think as far as availability of the product, as we discussed earlier, the product is available and physicians can prescribe it as of today. As far as coverage, just a couple of comments, I think, in terms of what is normal in an oncology launch is that in the early stages, we expect very quickly that payers will prescribe their medical policy. We will change their medical policy and publish those. But in the meantime, it is quite common that approval will be gained through medical exception, and we expect that to happen with RASONQUE. But we expect patients to be able to access that relatively quickly. So again, as I mentioned, we have had very robust payer pre-approval information exchanges, and we expect to be able to get approval through medical exception relatively quickly. Hope that answers the question, Tyler. Thank you. That's great. Thanks. Thank you. Our next question comes from the line of Charles Zhu from LifeSci Capital. Your question, please. Hello, everyone. Congrats on everything, and thanks for taking the questions. A couple of quick ones from me. First, how is chemo ineligibility being defined? Are there clinical criteria only, or is there some sort of a patient desire factored in as well? The second one, can you comment a little bit more on the paid process for patients outside the U.S. to access daraxonrasib, perhaps how you might be thinking about ex U.S. pricing in general? Thank you. Thanks, Charles. I think we'll start with Alan, then Anthony can address your second question. Yeah. Thanks, Charles. The U.S. prescribing information doesn't define specific criteria for determining whether a patient's a candidate or not for multi-agent systemic therapy. That said, treatment decisions among approved options should be made by the treating physician in consultation, of course, with the patient and taking into account the individual needs of the patient, circumstances, supporting evidence, and importantly, the risks and benefits of available treatment options. And this allows, again, for the flexibility for patients, as with other treatment decisions, to allow physicians those flexibilities in having multiple treatment options for interactions with patients. Very good, Anthony. So maybe, Charles, I'll start with the question on the global new patient access. And really, this is to support healthcare provider-initiated unsolicited requests for RASONQUE on behalf of eligible patients. It provides an interim and compliant pre-approval access pathway in countries where it's permitted under local laws and regulations. It reflects our commitment to responsibly expand access for eligible patients while we continue to advance clinical development, regulatory approval, and work towards broader commercial availability. Again, this is a program that provides daraxonrasib on a paid basis, and in accordance with terms that are specific to the country in question. Our long goal is to make daraxonrasib available to the broadest possible patient population through regulatory approvals and through commercial availability. And maybe I'll comment a little bit on your ex U.S. question as well. Clearly, we will make launch and access decisions market by market, taking into account regulatory requirements, local reimbursement and access considerations, and of course, the evolving policy environment. And we've set a U.S. price, really, that's grounded in demonstrating clinical patient and societal value of RASONQUE. And we're optimistic about our overall pricing strategy and approach as we continue to build our launch plans, excuse me, in markets outside the U.S. And I think I'll leave it there, Charles. Great. Thanks again, and congrats again. Thank you. Our next question comes from the line of Cory Kasimov from Evercore ISI. Your question, please. Great. Thank you, guys. Let me add my congrats on this landmark approval. Two questions from me as well. I suspect you are aware that there is other news out there this afternoon that the Trump administration plans to announce new drug pricing deals with several mid-cap biotech companies next week. I am wondering if the timing of that is not a coincidence and if RASONQUE is part of this. Is this something you are able to comment on at all right now? We do not have any comments on that at this point. Okay. I figured as much. The other question was just related to that with the pricing. How should we think about gross to net in the first handful of quarters? Should we assume something roughly comparable to the G12C when they launched, or should we be looking at this in a completely different lens? Thanks again for that question. Jack Anders, our CFO, has been waiting for this opportunity. Thanks, Cory. Cory, we expect the gross to net discount to initially be in a range of 20%-30%. This is ultimately going to depend based on the payer mix. We do expect a significant portion of eligible patients to be covered through government payers, particularly Medicare Part D. As you know, utilization through government payers comes with mandatory discounts and rebates. Got it. Thank you very much. Thank you. Thank you. Our next question comes from the line of Faisal Khurshid from Jefferies. Your question, please. Hey, guys. Thank you for taking the question and congratulations on this milestone. I just wanted to ask if you could help us understand the interplay of dose reduction with realized price for the drug. I understand you are supplying the drug in 100 mg and 150 mg bottles, but the label says that the dose reductions are 300 mg, 200 mg and 150 mg. So I just want to understand how that may or may not impact what you ultimately realize on a net price per patient. Thank you. Thanks for your question. Anthony? Yeah. I will address that, Faisal. Thanks for the question. As you said, RASONQUE is available in 30-count bottles, both the 150 mg and the 100 mg, and those support the recommended dose in the approved prescribing information. Each is flat priced. The 100 mg count bottle and the 150 mg count bottle are priced at the same. That should hopefully clarify things. Got it. But if a patient has two dose reductions and they are at the 150 mg dose, what does that mean then? Well, the recommended dose is 300 mg and the recommended dose reduction, which we saw in the clinical trial can happen, is 200 mg. We expect there to be very few patients below that. Got it. Thank you for clarifying. Thank you. Our next question comes from the line of Michael Yee from UBS. Your question please. Hey, this is Roy on for Michael Yee. Thanks for taking our question. Can you help us understand a little bit how baseline liver function could modify the real-world uptake? In particular, what proportion of PDAC patients might be ineligible or have trouble getting the drug because of this? Thank you. Thanks for that question. Wei, do you want to just comment on that just generally? Yeah. Generally, obviously, some patients will have liver elevation due to passes or other liver abnormalities at baseline, and those patients may not be eligible to receive any medicine in general. But I think a majority of cancer patients will be eligible for daraxonrasib. Maybe Alan can add a point to that. Yeah. So we are conducting studies looking at those patients with moderately elevated liver function tests to see how they are able to tolerate therapy as well. Great. Just as a second question, can you maybe provide a little bit more detail on the patient services program? Which payers are participating in this and what percentage of patients would you anticipate getting that zero dollar copay? Okay. Yeah. Look, I think first of all, (ON)Path is a standard sort of set of offerings, and it's voluntary and patients sign up for this. This is going to be offered very broadly, and we expect there to be a high level of participation. But again, it is voluntary. So I think that's the first part of the question. I think your second part of the question is more asking specifics around what (ON)Path is and for patients that opt in, there's four core service areas, and I'll expand a little bit on what they are. So the coverage navigation piece really helps patients and providers work through prior authorizations and payer requirements. A financial support component really is assistance programs to help reduce out-of-pocket burden. The adherence support piece are resources to keep patients on therapy and managing side effects. There are educational materials for patients and caregivers and the care team. As far as the mix, as Jack sort of alluded to in his answer, we expect the majority of patients to be Medicare Part D. The biggest subtype of our mix to be Medicare Part D. The second-largest subgroup of patients will be commercially insured patients, followed by others. For the commercially insured patients, it really depends on that commercial plan. So it really varies patient by patient. As you know, for a Medicare Part D patient, $2,100 is the maximum out-of-pocket based on the benefit redesign, and so that is across all of their medicines. So that is the maximum out-of-pocket cost for the biggest segment of patients that will receive RASONQUE per year. Thanks so much. Thank you. Our next question comes from the line of Laura Prendergast from Stifel. Your question please. Hey, guys. Congrats on the historic update today. Do you have any plans to pursue any type of accelerated approval path for first-line PDAC? Anything that would get approval faster than waiting for RASolute 303 to read out on OS. How should we think about time on therapy in the real world? I know you previously said patients had to come off drug upon progression on 302. Do you expect that to be reflected in the real world? Hi, Laura. Thanks for your questions. I am going to comment on the second question, Wei, which is time on drug. Yeah. Time on drug. I think every clinician, when it comes to managing a patient, always thinks about the risk-benefit of maintaining the current event versus transitioning to next therapy and the risk benefits from that. And oftentimes that has to do with the rapidity at which the progression occurs and how well the patient is doing symptomatically. I think 302, the studies done ended this treatment at the time of progression or future trials are generating data to evaluate continuation or treatment beyond progression as a concept, and as the data emerges for that, I think it will provide evidence for the physician to make that judgment call for For the first question that has to do with first-line pancreatic cancer, as Alan described earlier, the label enables flexibility by a physician and a patient to determine what is the best course of treatment for them. In addition, as you pointed out, we have the RASolute 303 trial, which is a three-arm trial, plus evaluation of daraxonrasib plus chemotherapy versus chemotherapy. And that is designed to establish the overall durability as you asked about. With regard to anything that might be an acceleration of that, as you know, we generally do not project that sort of thing into the future. So we do not have any particular comments to make about that today. Got it. Thanks. Congrats again. Thank you. Thank you. Our next question comes from the line of Jay Olson from Oppenheimer. Your question, please. Oh, hey. Congrats on this landmark achievement. We have a question about the patient-reported outcomes benefits from RASolute 302, such as the delay in pain deterioration and preservation of quality of life. How important do you think those benefits will be in driving treatment decisions versus the survival data alone? Are there specific physician or patient segments where the quality-of-life data should be especially important? Thank you. Thanks for the question. I think Alan would like to comment on that. Yeah, I think overwhelmingly survival advantage is of significant importance. I think the key with this particular, the results from 302 is the fact that not only did you have an overwhelming survival advantage, essentially nearly doubling the median and a 60% improvement in survival. You also had similar improvements with the PROs in terms of, as you mentioned, delay to onset of new treatments and delay to deterioration of quality of life. So I think most physicians and patients will view those in tandem and look at this as just a remarkable step forward to have not only improvement in survival but feeling well longer, delay of symptoms. Particularly because it is such a symptomatic disease, and so we think that that is going to be very important for every patient. Thank you. Super helpful. Congrats again. Thank you. Our next question comes from the line of Alec Stranahan from Bank of America. Your question, please. Hey, guys. I want to offer my congrats on the approval as well. Two questions. First, since the label seems to mostly reflect the RASolute 302 data, curious if this maybe affects how you can speak about the totality of the data available at launch in your physician education materials, particularly thinking about the ACR data we saw from the broader metastatic population. Second, maybe you could just remind us whether the CMPV or any of your other designations for RASONQUE carry over for frontline review, or if this is something you will seek in this setting as well. Thank you. Yeah. Thank you, Alec. Well, of course, all of our commercial efforts will be compliant, and that means we will cite the data that are the explicit basis for the approval. With regard to the CMPV, we have now spent the CMPV. We have used that. But we have a very good relationship with the FDA. We are engaged with them on obviously every study that we have ongoing and every patient population, and we will continue to engage with them. I think their announcement today indicates a level of enthusiasm for the drug, a label that is very attractive for physicians and patients, and we will just look forward to the future. Great. Thanks, Mark. Congrats again. Thank you. Our next question comes from the line of Gregory Renza from Truist Securities. Your question, please. Greg, good afternoon and good morning, Mark and team. Let me add my congratulations on this monumental day as well. Mark, maybe just following up on the CMPV status and the voucher. Just wanted to ask if you could provide perhaps a little more color on the drivers that went into arriving at the price that you've set today, and perhaps to what extent, if at all, did the voucher status play a role in determining the value and also the affordability for patients? Thanks so much, and congrats again. Yeah, thank you very much. I think to us, the CMPV was a reflection of the inherent value of the asset rather than a driver of the value. We very much appreciated the engagement by the FDA and their very efficient process by which they supported all steps along the way, including opening the expanded access program and now moving with light speed to evaluate under the expedited review program. But I don't think from our point of view, it really had anything to do ultimately with pricing. As Anthony described earlier, there are a number of factors that went into pricing consideration. We think that it is appropriately priced and optimistic that it will serve everybody's needs. That's great. Thank you, and congrats again. Thank you. Thank you. Our next question comes from the line of Sean McCutcheon from Raymond James. Your question, please. Hi, guys. Thanks for the question, and I will throw in my congrats as well. A couple from us. Putting maybe a finer point on Charles's question from earlier. You noted 74% of patients received frontline treatment. What proportion of that 26% that do not do you see as potentially amenable for daraxonrasib monotherapy? Secondly, can you speak to any early experience during the EAP period that you have had on daraxonrasib AD management educational efforts at centers that were not part of the clinical program? Thanks. Yeah. Let me comment on the first point. The treatment patterns that we are familiar with and that you just cited, of course, are the pre-daraxonrasib era. We really do not know what things will look like going forward, and we imagine there will be some change in those. It is also hard for us to say among any particular population exactly what percent will choose to take daraxonrasib. I do not think we can provide any more color about that. With regards to the second question, could you remind me what that question was? AD management. Oh, AD management. I think the question was with regard to impact of our educational materials on investigator familiarity, maybe even add to that, investigator experience. Right Also quickly growing their understanding. Since 2022, when there was the first patient with RASONQUE, we certainly sought from the patients and gained a wealth of experience through the experienced investigators with the patients. So we have crafted a very clear guideline that is part of the label, which our commercial and unmet clear team will be actually distributing and working with physicians throughout the U.S. in implementing that. I think it is actually a very well-thought-out plan and to be able to keep the patient on drug and to extend their survival stream, we are lucky in RASolute 302 trial. Yeah. Maybe just to complement Wei's comments. We learned a great deal from the clinical experience, and that data gathering has been happening for several years. The educational program that we are launching with today reflects all of that learning, and we are really pleased with the input we have gotten from investigators along the way. We are confident that we will be well-positioned to manage adverse events in the real world, like we were able to do so in the clinical trial. Hopefully, we can continue to improve on that over time. We deploy those very similar materials in the expanded access program, which included some investigators who had a lot of experience, but also many physicians who had no prior experience. So we have already had an opportunity to see how receptive they are to it, and they are receptive. Research. Thanks. Thank you. Our next question comes from the line of Leonid Timashev from RBC Capital Markets. Hey, guys. Josh on for Leo, and congratulations on today's approval. The news today refers to not candidates for multi-agent systemic therapy, and I was wondering if you could just provide a bit more color on exactly what that means to how the dynamics might shake out for first-line attacked patients. Thank you. Thank you for your question. Alan? Sure. Just want to maybe help reiterate that the prescribing information does not define specific criteria for determining, again, whether a patient's candidate for that, as you pointed out. Therefore, these treatment decisions, as often happens in other treatment settings as well, will be made by the treating physician in combination with the patient themselves to evaluate their specific situation and the risks and benefits that are specific to that particular patient moving forward. And I think as with all treatment decisions, this will allow for some flexibility for both the patient and the physician in making these treatment decisions. All right. Thanks so much. Certainly. Our next question comes from the line of Kalpit Patel from Wolfe Research. Yeah. Hey, good afternoon, and congrats on the approval today. I guess one on the label outcome here. Given that you have a broader label than expectations, how does that impact the enrollment timing for the ongoing first-line studies? Then second question, what percentage of the first-line market do you ultimately think remains truly inaccessible under today's label? Thank you. Okay. Thanks for your question. The first question is potential impact on enrollment of ongoing studies, and maybe Wei can comment on that. Yeah. As we've discussed before, I think on prior calls, we've been very thoughtful and forward-looking when it comes to the potential impact of the launch of RASONQUE in pancreatic cancer, and I think given the breadth of the label and the potential uses in other areas. I think we're still going to follow through with our operational plan, which is really focused on key U.S. sites, enroll difficult patients, and the lion's share of the operational footprint will be outside the U.S. where the RASONQUE is not commercially available. That would help us to be able to demonstrate the efficacy of both monotherapy RASONQUE as well as RASONQUE plus gemcitabine compared to standard care in the first-line setting. With regard to your second question, we understand your desire to get more clarity about it. We think it's fairly straightforward. Patients with and without prior systemic therapy may be considered for treatment with RASONQUE. For those who have received prior systemic therapy, treatment may have been initiated either at the initial diagnosis of metastatic disease or before recognized metastatic disease. For patients who've not received prior systemic therapy, consideration should include whether the patient's a candidate for multi-systemic therapy. As to what those percentages will prove to be, that's something we'll find out over time, how doctors and their patients make those decisions, but we can't give you any forward-looking insight into that. Okay. Thanks for taking the questions. Thank you. This does conclude the question and answer session of today's program. I'd like to hand the program back to Dr. Goldsmith for any further remarks. Thank you, operator, and thanks again to everyone who joined us today. The approval of RASONQUE is a far-reaching milestone for Revolution Medicines, and it's a monumental step forward for patients with metastatic pancreatic cancer who now have a new treatment option. We're extremely well-prepared to fulfill our responsibility. We're energized to enter this next chapter, and we're grateful for your continued support. We look forward to updating you as we bring RASONQUE to patients and advance our broader mission. Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.