레볼루션 메디신스(RVMD) 2026년 3분기 실적 발표 콘퍼런스콜: RASONQUE 매출 1억 9,760만 달러 기록

핵심 요약

• RASONQUE는 2026년 8월 26일 FDA 승인 이후 약 5주간의 미국 상업화 기간 동안 1억 9,760만 달러의 순제품 매출을 기록했다. 5,000명이 넘는 개별 상업 환자가 치료를 받았다.
• 초기 수요에는 동정적 사용 승인 프로그램(EAP)에서 전환된 환자, 가능한 치료법을 소진한 후 새로운 대안을 기다리던 환자, 신규 적격 환자가 포함됐다. 경영진은 앞의 두 환자군은 출시 초기의 한시적인 요인이라고 주의를 당부했다.
• 레볼루션 메디신스는 2026년 3분기 말 기준 37억 달러의 현금, 현금성 자산 및 시장성 유가증권을 보유했다. 이 잔액에는 로열티 파마(Royalty Pharma) 자금 조달 계약에 따라 10월에 수령한 2억 5,000만 달러는 제외되어 있다.
• 임상 개발 및 상업화 운영 확대로 3분기 R&D 비용은 전년 동기 2억 6,250만 달러에서 4억 1,710만 달러로 증가했으며, 판관비는 5,280만 달러에서 1억 5,330만 달러로 증가했다.
• 회사는 예상 주식기준보상 2억 7,000만~2억 9,000만 달러를 포함한 2026년 연간 GAAP 영업비용 가이던스를 기존의 21억~22억 달러로 재확인했다.
• 경영진은 RAS(ON) 포트폴리오 투자와 글로벌 상업화 인프라 확장에 따라 2027년 연간 GAAP 영업비용이 현재 지출 수준(런레이트)보다 증가할 것으로 예상하고 있다.

핵심 재무 데이터

분기 말 유통 채널 재고는 2주 미만이었다. 경영진은 장기적으로 재고를 약 2주 수준으로 유지할 것으로 예상하고 있다.

총매출 대비 순매출 할인율은 예상 범위인 20~30%의 하단에 머물렀다. 회사는 340B 프로그램 및 유통 수수료에 따른 잠재적 영향을 포함해 보험자 구성과 채널 할인이 성숙해짐에 따라 해당 범위 내에서 할인율이 상승할 것으로 예상하고 있다.

사업 및 운영 실적

RASONQUE 출시

미국 내 초기 출시를 통해 5,000명 이상의 개별 상업 환자와 약 2,700명의 처방 의료진에 도달했다. 사용량의 약 60%는 지역 병·의원 종양학 치료 현장에서, 40%는 대형 학술 센터에서 발생하여 해당 채널 전반의 환자 비중을 대체로 반영했다.

보험 급여 청구는 미국 췌장관 선암종 보장 인구의 90% 이상을 차지하는 건강보험 플랜들로부터 발생했다. 공식 급여 정책은 아직 수립 중이지만, 환자들은 사전 승인 및 의학적 예외 조항 등 기존 보험자 심사 절차를 통해 치료를 받고 있다.

초기 환자의 대부분은 이전에 치료받은 적이 있는 전이성 질환 환자였다. 경영진은 초기 환자군의 상당 부분이 전신 수행 능력이 낮은 말기 환자로 구성되어 있어 치료 지속 기간이 짧아질 수 있다고 밝혔다. 미국 내 동정적 사용 승인 프로그램(EAP)에서의 전환은 10월 말에 완료됐다.

NCCN 가이드라인은 이전 전신 치료 후 질환이 재발한 국소 진행성 또는 전이성 췌장암 적격 환자를 위한 선호되는 카테고리 1 후속 치료 옵션으로 RASONQUE를 등재했다. 이러한 권고 사항이 FDA 승인 적응증을 변경하는 것은 아니다.

해외 시장 확장

유럽의약품청(EMA) 산하 약물사용자문위원회(CHMP)는 최소 한 차례 이상의 전신 치료를 받은 전이성 췌장선암 성인 환자를 대상으로 한 다락손라십(daraxonrasib) 단독요법에 대해 긍정적 의견을 제시했다. 유럽연합 집행위원회(EC)의 최종 결정은 아직 계류 중이다.

레볼루션 메디신스는 유럽 국가별 보험 급여, 약가 책정 및 의료기술평가(HTA) 절차를 준비하고 있다. 또한 규제 당국의 승인을 전제로 일본 내 출시 준비도 진행하고 있다.

임상 파이프라인

임상 3상 RASolute 303 시험의 미국 내 환자 등록이 완료되었으며, 경영진은 2027년 상반기에 글로벌 환자 등록이 마무리될 것으로 예상하고 있다. 이 임상시험은 1차 전이성 췌장암에서 RASONQUE 단독요법 및 항암화학요법과의 병용요법을 평가한다.

회사는 1차 RAS G12D 변이 췌장암을 대상으로 RASONQUE와 졸돈라십(zoldonrasib) 병용을 평가하는 임상 3상 RASolute 309의 투약을 시작했다. 수술 후 보조요법을 평가하는 RASolute 304와 졸돈라십 및 항암화학요법 병용을 평가하는 RASolute 305도 진행 중이다.

비소세포폐암의 경우 RASolve 301의 환자 등록이 마무리 단계에 있으며, 2026년 11월 말까지 모든 기관에서 등록이 마감될 예정이다. 첫 임상 3상 결과 발표는 2027년으로 계획되어 있다. RASONQUE는 해당 적응증에서 여전히 연구용 단계에 있다.

레볼루션 메디신스는 또한 RAS G12D 및 RAS G12C 변이 비소세포폐암을 대상으로 각각 졸돈라십 및 엘리론라십(elironrasib) 병용요법의 1차 치료 임상시험에 착수했다.

대장암 분야에서 회사는 졸돈라십, 세툭시맙, 그리고 연구자 선택 FOLFOX 또는 FOLFIRI 병용을 평가하는 임상 3상 RASonate 312를 시작하고 있다. 비원 메디신스(BeOne Medicines)가 이 글로벌 허가용 임상시험의 자금을 지원하고 주도한다. 레볼루션 메디신스는 2027년 상반기에 초기 단계 대장암 데이터 업데이트와 임상 3상 시험 디자인을 공개할 예정이다.

경영진 가이던스

• 2026년 연간 GAAP 영업비용은 기존 전망대로 21억~22억 달러로 예상된다.
• 가이던스에는 2억 7,000만~2억 9,000만 달러의 예상 비현금성 주식기준보상이 포함되어 있다.
• 경영진은 RAS(ON) 포트폴리오 전반에 대한 투자와 글로벌 상업화 인프라 확장에 따라 2027년 연간 GAAP 영업비용이 현재 지출 수준보다 증가할 것으로 예상했다. 2027년에 대한 구체적인 수치 범위는 제시되지 않았다.
• RASolute 303의 글로벌 환자 등록은 2027년 상반기에 완료될 것으로 예상된다.
• RASolve 301의 초기 임상 3상 결과 발표는 2027년으로 계획되어 있다.
• RMC-5127의 초기 단독요법 데이터는 2027년에 발표될 예정이며, RM-055의 최초 인간 대상 임상시험은 2026년 4분기로 계획되어 있다.

리스크 및 주시 요인

RASONQUE의 초기 5주 매출에는 동정적 사용 승인 프로그램(EAP) 전환 환자, 초기 유통 채널 재고, 새로운 치료 옵션을 기다리던 환자 등이 포함되었다. 경영진은 정상화된 출시 궤적을 판단하기에는 아직 이르다고 밝혔다.

초기 환자 중 일부는 질병 단계가 많이 진행되어 있었고 전신 수행 능력이 낮았기 때문에, 초기 환자들의 투약 기간이 향후 추세를 대변하지 않을 수 있다. 경영진은 출시가 안착됨에 따라 신규 적격 환자와 지속적인 치료 기간 중심으로 수요가 이동할 것으로 예상하고 있다.

보험자 구성, 340B 프로그램 영향, 유통 수수료 및 공식 급여 정책이 구체화됨에 따라 총매출 대비 순매출 할인율은 20~30% 범위 내에서 상승할 것으로 예상된다.

비소세포폐암 대상 RASONQUE 및 1차 췌장암 병용요법을 포함한 몇몇 주요 파이프라인 프로그램은 여전히 연구 단계에 있다. 유럽 및 일본 상업화 일정 또한 규제 당국의 결정과 국가별 급여 등재 요건에 달려 있다.

애널리스트 Q&A 주요 내용

• 출시 구성: 경영진은 초기 수요군을 동정적 사용 승인 프로그램(EAP) 전환 환자, 승인된 치료제를 기다리던 환자, 신규 적격 환자의 세 그룹으로 구분했다. 이 중 세 번째 그룹만이 보다 정상화된 수요 궤적을 대변한다고 설명했다.
• 실제 임상 현장 내약성: 경영진은 초기 의료진과 환자의 반응이 긍정적이었다고 밝혔으나, 유의미한 결론을 내리기에는 출시 초기 단계라는 점을 강조했다.
• 보험자 접근성: 회사는 급여 승인 요건을 충족하는 데 있어 대형 학술 병원과 지역 병·의원 간에 실질적인 차이가 없다고 보고했다. 회사의 급여 전담팀이 두 환경 모두에서 사전 승인, 의학적 예외 신청 및 보험 적용 절차를 지원하고 있다.
• 1차 췌장암 치료 전략: 경영진은 화학요법을 배제한 요법과 화학요법을 포함한 요법 중 어느 쪽이 궁극적으로 더 큰 장기적 이점을 제공할지에 대해 중립적인 입장을 유지하고 있다고 밝혔다. 현재 임상 3상 프로그램들은 RASONQUE 단독요법, RASONQUE 및 졸돈라십 병용요법, 항암화학요법과의 병용요법을 각각 평가하고 있다.
• 대장암 치료제 개발: 비원(BeOne)의 RASonate 312 자금 지원 및 임상 진행을 통해 글로벌 개발 역량을 추가로 확보하는 동시에 레볼루션 메디신스의 내부 자원을 다른 연구에 집중할 수 있게 됐다. 경영진은 데이터가 도출됨에 따라 대장암 개발이 초기 G12D 프로그램을 넘어 확장될 수 있다고 밝혔다.
• 임상 평가지표: 경영진은 전체 생존기간(OS)이 임상적으로 가장 유의미한 평가지표라고 강조했다. RASolute 303, 305, 309는 무진행 생존기간(PFS)과 전체 생존기간(OS)을 공동 1차 평가지표로 포함하고 있다.

실적 발표 콘퍼런스콜 전문

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전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good day, and thank you for standing by. Welcome to the Revolution Medicines Q3 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Ryan Asay, Senior Vice President, Corporate Affairs. Please go ahead.

Ryan Asay

Thank you, and welcome, everyone, to the Third Quarter 2026 Earnings Call. Joining me on today's call are Dr. Mark Goldsmith, Revolution Medicines' Chairman and Chief Executive Officer; Anthony Mancini, our Chief Global Commercialization Officer; Dr. Alan Sandler, our Chief Development Officer; and Jack Anders, our Chief Financial Officer. Dr. Wei Lin, our Chief Medical Officer, will join us for the Q&A portion of today's call.

I'd like to inform you that certain statements we make during this call will be forward-looking because such statements deal with future events and are subject to many risks and uncertainties. Actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our recent periodic report that has been filed with the U.S. Securities and Exchange Commission.

This afternoon, we released financial results for the quarter ended September 30, 2026, and recent corporate updates. The press release and updated corporate presentation are available on the Investors section of our website at revmed.com.

With that, I'll turn the call over to our Chief Executive Officer, Dr. Mark Goldsmith. Mark?

Mark Goldsmith

Thank you, Ryan, and good afternoon, everyone. I'll begin today with several remarks focused on our progress in pancreatic cancer and across our broader RAS(ON) portfolio. Anthony will then provide an update on the initial launch of RASONQUE. Alan will discuss progress across our clinical development programs, and Jack will review our third quarter financial results before I return with brief concluding remarks.

The third quarter marked a transformational period for Revolution Medicines. On August 26, less than 2 years after enrollment began in the global randomized RASolute 302 clinical trial, the FDA approved RASONQUE for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy, and we immediately began making it available by prescription in the United States.

The approval provided an important regulatory proof point for our RAS(ON) approach and marked the beginning of a new chapter for our company. More importantly, eligible patients and their physicians now have an approved oral targeted medicine designed to directly and broadly inhibit RAS, the main cause of pancreatic cancer in a disease with a profound need for a therapeutic breakthrough. This milestone reflects years of scientific conviction, disciplined development and focused execution by our team and collaborators.

It also formally opens the delivery phase of responsibility for Revolution Medicines. We are working tirelessly to execute the U.S. launch with urgency, help eligible patients access RASONQUE promptly and support a positive treatment experience and rigorously prepare to expand the launch internationally. With the U.S. approval in hand and our execution plan's operational, the foundation in pancreatic cancer is being further reinforced by guideline recognition.

The NCCN Guidelines are more expansive than the approved label and now include RASONQUE as a Category 1 preferred subsequent therapy option for appropriate patients with locally advanced or metastatic pancreatic cancer as well as recurrent disease following prior systemic therapy. In metastatic pancreatic cancer, we believe this guideline placement highlights the strength and relevance to medical practice of RASONQUE and supports the use of RASONQUE in the FDA-approved settings.

Importantly, NCCN's recommendation for treatment in locally advanced disease extends its recommendation beyond the FDA-approved metastatic disease setting, while its first-line metastatic listing recognizes RASONQUE as a Useful in Certain Circumstances option with the applicable category linked to prescribers' assessments of performance status. While these NCCN placements do not change the FDA-approved indication, they reflect NCCN's independent evaluation of the clinical data for RASONQUE in the context of significant unmet needs among patients with advanced pancreatic cancer.

Based on the totality of clinical evidence, we believe RASONQUE is well positioned to become a new global standard of care option for appropriate patients with advanced pancreatic cancer. This progress indicates significant momentum in our pursuit of bold ambitions in pancreatic cancer through a multi-asset strategy designed to extend RAS(ON) inhibition as the core of treatment in earlier lines of therapy and additional disease settings in which RAS is a key cancer driver.

Recent regulatory designations further underscore the momentum. The FDA granted breakthrough therapy designation for the investigational combination of RASONQUE with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic cancer. In addition, the FDA granted orphan drug designation to zoldonrasib for the treatment of pancreatic cancer. We are conducting 4 additional global Phase III studies across first-line metastatic and adjuvant pancreatic cancer, including programs evaluating 2 distinct regimens in first-line RAS G12D pancreatic cancer. Zoldonrasib plus chemotherapy and the novel RAS(ON) inhibitor doublet of RASONQUE plus zoldonrasib.

While each of these regimens remains investigational, together, they reflect our determination to develop multiple potential best-in-class options for patients across the pancreatic cancer continuum. The growing body of evidence is also beginning to drive impact beyond pancreatic cancer. During the quarter, based on promising Phase I/II clinical evidence for RASONQUE in previously treated RAS-mutant non-small cell lung cancer, the NCC guidelines recommended RASONQUE as a Category 2A available targeted agent for patients with metastatic non-small cell lung cancer harboring KRAS G12, G13 or Q61 mutations.

While RASONQUE remains investigational in non-small cell lung cancer, this is an important treatment recommendation in RAS-mutant non-small cell lung cancer where substantial unmet need remains. Later, Alan will provide an update on RASolve 301, a Phase III study of RASONQUE in RAS-mutant non-small cell lung cancer and our broader development strategy in non-small cell lung cancer. We are highly encouraged that the EMA's Committee for Medicinal Products for Human Use, or CHMP, has also moved rapidly to adopt a positive opinion for daraxonrasib as a monotherapy indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.

For eligible patients in the European Union living with metastatic pancreatic cancer, a disease where profound unmet need persists, this opinion is a major step towards the potential availability of a new targeted medicine. The unprecedented clinical benefit shown in RASolute 302 provides the foundation for this milestone with superior efficacy versus chemotherapy, along with a manageable safety profile and favorable patient-reported outcomes.

Together with the U.S. approval, the CHMP opinion advances our broader ambition to bring the potential benefits of RAS(ON) inhibition to patients around the world. The European Commission decision remains pending. Anthony will discuss the work underway to prepare for country-level access following a potential approval.

With that, I'll turn the call over to Anthony for an update on the initial launch of RASONQUE and our commercial readiness outside the U.S. Anthony?

Anthony Mancini

Thank you, Mark. The U.S. launch of RASONQUE is off to a strong start. At approval, we outlined 3 priorities: enabling health care providers and eligible patients to achieve a positive treatment experience, ensuring broad coverage and seamless patient access with coordinated support and establishing RASONQUE as a new standard of care for eligible patients with metastatic pancreatic cancer.

Early in the launch, we're encouraged by the progress we're seeing against each of these priorities. RASONQUE generated net product revenue of $198 million for the quarter, reflecting more than 5,000 unique patients treated on a commercial basis. As a reminder, FDA approval occurred on August 26, so these results reflect approximately 5 weeks of commercialization activity.

Demand in the quarter reflected 3 components. First, demand included the transition of patients from our U.S. Expanded Access Program to commercial supply. That transition is now complete for U.S. patients continuing treatment. We prioritized continuity of care and successfully supported patients in obtaining their medication through the transition. Second, separate from the Expanded Access Program transition, early commercial demand included a sizable cohort of patients who had exhausted available treatment options at the time of approval and were waiting for a new treatment option, including patients later in their treatment journey.

And third, following approval, we began serving new eligible patients initiating RASONQUE. We're encouraged by the speed with which we were able to begin serving patients following approval, which reflects the significant unmet need in metastatic pancreatic cancer, the strength of RASONQUE's clinical profile and label, the strong launch readiness and initial execution across functions as well as payer engagement and patient support in line with our expectations.

These early results are highly encouraging. At the same time, with only 5 weeks of commercialization activity, it's too early to draw conclusions about the normalized trajectory of the launch. The Expanded Access Program transition and the initial cohort of patients awaiting commercial availability are finite early launch dynamics. As our launch matures, revenue will increasingly reflect ongoing treatment for newly eligible patients and ongoing treatment duration.

We are also pleased by the breadth of early physician engagement with activation across both academic and community oncology settings and health care providers have responded positively to the RASONQUE data, the approved label and the recent NCCN guideline inclusion. Early payer access has been encouraging. We have strong functional access with RASONQUE claims reimbursed across health plans collectively representing greater than 90% of U.S. PDAC covered lives.

Formal coverage policies are still developing for most plans as would be expected this early in the launch. Our field access and (ON)Path patient services teams are fully operational, supporting benefits verifications, coverage navigation, financial assistance and patient support needs. Their work is central to our goal of helping eligible patients start and remain on treatment as seamlessly as possible.

Overall, we're very encouraged by the early launch experience and by the progress we're seeing across key launch priorities. We remain focused on supporting health care providers and eligible patients, ensuring seamless access and coordinated support and establishing RASONQUE as the new standard of care in metastatic pancreatic cancer.

Following the October 15 positive opinion from the Committee for Medicinal Products for Human Use, or CHMP, we are advancing European launch preparations and country-level reimbursement activities in parallel while awaiting the European Commission decision. The RASolute 302 study provides a strong clinical foundation for our European access plans, including work to support the Joint Clinical Assessment or JCA and National Health Technology Assessment, pricing and reimbursement processes.

Launch time lines will depend on regulatory approval and country-specific access requirements. We expect to be ready to launch as these are met. Subject to regulatory approval, we are also advancing launch readiness work in Japan. With that, Jack will provide additional financial information for the quarter later in the call.

I'll now turn the call over to Dr. Alan Sandler.

Alan Bart Sandler

Thank you, Anthony. RASONQUE's approval provides an important foundation for our deep commitment in pancreatic cancer. At the European Society for Medical Oncology Congress, we presented additional RASolute 302 analyses showing that the overall survival benefit with RASONQUE versus chemotherapy was observed consistently across key patient subgroups, including RAS genotype subgroups, prior treatment settings and preselected chemotherapy regimens.

Overall survival is the most clinically meaningful endpoint in metastatic pancreatic cancer, and these findings reinforce the broad clinical relevance of RASONQUE in the previously treated setting. Our strategy in pancreatic cancer extends well beyond the current approved setting, and we are advancing a broad pancreatic cancer development program across first-line metastatic and resectable disease.

Let's begin with RASolute 303, our global Phase III study of RASONQUE monotherapy and in combination with chemotherapy in first-line metastatic pancreatic cancer. I'm pleased to report that U.S. enrollment is now complete, and we expect to complete global enrollment in the first half of 2027. We are also pleased to have begun dosing patients in RASolute 309, our global Phase III study of the novel RAS(ON) inhibitor doublet of RASONQUE plus zoldonrasib in first-line RAS G12D pancreatic cancer. Taken together with the ongoing RASolute 304 study in the adjuvant setting and RASolute 305 evaluating zoldonrasib plus chemotherapy in the first-line setting, these active studies reflect the breadth and pace of our multi-asset pancreatic cancer Phase III development strategy.

At the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics later this month, we will present longer-term follow-up from the Phase I study of the combination of RASONQUE with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic cancer, building on encouraging data previously reported and further characterizing the regimen's clinical activity and safety profile.

As Mark noted, the FDA's breakthrough therapy designation for the combination of RASONQUE with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic cancer is an important regulatory milestone for that program.

Turning to non-small cell lung cancer. We continue to execute a broad strategy designed to address substantial unmet needs across RAS-driven disease. In RASolve 301, our global Phase III study of RASONQUE monotherapy in patients with previously treated RAS-mutant non-small cell lung cancer, we are winding down global enrollment and expect all sites to close enrollment by the end of the month, positioning us for the planned initial Phase III readout in 2027.

During the quarter, Phase I/II data for RASONQUE in previously treated RAS-mutant non-small cell lung cancer were published in the New England Journal of Medicine, providing peer-reviewed support for the program. As Mark noted, the NCCN guidelines also now include RASONQUE as a Category 2A available targeted agent in the emerging biomarkers table for metastatic non-small cell lung cancer with KRAS G12, G13 or Q61 mutations.

RASONQUE remains investigational in non-small cell lung cancer, and we will continue to advance its development through the RASolve 301 study. We are also advancing our broader first-line non-small cell lung cancer strategy with our mutant selective RAS(ON) inhibitors. We have begun dosing patients in RASolve 308, evaluating zoldonrasib in combination with pembrolizumab and platinum-doublet chemotherapy in first-line RAS G12D non-small cell lung cancer.

We have also initiated RASolve 307, evaluating elironrasib in combination with pembrolizumab and platinum-doublet chemotherapy in first-line RAS G12C non-small cell lung cancer. In colorectal cancer, we are encouraged by the strong clinical activity we've seen in a cohort of patients with RAS G12D colorectal cancer receiving first-line treatment with a combination of zoldonrasib, cetuximab and FOLFOX.

We've observed encouraging objective response rates and disease control rates along with an acceptable safety and tolerability profile that is generally consistent with what would be expected for cetuximab and FOLFOX. We'll need longer follow-up to assess durability.

Nevertheless, we believe the initial clinical profile in this very challenging disease merits a global randomized Phase III trial, RASonate 312 comparing the combination of zoldonrasib, cetuximab and investigators' choice of FOLFOX or FOLFIRI with standard of care. We expect to provide a clinical data update from our earlier phase colorectal cancer studies, along with the RASonate 312 trial design in the first half of 2027.

The RASonate 312 trial is being initiated. Under the agreement we announced earlier this year, BeOne is funding and conducting this global registrational Phase III study on our behalf using its global development superhighway. We are steadfast in our commitment to address this important RAS-driven cancer and the needs of this underserved patient population. In our earlier-stage pipeline, RMC-5127, our RAS(ON) G12D selective inhibitor, continues in its first-in-human study. We are in the late stages of identifying a candidate recommended Phase II dose, and we expect to share initial clinical monotherapy data in 2027.

Finally, RM-055, our first mutant targeted catalytic RAS(ON) inhibitor remains on track for initiation of its first-in-human clinical study in the fourth quarter. Taken together, the progress across our pipeline reinforces the breadth of our RAS(ON) platform and our opportunity to build multiple important medicines for patients with RAS-driven cancers. Beyond the programs we sponsor directly, we are collaborating with leading academic institutions and investigators to advance a robust externally sponsored research program.

Studies that Revolution Medicines supports through this program enable independent investigators to explore our RAS(ON) inhibitors in additional scientifically compelling settings and populations with significant unmet medical needs, including but not limited to pancreatic and other gastrointestinal cancers. This program provides another avenue to build evidence across RAS-driven cancers and underscores the breadth of interest in our pipeline.

With that, I'll now turn the call over to Jack.

Jack Anders

Thanks, Alan. The third quarter of 2026 represented our first quarter as a commercial-stage company following the U.S. approval of RASONQUE. RASONQUE generated net product revenue of $197.6 million during the quarter. This reflects a partial quarter and also includes initial stocking of inventory into the channel. We ended the quarter with less than 2 weeks of inventory in the channel and in the long run, expect to manage channel inventory at approximately 2 weeks.

The gross-to-net discount for the quarter came in at the lower end of our anticipated 20% to 30% range. We are early in the U.S. launch, and as payer mix and discounts evolve and mature, we expect the gross-to-net discount to increase within that anticipated range. Cost of sales for the quarter was $0.3 million. This amount should not be viewed as representative of normalized cost of sales as products sold during the quarter includes product manufactured before FDA approval, which was previously expensed to R&D.

Turning to our capital position. We ended the third quarter with $3.7 billion in cash, cash equivalents and marketable securities. This balance does not include an additional $250 million in proceeds received after the quarter relating to the first debt tranche under our funding arrangement with Royalty Pharma.

The approval of RASONQUE triggered 2 separate financing tranches under the agreement, a mandatory first debt tranche, which we received in October and an optional third royalty tranche. We elected not to draw the optional third royalty tranche given our strong cash position as taking the optional tranche would have committed us to pay incremental future royalties under the funding arrangement.

There remains up to an additional $1 billion in committed capital under the funding arrangement, subject to the achievement of specified milestones, all of which is optional and at our election to draw. Our financial position continues to provide the flexibility to support the U.S. launch of RASONQUE, our continued global commercialization build-out and the broad advancement of our RAS(ON) inhibitor portfolio.

Moving to expenses. R&D expenses for the third quarter of 2026 were $417.1 million compared to $262.5 million for the third quarter of 2025. The increase in R&D expenses was primarily driven by higher clinical trial and manufacturing expenses for RASONQUE, zoldonrasib and RMC-5127, increased personnel-related costs due to additional headcount and higher stock-based compensation expense.

SG&A expenses for the third quarter of 2026 were $153.3 million compared to $52.8 million for the third quarter of 2025. The increase in SG&A expenses was primarily driven by higher personnel-related costs associated with additional headcount, higher commercial expenses associated with the RASONQUE commercial launch and higher stock-based compensation expense.

Net loss for the third quarter of 2026 was $407.5 million compared to $305.2 million for the third quarter of 2025. Net loss for the third quarter of 2026 included a noncash charge of $40.7 million related to a change in the fair value of warrants we assumed as part of our EQRx acquisition. This charge related to an increase in our stock price during the quarter.

Turning to financial guidance. We are reiterating our guidance for full year 2026 GAAP operating expenses of $2.1 billion to $2.2 billion. This includes expected noncash stock-based compensation expense of $270 million to $290 million. As we turn to 2027, we expect to increase our investments in advancing our broad RAS(ON) inhibitor portfolio and also expect to increase our commercialization efforts, including expanding our global commercialization infrastructure. While we are not providing a specific range at this time, we do expect full year 2027 GAAP operating expenses to increase from our current GAAP operating expense run rate. That concludes the financial update.

I'll now turn the call back over to Mark.

Mark Goldsmith

Thank you, Jack. Before we open the call for questions, I'd like to briefly highlight 2 collaborations that further support our long-term strategy. During the quarter, we announced a multipart collaboration with BeOne Medicines that expands both our combination development capabilities and our regional commercial reach. The clinical development component will evaluate novel combination approaches involving select BeOne oncology assets and assets from among our 4 clinical-stage RAS(ON) inhibitors, including RASONQUE. Under a separate regional rights agreement, BeOne holds exclusive development and commercialization rights for these 4 assets in select Asian markets.

Importantly, as referenced earlier by Alan, BeOne is also funding and conducting on our behalf, a global registrational Phase III study of zoldonrasib, RASonate 312 in first-line RAS G12D colorectal cancer. This brings significant additional development capability into play as we continue to execute our broad global portfolio strategy. In October, we also entered into clinical collaborations with Bristol Myers Squibb to evaluate pumitamig, an investigational PD-L1/VEGF bispecific antibody in 4 planned early-stage combination study cohorts across our portfolio of RAS(ON) inhibitors.

Pumitamig is an investigational PD-L1/VEGF bispecific immunomodulator jointly developed by BioNTech and Bristol Myers Squibb. The planned cohorts include RASONQUE in non-small cell lung cancer and pancreatic cancer, elironrasib in non-small cell lung cancer and zoldonrasib in colorectal cancer. We will provide additional details as the cohorts are initiated.

Our collaboration with Summit on ivonescimab, the first member of this class of bispecific inhibitors to enter clinical development remains fully active and productive. Together, these collaborations are components of our larger deliberate strategy to build development capacity, expand the reach of our medicines and evaluate rational combinations that may further improve outcomes for patients with RAS-addicted cancers.

Stepping back, we are proud of the robust activities and broad progress spanning all aspects of our discover, develop and deliver model on behalf of patients. That includes an encouraging initial phase of the U.S. commercial launch of RASONQUE with its compelling product profile, addressing serious unmet needs with strong progress toward entering international markets. A broad portfolio of pivotal trials with our first 3 clinical RAS(ON) inhibitors in 3 major RAS-driven tumor types, the RASolute Phase III series in pancreatic cancer, the RASolve Phase III series in non-small cell lung cancer and the RASonate Phase III series in colorectal cancer.

Exciting clinical collaborations exploring additional combination strategies as well as external research pushing the boundaries, building clinical momentum with our fourth RAS(ON) inhibitor and a pending first-in-human study of our fifth that represents a new class of inhibitors. And a maturing collection of innovative preclinical programs and assets that are continuously informed by our vast scientific and clinical experience in RAS-driven cancers.

Looking ahead, our priorities are clear: deliver RASONQUE with urgency to eligible U.S. patients with metastatic pancreatic cancer and prepare for potential commercial availability in Europe and Japan; advance our multi-asset clinical development strategy across pancreatic cancer, non-small cell lung cancer, colorectal cancer and other RAS-driven cancers; deliver the next wave of clinical milestones, including an update on our colorectal cancer program while continuing to advance our earlier-stage RAS(ON) pipeline.

RASONQUE's approval and launch mark a monumental step forward for patients living with RAS-dependent cancers and open an important new chapter for Revolution Medicines. With this momentum, we continue our deep commitment to discovering, developing and delivering innovative targeted medicines with the urgency patients deserve.

With that, I'll turn the call over to the operator for questions.

Operator

[Operator Instructions] Our first question comes from Charles Zhu at LifeSci Capital.

질의응답

Yue-Wen Zhu

Congratulations on your first partial quarterly sales and on all the progress as always. Maybe first on that quarterly sales figure. Are you able to provide some, sort of, high-level breakdown of some commercial patients, whether it's by line of therapy, dynamics related to treatment beyond progression? Basically, how has duration of treatment looked in the real world relative to your experience with RASolute 302 and the EAP?

Mark Goldsmith

Thanks a lot, Charles. Anthony?

Anthony Mancini

Yes. Thanks for the question, Charles. I think as I described in my prepared remarks, there are really 3 cohorts of patients described in the demand in this early phase, the EAP patients, several -- a good percentage of those EAP patients will have received several months of therapy before transitioning to commercial product. The patients who had exhausted available treatment options who are really awaiting an approved treatment. Those 2 treatment cohorts are finite as we outlined. We're not providing detail -- the detailed breakdown of those.

But what we can say is that a meaningful portion of those initial patients are later-stage patients that are lower performance status and as a result, may have shorter treatment durations. The third cohort, though, that we described really would represent, kind of, more of a normal demand trajectory. So they're really newly eligible patients on RASONQUE following approval, and we expect to see duration of therapy follow a duration that's more in line with our expectations in the clinical trial.

I think I'll leave it there, Charles. Thanks for the question.

Operator

Our next question comes from Tyler Van Buren at TD Cowen.

Tyler Van Buren

Congratulations on a historic first-month sales result. As we think about the trajectory for patients going on RASONQUE therapy moving forward and the over 5,000 patients starting commercial treatment, can you help us quantify, I guess, the amount of stocking in the $198 million sales number?

Jack Anders

Thanks for the question, Tyler. We said in our prepared remarks that the channel inventory, which is the stocking. We ended the quarter with less than 2 weeks of inventory in the channel. And on a go-forward basis, more long term, we'd expect to manage that level at around 2 weeks.

Operator

Our next question comes from Michael Schmidt at Guggenheim.

Michael Schmidt

Congrats on all the momentum in recent months. I had a question on colorectal cancer. So exciting to see the RASonate 312 study up and running now in frontline CRC with zoldonrasib. And I'm just curious how you think about the colorectal cancer opportunity in a broader sense. Do you see opportunity, for example, for a chemo-free option similar to what you're doing in pancreatic cancer? And how do you think about addressing some of the other KRAS mutation subsets longer term?

Mark Goldsmith

Yes. Thanks, Michael. I think that the scope of our CRC program will evolve over time. We're very committed to colorectal cancer. And so the 312 study is really just the first. We certainly don't expect it to be the last of the late-stage development programs. All of those decisions will be data-driven as the 312 study was as well. So I'd just say stay tuned. This is an area that will require significant investment over time. We'll continue to generate data across various combination strategies.

With regard to mutations beyond G12D, we certainly have high interest even though G12D is the most common mutation in colorectal cancer, G12V is the second most common. And of course, RMC-5127 is working its way through the dose escalation and RP2D evaluation. So stay tuned. We'll be working to cover as much of the colorectal cancer space as we can and to move -- to keep working towards early lines of therapy in order to have the greatest impact on behalf of patients.

Operator

Our next question comes from Andrea Newkirk at Goldman Sachs.

Andrea Tan

Congratulations on the quarter. I'm just curious if you're able to share how uptake has been split across community oncology networks versus the academic centers. And have you noticed any differences in prescribing velocity across the 2 settings?

Mark Goldsmith

Thank you, Andrea. Nice to have you back, Anthony?

Anthony Mancini

Yes. Thanks for the question, Andrea. We're really encouraged by the breadth of interest and the early uptake across both the academic cancer centers and the community oncology practices. But what I'll add is approximately 2,700 unique health care providers prescribed RASONQUE in the quarter. And the utilization across the academic and community settings was representative of the overall patient volume. So it was about a 40% academic contribution and about a 60% community contribution.

So we're really pleased with that. Our focus is to continue to educate health care providers and particularly as we build familiarity in the community practice, our goal is to create a positive patient and customer experience. And that really is all about understanding the label, understand the safety profile and really being aware of all the resources available to help eligible patients start on RASONQUE and stay on RASONQUE.

Operator

Our next question comes from Cory Kasimov at Evercore ISI.

Cory Kasimov

Yes, definitely great to see such an impressive start to the launch. So I -- look, I understand this might be tough to answer. I want to ask about the launch maybe from a different angle. But again, with over 5,000 patients receiving commercial RASONQUE in the first 5 weeks, can you, kind of, at least qualitatively comment on what you're seeing in October that might be able to help distinguish the initial backlog from, kind of, sustainable new patient demand?

Mark Goldsmith

I'll ask Anthony to deliver the disappointing news.

Anthony Mancini

No, Cory, thanks for the question. I think we're 5 weeks into the launch in the quarter. One of the things that has happened in October is the EAP program has officially wound down. And so we know that all of our EAP transitions have been completed by the end of this month. I think adding additional color probably at this time without the full quarter probably isn't going to be a helpful exercise. So we'll leave it there.

Operator

Our next question comes from Sean Laaman at Morgan Stanley.

Hyunji Sun

This is Katherine on for Sean. Congrats on the strong start to launch. Given that it's early, but could you please share some feedback you've been hearing about RASONQUE tolerability in the real world now that use is moving more into the community? Do you have any feedback on how physicians are managing the toxicities with either the prophylaxis or the education materials you mentioned? Any color here would be appreciated.

Mark Goldsmith

Is there anything that you want to comment on there? Anthony? Do you want to start and I'll...

Anthony Mancini

Maybe I'll comment in general that our experience thus far has been very positive. We have spent a considerable focus and attention on ensuring the education around our adverse event profile. So far, so good is what I would say. I think our plans are coming to fruition. The reactions have been positive to date. But again, it's very early. So we're really focused on ensuring a positive customer experience. And so far, so good is what I would say. There's really not a lot to add at this point, but I'll have a lot more to report with a full quarter [indiscernible] . Thanks for the question.

Operator

Our next question comes from Brian Cheng at JPMorgan.

Lut Ming Cheng

Congrats on the first print, very impressive out of the gate. You talked about NCCN guideline has a very broad usage recommendation, including locally advanced patients. I'm curious if you're starting to see that in this initial wave that you're seeing? And then second, on colorectal. I think you talked about how BeOne will be funding and conducting the study on RevMed's behalf. Can you provide a little bit more color on that decision to lean on BeOne here? Why not just run the colorectal data -- colorectal trial yourself?

Mark Goldsmith

You want to comment on the NCCN?

Anthony Mancini

Yes. Thanks, Brian, for the question. Right now, what I can comment on is that the majority of patients that we're seeing are metastatic PDAC patients that are previously treated. At this point, given their small numbers, I mean, there likely are some locally advanced patients and some frontline patients, but it's the majority is certainly in the later stages at this point.

Mark Goldsmith

Yes, Brian, with regard to CRC, I think your question related to the funding and conduct of the 312 trial and why BeOne. Well, we established a relationship with them earlier this year, a multipart collaboration. And part of that collaboration included their commitment of the resources, the person power, the global footprint to conduct one Phase III trial on our behalf and at their cost, which was essentially in exchange for certain commercial rights that they would obtain.

So this is simply part of a multilevel collaboration. It's an economic benefit to us, but it also takes advantage of a very high-quality global development capability that complements ours. We have similarly been developing that capability, but this adds bandwidth and it frees up our internal resources to continue to conduct other studies and to open up new lines of investigation. So it's a win for us, and we're very pleased and actually quite excited that they're moving forward with it, and they're initiating that study as we speak.

Operator

Our next question comes from Faisal Khurshid at Jefferies.

Faisal Khurshid

I wanted to ask -- so there's other companies in the space, those that have G12D inhibitors that have said that they think they can support filing in frontline pancreatic cancer based on overall response rate. Could I ask you to comment on this and whether this is a strategy you think that you can pursue with your frontline pancreatic studies?

Mark Goldsmith

Yes. Thanks a lot. Well, I guess there's a 2 parts. Is that a question we -- is that an opportunity we could pursue or want to pursue? Or are we pursuing it? Alan?

Alan Bart Sandler

Yes. Thanks for the question. So I think there's a number of different ways to, again, look at drug development. And of course, overall survival remains the most clinically meaningful endpoint and most important the overall benefit risk. And what I'd also like to say, this was established, of course, in RASolute 302 with RASONQUE. Importantly, RASolute 303, 305 and 309 already include PFS and OS as dual primary endpoints. So these are also well underway in their conduct.

With respect to ORR, it's certainly unclear that, that is an endpoint that can stand on its own and typically, historically has always been associated with an additional durability endpoints such as PFS and OS, which I just commented upon and stated that our studies have already incorporated that in. So I think we have a very robust approach, and we'll be in discussions with the FDA appropriately as data comes forward.

Operator

Our next question comes from Michael Yee at UBS.

Michael Yee

I was going to ask on November sales, but I think you're not going to talk to that, Mark. It's been a weekend in November. But instead, actually, there's a lot of development going on in PRMT5. You make a bunch of comments at the bottom about how you have collaborations. And also in August, you did one with BeOne.

Can you maybe just talk a little bit about the different assets that you're partnering with? And how to think about that since that is a big part of pancreatic? Pan-RAS, obviously, is the, sort of, the backbone and how we should think about whether you could either bring one in or just choose to collaborate and hopefully, all the different companies have a different shot at it.

Mark Goldsmith

Yes. Thank you, Michael. Well, we certainly recognize the encouraging clinical data that were generated by Tango as has the field that essentially provides proof of concept for the field. And I think there's no doubt that there will be continued investigation of PRMT inhibition in combination with RAS multi inhibitors or various other, I mean, selective inhibitors. And we certainly share the goal of advancing promising regimens for patients as quickly as possible.

As you point out, we're currently evaluating 3 PRMT5 inhibitors. We had 4. One of those was from Amgen. That program was discontinued, but we now have 3, Tango, of course, BMS and BeOne -- and each of those has a somewhat different profile. I don't think it's -- would be meaningful for me today to try to highlight what those features are because that will ultimately be proven out through extensive clinical evaluation in the combinations. But they do have distinct pharmacologic features, and we'll see how all of that goes.

We think it's very attractive and very serving of patients' interest to have those multiple studies underway for us to have an opportunity to see how they all perform relative to each other. As to whether or not we would bring in a PRMT5 inhibitor into our shop, well, I guess, first, I probably wouldn't tell you if that's something we did want to do, and I wouldn't tell you if that's something we didn't want to do. So I just really can't answer that. We do think that the community, the world is being served by the studies that are underway now, but that would ultimately just be a business or strategic question for us to make at any given point in time.

Operator

Our next question comes from Asthika Goonewardene at Leerink.

Asthika Goonewardene

My congratulations as well for an outstanding quarter here. Just to tag on to Brian's question, can you talk to us a little bit about maybe the restrictions that the payers may be putting up against off-label but [ on-compendia ] use? And if I can also ask, are community centers dealing with the prior authorizations and the restrictions as well as the academic counterparts?

Mark Goldsmith

Okay. Thanks for those questions. Anthony?

Anthony Mancini

Yes. Thanks, Asthika, for the questions. So far, look, as we said, there have been reimbursed claims across health plans that collectively represent greater than 90% of U.S. PDAC covered lives. What that means is really we have strong functional access and patients are gaining access through established payer review processes. So medical exception prior auth in advance of formal coverage policies. Now we have a full field-based reimbursement team that's assisting both the academic setting and the community setting with navigating those things.

That's going really, really well. But in this period of time before formal coverage policies, it's -- there are claims that are reimbursed that may not get reimbursed post coverage policies. It's just a period of time that in -- that we're in right now. But this is what we've expected, and we expect to continue to work on ensuring that the various payers have what they need at P&Ts that are coming up. But yes, there's no big differences, and we're not seeing anything unexpected at this point, Asthika.

Operator

Our next question comes from Jay Olson at Oppenheimer.

Jay Olson

Congratulations on a stellar launch. Could you describe any trends you're seeing in the typical profile of patients who were treated with RASONQUE in the first-line setting? And any anecdotal feedback from prescribers on how patients are responding to therapy? And maybe how those responses might influence their future decisions about treating patients in the first-line setting.

Mark Goldsmith

Jay, those are great questions. I think it's just too early to have any information that would be meaningful at this point. I think as we see more patients treated over time and for longer duration, I think those sorts of concepts will start to emerge.

Operator

Our next question comes from Gregory Renza at Truist Securities.

Gregory Renza

Mark, congrats on an excellent quarter. I just wanted to ask on the PD-1/VEGF strategy and perhaps on the partner breadth that you're pursuing. And maybe at first blush, the Bristol collaboration may appear in maybe greater scope than perhaps the ivonescimab combo.

I just wanted to ask how this, sort of, fits into the broader strategy? And if you could just comment on the scope that we are maybe observing on the Bristol versus the ivonescimab collaboration.

Mark Goldsmith

Yes. Thanks, Greg. I'm not sure that that's -- that we would necessarily see it that way. They're both pretty broad collaborations. There's both high interest by both of those parties. These compounds are not identical, of course. One is focused on PD-1 -- on the PD-1 axis and the other is a PD-L1 component on the PD-1 axis. Those may or may not have differences. I just think it's just far too early to tell. And we're excited to be -- we were the first to be combining RAS inhibitors with a bispecific.

Now we're the second to be combining RAS inhibitors or RAS(ON) inhibitors specifically with the bispecific. And this is part of a broad approach. We've got a very big footprint in the field in the industry now. And this is the best way for us to maximize assessment of the potential value of our compounds in various context in these very important diseases.

Operator

Our next question comes from Laura Prendergast at Stifel.

Laura Prendergast

Congrats on the very exciting start to the launch. I just want to get some expectations for upcoming data sets. First, what should we expect from the late-breaker abstract at Triple ENA meeting? Could we get PFS, OS Kaplan-Meier curves here? And then as far as the colorectal cancer data in first half of '27, will this strictly be supportive of the regimen you're bringing forward in this BeOne collaboration trial? Or would we maybe see a broader array of CRC data you've generated here?

Mark Goldsmith

Yes. Thank you, Laura. Generally, we don't give that level of resolution of guidance about future disclosures. I think Alan already pointed out in his prepared remarks that the ENA presentation would, kind of, reinforce the -- our understanding of the profile of that combination as to what exactly will be included. That's something that will be revealed when the presentation is made.

And similarly, with CRC, I think that our commitment has always been that we would provide the data supporting a decision to move forward. And sometimes we provide those data well ahead of initiating trials. Sometimes we provide it right at the time of launching a trial. And in this particular case, we'll provide it a little bit after the initiation of the trial. But as to exactly what's the scope of that disclosure, unfortunately, it's our practice not to -- and as you know, we've had this conversation before, it's our practice not to preview that in advance.

Operator

Our next question comes from Alex Stranahan at Bank of America.

Alec Stranahan

Big congrats on the early uptake and excited to see where the launch goes from here. Just on that 20% to 30% gross-to-net with the early dynamics being towards the low end of the range, like you said, I guess, could you talk about how payer mix is tracking versus your expectations? And which segments are maybe expected to grow as you see that gross-to-net normalizing over time?

Jack Anders

Yes. So we did note that we expect it to increase within that range as the payer mix and discounts, kind of, evolve and mature. I would say largely from an expectation perspective on a go-forward basis, as we think about, kind of, channel discounts, those are the ones that we would probably expect a little bit more to affect the gross-to-net discount. So we're talking [ 340B ], some potential distribution fees that we may be paying within the channel. But so that's how we're thinking. It's still very, very early in the launch, and we'll get more information as we go along, but that's, kind of, our -- how we're viewing it at this time.

Operator

Our last question comes from Sean McCutchen at Raymond James.

Sean McCutcheon

I'll send my congrats as well. We've continued to hear chemo-free therapy -- a chemo-free regimen is a priority for KOLs. Can you speak to the strategic import of a chemo-sparing frontline regimen in PDAC for you? And one of your competitors, your G12D competitors announced plans for an arm of their frontline study combining with EGFR antibody. I'd love to get your thoughts on how you're positioned with the dual RAS approach in that context.

Mark Goldsmith

Yes. Well, maybe I'll make a conceptual comment and then just a concrete point. The conceptual comment is that I think it's unclear, and we've had this position for several years now, whether an early chemo-free approach ultimately delivers the greatest long-term benefit or whether combining with chemo would deliver more value. We're very neutral on this point. And I think it's a debate that's been around in the oncology field for a long time, and it comes down to, sort of, just empirically evaluating it. There's no theoretical way to differentiate or to rank or prioritize those.

I think the second comment is, I think we've got the first chemo-free first-line regimen and the second first-line chemo-free regimen already well underway. The 303 trial already has an arm that's daraxonrasib alone. And even though the FDA has already approved, daraxonrasib for first-line use under -- when it's at the discretion of physicians based on candidacy for other treatments. So that's one.

And then secondly, we've combined daraxonrasib with zoldonrasib in our 309 trial, and that is moving forward as well. So we're evaluating that. We're evaluating in combination with chemo. We're evaluating daraxonrasib in combination with chemo, zoldonrasib in combination with chemo. I think we've got a lot going on there, but it's still TBD how those will all perform relative to each other.

Operator

This concludes the question-and-answer session. I would now like to turn it back to Mark for closing remarks.

Mark Goldsmith

Well, thank you, operator, and thank you to everyone who joined us today and for your continued interest in Revolution Medicines. We appreciate the continued support of our shareholders, collaborators, investigators and above all, the patients and families we serve.

Operator, you may now conclude the call.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.