Revolution Medicines — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net product revenue was $197.6 million for the quarter ended September 30, 2026, compared to $0 in the same period in 2025, reflecting approximately five weeks of commercial availability following FDA approval.
• Cost of sales was $0.3 million for the quarter, noted as not representative of normalized costs due to inventory manufactured prior to approval being expensed to R&D previously.
• Research and development expenses were $417.1 million for the quarter, an increase from $262.5 million in the prior year period, driven by higher clinical trial and manufacturing expenses, increased personnel costs, and higher stock-based compensation.
• Selling, general and administrative expenses were $153.3 million for the quarter, an increase from $52.8 million in the prior year period, driven by higher personnel costs, commercial launch expenses, and stock-based compensation.
• Net loss was $407.5 million for the quarter, compared to a net loss of $305.2 million in the prior year period; the current quarter included non-cash charges of $40.7 million related to a change in the fair value of warrants assumed from the EQRx acquisition.
• Cash, cash equivalents, and marketable securities were $3.7 billion as of September 30, 2026, excluding $250 million in proceeds received in October from a Royalty Pharma debt tranche.
• Total assets were $4.3 billion as of September 30, 2026, compared to $2.35 billion as of December 31, 2025.
• Total liabilities were $1.9 billion as of September 30, 2026, compared to $723.2 million as of December 31, 2025.

Guidance and Future Outlook:

• The company is reiterating full-year 2026 GAAP operating expense guidance of $2.1 billion to $2.2 billion, including expected non-cash stock-based compensation expense of $270 million to $290 million.
• Global enrollment for the Phase 3 trial RASolute 303 is expected to be completed in the first half of 2027.
• The company expects to report initial clinical monotherapy data for RMC-5127 in 2027.
• The company plans to initiate a first-in-human clinical trial for RM-055 in the fourth quarter of 2026.
• A clinical data update for colorectal cancer studies and the RASonate 312 trial design is expected in the first half of 2027.

Business Segments and Product Lines:

• RASONQUE (daraxonrasib) received U.S. FDA approval on August 26, 2026, for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
• More than 5,000 unique patients received commercial RASONQUE in the U.S. from FDA approval through September 30, 2026.
• RASONQUE claims have been reimbursed across health plans representing greater than 90% of U.S. PDAC covered lives.
• The NCCN Guidelines were updated to include RASONQUE as a Category 1 Preferred subsequent-therapy option for appropriate patients with locally advanced or metastatic pancreatic cancer.
• The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of daraxonrasib in the European Union for metastatic pancreatic cancer.
• The FDA granted Breakthrough Therapy Designation for the investigational combination of daraxonrasib with gemcitabine and nab-paclitaxel for treatment-naïve metastatic pancreatic cancer.
• The FDA granted Orphan Drug Designation to zoldonrasib for the treatment of pancreatic cancer.
• Global enrollment in RASolve 301 (daraxonrasib in previously treated RAS mutant NSCLC) is winding down with site closures expected by the end of November 2026.
• The company initiated RASolve 307, a global Phase 3 trial evaluating elironrasib in treatment-naïve metastatic RAS G12C NSCLC.
• The company initiated RASonate 312, a global Phase 3 trial evaluating zoldonrasib combinations in treatment-naïve metastatic RAS G12D colorectal cancer, funded by BeOne Medicines.
• Enrollment continues for RMC-5127, an oral RAS(ON) G12V-selective inhibitor, with a recommended Phase 2 dose selection nearing completion.

Market and Competitive Landscape:

• RASONQUE is the first targeted medicine in a Phase 3 trial in metastatic pancreatic cancer to demonstrate superior efficacy versus chemotherapy, showing an unprecedented survival benefit.
• RASONQUE consistently provided an overall survival benefit compared with chemotherapy across all evaluated RAS genotype subgroups, including those with no identified tumor RAS mutation.
• The company is advancing a broad portfolio of RAS(ON) inhibitors targeting RAS G12C, G12D, and G12V, which together account for more than 70% of RAS mutant NSCLC.
• The company is building international leadership teams with country general managers in place across key European markets, Canada, and Japan.

Risks and Challenges:

• Early launch dynamics, including the transition of patients from the U.S. Expanded Access Program and initial inventory stocking, are finite and third-quarter results should not be viewed as indicative of the launch's longer-term trajectory.
• European Commission approval and subsequent country-level pricing, reimbursement, and access processes remain pending.
• Commercialization capabilities in Europe, Canada, and Japan are still being scaled.
• Forward-looking statements regarding clinical trial timelines, regulatory approvals, and commercial success are subject to substantial risks and uncertainties, including development stage risks, regulatory approval processes, and manufacturing challenges.

Management Commentary and Tone:

• CEO Mark A. Goldsmith described the U.S. approval and launch of RASONQUE as a "monumental step forward" and a "transformational quarter."
• Management stated they are focused on delivering RASONQUE with urgency and supporting patients while rapidly scaling global commercialization capabilities.
• The company elected not to draw the optional third royalty tranche of $250 million under the Royalty Pharma arrangement due to its strong financial position, though up to an additional $1 billion remains available subject to milestones.

Other Key Points:

• The company announced a multi-part collaboration with BeOne Medicines, including a clinical development collaboration and a regional rights agreement granting BeOne exclusive development and commercialization rights to four clinical-stage RAS(ON) inhibitors in select Asian markets.
• The company entered into clinical collaborations with Bristol Myers Squibb to evaluate pumitamig in four planned early-stage combination study cohorts.
• RASONQUE's U.S. approval triggered the mandatory first debt tranche of $250 million under the Royalty Pharma funding arrangement, with proceeds received in October 2026.
• The company completed U.S. enrollment in RASolute 303, the global Phase 3 trial evaluating daraxonrasib in treatment-naïve metastatic pancreatic cancer.
• The company advanced RASolute 304, the global Phase 3 trial evaluating daraxonrasib in the adjuvant setting.
• The company began treating patients in RASolute 309, the global Phase 3 trial evaluating the RAS(ON) inhibitor doublet of daraxonrasib plus zoldonrasib in treatment-naïve metastatic RAS G12D pancreatic cancer.
• The company began treating patients in RASolve 308, the global Phase 3 trial evaluating zoldonrasib in combination with pembrolizumab and platinum doublet chemotherapy in treatment-naïve metastatic RAS G12D NSCLC.