Revolution Medicines(RVMD)
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Revolution Medicines(RVMD) - 2024 Q1 - Quarterly Results
2024-05-08 20:05
Exhibit 99.1 Revolution Medicines Reports First Quarter 2024 Financial Results and Update on Corporate Progress Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time REDWOOD CITY, Calif., May 8, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter ended March 31, 2024, and provided an update on corporate progress. The comp ...
Revolution Medicines(RVMD) - 2023 Q4 - Earnings Call Transcript
2024-02-27 03:45
Financial Data and Key Metrics Changes - The company ended 2023 with $1.85 billion in cash and investments, expected to fund operations into 2027 [18] - Collaboration revenue for Q4 2023 was $0.7 million, down from $15.3 million in the prior year quarter, and full-year revenue was $11.6 million compared to $35.4 million in the previous year [19] - Total operating expenses for Q4 2023 increased to $180.7 million, driven by R&D expenses totaling $148.5 million, while full-year operating expenses reached $498.8 million [26] - The net loss for Q4 2023 was $161.5 million, or $1.14 per share, and for the full year, the net loss was $436.4 million, or $3.86 per share [27][28] Business Line Data and Key Metrics Changes - The company reported favorable trends in aggregate objective response rates (ORR) for RMC-6236 in non-small cell lung cancer, reaching the low to mid-40s range, and in pancreatic ductal adenocarcinoma, trending into the mid-20s [12][13] - RMC-9805, an oral G12D selective inhibitor, has confirmed oral bioavailability in patients, with no dose-limiting toxicities reported [16][17] Market Data and Key Metrics Changes - The company is expanding the reach of RMC-6236 to include patients with tumors harboring RAS mutations beyond G12X, including G13X and Q61X mutations, and studying it in various tumor types beyond lung and pancreatic cancer [14] Company Strategy and Development Direction - The company has three strategic priorities for 2024: advancing RMC-6236 into pivotal trials, expanding its reach, and qualifying RMC-6291 and RMC-9805 for late-stage development [11][15] - The company aims to propel RMC-6236 into its first pivotal trial against standard-of-care chemotherapy for RAS-mutated non-small cell lung cancer and pancreatic ductal adenocarcinoma [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong balance sheet and pipeline, emphasizing the commitment to developing targeted therapies for patients with RAS-addicted cancers [24][29] - The company anticipates disclosing initial clinical data for RMC-6236 and its combinations in the second half of 2024, with a focus on safety and efficacy [15][40] Other Important Information - The company reported that the increase in expected GAAP net loss for 2024 is due to increased expenses associated with ongoing clinical development programs [28] - Management highlighted the importance of establishing a safety profile for combinations with checkpoint inhibitors before moving into first-line treatment settings [33] Q&A Session Summary Question: What data is needed to move combinations with pembrolizumab into pivotal development? - Management is primarily looking to validate safety, particularly concerning hepatotoxicity signals [33] Question: How much more data is needed to support initiation of Phase 3 trials for RMC-6236? - A mature progression-free survival (PFS) assessment is required, along with FDA input [39] Question: What are the gating steps for starting a frontline pancreatic combination study? - The company is exploring combinations with standard regimens like modified FOLFIRINOX and gem-ABRAXANE, focusing on response rates and survival benefits [54] Question: What is the primary endpoint for the Phase 3 trial in second-line pancreatic cancer? - The current thinking is to evaluate both PFS and overall survival (OS) as endpoints [64] Question: What indications should be expected for data updates from expansion cohorts? - Data will be provided for various RAS genotypes and tumor types, including colorectal cancer, in the second half of the year [72] Question: How does the company view partnering opportunities? - The company aims to build its own franchise in the U.S. but is open to partnerships outside the U.S. for commercialization [100][102]
Revolution Medicines(RVMD) - 2023 Q4 - Annual Report
2024-02-26 21:08
RAS(ON) Inhibitors Development - The company is developing a pipeline of RAS(ON) inhibitors, including RMC-6236, RMC-6291, and RMC-9805, which are designed to target RAS-addicted cancers[24][40]. - RMC-6236 demonstrated dose-dependent increases in exposure and reductions in circulating tumor DNA (ctDNA) variant allele frequency, indicating anti-tumor activity[26]. - Preliminary evidence of clinical activity for RMC-6236 was observed in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) patients[27]. - The company expects to disclose updated clinical data for RMC-6236 in NSCLC and PDAC in the second half of 2024[29]. - RMC-6291 showed preliminary evidence of clinical activity in KRAS G12C NSCLC and colorectal cancer patients, with a correlation between ctDNA reduction and clinical response[36]. - The company plans to initiate a global randomized Phase 3 trial for RMC-6236 against docetaxel in RAS-mutated NSCLC patients in the second half of 2024[32]. - RMC-9805 demonstrated oral bioavailability and favorable tolerability results, with no dose-limiting toxicities reported[41]. - The company is pursuing pipeline expansion programs focused on additional RAS mutations, including G12R[43]. - RAS proteins drive 30% of human cancers, and the company's RAS(ON) inhibitors aim to address the unmet need in this area[49]. - The company believes its RAS(ON) inhibitors have the potential to deliver deeper anti-tumor activity and more durable clinical benefits compared to existing therapies[50]. - RAS mutant variants account for approximately 30% of all human cancers in the U.S., with an estimated 213,000 new RAS-mutant cancer diagnoses annually, indicating a significant market opportunity for RAS inhibitors[52]. Clinical Trials and Efficacy - The company is advancing RMC-6236 into Phase 3 pivotal studies, with plans for two monotherapy registration studies in second line NSCLC and PDAC, pending regulatory input[53]. - RMC-6236 is currently in a Phase 1/1b clinical study with 131 patients treated across nine dose cohorts (10 mg to 400 mg daily), showing it was generally well tolerated[60]. - The most common treatment-related adverse events (TRAEs) in the RMC-6236 study included rash (70%), nausea (42%), and diarrhea (32%), primarily Grade 1 or 2 in severity[63]. - As of the October 12, 2023 data cut-off, RMC-6236 demonstrated dose-dependent increases in exposure, with clinical exposures at doses of 80 mg and above comparable to those inducing tumor regressions in preclinical models[67]. - The company reported molecular responses in 27 patients with detectable baseline plasma KRAS G12X alleles, with reductions in KRAS variant allele frequency consistent with anti-tumor activity[67]. - RMC-6236 is designed as a potent, oral, RAS-selective tri-complex inhibitor targeting multiple RAS(ON) variants, including G12, G13, and Q61 mutations[58]. - The median duration of treatment for RMC-6236 was 2.1 months (range: 0.2–10.9) as of the latest data cut-off[70]. - RMC-6236 demonstrated an objective response rate (ORR) of 38% among efficacy-evaluable NSCLC patients, with a disease control rate (DCR) of 85%[79]. - Among efficacy-evaluable PDAC patients, the ORR was 20%, with a DCR of 87%[83]. - RMC-6291 showed a generally well-tolerated profile, with the most common TRAEs being diarrhea (29%) and nausea (27%) across 63 patients[89]. - In the RMC-6291 study, 50% of NSCLC patients previously treated with a KRAS(OFF) G12C inhibitor achieved a partial response[96]. - RMC-6291 demonstrated dose-dependent plasma pharmacokinetics and reduction in ctDNA of the KRAS G12C allele correlated with clinical response[92]. - As of the latest data cut-off, RMC-6291's ORR among efficacy-evaluable CRC patients naïve to KRAS(OFF) G12C inhibitors was 40%[102]. - RMC-6236 showed preliminary evidence of clinical activity in patients with KRAS mutations G12D, G12V, or G12R[74]. - The 300 mg daily dose of RMC-6236 appeared attractive for safety and antitumor activity in both NSCLC and PDAC settings[86]. - RMC-9805 showed deep tumor regressions and complete responses in preclinical studies across NSCLC, PDAC, and CRC models with KRAS G12D mutation[105]. Regulatory and Market Considerations - The company plans to retain significant development and commercialization rights for its product candidates and build necessary infrastructure over time[124]. - The FDA requires substantial time and financial resources for obtaining regulatory approvals, impacting the company's operational timeline[144]. - The NDA submission process includes a user fee, which is substantial unless a waiver applies[153]. - The FDA aims to review standard applications within 10 to 12 months and priority applications within 6 to 8 months[155]. - The FDA may require a risk evaluation and mitigation strategy (REMS) program as a condition of NDA approval[159]. - Post-approval testing and surveillance are required to monitor the drug's safety and efficacy, which may affect marketing[160]. - The company intends to pursue orphan drug designation for certain oncology indications, which could lead to orphan drug exclusivity if approved[167]. - The FDA may grant orphan designation to drugs intended for rare diseases affecting fewer than 200,000 individuals in the U.S.[168]. - Orphan drug exclusivity provides a seven-year market protection for the first FDA-approved drug for a specific disease, with certain exceptions[169]. - The company plans to seek fast track designation for product candidates aimed at serious diseases, allowing for more frequent interactions with the FDA during development[162]. - Breakthrough therapy designation may be pursued for products showing substantial improvement over existing therapies, enhancing FDA guidance and support[163]. - Priority review for NDAs can shorten the FDA's review time to six months if the product shows significant improvement over existing treatments[164]. - Accelerated approval may be granted based on early evidence of clinical benefit, but requires confirmatory studies post-approval[165]. - Pediatric exclusivity can extend existing exclusivity periods by six months if a pediatric study is completed as requested by the FDA[172]. - The company must comply with ongoing FDA regulations post-approval, including marketing only for approved indications and maintaining compliance with cGMP[173][174]. - International regulatory compliance is necessary for marketing products outside the U.S., with varying requirements across countries[178]. - In the EU, new products authorized for marketing receive eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization (MA)[188]. - The overall market exclusivity period can be extended to a maximum of 11 years if the MA holder obtains authorization for new therapeutic indications during the first eight years[189]. - Orphan medicinal products are entitled to ten years of market exclusivity upon MA, which can be extended by two years if an agreed pediatric investigation plan (PIP) is complied with[191]. - The orphan exclusivity period may be reduced to six years if the product no longer meets the criteria for orphan designation by the end of the fifth year[192]. - The UK regulatory framework for clinical trials is derived from existing EU legislation, with changes introduced by the MHRA to streamline approvals and enhance transparency[196]. - The MHRA has implemented a 150-day assessment and a rolling review procedure to prioritize access to new medicines in the UK[195]. Financial and Market Dynamics - The company faces competition from major pharmaceutical and biotechnology companies, as well as academic institutions and research organizations[127][128]. - The availability of coverage and reimbursement will significantly affect the pricing and competitiveness of the company's products[133]. - The company has increased the minimum level of Medicaid rebates from 15.1% to 23.1% under the ACA, impacting pricing strategies[211]. - The Inflation Reduction Act (IRA) requires price negotiations for certain drugs with Medicare starting in 2026, affecting future revenue[211]. - Coverage and reimbursement for pharmaceutical products depend on third-party payors, with significant uncertainty regarding the coverage status of newly approved products[205]. - Third-party payors are increasingly reducing reimbursements and implementing cost-containment programs, which could limit sales of pharmaceutical products[207]. - In international markets, reimbursement systems vary significantly, with many countries instituting price ceilings on specific products[208]. - The EU allows member states to control the prices of medicinal products and restrict the range of products covered by national health insurance systems[208]. Workforce and Corporate Strategy - As of December 31, 2023, the company had 378 full-time employees, with 308 engaged in research and development[214]. - The company completed the acquisition of EQRx, Inc. on November 9, 2023, as part of its growth strategy[219]. - As of December 31, 2023, 56% of the company's full-time employees were female, and 53% of self-identified employees were from underrepresented minorities[216]. - The company aims to enhance employee retention and development through competitive compensation and benefit programs[215]. - The company is committed to inclusiveness and fairness, fostering diverse perspectives within its workforce[216]. - The company anticipates further healthcare reform measures that could limit government payments for healthcare products, potentially reducing demand[213]. - The company regularly reviews its compensation practices to support employee needs, including health and wellness programs[215]. - The company is subject to increased scrutiny over pharmaceutical pricing, leading to legislative changes aimed at transparency and pricing reforms[212].
Revolution Medicines(RVMD) - 2023 Q3 - Earnings Call Presentation
2023-11-07 01:05
November 6, 2023 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, availability of funding, ability to manage existing collaborations and establish new strategic collaborations, licensing or other arrangements, the scope, ...
Revolution Medicines(RVMD) - 2023 Q3 - Earnings Call Transcript
2023-11-07 01:04
Revolution Medicines, Inc. (NASDAQ:RVMD) Q3 2023 Earnings Conference Call November 6, 2023 4:30 PM ET Company Participants Erin Graves - Senior Director of Corporate Communications and IR Mark Goldsmith - Chairman and CEO Jack Anders - CFO Steve Kelsey - President of Research & Development Conference Call Participants Marc Frahm - TD Cowen Eric Joseph - JPMorgan Jonathan Chang - Leerink Partners Ami Fadia - Needham Alec Stranahan - Bank of America Operator Good day, and thank you for standing by. Welcome to ...
Revolution Medicines(RVMD) - 2023 Q3 - Quarterly Report
2023-11-06 21:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission File Number: 001-39219 Revolution Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 47-2029180 (State or ...
Revolution Medicines(RVMD) - 2023 Q2 - Earnings Call Transcript
2023-08-09 03:05
Financial Data and Key Metrics Changes - The company ended Q2 2023 with $909.5 million in cash, cash equivalents, and investments [8] - Total revenue for Q2 2023 was $3.8 million, primarily from a terminated collaboration agreement with Sanofi [8] - Total operating expenses for Q2 2023 were $112.6 million, driven by clinical trial and manufacturing expenses for RMC-6236 and RMC-6291 [17] - The net loss for Q2 2023 was $98.3 million, or $0.92 per share, with a full-year GAAP net loss guidance of $360 million to $400 million [18][19] Business Line Data and Key Metrics Changes - The company is focusing on the development of RAS(ON) inhibitors, specifically RMC-6236 and RMC-6291, with significant updates expected in the fall [21][72] - The acquisition of EQRx aims to strengthen the company's cash position and support the development of its RAS(ON) inhibitor pipeline [4][5] Market Data and Key Metrics Changes - The company is preparing for clinical updates on RMC-6236 and RMC-6291, with presentations scheduled for the ESMO Congress and the Triple Meeting in October [71][72] - The company is evaluating the potential of RMC-5552 as a RAS Companion Inhibitor in combination with RAS(ON) inhibitors [3][72] Company Strategy and Development Direction - The company is committed to a parallel development approach for its RAS(ON) inhibitor pipeline, aiming to maximize patient benefits quickly [57] - The acquisition of EQRx is intended to provide the financial depth necessary for pursuing multiple late-stage development paths [57] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming clinical updates and the potential for significant advancements in the second half of the year [6][21] - The company is focused on providing hope to patients with RAS-addicted cancers through its innovative drug development efforts [22] Other Important Information - The company plans to initiate pivotal clinical trials for RMC-6236 potentially in 2024, based on encouraging data trends [71][72] - The company is also advancing its oral mutant selective KRAS G12D inhibitor, RMC-9805, with site activation underway [73] Q&A Session Summary Question: Financial guidance and R&D expenses trajectory - The CFO indicated that the second half of the year will see a step-up in R&D expenses compared to the first half, with no guidance provided for 2024 yet [26][27] Question: Single agent path forward for RMC-6236 - Management stated that clinical updates will be provided in the fall, with more visibility expected based on actual data [29] Question: Dose selection for RMC-6236 - The selection of the optimal dose is ongoing, with management committed to ensuring efficacy and tolerability [33][39] Question: Current standard of care for lung and pancreatic cancer - Management discussed the complexities of current treatment options and the need for RMC-6236 to outperform existing therapies [48][50] Question: Pivotal studies for RMC-6236 - Management confirmed a commitment to a parallel approach for late-stage development, depending on data outcomes [57] Question: Update on RMC-5552 - The focus remains on dose optimization for RMC-5552 as a potential RAS Companion Inhibitor, with no immediate plans for single-agent development [60] Question: Plans for assessing different dosing schedules - Management clarified that daily dosing is currently effective, with no immediate plans to explore alternative schedules [62]
Revolution Medicines(RVMD) - 2023 Q2 - Quarterly Report
2023-08-08 20:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission File Number: 001-39219 Revolution Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 47-2029180 (State or othe ...
Revolution Medicines(RVMD) - 2023 Q1 - Earnings Call Transcript
2023-05-09 03:17
Financial Data and Key Metrics Changes - The company reported a net loss of $68.1 million for Q1 2023, equating to $0.72 per share, with an updated full-year GAAP net loss guidance of $360 million to $400 million, reflecting increased investments in clinical advancements [38][22][23] - Revenue from collaboration with Sanofi was $7.0 million in Q1 2023, while total operating expenses increased by 25% year-over-year to $82.2 million, primarily due to R&D expenses [23][22] Business Line Data and Key Metrics Changes - The company is advancing its first-in-class RASMULTI(ON) inhibitor, RMC-6236, with ongoing dose escalation studies showing encouraging antitumor activity and tolerability [5][8] - RMC-9805, a mutant selective oral and covalent KRAS G12D(ON) inhibitor, is on track for clinical evaluation in mid-2023, completing the first wave of RAS(ON) inhibitors under clinical evaluation [9] Market Data and Key Metrics Changes - The company raised $345 million in a public equity offering in March 2023, enhancing its financial position to support clinical development and organizational growth [7][22] - The estimated annual incidence of KRAS G12D cancers in the U.S. is around 55,000 cases, indicating a substantial patient population for ongoing studies [55] Company Strategy and Development Direction - The company aims to expand its clinical development capabilities and is focused on combination studies for RMC-6291, indicating a strategic shift towards combination therapies rather than monotherapy [49][34] - The management emphasized the importance of addressing unmet medical needs, particularly in brain metastases, as part of their long-term strategy [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical progress and pipeline, with plans for multiple updates throughout the year, particularly in Q3 [17][24] - The management acknowledged the competitive landscape, noting that standard of care remains the primary competition for many indications, while also recognizing emerging compounds in the clinic [99] Other Important Information - The company has made significant leadership additions, including a new Chief Medical Officer, to enhance its R&D capabilities [21] - The company plans to provide further updates on its clinical programs and organizational progress in the second half of the year [24][17] Q&A Session All Questions and Answers Question: Context for patient numbers and mutation focus - The company is currently focused on KRAS G12D patients due to epidemiology but is seeing additional genotypes and histologies in the study [41] Question: Growth in expenses and priority trials - The management indicated that the increase in expenses is linked to priority trials, including monotherapy expansion and combination studies [42] Question: Tolerability at 160 mg and dose escalation - The management confirmed that the tolerability profile of RMC-6236 remains favorable, allowing for continued dose escalation [44] Question: CNS activity and translatability to human subjects - The management noted that the impact of CNS metastases will depend on the patient population and the ability to control visceral disease effectively [51] Question: Combination partners for RMC-6236 - The management stated that all potential combination partners are currently open, with a focus on those that do not overlap in mechanism [52] Question: Feedback from physicians following AACR - The management reported positive feedback from investigators, highlighting the well-tolerated and active nature of RMC-6236 [90]
Revolution Medicines(RVMD) - 2023 Q1 - Quarterly Report
2023-05-08 20:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission File Number: 001-39219 Revolution Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 47-2029180 (State or oth ...