Revolution Medicines(RVMD)

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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 ...
Revolution Medicines(RVMD) - 2022 Q4 - Earnings Call Transcript
2023-02-28 03:42
Revolution Medicines, Inc. (NASDAQ:RVMD) Q4 2022 Earnings Conference Call February 27, 2023 4:30 PM ET Company Participants Margaret Horn - Chief Operating Officer Mark Goldsmith - Chairman, President and Chief Executive Officer Steve Kelsey - President of Research and Development Jack Anders - Chief Financial Officer Conference Call Participants Faisal Khurshid - SVB Securities Michael Schmidt - Guggenheim Partners Marc Frahm - Cowen and Company, LLC Eric Joseph - JPMorgan Chase & Co. Benjamin Burnett - St ...
Revolution Medicines(RVMD) - 2022 Q4 - Annual Report
2023-02-27 21:07
Financial Performance - The company has incurred significant net losses of $248.7 million, $187.1 million, and $108.2 million for the years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of $701.3 million as of December 31, 2022[197]. - The company has never generated revenue from product sales and does not anticipate doing so for the next several years, if ever[198]. - As of December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $644.9 million, with substantial funds required for ongoing preclinical and clinical development[202]. - The company raised $250.7 million in February 2020, $167.8 million in July 2020, $281.1 million in February 2021, and $248.1 million in July 2022 through public offerings[202]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future due to the nature of biopharmaceutical product development[197]. - The company may require additional financing to achieve its goals, which may not be available on acceptable terms[201]. Regulatory and Clinical Development Challenges - The collaboration agreement with Sanofi has been terminated effective June 2023, ending reimbursement obligations for research and development costs[197]. - The company plans to seek regulatory approval for its product candidates in the United States and select foreign countries, which will require compliance with varying regulatory requirements[213]. - The success of the company's product candidates depends on successful completion of clinical trials, obtaining marketing approvals, and establishing agreements with third-party manufacturers[214]. - The company has not yet demonstrated the ability to successfully complete clinical trials or obtain marketing approvals for any product candidates[197]. - Preclinical development is uncertain, with potential delays affecting the ability to obtain regulatory approvals or commercialize product candidates[216]. - Conducting preclinical testing is lengthy and expensive, often taking several years per program, which may lead to increased operating expenses[217]. - Clinical trials may not demonstrate sufficient safety or efficacy, impacting the ability to obtain regulatory approvals for product candidates[218]. - The regulatory approval processes are lengthy and unpredictable, with no current product candidates having received regulatory approval[226]. - Delays in clinical trials can harm commercial prospects and increase costs, jeopardizing the ability to generate product revenues[233]. - Clinical trial sites may be affected by the COVID-19 pandemic, leading to delays in patient enrollment and data collection[234]. - The company has not previously submitted an NDA to the FDA or a Marketing Authorization Application to the EMA, raising uncertainty about future approvals[229]. - Development of BRo5 compounds may face challenges such as solubility, potency, and bioavailability, increasing the risk of delays and costs[223]. - Regulatory authorities may impose suspensions or terminations of clinical trials due to various factors, impacting the approval process[232]. - The company faces potential delays in clinical trials due to COVID-19 impacts on third-party manufacturers and clinical trial sites[236]. - There is a high failure rate for drugs in clinical trials, and the company cannot guarantee the success of its current or future clinical trials[240]. - Interim data from clinical trials may differ significantly from final results, highlighting the uncertainty in early-stage clinical data[241]. - Patient enrollment challenges may arise due to competition with approved therapies and other clinical trials, potentially delaying development timelines[245]. - The ongoing conflict between Russia and Ukraine may adversely affect European clinical sites involved in the company's studies[247]. - The company has not yet demonstrated the safety of its product candidates in humans, and unforeseen side effects could arise during clinical development[251]. - Regulatory approval processes are expensive and time-consuming, with no guarantee of success for any product candidate[254]. - Marketing approval in one jurisdiction does not ensure approval in others, and varying requirements may complicate the process[258]. - The company may face increased costs and delays in clinical trials due to difficulties in patient enrollment[248]. - The results of preclinical studies may not predict the outcomes of later-stage clinical trials, leading to potential setbacks in product development[239]. - The company may face significant delays and costs in obtaining foreign marketing approvals due to compliance with international regulatory requirements[259]. - Public perception of targeted cancer therapies could negatively impact the commercial success of the company's products, especially if adverse events occur in clinical trials[260]. - Increased governmental regulation and stricter labeling requirements may arise from future adverse events in oncology, potentially delaying marketing approvals[261]. - Ongoing regulatory obligations and potential penalties could result in significant additional expenses even after receiving marketing approval for product candidates[262]. Competition and Market Dynamics - The market acceptance of any approved product candidate will depend on factors such as efficacy, pricing, and the willingness of physicians and patients to adopt new therapies[267]. - The addressable patient population for the company's therapies may be limited, impacting the potential for commercial success[268]. - The company faces significant competition from major pharmaceutical and biotechnology firms, which may have greater resources and established products[273]. - Competitors may obtain marketing approvals more rapidly, potentially establishing a strong market position before the company can enter the market[277]. - Pricing regulations and reimbursement policies in various countries could hinder the company's ability to recoup investments in product candidates[279]. - Coverage and reimbursement availability from government authorities and private insurers will significantly influence the commercialization success of the company's product candidates[280]. - The company faces significant delays in obtaining coverage and reimbursement for newly approved drugs, which can be time-consuming and costly[282]. - Reimbursement rates for drugs may vary significantly among third-party payors, impacting the commercial viability of product candidates[284]. Product Development and Liability Risks - The company has selected three RAS(ON) inhibitors, RMC-6236, RMC-6291, and RMC-9805, for clinical evaluation, but may face challenges in advancing these candidates due to limited resources[285]. - The company may not successfully identify or discover other product candidates, which could hinder its ability to capitalize on greater commercial opportunities[286]. - The company may seek orphan drug designation for its product candidates, which could provide financial incentives, but there is no guarantee of obtaining or maintaining such designation[298]. - The company may incur substantial liabilities from product liability lawsuits, which could limit the commercialization of approved products[302]. - The company may face challenges in obtaining sufficient product liability insurance, which could inhibit its ability to commercialize products[305]. Intellectual Property and Patent Challenges - The company's success significantly depends on obtaining and maintaining sufficient patent protection for its product candidates; failure to do so may impair its competitive position[367]. - The process of obtaining and maintaining pharmaceutical patents is costly and complex, and the company may not be able to secure necessary patent protections in a timely manner[368]. - The company has entered into licensing agreements, and any failure to comply with these agreements could harm its competitive position and financial condition[374]. - The termination of the Sanofi Agreement in June 2023 has resulted in the company regaining decision-making rights over its SHP2 inhibitor program, which may impact its patent management[376]. - The company may face challenges in enforcing its intellectual property rights, which could limit its ability to stop competitors from commercializing similar products[372]. - The government may have certain rights to the company's patent rights developed with federal funding, which could affect its competitive position[379]. - The company may struggle to obtain licenses from third parties on commercially reasonable terms, which could hinder its ability to commercialize products[382]. - The patent position of the company is uncertain, and its pending patent applications may not result in issued patents that provide meaningful protection[371]. - The company may need to rely on third parties for the preparation and maintenance of patent applications, which could jeopardize its intellectual property rights[375]. - The company may face infringement claims if it fails to identify and correctly interpret relevant patents, which could divert substantial financial and management resources[384]. - Patents have a limited lifespan of generally 20 years from the earliest U.S. non-provisional filing date, which may not provide sufficient protection against competition from generic medications[385]. - The company may be eligible for a patent term extension of up to five years under the Hatch-Waxman Amendments, but failure to meet specific requirements could shorten the enforcement period of patent rights[387]. - The company may struggle to protect its intellectual property rights globally due to high costs and varying enforcement practices in different jurisdictions[389]. - Compulsory licensing laws in many foreign countries could compel the company to grant licenses to third parties, potentially diminishing the value of its patents[391]. - Changes in patent law could weaken the company's ability to obtain new patents or enforce existing ones, leading to increased uncertainty regarding patent value[392]. - The company may not be able to list patents in the FDA's Orange Book, which could allow generic manufacturers to bypass advance notice requirements for abbreviated new drug applications[388]. - The company may face significant costs and risks in enforcing its intellectual property rights in foreign jurisdictions, which could divert attention from other business aspects[390]. - The company’s owned and licensed patent portfolio may not provide adequate rights to exclude competitors from commercializing similar products[385]. - The company may incorrectly determine the relevance or scope of third-party patents, negatively impacting its ability to market product candidates[383]. Operational and Compliance Risks - The company faces significant risks related to reliance on third parties for clinical trials, which could affect the ability to obtain marketing approval for product candidates[343]. - Cybersecurity risks are increasing due to reliance on third-party vendors and remote work, which could lead to potential data breaches and operational disruptions[329]. - The company has not experienced significant system failures or security breaches to date, but any future incidents could materially disrupt operations and research programs[330]. - The company may incur substantial costs related to compliance with U.S. and international data protection laws, which could adversely affect business practices[326]. - The company is dependent on third-party vendors for data collection and processing, and any failure to comply with data protection laws could result in enforcement actions and reputational harm[327]. - The complexity of transitioning rights and obligations from Sanofi to the company may adversely impact the development efforts for RMC-4630[333]. - The company may face challenges in establishing new collaborations on commercially reasonable terms, which could hinder the development of product candidates[337]. - The company relies heavily on collaborations for the commercialization of product candidates, and any disputes with collaborators could delay or terminate development efforts[342]. - The company relies on third parties for conducting clinical trials, which may lead to less direct control over data management and potential delays in marketing approval[347]. - The company does not own manufacturing facilities and relies on third-party manufacturers for preclinical and clinical drug supplies, increasing the risk of supply shortages[351]. - There is a risk that third-party manufacturers may not be able to scale up production in a timely or cost-effective manner, potentially delaying clinical trials and regulatory approvals[352]. - The company has no long-term agreements with third-party manufacturers for commercial supply, which may hinder its ability to secure necessary product quantities[356]. - The company must comply with various healthcare laws and regulations, which could expose it to legal and financial risks[362]. - Increased scrutiny of healthcare interactions may lead to investigations and settlements, diverting management's attention from core business activities[365]. - The company may face penalties, including civil and criminal penalties, if found in violation of applicable laws, which could harm its operations and financial results[366]. Geopolitical and Economic Factors - The ongoing conflict between Russia and Ukraine may lead to significant market disruptions, including volatility in commodity prices and supply chain interruptions[306]. - The U.S. and allied countries have imposed substantial sanctions against Russia, affecting major financial institutions and trade relationships[307]. - Russian authorities have implemented strict currency controls and economic restrictions, which could adversely impact global financial markets and the company's operations[308]. - The conflict may limit the company's ability to conduct clinical trials in Europe, potentially delaying or suspending operations[309]. - Legislative reforms in the U.S., such as the Inflation Reduction Act of 2022, may impose price negotiations and rebates that could affect the pharmaceutical industry[314]. - The Affordable Care Act has increased Medicaid rebates and established new coverage gap discount programs, impacting the company's financials[312]. - The company faces compliance challenges with evolving data protection laws, including the GDPR, which could result in significant penalties for non-compliance[325]. - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose additional data protection obligations that may increase operational costs[322]. - The company may incur liabilities and operational losses due to compliance with stringent privacy laws in various jurisdictions[324]. - Disruptions at the FDA and other regulatory agencies could delay the approval of new products, negatively impacting the company's business[318]. - The termination of the collaboration agreement with Sanofi effective June 2023 may require the company to seek additional funding to avoid delays or reductions in research and development programs[332]. - Following the termination of the Sanofi Agreement, the company will no longer receive research and development funding, milestone payments, or other benefits, which could impact its financial stability[334].
Revolution Medicines(RVMD) - 2022 Q3 - Earnings Call Transcript
2022-11-08 03:58
Financial Data and Key Metrics Changes - The company raised gross proceeds of $265 million through a follow-on equity financing, strengthening its balance sheet [11][17] - Revenue from collaboration with Sanofi was $3.4 million in Q3 2022, up from $1.1 million in the prior year [17] - Total operating expenses for Q3 2022 were $79.9 million, a 47% increase from the previous year, primarily due to clinical trial costs and personnel-related expenses [18] - The net loss for Q3 2022 was $73.3 million, or $0.87 per share, with a full-year GAAP net loss expected between $260 million and $280 million [19] Business Line Data and Key Metrics Changes - The company advanced two RAS(ON) inhibitor candidates into Phase I/Ib trials, with four compounds now in human studies [6][12] - RMC-6236, an oral RAS multi-on inhibitor, is in a Phase IIb trial targeting tumors with common KRAS G12 mutations [7] - RMC-6291, an oral KRAS G12C inhibitor, is in a Phase I/Ib trial, with promising preclinical data reported [8][10] Market Data and Key Metrics Changes - The company is focusing on RAS-addicted cancers, which represent 30% of all human cancers, indicating a significant market opportunity [6] - The collaboration with Amgen is showing promising preliminary evidence for the combination of RMC-4630 with Amgen's KRAS G12C inhibitor, sotorasib [10] Company Strategy and Development Direction - The company aims to deliver on important clinical milestones in 2023, focusing on the development of RAS(ON) inhibitors and companion inhibitors [11][12] - A second wave of RAS(ON) inhibitors is planned, including a KRAS G13C inhibitor, ARMC-8839, anticipated to enter development after 2023 [13] - The strategy includes evaluating RAS companion inhibitors in combination with RAS(ON) inhibitors in the future [10][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to fulfill its mission of treating RAS-addicted cancers, highlighting recent scientific and business progress [21] - The company is committed to a science-driven approach and is optimistic about the potential of its RAS(ON) inhibitor pipeline [15][16] Other Important Information - The company recorded a non-cash GAAP accounting adjustment that reduced collaboration revenue by $4.6 million due to changes in estimates [18] - The company expects to nominate its next RAS(ON) inhibitor development candidate by the end of the year [13] Q&A Session Summary Question: How does the company view the parallel development of RMC-6236 and mutant selective inhibitors? - Management indicated that it is too early to determine which indications will benefit most from the multi-RAS inhibitor versus mutant selective inhibitors, and that clinical data will guide this [24][25] Question: What are the initial focuses for RMC-5552 in combination studies? - The focus will be on co-mutations affecting the mTOR signaling pathway, with preclinical data supporting its efficacy in combination with RAS(ON) inhibitors [26][27] Question: How is the enrollment pace for multi-RAS versus specific programs like G12C? - Both programs are on track with expectations, with high demand for RMC-6236 due to the lack of approved therapies in those indications [29][30] Question: What qualifies as superior activity for RMC-6291? - Initial data will focus on safety, tolerability, and objective responses, with combination therapy expected to be crucial for patient impact [34][35] Question: What is the therapeutic window for RMC-9805? - RMC-9805 is highly mutant selective and is expected to have a favorable therapeutic window based on preclinical results [36][37] Question: How does the company plan to pursue specific tumor histologies for RMC-6236? - The company plans to develop RMC-6236 as a single agent and in combination with other therapies, focusing on G12 mutant tumors [52]