Revolution Medicines(RVMD)

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Revolution Medicines(RVMD) - 2022 Q1 - Quarterly Report
2022-05-09 20:13
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, 2022 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) (State or other jurisdiction of i ...
Revolution Medicines(RVMD) - 2021 Q4 - Earnings Call Transcript
2022-03-01 00:52
Financial Data and Key Metrics Changes - The company ended 2021 with $577 million in cash and investments, with revenue from collaboration agreements totaling $9.5 million for Q4 2021 and $29.4 million for the full year [42] - Total operating expenses for Q4 2021 increased to $62 million, primarily driven by R&D expenses of $54 million, while total operating expenses for the full year rose to $217 million, with R&D expenses increasing to $187 million [44] - The net loss for Q4 2021 was $53 million or $0.71 per share, and for the full year, the net loss was $187 million or $2.57 per share [45] - For 2022, the company expects a GAAP net loss between $260 million and $290 million, including estimated non-cash stock-based compensation of $35 million to $40 million [46] Business Line Data and Key Metrics Changes - The company is advancing its RAS (ON) inhibitor portfolio, which includes several drug candidates targeting RAS-addicted cancers, particularly focusing on KRAS mutations [5][10] - RMC-6236, the first RAS (ON) inhibitor, is in late stages of IND preparation, with plans to submit an IND in the coming months [11] - RMC-6291, a selective inhibitor for KRAS G12C, is also expected to submit an IND in the first half of 2022 [14] Market Data and Key Metrics Changes - The company targets over 130,000 new pancreatic, colorectal, and lung cancer patients in the US each year with tumors bearing various KRAS mutations [9] - RMC-6291 is aimed at approximately 29,000 new US patients per year, primarily with lung or colorectal cancers [13] Company Strategy and Development Direction - The company aims to combine RAS (ON) inhibitors with companion inhibitors to enhance clinical outcomes for patients with RAS-addicted cancers [21] - The strategy includes developing specific KRAS companion inhibitors to suppress cooperating targets and pathways that sustain RAS-addicted cancers [21] - The company is focused on expanding its pipeline with distinctive new assets derived from its RAS cancer innovation engine [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to aggressively pursue its mission for cancer patients, supported by a strong balance sheet and a compelling strategy [48] - The management highlighted the importance of addressing resistance mechanisms in RAS-mutant cancers and the potential for combination therapies to improve patient outcomes [28][30] Other Important Information - The company has initiated a global Phase 2 study of RMC-4630 in combination with sotorasib for KRAS G12C lung cancer patients [25] - RMC-5552, an innovative mTORC1 inhibitor, is in the dose escalation phase of its initial clinical trial, showing promising anti-tumor activity [36] Q&A Session Summary Question: How many addressable second line non-small cell lung cancer KRAS G12C patients are there in the US? - The company acknowledged the complexity of the question and suggested discussing it offline [52] Question: How does targeting just mTORC1 compare to targeting both mTORC1 and mTORC2? - The company explained that RMC-5552 selectively inhibits mTORC1 without the toxicity associated with mTORC2, allowing for higher dosing and better therapeutic effects [56] Question: How different are the pharmacokinetics of the KRAS inhibitors? - The company noted that pharmacokinetics vary among their RAS (ON) inhibitors, influenced by factors such as affinity for cyclophilin A and whether the warhead is covalent or non-covalent [64] Question: What are the expectations for the preliminary data readout from RMC-4630? - The company plans to treat up to 46 patients in the RMC-4630-03 study, with a focus on overall response rate as the primary outcome measure [69] Question: Will there be an accelerated pathway for RMC-4630? - The company indicated that options for accelerated approval are being explored, particularly for RAS inhibitors outside of the G12C space, which may have more straightforward pathways due to the lack of existing therapies [91] Question: Can you discuss the bioavailability and dosing for RMC-9805? - The company reported good pharmacodynamic effects in preclinical models, with expectations for once-daily dosing in humans, though actual dosing will depend on clinical pharmacokinetics [97]
Revolution Medicines(RVMD) - 2021 Q4 - Annual Report
2022-02-28 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 Registrant's telephone number, including area code: (650) 481-6801 Securities registered pursuant to Section 12(b) of the Act: ...
Revolution Medicines (RVMD) Investor Presentation - Slideshow
2022-02-12 14:42
Pipeline and Clinical Development - Revolution Medicines is developing RAS(ON) inhibitors and RAS companion inhibitors to target RAS-addicted cancers [6, 12] - RMC-6236, a RASMULTI(ON) inhibitor, shows robust anti-tumor activity in preclinical models with various KRASG12X drivers, with objective response rates (ORR) of 38% (5/13) in NSCLC, 57% (8/14) in PDAC, and 62% (8/13) in CRC models [24] - RMC-6291, a KRASG12C inhibitor, demonstrates superior outcomes in mouse clinical trials with KRASG12C NSCLC models, showing a 72% (18/25) ORR compared to 52% (13/25) for Adagrasib [47, 48] - RMC-9805, a KRASG12D inhibitor, exhibits tumor regressions in preclinical models of KRASG12D cancers [70, 71] - RMC-8839, a KRASG13C inhibitor, shows tumor regressions in preclinical models of KRASG13C cancers [82, 83] Market and Financial Position - RAS proteins drive 30% of human cancers, representing a high unmet need [6, 8, 108] - The company estimates 137,000 new KRASG12X patients per year in the U S [20] - The company estimates 29,000 new KRASG12C patients per year in the U S [43] - The company estimates 55,000 new KRASG12D patients per year in the U S [62] - The company estimates 3,000 new KRASG13C patients per year in the U S [74] - As of September 30, 2021, Revolution Medicines had $608 7 million in cash, cash equivalents, and marketable securities, expected to fund operations to the end of 2023 [106]
Revolution Medicines(RVMD) - 2021 Q3 - Earnings Call Presentation
2021-11-16 16:22
Translating Frontier | --- | --- | --- | |---------------------|-------|-------| | | | | | Oncology Targets to | | | © 2021 Revolution Medicines Legal Disclaimer 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, availabili ...
Revolution Medicines(RVMD) - 2021 Q3 - Earnings Call Transcript
2021-11-11 06:21
Revolution Medicines, Inc. (NASDAQ:RVMD) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Peg Horn - Chief Operating Officer Mark Goldsmith - Chairman & Chief Executive Officer Jack Anders - Senior Vice President of Finance & Principal Accounting Officer Steve Kelsey - President of R&D Conference Call Participants Michael Schmidt - Guggenheim Jonathan Chang - SVB Leerink Eric Joseph - JPMorgan Marc Frahm - Cowen & Company Chris Shibutani - Goldman Sachs Benjamin Burnett ...
Revolution Medicines(RVMD) - 2021 Q3 - Quarterly Report
2021-11-10 21:11
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, 2021 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) (State or other jurisdiction ...
Revolution Medicines(RVMD) - 2021 Q2 - Earnings Call Transcript
2021-08-12 03:05
Revolution Medicines, Inc. (NASDAQ:RVMD) Q2 2021 Results Conference Call August 11, 2021 4:30 PM ET Company Participants Peg Horn - Chief Operating Officer Dr. Mark Goldsmith - Chairman and Chief Executive Officer Dr. Steve Kelsey - President Research and Development Jack Anders - Senior Vice President of Finance and Principal Accounting Officer Conference Call Participants Chris Shibutani - Goldman Sachs Marc Frahm - Cowen Michael Schmidt - Guggenheim Eric Joseph - JPMorgan Faisal Khurshid - SVB Leerink Op ...
Revolution Medicines(RVMD) - 2021 Q2 - Quarterly Report
2021-08-11 20:06
Part I. Financial Information [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The company's unaudited financial statements for H1 2021 show increased cash and marketable securities, a wider net loss, and significant financing from a stock offering [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $774.0 million by June 30, 2021, driven by cash and marketable securities, with stockholders' equity growing from a stock offering Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $195,600 | $104,268 | | Marketable securities | $450,722 | $336,473 | | Total current assets | $661,011 | $454,122 | | Total assets | $774,046 | $567,401 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $45,801 | $47,176 | | Total liabilities | $89,040 | $92,725 | | Total stockholders' equity | $685,006 | $474,676 | | Total liabilities and stockholders' equity | $774,046 | $567,401 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For H1 2021, collaboration revenue decreased, while operating expenses, primarily R&D, significantly increased, leading to a wider net loss of $81.5 million Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Collaboration revenue | $18,829 | $21,571 | | Research and development | $86,794 | $60,375 | | General and administrative | $13,967 | $10,262 | | Total operating expenses | $100,761 | $70,637 | | Loss from operations | ($81,932) | ($49,066) | | Net loss | ($81,475) | ($46,734) | | Net loss per share - basic and diluted | ($1.13) | ($1.11) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations and investing activities was offset by $283.1 million from financing, leading to a $91.3 million net cash increase in H1 2021 Summary of Cash Flows (in thousands) | | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($71,327) | ($48,009) | | Net cash used in investing activities | ($120,473) | ($196,212) | | Net cash provided by financing activities | $283,132 | $252,408 | | **Net increase in cash, cash equivalents and restricted cash** | **$91,332** | **$8,187** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail liquidity, Sanofi collaboration terms, public offerings, stock-based compensation, and the deprioritization of the RMC-4630-02 study - The company has incurred net operating losses since inception, with an accumulated deficit of **$347.0 million** as of June 30, 2021, but management believes existing cash and securities are sufficient for at least 12 months[35](index=35&type=chunk) - In February 2021, the company raised net proceeds of **$281.1 million** from an underwritten public offering of **6,666,666 shares** of common stock at **$45.00 per share**[38](index=38&type=chunk) - Under the Sanofi Agreement for SHP2 inhibitors, the company received a **$50 million upfront payment** and could receive up to **$520 million** in future milestones, with revenue recognized using a cost-based input method[78](index=78&type=chunk)[80](index=80&type=chunk)[90](index=90&type=chunk) - In July 2021, the company and Sanofi deprioritized the RMC-4630-02 study, ceasing patient enrollment, and in August 2021, added the RMC-4630-03 study with Sanofi reimbursing **50% of costs**[110](index=110&type=chunk)[111](index=111&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the RAS-addicted cancer pipeline, increased R&D, decreased collaboration revenue, and confirmed liquidity for the next 12 months [Business and Pipeline Overview](index=26&type=section&id=Overview) A clinical-stage oncology firm, the company targets RAS-addicted cancers with RAS(ON) and RAS Companion Inhibitors, planning INDs for H1 2022 - The company's pipeline is divided into RAS(ON) Inhibitors, which directly target active RAS variants, and RAS Companion Inhibitors, designed for combination therapies[114](index=114&type=chunk) - IND submissions for two key RAS(ON) inhibitors, RMC-6291 (targeting KRASG12C) and RMC-6236 (targeting multiple RAS variants), are planned for the **first half of 2022**[115](index=115&type=chunk) - The RMC-4630-02 study, evaluating RMC-4630 with MEK inhibitor cobimetinib and EGFR inhibitor osimertinib, has been deprioritized due to insufficient clinical benefit and tolerability issues, respectively[123](index=123&type=chunk)[124](index=124&type=chunk) - The Phase 1 study of RMC-5552, an mTORC1 inhibitor, began dosing in **April 2021**, with initial data expected in **2022**[125](index=125&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20operations) H1 2021 saw a 13% decrease in collaboration revenue, a 44% rise in R&D expenses, and a 36% increase in G&A, resulting in a significantly higher net loss Comparison of Operating Results (in thousands) | | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $18,829 | $21,571 | ($2,742) | -13% | | Research and development | $86,794 | $60,375 | $26,419 | 44% | | General and administrative | $13,967 | $10,262 | $3,705 | 36% | | **Net loss** | **($81,475)** | **($46,734)** | **($34,741)** | **74%** | - The **$26.4 million increase** in R&D expenses for the first half of 2021 was primarily due to an **$18.6 million rise** in third-party costs for the preclinical research portfolio, including chemistry CRO, material sourcing, and manufacturing costs[155](index=155&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20capital%20resources) The company held $646.3 million in cash and securities as of June 30, 2021, bolstered by a $281.1 million public offering, ensuring liquidity for 12 months - The company held **$646.3 million** in cash, cash equivalents, and marketable securities as of June 30, 2021[166](index=166&type=chunk) - A public offering in February 2021 provided net proceeds of **$281.1 million**[164](index=164&type=chunk) - Management believes existing cash resources are sufficient to fund operations for at least **12 months** from the report date[169](index=169&type=chunk) Summary of Cash Flows (Six Months Ended June 30, 2021, in thousands) | Cash Flow Activity | Amount | | :--- | :--- | | Net cash used in operating activities | ($71,327) | | Net cash used in investing activities | ($120,473) | | Net cash provided by financing activities | $283,132 | [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its $646.3 million portfolio, with minor foreign currency exposure, neither deemed material - The company's main market risk is interest rate sensitivity on its **$646.3 million** portfolio of cash, cash equivalents, and marketable securities, but due to short-term maturities, the impact of interest rate changes is not expected to be material[191](index=191&type=chunk)[192](index=192&type=chunk) - The company has limited exposure to foreign currency risk through vendor contracts in foreign currencies and does not currently engage in formal hedging[193](index=193&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2021, with no material changes to internal control over financial reporting - Management concluded that as of June 30, 2021, the company's disclosure controls and procedures were effective to a reasonable assurance level[195](index=195&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[196](index=196&type=chunk) Part II. Other Information [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) Key risks include early development stage, history of losses, dependence on product development and Sanofi collaboration, intense competition, and COVID-19 impacts - **Financial and Operational Risks:** The company is a clinical-stage entity with a limited operating history, significant losses (**$347.0 million** accumulated deficit), and no approved products, requiring substantial additional financing to continue operations[211](index=211&type=chunk)[212](index=212&type=chunk)[216](index=216&type=chunk) - **Development and Regulatory Risks:** The business depends on the successful development of its product candidates, an inherently uncertain process, and its novel approach of targeting RAS(ON) proteins is unproven, with preclinical results not predicting clinical success[223](index=223&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk) - **Collaboration Risks:** The company is heavily dependent on its collaboration with Sanofi for the development and commercialization of RMC-4630, and Sanofi has the right to terminate the agreement for convenience, which would materially harm the business[335](index=335&type=chunk)[336](index=336&type=chunk) - **Competition Risks:** The company faces significant competition from major pharmaceutical and biotech companies with greater resources and more advanced programs, particularly in targeting KRAS mutations[287](index=287&type=chunk)[289](index=289&type=chunk) - **COVID-19 Pandemic Risks:** The pandemic could significantly disrupt business by delaying clinical trials, affecting patient enrollment, and impacting the supply chain for clinical materials[205](index=205&type=chunk)[207](index=207&type=chunk) - **Intellectual Property Risks:** The company's success depends on its ability to obtain and maintain patent protection for its product candidates, a costly and uncertain process, as competitors could develop similar products if IP protection is insufficient[369](index=369&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred this quarter, and the $250.7 million net IPO proceeds remain unchanged in their planned use - There were no unregistered sales of equity securities in the quarter[460](index=460&type=chunk) - The company confirmed no material change in the planned use of proceeds from its February 2020 IPO, which raised approximately **$250.7 million** net[461](index=461&type=chunk)[462](index=462&type=chunk) [Exhibits](index=85&type=section&id=Item%206.%20Exhibits) The company lists exhibits filed with the 10-Q report, including a letter agreement with Sanofi and certifications from the CEO and CFO - A key exhibit filed is a Letter Agreement and Amendment with Genzyme Corporation (a Sanofi affiliate), dated **August 5, 2021**[468](index=468&type=chunk)
Revolution Medicines(RVMD) - 2021 Q1 - Quarterly Report
2021-05-10 20:11
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q For the transition period from ___ to ___ Commission File Number: 001-39219 Revolution Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorporation or organization) 700 Saginaw Drive Redwood City, CA 94063 Delaware 47-2029180 (I.R.S. Employer Identification No.) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quar ...