Revolution Medicines(RVMD)
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Revolution Medicines(RVMD) - 2021 Q3 - Quarterly Report
2021-11-10 21:11
Drug Development - The company is focused on developing RAS(ON) inhibitors and RAS Companion Inhibitors to target RAS-addicted cancers, leveraging proprietary technologies and a deep understanding of cancer biology [116]. - RMC-6291 and RMC-6236, the company's RAS(ON) inhibitors, are in IND-enabling preclinical development, with plans to submit INDs in the first half of 2022 [118]. - RMC-4630, a RAS Companion Inhibitor, is being evaluated in multiple clinical studies, including a Phase 1b study in combination with Amgen's sotorasib, with a target dose of 200 mg [120][121]. - The company expects preliminary findings from the RMC-4630-03 study, which targets non-small cell lung cancer patients with KRASG12C mutations, by the end of 2022 [123]. - RMC-5552, another RAS Companion Inhibitor, is in a Phase 1 study, with initial data expected in 2022 [128]. - RMC-5845, targeting SOS1, is in the IND-enabling stage and expected to be IND-ready in the second half of 2021 [130]. - The company plans to nominate a third RAS(ON) Inhibitor as a development candidate in the second half of 2021 [118]. - The company has deprioritized the RMC-4630-02 study, which included combinations with MEK and EGFR inhibitors, and will not enroll additional patients [127]. Financial Performance - Collaboration revenue decreased by $11.6 million, or 91%, during the three months ended September 30, 2021, compared to the same period in 2020, and decreased by $14.3 million, or 42%, during the nine months ended September 30, 2021 [156]. - Research and development expenses increased by $11.6 million, or 33%, during the three months ended September 30, 2021, primarily due to a $7.1 million increase in third-party costs and a $2.6 million increase in salaries [157]. - General and administrative expenses increased by $2.4 million, or 46%, during the three months ended September 30, 2021, primarily due to an increase in stock-based compensation and salaries [159]. - As of September 30, 2021, the company had $608.7 million in cash, cash equivalents, and marketable securities [171]. - The accumulated deficit as of September 30, 2021, was $400 million, with primary cash usage for operating expenses related to research and development [172]. - The company expects research and development expenses to increase as it continues to invest in product candidates and advance them into later stages of development [148]. - Interest income decreased by $0.1 million and $1.3 million during the three and nine months ended September 30, 2021, respectively, due to lower interest rates [162]. - The company received an aggregate of $147.2 million from Sanofi, including upfront payments and research and development expense reimbursements [170]. - Cash used in operating activities for the nine months ended September 30, 2021, was $107.9 million, compared to $75.0 million for the same period in 2020, reflecting a net loss of $134.1 million in 2021 [177][178]. - Cash used in investing activities for the nine months ended September 30, 2021, was $150.7 million, primarily due to purchases of marketable securities totaling $560.5 million [179]. - Cash provided by financing activities for the nine months ended September 30, 2021, was $283.5 million, mainly from net proceeds of $281.1 million from a public offering [181]. - The company held cash, cash equivalents, and marketable securities of $608.7 million as of September 30, 2021, up from $440.7 million at the end of 2020 [197]. - Total contractual obligations as of September 30, 2021, amounted to $43.4 million, with $5.1 million due within one year [183]. - The company has a lease agreement for additional office and laboratory space, with an annual base rent of approximately $2.7 million, increasing by 3.5% each subsequent year [185]. - Non-cash charges in operating activities for the nine months ended September 30, 2021, included stock-based compensation of $14.5 million and depreciation of $2.3 million [177]. - The company experienced a net change of $4.2 million in operating assets and liabilities during the nine months ended September 30, 2021 [177]. - The company has not entered into any off-balance sheet arrangements as defined in Item 303 of Regulation S-K [188]. - Foreign currency transaction gains and losses have not been material to the company's consolidated financial statements, with no formal hedging program in place [198]. Collaboration and Agreements - The Sanofi Agreement includes an upfront payment of $50 million and potential milestone payments up to $520 million, with profit-sharing on commercialization in the U.S. [137]. - The company is responsible for early clinical development of RMC-4630, while Sanofi handles regulatory activities and commercialization [132][135]. - The company entered into a sales agreement to sell shares of common stock with aggregate gross sales proceeds of up to $250.0 million [169]. - The company believes that existing cash, cash equivalents, and marketable securities will fund planned operations for at least 12 months following the report date [173].
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 ...
Revolution Medicines (RVMD) Investor Presentation - Slideshow
2021-03-17 17:50
Translating Frontier Oncology Targets to Outsmart Cancer™ Corporate Overview Q1 2021 March 2, 2021 © 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, availability of funding, abi ...
Revolution Medicines(RVMD) - 2020 Q4 - Annual Report
2021-03-02 21:11
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, 2020 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 other jurisdict ...
Revolution Medicines(RVMD) - 2020 Q3 - Quarterly Report
2020-11-12 14:00
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, 2020 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) - 2020 Q2 - Quarterly Report
2020-08-10 13:00
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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Registrant's telephone number, including area code: (650) 481-6801 Commission File Number: 001-39219 Revolution Medicines, Inc. (Exact Name of Registrant as Specified in its Charter) (State or ...
Revolution Medicines(RVMD) - 2020 Q1 - Quarterly Report
2020-05-14 20:07
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, 2020 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) - 2019 Q4 - Annual Report
2020-03-30 20:06
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, 2019 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 other jurisdict ...