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Arvinas Appoints Jared Freedberg as General Counsel
Newsfilter· 2024-01-16 22:01
Company Announcement - Arvinas, Inc announced the appointment of Jared Freedberg as General Counsel, bringing over 20 years of legal and commercial experience to the company [1] - Jared Freedberg's previous roles include General Counsel at Intercept Pharmaceuticals and Immunomedics, Inc, as well as Vice President, Legal, Business Development and Licensing at Mallinckrodt Pharmaceuticals [1] - The company granted Mr Freedberg an option to purchase 67,314 shares of common stock and a restricted stock unit award for 45,504 shares as part of his employment inducement [2] Executive Compensation - The stock option has a 10-year term with an exercise price of $38.10 per share, equal to the closing price on the grant date [3] - The option vests over four years, with 25% vesting after one year and the remainder vesting monthly thereafter [3] - The restricted stock units vest in four equal annual installments, contingent on continued employment [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies that degrade disease-causing proteins using its proprietary PROTAC Discovery Engine platform [4] - The company has three clinical-stage programs: vepdegestrant (ARV-471) for ER+/HER2- breast cancer, and ARV-766 and bavdegalutamide for metastatic castration-resistant prostate cancer [4] Strategic Focus - The company aims to advance its pipeline of earlier stage assets driven by the PROTAC protein degrader platform while preparing for potential product commercialization [1] - Arvinas is pioneering scientific advancements in protein degradation to improve treatment options for patients with serious diseases [2][4]
Arvinas LLC(ARVN) - 2023 Q3 - Quarterly Report
2023-11-06 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ FORM 10-Q __________________________________________ (Mark One) ý 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 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |------------------------------------------------------------------ ...
Arvinas LLC(ARVN) - 2023 Q2 - Quarterly Report
2023-08-07 16:00
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Arvinas, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2023, reflecting a net loss of **$148.5 million** and approximately **$1.0 billion** in cash and marketable securities [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to **$1,083.5 million** from **$1,268.8 million**, driven by reduced marketable securities, while total liabilities and equity also declined Condensed Consolidated Balance Sheet Highlights (in millions) | Balance Sheet Item | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents, and marketable securities | $1,038.8 | $1,205.3 | | Total Assets | $1,083.5 | $1,268.8 | | **Liabilities & Equity** | | | | Deferred Revenue (Current & Non-current) | $540.6 | $623.7 | | Total Liabilities | $619.9 | $703.9 | | Total Stockholders' Equity | $463.6 | $564.9 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenue increased to **$87.0 million** for the six months ended June 30, 2023, but rising operating expenses led to a net loss of **$148.5 million** Statement of Operations Summary (in millions, except per share data) | Metric | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Revenue | $87.0 | $60.3 | | Research and development | $198.6 | $139.2 | | General and administrative | $50.7 | $44.5 | | Loss from operations | $(162.3) | $(123.4) | | Net loss | $(148.5) | $(133.4) | | Net loss per common share | $(2.78) | $(2.51) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$179.9 million** for the six months ended June 30, 2023, offset by **$187.2 million** from investing activities Cash Flow Summary (in millions) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(179.9) | $(135.7) | | Net cash provided by investing activities | $187.2 | $117.6 | | Net cash provided by financing activities | $2.0 | $3.0 | | Net increase (decrease) in cash | $9.3 | $(15.1) | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Detailed notes cover accounting policies, significant collaboration revenues, a **$10.0 million** contract dispute accrual, and a prior period error correction for the Oerth Bio joint venture - The company is a clinical-stage biotechnology firm focused on therapies that degrade disease-causing proteins and has not yet generated revenue from product sales. Operations are financed through equity sales, collaborations, grants, and debt[26](index=26&type=chunk)[31](index=31&type=chunk) - As of June 30, 2023, the company had **$540.6 million** in deferred revenue from its collaboration agreements, with **$110.2 million** anticipated for recognition in the remainder of 2023[48](index=48&type=chunk)[49](index=49&type=chunk) - The company accrued **$10.0 million** as of June 30, 2023, related to an early-stage contract dispute, with the ultimate resolution and possible range of loss currently unknown[95](index=95&type=chunk) - A prior period error related to the Oerth Bio joint venture accounting was corrected, adjusting previously reported revenue and loss from equity method investment for the three and six months ended June 30, 2022, without impacting net loss or EPS[90](index=90&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business overview, clinical program developments, financial results, and liquidity, with **$87.0 million** revenue, **$198.6 million** R&D expenses, and a **$148.5 million** net loss for H1 2023 [Overview](index=22&type=section&id=Overview) Arvinas, a clinical-stage biotech, is advancing PROTAC degraders like Vepdegestrant (Phase 3), Bavdegalutamide, and ARV-766, while expanding its preclinical pipeline with planned IND/CTA submissions by year-end 2023 - Vepdegestrant (ARV-471): The study-lead in of the VERITAC-3 Phase 3 trial in combination with palbociclib for first-line ER+/HER2- breast cancer has been initiated, and enrollment continues in the VERITAC-2 Phase 3 monotherapy trial[105](index=105&type=chunk)[107](index=107&type=chunk) - Bavdegalutamide (ARV-110): A global Phase 3 trial for mCRPC with specific AR tumor mutations is planned for initiation in the second half of 2023[112](index=112&type=chunk) - ARV-766: Showed promising activity in heavily pre-treated mCRPC patients, with **42%** of those with AR LBD mutations achieving PSA50, and a Phase 1b/2 combination trial with abiraterone is anticipated in the second half of 2023[115](index=115&type=chunk)[116](index=116&type=chunk) - Pipeline Expansion: The company expects to submit an IND/CTA for its BCL6 and LRRK2 PROTAC degraders by year-end 2023 and advance at least two additional programs into IND/CTA-enabling studies[119](index=119&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Revenue increased by **$26.7 million** to **$87.0 million**, while R&D expenses rose by **$59.4 million** to **$198.6 million**, leading to a **$15.1 million** higher net loss for the six months ended June 30, 2023 Financial Results Comparison (in millions) | Item | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change | | :--- | :--- | :--- | :--- | | Revenue | $87.0 | $60.3 | $26.7 | | Research and development expenses | $(198.6) | $(139.2) | $(59.4) | | General and administrative expenses | $(50.7) | $(44.5) | $(6.2) | | Net loss | $(148.5) | $(133.4) | $(15.1) | - The increase in revenue for the first six months of 2023 was primarily driven by a **$40.1 million** increase from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer[153](index=153&type=chunk) R&D Expenses by Program (in millions) | Program | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | AR program | $38.4 | $27.4 | | ER program | $59.7 | $34.9 | | Other research and development | $100.5 | $76.9 | | **Total R&D** | **$198.6** | **$139.2** | [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) With approximately **$1.0 billion** in cash and marketable securities as of June 30, 2023, the company expects to fund operations into 2026, despite **$179.9 million** net cash used in operating activities - The company had cash, cash equivalents, restricted cash, and marketable securities totaling approximately **$1.0 billion** as of June 30, 2023[174](index=174&type=chunk) - Management believes the current cash position will be sufficient to fund planned operating expenses and capital expenditure requirements into 2026[174](index=174&type=chunk) Cash Flow Summary (in millions) | Cash Flow Activity | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(179.9) | $(135.7) | | Net cash provided by investing activities | $187.2 | $117.6 | | Net cash provided by financing activities | $2.0 | $3.0 | [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its cash and marketable securities, while its **$1.0 million** fixed-rate debt mitigates related risk - The company's main market risk is interest rate sensitivity on its cash, cash equivalents, and marketable securities, with interest income for the six months ended June 30, 2023, increasing to **$16.6 million** from **$2.9 million** in the prior year due to higher interest rates[179](index=179&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[181](index=181&type=chunk) - No changes occurred during the quarter ended June 30, 2023, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[182](index=182&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though it may encounter litigation in the ordinary course of business - As of the filing date, Arvinas is not a party to any material legal proceedings[184](index=184&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) Investors are directed to the Annual Report on Form 10-K for comprehensive risk factors, as no new material risks are presented in this quarterly report - The company directs investors to review the risk factors disclosed in its Annual Report on Form 10-K filed on February 23, 2023, for a comprehensive understanding of the risks involved in investing in its common stock[185](index=185&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity securities were issued during the three and six months ended June 30, 2023 - There were no sales of unregistered equity securities during the second quarter of 2023[186](index=186&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the second quarter of 2023 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the quarterly period covered by this report[187](index=187&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including lease and collaboration agreement amendments, and officer certifications - Exhibits filed include the Sixth Amendment to a lease with Science Park Development Corporation and the First Amendment to the Collaboration and License Agreement with Bayer AG[189](index=189&type=chunk)
Arvinas LLC(ARVN) - 2023 Q1 - Quarterly Report
2023-05-04 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________ FORM 10-Q __________________________________________ (Mark One) ý 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 o 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: 001-38672 _______________ ...
Arvinas (ARVN) Investor Presentation - Slideshow
2023-04-06 17:16
Pioneering the future of targeted protein egradation therapeutics d Safe harbor and forward-looking statements ...
Arvinas LLC(ARVN) - 2022 Q4 - Annual Report
2023-02-22 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________________ FORM 10-K ________________________________________________ (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO . | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- ...