Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 03, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38672 | |
Entity Registrant Name | ARVINAS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-2566120 | |
Entity Address, Address Line One | 5 Science Park | |
Entity Address, Address Line Two | 395 Winchester Ave | |
Entity Address, City or Town | New Haven | |
Entity Address, State or Province | CT | |
Entity Address, Postal Zip Code | 06511 | |
City Area Code | 203 | |
Local Phone Number | 535-1456 | |
Title of 12(b) Security | Common stock, par value $0.001 per share | |
Trading Symbol | ARVN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 55,025,504 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001655759 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 113.7 | $ 81.3 |
Restricted cash | 5.5 | 5.5 |
Marketable securities | 884.8 | 1,124 |
Accounts receivable | 15.7 | 1 |
Other receivables | 4.9 | 7 |
Prepaid expenses and other current assets | 8.4 | 21.4 |
Total current assets | 1,033 | 1,240.2 |
Property, equipment and leasehold improvements, net | 12.7 | 13.4 |
Operating lease right of use assets | 3 | 4.4 |
Collaboration contract asset and other assets | 9.6 | 10.8 |
Total assets | 1,058.3 | 1,268.8 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 91 | 74.7 |
Deferred revenue | 224.2 | 218.6 |
Current portion of long term debt | 0.2 | 0 |
Current portion of operating lease liability | 1.9 | 1.8 |
Total current liabilities | 317.3 | 295.1 |
Deferred revenue | 281.9 | 405.1 |
Long term debt | 0.8 | 1 |
Operating lease liability | 1.1 | 2.7 |
Total liabilities | 601.1 | 703.9 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 55.0 and 53.2 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 0.1 | 0.1 |
Accumulated deficit | (1,177.9) | (965.4) |
Additional paid-in capital | 1,644.2 | 1,549.4 |
Accumulated other comprehensive loss | (9.2) | (19.2) |
Total stockholders’ equity | 457.2 | 564.9 |
Total liabilities and stockholders’ equity | $ 1,058.3 | $ 1,268.8 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares shares in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares issued (in shares) | 55 | 53.2 |
Common stock, shares outstanding (in shares) | 55 | 53.2 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) shares in Millions, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenue | $ 34.6 | $ 33.2 | $ 121.6 | $ 93.6 |
Operating expenses: | ||||
Research and development | 85.9 | 77.5 | 284.5 | 216.7 |
General and administrative | 22.6 | 20 | 73.3 | 64.5 |
Total operating expenses | 108.5 | 97.5 | 357.8 | 281.2 |
Loss from operations | (73.9) | (64.3) | (236.2) | (187.6) |
Other income (expenses) | ||||
Other expense, net | 0 | (0.2) | (1.1) | (0.4) |
Interest income, net | 10 | 3.4 | 26.6 | 6.3 |
Total other income | 10 | 3.2 | 25.5 | 5.9 |
Net loss before income taxes and loss from equity method investment | (63.9) | (61.1) | (210.7) | (181.7) |
Income tax (expense) benefit | 0 | (2.2) | 0.7 | (10.1) |
Loss from equity method investment | (0.1) | (2.9) | (2.5) | (7.8) |
Net loss | $ (64) | $ (66.2) | $ (212.5) | $ (199.6) |
Net loss per common share, basic (in dollars per share) | $ (1.18) | $ (1.24) | $ (3.97) | $ (3.76) |
Net loss per common share, diluted (in dollars per share) | $ (1.18) | $ (1.24) | $ (3.97) | $ (3.76) |
Weighted average common shares outstanding, basic (in shares) | 54.1 | 53.2 | 53.6 | 53.1 |
Weighted average common shares outstanding, diluted (in shares) | 54.1 | 53.2 | 53.6 | 53.1 |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (64) | $ (66.2) | $ (212.5) | $ (199.6) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on available-for-sale securities | 3 | (2.8) | 10 | (20.2) |
Comprehensive loss | $ (61) | $ (69) | $ (202.5) | $ (219.8) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited) - USD ($) shares in Millions, $ in Millions | Total | Common | Accumulated Deficit | Additional Paid-in Capital | Accumulated Other Comprehensive (Loss) Income |
Beginning balance (in shares) at Dec. 31, 2021 | 53 | ||||
Beginning balance at Dec. 31, 2021 | $ 781.7 | $ 0 | $ (682.9) | $ 1,469.2 | $ (4.6) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 55.4 | 55.4 | |||
Net loss | (199.6) | (199.6) | |||
Issuance of common stock under equity incentive plans (in shares) | 0.2 | ||||
Issuance of common stock under equity incentive plans | 4.2 | $ 0.1 | 4.1 | ||
Unrealized gain (loss) on available-for-sale securities | (20.2) | (20.2) | |||
Ending balance (in shares) at Sep. 30, 2022 | 53.2 | ||||
Ending balance at Sep. 30, 2022 | 621.5 | $ 0.1 | (882.5) | 1,528.7 | (24.8) |
Beginning balance (in shares) at Jun. 30, 2022 | 53.2 | ||||
Beginning balance at Jun. 30, 2022 | 670.6 | $ 0.1 | (816.3) | 1,508.8 | (22) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 18.8 | 18.8 | |||
Net loss | (66.2) | (66.2) | |||
Issuance of common stock under equity incentive plans | 1.1 | 1.1 | |||
Unrealized gain (loss) on available-for-sale securities | (2.8) | (2.8) | |||
Ending balance (in shares) at Sep. 30, 2022 | 53.2 | ||||
Ending balance at Sep. 30, 2022 | $ 621.5 | $ 0.1 | (882.5) | 1,528.7 | (24.8) |
Beginning balance (in shares) at Dec. 31, 2022 | 53.2 | 53.2 | |||
Beginning balance at Dec. 31, 2022 | $ 564.9 | $ 0.1 | (965.4) | 1,549.4 | (19.2) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 54.9 | 54.9 | |||
Net loss | (212.5) | (212.5) | |||
Issuance of common stock under equity incentive plans (in shares) | 0.3 | ||||
Issuance of common stock under equity incentive plans | 3.9 | 3.9 | |||
Common stock issued, net of issuance costs (in shares) | 1.5 | ||||
Common stock issued, net of issuance costs of $1.1 million | 36 | 36 | |||
Unrealized gain (loss) on available-for-sale securities | $ 10 | 10 | |||
Ending balance (in shares) at Sep. 30, 2023 | 55 | 55 | |||
Ending balance at Sep. 30, 2023 | $ 457.2 | $ 0.1 | (1,177.9) | 1,644.2 | (9.2) |
Beginning balance (in shares) at Jun. 30, 2023 | 53.4 | ||||
Beginning balance at Jun. 30, 2023 | 463.6 | $ 0.1 | (1,113.9) | 1,589.6 | (12.2) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 16.7 | 16.7 | |||
Net loss | (64) | (64) | |||
Issuance of common stock under equity incentive plans (in shares) | 0.1 | ||||
Issuance of common stock under equity incentive plans | 1.9 | 1.9 | |||
Common stock issued, net of issuance costs (in shares) | 1.5 | ||||
Common stock issued, net of issuance costs of $1.1 million | 36 | 36 | |||
Unrealized gain (loss) on available-for-sale securities | $ 3 | 3 | |||
Ending balance (in shares) at Sep. 30, 2023 | 55 | 55 | |||
Ending balance at Sep. 30, 2023 | $ 457.2 | $ 0.1 | $ (1,177.9) | $ 1,644.2 | $ (9.2) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Stockholders' Equity (unaudited) (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Statement of Stockholders' Equity [Abstract] | ||
Issuance of common stock, offering costs | $ 1.1 | $ 1.1 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (212.5) | $ (199.6) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3.6 | 4.6 |
Net accretion of bond discounts/premiums | (11.6) | 6.5 |
Loss on sale of marketable securities | 0.9 | 0.4 |
Amortization of right-of-use assets | 1.4 | 1.5 |
Amortization of collaboration contract asset | 2 | 1.3 |
Stock-based compensation | 54.9 | 55.4 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (14.7) | 14 |
Other receivables | 2.2 | 4.9 |
Prepaid expenses and other current assets | 12.3 | (2) |
Accounts payable and accrued liabilities | 16 | (5) |
Operating lease liability | (1.5) | (1.5) |
Deferred revenue | (117.7) | (82.8) |
Net cash used in operating activities | (264.7) | (202.3) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (665.7) | (702.2) |
Maturities of marketable securities | 873.4 | 872.2 |
Sales of marketable securities | 52.3 | 59.1 |
Purchases of property, equipment and leasehold improvements | (2.8) | (5.7) |
Net cash provided by investing activities | 257.2 | 223.4 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 37.1 | 0 |
Payment of common stock issuance costs | (1.1) | 0 |
Proceeds from exercise of stock options and issuance of ESPP shares | 3.9 | 4.2 |
Net cash provided by financing activities | 39.9 | 4.2 |
Net increase in cash, cash equivalents and restricted cash | 32.4 | 25.3 |
Cash, cash equivalents and restricted cash, beginning of the period | 86.8 | 112.8 |
Cash, cash equivalents and restricted cash, end of the period | 119.2 | 138.1 |
Supplemental disclosure of cash flow information: | ||
Purchases of property, equipment and leasehold improvements unpaid at period end | 0 | 0.3 |
Cash paid for taxes | $ 9.1 | $ 8.1 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business and Basis of Presentation | Nature of Business and Basis of Presentation Arvinas, Inc. and its subsidiaries (“Arvinas” or the "Company”) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development and commercialization of therapies that degrade disease-causing proteins. The accompanying unaudited condensed consolidated financial statements include the accounts of Arvinas, Inc. and its subsidiaries. The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X under the Securities Exchange Act of 1934, as amended (“Exchange Act”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to Securities and Exchange Commission (“SEC”) rules. In the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation have been included. The condensed consolidated balance sheet as of December 31, 2022 has been derived from the Company's audited consolidated financial statements as of that date. The financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2022, forming part of Arvinas’ 2022 Annual Report on Form 10-K filed with the SEC on February 23, 2023. As previously disclosed in the Company's 2022 Annual Report on Form 10-K, the Company revised the accounting for its investment in Oerth Bio LLC ("Oerth Bio"). Accordingly, Arvinas recorded an adjustment to the unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2022 that were previously included in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022. See Note 12, Equity Method Investments , for further details. The preparation of the Company’s unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amount of assets, liabilities, revenue and expenses. These estimates include assumptions and judgments based on historical experience, current conditions, future expectations and other factors the Company considers reasonable. These estimates are reviewed on an ongoing basis and revised as necessary. Actual results could differ from these estimates. Risks and Uncertainties The Company is subject to a number of risks similar to other biotechnology companies in the early stage, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products and protection of proprietary technology. If the Company does not successfully obtain regulatory approval, it will be unable to generate revenue from product sales or achieve profitability. To date, the Company has not generated any revenue from product sales and expects to incur additional operating losses and negative operating cash flows for the foreseeable future. The Company has financed its operations primarily through sales of equity interests, proceeds from collaborations, grant funding and debt financing. The Company had cash, cash equivalents, restricted cash and marketable securities of approximately $1.0 billion as of September 30, 2023. |
Accounting Pronouncements and S
Accounting Pronouncements and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Accounting Pronouncements and Significant Accounting Policies | Accounting Pronouncements and Significant Accounting Policies Accounting Pronouncements The Company reviews new accounting standards as issued. As of September 30, 2023, the Company has not identified any new standards that it believes will have a material impact on the Company’s financial statements. Significant Accounting Policies There were no changes to the Company’s significant accounting policies during the nine months ended September 30, 2023. Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the total amounts shown in the consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022: (dollars in millions) September 30, September 30, Cash and cash equivalents $ 113.7 $ 132.6 Restricted cash 5.5 5.5 Cash, cash equivalents and restricted cash $ 119.2 $ 138.1 Restricted cash represents a letter of credit collateralized by a certificate of deposit in the same amount as required under the terms of the Company's laboratory and office space lease entered into in May 2021 and amended in August 2022. |
Research Collaboration and Lice
Research Collaboration and License Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Research Collaboration And License Agreements [Abstract] | |
Research Collaboration and License Agreements | Research Collaboration and License Agreements Vepdegestrant ( ARV-471) Collaboration Agreement In July 2021, the Company entered into a Collaboration Agreement with Pfizer Inc. (“Pfizer”) (the “ Vepdegestrant ( ARV-471) Collaboration Agreement”) pursuant to which the Company granted Pfizer worldwide co-exclusive rights to develop and commercialize products containing the Company’s proprietary compound ARV-471 (the “Licensed Products”). Under the Vepdegestrant ( ARV-471) Collaboration Agreement, the Company received an upfront, non-refundable payment of $650.0 million. In addition, the Company is eligible to receive up to an additional $1.4 billion in contingent payments based on specific regulatory and sales-based milestones for the Licensed Products. Of the total contingent payments, $400.0 million in regulatory milestones are related to marketing approvals and $1.0 billion are related to sales-based milestones. There were no regulatory or sales-based milestone payments received through September 30, 2023. The Company and Pfizer share equally all development costs, including costs of conducting clinical trials, for the Licensed Products, subject to certain exceptions. Except for certain regions described below, the parties will also share equally all profits and losses in commercialization and medical affairs activities for the Licensed Products in all other countries, subject to certain exceptions. The Company will be the marketing authorization holder in the United States and, subject to marketing approval, book sales in the United States, while Pfizer will hold marketing authorizations outside the United States. The parties will determine which, if any, regions within the world will be solely commercialized by one party, and in such region the parties will adjust their share of profits and losses for the Licensed Products based on the role each party will be performing. As a direct result of the Company’s entry into the Vepdegestrant (ARV-471) Collaboration Agreement, the Company incurred direct and incremental costs to obtain the contract, paid to a financial advisor, totaling $12.9 million. In accordance with ASC 340, Other Assets and Deferred Costs , the Company recognized an asset of $12.9 million in collaboration contract asset and other assets in the condensed consolidated balance sheet at inception of the agreement, which is being amortized as general and administrative expense over the total estimated period of performance under the Vepdegestrant (ARV-471) Collaboration Agreement. Bayer Collaboration Agreement In June 2019, the Company and Bayer AG entered into a Collaboration and License Agreement (the “Bayer Collaboration Agreement”) setting forth the Company’s collaboration with Bayer AG to identify or optimize proteolysis targeting chimeras ("PROTAC® targeted protein degraders") that mediate the degradation of target proteins. Under the terms of the Bayer Collaboration Agreement, the Company received an upfront, non-refundable payment of $17.5 million in exchange for the use of the Company’s technology license. Bayer AG was committed to fund an additional $12.0 million through 2023, all of which was received as of September 30, 2023, including $1.5 million and $3.0 million in the nine months ended September 30, 2023 and 2022, respectively. These payments are being recognized over the total estimated period of performance. The Company is also eligible to receive up to $197.5 million in development milestone payments and up to $490.0 million in sales-based milestone payments for all designated targets. In addition, the Company is eligible to receive, on net sales of PROTAC targeted protein degrader-related products, mid-single digit to low-double digit tiered royalties, which may be subject to reductions. There were no development or sales-based milestone payments or royalties received through September 30, 2023. Pfizer Research Collaboration Agreement In December 2017, the Company entered into a Research Collaboration and License Agreement with Pfizer (the “Pfizer Research Collaboration Agreement”). Under the terms of the Pfizer Research Collaboration Agreement, the Company received an upfront, non-refundable payment and certain additional payments totaling $28.0 million in 2018 in exchange for use of the Company’s technology license and to fund Pfizer-related research as defined within the Pfizer Research Collaboration Agreement. These payments are being recognized as revenue over the total estimated period of performance. The Company is eligible to receive up to an additional $37.5 million in non-refundable option payments if Pfizer exercises its options for all targets under the Pfizer Research Collaboration Agreement. The Company is also entitled to receive up to $225.0 million in development milestone payments and up to $550.0 million in sales-based milestone payments for all designated targets under the Pfizer Research Collaboration Agreement, as well as tiered royalties based on sales. During the nine months ended September 30, 2023 and 2022, the Company received payments totaling $1.0 million and $3.5 million which were included in accounts receivable as of December 31, 2022 and 2021, respectively, for additional targets and services which are being recognized as revenue over the total period of performance. There were no sales-based milestone payments or royalties received through September 30, 2023. Restated Genentech Agreement In November 2017, the Company entered into an Amended and Restated Option, License, and Collaboration Agreement (the “Restated Genentech Agreement”) with Genentech, Inc. and F. Hoffman-La Roche Ltd. (together "Genentech"), amending a previous Genentech agreement entered into in September 2015. Under the Restated Genentech Agreement, the Company received additional upfront, non-refundable payments of $34.5 million (in addition to $11.0 million received under the previous agreement in 2015) to fund Genentech-related research. Upfront non-refundable payments were recognized as revenue over the performance period. The Company is eligible to receive up to $44.0 million per target in development milestone payments, $52.5 million in regulatory milestone payments and $60.0 million in commercial milestone payments based on sales as well as tiered royalties based on sales. There were no development, regulatory or commercial milestone payments or royalties received through September 30, 2023. Changes in the Company's contract balances for the nine months ended September 30, 2023 and 2022 were as follows: (dollars in millions) September 30, September 30, Accounts receivable related to collaborations Beginning balance $ 1.0 $ 15.0 Additions 21.7 2.4 Payments received (7.0) (16.4) Ending balance $ 15.7 $ 1.0 Accounts payable related to collaborations Beginning balance $ 5.0 $ — Additions 31.0 — Payments made (6.7) — Ending balance $ 29.3 $ — Contract assets: Collaboration contract asset Beginning balance $ 10.7 $ 12.5 Additions — — Amortization (2.0) (1.3) Ending balance $ 8.7 $ 11.2 Contract liabilities: Deferred revenue Beginning balance $ 623.7 $ 740.5 Revenue recognized from balances held at the beginning of the period (119.1) (85.8) Additions to collaboration agreements 1.5 3.0 Ending balance $ 506.1 $ 657.7 During the nine months ended September 30, 2023, the Company recorded cumulative catch-up adjustments from contract modifications totaling $(8.2) million, relating to performance obligations which were satisfied in prior periods. During the three months ended September 30, 2023 and the three and nine months ended September 30, 2022, the Company recorded no cumulative catch-up adjustments. The aggregate amount of the transaction price allocated to performance obligations that were unsatisfied as of September 30, 2023 was $506.1 million, which is expected to be recognized in the following periods: (dollars in millions) Remainder of 2023 $ 64.1 2024 200.9 2025 90.2 2026 55.3 2027 34.7 2028 10.8 Thereafter 50.1 Total $ 506.1 |
Marketable Securities and Fair
Marketable Securities and Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Marketable Securities and Fair Value Measurements | Marketable Securities and Fair Value Measurements The Company’s marketable securities consist of corporate bonds and government securities which are adjusted to fair value as of each balance sheet date based on quoted prices, which are considered Level 2 inputs. The following is a summary of the Company’s available-for-sale marketable securities measured at fair value on a recurring basis. September 30, 2023 (dollars in millions) Valuation Hierarchy Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate bonds Level 2 $ 821.6 $ — $ (9.1) $ 812.5 Government securities Level 2 72.4 — (0.1) 72.3 Total $ 894.0 $ — $ (9.2) $ 884.8 December 31, 2022 (dollars in millions) Valuation Hierarchy Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate bonds Level 2 $ 1,008.0 $ — $ (18.5) $ 989.5 Government securities Level 2 135.2 — (0.7) 134.5 Total $ 1,143.2 $ — $ (19.2) $ 1,124.0 The Company does not intend to sell any investments prior to recovery of their amortized cost basis for any investment in an unrealized loss position. As such, the Company has classified these losses as temporary in nature. The carrying values of accounts receivable and accounts payable and accrued liabilities approximate their fair values due to the short-term nature of these assets and liabilities. |
Property, Equipment and Leaseho
Property, Equipment and Leasehold Improvements | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Equipment and Leasehold Improvements | Property, Equipment and Leasehold Improvements Property, equipment and leasehold improvements consist of the following: (dollars in millions) September 30, December 31, Laboratory equipment $ 18.5 $ 17.1 Leasehold improvements 11.5 10.9 Office equipment 2.6 2.0 Total property, equipment and leasehold improvements 32.6 30.0 Less: accumulated depreciation and amortization (19.9) (16.6) Property, equipment and leasehold improvements, net $ 12.7 $ 13.4 Depreciation and amortization expense totaled $1.2 million and $1.6 million for the three months ended September 30, 2023 and 2022, respectively, and $3.6 million and $4.6 million for the nine months ended September 30, 2023 and 2022, respectively. |
Right-of-Use Assets and Liabili
Right-of-Use Assets and Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Right-of-Use Assets and Liabilities | Right-of-Use Assets and Liabilities The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the condensed consolidated balance sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit interest rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments, which ranges from 3.0% - 7.5%. Lease expense is recognized on a straight-line basis over the lease term. The Company considers options to extend or terminate leases in recognizing ROU assets and lease liabilities when it is reasonably certain that such options will be exercised. In May 2021, the Company entered into a lease arrangement, which was amended in August 2022, for approximately 160,000 square feet of laboratory and office space, expected to be occupied in 2025. Once occupied, the base rent will range from $7.7 million to $8.8 million annually over a ten-year lease term. In connection with the signing of the lease and the related amendment, and at the Company’s election to increase the landlord’s contribution to the tenant improvement allowance, the Company initially issued a letter of credit totaling $4.5 million, which was subsequently increased to $5.5 million, collateralized by a certificate of deposit in the same amount, which is presented as restricted cash in the consolidated balance sheets. The Company has operating leases for its corporate office, laboratories and certain equipment, which expire no later than January 2026. The leases have a weighted average remaining term of 1.6 years. The components of lease expense were as follows: Three Months Ended Nine Months Ended (dollars in millions) 2023 2022 2023 2022 Operating lease cost $ 0.5 $ 0.5 $ 1.5 $ 1.6 Supplemental cash flow information related to leases was as follows: Nine Months Ended (dollars in millions) 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 1.5 $ 1.5 Supplemental non-cash information: Right-of-use assets obtained in exchange for new lease obligations $ — $ 2.4 Maturities of operating lease liabilities as of September 30, 2023, were as follows: (dollars in millions) Remainder of 2023 $ 0.4 2024 2.2 2025 0.5 2026 — Total lease payments 3.1 Less: imputed interest (0.1) Total $ 3.0 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | Accounts Payable and Accrued Liabilities Accounts payable and accrued liabilities consisted of the following: (dollars in millions) September 30, December 31, Accounts payable $ 34.3 $ 5.7 Accrued liabilities Research and development expenses 36.0 35.9 Employee expenses 16.7 18.7 Professional fees and other 2.9 4.1 Income taxes 1.1 10.3 Total accounts payable and accrued liabilities $ 91.0 $ 74.7 |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt Debt obligations consisted of the following: (dollars in millions) Maturity Date Interest Rate September 30, December 31, 2018 Assistance Agreement Debt 09/28 3.25% $ 1.0 $ 1.0 Less: current installments (0.2) — Total long-term debt $ 0.8 $ 1.0 In June 2018, the Company entered into an additional assistance agreement with the State of Connecticut (the "2018 Assistance Agreement") to provide funding for the expansion and renovation of laboratory and office space. The Company borrowed $2.0 million under the 2018 Assistance Agreement in September 2018, of which $1.0 million was forgiven upon meeting certain employment conditions. Borrowings under the agreement bear an interest rate of 3.25% per annum, with interest-only payments required for the first 60 months, and mature in September 2028. The 2018 Assistance Agreement requires that the Company be located in the State of Connecticut through September 2028, with a default penalty of repayment of the full original funding amount of $2.0 million plus liquidated damages of 7.5% of the total amount of funding received. In connection with an assistance agreement with the State of Connecticut entered into in 2014 under which all the borrowings by the Company were forgiven, the Company is required to be located in the State of Connecticut through January 2024, with a default penalty of repayment of the full original funding amount of $2.5 million plus liquidated damages of 7.5%. Minimum future principal payments on long-term debt for the years ending December 31 are as follows: (dollars in millions) 2023 $ — 2024 0.2 2025 0.2 2026 0.2 2027 0.2 2028 0.2 Total $ 1.0 During the three and nine months ended September 30, 2023 and 2022, interest expense was immaterial. |
Equity
Equity | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Equity | Equity Equity Distribution Agreements In August 2021, the Company entered into an Equity Distribution Agreement with Piper Sandler & Company (“Piper Sandler”) and Cantor Fitzgerald & Co. (“Cantor”), as agents, pursuant to which the Company may offer and sell from time to time, through the agents, up to $300.0 million of the common stock registered under the Company's universal shelf registration statement pursuant to one or more “at-the-market" offerings. During the three months ended September 30, 2023, the Company issued 1,449,275 shares of common stock under this agreement, resulting in net proceeds of approximately $36.0 million, net of offering costs of approximately $1.1 million. Stock-based Compensation 2018 Employee Stock Purchase Plan In September 2018, the Company adopted the 2018 Employee Stock Purchase Plan (the “2018 ESPP”), with the first offering period under the 2018 ESPP commencing on January 1, 2020, by initially providing participating employees with the opportunity to purchase an aggregate of 311,850 shares of the Company’s common stock. The number of shares of the Company’s common stock reserved for issuance under the 2018 ESPP increased, pursuant to the terms of the 2018 ESPP, by additional shares equal to 1% of the Company’s then-outstanding common stock, effective as of January 1 of each year. As of September 30, 2023, 2,440,434 shares remained available for purchase. During the nine months ended September 30, 2023 and 2022, the Company issued 78,528 and 24,898 shares of common stock, respectively, of common stock under the 2018 ESPP. Incentive Share Plan In the Fourth Amendment to the Company’s Incentive Share Plan (the “Incentive Plan”) adopted in March 2018, the Company was authorized to issue up to an aggregate of 6,199,477 incentive units pursuant to the terms of the Incentive Plan. Generally, incentive units were granted at no less than fair value as determined by the board of managers and had vesting periods ranging from one 2018 Stock Incentive Plan In September 2018, the Company’s board of directors adopted, and the Company’s stockholders approved, the 2018 Stock Incentive Plan (the “2018 Plan”), which became effective upon the effectiveness of the registration statement on Form S-1 for the Company’s initial public offering. The number of shares of common stock initially available for issuance under the 2018 Plan equaled the sum of (1) 4,067,007 shares of common stock; plus (2) the number of shares of common stock (up to 1,277,181 shares) issued in respect of incentive units granted under the Incentive Plan that were subject to vesting immediately prior to the effectiveness of the registration statement that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right; plus (3) an annual increase on the first day of each fiscal year beginning with the fiscal year ended December 31, 2019 and continuing to, and including, the fiscal year ending December 31, 2028, equal to the lesser of 4,989,593 shares of the Company’s common stock, 4% of the number of shares of the Company’s common stock outstanding on the first day of the year or an amount determined by the Company’s board of directors. As of September 30, 2023, 2,111,046 shares remained available for issuance under the 2018 Plan. Shares of common stock subject to outstanding equity awards that expire or are terminated, surrendered, or canceled without having been fully exercised or are forfeited in whole or in part are available for future grants of awards. Compensation Expense During the three months ended September 30, 2023 and 2022, the Company recognized compensation expense of $16.7 million and $18.8 million, respectively, related to the issuance of incentive awards, including $0.2 million and $0.2 million, respectively, related to the 2018 ESPP. During the nine months ended September 30, 2023 and 2022, the Company recognized compensation expense of $54.9 million and $55.4 million, respectively, relating to the issuance of incentive awards, including $0.7 million and $0.5 million, respectively, related to the 2018 ESPP. As of September 30, 2023, there was $67.3 million of total unrecognized compensation expense that is expected to be amortized over a weighted average period of approximately 1.7 years. Stock Options The fair value of the stock options granted during the nine months ended September 30, 2023 and 2022 was determined using the Black-Scholes option pricing model with the following assumptions: September 30, September 30, Expected volatility 71.5 - 74.2% 73.2 - 76.0% Expected term (years) 5.5 - 7.0 5.5 - 7.0 Risk free interest rate 3.4% - 4.3% 1.5% - 3.3% Expected dividend yield 0 % 0 % Exercise price $23.23 - $36.27 $36.79 - $78.91 Given the Company’s common stock has not been trading for a sufficient period of time, the Company calculates volatility of its common stock by utilizing a weighted average of a collection of peer company volatilities and its own common stock volatility. The expected term is calculated utilizing the simplified method. A summary of the stock option activity under the 2018 Plan during the nine months ended September 30, 2023 is presented below. These amounts include stock options granted to employees and directors. (dollars in millions, Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding as of December 31, 2022 6,814,634 $ 49.06 7.7 $ 34.5 Granted 1,743,351 $ 33.25 Exercised (109,200) $ 19.01 Forfeited (445,796) $ 55.79 Expired (4,433) $ 71.30 Outstanding as of September 30, 2023 7,998,556 $ 45.67 7.4 $ 4.1 Vested and exercisable as of September 30, 2023 4,593,066 $ 42.85 6.5 $ 4.1 Vested and expected to vest as of September 30, 2023 7,701,049 $ 45.65 7.4 $ 4.1 The weighted-average grant date fair value per share of options granted during the nine months ended September 30, 2023 and 2022 was $22.51 and $39.69, respectively. The total intrinsic value of options exercised during the nine months ended September 30, 2023 and 2022 was $0.9 million and $7.6 million, respectively. Restricted Stock Units (RSUs) A summary of RSU activity under the 2018 Plan during the nine months ended September 30, 2023 is presented below. These amounts include RSUs granted to employees. Shares Weighted Average Grant Date Fair Value Per Share Unvested RSUs as of December 31, 2022 489,216 $ 51.37 Granted 828,400 $ 33.19 Vested (137,022) $ 45.16 Forfeited (54,696) $ 41.20 Unvested RSUs as of September 30, 2023 1,125,898 $ 39.24 The total fair value of RSUs vested during the nine months ended September 30, 2023 and 2022 was $6.2 million and $0.9 million, respectively. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes For the three months ended September 30, 2023, the Company did not recognize an income tax expense or benefit resulting in an effective tax rate of 0.0%, as compared to income tax expense of $2.2 million resulting in an effective tax rate of (3.5)% in the same period for 2022. The primary reconciling items between the federal statutory rate of 21.0% for the three months ended September 30, 2023 and the Company’s overall effective tax rate of 0.0% was the effect of equity compensation and the valuation allowance recorded against the full amount of its net deferred tax assets. The primary reconciling items between the federal statutory rate of 21.0% for the three months ended September 30, 2022 and the Company’s overall effective tax rate of (3.5)% was the effect of equity compensation, deferred state income taxes and the valuation allowance recorded against the full amount of its net deferred tax assets. For the nine months ended September 30, 2023, the Company recognized income tax benefit of $0.7 million resulting in an effective tax rate of 0.3%, as compared to income tax expense of $10.1 million resulting in an effective tax rate of (5.5)% in the same period for 2022. The primary reconciling items between the federal statutory rate of 21.0% for the nine months ended September 30, 2023 and the Company’s overall effective tax rate of 0.3% was the effect of expected benefits from state net operating loss carryback claims offset by equity compensation and the valuation allowance recorded against the full amount of its net deferred tax assets. The primary reconciling items between the federal statutory rate of 21.0% for the nine months ended September 30, 2022 and the Company’s overall effective tax rate of (5.5)% was the effect of equity compensation, generation of tax credits, deferred state income taxes and the valuation allowance recorded against the full amount of its net deferred tax assets. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic and diluted loss per common share was calculated as follows: For the Three Months Ended For the Nine Months Ended (dollars and shares in millions, except per share amounts) 2023 2022 2023 2022 Net loss $ (64.0) $ (66.2) $ (212.5) $ (199.6) Weighted average number of common shares outstanding - basic and diluted 54.1 53.2 53.6 53.1 Net loss per common share - basic and diluted $ (1.18) $ (1.24) $ (3.97) $ (3.76) The Company reported net losses for each of the three and nine months ended September 30, 2023 and 2022, and therefore excluded all stock options and restricted stock units from the calculation of diluted net loss per common share as their inclusion would have had an anti-dilutive effect, as summarized below: For the Three and Nine Months Ended (shares in millions) 2023 2022 Stock options 8.0 6.7 Restricted stock units 1.1 0.4 9.1 7.1 |
Equity Method Investments
Equity Method Investments | 9 Months Ended |
Sep. 30, 2023 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Equity Method Investments | Equity Method Investments In July 2019, the Company and Bayer CropScience LP (“Bayer LP”) formed Oerth Bio, a joint venture to research, develop and commercialize PROTAC targeted protein degraders for applications in the field of agriculture. The Company and Bayer LP each held an initial ownership interest in Oerth Bio of 50%. A 15% ownership interest of Oerth Bio was reserved for the future grants of incentive units to employees and service providers and, as a result, the Company's ownership interest totaled 45.2% and 47.2% as of September 30, 2023 and 2022, respectively, as a result of vested incentive units. In connection with the preparation of the Company's consolidated financial statements for the yea r ended December 31, 2022, the Company identified a prior period error related to the accounting of its investment in Oerth Bio in 2019. Previously, the Company disclosed that revenue of $24.7 million was deferred and would be recognized if and when Oerth Bio recognized revenue associated with the license. The Company has determined that the consideration received for the amounts associated with the deferred revenue should have been constrained, because at the time Bayer LP had contributed only a portion of its full cash commitment to Oerth Bio, and Bayer LP had the right to all the cash contributed, but not yet spent, upon liquidation of Oerth Bio. The constrained revenue should have been recognized upon both cash being contributed by Bayer LP and the related cash spent by Oerth Bio on research and development activities. As such, for each period presented, the revenue recognized is accompanied by corresponding equity method losses of the same amount. As of September 30, 2023, the Company recognized the remaining constrained revenue and therefore will discontinue applying the equity method and not recognize addition equity losses until Oerth Bio returns to profitability . The Company ev aluated the error a nd determined that the related impact did not materially misstate the previously issued unaudited condensed consoli dated financial statements for the three and nine months ended September 30, 2022. Although the Company concluded that the error was not material to its previously issued unaudited condensed consolidated financial statements, the Company has determined it is appropriate to adjust its previously issued unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2022 to correct the error and improve comparability . The following illustrates the effect of the correction of the immaterial error for the period presented. There was no impact to the balance sheets, net loss per common share, statements of cash flows or changes in stockholders’ equity. Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 (dollars in millions, except per share amounts) as previously reported adjustments as adjusted as previously reported adjustments as adjusted Revenue $ 30.3 $ 2.9 $ 33.2 $ 85.8 $ 7.8 $ 93.6 Loss from operations $ (67.2) $ 2.9 $ (64.3) $ (195.4) $ 7.8 $ (187.6) Loss from equity method investment $ — $ (2.9) $ (2.9) $ — $ (7.8) $ (7.8) Net loss $ (66.2) $ — $ (66.2) $ (199.6) $ — $ (199.6) Net loss per common share - basic and diluted $ (1.24) $ — $ (1.24) $ (3.76) $ — $ (3.76) Comprehensive loss $ (69.0) $ — $ (69.0) $ (219.8) $ — $ (219.8) Net loss of Oerth Bio for the three months ended September 30, 2023 and 2022 totaled $3.2 million and $6.2 million, respectively. The Company recognized equity method losses of $0.1 million and $2.9 million for the three months ended September 30, 2023 and 2022 , respectively. Net loss of Oerth Bio for the nine months ended September 30, 2023 and 2022 totaled $8.5 million and $16.3 million, respectively. The Company recognized equity method losses of $2.5 million and $7.8 million for the nine months ended September 30, 2023 and 2022 , respectively. As of September 30, 2023 and 2022 , the Company’s carrying value of t he investment was zero. The Company also provides Oerth Bio with compensated research, development and administrative services through a separate agreement. The services rendered by the Company during the three and nine months ended September 30, 2023 and 2022 were immaterial. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies From time to time, the Company may be subject to legal proceedings, claims and disputes that arise in the ordinary course of business. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount, which could differ materially. Legal fees and other costs associated with such actions are expensed as incurred. The Company's accrual for such matters totaled $10.0 million as of September 30, 2023, primarily related to a contract dispute that is in early stages. Due to the early stage of the dispute, the means of resolution are unknown and could involve contract modification and, or payment of consideration. An estimate of the possible range of loss associated with the dispute cannot be made at this time and the Company has accrued its best estimate as of September 30, 2023. Clinical and Preclinical Development and Licensing Arrangements From time to time, the Company enters into contracts in the normal course of business with various third parties who support its clinical trials, preclinical research studies, and other services related to its development activities. The scope of the services under these agreements can generally be modified at any time, and the agreement can be terminated by either party after a period of notice and receipt of written notice. In addition, under licensing and related arrangements to which the Company is a party, the Company may be obligated to make milestone payments to third parties. The payment obligations under these arrangements are contingent upon future events, such as achievement of specified milestones or generation of product sales, and the amount, timing and likelihood of such payments are not known. FMI Agreement In June 2022, the Company entered into a Master In Vitro Diagnostics Agreement (the "FMI Agreement") with Foundation Medicine, Inc. ("Foundation Medicine") for the development and commercialization of one or more of Foundation Medicine’s companion in vitro diagnostic assays for use with one or more of the Company's therapeutic products. The FMI Agreement does not have a fixed duration, and the Company may terminate the FMI Agreement for convenience by providing adequate written notice to Foundation Medicine, subject to payment of applicable termination fees. Either party may terminate the FMI Agreement in its entirety for an uncured material breach by the other party, upon the bankruptcy or insolvency of the other party or by the mutual written agreement of both parties. Additionally, Foundation Medicine may terminate the FMI Agreement with respect to an applicable program, (a) if a reasonably necessary third party license is not secured by Foundation Medicine or if the Company does not consent to payments for such license, (b) if Foundation Medicine reasonably determines that further development of the applicable assay is not technically feasible or (c) following a certain number of years after the first commercial launch of the applicable assay for use with the applicable therapeutic product. Certain license and other rights and certain obligations of Foundation Medicine survive termination of the FMI Agreement. If the FMI Agreement is terminated in its entirety or with respect to any program, the Company has certain payment obligations remaining to Foundation Medicine and may also be required to pay a termination fee, if applicable. Bavdegalutamide In exchange for the development of FoundationOne® Liquid CDx as a companion diagnostic for use with bavdegalutamide for androgen receptor protein (“AR”) metastatic castration-resistant prostate cancer (“mCRPC”) in the United States and European Union, pursuant to the terms of the FMI Agreement, the Company is subject to success-based milestone payments of up to low to mid tens of millions of dollars, in addition to certain validation fees per sample and related pass-through costs. ARV-766 In exchange for the development of FoundationOne® Liquid CDx as a companion diagnostic for use with ARV-766 for AR mCRPC in the United States and European Union, pursuant to the terms of the FMI Agreement, the Company is subject to success-based milestone payments of up to low tens of millions of dollars in addition to certain validation fees per sample and related pass-through costs. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||
Net loss | $ (64) | $ (66.2) | $ (212.5) | $ (199.6) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Accounting Pronouncements and_2
Accounting Pronouncements and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying unaudited condensed consolidated financial statements include the accounts of Arvinas, Inc. and its subsidiaries. The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X under the Securities Exchange Act of 1934, as amended (“Exchange Act”). Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to Securities and Exchange Commission (“SEC”) rules. In the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation have been included. The condensed consolidated balance sheet as of December 31, 2022 has been derived from the Company's audited consolidated financial statements as of that date. The financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2022, forming part of Arvinas’ 2022 Annual Report on Form 10-K filed with the SEC on February 23, 2023. |
Use of Estimates | The preparation of the Company’s unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amount of assets, liabilities, revenue and expenses. These estimates include assumptions and judgments based on historical experience, current conditions, future expectations and other factors the Company considers reasonable. These estimates are reviewed on an ongoing basis and revised as necessary. Actual results could differ from these estimates. |
Risks and Uncertainties | Risks and UncertaintiesThe Company is subject to a number of risks similar to other biotechnology companies in the early stage, including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products and protection of proprietary technology. If the Company does not successfully obtain regulatory approval, it will be unable to generate revenue from product sales or achieve profitability. |
Accounting Pronouncements | Accounting Pronouncements The Company reviews new accounting standards as issued. As of September 30, 2023, the Company has not identified any new standards that it believes will have a material impact on the Company’s financial statements. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted CashRestricted cash represents a letter of credit collateralized by a certificate of deposit in the same amount as required under the terms of the Company's laboratory and office space lease entered into in May 2021 and amended in August 2022. |
Accounting Pronouncements and_3
Accounting Pronouncements and Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the total amounts shown in the consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022: (dollars in millions) September 30, September 30, Cash and cash equivalents $ 113.7 $ 132.6 Restricted cash 5.5 5.5 Cash, cash equivalents and restricted cash $ 119.2 $ 138.1 |
Schedule of Restrictions on Cash and Cash Equivalents | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets to the total amounts shown in the consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022: (dollars in millions) September 30, September 30, Cash and cash equivalents $ 113.7 $ 132.6 Restricted cash 5.5 5.5 Cash, cash equivalents and restricted cash $ 119.2 $ 138.1 |
Research Collaboration and Li_2
Research Collaboration and License Agreements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Research Collaboration And License Agreements [Abstract] | |
Schedule of Contract Balances | Changes in the Company's contract balances for the nine months ended September 30, 2023 and 2022 were as follows: (dollars in millions) September 30, September 30, Accounts receivable related to collaborations Beginning balance $ 1.0 $ 15.0 Additions 21.7 2.4 Payments received (7.0) (16.4) Ending balance $ 15.7 $ 1.0 Accounts payable related to collaborations Beginning balance $ 5.0 $ — Additions 31.0 — Payments made (6.7) — Ending balance $ 29.3 $ — Contract assets: Collaboration contract asset Beginning balance $ 10.7 $ 12.5 Additions — — Amortization (2.0) (1.3) Ending balance $ 8.7 $ 11.2 Contract liabilities: Deferred revenue Beginning balance $ 623.7 $ 740.5 Revenue recognized from balances held at the beginning of the period (119.1) (85.8) Additions to collaboration agreements 1.5 3.0 Ending balance $ 506.1 $ 657.7 |
Schedule of Transaction Price Allocated to Performance Obligations | The aggregate amount of the transaction price allocated to performance obligations that were unsatisfied as of September 30, 2023 was $506.1 million, which is expected to be recognized in the following periods: (dollars in millions) Remainder of 2023 $ 64.1 2024 200.9 2025 90.2 2026 55.3 2027 34.7 2028 10.8 Thereafter 50.1 Total $ 506.1 |
Marketable Securities and Fai_2
Marketable Securities and Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Available-for-Sale Marketable Securities | The following is a summary of the Company’s available-for-sale marketable securities measured at fair value on a recurring basis. September 30, 2023 (dollars in millions) Valuation Hierarchy Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate bonds Level 2 $ 821.6 $ — $ (9.1) $ 812.5 Government securities Level 2 72.4 — (0.1) 72.3 Total $ 894.0 $ — $ (9.2) $ 884.8 December 31, 2022 (dollars in millions) Valuation Hierarchy Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Corporate bonds Level 2 $ 1,008.0 $ — $ (18.5) $ 989.5 Government securities Level 2 135.2 — (0.7) 134.5 Total $ 1,143.2 $ — $ (19.2) $ 1,124.0 |
Property, Equipment and Lease_2
Property, Equipment and Leasehold Improvements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Equipment and Leasehold Improvements | Property, equipment and leasehold improvements consist of the following: (dollars in millions) September 30, December 31, Laboratory equipment $ 18.5 $ 17.1 Leasehold improvements 11.5 10.9 Office equipment 2.6 2.0 Total property, equipment and leasehold improvements 32.6 30.0 Less: accumulated depreciation and amortization (19.9) (16.6) Property, equipment and leasehold improvements, net $ 12.7 $ 13.4 |
Right-of-Use Assets and Liabi_2
Right-of-Use Assets and Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense were as follows: Three Months Ended Nine Months Ended (dollars in millions) 2023 2022 2023 2022 Operating lease cost $ 0.5 $ 0.5 $ 1.5 $ 1.6 |
Schedule of Supplemental Cash Flow Information Related to Leases | Supplemental cash flow information related to leases was as follows: Nine Months Ended (dollars in millions) 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 1.5 $ 1.5 Supplemental non-cash information: Right-of-use assets obtained in exchange for new lease obligations $ — $ 2.4 |
Schedule of Maturities of Operating Lease Liabilities | Maturities of operating lease liabilities as of September 30, 2023, were as follows: (dollars in millions) Remainder of 2023 $ 0.4 2024 2.2 2025 0.5 2026 — Total lease payments 3.1 Less: imputed interest (0.1) Total $ 3.0 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Components of Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities consisted of the following: (dollars in millions) September 30, December 31, Accounts payable $ 34.3 $ 5.7 Accrued liabilities Research and development expenses 36.0 35.9 Employee expenses 16.7 18.7 Professional fees and other 2.9 4.1 Income taxes 1.1 10.3 Total accounts payable and accrued liabilities $ 91.0 $ 74.7 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt | Debt obligations consisted of the following: (dollars in millions) Maturity Date Interest Rate September 30, December 31, 2018 Assistance Agreement Debt 09/28 3.25% $ 1.0 $ 1.0 Less: current installments (0.2) — Total long-term debt $ 0.8 $ 1.0 |
Schedule of Minimum Future Payments on Long-Term Debt | Minimum future principal payments on long-term debt for the years ending December 31 are as follows: (dollars in millions) 2023 $ — 2024 0.2 2025 0.2 2026 0.2 2027 0.2 2028 0.2 Total $ 1.0 |
Equity (Tables)
Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Assumptions Used to Determine Fair Value of Stock Options Granted | The fair value of the stock options granted during the nine months ended September 30, 2023 and 2022 was determined using the Black-Scholes option pricing model with the following assumptions: September 30, September 30, Expected volatility 71.5 - 74.2% 73.2 - 76.0% Expected term (years) 5.5 - 7.0 5.5 - 7.0 Risk free interest rate 3.4% - 4.3% 1.5% - 3.3% Expected dividend yield 0 % 0 % Exercise price $23.23 - $36.27 $36.79 - $78.91 |
Schedule of Stock Option Activity | A summary of the stock option activity under the 2018 Plan during the nine months ended September 30, 2023 is presented below. These amounts include stock options granted to employees and directors. (dollars in millions, Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding as of December 31, 2022 6,814,634 $ 49.06 7.7 $ 34.5 Granted 1,743,351 $ 33.25 Exercised (109,200) $ 19.01 Forfeited (445,796) $ 55.79 Expired (4,433) $ 71.30 Outstanding as of September 30, 2023 7,998,556 $ 45.67 7.4 $ 4.1 Vested and exercisable as of September 30, 2023 4,593,066 $ 42.85 6.5 $ 4.1 Vested and expected to vest as of September 30, 2023 7,701,049 $ 45.65 7.4 $ 4.1 |
Schedule of Restricted Stock Grant Activity | A summary of RSU activity under the 2018 Plan during the nine months ended September 30, 2023 is presented below. These amounts include RSUs granted to employees. Shares Weighted Average Grant Date Fair Value Per Share Unvested RSUs as of December 31, 2022 489,216 $ 51.37 Granted 828,400 $ 33.19 Vested (137,022) $ 45.16 Forfeited (54,696) $ 41.20 Unvested RSUs as of September 30, 2023 1,125,898 $ 39.24 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Loss per Common Share | Basic and diluted loss per common share was calculated as follows: For the Three Months Ended For the Nine Months Ended (dollars and shares in millions, except per share amounts) 2023 2022 2023 2022 Net loss $ (64.0) $ (66.2) $ (212.5) $ (199.6) Weighted average number of common shares outstanding - basic and diluted 54.1 53.2 53.6 53.1 Net loss per common share - basic and diluted $ (1.18) $ (1.24) $ (3.97) $ (3.76) |
Schedule of Securities Excluded From Computation of Diluted Net Loss Per Common Share | The Company reported net losses for each of the three and nine months ended September 30, 2023 and 2022, and therefore excluded all stock options and restricted stock units from the calculation of diluted net loss per common share as their inclusion would have had an anti-dilutive effect, as summarized below: For the Three and Nine Months Ended (shares in millions) 2023 2022 Stock options 8.0 6.7 Restricted stock units 1.1 0.4 9.1 7.1 |
Equity Method Investments (Tabl
Equity Method Investments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity Method Investments and Joint Ventures [Abstract] | |
Schedule of Correction of the Immaterial Error for the Period | The following illustrates the effect of the correction of the immaterial error for the period presented. There was no impact to the balance sheets, net loss per common share, statements of cash flows or changes in stockholders’ equity. Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 (dollars in millions, except per share amounts) as previously reported adjustments as adjusted as previously reported adjustments as adjusted Revenue $ 30.3 $ 2.9 $ 33.2 $ 85.8 $ 7.8 $ 93.6 Loss from operations $ (67.2) $ 2.9 $ (64.3) $ (195.4) $ 7.8 $ (187.6) Loss from equity method investment $ — $ (2.9) $ (2.9) $ — $ (7.8) $ (7.8) Net loss $ (66.2) $ — $ (66.2) $ (199.6) $ — $ (199.6) Net loss per common share - basic and diluted $ (1.24) $ — $ (1.24) $ (3.76) $ — $ (3.76) Comprehensive loss $ (69.0) $ — $ (69.0) $ (219.8) $ — $ (219.8) |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Details) $ in Billions | Sep. 30, 2023 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents, restricted cash and marketable securities | $ 1 |
Accounting Pronouncements and_4
Accounting Pronouncements and Significant Accounting Policies - Cash Reconciliation (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 113.7 | $ 81.3 | $ 132.6 | |
Restricted cash | 5.5 | 5.5 | 5.5 | |
Cash, cash equivalents and restricted cash | $ 119.2 | $ 86.8 | $ 138.1 | $ 112.8 |
Research Collaboration and Li_3
Research Collaboration and License Agreements - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Nov. 30, 2017 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Jul. 31, 2021 | Jun. 30, 2019 | |
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | $ 8,700,000 | $ 11,200,000 | $ 8,700,000 | $ 11,200,000 | $ 10,700,000 | $ 12,500,000 | |||||
Collaboration contract asset and other assets | 9,600,000 | 9,600,000 | $ 10,800,000 | ||||||||
Revenue adjustments arising from contract modifications | 0 | $ 0 | (8,200,000) | 0 | |||||||
Pfizer, Inc. | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Payments received | 1,000,000 | 3,500,000 | $ 28,000,000 | ||||||||
Pfizer, Inc. | Regulatory and Sales-Based Milestones | Maximum | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | $ 1,400,000,000 | ||||||||||
Pfizer, Inc. | Collaboration Agreement | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 650,000,000 | ||||||||||
Collaboration agreement direct and incremental costs incurred | 12,900,000 | ||||||||||
Collaboration contract asset and other assets | 12,900,000 | 12,900,000 | |||||||||
Pfizer, Inc. | Regulatory Milestone Related to Marketing Approvals | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 400,000,000 | ||||||||||
Payments received | 0 | ||||||||||
Pfizer, Inc. | Sales-Based Milestones | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | $ 1,000,000,000 | ||||||||||
Pfizer, Inc. | Development Milestone Payments | Maximum | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 225,000,000 | 225,000,000 | |||||||||
Pfizer, Inc. | Sales Based Milestone Payments | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Payments received | 0 | ||||||||||
Pfizer, Inc. | Sales Based Milestone Payments | Maximum | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 550,000,000 | 550,000,000 | |||||||||
Pfizer, Inc. | Option Payments To License Agreement | Maximum | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 37,500,000 | 37,500,000 | |||||||||
Bayer Collaboration Agreement | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | $ 17,500,000 | ||||||||||
Bayer Collaboration Agreement | Research Funding Payments | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Payments received | 1,500,000 | $ 3,000,000 | |||||||||
Bayer Collaboration Agreement | Research Funding Payments | Scenario Forecast | Subsequent Event | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | $ 12,000,000 | ||||||||||
Bayer Collaboration Agreement | Development Milestone Payments | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Payments received | 0 | ||||||||||
Bayer Collaboration Agreement | Development Milestone Payments | Maximum | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 197,500,000 | ||||||||||
Bayer Collaboration Agreement | Sales Based Milestone Payments | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Payments received | 0 | ||||||||||
Bayer Collaboration Agreement | Sales Based Milestone Payments | Maximum | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | $ 490,000,000 | ||||||||||
Genentech, Inc. and F. Hoffman-La Roche Ltd. | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Payments received | $ 34,500,000 | ||||||||||
Additional upfront non-refundable amount received under previous agreement | $ 11,000,000 | ||||||||||
Genentech, Inc. and F. Hoffman-La Roche Ltd. | Regulatory Milestone Related to Marketing Approvals | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 52,500,000 | 52,500,000 | |||||||||
Genentech, Inc. and F. Hoffman-La Roche Ltd. | Development Milestone Payments | Maximum | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | 44,000,000 | 44,000,000 | |||||||||
Genentech, Inc. and F. Hoffman-La Roche Ltd. | Commercial Milestones | |||||||||||
Research Collaboration And License Agreements [Line Items] | |||||||||||
Contract revenue receivable if milestones achieved | $ 60,000,000 | 60,000,000 | |||||||||
Payments received | $ 0 |
Research Collaboration and Li_4
Research Collaboration and License Agreements - Summary of Contract Balances (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Accounts receivable related to collaborations | ||
Beginning balance | $ 1 | $ 15 |
Additions | 21.7 | 2.4 |
Payments received | (7) | (16.4) |
Ending balance | 15.7 | 1 |
Accounts payable related to collaborations | ||
Beginning balance | 5 | 0 |
Additions | 31 | 0 |
Payments made | (6.7) | 0 |
Ending balance | 29.3 | 0 |
Contract assets: Collaboration contract asset | ||
Beginning balance | 10.7 | 12.5 |
Additions | 0 | 0 |
Amortization | (2) | (1.3) |
Ending balance | 8.7 | 11.2 |
Contract liabilities: Deferred revenue | ||
Beginning balance | 623.7 | 740.5 |
Revenue recognized from balances held at the beginning of the period | (119.1) | (85.8) |
Additions to collaboration agreements | 1.5 | 3 |
Ending balance | $ 506.1 | $ 657.7 |
Research Collaboration and Li_5
Research Collaboration and License Agreements - Transaction Price Allocated to Performance Obligations (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 506.1 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2023-10-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 64.1 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 3 months |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2024-01-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 200.9 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 1 year |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2025-01-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 90.2 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 1 year |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2026-01-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 55.3 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 1 year |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2027-01-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 34.7 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 1 year |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2028-01-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 10.8 |
Revenue, remaining performance obligation, expected timing of satisfaction, period | 1 year |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2029-01-01 | |
Revenue Remaining Performance Obligation Expected Timing Of Satisfaction [Line Items] | |
Revenue, remaining performance obligation | $ 50.1 |
Revenue, remaining performance obligation, expected timing of satisfaction, period |
Marketable Securities and Fai_3
Marketable Securities and Fair Value Measurements - Summary of Available-for-Sale Marketable Securities (Details) - Level 2 - Fair Value, Measurements, Recurring - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Amortized Cost | $ 894 | $ 1,143.2 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (9.2) | (19.2) |
Fair Value | 884.8 | 1,124 |
Corporate bonds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Amortized Cost | 821.6 | 1,008 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (9.1) | (18.5) |
Fair Value | 812.5 | 989.5 |
Government securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Amortized Cost | 72.4 | 135.2 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (0.1) | (0.7) |
Fair Value | $ 72.3 | $ 134.5 |
Property, Equipment and Lease_3
Property, Equipment and Leasehold Improvements - Schedule of Property, Equipment and Leasehold Improvements (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Total property, equipment and leasehold improvements | $ 32.6 | $ 30 |
Less: accumulated depreciation and amortization | (19.9) | (16.6) |
Property, equipment and leasehold improvements, net | 12.7 | 13.4 |
Laboratory equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property, equipment and leasehold improvements | 18.5 | 17.1 |
Leasehold improvements | ||
Property Plant And Equipment [Line Items] | ||
Total property, equipment and leasehold improvements | 11.5 | 10.9 |
Office equipment | ||
Property Plant And Equipment [Line Items] | ||
Total property, equipment and leasehold improvements | $ 2.6 | $ 2 |
Property, Equipment and Lease_4
Property, Equipment and Leasehold Improvements - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation and amortization expense | $ 1.2 | $ 1.6 | $ 3.6 | $ 4.6 |
Right-of-Use Assets and Liabi_3
Right-of-Use Assets and Liabilities - Additional Information (Details) ft² in Thousands, $ in Millions | 1 Months Ended | |
May 31, 2021 USD ($) ft² | Sep. 30, 2023 USD ($) | |
Lessee Lease Description [Line Items] | ||
Lease for laboratory and office space | ft² | 160 | |
Base rent lease term (in years) | 10 years | |
Operating lease, weighted average remaining lease term (in years) | 1 year 7 months 6 days | |
Letter of Credit | Asset Pledged as Collateral | ||
Lessee Lease Description [Line Items] | ||
Letter of credit for collateralized by certificate of deposit | $ 4.5 | $ 5.5 |
Minimum | ||
Lessee Lease Description [Line Items] | ||
Percentage of incremental borrowing for lease payments | 3% | |
Base rent | 7.7 | |
Maximum | ||
Lessee Lease Description [Line Items] | ||
Percentage of incremental borrowing for lease payments | 7.50% | |
Base rent | $ 8.8 |
Right-of-Use Assets and Liabi_4
Right-of-Use Assets and Liabilities - Components of Lease Expense (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||||
Operating lease cost | $ 0.5 | $ 0.5 | $ 1.5 | $ 1.6 |
Right-of-Use Assets and Liabi_5
Right-of-Use Assets and Liabilities - Schedule of Supplemental Cash Flow Information Related to Leases (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | $ 1.5 | $ 1.5 |
Supplemental non-cash information: | ||
Right-of-use assets obtained in exchange for new lease obligations | $ 0 | $ 2.4 |
Right-of-Use Assets and Liabi_6
Right-of-Use Assets and Liabilities - Schedule of Maturities of Operating Lease Liabilities (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Leases [Abstract] | |
Remainder of 2023 | $ 0.4 |
2024 | 2.2 |
2025 | 0.5 |
2026 | 0 |
Total lease payments | 3.1 |
Less: imputed interest | (0.1) |
Total | $ 3 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 34.3 | $ 5.7 |
Accrued liabilities | ||
Research and development expenses | 36 | 35.9 |
Employee expenses | 16.7 | 18.7 |
Professional fees and other | 2.9 | 4.1 |
Income taxes | 1.1 | 10.3 |
Total accounts payable and accrued liabilities | $ 91 | $ 74.7 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long Term Debt (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Total | $ 1 | |
Less: current installments | (0.2) | $ 0 |
Total long-term debt | $ 0.8 | 1 |
2018 Assistance Agreement | ||
Debt Instrument [Line Items] | ||
Interest Rate | 3.25% | |
Total | $ 1 | $ 1 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2014 | |
Debt Instrument [Line Items] | ||||||
Interest expense | $ 0 | $ 0 | $ 0 | $ 0 | ||
2018 Assistance Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument bearing interest rate | 3.25% | 3.25% | ||||
2018 Assistance Agreement | State of Connecticut | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument face amount | $ 2 | |||||
Loan forgiveness | $ 1 | |||||
Debt instrument bearing interest rate | 3.25% | |||||
Debt instrument interest payments term (in months) | 60 months | |||||
Percentage of liquidated damages | 7.50% | |||||
2014 Assistance Agreement | State of Connecticut | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument face amount | $ 2.5 | |||||
Percentage of liquidated damages | 7.50% |
Long-Term Debt - Schedule of Mi
Long-Term Debt - Schedule of Minimum Future Payments on Long-Term Debt (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2023 | $ 0 |
2024 | 0.2 |
2025 | 0.2 |
2026 | 0.2 |
2027 | 0.2 |
2028 | 0.2 |
Total | $ 1 |
Equity - Additional Information
Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Jan. 01, 2020 | Mar. 31, 2018 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2019 | Aug. 31, 2021 | Sep. 30, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Proceeds from issuance of common stock | $ 37.1 | $ 0 | |||||||
Payments of stock issuance costs | $ 1.1 | $ 0 | |||||||
Weighted-average grant date fair value of options (in dollars per share) | $ 22.51 | $ 39.69 | |||||||
Intrinsic value of options exercised | $ 0.9 | $ 7.6 | |||||||
Restricted stock units | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Total fair value of RSUs vested | 6.2 | 0.9 | |||||||
Incentive Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Incentive units authorized for issuance (in shares) | 6,199,477 | ||||||||
Incentive Plan | Employees | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Compensation expense | 54.9 | $ 55.4 | |||||||
Incentive Plan | Employees | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Compensation expense | $ 16.7 | $ 18.8 | |||||||
Compensation expense not yet recognized | $ 67.3 | $ 67.3 | |||||||
Compensation expense not yet recognized, period of recognition (in years) | 1 year 8 months 12 days | ||||||||
Incentive Plan | Minimum | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Share-based award, vesting period (in years) | 1 year | ||||||||
Incentive Plan | Maximum | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock reserved for issuance (in shares) | 1,277,181 | ||||||||
Share-based award, vesting period (in years) | 4 years | ||||||||
2018 Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock reserved for issuance (in shares) | 4,067,007 | ||||||||
Common stock, shares remained available for purchase (in shares) | 2,111,046 | 2,111,046 | |||||||
Annual increase in reserved shares as percentage of outstanding common stock | 4% | ||||||||
2018 Plan | Minimum | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Annual increase in reserved shares of common stock (in shares) | 4,989,593 | ||||||||
2018 ESPP | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock reserved for issuance (in shares) | 311,850 | ||||||||
Common stock reserved for issuance represented as percentage on outstanding common stock | 1% | ||||||||
Common stock, shares remained available for purchase (in shares) | 2,440,434 | 2,440,434 | |||||||
Common stock, shares issued (in shares) | 78,528 | 24,898 | |||||||
2018 ESPP | Incentive Plan | Employees | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Compensation expense | $ 0.2 | $ 0.2 | $ 0.7 | $ 0.5 | |||||
Equity Distribution Agreement | At-the-Market Offering | Piper Sandler and Cantor | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Common stock aggregate offering price | $ 300 | ||||||||
Shares issued and sold (in shares) | 1,449,275 | ||||||||
Proceeds from issuance of common stock | $ 36 | ||||||||
Payments of stock issuance costs | $ 1.1 |
Equity - Schedule of Assumption
Equity - Schedule of Assumptions Used to Determine Fair Value of and Stock Options Granted (Details) - Stock options - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility, minimum | 71.50% | 73.20% |
Expected volatility, maximum | 74.20% | 76% |
Risk free interest rate, minimum | 3.40% | 1.50% |
Risk free interest rate, maximum | 4.30% | 3.30% |
Expected dividend yield | 0% | 0% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 5 years 6 months | 5 years 6 months |
Exercise price (in dollars per share) | $ 23.23 | $ 36.79 |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (years) | 7 years | 7 years |
Exercise price (in dollars per share) | $ 36.27 | $ 78.91 |
Equity - Summary of Stock Optio
Equity - Summary of Stock Option Activity (Details) - 2018 Plan - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Options | ||
Beginning balance (in shares) | 6,814,634 | |
Granted (in shares) | 1,743,351 | |
Exercised (in shares) | (109,200) | |
Forfeited (in shares) | (445,796) | |
Expired (in shares) | (4,433) | |
Ending balance (in shares) | 7,998,556 | 6,814,634 |
Vested and exercisable, ending balance (in shares) | 4,593,066 | |
Vested and expected to vest (in shares) | 7,701,049 | |
Weighted Average Exercise Price | ||
Beginning balance (in dollars per share) | $ 49.06 | |
Granted (in dollars per share) | 33.25 | |
Exercised (in dollars per share) | 19.01 | |
Forfeited (in dollars per share) | 55.79 | |
Expired (in dollars per share) | 71.30 | |
Ending balance (in dollars per share) | 45.67 | $ 49.06 |
Vested and exercisable (in dollars per share) | 42.85 | |
Vested and expected to vest (in dollars per share) | $ 45.65 | |
Weighted Average Remaining Contractual Term (Years) | ||
Outstanding (in years) | 7 years 4 months 24 days | 7 years 8 months 12 days |
Vested and exercisable (in years) | 6 years 6 months | |
Vested and expected to vest (in Years) | 7 years 4 months 24 days | |
Aggregate Intrinsic Value | ||
Outstanding | $ 4.1 | $ 34.5 |
Vested and exercisable | 4.1 | |
Vested and expected to vest | $ 4.1 |
Equity - Summary of Restricted
Equity - Summary of Restricted Stock (Details) - 2018 Plan - Restricted stock units - Employees | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Shares | |
Beginning balance (in shares) | shares | 489,216 |
Granted (in shares) | shares | 828,400 |
Vested (in shares) | shares | (137,022) |
Forfeited (in shares) | shares | (54,696) |
Ending balance (in shares) | shares | 1,125,898 |
Weighted Average Grant Date Fair Value Per Share | |
Beginning balance (in dollars per share) | $ / shares | $ 51.37 |
Granted (in dollars per share) | $ / shares | 33.19 |
Vested (in dollars per share) | $ / shares | 45.16 |
Forfeited (in dollars per share) | $ / shares | 41.20 |
Ending balance (in dollars per share) | $ / shares | $ 39.24 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax (expense) benefit | $ 0 | $ 2.2 | $ (0.7) | $ 10.1 |
Effective tax rate, percentage | 0% | (3.50%) | 0.30% | (5.50%) |
Federal statutory rate, percentage | 21% | 21% | 21% | 21% |
Net Loss Per Share - Basic and
Net Loss Per Share - Basic and Diluted Loss per Common Share (Details) - USD ($) $ / shares in Units, shares in Millions, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (64) | $ (66.2) | $ (212.5) | $ (199.6) |
Weighted average number of common shares outstanding, basic (in shares) | 54.1 | 53.2 | 53.6 | 53.1 |
Weighted average number of common shares outstanding, diluted (in shares) | 54.1 | 53.2 | 53.6 | 53.1 |
Net loss per common share - basic (in dollars per share) | $ (1.18) | $ (1.24) | $ (3.97) | $ (3.76) |
Net loss per common share - diluted (in dollars per share) | $ (1.18) | $ (1.24) | $ (3.97) | $ (3.76) |
Net Loss Per Share - Securities
Net Loss Per Share - Securities Excluded From Computation of Diluted Net Loss Per Common Share (Details) - shares shares in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted net loss per common share (in shares) | 9.1 | 7.1 | 9.1 | 7.1 |
Stock options | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted net loss per common share (in shares) | 8 | 6.7 | 8 | 6.7 |
Restricted stock units | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted net loss per common share (in shares) | 1.1 | 0.4 | 1.1 | 0.4 |
Equity Method Investments- Addi
Equity Method Investments- Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Jul. 31, 2019 | |
Schedule Of Equity Method Investments [Line Items] | |||||||
Contract with customer, liability | $ 506,100,000 | $ 657,700,000 | $ 506,100,000 | $ 657,700,000 | $ 623,700,000 | $ 740,500,000 | |
Net loss | 64,000,000 | 66,200,000 | 212,500,000 | 199,600,000 | |||
Loss from equity method investment | 100,000 | 2,900,000 | 2,500,000 | 7,800,000 | |||
Oerth | |||||||
Schedule Of Equity Method Investments [Line Items] | |||||||
Future grant of incentive units to service providers percentage | 15% | ||||||
Contract with customer, liability | $ 24,700,000 | ||||||
Loss from equity method investment | 100,000 | 2,900,000 | 2,500,000 | 7,800,000 | |||
Equity method investments | 0 | 0 | 0 | 0 | |||
Oerth | |||||||
Schedule Of Equity Method Investments [Line Items] | |||||||
Net loss | $ 3,200,000 | $ 6,200,000 | $ 8,500,000 | $ 16,300,000 | |||
Bayer LP | Oerth | |||||||
Schedule Of Equity Method Investments [Line Items] | |||||||
Ownership interest in joint venture (percentage) | 45.20% | 47.20% | 45.20% | 47.20% | 50% |
Equity Method Investments - Sch
Equity Method Investments - Schedule of Correction of Immaterial Error for the Period (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Revenue | $ 34.6 | $ 33.2 | $ 121.6 | $ 93.6 |
Loss from operations | (73.9) | (64.3) | (236.2) | (187.6) |
Loss from equity method investment | (0.1) | (2.9) | (2.5) | (7.8) |
Net loss | $ (64) | $ (66.2) | $ (212.5) | $ (199.6) |
Net loss per common share, basic (in dollars per share) | $ (1.18) | $ (1.24) | $ (3.97) | $ (3.76) |
Net loss per common share, diluted (in dollars per share) | $ (1.18) | $ (1.24) | $ (3.97) | $ (3.76) |
Comprehensive loss | $ (61) | $ (69) | $ (202.5) | $ (219.8) |
as previously reported | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Revenue | 30.3 | 85.8 | ||
Loss from operations | (67.2) | (195.4) | ||
Loss from equity method investment | 0 | 0 | ||
Net loss | $ (66.2) | $ (199.6) | ||
Net loss per common share, basic (in dollars per share) | $ (1.24) | $ (3.76) | ||
Net loss per common share, diluted (in dollars per share) | $ (1.24) | $ (3.76) | ||
Comprehensive loss | $ (69) | $ (219.8) | ||
adjustments | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Revenue | 2.9 | 7.8 | ||
Loss from operations | 2.9 | 7.8 | ||
Loss from equity method investment | (2.9) | (7.8) | ||
Net loss | $ 0 | $ 0 | ||
Net loss per common share, basic (in dollars per share) | $ 0 | $ 0 | ||
Net loss per common share, diluted (in dollars per share) | $ 0 | $ 0 | ||
Comprehensive loss | $ 0 | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | Jun. 04, 2022 | Sep. 30, 2023 |
Commitments And Contingencies [Line Items] | ||
Loss contingency | $ 10 | |
Foundation Medicine, Inc. | Maximum | Success-Based Milestone Payments | ||
Commitments And Contingencies [Line Items] | ||
Milestone payments (up to low) | $ 10 |