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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________________________________________
FORM 10-Q
__________________________________________
(Mark One)
ýQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2022
OR
oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to .
Commission File Number: 001-38672
__________________________________________
ARVINAS, INC.
(Exact name of registrant as specified in its Charter)
__________________________________________
Delaware47-2566120
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
5 Science Park
395 Winchester Ave.
New Haven, Connecticut
06511
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (203) 535-1456
__________________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each class 
Trading
Symbol(s)
 Name of each exchange on which registered
Common stock, par value $0.001 per share ARVN 
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ý No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerýAccelerated filero
Non-accelerated fileroSmaller reporting companyo
 Emerging growth companyo
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No ý
As of November 2, 2022, the registrant had 53,227,521 shares of common stock, $0.001 par value per share, outstanding.


Table of Contents
i

FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “goals,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:
the initiation, timing, progress and results of our current and future clinical trials of bavdegalutamide, ARV-471 and ARV-766, including statements regarding the period during which the results of the clinical trials will become available;
the timing of, and our ability to obtain, marketing approval of bavdegalutamide, ARV-471 and ARV-766, and the ability of bavdegalutamide, ARV-471, ARV-766 and our other product candidates to meet existing or future regulatory standards;
the potential achievement of milestones and receipt of payments under our collaborations, including our collaboration with Pfizer Inc., or Pfizer, entered into in July 2021, or the ARV-471 Collaboration;
our plans to pursue research and development of other product candidates;
the potential advantages of our platform technology and our product candidates;
the extent to which our scientific approach and platform technology may potentially address a broad range of diseases and disease targets;
the potential receipt of revenue from future sales of our product candidates;
the rate and degree of market acceptance and clinical utility of our product candidates;
our estimates regarding the potential market opportunity for our product candidates;
our sales, marketing and distribution capabilities and strategy;
our ability to establish and maintain arrangements for manufacture of our product candidates;
our ability to enter into additional collaborations with third parties;
our intellectual property position;
our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
the impact of COVID-19 on our business and operations;
the impact of government laws and regulations; and
our competitive position.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in our Annual Report on Form 10-K for the year ended December 31, 2021, filed on February 28, 2022, and this Quarterly Report on Form 10-Q, particularly in the “Risk Factors” sections, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do
ii

not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.
You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements except as required by applicable law.
In this Quarterly Report on Form 10-Q, unless otherwise stated or the context otherwise requires, references to the “Company,” “Arvinas,” “we,” “us,” and “our,” refer to Arvinas, Inc. and its consolidated subsidiaries, or any one or more of them as the context may require, and “our board of directors” refers to the board of directors of Arvinas, Inc.
We use Arvinas, the Arvinas logo, and other marks as trademarks in the United States and other countries. This Quarterly Report on Form 10-Q contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report on Form 10-Q, including logos, artwork and other visual displays, may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity.
iii

PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
ARVINAS, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets (unaudited)
(dollars and shares in millions)September 30,
2022
December 31,
2021
Assets
Current assets:
Cash and cash equivalents$132.6 $108.3 
Restricted cash5.5 4.5 
Marketable securities1,138.1 1,394.3 
Accounts receivable1.0 15.0 
Other receivables5.8 10.7 
Prepaid expenses and other current assets21.7 19.7 
Total current assets1,304.7 1,552.5 
Property, equipment and leasehold improvements, net14.0 12.7 
Operating lease right of use assets4.8 3.9 
Collaboration contract asset and other assets11.3 12.5 
Total assets$1,334.8 $1,581.6 
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued liabilities$49.7 $54.4 
Deferred revenue193.1 206.2 
Current portion of operating lease liability1.8 1.1 
Total current liabilities244.6 261.7 
Deferred revenue464.6 534.3 
Long term debt1.0 1.0 
Operating lease liability3.1 2.9 
Total liabilities713.3 799.9 
Commitments and Contingencies
Stockholders’ equity:
Common stock, $0.001 par value; 53.2 and 53.0 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively
0.1  
Accumulated deficit(882.5)(682.9)
Additional paid-in capital1,528.7 1,469.2 
Accumulated other comprehensive loss(24.8)(4.6)
Total stockholders’ equity621.5 781.7 
Total liabilities and stockholders’ equity$1,334.8 $1,581.6 
See accompanying notes to the condensed consolidated financial statements
2

ARVINAS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(dollars and shares in millions, except per share amounts)For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
Condensed Consolidated Statements of Operations2022202120222021
Revenue$30.3 $9.3 $85.8 $20.4 
Operating expenses:
Research and development77.5 40.6 216.7 118.5 
General and administrative20.0 16.0 64.5 42.8 
Total operating expenses97.5 56.6 281.2 161.3 
Loss from operations(67.2)(47.3)(195.4)(140.9)
Other income (expenses)
Other (expense) income, net(0.2)0.2 (0.4)1.7 
Interest income, net3.4 0.3 6.3 1.2 
Total other income3.2 0.5 5.9 2.9 
Net loss before income taxes(64.0)(46.8)(189.5)(138.0)
Income tax expense(2.2) (10.1) 
Net loss$(66.2)$(46.8)$(199.6)$(138.0)
Net loss per common share, basic and diluted$(1.24)$(0.94)$(3.76)$(2.81)
Weighted average common shares outstanding, basic and diluted
53.2 49.8 53.1 49.1 
(dollars in millions)For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
Condensed Consolidated Statements of Comprehensive Loss2022202120222021
Net loss$(66.2)$(46.8)$(199.6)$(138.0)
Other comprehensive loss:
Unrealized loss on available-for-sale securities(2.8)(0.1)(20.2)(1.2)
Comprehensive loss$(69.0)$(46.9)$(219.8)$(139.2)
See accompanying notes to the condensed consolidated financial statements
3

ARVINAS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)
(dollars and shares in millions)CommonAccumulated
Deficit
Additional
Paid-in
Capital
Accumulated
Other
Comprehensive
(Loss) Income
Total
Stockholders'
Equity
For the Three Months Ended September 30, 2022 and 2021
SharesAmount
Balance as of June 30, 202253.2 $0.1 $(816.3)$1,508.8 $(22.0)$670.6 
Stock-based compensation— — — 18.8 — 18.8 
Net loss— — (66.2)— — (66.2)
Proceeds from exercise of stock options— — — 1.1 — 1.1 
Unrealized loss on available-for-sale securities— — — — (2.8)(2.8)
Balance as of September 30, 2022
53.2 $0.1 $(882.5)$1,528.7 $(24.8)$621.5 
Balance as of June 30, 202149.0 $ $(583.1)$1,166.5 $(0.5)$582.9 
Stock-based compensation— — — 15.2 — 15.2 
Net loss— — (46.8)— — (46.8)
Restricted stock vesting0.1 — — — — — 
Proceeds from exercise of stock options0.2 — — 6.7 — 6.7 
Common stock issued, net of issuance costs of $4.6
3.5 — — 259.9 — 259.9 
Unrealized loss on available-for-sale securities— — — — (0.2)(0.2)
Balance as of September 30, 2021
52.8 $ $(629.9)$1,448.3 $(0.7)$817.7 
(dollars and shares in millions)CommonAccumulated
Deficit
Additional
Paid-in
Capital
Accumulated
Other
Comprehensive
Income (Loss)
Total
Stockholders'
Equity
For the Nine Months Ended September 30, 2022 and 2021
SharesAmount
Balance as of December 31, 2021
53.0 $ $(682.9)$1,469.2 $(4.6)$781.7 
Stock-based compensation— — — 55.4 — 55.4 
Net loss— — (199.6)— — (199.6)
Proceeds from exercise of stock options0.2 0.1 — 4.1 — 4.2 
Unrealized loss on available-for -sale securities
— — — — (20.2)(20.2)
Balance as of September 30, 2022
53.2 $0.1 $(882.5)$1,528.7 $(24.8)$621.5 
Balance as of December 31, 2020
48.5 $ $(491.9)$1,133.5 $0.6 $642.2 
Stock-based compensation— — — 40.1 — 40.1 
Net loss— — (138.0)— — (138.0)
Restricted stock vesting0.2 — — — — — 
Proceeds from exercise of stock options0.6 — — 14.8 — 14.8 
Common stock issued, net of issuance costs of $4.6
3.5 — — 259.9 — 259.9 
Unrealized loss on available-for-sale securities
— — — — (1.3)(1.3)
Balance as of September 30, 2021
52.8 $ $(629.9)$1,448.3 $(0.7)$817.7 
See accompanying notes to the condensed consolidated financial statements
4

ARVINAS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows (unaudited)
For the Nine Months Ended
September 30,
(dollars in millions)20222021
Cash flows from operating activities:
Net loss$(199.6)$(138.0)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization4.6 3.5 
Net accretion of bond discounts/premiums6.5 5.2 
Forgiveness of debt income (1.0)
Loss on sale of marketable securities0.4  
Amortization of right-of-use assets1.5 0.9 
Amortization of collaboration contract asset1.3 0.1 
Stock-based compensation55.4 40.1 
Changes in operating assets and liabilities:
Accounts receivable14.0 (0.9)
Other receivables4.9 0.7 
Prepaid expenses and other current assets(2.0)(12.4)
Collaboration contract asset (12.9)
Accounts payable and accrued liabilities(5.0)(7.6)
Operating lease liability(1.5)(0.9)
Deferred revenue(82.8)718.3 
Net cash (used in) provided by operating activities(202.3)595.1 
Cash flows from investing activities:
Purchases of marketable securities(702.2)(1,402.9)
Maturities of marketable securities872.2 200.5 
Sales of marketable securities59.1 7.2 
Purchases of property, equipment and leasehold improvements(5.7)(2.8)
Net cash provided by (used in) investing activities223.4 (1,198.0)
Cash flows from financing activities:
Proceeds from issuance of common stock 264.5 
Payment of common stock issuance costs (4.6)
Proceeds from exercise of stock options4.2 14.8 
Net cash provided by financing activities4.2 274.7 
Net increase (decrease) in cash, cash equivalents and restricted cash25.3 (328.2)
Cash, cash equivalents and restricted cash, beginning of the period112.8 588.4 
Cash, cash equivalents and restricted cash, end of the period$138.1 $260.2 
Supplemental disclosure of cash flow information:
Purchases of property, equipment and leasehold improvements
unpaid at period end
$0.3 $0.1 
Cash paid for taxes$8.1 $ 
See accompanying notes to the condensed consolidated financial statements
5

ARVINAS, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (unaudited)
1. Nature of Business and Basis of Presentation
Arvinas, Inc. and its subsidiaries (“Arvinas” or “the Company”) is a clinical-stage biopharmaceutical 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, 2021 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, 2021, forming part of Arvinas’ 2021 Annual Report on Form 10-K filed with the SEC on February 28, 2022.
Certain reclassifications have been made to prior period financial information in order to conform with current period presentation. Accounts payable and Accrued expenses have been condensed into Accounts payable and accrued liabilities, and Interest income and Interest expense have been condensed into Interest income, net.
The preparation of the Company’s unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires the use of estimates 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.
Concentration of Credit Risk and Other Risks and Uncertainties
The Company is subject to a number of risks similar to other biopharmaceutical 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 totaling $1.3 billion as of September 30, 2022.
Impact of the Coronavirus (“COVID-19”) Pandemic
As a result of the COVID-19 pandemic, many companies have experienced disruptions in their operations and in the markets they serve. The Company considered the impact of COVID-19 on the assumptions and estimates used and determined that there were no material adverse impacts on the Company’s financial position and results of operations as of and for the nine months ended September 30, 2022. The full extent of the impacts of COVID-19 on the Company’s operations remains uncertain and could have a material adverse impact on the Company's financial results and business operations, including the
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timing and ability of the Company to complete certain clinical trials and other efforts required to advance its preclinical pipeline.
2. Accounting Pronouncements and Significant Accounting Policies
The Company reviews new accounting standards as issued. As of September 30, 2022, the Company has not identified any new standards that it believes will have a material impact on the Company’s financial statements.
There were no changes to the Company’s significant accounting policies during the nine months ended September 30, 2022.
3. Research Collaboration and License Agreements
ARV-471 Collaboration Agreement
In July 2021, the Company entered into a Collaboration Agreement with Pfizer Inc. (“Pfizer”) (the “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 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.
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 ARV-471 Collaboration Agreement, the Company incurred direct and incremental costs to obtain the contract 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 on 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 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 is committed to fund an additional $12.0 million through 2023, of which of $10.5 million was received from inception through September 30, 2022. 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 as of September 30, 2022.
7

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, 2022, the Company received payments totaling $3.5 million, which was included in accounts receivable as of December 31, 2021, for an additional target and additional services which are being recognized as revenue over the total period of performance. There were no sales-based milestone payments or royalties received as of September 30, 2022.
Genentech Modification
In November 2017, the Company entered into an Amended and Restated Option, License, and Collaboration Agreement (the “Genentech Modification”) with Genentech, Inc. and F. Hoffman-La Roche Ltd. (together "Genentech"), amending a previous Genentech agreement. Under the Genentech Modification, the Company received additional upfront, non-refundable payments of $34.5 million (in addition to $11.0 million received under the previous agreement) to fund Genentech-related research. Under the Genentech Modification, Genentech has the right to designate up to ten targets. The Company is eligible to receive up to $27.5 million in additional expansion target payments if Genentech exercises its options on all remaining targets. Upfront non-refundable payments are recognized as revenue over the total estimated period of performance.
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 as of September 30, 2022.
Changes in the Company's contract balances for the nine months ended September 30, 2022 and 2021 were as follows:
(dollars in millions)September 30,
2022
September 30,
2021
Accounts receivable
Beginning balance$15.0 $1.0 
Additions2.4 1.9 
Payments received(16.4)(1.0)
Ending balance$1.0 $1.9 
Contract assets: Collaboration contract asset
Beginning balance$12.5 $ 
Additions 12.9 
Amortization(1.3)(0.1)
Ending balance$11.2 $12.8 
Contract liabilities: Deferred revenue
Beginning balance$740.5 $45.1 
Revenue recognized from balances held at the beginning of the period(85.8)(20.3)
Additions to collaboration agreements3.0 738.6 
Ending balance$657.7 $763.4 
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The aggregate amount of the transaction price allocated to performance obligations that are unsatisfied as of September 30, 2022 was $657.7 million, which is expected to be recognized in the following periods:
(dollars in millions)
Remainder of 2022$52.8 
2023190.0 
2024136.5 
2025100.4 
202663.4 
202734.1 
Thereafter80.5 
Total$657.7 
4. 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, 2022
(dollars in millions)
Valuation
Hierarchy
Effective
Maturity
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Corporate bondsLevel 2
2022 - 2023
$854.3 $ $(12.4)$841.9 
Corporate bondsLevel 2
2023 - 2025
218.1  (11.4)206.7 
Government securitiesLevel 2
2022 - 2023
76.3  (0.7)75.6 
Government securitiesLevel 2
2023 - 2024
14.2  (0.3)13.9 
Total$1,162.9 $ $(24.8)$1,138.1 
 December 31, 2021
(dollars in millions)
Valuation
Hierarchy
Effective
Maturity
Amortized
Cost
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Fair Value
Corporate bondsLevel 2
2022
$784.0 $ $(0.7)$783.3 
Corporate bondsLevel 2
2023 - 2024
582.5  (3.8)578.7 
Government securitiesLevel 2
2022
32.4  (0.1)32.3 
Total $1,398.9 $ $(4.6)$1,394.3 
The carrying values of accounts receivable, accounts payable and accrued liabilities approximate their fair values due to the short-term nature of these assets and liabilities.
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5. Property, Equipment and Leasehold Improvements
Property, equipment and leasehold improvements consist of the following at:
(dollars in millions)September 30,
2022
December 31,
2021
Laboratory equipment$16.8 $13.6 
Leasehold improvements10.4 8.4 
Office equipment1.7 1.4 
Total property, equipment and leasehold improvements28.9 23.4 
Less: accumulated depreciation and amortization(14.9)(10.7)
Property, equipment and leasehold improvements, net$14.0 $12.7 
Depreciation and amortization expense totaled $1.6 million and $1.2 million for the three months ended September 30, 2022 and 2021, respectively, and $4.6 million and $3.5 million for the nine months ended September 30, 2022 and 2021, respectively.
6. 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. The incremental borrowing rate ranges from 3.0% - 4.1%. Lease expense is recognized on a straight-line basis over the lease term. Some of the Company’s leases include options to extend or terminate the lease. The Company includes these options in the recognition of the Company’s ROU assets and lease liabilities when it is reasonably certain that the Company will exercise such options.
In May 2021, the Company entered into a lease, which was amended in August 2022, for approximately 160,000 square feet of laboratory and office space to be occupied in 2024. 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 issued a letter of credit for $5.5 million, collateralized by a certificate of deposit in the same amount, which is presented as restricted cash as of September 30, 2022. Once occupied, the base rent will range from $7.7 million to $8.8 million annually over a ten-year lease term.
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 2.2 years.
The components of lease expense were as follows:
 Three Months Ended
September 30,
Nine Months Ended
September 30,
(dollars in millions)2022202120222021
Operating lease cost$0.5 $0.3 $1.6 $1.0 
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Supplemental cash flow information related to leases was as follows:
Nine Months Ended
September 30,
(dollars in millions)20222021
Cash paid for amounts included in the measurement of lease liabilities:  
Operating cash flows from operating leases$1.5 $0.9 
Supplemental non-cash information:
Right-of-use assets obtained in exchange for new lease obligations$2.4 $3.2 
Maturities of lease liabilities for operating leases as of September 30, 2022, are as follows:
(dollars in millions)
Remainder of 2022$0.4 
20232.1 
20242.1 
20250.5 
2026 
Total lease payments5.1 
Less: imputed interest(0.2)
Total$4.9 
7. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consisted of the following:
(dollars in millions)September 30,
2022
December 31,
2021
Accounts payable$7.9 $31.3 
Accrued liabilities
Research and development expenses24.8 9.5 
Employee expenses12.2 12.4 
Income taxes2.0  
Professional fees and other2.8 1.2 
Total accounts payable and accrued liabilities$49.7 $54.4 
8. Long-Term Debt
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 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. As of September 30, 2022, $1.0 million remains outstanding under the 2018 Assistance Agreement.
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 $2.5 million plus liquidated damages of 7.5%.
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Minimum future principal payments on long-term debt for the years ending December 31 are as follows:
(dollars in millions)
2023$ 
20240.2 
20250.2 
20260.2 
20270.2 
20280.2 
Total$1.0 
During the three and nine months ended September 30, 2022 and 2021, interest expense was immaterial.
9. 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" offering. During the nine months ended September 30, 2022, no shares were issued under this agreement.
Share-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 increase, 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, 2022, 1,986,565 shares remained available for purchase. During the nine months ended September 30, 2022 and 2021, the Company issued 24,898 and 19,357 shares, 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 to four years. The Incentive Plan was terminated in September 2018.
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 common shares 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) 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 expired, terminated or were 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
12

first day of the year or an amount determined by the Company’s board of directors. As of September 30, 2022, 2,268,813 shares remained available for issuance under the 2018 Plan. Common shares 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, 2022 and 2021, the Company recognized compensation expense of $18.8 million and $15.2 million, respectively, relating to the issuance of incentive awards. During the nine months ended September 30, 2022 and 2021, the Company recognized compensation expense of $55.4 million and $40.1 million, respectively, relating to the issuance of incentive awards.
As of September 30, 2022, there was $76.7 million of unrecognized compensation expense that is expected to be amortized over a weighted average period of approximately two years.
Stock Options
The fair value of the stock options granted during the nine months ended September 30, 2022 and 2021 was determined using the Black-Scholes option pricing model with the following assumptions:
 September 30,
2022
September 30,
2021
Expected volatility
73.2 - 76.0%
74.8 - 78.0%
Expected term (years)
5.5 - 7.0
5.3 - 7.0
Risk free interest rate
1.5% - 3.3%
0.5% - 1.2%
Expected dividend yield0 %0 %
Exercise price
$36.79 - $78.91
$66.82 - $100.40
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, 2022 is presented below. These amounts include stock options granted to employees and directors.
(dollars in millions,
except weighted average exercise price)
Options
Weighted Average
Exercise Price
Weighted Average
Remaining Contractual
Term (Years)
Aggregate Intrinsic Value
Outstanding as of December 31, 2021
5,343,254 $44.98 
Granted1,716,817 $60.13 
Exercised(167,118)$18.11 
Forfeited(194,089)$61.70 
Outstanding as of September 30, 2022
6,698,864 $49.05 7.9$59.9 
Exercisable as of September 30, 2022
3,340,023 $35.62 7.0$53.8 
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The weighted-average grant date fair value per share of options granted during the nine months ended September 30, 2022 was $39.69. The total intrinsic value of options exercised during the nine months ended September 30, 2022 was $7.6 million.
As of September 30, 2022, there were 6,396,248 stock options under the 2018 Plan that have vested or are expected to vest.
Restricted Stock Awards
A summary of restricted stock award activity under the Incentive Plan during the nine months ended September 30, 2022 is presented below. These amounts include restricted stock granted to employees and directors.
Shares
Weighted Average
Grant Date
Fair Value Per
Share
Unvested restricted stock as of December 31, 2021
30,625 $16.00 
Vested(29,305)$16.00 
Cancelled(1,320)$16.00 
Unvested restricted stock as of September 30, 2022
 $16.00 
Restricted Stock Units
A summary of restricted stock unit activity under the 2018 Plan during the nine months ended September 30, 2022 is presented below. These amounts include restricted stock units granted to employees.
Shares
Weighted Average
Grant Date
Fair Value Per
Share
Unvested restricted stock units as of December 31, 2021
88,307 $20.02 
Granted370,466 $55.42 
Vested(42,500)$20.04 
Cancelled(14,774)$52.43 
Unvested restricted stock units as of September 30, 2022
401,499 $51.49 
As of September 30, 2022, there were 334,575 restricted stock units under the 2018 Plan that have vested or are expected to vest.
10. Income Taxes
For the three months ended September 30, 2022, the Company recognized income tax expense of $2.2 million resulting in an effective tax rate of (3.4)%, as compared to income tax expense of zero resulting in an effective tax rate of 0.0% in the same period for 2021. 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 (3.4)% was the effect of equity compensation, generation of research and development tax credits, deferred state income taxes 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, 2021 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.
For the nine months ended September 30, 2022, the Company recognized income tax expense of $10.1 million resulting in an effective tax rate of (5.3)%, as compared to income tax expense of zero resulting in an effective tax rate of 0.0% in the same period for 2021. 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 (5.3)% was the effect of equity compensation, generation of research and development tax credits,
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deferred state income taxes 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 21.00% for the nine months ended September 30, 2021 and the Company’s overall effective tax rate of 0.00% was the effect of equity compensation and the valuation allowance recorded against the full amount of its net deferred tax assets.
A valuation allowance is established when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company is projecting taxable income for the current year, and as a result projects current income tax expense for the year. The projection of taxable income is primarily due to revenue recognition for tax purposes from the ARV-471 Collaboration Agreement and the capitalization of qualified research and development expenses incurred on or after January 1, 2022, which upon recognition for tax purposes would create additional deferred tax assets. Under the Tax Cuts and Jobs Act of 2017, qualified research expenses incurred after 2021 are no longer immediately deductible for tax purposes and instead must be amortized over at least five years for tax purposes. The Company continues to establish a full valuation allowance against the Company’s net deferred tax assets since it is more likely than not that benefits will not be realized, including those benefits created in the current year. This assessment is based on the Company's historical cumulative losses which provide strong objective evidence that cannot be overcome with projections of income, as well as the fact the Company expects continuing losses in the future.
11. Net Loss Per Share
Basic and diluted loss per common share was calculated as follows:
For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
(dollars and shares in millions, except per common share amounts)2022202120222021
Net loss$(66.2)$(46.8)$(199.6)$(138.0)
Weighted average number of common shares outstanding
 - basic and diluted
53.2 49.8 53.1 49.1 
Net loss per common share
- basic and diluted
$(1.24)$(0.94)$(3.76)$(2.81)
The Company reported net losses for each of the three and nine months ended September 30, 2022 and 2021, and, therefore, excluded all stock options, restricted stock awards 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 For the Three and Nine Months Ended
September 30,
(shares in millions)20222021
Stock options6.7 5.3 
Restricted stock awards 0.1 
Restricted stock units0.4 0.1 
7.1 5.5 
12. Equity Method Investments
In July 2019, the Company and Bayer CropScience LP (“Bayer LP”) formed a joint venture, Oerth Bio LLC (“Oerth”), to research, develop and commercialize PROTAC targeted protein degraders for applications in the field of agriculture. As Oerth is jointly controlled by the Company and Bayer LP, the Company accounts for its 50% interest using the equity method of accounting. The Company also provides to Oerth compensated research and development services and administrative services through a separate agreement. The services
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rendered by the Company during the three and nine months ended September 30, 2022 and 2021 were immaterial.
Operating expenses and net loss of Oerth for the three months ended September 30, 2022 and 2021 totaled $6.2 million and $3.5 million, respectively. Operating expenses and net loss of Oerth for the nine months ended September 30, 2022 and 2021 totaled $16.3 million and $9.5 million, respectively.
The carrying value of the investment has been reduced to zero and, as a result, no additional losses were recorded against the carrying value of the investment during the three and nine months ended September 30, 2022 and 2021.
13. 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. Legal fees and other costs associated with such actions are expensed as incurred. As of September 30, 2022, the Company does not believe there are any such matters where there is at least a reasonable probability that a material loss, if any, has been or will be incurred.
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 we are a party, we 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
On June 4, 2022, the Company entered into a Master In Vitro Diagnostics Agreement, effective as of June 4, 2022 with Foundation Medicine, Inc. (the "FMI Agreement") 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.
Bavdegalutamide
In exchange for the development of FoundationOne® Liquid CDx as a companion diagnostic for use with bavdegalutamide 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 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.
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
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an applicable program, if (a) a reasonably necessary third party license is not secured by Foundation Medicine or if we do not consent to payments for such license (b) 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.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis is meant to provide material information relevant to an assessment of the financial condition and results of operations of our company, including an evaluation of the amount and certainty of cash flows from operations and from outside sources, so as to allow investors to better view our company from management’s perspective. You should read the following discussion and analysis of financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the consolidated financial statements and the related notes and discussion and analysis of financial condition and results of operations in our Annual Report on Form 10-K for the year ended December 31, 2021 filed on February 28, 2022. This discussion contains forward-looking statements that involve risks and uncertainties. As a result of many factors, such as those set forth in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021, filed on February 28, 2022 and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in or implied by these forward-looking statements.
Overview
Our Business
We are a clinical-stage biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development and commercialization of therapies to degrade disease-causing proteins. We use our PROTAC Discovery Engine, our proprietary technology platform to engineer proteolysis targeting chimeras, or PROTAC targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively remove disease-causing proteins. We believe that our targeted protein degradation approach is a therapeutic modality that may provide distinct advantages over existing modalities, including traditional small molecule therapies and gene-based medicines. Our small molecule PROTAC technology has the potential to address a broad range of intracellular disease targets, including those representing up to the 80% of proteins that currently cannot be addressed by existing small molecule therapies, commonly referred to as “undruggable” targets. We are using our PROTAC Discovery Engine to build an extensive pipeline of protein degradation product candidates to target diseases in oncology (including immuno-oncology), neuroscience, and other therapeutic areas. Our three lead product candidates are bavdegalutamide (ARV-110), ARV-471, and ARV-766.
Bavdegalutamide (ARV-110)
We are developing bavdegalutamide, an investigational orally bioavailable PROTAC protein degrader targeting the androgen receptor protein, or AR, for the treatment of men with metastatic castration-resistant prostate cancer, or mCRPC. In 2019, we initiated a Phase 1/2 clinical trial of bavdegalutamide designed to assess the safety, tolerability and pharmacokinetics of bavdegalutamide, which also includes measures of anti-tumor activity as secondary endpoints, including reduction in prostate specific antigen, or PSA, a well-recognized biomarker of prostate cancer progression. We received fast track designation for bavdegalutamide for mCRPC in May 2019. We have completed dose escalation in the Phase 1 clinical trial. In the fourth quarter of 2020, we initiated ARDENT, the Phase 2 single agent expansion portion of the bavdegalutamide clinical trial. In the fourth quarter of 2021, we initiated a Phase 1b clinical trial with bavdegalutamide in combination with abiraterone for the treatment of men with mCRPC.
In the first half of 2023, we plan to confirm the final dose selection and secure final health authority feedback for a global Phase 3 trial protocol and, in the second half of 2023, initiate a global Phase 3 trial in mCRPC for patients with AR T878/H875 tumor mutations. Also in the second half of 2023, we expect to complete enrollment in the Phase 1b clinical trial with bavdegalutamide in combination with abiraterone.
ARV-471
We are developing ARV-471, an investigational orally bioavailable PROTAC protein degrader targeting the estrogen receptor protein, or ER, for the treatment of patients with locally advanced or metastatic ER positive / HER2 negative breast cancer. In 2019, we initiated a Phase 1/2 clinical trial of ARV-471 designed to assess the safety, tolerability and pharmacokinetics of ARV-471, which also includes measures of anti-tumor
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activity as secondary endpoints. In the fourth quarter of 2020, we initiated a Phase 1b cohort expansion of ARV-471 in combination with Ibrance® (palbociclib). We have completed dose escalation in the Phase 1 clinical trial. In the first quarter of 2021, we initiated VERITAC, the Phase 2 single agent expansion cohort of the clinical trial. In July 2021, we entered into a collaboration agreement with Pfizer Inc., or Pfizer, pursuant to which we granted Pfizer worldwide coexclusive rights to develop and commercialize ARV-471. In the third quarter of 2022, we initiated TACTIVE-E, a Phase 1b clinical trial with ARV-471 in combination with everolimus in patients with metastatic breast cancer; initiated with Pfizer activities that will enable dosing in TACTIVE-U, a Phase 1b umbrella trial combination trial, with the cyclin-dependent kinase, or CDK, inhibitors abemaciclib and ribociclib in two of the combination arms in the fourth quarter of 2022; initiated with Pfizer a Phase 1b trial with ARV-471 as a monotherapy in Japanese patients; and initiated activity that will enable dosing for TACTIVE-N, a Phase 2 clinical trial with ARV-471 as a monotherapy in patients with early breast cancer in the neoadjuvant setting in the fourth quarter of 2022.
In the fourth quarter of 2022, we plan to present data from the VERITAC Phase 2 dose expansion cohort (with patients dosed at 200 mg and 500 mg). Also in the fourth quarter of 2022, in partnership with Pfizer, we plan to initiate a Phase 3 trial with ARV-471 in combination with palbociclib as a first-line treatment in patients with metastatic breast cancer and initiate a Phase 3 trial with ARV-471 as a second-line treatment in patients with metastatic breast cancer. In 2023, we plan, with Pfizer, to initiate additional arms of the Phase 1b combination trial TACTIVE-U of ARV-471 with other targeted therapies. In the first half of 2023, we plan to present data from the Phase 1b combination trial of ARV-471 with palbociclib at a medical conference.
ARV-766
We are developing ARV-766, an investigational orally bioavailable PROTAC protein degrader for the treatment of men with mCRPC. In preclinical studies, ARV-766 degraded all tested resistance-driving point mutations of AR, including L702H, a mutation associated with treatment with abiraterone and other AR-pathway therapies, which bavdegalutamide did not degrade in preclinical studies. In 2021, we initiated a Phase 1/2 clinical trial of ARV-766 designed to assess the safety, tolerability and pharmacokinetics of ARV-766, which also includes measures of anti-tumor activity as secondary endpoints, including reduction in PSA. In the fourth quarter of 2022, we initiated the Phase 2 expansion portion of the clinical trial at two dose levels.
In the second quarter of 2023, we plan to present Phase 1 dose escalation data.
Bavdegalutamide, ARV-471 and ARV-766 have all demonstrated potent and selective protein degradation in our preclinical studies. We believe that favorable clinical trial results in these initial oncology programs would provide validation of our platform as a new therapeutic modality for the potential treatment of diseases caused by dysregulated intracellular proteins regardless of therapeutic area.
We plan to submit two investigational new drug (IND)/clinical trial authorization (CTA) applications, one in neurology and one in oncology, by the end of 2023, with at least two additional programs in IND- or CTA-enabling studies.
Our Operations
As a result of the COVID-19 pandemic, many companies have experienced disruptions in their operations and in the markets they serve. We have instated some and may take additional precautionary measures intended to help ensure our employees’ well-being and minimize business disruption. We temporarily shut down our laboratories in mid-March 2020 and initiated work with biology contract research organizations, or CROs, but have since reopened our laboratories and our office-based employees are working in a hybrid of remote and in-person work. We considered the impact of COVID-19 on the assumptions and estimates used and determined that there were no material adverse impacts on our results of operations and financial position as of September 30, 2022. The full extent of the impacts of COVID-19 on our operations remains uncertain and could have a material adverse impact on our financial results and business operations, including the timing and our ability to complete certain clinical trials and other efforts required to advance our preclinical pipeline.
We commenced operations in 2013. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates, undertaking preclinical studies and clinical trials and establishing arrangements with third parties for the manufacture of initial quantities of our product candidates.
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To date, we have not generated any revenue from product sales and have financed our operations primarily through sales of our equity interests, proceeds from our collaborations, grant funding and debt financing. Since inception through September 30, 2022, we raised approximately $1.3 billion in gross proceeds from the sale of equity instruments and the exercise of stock options and had received an aggregate of $780.5 million in payments primarily from collaboration partners.
We are a clinical-stage company. Bavdegalutamide, ARV-471 and ARV-766 are each in Phase 1/2 clinical trials and our other drug discovery activities are at the research and preclinical development stages. Our ability to generate revenue from product sales sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Since inception, we have incurred significant operating losses. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. Our net loss was $199.6 million for the nine months ended September 30, 2022. As of September 30, 2022, we had an accumulated deficit of $882.5 million.
Our total operating expenses were $281.2 million for the nine months ended September 30, 2022. We anticipate that our expenses will increase substantially due to costs associated with our ongoing and anticipated clinical activities for bavdegalutamide, ARV-471, and ARV-766, development activities associated with our other product candidates, research activities in oncology, neurological and other disease areas to expand our pipeline, hiring additional personnel in research, clinical trials, quality and other functional areas, increased expenses incurred with contract manufacturing organizations, or CMOs, to supply us with product for our preclinical and clinical studies and CROs for the synthesis of compounds in our preclinical development activities, as well as other associated costs including the management of our intellectual property portfolio.
We do not expect to generate revenue from sales of any product for many years, if ever. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research or product development programs or any future commercialization efforts, or to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.
Financial Operations Overview
Revenue
To date, we have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products in the foreseeable future. Our revenues to date have been generated through research collaboration and license agreements. Revenue is recognized ratably over our expected performance period under each agreement. We expect that any revenue for the next several years will be derived primarily from our current collaboration agreements and any additional collaborations that we may enter into in the future. To date, we have not received any sales-based milestone payments or royalties under any of the collaboration agreements.
Genentech License Agreement
In September 2015, we entered into an Option and License Agreement with Genentech, Inc. and F. Hoffmann-La Roche Ltd, collectively referred to as Genentech, focused on PROTAC targeted protein degrader discovery and research for target proteins, or Targets, based on our proprietary platform technology, other than excluded Targets as described below. This collaboration was expanded in November 2017 through an Amended and Restated Option, License and Collaboration Agreement, which we refer to as the Restated Genentech Agreement.
Under the Restated Genentech Agreement, Genentech has the right to designate up to ten Targets for further discovery and research utilizing our PROTAC platform technology. Genentech may designate as a Target any protein to which a PROTAC targeted protein degrader, by design, binds to achieve its mechanism of action, subject to certain exclusions. Genentech also has the right to remove a Target from the collaboration and substitute a different Target that is not an excluded Target at any time prior to us commencing research on such Target or in certain circumstances following commencement of research by us.
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At the time we entered into the original agreement with Genentech we received an upfront payment of $11.0 million, and at the time we entered into the Restated Genentech Agreement, we received an additional $34.5 million in upfront and expansion target payments. We are eligible to receive up to an aggregate of $27.5 million in additional expansion target payments if Genentech exercises its options for all remaining Targets. We are also eligible to receive payments aggregating up to $44.0 million per Target upon the achievement of specified development milestones; payments aggregating up to $52.5 million per Target (assuming approval of two indications) subject to the achievement of specified regulatory milestones; and payments aggregating up to $60.0 million per PROTAC targeted protein degrader directed against the applicable Target, subject to the achievement of specified sales milestones. These milestone payments are subject to reduction if we do not have a valid patent claim covering the licensed PROTAC targeted protein degrader at the time the milestone is achieved. We are also eligible to receive, on net sales of licensed PROTAC targeted protein degraders, mid-single digit royalties, which may be subject to reductions.
Pfizer Research Collaboration Agreement
In December 2017, we entered into a Research Collaboration and License Agreement with Pfizer, setting forth our collaboration to identify or optimize PROTAC targeted protein degraders that mediate for degradation of Targets, using our proprietary platform technology that are identified in the agreement or subsequently selected by Pfizer, subject to certain exclusions. We refer to this agreement as the Pfizer Research Collaboration Agreement.
Under the Pfizer Research Collaboration Agreement, Pfizer has designated a number of initial Targets. For each identified Target, we and Pfizer will conduct a separate research program pursuant to a research plan. Pfizer may make substitutions for any of the initial Target candidates, subject to the stage of research for such Target.
In the year ended December 31, 2018, we received an upfront non-refundable payment and certain additional payments totaling $28.0 million in exchange for use of our technology license and to fund Pfizer-related research as defined within the Pfizer Research Collaboration Agreement. We are 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. We are 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 mid- to high-single digit tiered royalties, which may be subject to reductions, on net sales of PROTAC targeted protein degrader-related products. We received payments totaling $3.5 million in the nine months ended September 30, 2022, and $1.2 million and $4.4 million in the years ended December 31, 2021 and 2020, respectively, for additional targets and services.
Bayer Collaboration Agreement
In June 2019, we entered into a Collaboration and License Agreement, or the Bayer Collaboration Agreement, with Bayer AG, or, together with its controlled affiliates, Bayer, setting forth our collaboration to identify or optimize PROTAC targeted protein degraders that mediate for degradation of Targets, using our proprietary platform technology, that are selected by Bayer, subject to certain exclusions and limitations. The Bayer Collaboration Agreement became effective in July 2019.
Under the Bayer Collaboration Agreement, we and Bayer conduct a research program pursuant to separate research plans mutually agreed to by us and Bayer and tailored to each Target selected by Bayer. Bayer may make substitutions for any such initial Target candidates, subject to certain conditions and based on the stage of research for such Target. During the term of the Bayer Collaboration Agreement, we are not permitted, either directly or indirectly, to design, identify, discover or develop any small molecule pharmacologically-active agent whose primary mechanism of action is, by design, directed to the inhibition or degradation of any Target selected or reserved by Bayer, or grant any license, covenant not to sue or other right to any third party in the field of human disease under the licensed intellectual property for the conduct of such activities.
Under the terms of the Bayer Collaboration Agreement, we received an aggregate upfront non-refundable payment of $17.5 million. Bayer is committed to fund a total of $12.0 million in research funding
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payments through 2023, of which $10.5 million was received from inception through September 30, 2022, subject to potential increases if our costs for research activities exceed the research funding payments allocated to a Target and certain conditions are met. We are 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, we are 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.
Pfizer ARV-471 Collaboration Agreement
In July 2021, we entered into a collaboration agreement with Pfizer, or the ARV-471 Collaboration Agreement, pursuant to which we granted Pfizer worldwide co-exclusive rights to develop and commercialize products containing our proprietary compound ARV-471, or the Licensed Products.
Under the ARV-471 Collaboration Agreement, we received an upfront, non-refundable payment of $650.0 million. In addition, we are eligible to receive up to an additional $1.4 billion in contingent payments based on specified regulatory and sales-based milestones for the Licensed Products. Of the total contingent payments, $400 million in regulatory milestones are related to marketing approvals and $1.0 billion are related to sales-based milestones.
We and Pfizer share equally (50/50) all development costs (including costs for conducting any clinical trials) for the Licensed Products, subject to certain exceptions. Except for certain regions described below, we will also share equally (50/50) all profits and losses in commercialization and medical affairs activities for the Licensed Products in all other countries, subject to certain exceptions.
We will be the marketing authorization holder and, subject to marketing approval, book sales in the United States, while Pfizer will hold marketing authorizations outside the United States. We will determine with Pfizer 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 all profits and losses for the Licensed Products based on the role each party will be performing.
Unless earlier terminated in accordance with its terms, the ARV-471 Collaboration Agreement will expire on a Licensed Product-by-Licensed Product and country-by-country basis when such Licensed Products are no longer commercialized or developed for commercialization in such country. Pfizer may terminate the ARV-471 Collaboration Agreement for convenience in its entirety or on a region-by-region basis subject to certain notice periods. Either party may terminate the ARV-471 Collaboration Agreement for the other party’s uncured material breach or insolvency. Subject to applicable terms of the ARV-471 Collaboration Agreement, including certain payments to Pfizer upon termination for our uncured material breach, effective upon termination of the ARV-471 Collaboration Agreement, we are entitled to retain specified licenses to be able to continue to exploit the Licensed Products.
Subject to specified exceptions, we and Pfizer have each agreed not to directly or indirectly research, develop, or commercialize any competing products outside of the ARV-471 Collaboration Agreement anywhere in the world during the term of the ARV-471 Collaboration Agreement.
Operating Expenses
Our operating expenses since inception have consisted solely of research and development costs and general and administrative costs.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our product candidates, and include:
salaries, benefits and other related costs, including stock-based compensation expense, for personnel engaged in research and development functions;
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expenses incurred under agreements with third parties, including CROs and other third parties that conduct research and preclinical activities on our behalf as well as third parties that manufacture our product candidates for use in our preclinical studies and clinical trials;
costs of outside consultants, including their fees, stock-based compensation and related travel expenses;
the costs of laboratory supplies and developing preclinical studies and clinical trial materials;
facility-related expenses, which include direct depreciation costs of equipment and allocated expenses for rent and maintenance of facilities and other operating costs; and
third-party licensing fees.
We expense research and development costs as incurred.
We typically use our employee and infrastructure resources across our development programs, and as such, do not track all of our internal research and development expenses on a program-by-program basis. The following table summarizes our research and development expenses for our AR program, which includes bavdegalutamide and ARV-766, ER program, which includes ARV-471, and all other platform and exploratory research and development costs:
 For the Three Months Ended
September 30,
For the Nine Months Ended
September 30,
(in millions)2022202120222021
AR program development costs$13.4 $10.6 $40.7 $30.5 
ER program development costs16.1 4.3 51.1 15.9 
Other research and development costs48.0 25.7 124.9 72.1 
Total research and development costs$77.5 $40.6 $216.7 $118.5 
Research and development activities are central to our business model. We expect that our research and development expenses will continue to increase substantially for the foreseeable future as we conduct clinical trials for bavdegalutamide, ARV-471 and ARV-766, including our ongoing Phase 1/2 clinical trials for bavdegalutamide, ARV-471 and ARV-766 and continue to discover and develop additional product candidates. Research and development expenses related to ARV-471 are shared equally with Pfizer from July 22, 2021, the effective date of the ARV-471 Collaboration Agreement. The ER program development costs in the table above reflect the cost sharing with Pfizer.
We cannot reasonably estimate or determine with certainty the duration and costs of future clinical trials of bavdegalutamide, ARV-471 and ARV-766 or any other product candidate we may develop or if, when, or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The successful development and commercialization of our product candidates is highly uncertain. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
successful completion of preclinical studies;
successful initiation of clinical trials;
successful patient enrollment in and completion of clinical trials;
receipt and related terms of marketing approvals from applicable regulatory authorities;
obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;
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making arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of our product candidates;
establishing sales, marketing and distribution capabilities and launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;
acceptance of our products, if and when approved, by patients, the medical community and third-party payors;
obtaining and maintaining third-party coverage and adequate reimbursement;
maintaining a continued acceptable safety profile of the products following approval; and
effectively competing with other therapies.
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation for personnel in our executive, finance, business development and administrative functions. General and administrative expenses also include legal fees relating to intellectual property and corporate matters; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
We expect that our general and administrative expenses will increase in the future as we increase our personnel headcount to support increased research and development activities relating to our product candidates. We also expect to incur increased expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with the Nasdaq Stock Market and Securities and Exchange Commission requirements; director and officer insurance costs; and investor and public relations costs.
Income Taxes
Since our inception in 2013, we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in any year or for our federal or state earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. As of December 31, 2021, we had federal net operating loss carryforwards of $373.6 million, which begin to expire in 2033, state and local net operating loss carryforwards of $346.9 million, and federal and state research and development tax credit carryforwards of $15.2 million and $4.5 million, respectively, which begin to expire in 2033 and 2036, respectively. We expect to fully utilize these net operating loss and credit carryforwards in the current year due to taxable income resulting from revenue recognition for tax purposes from our ARV-471 Collaboration Agreement and the capitalization of qualified research and development expenses incurred on or after January 1, 2022. The revenue recognition and capitalization of research expenses are timing differences for tax purposes and deferred tax assets were established. We have provided a valuation allowance against the full amount of the deferred tax assets since, in the opinion of management, based upon our earnings history, it is more likely than not that the benefits will not be realized.
As of September 30, 2022, Arvinas, Inc. had four wholly-owned subsidiaries organized as C-corporations: Arvinas Operations, Inc., Arvinas Androgen Receptor, Inc., Arvinas Estrogen Receptor, Inc., and Arvinas Winchester, Inc. Prior to December 31, 2018, these subsidiaries were separate filers for federal tax purposes.
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Critical Accounting Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our condensed consolidated financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on February 28, 2022.
Results of Operations
Comparison of Three and Nine Months Ended September 30, 2022 and 2021
For the Three Months Ended
September 30,
For the For the Nine Months Ended
September 30,
(dollars in millions)20222021$ change20222021$ change
Revenue$30.3 $9.3 $21.0 $85.8 $20.4 $65.4 
Research and development expenses77.5 40.6 36.9 216.7 118.5 98.2 
General and administrative expenses20.0 16.0 4.0 64.5 42.8 21.7 
Other income3.2 0.5 2.7 5.9 2.9 3.0 
Income tax expense(2.2)— (2.2)(10.1)—