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Arvinas Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

Key Takeaway: Arvinas Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update NEW HAVEN, Conn. February 28, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today r

Full Press Release Details

Arvinas Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update
NEW HAVEN, Conn. February 28, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology
company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.
It has been an exciting time for Arvinas over the past 12 months, including the beginning of a transformational collaboration with Pfizer, and
compelling clinical updates supporting our two lead clinical programs, ARV-471 and bavdegalutamide, or ARV-110, said John Houston, Ph.D., chief executive officer
and president at Arvinas. We believe ARV-471 has the potential for a best-in-class profile for the treatment of ER+/HER2-
breast cancer and, looking ahead, we have a number of important clinical milestones upcoming with ARV-471, including the initiation of two planned Phase 3 trials in metastatic breast cancer as a monotherapy
To follow up our strong finish to 2021, we began 2022 by presenting new data at ASCO GU that showed bavdegalutamide
demonstrated a clinical profile that we believe supports its potential as a precision medicine for men with prostate cancer and tumors harboring AR T878/H875 point mutations, continued Dr. Houston. We anticipate starting a pivotal
trial with bavdegalutamide by year-end 2022, which will be our third pivotal trial planned for the year one with bavdegalutamide, and two with ARV-471. We are
making significant progress across our pipeline, bringing us one step closer to potentially delivering life-saving new therapies to patients.
Business Highlights and Recent Developments
Anticipated 2022 Milestones and Expectations
Bavdegalutamide (ARV-110)
Full Year and Fourth Quarter Financial Results
Cash Equivalents and Marketable Securities Position: As of December 31, 2021, cash, cash equivalents, restricted cash and marketable securities were $1,507.1 million, as compared with $688.6 million as of December 31, 2020. The
increase in cash, cash equivalents, restricted cash and marketable securities of $818.5 million for the year was primarily related to cash received from the global Pfizer collaboration agreement to develop and commercialize ARV-471 (ARV-471 Collaboration Agreement) of $650.0 million, the equity investment by Pfizer of $350.0 million and proceeds from the exercise of stock options of
$18.6 million, partially offset by cash used in operating activities of $172.7 million (net of $4.2 million received from two collaborators), professional fees associated with the ARV-471
Collaboration Agreement and equity investment of $17.5 million, the purchase of lab equipment and leasehold improvements of $4.7 million and unrealized loss on marketable securities of $5.2 million.
Research and Development Expenses: Research and development expenses were $180.4 million and $61.8 million for the year and quarter ended
December 31, 2021, respectively as compared with $108.4 million and $33.2 million for the year and quarter ended December 31, 2020, respectively. The increase in research and development expenses of $72.0 million for the
year ended December 31, 2021, was primarily due to an increase in expenses associated with our platform and exploratory programs of $41.2 million, our AR program (which includes bavdegalutamide and
ARV-766) of $17.4 million and our ER program of $13.4 million. The increase in research and development expenses of $28.6 million for the quarter ended December 31, 2021, was primarily due
to an increase in expenses associated with our platform and exploratory programs of $15.0 million, our AR program of $3.2 million and our ER program of $10.4 million.
General and Administrative Expenses: General and administrative expenses were $61.6 million and
$18.9 million for the year and quarter ended December 31, 2021, respectively, as compared with $38.3 million and $12.2 million for the year and quarter ended December 31, 2020, respectively. The increase in general and
administrative expenses of $23.3 million for the year ended December 31, 2021, was primarily due to an increase of personnel and facility related costs of $19.2 million and insurance, taxes and professional fees of $4.2 million.
The increase in general and administrative expenses of $6.7 million for the quarter ended December 31, 2021was primarily due to an increase of personnel and facility related costs of $6.0 million and insurance, taxes and professional
fees of $0.6 million.
Revenues: Revenue was $46.7 million and $26.3 million for the year and quarter ended December 31, 2021,
respectively, as compared with $21.8 million and $2.2 million for the year and quarter ended December 31, 2020, respectively. Revenue is related to the ARV-471 Collaboration Agreement with
Pfizer that was initiated in July 2021, the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license
agreement with Pfizer that was initiated in January 2018 and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017. The increase in revenue of $24.9 million and
$24.1 million for the year and quarter ended December 31, 2021, respectively was primarily due to revenue from the ARV-471 Collaboration Agreement with Pfizer.
Net Loss: Net loss was $191.0 million and $53.0 million for the year and quarter ended December 31, 2021, respectively as compared with
$119.3 million and $41.5 million for the year and quarter ended December 31, 2020, respectively. The increase in net loss for the year and quarter ended December 31, 2021, was primarily due to increased research and development
expenses and increased general and administrative expenses, partially offset by increased revenue.
About bavdegalutamide (ARV-110)
Bavdegalutamide (ARV-110) is an investigational orally
bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with metastatic
castration-resistant prostate cancer.
Bavdegalutamide has demonstrated activity in preclinical models of AR mutation or overexpression, both common
mechanisms of resistance to currently available AR-targeted therapies.
ARV-471 is an investigational orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.
In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor
shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in
combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of ARV-471; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.
ARV-766 is an investigational orally bioavailable PROTAC
protein degrader designed to selectively target and degrade AR. In preclinical studies, ARV-766 degraded all resistance-driving point mutations of AR, including L702H, a mutation associated with treatment with
abiraterone and other AR-pathway therapies.
ARV-766 is being developed as
a potential treatment for men with metastatic castration-resistant prostate cancer, and ARV-766 may also have applicability in other AR-driven diseases both in and
outside oncology. ARV-766 has demonstrated activity in preclinical models of resistance to currently available AR-targeted therapies.
Arvinas 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. Arvinas uses
its proprietary PROTAC Discovery Engine 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 and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC protein degraders against validated and undruggable targets, the company has three clinical-stage programs: bavdegalutamide and ARV-766 for the
treatment of men with metastatic castration-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit
Forward-Looking Statements
press release contains forward-looking statements that involve substantial risks and uncertainties, including statements regarding the potential benefits of the Pfizer collaboration and the potential advantages and therapeutic benefits of ARV-471, bavdegalutamide, ARV-766 and our other product candidates, the future development and potential marketing approval and commercialization of ARV-471, bavdegalutamide, ARV-766 and our other product candidates, including the initiation of and timing of data from our clinical trials. All statements, other than
statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. The words anticipate,
believe, estimate, expect, intend, may, might, plan, predict, project, target, potential, 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.
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 as a result of various risks and uncertainties, including but not limited
to:, each party s performance of its obligations under the Pfizer collaboration, whether we and, as applicable, Pfizer will be able to successfully conduct and complete clinical development, including whether we initiate and receive results
from our clinical trials on our expected timelines or at all, obtain marketing approval for and commercialize ARV-471, bavdegalutamide, ARV-766 and our other product
candidates on our current timelines or at all and other important factors discussed in the Risk Factors sections contained in our quarterly and annual reports on file with the Securities and Exchange Commission. The forward-looking
statements contained in this press release reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law. These forward-looking statements should
not be relied upon as representing our views as of any date subsequent to the date of this release.
ARVINAS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets (Unaudited)
December 31,
(dollars and shares in millions) 2021 2020
Assets
Current assets:
Cash and cash equivalents $ 108.3 $ 588.4
Restricted cash 4.5
Marketable securities 1,394.3 100.2
Accounts receivable 15.0 1.0
Other receivables 10.7 7.4
Prepaid expenses and other current assets 19.7 6.1
Total current assets 1,552.5 703.1
Property, equipment and leasehold improvements, net 12.7 12.3
Operating lease right of use assets 3.9 2.0
Collaboration contract asset and other assets 12.5
Total assets $ 1,581.6 $ 717.4
Liabilities and stockholders equity
Current liabilities:
Accounts payable $ 31.3 $ 7.1
Accrued expenses 23.1 18.9
Deferred revenue 206.2 22.2
Current portion of operating lease liability 1.1 1.0
Total current liabilities 261.7 49.2
Deferred revenue 534.3 22.9
Long term debt 1.0 2.0
Operating lease liability 2.9 1.1
Total liabilities 799.9 75.2
Commitments and contingencies
Stockholders equity:
Common stock, $0.001 par value, 53.0 and 48.5 shares issued and outstanding as of December 31, 2021 and 2020, respectively
Accumulated deficit (682.9 ) (491.9 )
Additional paid-in capital 1,469.2 1,133.5
Accumulated other comprehensive (loss) income (4.6 ) 0.6
Total stockholders equity 781.7 642.2
Total liabilities and stockholders equity $ 1,581.6 $ 717.4
ARVINAS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations (Unaudited)
Three Months Ended December 31, Year Ended December 31,
(dollars and shares in millions, except per share amounts) 2021 2020 2021 2020
Revenue $ 26.3 $ 2.2 $ 46.7 $ 21.8
Operating expenses:
Research and development 61.8 33.2 180.4 108.4
General and administrative 18.9 12.2 61.6 38.3
Total operating expenses 80.7 45.4 242.0 146.7
Loss from operations (54.4 ) (43.2 ) (195.3 ) (124.9 )
Interest and other income 1.4 1.7 4.3 5.6
Net loss $ (53.0 ) $ (41.5 ) $ (191.0 ) $ (119.3 )
Net loss per common share - basic and diluted $ (1.00 ) $ (0.99 ) $ (3.82 ) $ (3.02 )
Weighted average common shares outstanding - basic and diluted 52.8 41.8 50.0 39.5
Last updated: Feb 28, 2022