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Arvinas Reports Third Quarter 2019 Financial Results and Provides Corporate Update

Key Takeaway: Arvinas Reports Third Quarter 2019 Financial Results and Provides Corporate Update NEW HAVEN, Conn. November 4, 2019 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, today reported fina

Full Press Release Details

Arvinas Reports Third Quarter 2019 Financial Results and Provides Corporate Update
NEW HAVEN, Conn. November 4, 2019 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company
creating a new class of drugs based on targeted protein degradation, today reported financial results for the third quarter of 2019 and provided a corporate update.
We recently became the first company to present clinical data on a targeted protein degrader, sharing initial data on our first two oncology programs.
In addition, we shared preclinical data demonstrating that brain-penetrant PROTAC protein degraders could degrade pathologic tau in vivo, further demonstrating the potential of our
PROTAC platform, said John Houston, Ph.D., Chief Executive Officer of Arvinas. We look forward to the continued progress of our lead programs and pipeline, and ultimately to
making a difference in the lives of patients.
Business Highlights and Recent Developments
Anticipated Milestones and Expectations
Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned
operating expenses and capital expenditure requirements into the second half of 2021.
Financial Highlights
Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2019, cash, cash equivalents, and marketable securities were $190.5
million as compared to $187.8 million as of December 31, 2018. The increase in cash, cash equivalents and marketable securities of $2.7 million in the first nine months of 2019 primarily related to aggregate proceeds of $51.5 million from
a collaboration and license agreement with Bayer and the issuance of common stock to Bayer, partially offset by the purchase of lab equipment and leasehold improvements of $4.5 million and cash used to fund operations of $49.7 million.
Research and Development Expenses: Research and development expenses were $16.6 million for the quarter ended September 30, 2019, as compared to
$13.1 million for the quarter ended September 30, 2018. The increase in research and development expenses for the quarter primarily related to expenses associated with our ongoing Phase 1 clinical trial of
ARV-110 and the initiation of our Phase 1 clinical trial of ARV-471 as well as increased personnel and other expenses related to our platform research and exploratory
General and Administrative Expenses: General and administrative expenses were $8.0 million for the quarter ended September 30,
2019, as compared to $4.3 million for the quarter ended September 30, 2018. The increase in general and administrative expenses for the quarter was primarily related to increased employee expenses and other compliance costs associated with becoming
a public company in the fourth quarter of 2018.
Revenues: Revenue was $30.1 million for the quarter ended September 30, 2019, as compared to $3.4
million for the quarter ended September 30, 2018. Revenue for the quarter ended September 30, 2019 included $24.7 million of revenue recognized from the Arvinas contribution of the license to the joint venture between Bayer and Arvinas to pursue the
PROTAC technology in agricultural applications (the Joint Venture ). The remaining revenue of $5.4 million for the quarter was generated from 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.
Loss from Equity Method
Investment: Loss from equity method investment for the quarter ended September 30, 2019 was $24.7 million, which related to the loss from the equity method investment in the Joint Venture. The loss was generated from the Joint
Venture s expensing the values associated with the contributed intellectual property from the Joint Venture partners.
Net Loss: Net loss was
$17.7 million for the quarter ended September 30, 2019, as compared to $13.4 million for the quarter ended September 30, 2018. The increased revenue that related to the Joint Venture was offset by the loss from equity method
investment in the Joint Venture for the quarter ended September 30, 2019 and as such, the increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.
ARV-110 is an orally-bioavailable PROTAC protein degrader
designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with
metastatic castration-resistant prostate cancer (mCRPC). Arvinas Phase 1 trial of ARV-110 will assess its safety, tolerability, and pharmacokinetics,
and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.
ARV-110 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 a PROTAC protein degrader designed to
specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic breast cancer. Arvinas Phase 1 trial of ARV-471 will assess its safety, tolerability, and
pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.
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 as a single agent and in combination with a CDK4/6 inhibitor when compared to a standard of care agent, fulvestrant (as a single agent and in combination with a CDK4/6 inhibitor).
Arvinas 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. Arvinas
uses its 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 and efficiently degrade and remove disease-causing proteins. The company has two clinical-stage programs: ARV-110 for the treatment of patients with metastatic castrate-resistant
prostate cancer; and ARV-471 for the treatment of patients with ER+/HER2- locally advanced or metastatic breast cancer. For more information, visit www.arvinas.com.
Forward-Looking Statements
This press release contains
forward-looking statements that involve substantial risks and uncertainties, including statements regarding the development and regulatory status of our product candidates, such as the timing of our clinical trials for
ARV-110 and ARV-471 and data from those clinical trials, the potential advantages and therapeutic potential of our product candidates, and the sufficiency of cash
resources. 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:
whether we will be able to successfully conduct Phase 1 clinical trials for ARV-110 and ARV-471, complete other
clinical trials for our product candidates on our expected timelines, or at all, each party s ability to perform its obligations under the Bayer collaboration and/or the joint venture, whether our cash resources will be sufficient to fund our
foreseeable and unforeseeable operating expenses and capital expenditure requirements on our expected timeline 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.
Contacts for Arvinas
Will O Connor, Stern Investor Relations
Cory Tromblee, ScientPR
Consolidated Statement of Operations (Unaudited)
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2019 2018 2019 2018
Revenue $ 30,050,227 $ 3,375,264 $ 38,083,205 $ 10,883,755
Operating expenses:
Research and development 16,588,050 13,149,879 46,779,047 30,631,531
General and administrative 7,957,364 4,284,231 20,038,772 7,110,723
Total operating expenses 24,545,414 17,434,110 66,817,819 37,742,254
Income (loss) from operations 5,504,813 (14,058,846 ) (28,734,614 ) (26,858,499 )
Other income (expenses)
Other income, net 405,302 160,100 840,153 418,494
Change in fair value of preferred unit warrant (193,779 )
Interest income 1,112,415 523,338 3,394,269 1,273,988
Interest expense (22,903 ) (12,264 ) (69,319 ) (32,804 )
Total other income 1,494,814 671,174 4,165,103 1,465,899
Loss from equity method investment (24,675,000 ) (24,675,000 )
Net loss (17,675,373 ) (13,387,672 ) (49,244,511 ) (25,392,600 )
Change in fair value of redeemable convertible preferred units (112,050,609 ) (198,366,756 )
Net loss attributable to common shares $ (17,675,373 ) $ (125,438,281 ) $ (49,244,511 ) $ (223,759,356 )
Net loss per common share, basic and diluted $ (0.54 ) $ (62.38 ) $ (1.54 ) $ (115.62 )
Weighted average common shares outstanding, basic and diluted 32,740,486 2,010,807 31,876,074 1,935,299
Consolidated Balance Sheet (Unaudited)
September 30, 2019 December 31, 2018
Assets
Current assets:
Cash and cash equivalents $ 12,135,475 $ 3,190,056
Marketable securities 178,375,159 184,637,640
Account receivable 59,330 2,775,831
Other receivables 5,142,227 2,255,966
Prepaid expenses and other current assets 3,951,152 2,818,286
Total current assets 199,663,343 195,677,779
Property, equipment and leasehold improvements, net 7,152,151 3,583,036
Operating lease right of use assets 2,257,544
Other assets 20,760 20,760
Total assets $ 209,093,798 $ 199,281,575
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 2,277,824 $ 2,758,184
Accrued expenses 6,226,971 4,001,276
Deferred revenue 20,294,456 16,065,957
Current portion of long-term debt 154,461
Current portion of operating lease liability 597,014
Total current liabilities 29,396,265 22,979,878
Deferred revenue 41,770,160 37,484,714
Long term debt, net of current portion 2,000,000 2,000,000
Operating lease liability 1,767,775
Other noncurrent liability 150,000
Total liabilities 74,934,200 62,614,592
Commitments and Contingencies
Stockholders equity:
Common stock, $0.001 par value; 33,076,557 and 31,235,458 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively 33,076 31,236
Accumulated deficit (351,509,130 ) (302,264,619 )
Additional paid-in capital 485,439,007 439,118,089
Accumulated other comprehensive income (loss) 196,645 (217,723 )
Total stockholders equity 134,159,598 136,666,983
Total liabilities and stockholders equity $ 209,093,798 $ 199,281,575
Last updated: Nov 4, 2019