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 fourth
quarter and full year ended December 31, 2020 and provided a
corporate update.
“2020 was a breakthrough year for Arvinas and for the patients
we aim to serve, as we reported clear signals of efficacy in both
of our clinical-stage programs. These data provided further
validation that our approach to protein degradation could
potentially change the lives of patients with few or no therapeutic
options,” said John Houston, Ph.D., Chief Executive Officer at
Arvinas. “Despite the unprecedented circumstances of a pandemic,
our clinical trials and preclinical research continued to deliver,
and we enter 2021 well positioned to extend our success and
progress our programs in oncology and neurodegeneration.”
Business Highlights and Recent Developments
- Presented interim Phase 1 data for
ARV-471 showing potential for best-in-class safety and
tolerability, estrogen receptor (ER) degradation greater than that
previously reported for the current standard of care agent
(fulvestrant), and a robust efficacy signal in heavily pretreated
patients with locally advanced or metastatic ER positive / HER2
negative (ER+/HER2-) breast cancer
- Presented data from the ongoing dose
escalation portion of the Phase 1/2 trial of ARV-110 in men with
metastatic castration-resistant prostate cancer (mCRPC), providing
additional evidence of anti-tumor activity and patient benefit,
including a prostate specific antigen reduction ≥50% (PSA50) in 2
of 5 (40%) in a molecularly defined patient population
- Closed an underwritten public offering of 6,571,428 shares of
common stock at a public offering price of $70.00 per share,
including the exercise in full by the underwriters of their option
to purchase additional shares of common stock. Arvinas received net
proceeds of $431.9 million, after deducting underwriting discounts
and commissions and offering expenses
- Initiated the ARDENT Phase 2 dose
expansion study of ARV-110 (Dose: 420 mg daily)
- Initiated the VERITAC Phase 2 dose
expansion study of ARV-471 (Dose: 200 mg daily)
- Initiated a Phase 1b trial of
ARV-471 in combination with Ibrance® (palbociclib)
Anticipated Milestones and Expectations
ARV-471
- Completion of the Phase 1 dose
escalation (1H21)
- Presentation of completed Phase 1
dose escalation data (2H21)
- Announcement of safety data from the
Phase 1b trial in combination with Ibrance® (palbociclib)
(2H21)
- Initiation of a window of
opportunity study in adjuvant breast cancer (2H21)
- Initiation of a combination trial of
ARV-471 and another targeted therapy in 2L/3L metastatic breast
cancer (2H21)
ARV-110
- Completion of the Phase 1 dose
escalation (1H21)
- Presentation of completed Phase 1
dose escalation data (2H21)
- Announcement of interim data from
the ARDENT Phase 2 dose expansion at 420 mg (2H21)
- Initiation of combination trial(s)
with standards-of-care (2021)
Other Clinical Milestones
- Initiation of first-in-human study
of ARV-766, an androgen receptor (AR) degrader with a
differentiated profile from ARV-110, in patients with metastatic
castration-resistant prostate cancer (1H21)
Financial Guidance
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 expenditures into
2024.
Full Year and Fourth Quarter Financial
Results
Cash, Cash Equivalents and Marketable Securities
Position: As of December 31, 2020, cash, cash equivalents
and marketable securities were $688.5 million as compared with
$280.9 million as of December 31, 2019. The increase primarily
related to net proceeds from the issuance of common stock and
proceeds from the exercise of stock options of $504.7 million,
proceeds from two collaborators of $7.4 million, partially offset
by cash used to fund operations of approximately $98.1 million and
cash used to purchase fixed assets and leasehold improvements of
$6.4 million.
Research and Development Expenses: Research and
development expenses were $108.4 million and $33.2 million for the
year and quarter ended December 31, 2020, respectively, as compared
with $67.2 million and $20.4 million for the year and quarter ended
December 31, 2019, respectively. The increase in research and
development expenses for the year of $41.2 million primarily
related to Arvinas’ continued investment in its wholly owned
platform, exploratory and lead optimization programs of $17.6
million, its androgen receptor (AR) program of $12.3 million and
estrogen receptor program (ER) of $11.3 million. The increase in
research and development expense for the quarter of $12.8 million
primarily related to Arvinas’ continued investment in its wholly
owned platform, exploratory and lead optimization programs of $5.1
million, its AR program of $4.8 million and ER program of $2.9
million.
General and Administrative Expenses: General
and administrative expenses were $38.3 million and $12.2 million
for the year and quarter ended December 31, 2020, respectively, as
compared with $27.3 million and $7.3 million for the year and
quarter ended December 31, 2019, respectively. The increase in
general and administrative expenses for the year of $11.0 million
related to an increase of $9.6 million in personnel and facility
related costs, including $4.8 million related to stock compensation
expense, and insurance, taxes and professional fees of $1.4
million. The increase in general and administrative expenses for
the quarter of $5.0 million primarily related to an increase of
$2.9 in personnel and facility cost, including $1.4 million related
to stock compensation expense and $1.7 million of legal and other
professional services.
Revenues: Revenues were $21.8 million and $2.2
million for the year and quarter ended December 31, 2020,
respectively, as compared with $43.0 million and $4.9 million for
the year and quarter ended December 31, 2019, respectively. Revenue
for the year ended December 31, 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 collaboration revenue of $18.3 million and revenue of
$4.9 million for the year and quarter ended December 31, 2019,
respectively, 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. The increase in collaboration
revenue of $3.5 million for the year was primarily related to the
Bayer agreement having only a partial year of revenue recognized in
2019 and an increase in activities related to the Pfizer agreement.
The decrease in collaboration revenue of $2.7 million in the
quarter primarily related to a collaborator adding new targets that
extended the period of revenue recognition for the collaboration
agreement.
Loss from Equity Method Investment: Loss from
equity method investment for the year ended December 31, 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 $119.3 million and $41.5
million for the year and quarter ended December 31, 2020,
respectively, as compared with $70.3 million and $21.0 million for
the year and quarter ended December 31, 2019, respectively. The
increase in net loss for the year and quarter ended December 31,
2020 of $49.0 million and $20.5 million, respectively, primarily
related to Arvinas’ continued investment in its platform,
exploratory and lead optimization programs, its AR program, its ER
program, and an increase in general and administrative
infrastructure costs.
About ARV-110ARV-110 is an investigational
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.
ARV-110 has demonstrated activity in preclinical models of AR
mutation or overexpression, both common mechanisms of resistance to
currently available AR-targeted therapies.
About ARV-471ARV-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.
About ArvinasArvinas 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 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 two clinical-stage
programs: ARV-110 for the treatment of men with metastatic
castrate-resistant prostate cancer; and ARV-471 for the treatment
of patients with locally advanced or metastatic ER+/HER2- breast
cancer. For more information, visit www.arvinas.com.
Forward-Looking StatementsThis press release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements regarding the development
and regulatory status of our product candidates, including the
timing of initiation or completion of or availability of data from
our clinical trials for ARV-110 and ARV-471, 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 1/2 clinical trials for ARV-110 and
ARV-471, conduct a Phase 1 clinical trial of ARV-766 complete our
clinical trials for our other product candidates, and receive
results from our clinical trials on our expected timelines, or at
all, 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
InvestorsWill O’Connor, Stern Investor
Relations ir@arvinas.com
MediaKirsten Owens, Arvinas
Communicationskirsten.owens@arvinas.com
Arvinas, Inc. |
Consolidated
Statement of Operations (Unaudited) |
|
|
|
|
|
|
|
Quarter Ended December 31, |
Year Ended December 31, |
|
|
2020 |
|
|
2019 |
|
|
|
2020 |
|
|
2019 |
|
Revenue |
$ |
2,217,692 |
|
$ |
4,893,273 |
|
|
$ |
21,801,777 |
|
$ |
42,976,478 |
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
33,200,159 |
|
|
20,414,783 |
|
|
|
108,355,853 |
|
|
67,193,830 |
|
General and administrative |
|
12,230,997 |
|
|
7,268,390 |
|
|
|
38,303,401 |
|
|
27,307,162 |
|
Total
operating expenses |
|
45,431,156 |
|
|
27,683,173 |
|
|
|
146,659,254 |
|
|
94,500,992 |
|
Loss from operations |
|
(43,213,464 |
) |
|
(22,789,900 |
) |
|
|
(124,857,477 |
) |
|
(51,524,514 |
) |
Interest and
other income |
|
1,666,976 |
|
|
1,742,184 |
|
|
|
5,525,413 |
|
|
5,907,287 |
|
Loss from
equity method investment |
|
— |
|
|
— |
|
|
|
— |
|
|
(24,675,000 |
) |
Net
loss |
|
(41,546,488 |
) |
|
(21,047,716 |
) |
|
|
(119,332,064 |
) |
|
(70,292,227 |
) |
Net loss per
common share, basic and diluted |
|
(0.99 |
) |
$ |
(0.56 |
) |
|
|
(3.02 |
) |
|
(2.13 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
41,767,980 |
|
|
37,338,484 |
|
|
|
39,534,497 |
|
|
32,927,697 |
|
|
|
|
|
|
|
Arvinas,
Inc. |
Consolidated Balance
Sheet (Unaudited) |
|
|
|
|
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
588,373,232 |
|
|
$ |
9,211,057 |
|
Marketable securities |
|
100,157,618 |
|
|
|
271,661,456 |
|
Account receivable |
|
1,000,000 |
|
|
|
— |
|
Other receivables |
|
7,443,654 |
|
|
|
6,280,828 |
|
Prepaid expenses and other current assets |
|
6,113,122 |
|
|
|
3,727,294 |
|
Total
current assets |
|
703,087,626 |
|
|
|
290,880,635 |
|
Property,
equipment and leasehold improvements, net |
|
12,259,515 |
|
|
|
8,455,411 |
|
Operating
lease right of use assets |
|
1,992,669 |
|
|
|
2,278,623 |
|
Other
assets |
|
28,777 |
|
|
|
26,757 |
|
Total
assets |
$ |
717,368,587 |
|
|
$ |
301,641,426 |
|
Liabilities and stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
7,121,879 |
|
|
$ |
4,556,827 |
|
Accrued expenses |
|
18,859,840 |
|
|
|
7,602,904 |
|
Deferred revenue |
|
22,150,861 |
|
|
|
19,979,525 |
|
Current portion of operating lease liabilities |
|
952,840 |
|
|
|
673,896 |
|
Total
current liabilities |
|
49,085,420 |
|
|
|
32,813,152 |
|
Deferred
revenue |
|
22,938,233 |
|
|
|
38,427,882 |
|
Long term
debt, net of current portion |
|
2,000,000 |
|
|
|
2,000,000 |
|
Operating
lease liabilities |
|
1,087,422 |
|
|
|
1,714,111 |
|
Total
liabilities |
|
75,111,075 |
|
|
|
74,955,145 |
|
Commitments
and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Common stock, $0.001 par value, 48,455,741 and 38,461,353 shares
issued and outstanding as of December 31, 2020 and 2019,
respectively |
|
48,455 |
|
|
|
38,461 |
|
Accumulated deficit |
|
(491,888,910 |
) |
|
|
(372,556,846 |
) |
Additional paid-in capital |
|
1,133,537,171 |
|
|
|
599,097,090 |
|
Accumulated other comprehensive income |
|
560,796 |
|
|
|
107,576 |
|
Total
stockholders' equity |
|
642,257,512 |
|
|
|
226,686,281 |
|
Total
liabilities and stockholders' equity |
$ |
717,368,587 |
|
|
$ |
301,641,426 |
|
|
|
|
|
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