現金、現金同等物、および売り手証券のポジション:2024年9月30日時点で、現金、現金同等物、売り手証券は1億1216,000万ドルであり、これは2023年12月31日時点の現金、現金同等物、制限付き現金、および売り手証券の1億2665,000万ドルと比較して減少しています。2024年9月30日までの9ヶ月間における現金、現金同等物、および売り手証券の1億4490万ドルの減少は、主に2024年8月に101 College Street LLCとのラボおよびオフィススペースリースの契約終了に関連する一時的な現金解約手数料4150万ドル、ラボ機器とリースホールド改善品の購入費用150万ドルを含む15810万ドルの運営資金を差し引いたものです(ノバルティスとの合意から1億5000万ドルを差し引いた金額が含まれています)。これには、ストックオプションの行使に伴う770万ドルの収益と売り手証券の未実現利益720万ドルを部分的に相殺したものです。
Research and Development Expenses: Research and development expenses were $86.9 million for the quarter ended September 30, 2024, as compared with $85.9 million for the quarter ended September 30, 2023. The increase in research and development expenses of $1.0 million for the quarter was primarily due to an increase in compensation and related personnel expenses of $2.8 million, which are not allocated by program, partially offset by a decrease in external expenses of $2.2 million. External expenses include program-specific expenses, which decreased by $1.1 million, primarily driven by decreases in our ARV-766 and ARV-110 programs of $3.8 million and $1.6 million, respectively, partially offset by increases in our ARV-102 and ARV-393 programs of $2.5 million and $1.4 million, respectively, and our non-program specific expenses, which decreased by $1.1 million.
General and Administrative Expenses: General and administrative expenses were $75.8 million for the quarter ended September 30, 2024, as compared with $22.6 million for the quarter ended September 30, 2023. The increase in general and administrative expenses of $53.2 million for the quarter was primarily due to a loss on the termination of our laboratory and office space lease with 101 College Street LLC of $43.4 million as well as increases in personnel and infrastructure related costs of $5.0 million, professional fees of $3.4 million and in developing our commercial operations of $1.2 million.
Revenue: Revenue was $102.4 million for the quarter ended September 30, 2024 as compared with $34.6 million for the quarter ended September 30, 2023. Revenue for the quarter is related to the license agreement with Novartis, the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the collaboration and license agreement with Bayer and the collaboration and license agreement with Pfizer. The increase in revenue of $67.8 million was primarily due to revenue from the Novartis license agreement of $76.7 million, offset by a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $7.6 million related to timing differences in clinical trials and program expenses and a decrease in revenue from Bayer of $1.1 million related to the termination of the Bayer Collaboration Agreement in August 2024.
Investor Call & Webcast Details
Arvinas will host a conference call and webcast today, October 30, 2024, at 8:00 a.m. ET to review its third quarter 2024 financial results and discuss recent corporate updates. Participants are invited to listen by going to the Events and Presentation section under the Investors page on the Arvinas website at www.arvinas.com. A replay of the webcast will be available on the Arvinas website following the completion of the event and will be archived for up to 30 days.
About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with ER positive (ER+)/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Vepdegestrant is being developed as a potential monotherapy and as part of combination therapy across multiple treatment settings for ER+/HER2- metastatic breast cancer.
In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits.
The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- locally advanced or metastatic breast cancer previously treated with endocrine-based therapy.
About Arvinas
Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC® (PROteolysis Targeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding the expected timing in connection with the completion of enrollment and reporting of topline data from the VERITAC-2 clinical trial; the potential to change the treatment paradigm for ER+/HER2- breast cancer; the goal of becoming a multi-product, commercial-stage organization with a robust pipeline across several indications; novel PROTAC platform technology having the potential to enable opportunities across multiple therapeutic areas; plans to present initial safety and pharmacokinetic data from the TACTIVE-U sub-study of abemaciclib in combination with vepdegestrant at SABCS; plans to present data from the Phase 1 healthy volunteer pharmacokinetic trial of vepdegestrant in combination with midazolam at SABCS; plans to continue enrollment in the TACTIVE-U study and evaluate data from the study lead-in of the VERITAC-3 Phase 3 clinical trial; plans to continue enrollment and evaluate preliminary data from the TACTIVE-K clinical trial; the expected timing of initiation of Phase 3 vepdegestrant combination trials in the first- and second-line settings, pending emerging data and regulatory feedback; expected timing of filing an investigational new drug application for a KRAS
G12D degrader; plans to compete enrollment in the multiple ascending dose portion of the ARV-102 Phase 1 clinical trial, the timing of the presentation of data from such clinical trial, and the timing of sharing additional information about the program; plans to continue recruiting patients in the Phase 1 ARV-393 clinical trial and timing of sharing additional information about the program; and statements regarding Arvinas’ cash, cash equivalents and marketable securities. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ 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,” “goal,” “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.
Arvinas may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: Arvinas’ and Pfizer’s performance of the respective obligations with respect to Arvinas’ collaboration with Pfizer; whether Arvinas and Pfizer will be able to successfully conduct and complete clinical development for vepdegestrant; whether Arvinas will be able to successfully conduct and complete development for its other product candidates, including whether Arvinas initiates and completes clinical trials for its product candidates and receives results from its clinical trials and preclinical studies on its expected timelines or at all; whether Arvinas and Pfizer, as appropriate, will be able to obtain marketing approval for and commercialize vepdegestrant and other product candidates on current timelines or at all; Arvinas’ ability to protect its intellectual property portfolio; whether Arvinas’ cash and cash equivalent resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent other reports on file with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes 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 Arvinas’ views as of any date subsequent to the date of this release.
Contacts
Investors:
Jeff Boyle
+1 (347) 247-5089
Jeff.Boyle@arvinas.com
Media:
Kathleen Murphy
+1 (203) 584-0307
Kathleen.Murphy@arvinas.com
Arvinas, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(dollars and shares in millions, except per share amounts)
September 30, 2024
December 31, 2023
Assets
Current assets:
Cash and cash equivalents
$
85.2
$
311.7
Restricted cash
—
5.5
Marketable securities
1,036.4
949.3
Accounts receivable
7.3
—
Other receivables
7.5
7.2
Prepaid expenses and other current assets
13.1
6.5
Total current assets
1,149.5
1,280.2
Property, equipment and leasehold improvements, net
6.8
11.5
Operating lease right of use assets
1.0
2.5
Collaboration contract asset and other assets
9.8
10.4
Total assets
$
1,167.1
$
1,304.6
Liabilities and stockholders' equity
Current liabilities:
Accounts payable and accrued liabilities
$
75.9
$
92.2
Deferred revenue
199.2
163.0
Current portion of operating lease liabilities
0.8
1.9
Total current liabilities
275.9
257.1
Deferred revenue
304.5
386.2
Long-term debt
0.6
0.8
Operating lease liabilities
0.1
0.5
Total liabilities
581.1
644.6
Stockholders’ equity:
Preferred stock, $0.001 par value, zero shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively
—
—
Common stock, $0.001 par value; 68.7 and 68.0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively
0.1
0.1
Accumulated deficit
(1,486.5)
(1,332.7)
Additional paid-in capital
2,068.3
1,995.7
Accumulated other comprehensive income (loss)
4.1
(3.1)
Total stockholders’ equity
586.0
660.0
Total liabilities and stockholders’ equity
$
1,167.1
$
1,304.6
Arvinas, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
For the Three Months Ended September 30,
For the Nine Months Ended September 30,
(dollars and shares in millions, except per share amounts)
2024
2023
2024
2023
Revenue
$
102.4
$
34.6
$
204.2
$
121.6
Operating expenses:
Research and development
86.9
85.9
264.9
284.5
General and administrative
75.8
22.6
131.3
73.3
Total operating expenses
162.7
108.5
396.2
357.8
Loss from operations
(60.3)
(73.9)
(192.0)
(236.2)
Interest and other income
11.7
10.0
39.2
25.5
Net loss before income taxes and loss from equity method investment
(48.6)
(63.9)
(152.8)
(210.7)
Income tax (expense) benefit
(0.6)
—
(1.0)
0.7
Loss from equity method investment
—
(0.1)
—
(2.5)
Net loss
$
(49.2)
$
(64.0)
$
(153.8)
$
(212.5)
Net loss per common share, basic and diluted
$
(0.68)
$
(1.18)
$
(2.14)
$
(3.97)
Weighted average common shares outstanding, basic and diluted