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Arvinas Reports Second Quarter 2024 Financial Results and Provides Corporate Update

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Arvinas (NASDAQ: ARVN) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

  • Completed enrollment in VERITAC-3 Phase 3 trial lead-in for vepdegestrant in first-line ER+/HER2- metastatic breast cancer
  • VERITAC-2 Phase 3 trial enrollment completion expected in Q4 2024, with topline data in Q4 2024/Q1 2025
  • Received $150 million from Novartis for ARV-766 license and AR-V7 program sale
  • Q2 revenue: $76.5 million, up from $54.5 million in Q2 2023
  • Cash position: $1.23 billion as of June 30, 2024
  • Sufficient funding into 2027

The company continues to advance its PROTAC protein degradation platform across multiple indications.

Arvinas (NASDAQ: ARVN) ha riportato i risultati finanziari del secondo trimestre del 2024 e fornito un aggiornamento aziendale. I punti salienti includono:

  • Completamento dell'arruolamento nel trial di fase 3 VERITAC-3 per vepdegestrant nel trattamento del carcinoma mammario metastatico ER+/HER2- di prima linea
  • Completamento dell'arruolamento nel trial di fase 3 VERITAC-2 previsto per il quarto trimestre del 2024, con i dati preliminari attesi per il quarto trimestre del 2024/primo trimestre del 2025
  • Ricevuti 150 milioni di dollari da Novartis per la licenza di ARV-766 e la vendita del programma AR-V7
  • Ricavi del secondo trimestre: 76,5 milioni di dollari, in aumento rispetto ai 54,5 milioni di dollari nel secondo trimestre del 2023
  • Posizione di cassa: 1,23 miliardi di dollari al 30 giugno 2024
  • Finanziamenti sufficienti fino al 2027

L'azienda continua a far progredire la sua piattaforma di degradazione proteica PROTAC in diverse indicazioni.

Arvinas (NASDAQ: ARVN) informó los resultados financieros del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los aspectos más destacados incluyen:

  • Finalización de la inscripción en el ensayo de fase 3 VERITAC-3 para vepdegestrant en cáncer de mama metastásico ER+/HER2- de primera línea
  • Se espera completar la inscripción del ensayo de fase 3 VERITAC-2 en el cuarto trimestre de 2024, con datos preliminares en el cuarto trimestre de 2024/primer trimestre de 2025
  • Recibidos 150 millones de dólares de Novartis por la licencia de ARV-766 y la venta del programa AR-V7
  • Ingresos del segundo trimestre: 76,5 millones de dólares, en comparación con 54,5 millones de dólares en el segundo trimestre de 2023
  • Posición de efectivo: 1,23 mil millones de dólares al 30 de junio de 2024
  • Financiamiento suficiente hasta 2027

La empresa continúa avanzando en su plataforma de degradación de proteínas PROTAC en múltiples indicaciones.

Arvinas (NASDAQ: ARVN)는 2024년 2분기 재무 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:

  • 1차 ER+/HER2- 전이성 유방암에서 vepdegestrant에 대한 VERITAC-3 3상 시험 등록 완료
  • VERITAC-2 3상 시험의 등록 완료는 2024년 4분기에 예상되며, topline 데이터는 2024년 4분기 또는 2025년 1분기에 발표될 예정입니다
  • ARV-766 라이센스와 AR-V7 프로그램 판매로 인해 Novartis로부터 1억 5천만 달러를 수령했습니다
  • 2분기 수익: 7천 6백 5십만 달러, 2023년 2분기 5천 4백 5십만 달러에서 증가
  • 현금 잔고: 2024년 6월 30일 기준 12억 3천만 달러
  • 2027년까지 충분한 자금 보유

회사는 여러 적응증에 대해 PROTAC 단백질 분해 플랫폼을 계속 발전시키고 있습니다.

Arvinas (NASDAQ: ARVN) a annoncé les résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour sur l'entreprise. Les points clés comprennent :

  • Achèvement de l'inscription dans l'essai de phase 3 VERITAC-3 pour vepdegestrant dans le cancer du sein métastatique ER+/HER2- en première ligne
  • Achèvement de l'inscription dans l'essai de phase 3 VERITAC-2 prévu pour le quatrième trimestre 2024, avec des données préliminaires attendues au quatrième trimestre 2024/premier trimestre 2025
  • Réception de 150 millions de dollars de Novartis pour la licence de l'ARV-766 et la vente du programme AR-V7
  • Chiffre d'affaires du deuxième trimestre : 76,5 millions de dollars, en hausse par rapport à 54,5 millions de dollars au deuxième trimestre 2023
  • Position de trésorerie : 1,23 milliard de dollars au 30 juin 2024
  • Financement suffisant jusqu'en 2027

L'entreprise continue de faire progresser sa plateforme de dégradation des protéines PROTAC dans plusieurs indications.

Arvinas (NASDAQ: ARVN) hat die finanziellen Ergebnisse des zweiten Quartals 2024 veröffentlicht und ein Unternehmensupdate gegeben. Zu den wichtigen Punkten gehören:

  • Abschluss der Rekrutierung in der VERITAC-3 Phase-3-Studie für vepdegestrant bei ER+/HER2- metastasiertem Brustkrebs in der ersten Linie
  • Der Abschluss der Rekrutierung in der Phase-3-Studie VERITAC-2 wird im vierten Quartal 2024 erwartet, mit den Topline-Daten im vierten Quartal 2024/ersten Quartal 2025
  • Erhalt von 150 Millionen Dollar von Novartis für die Lizenzierung von ARV-766 und den Verkauf des AR-V7-Programms
  • Umsatz im zweiten Quartal: 76,5 Millionen Dollar, im Vergleich zu 54,5 Millionen Dollar im zweiten Quartal 2023
  • Liquiditätsposition: 1,23 Milliarden Dollar zum 30. Juni 2024
  • Ausreichende Finanzierung bis 2027

Das Unternehmen arbeitet weiterhin an seiner PROTAC-Proteinabbauplattform in mehreren Indikationen.

Positive
  • Received $150 million upfront payment from Novartis deal, with potential for additional $1.01 billion in milestone payments
  • Q2 revenue increased to $76.5 million from $54.5 million in Q2 2023
  • Strong cash position of $1.23 billion, sufficient to fund operations into 2027
  • VERITAC-2 Phase 3 trial enrollment on track for completion in Q4 2024
  • Initiated first-in-human Phase 1 trial for ARV-393 in B-cell lymphomas
Negative
  • Research and development expenses decreased to $93.7 million from $103.4 million in Q2 2023
  • General and administrative expenses increased to $31.3 million from $25.7 million in Q2 2023
  • Cash position decreased by $32.3 million in the first six months of 2024

Insights

Arvinas' Q2 2024 financial results reveal a mixed picture. While the company's cash position remains strong at $1.23 billion, sufficient to fund operations into 2027, there are some concerning trends in their financials.

Revenue increased significantly to $76.5 million, up 40% year-over-year, primarily due to a one-time $150 million payment from Novartis. However, this masks a substantial decrease in revenue from the Vepdegestrant collaboration with Pfizer, which fell by $22.2 million. This decline in core collaboration revenue is worrying and warrants close monitoring.

R&D expenses decreased by 9.4% to $93.7 million, which could be seen as either cost control or a potential slowdown in research activities. The increase in G&A expenses by 21.8% to $31.3 million is significant and may impact profitability if not managed carefully.

The company's cash burn rate appears manageable, with a net decrease of only $32.3 million in cash and equivalents over six months. However, this was heavily supported by the Novartis deal and the underlying burn rate is likely higher.

Overall, while Arvinas maintains a strong cash position, the decline in core collaboration revenue and increasing G&A expenses are concerning trends that investors should watch closely in future quarters.

Arvinas' clinical progress in oncology, particularly with vepdegestrant, shows promise but also faces some challenges. The completion of enrollment in the VERITAC-3 Phase 3 trial lead-in for first-line treatment of ER+/HER2- metastatic breast cancer is a positive step. However, the delay in topline data readout for VERITAC-2 to Q4 2024/Q1 2025 might raise some concerns about potential issues in the trial.

The updated data from the Phase 1b trial of vepdegestrant in combination with palbociclib is encouraging. A clinical benefit rate of 63% and an objective response rate of 42% in heavily pre-treated patients are noteworthy. The median progression-free survival of 11.2 months across all dose levels and 13.9 months at the recommended Phase 3 dose, are promising results for this patient population.

The initiation of a Phase 1 trial for ARV-393, a PROTAC BCL6 degrader, in B-cell lymphomas represents an expansion of Arvinas' oncology pipeline. The preclinical data showing tumor regression in various lymphoma models is intriguing, but it's important to remember that preclinical success doesn't always translate to clinical efficacy.

While these developments are positive, the true test will be the VERITAC-2 Phase 3 results. If positive, they could pave the way for Arvinas' first new drug application, marking a significant milestone for the company and potentially offering a new treatment option for breast cancer patients.

Arvinas' Q2 2024 update highlights the company's progress in advancing its PROTAC protein degradation platform across multiple therapeutic areas. The $150 million upfront payment from Novartis for the ARV-766 license and AR-V7 program sale not only validates Arvinas' technology but also significantly bolsters their financial position.

The potential for up to $1.01 billion in additional milestone payments from Novartis underscores the perceived value of Arvinas' PROTAC platform in prostate cancer treatment. This deal structure, combining upfront cash with substantial milestone potential, is typical in biotech and helps de-risk the program for Arvinas while maintaining significant upside.

The advancement of ARV-102, a PROTAC LRRK2 degrader, into multiple ascending dose studies for neurodegenerative diseases represents an important expansion beyond oncology. The preclinical data suggesting potentially reduced pulmonary function risk compared to kinase inhibitors could be a significant differentiator if confirmed in human studies.

The company's pipeline diversification, including programs in breast cancer, prostate cancer, neurodegenerative diseases and now B-cell lymphomas with ARV-393, demonstrates the versatility of the PROTAC platform. This broad applicability could position Arvinas as a leader in targeted protein degradation therapeutics across multiple disease areas.

However, investors should note that despite the promising pipeline, Arvinas remains a clinical-stage company with no approved products. The success of VERITAC-2 will be important in determining Arvinas' near-term prospects and potential transition to a commercial-stage company.

– Completed enrollment in the study lead-in for the VERITAC-3 Phase 3 trial in the first-line setting; continued enrollment globally in multiple clinical trials of vepdegestrant in ER+/HER2- metastatic breast cancer, including the VERITAC-2 Phase 3 trial in the second-line setting–

– Completion of enrollment in VERITAC-2 expected in 4Q24 and topline data readout now expected 4Q24/1Q25 –

– Received $150 million upon close of ARV-766 license agreement and sale of preclinical AR-V7 program to Novartis; potential for up to an additional $1.01 billion based on achievement of development, regulatory and commercial milestones and future royalties –

– Strengthened executive team with the appointment of Andrew Saik as Chief Financial Officer and the promotions of Ian Taylor to President of R&D, Angela Cacace to Chief Scientific Officer, and Randy Teel to Chief Business Officer –

NEW HAVEN, Conn., July 30, 2024 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2024, and provided a corporate update.

“During the second quarter, we continued making meaningful progress across our entire portfolio, with upcoming milestones that will further support our mission to improve patient lives with pioneering therapies from our revolutionary PROTAC® protein degradation platform,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “The readout of VERITAC-2, our first Phase 3 clinical trial, will be a landmark event for Arvinas. We are on-track to complete enrollment in the fourth quarter of the year, with topline data anticipated in either the fourth quarter of 2024 or first quarter of 2025. If positive, we believe these results will support our first new drug application filing and our transition to a commercial-stage company, assuming regulatory approval.”

“We are well on our way to becoming a multi-product, commercial-stage organization with strong leadership and a robust pipeline across several indications,” continued Dr. Houston. “Our first PROTAC degrader with the potential to treat neurodegenerative diseases, ARV-102, was recently cleared to initiate the multiple ascending dose portion of our Phase 1 clinical trial. In addition, we initiated the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with our PROTAC BCL6 degrader ARV-393. I’m excited by the progress we have made and the ongoing confidence we have in our PROTAC platform, which was further validated by our recent strategic transaction with Novartis. We believe Novartis will accelerate and broaden the development of ARV-766 as a potential best-in-class treatment for patients with prostate cancer.”

Recent Developments and 2Q Business Highlights

Vepdegestrant

  • Evaluated enrollment and blinded event rates in the ongoing VERITAC-2 Phase 3 monotherapy clinical trial (NCT05654623) in patients with metastatic breast cancer.
    • The trial is on track to complete enrollment in 4Q24.
    • Based on current trial status, the primary completion date has been reprojected to November 2024, with topline data now anticipated in 4Q24/1Q25.
  • Completed enrollment of the study lead-in for the VERITAC-3 Phase 3 clinical trial of vepdegestrant in combination with palbociclib as a first-line treatment in patients with estrogen receptor (ER) positive/human growth epidermal growth factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer.
  • Continued enrollment globally in multiple clinical studies of vepdegestrant in ER+/HER2- metastatic breast cancer.
  • Presented updated clinical data from a Phase 1b clinical trial combination cohort evaluating vepdegestrant in combination with palbociclib in heavily pre-treated patients with locally advanced or metastatic ER+/HER2- breast cancer at the 2024 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress.
    • After six months of additional follow-up, updated data from the trial continued to demonstrate an encouraging clinical benefit rate, objective response rate and progression-free survival, and a consistent safety profile as previously reported at the San Antonio Breast Cancer Symposium (SABCS) in December 2023.
    • The clinical benefit rate across all dose levels (n=46) was 63%; the objective response rate in evaluable patients with measurable disease at baseline (n=31) was 42%; median progression-free survival based on 27 (59%) events across all dose levels was 11.2 months (95% CI: 8.2 – 16.5) and the safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023.
    • Patients receiving the recommended Phase 3 dose of vepdegestrant (200mg) in combination with palbociclib 125mg (n=21), achieved a median progression-free survival of 13.9 months (95% CI: 8.1-NR).

Strategic Transaction with Novartis

  • Entered into a license agreement and asset purchase agreement with Novartis (NYSE: NVS) for the exclusive, worldwide development, manufacture and commercialization of ARV-766, Arvinas’ second generation PROTAC® androgen receptor (AR) degrader for patients with prostate cancer, and the sale of Arvinas’ preclinical AR-V7 program, which closed on May 28, 2024.
    • Arvinas received a one-time, upfront payment in the aggregate amount of $150.0 million in accordance with the terms of the license agreement and the asset purchase agreement. Under the terms of the license agreement, Arvinas is also eligible to receive up to an additional $1.01 billion as contingent payments based on specified development, regulatory, and commercial milestones for ARV-766 being met, as well as tiered royalties based upon worldwide net sales of ARV-766.

Pipeline

ARV-102: Oral PROTAC LRRK2 degrader

  • Presented preclinical data at the Biennial International LRRK2 Meeting further supporting the potential of PROTAC-induced leucine-rich repeat kinase 2 (LRRK2) degradation as a potential treatment for neurodegenerative diseases. Key findings included:
    • With Arvinas' PROTAC LRRK2 degrader, near-complete LRRK2 target engagement, as well as LRRK2 degradation, in mouse and non-human primate lung and brain.
    • Differing effects of the LRRK2 PROTAC degraders in the lungs compared to kinase inhibitors, suggesting reduced pulmonary function risk.
      • Substantially less Type II pneumocyte enlargement compared to MLi-2, an experimental LRRK2 kinase inhibitor.
      • Surfactant protein accumulation in mouse lung observed after treatment with the LRRK2 kinase inhibitor MLi-2, but not after treatment with the PROTAC LRRK2 degrader.
      • No evidence of collagen deposition in lung to date with PROTAC LRRK2 degraders in non-human primates.
  • Received health authority approval to initiate the multiple ascending dose portion of the ongoing Phase 1 clinical trial in healthy volunteers with the PROTAC LRRK2 degrader ARV-102.

ARV-393: Oral PROTAC BCL6 degrader

  • Presented preclinical data for ARV-393 at the European Hematology Association 2024 Annual Congress that showed ARV-393:
    • Potently and rapidly degraded the BCL6 protein and inhibited cell growth in diffuse large B-cell lymphoma (DLBCL) and Burkitt cell lines.
    • Showed tumor growth inhibition, including tumor regression, in various DLBCL cell line-derived xenograft (CDX) models and in multiple patient-derived xenograft (PDX) models of non-Hodgkin lymphoma (NHL), including germinal center B-cell-like (GCB), activated B-cell (ABC), GCB/ABC, BCL not otherwise specified (BCL/NOS) subtypes of DLBCL, and Burkitt lymphoma.
  • Initiated the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with PROTAC BCL6 degrader ARV-393.

Corporate

  • Announced the appointment of Andrew Saik, MBA, to the role of Chief Financial Officer.
  • Announced the promotion of Ian Taylor, Ph.D., to President of Research and Development.
  • Announced the promotion of Angela Cacace, Ph.D., to Chief Scientific Officer.
  • Announced the promotion of Randy Teel, Ph.D., to Chief Business Officer.

Anticipated Upcoming Milestones and Expectations

Vepdegestrant (ARV-471)
As part of Arvinas’ global collaboration with Pfizer, the companies plan to:

  • Complete enrollment (4Q24) and announce topline data (4Q24/1Q25) for the VERITAC-2 Phase 3 monotherapy clinical trial.
  • Evaluate data from the study lead-in of the VERITAC-3 Phase 3 trial to support dose selection for vepdegestrant plus palbociclib in planned Phase 3 combination trials in patients with ER+/HER2- locally advanced or metastatic breast cancer (2H24).
  • Present initial safety and pharmacokinetic data from the abemaciclib arm of the ongoing TACTIVE-U trial (2H24).
  • Continue enrollment of the ongoing Phase 1b/2 combination umbrella trial evaluating combinations of vepdegestrant with abemaciclib, ribociclib, or samuraciclib (TACTIVE-U; ClinicalTrials.gov Identifiers: NCT05548127, NCT05573555, and NCT06125522).
  • Continue enrollment and evaluate preliminary data from the ongoing clinical trial with vepdegestrant plus Pfizer’s novel CDK4 inhibitor atirmociclib (TACTIVE-K; ClinicalTrials.gov Identifier: NCT06206837) to inform the study design for the planned Phase 3 first line combination trial with either atirmociclib or palbociclib, with planned initiation in 2025.

Pipeline

  • Continue enrollment in the single ascending dose portion of the Phase 1 clinical trial in healthy volunteers with the PROTAC LRRK2 degrader ARV-102 and begin enrolling the multiple ascending dose portion by the end of 2024.
  • Continue enrollment in the first-in-human Phase 1 clinical trial in patients with B-cell lymphomas with PROTAC BCL6 degrader ARV-393.

Financial Guidance
Based on its current operating plan, Arvinas believes its cash, cash equivalents, restricted cash and marketable securities as of June 30, 2024, is sufficient to fund planned operating expenses and capital expenditure requirements into 2027.

Second Quarter Financial Results
Cash, Cash Equivalents, Restricted Cash and Marketable Securities Position: As of June 30, 2024, cash, cash equivalents, restricted cash and marketable securities were $1,234.2 million as compared with $1,266.5 million as of December 31, 2023. The decrease in cash, cash equivalents, restricted cash and marketable securities of $32.3 million for the six months ended June 30, 2024 was primarily related to cash used in operations of $36.0 million (net of $150.0 million received from the Novartis agreements), unrealized losses on marketable securities of $0.7 million and the purchase of lab equipment and leasehold improvements of $0.8 million, partially offset by proceeds from the exercise of stock options of $5.3 million.

Research and Development Expenses: Research and development expenses were $93.7 million for the quarter ended June 30, 2024, as compared with $103.4 million for the quarter ended June 30, 2023. The decrease in research and development expenses of $9.7 million for the quarter was primarily due to decreases in expenses related to our ER program (which includes the cost sharing of vepdegestrant under the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer) of $6.6 million and our platform and exploratory programs of $5.7 million, partially offset by an increase in our AR program (which includes ARV-766 and bavdegalutamide (ARV-110)) of $2.6 million.

General and Administrative Expenses: General and administrative expenses were $31.3 million for the quarter ended June 30, 2024, as compared with $25.7 million for the quarter ended June 30, 2023. The increase in general and administrative expenses of $5.6 million for the quarter was primarily due to an increase in personnel and infrastructure related costs of $4.0 million and professional fees of $1.6 million.

Revenues: Revenues were $76.5 million for the quarter ended June 30, 2024, as compared with $54.5 million for the quarter ended June 30, 2023. Revenue for the quarter is related to the license agreement and the asset purchase agreement with Novartis, the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer, the collaboration and license agreement with Bayer, the collaboration and license agreement with Pfizer, and revenue related to our Oerth Bio joint venture. The increase in revenue of $22.0 million was primarily due to revenue from the Novartis agreements, which were entered into during the quarter, of $45.4 million, offset by a decrease in revenue from the Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer of $22.2 million and a decrease of $1.3 million of previously constrained deferred revenue related to our Oerth Bio joint venture.

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-102, targeting LRRK2 for neurodegenerative disorders; and ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma. 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 readout of topline data from the VERITAC-2 clinical trial, submission of Arvinas’ first new drug application filing and transition to a commercial-stage company, assuming regulatory approval, the availability and timing of data from other clinical trials, the receipt of milestone and royalty payments in connection with the transaction with Novartis and the future development, potential marketing approval and commercialization of ARV-766, the potential of Arvinas’ PROTAC protein degrader platform and its potential to deliver new treatments, Arvinas’ and Pfizer’s plans to determine the recommended palbociclib dose to be combined with vepdegestrant in the planned Phase 3 combination trials in patients with ER+/HER2- locally advanced or metastatic breast cancer, and statements regarding Arvinas’ cash, cash equivalents, restricted cash 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,” “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 and including whether Arvinas initiates and completes clinical trials for its product candidates and receive results from its clinical trials 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’ and Novartis’ performance of their respective obligations under the license agreement; whether Novartis will be able to successfully conduct and complete clinical development, obtain marketing approval for and commercialize ARV-766; 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:
Kirsten Owens
+1 (203) 584-0307
Kirsten.Owens@arvinas.com


Arvinas, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
 
(dollars and shares in millions, except per share amounts)June 30,
2024
December 31,
2023
Assets  
Current assets:  
Cash and cash equivalents$154.8 $311.7 
Restricted cash 5.5  5.5 
Marketable securities 1,073.9  949.3 
Other receivables 10.0  7.2 
Prepaid expenses and other current assets 12.5  6.5 
Total current assets 1,256.7  1,280.2 
Property, equipment and leasehold improvements, net 9.8  11.5 
Operating lease right of use assets 1.5  2.5 
Collaboration contract asset and other assets 11.6  10.4 
Total assets$1,279.6 $1,304.6 
Liabilities and stockholders' equity  
Current liabilities:  
Accounts payable and accrued liabilities$78.1 $92.2 
Deferred revenue 267.9  163.0 
Current portion of operating lease liabilities 1.2  1.9 
Total current liabilities 347.2  257.1 
Deferred revenue 331.3  386.2 
Long term debt 0.7  0.8 
Operating lease liabilities 0.2  0.5 
Total liabilities 679.4  644.6 
Stockholders’ equity:  
Preferred stock, $0.001 par value, zero shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively    
Common stock, $0.001 par value; 68.6 and 68.0 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 0.1  0.1 
Accumulated deficit (1,437.3) (1,332.7)
Additional paid-in capital 2,041.2  1,995.7 
Accumulated other comprehensive loss (3.8) (3.1)
Total stockholders’ equity 600.2  660.0 
Total liabilities and stockholders’ equity$1,279.6 $1,304.6 
   


Arvinas, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
     
 Three Months Ended
June 30,
Six Months Ended
June 30,
(dollars and shares in millions, except per share amounts) 2024  2023  2024  2023 
Revenue$76.5 $54.5 $101.8 $87.0 
Operating expenses:    
Research and development 93.7  103.4  178.0  198.6 
General and administrative 31.3  25.7  55.6  50.7 
Total operating expenses 125.0  129.1  233.6  249.3 
Loss from operations (48.5) (74.6) (131.8) (162.3)
Interest and other income 13.5  9.0  27.5  15.5 
Net loss before income taxes and loss from equity method investment (35.0) (65.6) (104.2) (146.8)
Income tax (expense) benefit (0.2) 0.3  (0.3) 0.7 
Loss from equity method investment   (1.3)   (2.4)
Net loss$(35.2)$(66.6)$(104.6)$(148.5)
Net loss per common share, basic and diluted$(0.49)$(1.25)$(1.46)$(2.78)
Weighted average common shares outstanding, basic and diluted 71.9  53.4  71.7  53.4 
     

FAQ

When is Arvinas expecting topline data from the VERITAC-2 Phase 3 trial for vepdegestrant?

Arvinas expects topline data from the VERITAC-2 Phase 3 trial for vepdegestrant in Q4 2024 or Q1 2025.

What was Arvinas' revenue for Q2 2024?

Arvinas reported revenue of $76.5 million for Q2 2024, an increase from $54.5 million in Q2 2023.

How much did Arvinas receive from the Novartis deal for ARV-766?

Arvinas received a $150 million upfront payment from Novartis for the ARV-766 license and AR-V7 program sale, with potential for up to an additional $1.01 billion in milestone payments.

What is Arvinas' cash position as of June 30, 2024?

Arvinas reported a cash position of $1.234 billion as of June 30, 2024, which is expected to fund operations into 2027.

Arvinas, Inc

NASDAQ:ARVN

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Biotechnology
Pharmaceutical Preparations
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United States of America
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