DBV Technologies S.A. SEC 10-K Report

DBV Technologies S.A., a clinical-stage biopharmaceutical company focused on developing novel therapies for food allergies using its proprietary Viaskin technology platform, has released its annual 10-K report. The report provides a comprehensive overview of the company's financial performance, business operations, strategic initiatives, and the challenges it faces as it advances its product pipeline, particularly Viaskin Peanut for peanut allergies.

Financial Highlights

• Operating Income: $4.2 million, a decrease of 74% from the previous year due to lower Research Tax Credit and nil revenue recognition following the termination of the Collaboration Agreement with NESTEC.
• Net Loss: $113.9 million, an increase of 57% compared to the previous year, primarily due to increased Research and Development expenses.
• Net Loss Per Share: $1.17, compared to $0.76 in the previous year, reflecting the increased net loss.
• Total Operating Expenses: $120.7 million, an increase of 31% from the previous year, driven by higher Research and Development expenses and pre-commercialization activities for Viaskin Peanut.

Business Highlights

• Viaskin Technology Platform: DBV Technologies has developed a novel technology platform called Viaskin, which uses epicutaneous immunotherapy (EPIT) to deliver biologically active compounds through intact skin. This platform is primarily focused on treating food allergies, with a key product candidate being Viaskin Peanut for peanut allergies.
• Viaskin Peanut Clinical Trials: The company has conducted multiple clinical trials for Viaskin Peanut, including four Phase 2 trials and four completed Phase 3 trials. An ongoing Phase 3 trial is evaluating the product in children aged 4-7, with additional studies planned for toddlers aged 1-3.
• Regulatory Designations: Viaskin Peanut has received fast track and breakthrough therapy designations from the FDA, which are intended to expedite the review process for treatments addressing serious or life-threatening conditions.
• Product Pipeline: In addition to Viaskin Peanut, DBV Technologies is developing Viaskin Milk for cow's milk allergy and exploring applications for eosinophilic esophagitis (EoE). The company aims to expand its product pipeline using the Viaskin technology platform.
• Unmet Medical Need: Peanut allergy is a significant concern, particularly in children, with a prevalence of approximately 2.2% in the pediatric population in the United States. The current standard of care involves strict allergen avoidance and emergency use of epinephrine, highlighting the need for new treatment options.
• Current and Emerging Treatments: Various treatment approaches for peanut allergy are in development, including oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and EPIT. Viaskin Peanut offers a non-invasive alternative with a potentially favorable safety profile.
• Viaskin Peanut for Toddlers: The company is advancing Viaskin Peanut for toddlers aged 1-3, with positive results from the EPITOPE Phase 3 trial showing significant treatment effects. A supplemental safety study, COMFORT Toddlers, is planned to support regulatory submissions.
• Viaskin Peanut for Children 4-7: The VITESSE Phase 3 trial is evaluating a modified Viaskin Peanut patch in children aged 4-7. The trial aims to support a future Biologics License Application (BLA) submission.
• Manufacturing and Supply: DBV Technologies relies on a proprietary manufacturing process using electrospray technology to produce Viaskin patches. The company has agreements with contract manufacturers for the supply of active pharmaceutical ingredients and finished products.
• Intellectual Property: The company holds patents related to the Viaskin technology, including the electrostatic patch and allergen desensitization methods. These patents provide protection in major markets such as the United States and Europe.
• Regulatory Pathway: DBV Technologies is pursuing regulatory approval for Viaskin Peanut in both the United States and Europe. The company has engaged in discussions with the FDA and EMA to align on approval pathways and study requirements.
• Future Outlook: The company plans to continue developing its Viaskin technology platform, expand its product pipeline, and seek regulatory approvals to bring new treatments to market. The focus remains on addressing unmet medical needs in food allergies and other immunological conditions.

Strategic Initiatives

• Strategic Initiatives: The company is advancing its Viaskin technology platform, focusing on the development and potential commercialization of Viaskin Peanut for treating peanut allergies in children. Strategic initiatives include ongoing clinical trials and preparation for regulatory submissions in the U.S. and EU. The company is also exploring additional product candidates and technologies through potential acquisitions or in-licensing agreements.
• Capital Management: The company has primarily funded its operations through equity financings, including a recent private placement financing (2025 PIPE) that raised $125.5 million. This financing is expected to support operations into June 2026. The company also maintains an At-The-Market (ATM) program to offer and sell up to $100 million of American Depositary Shares. Additionally, the company has no bank debt and relies on equity and public assistance, such as research tax credits, for funding.
• Future Outlook: The company anticipates needing additional capital to support the potential launch of Viaskin Peanut and other R&D efforts. It plans to seek financing through public or private equity, debt financings, collaborations, and other non-dilutive options. The company estimates that, with the potential issuance of all warrant shares, it could extend financial visibility into 2028, covering the period through potential commercialization of Viaskin Peanut in the U.S., if approved.

Challenges and Risks

• Financial Risks: The company faces significant financial risks due to its history of net losses and the expectation of continued losses as it advances its clinical-stage biopharmaceutical products. The company's future financial stability heavily depends on the successful development, regulatory approval, and commercialization of Viaskin Peanut. The company has raised additional funds through a private placement financing, but it still requires substantial additional funding to continue its operations and product development efforts. Failure to secure necessary capital could force the company to delay or terminate its product development efforts.
• Market Risks: The company is exposed to market risks, including potential declines in the market price of its securities, which could result in significant losses for investors. Economic downturns, inflation, and geopolitical events, such as the ongoing conflicts in Ukraine and the Middle East, could negatively impact the company's business and financial performance. These macroeconomic conditions may also affect the company's ability to raise additional capital on favorable terms.
• Regulatory Risks: Regulatory risks are significant, as the company depends almost entirely on the successful development of its Viaskin technology. The regulatory approval process is complex, lengthy, and uncertain, with the potential for delays or denials from the FDA or other regulatory authorities. The company must demonstrate the safety and efficacy of its product candidates through extensive clinical trials, which are costly and time-consuming. Any setbacks in these trials could jeopardize the company's ability to obtain regulatory approval and successfully market its products.
• Operational Risks: Operational risks include the company's reliance on third-party manufacturers and suppliers for the production of its product candidates. Any disruptions in the supply chain, such as those caused by natural disasters or public health crises, could adversely affect the company's ability to conduct clinical trials and commercialize its products. Additionally, the company faces challenges in establishing a sales and marketing infrastructure to support the commercialization of its products, if approved.
• Management Strategies: Management acknowledges the financial challenges posed by the company's ongoing net losses and the need for additional funding. The company plans to address these challenges by seeking additional capital through public or private equity or debt financings, collaborations, and other non-dilutive financings. Management is also focused on advancing the clinical development of Viaskin Peanut and other product candidates to achieve regulatory approval and commercialization.
• Market Risk Management: The company is exposed to market risks related to foreign currency exchange rate fluctuations, which could adversely affect its financial results. The company operates in multiple countries and is subject to currency exchange rate volatility, which may impact its financial performance and cash flows. Management is monitoring these risks and may implement strategies to mitigate their impact on the company's financial results.

SEC Filing: DBV Technologies S.A. [ DBV ] - 10-K - Apr. 11, 2025