DBV Technologies S.A.

Current report

Relying on third-party manufacturers may result in delays in our clinical development or commercialization efforts.

Current report

Developing and commercializing new medicines entails significant risks and expenses. Our clinical trials may be delayed if third-party manufacturers are unable to assure a sufficient quantity of the drug product to meet our study needs. Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the API used in our Viaskin product candidates, including Viaskin Peanut patch, such as peanut protein extract and unmodified allergen milk extract. In February 2020, Sanofi announced that it planned to create a new company dedicated to the production and marketing to third parties of API. Subsequently, Sanofi consolidated its API commercial and development activities conducted in six of its European API production sites. While those API sites do not include the site in which the API used in our Viaskin product candidates is produced, there can be no assurances that this transition will not adversely impact our supply of API from Sanofi. If Sanofi does not continue to manufacture the API as required by us in a timely manner, we may not be able to find a substitute manufacturer on a timely basis and our commercialization efforts and clinical trials may be delayed. Notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.

Current report

In December 2025, Stallergenes Greer announced that it intends to discontinue the commercialization of Palforzia, on July 31, 2026, for business reasons.

Current report

We also expect to rely on Sanofi and on FAREVA for the manufacturing of the patch and on other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval. Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms. Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

Current report

Once regulatory approval is obtained, a marketed product and its manufacturer are subject to continual review. The discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer or manufacturing facility, including withdrawal of the product from the market. Manufacturers of products with which we contract are required to operate in accordance with FDA-mandated cGMPs or comparable GMP requirements in foreign countries. A failure of any of our contract manufacturers to establish and follow cGMPs and to document their adherence to such practices may lead to significant delays in the launch or availability of products based on our product candidates into the market. Moreover, the constituent parts of a combination product retain their regulatory status (as a biologic or medical device, for example) and, as such, we or our contract manufacturers may be subject to additional requirements in the QSR or comparable quality management systems in foreign countries, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action. We, our contract manufacturers, any future collaborators and their contract manufacturers could be subject to periodic unannounced inspections by the FDA or other comparable foreign regulatory authorities, to monitor and ensure compliance with cGMP. Despite our efforts to audit and verify regulatory compliance, one or more of our third-party manufacturing vendors may be found on regulatory inspection by the FDA or other comparable foreign regulatory authorities to be noncompliant with cGMP regulations. Failure by third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including shutdown of the third-party vendor, fines, injunctions, civil penalties, revocation or suspension of regulatory approval for any products granted pre-market approvals, invalidation of drug product lots or processes, seizures or recalls of products, operating restrictions, and criminal prosecutions.

Current report

We have been informed by FAREVA Amboise (“FAREVA”), our sole contract manufacturer for Viaskin Peanut patches, that the FDA has issued warning letters to FAREVA identifying certain current Good Manufacturing Practice (“cGMP”) deficiencies, including at the FAREVA facility at which our Viaskin Peanut patches are manufactured. We are working collaboratively with FAREVA on its remediation and mitigation efforts in response to these warning letters. If FAREVA is unable to remediate these deficiencies to the FDA's satisfaction in a timely manner, or if the FDA takes further enforcement action with respect to the FAREVA Amboise facility, our ability to manufacture Viaskin Peanut patches for our clinical trials or, if approved, for commercial supply could be materially and adversely affected. Because FAREVA is currently our sole manufacturer of Viaskin Peanut patches, we do not have an alternative manufacturing source to which we could readily transition, and any interruption or restriction on manufacturing at the FAREVA Amboise facility could significantly delay our clinical development and regulatory timelines, including timing of the filing, acceptance or approval of our anticipated BLA submission for the Viaskin Peanut patch in children ages 4 through 7 years, and could have a material adverse effect on our business, results of operations, and financial condition.

Current report

Our current and anticipated future dependence upon others for the manufacture of our product candidates or products, if approved, may adversely affect our future profit margins and our ability to commercialize any products that receive regulatory approval on a timely and competitive basis.

Current report

None.