DBV Technologies S.A.

What they do

DBV Technologies S.A. is a French societe anonyme developing a proprietary method of delivering biologically active compounds through intact skin using the Viaskin patch, called EPIT. Its most advanced candidate is the Viaskin Peanut patch, evaluated in twelve completed clinical trials including five Phase 3 trials, and it has earlier-stage programs including Viaskin Milk. The company had 296,042,447 ordinary shares outstanding as of April 15, 2026, and its shares trade on Nasdaq (ADS: DBVT) and Euronext Paris.

Revenue drivers

• Viaskin Peanut patch (pre-commercial) — Lead product candidate, not yet approved or marketed; the company is planning a BLA submission in the third quarter of 2026 for children aged 4 through 7 years, so it generates no product revenue today.
• Viaskin Peanut for toddlers and infants — Supplementary safety study in children aged 1 to 3 (COMFORT Toddlers) and Phase 2 THRIVE study in infants aged 6 to 12 months; conditional BLA submission planned for the second half of 2026 for ages one to three.
• Earlier-stage programs — Viaskin Milk and other autoimmune inflammatory disease programs, described as earlier-stage with no reported revenue contribution.
• Reported revenue base — Annual revenue was $5.6M in 2025 and $4.2M in 2024; quarterly revenue was $0.7M in Q2 2026, $0.9M in Q1 2026, and $0.562M in Q4 2025, all small relative to operating spending.

Recent performance

Operating income was $1.6 million for the six months ended June 30, 2026, including $0.7 million for Q2 2026, versus $2.2 million and $1.5 million in the prior-year periods. Revenue was $0.9 million in Q1 2026 and $0.7 million in Q2 2026. Annual net loss widened to $146.9 million in 2025 from $113.9 million in 2024, and operating cash flow was negative $121.2 million in 2025. Cash and cash equivalents were $174.9 million as of June 30, 2026, which the company says funds operations into the third quarter of 2027.

Strategy

DBV is preparing for a potential commercial launch of the Viaskin Peanut patch, investing in Medical Affairs, Sales, Market Access, Marketing, Account Management, and Pharmacovigilance. On June 29, 2026, it said it received FDA input on the organization, mapping, and formatting of CMC and biostatistical data sets and now expects to submit the BLA in the third quarter of 2026 without additional data. It closed recruitment in Q2 2026 for the COMFORT Toddlers safety study and initiated the Phase 2 THRIVE study in infants aged 6 to 12 months. A letter of intent with Fareva covers planned commercial manufacturing, with planned investment estimated at $7.5 million, of which up to $5.2 million is expected to be supported by the company.

Risks

• Regulatory and BLA timing risk — The Viaskin Peanut patch is not approved, and the BLA submission for children 4 to 7 has already moved to the third quarter of 2026 while the company incorporates FDA feedback.
• Recurring losses and cash consumption — Net loss was $146.9 million in 2025 and operating cash flow was negative $121.2 million, with funding described only into the third quarter of 2027.
• Limited current revenue — Reported revenue is small and irregular, at $5.6 million for 2025 and $0.7 million in Q2 2026, and does not cover operating costs.
• Manufacturing and supply-chain dependence — Commercial-scale production depends on a Fareva letter of intent and a definitive commercial manufacturing and supply agreement that the parties are still negotiating.

Outlook

Management anticipates submitting the BLA for the Viaskin Peanut patch in children aged 4 through 7 in the third quarter of 2026 and, conditional on successful completion of the toddler safety study, a BLA submission for children aged one to three in the second half of 2026. The company states the $174.9 million in cash and cash equivalents as of June 30, 2026 funds operations and commercial preparedness into the third quarter of 2027. DBV also expects the THRIVE study to add information on use in younger patient populations.