DBV Technologies (DBV) Q3 2026 earnings summary

Executive summary

• Submitted the VIASKIN Peanut Patch BLA for children aged 4–7 on September 29, 2026, requesting Priority Review; the Phase 3 VITESSE trial enrolled 654 children.

• Advanced U.S. launch preparation, manufacturing readiness and commercial infrastructure; toddler BLA submission is expected in 2027 as FDA discussions continue.

Financial highlights

• Q3 2026 operating expenses were $66.3M, up 79% year over year; net loss was $64.5M versus $33.2M.

• 9M 2026 operating expenses were $166.4M, up 56% year over year; net loss was $162.5M versus $102.1M.

• Q3 R&D, sales and marketing, and G&A expenses were $47.0M, $5.3M and $14.0M, respectively; R&D included $4.7M in BLA filing fees.

• Operating income, consisting of Research Tax Credit, was $1.6M in Q3 2026 versus $2.8M in Q3 2025; no operating revenue was generated.

Outlook and guidance

• Cash of $165.7M was forecast to fund operations into Q3 2027, based on current plans and milestone-based spending assumptions.

• A BLA for ages 1–3 is expected in 2027; FDA discussions include a potential rolling submission and coordinated review with the older-children BLA.

• FDA determination on acceptance for substantive review, including Priority Review, was expected in Q4 2026; Priority Review, if granted, would shorten standard review from 10 to 6 months.

• No first-year sales guidance was provided; a launch-day investor and analyst event is planned closer to launch.