DBV Technologies (DBV) investor relations material

Executive summary

• The company is advancing the VIASKIN Peanut Patch for children aged 4–7, with BLA submission targeted for Q3 2026 following FDA engagement; additional clinical programs are ongoing for younger children, including the COMFORT Toddlers safety study and the THRIVE study in infants.

• Significant investments have been made in regulatory, clinical, manufacturing, and commercial readiness, including new manufacturing agreements and expanded U.S. infrastructure.

• No revenue generated; operating income consists mainly of research tax credits.

• Raised visibility through inclusion in major stock indices and continued investor engagement.

• Funding is secured into Q3 2027 to support operations and commercial preparedness.

Financial highlights

• Net loss for H1 2026 was $98.0 million, up from $69.0 million in H1 2025; net loss per share improved to $(0.23) from $(0.58) due to a strengthened equity base.

• Cash and cash equivalents totaled $174.9 million as of June 30, 2026, down from $194.2 million at year-end 2025.

• Operating income was $1.6 million for H1 2026, down from $2.2 million in H1 2025, mainly from reduced research tax credits.

• Net cash used in operating and investing activities was $102.6 million for H1 2026, up from $54.0 million in H1 2025.

• Sales and marketing expenses rose sharply to $10.4 million for H1 2026, reflecting commercial launch preparations.

Outlook and guidance

• BLA submission for VIASKIN Peanut Patch in children 4–7 years is expected in Q3 2026, with priority review to be requested.

• Sufficient funding is projected into Q3 2027, with spending aligned to regulatory timelines and commercial launch preparedness.

• The COMFORT Toddlers safety study is expected to be filed by year-end 2026; submission for toddlers is contingent on study completion.

• Continued significant cash outflows are expected as the company advances toward regulatory submissions and commercialization.

• No profit guidance provided; future cash needs may arise depending on regulatory, clinical, and commercial developments.