DBV Technologies — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported a net loss of $64.5 million for the third quarter of 2026, compared to a net loss of $33.2 million in the same period in 2025; net loss per share was $0.14 for Q3 2026 versus $0.24 in Q3 2025.
• Net loss for the nine months ended September 30, 2026, was $162.5 million, compared to $102.1 million for the same period in 2025; net loss per share was $0.37 for the nine months of 2026 versus $0.82 in 2025.
• Operating income was $1.6 million for Q3 2026, down from $2.8 million in Q3 2025; for the nine months of 2026, operating income was $3.1 million compared to $5.0 million in 2025.
• Research and Development (R&D) expenses increased to $47.0 million in Q3 2026 from $28.6 million in Q3 2025, and to $111.6 million for the first nine months of 2026 from $83.8 million in 2025.
• Sales and Marketing expenses rose to $5.3 million in Q3 2026 from $1.2 million in Q3 2025, and to $15.7 million for the first nine months of 2026 from $1.9 million in 2025.
• General and Administrative (G&A) expenses increased to $14.0 million in Q3 2026 from $7.3 million in Q3 2025, and to $39.1 million for the first nine months of 2026 from $21.3 million in 2025.
• Financial income was $0.6 million for Q3 2026 compared to $1.1 million in Q3 2025, and $1.5 million for the first nine months of 2026 compared to nil in 2025.
• Income tax expense was $0.3 million for Q3 2026 compared to nil in Q3 2025, and $0.7 million for the first nine months of 2026 compared to $0.1 million in 2025.
• Net cash used in operating and investing activities was $159.4 million for the nine months ended September 30, 2026, compared to $86.7 million for the same period in 2025.
• Cash and cash equivalents stood at $165.7 million as of September 30, 2026.

Guidance and Future Outlook:

• Management estimates that existing cash and cash equivalents will fund operations into the third quarter of 2027.
• Management concluded that existing cash is not expected to be sufficient to fund operations for at least twelve months from the date of issuance, creating substantial doubt about the ability to continue as a going concern within that period.
• The company expects to receive a determination from the FDA regarding whether the BLA for children aged 4 through 7 years is sufficiently complete to begin full substantive review, including Priority Review, in the fourth quarter of 2026.
• DBV plans to submit the BLA for the toddler program (ages 1 through 3) in 2027 following discussions with the FDA regarding a potential rolling submission.
• Management is actively evaluating multiple financing alternatives, including additional sales under the ATM Program, equity transactions, warrant exercises, and other forms of financing, though no assurance exists that additional financing will be available on acceptable terms.

Business Segments and Product Lines:

• Submitted the Biologics License Application (BLA) to the U.S. FDA for the VIASKIN® Peanut Patch in children aged 4 through 7 years on September 29, 2026, and requested Priority Review.
• The BLA for the 4-7 age group is supported by the Phase 3 VITESSE trial, which enrolled 654 children, the largest immunotherapy trial to date in this population.
• Advanced the COMFORT Toddlers and THRIVE programs.
• Recorded $4.7 million in BLA filing fees during the quarter.
• Invested $4.5 million in Q3 2026 and $10.2 million for the first nine months of 2026 in launch capabilities and precommercial inventory build-up to support a potential launch if approved.
• Expanded the commercial organization and advanced launch infrastructure, including distribution and specialty pharmacy selection.

Market and Competitive Landscape:

• No specific market share data or direct competitor comparisons were provided in the press release.
• The company focuses on the treatment of food allergies, specifically peanut allergy, using epicutaneous immunotherapy (EPIT).

Risks and Challenges:

• Substantial doubt exists regarding the company's ability to continue as a going concern within twelve months due to insufficient cash to fund operations.
• The company faces risks related to the regulatory review process, including the outcome of the FDA review of the BLA and the Pre-Approval Inspection (PAI).
• Manufacturing challenges persist following an April 2026 FDA Warning Letter issued to contract manufacturer Fareva Amboise; remediation activities are ongoing with external specialists.
• The target date for the Pre-Approval Inspection (PAI) is scheduled after Fareva expects to complete remediation activities.
• Future capital requirements may differ materially from current estimates depending on regulatory outcomes, clinical development pace, manufacturing commitments, and foreign exchange fluctuations.
• No product candidates have been authorized for sale in any country as of the report date.

Management Commentary and Tone:

• CEO Daniel Tassé described the third quarter as a "defining step" in the company's evolution from a clinical-stage company to a commercial organization.
• Management expressed gratitude for the "productive, ongoing dialogue" with the FDA regarding both the 4-7 year and toddler BLAs.
• The company is aligning all functions to support a complete and efficient review of both dossiers, advancing manufacturing readiness, and preparing launch plans with discipline.
• Management noted that the increase in operating expenses reflects the scaling of corporate infrastructure across core functions including Medical Affairs, Sales, Market Access, Marketing, Account Management, and Pharmacovigilance.

Other Key Points:

• Refreshed the Company's $150 million ATM program and completed a sale of $50 million in gross proceeds of ADSs to RA Capital Management.
• The BLA submission for the 4-7 age group includes a target date for the Pre-Approval Inspection (PAI) in line with FDA regulations.
• The FDA indicated that initiating a review of the 1-3 year BLA shortly after the 4-7 year BLA would allow the Agency to build on learnings and leverage content overlap for efficiency.
• The company will host a conference call on October 28 at 5:00pm ET to discuss the results.
• The Company's ordinary shares trade on Euronext Paris (DBV) and ADSs trade on the Nasdaq Capital Market (DBVT).