DBV Technologies S.A. Q2 FY2026 earnings call

### BLA Preparation for Viaskin Peanut Patch (4-7 age group) - The company is optimizing its Biologics License Application (BLA) submission for the Viaskin Peanut Patch for children aged 4 through 7, based on constructive, collaborative feedback from the FDA. - The FDA has not requested additional clinical data; all ongoing work relates to formatting, mapping, and organizing existing CMC (chemistry, manufacturing, and controls) and biostatistical datasets to meet FDA requirements. - The optimized BLA is planned for submission in Q3 2026 to enable a timely, efficient regulatory review.

### Clinical Program Updates - Recruitment for the Comfort Toddler supplemental safety study (evaluating the peanut patch in 1 to 3-year-olds) was completed in Q2 2026; this is a 6-month study with no primary efficacy endpoint. - New phase 3 data for the 4-7 age group was presented at major allergy conferences, showing consistent treatment efficacy across baseline sensitivity levels and statistical subgroups, and no difference in safety/efficacy for patients with common comorbidities (asthma, eczema, other food allergies). This reinforces confidence in the product's use in real-world peanut allergy populations. - The first patient was enrolled in the THRIVE study, a first-of-its-kind phase 2 proof-of-concept trial evaluating the Viaskin Peanut Patch for infants aged 6 to 12 months with peanut allergy, with the goal of assessing achievement of ad lib peanut consumption after 3-4 years of treatment. - A new independent clinical study confirmed that U.S. pediatric peanut allergy prevalence remains stable at approximately 2%, consistent with data collected 7 years prior, confirming a persistent, large patient population for the product.

### Commercial Preparation - The company is building full commercial infrastructure across market access, patient services, brand readiness, field force planning, and launch operations, with cross-functional coordination between commercial, medical affairs, regulatory, pharmacovigilance, quality, and supply chain teams to prepare for a U.S. launch if approved. - DBV is engaging with key food allergy community stakeholders (caregivers, advocates, physicians, payers) to identify adoption barriers and align the launch with patient and provider needs. - The company is conducting proactive planning for manufacturing capacity, supply chain readiness, and capital requirements to support potential peak demand if the product is approved, with disciplined capital allocation aligned with regulatory progress.

DBV Technologies is a clinical-stage biotech focused on food allergy treatments, and no separate product segment financial performance data (including absolute revenue or revenue contribution percentages) was disclosed in this call.

- The company confirmed its planned timeline to submit the optimized BLA for the 4-7 age group Viaskin Peanut Patch in the third quarter of 2026, with no delay to this target. - The company maintains its target to submit the supplemental BLA for the 1-3 age group by the end of 2026, leveraging overlap and learnings from the 4-7 BLA submission process. - DBV confirmed that it has sufficient funding to support operations, clinical progress, and commercial preparedness through the third quarter of 2027. - Management plans to share additional detailed commercial segmentation, pricing, and launch planning in the second half of 2026, likely at a dedicated commercial update event.

- All forward-looking statements (including BLA submission timelines, regulatory review outcomes, commercial launch plans, and clinical study results) are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in the company's SEC and French AMF filings. - Completing the large, complex BLA formatting and organizational work carries risk of unforeseen delays, even though management does not expect incremental data requests or fundamental issues from the FDA. - Regulatory acceptance of the BLA and a decision on priority review are ultimately at the FDA's discretion, and the requested 6-month priority review timeline is not guaranteed. - Commercial adoption and pricing of the Viaskin Peanut Patch, if approved, depends on payer acceptance and market demand, which are uncertain at this pre-approval stage.

Q: What are the expected timelines for BLA acceptance and review, will the company request priority review, and has FDA feedback required any manufacturing changes? / A: The company will formally request priority review when submitting the BLA, as Viaskin Peanut holds FDA breakthrough therapy designation making it eligible. After submission, the FDA has up to 60 days to accept the filing and confirm the review designation; a 6-month review would follow if priority review is granted. No changes to the product or its manufacturing process are required; all adjustments to the CMC section of the BLA are just organizational changes to address FDA feedback on formatting, not substantive product changes. Completion of ongoing FDA discussions on CMC and biostatistical data tabulation are the final gating items for BLA submission.

Q: Why is reformatting the BLA such a large, time-consuming undertaking that requires extending the preparation timeline? / A: A BLA is an extremely large submission containing hundreds of thousands of pages of testing, validation, and protocol data, which must be strictly organized per FDA regulations with extensive working hyperlinks for reviewers to navigate easily. The formatting must also comply with FDA IT system requirements to avoid processing issues. All linkages and cross-references across the massive document must be verified to avoid broken connections or unintended errors from incremental adjustments, making the process highly detail-oriented, even without new content being added.

Q: What is the strategic purpose of the THRIVE study in 6-12 month old infants, and is it intended for regulatory submission and a future label expansion? / A: THRIVE is an early-phase proof-of-concept study, not a registration trial at this stage. It builds on positive prior efficacy data for 1-3 year olds to test the product in even younger patients, who typically have more responsive immune systems, to assess if they can achieve ad lib peanut consumption after multi-year treatment. The study was launched earlier rather than waiting for post-approval because the question of early intervention is clinically important, and the company has sufficient confidence in the product's profile to pursue the data now; any future regulatory discussions based on study results will happen after data is generated.

Q: What is the expected price range for Viaskin Peanut, and what share of 1-7 year old peanut allergy patients is expected to seek therapy? / A: Competitor Xolair's pricing ranges from ~$10,000 to $30,000 annually based on age and weight. DBV has tested multiple price points with payers but has not finalized pricing, and will share more details closer to launch. Market research indicates significant patient demand, and the company has developed a segmentation framework prioritizing recently diagnosed patients, patients who discontinued other immunotherapies due to burden or tolerability, and later-adoption patients who require more education. More detailed demand data will be shared at a commercial update event in the second half of 2026.