DBV Technologies S.A. Q4 FY2022 earnings call

Clinical Updates

• Finalized design and protocol of VITESSE, the Phase III pivotal study of modified Viaskin Peanut patch in 4-7 year olds with peanut allergy, on track to screen first patient by end of Q1 2023.
• Completed EVOLVE study, a 12-week user experience study with modified Viaskin Peanut patch in 50 peanut-allergic children ages 4-11, to optimize eDiary tool for VITESSE.

EVOLVE Study Details

• Validated eDiary tool for capturing patch adhesion and experience data.
• Updated instructions for use supported correct patch application, with majority of parents/caregivers reporting positive ease of use.

AAAAI Meeting

• Presented Viaskin Peanut data showing consistency in safety and efficacy across patient groups (with/without other food allergies and atopic dermatitis), and no change in atopic dermatitis severity for 1-3 year olds.

No detailed product segment financials with revenue contributions provided. Key financial highlights: Cash and cash equivalents were $209.2 million as of December 31, 2022 compared to $77.3 million as of December 31, 2021 (increase by $131.9 million). Net cash used in operating activities for the full year was $81.8 million, a 24% decrease compared to prior year due to cost containment measures.

VITESSE Progress

• On track to screen first patient in VITESSE by end of Q1 2023. Planning to start safety trial later to not compete with VITESSE enrollment, aiming to complete safety trial before or at same time as VITESSE database lock.

Toddler Program

• Will communicate with FDA this quarter regarding the toddler program, following traditional application processes.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ from expectations. Refer to the company's filings with the SEC and French AMF for risk factors that could impact results, including those related to forward-looking statements.

Q: Questions about EVOLVE study, including if FDA requested it, data collected besides eDiary validation, and 4-11 vs 4-7 age range.

A: EVOLVE was DBV's own decision to optimize the eDiary tool for VITESSE. Collected safety data, and the 4-11 age range was chosen for efficient data generation.

Q: Update on VITESSE safety study start and toddler program.

A: Safety trial to start later to not compete with VITESSE enrollment; will communicate with FDA this quarter regarding the toddler program.

Q: R&D spend increase.

A: R&D increase related to upfront costs for VITESSE initiation, with a slight ramp-up in R&D expenses for VITESSE commencement.