DBV Technologies S.A. Q4 FY2023 earnings call

• Participated in AAAAI, with a highly attended product theater on early intervention for peanut allergy, highlighting interest in Viaskin Peanut.
• Discussed open-label extension studies for Viaskin Peanut, including interim year two data from toddlers and plans for year three data.
• Details on Phase 3 trials for one to seven-year-olds, aiming to enroll ~1,400 children globally. Updates on the EPITOPE study in toddlers, including second-year treatment results and safety profile.
• Plans for two separate BLAs: one for one to three-year-olds (square patch) and another for four to seven-year-olds (modified circular patch), with COMFORT studies for supplemental safety.
• Corporate updates: Strengthened leadership team with new CFO and COO; termination of collaboration with Nestlé positively impacted financials.

No detailed product segment financials with revenue contribution % were provided in the transcript. The focus is on Viaskin Peanut, the lead candidate for treating food allergies.

• Anticipated milestones in 2024 include initiating COMFORT-II trial, completing enrollment of Vitesse Phase 3 trial, hosting Investor Day, announcing three-year results from open-label extension, and publishing additional manuscripts.
• Plan to proceed with two separate BLAs for different age groups and prepare for commercialization.

• EU Clinical Trials Directive: Delays in site openings in Europe due to the new directive.
• Regulatory Uncertainties: Uncertainty around FDA feedback timing for protocol approvals, affecting study initiation.
• Market and Commercial Risks: Dependence on successful BLA submissions and commercialization, with competition from other treatments in the food allergy space.

Q: Could you give color on the EU directive and how many of the 600 expected patients in VITESSE have been enrolled to-date?

A: Pharis explained the EU directive's complexity where countries are banded together, causing potential delays, and stated enrollment details are competitive.

Q: Timing guidance on when COMFORT Toddlers will be starting and benefits of parallel programs?

A: Daniel and Pharis discussed waiting for FDA feedback on the protocol for COMFORT Toddlers and the benefits of parallel BLAs for different age groups.

Q: Product approval and market overlap between Viaskin Peanut for different age groups?

A: Pharis and Daniel talked about distinct patient populations for the one to three-year-old and four to seven-year-old programs, with little overlap.

Q: Steps ahead to get to the BLA filing for the Toddlers and cash runway?

A: Daniel discussed needing FDA protocol sign-off for Toddlers and cash runway including initiation of studies and regulatory preparations.