DBV Technologies (DBV) investor relations material

Platform and clinical evidence

• VIASKIN uses epicutaneous immunotherapy to engage skin immune cells and re-educate the immune response; initial focus is food allergy, with potential applications in aeroallergens and other immunotherapies.

• Children ages 1–7 are the target sweet spot, reflecting typical diagnosis at ages 1–4, high parental willingness to treat, and stronger response to immunotherapy in younger patients.

• In the pivotal 4–7 study, 47% on active treatment vs 14% on placebo met the efficacy measure at 1 year; treatment commonly spans 3–5 years, with ongoing follow-up to assess benefit in years 2–4.

• Clinical efficacy is assessed at 12 months; protection at 3 weeks or 3 months is not established. At AAAAI, 83% on VIASKIN increased eliciting dose, while 1 in 4 untreated patients had reduced tolerance.

Regulatory and development plans

• The 4–7 BLA was filed September 29; an FDA file-acceptance decision was expected in late November, 60 days after filing. The filing request seeks priority review, supported by breakthrough designation.

• FDA discussions focused on CMC and biostatistics organization, traceability, and filing architecture; no new data generation was required.

• FDA pre-BLA minutes indicated an AdCom was not expected, subject to review; preparation is underway in case the agency changes its position.

• Fareva Amboise’s warning letter stemmed from sterile manufacturing observations involving a veterinary product; site-wide quality systems are implicated, and remediation is expected to be addressed before the pre-approval inspection.

• The 1–3 BLA timing and process are under discussion with FDA to avoid a review-team bottleneck; COMFORT data will be incorporated, with filing planned to support an expeditious review after the 4–7 filing experience.

Market and commercial preparation

• The 4–7 launch opportunity is estimated at 600,000 children with peanut allergy; 80% of children persist with peanut allergy, and 1 in 5 in this age range visits the ER annually.

• Claims data indicate XOLAIR use in about 1% of children; commercial plans include roughly 50–70 specialty sales reps, focused digital outreach to families, and ongoing payer discussions.

• In the study, 54% had at least one additional food allergy and about one-third had peanut allergy only; parents identify peanut as a major concern because of severe reactions and frequent accidental exposure.

• VIASKIN is positioned as a daily at-home patch after first-dose observation, without oral updosing; pricing work continues, with specialty pharmacy distribution, a hub, prior-authorization support, and potential commercial copay assistance planned.

• Supply-chain and launch preparations are underway; product availability is expected within weeks after PDUFA, with sales detailing able to begin at PDUFA and representatives to be trained before approval.