DBV Technologies (DBV) investor relations material

Regulatory and filing timeline

• VIASKIN Peanut BLA for children ages 4–7 planned by end of Q3 2026 after constructive agency discussions on the novel drug-device combination.

• Toddler ages 1–3 BLA planned by year-end 2026; filing format and other details to be discussed in pre-BLA meetings after the first BLA submission.

• Agency discussions focused on organizing extensive CMC, data-tabulation and biostatistical-analysis materials for easier review, not redoing rejected content.

Patient need and clinical goals

• Peanut allergy affects family routines and can drive daily anxiety; VIASKIN aims to reduce the consequences of accidental exposure and improve quality of life.

• Average diagnosis has shifted from ages 3–5 to closer to age 3, with some diagnoses as early as 18 months; younger immune systems may be more responsive to immunotherapy.

• THRIVE studies infants ages 6–12 months; the goal is to show ad libitum peanut consumption after 3–4 years of treatment and 12 months off therapy, supporting a disease-modification claim.

• Differentiators cited were efficacy, safety and ease of use; common adverse event is patch-site redness, rarely treatment-limiting, with few discontinuations.

Market and commercial positioning

• Palforzia had strong allergist prescribing support and market access, but daily dosing and 3 hours of post-dose rest were burdensome for families; VIASKIN application takes 10–12 seconds and does not restrict daily activities.

• Management views immunotherapy as the preferred approach for younger children, while IgE blockade may suit older patients; XOLAIR penetration in peanut-allergic children was cited at about 1%.

• Commercial planning covers prescriber and family information needs, pricing, payer access and prior authorization; about 60% of children ages 1–7 with peanut allergy are already seen by an allergist.

• Management plans an internal launch, has not pursued partnering and said cash runway extends into Q3 2027, sufficient for launch investments including sales-force hiring.

• Incremental capital would be welcome, while current resources were described as sufficient to make launch investments intended to support product success.