DBV Technologies (DBV) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Company overview and market landscape

• Focuses on immunology using skin-based therapies to treat food allergies in children, primarily targeting peanut allergy.

• Peanut allergy prevalence in US children remains steady at 1.8%-2.2%, affecting over 600,000 kids aged 1-7.

• Early peanut introduction has not reduced prevalence due to strict protocols and practical challenges for families.

• Diagnosis age is now younger, improving chances for successful intervention.

• Parental demand for effective, safe treatments remains high due to the ubiquity and unpredictability of peanut exposure.

Treatment approaches and competitive landscape

• Most allergists do not offer oral immunotherapy (OIT); only about 100 clinics in the US provide it at scale.

• Desensitization is preferred for young children due to immune system plasticity; Xolair is rarely used in this group.

• Viaskin Peanut uses epicutaneous immunotherapy (EPIT) with a patch delivering a minuscule, fixed dose, avoiding escalation and offering a strong safety profile.

• Patch therapy is convenient, with only the first application supervised in-office; subsequent use is at home.

• Long-term data show 68.2% of children could tolerate a full food challenge after three years of treatment.

Commercial outlook and regulatory progress

• Market size is estimated at 600,000 US children; engagement is high among parents and caregivers.

• Product is positioned as a blockbuster due to compliance-driven outcomes and high unmet need.

• Regulatory discussions with the FDA have focused on chemistry, manufacturing, and clinical data organization; BLA submission is nearing completion.

• Preparations for launch include medical community engagement, payer discussions, inventory build-up, and market research.

• Financing for launch is a key consideration, with current cash runway for one year.