GUGGENHEIM 3RD ANNUAL HEALTHCARE INNOVATION CONFERENCE - DBV TECHNOLOGIES SA

Financial Performance:

• Company maintains a cash runway extending into Q3 of the following year, which covers all necessary commercialization investments and inventory build-up required for launch.
• No specific revenue, earnings, or margin figures provided as the company is pre-commercial; however, the current cash position is deemed sufficient to reach the product launch milestone.
• The company is actively exploring various financing tools to secure additional capital if the BLA receives Priority Review designation, anticipating a need for further funding post-launch.

Guidance and Future Outlook:

• The Lead BLA for children aged 4-7 was filed on September 28, with an expected acceptance action date in late November (60-day window).
• Management requests Priority Review based on Breakthrough Designation status; a Pre-Approval Inspection (PAI) is expected post-mid-cycle review, likely requiring remediation of a prior CRO warning letter.
• BLA submission for the toddler population (ages 1-3) is being coordinated to align with the 4-7 review timeline to avoid regulatory bottlenecks, pending final FDA agreement on filing strategy.
• Commercial launch preparation is on track, with distribution and specialty pharmacy partners selected; product supply chain (manufactured in Amboise, France) is expected to be ready for market entry weeks after PDUFA.

Business Segments and Product Lines:

• Core platform is ViaSkin, an epicutaneous immunotherapy patch exploiting skin immune properties (Langerhans cells) to desensitize patients to allergens.
• Primary focus is peanut allergy in pediatric patients (ages 1-7), leveraging a "sweet spot" of early diagnosis, parental mobilization, and favorable biology.
• Clinical data for the pivotal 4-7 study shows 47% efficacy on active treatment vs. 14% on placebo at one year, with projections for continued efficacy in years 2-4.
• The "Comfort" study has successfully expanded the safety database to over 1,000 patients (adding ~260 patients to the previous 240), meeting the FDA's requirement for 600 patients on active treatment for safety confirmation.
• Target Product Profile (TPP) emphasizes a non-invasive, at-home therapy (daily patch) versus oral immunotherapy (OIT) or injectables, eliminating the need for updosing clinic visits.

Market and Competitive Landscape:

• Addressable market is approximately 600,000 children; 80% of peanut allergies persist into adulthood, while milk/egg allergies often resolve.
• Current competition includes Palforzia (OIT) and Zolair (injectable); claims data indicates only ~1% market penetration for Zolair in this age group due to needle aversion and long-term immunosuppression concerns.
• Market barriers for Palforzia include the limited number of allergists (approx. 100) performing OIT at scale and the high burden of frequent clinic visits for updosing.
• Management differentiates ViaSkin as the first at-home immunotherapy option with a favorable safety profile and lower operational burden for families.

Risks and Challenges:

• Regulatory Risk: A warning letter received by contract research organization (CRO) "Forever" regarding sterile manufacturing practices at the Amboise facility; management asserts this is process-related, not product-specific, and confidence is high it will be resolved before the PAI.
• Review Bottleneck: Potential for FDA review delays if the agency reviews the 4-7 and 1-3 BLAs in parallel.
• Clinical Uncertainty: No clinical data exists on the speed of efficacy onset (e.g., risk reduction at 3 months); protection thresholds are validated at 12 months.
• Pricing and Reimbursement: Final pricing is not yet set; commercial viability depends on successful payer value proposition discussions and navigating prior authorization processes.

Management Commentary and Tone:

• Management conveyed high confidence in the regulatory pathway, emphasizing that no new data generation was needed for the BLA, only structural reorganization of existing data.
• The tone regarding the CRO warning letter was transparent yet dismissive of long-term risk, characterizing the issue as "typical" and actively managed.
• Confidence is expressed in the commercial readiness, with a focus on the high unmet need and the superior convenience of the patch compared to existing therapies.
• CEO Daniel Tesse and CCO Kevin Trapp emphasized the biological advantage of treating younger children (ages 1-7) and the strong parental demand for a non-invasive solution.

Analyst Questions and Answers:

• Q: Timeline for BLA acceptance and potential Advisory Committee (AdCom)?
  • A: Acceptance expected late November; AdCom is not currently expected as per pre-BLA minutes, though this remains subject to review.
• Q: Status of the CRO warning letter and its impact on the timeline?
  • A: Issues are confined to veterinary manufacturing processes at the facility; management is confident resolution will occur prior to the PAI, which will happen post-mid-cycle review.
• Q: Is the 1-3 BLA filing dependent on the 4-7 approval?
  • A: No, but filing is being synchronized to facilitate parallel review and avoid bottlenecks, incorporating learnings from the first submission.
• Q: How does ViaSkin compare to Palforzia regarding onset of action and dosing?
  • A: Unlike Palforzia, ViaSkin has no updosing requirements and allows for at-home administration, removing the burden of frequent clinic visits.
• Q: What is the pricing strategy and competition from Zolair?
  • A: Pricing is under analysis against Palforzia/Zolair; Zolair has minimal penetration (<1%) due to safety and needle aversion. Distribution will be via specialty pharmacy with a hub model.

Other Key Points:

• Demographics: Approximately 33% of the target population has peanut-only allergy, while ~54% are polyallergic; parents prioritize peanut due to its ubiquity in the food supply.
• Commercial Strategy: Will deploy 50-70 specialty sales reps targeting allergists, supplemented by direct-to-consumer digital campaigns focusing on parental anxiety and advocacy groups.
• Manufacturing: All production is centralized in Amboise, France; no new manufacturing sites are required for launch.
• Safety: No new safety signals identified in the expanded database; adverse event profile remains consistent with the initial 1,000+ patient experience.