DBV Technologies (DBV) Q2 2024 earnings summary

Executive summary

• VIASKIN Peanut, an epicutaneous immunotherapy patch, is in late-stage development for peanut-allergic children aged one to seven, addressing a significant unmet need.

• VITESSE Phase 3 trial for children ages 4–7 is on track, with enrollment expected to complete by end of Q3 2024; EPITOPE/COMFORT studies ongoing in toddlers aged one to three.

• Ongoing regulatory dialogue with the FDA includes a submitted draft labeling proposal for toddlers, focusing on patch wear-time experience.

• Cost-saving measures have extended the cash runway into Q1 2025, with a cash balance of $66.2 million at the end of Q2 2024.

Financial highlights

• Net loss for H1 2024 was $60.5 million, compared to $44.8 million for the same period in 2023.

• Operating income for H1 2024 was $2.6 million, mainly from research tax credits, down from $4.5 million year-over-year.

• Operating expenses rose to $65 million for H1 2024, up 28% year-over-year, driven by clinical, CMC, and increased R&D activities; one-third were non-recurring.

• Cash and cash equivalents decreased to $66.2 million as of June 30, 2024, from $141.4 million at December 31, 2023.

• Net cash used in operating activities was $69.8 million for H1 2024, including $24 million in non-recurring costs.

Outlook and guidance

• VITESSE trial enrollment expected to complete by end of Q3 2024; top-line results anticipated 12 months after last patient screened.

• Awaiting FDA feedback on proposed labeling for VIASKIN Peanut in toddlers; study preparations continue.

• Year three results from the EPITOPE open-label extension and publication of year two results expected later in 2024.

• Additional capital will be sought to support ongoing R&D and potential product launch; ability to secure financing remains uncertain.