DBV Technologies S.A. (DBVT) Q2 2025 Earnings Summary

Executive Summary

Q2 2025 revenue of $1.47M was above consensus ($0.75M) and up sequentially from Q1 ($0.75M), driven by higher “operating income” recognition (primarily French R&D tax credit) in the quarter . Revenue beat vs estimates: +94% and EPS beat (actual: $(0.31) vs consensus: $(0.34)) with limited street coverage (one EPS estimate; three revenue estimates) [*S&P Global].
Operating expenses rose to $42.6M in Q2 (+22% YoY), largely due to COMFORT Toddlers supplemental safety study ramp; net loss widened to $(41.9)M vs $(33.1)M in Q2’24 .
Cash and equivalents increased to $103.2M at quarter-end following the April financing; management reiterated cash runway “into Q2 2026,” while noting substantial doubt as a going concern absent additional warrant exercises or financing .
Regulatory execution remains a key catalyst: first subject screened in COMFORT Toddlers (June 25) and FDA alignment on an accelerated approval pathway for toddlers (Dec 2024); BLA filing targeted for 2H 2026 .

What Went Well and What Went Wrong

What Went Well

COMFORT Toddlers initiated enrollment: “Screening our first subject marks a crucial step forward… we are now well underway with both of our core clinical programs” — Daniel Tassé, CEO .
Regulatory clarity: “DBV is pleased to have received… a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1–3-years-old” — Daniel Tassé .
Revenue/“operating income” recognition increased YoY (Q2: $1.5M vs $1.2M) supporting a top-line beat versus consensus in the quarter [*S&P Global].

What Went Wrong

Operating expenses climbed with trial ramp (Q2 OpEx: $42.6M vs $35.0M YoY); R&D rose to $33.7M from $25.4M YoY, widening quarterly net loss to $(41.9)M .
Financial items turned negative (Q2 financial income/(expense): $(0.6)M vs +$0.7M YoY), adding pressure to the P&L .
Going concern language persists despite financing: “With… proceeds… the Company estimates… sufficient to fund operations into the second quarter of 2026. As such, there is substantial doubt regarding our ability to continue as a going concern.” .

Financial Results

Metric	Q2 2024	Q1 2025	Q2 2025
Revenue (“Operating income”) ($USD)	$1.161M	$0.753M	$1.465M
Net Income ($USD)	$(33.116)M*	$(27.079)M	$(41.875)M
Diluted EPS ($USD/share)	$(0.344)*	$(0.264)	$(0.311)
Total Operating Expenses ($USD)	$35.003M	$27.371M	$42.575M
Cash and Equivalents ($USD)	$66.213M	$12.962M	$103.207M

Notes: Asterisk denotes values retrieved from S&P Global (no embedded doc citation).

Segment breakdown: Not applicable; DBVT does not report product revenue and recognizes “operating income” primarily from research tax credits .

KPIs (OpEx components – quarterly)

KPI ($USD)	Q2 2024	Q1 2025	Q2 2025
Research & Development	$25.4M	$21.5M	$33.7M
Sales & Marketing	$1.0M	$0.3M	$0.4M
General & Administrative	$8.6M	$5.6M	$8.5M

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Through 2026	“Into June 2026” (as of Q1 update, post-financing)	“Into Q2 2026” (as of Board review June 23, 2025)	Lowered
BLA Submission – Viaskin Peanut (Toddlers 1–3)	Regulatory timeline	2H 2026 target (FDA alignment)	2H 2026 reaffirmed	Maintained
Warrants Exercise Proceeds	Financing plan	Up to $181.4M gross proceeds contingent on milestones	Acceleration tied to VITESSE Phase 3 primary endpoint	Clarified trigger
Use of Proceeds	Program funding	Working capital, Viaskin Peanut development, BLA prep, U.S. launch readiness	Same	Maintained

No revenue, margin, OpEx or tax-rate numeric guidance ranges were provided for Q2 2025 .

Earnings Call Themes & Trends

No Q2 2025 earnings call transcript was found; DBV held an investor call June 25 related to COMFORT Toddlers initiation, but a transcript was not available via our sources .

Topic	Previous Mentions (Q4 2024)	Previous Mentions (Q1 2025)	Current Period (Q2 2025)	Trend
FDA/Regulatory Pathway (Toddlers)	Accelerated Approval pathway confirmed; endpoint agreed (EPITOPE efficacy as intermediate)	Financing secured to advance toward BLA; cash runway extended	COMFORT Toddlers screening initiated; BLA targeted 2H 2026	Improving regulatory clarity; execution underway
Clinical Program Execution	Post-marketing confirmatory study criteria set	VITESSE/EPITOPE progression highlighted	COMFORT Toddlers sites activated; enrollment start	Execution ramping
Cash & Financing	N/A	Financing of up to $306.9M announced (gross $125.5M received Apr 7)	Cash $103.2M; runway into Q2 2026; going concern language	Liquidity improved; caution remains
Manufacturing/Commercial Patch	FDA views commercial patch as different; used in ongoing OLE; no safety/efficacy differences	N/A	Commercial patch to be used in COMFORT Toddlers and confirmatory study	Readiness progressing
R&D/OpEx Discipline	N/A	Q1 OpEx down YoY (G&A lower on office moves)	Q2 OpEx up YoY (COMFORT ramp)	Spending up with trial activity

Management Commentary

“Screening our first subject marks a crucial step forward in our mission to develop this potential groundbreaking therapy… we are now well underway with both of our core clinical programs” — Daniel Tassé, CEO .
“DBV is pleased to have received… a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1–3-years-old” — Daniel Tassé .
Cash runway and going concern: “With the receipt of… proceeds… the Company estimates… sufficient to fund its operations into the second quarter of 2026. As such, there is substantial doubt regarding our ability to continue as a going concern.” .
Use of proceeds and warrant triggers: funding to support development, BLA prep and potential launch readiness; warrant exercise acceleration if VITESSE Phase 3 hits primary endpoint .

Q&A Highlights

No Q2 2025 earnings call transcript was available. DBV hosted an investor call June 25 to discuss COMFORT Toddlers screening, but a transcript was not accessible via our document sources .
Prior regulatory webcast (Dec 11, 2024) focused on accelerated approval pathway criteria and confirmatory study design; no Q&A transcript retrieved .

Estimates Context

Q2 2025 Revenue: Actual $1.47M vs consensus $0.75M (3 estimates) — beat; EPS: Actual $(0.31) vs consensus $(0.34) (1 estimate) — beat [*S&P Global].
Q1 2025 Revenue: Actual $0.75M vs consensus $0.50M (1 estimate) — beat [*S&P Global].
Coverage remains thin (few estimates), increasing volatility of estimate-based comparisons; nonetheless, top-line upside reflects higher “operating income” recognition (R&D tax credits) and program activity [*S&P Global].

Estimates source: Values retrieved from S&P Global.

Metric	Q2 2025 Consensus	Q2 2025 Actual	Beat/Miss
Revenue ($USD)	$0.752M*	$1.465M	Bold beat
EPS ($USD/share)	$(0.343)*	$(0.311)	Bold beat
# of Estimates (Revenue/EPS)	3 / 1*	—	—

Key Takeaways for Investors

Regulatory execution is the core driver: COMFORT Toddlers is live and enrollment underway; FDA accelerated approval pathway for toddlers de-risks the route to a 2H 2026 BLA filing .
Near-term P&L will remain loss-making as R&D scales with study activity; expect OpEx pressure to persist through COMFORT and confirmatory study execution .
Liquidity strengthened post-financing (cash $103.2M), but management still includes going-concern language; warrants tied to VITESSE outcomes are a material optionality for runway extension .
Limited street coverage amplifies estimate volatility; Q2 delivered top-line/EPS beats, primarily from operating-income recognition (tax credits) rather than product revenue, a dynamic to consider when modeling [*S&P Global].
Key catalysts over next 6–12 months: COMFORT enrollment/adhesion data updates, VITESSE Phase 3 milestone(s) that could accelerate warrant exercises, and manufacturing/commercial readiness for Viaskin Peanut .
Trading implications: headline sensitivity to clinical/regulatory updates likely outweighs quarterly financials; monitor COMFORT operational milestones and any VITESSE data readouts as potential stock movers.

Appendix: Source Tables and Disclosures

All quarterly financial figures and cash balances sourced from DBV’s Q2 2025 and Q1 2025 8-Ks/press releases .
Consensus estimates sourced from S&P Global; where no embedded citations are available, values are marked with an asterisk and noted as S&P Global-derived.