DBV Technologies S.A. (DBVT) Q4 2024 Earnings Summary

Executive Summary

DBV Technologies furnished preliminary unaudited FY 2024 results in March 2025 alongside a material FDA update; separate Q4 2024 quarterly detail was not provided, so this recap anchors on FY 2024 outcomes and Q3/Q2 trends .
FDA agreed COMFORT Children is no longer required; DBV accelerated the 4–7-year BLA submission to 1H 2026, with VITESSE topline still on track for Q4 2025, a key stock catalyst given potential one-year earlier launch if approved .
FY 2024 operating expenses rose to $120.7M (vs $92.2M FY 2023), driving a net loss of $113.9M and EPS of $(1.17); cash fell to $32.5M at year-end with going-concern language, later mitigated by a financing announced March 2025 intended to fund through submission/launch if warrants are exercised .
Near-term focus: initiate COMFORT Toddlers in Q2 2025 and deliver VITESSE topline in Q4 2025; regulatory clarity (AA in toddlers, expedited path in children) and the financing lower execution risk heading into BLA submissions in 2026 .

What Went Well and What Went Wrong

What Went Well

FDA alignment removed COMFORT Children safety study and accelerated the 4–7-year BLA to 1H 2026; “DBV’s alignment with FDA represents a tremendous achievement…” (CEO) .
VITESSE enrolled 654 participants, the largest Phase 3 peanut allergy trial in 4–7-year-olds; safety database at BLA submission will exceed 500 active-treated subjects .
Toddlers program secured an Accelerated Approval pathway with EPITOPE efficacy serving as the intermediate endpoint; COMFORT Toddlers on-track to initiate Q2 2025 .

What Went Wrong

FY 2024 cash declined to $32.5M with going-concern disclosure (sufficient only into April 2025 pre-financing), reflecting heavy external clinical and regulatory spend .
Operating income fell to $4.2M (from $15.7M FY 2023) primarily due to the Nestlé collaboration termination and lower French research tax credits as more activity shifted to North America .
Operating expenses increased by $28.5M YoY to $120.7M, driven by R&D for VITESSE, COMFORT preparations, and regulatory/manufacturing support, pressuring losses .

Financial Results

DBVT is pre-commercial; “Operating income” reflects research tax credits and other operating income. Separate Q4 2024 quarter data was not furnished; FY results and Q3/Q2 trends are used below.

Quarterly comparison (oldest → newest):

Metric	Q2 2024	Q3 2024
Operating income ($USD Millions)	$1.161	$1.1
Total Operating Expenses ($USD Millions)	$35.003	$31.4
Net Loss ($USD Millions)	$(33.116)	$(30.4)
Basic/Diluted EPS (USD/share)	$(0.34)	$(0.32)
Cash & Cash Equivalents ($USD Millions)	$66.2	$46.4

Full-year comparison:

Metric	FY 2023	FY 2024
Operating income ($USD Millions)	$15.7	$4.2
Operating Expenses ($USD Millions)	$92.2	$120.7
Net Loss ($USD Millions)	$(72.7)	$(113.9)
EPS (USD/share)	$(0.76)	$(1.17)
Cash & Cash Equivalents at Period End ($USD Millions)	$141.4	$32.5

KPIs (program/regulatory):

KPI	Q2 2024	Q3 2024	Q4 2024
VITESSE enrollment status	“Close recruitment by end Q3”	Fully enrolled at 654	Topline on-track Q4 2025
Regulatory alignment (toddlers)	Label-in/label-out proposal submitted (Jun 28)	FDA proposed AA pathway; EPITOPE efficacy as endpoint	COMFORT Toddlers initiation Q2 2025
Regulatory alignment (children 4–7)	VITESSE ongoing	COMFORT Children planned post-VITESSE	COMFORT Children no longer required; BLA in 1H 2026
Cash runway disclosure	Into Q1 2025	Into Q1 2025	Only into April 2025 (pre-financing)

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
VITESSE topline (children 4–7)	Program milestone	Q4 2025	Q4 2025 (reaffirmed)	Maintained
BLA submission (children 4–7)	Regulatory	2H 2026 (prior plan)	1H 2026	Raised (accelerated)
COMFORT Children (4–7)	Study requirement	6-month safety study planned ~250 subjects starting 2Q 2025	No longer required	Removed
COMFORT Toddlers (1–3)	Study start	Initiate in 2Q 2025	On-track for 2Q 2025	Maintained
Toddlers BLA (Accelerated Approval)	Regulatory	2H 2026	2H 2026 (reaffirmed)	Maintained
Cash runway	Liquidity	Into Q1 2025	Into April 2025 pre-financing ; post-deal upfront into 2Q 2026	Lowered then extended (financing)

Earnings Call Themes & Trends

Topic	Previous Mentions (Q2 2024, Q3 2024)	Current Period (Q4 2024 context)	Trend
Patch wear-time/labeling	Label-in/label-out framework proposed (Jun 28) to guide early discontinuation decisions	FDA accepted EPITOPE efficacy as intermediate endpoint (toddlers AA); adhesion not a study objective in COMFORT Toddlers	Clarified, regulatory convergence
Supply chain/CMC	Ongoing regulatory/manufacturing activities to support trials	Continued manufacturing/regulatory support noted	Stable investment
Regulatory/legal	EMA positive advice for EU indication (1–7) ; AA pathway in toddlers	COMFORT Children removed; accelerated 4–7 BLA; AA in toddlers detailed	De-risked timelines
R&D execution	VITESSE enrollment momentum; 86 sites; plan to close by Q3	Fully enrolled 654; safety DB >500 at BLA	On track
Cash runway/financing	Runway into Q1 2025; cost discipline	Pre-financing runway only into April 2025; financing up to $306.9M announced	Extended post-deal
Competitive landscape	—	Xolair usage skewed adult; limited 1–7 overlap; not a direct competitor for DBVT’s target	Favorable positioning

Management Commentary

“DBV’s alignment with FDA represents a tremendous achievement… DBV is commencing preparations for a BLA submission in the first half of 2026… VITESSE… on-track for readout of topline results in the fourth quarter of 2025.” — Daniel Tassé, CEO .
“FDA agrees that the VITESSE safety exposure data… is sufficiently robust to support a BLA in this age group… This is the largest, most rigorous study ever conducted in peanut allergic children between 4 and 7 years of age.” — Dr. David Fleischer, Global PI, VITESSE .
“On behalf of our 6,500 members… we are pleased to support… the Viaskin peanut patch… our community encourages as many treatment options as possible.” — Dr. James Tracy, President, ACAAI .
“We are… sufficiently funded through expected BLA submissions and commercial launch… [and] accelerated… BLA submission… in the first half of 2026.” — Daniel Tassé on financing and timelines .

Q&A Highlights

Quantifying patch wear-time vs adhesion: Management clarified a holistic patch wear-time experience drives label-in/out differentiation within first 90 days; detailed metrics pending FDA alignment .
Placebo response in VITESSE: Prior 4–7 data showed ~9.6% placebo response; design changes (ED thresholds) aim for robust active delta with conservative powering .
Study sequencing: Confirmatory effectiveness study (toddlers) will be initiated by BLA submission; COMFORT Toddlers safety study starts in Q2 2025; no interference between studies .
Competitive positioning: Xolair adoption skewed to adults; only ~10% of peanut-allergic patients treated are 1–7, supporting Viaskin’s focus on pediatric segment .
Independence of BLAs: Toddlers and children BLAs are distinct; some shared CMC elements, but core dossiers separate .

Estimates Context

Wall Street consensus (S&P Global) for Q4 2024/FY 2024 EPS and revenue was unavailable via our S&P Global access at this time; DBVT does not report product revenue yet and provided preliminary FY results without a stand-alone Q4 breakdown .
Given the lack of product revenue and preliminary nature of FY data, near-term models will hinge on operating expense trajectory, cash runway updates, and regulatory timelines rather than sales/EPS beats/misses .

Key Takeaways for Investors

Regulatory de-risking: Removal of COMFORT Children and AA pathway in toddlers materially accelerates timelines and lowers execution risk into BLA submissions (children 1H 2026; toddlers 2H 2026) .
2025 catalyst: VITESSE topline in Q4 2025 is the pivotal efficacy read for 4–7-year-olds; success would trigger warrant exercise (financing) and set up priority review potential .
Liquidity: Year-end cash of $32.5M and going-concern language were a concern; March 2025 financing aims to fund through submission/launch in children, subject to warrant triggers post-positive topline .
P&L trajectory: FY 2024 operating expenses up ~$28.5M YoY due to clinical execution; expect continued high R&D until post-VITESSE and COMFORT Toddlers completion .
Competitive positioning: Pediatric focus differentiates Viaskin vs biologics like Xolair; clinician and society support underscores unmet need in 1–7-year-olds .
Trading setup: Stock likely sensitive to regulatory updates (protocols, AA specifics), financing milestones, and VITESSE data cadence; consider positioning ahead of Q4 2025 readout .
Risk monitor: Execution risks (trial timelines, manufacturing scale-up), financing conditionality (warrant exercise dependent on topline), and ongoing burn remain key watch items .

Additional notes:

No Q4 2024 earnings call transcript was available in the filing catalog; narrative synthesized from the March 31, 2025 investor call, Q3/Q2 materials, and press releases .