Châtillon, France, November 6, 2024
DBV Technologies Reports Third Quarter
2024 Financial Results
DBV closes Q3 2024 with a cash balance
of $46.4 million; cash runway into Q1
2025
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J200), a
clinical-stage biopharmaceutical company, today reported financial
results for the third quarter of 2024. The quarterly and nine
months financial statements were approved by the Board of Directors
on November 6, 2024.
Financial Highlights for the third
quarter Ended September 30,
2024
The Company’s interim condensed consolidated
financial statements for the nine months ended September 30, 2024,
are prepared in accordance with accounting principles generally
accepted in the United States (“U.S. GAAP”).
Cash and Cash EquivalentsCash
and cash equivalents amounted to $46.4 million as of September 30,
2024, compared to $141.4 million as of December 31, 2023, a net
decrease of $95.0 million. This decrease includes $92.2 million in
operating activities, mainly in external clinical trial related
expenses, notably progress on patient enrollment in VITESSE Phase 3
clinical trial, as well as Regulatory and Manufacturing activities
to support ongoing clinical trials.
The Company has incurred operating losses and
negative cash flows from operations since inception. As of the date
of the filling, DBV’s available cash and cash equivalents will not
be sufficient to support our operating plan for at least the next
12 months. As such, there is substantial doubt regarding its
ability to continue as a going concern.
Based on its current operations, plans and
assumptions, the Company expects that its balance of cash and cash
equivalents will be sufficient to fund its operations into Q1
2025.
The Company intends to seek additional capital
as it continues research and development efforts and prepares for
the launch of Viaskin Peanut, if approved. The Company cannot
guarantee that it will be able to obtain the necessary financing to
meet its needs or to obtain funds at attractive terms and
conditions, including as a result of disruptions or fluctuations of
the global financial markets due to various factors outside the
Company's control. A severe or prolonged economic downturn could
result in a variety of risks to the Company, including reduced
ability to raise additional capital when needed or on acceptable
terms, if at all.
If the Company is not successful in its
financing objectives, the Company could have to scale back its
operations, notably by delaying or reducing the scope of its
research and development efforts or obtain financing through
arrangements with collaborators or others that may require the
Company to relinquish rights to its product candidates that the
Company might otherwise seek to develop or commercialize
independently.
In millions of USD(unaudited) |
U.S. GAAP |
nine months ended September 30, |
2024 |
2023 |
Net cash & cash equivalents at the beginning
of the period |
141.4 |
209.2 |
Net cash flow used in operating activities |
(92.2) |
(66.0) |
Net cash flow provided by / (used in) investing activities |
(1.5) |
(0.6) |
Net cash flow provided by / (used in) financing activities |
(0.1) |
7.0 |
Effect of exchange rate changes on cash & cash equivalents |
(1.1) |
(0.4) |
Net cash & cash equivalents at the end of the period |
46.4 |
149.1 |
This interim condensed financial information
does not include any adjustments to the carrying amounts and
classification of assets, liabilities, and reported expenses that
may be necessary if the Company was unable to continue as a going
concern.
Operating IncomeUntil the end
of 2023, our operating income was composed of both the French
Research Tax Credit scheme (Crédit d’Impôt Recherche, or “CIR”) and
the revenue recognized under the Collaboration Agreement with
NESTEC. Following the termination of the Collaboration Agreement on
October 30, 2023, our operating income is now exclusively generated
by the French Research Tax Credit.
Operating income amounted to $3.6 million
for the 9 months ended September 30, 2024, compared with
$6.9 million for the same period in 2023. This decrease by
$3.2 million is composed of (1) $1.9 million following the
termination of the Collaboration Agreement with NESTEC, and (2) a
lower Research Tax Credit entitlement as a greater proportion of
studies activities are carried out in North America by $1.3
million
In millions of USD(unaudited) |
U.S. GAAP |
U.S. GAAP |
nine months ended September 30, |
three months ended September 30, |
2024 |
2023 |
2024 |
2023 |
Research tax credits |
3.6 |
5.0 |
1.1 |
1.2 |
Other operating income |
— |
1.9 |
— |
1.1 |
Operating income |
3.6 |
6.9 |
1.1 |
2.4 |
|
|
|
|
|
Operating ExpensesOperating
expenses amounted to $96.4 million for the nine months ended
September 30, 2024, compared with $71.4 million for the nine months
ended September 30, 2023, an increase by $25.0 million. This
increase is primarily driven by Research & Development for
$23.0 million resulting from (1) patient enrollment in VITESSE
Phase 3 clinical trial, (2) preparatory activities for the
COMFORT studies in anticipation of initiation after FDA alignment,
(3) Regulatory and Manufacturing activities to support ongoing
clinical trials.
General and Administrative expenses increased by
$1.4 million during the nine months ended September 30, 2024,
compared to the nine months ended September 30, 2023, mainly due to
one-time costs associated with (1) office moves in France and the
U.S., (2) financing activities and (3) trademark and patent
activities.
In millions of USD(unaudited) |
U.S. GAAP |
U.S. GAAP |
nine months ended September 30, |
three months ended September 30, |
2024 |
2023 |
2024 |
2023 |
Research & Development |
(70.4) |
(47.4) |
(23.7) |
(13.8) |
Sales & Marketing |
(2.3) |
(1.6) |
(0.5) |
(0.7) |
General & Administrative |
(23.7) |
(22.3) |
(7.2) |
(6.2) |
Operating expenses |
(96.4) |
(71.4) |
(31.4) |
(20.6) |
Net Loss and Net Loss Per
ShareThe Company recorded a net loss for the nine months
ended September 30, 2024, of $90.9 million, compared to a net
loss of $61.5 million for the nine months ended September 30,
2023.
On a per share basis, net loss (based on the
weighted average number of shares outstanding over the period) was
$(0.95) for the nine months ended September 30, 2024.
|
U.S. GAAP |
U.S. GAAP |
|
nine months ended September 30, |
three months ended September 30, |
|
2024 |
2023 |
2024 |
2023 |
Net income / (loss) (in millions of USD) |
(90.9) |
(61.5) |
(30.4) |
(16.7) |
Basic / diluted net income / (loss) per share (USD/share) |
(0.95) |
(0.65) |
(0.32) |
(0.17) |
CONDENSED CONSOLIDATED STATEMENTS OF
FINANCIAL POSITION (unaudited)
In millions of USD |
U.S. GAAP |
September 30, 2024 |
December 31, 2023 |
Assets |
93.1 |
183.0 |
of which cash & cash equivalents |
46.4 |
141.4 |
Liabilities |
39.0 |
42.8 |
Shareholders’ equity |
54.0 |
140.2 |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited)
In millions of USD |
U.S. GAAP |
U.S. GAAP |
nine months ended September 30, |
three months ended September 30, |
2024 |
2023 |
2024 |
2023 |
Operating income |
3.6 |
6.9 |
1.1 |
2.4 |
Research & Development |
(70.4) |
(47.4) |
(23.7) |
(13.8) |
Sales & Marketing |
(2.3) |
(1.6) |
(0.5) |
(0.7) |
General & Administrative |
(23.7) |
(22.3) |
(7.2) |
(6.2) |
Operating expenses |
(96.4) |
(71.4) |
(31.4) |
(20.6) |
Financial income/(expenses) |
1.9 |
3.0 |
(0.1) |
1.5 |
Income tax |
— |
— |
— |
— |
Net loss |
(90.9) |
(61.5) |
(30.4) |
(16.7) |
Basic/diluted net loss per share attributable
to shareholders |
(0.95) |
(0.65) |
(0.32) |
(0.17) |
CONDENSED CONSOLIDATED STATEMENTS OF
CASH FLOWS (unaudited)
In millions of USD |
U.S. GAAP |
nine months ended September 30, |
2024 |
2023 |
Net cash flows provided / (used) in operating activities |
(92.2) |
(66.0) |
Net cash flows provided / (used) in investing activities |
(1.5) |
(0.6) |
Net cash flows provided / (used) in financing activities |
(0.1) |
7.0 |
Effect of exchange rate changes on cash & cash equivalents
(U.S. GAAP presentation) |
(1.1) |
(0.4) |
Net increase / (decrease) in cash & cash equivalents |
(94.9) |
(60.1) |
Net cash & cash equivalents at the beginning of the period |
141.4 |
209.2 |
Net cash & cash equivalents at the end of the period |
46.4 |
149.1 |
About DBV TechnologiesDBV
Technologies is a clinical-stage biopharmaceutical company
developing treatment options for food allergies and other
immunologic conditions with significant unmet medical need. DBV is
currently focused on investigating the use of its proprietary
technology platform, Viaskin, to address food allergies, which are
caused by a hypersensitive immune reaction and characterized by a
range of symptoms varying in severity from mild to life-threatening
anaphylaxis. Millions of people live with food allergies, including
young children. Through epicutaneous immunotherapy (EPIT™), the
Viaskin platform is designed to introduce microgram amounts of a
biologically active compound to the immune system through intact
skin. EPIT is a new class of non-invasive treatment that seeks to
modify an individual’s underlying allergy by re-educating the
immune system to become desensitized to allergen by leveraging the
skin’s immune tolerizing properties. DBV is committed to
transforming the care of food allergic people. The Company’s food
allergy programs include ongoing clinical trials of Viaskin Peanut
in peanut allergic toddlers (1 through 3 years of age) and children
(4 through 7 years of age).
DBV Technologies is headquartered in Châtillon,
France, with North American operations in Warren, NJ. The Company’s
ordinary shares are traded on segment B of Euronext Paris (Ticker:
DBV, ISIN code: FR0010417345) and the Company’s ADSs (each
representing one ordinary share) are traded on the Nasdaq Capital
Select Market (Ticker: DBVT – CUSIP: 23306J200).
For more information, please visit
www.dbv-technologies.com and engage with us on X (formerly Twitter)
and LinkedIn.
Forward Looking StatementsThis
press release may contain forward-looking statements and estimates,
including statements regarding DBV’s financial condition, forecast
of its cash runway, the therapeutic potential of Viaskin® Peanut
patch and EPIT™, designs of DBV’s anticipated clinical trials,
DBV’s planned regulatory and clinical efforts including timing and
results of communications with regulatory agencies, the ability of
any of DBV’s product candidates, if approved, to improve the lives
of patients with food allergies. These forward-looking statements
and estimates are not promises or guarantees and involve
substantial risks and uncertainties. At this stage, DBV’s product
candidates have not been authorized for sale in any country. Among
the factors that could cause actual results to differ materially
from those described or projected herein include uncertainties
associated generally with research and development, clinical trials
and related regulatory reviews and approvals, and DBV’s ability to
successfully execute on its budget discipline measures. A further
list and description of risks and uncertainties that could cause
actual results to differ materially from those set forth in the
forward-looking statements in this press release can be found in
DBV’s regulatory filings with the French Autorité des Marchés
Financiers (“AMF”), DBV’s filings and reports with the U.S.
Securities and Exchange Commission (“SEC”), including in DBV’s
Annual Report on Form 10-K for the year ended December 31, 2023,
filed with the SEC on March 7, 2024, and future filings and reports
made with the AMF and SEC by DBV. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements and estimates, which speak only as of
the date hereof. Other than as required by applicable law, DBV
Technologies undertakes no obligation to update or revise the
information contained in this Press Release.
Viaskin is a registered trademark and EPIT is a
trademark of DBV Technologies.
Investor Contact Katie
MatthewsDBV Technologieskatie.matthews@dbv-technologies.com
Media ContactAngela MarcucciDBV
Technologiesangela.marcucci@dbv-technologies.com
DBV Technologies (NASDAQ:DBVT)
過去 株価チャート
から 11 2024 まで 12 2024
DBV Technologies (NASDAQ:DBVT)
過去 株価チャート
から 12 2023 まで 12 2024