Montrouge, France, March 7, 2024
DBV Technologies Reports Full Year 2023 Financial Results and Business Update
* Advanced Viaskin(TM) Peanut clinical development programs in peanut-allergic
toddlers (1 through 3 years old) and children (4 through 7 years old)
* Strengthened executive leadership team in preparation for BLA submission
* Reported cash and cash equivalents of $141 million
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), a clinical-stage biopharmaceutical company focused on treatment options
for food allergies and other immunologic conditions with significant unmet
medical need, today reported financial results for the full year 2023. The audit
procedures have been substantially completed by the Company's statutory auditors
and financials - prepared under both US GAAP and IFRS for the purpose of Form
10-K and Universal Registration Document respectively - were approved by the
Board of Directors on March 7, 2024.
"During 2023, we made significant progress advancing our two Viaskin Peanut
clinical development programs in two distinct age groups, one for toddlers ages
1 to 3 years, and one for children ages 4 to 7 years," said Daniel Tassé, Chief
Executive Officer of DBV Technologies. "In 2024, we are focused on completing
enrollment in VITESSE, our Phase 3 efficacy and safety trial in children.
Despite the delays experienced as a result of the new European Commission
directive on Clinical Trials Regulation, all countries are open and actively
recruiting. We expect good momentum regarding Vitesse recruitment in the next
several months and last subject screened by Q3 2024.
In addition, we are initiating two supplemental six-month safety trials, COMFORT
Toddlers and COMFORT Children, as the final clinical pieces to support two
separate and robust packages for our Biologics License Applications to the FDA."
Mr. Tassé continued, "We are committed to working as swiftly and diligently as
possible to bring this novel treatment option to market for toddlers and
children and their families who are living with the daily and significant burden
of a peanut allergy."
2023 Operational Highlights
* Confirmed EPITOPE, DBV's Phase 3 efficacy and safety study of Viaskin Peanut
in peanut-allergic toddlers aged 1 through 3 years, is sufficient for the
clinical portion of a BLA, and no additional efficacy studies were requested
by the FDA.
* Prepared for initiation of COMFORT Toddlers and COMFORT Children, including
protocol development for both supplemental six-month safety studies.
* Number of participants on active treatment will total approximately 600
children in each of the two BLAs, 1 to 3-year-olds and 4 to 7-year-olds.
* Implemented simplified protocol language for both COMFORT Toddlers and
COMFORT Children indicating that Viaskin Peanut is "intended to be worn for
a full day" with any reference to minimum wear time removed.
* Initiated VITESSE, a Phase 3 clinical trial to evaluate the efficacy and
safety of the circular Viaskin Peanut patch in peanut-allergic children aged
4 through 7 years and activated more than 85 trial sites across North
America, Australia and Europe.
* Published EPITOPE results (https://dbv-technologies.com/press_releases/dbv-
technologies-announces-new-england-journal-of-medicine-publication-of-phase-
3-epitope-trial-data-evaluating-viaskin-peanut-in-toddlers/) in the New
England Journal of Medicine with an accompanying editorial, entitled, Good
News for Toddlers with Peanut Allergy.
* Presented interim safety and efficacy data from the open-label extension of
EPITOPE (https://dbv-technologies.com/wp-
content/uploads/2023/11/Greenhawt_ACAAI_EPOPEX-Year-1_FINAL-v3.0-
08Nov2023.pdf), which demonstrate a robust continued treatment effect with
Viaskin Peanut after two years of treatment, at The American College of
Allergy, Asthma, and Immunology annual meeting.
* Strengthened the executive leadership team with the appointment of Virginie
Boucinha as Chief Financial Officer and Dr. Kevin Malobisky, PhD., as Chief
Operations Officer.
Anticipated 2024 Events
* Initiate COMFORT Toddlers, the six-month supplemental safety trial in
support of BLA.
* Screen last patient in VITESSE, now expected by Q3 2024.
* Initiate COMFORT Children, the six-month supplemental safety trial in
support of BLA.
* Announce top-line efficacy and safety data from year three of EPITOPE,
corresponding to end-of-study results for participants completing three
years of active treatment.
* Publish manuscripts including invited reviews in peer-reviewed scientific
journals and submit abstracts on new data at upcoming scientific
conferences.
Financial Highlights for the Full Year 2023
2023 Financial Highlights are presented under both U.S GAAP and IFRS. Financial
statements comments refer to U.S. GAAP financial statements.
Differences between US GAAP and IFRS consolidated financial statements result
mainly from the discrepancies arising from the application of lease accounting
standards.
Cash and cash equivalents totaled $141.4 million as of December 31, 2023,
compared to $209.2 million as of December 31, 2022, a net decrease of $67.8
million.
* Overall, the Company used $79.6 million of cash in operations, primarily in
Research and Development, with the initiation of the VITESSE trial, with the
first patient screened in March 2023, preparation activities related to
COMFORT studies, as well as an increase in regulatory and pre-
commercialization activities. Cash used in operations increased by $23.9
million as of December 2023 compared to December 2022.
* Cash provided by financing activities decreased by $187.4 million in 2023,
compared to 2022. In June of 2022, the Company had completed a private
placement financing ("PIPE") which raised total net proceeds of $194.4
million. The net proceeds from the issuance and sale of new ordinary shares
in the form of American Depositary Shares ("ADSs") on June 16, 2023, totaled
$6.9 million.
* The Company also benefitted from a favorable exchange rate in the amount of
$5.9 million.
Operating income amounts to $15.7 million as of December 31, 2023, an increase
of $10.9 million compared to $4.8. million as of December 31, 2022, mainly due
to:
* A $7.8 million increase in other operating income from revenues recognized
as part of the Development, Collaboration, and Licensing Agreement with
Nestlé Health Science (the "Nestlé Collaboration Agreement"), which
terminated on October 30(th), 2023.
* Research Tax Credit increase by $3.0 million. As of December 31, 2023, the
Company filed an additional research tax credit claim for the years
2020, 2021 and 2022.
Operating income, excluding revenues from the Nestlé, Collaboration, Agreement
amounts to $8.8 million.
Operating expenses amount to $92.2 million as of December 31, 2023, compared to
$101.5 million as of December 31, 2022, a decrease of $9.3 million due to:
(1) A $15.3 million decrease in Research and Development expenses, composed
of:
a. A $30.7 million favorable impact due to the termination of Nestlé
Collaboration Agreement (primarily the reversal of the loss on completion
accrual by $17.6 million in 2023 compared to a $10.4 million loss on
completion accrual as of December 31(st), 2022).
b. An increase of $15.4 million in Research and Development expenses reflecting
intensified Research and Development activities following the initiation of
the VITESSE trial, with the first patient screened in March 2023, as well as
preparations for COMFORT.
(2) A $5.2million increase in General and Administrative expenses, primarily
due to $2.8 million in external services fees incurred in the Company's
financing activities.
(3) A $0.8 million increase in Sales and Marketing expenses related to pre-
commercialization activities for Viaskin Peanut in North America.
Operating expenses totaled $107.3 million as of December 31, 2023. when
excluding the loss on completion accrual reversal from the Nestlé Collaboration
Agreement.
DBV recorded a net loss of $72.7 million as of December 31, 2023, compared to a
net loss of $96.3 million as of December 31, 2022.
On a per share basis, net loss (based on the weighted average number of shares
outstanding over the period) is $0.76 as of December 31, 2023.
Excluding the Nestlé Collaboration Agreement termination, net loss as of
December 31, 2023, would amount to $94.7 million.
The Company has incurred operating losses and negative cash flows from
operations since inception. As of the date of the filing, the Company's
available cash and cash equivalents are not projected to be sufficient to
support its operating plan for at least the next 12 months. As such, there is
substantial doubt regarding the Company's ability to continue as a going
concern.
Based on current operations, as well as plans and assumptions, the Company
expects that its balance of cash and cash equivalents of $141,4 million as of
December 31, 2023, will be sufficient to fund its operations until December
31,2024.
The Company intends to seek additional capital through debt and equity offerings
as it continues research and development efforts and prepares for the launch of
Viaskin Peanut, if approved.
Conference Call Information
DBV will host a live conference call and webcast today at 5:00 p.m. ET to
discuss full year 2023 financial results and provide a business update. The
conference call may be accessed by dialing:
? United States: 1-844-481-2866
? International: 1-412-317-1859
A webcast of the call will also be available under "Events" in the Investors
section of the DBV Technologies website: https://dbv-technologies.com/investor-
overview/events (https://dbv-technologies.com/events/dbv-technologies-to-report-
full-year-2023-financial-results-and-business-update/). A replay of the
presentation will also be available on DBV's website after the event.
Cash and Cash Equivalents
US GAAP IFRS
In millions of USD Year ended December Year ended December
31, 31,
2023 2022 2023 2022
----------------------- ----------------------
Net cash & cash equivalents at
the beginning of the period 209,2 77,3 209,2 77,3
Net increase/(decrease) in
cash & cash equivalents, of
which: (67,8) 131,9 (67,8) 131,9
Net cash flow used in
operating activities (79,6) (55,7) (77,6) (51,4)
Net cash flow used in
investing activities (0,8) (0,1) (0,8) (0,1)
Net cash flow provided by /
((used in) financing
activities 6,7 194,1 4,8 189,9
Effect of exchange rate
changes on cash & cash
equivalents 5,9 (6,5) 5,8 (6,5)
-------------------------------- ----------------------- ----------------------
Net cash & cash equivalents at
the end of the period 141,4 209,2 141.2 209,2
-------------------------------- ----------------------- ----------------------
Operating income
US GAAP IFRS
In millions of USD Year ended December Year ended December
31, 31,
2023 2022 Variation 2023 2022 Variation
------------------------------------------------
Research tax credit 8,8 5,7 +3,0 +53% 8,8 5,7 +3,0 +53%
Other operating income 6,9 (0,9) +7,8 -896% 6,9 (0,9) +7,8 -896%
------------------------ ------------------------ -----------------------
Operating income 15,7 4,8 +10,9 +225% 15,7 4,8 +10,9 +225%
------------------------ ------------------------ -----------------------
Operating expenses
US GAAP IFRS
In millions of USD Year ended December Year ended December
31, 31,
2023 2022 Variation 2023 2022 Variation
----------------------------------------------
Research & Development 60,2 75,5 -15,3 -20% 60,1 75,2 -15,1 -20%
Sales & Marketing 2,4 1,6 +0,8 +52% 2,4 1,6 +0,8 +56%
General & Administrative 29,5 24,3 +5,2 +21% 29,5 24,2 +5,2 +22%
-------------------------------- ----------------------- ----------------------
Total operating expenses 92,2 101,5 -9,3 -9% 92,0 101,0 -9,0 -9%
-------------------------------- ----------------------- ----------------------
including internal
compensation 29,2 24,0 +5,2 +22% 29,3 24,0 +5,3 +22%
-------------------------------- ----------------------- ----------------------
Net Loss and Net Loss per Share
US GAAP IFRS
Year ended December 31, Year ended December 31,
2023 2022 Variation 2023 2022 Variation
----------------------------------------------------
Net (loss) in millions
of USD (72,7) (96,3) +23,5 -24% (72,7) (96,0) +23,1 -24%
Basic / diluted net
(loss) per share in USD (0,76) (1,24) +0,5 -38% (0,76) (1,24) +0,5 -38%
About DBV Technologies
DBV 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(TM), 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(TM)), 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 Montrouge, France, with North American
operations in Basking Ridge, 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-half of one ordinary share) are traded on
the Nasdaq Global Select Market (Ticker: DBVT).
For more information, please visit www.dbvtechnologies.com
(http://www.dbvtechnologies.com) and engage with us on X (formerly Twitter)
(https://twitter.com/DBVTechnologies) and LinkedIn
(https://www.linkedin.com/company/dbv-technologies/).
Forward Looking Statements
This press release may contain forward-looking statements and estimates,
including statements regarding DBV's forecast of its cash runway, the
therapeutic potential of Viaskin(TM) Peanut and EPIT(TM), 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, and the outcome of any litigation. 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 and EPIT are trademarks of DBV Technologies.
Investor Contact
Katie Matthews
DBV Technologies
katie.matthews@dbv-technologies.com (mailto:katie.matthews@dbv-technologies.com)
Media Contact
Aurora Krause
DBV Technologies
aurora.krause-ext@dbv-technologies.com (mailto:aurora.krause-ext@dbv-
technologies.com)
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