DBV Technologies Reports Full Year 2023 Financial Results and Business Update
- Advanced Viaskin™ 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
“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
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.”
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 andEurope . - Published EPITOPE results 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, 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
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
- 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 inMarch 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 ofDecember 2023 compared toDecember 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”) onJune 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
- 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 onOctober 30 th, 2023. - Research Tax Credit increase by
$3.0 million . As ofDecember 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
Operating expenses amount to
(1) 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 ofDecember 31 st, 2022). - 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 inMarch 2023 , as well as preparations for COMFORT.
(2) A
(3) A
Operating expenses totaled
DBV recorded a net loss of
On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is
Excluding the Nestlé Collaboration Agreement termination, net loss as of
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
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
•
• International: 1-412-317-1859
A webcast of the call will also be available under "Events" in the Investors section of the
Cash and Cash Equivalents
In millions of USD | US GAAP | IFRS | ||||
Year ended | Year ended | |||||
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
In millions of USD | US GAAP | IFRS | |||||||||
Year ended | Year ended | ||||||||||
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
In millions of USD | US GAAP | IFRS | ||||||||
Year ended | Year ended | |||||||||
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 | Year ended | |||||||||
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% |
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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™ Peanut 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, 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
Viaskin and EPIT are trademarks of
Investor Contact
katie.matthews@dbv-technologies.com
Media Contact
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