Montrouge, France, March 3, 2022
DBV Technologies Reports Full Year 2021
Financial Results and Recent Business Updates
mVP
Pivotal Protocol Complete and Ready for Submission to
FDADBV Continues to
Engage in Productive Exchanges with
FDACash Runway Extended into the First Quarter
2023
DBV Technologies S.A. (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
specialty biopharmaceutical company, today reported financial
results for the full year of 2021. The audit procedures have been
substantially completed by the Company’s statutory auditors and
financials were approved by the Board of Directors on March 3,
2022. The audit report will be issued by the Company’s auditors in
March 2022.
DBV has extended its cash runway into the first
quarter of 2023 as a result of continued financial diligence and
cost containment measures. These targeted efforts adequately
support the critical research and development work underway to
advance the Viaskin platform. The protocol for the new Phase 3
pivotal study of the modified Viaskin Peanut (“mVP”) patch was
completed at the end of February 2022 and has been prepared for FDA
submission. The Company is currently engaged in fruitful
discussions with FDA in preparation for protocol submission and
review. DBV expects to complete protocol submission following
further alignment with FDA.
“Initiating our new Phase 3 trial with the mVP
is our top priority. We are pleased with our ongoing exchanges with
FDA. In parallel to these discussions, DBV continues to maximize
the efficiency of its spend. Based on our current assumptions, we
have extended our cash runway into the first quarter of 2023,” said
Daniel Tasse, Chief Executive Officer, DBV Technologies. “We expect
that this cash position, combined with our continued discipline to
reduce general and administrative expenses without sacrificing
research and development, will give DBV sufficient time to gain
alignment with FDA on the protocol for the mVP pivotal trial. DBV
has been strategic in advancing its EPIT pipeline, and through
these efforts, we aim to realize the full potential of the Viaskin
technology for patients and families.
Full-Year 2021
Financial Highlights 1
Cash and Cash Equivalents
|
U.S. GAAP |
|
IFRS |
|
Year ended, |
|
Year ended, |
|
|
December
31, 2021 |
|
December
31, 2020
(*) |
|
|
December
31, 2021 |
|
December
31, 2020
(*) |
(in millions) |
|
|
|
|
|
|
|
|
Net (decrease) / increase in cash and cash equivalents, of
which |
$ |
(119.1) |
$ |
3.1 |
|
$ |
(119.1) |
$ |
3.1 |
Net cash flow used in operating activities |
|
(108.2) |
|
(165.6) |
|
|
(104.1) |
|
(160.9) |
Net cash flow provided by / (used in) investing activities |
|
(0.4) |
|
(2.9) |
|
|
(0.4) |
|
(2.9) |
Net cash flow provided by / (used in) financial activities |
|
0.3 |
|
149.5 |
|
|
(3.9) |
|
144.8 |
Effect of exchange rate changes on cash and cash equivalents |
(10.7) |
|
22.0 |
|
|
(10.7) |
|
22.0 |
|
|
|
|
|
|
|
|
|
|
Net cash and cash equivalents at the end of the
period |
$ |
77.3 |
$ |
196.4 |
|
$ |
77.3 |
$ |
196.4 |
|
|
|
|
|
|
|
|
|
|
(*) including $150.0 million cash flows provided by 1Q20 capital
increase |
|
|
|
|
|
As of December 31, 2021, cash and cash
equivalents were $77.3 million, compared to $196.4 million as of
December 31, 2020. In 2021, cash used in operating activities was
$(108.2) million under U.S. GAAP and $(104.1) million under IFRS
compared to $(165.6) million under U.S. GAAP and $(160.9) million
under IFRS in 2020.
The 35% decrease in net cash used in operating
activities between the years ended December 31, 2021 and 2020
reflects the Company’s continued implementation of budget
discipline measures.
Over the past 2 years, DBV reduced its net cash
used in operating activities by 54%.
Net cash used in operating activities, including
restructuring amounts paid as part of the global restructuring plan
launched in June 2020 (in millions of $)
|
|
|
% Change vs |
|
|
|
% Change vs |
|
FY21 |
|
FY20 |
|
2H21 |
|
1H21 |
2H20 |
1H20 |
Net cash flow used in operating activities -
U.S.GAAP |
(108.2) |
|
(34.7)% |
|
(41.7) |
|
(37.3)% |
(45.0)% |
(53.6)% |
Net cash flow used in operating activities -
IFRS |
(104.1) |
|
(35.3)% |
|
(40.0) |
|
(37.6)% |
(45.4)% |
(54.3)% |
Cash flows used in investment activities were
$(0.4) million in 2021, compared to $(2.9) million in 2020.
Cash from financing activities were $0.3 million
under U.S. GAAP and $(3.9) million under IFRS compared to net cash
flows provided by financing activities of $149.5 million under U.S.
GAAP and $144.8 million under IFRS in 2020, including $150.0
million received in connection with DBV’s follow-on public offering
of its securities in the first quarter of 2020.
DBV has continued to practice financial
diligence and implemented further cost containment strategies.
Based on its current operations, as well as its plans and
assumptions as revised pursuant to its change of strategy announced
in December 2021, DBV expects that its current cash and cash
equivalents will support its operations into the first quarter of
2023.
Operating
Income is primarily generated from DBV’s Research Tax
Credit (French Crédit Impôt Recherche, or CIR) and from revenue
recognized by DBV under its collaboration agreement with Nestlé
Health Science. Operating income was $5.7 million, for the year
ended December 31, 2021, compared to $11.3 million the year ended
December 31, 2020. The decrease in operating income is primarily
attributable to the revision of the revenue recognized under
Nestlé’s collaboration agreement, as the Company updated its
measurement of progress of its Phase II clinical study conducted as
part of the contract due to recruitments’ delays.
Operating
Expenses
|
|
U.S. GAAP |
|
|
IFRS |
(in thousands of $) |
|
December 31, |
|
|
December 31, |
|
|
2021 |
|
2020 |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
Operating expenses
: |
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
(70,336) |
|
(101,607) |
|
|
(70,104) |
|
(101,346) |
Sales and marketing expenses |
|
(4,387) |
|
(9,879) |
|
|
(4,403) |
|
(9,747) |
General and administrative expenses |
|
(30,520) |
|
(35,081) |
|
|
(30,385) |
|
(35,137) |
Restructuring income (expenses) |
|
920 |
|
(23,552) |
|
|
920 |
|
(22,994) |
Total Operating expenses |
|
(104,323) |
|
(170,118) |
|
|
(103,972) |
|
(169,224) |
Operating
Expenses for the year ended
December 31, 2021, were $104.3 million under U.S. GAAP and $104.0
million under IFRS, compared to $170.1 million under U.S. GAAP and
$169.2 million under IFRS for the year ended December 31, 2020. The
decrease in operating expenses for both periods is mainly
attributable to the decrease in external clinical-related expenses
and professional fees due to the budget discipline measures taken
by DBV, as well as the decrease in employee-related costs, which is
directly related to the workforce reduction DBV implemented as part
of its 2020 global restructuring plan.
Excluding restructuring and share-based payments
expenses, employee-related costs decreased by $19.2 million, from
$42.0 million for the year ended December 31, 2020 to $22.7 million
for the year ended December 31, 2021, under U.S. GAAP. Under IFRS,
excluding share-based payments expenses, employee-related costs
decreased by $19.5 million, from $42.3 million for the year ended
December 31, 2020 to $22.8 million for the year ended December 31,
2021.
The average headcount decreased by 63% between
the two periods, from 270 full-time equivalent employees for the
year ended December 31, 2020 to 101 for the year ended December 31,
2021. As of December 31, 2021, DBV had 92 employees.
Net
Loss and Net
Loss
Per
Share
|
|
U.S. GAAP |
|
|
IFRS |
($ in thousands) |
|
December 31, |
|
|
December 31, |
|
|
2021 |
|
2020 |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
Net (loss) |
$ |
(97,809) |
$ |
(159,555) |
|
$ |
(98,052) |
$ |
(159,665) |
Basic / diluted net loss per share ($/share) |
$ |
(1.78) |
$ |
(2.95) |
|
$ |
(1.79) |
$ |
(2.95) |
For the year ended December 31, 2021, net loss
was $(97.8) million under U.S. GAAP and $(98.1) million under IFRS,
compared to a net loss of $(159.6) million and $(159.7) million,
respectively, for the year ended December 31, 2020.
On a per share basis, net loss (based on the
weighted average number of shares outstanding over the period) was
$(1.78) under U.S. GAAP and $(1.79) under IFRS for the year ended
December 31, 2021.
Conference Call
Information:
DBV will host a conference call and live audio
webcast on Thursday, March 3, 2022, at 5:00 p.m. ET to report
fourth quarter and full year 2021 financial results and review
recent business updates.
This call is accessible via the below
teleconferencing numbers, followed by the reference ID:
50283860
- United States: 1 (866)
939-3921
- Canada: 1 (866)
215-5508
- United Kingdom: 0808 238
9578
- France: 0805 102 604
A live webcast of the call will be available on
the Investors & Media section of the Company’s website:
https://www.dbv-technologies.com/investor-relations/. A replay of
the presentation will also be available on DBV’s website after the
event.
CONDENSED STATEMENT OF
CONSOLIDATED FINANCIAL POSITION
(unaudited)($ in thousands)
|
|
U.S. GAAP2 |
|
|
IFRS3 |
|
|
December 31, |
|
|
December 31, |
|
|
2021 |
|
2020 |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
Assets |
$ |
146,723 |
$ |
272,246 |
|
$ |
146,323 |
$ |
272,019 |
of which cash and cash equivalents |
|
77,301 |
|
196,352 |
|
|
77,301 |
|
196,352 |
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
47,449 |
|
66,754 |
|
|
47,294 |
|
66,631 |
|
|
|
|
|
|
|
|
|
|
Shareholders’
equity |
$ |
99,274 |
$ |
205,491 |
|
$ |
99,030 |
$ |
205,388 |
of which net result |
|
(97,809) |
|
(159,555) |
|
|
(98,052) |
|
(159,665) |
CONDENSED STATEMENT OF
CONSOLIDATED OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)($ in thousands, except per share
data)
|
|
U.S. GAAP2 |
|
|
IFRS3 |
|
|
December 31, |
|
|
December 31, |
|
|
2021 |
|
2020 |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
5,708 |
$ |
11,276 |
|
$ |
5,708 |
$ |
11,276 |
|
|
|
|
|
|
|
|
|
|
Operating expenses
: |
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
(70,336) |
|
(101,607) |
|
|
(70,104) |
|
(101,346) |
Sales and marketing expenses |
|
(4,387) |
|
(9,879) |
|
|
(4,403) |
|
(9,747) |
General and administrative expenses |
|
(30,520) |
|
(35,081) |
|
|
(30,385) |
|
(35,137) |
Restructuring income (expenses) |
|
920 |
|
(23,552) |
|
|
920 |
|
(22,994) |
Total Operating expenses |
|
(104,323) |
|
(170,118) |
|
|
(103,972) |
|
(169,225) |
Financial income (expenses) |
|
425 |
|
(724) |
|
|
(169) |
|
(1,727) |
Income tax |
|
381 |
|
10 |
|
|
381 |
|
10 |
Net (loss) |
$ |
(97,809) |
$ |
(159,555) |
|
$ |
(98,052) |
$ |
(159,665) |
|
|
|
|
|
|
|
|
|
|
Basic/diluted Net loss per share attributable to shareholders |
$ |
(1.78) |
$ |
(2.95) |
|
$ |
(1.79) |
$ |
(2.95) |
CONDENSED STATEMENT OF
CONSOLIDATED CASH FLOW
(unaudited)($ in thousands)
|
|
U.S. GAAP4 |
|
|
IFRS5 |
|
|
December 31, |
|
|
December 31, |
|
|
2021 |
|
2020 |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
Net cash flow used in operating activities |
$ |
(108,242) |
$ |
(165,607) |
|
$ |
(104,058) |
$ |
(160,891) |
Net cash flows used in investing activities |
|
(433) |
|
(2,865) |
|
|
(433) |
|
(2,865) |
Net cash flows provided by financing activities |
|
274 |
|
149,548 |
|
|
(3,909) |
|
144,837 |
Effect of exchange rate changes on cash and cash equivalents |
|
(10,651) |
|
22,022 |
|
|
(10,650) |
|
22,017 |
Net (decrease) / increase in cash and cash
equivalents |
|
(119,051) |
|
3,097 |
|
|
(119,051) |
|
3,097 |
Net cash and cash equivalents at the beginning of the period |
|
196,352 |
|
193,255 |
|
|
196,352 |
|
193,255 |
Net cash and cash equivalents at the end of the
period |
$ |
77,301 |
$ |
196,352 |
|
$ |
77,301 |
$ |
196,352 |
About DBV TechnologiesDBV
Technologies is developing Viaskin™, an investigational proprietary
technology platform with broad potential applications in
immunotherapy. Viaskin is based on epicutaneous immunotherapy, or
EPIT™, DBV’s method of delivering biologically active compounds to
the immune system through intact skin. With this new class of
non-invasive product candidates, the Company is dedicated to safely
transforming the care of food allergic patients. DBV’s food
allergies programs include ongoing clinical trials of Viaskin
Peanut. DBV Technologies has global headquarters in Montrouge,
France, and North American operations in Summit, 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).
Forward Looking StatementsThis
press release may contain forward-looking statements and estimates,
including statements regarding DBV’s forecast of its cash runway,
designs of DBV’s anticipated clinical trials, DBV’s planned
regulatory and clinical efforts including timing and results of
communications with regulatory agencies, and 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, including the impact of
the COVID-19 pandemic, 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, 2020, filed with the SEC on March 17, 2021, 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.
Investor Contact Anne PollakDBV
Technologies+1 857-529-2363anne.pollak@dbv-technologies.com
Media ContactAngela MarcucciDBV
Technologies+1 646-842-2393angela.marcucci@dbv-technologies.com
1The Company’s annual consolidated financial
statements are prepared in accordance with both generally accepted
accounting principles in the U.S. ("U.S. GAAP") and International
Financial Reporting Standards (“IFRS”) as adopted by the European
Union. Unless otherwise indicated, the financial figures presented
in the Full Year 2021 Financial Highlights comply with both U.S
GAAP and IFRS financial statements. Differences between U.S. GAAP
and IFRS consolidated financial statements are mainly due to
discrepancies arising from the application of lease accounting
standards.2 Unaudited financial statements prepared in accordance
with generally accepted accounting principles in the U.S. ("U.S.
GAAP").3 Unaudited financial statements prepared in accordance with
International Financial Reporting Standards (“IFRS”) as adopted by
the European Union.4 Unaudited financial statements prepared in
accordance with generally accepted accounting principles in the
U.S. ("U.S. GAAP").5 Unaudited financial statements prepared in
accordance with International Financial Reporting Standards
(“IFRS”) as adopted by the European Union.
DBV Technologies (EU:DBV)
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