DBV Technologies Reports Third Quarter 2021 Financial Results and
Recent Regulatory Developments
Montrouge, France, October 26, 2021
DBV Technologies
Reports Third
Quarter 2021 Financial
Results and Recent
Regulatory Developments
DBV Technologies S.A. (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today reported financial results for the
third quarter of 2021. The quarterly financial statements were
approved by the Board of Directors on October 26, 2021. The Company
also provided regulatory updates from the U.S. Food and Drug
Administration (FDA) and European Medicines Agency (EMA) for
Viaskin™ Peanut.
US Regulatory Update:
On October 14, 2021, DBV received communication
from the FDA concerning the STAMP protocol submission of May 6,
2021. The FDA has requested a stepwise approach to DBV’s modified
Viaskin Peanut (mVP) development program. The FDA would like to
review the data from DBV’s protein uptake release study prior to
providing additional comments on the STAMP protocol design.
In its communication, FDA stated that guidance
is forthcoming on how best to demonstrate the protein uptake
comparability of the mVP to the reference or current patch
(cVP).
The STAMP trial will not be initiated until DBV
receives complete feedback from the FDA.
“DBV is working hard to find an efficient and
timely path forward. On behalf of patients and providers urgently
awaiting a therapeutic advancement in treating peanut allergy, DBV
will continue to pursue our goal of bringing Viaskin Peanut to the
food allergy community,” said Daniel Tasse, Chief Executive
Officer, DBV Technologies.
EU Regulatory Update:
The EMA review of the Viaskin Peanut Marketing
Authorization Application is progressing according to established
EMA processes and ongoing conversations with the EMA. DBV is
preparing its responses to the Day 180 letter and evaluating how to
best address the Objections, including the remaining Major
Objection which questions the limitations of the data, for example,
the clinical relevance and effect size supported by a single
pivotal study. Further exchanges with EMA are anticipated. DBV
estimates the EMA could issue its decision on potential marketing
authorization for Viaskin Peanut in 1Q 2022.
Financial Highlights for the
Third Quarter
Ended September
30, 20211
Cash and
Cash
Equivalents:
|
Three months ended |
|
|
March 31, 20202 |
|
June 30, 2020 |
|
September 30, 2020 |
|
December 31, 2020 |
|
March 31, 2021 |
|
June 30, 2021 |
|
September 30, 2021 |
|
(in millions) |
Net (decrease) / increase in cash and cash equivalents, of
which |
$ |
94.2 |
$ |
(34.5) |
$ |
(31.5) |
$ |
(25.1) |
$ |
(43.9) |
$ |
(27.0) |
$ |
(27.3) |
Net cash flow used in operating
activities3 |
|
(49.7) |
|
(40.2) |
|
(42.2) |
|
(33.5) |
|
(36.2) |
|
(30.3) |
|
(22.9) |
Net cash flow provided by / (used in) investing and financial
activities |
|
149.7 |
|
(0.5) |
|
(1.8) |
|
(0.7) |
|
0.3 |
|
0.8 |
|
(1.1) |
Effect of exchange rate changes on cash and cash equivalents |
|
(5.8) |
|
6.1 |
|
12.5 |
|
9.2 |
|
(7.9) |
|
2.5 |
|
(3.2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash and cash equivalents at the end of the
period |
$ |
287.4 |
$ |
252.9 |
$ |
221.4 |
$ |
196.4 |
$ |
152.5 |
$ |
125.5 |
$ |
98.2 |
As of September 30, 2021, cash and cash
equivalents were $98.2 million, compared to $196.4 million as of
December 31, 2020 and $125.5 million as of June 30, 2021. The $98.2
million decrease in cash position during the first nine months of
2021, consisting of $43.9 million, $27.0 million, and $27.3 million
in the first, second and third quarter of 2021, respectively, was
mostly comprised of $89.5 million of net cash used in operating
activities and the effect of exchange rates on cash and cash
equivalents for $(8.6) million.
The 32% decrease in net cash used in operating
activities between the first nine months of 2020 and 2021 reflects
the Company’s continued implementation of cost containment measures
and the decrease in personnel expenses related to the workforce
reduction as part of the Company’s global restructuring plan. Based
on its current assumptions, DBV expects that its current cash and
cash equivalents will support its operations into the third quarter
of 2022.
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 $1.3
million and $2.8 million, for the three and nine months ended
September 30, 2021, respectively, compared to $4.2 million and
$12.5 million for the three and nine months ended September 30,
2020, respectively. The decrease in operating income is primarily
attributable to the revision of the revenue recognized under
Nestlé’s collaboration agreement, as the Company updated its
measurement of progress of its Phase II clinical study conducted as
part of the contract due to delays in new patient enrollment.
Operating
expenses:
|
|
U.S. GAAP1 |
|
|
Three months ended September
30, |
|
Nine months ended
September 30, |
($ in thousands) |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Operating expenses : |
|
|
|
|
|
|
|
|
Research and development |
$ |
(16,320) |
|
(25,751) |
$ |
(58,663) |
|
(75,214) |
Sales & marketing |
|
(1,072) |
|
(1,595) |
|
(2,999) |
|
(8,114) |
General & administrative |
|
(8,299) |
|
(6,863) |
|
(26,250) |
|
(26,838) |
Restructuring |
|
- |
|
286 |
|
- |
|
(21,003) |
Total Operating expenses |
$ |
(25,691) |
|
(33,923) |
$ |
(87,912) |
|
(131,169) |
Operating
Expenses for the three months
ended September 30, 2021, were $(25.7) million, compared to $(33.9)
million for the three months ended September 30, 2020. For the nine
months ended September 30, 2021, operating expenses were $(87.9)
million, compared to $(131.2) million for the nine months ended
September 30, 2020, or a decrease of 33%. 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 $13.8 million, from
$32.9 million for the nine months ended September 30, 2020 to $19.1
million for the nine months ended September 30, 2021, a 42%
decrease, compared to a 64% decrease of the average number of
headcounts between the two periods (105 and 291 full-time
equivalent employees for the nine months ended September 30, 2021
and 2020 respectively). As of September 30, 2021, DBV had 92
employees.
Net
Loss and Net
Loss Per
Share:
|
|
U.S. GAAP1 |
|
|
Three months ended September
30, |
|
Nine months ended
September 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
Net (loss) ($ in thousands) |
$ |
(24,033) |
|
(30,955) |
$ |
(84,136) |
|
(120,071) |
Basic / diluted net loss per share ($/share) |
$ |
(0.44) |
|
(0.56) |
$ |
(1.53) |
|
(2.23) |
For the three and nine months ended September
30, 2021, net loss was $(24.0) million and $(84.1) million,
respectively, compared to a net loss of $(31.0) million and
$(120.1) million, respectively, for the comparable periods in
2020.
On a per share basis, net loss (based on the
weighted average number of shares outstanding over the period) was
$(0.44) and $(1.53) for the three and nine months ended September
30, 2021, respectively.
Conference Call
Information:
DBV will host a conference call and live audio
webcast on Tuesday, October 26, 2021, at 5:00 p.m. ET to report
third quarter 2021 financial results and provide a corporate
update.
This call is accessible via the below
teleconferencing numbers, followed by the reference ID:
50247411
- United States: 1 (866)
939-3921
- Canada: 1 (866)
215-5508
- United Kingdom: 0808 238
9578
- France: 0805 102 604
A live webcast of the call will be available on
the Investors & Media section of the Company’s website:
https://www.dbv-technologies.com/investor-relations/. A replay of
the presentation will also be available on DBV’s website after the
event.
CONDENSED STATEMENT OF CONSOLIDATED
FINANCIAL POSITION (unaudited)($ in
thousands)
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Assets |
$ |
170,924 |
$ |
272,246 |
of which cash and cash equivalents |
|
98,195 |
|
196,352 |
|
|
|
|
|
Liabilities |
$ |
54,033 |
$ |
66,754 |
|
|
|
|
|
Shareholders’ equity |
$ |
116,892 |
$ |
205,491 |
of which net result |
|
(84,136) |
|
(159,555) |
CONDENSED STATEMENT OF
CONSOLIDATED OPERATIONS AND
COMPREHENSIVE LOSS (unaudited)($ in
thousands, except per share data)
|
|
Three months ended September
30, |
|
Nine months ended September
30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
1,323 |
$ |
4,158 |
$ |
2,776 |
$ |
12,488 |
|
|
|
|
|
|
|
|
|
Operating expenses : |
|
|
|
|
|
|
|
|
Research and development |
|
(16,320) |
|
(25,751) |
|
(58,663) |
|
(75,214) |
Sales & marketing |
|
(1,072) |
|
(1,595) |
|
(2,999) |
|
(8,114) |
General & administrative |
|
(8,299) |
|
(6,863) |
|
(26,250) |
|
(26,838) |
Restructuring |
|
- |
|
286 |
|
- |
|
(21,003) |
Total Operating expenses |
|
(25,691) |
|
(33,923) |
|
(87,912) |
|
(131,169) |
Financial Income (Expenses) |
|
336 |
|
(1,184) |
|
597 |
|
(1,380) |
Income tax |
|
- |
|
(7) |
|
404 |
|
(10) |
Net (loss) |
$ |
(24,033) |
$ |
(30,955) |
$ |
(84,136) |
$ |
(120,071) |
|
|
|
|
|
|
|
|
|
Basic/diluted Net loss per share attributable to shareholders |
$ |
(0.44) |
$ |
(0.56) |
$ |
(1.53) |
$ |
(2.23) |
CONDENSED STATEMENT OF
CONSOLIDATED CASH FLOW (unaudited)($ in thousands)
|
|
Nine months ended
September 30, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Net cash flow used in operating activities |
$ |
(89,452) |
$ |
(132,076) |
Net cash flows provided by (used in) investing activities |
|
41 |
|
(2,232) |
Net cash flows provided by (used in) financing activities |
|
(103) |
|
149,624 |
Effect of exchange rate changes on cash and cash equivalents |
|
(8,643) |
|
12,834 |
Net (decrease) / increase in cash and cash
equivalents |
|
(98,157) |
|
28,150 |
Net cash and cash equivalents at the beginning of the period |
|
196,352 |
|
193,255 |
Net cash and cash equivalents at the end of the
period |
$ |
98,195 |
$ |
221,404 |
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), part of the SBF120 index, 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,
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
1 The Company’s unaudited
consolidated financial statements for the quarter ended September
30, 2021 are prepared in accordance with generally accepted
accounting principles in the U.S. ("U.S. GAAP").2
For the three months ended March 31, 2020, net cash provided by
financing activities includes $151.0 million cash flows received in
connection with DBV’s follow-on public offering of its securities
in the first quarter of 2020.3 Net cash flows used
in operating activities include restructuring amounts paid as part
of the global restructuring plan launched in June 2020.
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