DBV Technologies Reports Third Quarter Financial Results and
Business Update
Montrouge, France, November 3, 2022
DBV Technologies Reports
Third Quarter Financial Results and Business Update
- DBV closes Q3 with a cash balance
of $213M
- DBV continues to practice budget
discipline measures; cash used in operating activities decreased
more than 35% between the nine months ended September 30, 2021, and
2022
- DBV continues to engage with the
U.S. Food and Drug Administration (FDA) regarding the partial
clinical hold on the VITESSE Phase 3 clinical study
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today reported financial results for the
third quarter of 2022. The quarterly financial statements were
approved by the Board of Directors on November 3, 2022. The Company
also announced recent business updates concerning the VITESSE
(Viaskin Peanut Immunotherapy
Trial to Evaluate
Safety, Simplicity and
Efficacy) Phase 3 study.
DBV continues to engage with the FDA to address
the feedback provided in the partial clinical hold letter and to
finalize the VITESSE Phase 3 study protocol in children ages 4 to 7
years with a confirmed peanut allergy. The Company reports that
progress has been made to address key elements of the partial
clinical hold letter, but it will not meet the targeted first
patient screened by year-end 2022. In parallel, DBV continues
internal preparations for VITESSE and is conducting certain site
assessment and start-up activities for prompt study launch once the
partial clinical hold is lifted.
It is currently premature to assess the impact
of the partial clinical hold letter on other previously announced
milestones related to the VITESSE Phase 3 study. DBV will
communicate additional updates publicly as appropriate, including
once the partial clinical hold has been lifted. The Company plans
to host a conference call following that announcement.
VITESSE is a Phase 3, double-blind,
placebo-controlled, randomized study to assess the efficacy and
safety of epicutaneous immunotherapy with the modified Viaskin™
Peanut 250 µg patch in peanut-allergic children ages 4 to 7
years.
Financial Highlights
for the Third Quarter
and the Nine
Months Ended
September 30,
20221
Cash and Cash Equivalents
|
|
Nine months
ended September
30, |
|
|
2022 |
|
2021 |
(in thousands $) |
|
|
|
|
Net (decrease) / increase in cash and cash
equivalents |
$ |
135,369 |
$ |
(98,157) |
Net cash flow used in operating activities |
$ |
(31,781) |
|
(89,452) |
Net cash flows used in investing activities |
|
(66) |
|
41 |
Net cash flows provided by financing activities |
|
194,403 |
|
(103) |
Effect of exchange rate changes on cash and cash equivalents |
|
(27,186) |
|
(8,643) |
Net cash and cash equivalents at the end of the
period |
$ |
212,670 |
$ |
98,195 |
Cash and cash equivalents were $212.7 million,
as of September 30, 2022, compared to $77.3 million as of December
31, 2021, and $98.2 million as of September 30, 2021. The net
increase of $135.4 million for the nine months ended September 30,
2022, was mostly comprised of a $194.7 million net cash flow
received from the ATM Offering in May 2022 for $14.1 million; net
of transaction costs and PIPE Offering in June 2022 for $180.6
million; net of transaction costs as well as a $26.4 million cash
flow received following the reimbursement of the 2019, 2020 and
2021 Research Tax Credit (French Crédit Impôt Recherche, or CIR)
offset by a $(58.2) million cash utilization in operating
activities; and the effect of exchange rates on cash and cash
equivalents for $(27.2) million.
Excluding the effect of reimbursement of the
Research Tax Credit, the cash used in operating activities
decreased by 35% between the nine months ended September 30, 2021
and September 30, 2022, respectively, reflecting the Company’s
continued implementation of budget discipline measures.
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 $6.1
million for the nine months ended September 30, 2022, compared to
$2.8 million for the nine months ended September 30, 2021. The
variation in operating income is primarily attributable to the
revision of the revenue recognized under Nestlé’s collaboration
agreement conducted as part of the existing contract, as the
Company updated the measurement of progress of its Phase 2 APTITUDE
milk-diagnostic tool clinical study.
Operating
Expenses
|
|
U.S. GAAPThree months ended
September 30, |
|
U.S. GAAPNine months
ended September
30, |
($ in thousands) |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
(15,096) |
$ |
(16,320) |
$ |
(45,930) |
$ |
(58,663) |
Sales and marketing |
|
(159) |
|
(1,072) |
|
(1,659) |
|
(2,999) |
General and administrative |
|
(4,839) |
|
(8,299) |
|
(17,173) |
|
(26,250) |
Total operating expenses |
$ |
(20,094) |
$ |
(25,691) |
$ |
(64,762) |
$ |
(87,912) |
Operating Expenses for the three months ended
September 30, 2022, were $(20.1) million, compared to $(25.7)
million for the three months ended September 30, 2021, or -22%. For
the nine months ended September 30, 2022, operating expenses were
$(64.8) million compared to $(87.9) million for the nine months
ended September 30, 2021, or -26%. DBV has continued to practice
financial diligence and implemented further cost containment
strategies to support its clinical trial objectives.
Employee-related costs decreased by $6.1
million, from $23.1 million for the nine months ended September 30,
2021, to $17.0 million for the nine months ended September 30, 2022
– a 26% decrease, compared to a 24% decrease of the average number
of headcounts between the two periods (85 and 105 full-time
equivalent employees for the nine months ended September 30, 2022,
and 2021, respectively). As of September 30, 2022, DBV had 83
employees.
Net Loss and Net Loss
Per Share
|
|
U.S. GAAPThree months
ended September 30, |
|
U.S. GAAPNine months
ended September 30, |
|
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
Net (loss) ($ in thousands) |
$ |
(17,287) |
$ |
(24,033) |
$ |
(57,033) |
$ |
(84,136) |
|
Basic / diluted net loss per share ($/share) |
$ |
(0.18) |
$ |
(0.44) |
$ |
(0.79) |
$ |
(1.53) |
|
For the three and nine months ended September
30, 2022, net loss was $(17.3) million and $(57.0) million,
respectively, compared to a net loss of $(24.0) million and $(84.1)
million, respectively, for the comparable periods in 2021. On a per
share basis, net loss (based on the weighted average number of
shares outstanding over the period) was $(0.18) and $(0.79) for the
three and nine months ended September 30, 2022, respectively.
Conference Call Information
DBV will host a conference call and live audio
webcast on Thursday, November 3, 2022, at 5:00 p.m. ET to report
third quarter 2022 financial results and provide a business
update.
This call is accessible via the below
teleconferencing numbers, followed by the reference ID:
94309191#
- United States: 866 374
5140
- Canada: 866 455 3403
- United Kingdom: 808 238
9813
- France: 805 102 712
A live webcast of the call will be available on
the Investors & Media section of the Company’s website:
https://www.dbv-technologies.com/investor-relations/. A replay of
the presentation will also be available on DBV’s website after the
event.
CONDENSED STATEMENT OF CONSOLIDATED
FINANCIAL POSITION2
(unaudited)($ in thousands)
|
|
U.S. GAAPSeptember
30, |
|
U.S. GAAPDecember
31, |
|
|
2022 |
|
2021 |
(in thousands $) |
|
|
|
|
Assets |
$ |
248,117 |
$ |
146,723 |
of which cash and cash equivalents |
|
212,670 |
|
77,301 |
|
|
|
|
|
Liabilities |
|
36,065 |
|
47,449 |
|
|
|
|
|
Shareholders’
equity |
$ |
212,052 |
$ |
99,274 |
of which net result |
|
(57,033) |
|
(97,809) |
CONDENSED STATEMENT OF CONSOLIDATED
OPERATIONS AND COMPREHENSIVE LOSS1
(unaudited)($ in thousands, except per share
data)
|
|
U.S. GAAPThree months
ended September 30, |
|
U.S. GAAPNine months
ended September 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
2,074 |
$ |
1,323 |
$ |
6,148 |
$ |
2,776 |
|
|
|
|
|
|
|
|
|
Operating expenses : |
|
|
|
|
|
|
|
|
Research and development expenses |
|
(15,096) |
|
(16,320) |
|
(45,930) |
|
(58,663) |
Sales and marketing expenses |
|
(159) |
|
(1,072) |
|
(1,659) |
|
(2,999) |
General and administrative expenses |
|
(4,839) |
|
(8,299) |
|
(17,173) |
|
(26,250) |
Total Operating expenses |
|
(20,094) |
|
(25,691) |
|
(64,762) |
|
(87,912) |
Financial income |
|
732 |
|
336 |
|
1,668 |
|
597 |
Income tax |
|
- |
|
- |
|
(87) |
|
404 |
Net (loss) |
$ |
(17,287) |
$ |
(24,033) |
$ |
(57,033) |
$ |
(84,136) |
|
|
|
|
|
|
|
|
|
Basic/diluted Net loss per share attributable to shareholders |
$ |
(0.18) |
$ |
(0.44) |
$ |
(0.79) |
$ |
(1.53) |
CONDENSED STATEMENT OF CONSOLIDATED CASH
FLOW3 (unaudited)($ in
thousands)
|
|
U.S. GAAPNine months
ended September 30, |
|
|
2022 |
|
2021 |
|
|
|
|
|
Net cash flow used in operating activities |
$ |
(31,781) |
|
(89,452) |
Net cash flows used in (provided by) investing activities |
|
(66) |
|
41 |
Net cash flows provided by financing activities |
|
194,403 |
|
(103) |
Net (decrease) / increase in cash and cash
equivalents |
$ |
162,556 |
$ |
(89,514) |
Net cash and cash equivalents at the beginning of the period |
|
77,301 |
|
196,352 |
Effect of exchange rate changes on cash and cash equivalents |
|
(27,186) |
|
(8,643) |
Net cash and cash equivalents at the end of the
period |
$ |
212,670 |
$ |
98,195 |
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™, and is DBV Technologies’ 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 Technologies’ food allergies programs include ongoing
clinical trials of Viaskin Peanut. DBV Technologies has global
headquarters in Montrouge, France, and 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).
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, 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, 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, 2021,
filed with the SEC on March 9, 2022, 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+1 646-842-2393
angela.marcucci@dbv-technologies.com
Viaskin and EPIT are trademarks of DBV
Technologies.
1 The Company’s unaudited consolidated financial
statements for the nine months ended September 30, 2022, are
prepared in accordance with generally accepted accounting
principles in the U.S. ("U.S. GAAP").
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 generally accepted accounting principles in the
U.S. ("U.S. GAAP").
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