Montrouge, France, August 1, 2022
DBV Technologies
Reports Second Quarter
2022 Financial Results
- DBV closes Q2 with a cash balance
of $248M following recent ATM and PIPE offerings
- DBV continues to practice budget
discipline measures; cash used in operating activities decreased
more than 40% between the first half of 2021 and 2022
- The U.S. District Court, District
of New Jersey, entered an order granting DBV’s Motion to Dismiss
the Third Amended Class Action Complaint with prejudice
DBV Technologies (Euronext: DBV
– ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today reported financial results for the
second quarter of 2022. The quarterly financial statements were
approved by the Board of Directors on July 29, 2022.
Financial Highlights
for the Second Quarter
and the Six Months Ended
June 30,
2022:1
Cash and cash equivalents were $248.0 million,
as of June 30, 2022, compared to $77.3 million as of December 31,
2021, and $74.1 million as of March 31, 2022. The net increases of
respectively $173.9 million and $170.7 million for the quarter and
six months ended June 30, 2022, were mostly comprised of a $195.3
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 $181.2 million; net of transaction costs as well as a
$27.1 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 $(38.9) million cash utilization in
operating activities; and the effect of exchange rates on cash and
cash equivalents for $(12.6) million.
Excluding the effect of second quarter financing
and reimbursement of the Research Tax Credit, the cash used in
operating activities decreased by 42% in U.S. GAAP and 44% in IFRS
between the first half of 2021 and 2022, reflecting the
1The
Company’s interim consolidated financial statements for the six
months ended June 30, 2022, 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 Q2 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.Company’s continued implementation of budget discipline
measures.
Cash and Cash Equivalents
|
|
U.S. GAAP |
|
IFRS |
|
|
Six months ended
June 30, |
|
Six months ended
June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
Net (decrease) / increase in cash and cash
equivalents |
$ |
170,670 |
$ |
(70,868) |
$ |
170,671 |
$ |
(70,869) |
Net cash flow used in operating activities |
$ |
(11,733) |
|
(66,503) |
|
(8,585) |
|
(64,102) |
Net cash flows used in investing activities |
|
(218) |
|
(13) |
|
(218) |
|
(13) |
Net cash flows provided by financing activities |
|
195,221 |
|
1,071 |
|
192,075 |
|
(1,336) |
Effect of exchange rate changes on cash and cash equivalents |
|
(12,600) |
|
(5,423) |
|
(12,600) |
|
(5,418) |
Net cash and cash equivalents at the end of the
period |
$ |
247,971 |
$ |
125,484 |
$ |
247,971 |
$ |
125,484 |
Based on its current assumptions, DBV expects
that its current cash and cash equivalents will support its
operations several months beyond the current projected completion
of VITESSE, the planned Phase 3 clinical study of the modified
Viaskin™ Peanut patch in peanut-allergic children ages 4 years and
older. DBV continues to engage in productive dialogue with the FDA
on the key elements of the VITESSE protocol. As previously
disclosed, the Company will communicate key elements of the VITESSE
trial design and projected timelines once this process has
concluded.
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 $4.1 million for the six
months ended June 30, 2022, compared to $1.5 million for the six
months ended June 30, 2021. The variation in operating income is
primarily attributable to the revision of the revenue recognized
under Nestlé’s collaboration agreement conducted as part of the
existing contract, as the Company updated the measurement of
progress of its Phase II APTITUDE milk-diagnostic tool clinical
study.
Operating
Expenses
|
|
U.S. GAAP |
|
U.S. GAAP |
|
IFRS |
|
|
Three months
ended June 30, |
|
Six months
ended June
30, |
|
Six months
ended June
30, |
($ in thousands) |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
(18,611) |
$ |
(20,179) |
$ |
(30,834) |
$ |
(42,343) |
$ |
(30,694) |
$ |
(42,185) |
Sales and marketing |
|
(1,037) |
|
(1,198) |
|
(1,500) |
|
(1,927) |
|
(1,476) |
|
(1,905) |
General and administrative |
|
(5,704) |
|
(8,269) |
|
(12,334) |
|
(17,951) |
|
(12,166) |
|
(17,939) |
Total operating
expenses |
$ |
(25,352) |
$ |
(29,646) |
$ |
(44,669) |
$ |
(62,221) |
$ |
(44,336) |
$ |
(62,029) |
Operating
Expenses for the three months ended June 30, 2022, were
$(25.4) million, compared to $(29.6) million for the three months
ended June 30, 2021, each under U.S. GAAP or -14%. For the six
months ended June 30, 2022, operating expenses were $(44.7) million
under U.S. GAAP and $(44.3) million under IFRS, compared to $(62.2)
million and $(62.0) million under U.S. GAAP and IFRS respectively,
for the six months ended June 30, 2021. DBV has continued to
practice financial diligence and implemented further cost
containment strategies.
Employee-related costs decreased by $3.8
million, from $15.9 million for the six months ended June 30, 2021,
to $12.1 million for the six months ended June 30, 2022 – a 23.8%
decrease, compared to a 21% decrease of the average number of
headcounts between the two periods (88 and 111 full-time equivalent
employees for the six months ended June 30, 2022 and 2021,
respectively). As of June 30, 2022, DBV had 86 employees.
Net Loss and Net Loss
Per Share
|
|
U.S. GAAP |
|
U.S. GAAP |
|
|
IFRS |
|
|
Three months
ended June
30, |
|
Six months
ended June
30, |
|
|
Six months
ended June
30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) ($ in thousands) |
$ |
(23,039) |
$ |
(30,654) |
$ |
(39,746) |
$ |
(60,103) |
|
$ |
(39,522) |
$ |
(60,240) |
Basic / diluted net loss per share ($/share) |
$ |
(0.35) |
$ |
(0.56) |
$ |
(0.66) |
$ |
(1.09) |
|
$ |
(0.65) |
$ |
(1.10) |
For the three months ended June 30, 2022, net
loss was $(23.0) million compared to a net loss of $(30.7) million
for the comparable period in 2021.
On a per share basis, net loss (based on the
weighted average number of shares outstanding over the period) was
$(0.35) and $(0.56) for the three months ended June 30, 2022 and
2021, respectively.
For the six months ended June 30, 2022, net loss
was $(39.7) million and $(39.5) million under U.S. GAAP and IFRS,
respectively. Net loss per share was $(0.66) under U.S. GAAP and
$(0.65) under IFRS.
Monthly
Information
Regarding the
Total
Number of
Voting
Rights and
Total
Number of
Shares of the Company as of June 30,
2022:
(Article 223-16 of the General Regulations of
the Autorité des Marchés Financiers)
Date |
Total number of shares |
Total number of voting rights |
06/30/2022 |
94,022,679 |
Total gross of voting rights: 94,022,679 |
Total net* of voting rights: 93,916,392 |
* Total net = total number of voting rights
attached to shares – shares without voting rights
The PIPE financing DBV completed in June
included the sale of prefunded warrants to purchase up to
28,276,331 ordinary shares. The pre-funded warrants are not
included in the number of shares outstanding. If all 28,276,331
pre-funded warrants were exercised, the total number of DBV shares
outstanding would be 122,299,010.
Class Action
Complaint:
As previously disclosed, a class action
complaint was filed in January 2019 in the U.S. District Court,
District of New Jersey, alleging that the Company and certain
current and former executive officers violated certain U.S. federal
securities laws. Plaintiffs filed a Third Amended Complaint on
September 30, 2021. On July 29, 2022, the Court entered an order
granting the Company’s Motion to Dismiss the Plaintiff’s Third
Amended Complaint with prejudice. The Court indicated that the
Third Amended Complaint was deficient in a number of ways, failing
to allege a violation of the Securities Exchange Act of 1934, and
ordered the matter closed. Per court procedural rules, the
Plaintiffs have 30 days to appeal the dismissal of the Third
Amended Complaint. The Company believes that the allegations
contained in the complaint are without merit and will continue to
defend the case vigorously.
CONDENSED STATEMENT OF CONSOLIDATED
FINANCIAL POSITION (unaudited)($ in
thousands)
|
|
U.S. GAAP2 |
|
|
IFRS3 |
|
|
June 30, |
|
December 31, |
|
|
June 30, |
|
December 31, |
|
|
|
2022 |
|
2021 |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
$ |
284,978 |
$ |
146,723 |
|
$ |
284,922 |
$ |
146,323 |
|
of which cash and cash equivalents |
|
247,971 |
|
77,301 |
|
|
247,971 |
|
77,301 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
40,562 |
|
47,449 |
|
|
40,501 |
|
47,293 |
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders’
equity |
$ |
244,416 |
$ |
99,274 |
|
$ |
244,421 |
$ |
99,030 |
|
of which net result |
|
(39,746) |
|
(97,809) |
|
|
(39,522) |
|
(98,052) |
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED STATEMENT OF CONSOLIDATED
OPERATIONS AND COMPREHENSIVE LOSS (unaudited)($ in
thousands, except per share data)
|
|
U.S. GAAP2 |
|
U.S. GAAP2 |
|
|
IFRS3 |
|
|
Three months
ended June
30, |
|
Six months
ended June
30, |
|
|
Six months
ended June 30, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
1,529 |
$ |
(1,488) |
$ |
4,074 |
$ |
1,453 |
|
$ |
4,074 |
$ |
1,453 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
(18,611) |
|
(20,179) |
|
(30,834) |
|
(42,343) |
|
|
(30,694) |
|
(42,185) |
Sales & marketing |
|
(1,037) |
|
(1,198) |
|
(1,500) |
|
(1,927) |
|
|
(1,476) |
|
(1,905) |
General & administrative |
|
(5,704) |
|
(8,269) |
|
(12,334) |
|
(17,951) |
|
|
(12,166) |
|
(17,939) |
Total operating
expenses |
|
(25,352) |
|
(29,646) |
|
(44,669) |
|
(62,221) |
|
|
(44,336) |
|
(62,029) |
Financial income (expenses) |
|
784 |
|
46 |
|
936 |
|
261 |
|
|
827 |
|
(68) |
Income tax |
|
- |
|
434 |
|
(87) |
|
404 |
|
|
(87) |
|
404 |
Net
(loss) |
$ |
(23,039) |
$ |
(30,654) |
$ |
(39,746) |
$ |
(60,103) |
|
$ |
(39,522) |
$ |
(60,240) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic/diluted net loss per share attributable to
shareholders |
$ |
(0.35) |
$ |
(0.56) |
$ |
(0.66) |
$ |
(1.09) |
|
$ |
(0.65) |
$ |
(1.10) |
2Unaudited
financial statements prepared in accordance with generally accepted
accounting principles in the U.S. ("U.S. GAAP").3Unaudited
financial statements prepared in accordance with International
Financial Reporting Standards (“IFRS”) as adopted by the European
Union.CONDENSED STATEMENT OF CONSOLIDATED CASH FLOW
(unaudited)
($ in thousands)
|
|
U.S. GAAP4 |
|
|
IFRS5 |
|
|
Six months
ended June
30, |
|
|
Six months
ended June
30, |
|
|
2022 |
|
2021 |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
|
Net cash flow used in operating activities |
$ |
(11,733) |
$ |
(66,503) |
|
$ |
(8,585) |
$ |
(64,102) |
Net cash flows used in investing activities |
|
(218) |
|
(13) |
|
|
(218) |
|
(13) |
Net cash flows provided by (used in) financing
activities |
|
195,222 |
|
1,071 |
|
|
192,075 |
|
(1,336) |
Effect of exchange rate changes on cash and cash
equivalents |
|
(12,600) |
|
(5,423) |
|
|
(12,600) |
|
(5,418) |
Net (decrease) / increase in cash and cash
equivalents |
|
170,670 |
|
(70,868) |
|
|
170,670 |
|
(70,869) |
Net cash and cash equivalents at the beginning of the
period |
|
77,301 |
|
196,352 |
|
|
77,301 |
|
196,352 |
Net cash and cash equivalents at the end of the
period |
$ |
247,971 |
$ |
125,484 |
|
$ |
247,971 |
$ |
125,484 |
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).
4Unaudited
financial statements prepared in accordance with generally accepted
accounting principles in the U.S. ("U.S. GAAP").5Unaudited
financial statements prepared in accordance with International
Financial Reporting Standards (“IFRS”) as adopted by the European
Union.
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.
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