On March 2, 2023 Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the full year 2022 (Press release, DBV Technologies, MAR 2, 2023, View Source [SID1234628113]). The audit procedures have been substantially completed by the Company’s statutory auditors and financials – prepared under both US GAAP and IFRS for the purpose of Form 10-K and Universal Registration Document respectively – were approved by the Board of Directors on March 2, 2023.
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EVOLVE
DBV completed EVOLVE, a 12-week caregiver and patient user experience study of the modified Viaskin Peanut patch in 50 peanut allergic children ages 4 – 11-years old. The objective of EVOLVE was to evaluate the Instructions for Use (IFU) and ease of use for the modified Viaskin Peanut patch. The study concluded that the updated Viaskin Peanut IFU supported correct patch application, which included no lifting of the patch edges or detachment directly after application. Furthermore, EVOLVE concluded that the majority of parents/caregivers reported a positive ease of use experience with the modified Viaskin Peanut patch.
In EVOLVE, DBV also tested the functionality of an electronic patient diary (eDiary) to collect information on activities of daily living and patch adhesion scores. As previously announced, VITESSE will assess patch adhesion of the modified Viaskin Peanut patch and DBV will include a statistical test of adhesion in the VITESSE statistical analysis plan. EVOLVE verified that the eDiary tool can be used by caregivers in VITESSE to capture the adhesion data in support of a potential BLA application.
Financial Highlights for the Full Year 2022
The Company’s annual consolidated financial statements are prepared in accordance with both generally accepted accounting principles in the U.S. ("US GAAP") and International Financial Reporting Standards ("IFRS") as adopted by the European Union. Unless otherwise indicated, the financial figures in the Full Year 2022 Financial Highlights are presented under both U.S GAAP and IFRS financial statements, and commented using U.S. GAAP financial statements. Differences between US GAAP and IFRS consolidated financial statements are mainly due to discrepancies arising from the application of lease accounting standards.
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Cash and Cash Equivalents
US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Net cash & cash equivalents at the beginning of the period
77,3 196,4 77,3 196,4
Net increase / (decrease) in cash & cash equivalents, of which:
131,9 (119,1 ) 131,9 (119,1 )
Net cash flow used in operating activities
(55,7 ) (108,2 ) (51,4 ) (104,1 )
Net cash flow used in investing activities
(0,1 ) (0,4 ) (0,1 ) (0,4 )
Net cash flow provided by / (used in) financing activities
194,1 0,3 189,9 (3,9 )
Effect of exchange rate changes on cash & cash equivalents
(6,5 ) (10,7 ) (6,5 ) (10,7
Net cash & cash equivalents at the end of the period
209,2 77,3 209,2 77,3
Cash and cash equivalents amount to $209,2 million as of December 31, 2022, compared to $77,3 million as of December 31, 2021, which is an increase by $131,9 million due to:
(1)
$194,1 million due to financing activities, mainly from ATM Program in May 2022 ($14,1 million, net of transaction costs), then from private investment in public equity ($180,4 million, net of transaction costs);
(2)
$26,1 million reimbursed by French tax administration for research tax credits related to years 2019, 2020, and 2021;
And partially offset by :
(3)
$81,8 million of cash used for operations, before $26,1 million reimbursement of research tax credits. This is a decrease of 24% compared to prior year reflecting the cost containment measures that has been continuously maintained since their implementation in 2020.
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US GAAP IFRS
In millions of USD FY22 FY21 FY20 FY22 FY21 FY20
Net cash flow used in operating activities
55,7 108,2 165,6 51,4 104,1 160.9
Reimbursements of Research Tax Credits
26,1 — — 26,1 — —
Net cash flow used in operating activities, excluding reimbursements of Research Tax Credits
81,8 108,2 165,6 77,5 104,1 160,9
Compared to prior year
-26,4 -57,4 -26,6 -56,8
-24 % -35 % -26 % -35 %
(4)
$6,5 million negative impact of changes in exchange rates.
The Company’s treasury position, stated in US Dollars, has benefited in the last quarter from a change in the Euro to US Dollar exchange rate. The company’s activities and expenditures in the fourth quarter were in line with expectations and continue to reflect DBV’s expense discipline.
Operating Income
US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 Variation 2022 2021 Variation
Research tax credits
5,7 7,5 -1,8 -24 % 5,7 7,5 -1,8 -24 %
Other operating income
(0,9 ) (1,8 ) +0,9 -51 % (0,9 ) (1,8 ) +0,9 -51
Produits opérationnels
4,8 5,7 -0,9 -15 % 4,8 5,7 -0,9 -15
Operating income amounts to $4,8 million as of December 31, 2022, compared to $5,7 million as of December 31, 2021, which is a decrease by $0,9 million due to:
(1)
A decrease in 2022 research tax credit by $1.8 million compared to 2021. This reflects the impact of the global restructuring plan initiated in 2020 and completed in 2021 which has impacted the expenses eligible to the research tax credit.
(2)
Partially offset by the variance in other operating income that consists of revenues recognized in advance of the completion of the collaboration agreement with Nestlé Health Science ("NHS").
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Operating Expenses
US GAAP IFRS
In millions of USD Year ended December 31, Year ended December 31,
2022 2021 Variation 2022 2021 Variation
Research & Development
75,5 70,3 +5,2 +7 % 75,2 70,1 +5,1 +7 %
Sales & Marketing
1,6 4,4 -2,8 -63 % 1,6 4,4 -2,8 -65 %
General & Administrative
24,3 30,5 -6,2 -20 % 24,2 30,4 -6,1 -20 %
Restructuring
— (0,9 ) +0,9 -100 % — (0,9 ) +0,9 -100
Total operating expenses
101,5 104,3 -2,8 -3 % 101,0 104,0 -2,9 -3
including personnel expenses
24,0 31,1 -7,1 -23 % 24,0 31,1 -7,1 -23 %
Operating expenses amount to $101,5 million as of December 31, 2022, compared to $104,3 million as of December 31, 2021, which is a decrease by $2,8 million mainly due to the decrease in personnel expenses as a result of the global restructuring plan that was announced in 2020 and completed in the course of 2021. The average number of employees was 86 for the year ended December 31, 2022, compared to 101 and 270 for the years ended December 31, 2021 and 2020 respectively.
This reduction in our operating expenses also reflects the strict financial discipline maintained across all services to focus our resources on the support of our clinical trial objectives.
Net Loss and Net Loss per Share
US GAAP IFRS
Year ended December 31, Year ended December 31,
2022 2021 Variation 2022 2021 Variation
Net (loss) in millions of USD
(96,3 ) (97,8 ) +1,5 -2 % (96,0 ) (98,1 ) +2,0 -2 %
Basic / diluted net (loss) per share in USD
(1,24 ) (1,78 ) +0,5 -30 % (1,24 ) (1,79 ) +0,6 -31 %
Net result for the year ended December 31, 2022, is a loss amounting to $96,3 million compared to a loss amounting to $97,8 million for the year ended December 31, 2021.
On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) is $1.24 for the year ended December 31, 2022.
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Conference Call Information DBV will host a conference call and live audio webcast today, Thursday, March 2, 2023, at 5:00 p.m. ET to report fourth quarter 2022 financial results and provide a
business update.
Attendees may access the call via the below teleconferencing numbers and asking to join the DBV Technologies call:
•
United States: 1-866-777-2509
•
International: 1-412-317-5413
A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event
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CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION
US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Assets
246,5 146,7 246,5 146,3
of which cash & cash equivalents
209,2 77,3 209,2 77,3
Liabilities
52,1 47,4 52,0 47,3
Shareholders’ equity
194,5 99,3 194,5 99,0
of which net result
(96,3 ) (97,8 ) (96,0 ) (98,1 )
CONDENSED STATEMENT OF CONSOLIDATED OPERATIONS AND COMPREHENSIVE LOSS
US GAAP IFRS
In millions of USD Year ended December 31, Year ended December 31,
2022 2021 2022 2021
Revenues
4,8 5,7 4,8 5,7
Research & Development
(75,5 ) (70,3 ) (75,2 ) (70,1 )
Sales & Marketing
(1,6 ) (4,4 ) (1,6 ) (4,4 )
General & Administrative
(24,3 ) (30,5 ) (24,2 ) (30,4 )
Restructuring income/(expenses)
— 0,9 — 0,9
Operating expenses
(101,5 ) (104,3 ) (101,0 ) (104,0 )
Finance income/(expenses)
0,4 0,4 0,3 (0,2 )
Income tax
(0,1 ) 0,4 (0,1 ) 0,4
Net gain/(loss)
(96,3 ) (97,8 ) (96,0 ) (98,1 )
Résultat de base et dilué par action ($/action)
(1,24 ) (1,78 ) (1,24 ) (1,79 )
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CONDENSED STATEMENT OF CONSOLIDATED CASH FLOW
US GAAP IFRS
Year ended December 31, Year ended December 31,
In millions of USD 2022 2021 2022 2021
Net cash flows provided / (used) in operating activities
(55,7 ) (108,2 ) (51,4 ) (104,1 )
Net cash flows provided / (used) in investing activities
(0,1 ) (0,4 ) (0,1 ) (0,4 )
Net cash flows provided / (used) in financing activities
194,1 0,3 189,9 (3,9 )
Effect of exchange rate changes on cash & cash equivalents (US GAAP presentation)
(6,5 ) (10,7
Net increase / (decrease) in cash & cash equivalents
131,9 (119,1 ) 138,4 (108,4
Net cash & cash equivalents at the beginning of the period
77,3 196,4 77,3 196,4
Effect of exchange rate changes on cash & cash equivalents (IFRS presentation)
(6,5 ) (10,7
Net cash & cash equivalents at the end of the period
209,2 77,3 209,2 77,3