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DBV Technologies Reports Second Quarter 2022 Financial Results
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) | ? |
By: GlobeNewswire
- 01 Aug 2022
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