Conference call and webcast for analysts and investors
scheduled for August 11, 2020 at 08:00 a.m. ET (2:00 p.m. CET)
MAINZ, Germany, Aug. 11, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and infectious diseases, today provided an update on its corporate progress and reported financial results for the quarter ended June 30, 2020.
“We made significant progress in the second quarter toward our goal of advancing our oncology programs and toward bringing a COVID-19 vaccine to market as quickly as possible. I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and Co-founder. “In addition, we have significantly strengthened our balance sheet, providing financial resources to advance our broad pipeline of novel immunotherapies targeting oncology and infectious disease.”
Second Quarter 2020 and Subsequent Updates
Infectious disease
COVID-19 Vaccine Program – BNT162
Oncology
FixVac
Individualized neoantigen specific immunotherapy (iNeST)
mRNA intratumoral immunotherapy
CAR-T cell immunotherapy
Neoantigen-Targeting T Cells
Next-generation checkpoint immunomodulators
Toll-Like receptor binding agonist
Corporate Development
During the second quarter, BioNTech completed the acquisition of Neon Therapeutics, Inc. BioNTech continues to integrate the new subsidiary, based in Cambridge, Massachusetts, which serves as BioNTech’s U.S. headquarters.
Second Quarter 2020 Financial Results
Cash Position: Cash and cash equivalents as of June 30, 2020, were €573.0 million.
Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was €41.8 million for the three months ended June 30, 2020, compared to €25.8 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total revenue was €69.4 million, compared to €51.9 million for the comparative prior year period. The revenue from collaboration agreements overall increased due to the recognition of revenue from our new collaboration agreements signed with Pfizer and Fosun Pharma as part of the Company’s BNT162 vaccine program against COVID-19. The revenues from other sales transactions increased due to increased orders and include sales of diagnostic products, peptides, retroviral vectors for clinical supply and development and manufacturing services sold to third-party customers.
Research and Development Expenses: Research and development expenses were €95.2 million for the three months ended June 30, 2020, compared to €53.4 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total research and development expenses were €160.3 million, compared to €110.6 million for the comparative prior year period. The increase was mainly due to an increase in headcount leading to higher wages, benefits and social security expenses as well as an increase in expenses for purchased research and development services, especially with respect to our BNT162 program. In addition, from the date of acquisition, the new U.S.-based subsidiary, BioNTech US Inc., contributed to our research and development expenses.
General and Administrative Expenses: General and administrative expenses were €18.8 million for the three months ended June 30, 2020, compared to €14.6 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total general and administrative expenses were €34.6 million, compared to €23.9 million for the comparative prior year period. The increase was mainly influenced by higher expenses for purchased management consulting and legal services as well as an increase in headcount leading to higher wages, benefits and social security expenses. In addition, from the date of acquisition, our new U.S.-based subsidiary, BioNTech US Inc., contributed to our general and administrative expenses.
Net Loss: Net loss was €88.3 million for the three months ended June 30, 2020, compared to €50.1 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total net loss was €141.7 million, compared to €90.8 million for the comparative prior year period.
Shares Outstanding: Shares outstanding as of June 30, 2020 were 232,673,455.
Financial Guidance:
Conference Call and Webcast Information
BioNTech SE will host a conference call and webcast today at 08:00 a.m. ET (2:00 p.m. CET) to report its financial results for the quarter ended June 30, 2020 and provide a corporate update.
To participate in the conference call, please dial the following numbers 15-20 minutes prior to the start of the call and provide the Conference ID: 1963889.
United States international: +1 646 741 3167
United States domestic (toll-free): +1 877 870 9135
Germany: +49 692 2222 625
Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor Relations section of the Company’s website at https://biontech.de/. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.
1 All amounts translated using the exchange rate published by the German Central Bank (Deutsche Bundesbank) in effect as of June 30, 2020.
2 IVAC_M_uID is also being investigated in arm 2 (N=15) of the 3 arm TNBC-MERIT trial, with BNT114 as an optional treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC-MERIT trial (total patients in study: N=42).
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit www.BioNTech.de
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: our expected cash usage for 2020 and beyond; our anticipated cash runway; the timing, completion and extent of subscription of the rights offering; the planned next steps in BioNTech’s pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech’s product candidates; expectations for data announcements with respect to BioNTech’s clinical trials; the timing for any potential emergency use authorizations or approvals for BNT162; and our ability to scale-up manufacturing capacity for BNT162 and supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 31, 2020 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.
Investor Relations
Sylke Maas, Ph.D.
VP Investor Relations & Business Strategy
Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de
Media Relations
Jasmina Alatovic
Senior Manager Global External Communications
Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385
E-mail: Media@biontech.de
Interim Condensed Consolidated Statements of Financial Position
June 30, | December 31, | ||||
(in thousands) | 2020 | 2019 | |||
Assets | (unaudited) | ||||
Non-current assets | |||||
Intangible assets | € 183,281 | € 89,434 | |||
Property, plant and equipment | 112,829 | 93,044 | |||
Right-of-use assets | 54,905 | 55,018 | |||
Other assets | 1,316 | - | |||
Total non-current assets | € 352,331 | € 237,496 | |||
Current assets | |||||
Inventories | 8,615 | 11,722 | |||
Trade receivables | 7,679 | 11,913 | |||
Contract assets | 1,621 | - | |||
Other financial assets | 1,953 | 1,680 | |||
Other assets | 16,329 | 9,069 | |||
Income tax assets | 1,012 | 756 | |||
Deferred expense | 10,896 | 5,862 | |||
Cash and cash equivalents | 573,011 | 519,149 | |||
Total current assets | € 621,116 | € 560,151 | |||
Total assets | € 973,447 | € 797,647 | |||
Equity and liabilities | |||||
Equity | |||||
Share capital | 238,198 | 232,304 | |||
Capital reserve | 918,174 | 686,714 | |||
Treasury shares | (5,525 | ) | (5,525 | ) | |
Accumulated losses | (566,509 | ) | (424,827 | ) | |
Other reserves | 17,596 | 4,826 | |||
Total equity | € 601,934 | € 493,492 | |||
Non-current liabilities | |||||
Financial liabilities | 70,289 | 68,904 | |||
Other liabilities | 431 | - | |||
Contract liabilities | 86,793 | 97,109 | |||
Deferred tax liabilities | 5,434 | - | |||
Total non-current liabilities | € 162,947 | € 166,013 | |||
Current liabilities | |||||
Tax provisions | 150 | 150 | |||
Provisions | 833 | 762 | |||
Financial liabilities | 2,591 | 1,823 | |||
Trade payables | 35,690 | 20,498 | |||
Contract liabilities | 117,661 | 93,583 | |||
Other financial liabilities | 33,763 | 13,836 | |||
Other liabilities | 17,878 | 7,490 | |||
Total current liabilities | € 208,566 | € 138,142 | |||
Total liabilities | € 371,513 | € 304,155 | |||
Total equity and liabilities | € 973,447 | € 797,647 |
Interim Condensed Consolidated Statements of Operations
Three months ended June 30, | Six months ended June 30, | |||||||||
2020 | 2019 | 2020 | 2019 | |||||||
(in thousands, except per share data) | (unaudited) | (unaudited) | ||||||||
Revenues from contracts with customers | € 41,762 | € 25,785 | € 69,425 | € 51,939 | ||||||
Cost of sales | (5,662 | ) | (5,489 | ) | (11,504 | ) | (8,694 | ) | ||
Gross profit | € 36,100 | € 20,296 | € 57,921 | € 43,245 | ||||||
Research and development expenses | (95,189 | ) | (53,402 | ) | (160,311 | ) | (110,643 | ) | ||
Sales and marketing expenses | (3,054 | ) | (678 | ) | (3,540 | ) | (1,238 | ) | ||
General and administrative expenses | (18,813 | ) | (14,623 | ) | (34,628 | ) | (23,899 | ) | ||
Other operating income | 773 | 660 | 1,198 | 991 | ||||||
Other operating expenses | (759 | ) | (120 | ) | (859 | ) | (158 | ) | ||
Operating loss | € (80,942) | € (47,867) | € (140,219) | € (91,702) | ||||||
Finance income* | 205 | 425 | 593 | 1,876 | ||||||
Finance expenses* | (9,300 | ) | (2,204 | ) | (3,374 | ) | (151 | ) | ||
Interest expense related to lease liability | (465 | ) | (425 | ) | (880 | ) | (850 | ) | ||
Loss before tax | € (90,502) | € (50,071) | € (143,880) | € (90,827) | ||||||
Income taxes | 2,206 | (13 | ) | 2,198 | (19 | ) | ||||
Loss for the period | € (88,296) | € (50,084) | € (141,682) | € (90,846) | ||||||
Attributable to: | ||||||||||
Equity holders of the parent | (88,296 | ) | (50,084 | ) | (141,682 | ) | (90,730 | ) | ||
Non-controlling interests | - | - | - | (116 | ) | |||||
€ (88,296) | € (50,084) | € (141,682) | € (90,846) | |||||||
Earnings per share | ||||||||||
in EUR | ||||||||||
Basic & diluted, loss per share for the period attributable to equity holders of the parent** | € (0.38) | € (0.24) | € (0.62) | € (0.45) |
* Foreign exchange differences on a cumulative basis are either shown as finance income or expenses and might switch between those two positions during the year-to-date reporting periods.
** Numbers of shares for calculating the earnings per share for the three and six months ended June 30, 2019 have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019.
Interim Condensed Consolidated Statements of Cash Flows
Six months ended June 30, | |||||
2020 | 2019 | ||||
(in thousands) | (unaudited) | ||||
Operating activities | |||||
Loss for the period | € (141,682) | € (90,846) | |||
Income taxes | (2,198 | ) | 19 | ||
Loss before tax | € (143,880) | € (90,827) | |||
Adjustments to reconcile loss before tax to net cash flows: | |||||
Depreciation and amortization of property, plant, equipment and intangible assets | 17,425 | 15,595 | |||
Share-based payment expense | 16,263 | 17,986 | |||
Net foreign exchange differences | (50 | ) | 143 | ||
Loss on disposal of property, plant and equipment | 80 | 9 | |||
Finance income | (593 | ) | (769 | ) | |
Interest on lease liability | 880 | 850 | |||
Finance expense | 208 | 151 | |||
Other non-cash income | (151 | ) | - | ||
Working capital adjustments: | |||||
Decrease/(Increase) in trade receivable and contract assets | (9,770 | ) | 9,715 | ||
Decrease/(Increase) in inventories | 3,246 | (1,355 | ) | ||
(Decrease)/Increase in trade payables, other liabilities, contract liabilities and provisions | 46,918 | (36,936 | ) | ||
Interest received | 576 | 769 | |||
Interest paid | (985 | ) | (1,001 | ) | |
Income tax paid | (375 | ) | (19 | ) | |
Net cash flows used in operating activities | € (70,208) | € (85,689) | |||
Investing activities | |||||
Purchase of property, plant and equipment | (21,396 | ) | (10,608 | ) | |
Proceeds from sale of property, plant and equipment | 2 | 557 | |||
Purchase of intangibles assets | (4,174 | ) | (29,665 | ) | |
Acquisition of subsidiaries and businesses, net of cash acquired | 891 | (6,050 | ) | ||
Net cash flows used in investing activities | € (24,677) | € (45,766) | |||
Financing activities | |||||
Proceeds from issuance of share capital, net of costs | 147,806 | 175 | |||
Proceeds from loans and borrowings | 2,899 | 6,035 | |||
Repayment of loans and borrowings | (319 | ) | - | ||
Payments related to lease liabilities | (2,173 | ) | (1,291 | ) | |
Net cash flows from financing activities | € 148,213 | € 4,919 | |||
Net increase/(decrease) in cash and cash equivalents | 53,328 | (126,536 | ) | ||
Change in cash resulting from exchange rate differences | 534 | (69 | ) | ||
Cash and cash equivalents at January 1 | 519,149 | 411,495 | |||
Cash and cash equivalents at June 30 | € 573,011 | € 284,890 |