Conference call and webcast scheduled for March 30, 2021, at 08:00 a.m. ET (2:00 p.m. CET)
MAINZ, Germany, March 30, 2021 (GLOBE NEWSWIRE) — BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, today provided an update on its corporate progress and reported financial results for the quarter and full year ended December 31, 2020.
“2020 was a transformational year for BioNTech with the development and approval of the first mRNA drug in history. As of March 2021, we had delivered more than 200 million doses of our vaccine to more than 65 countries and regions together with our partners, and we are already seeing the first signs of vaccine associated reduction of COVID-19 cases and mortality in multiple countries” said Ugur Sahin, Co-founder and CEO of BioNTech. “We will continue to focus on innovating in the COVID-19 field by advancing new formulations and addressing vaccine variants, as well as initiating new trials in additional sub-populations. At the same time, we are accelerating the development of our cancer immunotherapies. We see a tremendous opportunity to reinvest the proceeds from our COVID-19 vaccine into extending and accelerating the research and development of new vaccines and therapeutics to improve the health of people worldwide by harnessing the full potential of the immune system.”
Fourth Quarter 2020 and Subsequent Updates
Infectious disease
COVID-19 vaccine program – BNT162b2
In December 2020, BNT162b2 became the first mRNA vaccine to be approved or authorized for emergency or conditional use. BNT162b2 now has authorization or approval for emergency use or temporary use in more than 65 countries worldwide, including the United States, United Kingdom and European Union.
Clinical development updates
Data on SARS-CoV-2 variants
Regulatory updates
Commercial Updates
We and our collaboration partners have supplied more than 200 million doses of our COVID-19 vaccine worldwide, as of March 23, 2021.
BioNTech and Pfizer have signed orders of 1.4 billion doses for delivery in 2021. Discussions for additional dose commitments are ongoing.
Manufacturing
BioNTech and Pfizer expect to increase BNT162b2 manufacturing capacity to up to 2.5 billion doses by the end of 2021. The increase is driven by the optimization of production processes, the recent initiation of production at BioNTech’s Marburg, Germany facility, regulatory approval for six dose vials, and the expansion of our manufacturing and supplier network. Additional measures and discussions with potential partners to further expand the manufacturing capacity and network are ongoing.
Oncology
BioNTech is accelerating the development of its broad oncology pipeline with 13 product candidates in 14 ongoing trials. In 2021, we expect at least four data updates from our oncology pipeline with up to three programs expected to move into randomized Phase 2 trials and six preclinical programs moving into Phase 1 trials. This includes the first-in-human trials started for the lead candidates for both the CARVac (BNT211) and RiboCytokines (BNT151) product candidates.
mRNA programs
FixVac
Individualized neoantigen specific immunotherapy (iNeST)
Our iNeST product candidate BNT122 is partnered with Genentech.
RiboCytokines
RiboMabs
Antibodies
Next-generation checkpoint immunomodulators
BNT311 and BNT312 are partnered with Genmab.
Cell therapies
CAR-T cell immunotherapy
BNT211, BioNTech’s most advanced CAR-T product candidate, targets the tumor-specific antigen CLDN6 and was developed in combination with a CAR-T cell Amplifying RNA Vaccine (CARVac) that encodes the CAR target for in vivo expansion upon CAR-T administration. CARVac is based on RNA-LPX technology known from FixVac and selectively delivers the RNA-encoded CAR target to antigen presenting cells, leading to CAR target expression on the cell surface.
Neoantigen-targeting T cell therapy
Small molecule immunomodulators
Toll-like receptor binding agonist
Full Year 2020 Financial Results
Revenues: Total revenues were estimated to be €345.4 million for the three months ended December 31, 2020, compared to €28.0 million for the three months ended December 31, 2019. For the year ended December 31, 2020, total revenues were estimated to be €482.3 million, compared to €108.6 million for the comparative prior year period. Total revenues increased due to recognizing revenues for the first time under our two new collaboration agreements to develop a COVID-19 vaccine and ultimately led to the recognition of COVID-19 vaccine commercial revenues. Under the Pfizer collaboration, territories have been allocated to BioNTech and Pfizer based on marketing and distribution rights. Our commercial revenues comprise an estimated amount of €188.5 million1 share of gross profit from COVID-19 vaccine sales in the collaboration partner’s territory, which represents a net figure. In addition, €61.4 million sales to our collaboration partner of products manufactured by us and €20.6 million direct COVID-19 vaccine sales to customers in our territory Germany have been recognized.
Cost of Sales: Cost of sales were estimated to be €41.0 million for the three months ended December 31, 2020, compared to €4.4 million for the three months ended December 31, 2019. For the year ended December 31, 2020, cost of sales were estimated to be €59.3 million, compared to €17.4 million for the comparative prior year period. €35.6 million estimated cost of sales were recognized for the first time with respect to our COVID-19 vaccine sales and include Pfizer’s share of gross profits earned by BioNTech. Cost of sales do not include costs relating to production of pre-launch products since those are expensed as research and development expenses in the period incurred.
Research and Development Expenses: Research and development expenses were €257.0 million for the three months ended December 31, 2020, compared to €65.4 million for the three months ended December 31, 2019. For the year ended December 31, 2020, research and development expenses were €645.0 million, compared to €226.5 million for the comparative prior year period. The increase was mainly due to an increase in research and development expenses for our BNT162 program. Research and development expenses include our share of expenses under the terms of the Pfizer collaboration agreement. Development costs are shared equally between Pfizer and us. The increase was further driven by an increase in expenses for purchased laboratory supplies as well as an increase in headcount leading to higher wages, benefits and social security expenses. In addition, from May 6, 2020, the date of acquisition of our new U.S.-based subsidiary, BioNTech US Inc., contributed to our research and development expenses.
General and Administrative Expenses: General and administrative expenses were €36.1 million for the three months ended December 31, 2020, compared to €11.1 million for the three months ended December 31, 2019. For the year ended December 31, 2020, general and administrative expenses were €94.0 million, compared to €45.5 million for the comparative prior year period. The increase was mainly due to higher expenses for professional services, an increase in headcount leading to higher wages, benefits and social security expenses and higher insurance premiums. In addition, from May 6, 2020, the date of acquisition of our new U.S.-based subsidiary, BioNTech US Inc., contributed to our general and administrative expenses.
Income Taxes: Following the authorization and approval of our COVID-19 vaccine for emergency or temporary use or having been granted conditional marketing authorization, the recognition of deferred tax assets was reevaluated. As of December 31, 2020, net deferred tax assets with respect to the accumulated tax losses and temporary differences of the German tax group were recognized with €161.0 million income tax effect.
Net Profit / Loss: Net profit was €366.9 million for the three months ended December 31, 2020, compared to €58.2 million net loss for the three months ended December 31, 2019. For the year ended December 31, 2020, net profit was €15.2 million, compared to €179.2 million net loss for the comparative prior year period.
Cash Position: Cash and cash equivalents as of December 31, 2020 were €1.2 billion.
Shares Outstanding: Shares outstanding as of December 31, 2020 were 241,521,065.
COVID-19 vaccine order book update:
Estimated COVID-19 vaccine revenues to BioNTech upon delivery of currently signed supply contracts (~1.4 billion doses): ~€9.8 billion.
Estimate reflects:
Additional revenues related to further supply contracts for deliveries in 2021 expected. Full year 2021 manufacturing capacity target raised from 2.0 to 2.5 billion doses to be able to address increased demand. |
2021 financial outlook: BioNTech is providing the following outlook for the full year 2021 of selected financial metrics based on the current base case projections:
Planned Full Year 2021 Expenses and Capex2 | |
R&D expenses | €750 million – €850 million
Ramp-up of R&D investment in 2H 2021 and beyond planned to broaden and accelerate pipeline development. |
SG&A expenses | Up to €200 million |
Capital expenditures | €175 million – €225 million |
Estimated Full Year 2021 Tax Assumptions | |
German tax group corporate tax rate | ~31% |
German tax group accumulated tax loss carryforwards as of December 31, 2020 | ~€450million3 |
Full financial statements can be found in the 20F filing as published on the SEC website under https://www.sec.gov/.
1 Estimated figures based on preliminary data shared between Pfizer and BioNTech as fully described in our Annual Report on Form 20-F. Changes in our share of the collaboration partner’s gross profit will be recognized prospectively.
2 Ranges reflect current base case projections.
3 €457.9 million corporate income tax losses and €450.9 million trade tax losses related to the German tax group.
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, bispecific 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 BioNTech’s expected revenues and net profit related to sales of BioNTech and Pfizer’s COVID-19 vaccine, referred to as COMIRNATY® in the European Union as authorized for use under conditional marketing approval, in territories controlled by BioNTech’s collaboration partners, particularly those such figures that are derived from preliminary estimates provided by BioNTech’s partners; the extent to which a COVID-19 vaccine continues to be necessary in the future; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the pricing and reimbursement of BioNTech and Pfizer’s COVID-19 vaccine and BioNTech’s investigational medicines, if approved; the rate and degree of market acceptance of BioNTech and Pfizer’s COVID-19 vaccine and BioNTech’s investigational medicines, if approved; the initiation, timing, progress, results, and cost of BioNTech’s research and development programs and BioNTech’s current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and BioNTech’s research and development programs; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for BioNTech’s product candidates; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and claims for personal injury or death arising from the use of BioNTech and Pfizer’s COVID-19 vaccine, and other products and product candidates developed or manufactured by BioNTech; BioNTech’s estimates of its expenses, ongoing losses, future revenue and capital requirements and BioNTech’s needs for or ability to obtain additional financing; the development of and projections relating to BioNTech’s competitors or its industry; BioNTech’s ability to effectively scale its production capabilities and manufacture its products, including BioNTech and Pfizer’s COVID-19 vaccine, and BioNTech’s product candidates; BioNTech’s projected net sales for the COVID-19 vaccine in 2021; BioNTech’s projected gross margins, expenses and expenditures and tax rate for 2021; BioNTech’s target vaccine production for 2021; and BioNTech’s COVID-19 vaccine revenues and net sales, which are subject to numerous estimates as more fully described in our Annual Report on Form 20-F. 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 US Securities and Exchange Commission (SEC) on March 31, 2020 and in subsequent filings made by BioNTech with the SEC, including the third quarter report, which are available on the SEC’s website at 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 & Strategy
Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de
Media Relations
Jasmina Alatovic
Director Global External Communications
Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385
E-mail: Media@biontech.de
Consolidated Statements of Financial Position
December 31, | December 31, | |
(in thousands) | 2020 | 2019 |
Assets | ||
Non-current assets | ||
Intangible assets | € 163,490 | € 89,434 |
Property, plant and equipment | 226,968 | 93,044 |
Right-of-use assets | 98,988 | 55,018 |
Other assets | 1,045 | – |
Deferred tax assets | 161,233 | – |
Total non-current assets | € 651,724 | € 237,496 |
Current assets | ||
Inventories | 64,120 | 11,722 |
Trade receivables | 165,468 | 11,913 |
Other financial assets | 137,234 | 1,680 |
Other assets | 60,966 | 9,069 |
Income tax assets | 898 | 756 |
Deferred expenses | 28,001 | 5,862 |
Cash and cash equivalents | 1,210,209 | 519,149 |
Total current assets | € 1,666,896 | € 560,151 |
Total assets | € 2,318,620 | € 797,647 |
Equity and liabilities | ||
Equity | ||
Share capital | 246,310 | 232,304 |
Capital reserve | 1,514,451 | 686,714 |
Treasury shares | (4,789) | (5,525) |
Accumulated losses | (409,629) | (424,827) |
Other reserves | 25,503 | 4,826 |
Total equity | € 1,371,846 | € 493,492 |
Non-current liabilities | ||
Interest-bearing loans and borrowings | 231,047 | 68,904 |
Other financial liabilities | 31,476 | – |
Provisions | 5,498 | – |
Contract liabilities | 71,892 | 97,109 |
Other liabilities | 566 | – |
Deferred tax liabilities | 281 | – |
Total non-current liabilities | € 340,760 | € 166,013 |
Current liabilities | ||
Interest-bearing loans and borrowings | 9,142 | 5,307 |
Trade payables | 102,288 | 20,498 |
Other financial liabilities | 74,075 | 10,352 |
Government grants | 91,951 | – |
Tax provisions | 11 | 150 |
Other provisions | 903 | 762 |
Contract liabilities | 299,583 | 93,583 |
Other liabilities | 28,061 | 7,490 |
Total current liabilities | € 606,014 | € 138,142 |
Total liabilities | € 946,774 | € 304,155 |
Total equity and liabilities | € 2,318,620 | € 797,647 |
Consolidated Statements of Operations
Years ended December 31, |
|||
2020 | 2019 | 2018 | |
(in thousands, except per share data) | |||
Revenues | |||
Research & development revenues | € 178,849 | € 84,428 | € 101,837 |
Commercial revenues | 303,476 | 24,161 | 25,738 |
Total revenues | 482,325 | 108,589 | 127,575 |
Cost of sales | (59,333) | (17,361) | (13,690) |
Research and development expenses | (645,029) | (226,466) | (143,040) |
Sales and marketing expenses | (14,512) | (2,718) | (3,041) |
General and administrative expenses | (94,049) | (45,547) | (26,334) |
Other operating expenses | (2,358) | (739) | (720) |
Other operating income | 250,539 | 2,724 | 5,396 |
Operating loss | € (82,417) | € (181,518) | € (53,854) |
Finance income* | 1,564 | 4,122 | 8,046 |
Finance expenses* | (62,946) | (326) | (48) |
Interest expenses related to lease liabilities | (2,003) | (1,718) | (1,721) |
Share of loss of equity method investees | – | – | (84) |
Loss before tax | € (145,802) | € (179,440) | € (47,662) |
Income taxes | 161,000 | 268 | (600) |
Profit / (Loss) for the period | € 15,198 | € (179,172) | € (48,262) |
Attributable to: | |||
Equity holders of the parent | 15,198 | (179,056) | (48,019) |
Non-controlling interests | – | (116) | (243) |
Profit / (Loss) for the period | € 15,198 | € (179,172) | € (48,262) |
Earnings per share | |||
Basic and diluted, profit / (loss) for the period attributable to ordinary equity holders of the parent** | € 0.06 | € (0.85) | € (0.25) |
* 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 years ended December 31, 2019 and December 31, 2018 have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019.
Consolidated Statements of Cash Flows
Years ended December 31, |
|||
2020 | 2019 | 2018 | |
(in thousands) | |||
Operating activities | |||
Profit / (Loss) for the period | € 15,198 | € (179,172) | € (48,262) |
Income taxes | (161,000) | (268) | 600 |
Loss before tax | € (145,802) | € (179,440) | € (47,662) |
Adjustments to reconcile loss before tax to net cash flows: | |||
Depreciation and amortization of property, plant, equipment and intangible assets | 38,744 | 33,896 | 21,984 |
Share-based payment expense | 32,142 | 30,236 | 7,641 |
Net foreign exchange differences | 41,275 | 70 | 459 |
(Gain) / Loss on disposal of property, plant and equipment | 595 | 542 | (14) |
Finance income | (1,564) | (1,782) | (1,996) |
Interest on lease liability | 2,003 | 1,717 | 1,721 |
Finance expense | 20,336 | 326 | 48 |
Movements in government grants | 91,951 | – | – |
Share of loss of an associate and a joint venture | – | – | 84 |
Other non-cash income | 1,749 | – | – |
Working capital adjustments: | |||
Decrease / (Increase) in trade receivable and contract assets | (247,886) | 2,939 | (18,732) |
Decrease / (Increase) in inventories | (49,794) | (5,798) | (1,253) |
(Decrease) / Increase in trade payables, other liabilities, contract liabilities and provisions | 204,583 | (80,577) | (21,080) |
Interest received | 1,444 | 1,256 | 1,996 |
Interest paid | (3,628) | (2,044) | (1,769) |
Income tax received (paid), net | 378 | 122 | (304) |
Net cash flows used in operating activities | € (13,474) | € (198,537) | € (58,877) |
Investing activities | |||
Purchase of property, plant and equipment | (66,033) | (38,592) | (29,901) |
Proceeds from sale of property, plant and equipment | 1,241 | 21 | 705 |
Purchase of intangibles assets and right of use assets | (19,413) | (32,488) | (37,256) |
Acquisition of subsidiaries and businesses, net of cash acquired | (60,643) | (6,056) | – |
Net cash flows used in investing activities | € (144,848) | € (77,115) | € (66,452) |
Financing activities | |||
Proceeds from issuance of share capital, net of costs | 753,007 | 375,351 | 361,725 |
Proceeds from loans and borrowings | 156,027 | 11,000 | 5,600 |
Repayment of loans and borrowings | (1,566) | – | – |
Payments related to lease liabilities | (12,743) | (3,061) | (2,148) |
Net cash flows from financing activities | € 894,725 | € 383,290 | € 365,177 |
Net increase in cash and cash equivalents | 736,403 | 107,638 | 239,848 |
Change in cash and cash equivalents resulting from exchange rate differences | (45,343) | 16 | (459) |
Cash and cash equivalents at January 1 | 519,149 | 411,495 | 172,106 |
Cash and cash equivalents at December 31 | € 1,210,209 | € 519,149 | € 411,495 |
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