MAINZ, Germany, May 12, 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 March 31, 2020.
“BioNTech has demonstrated significant progress to date in 2020. We advanced our oncology pipeline, announced the closing of our acquisition of Neon Therapeutics in the U.S., and signed several new value-adding partnerships,” said Ugur Sahin, BioNTech’s CEO. “Most notably, we have rapidly initiated a global clinical development program in Europe and the U.S. for multiple COVID-19 vaccine candidates.”
First Quarter 2020 and Subsequent Updates
BioNTech continues to monitor the effect of the current COVID-19 pandemic situation on its overall operations. As previously announced, the company has put significant measures in place to protect supply chain, operations, employees and the execution of clinical trials. The Company has not seen any impact on its mRNA manufacturing, nor on its CAR-T manufacturing operations. BioNTech has implemented a plan to manage the evolving disruptions on the Company’s clinical programs, and as previously detailed, is prioritizing execution of ongoing clinical trials, whereas certain first-in-human (FIH) clinical trial timelines have been affected. BioNTech intends to initiate Phase 2 trials planned for end of 2020, manage ongoing Phase 1 trials to support completion and optimize ability to initiate and conduct FIH studies. BioNTech will continue to evaluate potential effects and provide updates as appropriate.
BioNTech has made significant progress in its efforts to develop a potential vaccine to induce immunity and prevent COVID-19 infection in response to the global health threat posed by the disease. During the first quarter, the company assembled a global consortium of partners including Pfizer (worldwide collaboration outside of China) and Fosun Pharma (China). BioNTech’s goal is to make a vaccine available to the public worldwide as quickly as possible.
COVID-19 Vaccine Program
BNT162 - BioNTech’s vaccine program against COVID-19, BNT162, leverages the Company’s proprietary mRNA platform. Currently there are four vaccine candidates, two of the four vaccine candidates include a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA). Each mRNA format is combined with a lipid nanoparticle (LNP) formulation. The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor binding domain (RBD) from the spike protein is included in the other two candidates.
BioNTech has also continued to advance its broad oncology pipeline. There are currently ten oncology products in 11 ongoing trials with multiple data readouts expected in 2020. BioNTech intends to initiate four Phase 2 trials (BNT111, BNT113, BNT122) and two additional FIH trials (BNT211, BNT411) in 2020.
Individualized neoantigen specific immunotherapy (iNeST)
mRNA intratumoral immunotherapy
CAR-T cell immunotherapy
Next-generation checkpoint immunomodulators
Toll-Like Receptor Binding
1 We expect this data update to include an update on the ongoing study, including patient enrollment numbers, with full efficacy and safety data for an interim update expected in the second half of 2021.
Recently, BioNTech completed the acquisition of Neon Therapeutics, Inc. in an all-stock transaction. BioNTech is now in the integration phase and expects the new subsidiary, based in Cambridge, Massachusetts, to serve as BioNTech’s U.S. headquarters.
First Quarter 2020 Financial Results
Cash Position: Cash and cash equivalents as of March 31, 2020, were €451.6 million.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was €27.7 million for the three months ended March 31, 2020, compared to €26.2 million for the three months ended March 31, 2019. The increase was mainly due to revenues resulting from other sales transactions i.e. development and manufacturing services sold to third-party customers, retroviral vectors for clinical supply, and sales of peptides.
Research and Development Expenses: Research and development expenses were €65.1 million for the three months ended March 31, 2020, compared to €57.2 million for the three months ended March 31, 2019. The increase was primarily 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 services.
General and Administrative Expenses: General and administrative expenses were €15.8 million for the three months ended March 31, 2020, compared to €9.3 million for the three months ended March 31, 2019. This increase was mainly driven by higher legal expenses, an increase in headcount leading to higher wages, benefits and social security expenses as well as higher expenses due to newly concluded insurance premiums.
Net Loss: Net loss was €53.4 million for the three months ended March 31, 2020, compared to a net loss of €40.8 million for the three months ended March 31, 2019.
Shares Outstanding: Shares outstanding as of March 31, 2020 were 226,779,744.
Interim quarterly financial statements can be found in the 6-K filing as published on the SEC website under https://www.sec.gov/.
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 March 31, 2020 and provide a corporate update.
To participate in the conference call, please dial the following numbers 10-15 minutes prior to the start of the call and provide the Conference ID: 9282359.
|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.
Biopharmaceutical New Technologies (BioNTech) 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 Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer.
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: 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 BNT111, BNT113, iNeST (BNT122), BNT211 and BNT411; expectations for data announcements with respect to BioNTech’s BNT111, BNT114, iNeST (BNT122), BNT131, BNT162 and BNT311 clinical trials; and our ability to scale-up manufacturing capacity for BNT162 and supply millions of vaccine doses by the end of 2020. 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.
Interim Condensed Consolidated Statements of Financial Position
|As of March 31,||As of December 31,|
|Property, plant and equipment||96,290||93,044|
|Total non-current assets||€239,353||€237,496|
|Other financial assets||1,723||1,680|
|Income tax assets||980||756|
|Cash and cash equivalents||451,597||519,149|
|Total current assets||€492,855||€560,151|
|Equity and liabilities|
|Total non-current liabilities||€142,035||€166,013|
|Other financial liabilities||14,030||13,836|
|Total current liabilities||€142,043||€138,142|
|Total equity and liabilities||€732,208||€797,647|
Interim Condensed Consolidated Statements of Operations
|Three months ended|
|(in thousands, except per share data)||(unaudited)|
|Revenues from contracts with customers||€27,663||€26,154|
|Cost of sales||(5,842)||(3,205)|
|Research and development expenses||(65,122)||(57,241)|
|Sales and marketing expenses||(486)||(560)|
|General and administrative expenses||(15,815)||(9,276)|
|Other operating income||425||331|
|Other operating expenses||(100)||(38)|
|Interest expense related to lease liability||(415)||(425)|
|Loss before tax||€(53,378)||€(40,756)|
|Loss for the period||€(53,386)||€(40,762)|
|Equity holders of the parent||(53,386)||(40,646)|
|Earnings per share|
|Basic & diluted, loss per share for the period attributable to ordinary equity holders of the parent*||€(0.24)||€(0.20)|
|* Numbers of shares for calculating the earnings per share for the three months ended March 31, 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
|Three months ended|
|Loss for the period||€(53,386)||€(40,762)|
|Loss before tax||€(53,378)||€(40,756)|
|Adjustments to reconcile loss before tax to net cash flows:|
|Depreciation and amortization of property, plant, equipment and intangible assets||8,593||7,185|
|Share-based payment expense||8,150||13,496|
|Net foreign exchange differences||(268)||(9)|
|(Gain)/Loss on disposal of property, plant and equipment||62||8|
|Interest on lease liability||415||425|
|Working capital adjustments:|
|Decrease/(Increase) in trade receivable and contract assets||(2,059)||9,710|
|Decrease/(Increase) in inventories||2,231||(684)|
|(Decrease)/Increase in trade and other payables, contract liabilities and provisions||(17,768)||(20,161)|
|Income tax paid||(231)||(6)|
|Net cash flows used in operating activities||€(54,686)||€(31,217)|
|Purchase of property, plant and equipment||(6,295)||(6,300)|
|Proceeds from sale of property, plant and equipment||-||539|
|Purchase of intangibles assets||(2,122)||(27,407)|
|Acquisition of subsidiaries and businesses, net of cash acquired||(6,516)||-|
|Net cash flows used in investing activities||€(14,933)||€(33,168)|
|Proceeds from issuance of share capital, net of costs||-||9|
|Proceeds from loans and borrowings||2,899||1,565|
|Payments related to lease liabilities||(889)||(615)|
|Net cash flows from financing activities||€2,010||€959|
|Decrease in cash and cash equivalents||(67,609)||(63,426)|
|Change in cash resulting from exchange rate differences||57||9|
|Cash and cash equivalents at January 1||519,149||411,495|
|Cash and cash equivalents at March 31||€451,597||€348,078|
Sylke Maas, Ph.D.
VP Investor Relations & Business Strategy
Tel: +49 (0)6131 9084 1074
Senior Manager Global External Communications
Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385