Full Press Release Details
BioNTech Announces First Quarter 2020 Financial Results and Corporate Progress
Conference call and webcast scheduled for May 12, 2020 at 08:00 a.m. ET (2:00 p.m. CET)
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 our mRNA manufacturing, nor on our CAR-T manufacturing operations. BioNTech has implemented a plan to manage the evolving disruptions on our 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 as planned, 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
Corporate Development
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 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 c1nference 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.
("BioNTech" or "the Company")
Financial and Operational Results for the First Quarter Ended March 31, 2020
Key Pipeline Updates
Below is a summary of our clinical product candidates, organized by platform and indications.
FixVac. Our FixVac product candidates contain selected combinations of pharmacologically optimized uridine mRNA encoding known cancer-specific shared antigens. They feature our proprietary immunogenic mRNA backbone and proprietary RNA-lipoplex, or RNA-LPX, delivery formulation, designed to enhance stability and translation, target dendritic cells and trigger both innate and adaptive immune responses. FixVac is currently being evaluating in five clinical trials, including:
Individualized neoantigen specific immunotherapy (iNeST). Our iNeST immunotherapies contain unmodified, pharmacologically optimized mRNA encoding up to 20 patient-specific neoantigens and also feature our proprietary RNA-LPX formulation.
mRNA intratumoral immunotherapy. In collaboration with Sanofi, we are conducting a Phase 1 trial of SAR441000 (BNT131), our first mRNA-based intratumoral immunotherapy, as a monotherapy and in combination with cemiplimab in patients with solid tumors. SAR441000 (BNT131) consists of a modified mRNA that encodes the IL-12sc, IL-15sushi, GM-CSF and IFN-a cytokines. SAR441000 (BNT131) is designed to be administered directly into the tumor in order to alter the tumor microenvironment and enhance the immune system's ability to recognize and fight cancer within the tumor (proximal) as well as in other untreated locations (distal). We expect to report a data update in the second half of 2020.
CLDN6 CAR-T cell immunotherapy. We are developing a proprietary chimeric antigen receptor T cell, or CAR-T, product candidate, BNT211, targeting Claudin-6, or CLDN6, a novel solid tumor-specific antigen. We developed BNT211 utilizing our target discovery engine, and we plan to administer it along with a CARVac "primer" to boost the immune response and promote CAR-T cell persistence. We expect to initiate a Phase 1/2 clinical trial for BNT211 in patients with advanced CLDN6 + solid tumors in the second half of 2020.
Next-generation checkpoint immunomodulators. We are developing, in collaboration with Genmab, novel next-generation bispecific antibodies that are designed for conditional activation of immunostimulatory checkpoint molecules. Our first bispecific candidates are GEN1046 (BNT311), which targets PD-L1 in conjunction with 4-1BB, and GEN1042 (BNT312), which targets CD40 in conjunction with 4-1BB. While 4-1BB is a known immune checkpoint target that is expressed on T cells and natural killer, or NK, cells, prior attempts to target 4-1BB with monoclonal antibodies have been severely limited by liver toxicities. Our 4-1BB targeting product candidates are designed to avoid toxicities by conditionally activating a 4-1BB receptor only together with the binding of either PD-L1 or CD40. We have initiated Phase 1/2a trials of GEN1046 (BNT311) and GEN1042 (BNT312) in solid tumors. The expansion cohort has been initiated in the Phase 1/2 trial in multiple solid tumors for BNT311 (PD-L1x4-1BB). BioNTech expects to provide a data update, to include dose-escalation and potentially some limited expansion data from the trial in 2H 2020.
Targeted Cancer Antibodies. BNT321 is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), a novel epitope expressed specifically in pancreatic and other solid tumors. MVT-5873 (BNT321) is currently in Phase 1 clinical development in pancreatic cancer, which we resumed in December 2019 upon the enrollment of the first patient.
Small molecule immunomodulators. BNT411 is our novel small molecule TLR7 agonist product candidate. BNT411 is engineered for high potency and high selectivity for the TLR7 receptor to activate both the adaptive and innate immune system. BNT411 will be given as a monotherapy or in combination with chemotherapy and/or checkpoint inhibitors in multiple solid tumors, including colorectal cancer, bladder cancer and small cell lung cancer. We expect to initiate a Phase 1 clinical trial for BNT411 in solid tumors in the second half of 2020.
In addition, we have several other cancer immunotherapy programs in development, including:
Infectious Disease Immunotherapies
We have collaborated with third parties to exploit the immunotherapeutic properties of our mRNA drug class for the treatment and prevention of infectious diseases.
COVID-19 Vaccine Program
In response to the Coronavirus global pandemic, the company assembled a global consortium of partners including Pfizer (worldwide collaboration outside of China) and Fosun Pharma (China). 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.
Flu vaccine: In August 2018, we entered into a collaboration with Pfizer to develop mRNA-based immunotherapies for the prevention of influenza, product candidate BNT161. We expect to begin clinical testing in the first half of 2021
Infectious diseases: In October 2018, we entered into a research collaboration with Penn, under which we have the exclusive option to develop and commercialize mRNA immunotherapies for the treatment of up to 10 infectious disease indications. In August 2019, we entered into a letter agreement and investment agreement with the Bill & Melinda Gates Foundation to advance the development of immunotherapies for the prevention and/or treatment of HIV and tuberculosis and up to three additional infectious diseases.
Rare Disease Protein Replacement Therapies
We are collaborating with Genevant in order to capitalize on opportunities for our mRNA technology in rare disease indications potentially featuring expedited paths to market. We are combining our mRNA technology with Genevant's lipid nanoparticle, or LNP, delivery technology to create up to five mRNA protein replacement therapies for the treatment of rare diseases with high unmet medical needs. We expect our first compound to enter the clinic in the first half of 2021.
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.
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: 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, BNT141, BNT142, BNT151, BNT152/BNT153, 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.
For more information, please contact:
VP Investor Relations & Business Strategy
Tel: +49 (0)6131 9084 1074
E-mail: Investors@biontech.de
Senior Manager Global External Communications
Tel: +49 (0)6131 9084 1513 or +49 (0)151 1978 1385
E-mail: Media@biontech.de
Quarterly Report for the Three Months ended March 31, 2020
Index to the Quarterly Report for the Three Months ended March 31, 2020
Interim Condensed Consolidated Financial Statements
| Interim Condensed Consolidated Statements of Financial Position | 3 | |
| Interim Condensed Consolidated Statements of Operations | 4 | |
| Interim Condensed Consolidated Statements of Comprehensive Loss | 5 | |
| Interim Condensed Consolidated Statements of Changes in Stockholder's Equity | 6 | |
| Interim Condensed Consolidated Statements of Cash Flows | 7 | |
| Selected Explanatory Notes to the Interim Condensed Consolidated Financial Statements | 8 |
| 1 | Corporate Information | 8 | ||
| 2 | Basis of Preparation and Significant Accounting Policies | 8 | ||
| 3 | Segment Information | 10 | ||
| 4 | Revenue from Contracts with Customers | 11 | ||
| 5 | Business Combinations | 12 | ||
| 6 | Income Tax | 13 | ||
| 7 | Intangible Assets | 13 | ||
| 8 | Property, Plant and Equipment | 13 | ||
| 9 | Financial Assets and Financial Liabilities | 14 | ||
| 10 | Issued Capital and Reserves | 14 | ||
| 11 | Share-Based Payments | 15 | ||
| 12 | Related Party Disclosures | 18 | ||
| 13 | Events after the Reporting Period | 19 |
Operating and Financial Review and Prospects
| Operating Results | 21 | |
| Liquidity and Capital Resources | 31 |
Interim Condensed Consolidated Financial Statements
Interim Condensed Consolidated Statements of Financial Position
| As of March 31, | As of December 31, | |||
| (in thousands) | 2020 | 2019 | ||
| Assets | Note | (unaudited) | ||
| Non-current assets | ||||
| Intangible assets | 7 | 93,932 | 89,434 | |
| Property, plant and equipment | 8 | 96,290 | 93,044 | |
| Right-of-use assets | 49,131 | 55,018 | ||
| Total non-current assets | 239,353 | 237,496 | ||
| Current assets | ||||
| Inventories | 9,629 | 11,722 | ||
| Trade receivables | 9 | 10,310 | 11,913 | |
| Contract assets | 1,191 | - | ||
| Other financial assets | 9 | 1,723 | 1,680 | |
| Other assets | 9,263 | 9,069 | ||
| Income tax assets | 980 | 756 | ||
| Deferred expense | 8,162 | 5,862 | ||
| Cash and cash equivalents | 451,597 | 519,149 | ||
| Total current assets | 492,855 | 560,151 | ||
| Total assets | 732,208 | 797,647 | ||
| Equity and liabilities | ||||
| Equity | ||||
| Share capital | 10 | 232,304 | 232,304 | |
| Capital reserve | 10 | 686,714 | 686,714 | |
| Treasury shares | 10 | (5,525) | (5,525) | |
| Accumulated losses | (478,213) | (424,827) | ||
| Other reserves | 11 | 12,850 | 4,826 | |
| Total equity | 448,130 | 493,492 | ||
| Non-current liabilities | ||||
| Financial liabilities | 9 | 66,641 | 68,904 | |
| Other liabilities | 207 | - | ||
| Contract liabilities | 75,187 | 97,109 | ||
| Total non-current liabilities | 142,035 | 166,013 | ||
| Current liabilities | ||||
| Tax provisions | 150 | 150 | ||
| Provisions | 957 | 762 | ||
| Financial liabilities | 9 | 2,247 | 1,823 | |
| Trade payables | 9 | 19,417 | 20,498 | |
| Contract liabilities | 94,824 | 93,583 | ||
| Other financial liabilities | 9 | 14,030 | 13,836 | |
| Other liabilities | 10,418 | 7,490 | ||
| Total current liabilities | 142,043 | 138,142 | ||
| Total liabilities | 284,078 | 304,155 | ||
| Total equity and liabilities | 732,208 | 797,647 |
The accompanying notes form an integral part of these interim condensed consolidated financial statements.
Interim Condensed Consolidated Statements of Operations
| Three months ended March 31, | ||||
| 2020 | 2019 | |||
| (in thousands, except per share data) | Note | (unaudited) | ||
| Revenues from contracts with customers | 4 | 27,663 | 26,154 | |
| Cost of sales | (5,842) | (3,205) | ||
| Gross profit | 21,821 | 22,949 | ||
| 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) | ||
| Operating loss | (59,277) | (43,835) | ||
| Finance income | 6,417 | 3,578 | ||
| Finance expenses | (103) | (74) | ||
| Interest expense related to lease liability | (415) | (425) | ||
| Loss before tax | (53,378) | (40,756) | ||
| Income taxes | 6 | (8) | (6) | |
| Loss for the period | (53,386) | (40,762) | ||
| Attributable to: | ||||
| Equity holders of the parent | (53,386) | (40,646) | ||
| Non-controlling interests | - | (116) | ||
| (53,386) | (40,762) | |||
| Earnings per share | ||||
| in EUR | ||||
| 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. |
The accompanying notes form an integral part of these interim consolidated financial statements.
Interim Condensed Consolidated Statements of Comprehensive Loss
| Three months ended March 31, | ||||
| 2020 | 2019 | |||
| (in thousands) | Note | (unaudited) | ||
| Loss for the period | (53,386) | (40,762) | ||
| Other comprehensive income | ||||
| Other comprehensive income that may be reclassified to profit or loss in subsequent periods (net of tax) | ||||
| Exchange differences on translation of foreign operations | (126) | 4 | ||
| Net other comprehensive income that may be reclassified to profit or loss in subsequent periods | (126) | 4 | ||
| Other comprehensive income for the period, net of tax | (126) | 4 | ||
| Comprehensive loss for the period, net of tax | (53,512) | (40,758) | ||
| Attributable to: | ||||
| Equity holders of the parent | (53,512) | (40,642) | ||
| Non-controlling interests | - | (116) | ||
| Comprehensive loss for the period, net of tax | (53,512) | (40,758) |
The accompanying notes form an integral part of these interim condensed consolidated financial statements.
Interim Condensed Consolidated Statements of Changes in Stockholders' Equity
| Three months ended March 31, 2020 | |||||||||||
| Equity attributable to equity holders of the parent | |||||||||||
| (in thousands) | Note | Share capital | Capital reserve | Treasury shares | Accumulated losses | Other reserves | Foreign currency translation reserve | Total | Non-controlling interest | Total equity | |
| As of January 1, 2020 | 232,304 | 686,714 | (5,525) | (424,827) | 4,762 | 64 | 493,492 | - | 493,492 | ||
| Loss for the period | - | - | - | (53,386) | - | - | (53,386) | - | (53,386) | ||
| Other comprehensive income | - | - | - | - | - | (126) | (126) | - | (126) | ||
| Total comprehensive income | - | - | - | (53,386) | - | (126) | (53,512) | - | (53,512) | ||
| - | |||||||||||
| Share-based payments | 11 | - | - | - | - | 8,150 | - | 8,150 | - | 8,150 | |
| As of March 31, 2020 | 232,304 | 686,714 | (5,525) | (478,213) | 12,912 | (62) | 448,130 | - | 448,130 | ||
| (unaudited) |
| Three months ended March 31, 2019 | |||||||||||
| Attributable to the equity holders of the parent | |||||||||||
| (in thousands) | Note | Share capital* | Capital reserve* | Treasury shares* | Accumulated losses | Other reserves | Foreign currency translation reserve | Total | Non-controlling interest | Total equity | |
| As of January 1, 2019 | 193,296 | 344,115 | - | (245,771) | (25,474) | (13) | 266,153 | 847 | 267,000 | ||
| Loss for the period | - | - | - | (40,646) | - | - | (40,646) | (116) | (40,762) | ||
| Other comprehensive income | - | - | - | - | - | 4 | 4 | - | 4 | ||
| Total comprehensive income | - | - | - | (40,646) | - | 4 | (40,642) | (116) | (40,758) | ||
| Issuance of share capital | 10 | 5,088 | (5,079) | - | - | - | - | 9 | - | 9 | |
| Share based payments | 11 | - | - | - | - | 13,496 | - | 13,496 | - | 13,496 | |
| As of March 31, 2019 | 198,384 | 339,036 | - | (286,417) | (11,978) | (9) | 239,016 | 731 | 239,747 | ||
| (unaudited) | |||||||||||
| * Numbers have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019. |
The accompanying notes form an integral part of these interim condensed consolidated financial statements.
Interim Condensed Consolidated Statements of Cash Flows
| Three months ended March 31, | |||
| 2020 | 2019 | ||
| (in thousands) | (unaudited) | ||
| Operating activities | |||
| Loss for the period | (53,386) | (40,762) | |
| Income taxes | 8 | 6 | |
| 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 | |
| Finance income | (388) | (344) | |
| Interest on lease liability | 415 | 425 | |
| Finance expense | 103 | 74 | |
| 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) | |
| Interest received | 323 | 344 | |
| Interest paid | (471) | (499) | |
| Income tax paid | (231) | (6) | |
| Net cash flows used in operating activities | (54,686) | (31,217) | |
| Investing activities | |||
| 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) | |
| Financing activities | |||
| 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 |
The accompanying notes form an integral part of these interim condensed consolidated financial statements.
Selected Explanatory Notes to the Interim Condensed Consolidated Financial Statements
BioNTech SE is a limited company incorporated and domiciled in Germany. American Depository Shares (ADS) representing BioNTech's shares are publicly traded on Nasdaq Global Select Market since October 10, 2019. The registered office is located in Mainz, An der Goldgrube 12, 55131 Germany. The accompanying International Financial Reporting Standards, or IFRS, unaudited interim condensed consolidated financial statements present the financial position and the results of operation of BioNTech SE and its subsidiaries, hereinafter also referred to as "BioNTech" or the "Group" and have been prepared on a going concern basis in accordance with the IFRS as issued by the International Accounting Standards Board, or IASB.
The Group is principally engaged in developing innovative immunotherapies for the individualized treatment of cancer and other infectious diseases.
During the three months ended March 31, 2020, a change to the Group structure occurred: A new entity was founded in the United States: BioNTech US, Inc., Cambridge/Massachusetts (previously Endor Lights Inc., New York), United States, a wholly owned subsidiary of BioNTech SE. All entities are included in the Group's unaudited interim condensed consolidated financial statements.
The unaudited interim condensed consolidated financial statements of the Group as of and for the three months ended March 31, 2020 were authorized for issuance in accordance with a resolution of the directors on May 11, 2020.
Basis of Preparation
These unaudited interim condensed consolidated financial statements as of and for the three months ended March 31, 2020 have been prepared in accordance with IAS 34 Interim Financial Reporting.
The unaudited interim condensed consolidated financial statements do not include all the information and disclosures required in the consolidated financial statements, and should be read in conjunction with the Group's consolidated financial statements as of and for the year ended December 31, 2019.
BioNTech prepares and presents its unaudited interim condensed consolidated financial statements in Euros. Unless otherwise stated, the numbers are rounded to thousands of Euros. Accordingly, numerical figures shown as totals in some tables may not be exact arithmetic aggregations of the figures that preceded them.
Significant Accounting Policies
The accounting policies adopted in the preparation of the unaudited interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group's consolidated financial statements for the year ended December 31, 2019. The standards applied for the first time as of January 1, 2020, as disclosed in the notes to the consolidated financial statements as of December 31, 2019, had no impact on the unaudited interim condensed consolidated financial statements of the Group as of March 31, 2020.
In early March 2020 BioNTech announced details of its efforts to develop a potential vaccine to induce immunity for and prevent COVID-19 infection. BioNTech's product candidate, BNT162, is a potential
first-in-class mRNA vaccine in the worldwide effort against COVID-19. As part of the program, BioNTech announced two strategic collaborations with large pharmaceutical companies to globally develop BioNTech's vaccine candidates and supply an approved vaccine globally. BioNTech and Pfizer Inc. ("Pfizer"; NYSE: PFE) aim to accelerate the development of BNT162, building on the existing research and development partnership between Pfizer and BioNTech, signed in 2018, under which the companies have been working together to develop mRNA-based vaccines for the prevention of influenza. The companies expect to utilize multiple research and development sites from both companies to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. BioNTech also announced a strategic alliance with Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Symbol: 600196.SH, 02196.HK) to develop its COVID-19 vaccine candidates in China. Under the terms of the agreement, the two companies will work together on the development of BNT162 in China, conducting clinical trials in China and leveraging Fosun Pharma's extensive clinical development, regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialize the vaccine in China. Under the terms of the agreement, Fosun Pharma has agreed to make an equity investment of $50 million ( 46 million) for 1,580,777 ordinary shares in BioNTech, subject to execution of share subscription documentation and approval from regulatory authorities in China. The capital increase became effective after March 31, 2020.
In addition to its development efforts, as the global COVID-19 pandemic continues to evolve, BioNTech has continuously monitored the situation in regards to its operations and has put significant measures in place to protect supply chain, operations, employees and the execution of clinical trials. BioNTech 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 clinical pro-grams, and 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 as planned, manage ongoing Phase 1 trials to support timely completion and optimize ability to initiate and conduct FIH studies. The extent to which the COVID-19 pandemic impacts BioNTech's operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others. All factors were evaluated and considered carefully when preparing these unaudited interim condensed consolidated financial statements. BioNTech will continue to evaluate potential effects and will provide updates as appropriate.