bntx-6k_20200512.DOCX.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

FOR THE MONTH OF MAY 2020

COMMISSION FILE NUMBER 001-39081

BioNTech SE
(Translation of registrant’s name into English)

An der Goldgrube 12

D-55131 Mainz

Germany

+49 6131-9084-0
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F Form 40‑F

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7):



DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K

 

On May 12, 2020, BioNTech SE (the “Company”) issued a press release providing a development update and reporting its financial results for the three months ended March 31, 2020. Attached hereto as Exhibit 99.1 are the press release, the interim condensed consolidated financial statements as well as the operating and financial review and prospects of the Company, for the three months ended March 31, 2020.



SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

BioNTech SE

 

 

 

 

 

 

 

By:

/s/ Dr. Sierk Poetting

 

 

Name: Dr. Sierk Poetting

 

 

Title:   Chief Financial Officer

Date: May 12, 2020



EXHIBIT INDEX

 

 

Exhibit

Description of Exhibit

 

 

99.1

First Quarter 2020 Financial Results Press Release dated May 12, 2020 and Quarterly Report for the Three Months Ended March 31, 2020

 

 

 

 

 

bntx-ex991_6.htm

Exhibit 99.1

 

 

BioNTech Announces First Quarter 2020 Financial Results and Corporate Progress

 

 

Global Phase 1/2 clinical trial for BNT162 vaccine program to prevent COVID-19 infection in dose escalation phase in Europe and the U.S.; first cohorts dosed in both regions

 

BNT122 Phase 1/2 trial update expected at AACR Virtual Annual Meeting II in June

 

Ended 1Q 2020 with cash equivalents of $495 million (€452 million) with additional $236 million (€217 million) in equity investments and non-dilutive upfront payments due in 2Q 2020 from Pfizer and Fosun Pharma

 

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.

 

Infectious disease

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.

 

BNT162 (Europe) - BioNTech’s Phase 1/2 clinical trial, the first of a COVID-19 vaccine candidate in Europe, has dosed the first cohort of patients. Twelve study participants were dosed with the first BNT162 vaccine candidate as of April 29th. The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg, aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine. Three vaccine candidates that utilize uRNA or modRNA will be administered as two injections. The fourth vaccine candidate, which contains saRNA, will be evaluated after a single dose of vaccine. Subjects with a higher risk of severe COVID-19 disease will be included in the second part of the study. First clinical data from the trial is expected end of June or in July 2020.  

 

BNT162 (U.S) – The first cohort has been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of the four mRNA vaccine candidates. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age) and will be seamlessly followed by administering the selected vaccine candidate to several thousands of subjects. The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age.

 

BioNTech will provide clinical supply of the BNT162 vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. BioNTech believes it has the potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021.

 

 

2

 


 

 

Oncology

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.

 

FixVac

 

BNT111 – Data from a Phase 1 trial in advanced melanoma remains on track for publication in late 1H 2020. BioNTech expects to initiate a Phase 2 trial in advanced melanoma with registrational potential for BNT111 in 2H 2020.

 

BNT 113 – Initiation of a Phase 2 trial in HPV+ head and neck cancer with registrational potential is on track for 2H 2020.

 

BNT114 – Data update from a Phase 1 trial in triple negative breast cancer (TNBC) is expected in 2H 2020.

Individualized neoantigen specific immunotherapy (iNeST)

 

BNT122 – BioNTech expects the data update presentation for the Phase 1 trial in multiple solid tumors to be disclosed in June 2020 as part of the American Association for Cancer Research (AACR) Virtual Annual Meeting II. Safety, immunogenicity and tumor response data will be included. BioNTech expects to provide an enrollment update1 from the Phase 2 trial (IMCODE-001) in first line melanoma in 2H 2020 with an interim data update anticipated in 2021. BNT122 is partnered with Genentech.

 

BNT122 – Two Phase 2 clinical trials are expected to be initiated in the adjuvant setting in 2H 2020. The first adjuvant Phase 2 study will evaluate the efficacy and safety of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with Stage 2-3 non-small cell lung cancer (NSCLC) who are circulating tumor DNA (ctDNA) positive following surgical resection and have received standard-of-care adjuvant platinum-doublet chemotherapy.

mRNA intratumoral immunotherapy

 

BNT131 – Data update from Phase 1/2 trial in solid tumors remains on track for 2H 2020.  BNT131 is partnered with Sanofi.

CAR-T cell immunotherapy

 

BNT211 – Initiation of a Phase 1/2a trial in multiple solid tumors (CLDN6) is now expected in 2H 2020.

Next-generation checkpoint immunomodulators

 

BNT311 – 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. BNT311 is partnered with Genmab.

 


 

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.

3

 


 

 

Toll-Like Receptor Binding

 

BNT411 – A Phase 1/2a clinical trial of BNT411 is still expected to be initiated in multiple solid tumors in 2H 2020.

 

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.

Financial Guidance:

 

On track with previous guidance of approximately €300 million net cash to be used for operating activities and investments into property, plant and equipment in 2020 base business plan (prior to impact of Neon acquisition and BNT162 program).

 

Majority of BioNTech development costs for our BNT162 program in 2020 will be funded via Pfizer and Fosun Pharma cost sharing, equity investments and upfront payments.

 

Also anticipate additional funding to support the manufacturing scale-up for our BNT162 program in 2020.

Interim quarterly financial statements can be found in the 6-K filing as published on the SEC website under www.sec.gov.

 

4

 


 

 

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.

 

 

 


5

 


 

 

BioNTech SE

(“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.

 

Oncology

 

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:

 

BNT111 in a Phase 1 trial in advanced melanoma with a data update expected via publication in a medical journal late in the first half of 2020. We expect to initiate a Phase 2 trial with registrational potential for BNT111 in metastatic melanoma in the second half of 2020.

 

BNT112 in a Phase 1/2 trial in prostate cancer.

 

BNT113 in a Phase 1 trial in HPV+ head and neck cancers. We are planning to initiate a Phase 2 trial with registrational potential for BNT113 in HPV+ head and neck cancers in the second half of 2020.

 

BNT114 in a Phase 1 trial in triple negative breast cancer.  A data updated from the trail is expected in the second half of 2020.

 

BNT115 in a Phase 1 trial in ovarian cancer.

 

BNT116 is also in preclinical development for non-small cell lung cancer.

 

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.

 

We, in collaboration with Genentech, initiated a randomized iNeST Phase 2 trial in first-line metastatic melanoma in combination with pembrolizumab. We and Genentech expect to report a data update from our RO7198457 (BNT122) Phase 1 trial in multiple solid tumors in June 2020, and topline data update from our RO7198457 (BNT122) Phase 2 trial in first-line melanoma in the second half of 2020. We expect this topline 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 2021.

 

We and Genentech plan to initiate two additional clinical trials for RO7198457 (BNT122) in the second half of 2020 in first-line solid cancers in the adjuvant setting, one in combination with atezolizumab and the other as a monotherapy.

6

 


 

 

 

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.

 

7

 


 

 

In addition, we have several other cancer immunotherapy programs in development, including:

 

RiboMabs: novel classes of mRNA-based therapeutics that are designed to encode antibodies directly in the patient’s body. We expect to initiate Phase 1 clinical trials for our first two RiboMab product candidates, BNT141 and BNT142, both in the first half of 2021.

 

RiboCytokines: novel classes of mRNA-based therapeutics that are designed to encode cytokines directly in the patient’s body. We expect to initiate Phase 1 clinical trials for our first RiboCytokine product candidates, BNT151 and BNT152/BNT153 (combination), in the first half of 2021.

 

TCR therapy: T cells with engineered TCRs that are designed to specifically target cancer cells.

 

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.

 

BNT162 (Europe) - The first cohort of our Phase 1/2 clinical trial in Europe has been dosed. Twelve study participants were dosed with vaccine candidate BNT162 as of April 29th. The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg, aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine. The three vaccine candidates that utilize uRNA or modRNA wil be administered as two injections. The fourth vaccine candidate, which contains saRNA, will be evaluated after a single dose of vaccine. Subjects with a higher risk of severe COVID-19 disease will be included in the second part of the study. First clinical data from the trial is expected end of June or in July 2020.  

8

 


 

 

 

BNT162 (U.S) - The first cohort has been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of the four mRNA vaccine candidates. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age) and will be seamlessly followed by administering the selected vaccine candidate to several thousands of subjects. The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age.

 

We will provide clinical supply of the BNT162 vaccine from our GMP-certified mRNA manufacturing facilities in Europe. We and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. We believe we have the potential to supply millions of vaccine doses by the end of 2020 subject to technical success of the development program and approval by regulatory authorities, and then rapidly scale up capacity to produce hundreds of millions of doses in 2021.

 

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.

 

9

 


 

 

About BioNTech

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.

 

10

 


 

 

For more information, please contact:

 

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

 

11

 


 

 

 

 

 

 

BioNTech SE

Quarterly Report for the Three Months ended March 31, 2020

 

 

 

1

 


 

BioNTech SE

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

 

 

 

 

 

 

 

 

2

 


 

 

 

 

 

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.

3


 

 

 

 

 

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.

4


 

 

 

 

 

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.


 

5


 

 

 

 

 

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.

 

6


 

 

 

 

 

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.

7


 

 

 

 

 

Selected Explanatory Notes to the Interim Condensed Consolidated Financial Statements

1

Corporate Information

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.

2

Basis of Preparation and Significant Accounting Policies

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.

Impact of COVID-19

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

8


 

 

 

 

 

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.

9


 

 

 

 

 

3

Segment Information

For the three months ended March 31, 2020 and 2019, respectively, the following tables present revenue and operating results for the Group’s operating segments consistent with the presentation in the notes to the consolidated financial statements as of December 31, 2019:

 

 

 

Business Unit Biotech

Business Unit External Services

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product Sales &

External Services

Total

Adjustments

Group

Three months ended March 31, 2020

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€6,809

€1,946

€12,406

-

-

€21,161

-

€21,161

Revenues from other sales transactions

 

103

157

-

-

6,242

6,502

-

6,502

Cost of sales

 

-

-

-

-

(5,655)

(5,655)

(187)

(5,842)

Gross profit

 

€6,912

€2,103

€12,406

-

€587

€22,008

€(187)

€21,821

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(21,333)

(26,799)

(15,829)

(1,187)

(161)

(65,309)

187

(65,122)

Sales and marketing expenses

 

-

-

-

(164)

(322)

(486)

-

(486)

General and administrative expenses

 

-

-

(1,158)

(14,018)

(638)

(15,814)

(1)

(15,815)

Other result

 

(13)

55

12

246

25

325

-

325

Segment operating loss

 

€(14,434)

€(24,641)

€(4,569)

€(15,123)

€(509)

€(59,276)

€(1)

€(59,277)

 

 

Business Unit Biotech

Business Unit External Services

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product Sales &

External Services

Total

Adjustments

Group

Three months ended March 31, 2019

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€9,290

-

€12,608

-

-

€21,898

-

€21,898

Revenues from other sales transactions

 

-

140

-

-

4,116

4,256

-

4,256

Cost of sales

 

-

-

-

-

(3,102)

(3,102)

(103)

(3,205)

Gross profit

 

€9,290

€140

€12,608

-

€1,014

€23,052

€(103)

€22,949

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(24,327)

(18,401)

(13,922)

(610)

(85)

(57,345)

104

(57,241)

Sales and marketing expenses

 

-

-

-

(286)

(274)

(560)

-

(560)

General and administrative expenses

 

-

-

(741)

(7,836)

(699)

(9,276)

-

(9,276)

Other result

 

109

142

6

50

(11)

296

(3)

293

Segment operating loss

 

€(14,928)

€(18,119)

€(2,049)

€(8,682)

€(55)

€(43,833)

€(2)

€(43,835)

The segments are managed based on external sales and operating profit/loss, which represents the operating profit/loss incurred within each segment. Segment figures are reported consolidated, which reflects the way management steers the business.

BioNTech’s internal reporting is generally in accordance with IFRS and in line with the Group’s accounting policies, except for minor deviations in classification between cost of sales and research and development cost. Whenever revenues are attributable to different segments, these revenues are split based on the cost incurred. Internal overhead costs are allocated to segments based on revenues when

10


 

 

 

 

 

they are directly attributable to a service rendered. Sales and marketing expenses, general and administrative expenses and the other result that are not directly attributable to one of the segments are allocated to Business Service.

In order to reconcile the segment figures to the Group unaudited interim condensed consolidated financial statements, some of the research and development expenses are reclassified to cost of sales.

Revenue at BioNTech is differentiated between revenues resulting from collaboration and license agreements and revenues from other sales. The Company collaborates with pharmaceutical and healthcare companies and several global academic collaborators. During the three months ended March 31, 2020, the revenue generated from the Genentech and Pfizer collaboration agreements each represented more than 10% of BioNTech’s overall revenue resulting from collaboration and license agreements. The revenues were partly recorded in the Clinical as well as Manufacturing segment. During the three months ended March 31, 2019, the revenue generated from the Genentech, Pfizer and Sanofi collaboration agreements each represented more than 10% of BioNTech’s overall revenue resulting from collaboration and license agreements. The revenues were partly recorded in the Clinical as well as Manufacturing segment. The total amounts of revenues generated with these customers in the periods presented are disclosed in Note 4.

Revenues from other sales result from the sale of medical products (e.g., peptides and retroviral vectors) for clinical supply. Research and development activities are managed on a worldwide basis but the operative manufacturing facilities and sales offices are located and managed in Germany. External sales originate in Germany.

4

Revenue from Contracts with Customers

Disaggregated revenue information

Set out below is the disaggregation of the Group’s revenue from contracts with customers:

 

 

 

Three months ended

March 31,

(in thousands)

 

2020

2019

Revenues resulting from collaboration and license agreements

 

€21,161

€21,898

Genentech Inc.

 

15,628

16,131

Pfizer Inc.

 

3,587

3,587

Sanofi S.A.

 

1,502

2,180

Fosun Pharmaceutical (Group) Co., Ltd.

 

444

-

Revenues from other sales transactions

 

6,502

4,256

Total

 

€27,663

€26,154

 

During the three months ended March 31, 2020, revenues from our new collaboration agreement with Fosun Pharma were recognized for the first time. BioNTech and Fosun Pharma work together on the development of BNT162, a potential first-in-class mRNA vaccine in the worldwide effort against COVID-19, in China.

The transactions resulting from product sales that are included within the revenue from other sales transactions are displayed below:

 

 

Three months ended

March 31,

(in thousands)

 

2020

2019

Product sales of JPT Peptide Technologies GmbH

 

€3,153

€2,826

11


 

 

 

 

 

5

Business Combinations

Lipocalyx GmbH

In December 2019, BioNTech Delivery Technologies GmbH (previously BioNTech Protein Therapeutics GmbH; “BioNTech Delivery Technologies”), a wholly owned subsidiary of BioNTech SE, entered into an agreement to acquire all assets, employees and proprietary know-how of Lipocalyx GmbH (“Lipocalyx”) in exchange for a total consideration of cash at an amount of k€6,516 and additional contingent consideration provisionally estimated at an amount of k€572. The employees of Lipocalyx were transferred automatically to BioNTech Delivery Technologies with effect as of the closing date. The acquisition closed on January 6, 2020.

The group has acquired Lipocalyx to combine the acquired technologies and the related know-how with already existing product candidates of the group to improve their functionality and performance.

The final fair values of the identifiable net assets of Lipocalyx as at the date of acquisition were:

 

 

Fair value

recognized on

acquisition

(in thousands)

Lipocalyx GmbH

Assets

 

Goodwill

€896

Other intangible assets

5,978

Property, plant and equipment

75

Inventories

139

Total identifiable net assets at fair value

€7,088

 

 

Consideration

 

Cash paid

€6,516

Contingent consideration liability

572

Total consideration

€7,088

 

 

Cash flow

on acquisition

(in thousands)

Lipocalyx GmbH

Transaction costs (included in cash flows used in operating activities)

€17

Cash paid (included in cash flow used in investing activities)

6,516

Net cash flow on acquisition

€(6,533)

 

The interim condensed consolidated statement of operations includes the result of Lipocalyx since the acquisition date. From the date of acquisition, Lipocalyx contributed k€191 to loss before tax in the Technology Platform business segment of the Group. From the date of acquisition, Lipocalyx generated k€136 in revenues. Given the timing of closing, the contribution to loss before tax and revenues, if the transaction would have occurred at the beginning of the reporting period, would not differ materially. Goodwill recognized is primarily attributed to the expected synergies and other benefits from combining the assets and activities of Lipocalyx with those of the Group. The goodwill recognized for tax purposes is deductible over a period of 15 years. The goodwill resulting from the Lipocalyx acquisition during the three months ended March 31, 2020 was allocated to the Technology Platform segment.

Transaction costs of k€17 relating to the acquisition have been expensed and are included in the general and administrative expenses within the interim condensed consolidated statement of operations and are included in cash flows used in operating activities in the interim condensed consolidated statement of cash flows.

12


 

 

 

 

 

The purchase agreement with Lipocalyx includes the following contingent cash considerations to the previous owners:

 

k€1,000 upon successful completion of a Phase I Clinical Trial designed to show and establish a sufficient safety margin justifying further development of only the first pharmaceutical product relating to acquired technologies formulated in a manner covered by a valid granted claim in a major country of a patent within the assigned IP Rights; and

 

k€1,000 upon successful completion of the first Phase II Clinical Trial of only the first pharmaceutical product relating to acquired technologies formulated in a manner covered by a valid granted claim in a major country of a patent within the assigned IP Rights.

At the acquisition date, the fair value of the contingent consideration was estimated to be k€572. The contingent consideration is presented in ‘non-current financial liabilities’ in the statement of financial position.

6

Income Tax

The Group calculates the interim income tax expense using the tax rate that would be applicable to the expected total annual earnings. Deferred tax assets on tax losses have not been capitalized as there is not sufficient probability in terms of IAS 12 that there will be future taxable profits available against which the unused tax losses can be utilized. The accumulated tax losses relate to Germany and the United States. There is no expiration date for any of the accumulated tax losses under German or US tax law.

7

Intangible Assets

During the three months ended March 31, 2020, the Group acquired intangible assets with a cost of k€2,122 (three months ended March 31, 2019: k€8,193), excluding intangible assets acquired through business combinations (see Note 5). The acquisitions during the three months ended March 31, 2020 were mainly related to advance payments (k€1,394) as well as concessions, licenses and similar rights (k€728). During the three months ended March 31, 2019 the acquisitions were mainly related to advance payments (k€5,930) as well as concessions, licenses and similar rights (k€2,263).

8

Property, Plant and Equipment

During the three months ended March 31, 2020, the Group acquired property, plant and equipment with a cost of k€6,295 (three months ended March 31, 2019: k€6,300). The acquisitions during the three months ended March 31, 2020 were related to construction in progress and advanced payments (k€4,275), equipment, tools and installations (k€1,932) as well as land and buildings (k€88). During the three months ended March 31, 2019, the acquisitions were related to equipment, tools and installations (k€3,049), construction in progress and advance payments (k€2,850) as well as land and buildings (k€401).

13


 

 

 

 

 

9

Financial Assets and Financial Liabilities

Set out below, is an overview of financial assets, other than cash and cash equivalents, held by the Group as of March 31, 2020 and December 31, 2019:

 

Financial assets at amortized cost

(in thousands)

 

March 31,

2020

December 31,

2019

Trade receivables

 

€10,310

€11,913

Other financial assets and receivables

 

1,723

1,680

Total

 

€12,033

€13,593

Total current

 

12,033

13,593

Total non-current

 

-

-

Set out below, is an overview of financial liabilities held by the Group as of March 31, 2020 and December 31, 2019:

 

Financial liabilities: Financial liabilities at amortized cost (including interest-bearing loans and borrowings)

(in thousands)

Maturity

March 31,

2020

December 31,

2019

Trade payables

 

€19,417

€20,498

Lease liabilities

 

51,784

57,614

2.15% € 10,000,000 secured bank loan

12/30/2027

10,050

9,000

2.08% € 9,450,000 secured bank loan

09/30/2028

9,498

7,600

Other financial liabilities

 

11,587

10,349

Total

 

€102,335

€105,061

Total current

 

35,694

36,157

Total non-current

 

66,641

68,904

 

Risk management activities

No changes have occurred regarding the Group’s risk management activities as disclosed in the notes to the consolidated financial statements as of December 31, 2019.

Fair values

Fair values of cash and cash equivalents, trade receivables, trade payables, and other current liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.

The liabilities include two fixed-interest rate loans. The fair value of the two fixed-interest rate loans is calculated based on significant observable inputs (Level 2). As of March 31, 2020 and December 31, 2019, the carrying value approximates their fair values as there have been no significant changes in relevant interest rates since inception of the respective loans.

10

Issued Capital and Reserves

On September 18, 2019, BioNTech effected a 1:18 share split by issuing 206,595,492 shares by way of a capital increase from its own funds; thus, no outside proceeds were received. This capital increase came into effect upon registration with the commercial register (Handelsregister). The accompanying unaudited interim condensed consolidated financial statements and notes to the unaudited interim condensed consolidated financial statements give retroactive effect to the share split for all periods presented.

14


 

 

 

 

 

During the three months ended March 31, 2020, there were no transactions which had an effect on share capital. Each share has a nominal value of EUR 1.00.

During the three months ended March 31, 2019, BioNTech issued 5,088,204 shares and increased its share capital by k€5,088. The cash investment of k€80,006 was received in 2018 (k€79,997). As a result of the share split and the financing transaction, the capital reserve decreased during the three months ended March 31, 2019, by k€5,079.

11

Share-Based Payments

Management Board Grant (Cash-Settled)

From the beginning of 2020, the first year following the completion of BioNTech’s initial public offering (IPO), the current service agreements with BioNTech’s Management Board provide for a short-term incentive compensation of up to a maximum of 50% of the annual base salary for the years 2020, 2021 and 2022. The amount of such short-term incentive compensation will depend on the achievement of certain company goals in the particular fiscal year, which goals will be set uniformly for all members of the Management Board. 50% of the incentive compensation will be paid promptly upon achievement of the applicable company goals (first installment), with the remaining amount payable one year later, subject to adjustment relative to BioNTech’s share price performance during that year (second installment).

For each of the three yearly awards, the second installment of the short-term incentive compensation that is dependent on BioNTech’s share price, represents a cash-settled share-based payment arrangement. The fair values of the liabilities are recognized over the award’s vesting period beginning as of the service commencement date (January 1, 2020) until each separate determination date and are remeasured until settlement date.

During the three months ended March 31, 2020 the Group recognized share-based payment expenses of k€83 as research & development expenses and of k€124 as general & administrative expenses in the interim condensed consolidated statement of operations (three months ended March 31, 2019: Nil).

Management Board Grant (Equity-Settled)

From the beginning of the year 2020, the first year following the completion of BioNTech’s initial public offering (IPO), until the end of the term of the Management Board Member’s employment agreement, the service agreements of BioNTech’s Management Board provide for a long-term incentive compensation in terms of a yearly grant of options to purchase BioNTech shares. The right to receive options in 2020, 2021 and 2022 represents an equity-settled share-based payment arrangement.

The options allocated each year will be subject to the terms, conditions, definitions and provisions of the Employee Stock Ownership Plan (ESOP) and the applicable option agreement thereunder. The number of options to be allocated each year to Prof. Ugur Sahin, Sean Marett, Dr. Sierk Poetting, Dr. Özlem Türeci and Ryan Richardson is to be calculated based on a value of €750,000, €300,000, €300,000, €300,000 and €260,000, respectively, in each case divided by the amount by which a certain target share price exceeds the exercise price. For Ryan Richardson the amount to calculate the number of options increases to €280,000 for the year 2022.

The allocation of the number of options to be received in 2020 was done on February 13, 2020 (allocation date). The allocations of the number of options to be received in 2021 and 2022 are estimated to take place on the 1st and 2nd anniversary of the Allocation date (estimated allocation dates).

15


 

 

 

 

 

The share options allocated and expected to be allocated to BioNTech’s Management Board as of the dates indicated are presented in the tables below.

 

Allocation date February 13, 2020

 

Share options

outstanding

Weighted-average exercise price (€)

Prof. Ugur Sahin, M.D.

 

97,420

€28.32

Sean Marett

 

38,968

€28.32

Dr. Sierk Poetting

 

38,968

€28.32

Dr. Özlem Türeci

 

38,968

€28.32

Ryan Richardson

 

33,772

€28.32

 

Estimated allocation date February 13, 2021

 

Share options expected to be allocated

Weighted-average exercise price (€)

Prof. Ugur Sahin, M.D.

 

49,804

€53.78*

Sean Marett

 

19,921

€53.78*

Dr. Sierk Poetting

 

19,921

€53.78*

Dr. Özlem Türeci

 

19,921

€53.78*

Ryan Richardson

 

17,265

€53.78*

* Valuation parameter derived from the Monte-Carlo simulation model

 

Estimated allocation date February 13, 2022

 

Share options expected to be allocated

Weighted-average exercise price (€)

Prof. Ugur Sahin, M.D.

 

49,443

€54.17*

Sean Marett

 

19,777

€54.17*

Dr. Sierk Poetting

 

19,777

€54.17*

Dr. Özlem Türeci

 

19,777

€54.17*

Ryan Richardson

 

18,459

€54.17*

* Valuation parameter derived from the Monte-Carlo simulation model

For the awards with estimated allocation dates, the numbers of awards expected to be allocated have been calculated using the valuation parameter derived from the Monte-Carlo simulation model. Unless the actual allocation has occurred, these numbers will be considered with a true-up to the number ultimately satisfied. The options will vest annually in equal installments over four years commencing on the first anniversary of the allocation date and will be exercisable four years after the allocation date.

The options will be subject to the terms, conditions, definitions and provisions of the Employee Stock Ownership Plan (ESOP) and the applicable option agreement thereunder. The vested options can only be exercised if and to the extent that each of the following performance criteria has been achieved: (i) at the time of exercise, the current price is equal to or greater than the threshold amount (that is, the exercise price, provided that such amount increases by seven percentage points on each anniversary of the allocation date); (ii) at the time of exercise, the current price is at least equal to the target price (that is, (a) for the twelve-month period starting on the fourth anniversary of the allocation date, $8.5 billion divided by the total number of the shares outstanding immediately following the initial public offering (other than shares owned by BioNTech), and (b) for each twelve-month period starting on the fifth or subsequent anniversary of the allocation date, 107% of the target share price applicable for the prior twelve-month period); and (iii) the closing price for the fifth trading day prior to the start of the relevant exercise window is higher than the exercise price by at least the same percentage by which the Nasdaq Biotechnology Index or a comparable successor index as of such time is higher than such index was as of the last trading day before the allocation date. The options can be exercised at the latest ten years after the allocation date. If they have not been exercised by that date, they will lapse without compensation.

A Monte-Carlo simulation model has been used to measure the fair values at the (estimated) allocation dates of the Management Board Grant. This model incorporates the impact of the performance criteria

16


 

 

 

 

 

regarding share price and index development described above. The parameters used for measuring the fair values as of the respective (estimated) allocation dates were as follows:

 

 

Allocation date February 13, 2020

Estimated allocation date February 13, 2021

Estimated allocation date February 13, 2022

Weighted average fair value*

 

€10.83

€20.06

€22.21

Weighted average share price

 

€28.20

€53.30*

€53.30*

Exercise price

 

€28.32

€53.78*

€54.17*

Expected volatility (%)

 

36.6%

36.9%

39.9%

Expected life (years)*

 

4.75

5.68

6.76

Risk-free interest rate (%)

 

1.61 %

0.68%

0.68%

* Valuation parameter derived from the Monte-Carlo simulation model

The exercise of the option rights in accordance with the terms of the ESOP gives the Management Board members the right to obtain shares against payment of the exercise price. The options’ per share exercise price is the Euro translation of the arithmetic mean of the closing prices of the ten last trading days prior to the allocation date. For the award allocated as of February 13, 2020 the exercise price has been determined at $30.78 (€28.32). The exercise prices for the awards with estimated allocation dates as of February 13, 2021 and February 13, 2022 have been derived from the Monte-Carlo simulation model. Expected volatility was based on an evaluation of the historical volatilities of comparable companies over the historical period commensurate with the expected option term. The expected term was based on general optionholder behavior for employee options.

The share options allocated and expected to be allocated under the Management Board Grant were as follows:

 

 

Share options (expected to be allocated)

Weighted-average exercise price (€)

As of January 1, 2020

 

-

-

Granted as of allocation date February 13, 2020

 

248,096

€28.32

Expected to be allocated as of estimated allocation date February 13, 2021

 

126,832

€53.78*

Expected to be allocated as of estimated allocation date February 13, 2022

 

127,233

€54.17*

As of March 31, 2020

 

502,161

€41.30

* Valuation parameter derived from the Monte-Carlo simulation model

As of March 31, 2020, the share options allocated and expected to be allocated had a weighted-average expected life of 5.37 years.

The expenses recognized for employee services received during the three months ended March 31, 2020 are shown in the following table:

 

 

 

Three months ended

March 31,

(in thousands)

 

2020

Research and development expenses

 

€369

General and administrative expenses

 

304

Total

 

€673

17


 

 

 

 

 

Chief Executive Officer Grant (Equity-Settled)

In September 2019, BioNTech agreed to grant Prof. Ugur Sahin, M.D. an option to purchase 4,374,963 ordinary shares, subject to Prof. Sahin’s continuous employment with BioNTech. As disclosed in the notes to the consolidated financial statements as of December 31, 2019, the option will be subject to the terms, conditions, definitions and provisions of the Employee Stock Ownership Plan (ESOP) and the applicable option agreement thereunder.

During the three months ended March 31, 2020, no further options were granted or forfeited.

During the three months ended March 31, 2020 the Group has recognized k€3,208 of share-based payment expenses as research & development expenses in the interim condensed consolidated statement of operations (three months ended March 31, 2019: Nil).

Employee Stock Ownership Plan (Equity-Settled)

On November 15, 2018, the Group established a share option program that grants selected employees options to receive shares in the company. The program is designed as an Employee Stock Ownership Plan (ESOP) as disclosed in the notes to the consolidated financial statements as of December 31, 2019. The amounts disclosed in this note have been retrospectively adjusted to reflect the share split as described in note 10.

Set out below is an overview of changes in ESOP during the three months ended March 31, 2020.

 

 

 

Share options

outstanding

Number of

Ordinary Shares

underlying

options

Weighted-average exercise price (€)

As of January 1, 2020

 

655,383

11,796,894

10.23

Forfeited

 

(4,536)

(81,648)

11.48

As of March 31, 2020

 

650,847

11,715,246

10.22

 

During the three months ended March 31, 2020, no further options were granted but 4,536 options were forfeited.

During the three months ended March 31, 2020 the Group has recognized k€4,269 of share-based payment expenses in the interim condensed consolidated statement of operations (three months ended March 31, 2019: k€13,496).

 

 

Three months ended

March 31,

(in thousands)

2020

2019

Cost of sales

€213

€228

Research and development expenses

2,786

11,770

Sales and marketing expenses

28

28

General and administrative expenses

1,242

1,470

Total

€4,269

€13,496

12

Related Party Disclosures

Key Management Personnel Transactions

A number of key management personnel or their related parties hold positions in other companies that results in them having control or significant influence over these companies. A number of these companies have consummated transactions with the Group during the period.

18


 

 

 

 

 

BioNTech has a longstanding relationship with Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz (Translationale Onkologie an der Universitätsmedizin der Johannes Gutenberg Universität Mainz gemeinnützige GmbH), or TRON. TRON is a non-profit limited liability company engaged in biopharmaceutical research. Prof. Ugur Sahin, M.D., BioNTech’s co-founder and Chief Executive Officer, is a significant shareholder of TRON.

The aggregate value of transactions related to key management personnel were as follows for the periods indicated:

 

(in thousands)

 

March 31,

2020

March 31,

2019

Consulting services / patent assignment

 

-

€6

Purchases of various goods and services from TRON

 

2,233

2,597

Total

 

€2,233

€2,603

 

The outstanding balances of transactions related to key management personnel were as follows as at the periods indicated:

 

(in thousands)

 

March 31,

2020

March 31,

2019

TRON

 

€913

1,367

Total

 

€913

€1,367

Other Related Party Transactions

ATHOS KG, Holzkirchen, Germany owns 100% of shares in AT Impf GmbH, Munich, Germany and is the beneficial owner of BioNTech SE. AT Impf GmbH, Munich, Germany is the parent company of the Group. The total amount of transactions with ATHOS KG or entities controlled by them was as follows for the periods indicated:

 

(in thousands)

 

March 31,

2020

March 31,

2019

Purchases of various goods and services from entities controlled by  ATHOS KG

 

€489

€534

Total

 

€489

€534

 

The outstanding balances of transactions with ATHOS KG or entities controlled by them were as follows as at the periods indicated:

 

(in thousands)

 

March 31,

2020

March 31,

2019

ATHOS KG

 

€232

-

Total

 

€232

-

None of the balances are secured and no bad debt expense has been recognized in respect of amounts owed by related parties.

13

Events after the Reporting Period

As part of the strategic alliance with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”; Stock Symbol: 600196.SH, 02196.HK) whereby the two companies will work together on the development of BNT162 in China, Fosun agreed to make an equity investment which was received in mid-April 2020. The issuance of 1,580,777 ordinary shares with the nominal amount of k€ 1,581 was registered within the commercial register (Handelsregister) as of April 23, 2020.

19


 

 

 

 

 

On April 9, 2020, BioNTech and Pfizer Inc. (“Pfizer”; NYSE: PFE) announced that they have entered into a collaboration agreement to co-develop BioNTech’s potential first-in-class COVID-19 mRNA vaccine program, BNT162 aimed at preventing COVID-19 infection. The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple sites. In late April, both companies announced that the German regulatory authority, the Paul-Ehrlich-Institut, approved the Phase 1/2 clinical trial and the first cohort of BioNTech’s Phase 1/2 clinical trial were dosed shortly thereafter. In early May, Pfizer and BioNTech initiated a clinical trial for BNT162 in the United States and the first participants were dosed shortly thereafter. During the clinical development stage, BioNTech and its partners will provide clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe. BioNTech and Pfizer will work together to scale-up manufacturing capacity at risk to provide worldwide supply in response to the pandemic. If the vaccine candidate is approved, BioNTech and Pfizer would also work jointly to commercialize the vaccine worldwide (excluding China which is already covered by BioNTech’s collaboration with Fosun Pharma). Under the terms of the agreement, Pfizer agreed to pay BioNTech $185 million in upfront payments, including an equity investment of $113 million (€104 million) which was received in late April 2020 and a cash payment of $72 million. The issuance of 2,377,446 ordinary shares with the nominal amount of k€ 2,377 was registered within the commercial register (Handelsregister) as of May 5, 2020. BioNTech is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Pfizer and BioNTech will share development costs equally. Initially, Pfizer will fund 100% of the development costs, and BioNTech will repay Pfizer its 50% share of these costs during the comme