bntx-6k_20200811.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 AUGUST 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 August 11, 2020, BioNTech SE (the “Company”) issued a press release providing a development update and reporting its financial results for the three and six months ended June 30, 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 and six months ended June 30, 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: August 11, 2020



EXHIBIT INDEX

 

 

Exhibit

Description of Exhibit

 

 

99.1

Second Quarter 2020 Financial Results Press Release dated August 11, 2020 and Quarterly Report for the Three and Six Months Ended June 30, 2020

 

 

 

 

 

bntx-ex991_6.htm

Exhibit 99.1

 

 

 

BioNTech Announces Second Quarter 2020 Financial Results and Corporate Progress

 

 

 

Pivotal Phase 2b/3 trial for BNT162 vaccine program against COVID-19 initiated with first clinical results expected as early as October 2020

 

Initial commercial supply agreements for BNT162 signed with the United States, Japan, Canada and the United Kingdom for more than 250 million doses in 2020 and 2021

 

Published data update for the lead FixVac product candidate BNT111 in Nature and announced a partnership with Regeneron to advance combination therapy with anti-PD-1 into Phase 2 trial in melanoma

 

Presented data for BNT122 Phase 1 trial in multiple solid tumors at AACR Annual Meeting; on track to initiate randomized Phase 2 trials in adjuvant NSCLC and adjuvant CRC by the end of 2020

 

Ended Q2 2020 with cash and cash equivalents of €573 million ($642 million1) and raised an additional €681 million ($762 million1) in gross proceeds from an equity private placement and follow-on underwritten offering leading to an expected pro-forma cash and cash equivalents balance of €1.25 billion ($1.40 billion1). In addition, up to €100 million ($112 million1) secured in loan financing from the European Investment Bank in June 2020. Financing transactions are subject to closing conditions which were not fulfilled before June 30, 2020

 

Conference call and webcast for analysts and investors
scheduled for August 11, 2020 at 08:00 a.m. ET (2:00 p.m. CET)

 

MAINZ, Germany, August 11, 2020 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and infectious diseases, today provided an update on its corporate progress and reported financial results for the quarter ended June 30, 2020.

 

“We made significant progress in the second quarter toward our goal of advancing our oncology programs and toward bringing a COVID-19 vaccine to market as quickly as possible.  I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and Co-founder. “In addition, we have significantly strengthened our balance sheet, providing financial resources to advance our broad pipeline of novel immunotherapies targeting oncology and infectious disease.”  

 


 

 

Second Quarter 2020 and Subsequent Updates

 

Infectious disease

 

COVID-19 Vaccine Program – BNT162

 

Released data from the ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, evaluating nucleoside-modified messenger RNA vaccine candidate (BNT162b1) in 45 subjects, and data from the ongoing Germany trial in 60 subjects.

 

Received Fast Track designation for BNT162b1 and BNT162b2 from the U.S. Food and Drug Administration (FDA).

 

Initiated a Phase 2b/3 study for BNT162b2 in up to 30,000 participants aged 18 to 85 years at approximately 120 sites globally; if successful, BioNTech and Pfizer plan to file for market authorization or regulatory approval as early as October 2020.

 

Initiation of a Phase 1 study for BNT162b1 to evaluate safety and immunogenicity in Chinese participants to support potential regulatory approval in China.

 

Announced initial commercial supply agreements totaling more than 250 million doses with the United Kingdom, the United States, Japan and Canada in 2020 and 2021, with an option to purchase up to an additional 500 million doses. All agreements are subject to clinical success and regulatory approval.

 

Oncology

 

FixVac

 

BNT111 – On July 30, BioNTech announced the publication of interim Phase 1 data for BNT111, the Company’s lead mRNA-based FixVac cancer vaccine program, in Nature. The trial, designed to evaluate safety and tolerability of vaccinated patients with stage IIIB-C and stage IV melanoma, included 89 patients and highlighted a favorable tolerability profile of BNT111. An efficacy analysis conducted within a subset of 42 checkpoint-inhibitor (CPI)-experienced metastatic melanoma patients showed that BNT111 mediates durable responses both as a single agent and in combination with anti-PD-1 antibodies by establishing an association with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells.

 

BNT111 – On July 31, BioNTech and Regeneron Pharmaceuticals, Inc. announced a strategic collaboration to jointly conduct a randomized Phase 2 study for the treatment of melanoma that has progressed after prior PD-1 blockade, utilizing BNT111 FixVac and Regeneron’s Libtayo® in combination.

 

BNT111 – BioNTech expects to initiate this Phase 2 trial with registrational potential in the second half of 2020.

 

BNT113 – Planned initiation of a potentially registrational Phase 2 trial in HPV16+ head and neck cancer expected in 2H 2020.

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BNT1142 – Planned data update from a Phase 1 trial in triple negative breast cancer (TNBC) is expected in 2H 2020. The exploratory Phase 1 study tests immunogenicity and safety of vaccination with individualized neoantigen immunotherapy and non-mutated tumor-associated antigens in TNBC.

Individualized neoantigen specific immunotherapy (iNeST)

 

BNT122 – BioNTech and Genentech reported a data update for the Phase 1a and 1b trial in multiple solid tumors in June 2020 as part of the American Association for Cancer Research (AACR) Virtual Annual Meeting II. As a monotherapy and in combination with atezolizumab, RO7198457 (BNT122/RG6180) was observed to have a manageable safety profile and to induce significant levels of neoantigen-specific immune responses, even in late-stage, heavily pre-treated patients. RO7198457 (BNT122/RG6180) is partnered with Genentech.

 

BNT122 – BioNTech expects to provide an enrollment update from the Phase 2 trial (IMCODE-001) in first line melanoma in 2H 2020 with an interim data update anticipated in 2H 2021.

 

BNT122 – Two Phase 2 clinical trials are planned in the adjuvant setting. The first adjuvant Phase 2 study is currently recruiting for patients and first patient dosing is expected in 2H 2020. The trial is designed to evaluate the efficacy and safety of RO7198457 (BNT122/RG6180) plus atezolizumab compared with atezolizumab alone in patients with early and adjuvant stage non-small-cell lung cancer (NSCLC). The second Phase 2 study will be in colorectal cancer in adjuvant setting and is expected to initiate in 2H 2020. This trial will be a multi-site, open-label, Phase 2, randomized trial to compare the efficacy of RO7198457 (BNT122/ RG6180) versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage 2/3 rectal cancer, or Stage 2 (high risk)/Stage 3 colon cancer.

mRNA intratumoral immunotherapy

 

BNT131 – BioNTech expects to provide a data update from the Phase 1 trial in solid tumors in 2H 2020. The trial is a first-in-human (FIH), multi-site, open-label, Phase 1, dose escalation and expansion trial to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR441000/BNT131 administered intratumorally as a monotherapy and in combination with cemiplimab in patients with advanced solid tumors. The data to be presented will include safety, tolerability and pharmacodynamic biomarkers. SAR441000/BNT131 is partnered with Sanofi.

CAR-T cell immunotherapy

 

BNT211 – Initiation of a Phase 1/2a open-label, multi-site dose escalation and dose expansion basket trial with or without a CLDN6 CARVac immunotherapy is expected in 2H 2020. While the preclinical focus has mainly been on ovarian cancer, patients with uterine, testicular, lung and gastric cancers may also be enrolled.

Neoantigen-Targeting T Cells

 

BNT221 (NEO-PTC-01) – Initiation of a Phase 1 dose escalation trial of BNT221 is expected in 2H 2020 for the treatment of metastatic melanoma in patients who are refractory or unresponsive to checkpoint inhibitors. The primary objectives will be to evaluate the safety and feasibility of administering BNT221 to patients. Additional objectives include evaluation of immunogenicity and clinical efficacy.

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Next-generation checkpoint immunomodulators

 

BNT311 – BioNTech expects to provide a data update in 2H 2020, which will include dose-escalation data from the Phase 1/2 trial in multiple solid tumors for GEN1042/BNT311 (PD-L1x4-1BB). The program is partnered with Genmab.

Toll-Like receptor binding agonist

 

BNT411 – On July 8, the first patient was dosed in a Phase 1/2a, first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of BNT411 as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).

 

Corporate Development

During the second quarter, BioNTech completed the acquisition of Neon Therapeutics, Inc. BioNTech continues to integrate the new subsidiary, based in Cambridge, Massachusetts, which serves as BioNTech’s U.S. headquarters.

 

Second Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2020, were €573.0 million.

 

On July 27, 2020, BioNTech announced the closing of an underwritten offering of 5,500,000 American Depositary Shares (“ADSs”), each representing one of BioNTech’s ordinary shares, at a public offering price of $93.00 per ADS, for gross proceeds of €456.8 million ($511.5 million1). The underwritten offering had no accounting impact within the second quarter 2020.

 

On July 22, 2020, BioNTech announced the terms of a rights offering of rights to subscribe for ordinary shares, including ordinary shares represented by ADSs, extended to holders of its ordinary shares and ADSs. Certain holders irrevocably agreed not to transfer or exercise their rights in the rights offering, and the shares underlying those rights were offered in the underwritten offering. The ADS rights exercise period expires at 12:01 a.m. (New York City time) on August 14, 2020 and the ordinary share rights exercise period expires one minute after 11:59 p.m. (Mainz, Germany time) on August 14, 2020. The rights offering had no accounting impact within the second quarter 2020.

 

On June 29, 2020, BioNTech announced the signing of a private investment of €223.9 million ($250.7 million1) by Temasek and another accredited investor. The private placement includes an investment of approximately €123.9 million ($138.7 million1) in ordinary shares and a €100.0 million ($112.0 million1) investment in a 4-year mandatory convertible note. Upon closing, private placement investors will receive 2,595,996 ordinary shares in BioNTech, which will be subject to a 180-day lock-up agreement. The 4-year mandatory convertible note will come with a coupon of 4.5% per annum and a conversion premium of 20% above the reference price. The investment is subject to customary closing conditions, which were not fulfilled before June 30, 2020 and had no accounting impact within the second quarter 2020.

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On June 11, 2020, the European Investment Bank (EIB) and BioNTech entered into a €100.0 million ($112.0 million1) loan financing agreement to support the development of BNT162. The deal will also allow the Company to expand its manufacturing capacity in order to rapidly supply the vaccine, worldwide, in response to the pandemic. The EIB debt investment will be disbursed in two tranches of €50.0 million ($56.0 million1) each. The closing of the financing agreement, subject to achieving certain milestone events, was not fulfilled before June 30, 2020 and had no accounting impact within the second quarter 2020.

 

In Q2 2020 BioNTech received an aggregate of €216.7 million ($236.0 million) in non-refundable upfront payments from the BNT162 collaboration agreements and equity investments with Pfizer and Fosun Pharma.

Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was €41.8 million for the three months ended June 30, 2020, compared to €25.8 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total revenue was €69.4 million, compared to €51.9 million for the comparative prior year period. The revenue from collaboration agreements overall increased due to the recognition of revenue from our new collaboration agreements signed with Pfizer and Fosun Pharma as part of the Company’s BNT162 vaccine program against COVID-19. The revenues from other sales transactions increased due to increased orders and include sales of diagnostic products, peptides, retroviral vectors for clinical supply and development and manufacturing services sold to third-party customers.

Research and Development Expenses: Research and development expenses were €95.2 million for the three months ended June 30, 2020, compared to €53.4 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total research and development expenses were €160.3 million, compared to €110.6 million for the comparative prior year period. The increase was mainly due to an increase in headcount leading to higher wages, benefits and social security expenses as well as an increase in expenses for purchased research and development services, especially with respect to our BNT162 program. In addition, from the date of acquisition, the new U.S.-based subsidiary, BioNTech US Inc., contributed to our research and development expenses.

General and Administrative Expenses: General and administrative expenses were €18.8 million for the three months ended June 30, 2020, compared to €14.6 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total general and administrative expenses were €34.6 million, compared to €23.9 million for the comparative prior year period. The increase was mainly influenced by higher expenses for purchased management consulting and legal services as well as an increase in headcount leading to higher wages, benefits and social security expenses. In addition, from the date of acquisition, our new U.S.-based subsidiary, BioNTech US Inc., contributed to our general and administrative expenses.

Net Loss: Net loss was €88.3 million for the three months ended June 30, 2020, compared to €50.1 million for the three months ended June 30, 2019. For the period of six months ended June 30, 2020, total net loss was €141.7 million, compared to €90.8 million for the comparative prior year period.

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Shares Outstanding: Shares outstanding as of June 30, 2020 were 232,673,455.

Financial Guidance:

 

As a result of increased spending related to BNT162, BioNTech now expects net cash used in operating activities and for purchases of property and equipment to be between €450 million and €600 million in the full year 2020.

 

BioNTech anticipates that existing cash and cash equivalents, the net proceeds from the recent underwritten offering and the expected net proceeds from the private investment announced in June 2020 will enable the Company to fund operating expenses and capital requirements through at least the next 24 months.

 

Full financial statements can be found in the 6-K filing as published on the SEC website under https://www.sec.gov/.

 

Conference Call and Webcast Information

BioNTech SE will host a conference call and webcast today at 08:00 a.m. ET (2:00 p.m. CET) to report its financial results for the quarter ended June 30, 2020 and provide a corporate update.

 

To participate in the conference call, please dial the following numbers 15-20 minutes prior to the start of the call and provide the Conference ID: 1963889.

 

United States international:  +1 646 741 3167

United States domestic (toll-free):  +1 877 870 9135

Germany: +49 692 2222 625

 

Participants may also access the slides and the webcast of the conference call via the “Events & Presentations” page of the Investor Relations section of the Company’s website at https://biontech.de/. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

 

 


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BioNTech SE

(“BioNTech” or “the Company”)

 

Financial and Operational Results for the Second Quarter Ended June 30, 2020

 

Key Pipeline Updates

Below is a summary of our clinical product candidates, organized by platform and indication.

Oncology

BioNTech has also continued to advance its broad oncology pipeline. With the initiation of a first-in-human (FIH) Phase 1 clinical trial for TLR7 agonist (BNT411), the oncology pipeline now includes 11 products in 12 ongoing trials across the mRNA-, antibody- and small molecule technologies. In Q2 and subsequent, BioNTech reported 2 interim data updates on clinical trials for 2 different oncology product candidates. Up to four further data updates are expected in 2H 2020. In 2H 2020, BioNTech intends to initiate three Phase 2 trials (BNT111, BNT 113, BNT122), two additional FIH trials (BNT211, BNT221) and is currently recruiting subjects for RO7198457 (BNT122/RG6180) for a Phase 2 clinical trial in adjuvant NSCLC.

FixVac

Our FixVac product candidates contain selected combinations of pharmacologically optimized uridine mRNA encoding known cancer-specific shared antigens. These candidates 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.

 

o

A data update was recently published in Nature. The trial, designed to evaluate safety and tolerability of vaccinated patients with stage IIIB-C and stage IV melanoma, included 89 patients and highlighted a favorable tolerability profile of BNT111. An efficacy analysis conducted within a subset of 42 checkpoint-inhibitor (CPI)-experienced metastatic melanoma patients showed that BNT111 mediates durable responses both as a single agent and in combination with anti-PD-1 antibodies by establishing an association with activation and strong expansion of tumor-antigen-specific CD4+ and CD8+ T cells.

 

o

On July 31, BioNTech and Regeneron Pharmaceuticals, Inc. announced a strategic collaboration to jointly conduct a randomized Phase 2 study for the treatment of melanoma that has progressed after prior PD-1 blockade, utilizing BNT111 FixVac and Regeneron’s Libtayo® in combination.

 

o

We expect to initiate this Phase 2 trial with registrational potential in the second half of 2020.

 

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

 

BNT113 in a Phase 1 trial in HPV16+ 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.

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BNT1142 in a Phase 1 trial in triple negative breast cancer (TNBC).  A data update from the trial is expected in the second half of 2020. The exploratory Phase 1 study evaluates immunogenicity and safety of vaccination with individualized neoantigen immunotherapy and non-mutated tumor-associated antigens in TNBC.

 

BNT115 in a Phase 1 trial in ovarian cancer ongoing.

 

BNT116 is 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. RO7198457 (BNT122/ RG6180) is partnered with Genentech.

 

We, in collaboration with Genentech, reported a data update for the Phase 1a and 1b trial in multiple solid tumors in June 2020 as part of the American Association for Cancer Research (AACR) Virtual Annual Meeting II. As a monotherapy and in combination with atezolizumab, RO7198457 (BNT122/RG6180) was observed to have a manageable safety profile and to induce significant levels of neoantigen-specific immune responses, even in late-stage, heavily pre-treated patients.

 

We expect to provide an enrollment update from the Phase 2 trial (IMCODE-001) in first line melanoma in the second half of 2020 with an interim data update anticipated in the second half of 2021.

 

We and Genentech plan to conduct two Phase 2 clinical trials in the adjuvant setting. The first adjuvant Phase 2 study is currently recruiting for patients, and first patient dosing is expected in the second half of 2020. The trial is designed to evaluate the efficacy and safety of RO7198457 (BNT122/RG6180) plus atezolizumab compared with atezolizumab alone in patients with early and adjuvant stage non-small cell lung cancer (NSCLC). The second Phase 2 study will be in colorectal cancer in adjuvant setting and is expected to initiate in the second half of 2020. This trial will be a multi-site, open-label, Phase 2, randomized trial to compare the efficacy of RO7198457 (BNT122/RG6180) versus watchful waiting in patients with circulating tumor DNA (ctDNA) positive, surgically resected Stage 2/3 rectal cancer or Stage 2 (high risk)/Stage 3 colon cancer.

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).  

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We expect to report a data update in the second half of 2020 from the ongoing Phase 1 trial. The trial is a first-in-human, multi-center, open-label, dose escalation and expansion trial to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR441000 (BNT131) administered intratumorally as a monotherapy and in combination with cemiplimab in patients with advanced solid tumors. The data to be presented will include safety, tolerability and pharmacodynamic biomarkers.

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 sdiscovery 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 1/2a clinical trial for BNT211 in patients with advanced CLDN6+ solid tumors in the second half of 2020. While the preclinical focus has mainly been on ovarian cancer, patients with uterine, testicular, lung and gastric cancers may also be enrolled.

Neo-antigen targeting T cells

Through our recent Neon acquisition, we obtained a neoantigen-targeting T cell platform that can be utilized to develop product candidates across several neoantigen-targeting non-engineered and engineered T cell therapies. Our lead product candidate under this platform is our individualized neoantigen-targeting T cell therapy, BNT221.

 

We expect to initiate a Phase 1 dose escalation trial of BNT221 in the second half of 2020 for the treatment of metastatic melanoma in patients who are refractory or unresponsive to checkpoint inhibitors. The primary objectives will be to evaluate the safety and feasibility of administering BNT221 to patients. Additional objectives include evaluation of immunogenicity and clinical efficacy.

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.  BioNTech expects to provide a data update for the BNT311 trial, which will include dose-escalation data in the second half of 2020.

Targeted cancer antibodies

MVT-5873 (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.

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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.

 

On July 8, 2020, the first patient was dosed in a Phase 1/2a, first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of BNT411 as a monotherapy in patients with solid tumors, and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).

In addition, we have several other cancer immunotherapy programs in pre-clinical 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.

 

Infectious Disease Immunotherapies

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 our 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.

Along with our partner, Pfizer:

 

We released data from the ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, evaluating nucleoside-modified mRNA vaccine candidate (BNT162b1) in 45 subjects, and data from an ongoing Germany trial in 60 subjects.

 

We received Fast Track designation for BNT162b1 and BNT162b2 from the U.S. Food and Drug Administration (FDA).

 

We initiated a Phase 2b/3 study for BNT162b2 in up to 30,000 participants aged 18 to 85 years at approximately 120 sites globally. If successful, BioNTech and Pfizer plan to file for market authorization or regulatory approval as early as October 2020.

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We completed initial commercial supply agreements totaling more than 250 million doses with the United Kingdom, the United States, Japan and Canada to be delivered in 2020 and 2021, with an option to purchase an additional 500 million doses. All agreements are subject to clinical success and regulatory approval.

Along with our partner, Fosun, we have initiated a Phase 1 study for BNT162b1 to evaluate safety and immunogenicity in Chinese participants to support a potential regulatory approval pathway in China.

Flu vaccine

We have a collaboration with Pfizer to develop mRNA-based immunotherapies for the prevention of influenza, product candidate BNT161. We expect to begin clinical testing in 2021.

Infectious diseases

We have a research collaboration with the University of Pennsylvania, under which we have the exclusive option to develop and commercialize mRNA immunotherapies for the treatment of up to 10 infectious disease indications. We expect the first clinical trial under this collaboration to start in the first half of 2021. We have also 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 product to enter the clinic in the second half of 2021.

1 All amounts translated using the exchange rate published by the German Central Bank (Deutsche Bundesbank) in effect as of June 30, 2020.

 

2 IVAC_M_uID is also being investigated in arm 2 (N=15) of the 3 arm TNBC-MERIT trial, with BNT114 as an optional treatment; BNT114 is investigated in arm 1 (N=12) and arm 3 (N=15) of the TNBC-MERIT trial (total patients in study: N=42).

 

 

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About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

 

For more information, please visit www.BioNTech.de

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: our expected cash usage for 2020 and beyond; our anticipated cash runway; the timing, completion and extent of subscription of the rights offering; the planned next steps in BioNTech’s pipeline programs and specifically including, but not limited to, statements regarding plans to initiate clinical trials of BioNTech’s product candidates; expectations for data announcements with respect to BioNTech’s clinical trials; the timing for any potential emergency use authorizations or approvals for BNT162; and our ability to scale-up manufacturing capacity for BNT162 and supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 31, 2020 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.

 

 

12

 


 

 

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

 

 

13

 


 

 

 

 

 

 

BioNTech SE

Quarterly Report for the Three and Six Months ended June 30, 2020

 

 

 

1

 


 

BioNTech SE

Quarterly Report for the Three and Six Months ended June 30, 2020

Index

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, Significant Accounting Policies and further Accounting Topics

 

8

 

 

 

 

 

 

3

Segment Information

 

10

 

 

 

 

 

 

4

Revenue from Contracts with Customers

 

12

 

 

 

 

 

 

5

Business Combinations

 

13

 

 

 

 

 

 

6

Income Tax

 

16

 

 

 

 

 

 

7

Intangible Assets

 

16

 

 

 

 

 

 

8

Property, Plant and Equipment

 

16

 

 

 

 

 

 

9

Financial Assets and Financial Liabilities

 

17

 

 

 

 

 

 

10

Issued Capital and Reserves

 

18

 

 

 

 

 

 

11

Share-Based Payments

 

19

 

 

 

 

 

 

12

Related Party Disclosures

 

23

 

 

 

 

 

 

13

Events after the Reporting Period

 

24

 

Operating and Financial Review and Prospects

 

 

 

Operating Results

 

26

 

 

 

Liquidity and Capital Resources

 

40

 

 

 

Risk Factors

 

45

 

 

 

 

 

 

 

 

 

 

 

2

 


 

 

 

 

 

Interim Condensed Consolidated Financial Statements

Interim Condensed Consolidated Statements of Financial Position

 

 

 

June 30,

December 31,

(in thousands)

 

 

2020

2019

Assets

 

Note

(unaudited)

 

Non-current assets

 

 

 

 

Intangible assets

 

7

€183,281

€89,434

Property, plant and equipment

 

8

112,829

93,044

Right-of-use assets

 

 

54,905

55,018

Other assets

 

 

1,316

-

Total non-current assets

 

 

€352,331

€237,496

Current assets

 

 

 

 

Inventories

 

 

8,615

11,722

Trade receivables

 

9

7,679

11,913

Contract assets

 

 

1,621

-

Other financial assets

 

9

1,953

1,680

Other assets

 

 

16,329

9,069

Income tax assets

 

 

1,012

756

Deferred expense

 

 

10,896

5,862

Cash and cash equivalents

 

 

573,011

519,149

Total current assets

 

 

€621,116

€560,151

Total assets

 

 

€973,447

€797,647

 

 

 

 

 

Equity and liabilities

 

 

 

 

Equity

 

 

 

 

Share capital

 

10

238,198

232,304

Capital reserve

 

10

918,174

686,714

Treasury shares

 

10

(5,525)

(5,525)

Accumulated losses

 

 

(566,509)

(424,827)

Other reserves

 

11

17,596

4,826

Total equity

 

 

€601,934

€493,492

Non-current liabilities

 

 

 

 

Financial liabilities

 

9

70,289

68,904

Other liabilities

 

 

431

-

Contract liabilities

 

 

86,793

97,109

Deferred tax liabilities

 

 

5,434

-

Total non-current liabilities

 

 

€162,947

€166,013

Current liabilities

 

 

 

 

Tax provisions

 

 

150

150

Provisions

 

 

833

762

Financial liabilities

 

9

2,591

1,823

Trade payables

 

9

35,690

20,498

Contract liabilities

 

 

117,661

93,583

Other financial liabilities

 

9

33,763

13,836

Other liabilities

 

 

17,878

7,490

Total current liabilities

 

 

€208,566

€138,142

Total liabilities

 

 

€371,513

€304,155

Total equity and liabilities

 

 

€973,447

€797,647

 

The accompanying notes form an integral part of these interim condensed consolidated financial statements.

3


 

 

 

 

 

Interim Condensed Consolidated Statements of Operations

 

 

 

Three months ended

June 30,

Six months ended

June 30,

 

 

 

2020

2019

2020

2019

(in thousands, except per share data)

 

Note

(unaudited)

(unaudited)

 

 

 

 

 

 

 

Revenues from contracts with customers

 

4

€41,762

€25,785

€69,425

€51,939

Cost of sales

 

 

(5,662)

(5,489)

(11,504)

(8,694)

Gross profit

 

 

€36,100

€20,296

€57,921

€43,245

 

 

 

 

 

 

 

Research and development expenses

 

 

(95,189)

(53,402)

(160,311)

(110,643)

Sales and marketing expenses

 

 

(3,054)

(678)

(3,540)

(1,238)

General and administrative expenses

 

 

(18,813)

(14,623)

(34,628)

(23,899)

Other operating income

 

 

773

660

1,198

991

Other operating expenses

 

 

(759)

(120)

(859)

(158)

Operating loss

 

 

€(80,942)

€(47,867)

€(140,219)

€(91,702)

 

 

 

 

 

 

 

Finance income*

 

 

205

425

593

1,876

Finance expenses*

 

 

(9,300)

(2,204)

(3,374)

(151)

Interest expense related to lease liability

 

 

(465)

(425)

(880)

(850)

Loss before tax

 

 

€(90,502)

€(50,071)

€(143,880)

€(90,827)

 

 

 

 

 

 

 

Income taxes

 

6

2,206

(13)

2,198

(19)

Loss for the period

 

 

€(88,296)

€(50,084)

€(141,682)

€(90,846)

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

Equity holders of the parent

 

 

(88,296)

(50,084)

(141,682)

(90,730)

Non-controlling interests

 

 

-

-

-

(116)

 

 

 

€(88,296)

€(50,084)

€(141,682)

€(90,846)

 

 

 

 

 

 

 

Earnings per share

 

 

 

 

 

 

in EUR

 

 

 

 

 

 

Basic & diluted, loss per share for the period attributable to equity holders of the parent**

 

 

€(0.38)

€(0.24)

€(0.62)

€(0.45)

* Foreign exchange differences on a cumulative basis are either shown as finance income or expenses and might switch between those two positions during the year-to-date reporting periods.

** Numbers of shares for calculating the earnings per share for the three and six months ended June 30, 2019 have been adjusted to reflect capital increase due to 1:18 share split which occurred on September 18, 2019.

 

The accompanying notes form an integral part of these interim consolidated financial statements.

4


 

 

 

 

 

Interim Condensed Consolidated Statements of Comprehensive Loss

 

 

 

Three months ended

June 30,

Six months ended

June 30,

 

 

 

2020

2019

2020

2019

(in thousands)

 

Note

(unaudited)

(unaudited)

Loss for the period

 

 

€(88,296)

€(50,084)

€(141,682)

€(90,846)

 

 

 

 

 

 

 

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

 

 

(3,367)

2

(3,493)

6

Net other comprehensive income that may be reclassified to profit or loss in subsequent periods

 

 

(3,367)

2

(3,493)

6

 

 

 

 

 

 

 

Other comprehensive income for the period, net of tax

 

 

(3,367)

2

(3,493)

6

 

 

 

 

 

 

 

Comprehensive loss for the period, net of tax

 

 

€(91,663)

€(50,082)

€(145,175)

€(90,840)

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

Equity holders of the parent

 

 

(91,663)

(50,082)

(145,175)

(90,724)

Non-controlling interests

 

 

-

-

-

(116)

Comprehensive loss for the period, net of tax

 

 

€(91,663)

€(50,082)

€(145,175)

€(90,840)

 

The accompanying notes form an integral part of these interim condensed consolidated financial statements.


 

5


 

 

 

 

 

Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity

 

 

Six months ended June 30, 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

 

 

-

-

-

(141,682)

-

-

(141,682)

-

(141,682)

Other comprehensive loss

 

 

-

-

-

-

-

(3,493)

(3,493)

-

(3,493)

Total comprehensive loss

 

 

-

-

-

(141,682)

-

(3,493)

(145,175)

-

(145,175)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of share capital

 

10

5,894

233,113

-

-

-

-

239,007

-

239,007

Transaction costs

 

10

-

(1,653)

-

-

-

-

(1,653)

-

(1,653)

Share-based payments

 

11

-

-

-

-

16,263

-

16,263

-

16,263

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 2020

 

 

€238,198

918,174

(5,525)

(566,509)

21,025

(3,429)

601,934

-

601,934

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six months ended June 30, 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

 

 

-

-

-

(90,730)

-

-

(90,730)

(116)

(90,846)

Other comprehensive income

 

 

-

-

-

-

-

6

6

-

6

Total comprehensive income / (loss)

 

 

-

-

-

(90,730)

-

6

(90,724)

(116)

(90,840)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of share capital

 

10

5,088

(5,078)

-

-

-

-

10

-

10

Capital increase Series B

 

10

11,990

178,845

-

-

-

-

190,835

-

190,835

Acquisition of non-controlling interest

 

10

2,375

(1,644)

-

-

-

-

731

(731)

-

Transaction costs

 

10

-

(501)

-

-

-

-

(501)

-

(501)

Share based payments

 

11

-

-

-

-

17,986

-

17,986

-

17,986

 

 

 

 

 

 

 

 

 

 

 

 

As of June 30, 2019

 

 

€212,749

515,737

-

(336,501)

(7,488)

(7)

384,490

-

384,490

(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

 

 

Six months ended

June 30,

 

 

2020

2019

(in thousands)

 

(unaudited)

 

 

 

 

Operating activities

 

 

 

Loss for the period

 

€(141,682)

€(90,846)

Income taxes

 

(2,198)

19

Loss before tax

 

€(143,880)

€(90,827)

Adjustments to reconcile loss before tax to net cash flows:

 

 

 

Depreciation and amortization of property, plant, equipment and intangible assets

 

17,425

15,595

Share-based payment expense

 

16,263

17,986

Net foreign exchange differences

 

(50)

143

Loss on disposal of property, plant and equipment

 

80

9

Finance income

 

(593)

(769)

Interest on lease liability

 

880

850

Finance expense

 

208

151

Other non-cash income

 

(151)

-

Working capital adjustments:

 

 

 

Decrease/(Increase) in trade receivable and contract assets

 

(9,770)

9,715

Decrease/(Increase) in inventories

 

3,246

(1,355)

(Decrease)/Increase in trade payables, other liabilities, contract liabilities and provisions

 

46,918

(36,936)

Interest received

 

576

769

Interest paid

 

(985)

(1,001)

Income tax paid

 

(375)

(19)

Net cash flows used in operating activities

 

€(70,208)

€(85,689)

 

 

 

 

Investing activities

 

 

 

Purchase of property, plant and equipment

 

(21,396)

(10,608)

Proceeds from sale of property, plant and equipment

 

2

557

Purchase of intangibles assets

 

(4,174)

(29,665)

Acquisition of subsidiaries and businesses, net of cash acquired

 

891

(6,050)

Net cash flows used in investing activities

 

€(24,677)

€(45,766)

 

 

 

 

Financing activities

 

 

 

Proceeds from issuance of share capital, net of costs

 

147,806

175

Proceeds from loans and borrowings

 

2,899

6,035

Repayment of loans and borrowings

 

(319)

-

Payments related to lease liabilities

 

(2,173)

(1,291)

Net cash flows from financing activities

 

€148,213

€4,919

 

 

 

 

Net increase/(decrease) in cash and cash equivalents

 

53,328

(126,536)

Change in cash resulting from exchange rate differences

 

534

(69)

Cash and cash equivalents at January 1

 

519,149

411,495

Cash and cash equivalents at June 30

 

€573,011

€284,890

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 Depositary Shares (ADS) representing BioNTech’s shares have been publicly traded on the 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.

BioNTech combines decades of groundbreaking research in immunology, cutting-edge therapeutic platforms and a suite of patient profiling and bioinformatic tools to develop immunotherapies for cancer and other diseases. BioNTech leverages powerful new therapeutic mechanisms and exploits a diverse array of biological targets to harness the power of each patient’s immune system to address the unique molecular signature of each patient’s underlying disease. The breadth of BioNTech’s immunotherapy technologies and expertise has enabled the Group to develop therapies to address a range of rare and infectious diseases, and BioNTech has recently rapidly mobilized these with the aim of addressing the COVID-19 pandemic.

On May 6, 2020 BioNTech SE acquired Neon Therapeutics, Inc., Cambridge, Massachusetts, United States (formerly Nasdaq: NTGN), or Neon. Under the merger agreement by and among BioNTech, Neon and BioNTech’s wholly owned subsidiary, Endor Lights, Inc., New York, United States, Endor Lights, Inc. merged with and into Neon. The new subsidiary operates under the name BioNTech US Inc., a wholly owned subsidiary of BioNTech SE, and serves as BioNTech’s headquarters in the United States. All BioNTech entities are included in the Group’s unaudited interim condensed consolidated financial statements.

These unaudited interim condensed consolidated financial statements of the Group as of and for the three and six months ended June 30, 2020 were authorized for issuance in accordance with a resolution of the audit committee on August 10, 2020.

2

Basis of Preparation, Significant Accounting Policies and further Accounting Topics

Basis of Preparation

These unaudited interim condensed consolidated financial statements as of and for the three and six months ended June 30, 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. Due to rounding, numbers presented throughout this document may not add up precisely to the totals provided and percentages may not precisely reflect the absolute figures.

8


 

 

 

 

 

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 June 30, 2020.

Impact of COVID-19

On March 11, 2020, the World Health Organization declared the outbreak of COVID-19 as a pandemic, which continues to spread throughout the United States, the European Union and around the world.

In response, BioNTech’s BNT162 program is evaluating at least four experimental vaccines aimed at preventing COVID-19 infection. As part of the program, BioNTech executed two strategic collaborations with large pharmaceutical companies to globally develop BioNTech’s vaccine candidates and supply an approved vaccine globally. BioNTech and Pfizer Inc. (NYSE: PFE), or Pfizer, aim to accelerate the development of BNT162 worldwide, excluding China, which is covered by BioNTech’s strategic alliance with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (Stock Symbol: 600196.SH, 02196.HK), or Fosun Pharma.

As BioNTech advances its clinical programs, it is in close contact with its principal investigators and clinical sites, which are located in jurisdictions affected by the COVID-19 pandemic, and is assessing the impact of the COVID-19 pandemic on its clinical trials, expected timelines and costs on an ongoing basis. In light of recent developments relating to the COVID-19 pandemic, the primary focus of healthcare providers and hospitals remains on fighting the novel coronavirus. BioNTech has also modified its business practices, in response to the spread of COVID-19, including restricting employee travel, developing social distancing plans for employees and cancelling physical participation in meetings, events and conferences. In addition, for certain earlier stage programs, including BNT141 and BNT142 (RiboMabs), BNT151 and BNT152/153 (RiboCytokines), BNT161 (Influenza), BNT171 (Rare Disease) and BNT411 (TLR7), BioNTech has delayed commencement of trials, experienced slowed patient enrollment or experienced other delays as a result of the COVID-19 pandemic. This partial disruption, even temporary, may severely impact BioNTech’s operations and overall business by delaying the progress of its clinical trials and preclinical studies. Such factors were evaluated and considered carefully when preparing these unaudited interim condensed consolidated financial statements. BioNTech will continue to evaluate potential effects of the COVID-19 pandemic and will provide updates as appropriate.

9


 

 

 

 

 

3

Segment Information

For the three and six months ended June 30, 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:

 

 

Biotech Business Unit

External 

Services

Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External 

Services

Total

Adjustments

Group

Three months ended June 30, 2020

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€12,154

€5,479

€14,952

-

-

€32,585

-

€32,585

Revenues from other sales transactions

 

-

88

-

-

9,089

9,177

-

9,177

Cost of sales

 

-

-

-

-

(4,779)

(4,779)

(883)

(5,662)

Gross Profit

 

€12,154

€5,567

€14,952

-

€4,310

€36,983

€(883)

€36,100

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(37,111)

(35,905)

(21,026)

(1,883)

(147)

(96,072)

883

(95,189)

Sales and marketing expenses

 

-

-

-

(2,459)

(595)

(3,054)

-

(3,054)

General and administrative expenses

 

-

(5)

(1,018)

(16,956)

(835)

(18,814)

1

(18,813)

Other result

 

(2)

13

30

(16)

(11)

14

-

14

Segment operating income / (loss)

 

€(24,959)

€(30,330)

€(7,062)

€(21,314)

€2,722

€(80,943)

€1

€(80,942)

 

 

Biotech Business Unit

External 

Services

Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External 

Services

Total

Adjustments

Group

Three months ended June 30, 2019

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€9,141

-

€10,984

-

-

€20,125

-

€20,125

Revenues from other sales transactions

 

-

323

2

8

5,327

5,660

-

5,660

Cost of sales

 

-

-

-

-

(5,501)

(5,501)

12

(5,489)

Gross Profit

 

€9,141

€323

€10,986

€8

€(174)

€20,284

€12

€20,296

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(19,359)

(19,813)

(12,315)

(1,725)

(177)

(53,389)

(13)

(53,402)

Sales and marketing expenses

 

-

-

-

(283)

(395)

(678)

-

(678)

General and administrative expenses

 

-

-

(1,117)

(12,860)

(646)

(14,623)

-

(14,623)

Other result

 

151

146

8

(24)

256

537

3

540

Segment operating loss

 

€(10,067)

€(19,344)

€(2,438)

€(14,884)

€(1,136)

€(47,869)

€2

€(47,867)

 

10


 

 

 

 

 

 

Biotech Business Unit

External 

Services

Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External 

Services

Total

Adjustments

Group

Six months ended June 30, 2020

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€18,963

€7,425

€27,358

-

-

€53,746

-

€53,746

Revenues from other sales transactions

 

103

245

-

-

15,331

15,679

-

15,679

Cost of sales

 

-

-

-

-

(10,434)

(10,434)

(1,070)

(11,504)

Gross profit

 

€19,066

€7,670

€27,358

-

€4,897

€58,991

€(1,070)

€57,921

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(58,444)

(62,704)

(36,855)

(3,070)

(308)

(161,381)

1,070

(160,311)

Sales and marketing expenses

 

-

-

-

(2,623)

(917)

(3,540)

-

(3,540)

General and administrative expenses

 

-

(5)

(2,176)

(30,974)

(1,473)

(34,628)

-

(34,628)

Other result

 

(15)

68

42

230

14

339

-

339

Segment operating income / (loss)

 

€(39,393)

€(54,971)

€(11,631)

€(36,437)

€2,213

€(140,219)

-

€(140,219)

 

 

Biotech Business Unit

External 

Services

Business 

Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product 

Sales &

External 

Services

Total

Adjustments

Group

Six months ended June 30, 2019

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€18,431

-

€23,592

-

-

€42,023

-

€42,023

Revenues from other sales transactions

 

-

463

2

8

9,443

9,916

-

9,916

Cost of sales

 

-

-

-

-

(8,603)

(8,603)

(91)

(8,694)

Gross profit

 

€18,431

€463

€23,594

€8

€840

€43,336

€(91)

€43,245

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(43,686)

(38,214)

(26,237)

(2,335)

(262)

(110,734)

91

(110,643)

Sales and marketing expenses

 

-

-

-

(569)

(669)

(1,238)

-

(1,238)

General and administrative expenses

 

-

-

(1,858)

(20,696)

(1,345)

(23,899)

-

(23,899)

Other result

 

260

288

14

26

245

833

-

833

Segment operating loss

 

€(24,995)

€(37,463)

€(4,487)

€(23,566)

€(1,191)

€(91,702)

-

€(91,702)

 

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

11


 

 

 

 

 

they are directly attributable to a service rendered. Sales and marketing expenses, general and administrative expenses and other results 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’s 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 transactions. The Company collaborates with pharmaceutical and healthcare companies and several global academic collaborators. During the three and six months ended June 30, 2020, revenue generated from the Genentech, Inc., or Genentech, and Pfizer collaboration agreements each represented more than 10% of BioNTech’s overall revenue resulting from collaboration and license agreements. Revenues were partly recorded in the Clinical and the Manufacturing segment and, with respect to Pfizer, in the Technology Platform segment as well. During the three months ended June 30, 2019, only revenue generated from the Genentech collaboration agreement represented more than 10% of BioNTech’s overall revenue from collaboration and license agreements. Revenues were partly recorded in the Clinical as well as the Manufacturing segment. During the six months ended June 30, 2019, revenue generated from the Genentech and Pfizer collaboration agreements each represented more than 10% of BioNTech’s overall revenue from collaboration and license agreements and were recorded in the Clinical segment and, with respect to Genentech, in the Manufacturing segment. Total amounts of revenues from these collaboration and license agreements in the periods presented are disclosed in Note 4.

Revenues from other sales transactions are 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 while manufacturing facilities and sales offices are located and managed in Germany. External sales originate in Germany.

4

Revenues from Contracts with Customers

Disaggregated revenue information

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

 

 

Three months ended

June 30,

Six months ended

June 30,

(in thousands)

 

2020

2019

2020

2019

Revenues resulting from collaboration and license agreements

 

€32,585

€20,125

€53,746

€42,023

Genentech Inc.

 

11,258

15,619

26,886

31,750

Pfizer Inc.