bntx-6k_20191114.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 NOVEMBER 2019

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 November 14, 2019, BioNTech SE (the “Company”) issued a press release, attached hereto as Exhibit 99.1, providing a development update and reporting its financial results for the three months ended September 30, 2019. Attached hereto as Exhibit 99.2 are the financial statements of the Company, for the three and nine months ended September 30, 2019.

 



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/ Prof. Ugur Sahin, M.D.

 

 

Name: Prof. Ugur Sahin, M.D.

 

 

Title:   Chief Executive Officer

Date: November 14, 2019



EXHIBIT INDEX

 

 

Exhibit

Description of Exhibit

 

 

99.1

Press Release dated November 14, 2019 - BioNTech SE Provides Update on Corporate Progress and Third Quarter 2019 Financial Results

99.2

Financial Statements of BioNTech SE for the Three and Nine Months Ended September 30, 2019

 

 

 

 

 

bntx-ex991_6.htm

 

Exhibit 99.1

 

BioNTech SE Provides Update on Corporate Progress and Third Quarter 2019 Financial Results

 

 

Successfully transferred IND for BNT321 to BioNTech. All necessary safety and other reports and an updated protocol filed with the FDA. Phase 1/2 trial of BNT321 expected to be re-initiated in the fourth quarter of 2019.  

 

Initiated a first-in-human global Phase 1/2a trial in collaboration with Genmab for GEN1042 (BNT312), a bispecific antibody targeting CD40 and 4-1BB for the treatment of multiple solid tumors.

 

Entered into a clinical trial supply agreement with Regeneron to supply cemiplimab for use in combination with BioNTech’s BNT112 in a first-in-human Phase 1/2 trial of FixVac in advanced prostate cancer and received approval of clinical trial applications (CTAs) in various European countries to support the initiation of this trial.

 

Filed IND for BNT411. Phase 1/2a clinical trial of BNT411 expected to be initiated as a mono- or combination therapy in solid tumors in the first half of 2020. The selective toll-like receptor 7 agonist has shown activity in numerous mouse tumor models, such as reduced tumor growth and tumor clearance.

 

Ended the third quarter of 2019 with cash equivalents of $505m (€463.3m1).

 

Raised additional $149m (approx. €135m) in net proceeds (after underwriting discounts and commissions) in Nasdaq IPO in October/November 2019.

 

 

Conference call and webcast (in English) scheduled for November 14, 2019 at 08:00 a.m. ET (2:00 p.m. CET)

 

MAINZ, GERMANY, NOVEMBER 14, 2019 (GLOBE NEWSWIRE) -- BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”), a clinical-stage biotechnology company focused patient-specific immunotherapies for the treatment of cancer and other serious diseases, today provided an update on its corporate progress and reported financial results for the quarter ended September 30, 2019.

 

“In the third quarter, we achieved important milestones in our ambition to become the leading global biotechnology company for individualized cancer medicine,” said Prof. Ugur Sahin, BioNTech’s CEO. “In addition to our successful IPO, we are also pleased with the advancement of our programs. We initiated the second first-in-human clinical trial in our 50:50 collaboration program with Genmab and successfully transferred the IND for BNT321 from MabVax to BioNTech. Our balance sheet remains strong and we are looking forward to advancing the development of our planned clinical development program and growth plans. We plan to initiate up to six first-in-human clinical trials by the end of 2020.”

 

Key Pipeline Updates

 

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

 

Oncology

 

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

 

1 

ECB exchange rate on September 30th was 1.0889.

 


 

 

 

BNT111 (advanced melanoma): We expect to initiate both a Phase 2 trial and a registrational, randomized Phase 3 trial for BNT111 in 2020.

 

 

BNT112 (prostate cancer): We plan to initiate a Phase 1/2 trial for BNT112 targeting prostate cancer in the second half of 2019. In the third quarter of 2019, CTAs were approved in various European countries to support the initiation of this trial.

 

 

BNT113 (HPV+ head and neck cancers): We are planning to initiate a Phase 2 trial for BNT113 in HPV+ head and neck cancers by the second half of 2020.

 

 

BNT114 (triple negative breast cancer): We are conducting a Phase 1 trial of BNT114 in triple negative breast cancer and expect to report a data update in the first half of 2020.

 

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 are conducting, in collaboration with Genentech, clinical trials of our iNeST product candidate, RO7198457 (BNT122). We and Genentech expect to provide a data update from our RO7198457 (BNT122) Phase 1 trial in multiple solid tumors in 2020 and expect to report topline interim data from our RO7198457 (BNT122) Phase 2 trial in first-line melanoma in the second half of 2020.

 

mRNA intratumoral immunotherapy. In collaboration with Sanofi, we are conducting a Phase 1/2 trial of SAR441000 (BNT131), our first mRNA-based intratumoral immunotherapy, as a monotherapy or in combination with cemiplimab in patients with solid tumors. We plan to provide an update on this trial 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 expect to initiate a Phase 1/2 clinical trial for BNT211 in patients with advanced CLDN6 + solid tumors in the first half of 2020.

 

Next-generation checkpoint immunomodulators. We are developing, in collaboration with Genmab, novel 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. Genmab has initiated a Phase 1/2a trial for each of GEN1046 (BNT311) and GEN1042 (BNT312) in solid tumors.

 

GEN1042 (BNT312) is a bispecific antibody designed to enhance an anti-tumor immune response through conditional CD40-mediated stimulation of antigen presenting cells crosslinked with conditional stimulation of 4-1BB+ T cells. We and Genmab began enrollment in August 2019 for a Phase 1/2a trial of BNT312 for the treatment of malignant solid tumors, including non-small cell lung cancer, colorectal cancer and melanoma. The first patient in this study was dosed in September 2019.

 

In the preclinical setting, GEN1042 (BNT312) activated antigen presenting cells and enhanced T cell activation, and also resulted in the conditional activation and expansion of previously activated CD8+ T cells and cytokines. The ongoing Phase 1/2a trial has an estimated enrollment of 126 participants and is an open-label, multi-center safety trial of GEN1042 (BNT312) administered intravenously every 21 days. The trial consists of a dose escalation phase and an expansion phase which will be initiated once the

 


 

recommended Phase 2 dose has been determined. GEN1042 (BNT312) is one of two bispecific antibodies currently in clinical trials by Genmab and BioNTech as part of a 50:50 strategic collaboration in which development costs and future profit are shared. BioNTech and Genmab shall jointly commercialize GEN1042 (BNT312) as to be further defined in a commercialization agreement between the parties.

 

Targeted cancer antibodies. BNT321 (MVT-5873) is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A (sLea), a novel epitope expressed specifically in pancreatic and other solid tumors. BNT321 (MVT-5873) is currently in Phase 1 clinical development in pancreatic cancer. We have filed the updated protocol and supporting regulatory documentation with the FDA to transfer the IND for MVT-5873 to BioNTech and resume the clinical trial following the acquisition of the assets of MabVax Therapeutics Holdings, Inc. and MabVax Therapeutics, Inc. in May 2019. The IND transfer of MVT-5873 to BioNTech was successfully achieved in August 2019. We expect the trial to be re-initiated in the fourth quarter of 2019 and anticipate resuming patient enrollment in the fourth quarter. This will be the first BioNTech-sponsored study conducted in the US under an IND.

 

BNT321 is a fully human IgG1 monoclonal antibody targeting sialyl Lewis A or CA19-9, an epitope expressed in pancreatic and other gastrointestinal cancers that plays a role in tumor adhesion and metastasis formation and is a marker of an aggressive cancer phenotype.

 

In a Phase 1 dose-escalating study, 12 pancreatic cancer patients with CA19-9 positive metastatic malignancies were injected with MVT-2163, a radiolabelled PET imaging version of BNT321. A significant portion of patients demonstrated high uptake of BNT321 in tumor tissue, suggesting that the PET imaging high-affinity antibody version of BNT321 may be used as a theranostic tool for the sensitive detection of primary tumors and metastatic disease. BNT321 may also have potential to deliver therapeutic doses of radiation to cancer cells.

 

BNT321 has also been investigated as a naked antibody in an open-label, multi-center, non-randomized dose escalation Phase 1/2 trial evaluating the safety and recommended Phase 2 dose both as a monotherapy or in combination with a standard of care chemotherapy. In this cohort, BNT321 was given in combination with nab-paclitaxel and gemcitabine to six patients newly diagnosed with CA19-9+ pancreatic cancer. At a dose of 0.125mg/kg, BNT321 was generally well tolerated by all patients when added to first line chemotherapy. All six patients evaluated had measurable tumor reductions by RECIST criteria, with four patients meeting the criteria for partial response and two patients meeting the criteria for stable disease.

 

BioNTech intends to further evaluate BNT321 in CA19-9+ tumors, including in advanced pancreatic cancer and expects to resume the Phase 1/2 trial in the fourth quarter of 2019.

 

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 filed an IND with the FDA in early November 2019 and expect to initiate a Phase 1/2a clinical trial of BNT411 in the first half of 2020.

 

In preclinical studies, BNT411 induced a strong type-1 Interferon-dominated release of cytokines and a potent stimulation of antigen-specific CD8+ T cells, B cells, and innate immune cells such as NK cells and macrophages, resulting in potent anti-tumor activity in various mouse models.

 

 


 

Recent Corporate Developments

 

Clinical trial supply agreement with Regeneron:

In November 2019, BioNTech signed a clinical trial supply agreement with Regeneron to supply cemiplimab for use in combination with BioNTech’s BNT112 in a first-in-human Phase 1/2 trial in advanced prostate cancer. Under the terms of the agreement, BioNTech and Regeneron will agree to a joint clinical development plan in prostate cancer and Regeneron will agree to supply their PD-1 checkpoint inhibitor Libtayo® (cemiplimab) at no cost to BioNTech for use in combination with BNT112 in BioNTech’s planned Phase 1/2 trial. BioNTech and Regeneron will each retain full commercial rights to BNT112 and Libtayo respectively.  BioNTech will be the sponsor of the trial. The CTA in various European countries was accepted on November 5, 2019. BioNTech expects to initiate the single-agent dose escalation part of the Phase 1/2 trial in the fourth quarter of 2019.

 

Exercise of Greenshoe:

On October 29, 2019, JP Morgan Securities LLC, BOFA Securities, Inc, UBS Securities LLC and SVB Leerink LLC, as representatives of the lead joint book-running managers of BioNTech’s recently closed initial public offering on the Nasdaq Global Market, exercised their over-allotment option to purchase an additional 517,408 American Depository Shares (“ADSs”) at a price to the public of US$15 per ADS, representing 517,408 ordinary shares with no par value with a notional amount attributable to each ordinary share of €1 each. The option exercise closed on November 6, 2019 and raised additional net proceeds of approximately $7 million (€6,6 million), after deducting underwriting discounts and commissions.

 

Third Quarter 2019 Financial Results

 

Cash Position: Cash and cash equivalents as of September 30, 2019, were €463.3 million, compared to €411.5 million as of December 31, 2018.

 

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was €28.7 million for the quarter ended September 30, 2019, compared to €20.4 million for the quarter ended September 30, 2018. The increase was primarily due to progress in our collaboration agreements with Genentech and Eli Lilly.

 

Research and Development Expenses: Research and development expenses were €50.4 million for the quarter ended September 30, 2019, compared to €32.8 million for the quarter ended September 30, 2018. The increase was primarily due to an increase in headcount, the expense recognized from the granting of options under the ESOP program and higher expenses regarding our collaboration agreements.

 

General and Administrative Expenses: General and administrative expenses were €10.6 million for the quarter ended September 30, 2019, compared to €6.6 million for the quarter ended September 30, 2018. This increase was primarily due to an increase in headcount and the expense recognized from the granting of options under the ESOP program.

 

Net Loss: Net loss was €30.1 million for the quarter ended September 30, 2019, compared to net loss of €23.5 million for the quarter ended September 30, 2018.

 

Shares Outstanding: Shares outstanding as of September 30, 2019 were 216,262,336.

 

 


 

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 third quarter ended September 30, 2019 and provide a corporate update.

 

To participate in the conference call, please dial the following numbers five minutes prior to the start of the call and provide the Conference ID: 8453733.

 

United States international:

+1 631 510 7495

United States domestic (toll-free):

+1 866 966 1396

Germany:

+49 692 443 7351

 

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.

 

About BioNTech

 

BioNTech was founded in 2008 on the understanding that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized. Its cutting-edge pipeline includes individualized mRNA-based product candidates, innovative chimeric antigen receptor T cells, novel checkpoint immunomodulators, targeted cancer antibodies and small molecules. BioNTech has established relationships with seven pharmaceutical collaborators, including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant and Pfizer, and has published over 150 peer-reviewed publications on its scientific approach.

 

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 the re-initiation of clinical trials for BNT321; plans to initiate clinical trials of BNT111, BNT112, BNT113 and BNT211; and expectations for data announcements with respect to BioNTech’s iNeST and BNT114 clinical trials. 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” and those described in BioNTech’s Prospectus filed with the U.S. Securities and Exchange Commission (SEC) on October 11, 2019 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on BioNTech’s current expectations and speak only as of the date hereof.

 


 

 

For more information, please contact:

 

BioNTech SE

 

Michael Boehler, MD

Head of Global External Communications

Tel: +49 (0)6131 9084 1640

Email: Michael.Boehler@biontech.de

 

For all media inquiries:

 

Trophic Communications

Gretchen Schweitzer / Stephanie May, PhD

Tel: +49 (0)89 23 88 77 30 or +49 171 185 56 82

Email: May@trophic.eu

 

 

 

bntx-ex992_7.htm

Exhibit 99.2

 

 

 

 

BioNTech SE

Interim condensed consolidated financial statements
September 30, 2019

 

 

 


Index to the Interim Condensed Consolidated
Financial Statements

 

Interim condensed consolidated statements of operations

 

3

 

 

 

Interim condensed consolidated statements of comprehensive income (loss)

 

4

 

 

 

Interim condensed consolidated statements of financial position

 

5

 

 

 

Interim condensed consolidated statements of changes in equity

 

6

 

 

 

Interim condensed consolidated statements of cash flows

 

8

 

 

 

Condensed explanatory notes to the financial statements

 

9

 

1

Corporate information

 

9

 

 

 

 

2

Significant accounting policies

 

9

 

 

 

 

3

Segment information

 

10

 

 

 

 

4

Revenue from contracts with customers

 

12

 

 

 

 

5

Business combinations

 

13

 

 

 

 

6

Income tax

 

14

 

 

 

 

7

Property, plant and equipment

 

14

 

 

 

 

8

Intangible assets

 

14

 

 

 

 

9

Financial assets and financial liabilities

 

15

 

 

 

 

10

Issued capital and reserves

 

16

 

 

 

 

11

Share-based payments

 

17

 

 

 

 

12

Related party disclosures

 

18

 

 

 

 

13

Events after the reporting period

 

19

 

 

 


 

Notes

 

 

 

Interim condensed consolidated statements of operations

for the three months ended and the nine months ended September 30, 2019 and 2018

 

 

 

 

Three months ended

September 30,

 

Nine months ended

September 30,

 

 

 

2019

2018

 

2019

2018

(in thousands, except per share data)

 

Note

(unaudited)

 

(unaudited)

 

 

 

 

 

 

 

 

Revenues from contracts with customers

 

4

€28,662

€20,397

 

€80,601

€63,796

Cost of sales

 

 

(4,230)

(2,778)

 

(12,925)

(9,215)

Gross profit

 

 

€24,432

€17,619

 

€67,676

€54,581

 

 

 

 

 

 

 

 

Research and development expenses

 

 

(50,396)

(32,791)

 

(161,039)

(91,244)

Sales and Marketing expenses

 

 

(670)

(769)

 

(1,908)

(1,984)

General and administrative expenses

 

 

(10,582)

(6,558)

 

(34,481)

(16,222)

Other operating income

 

 

347

1,428

 

1,340

4,043

Other operating expenses

 

 

(5)

(558)

 

(163)

(631)

Operating loss

 

 

€(36,874)

€(21,629)

 

€(128,575)

€(51,457)

 

 

 

 

 

 

 

 

Finance income

 

 

7,294

362

 

9,170

6,644

Finance expenses

 

 

(82)

(1,189)

 

(233)

(12)

Interest expense related to lease liability

 

 

(433)

(429)

 

(1,283)

(1,297)

Share of loss of equity method investees

 

 

-

(21)

 

-

(84)

Loss before tax

 

 

€(30,095)

€(22,906)

 

€(120,921)

€(46,206)

 

 

 

 

 

 

 

 

Income taxes

 

6

(8)

(573)

 

(28)

(583)

Loss for the period

 

 

€(30,103)

€(23,479)

 

€(120,949)

€(46,789)

 

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

 

Equity holders of the parent

 

 

(30,103)

(23,432)

 

(120,833)

(46,667)

Non-controlling interests

 

 

-

(47)

 

(116)

(122)

 

 

 

€(30,103)

€(23,479)

 

€(120,949)

€(46,789)

 

 

 

 

 

 

 

 

Earnings per share

 

 

 

 

 

 

 

In EUR

 

 

 

 

 

 

 

Basic & diluted, loss for the year attributable to ordinary equity holders of the parent

 

 

€(0.14)

€(0.12)

 

€(0.59)

€(0.25)

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

 

 

3


 

Notes

 

 

 

Interim condensed consolidated statements of comprehensive income (loss)

for the three months ended and the nine months ended September 30, 2019 and 2018

 

 

 

 

Three months ended

September 30,

 

Nine months ended

September 30,

 

 

 

2019

2018

 

2019

2018

(in thousands)

 

Note

(unaudited)

 

(unaudited)

Loss for the period

 

 

€(30,103)

€(23,479)

 

€(120,949)

€(46,789)

 

 

 

 

 

 

 

 

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

 

 

(8)

1

 

(2)

7

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

 

 

(8)

1

 

(2)

7

 

 

 

 

 

 

 

 

Other comprehensive income for the period, net of tax

 

 

(8)

1

 

(2)

7

 

 

 

 

 

 

 

 

Comprehensive loss for the period, net of tax

 

 

€(30,111)

€(23,478)

 

€(120,951)

€(46,782)

 

 

 

 

 

 

 

 

Attributable to:

 

 

 

 

 

 

 

Equity holders of the parent

 

 

(30,111)

(23,431)

 

(120,835)

(46,660)

Non- controlling interests

 

 

-

(47)

 

(116)

(122)

Comprehensive loss for the period, net of tax

 

 

€(30,111)

€(23,478)

 

€(120,951)

€(46,782)

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


4


 

Notes

 

 

 

Interim condensed consolidated statements of financial position

for the periods ended September 30, 2019 and December 31, 2018

 

 

 

 

 

September 30,

December 31,

(in thousands)

 

 

2019

2018

Assets

 

Note

(unaudited)

 

Non-current assets

 

 

 

 

Intangible assets

 

8

€94,482

€88,042

Property, plant and equipment

 

7

142,631

115,966

Other financial assets

 

9

-

18

Total non-current assets

 

 

€237,113

€204,025

Current assets

 

 

 

 

Inventories

 

 

10,869

5,789

Trade receivables

 

9

8,931

18,938

Other financial assets

 

9

356

336

Other assets

 

 

9,345

9,164

Income tax assets

 

 

546

891

Deferred expense

 

 

7,940

2,348

Cash and cash equivalents

 

 

463,308

411,495

Total current assets

 

 

€501,295

€448,961

Total assets

 

 

€738,408

€652,986

 

 

 

 

 

Equity and liabilities

 

 

 

 

Equity

 

 

 

 

Share capital

 

10

221,787

193,296

Capital reserve

 

10

569,751

344,115

Treasury shares

 

10

(5,525)

-

Accumulated losses

 

 

(366,604)

(245,771)

Other reserves

 

 

(3,004)

(25,487)

Equity attributable to equity holders of the parent

 

 

€416,405

€266,153

Non-controllng interest

 

 

-

847

Total equity

 

 

€416,405

€267,000

Non-current liabilities

 

 

 

 

Financial liabilities

 

9

67,813

54,218

Contract liabilities

 

 

126,067

205,647

Total non-current liabilities

 

 

€193,880

€259,865

Current liabilities

 

 

 

 

Tax provisions

 

 

297

297

Provisions

 

 

851

710

Trade payables

 

9

21,813

41,721

Contract liabilities

 

 

82,585

66,027

Other financial liabilities

 

9

15,730

8,266

Other liabilities

 

 

6,847

9,100

Total current liabilities

 

 

€128,123

€126,121

Total liabilities

 

 

€322,003

€385,986

Total equity and liabilities

 

 

€738,408

€652,986

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

 

 

5


 

Notes

 

 

 

Interim condensed consolidated statements of changes in equity

 

  

 

 

Nine months ended September 30, 2019

 

 

 

Attributable to the equity holders of the parent

 

 

 

(in thousands)

 

Note

Issued

capital

Capital

reserve

Treasury shares

Accumulated

losses

Other

reserves

Foreign

currency

translation

reserve

Total

Non-controlling

interests

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

As at January 1, 2019

 

 

€193,296

344,115

-

(245,771)

(25,474)

(13)

266,153

847

267,000

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

-

-

-

(120,833)

-

-

(120,833)

(116)

(120,949)

Other comprehensive income

 

 

-

-

-

-

-

(2)

(2)

-

(2)

Total comprehensive income

 

 

-

-

-

(120,833)

-

(2)

(120,835)

(116)

(120,951)

 

 

 

 

 

 

 

 

 

-

 

 

Issuance of share capital

 

10

8,126

41,748

-

-

-

-

49,874

-

49,874

Capital increase Series B

 

10

17,990

186,390

(5,525)

-

-

-

198,855

-

198,855

Acquisition of non-controlling interest

 

10

2,375

(1,644)

-

-

-

-

731

(731)

-

Transaction costs

 

10

-

(858)

-

-

-

-

(858)

-

(858)

Share-based payments

 

11

-

-

-

-

22,485

-

22,485

-

22,485

 

 

 

 

 

 

 

 

 

 

 

 

At September 30, 2019

 

 

€221,787

569,751

(5,525)

(366,604)

(2,989)

(15)

416,405

-

416,405

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine months ended September 30, 2018

 

 

 

Attributable to the equity holders of the parent

 

 

 

(in thousands)

 

Note

Issued

capital

Capital

reserve

Treasury shares

Accumulated

losses

Other

reserves

Foreign

currency

translation

reserve

Total

Non-controlling

interests

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

As at January 1, 2018

 

 

€166,764

8,922

-

(197,753)

(27,206)

(23)

(49,296)

1,090

(48,206)

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

-

-

-

(46,667)

-

-

(46,667)

(122)

(46,789)

Other comprehensive income

 

 

-

-

-

-

-

5

5

-

5

Total comprehensive income

 

 

-

-

-

(46,667)

-

5

(46,662)

(122)

(46,784)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of share capital Series A

 

10

22,588

206,216

-

-

-

-

228,804

-

228,804

Issuance of share capital

 

10

3,943

48,980

-

-

-

-

52,923

-

52,923

Settlement of share-based payment plan

 

 

-

-

-

-

(5,909)

-

(5,909)

-

(5,909)

 

 

 

 

 

 

 

 

 

 

 

 

At September 30, 2018

 

 

€193,295

264,118

-

(244,420)

(33,115)

(18)

179,860

968

180,828

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 


6


 

Notes

 

 

 

 

  

 

 

Three months ended September 30, 2019

 

 

 

Attributable to the equity holders of the parent

 

 

 

(in thousands)

 

Note

Issued

capital

Capital

reserve

Treasury shares

Accumulated

losses

Other

reserves

Foreign

currency

translation

reserve

Total

Non-controlling

interests

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

As at July 1, 2019

 

 

€212,749

515,737

-

(336,501)

(7,488)

(7)

384,490

-

384,490

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

-

-

-

(30,103)

-

-

(30,103)

-

(30,103)

Other comprehensive income

 

 

-

-

-

-

-

(8)

(8)

-

(8)

Total comprehensive income

 

 

-

-

-

(30,103)

-

(8)

(30,111)

-

(30,111)

 

 

 

 

 

 

 

 

 

-

 

 

Issuance of share capital

 

10

3,038

46,826

-

-

-

-

49,864

-

49,864

Capital increase Series B

 

10

6,000

7,545

(5,525)

-

-

-

8,020

-

8,020

Transaction costs

 

10

-

(357)

-

-

-

-

(357)

-

(357)

Share-based payments

 

11

-

-

-

-

4,499

-

4,499

-

4,499

 

 

 

 

 

 

 

 

 

 

 

 

At September 30, 2019

 

 

€221,787

569,751

(5,525)

(366,604)

(2,989)

(15)

416,405

-

416,405

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

 

Three months ended September 30, 2018

 

 

 

Attributable to the equity holders of the parent

 

 

 

(in thousands)

 

Note

Issued

capital

Capital

reserve

Treasury shares

Accumulated

losses

Other

reserves

Foreign

currency

translation

reserve

Total

Non-controlling

interests

Total equity

 

 

 

 

 

 

 

 

 

 

 

 

As at July 1, 2018

 

 

€189,352

215,138

-

(220,988)

(33,115)

(18)

150,369

1,015

151,384

 

 

 

 

 

 

 

 

 

 

 

 

Loss for the period

 

 

-

-

-

(23,432)

-

-

(23,432)

(47)

(23,479)

Other comprehensive income

 

 

-

-

-

-

-

-

-

-

-

Total comprehensive income

 

 

-

-

-

(23,432)

-

-

(23,432)

(47)

(23,479)

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of capital share

 

10

3,943

48,980

-

-

-

-

52,923

-

52,923

 

 

 

 

 

 

 

 

 

 

 

 

At September 30, 2018

 

 

€193,295

264,118

-

(244,420)

(33,115)

(18)

179,860

968

180,828

(unaudited)

 

 

 

 

 

 

 

 

 

 

 

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

 

 

7


 

Notes

 

 

 

Interim condensed consolidated statements of cash flows

for the three months ended and the nine months ended September 30, 2019 and 2018

 

 

Nine months ended

September 30,

 

 

2019

2018

(in thousands)

 

(unaudited)

 

 

 

 

Operating activities

 

 

 

Loss for the period

 

€(120,949)

€(46,789)

Income taxes

 

28

583

Loss before tax

 

€(120,921)

€(46,206)

Adjustments to reconcile loss before tax to net cash flows:

 

 

 

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

 

24,087

13,759

Share-based payment expense

 

22,485

-

Net foreign exchange differences

 

(170)

(10)

(Gain)/Loss on disposal of property, plant and equipment

 

11

-

Finance income

 

(1,102)

(1,500)

Interest on lease liability

 

1,283

1,295

Finance expense

 

233

12

Share of loss of an associate and a joint venture

 

-

84

Working capital adjustments:

 

 

 

Decrease/(Increase) in trade receivable and contract assets

 

4,575

(12,913)

Decrease/(Increase) in inventories

 

(4,945)

(1,525)

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

 

(60,003)

(8,313)

Interest received

 

1,102

1,500

Interest paid

 

(1,517)

(1,308)

Income tax paid

 

(28)

(287)

Net cash flows used in operating activities

 

€(134,910)

€(55,412)

 

 

 

 

Investing activities

 

 

 

Purchase of property, plant and equipment

 

(28,621)

(17,448)

Proceeds from sale of property, plant and equipment

 

568

565

Purchase of intangibles assets

 

(32,937)

(29,254)

Acquisition of subsidiaries and businesses, net of cash acquired

 

(6,056)

-

Net cash flows used in investing activities

 

€(67,046)

€(46,137)

 

 

 

 

Financing activities

 

 

 

Proceeds from issuance of share capital, net of costs

 

247,871

281,727

Proceeds from loans and borrowings

 

8,067

2,500

Payment of finance lease liabilities

 

(2,215)

(1,618)

Net cash flows from/(used in) financing activities

 

€253,723

€282,609

 

 

 

 

Net increase/(decrease) in cash and cash equivalents

 

51,767

181,060

Change in cash resulting from exchange rate differences

 

46

10

Cash and cash equivalents at beginning of period

 

411,495

172,106

Cash and cash equivalents at September 30

 

€463,308

€353,176

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

8


 

Notes

 

 

 

Condensed explanatory notes to the financial statements

1

Corporate information

BioNTech SE is a limited company incorporated and domiciled in Germany. American Depository Shares (ADS) representing our 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 IFRS 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 (IASB).

Effective March 8, 2019, BioNTech AG changed its name and legal form to BioNTech SE. The Group is principally engaged in developing innovative molecular immunotherapies and biomarker-based diagnostic approaches for the individualized treatment of cancer and other infectious diseases.

During the nine months ended September 30, 2019, the following changes to our Group structure occurred (details are described in note 5):

 

-

Two new entities have been founded in the United States: BioNTech USA Holding, LLC and BioNTech Research & Development, Inc. Both are wholly owned subsidiaries of BioNTech SE.

 

-

The reBOOST Management GmbH, a related party, was acquired through a share purchase.

All entities are included in our Group’s consolidated financial statements.

The interim condensed consolidated financial statements of the Group as of and for the three and nine months ended September 30, 2019 were authorized for issuance in accordance with a resolution of the directors on November 13, 2019.

2

Significant accounting policies

Basis of preparation

The interim condensed consolidated financial statements as of and for the three and nine months ended September 30, 2019 have been prepared in accordance with IAS 34 Interim Financial Reporting.

The 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 at December 31, 2018 and 2017 and for the two years then ended.

BioNTech prepares and presents its consolidated financial statements in Euros. Unless otherwise stated, the numbers are rounded to thousands of Euros.

The accounting policies adopted in the preparation of the 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, 2018. The standards applied

9


 

Notes

 

 

 

for the first time as of January 1, 2019, as disclosed in the notes to the consolidated financial statements as of December 31, 2018, had no impact on the interim condensed consolidated financial statements of the Group as of September 30, 2019.

3

Segment information

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, 2018 for the nine months and the three months ended September 30, 2019 and 2018, respectively:

 

  

 

Business Unit BioNTech

External Services Business Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product Sales &

External Services

Total

Adjustments

Group

Nine months ended September 30, 2019

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€25,605

€1,972

€36,683

-

-

€64,260

 

€64,260

Revenues from other sales transactions

 

-

605

2

8

15,726

16,341

 

16,341

Cost of sales

 

-

-

-

-

(12,770)

(12,770)

(155)

(12,925)

Gross Profit

 

€25,605

€2,577

€36,685

€8

€2,956

€67,831

€(155)

€67,676

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(65,634)

(52,503)

(38,905)

(3,732)

(420)

(161,194)

155

(161,039)

Sales and Marketing expenses

 

-

-

-

(924)

(984)

(1,908)

 

(1,908)

General and administrative expenses

 

-

-

(2,741)

(29,398)

(2,204)

(34,343)

(138)

(34,481)

Other result

 

307

389

42

61

378

1,177

-

1,177

Segment operating income / (loss)

 

€(39,722)

€(49,537)

€(4,919)

€(33,985)

€(274)

€(128,437)

€(138)

€(128,575)

 

10


 

Notes

 

 

 

 

 

Business Unit BioNTech

External Services

Business Unit

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product Sales &

External Services

Total

Adjustments

Group

Nine months ended September 30, 2018

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€22,986

€4,627

€17,871

-

-

€45,484

 

€45,484

Revenues from other sales transactions

 

-

5,786

-

42

12,484

18,312

 

18,312

Cost of sales

 

-

-

-

(40)

(9,024)

(9,064)

(151)

(9,215)

Gross Profit

 

€22,986

€10,413

€17,871

€2

€3,460

€54,732

€(151)

€54,581

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(27,777)

(42,295)

(19,340)

(1,430)

(553)

(91,395)

151

(91,244)

Sales and Marketing expenses

 

-

-

-

(983)

(1,001)

(1,984)

-

(1,984)

General and administrative expenses

 

-

-

(1,894)

(12,643)

(1,685)

(16,222)

-

(16,222)

Other result

 

3,058

127

26

(94)

272

3,389

23

3,412

Segment operating income / (loss)

 

€(1,733)

€(31,755)

€(3,337)

€(15,148)

€493

€(51,480)

€23

€(51,457)

 

 

 

Business Unit BioNTech

Business Unit

External Services

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product Sales &

External Services

Total

Adjustments

Group

Three months ended September 30, 2019

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€7,174

€1,972

€13,091

-

-

€22,237

-

€22,237

Revenues from other sales transactions

 

-

142

-

-

6,283

6,425

-

6,425

Cost of sales

 

-

-

-

-

(4,166)

(4,166)

(64)

(4,230)

Gross Profit

 

€7,174

€2,114

€13,091

-

€2,117

€24,496

€(64)

€24,432

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(21,948)

(14,289)

(12,668)

(1,397)

(158)

(50,460)

64

(50,396)

Sales and Marketing expenses

 

-

-

-

(355)

(315)

(670)

-

(670)

General and administrative expenses

 

-

-

(883)

(8,702)

(859)

(10,444)

(138)

(10,582)

Other result

 

47

101

28

35

131

342

-

342

Segment operating loss

 

€(14,727)

€(12,074)

€(432)

€(10,419)

€916

€(36,736)

€(138)

€(36,874)

 

11


 

Notes

 

 

 

  

 

Business Unit BioNTech

Business Unit

External Services

 

 

 

(in thousands)

 

Clinical

Technology

Platform

Manufacturing

Business Service

Product Sales &

External Services

Total

Adjustments

Group

Three months ended September 30, 2018

 

 

 

 

 

 

 

 

 

Revenues

 

 

 

 

 

 

 

 

 

Collaboration Revenues

 

€9,552

€248

€6,401

-

-

€16,201

-

€16,201

Revenues from other sales transactions

 

-

173

-

27

3,996

4,196

-

4,196

Cost of sales

 

-

-

-

-

(2,638)

(2,638)

(140)

(2,778)

Gross Profit

 

€9,552

€421

€6,401

€27

€1,358

€17,759

€(140)

€17,619

Income / Expenses

 

 

 

 

 

 

 

 

 

Research and development expenses

 

(9,051)

(14,945)

(8,295)

(465)

(175)

(32,931)

140