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.
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BioNTech SE |
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By: |
/s/ Prof. Ugur Sahin, M.D. |
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Name: Prof. Ugur Sahin, M.D. |
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Title: Chief Executive Officer |
Date: November 14, 2019
EXHIBIT INDEX
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Exhibit |
Description of Exhibit |
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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 |
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Exhibit 99.1
BioNTech SE Provides Update on Corporate Progress and Third Quarter 2019 Financial Results
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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. |
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• |
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. |
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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. |
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• |
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. |
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Ended the third quarter of 2019 with cash equivalents of $505m (€463.3m1). |
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• |
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.
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1 |
ECB exchange rate on September 30th was 1.0889. |
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• |
BNT111 (advanced melanoma): We expect to initiate both a Phase 2 trial and a registrational, randomized Phase 3 trial for BNT111 in 2020. |
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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. |
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• |
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. |
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• |
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.
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
Exhibit 99.2
BioNTech SE
Interim condensed consolidated financial statements
September 30, 2019
Index to the Interim Condensed Consolidated
Financial Statements
1 |
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9 |
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2 |
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9 |
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3 |
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10 |
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|
|
4 |
|
12 |
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5 |
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13 |
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|
|
|
6 |
|
14 |
|
|
|
|
|
7 |
|
14 |
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|
|
|
|
8 |
|
14 |
|
|
|
|
|
9 |
|
15 |
|
|
|
|
|
10 |
|
16 |
|
|
|
|
|
11 |
|
17 |
|
|
|
|
|
12 |
|
18 |
|
|
|
|
|
13 |
|
19 |
Notes |
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Interim condensed consolidated statements of operations
for the three months ended and the nine months ended September 30, 2019 and 2018
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Three months ended September 30, |
|
Nine months ended September 30, |
||
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|
|
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
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Three months ended September 30, |
|
Nine months ended September 30, |
||
|
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|
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
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.
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.
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 |
(32,791) |
Sales and Marketing expenses |
|
- |
- |
- |
(423) |
(346) |
(769) |
- |
(769) |
General and administrative expenses |
|
- |
- |
(729) |
(5,265) |
(564) |
(6,558) |
- |
(6,558) |
Other result |
|
931 |
(91) |
(2) |
(37) |
46 |
847 |
23 |
870 |
Segment operating loss |
|
€1,432 |
€(14,615) |
€(2,625) |
€(6,163) |
€319 |
€(21,652) |
€23 |
€(21,629) |
The goodwill recorded through the acquisitions of MAB Discovery as well as reBOOST Management GmbH during the nine months ended September 30, 2019 were allocated to the Technology Platform segment.
In order to reconcile the segment figures to the Group interim condensed consolidated financial statements, some of the research and development expenses need to be reclassified to cost of sales.
Disaggregated revenue information
Set out below is the disaggregation of the Group’s revenue from contracts with customers:
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
||
(in thousands) |
|
2019 |
2018 |
|
2019 |
2018 |
Revenues resulting from collaboration and license agreements |
|
€22,237 |
€16,201 |
|
€64,260 |
€45,482 |
Genentech Inc. |
|
16,677 |
12,365 |
|
47,620 |
34,528 |
Pfizer Inc. |
|
3,587 |
3,587 |
|
10,761 |
3,587 |
Sanofi S.A. |
|
152 |
249 |
|
4,058 |
3,951 |
Genmab A/S |
|
- |
- |
|
- |
2,740 |
Eli Lilly and Company |
|
1,821 |
- |
|
1,821 |
676 |
Revenues from other sales transactions |
|
6,425 |
4,196 |
|
16,341 |
18,314 |
Total |
|
€28,662 |
€20,397 |
|
€80,601 |
€63,796 |
12
Notes |
|
|
|
The transactions resulting from product sales that are included within the revenue from other sales transactions are displayed below:
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
||
(in thousands) |
|
2019 |
2018 |
|
2019 |
2018 |
Product sales of JPT Peptide Technologies GmbH |
|
€3,057 |
€2,669 |
|
€8,892 |
€7,601 |
MAB Discovery GmbH
In January 2019, BioNTech entered into an asset purchase agreement to acquire MAB Discovery GmbH’s operational antibody generation unit based near Munich, Germany (hereinafter also referred to as “MAB Discovery”), for a total consideration of k€6,050. The employees of MAB Discovery were transferred automatically to BioNTech with effect as of the closing date. The acquisition closed on April 1, 2019.
The Group has acquired MAB Discovery because it intends to adopt and pursue the unit’s current business into its own.
The fair values of the identifiable net assets of MAB Discovery as at the date of acquisition were:
|
Fair value recognized on acquisition |
(in thousands) |
MAB Discovery GmbH |
Assets |
|
Goodwill |
€2,205 |
Other intangible assets |
2,711 |
Property, plant and equipment |
999 |
Inventories |
135 |
Total identifiable net assets at fair value |
€6,050 |
|
Cash flow on acquisition |
(in thousands) |
MAB Discovery GmbH |
|
|
Net cash acquired |
- |
Cash paid |
6,050 |
Net cash flow on acquisition |
€(6,050) |
The interim condensed consolidated financial statements include the results of MAB Discovery since the acquisition date. From the date of acquisition, MAB Discovery contributed kEUR 3,251 to loss before tax in the Technology Platform business segment from continuing operations of the Group. From the date of acquisition, MAB Discovery did not generate any revenue. Goodwill recognized is primarily attributed to the expected synergies and other benefits from combining the assets and activities of MAB Discovery with those of the Group.
13
Notes |
|
|
|
Transaction costs related to the acquisition have been expensed and are included in the general and administrative expenses within the interim condensed consolidated statement of operations and are part of operating cash flows in the statement of cash flows.
reBOOST Management GmbH
On August 29, 2019, BioNTech entered into an agreement to purchase all of the outstanding shares of reBOOST Management GmbH from Medine GmbH, which is wholly owned by BioNTech’s Chief Executive Officer, Ugur Sahin. The kEUR 279 purchase price consists of kEUR 31 cash consideration and assumption of liabilities of up to kEUR 248. The related party acquisition closed on September 2, 2019.
The Group acquired reBOOST because it expects to lift synergies and other benefits arising from the ongoing collaborations of reBOOST with different cooperations.
The Group calculates the interim income tax expense using the tax rate that would be applicable to the expected total annual earnings. For the three months ended September 30, 2019 an amount of kEUR 8 was recorded. For the three months ended September 30, 2018 kEUR 573 were recorded respectively. For the nine months ended September 30, 2019 an amount of kEUR 28 was recorded. For the nine months ended September 30, 2018 kEUR 583 were recorded respectively.
During the nine months ended September 30, 2019, the Group acquired property, plant and equipment with a cost of kEUR 28,621 (nine months ended September 30, 2018: kEUR 13,948). The acquisitions during the nine months ended September 30, 2019 were related to constructions in progress and advanced payments (kEUR 12,012), land and buildings (kEUR 7,176) as well as equipment, tools and installations (kEUR 9,433). During the nine months ended September 30, 2018, the acquisitions were related to equipment, tools and installations (kEUR 6,305), land and buildings (kEUR 4,364) as well as construction in progress and advance payments (kEUR 3,279).
During the nine months ended September 30, 2019, the Group acquired intangible assets with a cost of kEUR 13,721 (nine months ended September 30, 2018: kEUR 6,526), excluding intangible assets acquired through business combinations (see note 5). The acquisitions during the nine months ended September 30, 2019 were mainly related to advance payments (kEUR 5,403) as well as concessions, licenses and similar rights (kEUR 8,318). During the nine months ended September 30, 2018 the acquisitions were mainly related to concessions, licenses and similar rights (kEUR 4,962) as well as advance payments (kEUR 1,564).
14
Notes |
|
|
|
Set out below, is an overview of financial assets, other than cash and cash equivalents, held by the Group as at September 30, 2019 and December 31, 2018:
Financial assets at amortized cost |
|
|
|
|
(in thousands) |
|
|
September 30, 2019 |
December 31, 2018 |
Trade receivables |
|
|
€8,931 |
€18,938 |
Other financial assets and receivables |
|
|
356 |
354 |
Total |
|
|
€9,287 |
€19,292 |
Total current |
|
|
9,287 |
19,274 |
Total non-current |
|
|
- |
18 |
Set out below, is an overview of financial liabilities held by the Group as at September 30, 2019 and December 31, 2018:
Financial liabilities: Interest-bearing loans and borrowings |
|
|
|
|
(in thousands) |
|
Maturity |
September 30, 2019 |
December 31, 2018 |
2.15% € 10,000,000 secured bank loan |
|
12/30/2027 |
€9,000 |
€4,000 |
2.08% € 9,450,000 secured bank loan |
|
09/30/2028 |
4,600 |
1,600 |
Total |
|
|
€13,600 |
€5,600 |
Total current |
|
|
- |
- |
Total non-current |
|
|
13,600 |
5,600 |
Other financial liabilities at amortized cost, other than interest-bearing loans and borrowings |
|
|
||
(in thousands) |
|
|
September 30, 2019 |
December 31, 2018 |
Trade and other payables |
|
|
€21,813 |
€41,721 |
Lease liabilities |
|
|
57,672 |
50,752 |
Other payables |
|
|
12,271 |
6,132 |
Total |
|
|
€91,756 |
€98,605 |
Total current |
|
|
37,543 |
49,987 |
Total non-current |
|
|
54,213 |
48,618 |
Risk management activities
No changes have occurred regarding our risk management activities as disclosed in the notes to the consolidated financial statements as of December 31, 2018.
Fair values
Fair values of cash and cash equivalents, trade receivables, trade payables, and other current liabilities approximate their carrying amounts largely due to the short-term maturities of these instruments.
The liabilities include two fixed-interest rate loans. The fair value of the two fixed-interest rate loans is calculated based on significant observable inputs (Level 2). As of September 30, 2019
15
Notes |
|
|
|
and December 31, 2018, the carrying value approximates their fair values as there have been no significant changes in relevant interest rates.
There were no transfers between Level 1 and Level 2 fair value measurements and no transfers into or out of Level 3 fair value measurements during the three and nine months ended September 30, 2019.
On September 18, 2019, BioNTech effected a 1:18 share split by issuing 206,595,492 shares by way of a capital increase from its own funds; thus, no outside proceeds were received. This capital increase came into effect upon registration with the commercial register (Handelsregister). The accompanying financial statements and notes to the financial statements give retroactive effect to the share split for all periods presented.
During the nine months ended September 30, 2019, the issued capital of BioNTech was increased by kEUR 28,491 (nine months ended September 30, 2018: kEUR 26,531). Each share has a nominal value of EUR 1.00. As a result of the financing transactions the capital reserve increased during the nine months ended September 30, 2019 by kEUR 226,494. Costs related to equity transactions (kEUR 858) were recorded in equity as deduction from capital reserves. The financing transactions that occurred during the nine months ended September 30, 2019 were as follows:
Issuance of share capital
In January 2019, BioNTech issued 5,088,204 shares and increased its share capital by kEUR 5,088. The cash investment of kEUR 80,006 was mainly already received in 2018 (kEUR 79,997).
On August 30, 2019, BioNTech entered into agreements with the Bill & Melinda Gates Foundation (BMGF). BMGF agreed to purchase 3,038,674 ordinary shares of BioNTech for a total of kEUR 49,864 (kUSD 55,000). These agreements require BioNTech to perform certain research and development activities to advance the development of products for the prevention and treatment of HIV and tuberculosis. In the event of a breach of the underlying conditions, including such research and development activities, BMGF has the right to sell its shares back to BioNTech at the initial share price or fair market value, whichever is higher, subject to certain conditions. BioNTech’s ability to pay dividends is also limited under the terms of these agreements.
Capital increase Series B
In June and August 2019, BioNTech issued an aggregate of 12,465,288 of ordinary shares (excluding 5,524,506 ordinary shares which were issued to a Hong Kong-based investor and subsequently transferred to BioNTech for no consideration; these shares are now held as treasury shares) to certain new and existing shareholders at a price of USD 18.10 per share for aggregate proceeds of kEUR 198,548 (kUSD 225,622).
16
Notes |
|
|
|
Acquisition of non-controlling interest
As of March 14, 2019, BioNTech acquired the remaining 5.5% of non-controlling interests in BioNTech Cell & Gene Therapies GmbH held by Eli Lilly Nederland B.V. in exchange of issuing 2,374,794 new ordinary shares with an imputed share in the share capital of EUR 1.00 each. This acquisition was recognized within equity and resulted in the derecognition of the non-controlling interest of kEUR 731 as well as an increase to the share capital of kEUR 2,375. The net effect of the transaction of kEUR 1,644 was recognized as a decrease in the capital reserve.
Capital transaction in the period of nine months ended September 30, 2018
During the comparative period of nine months ended September 30, 2018, the issued capital increased by kEUR 26,531. The increase was mainly related to kEUR 22,588 issued during the Series A financing round, kEUR 3,361 issued as qualifying shares and kEUR 582k as ordinary shares each having a nominal value of EUR 1.00. As a result of the financing transactions the capital reserve increased during the nine months ended September 30, 2018 by kEUR 255,196.
On November 15, 2018, the Group established a share option program that grants selected employees options to receive shares in the company. The program is designed as an Employee Stock Ownership Plan (ESOP) as disclosed in the notes to the consolidated financial statements as of December 31, 2018. The amounts disclosed in this note have been retrospectively adjusted to reflect the share split as described in note 10.
Set out below is an overview of changes in ESOP during the nine months ended September 30, 2019.
|
|
Share options outstanding |
Number of Ordinary Shares underlying options |
As at January 1, 2019 |
|
658,109 |
11,845,962 |
Added |
|
12,991 |
233,838 |
Forfeited |
|
(12,612) |
(227,016) |
As at September 30, 2019 |
|
658,488 |
11,852,784 |
The 12,991 options granted during the nine months ended September 30, 2019 consists of 9,471 options (representing 170,478 ordinary shares) granted between February 21, 2019 and April 3, 2019 and 3,520 options (representing 63,360 ordinary shares) granted between April 29, 2019 and May 31, 2019.
The fair value of options granted during the nine months ended September 30, 2019 was estimated on the grant date using the following assumptions:
17
Notes |
|
|
|
|
|
Grant dates between February 21 - April 3, 2019 |
Grant dates between April 29 - May 31, 2019 |
Weighted average fair value |
|
€6.93 |
€7.04 |
Weighted average share price |
|
€15.72 |
€16.03 |
Exercise price |
|
€15.03 |
€15.39 |
Expected volatility (%) |
|
46.0% |
|
Expected life (years) |
|
6.00 |
|
Risk-free interest rate (%) |
|
0.05% |
During the three months ended September 30, 2019 the Group has recognized kEUR 4,499 of share-based payment expenses in the statement of operations (three months ended September 30, 2018: Nil).
During the nine months ended September 30, 2019 the Group has recognized kEUR 22,485 of share-based payment expenses in the statement of operations (nine months ended September 30, 2018: Nil).
|
|
Three months ended September 30, |
Nine months ended September 30, |
(in thousands) |
|
2019 |
2019 |
Cost of sales |
|
€228 |
€684 |
Research and development expenses |
|
2,745 |
17,249 |
Sales and Marketing expenses |
|
26 |
80 |
General and administrative expenses |
|
1,500 |
4,472 |
|
€4,499 |
€22,485 |
The following table describes the transactions that have been entered into with AT Impf GmbH or entities controlled by them during the nine months ended September 30, 2019 and 2018:
|
|
Transaction value |
|
(in thousands) |
|
September 30, 2019 |
September 30, 2018 |
Purchases of various goods and services from entities controlled by AT Impf GmbH |
|
€1,523 |
€1,783 |
Purchases of property and other assets from entities controlled by AT Impf GmbH |
|
- |
3,094 |
Total |
|
€1,523 |
€4,877 |
18
Notes |
|
|
|
The following table describes the outstanding balances payable (receivable) to AT Impf GmbH (parent company of the Group) or entities controlled by them as per September 30, 2019 and 2018:
(in thousands) |
|
September 30, 2019 |
September 30, 2018 |
AT Impf GmbH |
|
€41 |
€(1,788) |
Total |
|
€41 |
€(1,788) |
The aggregate value of transactions related to key management personnel, or entities which they control, were as follows:
(in thousands) |
|
September 30, 2019 |
September 30, 2018 |
Consulting services |
|
€19 |
€19 |
Purchases of various goods and services from TRON |
|
6,259 |
6,090 |
Total |
|
€6,278 |
€6,109 |
The outstanding balances payable to key management personnel, or entities which they control, as per September 30, 2019 and 2018 were as follows:
(in thousands) |
|
September 30, 2019 |
September 30, 2018 |
TRON |
|
- |
€612 |
Total |
|
- |
€612 |
On October 10, 2019, BioNTech granted Prof. Ugur Sahin, M.D., BioNTech’s Chief Executive Officer, an option to purchase 4,374,963 of its ordinary shares. The grant is subject to the terms of BioNTech’s ESOP and contains vesting conditions consisting of a four-year service period (i.e. annually in equal installments over four years) and completion of an initial public offering by BioNTech. The latter has already taken place with effect of October 10, 2019. Exercise of the options is also subject to a four-year waiting period after the public offering. The option will have a per share exercise price at the price of the initial public offering.
On October 10, 2019, BioNTech increased its share capital by kEUR 10,000 in conjunction with the Initial Public Offering. American Depositary Shares which represent ordinary shares were offered on the Nasdaq Global Select Market at a price of USD 15.00. The net proceeds were kUSD 141,750 (kEUR 128,770).
On November 6, 2019, BioNTech increased its share capital by kEUR 517 upon the execution of the underwriter´s option. American Depositary Shares which represent ordinary shares were issued at a price of USD 15.00. The net proceeds were kUSD 7,334 (kEUR 6,610).
19