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 date of November 24, 2021
Commission File Number 001-39124
Centogene N.V.
(Translation of registrant’s name into English)
Am Strande 7
18055 Rostock
Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of 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): ◻
Centogene N.V.
On November 24, 2021, Centogene N.V. (the “Company”) issued a press release reporting its financial results for the nine months ended September 30, 2021. A copy of the press release is attached hereto as Exhibit 99.1.
Attached hereto as Exhibits 99.2, 99.3 and 99.4 are also the financial statements of the Company for the three and nine months ended September 30, 2021, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three and nine months ended September 30, 2021, and a risk factor on Going Concern, respectively. All exhibits attached hereto are incorporated by reference herein.
Exhibit 99.1 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the U.S. Securities Act of 1933, as amended, or the Exchange Act.
Exhibits 99.2, 99.3 and 99.4 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form S-8 (Registration Number 333-234551) of the Company and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
2
Signatures
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.
CENTOGENE N.V. | |||
Date: November 24, 2021 | |||
By: | /s/ Rene Just | ||
Name: | Rene Just | ||
Title: | Chief Financial Officer |
3
Exhibit Index
Exhibit |
| Description of Exhibit |
|
99.1 | |||
99.2 | |||
99.3 | |||
99.4 |
4
Exhibit 99.1
CENTOGENE Reports Third Quarter 2021 Financial Results
Second Consecutive Quarter of Core Business Growth, Phasing Out COVID-19 Testing and Restructuring Organization for Core Rare Disease Business
CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, November 24, 2021 (GLOBE NEWSWIRE– Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on generating data-driven insights to diagnose, understand, and treat rare diseases, today announced financial results for the third quarter ended September 30, 2021, and provided a recent business update.
Executive Commentary
“We are encouraged by the progress achieved in Q3 on our continued path to return focus and growth to our rare disease business, driving strategic Core Business execution,” stated Andrin Oswald, M.D., Chief Executive Officer at CENTOGENE. “We saw continued recovery trends in the Diagnostics segment, with over 40% increase in revenues compared to Q3 2020. While recovery in Pharma revenues is lagging, we remain optimistic for acceleration in the fourth quarter, given the ongoing growth in signed contract value as our new management team gains traction with current and prospective Pharma partners.”
Q3 Financial Highlights
● | Overall revenues of €30.2 million in Q3 2021, a 17% decrease compared to €36.3 million in Q3 2020 |
● | Revenues from the Company’s Pharma and Diagnostics segments (“Core Business”) increased 13%, including Diagnostics revenues (excl. COVID) of €7.3 million, an increase of 43% compared to €5.1 million in Q3 2020, and Pharma revenues of €2.7 million in Q3 2021, a decrease of 28% compared to €3.8 million in Q3 2020 |
● | Commercial COVID-19 testing revenues of €20.2 million in Q3 2021, down from €27.4 million in Q3 2020 |
● | Total segment adjusted EBITDA of €(2.5) million compared to €9.2 million in Q3 2020 from the Company’s Pharma, Diagnostics, and COVID-19 testing segments, mainly reflecting the adjusted EBITDA contribution from COVID-19 testing having decreased by €13.4 million compared to the same quarter last year, partially offset by stronger adjusted EBITDA contribution from the Core Business segments |
● | Cash and cash equivalents of €25.7 million as of September 30, 2021, compared to €34.8 million for the period ending June 30, 2021. There is uncertainty about the Company's ability to continue as a going concern. Please refer to the Company's Q3 2021 interim financial statements and related disclosures. |
“While the business team’s full focus is on the Core Business, we are also prudently managing the phaseout of our ancillary COVID-19 testing business. We will leverage this process to also streamline the operational footprint for the Core Business and fully align with the strategic framework unveiled to the shareholders in June. This is expected to lead to savings of up to EUR 15 million annualized excluding restructuring costs, predominantly reflecting a reduction in personnel-related and operational expenditures and will reduce the Company’s cash burn rate,” added René Just, Chief Financial Officer of CENTOGENE.
Recent Business Highlights
Corporate
● | Added approximately 22,000 individuals to rare disease-centric Bio/Databank in Q3 2021. This is a one-of-a-kind real-world data repository which includes samples as well as data and cell lines for rare diseases from patients from over 120 countries |
● | Published a research study in the New England Journal of Medicine highlighting ground-breaking family genetic research and path to a potential cure for structural birth defects. The study utilized insights gained from CENTOGENE’s Bio/Databank as part of a cross-organizational international team that analyzed data of more than 20,000 families. The findings provide a deeper understanding of syndromic structural birth defects and pave the way to advancing pharmacological treatment for the approximately 4 million infants every year that are born with these types of defects |
● | Authored nine peer-reviewed scientific publications in Q3 2021, focused on generating critical insights into an array of diseases, including Parkinson’s disease, as well as structural birth defects |
Pharma
● | Enrolled first patient in frontotemporal dementia (FTD) clinical study, which aims to enroll and complete data-rich genetic testing for more than 3,000 FTD patients at participating centers in Belgium, Germany, Greece, Italy, Portugal, Spain, and Turkey. The observational EFRONT Study is being conducted with support from Alector, Inc. Patients displaying the progranulin gene mutation (FTD-GRN) will have the option to enroll in Alector’s Phase 3 INFRONT-3 clinical trial |
● | Expanded partnership with Agios Pharmaceuticals, Inc. to generate novel insights into rare blood diseases. CENTOGENE will provide genetic testing and clinical trial support via a three-year fee-for-service agreement for Agios’ three global, pivotal trials in thalassemia and sickle cell disease |
● | Currently leading 12 observational longitudinal clinical studies to validate/monitor biomarkers, covering several disease categories, such as Parkinson’s disease, transthyretin amyloidosis, and inborn errors of metabolism |
Diagnostic
● | Reported order intake of 14,770, which represents a 46% increase compared to 10,150 in the same period in 2020 |
● | Combined the Company’s expertise with Twist Bioscience to develop advanced sequencing tools to make genetic testing rapidly accessible for more patients with rare diseases |
COVID-19 Testing & Organizational footprint
● | Leveraged CENTOGENE’s diagnostic expertise and resources with continued COVID-19 testing, including the processing of 342,300 test requests for SARS-CoV-2 testing in Q3 2021 |
2021 Financial Guidance
The Company updated its overall topline guidance and expects total revenue growth for FY2021 between 30-40% versus the prior year, driven mainly by COVID-19 related revenues. The portion of total revenues derived from COVID-19 testing has declined over the past three quarters and is expected to decline further in the fourth quarter – leading to a phaseout by the end of Q1 2022. After a decline of 20% from FY2019 to FY2020, the Company expects its Core Business to return to growth for FY2021 in the mid to high single digits.
Webcast and Conference Call Information
Management will host a conference call and webcast today at 2 p.m. CET/8 a.m. ET on November 24, 2021, to discuss financial results and recent developments. To access the conference call and webcast, please register at: http://emea.directeventreg.com/registration/6469305
Upon registering, each participant will be provided with Participant Dial-in information, a Direct Event Passcode, and a unique Registrant ID. Registrants can then join up to 10 minutes prior to the start of the call.
The webcast of the conference call and the slide deck will also be available on the Investor Relations page of the Company’s website at http://investors.centogene.com.
These results reflect another step forward for CENTOGENE’s mission to enable the cure of 100 rare diseases within the next 10 years. To learn more, visit: https://www.centogene.com/virtual-investor-event
About CENTOGENE
CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical, genetic, and multiomic data to diagnose, understand, and treat rare diseases. Our goal is to bring rationality to treatment decisions and to accelerate the
development of new orphan drugs by using our extensive rare disease knowledge and data. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository of over 600,000 patients representing over 120 different countries.
The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, as well as a biobank of patients’ blood samples and cell cultures. CENTOGENE believes this represents the only platform focused on comprehensive analysis of multi-level data to improve the understanding of rare hereditary diseases. It allows for better identification and stratification of patients and their underlying diseases to enable and accelerate discovery, development, and access to orphan drugs. As of December 31, 2020, the Company collaborated with over 30 pharmaceutical partners.
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Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Statements contained herein that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “continues,” “expect,” “estimate,” “intend,” “project,” and similar expressions and future or conditional verbs such as “will,” “would,” “should,” “could,” “might,” “can,” and “may,” are generally intended to identify forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties, and other important factors that may cause CENTOGENE’s actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates, our ability to streamline cash usage, our requirement for additional financing and our ability to continue as a going concern, or other factors. For further information on the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to CENTOGENE’s business in general, see CENTOGENE’s risk factors set forth in CENTOGENE’s Form 20-F filed on April 15, 2021, with the Securities and Exchange Commission (the “SEC”) and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and CENTOGENE’s specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Media Contact:
CENTOGENE
Lennart Streibel
Investor Relations
Investor.Relations@centogene.com
Ben Legg
Corporate Communications
Ben.Legg@centogene.com
Stern IR
Brendan Payne
+1 (212) 698 8695
brendan.payne@sternir.com
Exhibit 99.2
Centogene N.V.
Unaudited interim condensed consolidated statements of comprehensive loss
for the three and nine months ended September 30, 2021, and 2020
(in EUR k)
|
| For the three months ended September 30 |
| For the nine months ended September 30 | ||||||
Note | 2021 |
| 2020 |
| 2021 |
| 2020 | |||
Revenue |
| 4, 5 | | |
| | | |||
Cost of sales |
| | |
| | | ||||
Gross (loss)/ profit |
| ( | |
| | | ||||
Research and development expenses |
| | |
| | | ||||
General administrative expenses |
| | |
| | | ||||
Selling expenses |
| | |
| | | ||||
Impairment of financial assets |
| 7 | | |
| | | |||
Other operating income |
| 6.1 | | |
| | | |||
Other operating expenses |
| 6.2 | — | |
| | | |||
Operating loss |
|
| ( | ( |
| ( | ( | |||
Interest and similar income |
|
| — | — |
| — | | |||
Interest and similar expense |
|
| | |
| | | |||
Financial costs, net |
| ( | ( |
| ( | ( | ||||
Loss before taxes |
|
| ( | ( |
| ( | ( | |||
Income tax expenses |
| | |
| | | ||||
Loss for the period |
|
| ( | ( |
| ( | ( | |||
Other comprehensive income/ (loss), all attributable to equity holders of the parent |
|
| | ( |
| | | |||
Total comprehensive loss |
|
| ( | ( |
| ( | ( | |||
Attributable to: |
|
|
| |||||||
Equity holders of the parent |
|
| ( | ( |
| ( | ( | |||
Non‑controlling interests |
|
| | |
| | ( | |||
( | ( |
| ( | ( | ||||||
Loss per share - Basic and diluted (in EUR) |
|
| ( | ( |
| ( | ( |
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements
1
Centogene N.V.
Unaudited interim condensed consolidated statements of financial position
as at September 30, 2021, and December 31, 2020
(in EUR k)
Assets |
| Note |
| Sep 30, 2021 | Dec 31, 2020 | |
Non‑current assets |
|
|
|
|
|
|
Intangible assets |
|
| | | ||
Property, plant and equipment |
|
| | | ||
Right-of-use assets | | | ||||
Other assets |
| 7 |
| | | |
| | | ||||
Current assets |
|
|
| |||
Inventories |
|
| | | ||
Trade receivables and contract assets |
| 7 |
| | | |
Other assets |
| 7 |
| | | |
Cash and cash equivalents |
| 8 |
| | | |
| | | ||||
| | |
Equity and liabilities |
| Note |
| Sep 30, 2021 | Dec 31, 2020 | |
Equity |
|
|
|
|
|
|
Issued capital |
| 9 |
| | | |
Capital reserve |
| 9 |
| | | |
Retained earnings and other reserves |
|
|
| ( | ( | |
Non‑controlling interests |
|
|
| | | |
| | | ||||
Non‑current liabilities |
|
|
| |||
Non‑current loans |
| 10.1 |
| | | |
Lease liabilities |
| 10.1 |
| | | |
Deferred tax liabilities |
|
| | | ||
Government grants |
| 10.2 |
| | | |
| | | ||||
Current liabilities |
|
|
| |||
Government grants |
| 10.2 |
| | | |
Current loans |
| 10.1 |
| | | |
Lease liabilities |
| 10.1 |
| | | |
Trade payables |
| 10.2 |
| | | |
Liabilities from income taxes | 10.2 | | | |||
Other liabilities |
| 10.2 |
| | | |
| | | ||||
| | |
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements
2
Centogene N.V.
Unaudited interim condensed consolidated statements of cash flows
for the nine months ended September 30, 2021, and 2020
(in EUR k)
For the nine months ended September 30 | ||||||
| Note |
| 2021 | 2020 | ||
Operating activities |
|
|
|
|
| |
Loss before taxes |
|
|
| ( | ( | |
Adjustments to reconcile loss to cash flow from operating activities |
|
|
| |||
Depreciation and amortization |
| 5 |
| | | |
Inventory write-off | | — | ||||
Interest income |
|
| — | ( | ||
Interest expense |
|
| | | ||
Loss on the disposal of property, plant and equipment | | — | ||||
Expected credit loss allowances on trade receivables and contract assets | 7 | | | |||
Share‑based payment expenses |
| 11 |
| | | |
Tax expense | | — | ||||
Other non‑cash items |
|
|
| ( | ( | |
Changes in operating assets and liabilities |
|
|
| |||
Inventories |
|
| | ( | ||
Trade receivables and contract assets |
| 7 |
| | ( | |
Other assets |
| 7 |
| | | |
Trade payables |
| 10.2 |
| ( | | |
Other liabilities |
| 10.2 |
| ( | | |
Cash flow used in operating activities |
|
|
| ( | ( | |
Investing activities |
|
|
| |||
Cash paid for investments in intangible assets |
| 5 |
| ( | ( | |
Cash paid for investments in property, plant and equipment |
| 5 |
| ( | ( | |
Grants received for investment in property, plant and equipment |
| 10.2 |
| — | | |
Interest received | — | | ||||
Cash flow used in investing activities |
|
|
| ( | ( | |
Financing activities |
|
|
| |||
Cash received from issuance of shares | — | | ||||
Cash paid for acquisition of non-wholly owned subsidiary | — | ( | ||||
Cash received from loans |
| 10.1 |
| | | |
Cash repayments of loans |
| 10.1 |
| ( | ( | |
Cash repayments of lease liabilities |
| 10.1 |
| ( | ( | |
Interest paid |
|
| ( | ( | ||
Cash flow used in/ generated from financing activities |
|
|
| ( | | |
Changes in cash and cash equivalents |
|
|
| ( | ( | |
Cash and cash equivalents at the beginning of the period |
|
|
| | | |
Cash and cash equivalents at the end of the period |
|
|
| | |
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements
3
Centogene N.V.
Unaudited interim condensed consolidated statements of changes in equity
for the nine months ended September 30, 2020, and 2021
Attributable to the owners of the parent | ||||||||||||||||
Currency | Non- | |||||||||||||||
Issued | Capital | translation | Retained | controlling | Total | |||||||||||
in EUR k |
| Note |
| capital |
| reserve |
| reserve |
| earnings |
| Total |
| interests |
| equity |
| ||||||||||||||||
As of January 1, 2020 | | | — | ( | | ( | | |||||||||
Loss for the period |
| — | — | — | ( | ( | ( | ( | ||||||||
Other comprehensive loss |
| — | — | | — | | — | | ||||||||
Total comprehensive loss | — |
| — |
| |
| ( |
| ( |
| ( |
| ( | |||
Share-based payments | 11 | — | | — | — | | — | | ||||||||
Issuance of shares | | | — | — | | — | | |||||||||
Exercise of options | | ( | — | — | — | — | — | |||||||||
Transaction costs | — | ( | — | — | ( | — | ( | |||||||||
Disposal of non-wholly owned subsidiary | 6.2 | — | — | — | — | — | | | ||||||||
Acquisition of non-wholly owned subsidiary | — | — | — | ( | ( | | ( | |||||||||
As of September 30, 2020 | |
| |
| |
| ( |
| |
| ( |
| |
Attributable to the owners of the parent | ||||||||||||||||
Currency | Non- | |||||||||||||||
Issued | Capital | translation | Retained | controlling | Total | |||||||||||
in EUR k |
| Note |
| capital |
| reserve |
| reserve |
| earnings |
| Total |
| interests |
| equity |
| ||||||||||||||||
As of January 1, 2021 | | | ( | ( | | | | |||||||||
Loss for the period |
| — | — | — | ( | ( | | ( | ||||||||
Other comprehensive loss |
| — | — | | — | | — | | ||||||||
Total comprehensive loss | |
| |
| |
| ( |
| ( |
| |
| ( | |||
Share-based payments | 11 | — | | — | — | | — | | ||||||||
Exercise of options | | ( | — | — | — | — | — | |||||||||
As of September 30, 2021 | |
| |
| ( |
| ( |
| |
| |
| |
The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements
4
Notes to the unaudited interim condensed consolidated financial statements as of September 30, 2021 and December 31, 2020 and for the three months and nine months ended September 30, 2021, and 2020
1General Company Information
Centogene N.V. (“the Company”) and its subsidiaries (“the Group”) focus on rare diseases and seek to transform real-world clinical and genetic or other data into actionable information for patients, physicians and pharmaceutical companies. The mission of the Company is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our knowledge of the global rare disease market, including epidemiological and clinical data and innovative biomarkers.
On November 7, 2019, the Company completed an initial public offering (“IPO”) and has since been listed on Nasdaq Global Market under stock code “CNTG”. Centogene N.V. is a public company with limited liability incorporated in the Netherlands, with registered office located at Am Strande 7 in 18055 Rostock, Germany and Dutch trade register number 72822872.
In July 2020, the Company completed a follow-on offering of
2Basis of Preparation
The interim condensed consolidated financial statements for the three and nine months ended September 30, 2020 and 2021 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 annual financial statements, and should be read in conjunction with the Group’s annual consolidated financial statements as of December 31, 2019, and 2020 and for the three years ended December 31, 2020. Unless otherwise specified, "the Company" refers to Centogene N.V. and Centogene GmbH throughout the remainder of these notes, while "the Group" refers to Centogene N.V., Centogene GmbH and its subsidiaries.
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 annual consolidated financial statements for the year ended December 31, 2020, except as described below. The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective, and there are no new or amended standards or interpretations that are issued and became effective for the 2021 annual reporting period, that have a material impact on the Group.
These interim condensed consolidated financial statements are presented in euro, which is the Group's functional currency. Unless otherwise specified, all financial information presented in euro is rounded to the nearest thousand (EUR k) in line with customary commercial practice.
2.1New significant accounting policies and accounting judgments and estimates
Revenues from contracts with customer
The Group has a diagnostics customer from the Middle Eastern region with a history of significant payment delays. This history has resulted in the recognition of significant subsequent impairment losses by applying the expected credit loss method as the collection of the contractual consideration was historically considered probable upon recognition of revenue. Based on recent developments in its collection experience, recent negotiations with the customer, and past experiences, the Group considered it necessary to reassess its judgments related to the recognition of revenue from contracts with this customer.
The Group’s management concluded, based on the facts and circumstances and management’s expectations regarding this customer, that this uncertainty in the amount of the contract consideration it expects to collect, and the
5
Notes to the unaudited interim condensed consolidated financial statements as of September 30, 2021 and December 31, 2020 and for the three months and nine months ended September 30, 2021, and 2020
likelihood of accepting a lower amount or changing payment terms represents an “implicit price concession” such that the contract consideration is variable. Therefore, the Group’s management estimates the amount of the contractual consideration it expects to ultimately collect and for which it is highly probable that related revenue recognized would not be subject to significant future reversals when such uncertainty is resolved. The Group’s management estimates the implicit price concessions by applying an estimated rate of
Despite the uncertainties related to the amount expected to be collected from the customer, based on experience and the facts and circumstances related to the customer, the Group considers it probable that it will collect
2.2Going Concern
As an early commercial-stage company, the Group is still in progress towards reaching break-even in its diagnostic and pharma businesses. The Group and Company are subject to a number of risks similar to those of other development and early commercial stage companies. These risks include, among other things, the failure to enter into and successfully execute further collaborations with pharmaceutical partners, the failure to generate revenue from the Company’s development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals in relation to our product candidates. The Group´s ongoing success and ultimately the attainment of profitable operations depends on future uncertain events which include, among other things, obtaining adequate financing to promote our commercial and development activities until the Group can generate sufficient revenues to support its operating cash requirements.
The Group has incurred operating losses since inception. For the nine months ended September 30, 2021 the Group incurred a net loss of €
Considering cash and cash equivalents as of September 30, 2021 of €
Consequently, until the Group completes a significant financing, it plans to obtain interim bridge financing, enact measures aimed at reducing personnel and infrastructure costs, and where possible, operate at a lower spending level by pacing investments on new research programs. Additionally, the Group plans to seek funds through further private or public equity financings, debt financings, strategic collaborations and marketing, distribution or licensing arrangements, business and asset divestitures and grant funding among other things. Despite the Company’s efforts to obtain the necessary funding and improve profitability of its operations, there can be no assurance of its success in doing so, or obtaining necessary funding on acceptable terms.
6
Notes to the unaudited interim condensed consolidated financial statements as of September 30, 2021 and December 31, 2020 and for the three months and nine months ended September 30, 2021, and 2020
The accompanying unaudited interim condensed consolidated financial statements for the three and nine months ended September 30, 2021 have been therefore prepared on a going concern basis contingent upon the successful implementation of the plans described above. This contemplates the Group will continue in operation for the foreseeable future and will be able to realize its assets and discharge its liabilities in the normal course of operations. The unaudited interim condensed consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of assets or the amounts and classification of liabilities that would be necessary, was the Group unable to continue as a going concern.
3Effect of COVID-19 Pandemic
The COVID-19 pandemic has spread worldwide and continues to cause many governments to maintain measures to slow the spread of the outbreak through quarantines, travel restrictions, closures of borders and requiring maintenance of physical distance between individuals.
Since the second quarter of 2020, the COVID-19 pandemic has resulted in a slowdown in our diagnostics and pharmaceutical businesses. As part of the Company’s initiative to assist local, national and international authorities as well as other partners in their efforts to facilitate the earliest possible diagnosis of COVID-19 and thereby contribute to allowing society to return to a “new” normal, the Company commenced testing for COVID-19 in March 2020.
During the nine months ended September 30, 2021, the Group continued the COVID-19 testing activities started in 2020 with a leading role in providing testing services at airports in Germany. Furthermore, new variants of the virus have emerged since mid-December 2020. How these mutations develop and their impact on the effectiveness of vaccines is not yet fully clear. Furthermore, vaccination campaigns in several countries started during the nine months ended September 30, 2021, and due to the expected increase in the availability of vaccines until the end of the year, the expectation is that governments will reduce restrictions during 2021. As a result of these developments in the COVID-19 pandemic, the Group has noticed a decrease in COVID-19 test order intakes in the three months ended September 30, 2021. How and when these developments would affect the potential prolongation of the need for testing on a broader scale remains uncertain.
Although the Group is taking a number of measures aimed at minimizing disruptions to the business and operations, and while the provision of testing for the COVID-19 virus is anticipated to generate additional revenues for us, the full extent to which the global COVID-19 pandemic may impact the business will depend on future developments, which are highly uncertain and cannot be predicted, such as the duration of the pandemic, the availability and effectiveness of vaccines against new variants, the probability of the occurrence of further outbreaks and the ultimate impact on the financial markets and the global economy, and could result in an unforeseen negative impact on the business and future results of operations.
7
Notes to the unaudited interim condensed consolidated financial statements as of September 30, 2021 and December 31, 2020 and for the three months and nine months ended September 30, 2021, and 2020
4Revenues from Contracts with Customers
in EUR k | Three Months Ended September 30, 2021 | |||||||
| Pharmaceutical |
| Diagnostics | COVID-19 |
| Total | ||
Rendering of services | | | | | ||||
Sales of goods | | — | — | | ||||
Total Revenues from contracts with external customers | | | | | ||||
Recognized over time | | | | | ||||
Recognized at a point in time | | — | | | ||||
Total Revenues from contracts with external customers | | | | | ||||
| ||||||||
Geographical information |
| |||||||
Europe |
| | | | | |||
—Germany*# |
| — | | | | |||
—Netherlands** | — | | | | ||||
Middle East |
| | | — | | |||
North America |
| | | | | |||
—United States# | 2,696 | 867 | 232 | 3,795 | ||||
Latin America |
| | | — | | |||
Asia Pacific |
| — | | — | | |||
Total Revenues from contracts with external customers |
| |
| | |
| |
*Country of the incorporation of Centogene GmbH
**Country of the incorporation of Centogene N.V.
# | Countries contributing more than 10% of the Group’s total consolidated revenues for the three months ended September 30, 2020, and 2021, respectively. |
in EUR k | Three Months Ended September 30, 2020 | |||||||
| Pharmaceutical |
| Diagnostics |
| COVID-19 | Total | ||
Rendering of services | | | | | ||||
Sales of goods | | — | | | ||||
Total Revenues from contracts with external customers | | | | | ||||
Recognized over time | | | | | ||||
Recognized at a point in time | | — | | | ||||
Total Revenues from contracts with external customers | | | | | ||||
Geographical information | ||||||||
Europe |
| | |
| | | ||
—Germany*# |
| | |
| | | ||
—Netherlands** | — | — |
| | | |||
Middle East |
| | |
| — | | ||
North America |
| | |
| | | ||
—United States# |
| | |
| | | ||
Latin America |
| — | |
| | | ||
Asia Pacific |
| — | |
| — | | ||
Total Revenues from contracts with external customers |
| |
| |
| | |
8
Notes to the unaudited interim condensed consolidated financial statements as of September 30, 2021 and December 31, 2020 and for the three months and nine months ended September 30, 2021, and 2020
in EUR k | Nine months ended September 30, 2021 | |||||||
| Pharmaceutical |
| Diagnostics | COVID-19 | Total | |||
Rendering of services | | | | | ||||
Sales of goods | | — | | | ||||
Total Revenues from contracts with external customers | | | | | ||||
Recognized over time | | | | | ||||
Recognized at a point in time | | — | | | ||||
Total Revenues from contracts with external customers | | | | | ||||
| ||||||||
Geographical information |
| |||||||
Europe |
| | | | | |||
—Germany*# |
| — | | | | |||
—Netherlands** | — | | | | ||||
Middle East |
| | | — | | |||
North America |
| | | | | |||
Latin America |
| | | — | | |||
Asia Pacific |
| — | | | | |||
Total Revenues from contracts with external customers |
| | | | |
*Country of the incorporation of Centogene GmbH
**Country of the incorporation of Centogene N.V.
# | Countries contributing more than 10% of the Group’s total consolidated revenues for the nine months ended September 30, 2020, and 2021, respectively. |
in EUR k | Nine months ended September 30, 2020 | |||||||
| Pharmaceutical |
| Diagnostics |
| COVID-19 | Total | ||
Rendering of services | | | | | ||||
Sales of goods | | — | | | ||||
Total Revenues from contracts with external customers | | | | | ||||
Recognized over time | | | | | ||||
Recognized at a point in time | | — | | | ||||
Total Revenues from contracts with external customers | | | | | ||||
| ||||||||
Geographical information |
| |||||||
Europe |
| | | | | |||
—Germany*# |
| | | | | |||
—Netherlands** |