UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the date of July 15, 2022
Commission File Number 001-39124
(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 July 15, 2022, Centogene N.V. (the “Company”) issued a press release reporting its financial results for the three months ended March 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1.
Attached hereto as Exhibit 99.2 and 99.3 are also the financial statements of the Company for the three months ended March 31, 2022 and the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three months ended March 31, 2022, 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 and 99.3 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333-234551) of the Company and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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: July 15, 2022 | |||
By: | /s/ Jose Miguel Coego Rios | ||
Name: | Jose Miguel Coego Rios | ||
Title: | Chief Financial Officer |
3
Exhibit Index
Exhibit |
| Description of Exhibit |
99.1 | ||
99.2 | ||
99.3 | ||
4
Exhibit 99.1
CENTOGENE Reports First Quarter 2022 Financial Results
On Track for FY 2022 Guidance
● | Q1 2022 revenue rises 3% to €10.3 million |
● | Completed phase out of COVID-19 Business segment in Q1 2022 |
● | Positioning Pharma and Diagnostics for post-COVID recovery and growth in 2022 and beyond |
● | Reaffirms FY 2022 guidance of 15-20% revenue growth |
CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, July 15, 2022 (GLOBE NEWSWIRE)
Centogene N.V. (Nasdaq: CNTG), the commercial-stage essential biodata life science partner for rare and neurodegenerative diseases, today announced financial results for the first quarter ending March 31, 2022, reaffirmed guidance and provided a business update.
“We are on track with our renewed focus on the Core Business. The Diagnostics segment continued to show double digit growth rates year-over-year and is planned to grow faster than the market. We are on target to enhance our Pharma offering – broadening our commercial team, marketing a differentiated product portfolio, and growing the pipeline to return the Pharma segment to steady growth in 2022. We see the extension of the market access partnership with Takeda and the new contract with Agios as important proof points of our biopharma strategy,” stated Kim Stratton, Chief Executive Officer at CENTOGENE. “In the first quarter, we phased out the COVID-19 Business as planned, allowing our organization to pivot and be focused on Core Business execution."
First Quarter 2022 Financial Highlights
● | Overall revenues of €10.3 million were recorded in Q1 2022, a 3% increase compared to €10.0 million in Q1 2021 |
● | Diagnostics segment revenues of €7.1 million in Q1 2022, an increase of 11% compared to €6.4 million in Q1 2021, reflecting the fourth consecutive quarter of year-over-year revenues growth in the segment. The increase in revenues was primarily related to an increase in revenues from Whole Exome Sequencing (WES) and Whole Genome Sequencing (WGS) of 18% |
● | Pharma segment revenues of €3.2 million in Q1 2022, a decrease of 10% compared to €3.6 million in Q1 2021 |
● | The COVID-19 Business was phased out in Q1 2022 and reported as discontinued operations. Revenues from the COVID-19 Business were €19.5 million in Q1 2022, compared to €55.0 million in Q1 2021. Discontinued operations in the period contributed positively to net income and cash flow |
● | Net loss of €6.5 million in Q1 2022, compared to net loss of €4.9 million in Q1 2021 |
● | Total segment adjusted EBITDA of €1.9 million was recorded in Q1 2022, compared to €2.6 million in Q1 2021. This mainly reflects the lower proportion of revenues in the higher margin Pharma segment |
● | Adjusted EBITDA from COVID-19 business for the three months ended March 31, 2022 was €6.1 million as compared to €10.2 million for the three months ended March 31, 2021. The decrease was driven by the reduction in COVID-19 test order intakes as the business was phased out |
● | Cash and cash equivalents were €42.7 million as of March 31, 2022, compared to €17.8 million as of December 31, 2021. The reported cash position per end of Q1 2022 reflects proceeds from the debt (first tranche) and equity financings completed in February 2022 |
“With the completion of the financings earlier this year, CENTOGENE is operating from a stable financial position. We rolled out multiple initiatives to extend our cash runway by closely managing margins and corporate expenses. As a result, we are expecting to show improvements in our segments’ 2022 adj. EBITDA versus the prior year,” added Miguel Coego, Chief Financial Officer of CENTOGENE.
Recent Business Highlights
Corporate
● | Appointed executive and Supervisory Board leadership, including Kim Stratton as CEO, Miguel Coego as CFO, and Dr. Andreas Busch as Vice Chairman of the Supervisory Board |
● | Closed $62 million aggregate equity and debt financings to support growth plan, including a €15 million (approx. $17 million) private placement incl. 1.3 million warrants at an exercise price of $7.72 per share from leading growth investors and a $45 million senior secured loan from Oxford Finance in Q1 2022, with the second tranche of the loan subject to operating covenants |
● | Added ~28,000 individuals to the CENTOGENE Biodatabank in Q1 2022; CENTOGENE believes its Biodatabank is the world’s largest real-world data repository for rare and neurodegenerative diseases, which includes samples as well as data and cell lines from patients from over 120 countries |
● | Authored 15 peer-reviewed scientific publications in Q1 2022, focused on generating critical insights into an array of diseases, including rare genetic and neurological diseases, e.g., the prevalence of Fabry disease among patients with Parkinson's disease |
● | Phased out the COVID-19 testing services end of Q1 2022 according to plan |
Pharma
● | Expanded partnership with Agios Pharmaceuticals for clinical development of PYRUKYND® (mitapivat) to treat children with rare blood disease |
● | Extended market access partnership with Takeda to accelerate path from diagnosis to available treatments for rare metabolic and rare neurodegenerative diseases |
● | Expanded Data Access and Collaboration R&D Agreement with Pfizer to advance discovery and validation of novel genetic targets as candidates for the development of new therapies for rare diseases |
● | Initiated collaboration with Insilico Medicine for Niemann-Pick disease Type C (NPC) target discovery, leveraging the CENTOGENE Biodatabank |
● | Currently leading three observational studies for patient finding and market access in collaboration with our pharma partners in rare and neurodegenerative disorders |
Diagnostics
● | Launch of CENTOGENE MOx – a portfolio of single-step multiomic solutions that combines sequencing and biochemical testing to enable early diagnosis, improved prognosis, and precision medicine |
● | Global release of CentoCloud, a cloud-based, clinical decision support platform enabling decentralized analysis, interpretation, and quality reporting for laboratories around the world |
● | Received CE-mark for CentoCloud, making it one of the only decentralized SaaS and clinical decision support platforms compliant with European IVD regulatory framework |
● | Major Next Generation Sequencing (NGS) panel update with more than 3,000 genes revised and 1,864 genes added to maximize the clinical utility for rare metabolic and neurodegenerative diseases |
● | Contributed to Europe-wide efforts to update guidelines for WGS in rare disease diagnostics |
2022 Financial Guidance
The Company has reaffirmed its previously communicated 2022 annual revenue guidance for year-over-year revenue growth in the Core Business of 15% to 20%. As a result, CENTOGENE expects revenues to be in the range of €50 million to €52 million. This reflects the classification of the COVID-19 Business as discontinued operations.
About CENTOGENE
CENTOGENE (Nasdaq: CNTG) is transforming real-world clinical, genetic, and multiomic data to enable better health outcomes for patients with rare and neurodegenerative diseases. For over 15 years, CENTOGENE has been providing diagnostic insights to patients with genetic diseases through our network of nearly 30,000 active physicians. CENTOGENE believes its Biodatabank is now the world’s largest real-world data repository of corresponding patients from more than 120 countries. Simplified logistics solutions, including CentoCard® for sending biosamples, and our ISO, CAP, & CLIA certified state-of-the-art multiomic reference labs offer patients rapid and reliable diagnoses to support the identification and personalization of their treatments. Ultimately, offering the best treatment for patients involves developing new or better therapies. We are de-risking orphan drug discovery and development by partnering with more than 30 biopharma in target & drug screening, clinical development, market access and expansion. CENTOGENE engages in biodata partnerships with our Biodata Licenses and Insight Reports.
To discover more about our products, pipeline, and patient-driven purpose, visit www.centogene.com and follow us on LinkedIn.
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 economic and geopolitical conditions and instability and volatility in the worldwide financial markets, 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, execute our business strategy 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 continued ongoing compliance with covenants linked to financial instruments, our requirement for additional financing, 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 March 31, 2022, 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
Press@centogene.com
Stern IR
Suzanne Messere
+1 (212) 698-8801
suzanne.messere@sternir.com
Exhibit 99.2
Centogene N.V.
Unaudited interim condensed consolidated statements of comprehensive loss
for the three months ended March 31, 2022 and 2021
(in EUR k)
|
| For the three months ended March 31 |
| ||||
Note | 2022 |
| 2021* |
| |||
Revenue |
| 4, 5 | |
| |
| |
Cost of sales |
| |
| |
| ||
Gross profit |
| |
| |
| ||
Research and development expenses |
| |
| |
| ||
General administrative expenses |
| |
| |
| ||
Selling expenses |
| |
| |
| ||
Impairment of financial assets |
| 8 | |
| |
| |
Other operating income |
| 6.1 | |
| |
| |
Other operating expenses |
| 6.2 | |
| |
| |
Operating loss |
|
| ( |
| ( |
| |
Changes in fair value of warrants | 11.2 | | — | ||||
Interest and similar income |
|
| |
| — |
| |
Interest and similar expense |
|
| |
| |
| |
Financial costs, net |
| ( |
| ( |
| ||
Loss before taxes from continuing operations |
|
| ( |
| ( |
| |
Income tax expenses |
| |
| — |
| ||
Loss for the period from continuing operations |
|
| ( |
| ( |
| |
Net income from discontinued operations, net of tax | 7 | | | ||||
Loss for the period | ( | ( | |||||
Other comprehensive income, all attributable to equity holders of the parent |
|
| |
| |
| |
Total comprehensive loss |
|
| ( |
| ( |
| |
Attributable to: |
|
|
|
| |||
Equity holders of the parent |
|
| ( |
| ( |
| |
Non‑controlling interests from continuing operations |
|
| — |
| — |
| |
Non‑controlling interests from discontinued operations | | | |||||
( |
| ( |
| ||||
Net loss per share - Basic and diluted from (in EUR) | |||||||
Continuing operations | ( | ( | |||||
Loss attributable to parent | ( | ( | |||||
|
|
|
*
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 of March 31, 2022 and December 31, 2021
(in EUR k)
Assets |
| Note |
| Mar 31, 2022 |
| Dec 31, 2021 |
Revised | ||||||
Non‑current assets |
|
|
|
|
|
|
Intangible assets |
|
| |
| | |
Property, plant and equipment* |
| 2.2 |
| |
| |
Right-of-use assets | |
| | |||
Other assets |
| 8 |
| |
| |
| |
| | |||
Current assets |
|
|
|
| ||
Inventories |
|
| |
| | |
Trade receivables and contract assets |
| 8 |
| |
| |
Other assets |
| 8 |
| |
| |
Cash and cash equivalents |
| 9 |
| |
| |
| |
| | |||
| |
| |
Equity and liabilities |
| Note |
| Mar 31, 2022 |
| Dec 31, 2021 |
Revised | ||||||
Equity |
|
|
|
|
|
|
Issued capital |
| 10 |
| |
| |
Capital reserve |
| 10 |
| |
| |
Retained earnings and other reserves |
|
| ( |
| ( | |
Non‑controlling interests |
|
|
| |
| |
| |
| | |||
Non‑current liabilities |
|
|
|
| ||
Non‑current loans |
| 11,1 |
| |
| — |
Lease liabilities* |
| 11,1 |
| |
| |
Deferred tax liabilities |
|
| |
| | |
Government grants |
| 11,2 |
| |
| |
Warrants liability | 11,2 | | — | |||
| |
| | |||
Current liabilities |
|
|
|
| ||
Government grants |
| 11,2 |
| |
| |
Current loans |
| 11,1 |
| |
| |
Lease liabilities* |
| 2.2, 11.1 |
| |
| |
Trade payables |
| 11,2 |
| |
| |
Liabilities from income taxes | 11,2 | | | |||
Other liabilities |
| 11,2 |
| |
| |
| |
| | |||
| |
| |
*
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 three months ended March 31, 2022 and 2021
(in EUR k)
For the three months ended March 31 | ||||||
| Note |
| 2022 |
| 2021* | |
Operating activities |
|
|
|
|
|
|
Loss before taxes from continuing operations | ( | ( | ||||
Income before taxes from discontinued operations | 7 | | | |||
Loss before taxes |
|
|
| ( | ( | |
Adjustments to reconcile loss to cash flow from operating activities |
|
|
| |||
Amortization and depreciation |
| 5 |
| | | |
Interest expense |
|
| | | ||
Expected credit loss allowances on trade receivables and contract assets | 8 | | | |||
Gain on disposal of property, plant and equipment | ( | — | ||||
Share‑based payment (true up)/ expenses |
| 12 |
| ( | | |
Fair value adjustments of warrants | ( | — | ||||
Other non‑cash items |
|
|
| ( | ( | |
Changes in operating assets and liabilities |
|
|
| |||
Inventories |
|
| | | ||
Trade receivables and contract assets |
| 8 |
| | | |
Other assets |
| 8 |
| | ( | |
Trade payables |
| 11.2 |
| ( | ( | |
Other liabilities |
| 11.2 |
| ( | | |
Thereof cash flow used in continuing operating activities |
|
|
| ( | ( | |
Thereof cash flow from discontinued operating activities | 7 | | | |||
Net cash flow (used in)/ from operating activities | ( | | ||||
Investing activities |
|
|
| |||
Cash paid for investments in intangible assets |
| 5 |
| ( | ( | |
Cash paid for investments in property, plant and equipment |
|
| ( | ( | ||
Cash received for disposal of property, plant and equipment | | — | ||||
Thereof cash flow from continuing investing activities | ( | ( | ||||
Thereof cash flow from discontinued investing activities | 7 | | ( | |||
Cash flow from/ (used in) investing activities |
|
|
| | ( | |
Financing activities |
|
|
|
| ||
Cash received from issuance of shares | 10 | | — | |||
Cash received from issuance of warrants | | — | ||||
Cash received from loans |
| 11.1 |
| | | |
Cash repayments of loans |
| 11.1 |
| ( | ( | |
Cash repayments of lease liabilities |
| 11.1 |
| ( | ( | |
Interest paid |
|
| ( | ( | ||
Thereof net cash flow from continuing financing activities | | | ||||
Thereof net cash flow used in discontinued financing activities | ( | ( | ||||
Net cash flow 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 comparative numbers have been re-presented as a result of the discontinued operations. Refer to Note 7- Discontinued Operations.
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 three months ended March 31, 2022 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, 2021 | | | ( | ( | | | | |||||||||
Loss for the period |
| — | — | — | ( | ( | | ( | ||||||||
Other comprehensive loss |
| — | — | | — | | — | | ||||||||
Total comprehensive loss | — |
| — |
| |
| ( |
| ( |
| |
| ( | |||
Share-based payments | 12 | — | | — | — | | — | | ||||||||
Exercise of options | | ( | — | — | — | — | — | |||||||||
As of March 31, 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 December 31, 2021 (as previously reported) | | | | ( | | | | |||||||||
Adjustment | 2,2 | — | — | — | | | — | | ||||||||
As of December 31, 2021/ January 1, 2022 (as revised)* | 2,2 | | | | ( | | | | ||||||||
Loss for the period |
| — | — | — | ( | ( | | ( | ||||||||
Other comprehensive loss |
| — | — | | — | | — | | ||||||||
Total comprehensive loss | |
| |
| |
| ( |
| ( |
| |
| ( | |||
Share-based payments | 12 | — | ( | — | — | ( | — | ( | ||||||||
Issuance of shares | | | — | — | | — | | |||||||||
Exercise of options | | ( | — | — | — | — | — | |||||||||
As of March 31, 2022 | |
| |
| |
| ( |
| |
| |
| |
*
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 March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
1 General 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.
The Company is listed on the 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.
2 Basis of preparation
The interim condensed consolidated financial statements for the three months ended March 31, 2022 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, 2021 and 2020 and for the three years ended December 31, 2021. 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, 2021 except for the changes in presentation relating to discontinued operations (refer to Note 2.1– New significant accounting policies and accounting judgments and estimates and Note 7– Discontinued operations). 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 2022 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
Discontinued operations
A discontinued operation is a component of an entity that either has been disposed of, or that is classified as held for sale. It must either: represent a major separate line of business or geographical area of operations; be part of a single coordinated disposal plan; or be a subsidiary acquired exclusively with a view to resale. A component also qualifies for presentation as a discontinued operation when activities are ultimately ended (abandoned). Non-current assets and disposal groups are not classified as assets held for sale if their carrying amount is to be recovered through continuing use.
In 2021, the Group decided to end its COVID-19 business activities in Q1 2022. The Group assessed that ending the activities of this operating segment would qualify as a discontinued operation. Therefore, the profit or loss related to the COVID-19 business is presented in a separate line item of the profit and loss section of the statement of comprehensive loss for the three months ended March 31, 2022 and 2021. The segment reporting note and notes to the unaudited interim condensed consolidated financial statements for the three months ended March 31, 2022 and 2021 only represent continuing operations. For further details on the discontinued operations refer to Note 7 – Discontinued operations.
5
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
Warrants
Warrants are classified as equity to the extent that they confer the right to purchase a fixed number of shares for a fixed exercise price. In the event that the exercise price or the numbers of shares to be issued are not deemed to be fixed, the warrants are classified as a non-current derivative financial liability. Warrants entitle the holder to purchase
2.2Revision of selected assets and liabilities in the consolidated statement of financial position and selected income and expenses in the consolidated statement of comprehensive loss
In accordance with IAS 8.42, the Group revised the amount presented for certain property, plant and equipment and lease liabilities balances on the consolidated statement of financial position and cost of sales and other operating income amounts in the statements of comprehensive loss as of and for the year ended December 31, 2021 These revised assets, liabilities, income and expenses are related to the COVID-19 segment which has been discontinued as of March 31, 2022.
In September 2021, management updated their long term COVID-19 outlook and took the decision to wind down the COVID-19 segment by Q1 2022. This resulted in an accelerated depreciation of COVID-19 segment related property, plant and equipment and right of use assets during Q4 2021.
In Q2 2022, management identified the accelerated depreciation was over-stated with an amount of EUR
To correct these unadjusted differences, property, plant and equipment has been revised by EUR
The changes to the consolidated statement of financial position as of December 31, 2021 are as follows:
in EUR k | Dec 31, 2021 | Adjustment | Dec 31, 2021 (revised) | |||
Property, plant & equipment | | | | |||
Non-current Assets | | | | |||
Total assets | | | | |||
Retained earnings and other reserves | ( | | ( | |||
Equity | | | | |||
Lease liabilities | | ( | | |||
Non-current liabilities | | ( | | |||
Lease liabilities | | ( | | |||
Current liabilities | | ( | | |||
Total Liabilities | | ( | |
6
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
The changes to the consolidated statements of comprehensive income for the year ended December 31, 2021 are as follows:
Dec 31, 2021 | Adjustment | Dec 31, 2021 (revised) | ||||
Revenue | | - | | |||
Cost of sales | | ( | | |||
Gross profit | | | | |||
Research and development expenses | | - | | |||
General administrative expenses | | - | | |||
Selling expenses | | - | | |||
Impairment of financial assets | | - | | |||
Other operating income | | | | |||
Other operating expenses | | - | | |||
Operating loss | ( | | ( | |||
Loss for the year | ( | | ( | |||
Total comprehensive loss | ( | | ( | |||
Loss per share- Basic and diluted (in EUR) | ( | | ( |
The revisions above have no impact on the changes in cash, cash equivalents and net cash flows in operating, investing, and financing activities within the consolidated statements of cash flows for the year ended December 31, 2021.
3 Effect of COVID-19 Pandemic and other geopolitical events
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.
The COVID-19 pandemic 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 three months ended March 31, 2022, we continued the COVID-19 testing activities that started in 2020. However, as at March 31, 2022, all COVID-19 operations at testing sites have ceased as all COVID-19 testing site contracts expired within the first quarter of 2022. The company is reporting the COVID-19 segment as a discontinued operation. See Note 2.1– New significant accounting policies and accounting judgments and estimates and Note 7 – Discontinued operations.
Although the Group is taking a number of measures aimed at minimizing disruptions to the business and operations, the full extent to which the global COVID-19 pandemic may continue to 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 could result in an unforeseen negative impact on the business and future results of operations.
In reaction to the recognition of the so-called Donetsk People’s Republic and the so-called Luhansk People’s Republic by the Russian Federation, the following Russian invasion of the Ukraine on February 24, 2022 and the since-then ongoing war in the Ukraine, a number of countries (including the United States, United Kingdom and the European Union) imposed sanctions and other measures. Sanctions and other measures imposed until July 2022 against, among others, certain individuals as well as private and state-owned entities in Russia and Belarus, include asset freezes, exports controls through tariffs, taxation or bans of goods and commodities and energy embargos,
7
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
including a ban by the United States of oil, gas and coal imports, financial sanctions and bans of foreign direct investments into Russia. Additional sanctions may be imposed.
Due to the war in Ukraine, there has been a significant increase in volatility on the securities and currency markets. It is expected that these events may affect the activities of Russian enterprises in various sectors of the economy and may have severe effects on macroeconomic developments in global and national markets due to spillovers and Russian counter measures, including on commodity markets and financial channels, contributing to supply chain disruptions and rising inflation. Although neither Centogene’s operations, supply chain, performance nor going concern basis has been significantly affected by the conflict, the impact of the conflict and its broader economic implications, such as higher costs of consumer goods, cannot be reliably quantified at this point in time.
4 Revenues from contracts with customers
in EUR k | For the three months ended March 31, 2022 | |||||
| Pharmaceutical |
| Diagnostics | 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 |
| | | | ||
—Saudi Arabia# | — | | | |||
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 March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
in EUR k | For the three months ended March 31, 2021 | |||||
| Pharmaceutical |
| Diagnostics |
| 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 |
| | | | ||
—Saudi Arabia# | — | | | |||
North America |
| | | | ||
—United States# | | | | |||
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 March 31, 2022 and 2021, respectively.
The Group collaborated with the majority of our existing pharmaceutical partners on a worldwide basis in 2022 and 2021. In addition, in cases where pharmaceutical partners are developing a new rare disease treatment, it is generally anticipated that the final approved treatment will be made available globally. As a result, the Group allocates the revenues of the pharmaceutical segment by geographical region by reference to the location where each pharmaceutical partner mainly operates, which is based on the region from which most of their revenues are generated. The allocation of revenues in the diagnostics segment is based on the location of each customer.
Pharmaceutical segment
During the three months ended March 31, 2022, revenues from
9
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
5 Segment information
in EUR k | For the three months ended March 31, 2022 | |||||||
| Pharmaceutical |
| Diagnostics |
| Corporate |
| Total | |
Total Revenues from contracts with external customers | | | — | | ||||
Adjusted EBITDA |
| | | ( | ( | |||
Capital Expenditures |
| |||||||
Additions to property, plant and equipment and right-of-use assets |
| — | — | | | |||
Additions to intangible assets |
| | — | | | |||
Other segment information |
| |||||||
Depreciation and amortization | | | | | ||||
Research and development expenses |
| — | — | | |
in EUR k | For the three months ended March 31, 2021 | |||||||
| Pharmaceutical |
| Diagnostics |
| Corporate |
| Total | |
Total Revenues from contracts with external customers | | | — | | ||||
Adjusted EBITDA |
| | | ( | ( | |||
Capital Expenditures |
| |||||||
Additions to property, plant and equipment and right-of-use assets |
| | | | | |||
Additions to intangible assets |
| | — | | | |||
Other segment information |
| |||||||
Depreciation and amortization | | | | | ||||
Research and development expenses |
| — | — | | |
Adjusted EBITDA
Adjustments to income/ loss include non-cash charges in relation to depreciation, amortization (including impairments), and share-based payments as well as net financial costs and income taxes. Certain costs, and related income, are not allocated to the reporting segment results and represent the residual operating activities of the Group reported as ‘Corporate’. These include financing costs which is largely composed of costs related to the Oxford Loan Facility (as defined below), corporate overheads, which are responsible for centralized functions such as communications, information technology, facilities, legal, finance and accounting, insurance (D&O), human resources, business development and strategic initiatives, certain professional and consulting services, procurement, research and development and other supporting activities.
Decreases in corporate expenses for the three months ended March 31, 2022 are mainly due to decreased personnel costs, legal, administrative, IT support and data center costs.
10
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
Reconciliation of segment Adjusted EBITDA to Group loss before taxes from continuing operations
For the three months ended March 31 |
| 2022 |
| 2021 |
Reported segment Adjusted EBITDA |
| |
| |
Corporate expenses |
| ( |
| ( |
| ( |
| ( | |
Share-based payment (true-up)/ expenses (Note 12) |
| |
| ( |
Depreciation and amortization |
| ( |
| ( |
Operating loss from continuing operations |
| ( |
| ( |
Financial costs, net |
| ( |
| ( |
Loss before taxes from continuing operations for the three months ended March 31 |
| ( |
| ( |
Non-current asset locations
Non-current assets of the Group consist of right-of-use assets (under IFRS 16), property, plant and equipment, as well as intangible assets. All of such assets are located in Germany, which is the country of the business address of Centogene GmbH, except for property, plant and equipment of EUR
6 Other income and expenses
6.1Other operating income
For the three months ended March 31 |
| ||||
in EUR k |
| 2022 |
| 2021 |
|
Government grants | | |
| ||
Others | | |
| ||
Total other operating income | | |
|
Government grants contain performance-based grants to subsidize research, development and innovation in the state of Mecklenburg-Western Pomerania from funds granted by the European Regional Development Fund. Furthermore, government grants contain the release of deferred income from investment related grants.
6.2Other operating expenses
For the three months ended March 31 |
| ||||
in EUR k |
| 2022 |
| 2021 |
|
Currency losses | |
| |
| |
Total other operating expenses | |
| |
|
7 Discontinued operations
At the end of the third quarter of 2021, management updated its long term outlook for the COVID-19 testing business, which led to management’s decision to initiate a wind down process in which lease contracts at unprofitable COVID-19 testing sites would not be renewed. Similarly, COVID-19 related inventory levels were significantly ramped down to align with the needs of the remaining test sites and laboratories.
As at March 31, 2022, operations at all COVID-19 testing sites have ceased. The Company has no intentions of renewing any of the COVID-19 testing site leases and has abandoned the COVID-19 business line. Consequently, the Company is reporting its COVID-19 segment as a discontinued operation.
All COVID-19 related property, plant and equipment have been fully depreciated as at March 31, 2022. In addition, all COVID-19 related accounts receivable and accounts payable are included in the balance sheet as at March 31, 2022 whilst all COVID-19 related inventory have been written down to
11
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
The Group has COVID-19 related advertising expenses, credit card fees and other selling expenses which were recognized under cost of sales in the statement of comprehensive loss since the COVID-19 business was added to the operations of the Group in the first quarter of 2020. During the 2021 year-end closing process, management identified this as a classification error and corrected it retrospectively. Accordingly, the Group reclassified EUR
Discontinued operations are presented separately from continuing operations in the consolidated statements of comprehensive loss and consolidated statements of cash flows.
For the three months ended March 31 | |||||
2022 |
| 2021 | |||
Results of discontinued operations | |||||
Revenue | | | |||
Cost of sales | | | |||
Gross profit | | | |||
General administrative expenses | | | |||
Selling expenses | | | |||
Other operating income | | - | |||
Operating income | | | |||
Financial costs, net | | - | |||
Income before taxes | | | |||
Income tax expense | | - | |||
Income for the period | | | |||
Total comprehensive income, attributable to equity holders of the parent | | | |||
Net income per share - Basic and diluted (in EUR) | | | |||
Cash flow from discontinued operations | |||||
Net cash flow from operating activities | | | |||
Net cash flow from/ (used in) investing activities | | ( | |||
Net cash flow used in financing activities | ( | ( |
8 Trade receivables and other assets
in EUR k |
| Mar 31, 2022 |
| Dec 31, 2021 |
Non‑current |
|
|
|
|
Other assets - Rental deposits |
| |
| |
Other assets – Others | | | ||
| |
| | |
Current |
|
| ||
Trade receivables, net |
| |
| |
Contract assets, net |
| |
| |
Other assets |
| |
| |
| |
| | |
Total non-current and current trade receivables and other assets | | |
Other non-current assets
The non-current portion of other assets mainly include cash deposits of EUR
12
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
machineries. It also includes the non-current part of the consideration receivable for the sale of the Laboratory Process Consulting GmbH for EUR
Trade receivables and contract assets
Trade receivables are non-interest bearing and are generally due in
in EUR k |
| Mar 31, 2022 |
| Dec 31, 2021 |
|
Not past due |
| |
| | |
Past due 1-30 days |
| |
| | |
Past due 31-90 days |
| |
| | |
Past due more than 90 days |
| |
| | |
Total gross amount of trade receivables and contract assets |
| |
| | |
Expected credit loss rate |
|
|
| ||
Not past due |
| | % | | % |
Past due 1-30 days |
| | % | | % |
Past due 31-90 days |
| | % | | % |
Past due more than 90 days |
| | % | | % |
Expected credit loss rate on total gross trade receivables and contract assets |
| | % | | % |
Expected credit loss |
| |
| |
The addition to the allowance for expected credit losses amounts to EUR
Other current assets
The current assets include VAT receivables of EUR
9 Cash and short-term deposits
As of March 31, 2022, the Group has pledged its short-term deposits with carrying amount of EUR
The restriction applying to the collateral may be terminated at any time subject to the full amount of the relevant bank loans and the overdrafts being repaid.
13
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
10 Equity
Common Shares
As of March 31, 2022,
On January 31, 2022, pursuant to a security purchase, each signed with certain investors, the Group received EUR
The holders of common shares are entitled to the Company's approved dividends and other distributions as may be declared from time to time by the Company, and are entitled to a vote per share on all matters to be voted at the Company's annual general meetings.
Capital reserve
On January 31, 2022, pursuant to the above mentioned securities purchase agreement and a warrant agreement, each signed with certain investors, the Group received EUR
As of March 31, 2022, capital reserve included a share premium of EUR
In addition, it also included amounts recorded in respect of share-based payments. For additional information on share-based payments, see Note 12 – Share-based payments
14
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
11 Financial liabilities
11.1Interest-bearing liabilities
in EUR k |
| Mar 31, 2022 |
| Dec 31, 2021 |
Revised | ||||
Non‑current liabilities |
|
|
|
|
Non‑current portion of secured bank loans |
| |
| — |
Total non‑current loans |
| |
| — |
Lease liabilities* |
| |
| |
Total non‑current liabilities |
| |
| |
Current liabilities |
|
| ||
Current portion of secured bank loans |
| |
| |
Bank overdrafts |
| |
| |
Total current loans |
| |
| |
Current portion of lease liabilities* | |
| | |
Total current liabilities |
| |
| |
Total non‑current and current liabilities |
| |
| |
* Lease liabilities as of December 31,2021 have been revised. Refer to Note 2.2 – Revision of selected assets and liabilities in the consolidated statement of financial position and selected income and expenses in the consolidated statement of comprehensive loss.
On January 31, 2022 the Company, Centogene GmbH, CentoSafe B.V. and Centogene US, LLC (together, the “Borrowers”), entered into a debt financing agreement in the total amount of up to USD
The Loan Facility is initially recognized at fair value minus transaction costs and subsequently carried at amortized cost measured using the effective interest rate method. The transaction costs deducted from the fair value of the Loan Facility at initial recognition was EUR
As of March 31, 2022, short-term cash deposits of EUR
15
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
The following table is based on the original terms and conditions:
Conditions and statement of liabilities
The outstanding interest-bearing liabilities as of March 31, 2022 and December 31, 2021 have the following conditions:
Mar 31, 2022 | Dec 31, 2021 | |||||||||||||
Nominal | Carrying | Nominal | Carrying | |||||||||||
in EUR k | Currency | Nominal interest rate | Maturity | amount | amount | amount | amount | |||||||
Revised | Revised | |||||||||||||
Secured bank loan |
| EUR |
| 2017‑22 |
| |
| |
| |
| | ||
Secured bank loan |
| USD |
| 2022-27 | | | — | — | ||||||
Bank overdrafts |
| EUR |
| Rollover |
| |
| |
| |
| | ||
Bank overdrafts |
| EUR |
| Rollover |
| |
| |
| |
| | ||
Bank overdrafts |
| EUR |
| Rollover |
| |
| |
| |
| | ||
Lease liabilities** | EUR | 2017-31 | |
| | | | |||||||
Total interest‑bearing financial liabilities |
|
|
|
|
|
| |
| |
| |
| |
* represents the incremental borrowing rate of the Group at the commencement of the leases
** Lease liabilities as of December 31, 2021 has been revised. Refer to Note 2.2 – Revision of selected
assets and liabilities in the consolidated statement of financial position and selected income and expenses in the
consolidated statement of comprehensive loss.
The bank overdrafts of EUR
11.2Trade payables and other liabilities
in EUR k |
| Mar 31, 2022 |
| Dec 31, 2021 |
Trade payables |
| |
| |
Government grants (deferred income) |
| |
| |
Contract liabilities | | | ||
Warrants liability | | — | ||
Others |
| |
| |
Trade payables and other liabilities |
| |
| |
Non‑current |
| |
| |
Current |
| |
| |
Government grants mainly include investment-related government grants. These were received for the purchase of certain items of property, plant and equipment for the research and development facilities in Mecklenburg-Western Pomerania, including the Rostock facility. The grants were issued in the form of investment subsidies as part of the joint federal and state program, "Verbesserung der regionalen Wirtschaftsstruktur" (improvement of the regional economic structure) in connection with funds from the European Regional Development Fund.
On January 31, 2022, pursuant to a securities purchase agreement and a warrant agreement, each signed with certain investors, the Group received EUR
16
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
fair value per share at the issuance date, the Group recognized the warrants as liabilities in the amount of USD
The fair value of the warrants was estimated at the date of issuance date using the Black-Scholes option pricing model. The key assumptions used to derive the warrants value are set out below:
Mar 31, 2022 | Jan 31, 2022 | ||
Exercise price (USD) | |||
Share price at grant date (USD) | |||
Volatility (%) | |||
Risk-free interest rate (%) | |||
Dividend yield (%) | | | |
Time to maturity |
In addition, other liabilities include a provision for outstanding invoices of EUR
12 Share-based payments
Expenses from share-based payment arrangements
During the three months ended March 31, 2022 and March 31, 2021, the following share-based payment arrangements existed leading to the expenses included in general administrative expenses for services received during the respective periods:
For the three months ended March 31 | ||||
in EUR k | 2022 | 2021 | ||
Expenses arising from equity-settled share-based payment transactions |
| |||
- Grants to management board and employees | | | ||
- Grants to new CEO | | | ||
- Supervisory board grant, including ESOP 2019 | | | ||
- Forfeiture of management board grants | ( | — | ||
- Expected forfeiture of management board grants | ( | — | ||
Total expenses arising from share‑based payment transactions | ( |
| |
Share-based award activity
A detailed description of the Company’s share-based payment arrangements is included in Note 20 of the Group’s annual consolidated financial statements for the year ended December 31, 2021. During the three months ended March 31, 2022 there were no changes to the terms and conditions of the Company’s share-based payment arrangements.
17
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
The following table presents a summary the Company’s share-based payment arrangement activity for the three months ended March 31, 2022.
ESOP 2017 | 2019-2022 awards (1) | |||||||||||
Number of awards (options and restricted stock units "RSUs") | Number | WAEP | Number of options | WAEP (USD) | Number of RSUs | WAEP | ||||||
Outstanding as of January 1, 2022 | | | | | | — | ||||||
Granted during the year(1) | — | | — | — | | — | ||||||
Exercised during the year | — | | — | — | ( | — | ||||||
Forfeited during the year | — | | — | — | ( | |||||||
Expected forfeited during the year | — | | — | — | ( | |||||||
Outstanding as of March 31, 2022 | | | | | | — | ||||||
Vested as of March 31, 2022 | | | | |||||||||
Exercisable as of March 31, 2022 | | | |
_____________________________________
(1) | The granted and outstanding options and RSUs do not include the number of RSUs and options to be granted to certain supervisory board members annually in 2022 and thereafter, as these depend on the trailing volume-weighted average stock price of the Company. |
The option and RSUs for the years 2019-2021 as reported in the table above reflect the activity related to the share-based payment awards under ESOP 2019, awards for management board, new CEO awards in 2022, and awards for supervisory board and employees.
Grants awarded
During the three months ended March 31, 2022 the following awards were granted:
Award Type (2019 Plan) | Market/ Performance Based | Number of Awards | Vesting Conditions | Expiration Date | ||||
RSUs | No | Vest in | anniversary of Grant Date | |||||
RSUs | Yes | Vest in | anniversary of Grant Date | |||||
RSUs | Yes | Up to | Vest in full after a change of control of the Group | anniversary of Grant Date | ||||
RSUs | No | Vest in | anniversary of Grant Date |
New CEO Awards
On February 1, 2022, the CEO was awarded
18
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
Performance-vested RSUs also have a market condition that
The fair value of the Performance-vested RSUs as of the grant date was determined using a Monte Carlo simulation model. The Monte Carlo simulation model utilizes multiple input variables to estimate the probability that market conditions will be achieved. The key assumptions used to derive the Performance-vested RSUs value are set out below:
| ||||
Tranche 1 |
| Tranche 2 | ||
Share price at grant date (USD) | | | ||
Fair value | | | ||
Vesting hurdle |
| |
| |
Date to reach vesting hurdle |
| January 1, 2024 |
| January 1, 2024 |
Expected volatility |
|
| ||
Risk-free rate |
| |
| |
Time to vesting hurdle year | ||||
Dividend yield |
With regard to the Annual RSUs, the CEO will receive an annual number of RSUs, starting from 2023, that will vest in
In the event of a change in control of the Company, all granted RSUs will vest immediately including a maximum of
M&A RSUs are already promised within the service agreement, therefore, the grant date is the same as for the Time-vested RSUs and Performance-vested RSUs. This is also the date on which the fair value of the M&A RSUs were determined using a Black-Scholes-Merton model in the amount of EUR
The remaining
The
19
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
The fair value of the
Exercises
During the three months ended March 31, 2022,
Forfeitures
On February 1, 2022, Andrin Oswald (the “Former CEO”) stepped down from his position and signed a separation agreement. Pursuant to his separation agreement, all unvested RSUs held by the Former CEO under the Company’s long term incentive plan continued to vest in accordance with their terms through the date of his termination on April 30, 2022. However, the number of RSUs he would receive would not exceed
On February 7, 2022, the Company announced the resignation of René Just as CFO effective March 31, 2022. According to his separation agreement signed on the same date, all unvested RSUs granted to Mr. Just as of March 31, 2022 were forfeited automatically without compensation for the loss of such RSUs. Since
13 Financial instruments at fair value
Classifications and fair values
The fair values of the Company’s cash and cash equivalents, accounts receivable and trade and other payables approximate their carrying values because of the short-term nature of these instruments.
Except for the warrant liability, the Group does not carry any financial instruments at fair value through profit and loss. The fair value of non-current loans is EUR
IFRS 13 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value as follows:
- | Level 1 - quoted prices (unadjusted) in active markets for identical assets or liabilities; |
- | Level 2 - inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly (i.e. as prices) or indirectly (i.e. derived from prices); and |
- | Level 3 - inputs for the asset or liability that are not based on observable market data (unobservable inputs). |
The following table shows the fair values of financial instruments as of March 31, 2022, including their level in the fair value hierarchy. It does not include fair value information for financial assets and financial liabilities not measured at fair value if the carrying amount is a reasonable approximation of fair value:
in EUR k | Level 1 | Level 2 | Level 3 | Total | |||
Non-current loans | - | | - | | |||
Warrants liability | - | - | | |
20
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
As of March 31, 2021, carrying amount of all financial assets or financial liabilities approximated their fair value.
Net gain recognized in the interim condensed consolidated statements of comprehensive loss, within changes in fair value of warrants, from the warrant liability fair value measurement differences was EUR
The valuation techniques used in measuring level 2 & level 3 fair value for financial instruments in the interim condensed consolidated statement of financial position, as well as the significant unobservable inputs used, were as follows:
- | The fair value of the warrant liabilities, recognized as non-current financial liability at FVTPL, was calculated by applying a Black-Scholes option pricing model. This model uses the Centogene’s share price and the share price volatility as material input factors. The volatility is considered as material unobservable input factor (Level 3). |
- | The fair value of non-current loans was calculated using the nominal amount less transaction costs and carried at amortized cost of € |
The table below summarizes the profit or loss impact on the fair values of Level 3 instruments, warrant liabilities, by changing the significant unobservable input factors.
March 31, 2022 | |||
in EUR k | increase | decrease | |
Expected volatility (movement +/- | | |
14 Financial risk management
The Group is exposed to certain financial risks which were disclosed in detail in the financial statements as of and for the year ended December 31, 2021. The Group’s financial risk management objective is to monitor and manage the financial risks relating to the operations of the Group. These risks include market risk (including currency risk and interest rate risk), credit risk and liquidity risk. In order to minimize the effect of financial risks, the Group invests time and resources to identify and evaluate the uncertainty of the market to mitigate risk exposures.
Currency risk
The Group is exposed to currency risk in cases where contracts are concluded in foreign currencies. The vast majority of goods delivered and services the Company provided, including those for international customers, are invoiced in euro. During the three months ended March 31, 2022, the Group undertook transactions denominated in foreign currencies such as warrant liabilities and non-current loans; consequently, was exposed to the exchange rate fluctuations.
The following table presents the net foreign currency exposure of the Group as of March 31, 2022 and December 31, 2021:
March 31, 2022 | |||
in EUR k | USD | INR | |
Trade receivables and other assets | | | |
Trade payables and other liabilities | ( | - | |
Financial liabilities | ( | - | |
Net exposure | ( | | |
Dec 31, 2021 | |||
in EUR k | USD | INR | |
Trade receivables and other assets | | | |
Trade payables and other liabilities | ( | ( | |
Net exposure | | |
21
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
Sensitivity analysis
The following tables demonstrate the sensitivity at the end of the reporting period to a reasonably possible change in the USD exchange rates, with all other variables held constant, of the Group’s earnings before tax and equity movement. The Group’s exposure to foreign currency risk for all other currencies is not material.
Earnings before tax | Equity | ||||||
in EUR k | 5% increase | 5% decrease | 5% increase | 5% decrease | |||
March 31, 2022 | | ( | | ( | |||
December 31, 2021 | ( | | ( | |
Interest rate risk
Interest bearing liabilities with floating interest rates exist for non-current loans as of March 31, 2022.
The following sensitivity analyses has been determined based on the exposure to interest rates at the reporting date. For the floating rate liabilities, the analysis is prepared assuming the amount of liability outstanding at the reporting date was outstanding for the whole period. In accordance with the relevant loan agreement, the interest rate cannot be lower than the determined interest rate and therefore the analysis has only been performed for the scenario where interest rate increases.
If interest rates had been 1.0 percentage point higher and all other variables were held constant, the Group’s earning before tax would decrease by EUR
15 Commitments
Future payments for non-cancellable leases
The Group has various lease contracts in relation to the expansion of the Rostock headquarters. The future lease payments and utilities for these non-cancellable lease contracts are EUR
The Group has various non-cancellable lease contracts of office equipment and storage spaces which had a lease term of less than 12 months or were related to leases of low-value assets, and therefore the short-term lease recognition exemption was applied to these contracts. The future lease payments for these non-cancellable lease contracts are EUR
Future payment obligations
As of March 31, 2022, the Group concluded agreements with suppliers, for goods and services to be provided subsequent to March 31, 2022 with a total payment obligation of approximately EUR
22
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
16 Contingent Liabilities
In May 2016, the Company was informed in writing by the Universitair Medisch Centrum Utrecht ("UMCU") that a claim had been initiated against UMCU regarding a prenatal diagnostic test that the Company conducted at their request which failed to identify a specific mutation present in a patient. On October 1, 2018, the UMCU and Neon Underwriting Limited formally filed a legal claim in the local court in Rostock, Germany against the Company alleging that the Company’s negligence in performing the test resulted in the misdiagnosis of the patient. UMCU is seeking recovery for compensatory damages as a result of the alleged misdiagnosis. By court order of November 8, 2018, the Regional Court of Rostock set the amount in dispute at EUR
On November 12, 2018, the Company submitted a notice to the Regional Court of Rostock of the intention to defend against the claim. On January 3, 2019, the Company filed a motion to dismiss in which the Company denied the merits of the claim. UMCU and Neon Underwriting Limited responded to this motion on March 15, 2019 with a statement of reply, and the parties made several court filings setting out their arguments since. By order dated June 3, 2019, the Regional Court of Rostock provided a first set of questions to be answered by an expert witness.
As of December 31, 2020, the amount in dispute was EUR
The Company intends to continue to rigorously defend its position and considers that it is not probable the legal claim towards the Company will be successful and as a result has not recognized a provision for this claim as of December 31, 2021. In addition, in case a settlement would be required, the Company believes that the corresponding liability will be fully covered by the respective existing insurance policies.
On August 7, 2021, our partnering laboratory physician and a key executive officer of ours, Prof. Dr. Peter Bauer was informed in writing by the Public Prosecutor's Office in Fulda that a criminal investigation had been initiated against him regarding allegedly false billing statements submitted to the Association of Statutory Health Insurance Physicians in Hessen (Kassenärztliche Vereinigung Hessen). The aggregate amount in question was EUR
17 Subsequent Events
Leadership transition
On May 2, 2022, Volkmar Weckesser resigned from his duties as the Chief Information Officer effective as of May 3, 2022. According to the separation agreement signed on the same date, his service agreement will terminate on June 29, 2022 (the “Termination Date”). All
On June 27, 2022, the Group announced the appointment of Jose Miguel Coego Rios as the Managing Director and Chief Financial Officer of the Company, effective June 22, 2022. The CFO and the Group entered into an award agreement pursuant to which the CFO will receive certain RSUs, which have no exercise price. According to the agreement, the RSUs are awarded in two forms as
23
Notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021
Effective June 22, 2022, each member of the Supervisory Board will receive an award of options and RSUs in ordinary shares (such options and RSUs collectively, the "LTIs") with a value of EUR
These unaudited interim condensed consolidated financial statements were approved by management on July 15, 2022.
24
Exhibit 99.3
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations should be read in conjunction with Centogene N.V.’s unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021 included as Exhibit 99.2 to this report on Form 6-K. We also recommend that you read our management’s discussion and analysis and our audited consolidated financial statements and the notes thereto included in our annual report for the year ended December 31, 2021 on Form 20-F, filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the U.S. Securities and Exchange Act of 1934, as amended, on March 31, 2022 (the “Annual Report”).
Unless otherwise indicated or the context otherwise requires, all references to “Centogene N.V.” or the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to Centogene N.V. and its subsidiaries.
The following discussion is based on our financial information prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”), which may differ in material respects from generally accepted accounting principles in the United States and other jurisdictions.
This discussion and analysis is dated as of July 15, 2022.
Overview
We are a commercial-stage company with our core businesses focused on rare diseases that transforms real-world clinical and genetic or other data into actionable information for patients, physicians and pharmaceutical companies. Our goal 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. Our platform includes multiomic data (such as epidemiologic, phenotypic and genetic and other data) that reflects a global population, and also a biobank of these patients’ blood samples. We believe this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market.
We have identified two reportable segments in the three months ended March 31, 2022:
● | Pharmaceutical. Our pharmaceutical solutions provide a variety of services to our pharmaceutical partners, including target discovery, early patient recruitment and identification, epidemiological insights, biomarker discovery and patient monitoring. Our information platforms, access to rare disease patients and their biomaterials, and ability to develop proprietary technologies and biomarkers enable us to provide services to our pharmaceutical partners in all phases of the drug development process as well as post-commercialization. Revenues from our pharmaceutical segment are generated primarily from collaboration agreements with our pharmaceutical partners. In addition, we have a variety of biomarker programs, and we are also pursuing a multi-omics approach, with a focus on genomics using next generation sequencing as well as the metabolome, to enhance diagnostic yields beyond genetic sequencing and testing and build a biomarker discovery pipeline for rare diseases. Our novel approach in metabolomics includes a tandem mass spectrometry methodology and artificial intelligence and, combined with the large volume of datasets in our global rare disease platform, has demonstrated value by enhancing diagnostic information and contributing to our biomarker pipeline. Such and other biomarker candidates are then further validated and optimized in epidemiological clinical trials. |
● | Diagnostics. Our diagnostics segment provides genome, exome and targeted genetic sequencing, testing and interpretation as well as other diagnostics services to our clients worldwide, who are typically physicians, laboratories or hospitals, either directly or through distributors. As of March 31, 2022, we believe we offer the broadest diagnostic testing portfolio for rare diseases, covering over 19,000 genes using over 10,000 different tests. In turn, the data collected from our diagnostics services and biomaterials allow us to continue to grow our repository and our CentoMD database. |
We discontinued our COVID-19 business in the three months ended March 31, 2022:
● | COVID-19. While not a core business, due to its growth and financial significance in relation to our total activities, our COVID-19 business was managed and reported as a separate segment from the third quarter of 2020 to the first quarter of 2022. We started offering COVID-19 testing in March 2020. Our initial COVID-19 test was a molecular diagnostic test performed for the in vitro qualitative detection of RNA from the SARS-CoV-2 in oropharyngeal samples from |
1
presymptomatic probands according to the recommended testing by public health authority guidelines. It has also been validated in our CAP/CLIA/ISO certified analytical laboratory and has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for use by authorized laboratories. The majority of these tests were performed in airport locations at the Frankfurt, Hamburg, Munich, Cologne/Bonn, Dusseldorf, and Berlin airports. Furthermore, tests were offered through collaborations with the state government and other companies. This segment was fully phased out in the first quarter of 2022 and is therefore presented as discontinued operations. |
In the three months ended March 31, 2022, we received over 394,330 total test requests, of which 367,230 account for COVID-19 tests. Excluding the COVID-19 test requests, we received 27,100 test requests in the three months ended March 31, 2022, representing a 9.1% decrease as compared to the three months ended March 31, 2021 of 29,800 non-COVID-19 related test requests.
Our total revenue for the three months ended March 31, 2022 was €10,327 thousand, an increase of €346 thousand, or 3.5%, from €9,981 thousand for the three months ended March 31, 2021. Our pharmaceutical and diagnostics segments contributed 31.3% and 68.7%, respectively, of our total revenues for the three months ended March 31, 2022, as compared to 36.0% and 64.0% for the pharmaceutical and diagnostics segments, respectively, of our total revenues for the three months ended March 31, 2021. The number of test requests received by our pharmaceutical segment in the three months ended March 31, 2022 was 9,700, representing a decrease of 29.7% as compared to 13,800 test requests received in the three months ended March 31, 2021, due to sustained negative effects of the pandemic since the second quarter of 2020. Test requests received by our diagnostics segment in the three months ended March 31, 2022, was 16,300, representing an increase of 24.4% as compared to 13,100 in the three months ended March 31, 2021. The number of test requests received by our discontinued COVID-19 business in the three months ended March 31, 2022, was 367,230, compared to 852,200 in the three months ended March 31, 2021.
Since the inception of our business, our research and development has been substantially devoted to our biomarkers, knowledge-based platform and interpretation-based solutions. For the three months ended March 31, 2022, we incurred research and development expenses of €4,614 thousand, an increase of €279 thousand, or 6.4%, from €4,335 thousand for the three months ended March 31, 2021. We received 1,100 test requests for our internal research and development projects in the three months ended March 31, 2022, representing a decrease of 62% as compared to 2,900 test requests in the three months ended March 31, 2021.
For the three months ended March 31, 2022, our loss before taxes from continuing operations was €11,079 thousand, a decrease of €3,050 thousand, or 22%, from €14,129 thousand for the three months ended March 31, 2021.
Recent Developments
Effect of the COVID-19 Pandemic, and Discontinued Operations
The COVID-19 pandemic has spread worldwide and continues to cause many governments to maintain measures, such as quarantines, travel restrictions, closures of borders, and mandatory maintenance of physical distance between individuals to slow the spread of the outbreak. Since the second quarter of 2020, the COVID-19 pandemic resulted in a slowdown in our diagnostics and pharmaceutical businesses. As part of our 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, we commenced testing for COVID-19 in March 2020.
During the three months ended March 31, 2022, we continued the COVID-19 testing activities that started in 2020. There were no investments made in the COVID-19 business in the three months ended March 31, 2022. Total investments in the COVID-19 business as of December 31, 2021 amounted to €2,834 thousand, of which €2,480 thousand related to property, plant and equipment and €354 thousand to intangible assets. These investments have been fully depreciated and amortized as of March 31, 2022.
Total gross profit for our diagnostics and pharmaceutical segments combined increased by €104 thousand or 2.8% in the three months ended March 31, 2022 as compared to the three months ended March 31, 2021. Gross profit for our COVID-19 business for the three months ended March 31, 2022 was €4,263 thousand representing a decrease of €6,169 thousand or of 59.1% as compared to €10,432 thousand for our former COVID-19 business in the prior year period. The decrease in gross profit within the COVID-19 business (which we report as a discontinued operation) is primarily due to the significant decline in COVID-19 testing orders.
At the end of the third quarter of 2021, management updated its long term outlook for the COVID-19 testing business, which led to management’s decision to initiate a wind down process in which lease contracts at unprofitable COVID-19 testing sites would not be renewed and a laboratory in Hamburg would be closed. Similarly, we significantly ramped down COVID-19 related inventory levels to align with the needs of the remaining test sites and laboratories. As at March 31, 2022, all COVID-19 operations at testing sites had ceased as all COVID-19 testing site contracts expired in the first quarter of 2022.
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Although we are taking a number of measures aimed at minimizing disruptions to our business and operations, the full extent to which the global COVID-19 pandemic may impact our business will depend on future developments, which are highly uncertain and cannot be predicted, such as the duration of the pandemic, its severity and strain mutations, the availability of vaccines, 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 our business and our future results of operations.
For further information, see “Note 7 – Discontinued operations” to our unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and for the three months ended March 31, 2022 and 2021.
Private Placement of Common Shares and Warrants
On January 31, 2022, we entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with the purchasers named therein (the “Investors”) and a Warrant Agreement (the “Warrant Agreement”) with the Investors. Pursuant to the Securities Purchase Agreement and the Warrant Agreement, we agreed to sell to the Investors (i) an aggregate of 4,479,088 common shares at a price per share of $3.73, and (ii) warrants initially exercisable for the purchase of up to an aggregate of 1,343,727 additional common shares at an initial exercise price per common share of $7.72 (the “Warrants”), for aggregate gross proceeds of €15.0 million. The Warrants are exercisable immediately as of the date of issuance and will expire on December 31, 2026. Refer to section “Liquidity and Capital Resources” below for further details.
Loan and Security Agreement
On January 31, 2022 (the “Closing Date”), Centogene N.V., Centogene GmbH, CentoSafe B.V. and Centogene US, LLC (together, the “Borrowers”), entered into a loan facility (the “Loan Facility”) with Oxford Finance LLC (“Oxford”) and the other financial institutions or entities from time to time parties to the Loan Facility (collectively, referred to as “Lenders”) and Oxford, in its capacity as collateral agent for itself and the Lenders (in such capacity, “Agent”). Under the Loan Facility, the Lenders agreed to make available to the Borrowers certain term loans in an aggregate principal amount of up to $45.0 million, subject to funding in two tranches as follows: (a) on the Closing Date, a loan in the aggregate principal amount of $25.0 million (the “Term A Loan”) and (b) on and after the Term B Milestone (as defined below) until the earlier of 60 days thereafter and July 31, 2023, a loan in the aggregate principal amount of $20.0 million (the “Term B Loan” and collectively with the Term A Loan, the “Term Loans”). The obligations of the Lenders to fund the Term B Loan are subject to our achievement of product revenues from our diagnostics and pharmaceutical services segments of at least $50.0 million calculated on a trailing twelve month basis as of the last day of any fiscal month (such achievement, the “Term B Milestone”). As security for the Borrowers’ obligations under the Loan Facility, the Borrowers granted the Lenders a first priority security interest on the Borrowers’ assets.
The maturity date of the Term Loans is January 29, 2027, with amortized payments commencing March 1, 2025 in 24 equal monthly payments. The Term Loans bear an interest rate of 7.93% per annum plus the 1-month CME Term SOFR reference rate as published by the CME Group Benchmark Administration Limited (subject to a floor of 0.07%), based on a year consisting of 360 days. Refer to section “Liquidity and Capital Resources” below for further details.
Research and Development
Despite the disruption from the COVID-19 pandemic, we continued to expand our medical and genetic knowledge of rare genetic diseases, with the vision of shortening the diagnostics process for rare disease patients and accelerating the development of new orphan drugs.
As of March 31, 2022, our BioDatabank included approximately 680,000 individuals representing over 120 different countries and more than approximately 400,000 of dried blood spots cards stored in our own physical biobank which enables retrospective analysis for research consented samples. Whole Exome Sequencing (“WES”) data and Whole Genome Sequencing (“WGS”) data is available for approximately 90,000 and 15,000 individuals, respectively. Equally notable is our network of approximately 28,000 active physicians with whom we have been in contact in the last five years.
Leadership transition
On May 2, 2022, Volkmar Weckesser resigned from his duties as the Chief Information Officer effective as of May 3, 2022. On February 8, 2022, we announced the appointment of Jose Miguel Coego Rios as Executive Vice President of Finance & Legal and interim Chief Financial Officer. On June 27, 2022, we announced the appointment of Mr. Coego as Managing Director and Chief Financial Officer of the Company, effective June 22, 2022.
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Geopolitical events
In reaction to the recognition of the so-called Donetsk People’s Republic and the so-called Luhansk People’s Republic by the Russian Federation, the following Russian invasion of the Ukraine on February 24, 2022 and the since-then ongoing war in the Ukraine, a number of countries (including the United States, United Kingdom and the European Union) imposed sanctions and other measures. Sanctions and other measures imposed until July 2022 against, among others, certain individuals as well as private and state-owned entities in Russia and Belarus, include asset freezes, exports controls through tariffs, taxation or bans of goods and commodities and energy embargos, including a ban by the United States of oil, gas and coal imports, financial sanctions and bans of foreign direct investments into Russia. Additional sanctions may be imposed.
Due to the war in Ukraine, there has been a significant increase in volatility on the securities and currency markets. It is expected that these events may affect the activities of Russian enterprises in various sectors of the economy and may have severe effects on macroeconomic developments in global and national markets due to spillovers and Russian counter measures, including on commodity markets and financial channels, contributing to supply chain disruptions and rising inflation. Although neither Centogene’s operations, supply chain, performance nor going concern basis has been significantly affected by the conflict, the impact of the conflict and its broader economic implications, such as higher costs of consumer goods, cannot be reliably quantified at this point in time.
Financial Operations Overview
Our revenue is principally derived from the provision of pharmaceutical solutions and diagnostic tests enabled by our knowledge and interpretation-based platform.
We expect our revenue to increase over time as we continue to expand our commercial efforts internationally with a focus on further growth in our pharmaceutical segment. Within our core business, we expect revenue from our diagnostics segment to grow in absolute terms but decrease as a percentage of total revenue if there is growth in our pharmaceutical segment.
Changes in revenue mix between our pharmaceutical and diagnostics segments can impact our results period over period. In general, the gross profit generated by our pharmaceutical segment is higher in comparison to our diagnostics segment.
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Results of Operations
Three Months Ended March 31, 2022 Compared to Three Months Ended March 31, 2021
|
| For the three months ended |
| ||
| | March 31, | | ||
|
| 2022 |
| 2021* |
|
|
| (unaudited, | |||
| | € in thousands) | |||
Condensed consolidated statement of comprehensive loss: | |
|
|
|
|
Revenue | | 10,327 |
| 9,981 |
|
Cost of sales | | 6,450 |
| 6,208 |
|
Gross profit | | 3,877 |
| 3,773 |
|
Research and development expenses | | 4,614 |
| 4,335 |
|
General administrative expenses | | 7,906 |
| 11,596 |
|
Selling expenses | | 2,394 |
| 1,949 |
|
Impairment of financial assets | | 154 |
| 95 |
|
Other operating income | | 733 |
| 366 |
|
Other operating expenses | | 1 |
| 34 |
|
Operating loss | | (10,459) |
| (13,870) |
|
Changes in fair value of warrants | | 238 | | — | |
Interest and similar income | | 1 | | — | |
Interest and similar expenses | | 859 |
| 259 |
|
Financial costs, net | | (620) | | (259) | |
Loss before taxes from continuing operations | | (11,079) |
| (14,129) |
|
Income tax expenses | | 4 |
| — |
|
Loss for the period from continuing operations | | (11,083) |
| (14,129) |
|
Net income from discontinued operations, net of tax | | 4,601 | | 9,240 | |
Loss for the period | | (6,482) | | (4,889) | |
Other comprehensive income, all attributable to equity holders of the parent | | 94 |
| 121 |
|
Total comprehensive loss | | (6,388) |
| (4,768) |
|
Attributable to: | | | | | |
Equity holders of the parent | | (6,415) |
| (4,803) |
|
Non-controlling interests from continuing operations | | — | | — | |
Non-controlling interests from discontinued operations | | 27 | | 35 | |
| | (6,388) | | (4,768) | |
| | | | | |
Net loss per share – Basic and diluted from (in €) | | | | | |
Continuing operations | | (0.48) | | (0.63) | |
Loss attributable to parent | | (0.28) | | (0.22) | |
| | | | |
|
* The comparative numbers have been re-presented as a result of the discontinued operations. Refer to “Note 7- Discontinued operations” to our unaudited interim condensed consolidated financial statements as of March 31, 2022 and December 31, 2021 and
for the three months ended March 31, 2022 and 2021.
Revenue
Our total revenues for the three months ended March 31, 2022 were €10,327 thousand representing an increase of €346 thousand, or 3.5% as compared to the three months ended March 31, 2021.
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The graphic below shows the number of test requests for the diagnostics, and pharmaceutical segments, as well as the number of test requests received for our internal research projects during the three months ended March 31, 2022 and 2021.
The breakdown of our revenue by segment was as follows:
|
| For the three months |
| ||
| | ended March 31, | | ||
|
| 2022 |
| 2021 |
|
|
| (unaudited, | |||
|
| € in thousands) | |||
Revenue by segment: |
|
|
|
|
|
Pharmaceutical |
| 3,235 |
| 3,598 |
|
Diagnostics |
| 7,092 |
| 6,383 |
|
Total Revenue |
| 10,327 |
| 9,981 |
|
Revenues from Pharmaceutical segment
Revenues from our pharmaceutical segment were €3,235 thousand for the three months ended March 31, 2022, a decrease of €363 thousand, or 10%, from €3,598 thousand for the three months ended March 31, 2021. Our partnership agreements are structured on a fee-per-sample basis, milestone basis, fixed fee basis, or a combination thereof. The 10% decrease was primarily due to the impact of the COVID-19 pandemic, which slowed the clinical studies of our pharmaceutical partners.
During the three months ended March 31, 2022, we entered into five new collaborations and successfully completed 8 collaborations resulting in a total of 42 active collaborations at March 31, 2022, compared to 45 active collaborations at December 31, 2021 and 55 active collaborations as of March 31, 2020. Revenues from our new collaborations totaled €31 thousand for the three months ended March 31, 2022 with no upfront payments.
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The graphs below show our revenues for the three months ended March 31, 2022 and 2021, resulting from our collaborations with our pharmaceutical partners, split between drug development stages:
During the three months ended March 31, 2022, revenues from one pharmaceutical partner represented 19.0% of our total revenue, as compared to 30.5% for the three months ended March 31, 2021.
Revenues from Diagnostics segment
Revenues from our diagnostics segment were €7,092 thousand for the three months ended March 31, 2022, an increase of €709 thousand, or 11%, from €6,383 thousand for the three months ended March 31, 2021. We received approximately 16,300 test requests in our diagnostics segment during the three months ended March 31, 2022, representing an increase of approximately 24.4% as compared to approximately 13,100 test requests received for the three months ended March 31, 2021.
For the three months ended March 31, 2022 and 2021, our total diagnostic segment revenues were split amongst our primary testing products as follows:
The increase in revenues was primarily related to an increase in test requests for WES and WGS during the three months ended March 31, 2022. Total revenues from WES and WGS for the three months ended March 31, 2022 amounted to €3,726 thousand, representing an increase of 18% as compared to €3,159 thousand for the three months ended March 31, 2021. The total number of WES and WGS test requests received in the diagnostics segment for the three months ended March 31, 2022 was approximately 5,467, representing an increase of 37% as compared to approximately 4,000 test requests received for the three months ended March 31, 2021.
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Revenue by geographical region
The breakdown of our revenue from all of our segments, in the aggregate, by geographical region was as follows:
|
| For the three months |
|
| ||
| | ended March 31, | |
| ||
|
| 2022 |
| 2021 |
|
|
|
| (unaudited, | | |||
|
| € in thousands) | | |||
Revenue by geographical region: |
|
|
|
|
| |
Europe |
| 1,439 |
| 1,363 |
| |
of which: Germany |
| 78 |
| 53 |
| |
of which: Netherlands |
| 7 |
| 2 |
| |
Middle East |
| 4,091 |
| 4,164 |
| |
North America |
| 3,770 |
| 3,869 |
| |
Latin America |
| 729 |
| 425 |
| |
Asia Pacific |
| 298 |
| 160 |
| |
Total Revenue |
| 10,327 |
| 9,981 |
| |
In cases where our pharmaceutical partners are developing a new rare disease treatment, we generally anticipate that the final approved treatment will be made available globally. As a result, we allocate the revenues of our pharmaceutical segment by geographical region by reference to the location where each pharmaceutical partner mainly operates, which is based on the region from which most of their revenues are generated. The allocation of revenues in our diagnostics segment is based on the location of each customer.
Our North America region contributed €3,770 thousand to revenues for the three months ended March 31, 2022, a decrease of €99 thousand, or 2.6%, from €3,869 thousand for the three months ended March 31, 2021, primarily driven by the decrease in revenues from our pharmaceutical segment, of which over 97.2% are allocated to the North America region. Revenues from the North America region represented 36.5%, of our total revenues for the three months ended March 31, 2022, as compared to 38.8% for the three months ended March 31, 2021.
Our Middle East region contributed €4,091 thousand to revenues for the three months ended March 31, 2022, a decrease of €73 thousand, or 1.8%, from €4,164 thousand for the three months ended March 31, 2021. This revenue decrease was primarily attributable to the decrease in diagnostic sales in the region.
Our Europe region contributed €1,439 thousand to revenue for the three months ended March 31, 2022, an increase of €76 thousand, or 6%, from €1,363 thousand for the three months ended March 31, 2021. This increase was mainly driven by an increase in our diagnostic sales in the region.
Cost of sales increased by €242 thousand, or 3.9%, to €6,450 thousand for the three months ended March 31, 2022, from €6,208 thousand for the three months ended March 31, 2021. Cost of sales for the three months ended March 31, 2022 represented 62.5% of total revenue, representing an increase of 0.3 percentage points as compared to 62.2% for the three months ended March 31, 2021.
Cost of sales incurred by our pharmaceutical and diagnostics segments for the three months ended March 31, 2022 represented 57.0% and 64.9% of revenues from the respective segments, a decrease of 3.4 percentage points and an increase of 1.7 percentage points, respectively, as compared to 60.4% and 63.2%, respectively, for the three months ended March 31, 2021. The decrease in our pharmaceutical segment was mainly due to operational efficiency improvements and product mix which resulted in lower consumable costs. The cost incurred in the diagnostics segment is relatively consistent between the three months ended March 31, 2022 and March 31, 2021.
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Gross Profit
As a result of the above factors, our gross profit increased by €104 thousand, or 2.8%, to €3,877 thousand for the three months ended March 31, 2022, from €3,773 thousand for the three months ended March 31, 2021.
Research and Development Expenses
Research and development expenses increased by €279 thousand, or 6.4%, to €4,614 thousand for the three months ended March 31, 2022, from €4,335 thousand for the three months ended March 31, 2021. The increase is mainly driven by the increased efforts on clinical studies, biomarker research and IT expenses incurred on the enhancements of internally generated software that do not qualify for capitalization.
General Administrative Expenses
General administrative expenses decreased by €3,690 thousand, or 31.8%, to €7,906 thousand for the three months ended March 31, 2022 compared to €11,596 thousand incurred for the three months ended March 31, 2021, principally due to the reduction in
personnel costs, share-based compensation expense and expenditure on IT support.
Personnel costs decreased by €3,851 thousand to €721 thousand for the three months ended March 31, 2022 compared to €4,572 thousand incurred for the three months ended March 31, 2021 due to cost savings driven by the restructuring that occurred at the end of the fourth quarter of 2021 and the true-up impact of share-based compensation expenses recognized in previous periods resulting from the updated estimate of vested options and RSUs granted to René Just and Andrin Oswald. The options and RSUs for René Just were forfeited during the quarter ended March 31, 2022 upon his resignation while the options and RSUs for Andrin Oswald were forfeited at the end of April 2022 based on the termination contract as signed during the quarter ended March 31, 2022. The share-based compensation expenses recognized for these forfeited awards in the previous periods, in the amount of €2,954 thousand, were derecognized under personnel expenses in general administrative expenses.
Selling Expenses
Selling expenses for the three months ended March 31, 2022 were €2,394 thousand, representing an increase of €445 thousand, or 22.8% as compared to €1,949 thousand for the three months ended March 31, 2021. The increase for the three months ended March 31, 2022 was principally due to increases in sales and marketing personnel costs within the pharmaceutical segment.
Impairment of Financial Assets
Impairment expenses for financial assets for the three months ended March 31, 2022 were €154 thousand, compared to €95 thousand for the three months ended March 31, 2021. The impairment recorded at March 31, 2022 was related to the re-assessment of the receivables and contract assets arising from contracts with customers.
Other Operating Income / (Expenses)
Other operating income increased by €367 thousand, or 100.3%, to €733 thousand for the three months ended March 31, 2022, from €366 thousand for the three months ended March 31, 2021, principally due to higher grant income released during the period.
Other operating expenses which relate to currency losses decreased by €33 thousand, or 97.1% to €1 thousand in the three months ended March 31, 2022, compared to the three months ended March 31, 2021.
Interest and Similar Income / (Expenses)
Net financial costs increased by €361 thousand to €620 thousand for the three months ended March 31, 2022, from €259 thousand for the three months ended March 31, 2021, principally due to interest paid on the Oxford Loan Facility of €668 thousand and partially offset by a reduction in fair value of warrants liability amounting to €238 thousand in the three months ended March 31, 2022.
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Loss Before Taxes from Continuing Operations
As a result of the factors described above, our loss before taxes from continuing operations for the three months ended March 31, 2022 was €11,079 thousand, representing a decrease of €3,050 thousand from a loss before taxes from continuing operations of €14,129 thousand for the three months ended March 31, 2021.
Segment Adjusted EBITDA
We evaluate segment performance based on segment results and measure it with reference to Adjusted EBITDA. Adjusted EBITDA is a financial measure which is not prescribed by IFRS, which we define as income/loss before financial costs (net), taxes, and depreciation and amortization (including impairments), adjusted to exclude corporate expenses as well as share-based payment expenses. Our Segment Adjusted EBITDA is as follows:
|
| For the three months |
| ||
| | ended March 31, | | ||
|
| 2022 |
| 2021 |
|
|
| (unaudited, | |||
|
| € in thousands) | |||
Segment Adjusted EBITDA: |
|
|
|
|
|
Pharmaceutical |
| 1,099 |
| 1,497 |
|
Diagnostics |
| 812 |
| 1,054 |
|
Total Segment Adjusted EBITDA |
| 1,911 |
| 2,551 |
|
Adjusted EBITDA from our pharmaceutical segment for the three months ended March 31, 2022 was €1,099 thousand representing a decrease of €398 thousand, as compared to €1,497 thousand for the three months ended March 31, 2021. The decrease was primarily attributable to the decrease in revenues from the pharmaceutical segment.
Adjusted EBITDA from our diagnostics segment for the three months ended March 31, 2022, was €812 thousand, a decrease of €242 thousand as compared to €1,054 thousand for the three months ended March 31, 2021. The decrease is mainly due to expected credit losses from financial assets of €146 thousand recognized for the three months ended March 31, 2022, compared to €95 thousand for the three months ended March 31, 2021.
Profit from Discontinued Operations
Discontinued operations represents our COVID-19 business. Due to increased vaccination rates and further relaxation of COVID-19 related restrictions, the number of COVID-19 test order intakes decreased significantly at the end of the third quarter of 2021. As a result, we updated our long term outlook for the COVID-19 business, which led to a decision by our management to initiate a wind down process in which lease contracts at unprofitable COVID-19 testing sites would not be renewed. As at March 31, 2022, operations at all COVID-19 testing sites has ceased. We have no intentions of renewing any of the COVID-19 testing site leases and have abandoned the COVID-19 business line.
Revenues from COVID-19 business
Revenues generated from our COVID-19 business for the three months ended March 31, 2022 amounted to €19,463 thousand as compared to €54,979 thousand for the three months ended March 31, 2021. We received 367,230 requests for our COVID-19 tests in the three months ended March 31, 2022 as compared to 852,200 in the three months ended March 31, 2021. During the three months ended March 31, 2022, revenues from one COVID-19 testing partner represented 66.3% of total COVID-19 revenues compared to 5.4% for the three months ended March 31, 2021
Cost of Sales
Cost of sales incurred by our COVID-19 business for the three months ended March 31, 2022 represent 78.1%, of the revenues from the business, representing a decrease of 2.9 percentage points as compared to 81.0% for the three months ended March 31, 2021. The decrease in the cost of sales to revenue percentage is primarily due to reduction in committed fixed overhead costs.
Adjusted EBITDA
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Adjusted EBITDA from our COVID-19 business for the three months ended March 31, 2022 was €6,106 thousand as compared to €10,167 thousand for the three months ended March 31, 2021. The decrease for the three months ended March 31, 2022, was driven by the reduction in COVID-19 test order intakes.
Liquidity and Capital Resources
Our cash requirements are principally for working capital and capital expenditures of all our businesses, including expansions and improvements to our laboratory facilities, technology infrastructure and research and development activities. In fiscal year 2022 and beyond, we anticipate that our capital expenditures in our rare disease business will increase from prior periods as we continue our research and development efforts. Historically, our main source of liquidity has been our secured loans, municipal loans and government funding of research programs, and proceeds from equity offerings.
Pursuant to the Securities Purchase Agreement and the Warrant Agreement the Company received €15.0 million in exchange for the issuance of an aggregate of 4,479,088 common shares at a price per share of USD3.73 and warrants initially exercisable for the purchase of up to an aggregate of 1,343,727 additional common shares at an initial exercise price per common share of USD7.72. The warrants are exercisable immediately as of the date of issuance and will expire on December 31, 2026. The Company initially recognized the warrants as financial derivative liabilities at fair value, in the amount of €2.9 million on the statement of financial position. As of March 31, 2022, the Company remeasured the fair value of the warrants and recognized €238 thousand income for the three months ended March 31, 2022 in the unaudited interim condensed consolidated statement of comprehensive loss.
On January 31, 2022, the Company drew down USD25.0 million (€22.3 million) from the Loan Facility. Under the Loan Facility, the Company will also have access to a second tranche of USD20.0 million (€17.9 million) upon achievement prior to July 31, 2023, of product revenue from our diagnostics and pharmaceutical services segments of at least USD50.0 million (€44.7 million) calculated on a trailing twelve month basis as of the last day of any fiscal month. The Loan Facility also includes covenants such that the Company is required to maintain product revenue, calculated as of the last day of each fiscal quarter and on a trailing twelve month basis as of such date, of at least EUR 30.0 million for any fiscal quarter prior to obtaining the second tranche and €40.0 million for any fiscal quarter on or after obtaining the second tranche. Both tranches mature on January 29, 2027 with amortized repayments commencing March 1, 2025. The loans extended under the Loan Facility bear monthly interest payments at an interest rate of 7.93% per annum plus the 1-month CME Term SOFR reference rate as published by the CME Company Benchmark Administration Limited (subject to a floor of 0.07%). The amount of the liabilities recognized on the statement of financial position, after reducing the transaction cost amount of €731 thousand, was €21.7 million on the date of recognition. As of March 31, 2022, the fair value amount for the Loan Facility was €21.8 million.
At any time following the Closing Date, the Borrowers may prepay an amount of not less than all of the then outstanding principal balance and all accrued and unpaid interest on the Term Loans, subject to at least fifteen days’ prior written notice to the Agent and the payment of a prepayment fee equal to (x) if made on or prior to the first anniversary of the Closing Date, 3.0% of the principal amount being prepaid, (y) if made after the first anniversary of the Closing Date but on or prior to the second anniversary of the Closing Date, 2.0% of the principal amount being prepaid and (z) otherwise, 1.0%.
The Loan Facility contains customary affirmative covenants, negative covenants and events of default, including covenants and restrictions that, among other things, require the Borrowers to satisfy a financial covenant, restrict Borrowers’ ability to transfer cash to their subsidiaries, and in certain circumstances restrict the ability of the Borrowers to incur liens, incur additional indebtedness, engage in mergers and acquisitions, make distributions or make asset sales without the prior written consent of Lenders.
Our financial condition and liquidity are and will continue to be influenced by a variety of factors, including our ability to continue to generate cash flows from our operations, our capital expenditure requirements, the impact of the COVID-19 pandemic on financial markets and the global economy.
Our known material liquidity needs for periods beyond the next twelve months are described below under “Contractual Obligations and Commitments”. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements for more than 12 months.
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Comparative Cash Flows
The table below summarizes our consolidated statement of cash flows for the three months ended March 31, 2022 and 2021:
|
| For the three months | ||
| | ended March 31, | ||
|
| 2022 |
| 2021 |
|
| (unaudited, | ||
|
| € in thousands) | ||
Consolidated statement of cash flows: |
|
|
|
|
Thereof cash flow (used in) continuing operating activities |
| (12,735) |
| (8,720) |
Thereof cash flow from discontinued operating activities | | 2,835 | | 8,962 |
Thereof cash flow (used in) continuing investing activities |
| (123) |
| (1,526) |
Thereof cash flow (used in) / from discontinued investing activities | | 575 | | (1,770) |
Thereof cash flow from continuing financing activities | | 34,705 | | 394 |
Thereof cash flow (used in) discontinued financing activities |
| (409) |
| (275) |
Net decrease in cash and cash equivalents |
| 24,848 |
| (2,935) |
Cash and cash equivalents at the beginning of the period |
| 17,818 |
| 48,156 |
Cash and cash equivalents at the end of the period |
| 42,666 |
| 45,221 |
Operating Activities
Our cash flow used in operating activities primarily relates to changes in the components of our working capital, including cash received from our pharmaceutical partners, diagnostics clients, discontinued COVID-19 business and payments made to our suppliers.
Continuing operating activities
For the three months ended March 31, 2022, cash flow used in operating activities was €12,735 thousand, an increase of €4,015 thousand as compared to cash flow used in operating activities of €8,720 thousand for the three months ended March 31, 2021. The increase in cash usage was driven mainly by repayments of trade payables and other liabilities.
Discontinued operating activities
For the three months ended March 31, 2022, cash flow generated from operating activities was €2,835 thousand, a decrease of €6,127 thousand as compared to cash flow generated from operating activities of €8.962 thousand for the three months ended March 31, 2021. This change was mainly due to the decrease in COVID-19 order intakes.
Investing Activities
Our cash flow used in investing activities consists of investments in intangible assets, property, plant and equipment.
Continuing investing activities
For the three months ended March 31, 2022, cash flow used in investing activities was €123 thousand, as compared to cash flow used of €1,526 thousand from investing activities for the three months ended March 31, 2021. The decrease was mainly due to a reduction in capital expenses related to biomarker development and other self-developed intangibles.
Cash used in investment activities in our rare disease business includes mainly costs incurred in the development of new products and solutions, and the development of our IT driven and interpretation-based solutions. It also includes investment in property, plant and equipment used in the laboratories and other business operations.
Discontinued investing activities
For the three months ended March 31, 2022, cash flow generated from investing activities was €575 thousand, as compared to cash flow used of €1,770 thousand from investing activities for the three months ended March 31, 2021. The cash flow generated from investing activities for the three months ended March 31, 2022 relates to cash received from sales of COVID-19 related property, plant and equipment. The cash used in the prior year related to investments made in respect of COVID-19 testing of €1,770 thousand, of which €1,416 thousand was included in property, plant and equipment and €354 thousand related to the development of the Corona Test Portal.
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Financing Activities
Our cash flow generated from and used in financing activities primarily relates to the Oxford Loan Facility and financial lease liabilities during the three months ended March 31, 2022.
Continuing financing activities
For the three months ended March 31, 2022, cash generated from financing activities was €34,705 thousand, an increase of €34,311 thousand as compared to cash flow generated of €394 thousand for the three months ended March 31, 2021. The increase was primarily driven by additional shares issued to certain investors and the drawdown of the Oxford Loan Facility which contributed €33,753 thousand in aggregate.
Discontinued financing activities
For the three months ended March 31, 2022, cash flow used in financing activities was €409 thousand, an increase of €134 thousand as compared to cash flow used in financing activities of €275 thousand for the three months ended March 31, 2021. The cash flow used in financing activities for the three months ended March 31, 2022 relates to payments of financial lease liabilities.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Contractual Obligations and Commitments
The table below presents the residual contractual terms of the financial liabilities and commitments, including estimated interest payments. The figures are undiscounted gross amounts, including estimated interest payments and interest on undrawn loan funds as of March 31, 2022, but without showing the impact of offsetting.
|
| |
| ||||||||
|
| Total |
| |
| Between 1 |
| Between 3 |
| |
|
| | contractual | | Less than | | and | | and | | More than |
|
| | cash flow | | 1 year | | 3 years | | 5 years | | 5 years |
|
| | |
| ||||||||
| | |
| ||||||||
Secured bank loans | | 31,202 |
| 2,127 |
| 5,529 |
| 23,546 |
| — | |
Bank overdraft | | 3,273 |
| 3,273 |
| — |
| — |
| — | |
Lease liabilities (1) | | 26,899 |
| 3,702 |
| 5,704 |
| 5,025 |
| 12,468 | |
Trade payables and purchase obligations | | 9,023 |
| 9,023 |
| — |
| — |
| — | |
Total | | 70,397 |
| 18,125 |
| 11,233 |
| 28,571 |
| 12,468 | |
(1) | Lease liabilities include leases related to lease contracts for land and buildings, offices, as well as various items including motor vehicles and other equipment which are accounted for according to IFRS 16, and measured at the present value of lease payments over the lease term at the commencement date of the leases. |
Lease liabilities also include cash flows in relation to the expansion of our Rostock headquarters. The future lease payments and utilities for these non-cancellable lease contracts are €113 thousand within one year, €2,373 thousand within five years and €4,056 thousand thereafter as at March 31, 2021.
Critical Accounting Policies and Estimates
There have been no material changes to the critical accounting policies and estimates described in “Item 5. Operating and Financial Review and Prospects—E. Critical Accounting Estimates” in our Annual Report other than the following:
Discontinued operations
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A discontinued operation is a component of an entity that either has been disposed of, or that is classified as held for sale. It must either: represent a major separate line of business or geographical area of operations; be part of a single coordinated disposal plan; or be a subsidiary acquired exclusively with a view to resale. A component also qualifies for presentation as a discontinued operation when activities are ultimately ended (abandoned). Non-current assets and disposal of companies are not classified as assets held for sale if their carrying amount is to be recovered through continuing use.
Warrants
Warrants are classified as equity to the extent that they confer the right to purchase a fixed number of shares for a fixed exercise price. In the event that the exercise price or the numbers of shares to be issued are not deemed to be fixed, the warrants are classified as a non-current derivative financial liability. Warrants entitle the holder to purchase one common share of the Company at an exercise price of $7.72 per share and can be settled for a fixed number of the Company's underlying common shares. Since the exercise price of the warrants are determined in US dollars which is different from the Company’s functional currency, warrants are classified as liabilities. This liability is initially recognized at its fair value on the date the contract is entered into and subsequently accounted for at fair value through profit and loss at each reporting date.
JOBS Act Exemption
As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the JOBS Act. As an emerging growth company, we are not required to provide an auditor attestation report on our system of internal controls over financial reporting. This exemption will apply for a period of five years following the completion of our initial public offering (November 6, 2019) or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, have more than $700 million in market value of our common shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.
Cautionary Statement Regarding Forward Looking Statements
Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the heading “Risk Factors” in our Annual Report filed with the SEC on March 31, 2022. These risks and uncertainties include factors relating to:
· our ability to generate cash from operations and attract financing;
· our strategic restructuring initiative and the related restructuring costs;
· our ability to effectively manage our future growth and to execute our business strategy;
· our ability to generate sufficient revenue from our relationships with our pharmaceutical partners and clients, and to otherwise maintain our current relationships, or enter into new relationships, with pharmaceutical partners and clients;
· the effects of the COVID-19 pandemic on our business, financial position and results of operations;
· economic, political or social conditions and the effects of these conditions on our pharmaceutical partners’ and diagnostics clients’ businesses and levels of business activity;
· our expectations for our products and solutions achieving commercial market acceptance, and our ability to keep pace with the rapidly evolving industry in which we operate;
· our assumptions regarding market size in the rare disease industry and our growth potential;
· our pharmaceutical partners’ and clients’ need for rare disease information products and solutions and any perceived advantage of our products over those of our competitors;
· our ability to manage our international expansion, including our exposure to new and complex business, regulatory, political, operational, financial, and economic risks, and numerous and conflicting legal and regulatory requirements;
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· our continued reliance on our senior management team, in particular our CEO, and other qualified personnel and our ability to retain such personnel;
· our ability to obtain, maintain, protect and enforce sufficient patent and other intellectual property protection for any products or solutions we develop and for our technology;
· the ongoing protection of our trade secrets, know-how, and other confidential and proprietary information;
· our ability to remediate our material weakness on internal control over financial reporting;
· general economic, political, demographic and business conditions in North America, the Middle East, Europe and other regions in which we operate;
· changes in government and industry regulation and tax matters;
· our continued ongoing compliance with covenants linked to financial instruments;
· other factors that may affect our financial condition, liquidity and results of operations; and
· other risk factors discussed under “Item 3. Key Information—D. Risk Factors” in our Annual Report.
You should refer to the section in our Annual Report titled “Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements included herein or incorporated by reference herein will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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