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 December 22, 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 December 22, 2022, Centogene N.V. (the “Company”) issued a press release reporting its financial results for the second quarter and first half of 2022 and 2021. A copy of the press release is attached hereto as Exhibit 99.1.
Attached hereto as Exhibits 99.2 and 99.3 are also the unaudited condensed interim financial statements of the Company for the second quarter and first half of 2022 and 2021 and risk factors on claims audits, capital raising and leverage, 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333-234551) of the Company and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
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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: December 22, 2022 | |||
By: | /s/ Jose Miguel Coego Rios | ||
Name: | Jose Miguel Coego Rios | ||
Title: | Chief Financial Officer |
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Exhibit 99.1
CENTOGENE Reports Second Quarter and First Half 2022 Financial Results
CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, December 22nd, 2022 (GLOBE NEWSWIRE)
Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced unaudited financial results for the second quarter and first half ended June 30, 2022 and updated its fiscal year 2022 financial outlook. The quarterly and half year results are compared to the same periods in the prior year, unless otherwise specified, and reflect revisions as described below.
Second Quarter 2022 - Financial Highlights
● | Overall revenues increased by 21.6% year-over-year to €11.2 million |
● | Diagnostics segment revenues increased by 18.3% year-over-year to €7.5 million |
● | Pharmaceutical segment (“Pharma”) revenues increased by 29% year-over-year to €3.7 million |
● | Net loss from continuing operations of €11.9 million in the second quarter of 2022, an improvement of 11.9% compared to net loss from continuing operations of €13.5 million in the second quarter of 2021. (Excludes discontinued operations reflecting the Covid-19 testing business exited first quarter of 2022.) |
● | Total segment adjusted EBITDA (reflecting the Diagnostics and Pharma segment) of €3.5 million was recorded in the second quarter of 2022, an improvement of 289% compared to €0.9 million in the second quarter of 2021. |
First Half 2022 - Financial Highlights
● | Overall revenues increased by 12.6% year-over-year to €21.4 million |
● | Diagnostics segment revenues increased by 15.3% year-over-year to €14.5 million, mainly driven by 34.7% growth in test requests received for higher value Whole Exome Sequencing (WES) and Whole Genome Sequencing (WGS). |
● | Pharma revenues increased by 7.1% year-over-year to €6.9 million, mainly driven by increased activity in the clinical studies of our pharmaceutical partners. |
● | Net loss from continuing operations of €23.1 million in the first half of 2022, an improvement of 16.9% compared to net loss from continuing operations of €27.8 million in the first half of 2021. |
● | Total segment adjusted EBITDA (reflecting the Diagnostics and Pharma segment) of €5.3 million in the first half of 2022, an improvement of 60.6% compared to €3.3 million in the first half of 2021, mainly reflecting gross margin improvements in both segments. |
● | Cash and cash equivalents were €33.5 million as of June 30, 2022, compared to €17.8 million as of December 31, 2021. |
Kim Stratton, Chief Executive Officer at CENTOGENE stated, “The current year is part of a transition at CENTOGENE, with renewed focus on the Core Business and exit of the COVID business. We are delivering on our goals in the Diagnostics segment, continuing to show double digit growth (+15.3%) year-over-year with strong execution on our initiatives around WES, WGS and multiomics. The first half of the year also indicated 7.1% year-over-year growth in our Pharma segment, putting us on a solid trajectory. We are experiencing strong growth in our pipeline of Pharma projects, which points to robust growth in revenues from this segment in 2023. However, given the lumpiness and timing of late year-end contract signings, we expect 2022 annual revenue growth between 9% to 13%.”
Commenting on the financial performance, Miguel Coego, Chief Financial Officer of CENTOGENE noted, “The second quarter has been another period of improvements in efficiencies and business operations, including managing margins and corporate expenses. The reporting of our results was delayed due to a lengthier than anticipated review of reimbursements in the U.S. for diagnostic tests done by a third party service provider. The overall revenue impact were revisions of approximately €2.2 million across the periods 2019, 2020, 2021, and Q1 2022, or approximately 0.5% of
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the revenues over the same time-frame. In the meantime, we have selected a new service provider for reimbursement processing in the US market and initiated an upgrade of our controls in this area.”
Recent Business Highlights
Corporate
● | Added ~24,000 individuals to the CENTOGENE Biodatabank in the second quarter of 2022; with nearly 700,000 patients total represented from over 120 highly diverse countries, estimated over 70% of whom are of non-European descent. |
● | Authored 23 peer-reviewed scientific publications in the first half of 2022, focusing on advanced multiomic diagnostics and generating critical insights into an array of diseases, including rare genetic and neurological diseases, such as Parkinson’s disease, Gaucher disease, and Niemann-Pick disease. |
● | Announced the appointment of Mary Sheahan as a member ad interim of the Supervisory Board, to be confirmed at the Company’s next General Meeting of Shareholders; it is planned that Ms. Sheahan will assume the role of Chair of the Audit Committee. |
● | Strengthened our Core Business focus with key additions to the team including appointment of CFO and expansion of Pharma leadership team bringing significant sector and commercial expertise. |
● | Closed the $20 million second tranche of secured loan from Oxford Finance, with funding expected before the end of the year. |
Pharma
● | 45 active collaborations as of June 30, 2022; 12 contracts were signed in the first half of 2022; 10 of which with existing customers. |
● | Launched the Biodata Network, a portfolio of data-driven partnering solutions for biopharma and research institutions; collaborating with BC Platforms to increase access to tranche of 80,000 genetic sequences via Global Data Partner Network, BCRQUEST.com. |
● | Expanded partnership with Agios Pharmaceuticals for clinical development of PYRUKYND® (mitapivat) to treat children with rare blood disease. |
● | Leading three observational studies for patient finding and market access in collaboration with our pharma partners in rare and neurodegenerative disorders. |
Diagnostics
● | Reported order intake of approximately 16,300 test requests in our diagnostics segment in the second quarter of 2022, representing an increase of approximately 17% as compared to 13,900 test requests in the second quarter of 2021. |
● | Published study in the European Journal of Human Genetics revealing the power of multiomic testing in diagnosing and accelerating treatments for patients with Inherited Metabolic Disorders (IMDs). |
● | Awarded a three-year tender for genetic testing in Malta by the Ministry for Health. |
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● | Launched the latest version of CentoArray, a genome-wide analysis optimized for best cytogenetic disease coverage and designed to represent the latest clinical and genetic insights; cytogenic variations known to cause a broad range of developmental disorders, primarily neurodevelopmental and congenital anomalies. |
● | Received CE-mark for CentoCloud, making it one of the only decentralized SaaS and clinical decision support platforms compliant with European IVD regulatory framework. |
● | Contributed to Europe-wide efforts to update guidelines for WGS in rare disease diagnostics. |
Second Quarter and First Half 2022 Financial Summary
Our total revenues for the second quarter and first half of 2022 were €11,198 thousand and €21,389 thousand respectively, representing an increase of €1,989 thousand and €2,387 thousand, or 21.6% and 12.6% respectively, as compared to the second quarter and first half of 2021.
Revenues from our pharmaceutical segment were €3,653 thousand for the second quarter of 2022, an increase of €822 thousand, or 29%, from €2,831 thousand for the second quarter of 2021. Our partnership agreements are structured on a fee-per-sample basis, milestone basis, fixed fee basis, or a combination thereof. The 29% increase was primarily due to increased activity in the clinical studies of our pharmaceutical partners.
Revenues from our pharmaceutical segment were €6,888 thousand for the first half of 2022, representing an increase of €459 thousand, or 7.1%, from €6,429 thousand for the first half of 2021.
During the first half of 2022, we entered into twelve new collaborations and successfully completed twelve collaborations resulting in a total of 45 active collaborations at June 30, 2022, compared to 45 active collaborations at December 31, 2021 and 53 active collaborations as of June 30, 2021. Revenues from our new collaborations totalled €298 thousand and €329 thousand, respectively, for the second quarter and first half of 2022.
Revenues from our diagnostics segment were €7,545 thousand for the second quarter of 2022, an increase of €1,167 thousand, or 18.3%, from €6,378 thousand for the second quarter of 2021 due to a 17.4% increase in test requests received. Revenues from our diagnostics segment were €14,501 thousand for the first half of 2022, an increase of €1,928 thousand, or 15.3%, from €12,573 thousand for the first half of 2021 due to a 17.8% increase in test requests received.
The increase in revenues was primarily related to an increase in test requests for WES and WGS during the second quarter of 2022. Total revenues from WES and WGS for the second quarter of 2022 amounted to €4,144 thousand, representing an increase of 26.7% as compared to €3,270 thousand for the second quarter of 2021. The total number of WES and WGS test requests received in the diagnostics segment for the second quarter of 2022 was approximately 5,800, representing an increase of 39.5% as compared to approximately 4,159 test requests received for the second quarter of 2021.
Total revenues from WES and WGS for the first half of 2022 amounted to €7,853 thousand, representing an increase of 22.1% as compared to €6,431 thousand for the first half of 2021. The total number of WES and WGS test requests received in the diagnostics segment for the first half of 2022 was approximately 11,266, representing an increase of 34.7% as compared to approximately 8,365 test requests received for the first half of 2021.
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Cost of sales decreased by €31 thousand, or 0.5%, to €6,586 thousand for the second quarter of 2022, and increased by €211 thousand, or 1.6%, to €13,036 thousand for the first half of 2022. Cost of sales for second quarter and first half of 2022 represented 58.8% and 60.9%, respectively, of total revenue, representing a decrease of 13.0% percentage points and 6.5% percentage points, respectively, as compared to 71.9% and 67.5%, respectively for the second quarter and first half of 2021. The decrease was mainly due to operational efficiency improvements and product mix which resulted in lower consumable costs.
As a result of the above factors, our gross profit increased by €2,020 thousand, or 77.9%, to €4,612 thousand for the second quarter of 2022, from €2,592 thousand for the second quarter of 2021 while our gross profit for the first half of 2022, increased by €2,176 thousand, or 35.2%, to €8,353 thousand from €6,177 thousand for the first half of 2021.
Research and development expenses increased by €404 thousand, or 10%, to €4,457 thousand for the second quarter of 2022, from €4,053 thousand for the second quarter of 2021 while our research and development expense increased by €683 thousand, or 8.1%, to €9,071 thousand for the first half of 2022, from €8,388 thousand for the first half of 2021. The increase is mainly driven by the increased IT expenses incurred on the enhancements of internally generated software that do not qualify for capitalization.
General administrative expenses decreased by €1,116 thousand, or 10.6%, to €9,378 thousand for the second quarter of 2022 compared to €10,494 thousand incurred for the second quarter of 2021 while general administrative expenses decreased by €4,806 thousand, or 21.8%, to €17,284 thousand for the first half of 2022, from €22,090 thousand for the first half of 2021. The decrease is principally due to the reduction in personnel costs 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 period and expenditure on IT support.
Selling expenses for the second quarter and first half of 2022 were €2,798 thousand and €5,192 thousand, respectively, representing an increase of €856 thousand, or 44.1% as compared to €1,942 thousand for the second quarter of 2021 and an increase of €1,301 thousand, or 33.4%, as compared to €3,891 thousand for the first half of 2021. The increase for the second quarter and first half of 2022 was principally due to increases in sales and marketing personnel costs within the pharmaceutical segment.
There were no impairment expenses for financial assets incurred for the second quarter and first half of 2022 as compared to €544 thousand and €615 thousand, respectively incurred for the second quarter and first half of 2021. Instead, a gain on reversal of financial asset impairment was recorded for the second quarter and first half of 2022 due to improved collection of aged accounts receivable resulting in a positive re-assessment of receivables and contract assets arising from contracts with customers. The gain on reversal of financial asset impairment for the second quarter and first half of 2022 was €1,035 thousand and €919 thousand, respectively.
Other operating income decreased by €619 thousand, or 48.5%, to €657 thousand for the second quarter of 2022, from €1,276 thousand for the second quarter of 2021 and decreased by €252 thousand, or 15.3%, to €1,390 thousand for the first half of 2022, from €1,642 thousand for the first half of 2021, principally due to lower grant income released during the period.
Other operating expenses which relate to currency losses increased by €504 thousand, to €506 thousand in the second quarter of 2022 and increased by €471 thousand, to €507 thousand in the first half of 2022, compared to €2 thousand and €36 thousand, respectively, for the second quarter and first half of 2021.
The increase in currency losses in the second quarter and first half of 2022 mainly relates to transactions denominated in USD that have been impacted by the devaluation of the EUR against the USD in the three and six months period.
The change in net financial costs by €702 thousand and €1,063 thousand, for the second quarter and first half of 2022 is mainly due to the increased interest expense and unrealized foreign exchange impact of the Oxford Loan Facility.
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As a result of the factors described above, our loss before taxes from continuing operations for the second quarter and first half of 2022 was €11,712 thousand and €22,889 thousand, respectively, representing a decrease of €1,630 thousand and €4,746 thousand, respectively, from a loss before taxes from continuing operations of €13,342 thousand and €27,635 thousand, respectively, for the second quarter and first half of 2021.
Adjusted EBITDA from our pharmaceutical segment for the second quarter and first half of 2022 was €1,472 thousand and €2,571 thousand representing an increase of €825 thousand and €427 thousand respectively, as compared to €647 thousand and €2,144 thousand respectively for the second quarter and first half of 2021. The increase was primarily attributable to the increase in revenues from the pharmaceutical segment.
Adjusted EBITDA from our diagnostics segment for the second quarter and first half of 2022, was €2,005 thousand and €2,719 thousand, respectively, an increase of €1,727 thousand and €1,551 thousand as compared to €278 thousand and €1,168 thousand respectively, for the second quarter and first half of 2021. The increase is mainly due to the gain on reversal of financial asset impairment of €1,035 thousand and €919 thousand, respectively, recognized for the second quarter and first half of 2022, compared to the impairment of financial asset expense of €544 thousand and €615 thousand, respectively, for the second quarter and first half of 2021.
Revision of previously issued financial statements
During the preparation of unaudited condensed consolidated financial statements as of and for the three months ended March 31, 2022, the Group identified unadjusted differences related to 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. The unadjusted differences were related to COVID segment which was discontinued as of March 31, 2022.
During the preparation of the unaudited financial results for the second quarter ended June 30, 2022, the Group identified unadjusted differences related to revenue recognized and impairment losses for the years ended December 31, 2021, December 31, 2020 and December 31, 2019 and trade receivables outstanding as of December 31, 2021, 2020 and 2019 for the Diagnostics segment.
Management assessed the materiality of these unadjusted differences on the previously issued consolidated financial statements and concluded that the errors were not material to any period presented. The Group revised the relevant amounts for the previously issued financial statements. Refer to “Note 2 - Revision of previously issued financial statements” to our unaudited interim condensed consolidated financial statements for the three and six months ended June 30, 2022 and 2021 for further details.
2022 Financial Guidance
The Company expects to report 2022 annual revenue growth between 9% to 13% versus fiscal year 2021 revenues as revised. As a result, CENTOGENE expects revenues to be in the range of €46.5 million to €48.2 million. (This reflects the classification of the COVID-19 Business as discontinued operations.)
Earnings Cadence
The Company’s next financial report will be the FY 2022 results. Going forward, the Company plans to follow a semi-annual reporting cadence.
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About CENTOGENE
CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
Since our founding in 2006, CENTOGENE has been offering rapid and reliable diagnosis – building a network of approximately 30,000 active physicians. Our ISO, CAP, and CLIA certified multiomic reference laboratories in Germany utilize Phenomic, Genomic, Transcriptomic, Epigenomic, Proteomic, and Metabolomic datasets. This data is captured in our CENTOGENE Biodatabank, with nearly 700,000 patients represented from over 120 highly diverse countries, over 70% of whom are of non-European descent. To date, the CENTOGENE Biodatabank has contributed to generating novel insights for more than 260 peer-reviewed publications.
By translating our data and expertise into tangible insights, we have supported over 50 collaborations with pharma partners. Together, we accelerate and de-risk drug discovery, development, and commercialization in target & drug screening, clinical development, market access and expansion, as well as offering CENTOGENE Biodatabank Licenses and Insight Reports to enable a world healed of all rare and neurodegenerative diseases.
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.
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Exhibit 99.2
Centogene N.V.
Unaudited consolidated statements of comprehensive loss
(in EUR k)
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| For the three months ended June 30 |
| For the six months ended June 30 | ||||||
2022 |
| 2021* (Revised) |
| 2022 | 2021* (Revised) | |||||
Revenue |
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Cost of sales |
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Gross profit |
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Research and development expenses |
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General administrative expenses |
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Selling expenses |
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Impairment of financial assets |
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Gain on reversal of financial asset impairment | | — | | — | ||||||
Other operating income |
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Other operating expenses |
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Operating loss |
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Changes in fair value of warrants | | — | | — | ||||||
Interest and similar income |
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Interest and similar expense |
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Financial costs, net |
| ( |
| ( |
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Loss before taxes from continuing operations |
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Income tax expenses |
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Loss for the period from continuing operations |
| ( |
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Net income from discontinued operations, net of tax | | | | | ||||||
Loss for the period | ( | ( | ( | ( | ||||||
Other comprehensive income/(loss), all attributable to equity holders of the parent |
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Total comprehensive loss |
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Attributable to: |
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Equity holders of the parent |
| ( |
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Non‑controlling interests from continuing operations |
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Non‑controlling interests from discontinued operations | ( | | ( | | ||||||
( |
| ( |
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Net loss per share - Basic and diluted from (in EUR) | ||||||||||
Continuing operations | ( | ( | ( | ( | ||||||
Loss attributable to parent | ( | ( | ( | ( | ||||||
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*
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Centogene N.V.
Unaudited consolidated statements of financial position
(in EUR k)
Assets |
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| June 30, 2022 |
| Dec 31, 2021 |
| Jan 1 2021 | |
Revised | Revised | |||||||
Non‑current assets |
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Intangible assets |
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Property, plant and equipment* |
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Right-of-use assets | |
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Other assets |
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Current assets |
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Inventories |
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Trade receivables and contract assets* |
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Other assets |
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Cash and cash equivalents |
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Equity and liabilities |
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| Dec 31, 2021 |
| Jan 1 2021 | |
Revised | Revised | |||||||
Equity |
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Issued capital |
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Capital reserve |
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Accumulated deficit and other reserves* |
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Non‑controlling interests |
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Non‑current liabilities |
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Non‑current loans |
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Lease liabilities* |
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Deferred tax liabilities |
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Government grants |
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Other liabilities* | — | | | |||||
Warrants liability | | — | — | |||||
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Current liabilities |
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Government grants |
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Current loans |
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Lease liabilities* |
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Trade payables |
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Liabilities from income taxes | | | | |||||
Other liabilities* |
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*
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Centogene N.V.
Unaudited consolidated statements of cash flows
(in EUR k)
For the six months ended June 30 | ||||||
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| 2022 |
| 2021* (Revised) | ||
Operating activities |
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Loss before taxes from continuing operations | ( | ( | ||||
Income before taxes from discontinued operations | | | ||||
Loss before taxes |
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Adjustments to reconcile loss to cash flow from operating activities |
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Amortization and depreciation |
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Interest income | ( | — | ||||
Interest expense |
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Expected credit loss allowances on trade receivables and contract assets | — | | ||||
Gain on revaluation of credit loss allowance on trade receivables and contract assets | ( | — | ||||
Gain on disposal of property, plant and equipment | ( | — | ||||
Share‑based payment (true up)/ expenses |
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Fair value adjustments of warrants | ( | — | ||||
Tax expense | | | ||||
Other non‑cash items |
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Changes in operating assets and liabilities |
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Inventories |
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Trade receivables and contract assets |
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Other assets |
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Trade payables |
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Other liabilities |
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Thereof cash flow (used in) continuing operating activities |
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Thereof cash flow from discontinued operating activities | | | ||||
Net cash flow (used in) operating activities | ( | ( | ||||
Investing activities |
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Cash paid for investments in intangible assets |
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Cash paid for investments in property, plant and equipment |
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Cash received for disposal of property, plant and equipment | | — | ||||
Thereof cash flow (used in) continuing investing activities | ( | ( | ||||
Thereof cash flow from/(used in) discontinued investing activities | | ( | ||||
Cash flow received/ (used in) investing activities |
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Financing activities |
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Cash received from issuance of shares | | — | ||||
Cash received from issuance of warrants | | — | ||||
Cash received from loans |
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Cash repayments of loans |
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Cash repayments of lease liabilities |
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Interest received | 1 | — | ||||
Interest paid |
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Thereof net cash flow from/(used in) continuing financing activities | | ( | ||||
Thereof net cash flow (used in) discontinued financing activities | ( | ( | ||||
Net cash flow from/ (used in) financing activities |
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Changes in cash and cash equivalents |
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Cash and cash equivalents at the beginning of the period |
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Cash and cash equivalents at the end of the period |
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* The comparative numbers have been re-presented as a result of the discontinued operations
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1 Segment information
in EUR k | For the three months ended June 30, 2022 | |||||||
| Pharmaceutical |
| Diagnostics |
| Corporate |
| Total | |
Total Revenues from contracts with external customers | | | — | | ||||
Adjusted EBITDA |
| | | ( | ( | |||
Capital Expenditures |
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Additions to property, plant and equipment and right-of-use assets |
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Additions to intangible assets |
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Other segment information |
| |||||||
Depreciation and amortization | | | | | ||||
Research and development expenses |
| — | — | | |
in EUR k | For the three months ended June 30, 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 |
| — | — | | |
For the six months ended June 30, 2022 | ||||||||
in EUR k |
| 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 |
| — | — | | |
5
For the six months ended June 30, 2021 | ||||||||
in EUR k |
| 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 |
| — | — | |
| |
For the year ended December 31, 2021 | ||||||||||
in EUR k |
| Pharmaceutical |
| Diagnostics* |
| COVID-19* |
| 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 |
| — | — | — |
| | |
* Total Revenues from contracts with external customers have been revised for the second quarter and first half of 2021 and for the year ended December 31, 2021. Refer to Note 2 – Revision of previously issued financial statements.
Adjusted EBITDA
Adjustments to income/ loss include non-cash charges in relation to depreciation, amortization (including impairments), one-off costs (as defined below), 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 costs include general financing costs and corporate overheads related to, 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.
“One-off costs” are related to the costs incurred for the process of obtaining the equity and debt financing which were not directly attributable to the Oxford Loan or issuance of shares. One-off costs primarily include legal and consulting fees. These costs were disclosed under corporate expenses for the first quarter of 2022. Management reassessed and classified the one-off costs as an adjustment item for the first half of 2022.
Decreases in corporate expenses for the second quarter and first half of 2022 are mainly due to decreases in personnel costs and implementation of cost saving measures.
6
Reconciliation of segment Adjusted EBITDA to Group loss before taxes from continuing operations
| For the three months ended June 30 | |||
in EUR k | 2022 |
| 2021* | |
Reported segment Adjusted EBITDA |
| |
| |
Corporate expenses |
| ( |
| ( |
| ( |
| ( | |
Share-based payment income/(expenses) |
| ( |
| ( |
Depreciation and amortization |
| ( |
| ( |
One-off costs | ( | — | ||
Operating loss from continuing operations |
| ( |
| ( |
Financial costs, net |
| ( |
| ( |
Income tax expenses | ( | ( | ||
Loss before taxes from continuing operations for the three months ended June 30 |
| ( |
| ( |
| For the six months ended June 30 | |||
in EUR k | 2022 |
| 2021* | |
Reported segment Adjusted EBITDA |
| |
| |
Corporate expenses |
| ( |
| ( |
| ( |
| ( | |
Share-based payment income/(expenses) |
| |
| ( |
Depreciation and amortization |
| ( |
| ( |
One-off costs | ( | — | ||
Operating loss from continuing operations |
| ( |
| ( |
Financial costs, net |
| ( |
| ( |
Income tax expenses |
| ( |
| ( |
Loss before taxes from continuing operations for the six months ended June 30 |
| ( |
| ( |
Reconciliation of segment Adjusted EBITDA to Group loss for the period
in EUR k | 2021* |
| 2020* | 2019* | ||
Reported segment Adjusted EBITDA |
| |
| | | |
Corporate expenses |
| ( |
| ( | ( | |
| ( |
| | ( | ||
Share-based payment income/(expenses) |
| ( |
| ( | ( | |
Depreciation and amortization |
| ( |
| ( | ( | |
Operating loss |
| ( |
| ( | ( | |
Financial costs, net |
| ( | ( | ( | ||
Income tax expenses |
| | ( | ( | ||
Loss for the year |
| ( |
| ( | ( | |
* Reported segment Adjusted EBITDA has been revised for the second quarter and first half of 2021 and for the years ended December 31, 2021, 2020 and 2019. Refer to Note 2 – Revision of previously issued financial statements.
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
7
8
2 Revision of previously issued financial statements
During the preparation of unaudited condensed consolidated financial statements as of and for the three months ended March 31, 2022, the Group identified unadjusted differences related to 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.
During the preparation of the unaudited financial results for the second quarter ended June 30, 2022, the Group identified unadjusted differences related to revenue recognized and impairment losses for the years ended December 31, 2021, December 31, 2020 and December 31, 2019 and trade receivables outstanding as of December 31, 2021, 2020 and 2019 for the Diagnostics segment.
The Group assessed the materiality of these unadjusted differences on the previously issued consolidated financial statements and concluded that the errors were not material to any period presented.
The Group revised the amounts presented for certain property, plant and equipment, lease liabilities, trade receivables and other liabilities balances on the consolidated statement of financial position and revenue, cost of sales, impairment of financial assets and other operating income amounts in the statements of comprehensive loss for the previous periods.
The impact of the revision on the previously issued financial statements is disclosed below.
The impact of the revisions on the consolidated statements of financial position as of March 31, 2022 and 2021, are as follows:
in EUR k | March 31 2022 (as previously reported) | March 31 2022 (revised) | March 31 2021 (as previously reported) | March 31 2021 (revised) | ||||
Non‑current assets | | | | | ||||
Trade receivables and contract assets | | | | | ||||
Current assets | | | | | ||||
Total Assets | | | | | ||||
Equity and liabilities | ||||||||
Retained earnings and other reserves | ( | ( | ( | ( | ||||
Equity | | | | | ||||
Other liabilities | - | - | - | | ||||
Non‑current liabilities | | | | | ||||
Other liabilities | | | | | ||||
Current liabilities | | | | | ||||
Total Equity and Liabilities | | | | |
9
The impact of the revisions on the consolidated statements of comprehensive income for the three months ended March 31, 2022 and 2021 are as follows:
in EUR k | For the three months ended March 31 2022 (as previously reported) | For the three months ended March 31 2022 (as revised) | For the three months ended March 31 2021 (as previously reported) | For the three months ended March 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 period from continuing operations | ( | ( | ( | ( | ||||
Net income from discontinued operations, net of tax | | | | | ||||
Loss for the period | ( | ( | ( | ( | ||||
Total comprehensive loss | ( | ( | ( | ( | ||||
Loss per share- Basic and diluted (in EUR) | ( | ( | ( | ( | ||||
The impact of the revisions on the consolidated statements of financial position as of June 30, 2021 are as follows:
in EUR k | June 30, 2021 (as previously reported) | June 30, 2021 (as revised) | ||
Non‑current assets | | | ||
Trade receivables and contract assets | | | ||
Current assets | | | ||
Total Assets | | | ||
Equity and liabilities | ||||
Retained earnings and other reserves | ( | ( | ||
Equity | | | ||
Other liabilities | - | | ||
Non‑current liabilities | | | ||
Current liabilities | | | ||
Total Equity and Liabilities | | |
10
The impact of the revisions on the consolidated statements of comprehensive income for the three and six months ended June 30, 2021 are as follows:
in EUR k | For the three months ended June 30, 2021 (as previously reported - including Discontinued Operations) | For the three months ended June 30, 2021 (as revised) | For the six months ended June 30, 2021 (as previously reported - including Discontinued Operations) | For the six months ended June 30, 2021 (as 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 period from continuing operations | ( | ( | ( | ( | ||||
Net income from discontinued operations, net of tax | | | | | ||||
Loss for the period | ( | ( | ( | ( | ||||
Total comprehensive loss | ( | ( | ( | ( | ||||
Net loss per share- Basic and diluted (in EUR) | ( | ( | ( | ( | ||||
The impact of the revisions on the consolidated statements of financial position as of September 30, 2021 are as follows:
in EUR k | September 30, 2021 (as previously reported) | September 30, 2021 (as revised) | ||
Non‑current assets | | | ||
Trade receivables and contract assets | | | ||
Current assets | | | ||
Total Assets | | | ||
Equity and liabilities | ||||
Retained earnings and other reserves | ( | ( | ||
Equity | | | ||
Other liabilities | - | | ||
Non‑current liabilities | | | ||
Current liabilities | | | ||
Total Equity and Liabilities | | |
11
The impact of the revisions on the consolidated statements of comprehensive income for the three and nine months ended September 30, 2021 are as follows:
in EUR k | For the three months ended September 30, 2021 (as previously reported - including Discontinued Operations) | For the three months ended September 30, 2021 (as revised) | For the nine months ended September 30, 2021 (as previously reported - including Discontinued Operations) | For the nine months ended September 30, 2021 (as 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 period from continuing operations | ( | ( | ( | ( | ||||
Net income from discontinued operations, net of tax | ( | ( | | | ||||
Loss for the period | ( | ( | ( | ( | ||||
Total comprehensive loss | ( | ( | ( | ( | ||||
Net loss per share- Basic and diluted (in EUR) | ( | ( | ( | ( | ||||
12
The impact of the revisions on the consolidated statements of financial position as of December 31, 2021, 2020 and 2019, are as follows:
in EUR k | Dec 31, 2021 | Dec 31, 2021 (as revised) | Dec 31, 2020 | Dec 31, 2020 (as revised) | Dec 31, 2019 | Dec 31, 2019 (as revised) | ||||||
Non‑current assets | | | | | | | ||||||
Trade receivables and contract assets | | | | | | | ||||||
Current assets | | | | | | | ||||||
Total Assets | | | | | | | ||||||
Equity and liabilities | ||||||||||||
Issued capital | | | | | | | ||||||
Capital reserve | | | | | | | ||||||
Retained earnings and other reserves | ( | ( | ( | ( | ( | ( | ||||||
Non‑controlling interests | | | | | ( | ( | ||||||
Equity | | | | | | | ||||||
Other liabilities | - | | - | | - | | ||||||
Non‑current liabilities | | | | | | | ||||||
Current liabilities | | | | | | | ||||||
Total Equity and Liabilities | | | | | | |
The impact of the revisions on the consolidated statements of comprehensive income for the years ended December 31, 2021, 2020, and 2019 are as follows:
in EUR k | Dec 31, 2021 | Dec 31, 2021 (as revised) | Dec 31, 2020 | Dec 31, 2020 (as revised) | Dec 31, 2019 | Dec 31, 2019 (as 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 | | | | | | | ||||||
Real estate transfer tax 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 all periods presented.
13
However, the revision will result in cash outflows in the amount of €
The impact of the revisions on the consolidated statements of cash flows as of June 30, 2021 are as follows:
For the six months ended June 30 | ||||||
|
| 2021 |
| 2021 (Revised) | ||
Operating activities |
|
|
|
|
| |
Loss before taxes from continuing operations | ( | ( | ||||
Income before taxes from discontinued operations | | | ||||
Loss before taxes |
|
| ( | ( | ||
Adjustments to reconcile loss to cash flow from operating activities |
|
| ||||
Amortization and depreciation |
|
| | | ||
Interest expense |
|
| | | ||
Expected credit loss allowances on trade receivables and contract assets | | | ||||
Gain on revaluation of credit loss allowance on trade receivables and contract assets | — | — | ||||
Gain on disposal of property, plant and equipment | — | — | ||||
Share‑based payment (true up)/ expenses |
|
| | | ||
Tax expense | | | ||||
Other non‑cash items |
|
| | | ||
Changes in operating assets and liabilities |
|
| ||||
Inventories |
|
| | | ||
Trade receivables and contract assets |
|
| | | ||
Other assets |
|
| | | ||
Trade payables |
|
| ( | ( | ||
Other liabilities |
|
| ( | ( | ||
Thereof cash flow (used in) continuing operating activities |
|
| ( | ( | ||
Thereof cash flow from discontinued operating activities | | | ||||
Net cash flow (used in) operating activities | ( | ( | ||||
Investing activities |
|
| ||||
Cash flow received/ (used in) investing activities |
|
| ( | ( | ||
Financing activities |
|
|
| |||
Net cash flow from/ (used in) 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 |
|
| | |
14
Exhibit 99.3
Risk Factors
In the course of conducting our business operations, we are exposed to a variety of risks, some of which are inherent in our industry and others of which are more specific to our own businesses. The discussion below addresses risks of which we are currently aware, that could affect our businesses, results of operations and financial condition and make an investment in the Company speculative or risky.
We face inspections, reviews, audits and investigations under federal and state government programs and contracts and health insurance providers regarding our billing practices.
We may be subject to inspections, reviews, audits and investigations regarding our billing practices to verify our compliance with federal and state government program requirements and contracts and applicable laws and regulations. Other third-party payors, including private health insurance providers, may also reserve the right to conduct audits. An adverse result of an inspection, review, audit or investigation could result in:
● | denial of claims or recoupment or refunding of amounts we have been paid pursuant to the Medicare or Medicaid programs or from other payors; |
● | state or federal agencies imposing fines, penalties or other sanctions on us, including under the federal U.S. False Claims Act; |
● | temporary suspension of payments; |
● | revocation of billing privileges or exclusion from participation in the Medicare or Medicaid programs or one or more payor networks; |
● | self-disclosure of violations to applicable regulatory authorities; |
● | damage to our reputation; |
● | criminal penalties; |
● | revision or restatements of historical financial statements, including due to derecognition of revenue for claims we were not entitled to; and |
● | loss of certain rights under, or termination of, our contracts with payors. |
We have in the past and may in the future be required to refund amounts we have been paid and/or pay fines and penalties as a result of these inspections, reviews, audits and investigations, in particular if our documentation, billing and other practices do not comply with applicable government program or other payor requirements.
We are currently responding to an asserted overpayment following an audit of claims for diagnostic tests we submitted to the U.S. government Medicare program previously recognized. In addition, we have refunded payments received from a private health insurance company relating to reimbursement claims submitted for COVID-19 testing services between November 2020 and November 2021 and recognized in 2021. As a result of the foregoing requests, we have recognized in our unaudited interim condensed consolidated financial statements as of and for the second quarter and first half of 2022 € 910 thousand of other liabilities to be refunded back to Medicare for overpayments made between 2019 and 2022.
Any current or future inspection, review, audit or investigation could have a material adverse effect on our business and operating results.
We will require additional funding, which may not be available to us in the desired amount, at the desired time or on acceptable terms, or at all.
We will in the future require additional funding to fund our operations. We will need to finance future cash needs primarily through public or private equity offerings, debt financings or strategic collaborations. We do not know whether additional funding will be available in the desired amount, at the desired time, or on acceptable terms, or at all. We cannot assure you that we will be able to secure the funding required to allow us to continue as a going concern. To the extent that we raise additional funds by issuing equity securities or securities convertible into, or exercisable or exchangeable for, equity securities, our shareholders may experience significant dilution. Any financing, if available, may require that we agree to covenants that restrict our operations. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish certain rights to our products or grant
licenses on terms that may not be favorable to us. If any one of these factors is unfavorable, we may not be able to obtain additional funding, in which case, our business could be jeopardized and we may not be able to continue our operations or pursue our strategic plans. If we are forced to scale down, limit or cease operations, our stockholders could lose all of their investment in our Company.
Increasing our financial leverage could affect our operations, profitability and ability to raise additional capital.
Following disbursement of the second tranche of USD 20.0 million loan of our Loan Facility, our leverage will increase further. Our leverage may materially affect the availability of additional capital resources as well as our operations in several ways, including higher levels of interest expense to service or maintain our outstanding debt; the unavailability of additional borrowings in the future to repay our indebtedness when it comes due; less attractive economic or legal terms on which capital may be available to us; and the possible diversion of liquidity from other uses.