CENTOGENE Reports Full Year 2022 Financial Results

Full Year 2022 total revenues with double-digit growth of 12% at €47.5 million, in line with prior guidanceSignificant expansion of gross profit margin from 32% to 42% and ongoing cost control resulted in significant improvement of net resultsBoth Pharma and Diagnostics segments positioned for strong performance in 2023, guidance of FY2023 total revenue growth between 10% to 15% CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, May 16, 2023 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG) (“we” or the “Company”), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced financial results for the fiscal year ended December 31, 2022, and provided a business update. “2022 reaffirms CENTOGENE’s focus and dedication to becoming the essential data-driven partner in rare and neurodegenerative diseases. With renewed focus on our Core Diagnostics and Pharma segments and the exit of the COVID-19 business, we have continued to deliver against our goals – recording double-digit revenue growth compared to the prior year. We expanded the CENTOGENE Biodatabank to over 750,000 patients – representing the world´s largest real-world integrated multiomic data repository in rare and neurodegenerative diseases to enable diagnostics, clinical development, and access to life-saving treatments for patients and partners around the world,” stated Kim Stratton, Chief Executive Officer at CENTOGENE. “While we continue to navigate a volatile market environment, we are proactively pursuing a number of initiatives to extend our cash runway and continue improving our cost structure. Looking ahead, we expect to see 2023 annual revenue growth between 10% to 15%.” Full Year 2022 Financial Highlights Total revenues increased by 12% to €47.5 million in FY2022, compared to €42.2 million in FY2021, reflecting growth in both the Diagnostics and Pharma segmentsDiagnostics segment revenues increased by 18% in 2022 to €31.4 million, primarily related to an increase of 34% in revenues for CentoXome® (CENTOGENE’s proprietary Whole Exome Sequencing) and CentoGenome® (CENTOGENE’s proprietary Whole Genome Sequencing). Achieved upselling 25% of CentoXome® and CentoGenome® orders to MOx (CENTOGENE’s portfolio of multiomic testing solutions) in FY2022Pharma segment revenues returned to growth after two years of decline, increasing by 3% year-over-year to €16.1 million, primarily driven by progressing observational studies for patient finding and market access in collaboration with pharma partners to support clinical development stage projects in rare and neurodegenerative disorders. Gross profit margins more than doubled to 55% in FY2022 compared to 26% in FY2021The overall gross profit margin improved by 10 percentage points to 42% of revenues or €19.8 million in FY2022, compared to a 32% gross profit margin in FY2021. The gross profit margin was mainly driven by better margins in the Pharma segment and solid margins in the Diagnostics segment due to product mix of innovative, high-end products including CentoXome®, CentoGenome®, and MOxThe Company improved its net loss position by 31% at €31.8 million in FY2022 compared to a net loss of €46.2 million in FY2021. Net loss from continuing operations showed an improvement of 33% at €38.7 million in FY2022 compared to €57.4 million in FY2021. G&A costs decreased by 25%, or €10.9 million, in FY2022. Discontinued operations reflected the contributions from the COVID-19 testing business, which was ceased end of Q1 2022 Total segment adjusted EBITDA showed a significant improvement of 69% overall at €13.2 million in FY2022 compared to €7.8 million in FY2021 from the Company’s Diagnostics and Pharma segments, representing higher adjusted EBITDA contributions from both business segments. Adjusted EBITDA from the Pharma segment increased by 42% to €6.8 million in FY2022, compared to €4.8 million in FY2021, as a result of strong revenue growth and an increase in gross margins. The Diagnostics segment recorded a notable increase in adjusted EBITDA of 112% to €6.4 million in FY2022, compared to €3.0 million in FY2021, primarily due to revenue growth and improved collections of receivablesCash and cash equivalents were €36.0 million as of December 31, 2022, compared to €17.8 million for the period ending December 31, 2021. There is uncertainty about the Company’s ability to continue as a going concern. Please refer to the Company’s FY2022 financial statements and related disclosures “We are very encouraged by the accelerating momentum and the performance we delivered in 2022, particularly in continuing to achieve strong segment adjusted EBITDA and optimizing operational efficiency. We have made a lot of progress towards building a sustainable business – simplifying and strengthening our organization as well as optimizing our cost structure and cost management. The results can be seen in significant improvements across gross margins, which are up 10 percentage points, corporate expenses being reduced, adjusted EBITDA improved, as well as the Company’s bottom line. In 2023, we continue to prioritize cost diligence as a key driver for profitability, while actively exploring additional transaction options to extend our cash runway. By strategically managing our expenses, we seek to enhance the stability of our balance sheet and foster sustainable financial performance,” added Miguel Coego, Chief Financial Officer at CENTOGENE. Recent Business Highlights Corporate Expanded the CENTOGENE Biodatabank to over 750,000 patients, over 70% of whom are of non- European descent, approximately 30,000 active physicians, and more than 70 million unique variants thanks to the increasing number of CentoXome® and CentoGenome® analyses, which contain significantly more variants than more targeted diagnostic testsAppointed Chief Commercial Officer & General Manager – Pharma, Ian Rentsch, and significantly strengthened Pharma Business Development by more than doubling the team size – underlining the Company’s strategic focus to better serve existing partners and significantly increase collaborations with new partnersStrengthened Diagnostics Sales team and expanded direct footprint distribution network in targeted geographic areas, such as Canada, Colombia, Italy, Spain, and PortugalAuthored 62 peer-reviewed scientific publications in FY2022, unlocking insights into Parkinson’s disease, Gaucher disease, frontotemporal dementia, Fabry disease, muscular dystrophy, Alport syndrome, mucopolysaccharidosis type VI, Suleiman-El-Hattab syndrome, Galloway-Mowat syndrome, HIDEA (hypotonia, hypoventilation, intellectual disability, dysautonomia, epilepsy and eye abnormalities) syndrome, and Diets-Jongmans syndrome, as well as a range of variants associated with epilepsy, genetic cancers, metabolic disorders, developmental disorders, and other rare and neurodegenerative diseasesClosed $20 million second tranche of secured loan from Oxford Finance in December 2022, upon achieving trailing twelve-months revenue performance targetAnnounced the appointment of Mary Sheahan as Chair of the Audit Committee, as well as Ad Interim Member of the Supervisory Board, which is to be confirmed at the Company’s next General Meeting of Shareholders in June Pharma Extended Takeda partnership to April 2024 to continue providing access to genetic testing for patients with lysosomal storage disordersEntered strategic collaborations with IQVIA and Premier Research to extend strategy and expand commercialization model with pharma partners via Contract Research Organizations (CROs)Extended, alongside Denali Therapeutics, the ROPAD Study, the world’s largest observational study on Parkinson’s disease genetics with approximately 15,000 enrolled patients to date. Patients enrolled in ROPAD and identified with LRRK2 genetic variations may be eligible for participation in ongoing interventional clinical studies. Denali, in collaboration with Biogen Inc., is currently evaluating the efficacy and safety of BIIB122 (DNL151), a small molecule LRRK2 inhibitorExtended and expanded, with support from Alector, Inc., the observational EFRONT Study to advance the genetic understanding of frontotemporal dementiaLaunched the CENTOGENE Biodata Network, a portfolio of data-driven partnering solutions for biopharma and research institutions, fueled by the CENTOGENE Biodatabank and over 15 years of patient insights. These customizable partnering solutions include Insight Reports, which are tailored data analysis reports that seamlessly enable partners to answer ad hoc research questions via real-world data. Biodata Licenses are also available, which enable partners to securely access CENTOGENE’s multiomic, clinical, and sociodemographic datasets via a Trusted Research Environment (TRE) Diagnostics Strong order intake of approximately 70,000 test requests for FY2022, which represents a 23% increase compared to approximately 57,000 in the prior yearLaunched CentoCloud®, one of the world’s only CE-marked Software as a Service (SaaS) under the In Vitro Diagnostics Directive (98/79/EC), as well as released CENTOGENE’s FilterTool application, one of the first applications to receive CE mark under the new In Vitro Diagnostic Regulation (IVDR). Pairing CentoCloud® and the FilterTool accelerates genetic data interpretation and helps labs and healthcare institutions around the globe to access the leading CENTOGENE Biodatabank, state-of-the-art certified dry labs, and automated bioinformatic pipelines to fully support rare and neurodegenerative patientsLaunched NEW CentoGenome®, the world’s most comprehensive Whole Genome Sequencing tool for diagnosis of rare and neurodegenerative diseases, which now detects Copy Number Variations associated with spinal muscular atrophy, as well as complex disease-causing variants associated with Gaucher disease and susceptibility to GBA1-related Parkinson’s diseaseLaunched MOx – CENTOGENE’s portfolio of single-step multiomic solutions that combines genomic and biochemical testing to lead to a higher diagnostic yield by up to 25%Launched together with TWIST Bioscience three Next Generation Sequencing target enrichment panels, Twist Alliance CNTG Exome, Twist Alliance CNTG Rare Disease Panel, and Twist Alliance CNTG Hereditary Oncology Panel, to support rare disease and hereditary cancer research and support diagnosticsUtilizing Illumina’s new NovaSeq X Sequencing System to further optimize throughput, scale, and cost efficiencies 2023 Revenue Guidance The Company expects revenue growth to be between 10 to 15% in FY2023 compared to FY2022. 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 over 750,000 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 275 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 Biodata 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 and our ability to continue as a going concern, or other factors. For further information on the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to CENTOGENE’s business in general, see CENTOGENE’s risk factors set forth in CENTOGENE’s Form 20-F filed on May 16, 2023, 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. Contact: CENTOGENE Ben LeggCorporate [email protected] Lennart StreibelInvestor [email protected]  Centogene N.V. Consolidated statements of comprehensive loss for the years ended December 31, 2022, 2021 and 2020 4(in EUR k)              Note    2022    2021*    2020*      Restated RestatedRevenue 7 47,473  42,234  38,453 Cost of sales   27,712  28,735  35,286 Gross profit    19,761   13,499   3,167 Research and development expenses   17,488  19,297  14,935 General administrative expenses   32,587  43,480  37,665 Selling expenses   9,924  9,326  7,580 Impairment of financial assets 22.2 —  827  3,636 Gain on reversal of financial asset impairment   432  —  — Other operating income 8.1 3,774  2,894  2,392 Other operating expenses 8.2 741  86  182 Operating loss    (36,773)  (56,623)  (58,439)Changes in fair value of warrants 8.3 2,574  —  — Interest and similar income   512  3  6 Interest and similar expenses   4,909  802  1,381 Financial costs, net 8.3 (1,823) (799) (1,375)Loss before taxes from continuing operations    (38,596)  (57,422)  (59,814)Income taxes expenses 10 107  (70) 224 Loss for the year from continuing operations    (38,703)  (57,352)  (60,038)Net income from discontinued operations, net of tax 9 6,862  11,106  38,052 Loss for the period    (31,841)  (46,246)  (21,986)Other comprehensive income/(loss), all attributable to equity holders of the parent   (76) 543  (48)Total comprehensive loss    (31,917)  (45,703)  (22,034)Attributable to:     —  — Equity holders of the parent   (31,917) (45,801) (22,094)Non‑controlling interests from continuing operations 24 —  98  60 Non‑controlling interests from discontinued operations   —  —  —     (31,917) (45,703) (22,034)Net loss per share – Basic and diluted from (in EUR)        Continuing operations 11 (1.45) (2.53) (2.87)Loss attributable to parent 11 (1.19) (2.04) (1.05)          *The comparative numbers have been re-presented as a result of the discontinued operations. Refer to Note 9 – Discontinued Operations. The accompanying notes form an integral part of these consolidated financial statements Centogene N.V. Consolidated statements of financial position as of December 31, 2022 and 2021 (in EUR k)            Assets    Note    Dec 31, 2022    Dec 31, 2021 Jan 1, 2021      Restated* Restated*Non‑current assets           Intangible assets 12 7,400  9,194  12,407 Property, plant and equipment 13 6,808  9,464  16,590 Right-of-use assets 14 15,351  18,904  22,120 Derivatives assets 22 510  —  — Other assets 16 2,911  2,972  1,967      32,980   40,534   53,084 Current assets           Inventories 15 1,819  3,869  11,405 Trade receivables and contract assets 16 16,548  23,462  28,988 Other assets 16 5,514  5,453  8,286 Cash and cash equivalents 17 35,951  17,818  48,156      59,832   50,602   96,835      92,812   91,136   149,919           Equity and liabilities    Note    Dec 31, 2022    Dec 31, 2021 Jan 1, 2021         Equity        Issued capital 18 3,307  2,708  2,654 Capital reserve 18 145,369  133,897  125,916 Accumulated deficit and other reserves   (141,265) (109,540) (63,739)Non‑controlling interests   —  193  95      7,411   27,258   64,926 Non‑current liabilities        Non‑current loans 20.1 40,051  —  401 Lease liabilities 20.1 13,125  15,394  17,677 Deferred tax liabilities   35  79  207 Government grants 20.2 6,687  8,028  8,950 Derivative liabilities 22 376  —  — Warrant liability 22 260  —  — Other liabilities 20.2, 21 202  960  640      60,736   24,461   27,875 Current liabilities        Government grants 20.2 1,263  1,368  1,342 Current loans 20.1 4,635  3,815  2,492 Lease liabilities 20.1 2,311  3,330  3,528 Liabilities from income taxes 10 89  178  58 Trade payables 20.2 6,317  11,252  31,736 Other liabilities 20.2, 21 10,050  19,474  17,962      24,665   39,417   57,118      92,812   91,136   149,919  *Property, plant and equipment and lease liabilities as of December 31, 2021, and Trade receivables and contract assets and other liabilities as of December 31, 2021, and January 1, 2021, have been restated. Refer to Note 2.4 – Restatement of selected assets and liabilities in the consolidated statements of financial position and selected income and expenses in the consolidated statements of comprehensive loss. The accompanying notes form an integral part of these consolidated financial statements Centogene N.V. Consolidated statements of cash flows for the years ended December 31, 2022, 2021 and 2020 (in EUR k)              Note    2022    2021* (Restated)    2020* (Restated)Operating activities                                   Loss before taxes from continuing operations   (38,596) (57,422) (59,815)Income before taxes from discontinued operations 9 6,875  11,152  38,110 Loss before taxes   (31,721) (46,270) (21,705)Adjustments to reconcile earnings to cash flow from operating activities                 Amortization (including impairments) and depreciation 12,13,14 10,378  19,974  15,128 Inventory write-off   —  1,795  — Interest income 8.3 —  (3) (6)Interest expense 8.3 4,909  851  1,400 Gain on the disposal of non‑current assets   (754) (18) — Expected credit loss allowances on trade receivables and contract assets 2.4 —  631  3,804 Share‑based payment expenses 21 (16) 8,035  5,658 Tax expense   (89) —  — Fair value adjustments of warrants 8.3 (2,574) —  — Other non‑cash items   (1,430) (625) (981)Net foreign exchange differences   963  —  —          Changes in operating assets and liabilities:        Inventories 15 2,050  5,741  (9,596)Trade receivables and contract assets 16 6,914  4,855  (16,172)Other assets 16 —  1,828  255 Trade payables 20.2 (4,935) (20,484) 23,996 Other liabilities 28 (10,182) 1,952  6,681          Thereof cash flow (used in) continuing operating activities 28 (35,497) (42,635) (30,603)Thereof cash flow from discontinued operating activities   9,009  20,897  39,065 Cash flow (used in)/from operating activities    (26,488)  (21,739)  8,462          Investing activities                 Cash paid for investments in intangible assets 12 (1,727) (2,787) (6,657)Cash paid for investments in property, plant and equipment 13 (367) (2,915) (9,890)Grants received for investment in property, plant and equipment 20.2 506  168  390 Grants refunded related to disposed property, plant and equipment 20.2 —  —  — Cash received from disposals of property, plant and equipment   855  171  — Interest received   —  3  6          Thereof cash flow (used in) continuing investing activities   (1,553) (2,494) (5,366)Thereof cash flow from/(used in) discontinued investing activities   820  (2,866) (10,785)Cash flow (used in)/from investing activities    (733)  (5,360)  (16,151)         Financing activities        Cash received from the issuance of shares 18 12,140  —  22,430 Cash received from issuance of warrants   2,833  —  — Cash paid for acquisition of non-wholly owned subsidiary   (1) —  (75)Cash received from loans 20, 22.2 40,568  1,772  438 Cash repayments of loans 20, 22.2 —  (464) (2,760)Cash repayments of lease liabilities 20, 22.2 (4,314) (4,244) (5,018)Interest paid 8.3 (4,909) (267) (173)         Thereof net cash flow from/(used in) continuing financing activities   46,798  (2,403) 13,561 Thereof net cash flow from/(used in) discontinued financing activities   (481) (800) 1,281 Cash flow from financing activities    46,317   (3,203)  14,842                   Changes in cash and cash equivalents   19,096  (30,302) 7,153 Cash and cash equivalents at the beginning of the period   17,818  48,156  41,095 Effect of movements in exchange rates on cash held   (963) (36) (92)Cash and cash equivalents at the end of the period   35,951  17,818  48,156  *The comparative numbers have been re-presented as a result of the discontinued operations. Refer to Note 9- Discontinued Operations. The accompanying notes form an integral part of these consolidated financial statements