GlobeNewswire Inc | Sep 7, 2021 06:36AM EDT

September 07, 2021

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on generating data-driven insights to diagnose, understand, and treat rare diseases, today announced financial results for the second quarter ended June 30, 2021, and provided an update on recent business progress.

We delivered a strong quarter and made meaningful progress on our strategic priorities, which we outlined at our Investor Event in June this year. This includes the appointment and onboarding of an expanded new management team, with the most recent addition of Patrice P. Denfle as Chief Scientific Officer to help lead our data-driven approach to reinvent rare disease drug discovery and development, stated Andrin Oswald, M.D., Chief Executive Officer at CENTOGENE. By leveraging the compounding value of our leading and continuously growing Bio/Databank within our diagnostic, research, and pharma initiatives, we have built a strong foundation and are set to enable the cure of 100 rare diseases in 10 years.

Q2 FinancialHighlights

-- Revenues of 51.9 million in Q2 2021, a 434% increase compared to 9.7 million in Q2 2020; Revenues from the Companys Pharma and Diagnostics segments (Core Business) increased 25% -- Clinical Diagnostics revenues (excl. COVID) of 6.7 million, an increase of 82% compared to 3.6 million in Q2 2020 -- Pharma revenues of 2.8 million in Q2 2021, down from 3.9 million in Q2 2020, with further revenues weighted towards the end of 2021 -- Commercial COVID-19 testing revenues of 42.3 million in Q2 2021, up from 2.1 million in Q2 2020 -- Positive total segment adjusted EBITDA of 7.5 million compared to 1.0 million in Q2 2020 from the Companys Pharma, Diagnostics, and COVID-19 testing segments -- Cash and cash equivalents of 34.8 million as of June 30, 2021, compared to 45.2 million for the period ending March 31, 2021

We are very encouraged by the accelerating momentum and the performance we delivered in Q2 2021, particularly in achieving strong segment adjusted EBITDA now multiple quarters in a row, said Ren Just, Chief Financial Officer of CENTOGENE. We will continue to efficiently deploy our capabilities and resources to drive further growth and value creation for our patients and shareholders.

Corporate Highlights

-- Set mission to enable the cure of 100 rare diseases in 10 years and outlined high value creating strategy and milestones for the next few years at first corporate Investor Event on June 22, 2021 -- Published 200th scientific publication accelerating scientific discoveries through leveraging CENTOGENE's vast Bio/Databank and studying over 115,000 patient cases to diagnose, understand, and treat rare disease patients around the world -- Added approximately 24,000 patients with high quality data sets to CENTOGENEs Bio/Databank, the worlds most geographically diverse source of rare disease-centric insights -- Announced key additions to executive management team, including most recently Patrice P. Denfle as Chief Scientific Officer, who is responsible for overseeing scientific activities to deliver on the Companys vision and strategy, while driving value creation

Pharma Highlights

-- Initiated new collaboration with immuno-neurology pioneer Alector to accelerate the diagnosis of patients with frontotemporal dementia, a geneticneurodegenerative disease -- Extended partnership with Takeda to enable access to genetic testing and diagnosis of patients with certain genetic disorders -- Extended global Parkinsons disease study (Rostock International Parkinson's Disease (ROPAD) Study) aiming to recruit and genetically test an additional 2,500 patients for Parkinsons, one of CENTOGENEs key prioritized diseases. In 2018, CENTOGENE entered into a strategic collaboration with Denali Therapeutics for the targeted global identification and recruitment of Parkinsons disease patients with mutations in the LRRK2 gene -- Currently leads 12 ongoing observational and longitudinal observational clinical studies to validate/monitor biomarkers, covering several disease categories, such as Parkinsons disease, transthyretin amyloidosis, and inborn errors of metabolism

Diagnostic Highlights

-- Launched enhanced Whole Exome Sequencing (WES) service NEW CentoXome, coupling insights from the Companys unique rare disease-centric Bio/Databank with superior omics technology to increase diagnostic yield by up to 20% compared to conventional WES -- Reported testing volume/order intake/test requests of 29,100 which represents a 54 % increase compared to 18,850 in the same period in 2020 -- Published latest research which led to the discovery of six new rare diseases, which are now incorporated into the Companys diagnostic offering, and diagnosis of over 90 patients by leveraging the Companys Bio/Databank -- Authored 18 peer-reviewed scientific publications in Q2 2021, focused on generating critical insights into diseases, including Parkinsons disease, as well as advancements in genetic sequencing technology

COVID-19 Testing

-- Leveraged CENTOGENEs diagnostic expertise and resources with continued COVID-19 testing, including the processing of 679,900 test requests for SARS-CoV-2 testing in Q2 2021

2021 FinancialGuidance

The Company continues to see Diagnostics recovery, alongside momentum in newly signed Pharma partnership deals. This trajectory indicates a return to solid core business growth for 2021. Despite anticipating COVID-19 revenues to decline in the second half of the year, overall revenue for FY 2021 is expected to surpass FY 2020.

Webcast and Conference Call Information

Management will host a conference call and webcast today at 2 p.m. CEST/ 8 a.m. EDT to discuss financial results and recent developments. To access the conference call and webcast, please register at: http://emea.directeventreg.com/registration/6090847. Upon registering, each participant will be provided with Participant Dial In Numbers, a Direct Event Passcode, and a unique Registrant ID. Registrants can then join up to 10 minutes prior to the start of the call.

The webcast of the conference call and the slide deck will also be available on the Investor Relations page of the Companys website at http://investors.centogene.com.

These results reflect another step forward for CENTOGENEs mission to enable the cure of 100 rare diseases within the next 10 years. To learn more, visit: https://www.centogene.com/virtual-investor-event

AboutCENTOGENECENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical, genetic, and multiomic data to diagnose, understand, and treat rare diseases. Our goal is to bring rationality to treatment decisions and to accelerate the development of new orphan drugs by using our extensive rare disease knowledge and data. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository with over 3.9 billion weighted data points from approximately 600,000 patients representing over 120 different countries as of December 31, 2020.

The Companys platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, as well as a biobank of patients blood samples and cell cultures. CENTOGENE believes this represents the only platform focused on comprehensive analysis of multi-level data to improve the understanding of rare hereditary diseases. It allows for better identification and stratification of patients and their underlying diseases to enable and accelerate discovery, development, and access to orphan drugs. As of December 31, 2020, the Company collaborated with over 30 pharmaceutical partners.

Forward-Looking StatementsThis 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 CENTOGENEs actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, the effects of the COVID-19 pandemic on our business and results of operations, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in our industry, the expense and uncertainty of regulatory approval, including from the U.S. Food and Drug Administration, our reliance on third parties and collaboration partners, including our ability to manage growth and enter into new client relationships, our dependency on the rare disease industry, our ability to manage international expansion, our reliance on key personnel, our reliance on intellectual property protection, fluctuations of our operating results due to the effect of exchange rates, 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 CENTOGENEs business in general, see CENTOGENEs risk factors set forth in CENTOGENEs Form 20-F filed on April 15, 2021, with the Securities and Exchange Commission (the SEC) and subsequent filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and CENTOGENEs specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Centogene N.V.Unaudited interim condensed consolidated statements of comprehensive loss for the three and six months ended June 30, 2021, and 2020(in EUR k)

For the three months For the six months ended ended June30 June30 Note 2020 2021 2020 2021 Revenue 4, 5 9,719 51,871 21,824 116,831 Cost of sales 6,815 43,760 13,833 95,707 Gross profit 2,904 8,111 7,991 21,124 Research anddevelopment 3,119 4,053 5,810 8,388 expensesGeneraladministrative 7,767 10,494 15,665 22,090 expensesSelling 2,386 1,942 4,712 3,891 expensesImpairment offinancial 7 500 580 1,674 675 assetsOther operating 6.1 801 1,276 1,746 1,642 incomeOther operating 6.2 37 2 138 36 expensesOperating loss (10,104 ) (7,684 ) (18,262 ) (12,314 )Interest and 13 ? 13 ? similar incomeInterest and 269 212 718 471 similar expenseFinancial (256 ) (212 ) (705 ) (471 )costs, netLoss before (10,360 ) (7,896 ) (18,967 ) (12,785 )taxesIncome tax ? 124 129 124 expensesLoss for the (10,360 ) (8,020 ) (19,096 ) (12,909 )periodOthercomprehensiveincome/ (loss),all (6 ) (191 ) 70 (70 )attributable toequity holdersof the parentTotalcomprehensive (10,366 ) (8,211 ) (19,026 ) (12,979 )lossAttributable to:Equity holders (10,364 ) (8,222 ) (18,963 ) (13,025 )of the parentNon?controlling (2 ) 11 (63 ) 46 interests (10,366 ) (8,211 ) (19,026 ) (12,979 )Loss per share- Basic and (0.52 ) (0.37 ) (0.95 ) (0.58 )diluted (inEUR)

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.

Centogene N.V.Unaudited interim condensed consolidated statements of financial position as at December 31, 2020, and June 30, 2021(in EUR k)

Assets Note Dec 31, June 30, 2020 2021Non?current assets Intangible assets 12,407 12,179 Property, plant and equipment 16,590 16,411 Right-of-use assets 22,120 20,558 Other assets 7 1,967 3,023 53,084 52,171 Current assets Inventories 11,405 9,281 Trade receivables and contract 7 29,199 18,490 assetsOther assets 7 8,286 6,064 Cash and cash equivalents 8 48,156 34,780 97,046 68,615 150,130 120,786

Equity and liabilities Note Dec 31, June 30, 2020 2021Equity Issued capital 9 2,654 2,693 Capital reserve 9 125,916 130,153 Retained earnings and other (62,888 ) (75,913 )reservesNon?controlling interests 95 141 65,777 57,074 Non?current liabilities Non?current loans 10.1 401 200 Lease liabilities 10.1 17,677 16,209 Deferred tax liabilities 207 246 Government grants 10.2 8,950 8,640 27,235 25,295 Current liabilities Government grants 10.2 1,342 1,352 Current loans 10.1 2,492 3,883 Lease liabilities 10.1 3,528 3,299 Trade payables 10.2 31,736 14,014 Liabilities from income taxes 10.2 58 143 Other liabilities 10.2 17,962 15,726 57,118 38,417 150,130 120,786

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.

Centogene N.V.Unaudited interim condensed consolidated statements of cash flows for thesix months ended June 30, 2020, and 2021(in EUR k)

For the six months ended June 30 Note 2020 2021 Operating activities Loss before taxes (18,967 ) (12,785 ) Adjustments to reconcile loss to cash flow from operating activities Amortization and depreciation 5 4,432 6,670 Interest income (13 ) ? Interest expense 718 471 Expected credit loss allowances on 7 1,674 675 trade receivables and contract assetsShare?based payment expenses 11 1,393 4,276 Tax expense 129 124 Other non?cash items (686 ) 126 Changes in operating assets and liabilitiesInventories (6,252 ) 2,124 Trade receivables and contract assets 7 (64 ) 10,034 Other assets 7 269 328 Trade payables 10.2 274 (17,722 )Other liabilities 10.2 2,457 (2,151 ) Cash flow used in operating activities (14,636 ) (7,830 ) Investing activities Cash paid for investments in intangible 5 (3,965 ) (2,089 )assetsCash paid for investments in property, (3,072 ) (2,696 )plant and equipmentGrants received for investment in 10.2 390 ? property, plant and equipmentInterest received 13 ? Cash flow used in investing activities (6,634 ) (4,785 ) Financing activities Cash paid for acquisition of non-wholly (75 ) ? owned subsidiaryCash received from loans 10.1 928 1,769 Cash repayments of loans 10.1 (1,260 ) (185 )Cash repayments of lease liabilities 10.1 (1,619 ) (2,263 )Interest paid (399 ) (82 ) Cash flow from used in financing (2,425 ) (761 )activities Changes in cash and cash equivalents (23,695 ) (13,376 )Cash and cash equivalents at the 41,095 48,156 beginning of the periodCash and cash equivalents at the end of 17,400 34,780 the period

The accompanying notes form an integral part of these unaudited interim condensed consolidated financial statements.

CENTOGENELennart Streibel Investor Relationsinvestor.relations@centogene.com

FTI ConsultingRobert Stanislarorobert.stanislaro@fticonsulting.com

Rachel Kleimanrachel.kleiman@fticonsulting.com