Longstanding global partnership provides an efficient and timely diagnosis to patients with Lysosomal Storage Disorders (LSDs) CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, March 19, 2024 (GLOBE NEWSWIRE) -- Centogene N.V. (NASDAQ:CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the extension of an ongoing partnership with Takeda (NYSE:TAK) to diagnose patients with Lysosomal Storage Disorders (LSDs). Under the renewed agreement, C ...

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Feb. 29, 2024 (GLOBE NEWSWIRE) -- CENTOGENE N.V. (NASDAQ:CNTG) (the "Company"), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the publication in Science of research on human pre-T cell receptor alpha (pre-TCRα) deficiency, a condition that often results in infection, lymphoproliferation, and autoimmune conditions, and its effect on human immunity. The research, conducted in collaboration wi ...

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Centogene N.V. (NASDAQ:CNTG) (the "Company"), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced that the Company has decided to explore a range of strategic alternatives focused on sustainable long-term value creation for the benefit of its stakeholders. "CENTOGENE is recognized as the world leader in rare and complex disease diagnostics, data, and pharma servi ...

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Jan. 25, 2024 (GLOBE NEWSWIRE) -- CENTOGENE N.V. (NASDAQ:CNTG) (the "Company"), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, and the Laboratory of Human Genetics of Infectious Diseases (the "Lab") at Institut Imagine today announced a strategic research collaboration to improve health outcomes for rare disease patients by accelerating and de-risking drug discovery and clinical development. As part of the ...

CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Centogene N.V. (NASDAQ:CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced that it has been recognized by the French Ministry of Higher Education and Research as a qualified organization to support partners conducting R&D projects in France. Accordingly, it has received accreditation under the French R&D tax credit initiative ('Crédit d'Impôt Recherche', ...

CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Centogene N.V. (NASDAQ:CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, and The Michael J. Fox Foundation for Parkinson's Research (MJFF), a non-profit organization dedicated to finding a cure for Parkinson's disease (PD), today announced a research project to accelerate research on genetic risk factors associated with PD, specifically targeting the role of variants i ...

Network and Data - CENTOGENE has built a network of approximately 30,000 active physicians since its founding in 2006[5] - The CENTOGENE Biodatabank includes data from over 750,000 patients across more than 120 countries, with over 70% being of non-European descent[5] - CENTOGENE's multiomic reference laboratories are ISO, CAP, and CLIA certified, utilizing various datasets for diagnosis[5] Collaborations and Research - The company has supported over 50 collaborations with pharmaceutical partners to accelerate drug discovery and commercialization[6] - CENTOGENE has contributed to generating novel insights for more than 275 peer-reviewed publications[5] Financial and Growth Strategy - Shareholders approved the external audit by Ernst & Young for the financial years ended December 31, 2022, and December 31, 2023[3] - The company aims to achieve sustainable growth and profitability through data-driven solutions for rare and neurodegenerative diseases[4] - The company is focused on expanding its market presence and enhancing its product pipeline[6] - The management board has been authorized to issue shares and limit pre-emption rights, indicating potential for future capital raising[3] Risks and Forward-Looking Statements - Forward-looking statements highlight risks including economic conditions, regulatory approvals, and reliance on third parties[8]

Financial Reporting and Internal Controls - The company identified three material weaknesses in financial reporting, including issues with the financial statement close process and IT controls [1807]. - Management is actively undertaking remediation efforts, including risk assessments and the implementation of a formalized IT controls framework [1808]. - During 2023, management will test and evaluate the effectiveness of the internal controls to prevent or detect material misstatements in financial statements [1809]. - The company’s internal controls over financial reporting are undergoing evaluation and improvement, which may require additional measures to address control deficiencies [1837]. Revenue and Profitability - The company reported gross revenues from activities in Iran amounted to €0, representing 0% of total gross revenues for the year ended December 31, 2022 [1824]. - The company did not generate any net profits from authorities in Iran for the year ended December 31, 2022 [1824]. - The company has reported recurring losses from operations since inception, raising significant doubt about its ability to continue as a going concern [1835]. Share Capital and Equity - The weighted average number of outstanding shares for the year ended December 31, 2022, was 26,811,357, compared to 22,437,301 in 2021 and 20,909,673 in 2020 [1844]. - The Group's common shares issued as of December 31, 2022, totaled 27,596k, an increase from 22,568k as of December 31, 2021, reflecting a growth of approximately 22.1% [1859]. - The Company received EUR 15.0 million for the issuance of 4,479,088 common shares at a price of EUR 3.35 per share on January 31, 2022 [1896]. Assets and Liabilities - Deferred tax assets and liabilities as of December 31, 2022, included intangible assets of €6,391k and leasing liabilities of €4,168k [1839]. - The company has reported a decrease in deferred tax liabilities from €8,241k in 2020 to €6,426k in 2022 [1839]. - As of December 31, 2022, total property, plant, and equipment amounted to EUR 33,159k, an increase from EUR 30,073k as of December 31, 2020, reflecting a growth of approximately 10.1% [1849]. - The Group's total cash outflows for leases in 2022 were EUR 5,111k, significantly reduced from EUR 11,467k in 2021, indicating a decrease of about 55.5% [1855]. - The total interest-bearing financial liabilities as of December 31, 2022, were EUR 57,825k, compared to EUR 60,122k in 2021 [1889]. - The carrying amount of lease liabilities as of December 31, 2022, was EUR 15,436k, a decrease from EUR 18,724k in 2021 [1889]. Trade Receivables and Credit Risk - Trade receivables as of December 31, 2022, were EUR 13,637k, down from EUR 21,065k in 2021, representing a decline of approximately 35.5% [1856]. - The expected credit loss for trade receivables as of December 31, 2022, was EUR 5,317k, with an expected credit loss rate of 19.0% [1986]. - The Group's total gross amount of trade receivables as of December 31, 2022, was EUR 28,779k, with overdue amounts exceeding 90 days totaling EUR 7,061k [1986]. - The average turnover period for overdue trade receivables from major customers in the Middle East was 201 days [1986]. - Credit risk is defined as the risk of a counterparty failing to meet obligations under financial instruments or contracts, potentially leading to financial loss [1999]. Government Grants and Financial Support - The company has reported government grants of €1,679k as of December 31, 2022 [1839]. - Government grants received during the year ended December 31, 2022, totaled EUR 506k, up from EUR 168k in 2021 [1894]. Share-Based Payments and Compensation - A total of 167,326 RSUs and 15,000 Options were granted under the 2019 Plan during the year ended December 31, 2021 [1906]. - The Company amended the 2019 Plan in November 2022 to include stock grants (SGAs) and PSUs, modifying the settlement of awards [1927]. - Total expenses arising from share-based payment transactions in 2022 were EUR (16k), a significant decrease from EUR 8,035k in 2021 [1976]. Financial Risk Management - The company is exposed to credit risk primarily from trade receivables and financing activities, including deposits with banks and foreign exchange transactions [1999]. - The company’s financial risk management includes monitoring credit risk and currency risk as part of its overall strategy [1998].

Company Overview - CENTOGENE is a biodata life science partner focused on rare and neurodegenerative diseases[1] - The company possesses a large real-world data repository for rare and neurodegenerative diseases and offers a broad diagnostic testing portfolio[6] - CENTOGENE aims to accelerate and de-risk drug discovery to market access[6] Market Opportunity - By 2024, 18% of prescription sales worldwide are expected to target rare diseases[7] - Approximately 350 million people are affected by rare genetic diseases, with about 90% remaining undiagnosed[7] - The rare diseases market is expected to grow at a rate of 11+% by 2024[7] - Over 50% of FDA approvals in 2021 were orphan drugs[7] Strategy and Growth - The company is focused on a unique and transformative business model and expanding pharma partnerships, targeting ~20+ new pipeline deals[19] - CENTOGENE aims to continue growing diagnostics at an above-market level, focusing on profitable growth, commercial excellence, CentoCloud & multiomics[19] - The company is managing costs by driving a fit-for-purpose organization and focusing on efficient operations and margin improvement[19] Financial Performance - The company's 2022 revenue guidance is +15-20% year-over-year, with revenues of approximately €50-52 million[19] - In 2022, the company had €10.3 million up +3% year-over-year acceleration in 2H22 driven by biopharma[20] - In Q1 2022, CENTOGENE secured $62 million (~€55 million) in financing, including a €15 million PIPE and a $45 million secured debt facility[20]

Revenue and Financial Performance - Centogene's total revenues for the year ended December 31, 2021, were significantly impacted by the COVID-19 segment, which represented 77.1% of total revenues [417]. - The diagnostics segment generated €27,900 thousand, or 14.7% of total revenues for the year ended December 31, 2021, compared to €22,108 thousand, or 17.2% in 2020 [413]. - The pharmaceutical segment contributed €15,641 thousand, or 8.2% of total revenues for the year ended December 31, 2021, down from €16,951 thousand, or 13.2% in 2020 [410]. - As of December 31, 2021, revenues from the pharmaceutical segment were €15.6 million, accounting for 8.2% of total revenues, a decrease from €17.0 million or 13.2% in 2020 [484]. - The diagnostics segment generated €27.9 million, representing 14.7% of total revenues for the year ended December 31, 2021, up from €22.1 million or 17.2% in 2020 [487]. Research and Development - Centogene's proprietary rare disease platform includes data from approximately 650,000 individuals across over 120 countries, aiding in the understanding of rare diseases [405]. - The company has developed 11 biomarkers covering 10 diseases as of December 31, 2021, which are crucial for orphan drug development [408]. - The BioDatabank supports over 300 disease cohorts, focusing on metabolic and neurological disorders, with more than 12 therapeutic indications covered [475][476]. - The BioDatabank contains the largest curated mutation database for rare diseases, positioning the company to lead in biomarker development [495]. - The company has developed an integrated multiomic panel to provide faster and more reliable diagnostic solutions for rare diseases [518]. - The company aims to create Disease Avatars for three top diseases, integrating omics data from 100-500 patients to enhance R&D cycles [479]. - The company has established a high-quality biobank with over 400,000 rare disease biosamples and more than 31 million unique variants, supporting research and development efforts [537]. - The ongoing global study on colon and pancreas carcinoma has recruited a total of 254 individuals, contributing tumor material and reference samples [553]. - The iPSC program has collected approximately 1,600 skin biopsies from patients with rare diseases, aimed at supporting orphan drug development [557]. - The ROPAD study has successfully recruited and genetically characterized over 10,000 subjects with Parkinson's Disease, with ongoing recruitment exceeding 400 subjects per month [558]. - The EHA study recruitment increased from 1,100 at the end of 2020 to 2,060 study subjects by the end of 2021, with plans to include an additional 1,200 individuals in 2022 [560]. - The TRAMoniTTR study screened approximately 1,449 subjects in 49 German centers, identifying 23 individuals with TTR mutations for follow-up visits [564]. Strategic Collaborations and Partnerships - The company has collaborated with 33 pharmaceutical partners on projects targeting over 46 different rare diseases as of December 31, 2021 [405]. - The company aims to accelerate the discovery and development of orphan drugs, focusing on collaborations with pharmaceutical partners and expanding its network [429]. - The company has entered into strategic collaborations with major pharmaceutical companies, including Takeda and Pfizer, to enhance diagnostic capabilities and support drug development efforts [503][511]. - The collaboration with Evotec aims to expedite the identification of new small molecule treatments for Gaucher disease, leveraging patient-derived cellular models [509]. - In January 2022, the company entered the third year of collaboration with Evotec to discover small molecule drug candidates for Gaucher disease, focusing on glucocerebrosidase (GBA-1) gene [567]. Market Trends and Insights - Investment in rare disease research reached $22.9 billion in 2021, a 28% increase from 2020, with orphan drug spending growing at over 14% annually [445]. - The market for rare disease drugs is projected to grow at a CAGR of 11.2% from 2019 to 2024, reaching $217 billion, capturing approximately 18% of worldwide prescription sales [445]. - Approximately 90% of rare disease patients are typically undiagnosed, with an average time to obtain a correct diagnosis ranging from five to seven years [441]. - There are approximately 5,600 rare hereditary diseases, but very few have FDA-approved treatments, highlighting significant unmet needs [446]. Diagnostic Innovations and Technologies - The company offers a comprehensive testing portfolio of over 10,000 genetic sequencing tests covering more than 19,000 genes as of December 31, 2021 [519]. - The CentoMetabolic MOx panel covers more than 180 metabolic disorders, integrating genetic and biochemical testing [518]. - The company's diagnostic processes aim to deliver medical reports within 30 days from sample receipt, ensuring high-quality diagnostics [522]. - The CentoCard sample collection method is registered in over 50 countries and allows for the collection of non-biohazardous materials, facilitating international shipping [532]. - The company has implemented various AI programs, including intelligent character recognition and clinical information extraction, to enhance diagnostic processes and reduce human error [577][578]. - The AI-based variant prioritization tool ranks variants based on disease-causing potential, improving the diagnostics process for whole exome and clinical exome sequencing [581]. - The proprietary AI-powered biomarker platform, CentoMetabolome, accelerates biomarker development processes from months to days and has received the Health-i Award for innovation [587]. - The company has developed a genome-wide association studies (GWAS) pipeline to identify genetic modifiers, incorporating various statistical tests for variant and gene-level analysis [591]. - The Big Data platform optimizes infrastructure for cross-departmental data evaluation, providing a scalable solution for data storage and analytics [592][593]. Clinical Trials and Patient Recruitment - The company recognizes the challenges in clinical trial recruitment due to the small and dispersed patient populations for rare diseases [453]. - The company plans to leverage its database for patient identification in therapeutic trials, reducing clinical trial enrollment time, which is critical in rare diseases [430]. - The biomarker validation process requires approximately 50 to 100 patients in a disease cohort and 8,000 to 10,000 different measurements to meet CAP/CLIA/ISO requirements [547]. - As of December 31, 2021, the company had a sales force of approximately 70 employees and consultants in its diagnostics segment, supporting rare disease patients globally [568]. - The company plans to expand its direct footprint and distribution network in 2022 to increase sample volumes in targeted geographic areas [569]. Publications and Scientific Contributions - The company published over 50 scientific papers in 2021, achieving a 33% increase in impact factor compared to 2020 [550].