Core Points - Centogene N.V. has completed the sale of its operating subsidiaries to Charme Capital Partners Limited [1][2] - The transaction involved the sale of 100% ownership in Centogene GmbH and certain intercompany receivables, along with the assumption of a loan from Oxford Finance LLC [2] - Following the transaction, Centogene will liquidate its remaining subsidiary, Centogene Switzerland AG, and will enter dissolution and liquidation as per Dutch law [3] - The company plans to make a liquidation distribution to its shareholders, with details to be communicated later [4] - Centogene's reporting obligations under the U.S. Securities Exchange Act have been suspended, and its securities are expected to cease trading on the OTC market [4]

Core Insights - The Rostock International Parkinson's Disease (ROPAD) Study reveals that approximately 90% of genetically confirmed Parkinson's disease patients have variants in the LRRK2 or GBA1 genes, indicating potential candidates for gene-targeted trials [1] - The study shows that around 15% of Parkinson's disease cases are linked to genetic variants, primarily LRRK2 and GBA1, emphasizing the importance of genetic testing in patient care [1] - CENTOGENE has launched the ROPAD Consortium to enhance PD research and treatment through collaboration with neurologists and non-profit organizations [2] Company Overview - CENTOGENE is focused on providing data-driven solutions for rare and neurodegenerative diseases, utilizing multiomic technologies and the CENTOGENE Biodatabank for precision medicine [4][6] - The company has built a network of approximately 30,000 active physicians and has conducted genetic testing on over 18,000 participants in the ROPAD Study over five years [5][3] - CENTOGENE's Biodatabank includes data from over 850,000 patients across 120 countries, contributing to more than 300 peer-reviewed publications [6][7] Research and Development - The ROPAD Study aims to characterize the genetics of Parkinson's disease to improve understanding of its etiology, diagnosis, and severity [3] - The study involved genetic testing of 50 genes in over 12,500 patients, with significant findings related to LRRK2, GBA1, PRKN, SNCA, and PINK1 genes [1] - The integration of genetic testing in routine care is expected to facilitate access to treatments and accelerate the development of gene-specific therapies [1]

Core Perspective - The signing of a Memorandum of Understanding (MOU) between Critical Path Institute (C-Path) and Centogene N.V. aims to enhance drug development for lysosomal diseases (LDs) and improve the quality of life for affected individuals [1][7]. Company Overview - Critical Path Institute (C-Path) is a nonprofit organization established in 2005, recognized for its role in accelerating drug development through public-private partnerships and collaborations involving over 1,600 scientists and representatives from various sectors [4][10]. - Centogene N.V. is a global leader in genomic and multiomic testing services, with a focus on rare and neurodegenerative diseases, and operates the CENTOGENE Biodatabank, which includes data from over 850,000 patients across more than 120 countries [2][6]. Collaborative Efforts - The MOU outlines a strategic partnership that leverages the strengths of both organizations in genetic and real-world data to address challenges in developing safe and effective therapies for lysosomal diseases [7][10]. - C-Path's Critical Path for Lysosomal Diseases (CPLD) Consortium, established in 2023, aims to accelerate drug development for LDs by forming collaborative work groups to identify and overcome specific barriers [8][10]. Data and Services - The partnership will focus on enhancing data enrichment and linkage for specific lysosomal diseases, providing genetic testing services for clinical trials, and offering sample analysis reporting services [9]. - Access to the CENTOGENE Biodatabank will be granted for analyzing patients involved in CPLD projects, facilitating joint efforts in research and development [9].

Core Insights - CENTOGENE and Critical Path Institute (C-Path) have signed a Memorandum of Understanding (MOU) to enhance drug development for lysosomal diseases (LDs) and improve patient quality of life [4][11] - The partnership aims to leverage genetic and real-world data to address challenges in developing safe and effective therapies for LDs [2][5] Company Overview - CENTOGENE is a global leader in genomic and multiomic testing services, focusing on rare and neurodegenerative diseases, with over 850,000 patients represented in its Biodatabank from more than 120 countries [10][13] - C-Path is a nonprofit organization established in 2005, recognized for its role in accelerating drug development through collaborations involving various stakeholders [8][12] Partnership Details - The MOU outlines collaborative efforts to enhance data enrichment and linkage for specific lysosomal diseases, provide genetic testing services, and offer sample analysis reporting [6][11] - The partnership will also promote joint branding efforts to highlight the unique collaboration in the field of real-world and genetic data for lysosomal diseases [6][11] Strategic Goals - The collaboration aims to combine expertise and resources to overcome significant barriers in lysosomal disease research and drug development [11] - C-Path's Critical Path for Lysosomal Diseases (CPLD) Consortium, established in 2023, focuses on accelerating drug development through public-private partnerships [5][8]

Core Points - CENTOGENE N.V. announced the voting results of its 2024 Annual General Meeting, with shareholders approving all proposals [1] - Shareholders extended the deadline for preparing the Dutch statutory annual accounts and board report for the financial year ended December 31, 2023, and appointed Ernst & Young Accountants LLP as the external auditor for the financial year ended December 31, 2024 [2] - The revised compensation structure for the Company's Supervisory Board was adopted, and the Management Board's authorization to issue shares and grant rights was extended [2] Company Overview - CENTOGENE's mission focuses on providing data-driven answers for rare and neurodegenerative diseases, integrating multiomic technologies with the CENTOGENE Biodatabank [3] - The company has built a network of approximately 30,000 active physicians and operates ISO, CAP, and CLIA certified multiomic reference laboratories in Germany [4] - The CENTOGENE Biodatabank includes data from over 850,000 patients across more than 120 countries, with over 70% of patients being of non-European descent [4] - CENTOGENE has supported over 50 collaborations with pharmaceutical partners to accelerate drug discovery and development [5]

Core Insights - Centogene N.V. reported a 2% increase in total revenues for FY2023, reaching €48.5 million, compared to €47.5 million in FY2022, despite challenges in Pharma program timelines [6][7] - The company anticipates revenue growth of 10-15% for FY2024, driven by a strong Diagnostics business and a record Pharma order book [2][11] - Centogene is focused on strategic growth, including strengthening its Diagnostic portfolio and expanding partnerships, notably with Lifera, which secured a $30 million investment [2][5] Financial Performance - Total revenues for FY2023 were €48.5 million, a 2% increase from €47.5 million in FY2022 [6][7] - Diagnostics segment revenues grew by 8% to €33.7 million, primarily due to an 11% increase in revenues from CentoXome® and CentoGenome® [7] - Pharma segment revenues decreased by 8% to €14.8 million, attributed to delays in Pharma program timelines [7] - The overall gross profit margin decreased to 36% in FY2023, down from 42% in FY2022, resulting in a gross profit of €17.2 million [7] - The net loss increased by 12.2% to €35.8 million in FY2023, compared to a net loss of €31.9 million in FY2022 [7] Strategic Initiatives - The company has initiated a strategic alternatives process to explore options such as asset divestitures and partnerships, with potential transactions expected by July 15, 2024 [12] - Centogene expanded its Biodatabank to over 850,000 patients, enhancing its capabilities in genomic and multiomic testing [10][14] - The company launched new products, including the CentoGenome® tool for rare disease diagnosis and the FilterTool for rapid analysis of genetic variants [10][18] Partnerships and Collaborations - Centogene formed a joint venture with Lifera to enhance access to genomic testing in Saudi Arabia, receiving a $30 million mandatory convertible loan and milestone payments [5][8] - The company has engaged in 48 collaborations with 34 pharmaceutical partners in FY2023, including new partnerships initiated in Q1 2024 [10]

Core Insights - Centogene N.V. reported a total revenue growth of 2% for FY2023, reaching €48.5 million, compared to €47.5 million in FY2022 [1][3] - The company expects a revenue growth of 10-15% for FY2024, driven by its Pharma business and solid growth in Diagnostics [1][8] - Centogene is engaged in a strategic alternatives process aimed at sustainable long-term value creation for stakeholders [1][9] Financial Performance - Diagnostics segment revenues increased by 8% to €33.7 million, with CentoXome® and CentoGenome® contributing significantly [3] - Pharma segment revenues decreased by 8% to €14.8 million due to delays in Pharma program timelines [3] - The overall gross profit margin decreased to 36% in FY2023, down from 42% in FY2022, resulting in a gross profit of €17.2 million [3] - The net loss increased by 12.2% to €35.8 million in FY2023 compared to €31.9 million in FY2022 [3] Strategic Developments - The company secured approximately $20 million from Lifera, enhancing its cash position and expanding its partnership [1][4] - A joint venture, Lifera Omics, was formed to improve access to genomic testing in Saudi Arabia and the GCC region [4] - Centogene expanded its Biodatabank to over 850,000 patients, with a significant portion being of non-European descent [4][11] Research and Collaborations - In FY2023, Centogene led 48 collaborations with 34 pharmaceutical partners, including new partnerships and extended existing ones [5] - The company published over 30 peer-reviewed scientific publications, contributing to advancements in understanding various rare and neurodegenerative diseases [4][7] Diagnostics Innovations - The company received approximately 81,500 test requests in FY2023, marking an 18% increase from the previous year [6] - Centogene launched new diagnostic tools, including the CentoGenome® for rare diseases and the FilterTool for genetic analysis [6][7] Cash Position - Cash and cash equivalents decreased to €19.1 million as of December 31, 2023, down from €35.9 million in the previous year [3][19]

Revenue Sources and Risks - The company generated 42.7% of its total revenues from North America and 15.9% from Europe for the year ended December 31, 2023[19]. - The top five pharmaceutical partners accounted for 26.7% of total revenues in 2023, down from 29.8% in 2022[22]. - The company relies on a limited number of pharmaceutical partners, which poses a risk to revenue stability and growth[42]. - The loss of major pharmaceutical partners could significantly harm the company's revenue and reputation[22]. - Economic volatility and uncertainty in key markets could adversely affect revenue growth and profitability[19]. - The company may face challenges in establishing its products as a standard of care, limiting revenue growth and future profitability[126]. - The company may not successfully respond to increasing demand for its products and solutions, affecting future sales[113]. Operational Challenges - The company faces challenges in maintaining relationships with pharmaceutical partners due to external factors affecting their R&D plans[36]. - The company must continue to drive clinical adoption of its tests to generate sufficient data for the CENTOGENE Biodatabank[17]. - The company anticipates future growth, which could strain its organizational and operational infrastructure, affecting quality and turnaround times of services[90]. - As sales volume increases, the company will need to enhance its infrastructure, including hiring additional certified laboratory scientists and expanding software capacity[98]. - The company may face challenges in managing growth and transitions, which could lead to delays, higher costs, and declining product quality[99]. - The negotiation of partnership agreements consumes significant management resources and may lead to unanticipated problems and expenses[62]. Competition and Market Dynamics - The competitive environment may lead to pricing pressures, as competitors could offer lower prices to gain market share[101]. - The success of the company's solutions depends on market acceptance and the willingness of pharmaceutical partners and physicians to utilize them[72]. - The company faces intense competition for qualified personnel, which may limit its ability to support research and development and sales programs[57]. - The company may struggle to attract and retain personnel with specific technical backgrounds necessary for its sales force, impacting revenue growth[109]. Regulatory and Compliance Risks - Regulatory and compliance risks may arise from maintaining accurate information and control over sales and distribution activities, particularly under the United States Foreign Corrupt Practices Act[60]. - The company is subject to significant civil penalties for HIPAA violations, which can exceed one million dollars per year[153]. - Compliance with complex federal, state, local, and foreign laws and regulations is critical, as violations could result in severe financial consequences[163]. - The company is subject to GDPR and UK GDPR, with potential fines of up to €20 million or 4% of total worldwide annual turnover for serious offenses, increasing compliance risks[171]. - Non-compliance with anti-bribery and anti-corruption laws could lead to significant fines and reputational harm, adversely affecting the company's operations[178]. - The interplay of federal and state laws may create complex compliance issues, exposing the company to additional expenses and liabilities[175]. - The company may face substantial penalties if found in violation of off-label promotion regulations, which could adversely affect financial condition[186]. Financial and Investment Considerations - The company faces risks in obtaining favorable pricing for its products and solutions, which could materially impact revenues and profitability[100]. - Limited resources for research and development may result in focusing on non-commercially viable programs, hindering cost recovery[103]. - Future acquisitions may lead to unforeseen operating difficulties and expenditures, potentially harming the financial condition of the company[157]. - Legislative changes in the healthcare system could impact the company's ability to sell products profitably[139]. - Changes in orphan drug designation laws could negatively impact the company's business and financial results[188]. Data Security and Ethical Concerns - Security breaches and data loss could expose the company to liability and damage its reputation[127]. - The company collects sensitive data, including protected health information, and faces risks related to unauthorized access and disclosure[149]. - Ethical, legal, and social concerns regarding genomic testing could reduce demand for the company's products and solutions[117]. - The company may face risks related to foreign currency exchange controls that may limit cash movement across global operations[155]. Product Development and Market Entry - New diagnostic test products and solutions require significant time and funds for development and commercialization, with no assurance of meeting client needs[68]. - The development of new products involves risks, including potential failure to obtain necessary regulatory approvals[107]. - The company may experience delays in pharmaceutical partners' clinical trials, affecting the demand for its products[146]. - The company may face challenges in obtaining timely approvals for tests subject to FDA or EU regulation, potentially delaying commercialization[184]. - Legislative changes regarding orphan drugs may impact investment and regulatory approvals in the rare disease space, affecting the company's operations[160].

Core Insights - Centogene N.V. has entered into agreements with Lifera, resulting in a $15 million purchase of accounts receivables and an increased investment in their joint venture, totaling approximately $20 million to support growth and profitability [1][2] Financial Position - The transaction enhances Centogene's financial position and liquidity, aiding in operational and strategic initiatives [2] - The company aims to achieve EBITDA breakeven by the end of 2024 and is on track to meet this target [2] Transaction Details - Lifera's financing is based on Centogene's assets, including accounts receivables, with adjustments to a previously announced $30 million convertible loan, extending it to 24 months and allowing a portion to convert at $0.79 [3] Company Overview - Centogene focuses on providing data-driven solutions for rare and neurodegenerative diseases, integrating multiomic technologies with its Biodatabank to enhance precision medicine [5][6] - The company has built a network of approximately 30,000 active physicians and has over 850,000 patients represented in its Biodatabank, contributing to over 300 peer-reviewed publications [6] Collaborations and Impact - Centogene has supported over 50 collaborations with pharmaceutical partners, facilitating drug discovery and development [7]

CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, May 10, 2024 (GLOBE NEWSWIRE) -- Centogene N.V. (NASDAQ:CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today revealed significant growth in the CENTOGENE Biodatabank, the world's largest real-world data repository for rare and neurodegenerative diseases. Analysis of this patient data enables precise diagnosis of disease, identification of new genetic variants, and potential de-risking of drug devel ...