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].
Centogene(CNTG) - 2021 Q4 - Annual Report