CAMBRIDGE, Mass., and ROSTOCK & BERLIN, Germany, September 23, 2020 (Globe Newswire) — Centogene N.V. (Nasdaq: CNTG) (“CENTOGENE” or the “Company”), a commercial-stage company focused on rare diseases that transforms real- world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, today provided an update on its corporate progress and reported its financial results for the three and six months ended June 30, 2020.
- Cautiously anticipate 2020 full year revenues to be within the range of €60 and €65 million
- H1 2020 revenues decreased slightly by 0.4% compared to H1 2019 and recovery in core businesses with increases in test requests and new pharmaceutical collaborations
- R&D collaborations with Molecular Health and Evotec further evidenced the value of CENTOGENE’s global proprietary rare disease platform, which, as of August 31, 2020, included real-world data repository with over 3.6 billion weighted data points from approximately 570,000 patients representing 120 different countries
- Comprehensive high-quality COVID-19 testing solutions available at major travel hubs in Germany, nursing homes, and educational institutions as well as via online marketplace, with close to 270,000 test requests received up to the end of August 2020
- CentoFast-SARS-CoV-2 RT-PCR test received U.S. Food and Drug Administration (“FDA”) Emergency Use Authorization (“EUA”)
- Completed follow-on equity offering in July 2020 with proceeds, net of underwriting discounts and commissions, of €24 million
Prof. Arndt Rolfs, CEO of CENTOGENE, said, “During the first half of 2020, we have shown resilience while facing global pandemic headwinds, and we believe we have weathered the worst of this unprecedented situation. Our core business in the rare disease space regained momentum as we continued to expand our COVID-19 efforts and address the urgent need for reliable testing solutions. Ultimately, this underlines the return to a “new normal” for patients, physicians, and orphan drug developers.”
Prof. Arndt Rolfs continued, “Supported by recovering diagnostic volumes, well-established pharma partnerships, and further expansion of our COVID-19 testing efforts, we remain confident in our outlook through the end of the year as we continue to deliver on our life-long commitment to support patients around the world.”
Unwavering Commitment to Patients Drives Recovery
During Q2 2020, the Company has been able to operate at full capacity and keep its commitment to supporting patients around the world. By rapidly responding to the novel coronavirus in Q1 2020 and deploying a series of testing initiatives to contribute to the important needs in diagnosis and disease surveillance, CENTOGENE has been able to minimize the disruption to its core businesses and maintain a solid financial and operational status. As the global community transitioning to a new normal, the number of test requests in the core diagnostics and pharmaceutical segments has gradually recovered. The Company’s pharmaceutical segment has also regained momentum with clinical trials of our pharmaceutical partners slowly resuming and further collaborations have been concluded.
The Company has been continuing to expand its medical and genetic knowledge of rare genetic diseases. With CENTOGENE’s expertise in rare diseases and biomarker discovery, as well as the large volume of datasets in its global proprietary rare disease platform, the Company entered into R&D collaborations its strategic partners, Molecular Health and Evotec, aiming to shorten the diagnostics odyssey of rare disease patients and accelerate the development of new orphan drugs.
Expanding COVID-19 Testing Initiatives
Since the commencement of its COVID-19 testing in March 2020, CENTOGENE has expanded the COVID-19 test offering from employees and essential workers in Rostock, Germany, to nursing homes and high school students throughout Germany in May 2020. In June 2020, CENTOGENE announced a partnership with Lufthansa and Fraport, the operator of Frankfurt airport, to open the first COVID-19 walk-in test center at Frankfurt Airport, providing on-site testing for travelers and the general public. Subsequent to June 2020, additional test centers were set up at Munich and Nuremberg Central Stations offering COVID-19 tests to travelers returning to Germany from “high risk regions” as defined by the Robert Koch Institute (RKI), the public health agency which compiles the COVID-19 statistics in Germany. In August 2020, CENTOGENE announced the opening of a further walk-in testing facility at Hamburg Airport offering its COVID-19 testing to passengers departing from Hamburg, and returning to Hamburg from non-high risk countries as well as the general public.
In addition, the Company offers its COVID-19 testing to the community through collaborations with the state government of Mecklenburg-Western Pomerania, educational institutions and other companies, as well as via the online marketplace.
This includes the RT-PCR test, which received EUAs from the FDA; a fully validated sample collection kit, CentoSwab™, which can either be used by healthcare professionals or self-administered by individuals; a secured digital platform, including the Corona-App and test portal, which followed stringent data privacy measures in compliance with the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA), allowing seamless registration and result notification.
CENTOGENE engages in diagnosis and research around rare diseases transforming real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies. 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, including epidemiological and clinical data, as well as innovative biomarkers. CENTOGENE has developed a global proprietary rare disease platform based on our real-world data repository with over 3.6 billion weighted data points from approximately 570,000 patients representing over 120 different countries as of August 31, 2020.
The Company’s platform includes epidemiologic, phenotypic, and genetic data that reflects a global population, and also a biobank of these patients’ blood samples. CENTOGENE believes this represents the only platform that comprehensively analyzes multi-level data to improve the understanding of rare hereditary diseases, which can aid in the identification of patients and improve our pharmaceutical partners’ ability to bring orphan drugs to the market. As of August 31, 2020, the Company collaborated with over 40 pharmaceutical partners covering over 45 different rare diseases.
Important Notice and Disclaimer
This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of our strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” or “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company. However, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, such as 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 govern-mental 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. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.
For further information, please refer to the Risk Factors section in our Annual Report for the year ended December 31, 2019 on Form 20-F filed with the SEC on April 23, 2020, Form 6-K containing our financial results for the three months ended March 31, 2020, filed with the SEC on June 15, 2020 and other current reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.