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Croissy-Beaubourg, April 22, 2020, 6:00pm CEST – THERADIAG (ISIN: FR0004197747, Ticker: ALTER) specializes in in vitro diagnostics and theranostics. 

Strategic positioning and decisions on Covid-19 serological tests

Following the approval of Theradiag’s Board of Directors, at a special meeting held on April 22, the Company announces that it has decided to act and structure its operations to support the nationwide effort to fight Covid-19. As public authorities have extended the scope of testing to serology, and as an immunology specialist, Theradiag has therefore decided to put its skills and extensive experience at the service of antibody testing.

As a matter of fact, Theradiag develops, manufactures and markets diagnostic and biotherapy monitoring tests. As a result, the Company has developed a wide range of antibody tests, CE marked and used on a routine basis by many laboratories worldwide.

Today, the medical emergency arising from the rapid spread of the 2019-nCoV coronavirus requires the involvement of all private and public sector research laboratories. At the beginning of April 2020, the French government set up an inter-ministerial Covid-19 unit tasked with drawing up an inventory of these institutions, which includes Theradiag.

In view of its expertise in cutting-edge ELISA technology (Enzyme Linked ImmunoSorbent Assay), Theradiag has started the distribution but overall the development of Covid-19 serological tests, tests of high-quality, that also facilitate and secure national supplies.

Since the beginning of the week of April 20, 2020, the Company has initiated a process of validation of serological test kits at the National Reference Centre for Respiratory Infection Viruses in Paris.

Theradiag involved in new Covid-19 clinical trials

Theradiag has recently been contacted by a number of clinical evaluators in France and abroad with regards to the clinical evaluation of biotherapies for Covid-19 treatment.

Indeed, some biotherapies currently approved for the treatment of chronic inflammatory diseases are being evaluated to treat severe forms of Covid-19. These assessments are relating to the “cytokine release syndrome”, also known as “cytokine storm”.  This is a phenomenon described for some severe Covid-19 cases, resulting in hyper-inflammatory pulmonary reactions.

As a matter of fact, Theradiag is now involved in the bioavailability (dosage) evaluations of biotherapies used as treatment candidates in these new clinical trials, in particular the Tocilizumab.

Theradiag does not have sufficient information to determine the potential financial impact of these clinical evaluations, which at this stage represent a non-recurring business for the Company.

In any case, this initiative shows once again the major role played by Theradiag and its authoritative status in the field of biotherapy monitoring.

Impact of Covid-19 pandemic on Theradiag

• Impact of Covid-19 on existing business

 Since its communication dated March 18, 2020, Theradiag has continued to assess the potential consequences of the Covid-19 epidemic on its business.  In line with government recommendations, the Company has continued to implement the required measures with regards to its staff continuing to manufacture, process orders, carry out shipments and provide a customer helpline service in accordance with the business continuity plan rolled out on March 17, 2020. However, as at the date of this press release, Theradiag is expecting 2020 revenue to probably be negatively impacted by around 10%. The Company has taken action in order to minimize the impact of this crisis and started to implement all the adequate measures, including short-time working for some employees and tightened cost control in order to protect margins and cash levels and to consolidate its financial position. For this purpose, Theradiag has also prepared an application for a state-guaranteed. The Company continues to follow developments with the utmost attention.

• Potential impact of new business related to COVID-19 testing

At this stage it is too early to say whether the Company’s contribution to Covid-19 serology testing or involvement in biotherapy dosage will have an effect on 2020 revenue. Accordingly, for the time being and by way of caution, no positive impact has been included in the Company forecasts. The Company will inform the market and stakeholders of all developments regarding these projects accordingly.

Financial calendar:

• Annual General Meeting, May 14, 2020
• H1 2020 revenue, Tuesday, July 21, 2020
• H1 2020 results, Monday, September 21, 2020

About Theradiag

Theradiag is the market leader in biotherapy monitoring. Capitalizing on its expertise in the diagnostics market, the Company has been developing, manufacturing and marketing innovative in vitro diagnostic (IVD) tests for over 30 years. 

Theradiag pioneered “theranostics” testing (combining therapy with diagnosis), which measures the efficacy of biotherapy in the treatment of chronic inflammatory diseases. Going beyond mere diagnosis, theranostics aims to help clinicians set up “customized treatment” for each patient. This method favors the individualization of treatment, evaluation of its efficacy and the prevention of drug resistance. In response to this challenge, Theradiag develops and markets the CE-marked TRACKER® range, a comprehensive solution of inestimable medical value.

The Company is based in Marne-la-Vallée, near Paris, has operations in over 70 countries and employs over 60 people. In 2019, the Company posted revenue of €9.6 million. The Theradiag share is listed on Euronext Growth Paris (ISIN: FR0004197747) and is eligible for the French PEA-PME personal equity plan.  For more information about Theradiag, please visit our website: www.theradiag.com