Theradiag: Full Year Results 2014

Regulatory News:

Theradiag (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostics and in vitro diagnostics, announced today its consolidated full-year 2014 financial results, as approved by its Board of Directors on March 3, 2015.

"We recorded in 2014 our best commercial and operational performance to date. Sales revenues are up by 6%, and we entered into a master agreement with the pharmaceutical company UCB. This growth in revenues is led by the sales of our internal products, which generate significant profit margins and shape the future of our company. I am thinking in particular of Lisa Tracker, our biotherapy monitoring kits, which not only improve patient care, but also allows a significant reduction in healthcare costs. Our financial results and cash position are in line with expectations, and we are moving forward in our discussions with potential partners in France and internationally,” commented Michel Finance, Chief Executive Officer of Theradiag.

Summary Financial Information

Consolidated financial information integrating FY2014 results of Prestizia, Theradiag’s 100% subsidiary

• 6% increase in sales revenue, for the first time since 2012

Revenues for 2014 were €7.1 million, led by the increase in sales of in-house products. The decrease in distribution revenues, anticipated as part of the Company’s strategic reorientation, is more than offset by the sales of internal products. Sales of LISA TRACKER and proceeds from services performed for UCB resulted in a surge of theranostics sales (x3.6 year-over-year at €1.4 million, including €1 million in export sales).

Overall export sales increased over the period, making up 41% of total revenues, compared to 33% in 2013.

Sales of in-house products represented 61% of total sales in 2014, compared to 40% in 2012. The gross profit margin reflects this favorable shift in the product mix toward in-house products, increasing by 5 points to 69% in 2014.

• Financial results for 2014

Operating costs were up 12% year-over-year due to the strengthening of marketing operations (staff and campaigns) and further recruitments to support an increase in production. As of December 31, 2014, Theradiag’s team counts 70 employees, compared to 63 in 2013.

The Company’s sustained investments in theranostics resulted in a 32% increase in R&D expenditures to €1.5 million. R&D investments were primarily dedicated to Lisa Tracker’s product range extension, and to research projects conducted by Prestizia, Theradiag’s subsidiary.

After taking into account €0.5 million in research tax credit (Crédit d’impôt Recherche, CIR), the net loss for the year ended December 2014 was €2.96 million, compared to €2.47 million for 2013.

• Cash position

Theradiag’s available cash balance as of December 31, 2014 was €3.28 million, compared to €4 million as of year-end 2013.

In April 2014, the company set up a Standby Equity Facility (SEF®), which generated €1.8 million through 3 draw-downs. Proceeds from the SEF® were applied to the international development of Theradiag’s theranostics portfolio. Theradiag renewed its SEF in 2015, which already allowed to raise €0.5 million. To date, less than a third of the equity facility has been drawn-down. Remaining funds will enable Theradiag to move forward with its international strategy and bring to market new theranostics products.

2014 confirms the rise in sales of theranostics products

Theranostics / Lisa Tracker

• Theradiag was selected by the European pharmaceutical and academic consortium ABIRISK to provide, over 3 years, Lisa-Tracker kits as part of a project to assess the immunogenicity risks linked to existing biotherapies.
• Theradiag enhanced the oncology offer of its Lisa Tracker range, with an 8th test receiving a CE-mark. This new monitoring product for Avastin® (bevacizumab), could improve patient care by dosing drugs and anti-drug antibody levels.
• Results from a pharmaco-economic study conducted by Theradiag in partnership with IBD¹ experts demonstrated that that the use of anti-TNF and anti-TNF antibodies monitoring in Crohn’s disease patients treated by biotherapies can save up to 25% of the cost of treatment, or €131 million over 5 years in France alone.

¹ Inflammatory Bowel Disease (IBD)

Theranostics / microRNA

• Rectal Cancer (miCRA project): Theradiag is developing 2 theranostics kits for rectal cancer, the 5^th most common type of cancer in France. The first test is a theranostics solution for early prediction of response to chemotherapy; the second test anticipates metastatic recurrences in rectal cancer. miCRA was one the winning projects of the Worldwide Innovation Challenge launched by the French Government in 2014, and received funding by the French government agency BPI. Biological validation of identified microRNA candidates on a 200-patient cohort began in 2014. Theradiag formed an expert committee to support its developments in rectal cancer.
• HIV/AIDS: Identification of theranostics tools as part of the CARENA project led with ABIVAX and CNRS. A pharmacokinetic study conducted in healthy patients validated this microRNA approach.
• Rheumatoid Arthritis: As part of a joint project with CNRS, the Institute of Molecular Genetics of Montpellier (IGMM) and the University of Montpellier, Theradiag is working of the identification of microRNA signatures which would improve diagnosis of Rheumatoid Arthritis (RA), allow for analysis of disease-activity and severity parameters, and provide prognosis information regarding response to treatment. This program, announced in 2014, is progressing in according to the development plans.

In Vitro Diagnostics

• Launch of Theralis®, Theradiag’s new CE Marked fully automated system, steered by the Solinium® multi-platform software. Theralis® can carry-out all of a laboratory’s auto-immune analyses, meeting the demands of public and private laboratories for greater polyvalence and speed, enhanced precision and reliability. This new platform further consolidates the Fidis portfolio.

Recent events

• Theradiag announced in 2015 that it has entered into a master agreement with the pharmaceutical company UCB. A performance study regarding UCB’s anti-TNF treatment certolizumab pegol (Cimzia®) was conducted as part of the agreement. The results of this performance study confirmed the suitability of Theradiag’s theranostic kit for the monitoring of patients treated with certolizumab pegol.
• Prestizia, Theradiag’s subsidiary, identified the first microRNA signature of HIV tropism. However, the decrease in sales of the anti-CCR5 treatment currently on the market (Selzentry®) has reduced the market opportunity for an HIV tropism test. Theradiag thus announced it will not to pursue the industrial development of this microRNA signature test.

About Theradiag

Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag notably markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is developing new biomarkers based on microRNAs for the diagnosis and monitoring of HIV/AIDS and rectal cancer. Theradiag is thus participating in the development of "customized treatment”, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 70 employees.

For more information about Theradiag, please visit our website: www.theradiag.com