Theradiag: First-Half 2016 Revenues and Results

Regulatory News:

THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, today released its consolidated interim results for the six months to June 30, 2016, as approved by the Board of Directors on September 13, 2016.

Prof. Gérard Tobelem, Theradiag’s Chairman, commented: "The significant improvement in our results in the first half of 2016 is a testament to the relevance and dynamism of our strategy. The agreements sealed in late 2015 with Miraca Life Sciences in the United States and with HOB Biotech in China, as well as the agreement between Janssen Biotech and Miraca Life Sciences in August 2016 represent major growth drivers, in particular internationally, for future periods.”

Michel Finance, Theradiag’s Chief Executive Officer, added: "As we had anticipated, the acceleration in the Theranostics business and growth in IVD sales combined with stable operating costs significantly curbed our loss. We are firmly back on the path to profitability.”

Interim 2016 results

Theradiag’s first-half 2016 revenues grew 36% to €4,631,000, up from €3,416,000 in the first half of 2015. This increase was driven by the Theranostics business unit and the sharp revenue increase from Lisa Tracker® kits (2.5x the total posted in the first six months of 2015). The IVD business unit, which posted growth of 7%, also contributed to this strong increase.

Revenues from in-house products came to €3,441,000, accounting for 74% of Theradiag’s total revenues, compared with just 60.6% in the first six months of 2015. The gross margin improved, moving up 3 points on the back of a supportive shift in the product mix towards in-house products.

Theradiag’s first-half 2016 operating costs were broadly stable compared with the same period of 2015.

R&D costs came to €793,000 in the first six months of 2016, down from €822,000 in 2015.

Taking these factors into account, Theradiag’s consolidated net loss came to €1,159,000, down 43% from €2,043,000 in the same period of 2015 after taking into account a tax-related gain of €122,000 related to the research tax credit.

Cash position

Theradiag held €2 million in cash at June 30, 2016, down from €2.4 million at June 30, 2015. Management anticipates a repayment of the research tax credit and the 2015 CICE tax credit amounting to €633,000 in the second half of 2016.

Significant events of the first half of 2016

• The BioCLIA® 1 200, a next-generation automated diagnostics system was launched at the International Congress on Autoimmunity (ICA), an event bringing together international autoimmunity and theranostics specialists every two years. This system was co-developed with HOB Biotech under the cross distribution agreement and partnership unveiled in November¹. HOB Biotech and Theradiag are co-developing a full range of autoimmunity, biotherapy monitoring and allergy reagents, which are scheduled for introduction gradually from 2017 on this new system. Theradiag is the exclusive distributor of this innovative new solution in Europe.
• Four LISA TRACKER® range tests were introduced in the US market under the licensing agreement with Miraca Life Sciences announced in November. These four new biotherapy monitoring tests target first and foremost inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis. No other US pharmaceutical company can offer all these monitoring tests, giving Miraca Life Sciences a major competitive advantage. Theradiag will sell the requisite raw materials and earn royalties on the sales realized by Miraca in the United States.

These two main events of the first half will bolster Theradiag’s growth in these areas in 2017 and 2018.

Subsequent events and outlook

• Pursuant to an agreement between Janssen Biotech and Miraca Life Sciences, InformTx^TM monitoring tests will be made available under the Janssen 2Inform program, which gives doctors access to two free monitoring tests p.a. for each patient treated with Remicade®. Under the partnership agreed in November 2015² between Miraca Life Sciences and Theradiag, Miraca Life Sciences is due to supply Theradiag’s monitoring tests under the InformTx^TM banner.
• Theradiag and HOB Biotech entered into an investment agreement on June 17, 2016 for the acquisition of a stake Theradiag. This agreement was contigent upon consent being obtained from the Chinese authorities, including the Reform and Development Committee. Once this consent was obtained, HOB Biotech was able to participate in Theradiag’s capital increase.

Thus, Theradiag will issue 741 056 new shares for €2,482,537.60 in total consideration as part of the increase in share capital by private placement. The shares will be issued without preferential subscription rights to existing shareholders, reserved for one category of beneficiaries, pursuant of the Fourteenth resolution approved by shareholders at the April 26, 2016 General Meeting and as authorized by the Board of Directors on May 12, 2016.

The new shares will bear dividend entitlement and will be listed on the Alternext Paris market, under the same code as the existing share, code ISIN FR0004197747, mnemonic : ALTER. Theradiag’s share capital will account for 6,881,928 shares at the settlement date, which was foreseen September 15 2016.

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 rectal cancer, auto-immune and inflammatory diseases and HIV/AIDS. 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 75 employees.

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

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