Consolidated financial statements including the financial statements of Prestizia, a wholly-owned subsidiary of Theradiag
- Revenues up 19%
In the financial year to December 31, 2016, Theradiag posted consolidated revenues of €9 million, up 19% from €7.6 million in 2015.
The Theranostics business unit recorded annual revenues of €4 million, compared with €2.3 million in the previous year, representing an increase of 74% and 45% of total revenues. These included revenues from direct sales to hospitals and laboratories and from the various partnerships with Miraca Life Sciences, Janssen, UCB and Hospira/Pfizer, with the latter accounting for a significant portion in 2016. The development of sales with Miraca Life Sciences in the US market is likely to be a major growth driver over the coming quarters and to have a positive impact in 2017.
The proportion of revenues from products developed in-house accounted for 75% of total revenues in 2016, compared with 65% in 2015. Sales of low value-added distribution products declined 18% in the 2016 financial year.
The shift in the product mix towards in-house products led to further improvement in the gross margin to 75% vs. 69% in 2015.
By moving into new markets and accelerating its international expansion, the percentage of revenues contributed by export markets came to €4.1 million in 2016 compared with €3 million in 2015, representing an increase of 36%.
- Full-year 2016 results
Operating costs increased by 2% compared with 2015. With the steep increase in revenues and the improvement in the gross margin, the operating loss was reduced by 35% to €2.2 million in the financial year to December 31, 2016.
During the 2016 financial year, direct research and development costs came to €1.4 million excluding subsidies. They were devoted primarily to the continued development of Lisa Tracker® kits and the projects carried out on the microRNA technology platform.
As a result, Theradiag recorded a net loss of €2.1 million, down 30% compared with 2015.
- Cash position
At December 31, 2016, Theradiag’s available net cash stood at €3.74 million, compared with €3.32 million at December 31, 2015.
2016: highly encouraging developments under our partnership agreements in the United States and China
- Growth in Theranostics and commercialization in the United States via its partnership with Miraca Life Sciences
During 2016, commercialization commenced in the US market of five tests in the Lisa Tracker® product range under the licensing agreement with Miraca Life Sciences announced in November 2015, via the launch of their InformTx™ platform.
These five biotherapy monitoring tests (Infliximab/Remicade®, Adalimumab/Humira®, Certolizumab/Cimzia®, Vedolizumab/Entyvio®, Ustekinumab/Stelara®) are intended in priority for inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis. Thanks to the launch of InformTx™, Certolizumab and Vedolizumab monitoring is available for the first time in the US market. No other US laboratory can offer all these monitoring tests, which gives Miraca Life Sciences a major competitive advantage.
Furthermore, in August 2016, Janssen Biotech Inc. launched the Janssen 2Inform program offering monitoring tests free of charge to help health professionals make better use of Remicade® in the treatment of patients with inflammatory bowel diseases (IBD). Thanks to the partnership entered into between Miraca Life Sciences and Theradiag, Miraca Life Sciences supplies Theradiag’s monitoring tests under the InformTxTM banner as part of the Janssen 2Inform program. Theradiag sells the materials required and earns royalties on sales generated by Miraca Life Sciences in the United States
- Consolidation of the partnership with HOB Biotech in China
- Launch of the BioCLIA 1200 automated system
Theradiag launched the BioCLIA 1200, a next-generation automated system, at the International Congress on Autoimmunity (ICA), which brings together international autoimmunity and theranostics specialists every two years.
Under the cross-distribution and partnership agreement, the BioCLIA® 1200 has been launched as a co-development with HOB Biotech. In addition, the companies are co-developing a full range of autoimmunity, biotherapy monitoring and allergy reagents, which will gradually be brought onto the market from 2017 using this new system.
Theradiag is the exclusive distributor of this innovative solution in Europe.
- Capital increase taken up by HOB Biotech
A reserved capital increase of €2.5 million was subscribed in full by HOB Biotech, which owns a 10.77% interest in Theradiag following this issue of shares.
Theradiag issued 741,056 new shares representing an increase in capital totaling €2,482,537.60. In accordance with the 14th resolution approved at the Annual General Meeting of April 26, 2016 and the authorization given by the Board of Directors on May 12, 2016, shareholders waived their preferential subscription rights for this issue to a single category of beneficiaries.
Theradiag’s share capital is made up of 6,881,928 shares after settlement-delivery, which took place on September 15, 2016.
- Further evidence of scientific and economic interest in biotherapy monitoring
The scientific community’s interest in biotherapy monitoring was demonstrated at the 11th ECCO (European Crohn’s and Colitis Organisation) Congress, with an increasingly large volume of data for biotherapy monitoring presented at the event, including over 25 oral presentations and 40 or so posters. This figure doubled in 2016, representing an endorsement of Theradiag’s theranostics-based approach. Around 15 presentations and posters were based on Theradiag’s Lisa Tracker® range of monitoring tests.
In addition, a systematic review of the pharmacoeconomic research published in the Journal of Gastroenterology highlights that monitoring the biotherapies used in the treatment of inflammatory diseases helps to reduce the cost of biotherapy treatment by 28% to 34% in the trials analyzed. This systematic review by Professor Laurent Peyrin-Biroulet of Nancy CHU teaching hospital focused on the research published on inflammatory bowel disease and rheumatoid arthritis, in both patients with a loss of treatment response and those in remission.
Subsequent events
- New appointments to Theradiag’s Board of Directors
Theradiag has announced the appointment of Dominique Costantini and Dominique Takizawa as directors[1]. Their high-level and complementary profiles will strengthen the Company’s Board of Directors and help to guide its expansion strategy.
- Support for the development of microRNA biomarkers in oncology
Prestizia has been selected by the Eurostars-2 program to receive financial support for its PIONEER collaborative project undertaken by its Prestizia molecular biology platform and its South Korean partners, the Asan Medical Center, and CbsBioscience. The purpose of the PIONEER project is to develop two tests based on circulating microRNA biomarkers and tissue messenger RNA (mRNA) in rectal cancer.
The total subsidy amounts to €1.3 million, approximately €300,000 of it for Theradiag. A consortium agreement between the three partners will be entered into over the next few weeks.
Next financial press release:
First-quarter 2017 revenues: Thursday, April 27, 2017 (after the market close)
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
