This new way of detecting anti cyclic citrullinated peptides (anti-CCPs) antibodies allows for highly-reliable detection of severe forms of RA through a more rapid dosing and at a lower cost than existing tests.

“This new CE mark shows our ability to further expand our high-value IVD portfolio. With this new addition to the Fidis range, we position ourselves as testing and monitoring leaders in auto-immune and inflammatory diseases. This anti-CCP test strengthens our in house products portfolio, in line with our development strategy. The new kits will be available internationally, like all our other Fidis products” commented Michel Finance, CEO of Theradiag.

The new anti-CCP test is the third proprietary diagnostic kit of Theradiag to obtain a CE mark this year. The auto-immune diseases segment grew strongly in 2012 (+17% for Fidis products), making-up for 43 percent of company sales in 2012.

About Theradiag

Backed by its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostic tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of “customized treatment”, which favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. Theradiag is also developing new diagnostic markers thanks to its microRNA platform, which will allow specific biomarkers to be identified in order to guide therapy and will be first and foremost applied to the treatment of AIDS. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has some 50 employees.

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

Theradiag Investor Relations Nathalie Trepo Tél: 01 64 62 10 12 ntrepo@theradiag.com

NewCap. Financial Communications and investor relations Valentine Brouchot / Pierre Laurent Tél. : 01 44 71 98 52 theradiag@newcap.fr

Alize RP Press Caroline Carmagnol caroline@alizerp.com Tél. : 06 64 18 99 59 Christian Berg christian@alizerp.com Tél. : 01 42 68 86 41

Croissy-Beaubourg, April 16 2013 – THERADIAG (ISIN : FR0004197747, Ticker : ALTER), a company specializing in theranostic and in vitro diagnostic, today reports its audited annual financial results for 2012 as approved by the Board of Directors on April 16, 2013.

“Financial results for 2012 are in line with our anticipations. The new development strategy based on proprietary, higher-value products presented during our IPO is now well acted and will allow us to improve our gross margin and international sales. Theradiag is implementing this strategy by focusing primarily on theranostics. Thanks to the success of our IPO and R&D efforts, we have the means to move forward with activities in our two business units. The two CE mark approvals that we received in February, and the renewed support of OSEO for the CaReNA project speak to our know-how and innovation skills. We head into 2013 with confidence and dedication to the development of our theranostic portfolio” commented Michel Finance, CEO of Theradiag.

In accordance with the new strategic direction presented during its IPO, Theradiag is now focusing on the development and sale of its proprietary, theranostic and high-value diagnostic portfolio. The decrease in sales incurred 2012 is thus exclusively linked to the downshifting of the distribution activities in coming years.

Theradiag recorded annual revenues of €8.3 million in 2012, an 18.7% decrease compared to the previous year. Sales originating from the marketing of IVD diagnostic tests, part of a distribution contract (distribution revenues) made up 60% of total sales, while 40% of sales originated from the marketing of in house developed products (in house revenues). In house revenues were pulled by the growth of the auto-immune diagnostic range Fidis (+17% yoy) and the performance of the theranostic portfolio, with sales of Lisa Tracker products up by 56%. The new molecular biology portfolio Amplidex also recorded a strong 57% increase.

The favorable shift in the product mix towards in house products resulted in the improvement of the gross margin from 55.8% in 2011 to 57.6% in 2012.

Exports totaled €2.4 million in 2012, making up for 29% of sales compared to 23% in 2011.

Operating costs fell by 15% over the period, demonstrating tight control over general and administrative expenditures. The company maintained a strong investment effort over the period with R&D expenses totaling €535K in 2012. Including R&D expenses of Prestizia (a 100% non-consolidated subsidiary of Theradiag), total R&D efforts reached €1,175K over the period, mainly dedicated to the Company’s expanding theranostic activities. The Company received a €384K in research tax credit (Crédit d’Impôt Recherche) for R&D expenses incurred in 2012.

After taking into account €104K in financial costs, the net loss for the year was €972K compared to €339K in 2011 due to:

• the intensification of the R&D effort into theranostic and high-value IVD activities;
• the goodwill impairment for €390K of a revenue-losing product range

The IVD business unit remained however profitable over the period.

Theradiag’s cash position was €8.4 million at December 31, 2012.

2012 highlights :

• Theradiag acquired in April 2012 100% of Prestizia and its highly innovative microRNA technology platform, thereby strengthening the company’s positioning into theranostics. This technology could pave the way for a large number of clinical applications, including a molecular biology test of HIV tropism, cancer (lung and colon) and auto-immune diseases (rheumatoid arthritis).

• The company signed in October 2012 a partnering deal with Sebia for the development, scale-up and production of a new IVD kit. According to the terms of the agreement, Theradiag will receive royalties on sales and revenues for future production.

• Theradiag announced in December 2012 the success of its €8.6 million IPO after full exercise of the extension clause, following an Open Price Offering in France (“OPO”) and global placement in France and abroad, notably excluding the United States of America. The funds raised provides the company with the means necessary to finance development in theranostics and in new therapies for treating inflammatory and autoimmune diseases, cancer and AIDS, in addition to its existing innovative diagnosis  proprietary products.

Major events since 2012 close:

• In February 2013, Theradiag received CE mark approval for two new Lisa Tracker monitoring  kits in theranostics. With these two  new additions available in all EU countries, Theradiag  now offers a range of seven  blood test kits providing  comprehensive multiparameter diagnosis solutions to monitor patients  with autoimmune and inflammatory diseases.

• The company announced in April 2013 that it would be granted 1.2 million euros by OSEO as part of the collaborative project CaReNA. As part of the project, Theradiag will develop and implement 4 new diagnostic kits through Prestizia miRNA platform

Upcoming financial publication:

HY 2013: October 1, 2013 (after market close)

About Theradiag

Backed by its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostic tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of “customized treatment”, which favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. Theradiag is also developing new diagnostic markers thanks to its microRNA platform, which will allow specific biomarkers to be identified in order to guide therapy and will be first and foremost applied to the treatment of AIDS. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has some 50 employees.

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

Theradiag Investor Relations Nathalie Trepo Tél: 01 64 62 10 12 ntrepo@theradiag.com

NewCap. Financial Communications and investor relations Valentine Brouchot / Pierre Laurent Tél. : 01 44 71 98 52 theradiag@newcap.fr

Alize RP Press Caroline Carmagnol caroline@alizerp.com Tél. : 06 64 18 99 59 Christian Berg christian@alizerp.com Tél. : 01 42 68 86 41

The Theradiag team will be delighted to welcome you and look forward to seeing you at its booth no. 136.

www.eshg.org/eshg2013

RNA-targeting therapeutic and diagnostic solutions

in two indications : HIV/AIDS and obesity

Croissy-Beaubourg, April 9 2013 – Theradiag (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostic and in vitro diagnostics, today announced it has been granted financial support by Oséo, the French Agency for Innovation, for its participation in CaReNA. Total development costs for the entire project could reach €18 M. CaReNA is a collaborative project between Splicos, alternative RNA splicing specialist and project-lead, Theradiag and the CNRS (French National Center for Research and Science) for the development of RNA-targeting therapeutic and diagnostic solutions in the treatment of HIV/AIDS and obesity. As part of the project, Theradiag will receive €1.2 million for developing and implementing 4 new diagnostic kits.

Theradiag will develop 2 new companion diagnostic kits to Splicos’ therapeutics, one for the treatment of HIV /AIDS and another for the monitoring of diabetes and associated metabolic disorders. These tests will be implemented right from the clinical development phases and will enable physicians to optimize patient care (as part of the theranostic strategy). A third test will be developed for early monitoring of HIV infection and disease evolution. A fourth test will allow for the assessment of patient response and/or resistance to antiretroviral treatments through the quantification of predicting miRNAs.

 “We are thrilled by this partnership with Splicos and CNRS. The support granted by Oséo for this project lends validation to our strategic development goal based on providing innovative theranotics through our miRNA platform. This new financing will allow us to expand our theranostic range with 4 new molecular biology/miRNA diagnostic kits, adding on to the existing 7 blood-test kits of the Lisa Tracker portfolio. We are now positioning ourselves as true leaders of miRNA diagnostics. With these new kits, we will be able to tap into the broad diagnostic markets of HIV/AIDS and metabolic disorders” concluded Michel Finance, CEO of Theradiag.

About Theradiag

Backed by its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostic tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of “customized treatment”, which favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. Theradiag is also developing new diagnostic markers thanks to its microRNA platform, which will allow specific biomarkers to be identified in order to guide therapy and will be first and foremost applied to the treatment of AIDS. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has some 50 employees.

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

Theradiag Investor Relations Nathalie Trepo Tél: 01 64 62 10 12 ntrepo@theradiag.com

NewCap. Financial Communications and investor relations Valentine Brouchot / Pierre Laurent Tél. : 01 44 71 98 52 theradiag@newcap.fr

Alize RP Press Caroline Carmagnol caroline@alizerp.com Tél. : 06 64 18 99 59 Christian Berg christian@alizerp.com Tél. : 01 42 68 86 41

]]> http://www.theradiag.com/en/theradiag-granted-1-2-million-euros-by-oseo-as-part-of-the-collaborative-project-carena/feed/ 0 http://www.theradiag.com/en/theradiag-receives-ce-mark-approval-for-two-new-lisa-tracker-monitoring-kits-in-theranostics/?utm_source=rss&utm_medium=rss&utm_campaign=theradiag-receives-ce-mark-approval-for-two-new-lisa-tracker-monitoring-kits-in-theranostics http://www.theradiag.com/en/theradiag-receives-ce-mark-approval-for-two-new-lisa-tracker-monitoring-kits-in-theranostics/#comments Fri, 15 Feb 2013 09:05:35 +0000 alexandra http://www.theradiag.com/en/?p=1057 Theradiag receives CE mark approval
for two new Lisa Tracker monitoring kits in theranostics

Croissy-Beaubourg, February 14 2013 – Theradiag (ISIN: FR0004197747, Ticker: ALTER), a company specializing in theranostic and in vitro diagnostics, today announced  it has obtained a CE mark for two new biotherapy monitoring kits; Tocilizumab (anti-IL6R) and Rituximab (anti-CD20) that further expand the Lisa Tracker range.

With these two new additions available in all EU countries, Theradiag now offers a range of seven blood test kits providing comprehensive multi-parameter diagnosis solutions to monitor patients with autoimmune and inflammatory diseases. Rituximab is also used to treat hematological cancers.

Michel Finance, CEO of THERADIAG, says: “These two new monitoring kits expand our theranostic range to cancerology and show that we are on track to meet our roadmap targets. The Lisa Tracker range is a unique diagnostic tool which enables physicians to tailor treatments and optimize patient care. This new CE mark outlines our expert know-how in our lines of innovative proprietary diagnostic products and their sale in international markets”.

About Theradiag

Backed by its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostic tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag is thus participating in the development of “customized treatment”, which favors the individualization of treatments, the evaluation of their efficiency and the prevention of drug resistance. Theradiag markets the Lisa-Tracker range (CE marked), which is a comprehensive multiparameter diagnosis solution for patients with autoimmune diseases treated with biotherapies. Theradiag is also developing new diagnostic markers thanks to its microRNA platform, which will allow specific biomarkers to be identified in order to guide therapy and will be first and foremost applied to the treatment of AIDS. Theradiag recorded revenue of €6.4 million at 30 September 2012. The Company is based in Marne-la-Vallée, near Paris, and has some 50 employees.

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

The Theradiag team will be delighted to welcome you and look forward to seeing you at its booth no. RN 19 located in Rashid Hall (in collaboration with our Partner GSC – Gulf Scientific Corporation).

 Subsequently, the Company has decided to set the issuance price of its new shares at €5.80, at the upper end of the offering range. Furthermore, given the level of demand, the Company has decided to exercise 100% of the extension clause, thus taking the total value of the offering to €8.2 million.

“We are delighted to announce the success of our IPO on Alternext”, says Michel Finance, CEO of Theradiag. “We would like to thank all our staff and partners, and in particular our majority shareholder, Truffle Capital, as well as our new shareholders for their trust and support. The funds raised will provide us with additional means to finance our future: our development in theranostics and in new therapies for treating inflammatory and autoimmune diseases, cancer and AIDS, in addition to our existing Lisa-Tracker range, but also our microRNA platform. We will of course continue to enhance our innovative diagnosis proprietary product ranges and their international marketing”, adds Michel Finance.

]]> http://www.theradiag.com/en/success-of-the-theradiag-ipo-e8-2-million-raised-global-demand-of-e15-1-million-price-set-at-the-upper-end-of-the-offering-range-at-e5-80/feed/ 0 http://www.theradiag.com/en/theradiag-announces-the-signature-of-a-partnership-agreement-with-sebia-for-the-development-of-a-new-diagnostic-kit-2/?utm_source=rss&utm_medium=rss&utm_campaign=theradiag-announces-the-signature-of-a-partnership-agreement-with-sebia-for-the-development-of-a-new-diagnostic-kit-2 http://www.theradiag.com/en/theradiag-announces-the-signature-of-a-partnership-agreement-with-sebia-for-the-development-of-a-new-diagnostic-kit-2/#comments Thu, 25 Oct 2012 07:56:15 +0000 odile http://www.theradiag.com/en/?p=293 Paris, October 23^rd 2012 – Theradiag, the theranostics and in vitro diagnostics company focused on autoimmune diseases, has just signed a partnership agreement with Sebia.

Within the framework of this partnership, Theradiag will play an advisory role in development and will be responsible for the scale-up and production of a future diagnostic kit. According to the terms of the agreement, Theradiag will receive royalties on sales and revenues for future production.

“We are delighted to have formed a partnership with Sebia that highlights our expertise and acknowledges Theradiag’s development and production capabilities in the field of diagnostics,” stressed Michel Finance, Theradiag’s Chief Executive Officer.

“The collaboration with Theradiag seemed a natural fit to us when we needed to find a partner for this new diagnostic kit. The two companies have complementary areas of expertise that will provide the necessary synergies for rapid development of the project, all within an area of geographical proximity,” added Benoît Adelus, Sebia’s Chairman and Chief Executive Officer.

About Theradiag

Theradiag has over 25 years of experience in the diagnostic market, especially for autoimmune diseases. It is currently moving into the theranostics market with the goal of improving monitoring for biologic treatments for autoimmune diseases in particular.
Theradiag, a recent positioning on the theranostic market

Thanks to an expertise in IVD and autoimmune diseases, from development to sales via  regulatory phases, Theradiag will focus its development strategy on theranostics tests for biotherapy monitoring. Theradiag was CE marked in 2011 and marketed a new range of products, Lisa Tracker, for improving the monitoring of treatments of patients being treated with Anti-TNF.

New theranostics products are currently being developed.

The company is based in Marne la Vallée (near Paris, France) and currently has 50 employees.

For more information about the company, visit our website: www.theradiag.com

About Sebia

For more than 40 years, Sebia, a global leader in protein electrophoresis, has been developing, manufacturing, and marketing reagents and instruments for in vitro diagnosis of certain cancers, inflammatory diseases, metabolic disorders, and hemoglobinopathies. Sebia’s expertise in electrophoresis techniques has allowed it to maintain a continuous research & development program, enabling it to provide genuine solutions to all kinds of laboratories.

Recently, Sebia has adapted that highly successful technology for the field of diabetes, in order to meet the growing global demand for more accurate and reproducible methods of measuring HbA1c levels.

For further information: www.sebia.com

You will be able to meet the Theradiag team at our booth Nr. D16. So you could discover our latest theranostic and diagnostic innovations.

You could also attend our presentation of “Towards a better interaction between Biologists & Clinicians LISA TRACKER: a new therapeutic decision-making tool for the follow-up of the patients under biotherapies” at the workshop BioMI, 7^th of November at 11:30 am room Darwin 4/level D.