On April 10, 2018 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported its consolidated annual results for the year ended December 31, 2017, approved by its Board of Directors on April 10, 2018, and its revenue to March 31, 2018 (Press release, Theradiag, APR 10, 2018, View Source;utm_medium=rss&utm_campaign=theradiag-reports-its-2017-annual-results-and-sales-for-first-quarter-2018 [SID1234525251]).
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"Having refocused our development efforts on our high value-added products, especially Lisa Tracker, we discontinued the Prestizia activity and reorganized our teams. Combined with the risks arising from our dispute with HOB Biotech and the termination of our agreements, this generated an exceptional loss in 2017", said Michel Finance, Theradiag’s CEO. "However, the results of our reorganization, the confirmation of first-quarter growth in our strategic activities, especially theranostics, and a solid financial position mean that we can look forward to 2018 with confidence and envisage a rapid return to breakeven while continuing to develop new partnerships."
As previously reported, Theradiag generated consolidated revenue of €9,058 K in the year to December 31, 2017, compared with €8,978 K in 2016. The sales of Lisa Tracker kits for routine use continue to grow strongly, rising by 20% in 2017, boosted by the partnerships concluded with pharmaceutical companies.
As in 2016, products developed in-house accounted for 75% of the company’s total sales.
Exports continued to grow as a proportion of sales, accounting for 51% of the total in 2017 as opposed to 46% in 2016.
The non-launch of BioCLIA, co-developed with HOB Biotech, impacted revenue growth in 2017.
Bottom line heavily impacted by non-recurring items
Before exceptional charges, Theradiag’s net loss in 2017 was close to that in 2016, excluding BioCLIA development costs. On the basis of the 2018 perimeter (i.e. without Prestizia and with the beneficial effects of the restructuring plan), the net loss excluding exceptional charges in 2017 would have been €850 K. Assuming moderate sales growth, the company’s new business structure and organization will bring it back to breakeven.
The net loss in 2017 was compounded by the company’s restructuring plan, which generated a charge of €423 K. As reported in December, the Board of Directors decided to discontinue the Prestizia research activity due to the absence of medium-term revenue prospects at the subsidiary and in order not to hamper the development of the rest of Theradiag’s activities. This had an impact of €1,655 K on the bottom line. In addition, as discussions on the renegotiation of agreements with the Chinese partner HOB Biotech are unfruitful, and following the termination of those agreements, Theradiag establishes a contingency provision of €1,637 K.
This generated an exceptional loss of €3,728 K (€2,224 K in exceptional charges and €1,504 K in amortization of goodwill for Prestizia) and a net loss of €5,959 K. The impact of these non-recurring items on the cash position was less than 30% of their total amount.
Excluding exceptional charges and with equivalent revenue, the net loss in 2017 would have been €2,236 K compared with a net loss of €2,112 K in 2016. The additional €124 K consisted mainly of costs associated with the development of BioCLIA.
Solid cash position
At December 31, 2017, Theradiag had available net cash of €5.16 million as opposed to €3.74 million at December 31, 2016, following the successful completion of a €4-million capital increase in May 2017.
2017 highlights: continuing development of theranostics
Launch on the US market of three new tests in the Lisa Tracker range
Further progress was made in bringing Lisa Tracker monitoring tests to the US market as part of the licensing agreement with Inform Diagnostics (formerly Miraca Life Sciences).
The Simponi (golimumab), Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda) monitoring kits supplemented the InformTxTM range.
The only company in the US to supply the Cimzia (certolizumab pegol) and Stelara (ustekinumab) monitoring kits, Inform Diagnostics now offers the most extensive range of monitoring kits on the US market. Inform Diagnostics also continues to offer the Remicade (infliximab), Humira (adalimumab) and Entyvio (vedolizumab) monitoring kits.
Conclusion of agreements with pharmaceutical companies
Partnership agreement with Biogen
Theradiag has entered into a partnership agreement with Biogen to provide its Lisa Tracker kits for monitoring Flixabi (an infliximab biosimilar).
As a result, Biogen now supplies Lisa Tracker monitoring kits in the competitive tenders in which it participates in France and other European countries to optimize the treatment of patients receiving Flixabi.
Under this agreement, Theradiag is Biogen’s preferred supplier of infliximab monitoring kits. Theradiag will also handle implementation, provide training to laboratories in how to use kits and follow up clinicians’ requests concerning monitoring. Biogen has previously validated the use of Lisa Tracker kits for monitoring Flixabi.
Partnership agreement with MSD
Theradiag has signed a partnership with MSD France (Merck Sharp & Dohme) to supply its Lisa Tracker kits for the monitoring of Remicade.
Under this agreement, MSD France has referenced the Lisa Tracker monitoring kits to accompany the supply of Remicade. Kits are supplied under the conditions set out in the contracts won by MSD France to supply Remicade.
Theradiag will also handle implementation, provide training to laboratories in how to use kits and follow up clinicians’ requests concerning monitoring.
Highlights since year-end
Partnership agreement with Biogaran
Theradiag has entered into a partnership agreement with the pharma group Biogaran to supply its Lisa Tracker kits for monitoring Biogaran’s biosimilar drugs.
Under the agreement, Biogaran has referenced the Lisa Tracker monitoring kits in France to support the biosimilar drugs it supplies. Theradiag will handle implementation, provide training to laboratories in how to use kits and follow up clinicians’ requests concerning monitoring.
"Theradiag positions itself as pharmaceutical companies’ preferred supplier of monitoring kits with all infliximab biosimilars on the market. These partnership initiatives continued in 2018 with recently announced agreements. The interest shown by these leading pharma companies validates our expertise and our theranostic approach and is instrumental in leveraging our growth and enhancing our reputation", said Gérard Tobelem, Chairman of the Board of Directors.
Termination of agreements with HOB Biotech
Since the last press release dated February 20th, 2018, discussions between Theradiag and HOB Biotech continued but no agreement was reached. In this context, Theradiag has given notice to HOB Biotech that all agreements between the two companies are terminated, on the grounds of contractual breaches identified but not remedied by HOB Biotech. Consequently, these agreements are now terminated. Theradiag will take all legal means to be indemnified by HOB Biotech, because of its losses.
Theradiag generated consolidated revenue of €2.3 million in the first quarter of 2018, the same level as in the first quarter of 2017.
The theranostics business unit generated revenue of €1 million in the first quarter of 2018, compared with €1.1 million in the first quarter of 2017. Theranostics sales over the period consisted entirely of kits for routine use and were 8% higher than in both the first and the last quarters of 2017. There were no non-recurring theranostics sales to pharmaceutical partners, whereas substantial revenue was generated in the first quarter of 2017 as a result of an agreement with a pharmaceutical company.
Sales of kits for routine use have been boosted by the agreements concluded in 2016 and 2017.
IVD sales got off to a great start in the first quarter with growth of 13%.