ThromboGenics NV has issued a business update and its nine-month financial results for the period ending 30 September, 2012.
Highlights (including post-period events)
• JETREA® (ocriplasmin) was approved by the U.S. Food and Drugs Administration (FDA) for the treatment of symptomatic Vitreomacular Adhesion (VMA) on the PDUFA date of 17 October.
• In August, the prestigious medical journal the New England Journal of Medicine (NEJM) published the results from the JETREA® (ocriplasmin) Phase III clinical trial program. The publication (“Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes”) highlighted that JETREA® is superior to placebo in resolving VMA and related vitreomacular traction (VMT).
• ThromboGenics is on target to build a first-class US commercial organization to launch JETREA in January 2013.
• The JETREA® Marketing Authorization Application (MAA) is under review in Europe by the EMA; a CHMP opinion is expected in January 2013. A positive opinion would pave the way for EU approval in March 2013.
• In March, ThromboGenics signed an important strategic deal with Alcon, the global leader in eye care, for the commercialization of JETREA® outside the U.S. ThromboGenics will receive up to €375 million in upfront and milestone payments plus royalties that will give it an important share of the economics from JETREA’s sales outside the U.S.
• On October 30, ThromboGenics hosted a Capital Markets Day in Brussels for investors and analysts.
• In March, ThromboGenics raised €77.8 million in a private placement.
• In June, the Belgian tax authorities granted the Company a positive ruling enabling it to benefit from the application of the Belgian patent income deduction regime in conjunction with the existing deduction carry forwards of ThromboGenics NV.
• ThromboGenics had €168.6 million in cash and cash investments as of 30 September 2012, compared with €88.3 million at the end of September 2011.
• The Company reported revenues of €75.1 million in the first nine months of 2012 versus €2.5 million in the first nine months of 2011. The revenues in 2012 are almost entirely due to the upfront payment from Alcon.
Dr. Patrik De Haes, CEO of ThromboGenics, said: “The FDA’s approval of JETREA®, the first pharmacological treatment for symptomatic Vitreomacular Adhesion (VMA) in the U.S., is a transformational event for ThromboGenics and our shareholders.
“We are making excellent progress in building our U.S. commercial organization and I am sure that we will have a first-class team in place to launch JETREA® in January 2013. We are also encouraged by the high level of awareness of symptomatic VMA and the clinical data that we have generated with JETREA®.
“We are confident that the launch of JETREA® will be successful in the US. I believe the U.S. retina community and thousands of patients suffering with symptomatic VMA will welcome JETREA® as the first pharmacological treatment option for this progressive sight threatening condition whose only current treatment option is surgery.”