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ThromboGenics Business Update H1 2013

Stocks in this article: THR

Financial Update

  • Revenues for the six months ended 30 June 2013 amounted to €102.7 million, compared to €75.1 million for the same period in 2012
  • US sales of JETREA ® for the first six months of 2013 amounted to €12.5 million
  • At the end of June 2013, the Company had a cash balance of €193.6 million
  • ThromboGenics reported a net profit of €54.6 million for the first six months of 2013
  • In March, the Company's shares started trading as part of the BEL20 index on the Euronext stock exchange

Commercializing JETREA ® (ocriplasmin)   in the US

  • ThromboGenics launched JETREA ® in the US on 14 January after it was approved as the first and only pharmacological treatment for symptomatic VMA
  • JETREA ® offers for the first time a treatment option for patients suffering from symptomatic VMA
  • Highly focused commercial team, including specialty sales force, working to build the US sales of JETREA ® and to increase awareness of the benefits of treating symptomatic VMA
  • ThromboGenics reimbursement support team in place to aid US physicians gain reimbursement for JETREA ® and assist qualified patients with potential co-pay burdens.
  • Permanent J-code expected January 1, 2014. A permanent J-code will assist in automated claims adjudication that will result in physicians being reimbursed in a more expedient manner
  • Early response from the US retina community suggests JETREA representing game-changing therapeutic approach for patients suffering from symptomatic VMA. True innovation takes time to find its way to the market and requires further medical education to ensure this novel product delivers its full commercial potential
  • JETREA ® US sales at end of June amounted to €12.5 million ( $US 16.6 million)
  • JETREA ® EU sales royalties at end of June amounted to €0.2 million
  • 51% of total targeted retina practices have ordered JETREA ® (vs 40% end of April 2013)
  • 62% of these practices have reordered the product (vs. 50% end of April 2013)
  • To date, the majority of JETREA ® has been used in moderate to severe patients

Commercializing JETREA ® in Europe and ROW

  • In March 2013, the European Medicines Agency (EMA) approved JETREA ® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
  • Partner Alcon launched JETREA ® in the UK in March, followed by Germany and the Nordic region
  • ThromboGenics received €90 million in milestone payments from Alcon: €45 million for the EU approval of JETREA ® and a further €45 million for the first sale of the drug in Europe
  • On August 30, 2013, the UK's National Institute of Health and Care Excellence (NICE) will issue its Final Appraisal Determination (FAD) for JETREA ® regarding reimbursement within the National Health Service (NHS) for the treatment of VMT
  • IQWiG, the German body that evaluates a drug's quality and efficiency, has confirmed that JETREA ® demonstrates major/significant added value compared with existing comparative treatment, when treating patients with mild/moderate vitreomacular traction (VMT) including when associated with a macular hole of less than or equal to 400 microns. Final guidance IQWiG expected in October 2013.
  • JETREA ® receives approval in Canada for the treatment of symptomatic vitreomacular adhesion (VMA)

JETREA ® Phase IIa wet AMD trial

  • ThromboGenics has reported positive data from a Phase IIa study showing that JETREA ® has potential to resolve VMA in patients with wet age-related macular degeneration (wAMD)
  • In the study (n=100 patients), at Day 28, 24% of the treated patients achieved resolution compared to 12% in the sham injection arm (primary endpoint, p=0.26)
  • No unexpected safety issues were identified, and the safety profile is consistent with the previous pivotal trials' safety data
  • Further studies to evaluate these potential clinical benefits are warranted
  • The full study results will be presented at AAO in November 2013

Dr. Patrik De Haes, CEO of ThromboGenics, said: "ThromboGenics has continued to make good progress delivering a number of key corporate milestones during the first half of 2013. The most important being our US commercial organization's launch of JETREA ® , the first pharmacological treatment for the progressive sight-threatening condition symptomatic VMA."

"Since launch we have succeeded in treating approximately 6% of the patients with moderate to severe symptomatic VMA in the  US . We will continue to work to build our share of this established market and at the same time look to gradually increase the use of JETREA ®   in mild to moderate patients, most of whom currently undergo watchful waiting. We believe that JETREA ® offers real value to these patients as it provides them with a new option that could prevent them having to experience a deterioration in their visual acuity and quality of life before being treated."

"Outside the US our partner Alcon has achieved a number of key milestones including introducing JETREA ®   in its first European market in May. It has also received positive health technology assessments in both the UK and Germany that have confirmed the value of JETREA ®   in treating patients with mild to moderate symptoms of VMA/VMT."

"We remain confident that with JETREA ® , we have provided the global retina community with a novel product that in time will play an important role in greatly expanding the number of patients with mild to moderate symptomatic VMA that can be treated pro-actively."

A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO of ThromboGenics, and Chris Buyse, CFO of ThromboGenics, today at 06:30 PM CET, 12:30 PM EST.

The dial-in numbers and participant passcode for the call are set out below:

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