Developing next generation treatments to preserve vision for patients with diseases affecting the back of the eye

ThromboGenics Q3 Business Update 2014

6 Nov 2014

REGULATED INFORMATION

 Highlights

 JETREA® in the US

  • ThromboGenics’ marketing and sales efforts are now focused on key accounts as it seeks to expand the use of JETREA® (ocriplasmin). These accounts comprise retina specialists who have already achieved satisfactory clinical results with JETREA® based on appropriate patient selection criteria, which are critical to delivering the drug’s important value in the treatment of symptomatic VMA
  • ThromboGenics continues to gather real-world data on JETREA®’s use: OASIS will report initial topline results in Q1 2015, with the full readout scheduled for end of Q3 2015; ORBIT study is progressing well with 110 centers now enrolled; OZONE study to assess the anatomic and symptomatic changes that potentially occur in the six months immediately after treatment with JETREA® is on track to report results in Q1 2015
  • ThromboGenics had a wide-ranging marketing and education program at the American Academy of Ophthalmology (AAO) 2014 meeting, which took place in Chicago from 17-21 October. A number of presentations at the AAO meeting suggested that the US retina community is developing a greater understanding of how to utilize JETREA® more effectively while better understanding its safety profile

JETREA® outside the US   

  • ThromboGenics’ partner Alcon, in conjunction with Novartis, continues to commercialize  JETREA® across Europe and Rest of the World (RoW) having achieved positive reimbursements
  • JETREA® has recently been approved in a number of countries including Australia, South Korea, Ukraine and Chile

Research & Development 

  • ThromboGenics is completing plans for a Phase II clinical study to be conducted in the US for developing JETREA® in diabetic retinopathy
  • Pre-clinical research projects in diabetic eye disease progressing as planned

Corporate

ThromboGenics’ transfer of cancer R&D activities: a new company is being formed in partnership with VIB (Flanders Institute for Biotechnology) which will seek external funding. ThromboGenics will have an equity stake in this new venture focusing on paediatric oncology

 Financial

  • Cash and investments of €136.6 million as of the end of September 2014, compared with €148.8 million at the end of June 2014
  • ThromboGenics remains on track to achieve its target of profitability in the US by 2016, based on JETREA® sales of around €30 million. The Company is also targeting to become cash flow positive by 2017, and to achieve total revenues of €100 million by 2019

 

Leuven, Belgium – 6 November, 2014 - ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today issues a business and financial update for the nine months ending 30 September, 2014.

ThromboGenics developed JETREA®, the first and only pharmacological treatment indicated for an important sight-threatening condition, symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) as known in the US and Europe respectively. Symptomatic VMA/VMT is a progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.

ThromboGenics’ strategy is focused on:

  • Driving the sales of JETREA® in the US
  • Supporting Alcon, in conjunction with Novartis, to develop the sales of JETREA® outside the US
  • Creating further value by supporting clinical programs documenting the real-world use of JETREA® in approved indications and developing new indications including diabetic retinopathy, and
  • Progressing its pipeline in earlier stage projects focused on diabetic eye disease

The commercial success of JETREA® in the USis at the heart of this strategy. To achieve this goal the Company is continuing to focus its sales and marketing activities on increasing the adoption rates within those accounts that use JETREA® for the treatment of patients with symptomatic VMA.

ThromboGenics is continuing to assist its partner Alcon which, in conjunction with its parent company Novartis, is commercializing JETREA® outside the US.

As part of its plans to build further value from JETREA®, ThromboGenics is planning to investigate this novel medicine for the treatment of diabetic retinopathy.

Dr Patrik De Haes, ThromboGenics’ CEO, said: “We are continuing to focus our sales and marketing efforts in the US on strategic key accounts. We believe these centers will form the strong platform we need to increase the use of JETREA® for the treatment of the significant number of patients with symptomatic VMA who could benefit from pharmacological intervention. In parallel, we are conducting a number of studies that will deliver additional real-world data to demonstrate to the broader retina community the clear benefits and value of using JETREA®. Our progress gives us confidence that we will achieve our near term target of profitability in the US in 2016, based on sales of JETREA of around €30 million.”