Financial
For the first half of 2015 ending June 30 2015, ThromboGenics reports total revenues of €6.0 million, including €4.25 million of JETREA® sales in the US and €1.75 million in royalties from Alcon based on its ex-US sales of JETREA®. This compares to €5 million of JETREA® sales in the US and royalty income of €1.7 million reported for the same period in 2014. For the period H2 2014, ThromboGenics reported €3.8 million of JETREA® sales in the US and a royalty income of €1.7 million.
• Cash and investments were €113.3 million as of the end of June 2015, compared with €127.1 million at the end of December 2014
• ThromboGenics' decision to reduce the size of its US organization so that it is cash flow neutral in 2016 means that its current cash resources, plus the anticipated royalties from Alcon, will be sufficient to support its business plans for at least 3 years.
JETREA® in the US
• JETREA® achieved sales in US of €4.2 million in the first half of 2015. There has been no meaningful change in sales momentum despite additional positive real world data that has been released in recent months
• ThromboGenics is adjusting its US organisation to current market needs
• ThromboGenics, Inc. will become a leaner customer-centric organisation. It will supply JETREA® via its existing distribution network, and will provide responsive medical and scientific data-driven support to the retina community. The Company will continue to support physicians' efforts to enhance patient awareness of the options available for treating symptomatic VMA
• US retina physicians who wish to treat patients with JETREA® will continue to have full access to the product and to receive scientific and medical support
JETREA® outside the US
• ThromboGenics received € 1.7 million in royalty income from its partner Alcon in the first half of 2015 (€ 1.7 million for H1 2014)
• Alcon continues to gain new marketing and reimbursement approvals and to execute commercial launches of JETREA® across Europe and Rest of the World (RoW)
• JETREA® is now approved in 53 countries globally and reimbursement is secured in over 20 countries
Pre-clinical Research & Clinical Development
• ThromboGenics reported positive top-line results from the OASIS study in March 2015. This randomized controlled study met its primary endpoint with 41.7% of patients treated with JETREA® achieving VMA resolution at day 28 post injection compared with only 6.2% of patients who received a sham injection (p<0.001). The study also showed that the JETREA® safety profile in this 24 month follow-up study was consistent with the drug's overall safety profile as known from the approved label
• ThromboGenics remains on track to initiate its Phase IIa clinical study assessing JETREA® for the treatment of diabetic retinopathy (DR) around the end of 2015. A recent report from the American Academy of Ophthalmology projects that by 2020 there will be 1.34 million people in the US with vision-threatening DR.
• ThromboGenics is also evaluating the development of JETREA® for the enzymatic treatment of Retinal Vein Occlusion (RVO). First in-vivo tests have been completed, and the results are currently being processed for publication in a peer-reviewed scientific publication
• New compounds under pre-clinical evaluation – focus is on diabetic eye disease.
• Company plans to host an R&D Investor Event in late 2015/early 2016 at which the Company will provide a review of its clinical and development pipeline going forward.
Oncurious
• ThromboGenics spun out its oncology research activities into Oncurious NV, a newly incorporated company in which ThromboGenics is the majority shareholder. This company has been founded in conjunction with VIB (Flanders Institute for Biotechnology). This new venture is initially focusing on developing TB-403 for the treatment of medulloblastoma, the most common form of brain cancer in children
• Oncurious is on track to commence a Phase I/IIa study before the end of 2015
Appointments
• Dominique Vanfleteren appointed ThromboGenics' Chief Financial Officer (CFO) in January 2015
• Emmanuèle Attout appointed Independent Non-Executive Director of the Board of ThromboGenics NV on May 5, 2015
• Baron Philippe Vlerick appointed Non-Executive Director of the Board of ThromboGenics NV at an extraordinary shareholders' assembly that took place on August 20, 2015
Leuven, Belgium – 26 August 2015 - ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative medicines for treatment of vitreo-retinal disorders, today issues a business and financial update for the six months ending 30 June, 2015.
ThromboGenics today has announced a re-sizing of its US organization to reflect the current market demand for JETREA®. A new leaner organization will be responsible for providing distribution services, customer support and on-going medical education for JETREA®.
This change is designed to ensure that the Company's US operations are cash flow neutral as of 2016. As a result of today's announcement, ThromboGenics expects that the income from JETREA®, including the royalty income from Alcon, should become a source of cash to support the Company's R&D activities from 2016 onwards.
For treating physicians and their patients, nothing will change with regard to the availability and support of the drug for use in symptomatic VMA/VMT.
ThromboGenics' strategy will continue to be focused on:
• Developing JETREA® in a significant new indication - Diabetic Retinopathy
• Progressing its pipeline of earlier stage projects which are focused on developing treatments for diabetes-related vitreo-retinal diseases
• Cash generation from the commercialization of JETREA® (in its first indication, sVMA/VMT), in the US and in the RoW via our partner Alcon
• Realizing value from Oncurious NV, a newly created oncology company in which ThromboGenics is a major shareholder
Dr Patrik De Haes, ThromboGenics' CEO, said: "In recent months it has become clear that we needed to evolve our strategy in order to generate significant returns for our shareholders.
We remain convinced that in time JETREA® will be able to play a key role in the changed standard of treatment for patients with sVMA. However this will not result from incremental promotional efforts, but rather from new medical data and clinical experience. This has resulted in today's announcement to make changes to our US organization and our commercial strategy for JETREA®.
Our smaller US team will continue to provide distribution, customer support and medical education services for JETREA®. US retina physicians and patients will have continued access and support when seeking treatment with JETREA®. These changes are designed to make our US business cash flow neutral from 2016 onwards.
We will invest these newly freed-up resources in the further clinical development of JETREA® in diabetic retinopathy, a very significant next indication where there is a clear need for improved treatment options. Our Phase II clinical trial in this indication remains on track to initiate around the end of this year.
Our current cash resources of over €100 million, along with anticipated royalty income, should support the internal development of next-generation ophthalmology products in diabetic eye disease for at least the next 3 years. This timeframe will allow us to generate the clinical data needed to demonstrate the value of a number of our pipeline projects.
Oncurious NV, a new oncology company we have set up with VIB, with ThromboGenics NV as the majority shareholder, holds great potential to generate incremental longer term value to our shareholders. The Phase I/IIa clinical trial planning for TB-403 in medulloblastoma is progressing well and we expect to recruit the first patient later this year."