ThromboGenics NV Full Year 2014 Business Update

Financial

•  Total revenues of €13.8 million in 2014  (2013 -  €112.8 million, including €90 million in milestone payments from Alcon)
   
•  US sales of JETREA^® (ocriplasmin) in 2014 reached €8.8 million (2013 - €20.2 million)

• Gross profit of €9.2 million - (2013 - €106.4 million)

•  Net loss of €51.1 million in 2014 - (2013 - profit of €26.4 million)

• Cash and investments of €127.1 million as of the end of December 2014, compared with €172.4 million at the end of December 2013 

Strategy

•  In June 2014, ThromboGenics announced that it would maintain an independent business strategy to deliver stakeholder value. This Board decision followed the evaluation of  various strategic options

• The implementation of the standalone strategy led to organizational changes  to focus resources on commercializing JETREA^® (ocriplasmin) in the US and to develop new clinical indications for this novel medicine

JETREA^® in the US

•  In 2014, over 3200 US patients were treated with JETREA^®.  This reduction in the number of patients treated was the result of decreasing adoption rates resulting from perceived safety concerns following a small number of published case series, a community in need of more and new real world data, and the uncertainty following our strategic review. The Company is addressing all challenges mentioned, and is ready to re-build sales.

• ThromboGenics continues to gather real-world data on JETREA^® to support the optimal use of this novel medicine. At present the Company is conducting 3 US studies: Data is expected from all 3 studies during the course of 2015.

• ThromboGenics' marketing and sales efforts in the US have evolved so that it is better placed to communicate to retina specialists the growing body of real-world data which can assist them to achieve the best possible clinical outcomes with JETREA^®.

• ThromboGenics is targeting US sales between 3,500 and 4,000 vials of JETREA^® in 2015.

JETREA^®outside the US                                                                      

• ThromboGenics' partner Alcon (Novartis), continues to introduce JETREA^® across Europe in an overall positive reimbursement environment.

• The last twelve months have seen the first approvals and launches of JETREA^® in Asia and South America.

• JETREA^® gained its 50^th country approval globally with the Philippines in February 2015.

Research & Development

• ThromboGenics will start a Phase II trial with JETREA^® in diabetic retinopathy (DR). This study is designed to assess the utility of the product in this significantly underserved patient population.  The first patient is expected to be recruited into this study in H2 2015.

• In February 2015 ThromboGenics was awarded a €1.1 million research grant from the Flemish Agency for Innovation by Science and Technology (IWT) to help fund on-going research into the pharmacological effects ocriplasmin is exerting in the back of the eye following intravitreal injection.

• ThromboGenics will spin-out its cancer R&D activities into a joint venture with VIB (Flanders Institute for Biotechnology). This new venture will focus on the clinical development of TB-403 for medulloblastoma, the most frequent form of brain cancer in children.

Corporate

• Dominique Vanfleteren was appointed as ThromboGenics Chief Financial Officer (CFO) in January 2015

• Paul G. Howes (Nanaimo Bioventures LLC) was appointed as Executive Chairman of ThromboGenics, Inc. in August 2014

• Paul G. Howes appointed member of ThromboGenics NV's Board of Directors in August 2014

• Emmanuèle Attout was nominated as a new Independent non-executive director in January 2015.

• Joseph Markoff, Ph.D., M.D. appointed Company Scientific Advisor in March 2015. 

LEUVEN, Belgium, March 12, 2015 (GLOBE NEWSWIRE) -- ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today issues its business and financial update for the year ending 31 December 2014.

ThromboGenics' strategy is focused on:  

• Driving sales growth of  JETREA^® in the US
• Supporting Alcon to build sales of JETREA^® outside the US
• Creating further value by developing new indications, and
• Progressing its pipeline of earlier stage projects focused on diabetic vitreo-retinal diseases

 The commercial success of JETREA^® in the USis at the heart of this strategy. To achieve this goal, ThromboGenics is focusing on increasing the number of strategic key accounts that use JETREA^® consistently for the treatment of patients with symptomatic VMA. This approach is designed to ensure effective communication of the growing body of real world data on JETREA^® to the members of the retina community who are spearheading the adoption of this novel medicine.

In 2014, the Company strengthened its US commercial capability with the appointments of Ed Kessig as US Head of Commercial, and Paul G. Howes, who joined as the Executive Chairman of our ThromboGenics US entity.

ThromboGenics is continuing to support its partner Alcon (Novartis), which is commercializing JETREA^® outside the US.

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

 Dr Patrik De Haes, ThromboGenics' CEO, said: "It is clear that 2014 has been a challenging year for ThromboGenics. Our sales of JETREA^® in the US have declined due to perceived safety concerns and a community waiting for more data before starting, or re-starting a treatment with JETREA^®. We have also seen some uncertainty which occurred in the wake of our strategic review.

These changes  have led to our strategic accounts approach, which has focused our marketing and sales efforts on key retinal centers across the US, and which has put us in a better position to further improve the awareness and acceptance of JETREA^®, the only pharmaceutical treatment for symptomatic VMA.

This commercial strategy, along with the growing body of real-world data that we are collecting to help inform patient selection and deliver improved treatment outcomes, will create the platform we need to start re-building the US sales of JETREA^® during the course of 2015.

We remain committed to creating significant additional long-term value through our R&D activities and we are about to initiate a Phase II study with JETREA^® for diabetic retinopathy in the US. This is an important step in our plans to build a stronger position in the treatment of diabetes related vitreo-retinal diseases.

To support the implementation of this strategy we have made a number of key senior management appointments in the last several months with Paul Howes becoming Executive Chairman of ThromboGenics in the US, Dominique Vanfleteren joining as our new CFO, and the more recent appointment of Dr Joseph Markoff as Scientific Advisor.

  2014 has been a challenging year for ThromboGenics but I am confident that the changes we have implemented and the JETREA^® real-world data that we will release in the coming months will put us in a strong position to create value for our shareholders."

JETREA^® in the US

ThromboGenics achieved JETREA^® sales of €8.8 million in 2014 in the US.

This sales outcome reflects the challenges the Company has faced in introducing this novel pharmacological therapy and changing the standard of care in terms of the way symptomatic VMA is treated.

In 2014, the sales of JETREA^® were negatively impacted by safety concerns caused by a small number of ad hoc publications and the changes that have occurred in our US organization.

ThromboGenics has learnt a great deal in 2014 and our experience has clearly shown that changing the way retina physicians treat this important sight threatening condition will require more data demonstrating the attractive clinical profile of JETREA^® - both in terms of efficacy and safety.

The importance of data in driving the sales of JETREA^® has led to ThromboGenics focusing its commercial efforts in the US on strategic accounts that have been early adopters and that have the most experience using the product. This approach is designed to increase gradually the number of retina physicians in the US who have detailed knowledge and extensive experience of using JETREA^®.

ThromboGenics is working to deliver the data needed to expand the use of JETREA^® by:

• further analyses of the data from the JETREA^® Phase III program,
• 3 real-world studies OASIS, ORBIT and OZONE which are due to report in 2015.

The other important factor which has been shaping our commercial activities in the US is the observation that physicians generate better treatment outcomes as they become more experienced in using JETREA^®. This is largely because they are able to identify the patients most suitable for treatment with this novel medicine.