From Research to Application Thrombogenics Corporate Highlights 2013 Thrombogenics Corporate Highlights 2013 4 Chairman Dr
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NEW PERSPECTIVES FROM RESEARCH TO APPLICATION THROMBOGENICS CORPORATE HIGHLIGHTS 2013 THROMBOGENICS CORPORATE HIGHLIGHTS 2013 4 Chairman Dr. Staf Van Reet 2013, a year of great importance We continue to believe that, in time, JETREA® will be recognized as 22 the new standard of care. Prof. Dr. Peter Stalmans The ‘watchful waiting’ approach has much more disadvantages than initially thought. 8 CEO Dr. Patrik De Haes A challenging and promising future 2013 has been a challenge for sure, but also a great source of pride 41 for us, as we look back at a pool of Prof. Dr. close to 7,000 patients treated with our product. Marc de Smet ThromboGenics can have a major impact on the lives of diabetes patients. 27 33 Prof. Dr. Peter Kaiser Clara Eaglen, RNIB SUMMARY A good patient Not having to undergo selection will surgery makes a huge dramatically raise difference for the anatomical and VMT patients. functional success rates of JETREA®. 4 Chairman Dr. Staf Van Reet 8 CEO Dr. Patrik De Haes 12 About ThromboGenics 18 JETREA® 26 JETREA® in the US 32 JETREA® in Europe 37 JETREA® in the rest of the world 38 Research and development 46 48 48 Our organization Prof. Dr. Koen Kas Our organization 56 Shareholder information Promising new data on People behind treating children’s brain the success of tumor. ThromboGenics. 4 FOREWORD OF THE CHAIRMAN THROMBOGENICS CORPORATE HIGHLIGHTS 2013 5 A YEAR OF GREAT IMPORTANCE Foreword of the Chairman Dear reader, Since its creation in 1998, ThromboGenics has successfully tackled numerous challenges. As someone who has been lucky enough to be a part of its story since 2006, I can confirm that it has been a truly exciting experience. The last twelve months have been a game-changing period, culminating in the recent decision by the Board to explore further strategic options for the Company. As the newly appointed Chairman of the Board, I look forward to 2014 with confidence as I know that the ThromboGenics team will relish the next step in our corporate development, much as they have done in each of the past 15 years. Following the successful clinical development of JETREA®, we have seen one important milestone after another during the last 18 months. The most important of these was the approval of JETREA® by the Food and Drug Administration (FDA) in the US (October 2012) and by the European Commission (EC) in Europe (March 2013). The importance of these achievements by the ThromboGenics team should not be underestimated given the very different approaches of the FDA and the EC. Other countries in the rest of the world have followed this lead with Canada granting JETREA® its first approval outside the US and Europe. These regulatory approvals led to the commercial introduction of JETREA® for the treatment of symptomatic Vitreomacular Adhesion (VMA) or symptomatic Vitreomacular Traction (VMT) on both sides of the Atlantic during 2013. In Europe this novel product has already received a number of positive endorsements. The National Institute for Health and Care Excellence (NICE) in the United Kingdom and the German Gemeinsamer Bundesausschuss (G-BA) emphasized in their health technology assessments that JETREA® offered real value to patients, including patients’ quality of life, especially when used for the earlier treatment of this progressive disease. These very positive evaluations of JETREA® highlight the value of this novel product for both patients and payers, and has created a strong platform from which to build the product’s sales. These positive reimbursement decisions and value assessments have strengthened our confidence in the intrinsic potential of the product to bring meaningful benefit to patients. We continue to believe that, in time, JETREA® will be recognized as the new standard of care. 6 FOREWORD OF THE CHAIRMAN Ensuring that JETREA® will meet success in each country is a complex operation with many requirements. It requires the sales teams and market access specialists to work together to ensure that they meet the needs of each country, as they all have their own particular systems and preferences. The reason why we chose to partner with Alcon is that it already has high-performing organizations in place in each of the over 40 markets worldwide where we intend to make JETREA® available in the years ahead. Given the more homogeneous nature of the US market, ThromboGenics decided to use its own organization to commercialize JETREA®. The sales development of this novel product has been slower than anticipated, and it has become clear that we are doing more than introducing a new drug – we are in fact looking to establish a totally new standard of care for the earlier treatment of patients with symptomatic VMA. Our US team remains focused on educating ophthalmologists and retinal specialists on the opportunity and important benefits that this groundbreaking treatment delivers. Over the coming years we believe that continued education, including further characterizing the efficacy and safety profile of JETREA®, combined with a marketing approach that focuses on highlighting its clear patient benefits, will help us realize the full potential of JETREA®. One of the more important developments at ThromboGenics has been the shift from a university originated research and development company to the market oriented company in which we operate today. As we shift to a more commercially focused organization, we intend to continue to invest in fundamental research and in leveraging our proven capabilities to bring products to market. It is central to our future strategy that we continue to leverage all of our current capabilities and expertise on both sides of the Atlantic. The growing importance of the US to ThromboGenics has been reflected at Board level, as we have been much honored to welcome Dr. David Guyer as our newest member. His proven skills and experience as a dedicated ophthalmic entrepreneur is and will be of great value for the Company, as we look to maximize the value of our business in the US. The arrival of Dr. Guyer also helps us to fill the gap left by the recent retirement of ThromboGenics´ founder Professor Doctor Désiré Collen. His contribution to the successful development of ThromboGenics and the life sciences industry in general cannot be over-estimated. The importance of his work led him to gain great acclaim from the international community, and this was reflected in his receiving the international Lifetime Achievement Awards from both the leading pharmaceutical publication, Scrip and the Belgian- American Chamber of Commerce (BelCham). The Company takes pride in its founder receiving these awards, as this reminds the whole ThromboGenics team of the significant progress that we have made. It gives us confidence that we can continue to produce many important achievements in the future. Dr. Staf Van Reet Chairman of the Board of Directors THROMBOGENICS CORPORATE HIGHLIGHTS 2013 7 “We continue to believe that, in time, JETREA® will be recognized as the new standard of care.” Chairman Dr. Staf Van Reet 8 FOREWORD OF THE CEO THROMBOGENICS CORPORATE HIGHLIGHTS 2013 9 A CHALLENGING AND PROMISING FUTURE Foreword of the CEO Dear reader, For ThromboGenics, the year 2013 was first and foremost the year of the commercial introduction of JETREA®. The launch of our flagship product in the United States in January was our most important event of the past year. Soon after, we landed our EC approval for JETREA® which was the starting signal for market introductions in Europe, and further approvals in the rest of the world. A Belgian biotechnology company introducing its own product in the US market by itself is unique. 2013 has been a learning year. It has been a challenge for sure, but also a great source of pride for us, as we look back at a pool of close to 7,000 patients treated with our product. We have done everything to make this product introduction a success, and this will remain our most important focus for 2014. 2013 also made it very clear how revolutionary JETREA® is for the treatment of patients suffering from symptomatic Vitreomacular Adhesion (VMA) and Vitreomacular Traction (VMT). For more than twenty years, the normal approach to treatment was waiting until the patient’s condition had worsened enough to justify an eye operation. JETREA®, which offers an earlier treatment option, has radically changed that, and has already brought relief to many patients. As much as JETREA® is a great opportunity for the patient, it is clearly also a game-changer for the treating specialists. When pioneering a new treatment method such as JETREA®, it is very important to also focus on bringing new insights to treating specialists, in our case the retinal specialists and surgeons in the United States. Should they stick to ‘watchful waiting’ as before, or can they start treating patients at an earlier stage? The broad range of strongly held opinions put forward by the retina community and by the wider ophthalmology community has set a number of additional tasks and challenges for ThromboGenics. Clinical ophthalmology is a domain of two specialties in the US. On the one hand we find the first-line ophthalmologists, on the other hand the retinal specialists and surgeons. Our sales force has focused on the retinal specialist and surgeons in 2013 and we intend to continue this approach. Meanwhile, we have also learned a lot about the referral networks that lead to patients being evaluated at these retina clinics where they receive any retina-related treatment. 10 FOREWORD OF THE CEO We know that the referral process for patients suffering from retina-related diseases will typically start at the level of the general ophthalmologists, who are highly experienced in identifying the first symptoms of various retina-related diseases.