- 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
- 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 50th 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.
- 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.
Patient selection delivers improved patient outcomes
A post-hoc data analysis of the Phase III trials with ocriplasmin showed that:
- VMA diameter less than or equal to 1,500 µm
- absence of an epiretinal membrane
- age below 65 years
- presence of a full thickness macular hole (< 400µm)
are independently associated with successful VMA resolution. Therefore, in clinical practice, many retinal specialists have been using these parameters to guide their patient selection for JETREA® injection.
The positive impact of this improved patient selection has been highlighted in a growing number of recent publications. One of these provided analysis of data from patients treated at the Cole Eye Institute in Cleveland and other centers. This analysis showed that improved patient selection achieves a treatment success rate of around 50%. This compares with a 26% nonsurgical resolution of VMA reported in patients treated with ocriplasmin in the drug's pivotal Phase III studies, which included over 30% patients who had an epiretinal membrane.
A similar outcome was published in a recent paper from retina specialists at the Wills Eye Hospital, Thomas Jefferson University, in Philadelphia. In this paper, they reported a 50% success rate in achieving VMT release in 58 eyes treated with intravitreal ocriplasmin. A 27% closure rate was seen in patients with full thickness macular hole. In this study higher rates of success were seen in younger patients with focal VMT and who did not have epiretinal membrane.
Focus on key strategic accounts
The importance of data in driving the sales of JETREA® has led to ThromboGenics focusing its commercial efforts in the US on those strategic accounts which have embraced this first-in-class technology and have gained valuable experience in delivering optimal outcomes.
With additional data coming in 2015, our plan is to broaden this approach to increase significantly in time the number of retina physicians in the US who have detailed knowledge and extensive experience of using JETREA®.
Since the US launch of JETREA®, it has also been clear that as retina physicians treat more patients they become more confident about the patient experience post therapy and as a result feel more comfortable in integrating this novel medicine into the way they manage symptomatic vitreomacular adhesion (VMA).
To help more physicians gain confidence in using this new pharmacological treatment approach, a key focus for the Company's medical education activities during 2014 has been to demonstrate that the real world safety profile seen with JETREA® is in line with the product's approved label in the US.
This message has been reinforced to the retina community via a range of conference presentations and published papers including a recent paper from the MIVI-TRUST group, which comprises the lead investigators from the JETREA® Phase III clinical trial program.
This analysis of the safety profile of JETREA® has shown that, in many cases, the short-term adverse effects that a patient experiences post-injection are a reflection of the drug's mode of action. This is supported by the fact that many of the short-term adverse effects are similar to the ones seen in patients who have undergone a surgical vitrectomy.
Paul G. Howes, Executive Chairman of ThromboGenics US, commenting on progress with JETREA® in the US, said: "We have realigned our US sales efforts to focus on key accounts, allowing us to communicate in a more effective manner with this group of retinal physicians who are important in driving the adoption of this novel medicine. We spent much of 2014 sharing with the retinal community that the real-world safety experience with JETREA® is no different from what is in our label. With the release of further clinical results planned for 2015 we are confident that these data will allow us to focus more on the positive balance of safety and efficacy outcomes that this novel medicine can deliver."
Collecting additional real-world JETREA® data
ThromboGenics is continuing to generate more real-world data on treatment with JETREA®.
With this additional real world data, the use of JETREA® could be optimized further. This is a key element of ThromboGenics' strategy to drive the adoption of this novel pharmacological option for the earlier treatment of symptomatic VMA.
ThromboGenics is currently conducting the "Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion including Macular Hole" (OASIS) study to generate long term data following treatment with ocriplasmin. This sham-controlled double-masked study, which has recruited a total of 220 patients, is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic VMA/ VMT including macular hole.
This is an important study in terms of generating real world data with JETREA® as the patients in the study are being followed up for a 24-month period post injection.
The primary endpoint of the study is the proportion of subjects with pharmacological VMA resolution at Day 28. This is the same primary endpoint as for the Phase III clinical trial program with ocriplasmin. The study will also provide data on a range of important secondary endpoints at the end of the 24-month follow-up period.
Topline results from this study are expected to be released in Q1 2015. ThromboGenics plans to communicate the full data from this study later this year via a number of presentations at major ophthalmology meetings.
In March 2014, ThromboGenics launched the "Ocriplasmin Research to Better Inform Treatment" (ORBIT) study. This study has met with significant interest from the US retina community and 97 retina centers across the US have been activated to recruit patients.
This prospective, observational study is designed to assess clinical outcomes and the safety of JETREA® administered in a real-world setting for the treatment of symptomatic VMA by assessing both anatomical and functional outcomes.
The study is looking at a number of parameters including resolution of VMA, full thickness macular hole (FTMH) closure, changes in visual acuity (VA) and occurrence and time to vitrectomy. It will also monitor adverse drug reactions (ADRs) and changes from baseline in ocular signs and symptoms, such as metamorphopsia, over time. These data will further characterize the efficacy and safety profile of the product and provide data complementary to those from JETREA®'s Phase III clinical program and physician experience during its first year on the market.
Patients will be followed for up to 12 months following a single treatment with JETREA®. The ORBIT study is due for completion in mid-2016. The Company intends to report data on a regular basis.
An interim analysis was presented by the ORBIT Steering Committee, represented by Dr Mathew MacCumber, during the Macula Society Meeting from February 25 - 28, 2015 in Scottsdale, Arizona.
Dr Mathew MacCumber stated, "The interim analysis in the ORBIT study has shown that the safety and efficacy profiles are consistent with the product's label and the data from the Phase III clinical trials. Further analysis is ongoing to assess these rates compared with the Phase III results.
The findings of the interim analysis suggest that ThromboGenics' medical education activities are beginning to deliver results. A growing number of retina centres are gaining the understanding they need, to select the patients most suited for this novel pharmacological treatment option for symptomatic VMA. With the ORBIT study, and other phase 4 studies ThromboGenics is doing, we will be able to better define the real world safety and efficacy profile of JETREA ® "
The next interim data from the ORBIT study will be discussed at the ARVO meeting of early May in Denver, Colorado.
In July 2014, ThromboGenics started the "Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study" (OZONE).
This is a retrospective patient US study designed to capture more data to characterize the anatomic and symptomatic changes that potentially occur in the six months immediately after treatment with JETREA® for symptomatic VMA.
Initial data from this study are expected in the first half of 2015.
Enhancing Symptomatic VMA Detection
Patients who first notice the symptoms of VMA often have their first discussion about their condition with their general ophthalmologist. ThromboGenics has begun implementation of its ID-VMA educational program to train ophthalmologists about sVMA so that they can better decide when it is appropriate to refer a patient with sVMA to a specialist retina clinic which has JETREA® experience.
A number of seminars in this program have already taken place with a total of more than 500 ophthalmologists receiving training from a team of retina specialists.
With greater experience of using JETREA® in the specialist retina centers and a growing number of referrals of patients suitable for treatment with this novel pharmacological treatment option, we are confident that JETREA®'s adoption will accelerate.
ThromboGenics' US organization - new leadership
ThromboGenics is undertaking a number of new initiatives to strengthen its US business and support the commercialization of JETREA® in the US.
Paul G. Howes (representing Nanaimo Bioventures LLC) appointed Executive Chairman of ThromboGenics US..
Paul G. Howes, was appointed to the newly created position of the Executive Chairman of ThromboGenics in the US. He also joined ThromboGenics NV's Board of Directors.
Mr Howes brings over 25 years of commercial strategy and sales and marketing experience to ThromboGenics, a significant amount of which has been in the field of ophthalmology. He was previously President & CEO of Inotek Pharmaceuticals where he is still an independent Board director. Prior to that he was President of the Americas Region for Bausch & Lomb, during which he led a major expansion of the US pharmaceutical business and a highly successful turn-around of the US cataract surgical business. Prior to joining Bausch & Lomb in 2003, Mr Howes spent 16 years in various senior management roles at Merck & Co., Inc.
Mr Howes is a graduate of Harvard College and earned his MBA from York University in Toronto, Canada. He also currently serves as the Chairman of the Board of Prevent Blindness America.
Ed Kessig appointed US Head of Commercial
Mr Kessig has significant commercial leadership experience across a broad range of therapeutic categories and markets. He has held senior commercial roles at Elan Pharmaceuticals, INO Therapeutics and Auxilium Pharmaceuticals. Before joining ThromboGenics, Ed was the Senior Vice President of Sales at Auxilium. Mr Kessig is also a member of the ThromboGenics' Executive Committee.
Dr Joseph Markoff, MD appointed Scientific Advisor
Joseph Markoff PhD MD joined the ThromboGenics as its Scientific Advisor. Dr Markoff received his undergraduate degree from Oberlin College where he currently serves as an honorary trustee. He received his medical training at the University of Minnesota and served an ophthalmology residency at Wills Eye Hospital in Philadelphia where he is currently a clinical professor. He founded Philadelphia Eye Associates in 1978 and has directed the visual physiology service at Wills Eye Hospital for over thirty years. He became Global Director of Ophthalmology at Merck & Co, Inc. in 2010, a post he held until 2014. He now consults extensively in the field of ophthalmology. He has published in the subspecialties of retina, glaucoma and cataract in addition to participating in over 50 clinical trials.
Optimizing the US Commercial Organization
During 2014, a series of operational improvements have been undertaken at ThromboGenics, Inc. These changes have been made both to reduce costs as well as to focus our marketing and sales efforts on those key accounts that have embraced our technology and gained the most experience in delivering optimal patient outcomes.
With additional data coming in 2015, our plan is to broaden this approach to increase significantly the number of retina physicians in the US who have detailed knowledge and extensive experience in using JETREA®.
All of the above is expected to have a positive impact on revenues in 2015.
JETREA® outside the US
ThromboGenics' partner Alcon (Novartis), is continuing to commercialize JETREA® across the rest of the world. The product recently received its 50th approval globally with the Philippines. Alcon has also been successful, with the support of ThromboGenics, in building a strong market access platform for JETREA® around the world.
In Europe, the main developments in 2014 concerned the reimbursement of JETREA®, with the product now being actively reimbursed in a number of key markets including the UK, Germany and Spain.
Alcon is also conducting studies to generate more real world data on the use of JETREA®.
The results of a 129 patient study across six European centers were presented by Alcon at the DOG Congress of Ophthalmology in Leipzig, Germany in September 2014. The study, which analyzed patients with early stage symptomatic VMT, showed total resolution rates of 45-85% depending on patient sub-groups. In patients with VMA diameter less than of equal to 1,500µm or the absence of an epiretinal membrane resolution rates of up to 85% were observed. These positive outcomes are in line with the success rates that are being reported by retina physicians in the US.
JETREA® approvals in the Rest of the World
In 2014, good progress has been made to bring JETREA® closer to the market in the Rest of the World, with first approvals in Asia and South America.
In April, JETREA® was approved in Malaysia for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns. The approval, the first in Asia, was gained following a Priority Review conducted in September 2013.
In July 2014, JETREA® was approved in Singapore for the same indication.
In the beginning of July, JETREA® was approved in Uruguay, the first country in South America, for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns.
In October, JETREA® was approved in Chile for the same indication.
In October, Australia's Therapeutic Goods Administration (TGA) approved JETREA® for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns.
In February 2015, JETREA® was granted approval in Argentina, Israel and the Philippines.
Progress towards gaining approval in Japan
Alcon has now completed a bridging clinical study in Japan. The Japanese trial, a randomized, double-masked, multi-center study with patients receiving either ocriplasmin or a sham injection, recruited a total of 168 patients with symptomatic VMA including those associated with macular hole. The results from this study are expected to form part of the regulatory submission that will be made to the Japanese Ministry of Health, Labour and Welfare in 2015 to request approval to market ocriplasmin in Japan.
Research & Development Update
Diabetic Retinopathy (DR)
The Company remains committed to expanding the use of JETREA® beyond symptomatic VMA/VMT as part of its strategy to maximize new value-creating opportunities for the drug.
ThromboGenics has decided that treatment of diabetic retinopathy (DR) is the next target indication for JETREA® in the US. A Clinical Research Organization has been engaged to assist in the conduct of a Phase II trial with JETREA® in diabetic retinopathy in the US. This study is designed to assess the utility of the product in this significantly underserved patient population.
The Company will start the DR study in H1 2015, with the first patient expected to be recruited in H2 2015.
ThromboGenics has decided to evaluate JETREA® in the treatment of DR based on the strong scientific rationale that supports why it could prove effective in treating patients with this sight threatening condition before their disease progresses. Research has shown that the presence of a posterior vitreous detachment, where the vitreous is separated from the retina, may prevent the growth of the new blood vessels that are responsible for proliferative DR (PDR). This finding has been reinforced by the fact that PDR is rare in patients who have undergone a posterior vitreous detachment.
JETREA® is able to generate a posterior vitreous detachment by cleaving the protein linkages between the vitreous and the retina and by liquefying the vitreous itself. The Company and its clinical advisors believe that by using JETREA® to generate this anatomical change, the development of the new blood vessels that cause PDR can be prevented. This is because the new blood vessels will no longer be able to use the scaffolding of the vitreous to grow along the surface of the retina or into the vitreous.
Given the growing number of diabetic patients in the US, it is clear that the number of patients who are anticipated to suffer from eye disease, including diabetic retinopathy is expected to increase substantially. A recent report from the American Academy of Ophthalmology has projected that prevalence of individuals with any diabetic retinopathy in the United States by the year 2020 will be 6 million people of whom 1.34 million persons will have vision threatening DR.
Diabetic retinopathy is increasing in prevalence in the US. "Almost a third of the adult population in the US are suffering from diabetes and a substantial proportion of these - hundreds of thousands - will develop proliferative diabetic retinopathy. Their number is going up every year; all these people will be confronted with vision loss if they are not treated adequately. Any investigation into how we can ameliorate the complications of this disease is most welcome," says Dr. Michael S. Ip, Director, Retina Service, William S. Middleton Memorial Veterans Hospital, and tenured Associate Professor, Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison, WI.
In addition to JETREA®, ThromboGenics' research is evaluating a number of other potential therapies for diabetic eye disease. The Company is working on compounds emanating from agreements with Eleven Biotherapeutics and Bicycle Therapeutics. These projects are both in the pre-clinical phase of development.
"In 2014, the company clarified its long-term strategy and reoriented to focus exclusively on ophthalmology. We are working hard to further expand the ThromboGenics' research portfolio with innovative new potential medicines for the treatment of eye disease. We will continue our strategy of partnering with academic groups and other companies. I am confident that this approach will lead us to a very exciting future," says Jean Feyen, Head of Pre-Clinical Research at ThromboGenics.
Oncology R&D Spin-Out
ThromboGenics, is about to spin out its oncology research activities into a joint venture with VIB (Flanders Institute for Biotechnology). This company will focus on the clinical development of TB-403 for the treatment of medulloblastoma, the most frequent form of brain cancer in children.
In time, ThromboGenics will look to raise funds from third parties in order to finance the further development of this exciting oncology business.
Ocriplasmin IWT Research Grant
ThromboGenics has been awarded a €1.1 million research grant from the Flemish Agency for Innovation by Science and Technology (IWT). The grant will be used to fund on-going research to further elucidate the pharmacological effects ocriplasmin is exerting in the back of the eye following intravitreal injection.
Nanaimo Bioventures LLC, represented by Paul G. Howes, appointed executive Chairman ThromboGenics, Inc. and Paul G. Howes as Member of ThromboGenics NV's Board of Directors
Mr Howes was previously President & CEO of Inotek Pharmaceuticals where he is still an independent Board director. Prior to that, he was President of the Americas Region for Bausch & Lomb, during which he led a major expansion of the US pharmaceutical business and a highly successful turn-around of the US cataract surgical business. Prior to joining Bausch & Lomb in 2003, Mr Howes spent 16 years in various senior management roles at Merck & Co., Inc.
Mr Howes is a graduate of Harvard College and earned his MBA from York University in Toronto, Canada.
He currently is the Chairman of the Board of Prevent Blindness America.
Dominique Vanfleteren appointed CFO
Dominique Vanfleteren was appointed as ThromboGenics' new Chief Financial Officer (CFO) in January 2015.
Dominique Vanfleteren has over 25 years of experience in senior finance, operational, control and reporting roles within quoted international biopharmaceutical companies.
Before joining ThromboGenics, Mr Vanfleteren spent 12 years at UCB, a global biopharmaceutical company, where he held a number of international managerial finance positions, the latest being the CFO of UCB's Asia Pacific Operations, operating from Brussels and Shanghai.
Prior to joining UCB, Dominique worked for GSK during 16 years. He held a number of senior finance positions in Brussels and London, his latest being Finance Director of GSK's Diversified Healthcare Services Europe.
Chris Buyse, ThromboGenics' former Chief Financial Officer and Board Member, left the Company at the end of June 2014 to pursue other interests. Luc Philips, former CFO of KBC group and Board Member of ThromboGenics since its IPO in 2006, acted as an interim CFO until the appointment of Dominique Vanfleteren.
Emmanuèle Attout - New Board Member
In January, ThromboGenics nominated Emmanuèle Attout to be its new Independent non-executive director. Mrs. Attout will join the Audit Committee of the Company.
Mrs. Attout has been an audit partner at PricewaterhouseCoopers since 1994. She has been in charge of audits of a range of clients including banks, insurance companies, investment funds and asset managers. She has in recent years been in charge of the audits of listed pharmaceutical companies and life sciences businesses.
In 2014, ThromboGenics had total revenues of €13.8 million, including €8.8 million of JETREA® sales in the US, €1.4 million of products recharged to Alcon, €3.4 million in royalties from Alcon based on its ex-US sales of JETREA®and €0.2 million of other income.
In 2013, ThromboGenics reported revenues of €112.8 million including €90 million in milestone payments from Alcon.
In 2014, ThromboGenics' R&D expenses were €22.6 million, including a €6.8 million amortization of the ocriplasmin Phase III program. This compares with €31.7 million of R&D expenses in 2013. This lower level of spending is partly the result of a real decrease in expenditure, but also the consequence of certain development work which ThromboGenics was able to invoice to external partners in 2014 and the increased use of grant money.
In 2014, selling and marketing expenses amounted to €29.9 million compared with €37.6 million in 2013. The decrease is the result of change in strategic priorities and the changes made to the company's commercial organization. The 2013 expenses also included some incremental costs resulting from the JETREA® launch campaign.
In 2014, ThromboGenics reported a net loss of €51.1 million, or €1.42 loss per share.
In 2013, the Company reported a net profit of €26.4 million or diluted earnings per share of €0.71, mainly as a result of the €90 million in milestone payments it received from Alcon.
At the end of December 2014, ThromboGenics had €127.1 million in cash and investments, compared to €136.6 million as of the end of September 2014, and €148.8 million at the end of June 2014.
ThromboGenics believes it has the financial resources needed to fully sustain the US commercialization of JETREA®, the research and development of selected new indications and formulations of JETREA®, in the US, expand its R&D pipeline and further broaden its commitment to become a leading ophthalmology company.
A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO of ThromboGenics, Dominique Vanfleteren, CFO of ThromboGenics, and Paul G. Howes, Executive Chairman of ThromboGenics, Inc. today at 06:30 PM CET, 13:30 PM EST.
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The presentation and transcript of the call will be made available shortly on www.thrombogenics.com under the investor information tab.
For further information please contact:
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About JETREA® (ocriplasmin)
JETREA® (ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, JETREA® is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.
JETREA® has been evaluated in two multi-center, randomized, double-masked Phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.
JETREA®'s Phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The Phase III program also showed that JETREA® was generally well tolerated with most adverse events being transient and mild in severity.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.
In Europe, JETREA® is approved for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.
ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.
ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of oncology indications.
ThromboGenics is headquartered in Leuven, Belgium, and has an office in Iselin, NJ (US). The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report.
This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the US Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable US state securities laws.
Financial information 2014
Consolidated statement of comprehensive income
|In '000 euro (for the year ended on 31 December)||2014||2013|
|Income from royalties||3,397||1,023|
|Cost of sales||-4,600||-6,384|
|Research and development expenses||-22,554||-31,734|
|General and administrative expenses||-9,520||-11,579|
|Other operating income||67||49|
|Other operating expense||-9||0|
|Result before income tax||-50,975||26,414|
|Income tax expense||-140||-13|
|Net result for the period||-51,115||26,401|
|Equity holders of the Company||-51,115||26,401|
|Result per Share|
|Basic earnings per share (euro)||-1.42||0.73|
|Diluted earnings per share (euro)||-1.42||0.71|
|In '000 euro (for the year ended on 31 December)||2014||2013|
|Result of the period||-51,115||26,401|
|Net change in fair value of available-for-sale financial assets||-72||23|
|Exchange differences on translation of foreign operations||29||-11|
|Actuarial losses on defined benefit plans||-229||0|
|Other comprehensive income, net of income tax||-272||12|
|Other comprehensive income that may be reclassified to profit or loss||0||0|
|Other comprehensive income that will not be reclassified to profit or loss||-272||12|
|Total comprehensive income for the period||-51,387||26,413|
|Equity holders of the Company||-51,387||26,413|
Consolidated statement of financial position
|In '000 euro (for the year ended on 31 December)||2014||2013|
|Property, plant and equipment||2,911||3,634|
|Other non-current assets||1,600||1,711|
|Non-current tax receivable||2,061||2,307|
|Trade and other receivables||12,604||11,145|
|Current tax receivable||2,264||2,017|
|Cash and cash equivalents||123,223||164,570|
|EQUITY AND LIABILITIES|
|Accumulated translation differences||-276||-305|
|Equity attributable to equity holders of the Company||208,012||258,772|
|Other short-term liabilities||5,333||2,030|
|Total equity and liabilities||220,714||271,154|
|In '000 euro (for the year ended on 31 December)||2014||2013|
|Cash flows from operating activities|
|(Loss) profit for the period||-51,115||26,401|
|Depreciation on property, plant and equipment||1,297||1,181|
|Amortization of intangible assets||6,833||6,483|
|Gain on sale of property, plant and equipment||0||0|
|Increase in accruals and employee benefits||110||0|
|Equity settled share-based payment transactions||554||1,433|
|Change in trade and other receivables including tax receivables and stock||-2,573||-10,060|
|Change in short-term liabilities||54||1,175|
|Net cash (used) from operating activities||-46,579||25,710|
|Cash flows from investing activities|
|Disposal of property, plant and equipment (following a sale)||27||24|
|Change in investments||3,938||1,031|
|Interest received and similar income||953||1,387|
|Acquisition of intangible assets||-12||-3,354|
|Acquisition of property, plant and equipment||-571||-2,155|
|Acquisition of other non-current assets||111||13|
|Net cash (used in) generated by investing activities||4,446||-3,054|
|Cash flows from financing activities|
|Proceeds from issue of share capital||0||2,960|
|Net cash (used in) generated by financing activities||-11||2,950|
|Net change in cash and cash equivalents||-42,144||25,606|
|Cash and cash equivalents at the start of the period||164,570||139,398|
|Effect of exchange rate fluctuations||797||-434|
|Cash and cash equivalents at the end of the period||123,223||164,570|
Consolidated statement of changes in equity
|Share capital||Share premium||Cumulative translation differences||Other reserves||Retained earnings|| Attributable |
to equity holders of the Company
|Balance as at 1 January 2013||150,938||155,754||-328||-15,205||-63,193||227,966||0||227,967|
|Net result 2013||26,401||26,401||26,401|
|Change to foreign currency translation difference and revaluation reserve||23||23||23|
|Net change in fair value of investments||-11||-11||-11|
|Issue of ordinary shares||0||0|
|Conversion of warrants by warrant holders||1,053||1,907||2,960||2,960|
|Share-based payment transactions||1,433||1,433||1,433|
|Balance as at 31 December 2013||151,991||157,661||-305||-13,783||-36,792||258,772||0||258,772|
|Net result 2014||-51,115||-51,115||-51,115|
|Change to foreign currency translation difference and revaluation reserve||29||29||29|
|Actuarial losses on defined benefit plans||-229||-229||-229|
|Net change in fair value of investments||1||1||1|
|Issue of ordinary shares||0||0|
|Conversion of warrants by warrant holders||0||0|
|Share-based payment transactions||554||554||554|
|Balance as at 31 December 2014||151,991||157,661||-276||-13,228||-88,136||208,012||0||208,012|
The statutory auditor, BDO Bedrijfsrevisoren represented by Bert Kegels, has confirmed that the audit procedures, which have been substantially completed, have not revealed any material adjustments which would have to be made to the accounting data included in the Company's annual announcement, and intends to issue an unqualified opinion.