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Oxurion NV — Management Reports 2012
Mar 8, 2012
3987_er_2012-03-08_ef47025b-6ee2-4f7f-92ce-cb43421a5781.pdf
Management Reports
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ThromboGenics Announces Business Update and 2011 Full-Year Results
REGULATED INFORMATION
Leuven, Belgium – 8 March, 2012 - ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today issued a business update and its financial results for the full year ending December 31, 2011.
Over the past 12 months, ThromboGenics has built its capabilities in anticipation of the launch of its lead product, ocriplasmin. It has filed a regulatory submission in Europe for ocriplasmin for symptomatic vitreomacular adhesion (VMA) including macular hole and plans to resubmit the Biologics License Application (BLA) filing for ocriplasmin in the U.S. in April 2012 for the same indication. The US Food and Drug Administration has advised that it will give Priority Review to the BLA filing.
During 2012, ThromboGenics is confident of delivering a number of further significant milestones as it remains on track to achieve its goal of becoming a successful and profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines.
2011 Highlights (including post-period events):
Ocriplasmin
- European Medicines Agency (EMA) accepts for review the Marketing Authorisation Application (MAA) for ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
- ThromboGenics submitted the BLA for ocriplasmin with the FDA in December 2011. Following discussions with the FDA, ThromboGenics will resubmit the BLA in April 2012 in order to meet the Agency's timelines for Priority Review.
- Continued expansion of the commercial organization ahead of the anticipated launch of ocriplasmin.
- Presentation of ocriplasmin clinical trial data by leading retina specialists at major international ophthalmology congresses.
Other clinical programs
- ThromboGenics initiates Phase IIb trial with TB-402 (anti-factor VIII), its novel longacting anticoagulant, for the prophylaxis of venous thromboembolism (VTE) after total hip replacement.
- Partner Roche starts Phase Ib/II trial with TB-403, a novel anticancer (anti-PIGF), in combination with Avastin for glioblastoma multiforme (brain tumor).
- Recruitment of two Chief Scientific Officers to develop the Company's preclinical ophthalmology and cancer pipelines.
Financial
- €80.4 million in cash and cash investments as of 31 December 2011, compared with €109.2 million at the end of December 2010.
- € 2.5 million in total revenue in 2011, compared with €6.2 million in 2010.
Net loss of €21.6 million in 2011, compared with €13.9 million in 2010, equivalent to diluted loss per share of €0.67 (€0.47 in 2010).
Dr Patrik De Haes, CEO of ThromboGenics, commenting on today's announcement, said: "We have made very good progress over the last year towards our goal of becoming a successful and profitable biopharmaceutical company developing and commercializing innovative ophthalmic medicines. We have filed ocriplasmin with the EMA. In the U.S., following discussions with the FDA, we plan to resubmit our BLA in order for ThromboGenics to meet the expedited timelines for Priority Review. We are encouraged that the FDA has indicated that ocriplasmin could be subject to Priority Review, as this designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.
"Over the coming months we will be working with the regulatory agencies in Europe and the US to gain approval for ocriplasmin. If approved, ocriplasmin could be the first pharmacological treatment for symptomatic VMA including macular hole. I look forward to the next 12 months and I am confident that we will deliver a number of very significant milestones that will create significant value for our shareholders."
Business Highlights
Ocriplasmin continues to make good progress
Ocriplasmin Regulatory submissions
European filing accepted for review
In October 2011, the European Medicines Agency accepted for review the MAA for ocriplasmin (2.5 mg/ml, solution for injection) for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
The ocriplasmin MAA will be evaluated through the EMA's Centralised Procedure with an official start date of mid-October. If approved, ocriplasmin will gain marketing authorization in all EU Member States simultaneously.
BLA filing in the U.S.
In December 2011, ThromboGenics submitted its BLA for ocriplasmin for symptomatic VMA including macular hole. Following subsequent discussions with the FDA, during which the Agency indicated that it intended to grant Priority Review for ocriplasmin, ThromboGenics decided to resubmit the BLA by end April 2012.
The resubmission will enable ThromboGenics to meet the Agency's timelines for a Priority Review and manage the resources needed to support the parallel European and U.S. submissions for ocriplasmin.
The FDA grants Priority Review designation to drugs that may offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.
Organizational developments
Key positions recruited for our commercial organization
During 2011, ThromboGenics recruited several people with expertise across a number of important areas including regulatory and medical affairs, marketing and market access. We intend to build our commercial organization so that we are well placed to launch ocriplasmin, if approved.
Vitreomacular adhesion (VMA) gains recognition among the medical community
New disease code recognizing VMA/vitreomacular traction as a separate identifiable vision-threatening condition granted in the U.S.
The U.S. National Center for Health Statistics granted a new ICD-9-CM disease code for VMA/vitreomacular traction at the request of the AAO (American Academy of Ophthalmology) and ASRS (American Society of Retina Specialists). The code took effect in October 2011.
ICD-9-CM is an official committee that assigns codes to diagnoses and procedures used in the U.S. The code is important because it will enable health authorities to track the prevalence of VMA and allow payors to reimburse physicians.
Raising Awareness of Symptomatic VMA
Medical education programs raise awareness among the medical community
ThromboGenics continued to support medical education efforts to raise greater awareness and understanding of symptomatic VMA as an important unmet medical need. International retina specialists presented at major global ophthalmology conferences including 2011 Euretina and Annual Meeting of the American Academy of Ophthalmology, the largest EU and US membership associations respectively of retina specialists and ophthalmologists.
Further presentations are planned at major retina congresses throughout 2012.
Earlier this year, the Company launched an informational site on symptomatic VMA aimed at physicians. The site, www.symptomaticvma.com, is an educational resource that explains the progression of this sight-threatening disease and how physicians diagnose and manage it currently.
Ocriplasmin IP Consolidated
ThromboGenics concluded intellectual property agreements with NuVue and Grifols. These have strengthened significantly the Company's portfolio of exclusive worldwide rights covering the use of plasmin and plasmin derivatives for the treatment of ophthalmologic diseases.
ThromboGenics' total royalty burden to all parties from which it has acquired IP or exclusive rights will be less than 5% of net sales of ocriplasmin.
Further progress with Other Pipeline Products
TB-402 (anti-factor VIII antibody): enrollment of Phase IIb trial for the prophylaxis of venous thromboembolism (VTE) after total hip replacement completed ahead of schedule
In April 2011, ThromboGenics and its co-development partner BioInvent International initiated a Phase IIb trial with TB-402 for the prophylaxis of venous thromboembolism (VTE) after total hip replacement.
This trial is comparing two doses of TB-402 (25mg and 50mg), given as a single intravenous infusion after total hip replacement, with the recently approved factor Xa inhibitor rivaroxaban (anti-factor Xa), which is given orally (10mg) once a day for 35 days. The trial is fully enrolled ahead of schedule, with 632 patients from 36 patients across Europe. Results are expected in the second quarter of 2012.
TB-403 (anti-PIGF antibody): Roche initiates Phase Ib/II trial in aggressive brain cancer trial
In May 2011, our development partner Roche initiated a Phase Ib/II multi-center trial to examine the safety and clinical effect of TB-403 in combination with Avastin® (bevacizumab) in patients with recurrent glioblastoma (brain cancer).
THR-100 (Staphylokinase): Regulatory filing submitted in India
ThromboGenics' partner Bharat Biotech International Limited (Hyderabad, India) completed a successful Phase III trial with THR-100, a thrombolytic agent for myocardial infarction, at the end of 2011.
Bharat Biotech, which is responsible for the development and commercialization of THR-100, has now filed the drug for marketing approval with Indian regulatory authorities.
R&D progress
During 2011, ThromboGenics appointed two Chief Scientific Officers to lead its R&D programs in ophthalmology and oncology. In October 2011, Dr David T. Shima joined ThromboGenics as CSO, Ophthalmology to help build the Company's pipeline of new ophthalmic medicines.
Dr Shima is Professor at UCL's Institute of Ophthalmology (UK) and has held several roles in the ophthalmic pharmaceutical industry including CSO of Jerini Ophthalmic Inc. and Senior Vice President of Research and Preclinical Development at Eyetech. He holds a PhD in Cell and Developmental Biology from Harvard.
ThromboGenics also appointed Dr Koen Kas as CSO, Oncology to advance the Company's preclinical anti-cancer research.
Dr Kas has extensive experience in oncology and drug development. He was most recently Founding CSO of Pronota and has held senior roles including Director of Drug Discovery at Galapagos and Director of Oncology at Tibotec-Virco. Dr Kas is also Chairman of the Scientific Committee of the European Cancer Prevention Organisation.
Corporate Update
Opening of new U.S. office
In early March 2012, ThromboGenics opened its new U.S. headquarters, which is located in Iselin, New Jersey, and led by Dr David Pearson, Head of U.S. Country Operations. As a result of the move, ThromboGenics will benefit from a Business Employment Incentive grant from the New Jersey Economic Development Authority whose value could exceed \$1.0 million over a multi-year period.
New Board members
ThromboGenics announced changes to its Board of Directors in late 2011.
Thomas Clay, Vice-President of East Hill Management Company, a US-based venture capital firm specializing in the lifescience sector, was appointed non-executive director in November 2011. He is also director of Golden Queen Mining Company Ltd., a developmentstage gold mining company, and the Clay Mathematics Institute. Thomas has an AB degree from Harvard University in Classics and a Masters degree from Oxford University in Greek and Latin Languages and Literatures. He replaces his father Landon Clay, who resigned from the Board.
The Board will also propose the nomination of Patricia Ceysens, a Flemish politician, as nonexecutive director at ThromboGenics' 2012 Annual Shareholder Meeting in May. Mrs Ceysens was the Flemish minister of Economy, Foreign Policy and Foreign Trade from 2003 to 2004, and Flemish minister of Economics, Business, science, Innovation and Foreign Trade from 2007 to 2009. She studied law at the Catholic University of Leuven.
Financial Overview
Revenue and Results
In 2011, ThromboGenics' total revenue was €2.5 million, mainly as a result of milestone income from Roche. In 2010, total revenue amounted to €6.2 million.
Gross profit in 2011 was €2.3 million due to the limited costs associated with milestone payment from Roche. In 2010, ThromboGenics reported a gross profit of €5.6 million.
R&D expenses in 2011 were €19.7 million compared with €17.9 million in 2010. This continued high level of expenditure was due to the number of the on-going late-stage clinical trials in 2011. In addition, €11.2 million of the costs related to the ocriplasmin development program were capitalized in 2011. This compares with €8.5 million in 2010.
In 2011, ThromboGenics' selling expenses increased to €.5.6 million (€1.8 million in 2010) as a result of the Company's preparations for the planned launch of ocriplasmin.
In 2011, ThromboGenics made an operating loss of €24.8 million, due to the higher levels of selling and general and administrative expenses as well as the continued high level of R&D investment. In 2010, the Company's operating loss was €14.7 million.
ThromboGenics had net financial income of €3.1 million in 2011. In 2010, the Company reported net financial income of €0.7 million.
In 2011, ThromboGenics made a pre-tax loss of €21.6 million. This compares with a pre-tax loss of €13.9 million in 2010.
The reported net loss in 2011 was €21.6 million or €0.67 diluted loss per share. In 2010, the Company made a net loss of €13.9 million, equivalent to diluted loss per share of €0.47.
Financial Position and Cash Flow
As of 31 December 2011, ThromboGenics had €80.4 million in cash and cash investments. This compares with €109.2 million in cash and cash investments as of 31 December 2010. The decrease in cash resources is due in part to the increased expenditure on the Company's rapidly growing commercial organization ahead of the planned launch of ocriplasmin and costs of the on-going Phase IIb study with TB-402.
ThromboGenics current level of funding will allow it to support its business until the launch of ocriplasmin.
At the end of 2011, ThromboGenics had total shareholder equity of €118.0 million, down from €138.2 million at the end of 2010.
Consolidated statement of comprehensive income
| In '000 euro (for the year ended on 31 December) |
2011 | 2010 | ||
|---|---|---|---|---|
| Income | 2,476 | 6,175 | ||
| License income | 2,400 | 6,067 | ||
| Income from royalties | 45 | 66 | ||
| Other income | 31 | 42 | ||
| Cost of sales | -216 | -540 | ||
| Gross profit | 2,260 | 5,635 | ||
| Research and development expenses | -19,676 | -18,680 | ||
| General and administrative expenses | -5,881 | -3,635 | ||
| Selling expenses | -5,555 | -1,815 | ||
| Other operating income | 4,080 | 3,835 | ||
| Operating result | -24,772 | -14,660 | ||
| Finance income | 3,350 | 946 | ||
| Finance expense | -214 | -206 | ||
| Result before income tax | -21,636 | -13,920 | ||
| Income tax expense | -1 | -22 | ||
| Net result for the period | -21,637 | -13,942 | ||
| Attributable to: | ||||
| Equity holders of the company | -21,637 | -13,942 | ||
| Result per Share | ||||
| Basic earnings per share (euro) | -0.67 | -0.47 | ||
| Diluted earnings per share (euro) | -0.67 | -0.47 |
| In '000 euro (for the year ended on 31 December) | 2011 | 2010 |
|---|---|---|
| Result of the period | -21,637 | -13,942 |
| Net change in fair value of available-for-sale financial assets | 13 | -13 |
| Exchange differences on translation of foreign operations | -653 | 19 |
| Other comprehensive income, net of income tax | -640 | 6 |
| Total comprehensive income for the period | -22,277 | -13,936 |
| Attributable to: | ||
| Equity holders of the company | -22,277 | -13,936 |
Consolidated statement of financial position
| In '000 euro (for the year ended on 31 December) | 2011 | 2010 |
|---|---|---|
| ASSETS | ||
| Property, plant and equipment | 1,492 | 894 |
| Intangible assets | 37,021 | 25,832 |
| Goodwill | 2,586 | 2,586 |
| Other financial assets | 133 | 75 |
| Employee benefits | 73 | 73 |
| Non-current assets | 41,305 | 29,460 |
| Trade and other receivables | 7,405 | 4,322 |
| Investments | 22,831 | 23,289 |
| Cash and cash equivalents | 57,548 | 85,866 |
| Current assets | 87,784 | 113,477 |
| Total assets | 129,089 | 142,937 |
| EQUITY AND LIABILITIES | ||
| Share capital | 138,351 | 138,095 |
| Share premium | 91,165 | 90,902 |
| Accumulated translation differences | -633 | 20 |
| Other reserves | -17,246 | -18,856 |
| Retained earnings | -93,608 | -71,971 |
| Equity attributable to equity holders of the company |
118,029 | 138,190 |
| Minority interests | ||
| Total equity | 118,029 | 138,190 |
| Trade payables | 9,336 | 4,034 |
| Other short-term liabilities | 1,724 | 713 |
| Current liabilities | 11,060 | 4,747 |
| Total equity and liabilities | 129,089 | 142,937 |
Consolidated statement of cash flows
| In '000 euro (for the year ended on 31 December) | 2011 | 2010 | |||
|---|---|---|---|---|---|
| Cash flows from operating activities | |||||
| (Loss) profit for the period | -21,637 | -13,942 | |||
| Finance expense | 214 | 206 | |||
| Finance income | -3,350 | -946 | |||
| Depreciation on property, plant and equipment | 382 | 426 | |||
| Gain on sale of property, plant and equipment | 0 | 0 | |||
| Equity settled share-based payment transactions | 1,597 | 1,053 | |||
| Change in trade and other receivables including tax receivables | -3,083 | -885 | |||
| Change in short-term liabilities | 6,313 | -2,754 | |||
| Net cash (used) from operating activities | -19,564 | -16,842 | |||
| Cash flows from investing activities | |||||
| Disposal of property, plant and equipment | 3 | 10 | |||
| Change in investments | 458 | -22,547 | |||
| Interest received and similar income | 1,427 | 712 | |||
| Acquisition of intangible assets | -11,189 | -8,475 | |||
| Acquisition of property, plant and equipment | -983 | -288 | |||
| Acquisition of other financial assets | -58 | -22 | |||
| Net cash (used in) generated by investing activities | -10,342 | -30,610 | |||
| Cash flows from financing activities | |||||
| Proceeds from issue of share capital | 519 | 57,355 | |||
| Paid interests | -9 | -6 | |||
| Net cash (used in) generated by financing activities 510 |
|||||
| 57,349 | |||||
| Net change in cash and cash equivalents | -29,396 | 9,897 | |||
| Cash and cash equivalents at the start of the period | 85,866 | 75,929 | |||
| Effect of exchange rate fluctuations 1,078 |
|||||
| Cash and cash equivalents at the end of the period 57,548 |
Consolidated statement of changes in equity
| Share capital | Share premium |
Cumulative translation differences |
Other reserves |
Retained earnings |
Attributable to equity holders of the company |
Minority interests |
Total | |
|---|---|---|---|---|---|---|---|---|
| Balance sheet as at 1 January 2010 |
125,122 | 46,520 | 1 | -19,896 | -58,029 | 93,718 | 0 | 93,718 |
| Net loss 2010 | -13,942 | -13,942 | -13,942 | |||||
| Change to foreign currency translation differences |
19 | 19 | 19 | |||||
| Net change in fair value of investments |
-13 | -13 | -13 | |||||
| Conversion of warrants by ThromboGenics NV |
1,735 | 1,684 | 3,419 | 3,419 | ||||
| Share-based payment transactions |
1,053 | 1,053 | 1,053 | |||||
| Issue of ordinary shares |
11,238 | 42,698 | 53,936 | 53,936 | ||||
| Balance sheet as at 31 December 2010 |
138,095 | 90,902 | 20 | -18,856 | -71,971 | 138,190 | 0 | 138,190 |
| Net loss 2011 | -21,637 | -21,637 | -21,637 | |||||
| Change to foreign currency translation differences |
-653 | -653 | -653 | |||||
| Net change in fair | ||||||||
| value of investments | 13 | 13 | 13 | |||||
| Conversion of warrants by ThromboGenics NV |
256 | 263 | 519 | 519 | ||||
| Share-based payment transactions |
1,597 | 1,597 | 1,597 | |||||
| Balance sheet as at 31 December 2011 |
138,351 | 91,165 | -633 | -17,246 | -93,608 | 118,029 | 0 | 118,029 |
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.
- End -
ThromboGenics NV, Leuven, Belgium tel +32 (0)16 75 13 10, www.thrombogenics.com
For further information please contact:
ThromboGenics
Dr. Patrik De Haes, CEO
Chris Buyse, CFO
Tel: + 32 16 75 13 10 [email protected]
Tel: + 32 16 75 13 10 [email protected]
Citigate Dewe Rogerson
| David Dible/ Nina Enegren/ Sita Shah | Tel: +44 (0) 207 638 9571 |
|---|---|
| -------------------------------------- | --------------------------- |
About ThromboGenics
ThromboGenics is a biopharmaceutical company focused on developing innovative ophthalmic medicines. The Company's lead product ocriplasmin has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (VMA). The MAA for ocriplasmin has been accepted for review in Europe and the BLA will be resubmitted in the U.S. by April 2012. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.
ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International. These include TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF), in Phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. 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 forwardlooking 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.