ThromboGenics NV Announces Business Update and Half Year Results 2009
By Prne, Gaea News NetworkWednesday, August 26, 2009
LEUVEN, Belgium - ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, is today issuing a business update and its half year results for the six month period ending 30 June, 2009.
During 2009, ThromboGenics has continued to focus on the activities which are key to its aim of becoming a profitable, integrated company focused on cutting edge ophthalmic medicines. Central to this plan is the Company’s lead product, microplasmin, which is in Phase III trials for the treatment of back of the eye disease. Patient recruitment in this Phase III program is running smoothly and the Company expects to report the first results from these studies by mid 2010.
The clinical development of the Company’s unique long-acting anticoagulant TB-402, which is in Phase II trials for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery, has progressed more rapidly than originally expected.
Patrik De Haes, CEO of ThromboGenics, said:
“ThromboGenics has seen most of its key programs make significant progress during the course of 2009. We are very happy with the speed of patient recruitment in the microplasmin Phase III program. Microplasmin is central to our aim of building a strong, profitable and integrated company centered on cutting edge ophthalmic medicines. Given our increasing confidence in the clinical merits of microplasmin we are now starting to develop our commercialization plans for this novel product. We are also very encouraged by the progress of the Phase II program for TB-402, as recruitment is ahead of schedule. This clinical study has reinforced our view that we have an attractive out-licensing opportunity for companies keen to enhance their position in the anti-coagulant therapy market. Our partnership with Roche for the novel anti-cancer antibody TB-403 is also going well, as evidenced by the success fee that we received from them earlier in the year.”
“ThromboGenics’ business has never been so well placed. We have a clear strategy, an exciting lead product in microplasmin and two further assets in TB-402 and TB-403 which will provide us with further opportunities to deliver value for our shareholders.”
Financial Update - ThromboGenics achieved revenues of EUR3.6 million in the first half of 2009, nearly all of which came from a success fee from Roche, our partner for TB-403. R&D expenses were EUR8.8 million during this six month period. In addition EUR5.7 million of expenses related to the microplasmin Phase III clinical program (called MIVI TRUST) have been capitalized. General and administrative costs in the first half increased from EUR1.2 million to EUR1.7 million due to higher one-time legal costs, in part due to the merger of ThromboGenics NV and ThromboGenics Ltd. In the first half, ThromboGenics made a net loss of EUR4.7 million. - As of June 30, 2009, ThromboGenics had EUR52.6 million in cash and cash equivalents. This compares to EUR40.4 million on June 30, 2008 and EUR58.9 million on December 31, 2008. The cash figure at the end of June includes the EUR3.1 million that ThromboGenics received in May as a result of the exercise of warrants. The Company’s cash resources are expected to allow ThromboGenics to execute its current operational plans for approximately the next two years.
Business Highlights
Clinical Highlights
Microplasmin - Back of the Eye Disease: Phase III clinical program to evaluate non-surgical treatment of patients with vitreomacular adhesion.
- Phase III program continues to progress well, with recruitment on track
In January 2009, ThromboGenics started the Phase III clinical program of microplasmin for the non-surgical treatment of back of the eye disease. Patient recruitment in this Phase III program is going well and a review by the independent Data Monitoring Committee (DMC) in June led to no changes in the protocols of the two pivotal trials. ThromboGenics expects to be able to report results of these studies from mid of 2010 onwards.
The microplasmin Phase III program comprises two clinical trials, one taking place in the United States (TG-MV-006 trial) and a second combined European/US study (TG-MV-007 trial). The indication for both of these Phase III microplasmin trials is the non-surgical treatment of focal vitreomacular adhesion. Vitreomacular adhesion is a condition in which the vitreous has an abnormally strong adhesion to the retina at the back of the eye. These adhesions can cause vessel and retinal distortion which results in deterioration in the patient’s vision. Both of these trials, which will each recruit 320 patients, are using 125μg of microplasmin.
Given the good progress that is being made with the Phase III program, ThromboGenics is now starting the initial activities needed to ensure the successful commercialization of this exciting product. Market research is being initiated to provide a clear understanding of how patients with back of the eye diseases are treated. This will provide the detailed market knowledge needed to commercialize the product.
It is ThromboGenics’ intention that, if successful, the Company would take this unique product further using its own resources. This is due to the very promising data that the Company has generated to date, the limited competition, and the large potential market for microplasmin with a focused prescribing group. Preliminary market research conducted by the Company suggests that this can be addressed by the small focused commercial organization that ThromboGenics intends to build.
Microplasmin - Diabetic Retinopathy: Phase II trial to evaluate microplasmin for the treatment of Diabetic Macular Edema (DME).
- First unmasked data due to be presented at ASRS Conference in New York, 4 October, 2009
ThromboGenics is currently investigating microplasmin in the treatment of diabetic retinopathy, as it seeks to extend the range of indications for which the product could be potentially used. ThromboGenics completed the enrolment of a Phase II trial of microplasmin intravitreal injection for treatment of DME (MIVI II DME) in March 2009. The first unmasked data from this trial will be presented at the ASRS (American Society of Retina Specialists) Conference in New York on 4 October, 2009 by Professor Stalmans, KULeuven. This trial is designed as the initial step in evaluating the utility of microplasmin in patients with diabetes, a group which is more prone to eye disease such as diabetic retinopathy, due to their underlying medical condition.
Diabetic retinopathy is a major cause of visual loss and the leading cause of blindness in patients aged 20-60. Studies in this patient population have shown that there is a great variability in the type and level of adhesion seen between the vitreous and the retina.
TB-402 - Phase II trial assessing its long-acting anticoagulant TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following orthopaedic surgery.
- Phase II trial proceeding well and ahead of schedule
TB-402 is a novel long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopedic surgery. The Phase II trial is proceeding well, with the first two cohorts (100 patients per cohort) of the study enrolled in just six months. We expect the third and final patient cohort to start recruiting shortly, after review by the Efficacy Safety Monitoring Board.
The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomized, open label trial evaluating TB-402 for the prophylaxis of DVT after knee surgery. Interest around TB-402, which is given as a single injection post surgery and has several weeks of activity, is due to its potential to overcome the major drawbacks, such as spontaneous bleeding and the need for extensive patient monitoring, associated with current anti-coagulant therapy.
ThromboGenics and its development partner BioInvent plan to engage in discussions with potential partners for TB-402.
During this period, additional data from the earlier successful Phase I studies were presented at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) on July 15, 2009 in Boston by Professor Peter Verhamme from KULeuven.
TB-403 (RG7334) - Novel anti-cancer agent partnered with Roche
- Partnership with Roche continues to run smoothly with TB-403 Phase Ib enrolment completed recently
In June 2008, ThromboGenics and its co-development partner BioInvent signed a strategic alliance deal with Roche for its novel anti-cancer agent, TB-403 (anti-PIGF). The partnership continues to run smoothly and enrolment for the Phase Ib trial was completed in the second quarter of 2009. This Phase Ib trial is assessing TB-403’s tolerability, pharmacokinetics and pharmacodynamics in patients with advanced cancer.
The results from this trial are currently planned to be presented at a scientific conference later this year.
In January 2009, ThromboGenics and BioInvent received their first success fee from Roche based on the successful transfer and implementation of technology and process development for TB-403 production. ThromboGenics received EUR3 million (60%) of the overall EUR5 million success fee.
Corporate Update - As of 1 July 2009, ThromboGenics was promoted to the NEXT 150 index on the Euronext stock exchange, reflecting the strong share price performance and progress that the Company has made. The NEXT 150 index comprises mid to large capitalization stocks on the Euronext exchange. The index consists of the 150 next largest stocks following the Euronext 100 index and includes stocks from the Amsterdam, Brussels, Lisbon and Paris exchanges of Euronext. The inclusion of the Company in the NEXT 150 index also follows the Company entering the VLAM-21 index earlier in the year, which is a capitalized-weighted index of the 21 most capitalized Flemish stocks that are traded on a stock exchange. - Cross-border merger of ThromboGenics NV and ThromboGenics Ltd finalized, leading to a streamlined legal structure and cost savings. - ThromboGenics has continued to strengthen its in-house expertise, following the strategic hires announced at the time of the Company’s first quarter 2009 Business Update. In June, Dr. Clive Long joined ThromboGenics as Head of Pre-Clinical Program Management. Dr. Long joins from Schering-Plough, where he was Proof-of-Concept Leader and has 26 years experience working for large pharmaceutical companies in research and development.
Financial Overview
Revenue and Results
In the first half of 2009, ThromboGenics achieved total revenue of EUR3.6 million, nearly all of which came from its out-licensing activities. Within this amount, EUR3 million came from the first success fee from Roche based on the successful transfer and implementation of technology and process development for TB-403 production. In the same period of 2008, ThromboGenics had revenues of EUR30.3 million due to the upfront payment from Roche which resulted from the signing of its strategic partnership for TB-403.
In the first half of 2009, gross profit amounted to EUR3.2 million. In the same period in 2008, ThromboGenics achieved a gross profit of EUR30.3 million due to the upfront payment from Roche mentioned earlier.
ThromboGenics invested EUR8.8 million in its R&D activities in the first six months of 2009. This compares with a spend on R&D of EUR11.6 million in the same period in 2008. This reduction in R&D spend was the result of the decision to capitalise the Phase III clinical trial costs relating to microplasmin for back of the eye disease. In the first half of 2009, EUR5.7 million of R&D costs were capitalized.
ThromboGenics general and administrative expenses increased to EUR1.7 million from EUR1.2 million due to higher (one-off) legal costs in part due to the merger of ThromboGenics NV with its subsidiary ThromboGenics Ltd.
In the first half of 2009, ThromboGenics reported an operating loss of EUR5.5 million. This compares with an operating profit of EUR17.3 million in the corresponding period in 2008, which resulted from the significant upfront payment received from Roche.
ThromboGenics achieved net financial income of EUR0.8 million in the first half of 2009. In the first half of 2008, the Company also had net financial income of EUR0.8 million.
In the first half of 2009, ThromboGenics had a pre-tax loss of EUR4.7 million. This compares with a pre-tax profit of EUR18.0 million in the first half of 2008. In both periods, ThromboGenics paid minimal tax expenses.
ThromboGenics reported a net loss of EUR4.7 million in the first half of 2009, giving a diluted loss per share of EUR0.17. This compares with a net profit of EUR18.0 million and diluted earnings per share of EUR0.67 in the first half of 2008.
Financial Position and Cash Flow
As of 30 June, ThromboGenics had a strong cash position of EUR52.6 million. This compares to EUR40.1 million in cash and EUR6.7 million in short term investments at 30 June 2008.
These funds will allow ThromboGenics to support its business for approximately the next two years. The Company’s underlying cash burn is expected to increase given the continuing investment in the Phase III program for microplasmin in eye disease, as well as the start of ThromboGenics own commercial activities to ensure the successful launch of this exciting new product.
At the end of June 2009, ThromboGenics had total shareholders equity of EUR61.1 million which compares with EUR67.6 million at the end of June 2008.
ThromboGenics experienced a EUR4.6 million cash outflow in the first half of 2009. This compares with a cash outflow of EUR8.1 million in the first half of 2008, when the Company was still awaiting payment of the EUR30 million upfront payment from Roche.
Unaudited consolidated statement of profit and loss ThromboGenics Unaudited consolidated statement of profit and loss Half year Half year In ‘000 Euro, except per share amounts 6 months 6 months According to IFRS Jan - June 2009 Jan - June 2008 Income 3,609 30,298 License income 3,549 30,255 Royalty income 54 - Other income 6 43 Cost of sales (454) (29) Gross profit 3,155 30,269 Research and development expenses (8,842) (11,582) General and administrative expenses (1,706) (1,212) Selling expenses (223) (222) Other operating income 2,092 33 OPERATING RESULT (5,524) 17,286 Financial income 1,033 1,022 Financial expenses (179) (190) Result before income tax (4,670) 18,118 Income tax 7 (90) Net result for the period (4,663) 18,028 Attributable to: Equity holders of the company (4,663) 18,028 Result per share Basic earnings per share {Euro} (0.18) 0.72 Diluted earnings per share {Euro} (0.17) 0.67
Unaudited consolidated statement of comprehensive income ThromboGenics Unaudited consolidated statement of other comprehensive income Half year Half year In ‘000 Euro - According to IFRS 6 months 6 months Jan - June 2009 Jan - June 2008 Available-for-sales investments Valuation gain/(loss) taken to equity 72 (58) Exchange differences on translation of foreign operations 11 4 Other comprehensive income net of tax 83 (54) Total result for the period (4,663) 18,028 Total comprehensive income (4,580) 17,974 Attributable to: Equity holders of the parent (4,580) 17,974
Unaudited consolidated statement of financial position ThromboGenics 30/06/2009 30/06/2008 Unaudited consolidated statement of financial position In ‘000 Euro - According to IFRS ASSETS: Property plant and equipment 960 934 Intangible Assets 7,756 - Goodwill 2,586 2,586 Fixed Assets: 11,302 3,520 Trade and other receivables 2,442 32,236 Investments 5,721 6,684 Cash and cash equivalents 46,866 33,614 Current Assets 55,029 72,534 Pension 73 39 Long-term Assets 73 39 Total Assets 66,404 76,093 EQUITY AND LIABILITIES Share capital 113,997 111,086 Share premium 15,907 15,733 Accumulated translation differences 39 13 Other reserves (20,235) (21,199) Retained earnings (48,622) (38,026) Equity attributable to equity holders of the parent 61,086 67,607 Minority interests - - Total Equity 61,086 67,607 Trade payables 4,246 7,380 Other short-term liabilities 1,072 1,106 Short-term liabilities 5,318 8,486 Total Equity and Liabilities 66,404 76,093
Unaudited consolidated statement of cash flows ThromboGenics Unaudited consolidated statement of cash flow For the period ended 6 months 6 months Jan 2009 Jan 2008 In ‘000 Euro, except per share amounts - June 2009 - June 2008 According to IFRS OPERATING ACTIVITIES {Loss} profit for the period (4,663) 18,028 Financial expenses 179 190 Financial income (1,034) (1,022) Depreciation of property, plant and equipment 224 195 Depreciation of intangible assets 1 - Costs of share-based payments 249 304 Cash flows before modification of the working capital (5,044) 1,695 (Increase) / decrease in trade and other receivables including tax receivables (85) (30,703) Increase / (decrease) in short-term liabilities 508 4,884 Net cash flow from operating activities (4,621) (8,124) INVESTING ACTIVITIES Retirement of fixed assets (6) (2) Investments 22,809 (32) Interest received and similar income 894 838 Acquisition of intangible assets (345) (95) Acquisition of property, plant and equipment (4,908) - Net cash (used for) / generated by investment activities 18,444 709 FINANCING ACTIVITIES Income from share issues 3,025 893 Paid interests (3) - Net cash (used for) /generated by financing activities 3,022 893 Net increase (decrease) in cash flow and cash equivalents 16,845 (6,522) Cash and cash equivalents at the start of the period 30,356 40,111 Effect of exchange rates modifications (335) 25 Cash and cash equivalents at the end of the period 46,866 33,614
Unaudited consolidated statement of changes in equity In ‘000 Euro - Share Share Cumulative Other According to capital premium translation reserves IFRS differences Balance sheet at 31 Dec. 2007 110,309 15,647 9 (21,476) Net result 2008 Conversion of 894 warrants by ThromboGenics Ltd Contribution in kind Thrombogenics Ltd shares 777 86 (863) Exchange rate differences as a result of retranslation of foreign subsidiary 4 Share based payments 304 Fair-Value Adjustment Investments (58) Balance sheet at 30 Jun 2008 111,086 15,733 13 (21,199) In ‘000 Euro - Retained Attributable Minority Total According to IFRS earnings to shareholders interests of the company Balance sheet at 31 Dec. 2007 (56,054) 48,435 - 48,435 Net result 2008 18,028 18,028 18,028 Conversion of warrants by ThromboGenics Ltd 894 894 Contribution in kind Thrombogenics Ltd shares 894 (894) Exchange rate differences as a result of retranslation of foreign subsidiary 4 4 Share based payments 304 304 Fair-Value Adjustment Investments (58) (58) Balance sheet at 30 Jun 2008 (38,026) 67,607 - 67,607 In ‘000 Euro - Share Share Cumulative Other According to capital premium translation reserves IFRS differences Balance sheet 111,338 15,837 28 (20,851) at 31 Dec. 2008 Net result 2009 Conversion of 2,783 warrants by ThromboGenics Ltd Contribution in 2,488 (2,488) kind Thrombogenics Ltd shares Conversion of 171 70 warrants by ThromboGenics NV Exchange rate 11 differences as a result of retranslation of foreign subsidiary Share based 249 payments Fair-Value 72 Adjustment Investments Balance sheet 113,997 15,907 39 (20,235) at 30 Jun 2009 In ‘000 Euro - Retained Attributable Minority Total According to IFRS earnings to shareholders interests of the company Balance sheet at 31 Dec. 2008 (43,959) 62,393 - 62,393 Net result 2009 (4,663) (4,663) (4,663) Conversion of warrants by 2,783 2,783 ThromboGenics Ltd Contribution in kind Thrombogenics Ltd shares 2,783 (2,783) Conversion of warrants by ThromboGenics NV 241 241 Exchange rate differences as a result of retranslation of foreign subsidiary 11 11 Share based payments 249 249 Fair-Value Adjustment Investments 72 72 Balance sheet at 30 Jun 2009 (48,622) 61,086 - 61,086
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal indications and as a potential therapy for stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.
ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels 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.
For further information please contact: ThromboGenics Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10 patrik.dehaes@thrombogenics.com Chris Buyse, CFO Tel: +32-16-75-13-10 chris.buyse@thrombogenics.com Citigate Dewe Rogerson Amber Bielecka/ David Dible/ Nina Enegren Tel: +44(0)207-638-95-71 amber.bielecka@citigatedr.co.uk
Source: ThromboGenics NV
For further information please contact: ThromboGenics : Dr. Patrik De Haes, CEO , Tel: +32-16-75-13-10, patrik.dehaes at thrombogenics.com; Chris Buyse, CFO , Tel: +32-16-75-13-10, chris.buyse at thrombogenics.com; Citigate Dewe Rogerson, Amber Bielecka/ David Dible/ Nina Enegren , Tel: +44(0)207-638-95-71, amber.bielecka at citigatedr.co.uk
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