LEUVEN, Belgium, February 15 /PRNewswire/ -- ThromboGenics NV , a biotechnology company focused on vascular disease, today announces a business update and its financial results for the six month period ending November 2006.
During the last nine months, ThromboGenics has made significant progress, becoming a listed company, strengthening its management team and advancing its product pipeline.
The highlights over the last nine months have included:
Company
- Successful IPO on the Eurolist by Euronext Brussels in June 2006. The fundraising, which accompanied the IPO enabled ThromboGenics to raise EUR35.0 million at a price of EUR4.5 per share. As a result of this fund raising, ThromboGenics had cash and cash equivalents of EUR33.7 million at the end of November 2006.
- Appointment of Chris Buyse as the company’s CFO. Mr Buyse was previously the CFO of the Belgian biotech company CropDesign NV, which was acquired by BASF in 2006.
- The management team was further strengthened with the appointment of Patrik De Haes as Chief Operating Officer and Franky Terras as Patent Counsel.
Product Pipeline
Microplasmin for eye disease
- The company completed enrolment and announced the positive results of the MIVI I trial evaluating Microplasmin in Vitrectomy in Europe. This 60 patient study was a dose-ranging Phase IIa clinical trial evaluating the effects of various doses of microplasmin injected intraocularly in patients undergoing vitrectomy.
- The company received approval from the FDA for an IND for microplasmin intraocular injection, allowing it to conduct clinical trials in the U.S.
- Following the period end, ThromboGenics started a Phase IIb trial with microplasmin intraocular injection in the U.S. (MIVI III). The results of this 120 patient study are expected to allow dose selection for subsequent Phase III development of the product.
- The company also started the enrolment of a European study assessing microplasmin in the treatment of diabetic macular edema (MIVI II) and other back of the eye conditions.
Microplasmin for vascular disease
- In September, ThromboGenics announced that it had started a Phase IIa trial evaluating microplasmin for the intra-arterial treatment of ischemic stroke (MITI-IA). This study is in addition to the on-going Phase IIa trial assessing microplasmin for the intravenous treatment of ischemic stroke (MITI-IV).
- In the same month, ThromboGenics announced that it was shifting the focus of its development strategy in peripheral vascular disease to acute deep vein thrombosis (DVT). This indication represents a more attractive commercial opportunity. A Phase IIa clinical study assessing microplasmin in DVT is expected to start Q1 2007
THR-100
- In December, the company announced that it had licensed its novel thrombolytic agent THR-100 to the Indian company Bharat Biotech. This deal will allow this novel form of recombinant staphylokinase to be developed in developing countries and certain industrialised countries for treatment of acute myocardial infarction (AMI or heart attack) and other vascular diseases based on its ability to dissolve blood clots. ThromboGenics will receive double digit royalties on the net sales of the product and Bharat Biotech will assume all future development and commercialisation costs.
Pre-clinical pipeline
- Post the period end, ThromboGenics and its partner BioInvent International received regulatory approval to begin clinical trials with the anticoagulant TB-402 (anti-factor VIII) in Denmark. Results are expected to be presented in late 2007.
- The novelty of ThromboGenics work surrounding PIGF growth factor has been recognised. Recently the company has received two grants from the EU for the ANGIOSTOP anti-angiogenesis programme and the VASOPLUS pro-angiogenesis programme (2 million euro each grant) that it is involved in.
Financial Highlights
- ThromboGenics shares have performed strongly since the IPO and finished 2006 at a price of EUR12.05 per share. This strong share price performance led to the company being awarded “1st Bel Small Performer” for 2006 by Euronext, Brussels.
- On November 30, ThromboGenics NV ended its first semester. ThromboGenics NV was incorporated in May 2006 in order to acquire, by way of a contribution in kind, all of the shares of the former holding company Thrombogenics Ltd on a share-for-share basis. This event took place on June 7, 2006. ThromboGenics NV has been quoted on the Euronext Brussels stockmarket since July 7, 2006.
- The company has a strong balance sheet with cash and cash equivalents at end November 2006 of EUR33.7 million. This compares with EUR8.9 million at the end of the FY 2005. The net cash proceeds due to the issue of new shares at the time of the IPO totalled EUR31.3 million. This much improved cash position will allow ThromboGenics to further finance the development of its therapeutic pipeline, as planned during IPO.
- In 2006, the company received its last royalties from Genentech relating to rights to tissue plasminogen activator (tPA). In 2006 these royalties amounted to EUR2.9 million, against EUR5.6 million in FY 2005. The net operating costs for the six month period covering June through November 2006, amounted to EUR5.7 million resulting in an operating loss for this period of EUR5.7 million against EUR5.0 million for the FY 2005 (for the former ThromboGenics Ltd holding).
Prof Desire Collen, CEO of ThromboGenics commenting on today’s announcement said: “The last nine months have been a very intense and productive period for ThromboGenics. Our successful IPO has provided us with the funds we need to further advance our exciting product portfolio, and the recruitment of a number of key people has enhanced our ability to deliver. The results that we have achieved with microplasmin in eye disease in particular are very encouraging. Over the next twelve months we expect to make further progress in this area, and to generate our first clinical results with microplasmin in stroke and peripheral vascular disease.”
About ThromboGenics
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuÂÂticals for the treatment of a range of vascular diseases. The Company has several programs in Phase II clinical development including microplasmin, which is being evaluated as a treatment for vitreoretinal disorders and as a thrombolytic agent for vascular occlusive diseases, including acute stroke. ThromboGenics also has five other drug candidates in preclinical development with preclinical proof-of-principle demonstrated, including TB-402 (Anti-Factor VIII) and TB-403 (Anti-PlGF). The Company has built strong links with the University of Leuven and has exclusive rights to certain therapeutics developed at the University. ThromboGenics is headquartered in Leuven, Belgium and has subsidiaries in Ireland and the U.S. 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 prospectus.
ThromboGenics NV Unaudited Consolidated Profit & Loss Statement 12 6 11 months For period ended 5 months months months ended June- Jan - December Jan - May Nov. FY Nov. FY 2005 FY 2006 2006 2006 In ‘000 Euros, except per share amounts (*) (**) (***) According to IFRS Revenues 2,527 691 3,218 5,988 Royalty income 2,422 484 2,906 5,579 Other income 105 207 312 409 Cost of sales -969 -225 -1,194 -2,448 Gross profit 1,558 466 2,024 3,540 Research and development Expense -4,007 -5397 -9,404 -7,548 General and Administrative Expenses -389 -812 -1,201 -1,499 Selling expenses -97 -107 -204 0 Other Operating income 162 180 342 539 OPERATING LOSS -2,774 -5,669 -8,443 -4,968 Financial Income 91 354 445 790 Financial Expense -236 -76 -312 -64 Loss before taxes -2,919 -5,391 -8,310 -4,242 Income taxes -2 -4 -6 81 Net loss for the period -2,921 -5,395 -8,316 -4,161 Attributable to: Equity holder of the parent -2,921 -5,395 -8,316 -4,436 Minority interests 0 0 0 10 Loss per share Basic and diluted - -0.24 -0.38 -0.30
(*) These pro-forma figures are communicated for information and comparison purposes only. They represent the results of the operations of the former holding ThromboGenics Ltd
(**) This Consolidated Profit & Loss represents the operations of ThromboGenics NV from its incorporation on May 31, 2006 to end of November. It includes the operations of its subsidiaries (Thromb-X NV, ThromboGenics Ltd and ThromboGenics Inc) from January-November 2006.
(***) For reasons of consistency and comparison, these figures are the consolidated FY 2005 figures of the former ThromboGenics Ltd Group as presented in the IPO Prospectus
ThromboGenics NV Unaudited Consolidated Balance Sheet 30/11/2006 31/12/2005 in 000 Euro in 000 Euro According to IFRS (*) Assets: Property plant and equipment 535 625 Intangible Assets 0 1,087 Goodwill 2,586 2,586 Non-Current Assets: 3,121 4,298 Inventories 0 0 Trade and other receivables 1,403 831 Current tax recoverable 26 88 Investments 25,000 725 Cash and cash equivalents 8,677 8,894 Current Assets 35,106 10,538 Total Assets 38,227 14,836 EQUITY AND LIABILITIES Share Capital 95,974 14,517 Share Premium Account 0 26,342 Cumulative translation adjustments 0 1 Other reserves -22,026 2,035 Retained earnings -31,542 -29,953 Result of the period (June - November 2006) -5,395 Equity attributable to equity holders of the parent 37,012 12,942 Minority interests 0 0 Total Equity 37,012 12,942 Retirement benefit obligations 9 9 Non-Current Liabilities 9 9 Trade payables 887 324 Current tax payable 0 0 Other current liabilities 319 1,561 Current Liabilities 1,206 1,885 Total Equity and Liabilities 38,227 14,836
(*) ThromboGenics Ltd Group’s consolidated balance sheet prepared in accordance with IFRS
ThromboGenics NV Unaudited Consolidated Statement of Cash Flows For the period ended 5 months 6 months 11 months 12 months ended In ‘000 Euros, except per share amounts Jan - May June- Nov. Jan - Nov. December 2006(*) 2006 2006 (**) 2005 (***) According to IFRS Operating activities Operating loss for the year -2,921 -5,395 -8,316 -4,307 Financial income -91 -354 -445 -790 Financial expenses 236 76 312 64 Depreciation of property, plant and equipment 101 129 230 232 Amortisation of intangible assets 906 181 1,087 2,175 Gain on disposal of property, plant and equipment 0 1 1 Share based payment expenses 289 644 933 555 Operating cash flows before movements in working capital -1,480 -4,718 -6,198 -2,071 Decrease in inventory 0 0 0 7 (Increase) / decrease in receivables 1,196 -981 215 -333 Increase / (decrease) in payables -21 -658 -679 149 Cash absorbed by operations -305 -6,357 -6,662 -2,248 Income taxes (paid)/received 0 0 64 Net cash used in operating activities -305 -6,357 -6,662 -2,184 Investing activities Proceeds on disposal of current investments 0 49 49 113 Proceeds on disposal of property, plant and equipment 0 5 5 0 Interest and similar income 90 327 417 264 Purchases of property, plant and equipment -117 -26 -143 -301 Purchases of current investments 0 0 -218 Net cash (used) from investing activities -27 355 328 -142 Financing activities 0 31,331 31,331 0 Interest paid 0 0 -11 Net cash (used) from finance activities 0 31,331 31,331 -11 Net decrease/(increase) in cash and cash activities -332 25,329 24,997 -2,337 Cash and cash equivalents at the beginning of the year 8,894 8,399 8,894 10,701 Effect of foreign rate changes -163 -51 -214 530 Cash and cash equivalents at the end of the year 8,399 33,677 33,677 8,894
(*) These pro-forma figures are communicated for information and comparison purposes only. They represent the results of the operations of the former holding ThromboGenics Ltd and its subsidiaries (Thromb-X NV and ThromboGenics Inc.)
(**) This Consolidated Profit & Loss represents the operations of ThromboGenics NV from its incorporation on May 31, 2006 to end of November. It includes the operations of its subsidiaries (Thromb-X NV, ThromboGenics Ltd and ThromboGenics Inc) from January-November 2006.
(***) For reasons of consistency and comparison, these figures are the consolidated FY 2005 figures of the former ThromboGenics Ltd Group as presented in the IPO Prospectus
ThromboGenics NV
CONTACT: For further information please contact: ThromboGenics: Prof.Desire Collen, CEO, Chris Buyse, Chief Financial Officer, Tel:+32-(0)-16-34-61-94, Fax: +32-(0)-16-34-61-34. Citigate Dewe Rogerson:David Dible / Valerie Auffray, Tel: +44-(0)207-638-95-71
