LEUVEN, Belgium, August 27 /PRNewswire-FirstCall/ -- 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

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