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Oxurion NV — Earnings Release 2010
Mar 10, 2011
3987_er_2011-03-10_b7a73da4-3496-4dbe-836d-d78f9fcba6b7.pdf
Earnings Release
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REGULATED INFORMATION
ThromboGenics Announces Business Update and 2010 Full-Year Results
Leuven, Belgium – 10 March, 2011 - 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, 2010.
The past 12 months have been a pivotal year for ThromboGenics as it achieved its most significant milestones to date, positive results from two Phase III trials with its lead product ocriplasmin (microplasmin). These clinical results have provided greater impetus to ThromboGenics' strategy of becoming a strong, profitable and integrated biopharmaceutical company, with a focus on innovative ophthalmic medicines.
2010 Highlights include:
- Positive results from two pivotal Phase III trials with ocriplasmin, for the treatment of symptomatic vitreomacular adhesion (sVMA). These trials also showed that ocriplasmin was able to close macular holes in approximately 40% of patients.
- TB-402, a novel, long-acting anticoagulant, reported promising Phase II data for venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. TB-402 is an antibody which inhibits Factor VIII.
- Development partner Roche announced plans to start two clinical trials in the first quarter of 2011:
- o Phase Ib/II trial with the anticancer agent TB-403 (anti-PIGF) in combination with the Roche antibody Avastin in patients with glioblastoma multiforme (brain tumor), and
- o Phase Ib trial with TB-403 in combination with sorafenib (Nexavar) in patients with hepatocellular cancer.
- Raised €56 million (gross) in a private placement in December.
During the year, the Company recruited a number of highly experienced people in core areas such as regulatory affairs and marketing as it prepares to commercialize ocriplasmin in the U.S. and Europe through its own organization.
These achievements have put ThromboGenics in an excellent position to deliver its strategic objectives.
Patrik De Haes, CEO of ThromboGenics, commenting on today's announcement, said: "We achieved robust results across all areas of our business in 2010, a credit to the dedication and hard work of the entire ThromboGenics team. Our lead product ocriplasmin has demonstrated significant benefit in treating patients whose vision has been impaired due to VMA. These clinical results will form a key part of our planned regulatory filings of ocriplasmin in the U.S. and Europe in the latter part of 2011. We are also continuing to invest in the multidisciplinary team that we will need to ensure ocriplasmin's successful commercialization."
"I am also pleased with the progress of our other key pipeline programs. TB-402 has delivered positive Phase II data in preventing VTE in a post-surgical setting and we are delighted that Roche is committed to advancing the development of TB-403. Our fundraising in late 2010 has given us sufficient resources to bring ocriplasmin to market ourselves and to maximize the value of our pipeline."
ThromboGenics is confident that it can continue to deliver significant returns for its shareholders over the next 24 months, as it prepares for the commercial launch of ocriplasmin.
Business Highlights
Ocriplasmin – Positive Phase III Results in sVMA:
- Positive Phase III data evaluating ocriplasmin for the pharmacological treatment of symptomatic vitreomacular adhesion (sVMA). During 2010, ThromboGenics reported consistent data from two pivotal trials, TG-MV-006 (U.S.) and TG-MV-007 (Europe and U.S.). Both trials met their primary endpoint of achieving a statistically significant improvement in the resolution of VMA compared with placebo.
- The pooled Phase III results showed that ocriplasmin:
- Resolved sVMA in close to 30% of patients
- Closed full thickness macular hole in 40% of patients
- Increased rate of clinically meaningful improvement in visual acuity and visual function
- Improved Quality of Life when compared with placebo, based on the VFQ-25 (the National Eye Institute Visual Functioning Questionnaire) results
- Was generally safe and well tolerated
Retinal specialists have presented the results at key ophthalmic conferences in North America and Europe. Further presentations of the results from the pivotal Phase III program are scheduled throughout 2011.
- U.S. and EU filings planned for 2nd half of 2011. ThromboGenics expects to file ocriplasmin with the FDA and the EMA in the 2nd half of 2011. Following initial discussions with the regulatory authorities, ThromboGenics is currently generating additional non-clinical data which will support its regulatory submissions. The Company believes that the inclusion of these data will lead to a more timely review process.
- Ocriplasmin is now the international nonproprietary name (INN) for what was formerly known as microplasmin.
sVMA – The Background
The vitreous (the central gel part of the eye) separates from the retina (back of the eye) as part of the normal aging process. This separation is called "posterior vitreous detachment" (PVD). However, if the separation is not complete, areas of focal attachment or vitreomacular adhesion (VMA) can occur.
VMA (traction) is a condition where the vitreous forms an abnormally strong adhesion to the surface of the macula. When VMA leads to symptoms such as distorted vision or visual impairment, it is called symptomic vitreomacular adhesion (sVMA).
The current standard of care for sVMA is either observation ("watch and wait") or a vitrectomy if the patient's vision deteriorates to the point that it affects their ability to carry out normal daily tasks. A vitrectomy is a surgical procedure that releases VMA, and is the only currently available treatment option for sVMA.
VMA can lead to the development of sight-threatening complications, such as macular puckers and macular holes. These can lead to distorted vision, a loss of visual acuity and/or blindness if left untreated.
There is also evidence that VMA is associated with several common eye disorders that can potentially cause blindness, including age-related macular degeneration and diabetic retinopathy.
- Preparing for the commercialization of ocriplasmin in the U.S. and Europe. ThromboGenics is building an experienced multidisciplinary team in order to plan and prepare for the launch of ocriplasmin through its own sales and marketing organization. In the last few months, the Company has appointed several key personnel to lead the team.
- Ram Palanki, PharmD Head of US Marketing for ocriplasmin. Ram was most recently Global Director for Marketing and Sales, Ophthalmology at Neovista Inc. He also helped to develop and launch the wet AMD treatments Lucentis® (Genentech's ranibizumab) and Macugen® (Eyetech Inc's pegaptanib sodium).
- Paul de Nijs, DvetMed Head of Market Access. He was previously Vice President, Health Economics and Pricing Global at Johnson & Johnson.
- Aniz Girach, MD and a retinal surgeon Head of Medical Ophthalmology. He was most recently Vice President, International Clinical Development Ophthalmology at Alcon Laboratories, Inc and has held senior ophthalmic roles at Merck and Eli Lilly.
ThromboGenics has also added experienced personnel in regulatory affairs, CMC and other disciplines needed to support the regulatory filings for ocriplasmin.
• Long-term commercial supply agreement for ocriplasmin. In September 2010, ThromboGenics signed a 10-year commercial supply agreement with MSD Biologics (UK) Ltd, part of the Merck Biomanufacturing Network, to meet its long-term commercial supply needs for ocriplasmin. MSD Biologics, a contract manufacturing organization with specific expertise in microbialderived biologics, has been producing ocriplasmin for ThromboGenics' clinical trial program since 2007. It will produce ocriplasmin at its FDA and EMA approved Billingham facility (UK). It has recently been announced that FUJIFILM Corporation will acquire MSD Biologics (UK) Ltd from Merck & Co., Inc.
ThromboGenics' Other Key Clinical Development Programs Progress
• TB-402 (Anti-Factor VIII Antibody) – A novel, long-acting anticoagulant: Positive Phase II results in patients undergoing orthopaedic surgery. In May, ThromboGenics reported promising Phase II data for TB-402, a novel, long-acting anticoagulant in development as a single intravenous injection for the prevention of venous thromboembolism (VTE) following orthopaedic surgery. It is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade.
The 315-patient study evaluated the efficacy and safety of three doses of TB-402 (0.3 mg/kg, 0.6 mg/kg and 1.2 mg/kg) against Lovenox (enoxaparin), a low molecular weight heparin, marketed by sanofi-aventis.
The positive pooled results of the three doses of TB-402 showed a 22% incidence of total VTE compared with 39% for enoxaparin (p<0.05). In addition, TB-402 was generally well tolerated and demonstrated comparable safety to enoxaparin. The results of this Phase II study were published in the Journal of Thrombosis and Haemostasis in February 20111 .
TB-402 has the potential to be an important new entrant in the anticoagulant market. A single dose of TB-402 could improve the prophylaxis of VTE after orthopaedic surgery by providing a stable, long-acting antithrombotic effect. Consequently, its ease of use for the surgeon and the compliance benefits for the patient could potentially become part of the standard post-surgical approach to the prophylaxis of VTE.
ThromboGenics and co-development partner BioInvent International are planning a Phase IIb study evaluating TB-402 against Xarelto (rivaroxaban) for the prophylaxis of VTE after total hip replacement surgery. The study is expected to start shortly.
ThromboGenics' goal remains to partner TB-402 for further development, given the size of the anti-coagulant market and the number of potential prescribers for this novel long-acting antibody.
• TB-403 - Anticancer: Roche to initiate two new clinical studies. In late 2010, development partner Roche announced plans to start a Phase Ib/II trial with TB-403 in combination with its Avastin (bevacizumab) in patients with glioblastoma multiforme. The trial is expected to start in March 2011.
The multi-center, Phase Ib/II trial will examine the safety and clinical effect of TB-403 in combination with Avastin in patients with recurrent glioblastoma. Secondary objectives include safety, tolerability and pharmacokinetics of the combination. The trial will also include an evaluation of candidate biomarkers. The study will recruit 80-100 patients.
Roche is also expected to start a Phase Ib study with TB-403 in combination with sorafenib in patients with hepatocellular carcinoma. The trial, which will recruit 60-70 patients, will evaluate the safety, pharmacokinetics and pharmacodynamics of this potential combination treatment.
1 "Single Intravenous Administration of TB-402 for the prophylaxis of Venous thromboembolism after Total Knee Replacement: A Dose-Escalating, Randomised, Controlled Trial", Peter Verhamme, MD, Marco Tangelder, MD, Raymond Verhaeghe, MD, Walter Ageno, MD, Steven Glazer, MD, Martin Prins, MD, Marc Jacquemin, MD, Harry Büller, MD, JTH.
Financial Highlights
- In December, ThromboGenics raised €56 million (gross) through a private placement. This was via the issue of 2,944,523 new shares (9.99% of the outstanding shares) to domestic and international investors, including the U.S., at a price of €19.00 per share.
- In 2010, ThromboGenics' revenue amounted to €6.2 million (2009: €4.2 million). This revenue is mainly due to milestone payments from Roche in relation to TB-403. Net operating costs were €23.7 million in 2010 compared with €23.7 million in 2009. The net loss for 2010 amounted to €13.9 million against a net loss of €14.1 million for 2009.
- ThromboGenics expects to see an increase in its operating expenses in 2011 as it prepares for the regulatory filing of ocriplasmin for sVMA in the second half of 2011. In addition, the Company expects to make further investments in the ocriplasmin supply chain and in its commercial infrastructure ahead of the product's launch.
- As of 31 December 2010, ThromboGenics had €109.2 million in cash and cash investments. This compares with €76.7 million in cash and cash investments at December 31, 2009. This level of cash resources is expected to allow ThromboGenics to drive forward its operational plans for at least the next two years.
Financial Overview
Revenue and Results
In 2010, ThromboGenics achieved total revenue of €6.2 million, mainly as a result of milestone income from Roche. In 2009, total revenue amounted to €4.2 million.
In 2010, gross profit amounted to €5.6 million due to the increased level of milestone income. In 2009, ThromboGenics achieved a gross profit of €3.9 million.
R&D expenses in 2010 were €17.9 million compared with €19.5 million in 2009. This continued high level of expenditure was due to the number of the late-stage clinical trials that were on going in 2010. In addition, €8.5 million of the costs related to the ocriplasmin Phase III MIVI-TRUST clinical program have been capitalized. This compares with €15.3 million in the corresponding period in 2009.
In 2010, ThromboGenics had an operating loss of €14.7 million, due to this high level of R&D investment. In 2009, the Company had an operating loss of €15.0 million.
ThromboGenics achieved net financial income of €0.7 million in 2010. In 2009, the Company had net financial income of €0.9 million.
In 2010, ThromboGenics had a pre-tax loss of €13.9 million. This compares with a pre-tax loss of €14.0 million in 2009.
The reported net loss in 2010 was €13.9 million or €0.47 diluted loss per share. In 2009, the Company had a net loss of €14.1 million, equivalent to diluted loss per share of €0.53.
Financial Position and Cash Flow
As of 31 December 2010, ThromboGenics had €109.2 million in cash and cash investments. This compares with €76.7 million in cash and cash investments at 31 December 2009. The increase in cash resources is in part due to the €56 million (gross) raised through a private placement that took place in December 2010. This level of funding will allow ThromboGenics to support its business for at least the next two years.
At the end of 2010, ThromboGenics had total shareholder equity of €138.2 million, up from €93.7 million at the end of 2009.
FINANCIAL INFORMATION
1.1.Consolidated income statement
| In '000 euro (for the year ended on 31 | 2010 | 2009 |
|---|---|---|
| December) | ||
| Income | 6,175 | 4,213 |
| License income | 6,067 | 3,542 |
| Income from royalties | 66 | 54 |
| Other income | 42 | 617 |
| Cost of sales | -540 | -270 |
| Gross profit | 5,635 | 3,943 |
| Research and development expenses | -17,945 | -19,476 |
| General and administrative expenses | -3,963 | -3,739 |
| Selling expenses | -1,815 | -462 |
| Other operating income | 3,428 | 4,747 |
| Operating result | -14,660 | -14,987 |
| Finance income | 946 | 1,326 |
| Finance costs | -206 | -381 |
| Result before income tax | -13,920 | -14,042 |
| Income tax expense | -22 | -28 |
| Net result for the period | -13,942 | -14,070 |
| Attributable to: | ||
| Equity holders of the company | -13,942 | -14,070 |
| Result per Share | ||
| Basic earnings per share (euro) | -0.47 | -0.53 |
| Diluted earnings per share (euro) | -0.47 | -0.53 |
1.2.Consolidated statement of comprehensive income
| In '000 euro (for the year ended on 31 December) | 2010 | 2009 |
|---|---|---|
| Result of the period | -13,942 | -14,070 |
| Net change in fair value of available-for-sale financial assets | -13 | 0 |
| Exchange differences on translation of foreign operations | 19 | -27 |
| Other comprehensive income, net of income tax | 6 | -27 |
| Total comprehensive income for the period | -13,936 | -14,097 |
| Attributable to: | ||
| Equity holders of the company | -13,936 | -14,097 |
| In '000 euro (for the year ended on 31 December) | 2010 | 2009 |
|---|---|---|
| ASSETS | ||
| Property, plant and equipment | 894 | 1,042 |
| Intangible assets | 25,832 | 17,357 |
| Goodwill | 2,586 | 2,586 |
| Other financial assets | 75 | 53 |
| Employee benefits | 73 | 73 |
| Non-current assets | 29,460 | 21,111 |
| Trade and other receivables | 4,322 | 3,437 |
| Investments | 23,289 | 742 |
| Cash and cash equivalents | 85,866 | 75,929 |
| Current assets | 113,477 | 80,108 |
| Total assets | 142,937 | 101,219 |
| EQUITY AND LIABILITIES | ||
| Share capital | 138,095 | 125,122 |
| Share premium | 90,902 | 46,520 |
| Accumulated translation differences | 20 | 1 |
| Other reserves | -18,856 | -19,896 |
| Retained earnings | -71,971 | -58,029 |
| Equity attributable to equity holders of the | 138,190 | 93,718 |
| company | ||
| Minority interests | ||
| Total equity | 138,190 | 93,718 |
| Trade payables | 4,034 | 6,688 |
| Other short-term liabilities | 713 | 813 |
| Current liabilities | 4,747 | 7,501 |
| Total equity and liabilities | 142,937 | 101,219 |
1.3.Consolidated statement of financial position
| In '000 euro (for the year ended on 31 December) | 2010 | 2009 |
|---|---|---|
| Cash flows from operating activities | ||
| (Loss) profit for the period | -13,942 | -14,070 |
| Finance costs | 206 | 381 |
| Finance income | -946 | -1,326 |
| Depreciation on property, plant and equipment | 426 | 490 |
| Gain on sale of property, plant and equipment | 0 | -12 |
| Equity settled share-based payment transactions | 1,053 | 658 |
| Change in trade and other receivables including tax receivables | -885 | -910 |
| Change in short-term liabilities | -2,754 | 2,691 |
| Net cash (used) from operating activities | -16,842 | -12,098 |
| Cash flows from investing activities | ||
| Disposal of property, plant and equipment | 10 | 6 |
| Change in investments | -22,547 | 27,823 |
| Interest received and similar income | 712 | 702 |
| Acquisition of intangible assets | -8,475 | -15,265 |
| Acquisition of property, plant and equipment | -288 | -534 |
| Acquisition of other financial assets | -22 | -53 |
| Net cash (used in) generated by investing activities | -30,610 | 12,679 |
| Cash flows from financing activities | ||
| Proceeds from issue of share capital | 57,355 | 44,764 |
| Paid interests | -6 | -11 |
| Net cash (used in) generated by financing activities | 57,349 | 44,753 |
| Net change in cash and cash equivalents | 9,897 | 45,334 |
| Cash and cash equivalents at the start of the period | 75,929 | 30,356 |
| Effect of exchange rate fluctuations | 40 | 239 |
| Cash and cash equivalents at the end of the period | 85,866 | 75,929 |
1.4.Consolidated statement of cash flow
| 1.5. 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 2009 | 111,338 | 15,837 | 28 | -20,851 | -43,959 | 62,393 | 0 | 62,393 |
| Net loss 2009 | -14,070 | -14,070 | -14,070 | |||||
| Change to foreign currency translation differences |
-27 | -27 | -27 | |||||
| Conversion of warrants by ThromboGenics Ltd |
2,785 | 2,785 | 2,785 | |||||
| Contribution in kind ThromboGenics Ltd |
||||||||
| shares | 2,488 | -2,488 | 2,785 | -2,785 | 0 | |||
| Conversion of warrants by |
||||||||
| ThromboGenics NV | 576 | 302 | 878 | 878 | ||||
| Share-based payment transacions |
658 | 658 | 658 | |||||
| Issue of ordinary |
||||||||
| shares | 10,720 | 30,381 | 41,101 | 41,101 | ||||
| Balance sheet as at | ||||||||
| 31 December 2009 | 125,122 | 46,520 | 1 | -19,896 | -58,029 | 93,718 | 0 | 93,718 |
| Net loss 2010 | -13,968 | -13,968 | -13,968 | |||||
| Change to foreign currency translation |
||||||||
| differences | 19 | 19 | 19 | |||||
| Net change in fair value of investments |
||||||||
| Conversion of |
13 | 13 | 13 | |||||
| warrants by |
||||||||
| ThromboGenics NV | 1,735 | 1,684 | 3,419 | 3,419 | ||||
| Share-based | ||||||||
| payment transacions | 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 | -18,830 | -71,997 | 138,190 | 0 | 138,190 |
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 -
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 95 71
About ThromboGenics
ThromboGenics is a biopharmaceutical 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 ocriplasmin (microplasmin) has completed two Phase III clinical trials for the pharmacological treatment of symptomatic vitreomacular adhesion (sVMA). Ocriplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is 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 NYSE 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 forwardlooking statement is contained in the Company's Annual Report.