2014

ThromboGenics Announces Business Update and 2012 Full-Year Results

LEUVEN, Belgium, March 14, 2013 /PRNewswire/ --

Transformational 2012 Delivers Euro 30 Million in Net Profit

REGULATED INFORMATION

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today issued a business update and its financial results for the full year ending December 31, 2012.

The past 12 months have been a defining period for ThromboGenics, resulting in the approval and launch of its lead drug JETREA® (ocriplasmin) in the US. US patients and physicians now have access to the first pharmacological treatment for the sight-threatening condition symptomatic vitreomacular adhesion (VMA). The launch of JETREA® has completed ThromboGenics' transformation into an integrated company with operations in R&D through to full-scale commercialization.  

ThromboGenics expects 2013 to be another crucial year as JETREA® gains more traction in the US and Europe, if approved.  

2012 Highlights (including post-period events):

JETREA®(ocriplasmin)

Commercializing JETREA®in the US

  • JETREA® was launched in the US on 14 January 2013 after the US Food and Drug Administration (FDA) approved it as the first pharmacological treatment of symptomatic vitreomacular adhesion (VMA)
  • Highly focused commercial team, including specialist salesforce, is now working to drive the US sales of JETREA®
  • Structure in place to help US physicians process reimbursement claims for JETREA®

Major strategic partnership alliance with Alcon in Europe and ROW

  • ThromboGenics entered into a €375 million strategic commercialization agreement with Alcon (Novartis) for the commercialization of ocriplasmin outside the US.
  • ThromboGenics received €75 million in an upfront payment
  • It is eligible for a further €90 million in potential near-term milestone payments, potential further milestones of €210 million, plus additional significant royalties on Alcon's sales of JETREA® outside the US.
  • ThromboGenics and Alcon are to share the costs equally of the further development of JETREA®, including new formulations and new indications  

  • In January 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency granted a positive opinion for JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns, paving the way for the product's potential EU approval

Financial

  • ThromboGenics raises €77.9 million through a private placement via the issue of 3,244,675 new shares in April 2012
  • Positive Belgian tax authority ruling in June 2012 has enabled ThromboGenics to benefit from a "patent income deduction regime" and, therefore, from a reduced tax rate for all patent-related JETREA® income
  • €148.2 million in cash and cash investments as of 31 December 2012, compared with €80.4 million at the end of December 2011
  • €75.1 million in total revenue in 2012, compared with €2.5 million in 2011
  • Net profit of €30.4 million in 2012, equivalent to diluted earnings per share of €0.84. In 2011, the Company reported a net loss of €21.6 million, equivalent to a diluted loss per share of €0.67

Dr Patrik De Haes, CEO of ThromboGenics, said: "The past 12 months have been the most important period in ThromboGenics' history. The recent launch of JETREA® has completed our transformation into a profitable fully integrated company focused on developing and commercializing innovative ophthalmic medicines. We are delighted that US patients and physicians now have access to JETREA® which is the first pharmacological treatment for symptomatic VMA, an important sight-threatening condition. Initial reactions from retinal physicians and patients to this novel treatment option have been positive and our commercial organization is now focused on building sales of JETREA®."

"Our partnership agreement with Alcon is progressing well and we anticipate gaining EU approval for JETREA® shortly. We are working with Alcon to finalize our reimbursement strategies in the five largest markets in Europe so we are well positioned for the JETREA® launch, which is expected in the first half of 2013. Over the next 12 months we expect to generate further shareholder value as the US sales of JETREA® continue to build and we receive further milestones and the first royalties from Alcon as this novel pharmacological treatment option for symptomatic VMA is commercialized in Europe."  

The full report can be accessed at: http://www.thrombogenics.com/content/thrombogenics-announces-business-update-and-2012-full-year-results

About JETREA® (ocriplasmin)

JETREA®(ocriplasmin) is a truncated form of human plasmin. In the US, JETREA® is indicated for the treatment of symptomatic VMA. In Europe, the CHMP granted a positive opinion for JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter ≤ 400 microns.

JETREA® is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.

JETREA® has been evaluated in two multi-center, randomized, double-masked phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.

JETREA®'s phase III program found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01).

The phase III program also showed that JETREA® was generally well tolerated. Any adverse reactions were ocular. The most commonly reported were vitreous floaters, eye pain and photopsia, as well as conjunctival haemorrhage resulting from the injection procedure. Most of the adverse reactions occurred within the first week after the injection. The majority of these reactions were non-serious, mild in intensity and resolved within 2 to 3 weeks.[1]  

About ThromboGenics

ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, JETREA®(ocriplasmin), has been approved by the US FDA for the treatment of symptomatic VMA and was launched in January 2013.  

In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of JETREA® outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in upfront and milestone payments. It will receive significant royalties from Alcon's net sales of JETREA®. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.

The JETREA® European Marketing Authorisation Application is currently under review by the European Medicines Agency. Following the positive CHMP recommendation, a final decision by the European Commission on European approval is expected in the first half of 2013.

ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403, for the treatment of ophthalmic and oncology indications.

ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, NJ (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at http://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.

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1. Stalmans P, Benz MS, Gandorfer A et al. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med 2012;367:606-615

This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of ThromboGenics in any jurisdiction. No securities of ThromboGenics may be offered or sold within the United States without registration under the US Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable US state securities laws.

For further information please contact:

Wouter Piepers, Global Head of Corporate Communications
+32-16-75-13-10 / +32-478-33-56-32
wouter.piepers@thrombogenics.com

Dr. Patrik De Haes, CEO
+32-16-75-13-10
Patrik.dehaes@thrombogenics.com

Chris Buyse, CFO
+32-16-75-13-10
Chris.buyse@thrombogenics.com


Citigate Dewe Rogerson

David Dible/ Nina Enegren/ Sita Shah
Tel: +44-20-7638-9571  
sita.shah@citigatedr.co.uk

The Trout Group (US investor relations)

Todd James/ Simon Harnest
Tel: +1-646-378-2926
tjames@troutgroup.com


SOURCE ThromboGenics NV



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