ThromboGenics Announces Business Update and 2012 Full-Year Results
LEUVEN, Belgium, March 14, 2013 /PRNewswire/ –
Transformational 2012 Delivers Euro 30 Million in Net Profit
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(R) (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(R) 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(R) gains more traction
in the US and Europe, if approved.
2012 Highlights (including post-period events):
Commercializing JETREA(R)in the US
- JETREA(R) 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(R) - Structure in place to help US physicians process reimbursement claims for JETREA(R)
Major strategic partnership alliance with Alcon in Europe and ROW
- ThromboGenics entered into a EUR375 million strategic commercialization agreement with Alcon (Novartis) for the commercialization of ocriplasmin outside the US. - ThromboGenics received EUR75 million in an upfront payment - It is eligible for a further EUR90 million in potential near-term milestone payments, potential further milestones of EUR210 million, plus additional significant royalties on Alcon's sales of JETREA(R) outside the US. - ThromboGenics and Alcon are to share the costs equally of the further development of JETREA(R), 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(R) 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
- ThromboGenics raises EUR77.9 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(R) income - EUR148.2 million in cash and cash investments as of 31 December 2012, compared with EUR80.4 million at the end of December 2011 - EUR75.1 million in total revenue in 2012, compared with EUR2.5 million in 2011 - Net profit of EUR30.4 million in 2012, equivalent to diluted earnings per share of EUR0.84. In 2011, the Company reported a net loss of EUR21.6 million, equivalent to a diluted loss per share of EUR0.67
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(R) 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(R) 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(R).”
“Our partnership agreement with Alcon is progressing well and we anticipate gaining EU
approval for JETREA(R) 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(R) 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(R) 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:
JETREA(R)(ocriplasmin) is a truncated form of human plasmin. In the US, JETREA(R) is
indicated for the treatment of symptomatic VMA. In Europe, the CHMP granted a positive
opinion for JETREA(R) for the treatment of vitreomacular traction (VMT), including when
associated with macular hole of diameter less than or equal to 400 microns.
JETREA(R) 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(R) 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(R)’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(R) 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
ThromboGenics is an integrated biopharmaceutical company focused on developing and
commercializing innovative ophthalmic medicines. The Company’s lead product,
JETREA(R)(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(R) outside the United States. Under this agreement,
ThromboGenics could receive up to a total of EUR375 million in upfront and milestone
payments. It will receive significant royalties from Alcon’s net sales of JETREA(R).
ThromboGenics and Alcon intend to share the costs equally of developing JETREA(R) for a
number of new vitreoretinal indications.
The JETREA(R) 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
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
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 email@example.com Dr. Patrik De Haes, CEO +32-16-75-13-10 Patrik.firstname.lastname@example.org Chris Buyse, CFO +32-16-75-13-10 Chris.email@example.com Citigate Dewe Rogerson David Dible/ Nina Enegren/ Sita Shah Tel: +44-20-7638-9571 firstname.lastname@example.org The Trout Group (US investor relations) Todd James/ Simon Harnest Tel: +1-646-378-2926 email@example.com
SOURCE ThromboGenics NV