ThromboGenics Business Update H1 2013

LEUVEN, Belgium, August 29, 2013 /PRNewswire/ --

Conference call and webcast scheduled today at 06:30 PM CET - 12:30 PM EST

  • Total H1 2013 revenue amounted to €102.7 million
  • Profitable first half - net profit of €54.6 million
  • End of June 2013 cash position of €193.6 million
  • JETREA® launched in the US in mid-January: initial US sales H1 2013 (end of June) amounted to €12.5 million ($US 16.6 million)
  • JETREA® approved in EU in March
  • JETREA® launched in April by partner Alcon (Novartis) in the EU - UK, Germany and Scandinavia
  • JETREA® received positive initial NICE recommendation for vitreomacular traction and macular hole
  • Germany's IQWiG confirmed JETREA® demonstrates major added value for the treatment of vitreomacular traction and macular hole
  • JETREA® received approval by Health Canada - first Rest of World (ROW)  and non-European market
  • Phase II trial with ocriplasmin in wet AMD patients showed a positive trend
  • Deal signed to build ophthalmology pipeline: Eleven Biotherapeutics - focus on diabetic macular edema

ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today issues a business and financial update for the six months ending 30 June, 2013.

The first six months of 2013 have been significant in transforming ThromboGenics into an integrated biopharmaceutical company.

In mid-January, the Company launched its lead drug JETREA® (ocriplasmin) in the US through its own commercial organization.

In April, its partner Alcon launched JETREA® in Europe after it was approved by the European Commission in March 2013. In Europe the drug is now available in the UK, Germany and the Nordic region.

ThromboGenics received €90 million in milestone payments from Alcon for the EU approval and first European launch of Jetrea. This funding will enable ThromboGenics to invest in the further development of its ophthalmic franchise anchored by JETREA®.

Earlier this month in August, ThromboGenics' JETREA® also received approval from Health Canada for the treatment of symptomatic vitreomacular adhesion, heralding the first approval for its drug in a market outside the US and Europe.

JETREA®is the first pharmacological treatment indicated for an important sight-threatening condition, symptomatic vitreomacular adhesion (VMA)/ vitreomacular traction (VMT) in the US and Europe respectively. VMT/ VMA is an age-related, progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness.

Highlights (including post-period events):

Financial Update

  • Revenues for the six months ended 30 June 2013 amounted to €102.7 million, compared to €75.1 million for the same period in 2012
  • US sales of JETREA® for the first six months of 2013 amounted to €12.5 million
  • At the end of June 2013, the Company had a cash balance of €193.6 million
  • ThromboGenics reported a net profit of €54.6 million for the first six months of 2013
  • In March, the Company's shares started trading as part of the BEL20 index on the Euronext stock exchange

Commercializing JETREA®(ocriplasmin) in the US

  • ThromboGenics launched JETREA® in the US on 14 January after it was approved as the first and only pharmacological treatment for symptomatic VMA
  • JETREA® offers for the first time a treatment option for patients suffering from symptomatic VMA
  • Highly focused commercial team, including specialty sales force, working to build the US sales of JETREA® and to increase awareness of the benefits of treating symptomatic VMA
  • ThromboGenics reimbursement support team in place to aid US physicians gain reimbursement for JETREA® and assist qualified patients with potential co-pay burdens.
  • Permanent J-code expected January 1, 2014. A permanent J-code will assist in automated claims adjudication that will result in physicians being reimbursed in a more expedient manner
  • Early response from the US retina community suggests JETREA representing game-changing therapeutic approach for patients suffering from symptomatic VMA. True innovation takes time to find its way to the market and requires further medical education to ensure this novel product delivers its full commercial potential
  • JETREA® US sales at end of June amounted to €12.5 million ($US 16.6 million)
  • JETREA® EU sales royalties at end of June amounted to €0.2 million
  • 51% of total targeted retina practices have ordered JETREA® (vs 40% end of April 2013)
  • 62% of these practices have reordered the product (vs. 50% end of April 2013)
  • To date, the majority of JETREA® has been used in moderate to severe patients

Commercializing JETREA®in Europe and ROW

  • In March 2013, the European Medicines Agency (EMA) approved JETREA® for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns
  • Partner Alcon launched JETREA® in the UK in March, followed by Germany and the Nordic region
  • ThromboGenics received €90 million in milestone payments from Alcon: €45 million for the EU approval of JETREA® and a further €45 million for the first sale of the drug in Europe
  • On August 30, 2013, the UK's National Institute of Health and Care Excellence (NICE) will issue its Final Appraisal Determination (FAD) for JETREA® regarding reimbursement within the National Health Service (NHS) for the treatment of VMT
  • IQWiG, the German body that evaluates a drug's quality and efficiency, has confirmed that JETREA® demonstrates major/significant added value compared with existing comparative treatment, when treating patients with mild/moderate vitreomacular traction (VMT) including when associated with a macular hole of less than or equal to 400 microns. Final guidance IQWiG expected in October 2013.
  • JETREA® receives approval in Canada for the treatment of symptomatic vitreomacular adhesion (VMA)

JETREA®Phase IIa wet AMD trial

  • ThromboGenics has reported positive data from a Phase IIa study showing that JETREA® has potential to resolve VMA in patients with wet age-related macular degeneration (wAMD)
  • In the study (n=100 patients), at Day 28, 24% of the treated patients achieved resolution compared to 12% in the sham injection arm (primary endpoint, p=0.26)
  • No unexpected safety issues were identified, and the safety profile is consistent with the previous pivotal trials' safety data
  • Further studies to evaluate these potential clinical benefits are warranted
  • The full study results will be presented at AAO in November 2013

Dr. Patrik De Haes, CEO of ThromboGenics, said: "ThromboGenics has continued to make good progress delivering a number of key corporate milestones during the first half of 2013. The most important being our US commercial organization's launch of JETREA®, the first pharmacological treatment for the progressive sight-threatening condition symptomatic VMA."

"Since launch we have succeeded in treating approximately 6% of the patients with moderate to severe symptomatic VMA in the US. We will continue to work to build our share of this established market and at the same time look to gradually increase the use of JETREA® in mild to moderate patients, most of whom currently undergo watchful waiting. We believe that JETREA®offers real value to these patients as it provides them with a new option that could prevent them having to experience a deterioration in their visual acuity and quality of life before being treated."

"Outside the US our partner Alcon has achieved a number of key milestones including introducing JETREA® in its first European market in May. It has also received positive health technology assessments in both the UK and Germany that have confirmed the value of JETREA® in treating patients with mild to moderate symptoms of VMA/VMT."

"We remain confident that with JETREA®, we have provided the global retina community with a novel product that in time will play an important role in greatly expanding the number of patients with mild to moderate symptomatic VMA that can be treated pro-actively."

A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO of ThromboGenics, and Chris Buyse, CFO of ThromboGenics, today at 06:30 PM CET, 12:30 PM EST.

The dial-in numbers and participant passcode for the call are set out below:

Belgium          080040305 (Toll Free)
France           0805110270 (Toll Free)
Germany          08001016676 (Toll Free)
Ireland          1800931389 (Toll Free)
Netherlands      08009494524 (Toll Free)
United Kingdom   08002799501 (Toll Free)
United States    (1)8666765866 (Toll Free)

Click here for more international toll and toll free dial in numbers.

Participant pincode: 536961#

We request that participants dial in 5-10 minutes prior to the start time of 06:30 PM CET, 12:30 PM EST.

The presentation will be webcasted live, click here to register.

The presentation and transcript of the call will be made available shortly on http://www.thrombogenics.com under the investor relations tab.

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, JETREA® is indicated 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 U.S. 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 was 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.

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 up-front 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.

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  

In Europe, JETREA® is approved for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. Alcon has launched JETREA® in the UK, Germany and the Nordic Region.

ThromboGenics is also further exploring anti-PIGF (Placental Growth Factor), also referred to as TB-403.

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.

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 U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.

For further information please contact:

ThromboGenics

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(0)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




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