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ThromboGenics NV (TBGNF) Business Update H1 2014



8/27/2014 11:19:10 AM

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REGULATED INFORMATION

Financial

  • Revenues of €7.1 million in the first half of 2014, compared with €102.7 million in the same period in 2013 (including €90 million in milestone payments)
  • Gross profit of €6.6 million
  • Financial income of €0.6 million
  • Net loss of €23.9 million in the first six months of 2014, against €54.6 million net profit in the first six months of 2013
  • Cash and investments of €148.8 million as of the end of June 2014, compared with €156.9 million at the end of March 2014

Strategy

  • In June 2014, ThromboGenics announced its intention to maintain an independent business strategy to deliver value for all of the Company's stakeholders. This Board decision followed a Strategic Review which evaluated a broad range of strategic options.
  • The implementation of the standalone strategy has led to organizational changes focusing on the optimal level of resources needed for commercializing JETREA® (ocriplasmin) in the US and the further clinical development of this novel drug in the US. At the same time medical affairs, market access and pre-clinical research activities in Europe have been significantly reduced. As a result of these changes ThromboGenics has around 150 employees, versus 192 on December 31, 2013.
  • These changes are designed to allow ThromboGenics to achieve profitability in the US by 2016, based on JETREA® sales of around €30 million.
  • The Company targets to become cash flow positive by 2017, and to achieve total revenues of €100 million by 2019.

JETREA® in the US

  • US sales of JETREA® (ocriplasmin) in the first-half of 2014 reached €5.0 million.
  • ThromboGenics marketing and sales efforts will be focused on Key Accounts as it seeks to expand the use of JETREA®. These accounts represent Retina Specialists who are satisfied with the clinical results of JETREA® and are using the product based on appropriate patient selection criteria. We believe this focus on appropriate patient selection is critical to delivering the drug's important value in the treatment of symptomatic VMA.
  • ThromboGenics continues to gather real-world data on JETREA® to support its use: ORBIT study progressing well with 97 centers now activated; OZONE study started recently to assess the anatomic and symptomatic changes that potentially occur in the six months immediately after treatment with JETREA®.

JETREA® outside the US

  • ThromboGenics' partner Alcon, now in conjunction with Novartis, continues to commercialize JETREA® across Europe against the background of a positive reimbursement environment
  • First approvals for JETREA® granted in Asia and South America

Research & Development

  • Following its decision to further develop JETREA® in diabetic retinopathy in the US, ThromboGenics has initiated a tendering process for a CRO to assist in conducting a Phase II trial with JETREA® in diabetic retinopathy in the US. This study is designed to assess the utility of the product in this significantly underserved patient population.
  • ThromboGenics has decided to spin out its cancer R&D activities. According to plan, a new company will be formed in partnership with VIB (Flanders Institute for Biotechnology) which will seek external funding. The Company will have an equity stake in this new venture that will focus on pediatric oncology. Further details will be provided in the month of September.

Corporate

  • Paul G. Howes appointed as Executive Chairman of ThromboGenics, Inc., and as member of ThromboGenics NV's Board of Directors
  • Ed Kessig appointed US Head of Commercial, and member of the ThromboGenics Executive Team.
  • A new commercial business structure has been implemented in the United States with a focused field team while simultaneously creating a new team of Strategic Account Managers
  • Several Market Access and Medical Affairs positions in Europe associated with supporting our non-US / RoW Alcon partnership are being phased out as the tasks are taken over by Alcon
  • ThromboGenics' Irish branch will be closed by end of October 2014
  • R&D organization reorganized in line with the outcome of a project portfolio review
  • Chris Buyse, ThromboGenics' former Chief Financial Officer and Board Member, resigned from the Company and the Board at the end of June to pursue other interests. Luc Philips, former CFO of KBC group and Board Member of ThromboGenics, appointed interim CFO, effective 1 July. Company conducting international search for a permanent CFO

LEUVEN, Belgium, Aug. 28, 2014 (GLOBE NEWSWIRE) -- 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, 2014.

The Company announced in June that following a review of strategic options the Board concluded that it was in the best interest of the Company and its shareholders to continue as an independent business.

ThromboGenics' strategy is focused on:

  • Driving the sales of JETREA® in the US
  • Supporting Alcon, in conjunction with Novartis, to develop the sales of JETREA® outside the US
  • Creating further value by supporting the approved indications for JETREA® and developing new indications in the US, and
  • Progressing its pipeline in earlier stage projects focused on diabetic eye disease

The commercial success of JETREA® in the US is at the heart of this strategy. To achieve this goal the Company is focusing on increasing the number of Strategic Key Accounts that use JETREA® consistently for the treatment of patients with symptomatic VMA. It has recently strengthened its US commercial capability with the appointments of Ed Kessig as US Head of Commercial, and Paul G. Howes, who has joined the Company as the Executive Chairman of ThromboGenics, Inc. The board of directors will propose to the next shareholders meeting to appoint Mr Howes as member of the ThromboGenics NV's Board of Directors.

ThromboGenics is continuing to assist its partner Alcon which, in conjunction with its parent company Novartis, is commercializing JETREA® outside the US.

As part of its plans to build further value from JETREA®, ThromboGenics is beginning to investigate this novel medicine for the treatment of diabetic retinopathy.

ThromboGenics developed JETREA®, the first and only pharmacological treatment indicated for an important sight-threatening condition, symptomatic vitreomacular adhesion (VMA)/vitreomacular traction (VMT) as known in the US and Europe respectively. Symptomatic VMA/VMT is a progressive, sight-threatening condition that may lead to visual distortion, decreased visual acuity and central blindness. ThromboGenics launched JETREA® in the US in early 2013 through its own commercial organization.

Dr Patrik De Haes, ThromboGenics' CEO, said: "We have adapted our organizational structure so that we are in position to achieve profitability in the US in 2016, based on sales of JETREA of around €30 million and to become overall cash flow positive in 2017.Our longer term target is to achieve overall revenues of €100 million by 2019. With our current cash of €148.8 million, we are in a position to achieve these targets while maintaining a good level of cash over this period. We are encouraged by the initial success of our Strategic Key Accounts focused marketing and sales approach and believe that these centers will form a strong platform to establish JETREA® as a treatment for patients with symptomatic VMA. In parallel, we are continuing to conduct studies that will deliver additional real-world data to demonstrate to the retina community the clear benefits and value of using JETREA®.

"These efforts give us confidence that in time we will be able to capture JETREA®'s significant commercial potential in the US. As part of our strategy we will be investing in developing JETREA® for diabetic retinopathy in the US as we look to expand the long term value that we can generate from this unique medicine."

For further information please contact:

ThromboGenics

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

David Dible/ Sita Shah

Tel: +44 20 7638 9571
sita.shah@citigatedr.co.uk

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 less than or equal to 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 with most adverse events being transient and mild in severity.

About ThromboGenics

ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic and oncology 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 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.

ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States. ThromboGenics and Alcon intend to share the costs equally of developing JETREA® for a number of new vitreoretinal indications.

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

ThromboGenics is headquartered in Leuven, Belgium, and has an office in Iselin, NJ (US). The Company is listed on the NYSE Euronext Brussels exchange 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.

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.

ThromboGenics Interims 2014 http://hugin.info/137324/R/1851969/647075.pdf

HUG#1851969

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