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Oxurion NV Interim / Quarterly Report 2012

May 15, 2012

3987_ir_2012-05-15_119bd500-f58d-461d-b2d5-d3e354c78ed6.pdf

Interim / Quarterly Report

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Regulated Information Disclosure in accordance with the law of May 2, 2007

ThromboGenics NV – Business Update

Leuven, Belgium – 10 May, 2012 – ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on developing innovative ophthalmic medicines, today issued a business update and its first-quarter financial results for the period ending 31 March 2012.

Highlights (including post-quarter events)

Ocriplasmin

  • ThromboGenics signed an important strategic deal with Alcon, the global leader in eye care, to commercialize ocriplasmin outside the U.S. ThromboGenics will receive up to €375 million in upfront and milestone payments plus royalties commensurate with a product that has successfully completed Phase III development and that has been filed for regulatory approval
  • The Company resubmitted a BLA for ocriplasmin, for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole, with the FDA in order to meet the agency's Priority Review timelines. The ocriplasmin Marketing Authorization Application (MAA) was filed with the EMA in Europe in October 2011

Financial Highlights

  • ThromboGenics raised €77.8 million through a private placement with a range of domestic and international investors at a price of €24 per share
  • The Company had €127 million in cash and cash investments as of 31 March 2012 compared with €101.1 million at the end of March 2011. The Q1 2012 figure excludes the proceeds from the private placement which were received in early April
  • Reported revenues of €75 million in the first three months of 2012 versus no revenue in the first three months of 2011

Patrik De Haes, CEO of ThromboGenics, said:

"ThromboGenics has made a positive start to 2012. Our strategic agreement with Alcon, the world leader in eyecare, provides us with the ideal partner to commercialize ocriplasmin outside the U.S. We will also benefit from Alcon's significant clinical development expertise as we jointly fund the evaluation of ocriplasmin for additional ophthalmic indications.

"In March we completed an oversubscribed €77.8 million private placement thanks to the support of both new and existing investors. With these funds, as well as the up-front and potential near-term milestones from Alcon, we will be able to execute the U.S. launch and commercialization of ocriplasmin ourselves, and be in a position to look for in-licensing opportunities to further develop our core ophthalmic franchise. Given these recent successes I believe we are well on track to become a profitable biopharmaceutical company focused on innovative ophthalmic medicines."

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: +44 207 638 9571

[email protected]

Business highlights

Ocriplasmin – Alcon Deal Highlights Ocriplasmin's Potential

  • Strategic deal with Alcon to help maximize ocriplasmin's global potential
  • ThromboGenics resubmitted the ocriplasmin Biological License Application (BLA) with the FDA in mid-April so that it can meet Priority Review timelines

Alcon to Maximize Ocriplasmin's Commercial Potential outside the U.S.

ThromboGenics signed an important strategic deal with Alcon, the global leader in eyecare, for the commercialization of ocriplasmin outside the U.S. ThromboGenics has retained all rights to ocriplasmin in the U.S. and intends to commercialize the product in the world's largest healthcare market itself.

Under the terms of the agreement, ThromboGenics has received an up-front payment of €75 million. The Company is also entitled to a further €90 million in potential near-term milestone payments. Additional milestones will bring the potential total of up-fronts and milestones to €375 million. Furthermore, ThromboGenics will receive royalties on net sales of ocriplasmin that are commensurate with a product that has successfully completed Phase III development and been filed for regulatory approval.

An important element of the agreement is that ThromboGenics will work in partnership with Alcon in launching and commercializing ocriplasmin in the five largest European markets plus Belgium. ThromboGenics expects ocriplasmin, if approved, to be launched in the first European markets in Q1 2013.

In addition, the European team that ThromboGenics is currently putting in place to support ocriplasmin will provide a foundation for the further future expansion of our own ophthalmology franchise.

In the Rest of the World we will benefit from Alcon's unrivalled commercial reach. This will allow us to ensure that ocriplasmin will be made available to the many patients who could benefit from this novel treatment.

The agreement also covers the further development of ocriplasmin. ThromboGenics and Alcon will work together, and share the costs equally, to explore the new potential clinical applications of the product that the companies could introduce in their respective territories.

The deal will also allow us to focus resources on developing a portfolio of innovative ophthalmic medicines through a combination of our own research and potential in-licensing deals.

BLA Resubmitted with the FDA

In April, ThromboGenics resubmitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for ocriplasmin intravitreal injection, 2.5 mg/mL, for the treatment of symptomatic Vitreomacular Adhesion (VMA) including macular hole. In February 2012, the FDA previously indicated that it intended to assign a Priority Review designation to the BLA submission for the same indication filed in December 2011.

The re-submission will allow ThromboGenics to meet the FDA's Priority Review timelines and to manage the phasing of its resources to support both its European and U.S. ocriplasmin filings. The FDA grants Priority Review designation to drugs that may offer major advances in treatment, or provide a treatment where no adequate therapy exists. The FDA has a goal of completing a Priority Review in six months.

The European Medicines Agency is currently reviewing ThromboGenics' Marketing Authorisation Application (MAA) for ocriplasmin for the same indication in Europe.

US Launch Preparations on Track

ThromboGenics is investing significant resources to prepare for the potential launch of ocriplasmin in the U.S. by early 2013 through its own commercial organization.

To-date the Company has conducted extensive customer market research in the U.S. and globally to ensure that it fully understands how to position this cutting edge product with the retinal physician community and healthcare payers.

ThromboGenics has made key executive leadership hires for its sales, customer operations and market access capabilities (see below) and is strengthening its infrastructure in preparation for the challenges of launching ocriplasmin.

As part of its medical education activities, ThromboGenics has recently launched a new website on symptomatic VMA, http://www.symptomaticvma.com/, to inform US healthcare professionals on the condition, its diagnosis and management.

Antibody Candidates – Clinical Development Update

TB-402 – A Novel Long Acting Anti-Coagulant

ThromboGenics has completed recruitment of a 600-patient Phase IIb trial assessing TB-402 (anti-Factor VIII antibody) for the prevention of venous thromboembolism (VTE) after total hip replacement surgery. The top line results of this study are expected in the second quarter of 2012.

TB-403 – An Anti-Cancer Antibody

ThromboGenics' partner Roche is continuing to enrol patients into a Phase Ib/II trial assessing TB-403 (anti-PIGF), a novel human anticancer antibody, for the treatment of glioblastoma multiforme, an aggressive form of primary brain cancer.

ThromboGenics Continues to Strengthen its Management

During the last quarter, ThomboGenics continued to hire experienced biopharmaceutical industry people in preparation for the anticipated launch of ocriplasmin in the U.S. and Europe.

Christian Jaeggi has joined as Head of Country Operations for Europe & ROW. In this newly created position he will play a key role in liaising with Alcon/Novartis on the commercialization of ocriplasmin outside the U.S.

Christian has more than 25 years' experience in the international pharmaceutical industry. He has held roles of increasing responsibilities in marketing, early commercial development and regional management and has a proven track record of successful product launches across multiple therapeutic areas with leading brands at Novartis, Roche and most recently Genzyme, where he was Director of the Transplant Business Europe.

During the quarter Dr Aniz Girach, the Company's global Head of Clinical Ophthalmology, assumed responsibility for all clinical research activities related to ocriplasmin. Prior to joining ThromboGenics one year and a half ago, Aniz was Vice-President, International Clinical Development Ophthalmology at Alcon. This change follows the decision of Dr Steve Pakola to leave the Company to pursue executive opportunities at an early-stage biotechnology company.

In the U.S. Wesley Winn has joined as Head of Commercial Operations and Market Access. Wesley joined the Company from Dendreon, where he was Senior Director Government Affairs and Managed Markets. Prior to Dendreon, Wesley worked for Genentech where he had a number of senior positions including being the lead on the market access activities for Lucentis® .

Financial Review

In March, the company raised €77.8 million in an over-subscribed private placement at a price of €24 per share. The new funds came from a range of domestic, international investors and qualified institutional buyers in the United States. The funds will be used to prepare for the launch and commercialization of ocriplasmin in the U.S. and to fund further clinical development of ocriplasmin for additional indications with Alcon, its

commercialization partner for non-U.S markets. The Company also intends to strengthen its core ophthalmology franchise by in-licensing development-stage product candidates.

As of 31 March 2012, ThromboGenics had €127 million in cash and cash investments, compared with €101.1 million on 31 March 2011 and €80.4 million as of 31 December 2011. The Q12012 figure excludes the proceeds from the private placement which were received in early April. Following the receipt of these funds, ThromboGenics has the cash resources that will allow it to execute its operational plans until well after the launch of ocriplasmin.

ThromboGenics reported €75 million in revenues for the three months to 31 March 2012, versus no revenue in the same period in 2011. All of the 2012 revenue came from the upfront payment from Alcon.

R&D expenses were €2.4 million in the first three months of 2012, versus €3.7 million in the same period in 2011, as the Company continued to invest in the development of its product pipeline, including the Phase IIb trial with TB-402. Half of the costs of this TB-402 study are being met by our co-development partner BioInvent. In addition, €15.8 million of the costs related to the ocriplasmin development program have been capitalized as a result of ThromboGenics strengthening its worldwide IP position. In 2011, €1.2 million of ocriplasmin development costs were capitalized.

In Q1 2012 selling and marketing expenses amounted to €1.5 million compared with €1.1 million in the first quarter of 2011. This increase reflects the growth of the Company's commercial organization ahead of the anticipated launch of ocriplasmin.

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, ocriplasmin, has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic Vitreomacular Adhesion (VMA). The MAA for ocriplasmin has been accepted for review in Europe and a BLA was re-submitted in the U.S. in April 2012. Ocriplasmin is in Phase II clinical development for additional vitreoretinal conditions.

In March 2012, ThromboGenics signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States. Under this agreement, ThromboGenics could receive up to a total of €375 million in up-front and milestone payments, plus an attractive level of royalties on Alcon's net sales of ocriplasmin. ThromboGenics and Alcon intend to share the costs equally of developing ocriplasmin for a number of new vitreoretinal indications.

ThromboGenics is also developing two novel antibody therapeutics in collaboration with BioInvent International. These are TB-402 (anti-Factor VIII), a long-acting anticoagulant in Phase II, and TB-403 (anti-PlGF), in Phase Ib/II for cancer, which has been partnered with Roche.

ThromboGenics is headquartered in Leuven, Belgium. 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 forwardlooking statement is contained in the Company's Annual Report.