Oxurion NV — Management Reports 2014

Nov 6, 2014

REGULATED INFORMATION

ThromboGenics Q3 Business Update 2014

Highlights

JETREA® in the US

• ThromboGenics' marketing and sales efforts are now focused on key accounts as it seeks to expand the use of JETREA® (ocriplasmin). These accounts comprise retina specialists who have already achieved satisfactory clinical results with JETREA® based on appropriate patient selection criteria, which are critical to delivering the drug's important value in the treatment of symptomatic VMA
• ThromboGenics continues to gather real-world data on JETREA® 's use: OASIS will report initial topline results in Q1 2015, with the full readout scheduled for end of Q3 2015; ORBIT study is progressing well with 110 centers now enrolled; OZONE study to assess the anatomic and symptomatic changes that potentially occur in the six months immediately after treatment with JETREA® is on track to report results in Q1 2015
• ThromboGenics had a wide-ranging marketing and education program at the American Academy of Ophthalmology (AAO) 2014 meeting, which took place in Chicago from 17-21 October. A number of presentations at the AAO meeting suggested that the US retina community is developing a greater understanding of how to utilize JETREA® more effectively while better understanding its safety profile

JETREA® outside the US

• ThromboGenics' partner Alcon, in conjunction with Novartis, continues to commercialize JETREA® across Europe and Rest of the World (RoW) having achieved positive reimbursements
• JETREA® has recently been approved in a number of countries including Australia, South Korea, Ukraine and Chile

Research & Development

• ThromboGenics is completing plans for a Phase II clinical study to be conducted in the US for developing JETREA® in diabetic retinopathy
• Pre-clinical research projects in diabetic eye disease progressing as planned

Corporate

ThromboGenics' transfer of cancer R&D activities: a new company is being formed in partnership with VIB (Flanders Institute for Biotechnology) which will seek external funding. ThromboGenics will have an equity stake in this new venture focusing on paediatric oncology

Financial

Cash and investments of €136.6 million as of the end of September 2014, compared with €148.8 million at the end of June 2014

ThromboGenics remains on track to achieve its target of profitability in the US by 2016, based on JETREA® sales of around €30 million. The Company is also targeting to become cash flow positive by 2017, and to achieve total revenues of €100 million by 2019

Leuven, Belgium – 6 November, 2014 - 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 nine months ending 30 September, 2014.

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' 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 clinical programs documenting the realworld use of JETREA® in approved indications and developing new indications including diabetic retinopathy, 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 continuing to focus its sales and marketing activities on increasing the adoption rates within those accounts that use JETREA® for the treatment of patients with symptomatic VMA.

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 planning to investigate this novel medicine for the treatment of diabetic retinopathy.

Dr Patrik De Haes, ThromboGenics' CEO, said: "We are continuing to focus our sales and marketing efforts in the US on strategic key accounts. We believe these centers will form the strong platform we need to increase the use of JETREA® for the treatment of the significant number of patients with symptomatic VMA who could benefit from pharmacological intervention. In parallel, we are conducting a number of studies that will deliver additional real-world data to demonstrate to the broader retina community the clear benefits and value of using JETREA® . Our progress gives us confidence that we will achieve our near term target of profitability in the US in 2016, based on sales of JETREA of around €30 million."

JETREA® in the US

ThromboGenics has increased its focus on strategic accounts, and its approach is designed to grow the number of retina physicians in the US who have extensive experience of using JETREA® .

On-going collection of additional real-world data will enable physicians to gain a greater understanding of the importance of patient selection. This will enable them to generate the best possible treatment outcomes with JETREA® and to understand the mainly transient adverse events that are sometimes seen in some patients shortly after treatment.

As they gain more experience with JETREA® , physicians are better able to identify those patients who are most suitable for treatment with JETREA® , resulting in improved clinical outcomes.

The retina community is driven by peer-to-peer interactions. With positive physician and patient experiences being shared with other physicians via peer-to-peer communication, increased adoption of JETREA® may be expected.

These are key elements of ThromboGenics' strategy in driving the adoption of this novel pharmacological option for the earlier treatment of symptomatic VMA in line with its approved US label.

Patient selection delivers improved patient outcomes

Recent studies of real-world experience have helped identify baseline characteristics that are predictive for success when treating VMA patients with JETREA® .

Based on positive ocular features for VMA resolution including focal VMA, presence of full thickness macular hole (FTMH), and absence of epiretinal membranes (ERM), increased overall VMA resolution rates have been reported in postmarketing experience at multiple centers. Optimal patient selection is crucial, and these baseline characteristics will guide retinal physicians in selecting patients that may gain the most benefit from ocriplasmin treatment. 1

ThromboGenics communicating with the US retina community at AAO

ThromboGenics implemented a wide range of marketing programs for JETREA® (ocriplasmin) at the recent American Academy of Ophthalmology (AAO) 2014 meeting, which took place in Chicago from 17-21 October. The AAO meeting is the largest ophthalmology meeting in the world with more than 24,000 people attending, including nearly 2000 retinal specialists.

ThromboGenics' activities at AAO focused on enabling the retina community to further characterize both the efficacy and safety profile of its lead drug JETREA® . The Company hosted a number of expert presentations at its booth during AAO.

¹ Jorge A Fortune, MD, Pharmacologic Resolution of VMA, Retina Today, October 2014

ThromboGenics' medical affairs staff also engaged in further dialogue with retina physicians taking part, or interested in the on-going OASIS, ORBIT and OZONE studies which have been designed to provide further real-world data on JETREA® . These studies are intended to help the retina community to further characterize JETREA® 's efficacy and safety profile, allowing specialists to build the proper level of confidence while treating patients suffering from symptomatic VMA. Symptomatic VMA is a progressive sight-threatening disease, which if left untreated, might lead to a macular hole and central blindness.

A number of sessions/presentations at AAO made it clear that an increasing number of retina physicians are realizing that appropriate patient selection is crucial in delivering the best possible treatment outcomes with JETREA® .

There was also a growing sense that retina physicians are gaining confidence that the side-effects seen immediately post-injection with JETREA® are transient and are in line with those reported in the pivotal Phase III program.

Collecting additional real-world JETREA® clinical data

ThromboGenics is continuing to collect more real-world data on treatment with JETREA® .

OASIS study

ThromboGenics is currently conducting the "Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion including Macular Hole" (OASIS) study to generate long term data following treatment with ocriplasmin. This blinded study, which has recruited a total of 220 patients, is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic VMA/ VMT including macular hole. Patients in the study are being followed up for a 24-month period post injection. The primary endpoint of the study is the proportion of subjects with pharmacological VMA resolution at Day 28. The study will also explore a range of secondary endpoints at the end of the 24 month follow-up period.

Initial topline results from this study are expected by Q1 2015, with a full readout scheduled for the end of Q3 2015.

ORBIT study

In March 2014, ThromboGenics launched the "Ocriplasmin Research to Better Inform Treatment" (ORBIT) study. This study has generated significant interest from the US retina community and 110 centers have been activated to recruit patients.

This ORBIT study is recruiting patients with symptomatic VMA across retina centers in the US. This prospective, observational study will assess clinical outcomes and the safety of JETREA® administered in a real-world setting for the treatment of symptomatic VMA by assessing both anatomical and functional outcomes.

The study will look at a number of parameters including resolution of VMA, FTMH closure, changes in visual acuity (VA) and occurrence and time to vitrectomy. It will also monitor adverse drug reactions (ADRs) and changes in ocular signs and symptoms, such as metamorphopsia, over time. These data will further characterize

the efficacy and safety profile of the product and provide data extending those from JETREA® 's Phase III clinical program and physician experience during its first year on the market.

Patients will be followed for up to 12 months following the standard single treatment with JETREA® . The ORBIT study is due for completion in mid-2016. The Company intends to report data on a regular basis, with first data expected to be presented by the end of Q1 2015.

OZONE study

Separately, in July, ThromboGenics started the "Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study" (OZONE).

This is a retrospective 200-patient US study designed to capture more data to characterize the anatomic and symptomatic changes that potentially occur in the six months immediately after treatment with JETREA® for symptomatic VMA.

First data are expected in the first half of 2015.

JETREA® in Europe and RoW

ThromboGenics' partner Alcon, in conjunction with Novartis, is continuing to commercialize JETREA® across Europe and is focusing on building on the strong market access platform that has been established in partnership with ThromboGenics.

In September, the Spanish Ministry of Health approved the reimbursement of JETREA® for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns. JETREA® has been included in the national list of available reimbursed products since September, at a regional and hospital level.

Further JETREA® approvals

In recent months good progress has been made in gaining further approvals for JETREA® outside the EU.

Europe

In October JETREA® was approved in Ukraine for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns.

Asia

In July 2014, JETREA® was approved in Singapore for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns.

South America

In the beginning of July, JETREA® was approved in Uruguay, the first country in South America, for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns.

In October, JETREA® was approved in Chile for the same indication.

Australia

In October, Australia's Therapeutic Goods Administration (TGA) approved JETREA® for the treatment of adults with VMT, including when associated with macular hole of diameter less than or equal to 400 microns.

Further marketing registrations submitted

ThromboGenics' partner has submitted JETREA® for marketing authorization in several other countries and has now completed a bridging study in Japan. The Japanese trial, a randomized, double-blind, multi-center study with patients receiving either ocriplasmin or a sham injection, recruited a total of 168 patients with symptomatic VMA including those associated with macular hole. The results from this study are expected to form part of the regulatory submission that will be made to the Japanese Ministry of Health, Labour and Welfare in 2015 to gain approval to market ocriplasmin in Japan.

Research & Development Update

Diabetic Retinopathy

Earlier this year, ThromboGenics announced its decision that the prevention of proliferative diabetic retinopathy (PDR) will be the next target indication for JETREA® .

ThromboGenics is currently completing a tendering process for a CRO to assist in the conduct of 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 intends to start this study in H1 2015.

Corporate

Oncology R&D transfer into new company

ThromboGenics has made significant progress in transferring its cancer R&D activities into a separate entity. A new company is being formed in partnership with VIB (Flanders Institute for Biotechnology) which will seek external funding.

ThromboGenics will have an equity stake in this new venture which will focus on paediatric oncology.

Financial review

At the end of September 2014, ThromboGenics had €136.6 million in cash and investments, compared with €148.8 million at the end of June 2014.

ThromboGenics believes that it has the financial resources it needs to fully sustain the US commercialization of JETREA® , to research and develop new indications and formulations of JETREA® for the US market, and to expand its R&D pipeline and further broaden its commitment to become a leading ophthalmology company.

END

For further information please contact:

ThromboGenics	Citigate Dewe Rogerson
Wouter Piepers, Global Head of Corporate Communications/ IR +32 16 75 13 10 / +32 478 33 56 32 wouter.piepers@thrombogenics.com	David Dible/ Sita Taylor
	Tel: +44 20 7638 9571 sita.taylor@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 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 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.

ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA® outside the United States.

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 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.