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Oxurion NV Earnings Release 2015

Mar 17, 2016

3987_er_2016-03-17_73f648f3-c812-46e4-a94f-a9c0810d497b.pdf

Earnings Release

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Press release March 17, 2016

Highlights

Strategy Update

  • ThromboGenics' strategy is to deliver shareholder value as a drug development company focused on innovative treatments for back of the eye disease, with a focus on diabetic eye disease
  • ThromboGenics is presenting for the first time its exciting drug development pipeline which is targeting diabetic eye disease on March 18 at an IR R&D meeting which will be held in London. This event will be webcast through the ThromboGenics website
  • The Company has cash resources of over €100 million which is expected to support its development plans for the next 3 years
  • ThromboGenics right-sized its commercial organization supporting JETREA® to ensure its US operations are cash flow neutral in 2016

Research & Development

  • ThromboGenics R&D activities are focused on delivering innovative treatments for back of the eye disease, with a focus on diabetic eye disease
  • The Company is aiming at delivering novel treatments for diabetic retinopathy (DR) (proliferative diabetic retinopathy (PDR) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME))
  • The Company has built an exciting and broad pipeline containing novel compounds designed to treat diabetic eye disease in its different forms and severities, and to prevent the progressive loss of vision
  • ThromboGenics has initiated a Phase IIa clinical study (CIRCLE) assessing the ability of multiple doses of ocriplasmin (THR-409) to induce a complete posterior vitreous detachment (PVD), and so prevent patients with nonproliferative diabetic retinopathy progressing to proliferative diabetic retinopathy, a serious sight threatening condition

Oncurious NV

• ThromboGenics' spun out its oncology research activities into Oncurious NV, a newly created company focused on developing orphan drugs for the treatment of pediatric cancer. Oncurious has been created in conjunction with the VIB (Flanders Institute for Biotechnology), with ThromboGenics being the majority shareholder

  • US FDA performed a safety review of its Investigational New Drug (IND) Application for its TB-403 anti-PlGF and concluded that the proposed pediatric clinical study could proceed
  • Oncurious plans to commence a Phase I/IIa study with TB-403 for the treatment of medulloblastoma, the most common form of brain cancer in children
  • Oncurious signed a collaboration agreement with the Neuroblastoma and Medulloblastoma Translational Research Center (NMTRC), a non-profit US organisation and clinical trial network with the mission to bring forward new effective therapies against neuroblastoma and medulloblastoma. This agreement will provide Oncurious with access to patients for its Phase I/IIa study with TB-403 which will start in Q2 2016

JETREA® - Clinical and Commercial Update

  • In 2015, ThromboGenics achieved overall revenues of € 11.2 million from JETREA®. This includes a € 3.2 million in royalty income from its partner Alcon
  • ThromboGenics reduced the size of its US organization to reflect the market demand for JETREA® in H2 2015. ThromboGenics Inc. is now a lean customercentric organization that is continuing to supply JETREA® via a wellestablished distribution network. As a result, the Company expects its US commercial operations to be cash neutral from 2016 onwards
  • ThromboGenics reported positive top-line results from the OASIS study in November 2015. The reported data analysis of the 2 year follow up safety data showed no new safety signals were identified

2015 Appointments

  • Dominique Vanfleteren (as permanent representative of D&V Consult BVBA) was appointed as ThromboGenics Chief Financial Officer (CFO) in January 2015
  • Emmanuèle Attout (as permanent representative of Investea sprl) was appointed Independent Non-Executive Director of the Board of ThromboGenics NV on May 5, 2015 and is also a member of the Company's Audit Committee
  • Philippe Baron Vlerick was appointed as Non-Executive Director of the Board of ThromboGenics NV at an extraordinary shareholders' assembly in August 2015

Financial

  • In 2015, ThromboGenics achieved overall revenues of € 11.2 million. This includes a € 3.2 million in royalty income from its partner Alcon
  • Cash and investments were €101.4 million as of the end of December 2015, compared with €127.1 million at the end of December 2014
  • Cash and investments together with revenues received from the commercial sales of JETREA® should support the Company's activities

Leuven, Belgium – 17 March 2016 - ThromboGenics NV (Euronext Brussels: THR), a clinical stage biotechnology company focused on developing novel medicines for back of the eye disease, particularly diabetic eye disease, today issues a business update and its financial update for the year ending December31, 2015.

In August, ThromboGenics took a strategic decision to focus its resources on drug development. ThromboGenics' resources are now focused on developing novel medicines for diabetic eye disease, particularly diabetic retinopathy and diabetic macular edema. This decision was driven by the significant potential of the Company's exciting and broad pipeline of next generation medicines that are targeting novel treatments for this significant and growing unmet medical need.

ThromboGenics significantly reduced the resources for commercializing JETREA® in the US in the second half of 2015, while retaining an organization able to support the existing business opportunity. As a result the Company's US commercial operations are expected to be cash flow neutral for 2016.

ThromboGenics' diabetic eye disease pipeline, which is one of the strongest in the industry, includes:

THR-409 – an ongoing Phase IIa (CIRCLE) clinical study is evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR).

THR-317 – a PLGF neutralizing monoclonal antibody is being developed for DME and/or for use in combination therapy with current anti-VEGF treatments. THR-317 is expected to enter clinical development in H2 2016.

THR-149 – a plasma kallikrein inhibitor is being developed to treat edema associated with diabetic retinopathy. (This compound has resulted from the Company's research collaboration with Bicycle Therapeutics)

THR-687 – a small molecule integrin antagonist being developed to treat a broad range of patients with diabetic retinopathy, with or without DME. (In-licensed from Galapagos NV)

The Company will outline the full details of its drug development pipeline on March 18, 2016 at a London organized Investor Relations meeting focused on its Ophthalmology Research and Development plans.

In addition, ThromboGenics, through its oncology spin-off Oncurious, is about to start a Phase I/IIa clinical trial in children assessing TB-403 for the treatment of medullablastoma, a pediatric brain tumor.

Dr. Patrik De Haes, ThromboGenics' CEO, said: "In recent months it has become clear that we have an opportunity to generate important returns for our shareholders by focusing on our exciting drug development pipeline of potential new disease modifying medicines for the treatment of diabetic eye disease. Diabetic Retinopathy and Diabetic Macular Edema (DME) are significant indications where there are clear unmet needs and a strong demand for improved or add-on treatment options. We now have THR-409 (ocriplasmin) in a Phase IIa study to assess whether multiple doses can prevent the progression of NPDR to PDR, a sight threatening condition which is currently treated poorly. In addition, we have 3 other compounds under development, one of which is expected to enter the clinic before the end of 2016, giving ThromboGenics one of the industry's strongest pipelines targeting diabetic eye disease.

Our oncology company, Oncurious, has the potential to become another important source of value as we continue the clinical development of TB-403 for pediatric brain cancers and potential other orphan indications.

With our current cash resources of over €100 million, we can support our activities for 3 years, allowing us to demonstrate the value of our exciting pipeline."

Research & Development Activities – Focus on Diabetic Eye Disease

Diabetes, Diabetic Retinopathy and DME

According to the World Health Organization (WHO), in 2014, 9% of adults 18 years and older had diabetes (WHO, 2015)1 .

Diabetic retinopathy (DR) is the leading cause of visual disability and blindness among professionally active adults (Cunha-Vaz, 1998; Fong et al., 1999). Worldwide, the prevalence rate of vision-threatening PDR or DME was estimated to be 11.72% of the diabetic population in 2010 (Yau et al., 2012).

DR progresses from mild, non-proliferative to more severe, or even proliferative stages. As DR progresses, there is a gradual closure of retinal vessels leading to impaired perfusion and retinal ischemia. When this progresses beyond certain thresholds, severe non-proliferative diabetic retinopathy (NPDR) is diagnosed.

1 World Health Organization (WHO). (2015). Diabetes. Fact sheet N°312. http://www.who.int/mediacentre/factsheets/fs312/en/ 21 May 2015.

The more advanced stage, PDR, is characterized by the development of new blood vessels at the inner surface of the retina as a result of retinal ischemia. These new vessels are prone to bleed, resulting in vitreous hemorrhage. These new vessels may also undergo fibrosis and contraction, which may lead to epiretinal membrane formation, vitreoretinal traction bands, retinal tears and traction or retinal detachments.

PDR is considered high risk when the new vessels are accompanied by vitreous hemorrhage, or when they cover a significant area of the optic disc, even in the absence of vitreous hemorrhage, patients with high risk PDR are at high risk of severe vision loss.

The current treatment standard for PDR patients is laser photocoagulation (PRP) therapy. More recently, an increasing role for anti-VEGF treatments has also been demonstrated.

PDR patients may still progress to severe vision loss or even complete vision loss resulting from persistent or recurrent disease, even when receiving recurrent panretinal photocoagulation (PRP). In addition, recurrent treatment with PRP may lead to complications such as visual field loss or worsening of macular edema.2 3

Exciting and Broad Pipeline of Novel Medicines Targeting Diabetic Eye Disease such asDiabetic Retinopathy and DME

In the last 12-18 months ThromboGenics has been working to develop a pipeline of next generation medicines that are designed to treat the various forms/symptoms of diabetic retinopathy and DME.

The diabetic eye disease pipeline, which is one of the strongest in the industry, includes:

THR-409 – is in a Phase IIa (CIRCLE) clinical study evaluating the efficacy and safety of multiple doses of ocriplasmin in inducing total posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (NPDR). The Phase IIa study was initiated in early 2016

THR-317 – a PLGF inhibitor being developed for DME or as a combination therapy for current anti-VEGF treatments. THR-317 is expected to enter the clinic in 2016

THR-149 – a plasma kallikrein inhibitor being developed to treat the edema associated with diabetic retinopathy. (This compound has resulted from the Company's research collaboration with Bicycle Therapeutics)

THR-687 – an integrin antagonist being developed to treat a broad range of patients with diabetic retinopathy. (In-licensed from Galapagos NV)

2 Bailey CC, Sparrow JM, Grey RH, Cheng H (1999). The National Diabetic Retinopathy Laser Treatment Audit. III. Clinical outcomes. Eye (Lond) 13 (Pt 2): 151-159.

3 Fong DS, Ferris FL 3rd, Davis MD, Chew EY (1999). Causes of severe visual loss in the early treatment diabetic retinopathy study: ETDRS report no. 24. Early Treatment Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 127 (2): 137-141.

To assist in assessing and selecting the most promising new drug candidates for development the Company has developed a number of new pre-clinical models of diabetic retinopathy.

These models have been validated in conjunction with a number of leading physicians in the treatment of this very serious condition.

Ocriplasmin for Non Proliferative Diabetic Retinopathy – CIRCLE on track

In January 2016, the Company announced the initiation of its Phase IIa (CIRCLE) study.

The CIRCLE study is evaluating the efficacy and safety of multiple doses of ocriplasmin (THR-409) in inducing total posterior vitreous detachment (PVD) in patients with nonproliferative diabetic retinopathy (NPDR).

ThromboGenics aims to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR) by inducing a total PVD using ocriplasmin. PDR is the major cause of blindness in patients with diabetes. Patients who progress to PDR are at high risk of experiencing severe vision loss or complete blindness.

The CIRCLE study is a Phase II, randomized, double-masked, sham-controlled, multicenter study that will evaluate the efficacy and safety of up to 3 intravitreal injections of either 0.125mg or 0.0625mg of ocriplasmin in subjects with moderately severe to very severe NPDR, to induce total PVD in order to reduce the risk of the patient developing sight-threatening PDR.

A total of 230 subjects will be recruited into the CIRCLE trial, approximately 92 in each ocriplasmin arm (0.125mg or 0.0625mg) and 46 in the sham arm. Patients will be accrued from sites across the US, Canada and EMEA.

The primary endpoint of the CIRCLE study is the percentage of patients with total PVD by the month 3 visit, confirmed by both B-scan ultrasound and SD-OCT.

The study has a number of exploratory secondary endpoints that are designed to provide further insights into ocriplasmin's potential in reducing the risk of progression of NPDR to PDR.

Research has suggested that total PVD, a complete separation of vitreous and retina, could prevent the progression of NPDR to PDR. This could be explained by total PVD leading to elimination of the scaffold needed for the development of new blood vessels and/or the improvement of oxygen supply to the retina, thereby reducing retinal ischemia, production of VEGF, vascular outgrowth and neovascularization.

Oncurious NV – orphan drug development in pediatric oncology

In April 2015, ThromboGenics, together with VIB, incorporated Oncurious NV, a new oncology company to develop TB-403 for the treatment of pediatric tumors. The company intends to assess other orphan disease opportunities in the pediatric cancer space. VIB is the leading life sciences research institute in Flanders (Belgium). ThromboGenics is the majority shareholder of Oncurious NV.

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. High expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall survival. Medulloblastoma is a rare, life-threatening brain tumor that mainly affects children.

Treatment with TB-403 in relevant animal models for medulloblastoma has demonstrated beneficial effects on tumour growth and survival.

The favourable safety profile of TB-403 has already been demonstrated in clinical trials in patients with other diseases.

This Phase I / IIa study is being conducted by Neuroblastoma and Medulloblastoma Translational Research Center (NMTRC) a non-profit organisation with the mission to bring forward new effective therapies against neuroblastoma and medulloblastoma. The organisation is a network of 18 leading university hospitals and paediatric clinics in the US.

In March 2016, Oncurious signed a partnership with the NMTRC to accelerate the clinical development of TB-403 for the treatment of medulloblastoma in the US. Oncurious is expected to initiate this study in Q2 2016.

BioInvent International is a co-development partner for this study.

IR R&D Day

ThromboGenics will be hosting an IR event in London on March 18 2016 to provide investors and analysts with an update on the Company's strategy and in particular will provide more detailed information on its ophthalmology R&D pipeline.

This event will be webcast through ThromboGenics' website.

JETREA US and Global Update

JETREA® Commercial

In 2015, ThromboGenics generated JETREA® sales of € 7.4 million in the US and received € 3.2 million in royalty income from its partner Alcon. This compares to € 8.8 million of JETREA® US sales and € 3.4 million in royalty income from Alcon's ex-US sales in 2014.

In the second half of 2015, ThromboGenics reduced the size of its US commercial organization to reflect the current market demand for JETREA®, targeting a cashneutral organization from 2016 onwards.

Today, ThromboGenics Inc. is a smaller customer-centric organization that is continuing to supply JETREA® via a well-established and specialized distribution network. The Company's US team provides medical and scientific support and data to the retina community and is supporting physicians' efforts to enhance patient awareness of the options available for treating symptomatic VMA.

In the rest of the world, Alcon continues the roll out of JETREA® following a similar demand driven and customer-centric approach with solid medical and scientific support.

JETREA® Regulatory & Markets Access

ThromboGenics JETREA® is now approved in 54 countries globally, the latest territory being Hong Kong. Patients are being treated and reimbursed in over 20 countries.

Importantly, following the completion of a regulatory bridging study, Alcon is now in the process of submitting JETREA® for approval in Japan, the second largest pharmaceutical market in the world.

Further JETREA® approvals and introductions are scheduled for 2016.

2015 Clinical data and real world clinical experience continue to confirm JETREA® a valuable treatment option for symptomatic VMA/ VMT

Since its first introduction, over 20,000 patients have been treated with JETREA®.

ThromboGenics and Alcon have continued to generate new clinical study and realworld clinical data with JETREA®, including during 2015. This is in line with both companies' commitment to ensuring that the most suitable patients with symptomatic VMA/VMT are treated with this novel medicine. These data are also designed to make sure that physicians are in a position to further characterize JETREA®'s benefit/ risk profile for their patients. In addition, many retinal practices across the globe are generating and publishing their own real-world data, leading to an increasing body of knowledge on the clinical outcomes that JETREA® can deliver.

OASIS study – Positive Top-Line Results

In April, ThromboGenics announced positive top-line results from its OASIS study "Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion is including Macular Hole" with JETREA® (ocriplasmin).

The key findings of the OASIS study were as follows:

  • 41.7% of patients treated with JETREA® achieved VMA resolution at Day 28 post injection compared with only 6.2% of patients who received a sham injection (p<0.001); and
  • The JETREA® safety profile in this 24 month follow up study was consistent with the drug's overall safety profile as known from the approved label. No new types of safety events were identified.

The OASIS data illustrate the importance of appropriate patient selection in order to generate higher rates of VMA resolution with JETREA® and improved patient outcomes. The ability to select patients with focal VMA and an absence of Epiretinal Membrane (ERM), has been shown to lead to better treatment outcomes with JETREA®.

It is known that an ERM adversely impacts the efficacy of JETREA®. Approximately 20% of the recruited patients in the OASIS study had an Epiretinal Membrane (ERM) (despite it being one of the exclusion criteria), suggesting that the 41.7% overall resolution rate at day 28 post-injection could have been even higher. This underscores the message that proper patient selection will lead to better treatment outcomes.

ORBIT study

ThromboGenics launched the "Ocriplasmin Research to Better Inform Treatment" (ORBIT) study in March 2014.

Six month data from the ORBIT study, were presented in a poster at the Association for Research in Vision and Ophthalmology (ARVO) meeting May 3-7, 2015, in Denver, Colorado.

The study showed that 58.1% of patients experienced VMT resolution within one month post treatment. The study also showed that the safety of JETREA® was consistent with the product's label and the data from the Phase III clinical trials.

Updated data presentations, which further highlighted the positive results from the OASIS and ORBIT studies were made at the American Academy of Ophthalmology (AAO) 2015 meeting, held in Las Vegas from 14-17 November, 2015.

Corporate Developments

Appointments

Philippe Baron Vlerick – Nominated Non-Executive Director

Mr Vlerick was appointed as a new Non-executive member of the Board of ThromboGenics NV at an extraordinary shareholders' assembly in August.

Mr Vlerick is owner, Chairman and CEO of several businesses in Belgium and abroad. He currently serves as the Chairman and Chief Executive Officer of Vlerick Group (Belgium). He also serves as the Chairman and CEO of UCO. In addition, he is the Vice-chairman of KBC Group, Corelio, smartphoto Group and Durabilis. Baron Vlerick is also a member of the Board of Directors of Exmar, Hamon & Cie, Besix Group BMT & LVD (Belgium).

Mr Baron Vlerick holds a Degree in Philosophy and Law from the University of Leuven, and an MBA General Management (PUB) (Ghent, Vlerick School of Management – 1979). He also holds a Masters Degree in Business Administration from Indiana University, Bloomington (USA – 1980).

He was elected 2006 Manager of the Year by Trends, a leading business magazine in Belgium. He was granted the title of Baron in 2008, and became Commander of the Order of Leopold in 2013.

Emmanuèle Attout as permanent representative of Investea sprl – Appointed Non-Executive Director

Emmanuèle Attout was appointed as a new Independent non-executive director. During the ThromboGenics Annual Shareholders Meeting of May 5, 2015. She has also joined the Audit Committee of the Company.

Ms Attout is a former audit partner at PricewaterhouseCoopers. She was in charge of the audits for a wide range of clients, including in recent years being in charge of the audits of publicly listed pharmaceutical companies and life sciences businesses.

Dominique Vanfleteren as permanent representative of D&V Consult BVBA – Appointed Chief Financial Officer

Dominique Vanfleteren was appointed as ThromboGenics' new Chief Financial Officer (CFO) in January 2015.

Dominique Vanfleteren has over 25 years of experience in senior finance, operational, control and reporting roles with quoted international biopharmaceutical companies. Before joining ThromboGenics, Mr. Vanfleteren spent 12 years at UCB, where he held a number of international managerial finance positions, the latest being the CFO of UCB's Asia Pacific Operations, operating from Brussels and Shanghai. Prior to joining UCB, Dominique worked for GSK for 16 years.

Financial review

In 2015, ThromboGenics had total revenues of € 11.2 million, including € 7.4 million of JETREA® sales in the US, € 3.2 million in royalties from Alcon based on its ex-US sales of JETREA®, and € 0.5 million from LSRP for a non-GMP manufacturing service.

In the corresponding period in 2014, ThromboGenics had total revenues of € 13.8 million, including € 8.8 million of JETREA® sales in the US, € 1.4 million of products recharged to Alcon, € 3.4 million in royalties from Alcon based on its ex-US sales of JETREA® and € 0.2 million of other income.

In 2015, ThromboGenics' R&D expenses were €21.4 million, including a €6.8 million amortization of the ocriplasmin Phase III program. This compares with €22.6 million of R&D expenses in the same period in 2014.

This comparable level of spending is due to the continuous effort in researching new compounds and generating clinical data in support of ocriplasmin's current approved indication and its development for a new indication, diabetic retinopathy.

In 2015, selling and marketing expenses amounted to €17.6 million compared with €29.9 million in 2014. In the second half of 2015 sales and marketing expenses amounted to €7.4 million, a 52% decline from the same period in 2014.

In 2015, ThromboGenics reported a net loss of €37.9 million, or €1.05 loss per share. In the corresponding period in 2014 the Company reported a net loss of €51.1 million or a loss per share of €1.42.

At the end of December 2015, ThromboGenics had €101.4 million in cash and investments, compared to €127.1 as of the end of December 2014.

ThromboGenics believes that following its decision to focus on its drug development activities to generate positive cash flow from its sales of JETREA® it has the financial resources to support its activities through the next 3 years.

END

For further information please contact:

ThromboGenics Citigate Dewe Rogerson
Wouter Piepers, David Dible/Sylvie Berrebi
Global Head of Corporate Communications & IR
+32 16 75 13 10 / +32 478 33 56 32 Tel: +44 20 7282 2867
[email protected] [email protected]
[email protected]

A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO and Dominique Vanfleteren, CFO of ThromboGenics, on Thursday March 17, starting at 06:30 PM CET, 13:30 PM EDT.

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

Belgium toll +32 (0) 24040305 France toll +33 (0)172040033 Germany toll +49 (0)7117074079 United Kingdom toll +44 (0)2077509926 United States toll +1 9148850779

Click here for more international toll and toll free numbers. Participant pin: 17000688#

We request that participants dial in 5-10 minutes prior to the start time of 06:30 PM CET, 13:30 PM EDT.

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

The presentation and transcript of the call will be made available in the investor information section of the website.

About ThromboGenics

ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative treatments for back of the eye disease, with a focus on diabetic eye disease.

ThromboGenics is conducting the CIRCLE study, a Phase II clinical trial to assess ocriplasmin (THR-409) as a potential treatment for diabetic retinopathy In addition the Company is evaluating several other disease modifying drug candidates that could potentially deliver a number of next generation treatments for diabetic eye disease.

ThromboGenics pioneered the new drug category of pharmacological vitreolysis with JETREA® (ocriplasmin) which is now approved for the treatment of vitreomacular traction in over 54 countries worldwide. In the US, ThromboGenics is commercializing JETREA® via its subsidiary ThromboGenics, Inc. . Alcon, a division of Novartis, commercializes JETREA® outside the United States.

ThromboGenics is headquartered in Leuven, Belgium, and 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.

Financial information 2015 Consolidated statement of comprehensive income

In '000 euro (for the year ended on 31 December) 2015 2014
Income 11.198 13.776
Sales 7.925 10.346
License income 0 33
Income from royalties 3.273 3.397
Cost of sales -3.230 -4.600
Gross profit 7.968 9.176
Research and development expenses -21.393 -22.554
General and administrative expenses -7.945 -9.520
Selling expenses -17.645 -29.874
Other operating income 98 67
Other operating expense 0 -9
Operating result -38.917 -52.714
Finance income 1.516 1.885
Finance expense -489 -146
Result before income tax -37.890 -50.975
Income tax expense -42 -140
Loss of the year -37.932 -51.115
Attributable to:
Equity holders of the company -37.884 -51.115
Non-controlling interest -48 0
Result per Share
Basic earnings per share (euro) -1,05 -1,42
Diluted earnings per share (euro) -1,05 -1,42
In '000 euro (for the year ended on 31 December) 2015 2014
Loss of the year -37.932 -51.115
Net change in fair value of available-for-sale financial assets 0 -72
Exchange differences on translation of foreign operations 55 29
Actuarial losses on defined benefit plans 0 -229
Other comprehensive income, net of income tax 55 -272
Other comprehensive income that may be reclassified to profit or
loss
0 0
Other comprehensive income that will not be reclassified to profit
or loss
55 -272
Total comprehensive income for the period -37.877 -51.387
Attributable to:
Equity holders of the company -37.829 -51.387

Non-controlling interest -48 0

Consolidated statement of financial position

In '000 euro (for the year ended on 31 December) 2015 2014
ASSETS
Property, plant and equipment 2.088 2.911
Intangible assets 55.699 62.388
Goodwill 2.586 2.586
Other non-current assets 235 1.600
Non-current tax receivable 1.645 2.061
Non-current assets 62.253 71.546
Inventories 6.498 7.224
Trade and other receivables 7.019 12.604
Current tax receivable 1.791 2.264
Investments 8.044 3.853
Cash and cash equivalents 93.341 123.223
Current assets 116.693 149.168
Total assets 178.946 220.714
EQUITY AND LIABILITIES
Share capital 151.991 151.991
Share premium 157.661 157.661
Accumulated translation differences -221 -276
Other reserves -13.473 -13.228
Retained earnings -126.068 -88.136
Equity attributable to equity holders of the company 169.938 208.012
Non-controlling interest 77 0
Total equity 170.015 208.012
Trade payables 4.128 7.369
Other short-term liabilities 4.803 5.333
Current liabilities 8.931 12.702
Total equity and liabilities 178.946 220.714

Consolidated statement of cash flows

In '000 euro (for the year ended on 31 December) 2015 2014
Cash flows from operating activities
(Loss) profit for the period -37.932 -51.115
Finance expense 489 146
Finance income -1.516 -1.885
Depreciation on property, plant and equipment 1.175 1.297
Amortization of intangible assets 6.814 6.833
Increase in accruals and employee benefits 0 110
Equity settled share-based payment transactions -251 554
Change in trade and other receivables including tax receivables and
stock
7.200 -2.573
Change in short-term liabilities -3.772 54
Net cash (used) from operating activities -27.793 -46.579
Cash flows from investing activities
Disposal of property, plant and equipment (following a sale) 2 27
Change in investments -4.191 3.938
Interest received and similar income 358 953
Acquisition of intangible assets 0 -12
Acquisition of property, plant and equipment -354 -571
Acquisition/divestments of other non-current assets 1.365 111
Net cash (used in) generated by investing activities -2.820 4.446
Cash flows from financing activities
Proceeds from issue of share capital 0 0
Paid interests -8 -11
Net cash (used in) generated by financing activities -8 -11
Net change in cash and cash equivalents -30.621 -42.144
Cash and cash equivalents at the start of the period 123.223 164.570
Effect of exchange rate fluctuations 739 797
Cash and cash equivalents at the end of the period 93.341 123.223

Consolidated statement of changes in equity

Share
capital
Share
premium
Cumulative
translation
differences
Other
reserves
Retained
earnings
Attributable
to equity
holders of
the
company
Non
controlling
interest
Total
Balance as at 1 January
2014
151.991 157.661 -305 -13.783 -36.792 258.772 0 258.772
Loss of the year 2014 0 0 0 0 -51.115 -51.115 0 -51.115
Change to foreign
currency translation
difference and
revaluation reserve
0 0 29 0 0 29 0 29
Actuarial losses on
defined benefit plans
0 0 0 0 -229 -229 0 -229
Net change in fair value
of investments
0 0 0 1 0 1 0 1
Issue of ordinary shares 0 0 0 0 0 0 0 0
Share-based payment
transactions
0 0 0 554 0 554 0 554
Balance as at 31
December 2014
151.991 157.661 -276 -13.228 -88.136 208.012 0 208.012
Loss of the year 2015 0 0 0 0 -37.932 -37.884 -48 -37.932
Change to foreign
currency translation
difference and
revaluation reserve
0 0 55 0 0 55 0 55
Net change in fair value
of investments
0 0 0 6 0 6 0 6
Issue of ordinary shares 0 0 0 0 0 0 0 0
Share-based payment
transactions
0 0 0 -251 0 -251 0 -251
Balance as at 31
December 2015
151.991 157.661 -221 -13.473 -126.068 169.938 -48 169.890

The statutory auditor, BDO Bedrijfsrevisoren represented by Bert Kegels, has confirmed that the audit procedures, which have been substantially completed, have not revealed any material adjustments which would have to be made to the accounting data included in the Company's annual announcement, and intends to issue an unqualified opinion.