Risks for ThromboGenics Inc.

Transcription

1 Regulated information ThromboGenics Business Update H US organization right-sized to meet current market needs targeting break-even in US from 2016 ThromboGenics clinical and pre-clinical programs progressing as planned focus on diabetic eye disease ThromboGenics confirms cash guidance for FY15 Cash position to support current business plans for at least 3 years Highlights Financial For the first half of 2015 ending June , ThromboGenics reports total revenues of 6.0 million, including 4.25 million of JETREA sales in the US and 1.75 million in royalties from Alcon based on its ex-us sales of JETREA. This compares to 5 million of JETREA sales in the US and royalty income of 1.7 million reported for the same period in For the period H2 2014, ThromboGenics reported 3.8 million of JETREA sales in the US and a royalty income of 1.7 million. Cash and investments were million as of the end of June 2015, compared with million at the end of December 2014 ThromboGenics decision to reduce the size of its US organization so that it is cash flow neutral in 2016 means that its current cash resources, plus the anticipated royalties from Alcon, will be sufficient to support its business plans for at least 3 years. JETREA in the US JETREA achieved sales in US of 4.2 million in the first half of There has been no meaningful change in sales momentum despite additional positive real world data that has been released in recent months ThromboGenics is adjusting its US organisation to current market needs ThromboGenics, Inc. will become a leaner customer-centric organisation. It will supply JETREA via its existing distribution network, and will provide responsive medical and scientific data-driven support to the retina community. The Company will continue to support physicians efforts to enhance patient awareness of the options available for treating symptomatic VMA US retina physicians who wish to treat patients with JETREA will continue to have full access to the product and to receive scientific and medical support 1

2 JETREA outside the US ThromboGenics received 1.7 million in royalty income from its partner Alcon in the first half of 2015 ( 1.7 million for H1 2014) Alcon continues to gain new marketing and reimbursement approvals and to execute commercial launches of JETREA across Europe and Rest of the World (RoW) JETREA is now approved in 53 countries globally and reimbursement is secured in over 20 countries Pre-clinical Research & Clinical Development ThromboGenics reported positive top-line results from the OASIS study in March This randomized controlled study met its primary endpoint with 41.7% of patients treated with JETREA achieving VMA resolution at day 28 post injection compared with only 6.2% of patients who received a sham injection (p<0.001). The study also showed that 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 ThromboGenics remains on track to initiate its Phase IIa clinical study assessing JETREA for the treatment of diabetic retinopathy (DR) around the end of A recent report from the American Academy of Ophthalmology projects that by 2020 there will be 1.34 million people in the US with visionthreatening DR. ThromboGenics is also evaluating the development of JETREA for the enzymatic treatment of Retinal Vein Occlusion (RVO). First in-vivo tests have been completed, and the results are currently being processed for publication in a peer-reviewed scientific publication New compounds under pre-clinical evaluation focus is on diabetic eye disease. Company plans to host an R&D Investor Event in late 2015/early 2016 at which the Company will provide a review of its clinical and development pipeline going forward. Oncurious ThromboGenics spun out its oncology research activities into Oncurious NV, a newly incorporated company in which ThromboGenics is the majority shareholder. This company has been founded in conjunction with VIB (Flanders Institute for Biotechnology). This new venture is initially focusing on developing TB-403 for the treatment of medulloblastoma, the most common form of brain cancer in children Oncurious is on track to commence a Phase I/IIa study before the end of

3 Appointments Dominique Vanfleteren appointed ThromboGenics Chief Financial Officer (CFO) in January 2015 Emmanuèle Attout appointed Independent Non-Executive Director of the Board of ThromboGenics NV on May 5, 2015 Baron Philippe Vlerick appointed Non-Executive Director of the Board of ThromboGenics NV at an extraordinary shareholders assembly that took place on August 20, 2015 Leuven, Belgium 26 August ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative medicines for treatment of vitreo-retinal disorders, today issues a business and financial update for the six months ending 30 June, ThromboGenics today has announced a re-sizing of its US organization to reflect the current market demand for JETREA. A new leaner organization will be responsible for providing distribution services, customer support and on-going medical education for JETREA. This change is designed to ensure that the Company s US operations are cash flow neutral as of As a result of today s announcement, ThromboGenics expects that the income from JETREA, including the royalty income from Alcon, should become a source of cash to support the Company s R&D activities from 2016 onwards. For treating physicians and their patients, nothing will change with regard to the availability and support of the drug for use in symptomatic VMA/VMT. ThromboGenics strategy will continue to be focused on: Developing JETREA in a significant new indication - Diabetic Retinopathy Progressing its pipeline of earlier stage projects which are focused on developing treatments for diabetes-related vitreo-retinal diseases Cash generation from the commercialization of JETREA (in its first indication, svma/vmt), in the US and in the RoW via our partner Alcon Realizing value from Oncurious NV, a newly created oncology company in which ThromboGenics is a major shareholder Dr Patrik De Haes, ThromboGenics CEO, said: In recent months it has become clear that we needed to evolve our strategy in order to generate significant returns for our shareholders. We remain convinced that in time JETREA will be able to play a key role in the changed standard of treatment for patients with svma. However this will not result from incremental promotional efforts, but rather from new medical data and clinical experience. This has resulted in today s announcement to make changes to our US organization and our commercial strategy for JETREA. 3

4 Our smaller US team will continue to provide distribution, customer support and medical education services for JETREA. US retina physicians and patients will have continued access and support when seeking treatment with JETREA. These changes are designed to make our US business cash flow neutral from 2016 onwards. We will invest these newly freed-up resources in the further clinical development of JETREA in diabetic retinopathy, a very significant next indication where there is a clear need for improved treatment options. Our Phase II clinical trial in this indication remains on track to initiate around the end of this year. Our current cash resources of over 100 million, along with anticipated royalty income, should support the internal development of next-generation ophthalmology products in diabetic eye disease for at least the next 3 years. This timeframe will allow us to generate the clinical data needed to demonstrate the value of a number of our pipeline projects. Oncurious NV, a new oncology company we have set up with VIB, with ThromboGenics NV as the majority shareholder, holds great potential to generate incremental longer term value to our shareholders. The Phase I/IIa clinical trial planning for TB-403 in medulloblastoma is progressing well and we expect to recruit the first patient later this year. Commercial Activities JETREA in the US In the first half of 2015, ThromboGenics generated JETREA sales of 4.2 million. This was below the Company s expectations as the uplift in sales, which was anticipated following the release of additional positive real-world data, did not materialize. This trend in sales has led the Company to change its commercial strategy in the US. This change will lead to a smaller organization focused on providing distribution, customer support and medical education services for JETREA. US retina physicians will continue to have access to JETREA to treat appropriate patients with symptomatic vitreomacular adhesion (svma). This adjustment to the commercial strategy should lead to ThromboGenics US operations being cash-flow neutral from 2016 onwards. 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 including Macular Hole with JETREA (ocriplasmin). The OASIS study (n=220 patients) is a randomized, sham-controlled, double-masked study that followed patients for 24 months post-injection. The study was designed to 4

5 provide long term and well-controlled efficacy and safety data for JETREA in patients being treated for symptomatic vitreomacular adhesion (svma). The 24 month followup data is the longest period patients have been studied post-treatment with this novel medicine. 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 improved patient selection in order to generate higher rates of VMA resolution with JETREA. It is known that an epiretinal membrane (ERM) often adversely impacts the efficacy of JETREA. Approximately 20% of the recruited patients in the OASIS study had an ERM (despite it being one of the exclusion criteria, indicating the challenge of accurately diagnosing this condition), suggesting that the 41.7% overall resolution rate at day 28 post-injection could have been even higher. This underscores the message that careful patient selection will lead to better treatment outcomes. Further analysis of all of the OASIS data, which will be interpreted with the help of retina physicians, is ongoing. The results from these analyses are planned to be shared with the retina community at the American Academy of Ophthalmology conference of November 14 17, ORBIT study In March 2014, ThromboGenics launched the Ocriplasmin Research to Better Inform Treatment (ORBIT) study. This prospective, observational study is designed to 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. Six month data from the ORBIT study, were presented in a poster at the Association for Research in Vision and Ophthalmology (ARVO) conference May 3-7 in Denver, Colorado. The study showed that 58.1% of patients experienced svma/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. More JETREA real-world data were the subject of several scientific poster presentations that were delivered at the recent ARVO 2015 meeting. 5

6 JETREA in Europe and RoW ThromboGenics received 1.7 million in royalty income from its partner Alcon in the first half of 2015 ( 1.7 million in H1 2014) Alcon is continuing to commercialize JETREA in its RoW territory. In February, JETREA was approved in Argentina, Israel and the Philippines. In April, JETREA was approved in New Zealand. This was the product s 52 nd approval outside the US. Also in April the new ready-diluted formulation of JETREA gained final EU approval. The planned launch of this new formulation of JETREA will eliminate the preparatory dilution steps prior to injection. At the point of administration into the eye, the strength, potency, composition and pharmaceutical form of the ready-diluted formulation remain identical to the currently available formulation after dilution. Research & Development Activities Diabetic Retinopathy A substantial potential new Indication for JETREA The Company is developing JETREA for DR as part of its strategy to maximize the value-creating opportunities for this novel drug and fill unmet medical needs. ThromboGenics decision to develop JETREA for the treatment of DR is based on a scientific rationale that supports its utility in treating patients suffering from this important sight-threatening condition before their disease progresses. Research has shown that the presence of a posterior vitreous detachment (PVD), where the vitreous is separated from the retina, may prevent the growth of new blood vessels that are responsible for proliferative DR (PDR). This finding has been reinforced by the fact that PDR is rare in patients who have a posterior vitreous detachment. JETREA is able to generate a PVD by cleaving the protein linkages between the vitreous and the retina and by liquefying the vitreous itself. The Company and its clinical advisors believe that by using JETREA to generate a PVD, the development of the new blood vessels that cause PDR can be prevented. This is because the new blood vessels will no longer be able to use the vitreous as scaffolding and grow along the surface of the retina or into the vitreous. Given the growing number of diabetic patients in the US, it is clear that the number of patients who are anticipated to suffer from diabetes-related eye diseases, including diabetic retinopathy, is expected to increase substantially. 6

7 A recent report from the American Academy of Ophthalmology has projected that the prevalence of individuals with any form of diabetic retinopathy in the United States in the year 2020 will be 6 million people, of whom 1.34 million persons will have visionthreatening DR. ThromboGenics remains on track to initiate the planned Phase IIa DR trial with JETREA around the end of Retinal Vein Occlusion Lysing blood clots with JETREA In April, ThromboGenics announced that it would be evaluating JETREA for the treatment of retinal vein occlusion. Retinal Vein Occlusion (RVO) is the second most common retinal vascular disease, and thought to negatively impact the quality of life of 16 million patients worldwide. RVO is caused by the formation of clots in either the central retinal vein or in branch retinal veins, which can profoundly affect visual acuity. This new vitreo-retinal project with JETREA aims to demonstrate the potential of using locally delivered ocriplasmin for lysing the blood clots (in the retinal veins) that are responsible for this condition. ThromboGenics has secured a 0.6 million grant from the Flemish Agency for Innovation by Science and Technology (IWT) and will use this to collaborate with the Ophthalmology Department of the University Hospital UZLeuven in Belgium to further evaluate this potential indication. The IWT grant will also support a partnership with the Mechanical Engineering Department of the KU Leuven to develop a roboticsassisted system which has the ability to deliver the local administration of ocriplasmin directly in the retinal veins. The first RVO in vivo tests have been completed, and results are currently being processed. The Company intends to work towards a scientific publication of these findings. Oncurious NV A new oncology company In April, ThromboGenics announced the formation of Oncurious NV, a new oncology company that will develop TB-403 for the treatment of pediatric brain tumors. Oncurious is a joint venture between ThromboGenics and VIB, the leading life sciences institute in Flanders (Belgium). ThromboGenics is the majority shareholder of Oncurious. 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. 7

8 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. Oncurious will initiate a Phase I/IIa program with TB-403 in medulloblastoma patients with the first patient expected to be enrolled by the end of ThromboGenics plans to host an R&D Investor Event in late 2015/early 2016 at which the Company will provide a detailed review of its clinical and development pipeline. Appointments Emmanuèle Attout Appointed Independent Non-Executive Director In January, ThromboGenics nominated Emmanuèle Attout to be its new independent non-executive director. Mrs. Attout was appointed during the ThromboGenics Annual Shareholders Meeting of May 5, Due to her accounting and auditing expertise, she is also a member of the Audit Committee of the Company. Mrs. Attout was an audit partner at PricewaterhouseCoopers from 1994 till She has been in charge of the audits for a wide range of clients, including in recent years publicly-listed pharmaceutical companies and life sciences businesses. Baron Philippe Vlerick Appointed Non-Executive Director In May, Baron Philippe Vlerick was appointed as a non-executive member of the Board of ThromboGenics NV. His appointment was confirmed at an extraordinary shareholders assembly that took place on August 20th. Philippe Vlerick is the 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 Textiles NV. 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 and I.V.C. (Belgium). Mr Vlerick holds a Degree in Philosophy and Law from the University of Leuven, and an MBA General Management degree (PUB) (Ghent, Vlerick School of Management 1979). He also holds a Master s 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

9 Dominique Vanfleteren Appointed Chief Financial Officer Dominique Vanfleteren was appointed as ThromboGenics new Chief Financial Officer (CFO) in January Dominique Vanfleteren has over 25 years of experience in senior finance, operational control and reporting roles with public international biopharmaceutical companies. Before joining ThromboGenics, Mr. Vanfleteren spent 12 years at UCB, where he held a number of senior 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 GlaxoSmithKline for 16 years. Financial review In the first half of 2015, ThromboGenics had total revenues of 6.0 million, including 4.25 million of JETREA sales in the US and 1.75 million in royalties from Alcon based on its ex-us sales of JETREA. In the corresponding period in 2014, ThromboGenics reported 5 million of JETREA US sales, and an ex-us royalty income of 1.7 million. In the second half of 2014, ThromboGenics reported 3.8 million of JETREA sales in the US and an ex-us royalties of 1.7 million. In the first half of 2015, ThromboGenics R&D expenses were 10.3 million, including a 3.4 million amortization of the ocriplasmin Phase III program. This compares with 11.6 million of R&D expenses in the same period in In the first half of 2015, selling and marketing expenses amounted to 10.2 million compared with 14.3 million in the first six months of The reduction is largely related to the transition from a contract sales organization to ThromboGenics own sales team and lower marketing expenses. For the first half of 2015, ThromboGenics reported a net loss of 19.2 million, or 0.53 per share. In the corresponding period in 2014 the Company reported a net loss of 23.9 million or 0.66 per share. At the end of June 2015, ThromboGenics had million in cash and investments, compared to at of the end of December ThromboGenics believes that with this cash, and the anticipated royalty stream from JETREA, it has the financial resources to support its activities for at least the next 3 years. On May 19, Baron Philippe Vlerick informed the Company that his ownership interest in ThromboGenics share capital had exceeded the 3% threshold. On July 14, Biggar Ltd notified the Company that its shareholding in ThromboGenics NV had dropped below transparency notification level. 9

10 A conference call for analysts, press and investors will be hosted by Dr Patrik De Haes, CEO and Dominique Vanfleteren, CFO of ThromboGenics, on Wednesday 26 August, starting at 06:30 PM CEST, 12:30 PM EDT. The dial-in numbers and participant passcode for the call are set out below: Belgium (Toll Free) France (Toll Free) Germany (Toll Free) Ireland (Toll Free) Netherlands (Toll Free) United Kingdom (Toll Free) United States (1) (Toll Free) Click here for more international toll and toll free dial in numbers Participant pin code: # We request that participants dial in 5-10 minutes prior to the start time of 06:30 PM CEST, 12:30 PM EDT. The presentation will be webcasted live, click here to register. The presentation and transcript of the call will be made available in the investor information section of the website. END 10

11 For further information please contact: ThromboGenics Wouter Piepers, Global Head of Corporate Communications/ IR / wouter.piepers@thrombogenics.com Citigate Dewe Rogerson David Dible/Malcolm Robertson Tel: David.Dible@citigatedr.co.uk About JETREA (ocriplasmin) JETREA (ocriplasmin) is a truncated form of human plasmin. JETREA acts as 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. In the US, JETREA is indicated for the treatment of symptomatic vitreomacular adhesion. 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 was 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. This 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. In March 2015, ThromboGenics reported top line results from OASIS, a Phase IIIb study. This randomized, sham controlled, double masked study followed-up patients for 24 months post injection. In this study, retina physicians were able to use SD-OCT to select patients with focal VMA and without Epiretinal Membrane (ERM), two criteria which have been shown to lead to better treatment outcomes with JETREA. Despite this, OASIS data showed over 20% of the patients recruited into study had ERM. The trial showed that 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 that the drug s safety profile in the 24 month follow period was consistent with the drug s overall safety profile as known from the approved label. About ThromboGenics ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company s lead product, JETREA (ocriplasmin) was approved by the US FDA for the treatment of symptomatic VMA and was launched by ThromboGenics in January ThromboGenics signed a strategic partnership with Alcon, a division of Novartis, for the commercialization of JETREA outside the United States in To-date JETREA has been approved in over 50 countries globally. JETREA is currently being developed for diabetic retinopathy (DR), and evaluated for retinal vein occlusion (RVO). ThromboGenics is the major shareholder in Oncurious NV, a cancer-focused company that was formed in April 2015 in collaboration with VIB, a leading life science institute in Flanders 11

12 (Belgium). Oncurious was created to develop TB-403 initially for medulloblastoma, the most frequent form of pediatric brain cancer. ThromboGenics has retained the exclusive rights to use TB-403 for ophthalmic indications. 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 Important information about forward-looking statements Certain statements in this press release may be considered forward-looking. Such forwardlooking 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. 12

13 Consolidated key figures as of June 30, 2015 Unaudited Consolidated statement of financial position In '000 euro 30 June 31 December Property, plant and equipment 2,494 2,911 Intangible assets 58,978 62,388 Goodwill 2,586 2,586 Other non-current assets 203 1,600 Non-current tax receivable 2,133 2,061 Inventories 7,151 7,224 Trade and other receivables 8,102 12,604 Current tax receivable 1,331 2,264 Investments 891 3,853 Cash and cash equivalents 112, ,223 Total assets 196, ,714 Total equity 188, ,012 Current liabilities 7,736 12,702 Total equity and liabilities 196, ,714 Unaudited Consolidated statement of comprehensive income In '000 euro Half-year Income 5,982 7,149 Operating result -19,789-24,414 Finance income 1, Finance expenses Result before income tax -19,178-23,803 Income tax expenses Net result for the period -19,179-23,849 Result per share Basic earnings per share (euro) Diluted earnings per share (euro) A full analysis of the interim financial statement, prepared in accordance to IAS 34, as declared applicable by the European Union, is included under the section Condensed consolidated interim financial statements. These statements were submitted to a limited review by the statutory auditor. 13

14 Condensed consolidated interim financial statements Unaudited consolidated statement of comprehensive income In '000 euro Half-year Income 5,982 7,149 Sales 4,241 5,366 License income 0 33 Income from royalties 1,741 1,750 Cost of sales -1, Gross profit 4,810 6,604 Research and development expenses -10,289-11,618 General and administrative expenses -4,208-5,096 Selling expenses -10,184-14,344 Other operating income Other operating expenses 0-2 Operating result -19,789-24,414 Finance income 1, Finance expenses Result before income tax -19,178-23,803 Income tax expenses Net result for the period -19,179-23,849 Attributable to: Equity holders of the company -19,179-23,849 Result per share Basic earnings per share (euro) Diluted earnings per share (euro) Unaudited consolidated statements of other comprehensive income In '000 euro Half-year Result of the period -19,179-23,849 Net change in fair value of available-for-sale financial assets 0 0 Exchange differences on translation of foreign operations Actuarial losses on defined benefit plans Other comprehensive income, net of income tax Total comprehensive income for the period -19,119-24,121 Attributable to: Equity holders of the company -19,119-24,121 14

15 Unaudited consolidated statement of financial position In '000 euro 30 June 31 December ASSETS Property, plant and equipment 2,494 2,911 Intangible assets 58,978 62,388 Goodwill 2,586 2,586 Other non-current assets 203 1,600 Employee benefits 0 0 Non-current tax receivable 2,133 2,061 Non-current assets 66,394 71,546 Inventories 7,151 7,224 Trade and other receivables 8,102 12,604 Current tax receivable 1,331 2,264 Investments 891 3,853 Cash and cash equivalents 112, ,223 Current assets 129, ,168 Total assets 196, ,714 EQUITY AND LIABILITIES Share capital 151, ,991 Share premium 157, ,661 Accumulated translation differences Other reserves -13,585-13,228 Retained earnings -107,315-88,136 Equity attributable to equity holders of the company 188, ,012 Minority interests 0 0 Total equity 188, ,012 Trade payables 4,592 7,369 Other short-term liabilities 3,144 5,333 Current liabilities 7,736 12,702 Total equity and liabilities 196, ,714 15

16 Unaudited consolidated statement of cash flows In '000 euro Half-year Cash flows from operating activities (Loss) profit for the period -19,179-23,849 Finance expenses Finance income -1, Depreciation of property, plant and equipment Amortization of intangible assets 3,410 3,415 Gain on sale of property, plant and equipment 0 16 Increase in accruals and employee benefits Equity settled share-based payment transactions Change in trade and other receivables including tax receivables and inventories 5,436-1,851 Change in short-term liabilities -4,967-1,818 Net cash (used) from operating activities -15,641-23,658 Cash flows from investing activities Disposal of property, plant and equipment 1 0 Change in investments 2,962-9,003 Interest received and similar income Acquisition of intangible assets 0-13 Acquisition of property, plant and equipment Acquisition (divestments) of other non-current assets 1, Net cash (used in) generated by investing activities 4,366-8,987 Cash flows from financing activities Proceeds from issue of share capital 0 0 Paid interest -4-5 Net cash (used in) generated by financing activities -4-5 Net change in cash and cash equivalents -11,279-32,650 Cash and cash equivalents at the start of the period 123, ,570 Effect of exchange rate fluctuations Cash and cash equivalents at the end of the period 112, ,977 16

17 Unaudited consolidated statement of changes in equity Share capital Share premium Cumulative translation differences Other reserves Retained earnings Attributable to equity holders of the company Minority interests Balance as at 1 January , , ,783-36, , ,772 Net result ,849-23,849-23,849 Change to foreign currency translation difference and revaluation reserve Actuarial losses on defined benefit plans Net change in fair value of investments 0 0 Issue of ordinary shares 0 0 Conversion of warrants by warrant holders 0 0 Share-based payment transactions Balance as at 30 June , , ,506-60, , ,928 Balance as at 1 January , , ,228-88, , ,012 Net result ,179-19,179-19,179 Change to foreign currency translation difference and revaluation reserve Actuarial losses on defined benefit plans 0 0 Net change in fair value of investments 0 0 Issue of ordinary shares 0 0 Conversion of warrants by warrant holders 0 0 Share-based payment transactions Balance as at 30 June , , , , , ,536 Total 17