To NASDAQ OMX Copenhagen A/S Announcement No. 19-10 / Copenhagen, 20 May 2010 Topotarget A/S Symbion Fruebjergvej 3 DK 2100 Copenhagen Denmark Tel: +45 39 17 83 92 Fax: +45 39 17 94 92 CVR-nr: 25695771 www.topotarget.com Interim report for the period 1 January to 31 March 2010 Copenhagen, Denmark - 20 May 2010 -The Board of Directors of Topotarget A/S (NASDAQ OMX: TOPO) today adopted the company's interim report for the period 1 January to 31 March 2010. • License and cooperation agreement, as of 2 February 2010, with Spectrum Pharmaceuticals Inc. comprising development and commercialisation of belinostat in USA and India. Potential value corresponding to USD 350 million cash plus double digit royalties on future sales. Topotarget has received non refundable upfront payment of USD 30.0 milllion • Divesture of Savene® rights to SpePharm for the European market on 2 March 2010. EUR 5.0 million received and royalties on sales to be received concurrently. Potential maximum value corresponds to EUR 6 million. • Topotarget generated revenue of DKK 29.2 million (137% increase) during the period compared with DKK 12.3 million in the same period last year. Operating expenses for the three months period ended 31 March 2010 were DKK 38.1 million (10% decrease) compared to DKK 42.1 million for the same period 2009 • Operating profit for the three months period ended 31 March 2010 was DKK 24.8 million compared to a loss of DKK 29.8 million for the same period 2009 • Totect sales development in the USA for Q1 2010 was stable despite the manufacturing problems in the first two months of the period. This shows a steady demand. Manufacturing problems are solved. • Cash and cash equivalents at 31 March 2010 were DKK 287.5 million compared to DKK 80.8 million at 31 March 2009 • Topotarget confirms its financial guidance as stated at the Annual General Meeting 22 April 2010 of a pre-tax profit for the 2010 financial year of approximately DKK 0 million to DKK 20 million. Selected highlights during Q1 2010 • On 6 January 2010 Topotarget announced that the GOG (The Gynecologic Oncology Group, US) initiated a phase 2 trial evaluating the efficacy and safety of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or peritoneal cancer. The GOG is receiving support for this trial from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). Page 1 of 21 Interim report for the period 1 January to 31 March 2010 • On 2 February 2010 it was announced that a co-development and commercialization agreement with Spectrum Pharmaceuticals Inc. for belinostat had been signed. ‐ Potential value of USD 350 million plus double digit royalties ‐ Topotarget to receive USD 30 million cash upfront ‐ Topotarget and Spectrum will jointly develop belinostat with Spectrum contributing 70% of future development costs ‐ Spectrum´s exclusive territory includes North America, India and a first right of offer for the Chinese market ‐ Topotarget have rights to all data for regulatory purposes to commercialize belinostat in Europe, Japan and rest of the world • On 23 February 2010 Topotarget announced a new CEO, M.D. Francois R. Martelet to prepare for the commercialisation of belinostat • On 2 March 2010 Topotarget announced that SpePharm Holding, BV acquired the rights to Savene® for EUR 6 million including potential EUR 1 million of royalties. The acquisition includes all the Savene® European assets and the transition of the Topotarget sales team in Europe to SpePharm. On 19 March 2010 Topotarget announced the initiation of a Phase I/II clinical trial of belinostat in combination with cisplatin, doxorubicin and cyclophosphamide in the first line treatment of malignancies of the thyroid gland. This trial is sponsored by the National Cancer Institute (NCI), USA and is expected to recruit between 30 and 48 patients. Highlights for the period after 31 March 2010 • On 7 April 2010 Topotarget announced a new CFO & Head of IR, Anders Fink Vadsholt. • On 7 April 2010 As a consequence of Topotarget's focus on belinostat, the Company restructured its research and pre-clinical development organization as well as its management structure leading to the reduction of eight full time employees. • On 13 April 2010 Topotarget announced the appointment of Professor Jean-Louis Misset as Chairman of it s global scientific and medical advisory board. Professor Misset is a full professor of Oncology at the University of Paris and at the St. Louis Hospital of Oncology Division in Paris, France. Professor Misset is an experienced Key Opinion Leader within Oncology who has served as an advisor to several big Pharma companies. • On 21 April 2010 Topotarget announced the presentation of preclinical data at the 101th Annual Meeting of the American Association for Cancer Research (AACR). The data showed schedule-dependent additive to synergistic activity of belinostat when combined with etoposide or cisplatin in small cell lung cancer cell lines. • On 22 April 2010 in connection with the Annual General Meeting, Topotarget established of a new Board of Directors. Bo Jesper Hansen became Chairman of the Board, Anker Lundemose was elected a new member. The former Chairman Håkan Åstrøm stepped down as well as Anders F. Vadsholt as he is now the CFO of Topotarget. • On 22 April 2010 in connection with the Annual General Meeting, Topotarget issued financial guidance of a pre-tax profit for the 2010 financial year in the range of DKK 0 million to DKK 20 million. Announcement No. 19-10 Page 2 of 21 Interim report for the period 1 January to 31 March 2010 Conference call Topotarget will host a conference call this afternoon, 20 May at 2.00 pm (CET), at which management will present and discuss the results for Q1 2010 in English. A presentation will be available on Topotarget's website, www.topotarget.com, before the start of the conference call. To participate in the conference call please dial: ?? From Denmark: 32 71 47 67 ?? Outside Denmark: +45 70 26 50 40 or +44 800 634 5205 (UK) or +1 866 629 2704 (US) or +46 200 125 785 (SE) A replay of the conference call will be available approximately two hours after the conference call and until 20 June, 2010 at the following number: +353 1 436 4267 or +44 207 769 6325, pin code: 2854904#. Announcement No. 19-10 Page 3 of 21 Interim report for the period 1 January to 31 March 2010 Highlights and key figuresConsolidated income statements3 months 20103 months 20092009DKK ' 000 DKK ' 000 DKK ' 000 Revenues29.230 12.343 43.979 Production costs(3.355) (2.230) (10.125) Research and development costs(19.525) (24.489) (89.884) Write down of research and development projects00(21.200)Sales and distribution costs(6.095) (9.275) (29.136) Administrative expenses(9.169) (6.108) (26.126) Financial income and expenses(1.225) (3.104) (10.250) Profit/loss before tax23.585 (32.863) (142.742) Basic EPS (DKK)0,18 (0,41) (1,36) Diluted EPS (DKK)0,18 (0,41) (1,36) 31 March31 March31 DecemberConsolidated balance sheets201020092009DKK ' 000 DKK ' 000 DKK ' 000 Cash and cash equivalents287.522 80.823 130.145 Assets744.776 564.053 585.413 Equity436.045 400.359 411.798 Consolidated cash flow statements3 months 20103 months 20092009DKK ' 000 DKK ' 000 DKK ' 000 Cash flows from operating activities10.062 (27.541) (99.198) Cash flows from investing activities680 35.785 37.861 Cash flows from financing activities146.635 (124) 118.780 31 March31 March31 DecemberConsolidated key figures201020092009DKK ' 000 DKK ' 000 DKK ' 000 Number of fully paid shares in issue as at period end132.609.020 66.304.510 61.304.510 132.609.020 66.304.510 53.955.186 Assets/equity1,71 1,41 1,42 Share price, closing (DKK)4,92 9,30 3,62 Share price, book value (DKK)3,29 6,04 6,72 Average number of employees54 60 58 Weighted average number of shares in issue for the period Announcement No. 19-10 Page 4 of 21 Interim report for the period 1 January to 31 March 2010 Management's report The agreement with Spectrum Pharmaceuticals Inc. to co-develop and commercialise Topotarget's lead anticancer drug belinostat in North America and India will strengthen Topotarget's ability to develop the product world wide. Spectrum commits to fund 100% of the costs for the ongoing PTCL study and Topotarget will fund 100% of the ongoing CUP study. Spectrum and Topotarget will split the development costs in a 70 to 30 ratio for development of possible future indications for belinostat. Belinostat: Belinostat is Topotarget's most advanced product candidate, and a number of patients have benefited from belinostat with substantial reduction, and in some cases complete regression of tumours for several types of cancer. It appears that belinostat exhibits a very favorable safety profile in relation to any other HDAC inhibitor in clinical development. For example, there are only mild or no cases of thrombocytopenia (benefit: reduced risk of bleeding) and there have been no report of pericarditis (benefit: reduced risk of cardiac side-effects). This may allow for both full dose of belinostat as single agent treatment and full dose of belinostat in combination with a full dose of chemotherapy, thereby maximizing clinical activity. Belinostat is currently the only HDAC inhibitor in clinical development with the possibility of both IV dosing (bolus or continuous infusion) and oral (tablet) administration routes, which provides additional flexibility in the clinical setting. The complete development program includes 26 ongoing and completed clinical trials including 13 clinical trials funded and coordinated by the NCI, USA. For the NCI funded clinical trials Topotarget only supplies belinostat without incurring any costs associated with the completion of these trials. Topotarget has access to all data for regulatory purposes. Furthermore Topotarget has a Cooperative Research and Development Agreement (CRADA) with the NCI to conduct preclinical and nonclinical studies on belinostat in order to better understand its anti-tumor activity and to provide supporting information for clinical trials. Steadily growing clinical data with belinostat as single agent and in combination with marketed drugs add further support to belinostat business development activities. Clinical trial progress: PTCL and CTCL - belinostat In March 2009 and in December 2009 positive updates of an initial Phase II study with belinostat in peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) was announced at an international T-cell lymphoma meeting in Italy and at the American Society of Clinical Oncology Meeting in the US. Complete/partial response (CR/PR) were observed in 29% of 19 evaluable patients and stable disease (SD) was demonstrated in 4 further patients, indicating a disease control rate (CR/PR/SD) rate of 53%. The achieved efficacy and safety data supports the registration plan in PTCL. Spectrum is on target to file NDA in 2011. Announcement No. 19-10 Page 5 of 21 Interim report for the period 1 January to 31 March 2010 PTCL - belinostat - the BELIEF-study Data from the study described above led Topotarget to initiate its pivotal BELIEF-study in PTCL in December 2008 following a Special Protocol Assessment (SPA) procedure and Fast Track agreement with the FDA (the US health authorities). In Q3 Topotarget received an Orphan Drug designation from the FDA granted for belinostat for the treatment of PTCL. This designation will entitle belinostat to 7 years of market exclusivity in the USA after eventual successful approval. The first data from the BELIEF-study are expected during 2010 in an interim analysis when 41 evaluable patients have been treated. Cancer of Unknown Primary Site (CUP) - belinostat in combination with carboplatin and paclitaxel (BelCaP) The CUP study is an ongoing open label randomized Phase II study of belinostat in combination with carboplatin and paclitaxel (BelCaP) compared to carboplatin and paclitaxel in patients with previously untreated CUP. The study aims to demonstrate the efficacy of belinostat in solid tumors in a randomized setting. Approximately 44 patients will be randomized to each group, in total 88 patients. Recruitment is ongoing and according to plan. Thymoma - belinostat In May 2009 positive data from a Phase II study of belinostat monotherapy in patients with thymoma and malignancies of the thyroid gland was announced and presented at the ASCO 2009 conference. A total of 27 patients were evaluable for response. In two out of 17 patients with thymoma a partial response was documented (13 and 13+ months), and in addition 11 patients had stable disease (4-15+ months). No response was seen in 10 patients with thymic carcinoma. The conclusion is that belinostat has activity in patients with recurrent or refractory thymoma. The thymoma cohort has been expanded to the second stage of the study and enrollment is ongoing. The study is sponsored by the NCI. A new study in thymoma was initiated by NCI in March 2010, examining a combination of belinostat with cisplatin, doxorubicin and cyclophosphamide as a first line treatment. The study expects to enrol 58 patients. Lymphoma - oral belinostat In May 2009 positive data from a Phase I study of belinostat given as oral monotherapy on days 1-14 every three weeks in patients with lymphoma were presented by Topotarget at the American Society of Clinical Oncology (ASCO) Conference. Oral belinostat can be delivered safely to lymphoma patients in doses that are higher than the maximum tolerated dose for patients with solid tumors. Despite extensive pre-treatment which normally makes the patients less receptive to treatment, remissions have been seen both in patients with Hodgkin's disease and Non-Hodgkin's lymphoma. The acceptable safety profile and early tumor shrinkage noted warrants continued evaluation of belinostat in lymphoma, especially in combination with other active compounds. Solid tumors - oral belinostat In May 2009 positive data from a Phase I study of belinostat given as oral monotherapy to patients with solid tumors were presented at the annual ASCO conference. Oral belinostat can be delivered safely in multiple schedules. Despite a median of 3 prior lines of therapy 48 (64%) of 75 evaluable patients achieved tumor growth control (SD), 15 patients had a treatment duration ≥ 3 months. The safety Announcement No. 19-10 Page 6 of 21 Interim report for the period 1 January to 31 March 2010 profile and long stabilizations in multiple tumor types adds further support to this option. Solid tumors - belinostat + bortezomib (Velcade) In November 2009 a NCI phase 1 dose escalation study of the combination of belinostat and Velcade was reported at the AACR/NCI/EORTC meeting on Molecular Targets. The combination proved well tolerated and induced disease stabilization in 4 of 20 patients. Small Cell Lung Cancer (SCLC) and other advanced cancers - continuous infusion (CIV) belinostat in combination with cisplatin and etoposide In August 2009 Topotarget announced the initiation of patient dosing in a Phase I study for the combination of 48 hours continuous intravenous infusion of belinostat with standard doses of cisplatin and etoposide for the treatment of patients with small cell lung carcinoma (SCLC) and other advanced cancers. The study is sponsored by the NCI. Ovarian Cancer In January 2010 it was announced that the Gynecologic Group, USA (GOG) initiated a phase 2 study evaluating belinostat in combination with carboplatin in patients with platinum-resistant ovarian cancer. Savene®/Totect®: Topotarget's first marketed product Savene®/Totect® is used for the prevention of serious tissue damage caused by anthracycline extravasation. Savene® was launched in October 2006 in selected European countries and Totect® was launched on the US market in October 2007. SpePharm Holding, BV acquired the rights to Savene® on 2 March 2010. Therefore the figure below illustrates sales in Q1 2008, 2009 and 2010 for Totect®, measured in TDKK. The production issues relating to Totect® were resolved during first quarter 2010. Announcement No. 19-10 Page 7 of 21 Interim report for the period 1 January to 31 March 2010 0100020003000400050006000Q1 ´08Q1 ´09Q1 ´10Sales DKK ´ 000Totect® sales development 2008 -2010 Expected key milestones for 2010 PTCL • Patients for the pivotal BELIEF study in PTCL will continue to be recruited during 2010 with expected regulatory filing in 2011. • Intermediate accrual data to be published from the BELIEF study (pivotal trial in PTCL) CUP • The ongoing trial, the proof-of-concept phase 2 randomized controlled study in solid tumors in CUP, will be fully recruited by the end of 2010 Intermediate accrual data to be published from the CUP study NSCLC • Initiate randomized phase 2 study in NSCLC MDS (Myelodysplastic Syndromes) • Preliminary data from phase 2 (NCI) Liver cancer • Pharmacokinetic data from study (NCI) Comments on the interim financial statements for the three months ended 31 March 2010 On 2 February 2010 Topotarget entered into an agreement with Spectrum Pharmaceuticals Inc. for the development and commercialisation of belinostat in North America and India. The agreement can be summarised as follows: • Potential value of USD 350 million plus double digit royalties Announcement No. 19-10 Page 8 of 21 Interim report for the period 1 January to 31 March 2010 • Topotarget to receive USD 30 million cash upfront • Topotarget and Spectrum will jointly develop belinostat with Spectrum contributing 70% of future development costs • Spectrum's exclusive territory includes North America, India and a first right of offer for the Chinese market • Topotarget can use data to commercialise belinostat in Europe, Japan and rest of the world On 2 March 2010 Topotarget divested the European rights to Savene® to SpePharm Holding, BV. The divesture included all the Savene® European assets and the transition of the Topotarget sales team in Europe. The right to receive royalty from sale of Savene® and Totect®, the US trademark for the same product, will remain with Topotarget and continue to be promoted by the Topotarget US sales team. This further reinforces Topotarget's focus on the development of our lead candidate belinostat. Topotarget generated revenue of DKK 29.2 million (137% increase) during the period compared with DKK 12.3 million in the same period last year. Revenues in the first 3 months of 2010 are primarily composed of deferred income of DKK 17.9 million in relation to the Spectrum upfront payment (total upfront payment received is USD 30.0 million) and reimbursement of FTE´s according to the Spectrum agreement of DKK 1.4 million. Also included in revenues are Savene®/Totect® sales of DKK 9.0 million and royalty income from SpePharm Holding, BV according to the Spepharm agreement as well as a small amount of rental income as detailed below. In the same period of 2009 revenues consisted of Savene®/Totect® sales plus a small amount of other income. Savene®/Totect® sales revenue for the first 3 months of 2010 was DKK 9.0 million compared to DKK 11.6 million in the same period of 2009. The main reason for the decline is that sales of Savene® in 2010 was only included for 2 months due to the divesture. A Savene® sale in the first 3 months of 2010 was DKK 3.7 million compared to 6.1 million in the same period of 2009. Totect® sales were DKK 5.3 million in the first 3 months of 2010 compared with DKK 5.4 million in the same period of 2009 despite supply problems during the first 2 months thus showing a continuous demand and sales development. The small amount of other income arises from the sublease in the Swiss subsidiary, which is in line with the comparative figure from the same period in 2009. The first 3 months of 2010 production costs were DKK 3.4 million. DKK 1.2 million is Topotarget personnel costs related to the Spectrum collaboration agreement and DKK 2.2 million is related to Savene®/Totect®. This is compared with DKK 2.2 million which is related to Savene®/Totect® in the same period of 2009. The difference is thus completely contributed to the reimbursement of DKK 1.4 million of Topotarget personnel costs related to the Spectrum agreement. The first 3 months of 2010 research and development costs were DKK 19.5 million (20% decrease) compared with DKK 24.5 million in the same period of 2009. The reduction is primarily due to the Spectrum agreement and Topotarget's focus on belinostat. The first 3 months of 2010 profit on sale of rights to Savene® were DKK 33.7 million compared with nil in the same period of 2009. The profit is recorded due to the divestiture of the European rights to Savene®. The first 3 months of 2010 sales and distribution costs were DKK 6.1 million, compared with DKK 9.3 million in the same period of 2009. The reduction is primarily due to the divestiture of Savene® on 2 March 2010. The first 3 months of 2010 administrative expenses were DKK 9.2 million compared with DKK 6.1 million in the same period of 2009. The increase can be attributed to the Announcement No. 19-10 Page 9 of 21 Interim report for the period 1 January to 31 March 2010 increase of holiday provision due to timing and recruitment and to one-off costs in relation to recruitment and increased investor relation activities. The first 3 months of 2010 net financial expenses were DKK 1.2 million compared with DKK 3.1 million in the same period of 2009. The primary difference between the amounts in the first 3 months of 2010 and the first 3 months of 2009 are an increased income of exchange rate adjustments to the bank deposits by DKK 3.9 million and increased expenses in relation to the translation of subsidiaries from foreign currencies to DKK with an amount of DKK 2.1 million. The first 3 months of 2010 tax income was DKK 0.0 million compared with 2.3 million in the same period of 2009. The comparison figure is resulting from a reduction in the deferred tax liability in Topotarget Switzerland S.A. In the period 1 January to 31 March 2010 Topotarget recorded a profit before tax of DKK 23.6 million compared with a loss before tax of DKK 32.9 million in the same period of 2009 and a profit after tax of DKK 23.6 million compared with a loss after tax of DKK 30.6 million in the same period of 2009. At 31 March 2010, total assets were DKK 744.8 million. Of this amount, cash and cash equivalents amounted to DKK 287.5 million. At 31 March 2009, total assets were DKK 564.1 million of which amount cash and cash equivalents amounted to DKK 80.8 million. The net reduction in intangible assets since 31 December 2009 of DKK 4.9 is directly contributable to the divestiture of Savene®. At 31 March 2010, equity amounted to DKK 436.0 million compared with DKK 400.4 million at the same time in 2009. The change consists of the net proceeds from the capital increase 2 July 2009 of DKK 119.1 million, the loss of DKK 86.4 million during the period from 1 April 2009 to 31 March 2010 and the additions during the period of share-based payment totalling DKK 2.9 million. Outlook for 2010 Topotarget confirms its financial statement as stated at the Annual General Meeting 22 April 2010 of a pre-tax profit for the 2010 financial year of approximately DKK 0 million to DKK 20 million. Topotarget A/S For further information, please contact: Francois Martelet, CEO: Direct: +45 39 17 94 99; Mobile: +45 31 36 83 41 Anders Vadsholt, CFO: Direct: +45 39 17 83 45; Mobile: +45 28 98 90 55 Announcement No. 19-10 Page 10 of 21 Interim report for the period 1 January to 31 March 2010 Statement by the Board of Directors and Senior Management The Board of Directors and Senior Management today discussed and adopted the interim report for Topotarget for the period 1 January to 31 March 2010. The interim report is presented in accordance with IAS 34 as adopted by EU and additional Danish disclosure requirements on the presentation of interim reports by listed companies. The interim report is not audited or reviewed. We consider the accounting policies to be appropriate. Accordingly, the interim report gives a true and fair view of the Group's assets, liabilities, and financial position at 31 March 2010 and of Group's operations and cash flows for the period 1 January to 31 March 2010. In our opinion, the management's report gives a true and fair view of developments in the activities and financial position of the Group, the results for the period and of the Group's financial position in general and gives a fair description of significant risk and uncertainty factors that may affect the Group. Copenhagen, 20 May 2010 Senior Management Francois Martelet Anders Vadsholt CEO CFO Board of Directors Bo Jesper Hansen Anker Lundemose Jeffrey Buchalter Chairman Anders Gersel Pedersen Ingelise Saunders Per Samuelsson Announcement No. 19-10 Page 11 of 21 Interim report for the period 1 January to 31 March 2010 Background information About Topotarget Topotarget (NASDAQ OMX: TOPO) is an international biotech company headquartered in Denmark, dedicated to improve cancer therapies. Topotarget currently focuses, in collaboration with Spectrum Pharmaceuticals Inc., on the development in pivotal studies of its lead drug candidate, belinostat, which has shown proof-of-concept as monotherapy in treating haematological malignancies and positive results in solid tumours. Belinostat can be used in combination with full doses of chemotherapy, and is currently in a pivotal trial within PTCL (peripheral T-cell lymphoma). Topotarget's key cancer drugs target HDAC, NAD+, mTOR, Fas ligand and topoisomerase II. The company's first marketed product, Savene®/Totect®, was approved by EMEA in 2006 and the FDA in 2007, and is marketed by Topotarget's own sales force in the US. For more information, please refer to www.Topotarget.com. Topotarget Safe Harbour Statement This announcement may contain forward-looking statements, including statements about our expectations of the progression of our preclinical and clinical pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Topotarget cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: The risk that any one or more of the drug development programs of Topotarget will not proceed as planned for technical, scientific or commercial reasons or due to patient enrolment issues or based on new information from non-clinical or clinical studies or from other sources; the success of competing products and technologies; technological uncertainty and product development risks; uncertainty of additional funding; Topotarget's history of incurring losses and the uncertainty of achieving profitability; Topotarget's stage of development as a biopharmaceutical company; government regulation; patent infringement claims against Topotarget's products, processes and technologies; the ability to protect Topotarget's patents and proprietary rights; uncertainties relating to commercialization rights; and product liability exposure; We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. Announcement No. 19-10 Page 12 of 21 Interim report for the period 1 January to 31 March 2010 Note 3 months 2010 3 months 2009 2009 DKK ' 000 DKK ' 000 DKK ' 000 Revenue 2,3 2 9.230 12.343 43.979 Production costs 4 (3.355) ( 2.230) (10.125) Research and development costs 4,5 (19.525) (24.489) (89.884) Divestiture of rights in Europe to Savene 33.724 0 0 Write down of research and development projects 0 0 (21.200) Sales and distribution costs 4 (6.095) ( 9.275) (29.136) Administrative expenses 4 (9.169) ( 6.108) (26.126) Operating profit/loss 24.810 ( 29.759) (132.492) Financial income and expenses (1.225) ( 3.104) (10.250) Profit/loss before taxes 23.585 ( 32.863) (142.742) Tax on profit/(loss) for the period 0 2.277 2.277 Net profit/loss for the period 23.585 ( 30.586) (140.465) Fair value adjustment of available-for-sale financial assets 0 0 0 adjustment of available-for-sale financial assets 0 0 0 Income tax relating to components of other comprehensive income 0 0 0 Other comprehensive income for the period (net of tax) 0 0 0 Total comprehensive income for the period 23.585 ( 30.586) (140.465) Basic EPS (DKK) 0,18 (0,41) (1,36) Diluted EPS (DKK) 0,18 (0,41) (1,36) Condensed income statements/comprehensive income Announcement No. 19-10 Page 13 of 21 Interim report for the period 1 January to 31 March 2010 Note31 March31 March201020092009DKK ' 000DKK ' 000DKK ' 00Intangible assets5426.635452.953431.8Property, plant and equipment5.81410.6347.0Non-current investments940 1.608 1.3 Non-current assets433.390 465.195 440.30 Inventories2.4582.6121.9Receivables21.40615.42313.0Cash and cash equivalents287.522 80.823 130.1 Current assets311.386 98.858 145.1 Assets744.776 564.053 585.41 Condensed balance sheets - assets08544710442445133Note31 March31 March201020092009DKK ' 000DKK ' 000DKK ' 000Equity436.045 400.359 411.798 Non-current liabilities6227.640121.675114.695Current liabilities781.091 42.018 58.920 Liabilities308.731 163.693 173.615 Equity and liabilities744.776 564.052 585.413 Accounting policies1Condensed balance sheets - equity and liabilities Announcement No. 19-10 Page 14 of 21 Interim report for the period 1 January to 31 March 2010 3 months 20103 months 20092009DKK ' 000DKK ' 000DKK ' 000Operating profit/loss24.812(29.759)(132.490)Reversal of share-based payments6611.5683.793Reversal of pension commitments00207Reversal of deferred income(17.927)00Depreciation, amortisation and impairment losses6.2321.64425.735Working capital changes(6.387) (6.112) (2.050) Cash flows from operating activities before interest7.391 (32.659) (104.806) Received and paid interest etc.2.671 5.118 5.608 Cash flows from operating activities10.062 (27.541) (99.198) Purchase of intangible assets000Purchase of property, plant and equipment(171)(6)(97)Sale of property, plant and equipment4181812.113Purchase of investments433315550Purchase of securities000Sale of securities035.295 35.295 Cash flows from investing activities680 35.785 37.861 Received upfront payment belinostat162.8940119.095Instalment on loans(16.259)(124) (315) Cash flows from financing activities146.635 (124) 118.780 Increase/decrease in cash and cash equivalents157.3778.12057.443Cash and cash equivalents at 1 January130.14572.703 72.703 Cash and cash equivalents at 31 March287.522 80.823 130.145 Cash and cash equivalents comprise:Deposit on demand and cash287.47780.77830.067Special-term deposits4545 100.078 Total287.522 80.823 130.145 Condensed cash flow statements Announcement No. 19-10 Page 15 of 21 Interim report for the period 1 January to 31 March 2010 Statement of equity for the period 1 January to 31 March 2010Share-Number ofShare-basedRetainedsharescapitalpaymentsearningsTotalDKK ' 000 DKK ' 000 DKK ' 000 DKK ' 000 Equity at 1 January 2010132.609.020 132.609 31.140 248.049 411.798 Recognition of share-based payment006610661Total comprehensive income for the period00023.58523.585Equity 31 March 2010132.609.020 132.609 31.801 271.634 436.044 The share capital is an undistributable reserve, while the other reserves are distributable for dividend purposes subject tothe provisions of the Danish Public Companies Act.Statement of equity for the period 1 January to 31 March 2009Share-Number ofShare-basedRetainedsharescapitalpaymentsearningsTotalDKK ' 000 DKK ' 000 DKK ' 000 DKK ' 000 Equity 1 January 200966.304.510 66.304 27.347 335.725 429.376 Recognition of share-based payment001.56901.569Total comprehensive income for the period000(30.586)(30.586)Equity 31 March 200966.304.510 66.304 28.916 305.139 400.359 The share capital is an undistributable reserve, while the other reserves are distributable for dividend purposes subject tothe provisions of the Danish Public Companies Act. Notes 1. ACCOUNTING POLICIES The interim financial statements have been prepared in accordance with IAS 34, Interim financial reporting, and additional requirements for interim financial statements of listed companies. No interim financial statements have been prepared for the parent company. The accounting policies applied in the interim report are unchanged relative to the accounting policies applied in TopoTarget's annual report for 2009, and are in accordance with the International Financial Reporting Standards (IFRS) as adopted by the EU and additional Danish disclosure requirements for annual reports of listed companies. The interim report has been prepared on a going concern basis. The interim report is presented in Danish kroner (DKK), which is the parent company's functional currency. Management's significant accounting assumptions and estimates Revenue recognition Revenue is recognised when it is probable that future economic benefits will flow to the company and such economic benefits can be measured reliably. In addition, recognition requires that all significant risks and rewards of ownership of the rights or services included in the transaction have been transferred to the buyer. Income from agreements with multiple components and where the individual components cannot be separated is recognised over the period of the agreement. In addition, recognition requires that all significant risks and rewards of ownership of the goods or services included in the transaction have been transferred to the buyer. If all risks and returns Announcement No. 19-10 Page 16 of 21 Interim report for the period 1 January to 31 March 2010 have not been transferred, revenue is recognised as deferred income until all components of the transaction have been completed. 2 February 2010 Topotarget entered a license and cooperation agreement with Spectrum Pharmaceuticals Inc. covering development and commercialisation of belinostat. Topotarget has received an upfront payment of USD 30.0 million. According to the agreement, the initial license fee payment concerns several components, which cannot be separated. The amount is recognised over a period of 18 months commencing 2 February 2010, which is the expected period of reimbursement of FTE services for development for the PTCL trials. Implementation of new and revised standards and interpretations The consolidated financial statements are presented in accordance with the new and revised standards (IFRS/IAS) and interpretations (IFRIC) which apply for financial years starting on or after 1 January 2010. The implementation of the new and revised standards and interpretations in the interim report for the first three months of 2010 has not resulted in changes to accounting policies. Standards and interpretations not yet in force At the date of the interim report for the first nine months of 2010, a number of new or amended standards and interpretations have not yet entered into force, and are therefore not included in this interim report. These new and revised standards and interpretations are not expected to result in any changes to the accounting policies applied. Announcement No. 19-10 Page 17 of 21 Interim report for the period 1 January to 31 March 2010 2. REVENUE3 months 20103 months 20092009DKK ´000DKK ´000DKK ´000Sales of goods9.03011.54939.708Sales of services2.2747933.213Milestone payments17.927 01.058Total29.23012.34243.9793. SEGMENT INFORMATIONThe Group has identified two segments comprising the activity Savene/Totect and the activity development of new productsSavene/Development Non-distributedTotalTotectactivitiesactivitiesQ1, 2010Q1, 2010Q1, 2010Q1, 2010DKK ´000DKK ´000DKK ´000DKK ´000Revenues9.27219.32163729.230Production costs(2.021)(1.333)0(3.355Research- and development costs0(19.525)0(19.525Divestiture of rights in Europe to Savene 33.7240033.724Sales and distribution costs(6.095)00(6.095Administrative expenses00(9.169)(9.169Operating profit/loss34.880 (1.538) (8.532) 24.810 Financial income and expenses00(1.225)(1.225Profit/loss before tax34.880 (1.538) (9.757) 23.585 Tax on profit/loss for the period0000Net profit/loss for the period34.880 (1.538) (9.757) 23.585 The Group is not relating assets or liabilities to the individual segments.Savene/Development Non-distributedTotalTotectactivitiesactivitiesQ1, 2009Q1, 2009Q1, 2009Q1, 2009DKK ´000DKK ´000DKK ´000DKK ´000Revenues11.549079312.342Production costs(2.230)00(2.230Research- and development costs0(24.489)0(24.489Write-down of research and development projects0000Sales and distribution costs(9.275)00(9.275Administrative expenses00(6.108)(6.108Operating profit/loss44 (24.489) (5.315) (29.759) Financial income and expenses00(3.104)(3.104Profit/loss before tax44 (24.489) (8.419) (32.863) Tax on profit/loss for the period002.2772.277Net profit/loss for the period44 (24.489) (6.142) (30.586) The Group is not relating assets or liabilities to the individual segments. Announcement No. 19-10 Page 18 of 21 Interim report for the period 1 January to 31 March 2010 The Group's revenue is divided into the following geographical areas:3 months 20103 months 20092009DKK ´000DKK ´000DKK ´000Denmark2182911.349Europe10.3176.64025.484USA18.695 5.41117.146RevenueTotal29.23012.34243.979 The Groups assets and additions to acquired research and development projects plus other fixtures and fittings, tools and equipment are divided geografically as follows:2010200920093 months 20103 months 20092009DKK ´000DKK ´000DKK ´000DKK ´000DKK ´000DKK ´000Denmark484.667307.074367.095171094Europe251.677247.632211.848003USA8.4329.34 66.470000Total744.775564.052585.413171097Additios to aquired research & development projects plus other fixtures and fittings, tools and equipmentAssets4. STAFF COSTS3 months 20103 months 20092009DKK ' 000DKK ' 000DKK ' 000Allocated by function:Production costs1.33300Research and development costs6.3766.59923.907Sales and distribution costs3.4015.34316.854Administrative expenses3.953 2.68910.978Total15.06414.63151.739Hereof share-based payments661 1.56810.015Average number of employees546058 Announcement No. 19-10 Page 19 of 21 Interim report for the period 1 January to 31 March 2010 5. INTANGIBLE ASSETS31 March31 March201020092009DKK ' 000DKK ' 000DKK ' 000Acquired research- and development projects still in progressCost at 1 January536.384549.180549.180Adjustment of acquisition value0(14.053)(12.796)Additions00Disposals00Cost at 31 March536.384 535.127 536.384 Amortisation 1 January(114.700)(93.500)(93.500)Amortisation and write downs00(21.200)Amortisation at 31 March(114.700) (93.500) (114.700) Carrying amount at 31 March421.684 441.627 421.684 Acquired research- and development projects -available for useCost at 1 January15.07615.07615.076Disposal(7.500)00Cost at 31 March7.576 15.076 15.076 Amortisation at 1 January(4.875)(3.375)(3.375)Amortisation(313)(375)(1.500)Amortisation related to the disposal2.56200Amortisation at 31 March(2.626) (3.750) (4.875) Carrying amount at 31 March4.951 11.326 10.201 Total acquired research and development projects426.635 452.953 431.885 The weighted average residual termof acquired research and development projects- available for use is approximately (number of years)6,507,506,75Amortisation and impairment by function:3 months 20103 months 20092009DKK ' 000DKK ' 000DKK ' 000 Announcement No. 19-10 Page 20 of 21 Interim report for the period 1 January to 31 March 2010 Announcement No. 19-10 Page 21 of 21 6. NON-CURRENT LIABILITIES31 March31 March201020092009DKK ' 000DKK ' 000DKK ' 000Deferred income tax46.18843.25943.985Pension commitments0751315Other debt73.51477.66570.395Accruals107.93800Total227.640 121.675 114.695 Other debt is primarily debt in relation to the APO866-milestone and the belinostat-milestone. Accruals are comprised of the non-current portion of the upfront payment in relation to belinostat. 7. CURRENT LIABILITIES31 March31 March201020092009DKK ' 000DKK ' 000DKK ' 000Leasing commitments01910Trade payables38.82635.30437.299Other payables6.2876.52321.621Deferred income35.97900Total81.091 42.018 58.920 Other debt in the comparison year 2009 is primarily debt in relation to the CuraGen-milestones.Accruals are comprised of the current portion of the upfront payment in relation to belinostat.