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Annual Report 2010 Content Annual report 2010 Content 4 Financial highlights and ratios Vision 5 Management letter Topotarget’s vision is to become a leading European biopharmaceutical 7 Belinostat company in the field of oncology. 9 Cancer and belinostat clinical trials 11 Partnerships Mission 12 Corporate Governance We are committed to the fight against 13 Risk profile and management cancer and aspire to treat cancer patients by developing and commercializing 14 The process of accounts preparation effective therapeutics. 15 Corporate social responsibility 16 Board of Directors and Management Goal 17 Shareholder information We want to become a profitable and robust business that delivers significant 21 Financial review returns to our shareholders. 22 Statement by the Board of Directors and Executive Management 23 Independent auditors’ report 24 Income statement 25 Comprehensive income for the year 26 Balance sheet 28 Cash flow 29 Equity – Group 30 Equity – Parent 31 Notes Strategy for 2011-2012 Our strategy is aiming at making belinostat one of the most successful HDAC-inhibitors in selected indications. • We will speed up the development of belinostat in pivotal trials in selected indications where we have reasons to believe berlinostat will have efficacy. • Subject to potential positive trial outcomes we will seek global registrations. • We are developing and will commercialize belinostat in North America together with our partner. • We will continue to evaluate how we can build our commercial business in the rest of the world in order to maximize shareholder value. Francois Martelet Chief Executive Officer 4 Financial highlights and ratios Topotarget • Annual Report 2010 Financial highlights and ratios DKK ‘ 000 2010 2009 2008 2007 2006 Financial highlights and ratios*) Consolidated financial highlights and ratios Revenue 129,038 43,979 43,890 44,890 45,730 Research and development costs (71,608) (89,884) (146,906) (129,111) (111,843) Write down of research and development projects (189,541) (21,200) (93,500) - - Divestiture of rights in Europe to Savene® 32,473 - - - - Sales and distribution costs (19,098) (29,136) (44,796) (57,722) (29,668) Operating loss (168,447) (132,492) (294,371) (219,801) (167,903) Net financials 68,773 (10,250) (11,737) 5,754 5,438 Net loss for the year (55,689) (140,464) (301,209) (211,600) (155,003) Basic and diluted EPS (0,42) (1,41) (4,68) (3,92) (3,76) Consolidated balance sheets Cash, cash equivalents and sec uritied 205,068 130,145 107,998 403,617 271,610 Equity 360,216 411,798 429,376 665,068 430,650 Total assets 465,824 585,413 619,032 834,175 476,184 Investment in tangible assets (net) (1,633) 2,016 (164) (7,965) (6,019) Consolidated cash-flow statement Cash flows from operating activities 40,102 (99,197) (169,545) (208,933) (144,558) Cash flows from investing activities 34,686 37,861 (44,366) 25,666 116,168 Cash flow from financing activities 138 118,780 (499) 332,026 135,517 Consolidated ratios Number of fully paid shares, year-end 132,652,050 132,609,020 66,304,510 61,304,510 45,684,880 Average number of shares for the period 132,640,379 99,456,765 64,323,636 53,955,186 41,260,562 Assets/equity 1.3 1.4 1.4 1.2 1.1 Market price, year-end (DKK) 3.57 2.59 3.62 16.76 36.20 Net asset value per share (DKK) 2.73 3.11 6.48 10.85 9.43 Average number of full-time employees 50 58 109 141 98 *) Figures for 2006 include Topotarget USA, Inc. from 12 July 2006. The figures for 2007 also include Topotarget Switzerland S.A. from 27 June 2007. Finally the figures for 2008 also include Topotarget Netherlands B.V. from 1 January 2008. Topotarget • Annual Report 2010 Management letter 2010 5 Management letter 2010 2010 was a year of transition for Topotarget. endeavor by top oncology-thought lead- GOG study in ovarian cancer We streamlined the organization from a ers which is in itself a sign of strong interest The Gynecologic Oncology Group (the research standpoint. At the same time we in our drug. US), supported by the National Cancer have significantly upgraded the level of Institute (the US), initiated a two-stage capabilities by adding to the management The year began with initiation of the GOG phase II evaluation of belinostat com- key members in the field of clinical devel- (the Gynecologic Oncology Group) belino- bined with carboplatin (chemotherapy) opment, business development, finance, stat phase II study in ovarian cancer, and it in platinum resistant ovarian cancer. The in vestor and public relations. Consequent- ended with the completion of patient re- first stage was completed on 15 November, ly, we are now prepared to focus entirely cruitment to the randomized Topotarget 2010, with the enrollment of 28 patients. on the late-stage development and sponsored phase II CUP (Cancer of Un- commercializa tion of our lead cancer com- known Primary, CLN-17). Belinostat in CUP pound belinostat. Topotarget is the only company to seek Topotarget also presented abstracts at global registration in CUP. Clinical progress ASCO (annual meeting of the American In 2010, we spent time on designing clini- Society of Clinical Oncology) and ASH A total of 89 patients have been enrolled cal development plans aiming at unlock- (American Society of Hematology). in the phase II randomized study, inves- ing the value of belinostat which remains tigating belinostat combined with car- one of the most promising HDACi hot tar- When the year came to a close, nearly 900 boplatin and paclitaxel. Carboplatin and get for the medical and scientific oncology patients had been exposed to belinostat paclitaxel is a first-time standard of care in community. We have been assisted in this with no safty concerns and reinforcing our CUP and we aim to evaluate the effect of expectations of the compound. adding belinostat. We have prepared Topotarget for a As a part of the collaboration with our US partner Spectrum, Topotarget has commit- robust start to 2011 ted to fund 100% of the CUP study. TOPOTARGET TAKE-OFF 2011 belinostat BELINOSTAT Early stage acquisitions • Optimized organisation PTCL* Savene/Totect • Prioritized late-stage pipeline Non small cell lung cancer Unfocused early-stage pipeline • Lean development Ovarian cancer Basic research • US partner Cancer of Unknown Primary Discovery platform • Clear-cut strategy New undisclosed cancer indications Curagen in and out • Basic research closed High burn rate, 100+ employee • Enhancement of BoD and management team Serveral cancer targets * Peripherial T-cell lymphoma Take-off 2011 6 Management letter 2010 Topotarget • Annual Report 2010 PTCL partner, Spectrum Pharmaceuticals Inc., The new members include Anders Belinostat is currently being evaluated in to strengthen our development activi- Vadsholt (Chief Financial Officer), Axel multiple indications and one of the key ties and unlock the commercial potential Mescheder (Chief Medical Officer), Inge clinical trials is the pivotal PTCL (periph- of belinostat in North America and India. Holm Lauritzen (VP Business Develop- eral T-cell lymphoma) study. The purpose Topotarget received an upfront payment ment and Licensing/Strategic Planning), of this study is to assess efficacy and safety of USD 30mio. The total value of the deal Elisabeth V. Carstensen (Director of Phar- of belinostat in patients with relapsed or is USD 350mio. with double digit royalties. maceutial Operations) and Annette Lykke refractory PTCL, who failed at least one (Director IR & PR). In addition, the en- prior systemic therapy. Organizational changes hancements of our board are reflecting In 2010, we changed our organization to the change of focus to a more commercial The primary study endpoint is objective achieve a more lean development struc- stage of Topotarget. response rate (ORR). Approximately 120 ture and concentrate our funding on late- patients will be enrolled. Patients will be stage clinical development of belinostat. treated with 1000 mg/m² belinostat ad- The measures included: ministered as a 30-minute infusion given daily for 5 days every 3 weeks until there • Investigating and selecting late-stage is disease progression or unmanageable indications in which we may have treatment-related toxicities. strongest chance of achieving proof of concept Our US partner Spectrum has committed to fund 100% of the PTCL study. Spectrum • Closure of basic research expects to finalize the PTCL study during 2011 followed by a NDA filing. • Prioritization of our late-stage pipeline US partnership • Strengthening our management team In early February 2010, we concluded with several new members the commercial deal with our American BELINOSTAT KEY CLINICAL TRIALS (TOPOTARGET OR SPECTRUM) Study Sponsor Indication Phase I Phase II Pivotal Target Status Milestone Time BELIEF SPPI PTCL 100-120 Recruiting NDA filing H2 2011 CLN-17 TT CUP 88 Complete Top-line results H2 2011 CLN-9 TT Solid tumor 92 Complete Scientific publ. H2 2011 CLN-9 TT Lymphoma 30 Recruiting LPFV *) H1 2011 Top-line results H2 2011 CLN-14 TT Solid + STS 55 Phase I LPFV stage I H2 2011 Phase II in Phase II Results stage I H2 2011 CLN-20 SPPI/TT Drug-Drug 24 Recruiting Top-line results H2 2011 SPI-1014 SPPI/TT NSCLC 35 Initiated FPFV **) H2 2011 Bel *) Last Patient First Visit **) First Patient First Visit Topotarget • Annual Report 2010 Belinostat 7 Belinostat Mode of action Belinostat belongs to a class of anti-cancer Belinostat has demonstrated synergistic activity agents, the so-called histone deacetylase when used in combination chemotherapy inhibitors (HDACi), which by enzymatic process (acetylation) works to normalize the abnormal gene function pattern char- chemotherapy and almost 900 patients The favorable safety profile for both acteristic of cancer cells. have been exposed to the drug.
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