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Annual Report 2015 Contents This Is Camurus INNOVATIVE NANOSCALE THERAPEUTICS ANNUAL REPORT 2015 CONTENTS THIS IS CAMURUS This is Camurus ................................................................................................ 1 Leading innovation Key performance indicators ............................................................. 2 • FluidCrystal® – award-winning drug delivery technology 2015 In brief ......................................................................................................... 3 • Broad and advanced product pipeline Statement from the CEO ...................................................................... 4 • More than 400 patents and patent applications Operating environment........................................................................ 6 Strategy..................................................................................................................... 7 The patient in focus Technology platforms ..........................................................................10 • Simple and flexible administration Our development portfolio ..........................................................14 • Long-acting formulations for improved compliance Marketing organisation ......................................................................18 • Improved treatment outcomes and quality of life Employee portraits ..................................................................................20 Our development portfolio, cont. .........................................21 Strategic partnerships Early R&D projects ....................................................................................26 • Technology collaborations Employees ..........................................................................................................27 4 • Product licenses The share..............................................................................................................28 • Commercialisation Sustainable development ...............................................................30 Glossary .................................................................................................................32 Qualified management team • Inventors and founders Directors’ report ......................................................................................... 34 • More than 150 years of combined experience in the industry Corporate governance report ....................................................38 • Broad and comprehensive expertise Risks ............................................................................................................................45 Consolidated statement of Entrepreneurship and agile company culture comprehensive income ...................................................................47 • Clear focus on innovation Income statement – parent company .............................47 • Solutions and execution are key Consolidated balance sheet ........................................................ 48 ........................................... 24 Balance sheet – parent company 49 Consolidated statement of changes in equity ................................................................................................................50 Camurus is a Swedish research-based pharmaceutical Parent company statement company committed to developing and commercialising of changes in equity ..............................................................................50 innovative and differentiated medicines for the treatment Consolidated statement of cash flow ...............................51 of severe and chronic conditions. New drug products with Parent company statement of cash flow ......................51 best-in-class potential are conceived based on the proprietary Notes .........................................................................................................................52 FluidCrystal® drug delivery technologies and an extensive Assurance by the Board of Directors and CEO ........74 R&D expertise. Camurus’ clinical pipeline includes products for Auditor’s report ............................................................................................75 treatment of cancer, endocrine diseases, pain and addiction. Board of directors ......................................................................................76 These are developed in-house and in collaboration with Group management ..............................................................................78 international pharmaceutical companies. The company’s Key figures and definitions ............................................................ 80 share is listed on Nasdaq Stockholm under the ticker “CAMX”. For further information, visit www.camurus.com Annual General Meeting .................................................................81 9 28 CAMURUS ANNUAL REPORT 2015 THIS IS CAMURUS LEADING DRUG DELIVERY STRONG PIPELINE STRATEGIC MARKET TECHNOLOGY PARTNERS POTENTIAL CAM2038 Opioid dependence Technology platforms CAM2038 Pain FluidCrystal® injection Depot CAM2029 Acromegaly FluidCrystal® Topical Bioadhesiv CAM2029 Neuroendocrine tumours FluidCrystal® Nanoparticles CAM2032 Prostate cancer In-house non-clinical projects USD7bn in annual sales products with same several collaborations on mode of action and indications, non-clinical projects excluding pain. CAMURUS ANNUAL REPORT 2015 1 KEY PERFORMANCE INDICATORS Key figures, SEK thousand 2015 2014 2013 2012 Net revenue 154,799 208,207 197,716 95,204 Operating result before items affecting comparability -30,464 62,319 127,316 18,761 Operating result -204,104 62,319 127,316 18,761 SEK million Result for the period -159,542 48,346 99,235 13,317 716 closing cash Cash flow from operating activities -5,657 69,429 163,064 24,735 Cash and cash equivalents 716,096 56 5 3 Total assets 816,349 207,668 111,656 57,405 Earnings per share before dilution, SEK -6.33 2.06 17.01 2.28 Earnings per share after dilution, SEK -6.33 1.92 15.75 2.11 SEK155 million revenue Number of employees at end of period 48 43 36 31 Number of employees in R&D at end of period 35 28 29 25 Equity, SEK thousand 640,557 123,457 50,047 40,210 SEK -30 million Equity ratio in Group, % 78 59 45 70 operating loss R&D costs as a percentage of operating expenses 83 77 71 76 Revenue Operating expenses 250 200 In 2015, revenues remained strong at SEK 155 million, primarily from milestone 200 payments, research and development 150 services, and a new license and 150 distribution agreement for episil. 100 100 50 License fees 50 Administration Milestone payments Marketing & sales Sales of products & services 0 0 Research & development 2012 2013 2014 2015 2012 2013 2014 2015 2 CAMURUS ANNUAL REPORT 2015 2015 IN BRIEF Q1 Q2 Q3 Q4 Two new research collaborations are GMP manufacture of CAM2038 is completed The FDA grants CAM2038 Fast Track status A Phase 2 trial investigating the opioid launched with international pharmaceuti- ahead of the launch of pivotal Phase 3 trials. for the treatment of opioid dependence. blocking effects of CAM2038 is launched. cal corporations focusing on new potential product candidates based on the The listing process is initiated for the Scientific Advice is completed with the EMA Global Phase 3 trials are launched for the use FluidCrystal® injection depot. Camurus’ share on Nasdaq Stockholm. with regard to the registration of CAM2038 of CAM2038 to treat opioid dependence. in Europe. Positive results are reported from two All patients are included in a Phase 2 The Phase 2 trial of CAM2032 for the treat- Phase 1 clinical trials comparing CAM2038 trial of CAM2032 for the treatment of The IND is approved for CAM2038 for the ment of prostate cancer is completed. with a reference treatment consisting prostate cancer. treatment of opioid dependence. of daily administration of sublingual Richard Jameson is appointed as Camurus’ buprenorphine tablets. An investigational new drug (IND) application Novartis pays a further USD 2.5 million Chief Commercial Officer. for CAM2038 is submitted to the US FDA. in R&D related milestone payments for A licensing and distribution agreement is CAM2029. Camurus’ share is listed on Nasdaq Stockholm signed with the Japanese company Solasia on 3 December 2015. Pharma, pertaining to the distribution of The Board of Directors of Camurus is rein- episil® in Japan and China. forced with new Board members: Kerstin Valinder Strinnholm and Marianne Dicander Novartis pays USD 2.5 million in R&D related Alexandersson. milestone payments for CAM2029. AFTER THE CLOSE OF THE FISCAL YEAR A licensing agreement was signed with Rhythm Inc. regarding long- acting setmelanotide FluidCrystal® for the treatment of genetic obesity. CAMURUS ANNUAL REPORT 2015 3 STATEMENT FROM THE CEO Breakthrough for our products and technologies Fast track-status from FDA for one of our most promising product candidates. Launch of Global Phase 3 trials. Promising collaborations on new exciting product candidates. Successful stock exchange listing. 2015 was a historic year for Camurus and a break- through for several of our products and advanced drug delivery technologies. Among the most significant events of the overdose continues to rise each year and is now year, I definitely count the successes achieved close to 30,000 cases per year in the US alone. in the collaboration with our US partner, There is an urgent need for new and Braeburn Pharmaceuticals. Together with improved treatment options, and there is Braeburn Pharmaceuticals, and in close much to be gained
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