Transforming treatments by long-acting medications. Fredrik Tiberg, President & CEO

Transcription

1 Transforming treatments by long-acting medications Fredrik Tiberg, President & CEO

2 Forward-looking statements This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements 2

3 Investment highlights FluidCrystal delivery technology In-house developed with strong IP protection Validated in 20 clinical trials 1 marketed product and approval processes ongoing Broad, late-stage R&D pipeline +10 clinical programs in opioid addiction, pain, cancer, obesity, endocrine and cardiovascular disease. Potential FDA/EMA/TGA product approvals in 2018 Emerging European commercial organization Strong pharma partnerships Leadership and key functions in place Fully operational for 2018 launch Novartis, Braeburn Pharmaceuticals, Rhythm R&D investments, milestones and royalty on sales Listed on Nasdaq STO (ticker CAMX) Market Cap: ~500 MUSD Cash position: 45 MUSD (Q3, 2017) Monthly OPEX: 3 MUSD (2017) Employees: 70 HQ: Lund, Sweden 3

4 Long-acting medications address key healthcare challenges 4

5 FluidCrystal injection depot in situ gel formation Easy to administer Rapid onset & long-acting release Applicable across substance classes Good safety profile Standard manufacturing processes Unique mixtures of endogenous lipids INJECTION WATER ABSORPTION DRUG RELEASE +400 PATENTS & APPLICATIONS LIQUID DRUG PRODUCT BEFORE INJECTION: LIPIDS+SOLVENT+DRUG SOLVENT RELEASE LIQUID CRYSTAL GEL DEPOT BIODEGRADATION TO COMPLETE RESOLUTION ~1500 SUBJECTS HAVE RECEIVED >15,000 INJECTIONS IN TIME CLINICAL TRIALS 5

6 Plasma concentration (ng/ml) Plasma concentration (ng/ml) FluidCrystal Tunable long-acting release FluidCrystal injection depot Immediate release octreotide (Sandostatin ) 1000 FC pasireotide FC octreotide 1000 subcutaneous octreotide FC somatostatin ,1 0,1 0, , Time (days) Time (days) Single dose injection at t=0; n=6 (SC); rodent; mean values 6

7 Clinically documented compounds & Validated proprietary technology 7

8 Diversified late-stage R&D pipeline FluidCrystal 8

9 CAM2038 Weekly and monthly buprenorphine depots Changing the treatment paradigm in opioid dependence

10 Global opioid addiction health crisis Escalating human crisis Largest society burden of all drugs 1 Patients need better access to care and new treatment choices Investment in treatment brings significant value Annual US opioid overdose deaths 2 (thousands) COST OF US OPIOID CRISIS: $500 bn WHITE HOUSE COUNCIL OF ECONOMIC ADVISERS Source: 1. UNODC, World Drug Report 2015; 2. Center for Disease Control & Prevention 2016; 3. White House Council of Economic Advisers Analysis

11 Long-acting treatment of opioid dependence from Day 1 to maintenance therapy Individualized treatment Weekly and monthly dosing options Rapid onset and sustained treatment effect from Day 1 Enhanced adherence to treatment Safeguards against diversion and misuse Efficacy supported by robust clinical data versus daily standard treatment Source: 1 CAM2038 is an investigational treatment under review by US, European and Australian regulatory authorities for treatment of opioid use disorder / dependence. 11

12 CAM2038 demonstrated efficacy and safety vs standard of care CAM2038 met FDA and EMA primary and key secondary efficacy endpoints in a pivotal 24-week Phase 3 study Demonstrating non-inferiority and superiority versus daily standard treatment Sustained suppression of withdrawal and cravings Opioid blockade from first dose Safety profile comparable to SL buprenorphine with no unexpected safety findings Confirmed in a 48-week Phase 3 safety study Superiority in % cumulative opioid abstinence, p= CAM2038 SL BUP/NX Percent urine samples confirmed by self-reports negative for illicit opioid use weeks % 75%-<100% 50%-<75% 25%-<50% 1%-<25% 0% 12

13 High acceptability amongst patients CAM2038 compared to my previously prescribed sublingual buprenorphine treatment Much better H Slightly better About the same N=133 83% POSITIVE Slightly worse Much worse 13

14 CAM2038 ongoing global approval processes Recommendation of approval from FDA Advisory Committee NDA submission to FDA TGA acceptance for evaluation of Australian MAA EMA & TGA MAA approval decisions May 2017 July 2017 Sept 2017 Nov 2017 Jan 2018 Q3/Q Positive phase 3 long-term safety data Priority review granted by FDA MAA validation by EMA PDUFA date set to 19 January 2018 Supported by comprehensive clinical program 944 participants across 7 clinical studies Four phase 1/2 studies of pharmacokinetics and pharmacodynamics after single and repeated dosing of CAM2038 Phase 2 opioid blocking study Phase 3 double-blind, double-dummy, active-controlled study Phase 3 long-term safety study 14

15 Limited competition on long-acting injectable (LAI) opioid dependence market Long-acting buprenorphine injectables PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL (US) APPROVAL (EU/Aus) Braeburn/Camurus CAM2038 Weekly & Monthly PDUFA Jan. 19, 2018 Estimated Q3/Q Indivior Sublocade Monthly APPROVED Nov. 30, 2017 BDSI BPN Depot 1 Heron HTX Long-acting naltrexone injectables Alkermes Vivitrol $275M expected 2017 sales 3 APPROVED Data of first single-ascending dose cohort from Phase I study expected to be released in Q4 2017; 2. No progress updates since Alkermes Q report 15

16 Global commercialization strategy for CAM million opioid problem users in Europe million diagnosed opioid dependent in the US million registered heroin users in China 4 ESTIMATED 15 million OPIOID DEPENDENT INDIVIDUALS GLOBALLY 1 187,000 opioid dependent in Australia 3 Braeburn markets Camurus markets Braeburn option right Source. 1. Data for 2010 by Degenhardt et al., Addiction, 2014; 109, EMCDD, European Drug Report SAHMSA, National Survey on Drug Use and Health (NSDUH) MedicineToday 2015; 16(6 Suppl): Beijing Review, War on drugs, No.28,July 9,

17 TRx Volume (000s) Prescription volume growth indicate high market potential for long-acting buprenorphine in the US Total TRx Volume 12 Months ending June % LAI SHARE ~$ PER MONTH CORRESPONDS TO $3-4 BN Q Q Q Q Q Q2 MARKET POTENTIAL buprenorphine/naloxone (Suboxone, Bunavail, Zubsolv & oral generics) buprenorphine HCL & generics naltrexone (Vivitrol) Source: 1. Symphony Health, PHAST Integrated Monthly; 2. Based on monthly Sublocade price ($1580), Indivior plc; LAI long acting injectables 17

18 Significant market potential for CAM2038 in Europe High physicians willingness to prescribe CAM2038 in EU4 1 86% 94% 96% 86% q4w 31% q1w 30% n=51 q4w 36% q1w 25% n=50 q4w 39% q1w 22% n=50 q4w 43% q1w 27% n=50 Physicians willingness to prescribe CAM2038 Anticipated share of patients on CAM2038 q4w Anticipated share of patients on CAM2038 q1w Germany 77,500 patients UK 148,686 patients Italy 75,964 patients France 161,388 patients Market potential for CAM2038 in Europe and Australia estimated to 180m 250m Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015 * % patients considered suitable for CAM2038 by surveyed physicians if available on the market. 18

19 Additional attractive product candidates PARTNER PRODUCT PRE-CLINICAL PHASE1-2 PHASE 3 CAM2038 q1w / q4w CHRONIC PAIN PHASE 3 CAM2029 ACROMEGALY CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2 PHASE 1-2 CAM2032 PROSTATE CANCER PHASE 1-2 CAM2047 CHEMOTHERAPY INDUCED NAUSEA & PAIN PHASE 1-2 CAM2048/2058 POSTOPERATIVE PAIN & POSTOPERATIVE NAUSEA & PAIN PHASE 1-2 CAM4072 GENETIC OBESITY PHASE 1-2 PHASE 1-2 CAM2043 PULMONARY ARTERIAL HYPERTENSION Undisclosed internal project candidates Early stage collaborations with pharma and biotech partners 19

20 Pipeline products overview CAM2038 chronic pain CAM2038 FORMULATION KEY FEATURES Weekly and monthly buprenorphine treatment depot based on FluidCrystal Round the clock pain relief Rapid and sustained blockade of euphorigenic and sedative opioid effects Flexible and individualized dosing HCP administration safeguards against misuse and diversion MARKET SIZE Global opioid pain market ~$6 bn 1 DEVELOPMENT STATUS PARTNER CHRONIC PAIN Three phase 1/2 trials completed Phase 3 efficacy and safety extension study ongoing; top-line efficacy results expected Q Braeburn Pharmaceuticals (North America) 1 IN 5 INDIVIDUALS SUFFERING FROM CHRONIC PAIN 1 CHRONIC PAIN ESTIMATED ~$ bn ANNUAL COST TO SOCIETY 2 Sources. 1. Current Medical Research & Opinion Vol. 26, No. 5, 2010, ; Disease Landscape and Forecast Chronic Pain, Decision Resources 2015; 2. Journal of Pain 2012, 13:

21 Pipeline products overview CAM2029 CAM2029 ACROMEGALY & NEUROENDOCRINE TUMORS SOMATOSTATIN ANALOGUE SALES m FORMULATION Subcutaneous octreotide depot based on FluidCrystal KEY ADVANTAGES Improved patient convenience Increased bioavaiability potential for enhanced treatment efficacy in currently underexposed patients MARKET SIZE Somatostatin analogue market >$2 bn 1 omatuline sen an ostatin Novartis DEVELOPMENT STATUS PARTNER Four phase 1/2 trials successfully completed Novartis currently evaluating new study designs recently suggested by health authorities Ongoing preparations for Phase 3 including additional manufacturing and packaging activities Novartis (exclusive worldwide license) Significant potential in converting Sandostatin LAR patients to CAM2029 Sources. 1. GlobalData

22 New clinical product candidates CAM4072 FORMULATION KEY ADVANTAGES MARKET SIZE DEVELOPMENT STATUS KEY RESULTS PARTNER GENETIC OBESITY DISORDERS Subcutaneous FC setmelanotide depot Weekly dosing Ready-to-use prefilled syringe Improved patient convenience Not communicated Phase 1 study completed, positive initial data communicated Submission earliest Positive initial phase 1 results met Rhythm s PK an tolerability criteria. Rhythm (exclusive worldwide license) CAM2043 FORMULATION KEY ADVANTAGES Subcutaneous FC treprostinil depot Weekly dosing High patient convenience No need for extracorporal pumps Reduced risk of treatment limiting infusion site pain and local reactions Low risk of infections and sepsis MARKET SIZE PAH market >$5 bn, tresprostinil ~1.2 bn 2 DEVELOPMENT STATUS KEY RESULTS PULMONARY ARTERIAL HYPERTENSION Phase 1 start Q Preclinical data confirmed target profile Sources. 1. Form S-1 Rhythm Pharmaceuticals PharmaCircle

23 Camurus positioned for continued value creation De-risked, late stage, differentiated pipeline Multibillion dollar specialty markets Opioid addiction, pain, cancer, endocrine disease Strong collaborations with dedicated partners Novartis, Braeburn Pharmaceuticals, Rhythm, Solasia Early project collaborations with global pharma companies Emerging commercial organization Strong, internationally experienced leadership Potential levers for future value creation NDA/MAA approvals of CAM2038 in the US/EU Phase 3 programs in pain, acromegaly and NET Advancement of early stage clinical programs Pipeline expansion and business development Anticipated CAM2038 launch in 2018 Braeburn launch US H Camurus launch Europe Q Geographical expansion in 2018/19 Solid financial position Potential for significant near-term regulatory milestone payments, and royalty from sales 23

24 Thank you! Camurus AB, Ideon Science Park, SE Lund, Sweden camurus.com

25 Experienced and committed management team Fredrik Tiberg, PhD, Prof. President & CEO In Company since: 2002 Holdings: 1,512,551 shares & 130,000 subsc. warrants Education: M.Sc. in Chemical Engineering, PhD in Physical Chemistry, Lund University Previous experience: Professor in Physical Chemistry at Lund University, Institute for Surface Chemistry (Section head), Visiting Professor at Oxford University Fredrik Joabsson, PhD Vice President, Business Development In Company since: 2001 Holdings: 36,391 shares & 20,000 subscription warrants Torsten Malmström, PhD Vice President, Technical Operations In Company since: 2013 Holdings: 36,391 shares & 20,000 subscription warrants Eva Pinotti-Lindqvist Chief Financial Officer In Company since: 2014 Holdings: 36,391 shares & 25,882 subscript. warrants Education: Bachelor s of cience in Economics, Lund University Previous experience: EQL Pharma (CFO), Nordic Drugs (Nordic Market Analyst), Poolia (Finance Consultant) Markus Johnsson, PhD Vice President, Pharmaceutical & Analytical Dev. In Company since: 2003 Holdings: 45,363 shares & 20,000 subscription warrants Rein Piir Vice President, Investor Relations In Company since: 2015 Holdings: 5,275 shares Richard Jameson Chief Commercial Officer In Company since: 2016 Holdings: 16,395 shares & 80,000 subscript. warrants Education: Bachelor s of cience in Applied Biological Sciences from University West of England Previous experience: GM, UK and Nordics for Reckitt Benckiser Pharmaceuticals Ltd ( ) and Area Director Europe, Middle East and Africa for Indivior PLC ( ). Margareta Linden, PhD Vice President, Project Management In Company since: 2004 Holdings: 36,291 shares & 25,000 subscript. warrants Agneta Svedberg Vice President, Clinical & Regulatory Development In Company since: 2015 Holdings: 9,073 shares & 45,000 subscription warrants Urban Paulsson Vice President Corporate Dev.& General Counsel In Company since: 2017 Holdings: 6,500 shares & 75,000 subscript. warrants Education: Master of Law from Lund University Previous experience: More than 20 years experience from the life science industry including as legal counsel at Pharmacia and general counsel for Vitrolife. Partner at law firms Bird & Bird and Nordia Law. Cecilia Callmer Vice President, Human Resources In Company since: 2017 Holdings: 17,650 subscription warrants 25

26 Major shareholders 31 October LARGEST STAKEHOLDERS SHARES (%) SANDBERG DEVELOPMENT AB ,7% GLADIATOR ,7% SWEDBANK ROBUR FONDER ,2% TIBERG, FREDRIK ,1% CATELLA FONDFÖRVALTNING ,0% SEB S.A. CLIENT ASSETS UCITS ,7% BACKAHILL UTVECKLING AB ,4% FJÄRDE AP FONDEN ,1% ENTER FONDER ,7% GRENSPECIALISTEN FORVALTNING AB ,6% TOTAL % 26

27 Value adding partnerships CAM2038, CAM2048, CAM2058 CAM2029, CAM other products CAM4072 Field Opioid use disorder (OUD) and pain Acromegaly, neuroendocrine tumors and other indications Genetic obesity Scope Exclusive license agreement for North America; option to China, Japan, Korea, and Taiwan Exclusive, worldwide, collaboration and license agreement Exclusive license to FluidCrystal Injection depot for setmelanotide Financials MUSD 20 received in upfront license fee Development milestones, include; MUSD 35 OUD MUSD 21 pain MUSD 50 received in upfront, option exercise and development milestones MUSD 700 in total potential development and sales milestones MUSD 65 in development and sales milestones Mid to mid-high single digit % royalties on sales Mid teen % royalties on sales + MUSD 75 in potential sales milestones Mid to high single digit % royalties on sales New Hope in The Search for Treatment for Obesity, WSJ, August 26,

28 Recruitment completed in pivotal Phase 3 chronic pain study and safety extension studies of CAM2038. Topline data expected early 2018 Double-blind, enriched-enrollment study in opioid experienced low back pain patients on morphine equivalent doses of 40 mg/day or higher (N est. =340) Screening Transition Open-label titration Double-Blind treatment Follow-Up 2 Weeks 2 Weeks Up to 10 Weeks 12 Weeks 4 weeks Moderate to severe lower back pain, patients on high daily dose of opioids (incl SL BPN) Down-titration of opioid dose and transitioned to IR morphine (only if not on SL BPN) CAM2038 q1w 8-32 mg/week Titrated to effect on a stable dose of CAM2038 R CAM2038 Placebo CAM2038 q1w 8-12 mg/day or CAM2038 q4w mg/day Primary and key secondary endpoints: Average and worst pain intensity as measured by 11-point numerical rating scale 28

29 Dissemination of CAM2038 data in publications and at scientific conferences Q1 Q2 Q3 Q4 Q1 Q2 Global Conferences CPDD Jun Montréal,Canada ISAM ISAM Oct Oct Abu Dhabi, UAE Abu Dhabi, UAE AAAP 8-11 Dec San Diego, USA ASAM Apr San Diego, USA AMERSA 3-5 Nov Washington DC European Conferences IOTOD May Berlin, Germany Lisbon Addictions Oct Lisbon, Portugal EUROPAD May Krakow, Poland National Conferences ATHS Oct Biarritz, France SSA 9-10 Nov Newcastle, UK APSAD Nov Melbourne, Australia Publications Advances in Therapy Albayatny et al, 2017: 34(2), J. Subst. Abuse Treat. Haasen et al, 2017: 78, JAMA Psychiatry Walsh et al, 2017: Published online Phase 3 publications in progress 29

30 Strong rationale for CAM2038 in Europe and Australia Nordic countries 16,535 Specialist market with a concentrated prescriber base High unmet medical needs No significant innovation for more than a decade Paradigm shift in opioid dependence treatment Pricing and reimbursement supported by sizeable health and socio-economic benefits UK 148,686 France 161,388 Spain 61,954 Germany 77,500 Italy 75,964 Australia 50,000 Internationally experienced leadership team Market access, medical affairs, global commercial strategy, opioid dependence & pain Establishment in key European markets & Australia Headcount build-up following to launch sequence Ongoing pre-launch activities HEOR, pricing and market access Strategic marketing Medical affairs Policy and education Country operating models 30