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CAM2038 Weekly Opioid Dependence

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CAM2038 Weekly Opioid Dependence Cowen & Co. Annual Health Care Conference 2017 Camurus Advancing late stage pipeline with high market potential Company Presentation, 7 March 2017 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 Camurus overview LISTED ON NASDAQ STOCKHOLM • Innovation that delivers 3rd DEC, 2015 − Proprietary FluidCrystal® technology used in 10 clinical programs − Preclinical to NDA/MAA enabling MARKET CAP pipeline programs − Expansive and rewarding pharma partnerships ~450 million USD − Emerging European commercial organization • Superior products for unmet markets − Long-acting medications for better treatment CASH POSITION outcomes and quality of life for patients − Initial focus on opioid dependence and chronic 55 million USD pain END 2016 • Lean and experienced team − 64 employees with 45 in R&D − Headquarter in Lund, Sweden 3 Late-stage, diversified pipeline PARTNERS PRODUCT PRECLINICAL PHASE 1/2 PHASE 3 REGISTRATION CAM2038 Weekly Opioid dependence CAM2038 Monthly Opioid dependence CAM2038 Weekly Chronic pain CAM2038 Monthly Chronic pain CAM2029 Neuroendocrine tumours CAM2029 Acromegaly CAM2032 Prostate cancer CAM4071 Not disclosed CAM2047 CINV* CAM2048 Pain CAM2058 Pain, nausea and vomiting *CINV Chemotherapy nausea and vomiting 4 Strong collaborations with strategic partners CAM2038, CAM2048, CAM2058 CAM2029, CAM4071 + other products CAM4072 Acromegaly, neuroendocrine Opioid dependence and pain Genetic obesity Field tumours and other indications • Exclusive license agreement for • Exclusive, worldwide, collaboration • Exclusive license to FluidCrystal® North America, with option to China, and license agreement Injection depot for setmelanotide Scope Japan, Korea, and Taiwan • USD 20 million in upfront license fee • USD 50 million received in upfront, • USD 65 million in potential received option exercise and development development • + USD 130 million in total potential milestones and sales milestones development and sales milestones • USD 700 million in total potential • Mid to mid-high single digit % • Mid double digit % royalties on sales development and sales milestones royalties on sales Financials • Mid to high single digit % royalties on “New Hope in The Search for Treatment for sales Obesity”, WSJ, August 26, 2016” 5 R&D highlights from 2016 PRODUCT EVENT TIME CAM2038 Opioid dependence • Positive results from pivotal Phase 3 efficacy trial November • Positive results from Phase 2 opioid challenge trial May • Completed enrollment in Phase 3 long-term safety trial April CAM2038 Chronic pain • First patient enrolled in Phase 3 efficacy trial September • Completed enrollment in pivotal Phase 2 chronic pain trial April CAM2029 Acromegaly & NET* • Positive results from Phase 2 trial in acromegaly and NET July CAM2032 Prostate cancer • Positive results from Phase 2 trial in prostate cancer June CAM4071 Not disclosed indication • Phase 1 clinical trial completed June CAM2047 CINV** • Phase 1 trial started October CAM2048 Pain CAM2058 Pain & nausea and vomiting *NET: Neuroendocrine tumours **CINV: Chemotherapy induced nausea and vomiting 6 FluidCrystal® technology Leader in lipid science and formulation technologies FluidCrystal® injection depot The FluidCrystal® technology is based on +400 functional liquid crystal nanostructures PATENTS & APPLICATIONS lipid 1 17 L2 CLINICAL FluidCrystal® topical bioadhesive TRIALS WITH FC TECHNOLOGY I2 H 1 2 COMMERCIAL PRODUCT La water lipid 2 FluidCrystal® nanoparticles 8 FluidCrystal® injection depot for easy and convenient dosing ~1500 SUBJECTS HAVE RECEIVED >10,000 INJECTIONS IN CLINICAL TRIALS Easy and convenient administration of long-acting injectables Good safety and local tolerability Applicable across drug substance classes Manufacturing by standard processes 9 Clinical performance of FluidCrystal® injection depot Weekly or monthly FluidCrystal® depot provides buprenorphine exposure within the range of current sublingual products for daily dosing – single dose and steady-state 100 10 1 Plasma BPN concentration (ng/mL) 0 0 7 14 21 28 Time (days) FluidCrystal® weekly depot (exemplified with buprenorphine clinical data) FluidCrystal® monthly depot (single dose, exemplified with buprenorphine clinical data) FluidCrystal® monthly depot (at steady state, simulated data) Comparator once daily product (exemplified with daily sublingual buprenorphine) 10 CAM2038: Weekly and Monthly Buprenorphine Injection Depots for Opioid Use Disorder Treatment Opioid dependence is a growing global health problem EACH DAY 30,1 28,6 4 91 1 US overdose epidemic • Estimated 32 million opioid users globally 24,5 Thousands AMERICAN’S DIE 21,3 21,9 1 19,7 FROM OPIOID ‒ Largest society burden of all drugs 18,9 17,8 16,8 OVERDOSES ‒ About 4 million diagnosed patients in Europe and 15,8 12,9 11,7 the US 10,6 9,5 2,3 7,3 ‒ Less than half in treatment (Europe and US ) 6,0 6,2 • Escalating opioid crisis 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 ‒ 207,400 drug related deaths worldwide 1999 • 30,000 US opioid overdose deaths in 2015 5 1000 • Growing concerns in Europe Opioid deaths in Sweden 900 Annual deaths with illicit drugs or opioid pharmaceutics 800 present during forensic examination 700 • A chronic relapsing disease 600 500 400 ‒ Opioid-use trajectories show that the disease is chronic 300 with less than 30% abstinence achieved over time 200 100 ‒ Opioid dependence mortality continues to increase 0 over time6 Heroin Non-heroin opioids Other drugs Source: 1. UNODC, World Drug Report 2015; 2. SAHMSA, National Survey on Drug Use and Health (NSDUH) – 2014; 3. EMCDD, European Drug Report Trends and Developments 2015; 4. Center for Disease Control & Prevention 2016; 5. Toxreg 2016; 6. Hser et al. Harvard Review Psychiatry 2015; 23: 76-89 12 Medication assisted treatment considered best practice treatment for opioid use disorder Large evidence-base for efficacy Important unmet medical needs • Standard of care with daily buprenorphine or • Limited adherence to treatment methadone medications ‒ Poor treatment retention with continued illicit opioid use / “use on top” • Demonstrated effective in treating opioid ‒ Extensive misuse and diversion dependence • Safety issues ‒ Suppresses withdrawal and reduces cravings ‒ Overdoses ‒ Decreases illicit drug use ‒ Cardiac events (methadone) ‒ Reduces risky behavior, spreading of blood-borne disease and mortality • Need for daily, frequently supervised, dosing • On the World Health Organization’s Essential ‒ Inconvenient, stigma, and reduced quality of life Medicines List ‒ Burdens to the healthcare and criminal justice systems No significant innovation in opioid use disorder treatment for the past 20 years 13 CAM2038 – a paradigm shift in opioid dependence treatment Buprenorphine FluidCrystal® injection depot CAM2038 key attributes • Small volume, subcutaneous, liquid injection • Encapsulating gel phase formed immediately Long-acting release and continuous after injection treatment effect Long-acting buprenorphine Rapid and sustained suppression of • Multiple doses of both weekly and monthly formulations withdrawal and blockade of opioid effects allow flexible, individualized treatment Safeguards against diversion, misuse and • Provided ready for use in a prefilled syringe accidental pediatric exposure • Room temperature storage Reduced number of doses/decisions Extensive clinical documentation from 365 to 12 times per year • From 7 clinical trials (phase 1, phase 2, phase 3) • Pharmacokinetics, pharmacodynamics, efficacy, and No daily supervised dosing and related safety (4 studies including active controls) stigma On track for NDA and MAA submissions mid-2017 Improved treatment adherence – dose given is dose taken • FastTrack designation by FDA 14 Flexible and individualized opioid dependence treatment – across treatment stages Weekly and monthly CAM2038 are administered as small dose volume subcutaneous (SC) injections by a prefilled syringe with a thin 23G needle Monthly Weekly Initiation Weekly Maintenance or Weekly CAM2038 CAM2038 Stabilization - induction CAM2038 treatment 15 Extensive clinical program for CAM2038 in opioid dependence 7 Trial no. No. subjects Key results / Study design Status CLINICAL TRIALS Extended release of BPN suited for once COMPLETED 60 healthy volunteers weekly dosing. Dose proportional exposure. 6-8 HS-11-426 Phase 1 AND UNDER under naltrexone block times higher bioavailability versus SL BPN COMPLETION tablets.
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