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Fluidcrystal® Injection Depot – in Situ Gel Formation

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Fluidcrystal® Injection Depot – in Situ Gel Formation Transforming treatments by long-acting medications Fredrik Tiberg, President & CEO 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 Investment highlights FluidCrystal® • In-house developed with strong IP protection • Validated in 20 clinical trials delivery technology • 1 marketed product and approval processes ongoing Broad, late-stage • +10 clinical programs in opioid addiction, pain, cancer, obesity, endocrine and cardiovascular disease. R&D pipeline • Potential FDA/EMA/TGA product approvals in 2018 Emerging European • Leadership and key functions in place commercial • Fully operational for 2018 launch Listed on Nasdaq STO (ticker CAMX) organization Market Cap: ~500 MUSD Cash position: 45 MUSD (Q3, 2017) Strong pharma • Novartis, Braeburn Pharmaceuticals, Rhythm… Monthly OPEX: 3 MUSD (2017) • R&D investments, milestones and royalty on sales partnerships Employees: 70 HQ: Lund, Sweden 3 Long-acting medications address key healthcare challenges 4 FluidCrystal® injection depot – in situ gel formation ✓ Easy to administer ✓ Good safety profile ✓ Rapid onset & long-acting release ✓ Standard manufacturing processes ✓ Applicable across substance classes ✓ Unique mixtures of endogenous lipids WATER INJECTION ABSORPTION DRUG RELEASE +400 PATENTS & APPLICATIONS LIQUID DRUG PRODUCT ~1500 BEFORE INJECTION: SOLVENT DEPOT BIODEGRADATION SUBJECTS HAVE RECEIVED LIPIDS+SOLVENT+DRUG RELEASE LIQUID CRYSTAL GEL TO COMPLETE RESOLUTION >15,000 INJECTIONS IN CLINICAL TRIALS TIME 5 FluidCrystal® – Tunable long-acting release FluidCrystal® injection depot Immediate release octreotide (Sandostatin®) FC pasireotide subcutaneous octreotide 1000 FC octreotide 1000 FC somatostatin 1-14 100 100 10 10 1 1 0,1 0,1 Plasma concentration (ng/mL) concentration Plasma (ng/mL) concentration Plasma 0,01 0,01 0 5 10 15 20 25 30 0 7 14 21 28 Time (days) Time (days) Single dose injection at t=0; n=6 (SC); rodent; mean values 6 Clinically documented compounds & Validated proprietary technology 7 Diversified late-stage R&D pipeline – FluidCrystal® 8 CAM2038 Weekly and monthly buprenorphine depots Changing the treatment paradigm in opioid dependence Global opioid addiction health crisis 2 Annual US opioid overdose deaths 30 (thousands) 25 • Escalating human crisis 20 • Largest society burden of all drugs1 15 10 • Patients need better access to care and 5 new treatment choices 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 • Investment in treatment brings 1999 significant value COST OF US OPIOID CRISIS: $500 bn WHITE HOUSE COUNCIL OF ECONOMIC ADVISERS3 Source: 1. UNODC, World Drug Report 2015; 2. Center for Disease Control & Prevention 2016; 3. White House Council of Economic Advisers Analysis 2017. 10 Long-acting treatment of opioid dependence – from Day 1 to maintenance therapy1 1 Individualized treatment 2 Weekly and monthly dosing options 3 Rapid onset and sustained treatment effect from Day 1 4 Enhanced adherence to treatment 5 Safeguards against diversion and misuse 6 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 CAM2038 demonstrated efficacy and safety vs standard of care Superiority in % cumulative • CAM2038 met FDA and EMA primary and key opioid abstinence, p=0.004 secondary efficacy endpoints in a pivotal 24-week Phase 3 study 100 Percent urine ‒ Demonstrating non-inferiority and superiority versus samples confirmed by daily standard treatment 80 self-reports negative for illicit opioid use • Sustained suppression of withdrawal and weeks 4-24. cravings 60 100% • Opioid blockade from first dose 40 75%-<100% 50%-<75% • Safety profile comparable to SL buprenorphine 25%-<50% 20 with no unexpected safety findings 1%-<25% 0% ‒ Confirmed in a 48-week Phase 3 safety study 0 CAM2038 SL BUP/NX 12 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 CAM2038 ongoing global approval processes ✓ Recommendation of approval from FDA Advisory Committee ✓ EMA & TGA ✓ NDA submission ✓ TGA acceptance for evaluation MAA approval to FDA of Australian MAA decisions May 2017 July 2017 Sept 2017 Nov 2017 Jan 2018 Q3/Q4 2018 ✓ Positive phase 3 ✓ Priority review ✓ PDUFA date set to long-term safety granted by FDA 19 January 2018 data ✓ MAA validation by EMA Supported by comprehensive clinical program ✓ 944 participants across 7 clinical studies ✓ Phase 2 opioid blocking study ✓ Four phase 1/2 studies of pharmacokinetics and ✓ Phase 3 double-blind, double-dummy, pharmacodynamics after single and repeated active-controlled study dosing of CAM2038 ✓ Phase 3 long-term safety study 14 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) PDUFA Estimated Braeburn/Camurus CAM2038 Weekly & Monthly Jan. 19, 2018 Q3/Q4 2018 ® APPROVED Indivior Sublocade Monthly Nov. 30, 2017 BDSI BPN Depot1 Heron HTX-0032 Long-acting naltrexone injectables 3 APPROVED Alkermes Vivitrol $275M expected 2017 sales 2010 1. Data of first single-ascending dose cohort from Phase I study expected to be released in Q4 2017; 2. No progress updates since 2015. 3. Alkermes Q3 2017 report 15 Global commercialization strategy for CAM2038 ESTIMATED 1.3 million 15 million opioid problem users in Europe1 OPIOID DEPENDENT 2.5 million 1.4 million INDIVIDUALS GLOBALLY1 diagnosed opioid registered heroin users 2 dependent in the US in China4 187,000 opioid dependent in Australia3 Braeburn markets Camurus markets Braeburn option right Source. 1. Data for 2010 by Degenhardt et al., Addiction, 2014; 109, 1306–1317. 2. EMCDD, European Drug Report 2015 2. SAHMSA, National Survey on Drug Use and Health (NSDUH) – 2014 3. MedicineToday 2015; 16(6 Suppl):10-15 4. Beijing Review, War on drugs, No.28,July 9,2015 16 Prescription volume growth indicate high market potential for long-acting buprenorphine in the US Total TRx Volume 12 Months ending June1 15 000 13 156 12 035 11 149 25% LAI SHARE 10 327 10 000 9 309 ~$15002 PER MONTH 8 040 CORRESPONDS TO 5 000 Volume (000s) Volume TRx $3-4 BN 0 2012 Q2 2013 Q2 2014 Q2 2015 Q2 2016 Q2 2017 Q2 MARKET POTENTIAL buprenorphine/naloxone buprenorphine HCL & generics (Suboxone, Bunavail, Zubsolv & oral generics) naltrexone (Vivitrol) Source: 1. Symphony Health, PHAST Integrated Monthly; 2. Based on monthly Sublocade™ price ($1580), Indivior plc; LAI – long acting injectables 17 Significant market potential for CAM2038 in Europe High physicians’ willingness to prescribe CAM2038 in EU41 86% 94% 96% 86% n=51 n=50 n=50 n=50 Physicians’ willingness to prescribe CAM2038 q4w q4w q1w q1w 31% q4w q4w 43% Anticipated share of patients 30% 36% q1w 39% q1w 27% 25% 22% on CAM2038 q4w Anticipated share of patients on CAM2038 q1w Germany UK Italy France 77,500 patients 148,686 patients 75,964 patients 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 Additional attractive product candidates PARTNER PRODUCT PRE-CLINICAL PHASE1-2 PHASE 3 CAM2038 q1w / q4w CHRONIC PAIN PHASE 3 CAM2029 ACROMEGALY PHASE 1-2 CAM2029 NEUROENDOCRINE TUMORS 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 Pipeline products overview – CAM2038 chronic pain CAM2038 CHRONIC PAIN FORMULATION Weekly and monthly buprenorphine treatment depot based on FluidCrystal® KEY FEATURES • Round the clock pain relief • Rapid and sustained blockade of euphorigenic and sedative opioid effects 1 IN 5 INDIVIDUALS SUFFERING 1 • Flexible and individualized dosing FROM CHRONIC PAIN • HCP administration safeguards against misuse and diversion CHRONIC PAIN ESTIMATED MARKET SIZE Global opioid pain market ~$6 bn1 DEVELOPMENT •
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