Company Presentation
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Company presentation January 2019 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 Unique FluidCrystal® • In-house developed with strong IP protection delivery technology • Used in +20 clinical trials and 2 approved products • +10 clinical programs in opioid addiction, pain, Broad, late-stage cancer, obesity, endocrine and CV disease R&D pipeline • EMA/TGA approvals (Buvidal®) in Nov 2018. Tentative US approval (Brixadi®) in Dec 2018 Own commercial • Fully operational for 2019 Buvidal® launches Listed on Nasdaq STO (ticker CAMX) organization in Europe and Australia Market Cap: USD ~280 million Cash position: USD ~24 million (Q3 2018) Employees: 85 • Braeburn Pharmaceuticals, Rhythm, Solasia Lund, Sweden Strong partnerships Pharma… HQ: Regional offices: Cambridge, Mannheim, Paris, Sydney Experienced management and dedicated teams 3 Broad and diversified product pipeline PRODUCT PRECLINICAL PHASE 1-2 PHASE 3 REGISTRATION MARKET Buvidal® (CAM2038) q1w OPIOID DEPENDENCE1 APPROVED Buvidal® (CAM2038) q4w OPIOID DEPENDENCE1 APPROVED CAM2038 q1w CHRONIC PAIN1 PHASE 3 CAM2038 q4w CHRONIC PAIN1 PHASE 3 CAM2029 ACROMEGALY PHASE 1-2 CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2 CAM2032 PROSTATE CANCER PHASE 1-2 CAM2047 CHEMOTHERAPY INDUCED NAUSEA & VOMITING PHASE 1-2 CAM2048/58 POSTOPERATIVE PAIN & PONV1,2 PHASE 1-2 CAM4072 GENETIC OBESITY DISORDERS3 PHASE 1-2 CAM2043 PULMONARY ARTERIAL HYPERTENSION PHASE 1-2 1. Braeburn holds rights to North America; 2. Postoperative nausea and vomiting; 3. Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal 4 Broad and diversified product pipeline PRODUCT PRECLINICAL PHASE 1-2 PHASE 3 REGISTRATION MARKET Buvidal® (CAM2038) q1w OPIOID DEPENDENCE APPROVED Buvidal® (CAM2038) q4w OPIOID DEPENDENCE APPROVED Brixadi® (CAM2038) q1w OPIOID DEPENDENCE1 TENTATIVELY APPROVED Brixadi® (CAM2038) q4w OPIOID DEPENDENCE1 TENTATIVELY APPROVED CAM2038 q1w CHRONIC PAIN1 PHASE 3 CAM2038 q4w CHRONIC PAIN1 PHASE 3 CAM2029 ACROMEGALY PHASE 1-2 CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2 CAM2032 PROSTATE CANCER PHASE 1-2 CAM2047 CHEMOTHERAPY INDUCED NAUSEA & VOMITING PHASE 1-2 CAM2048/58 POSTOPERATIVE PAIN & PONV1,2 PHASE 1-2 CAM4072 GENETIC OBESITY DISORDERS3 PHASE 1-2 CAM2043 PULMONARY ARTERIAL HYPERTENSION PHASE 1-2 1. Braeburn holds the rights to North America; 2. Postoperative nausea and vomiting; 3. Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal® 5 Recent company news flow PRODUCT EVENT TIME CAM2038 Opioid dependence Tentative NDA approval, US √ Dec. 2018 MAA approval, Australia √ Nov. 2018 MAA approval, EU √ Nov. 2018 Positive CHMP opinion recommending EU approval √ Sept. 2018 Publication of pivotal Phase 3 results in JAMA Int. Med. √ May 2018 CAM2038 Chronic pain Positive top-line Phase 3 efficacy results √ Sept. 2018 CAM2029 Acromegaly / NET Exclusive rights to CAM2029 regained from Novartis √ July 2018 CAM2043 PAH / 2nd indication Positive Phase 1 SAD and MAD results √ May 2018 6 Long-acting medications address key healthcare challenges 7 FluidCrystal® in situ gel formation Easy to administer Demonstrated safety and tolerability profile Rapid onset & long-acting release Unique mixtures of endogenous lipids Applicable across substance classes Strong intellectual properties INJECTION WATER ABSORPTION DRUG RELEASE +400 PATENTS & APPLICATIONS >2000 SUBJECTS HAVE RECEIVED ~20,000 INJECTIONS IN LIQUID DRUG PRODUCT SOLVENT RELEASE DEPOT BIODEGRADATION TO LIQUID CRYSTAL (LC) FORMULATION BEFORE INJECTION: COMPLETE RESOLUTION 20 CLINICAL TRIALS SPC+GDO+SOLVENT+DRUG SECONDS HOURS WEEKS / MONTHS 8 Tiberg F, Johnsson M, Jankunec M et al., Chemistry Letters 2012; 41(10): 1090-1092; Tiberg F, Johnsson M., J. Drug Delivery Science Techn. 2011; 21 (1): 101-1 FluidCrystal® formulated: Long-acting release of pasireotide – Phase 1 results Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071) 10 10 Pasireotide IR 600 ug Pasireotide FluidCrystal (SC thigh, n = 94) 20 mg (SC thigh, n = 12) 1 1 pasireotide plasma concentrationpasireotide plasma (ng/mL) concentrationpasireotide plasma (ng/mL) 0,1 0,1 0 7 14 21 28 0 7 14 21 28 Time (days) Time (days) Single dose injection at t=0; clinical Phase 1 data, mean values. Tiberg, F. et al, Poster presentation at ECE, Barcelona, May 2018 9 Clinically documented compounds + FluidCrystal® technology 10 Buvidal®/Brixadi™ (CAM2038) Weekly and monthly buprenorphine depots Game-changer in opioid dependence treatment Opioid dependence – escalating global health crisis Mounting US opioid overdose deaths2 (thousands) 50 • Largest society burden of all drugs1 45 40 • Public health epidemic in the US 35 30 • Patients need better access to care and 25 new treatment choices 20 15 • Investment in treatment brings 10 significant value 5 WHITE HOUSE ESTIMATES * Provisional data $504 billion #1 cause of death for people under 50 in the US PRICE TAG FOR US OPIOID CRISIS3 30:1 non-fatal to fatal overdoses4 Recent US life expectancy decline largely 5 Source: 1. UNODC, World Drug Report 2017; 2. Center for Disease Control & Prevention 2018; 3. The Council of Economic due to opioids Advisers, November 2017; 4. Frazier at al, 2017, Journal of the American Medical Association; 5. Crow D. Financial Times.com, accessed on March 13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da 12 Buvidal® has an unique product profile1 • Flexible dosing to match patient needs. CHOICE OF WEEKLY MONTHLY MULTIPLE Enhanced continuum of care with direct INJECTION DOSING DOSING DOSES initiation and switching from daily SITES treatments (‘‘dose matching”) • Removes burden and stigma of daily medication and increases adherence SMALL LOW ROOM TEMP. CLINICAL DATA VS. • HCP administration safeguards against NEEDLE VOLUMES STORAGE ACTIVE CONTROL diversion, misuse and pediatric exposure • Potential game-changer in opioid dependence treatment 23 gauge 0.16 – 0.64 mL Source: 1. CAM2038 is an investigational medicinal product and is currently not approved in any market 13 ® Strong clinical data for Buvidal Recent publications versus daily standard treatment Non-inferior and superior efficacy shown in pivotal Phase 3 study versus standard daily SL BPN/NX1 Effective suppression of withdrawal and cravings1,2,3 Blockade of opioid effects from the first dose2 Pharmacokinetic profiles for weekly and monthly dosing4 Safety profile comparable to SL BPN/NX except for mild and moderate injection site reactions1 No opioid overdoses across clinical studies for participants treated with Buvidal®1,2,3,5 High patient satisfaction including versus SL BPN6 1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 3Haasen, C, et al, J Subst Abuse Treat. 2017;78:22-29; 4Albayaty M, et al, Adv Ther. 2017 34(2):560-575; 5Lintzeris et al., Drug and alcohol 14 review. 2017;36(S1):47-48, 6Study HS-14-499, data on file. SL BPN sublingual buprenorphine/naloxone High satisfaction 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 15 Source: Poster presentation ASAM 2018. Phase 3 Long-Term Safety Study HS-14-499, data on file. Long-acting injectables for ODT on key global markets Long-acting buprenorphine injectables PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL US Tentative approval Dec 2018 Camurus/ Europe Approved Nov 2018 Braeburn CAM2038 Weekly & Monthly Australia Approved Nov 2018 US Approved Nov 2017 Indivior Sublocade™ Monthly Europe N/A Australia Estimated Q3 2019 Long-acting naltrexone injectables Alkermes Vivitrol® 2017 sales $269M2 US Approved 2010 Source: 1. Indivior, Q2 Financial Results, May 2, 2018; 2. GlobalData 2018. 16 2019 launches of CAM2038 (Buvidal®) prepared for the three largest global markets ESTIMATED 34 million WORLDWIDE OPIOID USERS 20161 127 thousand OPIOID OVERDOSE DEATHS1 11.2 million INJECTION USERS1 5.5 million WITH HEPATATIS C1 1.2 million WITH HIV1 Camurus 1st entry markets Camurus Braeburn Braeburn option right Medison (Israel) Source. 1. World drug report 2018 17 Significant market potential estimated ® for CA M2038 (Buvidal /Brixadi™) GlobalData estimates of opioid dependence market (US, CA, DE, AUS)1 • Escalating opioid crisis, high unmet need Long-acting injectables US$ 4.8 billion and high disease awareness Daily medication