Company Presentation
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Company presentation January 2019 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 2 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® 3 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 4 Long-acting medications address key healthcare challenges 5 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 6 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 7 Clinically documented compounds + FluidCrystal® technology 8 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 10 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 11 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 13 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 $269M2 US Approved 2010 Source: 1. Indivior, Q2 Financial Results, May 2, 2018; 2. GlobalData 2018. 14 2019 launches of CAM2038 (Buvidal®) prepared for the three largest global markets ESTIMATED 34 million WORLDWIDE OPIOID USERS 20161 127 thousand OPIOID OVERDOSE DEATHS1 11.2 million INJECTION USERS1 5.5 million WITH HEPATATIS C1 1.2 million WITH HIV1 Camurus 1st entry markets Camurus Braeburn Braeburn option right Medison (Israel) Source. 1. World drug report 2018 15 Significant market potential estimated ® for CAM2038 (Buvidal /Brixadi™) GlobalData estimates of opioid dependence market (US, CA, DE, AUS)1 • Escalating opioid crisis, high unmet need Long-acting injectables US$ 4.8 billion and high disease awareness Daily medication • Pronounced interest from patients, US$ 1.8 billion prescribers and payers $1.4 billion $264 m • Opioid dependence market predicted $3.4 billion to grow by 10.2% CAGR $1.5 billion • Sales estimated to US$ 1.4 billion in 20271 2017 2027 • Long-acting injectables are likely to become the new gold standard of treatment • >100,000 US patients estimated to be treated with CAM2038 in 20271 Source: 1. Opioid Use Disorder (OUD): Opportunity Analysis and Forecasts to 2027, GlobalData 2018 16 Camurus establishing leading commercialization platform in Europe and Australia HQ • Experienced international leadership in key markets Lund ‒ General managers, market access, medical affairs, marketing Sweden • Sales teams in early launch markets (UK, DE, Nordics) ‒ On-boarded and trained Cambridge UK • High pre-launch activity Regions ‒ Payer access, medical affairs and marketing Northern Europe ‒ Distribution and patient access Central Europe ‒ Country operating models Paris Southern Europe France ‒ Policy and education Australia ‒ Phase 4 studies and LCM in progress Mannheim Sydney Germany Australia 17 High HCPs’ willingness to prescribe Buvidal® (EU5)1 96% 96% 86% 94% 86% n=52 n=50 n=50 n=51 n=50 q4w q4w q1w q4w q4w q4w q1w 31% q1w q1w 43% 30% 36% 39% q1w 37% 27% 25% 22% 22% Germany UK Italy Spain France 78,800 patients 138,400 patients 62,800 patients 59,200 patients 169,700patients HCPs’ willingness to prescribe CAM2038 Anticipated share of patients on CAM2038 q4w if available Anticipated share of patients on CAM2038 q1w if available Source: 1. Market access dynamics in opioid addiction, Decision Resources 2015. 18 Patients and users perceive quality of life benefits with Buvidal® Perceived benefits of depot medications for UK patients & users not in treatment1: • Makes life easier 11 6 3 20 11 17 31 • No need for daily medication pick up 3 6 6 9 6 31 40 • Reduce problem of stigma or privacy 11 11 6 20 20 31 related to taking medication • Right dose consistently 6 3 11 9 14 57 1 2 3 4 5 6 7 Disagree Neutral Agree strongly strongly 1. Gilman et al Patient Preference and Adherence, Vol. 12, 2018, p. 2123-2129 19 Estimated addressable market of ~740,000 patients in EU and Australia Patients on Bup1 Patients on low dose Patients recycling Users out of Total Methadone 30mg2 within a year1 treatment addressable due to rules & market ≤ burden1,3,4 1. EMCDDA 2018 Drug report 2. Camurus estimate 3. Benyamina et al 2013 Heroin Addiction and Related Clinical Problems 14 (4): 65-80. 4. Camurus data on file 2018 Patient qualitative study . 20 Market potential of long-acting injectables in opioid dependence in EU and Australia 740,0001 20 – 30% Average Price point Estimated patients in suitable length of comparable market size addressable for depot treatment to depot € € 2,3, 200 - 300m market in EU