Camurus Company Presentation
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Corporate presentation Updated 15 July 2021 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 3 Long-acting medications addressing key healthcare challenges 4 Camurus snapshot Rapidly growing commercial Broad late-stage pipeline stage company • +10 innovative clinical programs in addiction, • Fully operational infrastructure in Europe pain, endocrine disorders and oncology and Australia • Three Phase 3 programs • Buvidal® to date available in 15 countries • Advancing early- and mid-stage candidates • Strong sales performance and growth Market approvals Unique FluidCrystal® Partnerships Experienced Weekly and monthly nanotechnologies R&D collaborations, management & ® Buvidal for opioid • New generation long-acting licensing and royalty dedicated teams dependence depot technology arrangements with • Validated in +25 clinical trials pharmautical and and by approved products biotech companies LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP ~ SEK 11 billion EMPLOYEES: 140 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney 5 Leading FluidCrystal® extended-release technology Easy and convenient administration Adopted to prefilled syringes and autoinjectors Rapid onset & long-acting release Manufacturing by standard processes Applicable across substance classes Strong intellectual property Injection of liquid . formulation Encapsulating Slow release Drug release and conc using prefilled H2O liquid crystal gel of drug biodegradation of syringe or triggered by blood gel matrix to full autoinjector water uptake drug resolution time Sources: Tiberg F, et al. Chapter in Long Acting Injections and Implants, Advances in Delivery Science and Technology 2012; Tiberg F, et al. OnDrugDelivery 2010; Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011. 6 FluidCrystal – Long-acting release Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071) 10 10 Pasireotide IR 600 ug (SC Pasireotide FluidCrystal 20 thigh, n = 94) mg (SC thigh, n = 12) 1 1 pasireotide plasma concentration (ng/mL) concentration plasma pasireotide pasireotide plasma concentration (ng/mL) concentration plasma pasireotide 0,1 0,1 0 7 14 21 28 0 7 14 21 28 Time (days) Time (days) 7 Weekly and monthly buprenorphine depots Population pharmacokinetic profiles for Buvidal vs sublingual buprenorphine Weekly Buvidal vs. Daily sublingual buprenorphine Weekly vs. Monthly Buvidal Population PK model analysis based on data from four clinical studies (N=236). Diagnostic testing demonstrated predictive buprenorphine concentrations and good agreement between observed and predicted data percentiles. Steady state data. Sources: Abstract presented at the Annual conference of the Society for the Study of Addiction-November 2018; Albayaty M, Linden M, Olsson H, Johnsson M, Strandgarden K, Tiberg F. Adv Ther. 2017;34(2):560–575. 8 Recent business progress •Strong commercial execution with Buvidal ‒ Expanding sales and commercial infrastructure ‒ Initiating diversification and prelaunch preparations for new products •Advancing pipeline ‒ Successful life-cycle management and new regulatory approvals ‒ Two ongoing Phase 3 studies of CAM2029 in acromegaly ‒ Phase 3 study of CAM2029 in neuroendocrine tumors (NET) starting ‒ Brixadi™ NDA filing accepted by FDA with PDUFA date 15 December 2021 ‒ Several early-stage clinical programs and partnerships advancing •Positive financial performance ‒ Strong revenue growth and improved financial results ‒ Solid cash position with no loans ‒ On track for profitability in 2022 1Total revenue SEK 680 – 750 million, whereof product sales SEK 620 – 680 million, and the operating result SEK -120 – 0 million excluding a USD 35 million milestone payment on approval of Brixadi™ in the US 9 Opioid dependence – worsened crisis during the pandemic • Largest society burden of all drugs1 Escalating overdose deaths ‒ High need for better access to care and new during COVID-19 treatment alternatives ‒ Investment in treatment brings substantial value 12 Month-ending Provisional Number and saves lives of Drug Overdose Deaths in the US1 • New funding initiatives 100 000 90 000 All drugs ‒ President Biden recently issued a US$1.5 billion 80 000 initiative for substance use treatment and 70 000 2 Opioids prevention 60 000 ‒ Scottish Government initiative £250m investment 50 000 3 to tackle drug death crisis 40 000 30 000 Start lock-down • Significant limitations with current daily 20 000 medications the in US of deaths Number 10 000 ‒ Diversion, misuse, risk of overdose, poor retention, 0 burdens and stigma of daily buprenorphine and methadone medications 12 month-ending period 1www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm; 10 Buvidal® – flexible long-acting treatment of opioid dependence Weekly and monthly, subcutaneous buprenorphine for individualized treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1 Buvidal provides significant benefits to patients and society “Buvidal became ‒ Improved treatment outcomes and patient satisfaction1-3 my way out” ‒ Reduced treatment burden and improved quality of life2 4 Justin, Buvidal patient in ‒ Diminished diversion, misuse and pediatric exposure Australia ‒ Reduced treatment costs in the criminal justice system5 1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Frost et al, Addiction, 2019;114(8):1416-1426; 3Lintzeris N, et al., Results of the DEBUT Study, presented at CPDD Virtual Meeting June 22-24, 2020. 4EPAR; 5Dunlop A, et al. Introduction of Long-Acting Depot Buprenorphine in Prison - the UNLOC-T Study. Presented at CPDD Virtual Meeting June 22-24, 2020 11 Robust Buvidal sales growth continues under pressure by the pandemic Consistent double-digit quarter-by-quarter growth Product sales by quarter (MSEK) ‒ Exceptional uptake in Australia and the Nordics MSEK ‒ Progress in the UK, Germany, Spain and other markets 137 COVID-19 remains a barrier on many markets ‒ 32% 124 Average Q/Q Buvidal market expansion continues growth rate 104 ‒ Available in 15 countries in Europe, Australia and MENA 94 ‒ P&R applications in new markets 76 ‒ 8 launches planned in 2021 49 Successful life-cycle management and growing 30 scientific evidence 20 ‒ New approvals and important scientific publications Increasing media coverage ‒ Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2019 2020 2021 MENA; – Middle East and North Africa; P&R – price and reimbursement 12 Buvidal market expansion continues Netherlands Switzerland ~10,000 patients in opioid 10,000 patients1 dependence treatment1 Marketing approval received Launch expected in Q3 2021 Launch expected in Q3 2021 France Croatia and Slovenia 1 >179,000 patients1 >8,000 patients Positive HEOR assessment by Preparing for launch Q3 2021 Haute Autorité de Santé Preparing for launch in Q3 2021 Italy ~70,000 patients1 Portugal PMA ongoing >17,000 patients1 Preparing for launch in Q3 2021 New Zealand ~5,500 patients2,3 MENA Launch sequence Market authorization received Early access program in three countries Wave 1& 2 Wave 3 markets PMA initiated Several regulatory submissions Launched Wave 4 markets progressing 1EMCDDA 2020; 2Office of the Director of Mental Health and Addiction Services Annual Report 2018 and 2019; 3New Zealand Practice Guidelines for Opioid Substitution Treatment 2014 13 Increasing support for Buvidal and improved access to innovative ODT treatments •Government initiatives to increase •Growing scientific evidence base funding and improve treatment access ‒ Positive results in peer-reviewed ‒ Scottish government and Public Health scientific journals England allocating funding for ODT and ‒ Affirmative “real world” outcome Buvidal1,2 studies ‒ Recommendation for significant investments ‒ Health-economical assessments in ODT and innovations in England3 demonstrating value of Buvidal to ‒ Processes ongoing in Germany and Sweden payors and society to improve HCP remuneration system •Increasing media attention •Adoption in the criminal justice system ‒ Unmet medical need and positive ‒ Expanding use of Buvidal with Australia, impact of ODT Germany and Scotland as forerunners ‒ Strong testimonials by patients ‒ Benefits of Buvidal clearly recognized, and HCPs including cost savings ‒ Buvidal identified as “game-changer” ‒ Estimated >100,000 people with opioid dependence in European prisons4 1https://www.gov.scot/publications/evaluation-opioid-substitution-treatment-scotlands-prisons-covid-19-contingency-patient-experience-follow-up-report/