Company Presentation
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Company presentation March 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 Long-acting medications addressing key healthcare challenges 4 Corporate highlights Rapidly growing commercial Broad late-stage pipeline stage company • +10 innovative clinical programs in • Fully operational infrastructure in Europe addiction, pain, oncology, endocrine and Australia disorders and CV diseases • Buvidal® to date available in 15 countries • Two ongoing Phase 3 studies • Strong growth of product sales • Advancing early-stage opportunities Market approvals Unique FluidCrystal® Partnerships Experienced Weekly and monthly nanotechnologies R&D collaborations, management ® Buvidal for opioid • New generation long-acting licensing and royalty and dedicated dependence depot technology arrangements with teams • Validated in +25 clinical trials pharma and biotech and by approved products companies LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP ~ SEK 12 billion EMPLOYEES: 136 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney 5 Camurus‘ FluidCrystal® long-acting release technology has unique properties 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) pasireotide plasma concentration (ng/mL) 0,1 0,1 0 7 14 21 28 0 7 14 21 28 Time (days) Time (days) 7 Camurus had a successful 2020 •Strong revenue growth – in line with our upgraded 2020 guidance • Net revenue SEK 336 million, up 218% (SEK 351 million, up 227% at CER1), • Product sales SEK 323 million, up 347% (SEK 337 million, up 362% at CER1) • OPEX was SEK 508 million, an increase of 15% •Successful commercialization of Buvidal • Scalable commercial platform in Europe and Australia • Expansion into new markets FY 2020 guidance • Established the value Buvidal brings to patients, HCPs, payors and society Expected FY net revenues ‒ Growing scientific evidence, including positive results from DEBUT and UNLOC-T SEK 340 - 380 million, clinical trials whereof product sales •Significant pipeline progress SEK 310 – 340 million • Progress of Phase 3 studies for CAM2029 in acromegaly Expected FY OPEX* SEK 505 – 525 million • Positive Phase 2 results for weekly FluidCrystal® setmelanotide for treatment of rare genetic obesity disorders by Rhythm *Without regard to the outcome of the ongoing arbitration process • Progress in the early pipeline has laid the ground for new value-adding clinical programs 1. Constant exchange rates (CER) December 2019 8 Fourth quarter 2020 highlights •Total revenues up by 201% (213% at CER1) Key figures ‒ Product sales up by 243% (256% at CER1) MSEK Oct – Dec Δ Jan – Dec Δ •Patients in treatment with Buvidal® increased to 2020 vs 2019 2020 vs 2019 over 15,000 Total revenues 106 +201% 336 +218% ‒ More than 200,000 Buvidal doses administered in 2020 whereof product sales 104 +243% 323 +347% •Buvidal approved in Switzerland ‒ Three additional MAAs submitted OPEX 175 +58% 508 +15% •Delay in the US Operating result -82 +8% -205 +43% 2 ‒ Braeburn received a CRL from FDA for the Brixadi™NDA Result for the period -65 +9% -167 +42% ‒ Partial award announced from arbitration process with Braeburn Result per share, before •New clinical studies and after dilution, SEK -1.22 +17% -3.18 +49% ‒ First patients treated in Phase 2 study of CAM2043 in Raynaud’s Cash position 462 +29% 462 +29% phenomenon and Phase 1 study of CAM2029 autoinjector ‒ Phase 3 study protocol finalized for CAM2029 in NET •New patents for Buvidal granted in the EU and US 1. Constant exchange rates (CER) December 2019 2. CRL – Complete Response Letter 9 Opioid dependence – escalating global health crisis • Largest society burden of all drugs1 Escalating overdose deaths • 58 million opioid users worldwide1 • High need for better access to care 1 200 and new treatment alternatives 1 000 • Investment in treatment brings substantial 800 value and saves lives 600 • Significant limitation with current daily medications 400 ‒ Diversion, misuse, risk of overdose, poor retention, 200 burdens and stigma of daily buprenorphine and methadone medications 0 Opioid related deaths in Scotland over the last 10 years2 1United Nations: World drug report 2020; National Records of Scotland https://www.nrscotland.gov.uk/statistics-and- data/statistics/statistics-by-theme/vital-events/deaths/drug-related-deaths-in-scotland/2019 10 Buvidal® – flexible long-acting treatment of opioid dependence Flexible-dose, weekly and monthly, subcutaneous buprenorphine for treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1 Launch initiated in Europe and Australia in 2019 “For me, Buvidal is a Buvidal provides significant benefits to patients and society revelation. I know that as ‒ Improved treatment outcomes and patient satisfaction1-3 long as I stay on Buvidal ‒ Reduced treatment burden and improved quality of life2 I’ve got a chance” ‒ Diminished diversion, misuse and pediatric exposure4 Sophie, Buvidal patient in Wales ‒ 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 Buvidal growth journey Continued progress in the fourth quarter Product sales by quarter ‒ Invoiced product sales grew by 10% versus Q3 2020, MSEK while the in-market Buvidal sales growth was 33% 110 104 Double-digit growth in all markets 100 ‒ 94 ‒ Largest markets: Australia, Finland, Norway and UK 90 ‒ Covid-19 barrier for uptake and delayed pricing and 80 reimbursement processes 70 76 60 Buvidal available in 15 countries 50 49 ‒ 12 countries in Europe and Australia 40 • Latest launch in Spain after price and reimbursement 30 30 decision in December 2020 20 19 11 ‒ 3 countries in MENA with Early Access Programs 10 11 ‒ Preparation for new launches in Wave 3 markets 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2019 2020 12 Buvidal scientific evidence base translated into significant patient benefits “…make available long acting treatments in both community & prison” Nicola Sturgeon, First Minister, Scotland, 21 Jan 2021 Strong science Supported claims Media recognition • 25 peer-reviewed scientific • Superior treatment outcome versus • Benefits of Buvidal being publications – 11 in 2020 daily sublingual buprenorphine recognized by wider society • 123 conference • Flexible, individualized treatment • Covid-19 highlights presentations – 24 in 2020 according to patients’ needs advantages of long-acting • Improved treament satisfaction treatments and quality of life of patients 13 Global strategy for Buvidal (Brixadi™) REGION PARTNER NO OF PATIENTS MARKET POTENTIAL EU ~1.3 million ~€300 million2 Australia LAUNCH INITIATED IN 2019 HIGH-RISK OPIOID USERS1 North >2 million $0.6-1.2 billion4, 5 America DIAGNOSED WITH OPIOID USE DISORDER IN THE US3 Middle East 5 & North >300,000 €25-75 million WITH OPIOID DEPENDENCE6 Africa EARLY ACCESS PROGRAMS INITIATED IN 2020 1European Drug Report 2019; 2Camurus estimate; 3SAMHSA, Results from the 2017 National Survey on Drug Use and Health, Sep. 2018; 4Opioid Use Disorder: Opportunity Analysis and Forecasts to 2027, GlobalData 2018; 5Camurus estimates; 6World Drug Report and NewBridge estimate 14 Buvidal (Brixadi) regulatory progress •New approval •Braeburn received CRL in the US CAM2038 Chronic pain Market authorization approval by Complete