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Fourth Quarter & Full Year Results 2019

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Fourth Quarter & Full Year Results 2019 Fourth quarter & full year results 2019 12 February 2020 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 Agenda • Fourth quarter 2019 overview Participants • Buvidal progress in EU & Australia Fredrik Tiberg, PhD • US approval and launch status President & CEO, Head R&D • R&D pipeline update • Key take-aways Eva Pinotti Lindqvist Chief Financial Officer • Q&A 3 Financial overview Financials Q4 2019 FY 2019 2019 Product sales 2020 Guidance FY 2020 MSEK MSEK MSEK 80 72.1 *) Net revenue 35.0 (7.8) 105.6 (49.3) 70 Total revenues 290 – 330 60 – product sales 240 – 280 – product sales 30.3 (5.1) 72.1 (11.3) 50 41.9 OPEX 570 – 610 Operating 40 result -88.4 (-103.2) -360.0 (-287.2) MSEK *) 30 excl. 35 million in Brixadi milestones 22.4 Result after 20 11.1 tax -71.9 (-87.1) -289.9 (-234.7) 10 0 Cash flow from Q1 Q2 Q3 Q4 operations*) -87.9 (-102.2) -355.5 (-282.9) Quarterly product sales Cash 358.7 (134.4) 358.7 (134.4) Accumulated product sales YTD *) excl. change in working capital 4 Operational highlights 2019 Buvidal® launch Buvidal® NDA filed initiated in EU (Finland, CAM2029 pivotal Phase 3 Buvidal launched in in New Zealand Sweden, Germany, UK program initiated in patients Norway and Australia and Denmark) FDA grants Citizen Petition with acromegaly allowing Brixadi™ on the US Rights issue License agreement Start of CAM2029 market in Dec 2020 with for Phase 3 long- SEK 403 million Ra Pharma Directed share issue long-acting zilucoplan term safety study SEK 300 million Publication of Buvidal® Phase 3 long-term DEBUT and Buvidal® receives Superior patient outcomes safety data in Addiction UNLOC-T clinical pricing and from DEBUT RCT trials fully enrolled reimbursement in chronic pain Partnership with CAM2038 and successfully key markets study for Buvidal Phase 3 safety completed NewBridge completed in 12 MENA countries 2019 2020 5 Buvidal® – first long-acting treatment of opioid dependence in the EU and Australia Flexible-dose, weekly and monthly, subcutaneous buprenorphine for treatment of opioid dependence within a framework of medical, social and phychological treatment in adults and adolescents 16 years or over1 Source: 1Buvidal Summary of Product Characteristics (SmPC), 2018 6 Global market strategy for Buvidal® (Brixadi™) REGION PARTNER NO OF PATIENTS PEAK MARKET POTENTIAL EU ~1.3 million ~€300 million2 Australia HIGH-RISK OPIOID USERS1 North >2 million $0.6-1.2 billion4, 5 America DIAGNOSED WITH OPIOID USE DISORDER IN THE US3 Middle East & >300,000 €25-75 million5 North Africa 6 (Israel) WITH OPIOID DEPENDENCE Source: 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; 7 Strong progress of Buvidal® in EU & Australia Launched in seven wave 1 markets in 2019 HQ Exceptional start in Finland with >40% BPN share year one Lund Sweden Strong start in Norway and Australia after pricing and reimbursement listings in Q3 2019 Cambridge Accelerating uptake in Germany, Sweden, Denmark and UK UK Very positive response by HCPs, patients and payers Estimated 4,000 patients in treatment with Buvidal end-2019 Paris Patients up 60% and sales up 55% from Q3 to Q4 France High retention in treatment, estimated 80-90% in first year Mannheim 2020 market expansion in Wave 2-3 markets Germany Full access in Australia, incl. GP’s, after 6-month restriction Launches in Austria, Spain, Italy, Benelux, and other EU countries following market access approvals Launch sequence Wave 1 markets Wave 3 markets Sydney Wave 2 markets Wave 4 expansion Australia 8 Brixadi™ – significant opportunity in the US • Tentative approval 21 Dec. 2018 ~40% of US oral buprenorphine 1 • FDA granted Citizen Petition and revoked the prescriptions are 7 days or less orphan designation for Sublocade™ Brixadi™ • Clear path to final approval on Dec 1, 2020 Monthly ‒ Triggers $35m approval milestone for OUD Sublocade™ ‒ $70m in sales milestones 28 days+ 7 days Rx 34% ‒ Mid teen royalty on net product sales Rx 40% most common • All product requirements in place for a successful launch 26% • Strategy addressed need for reliable, easy access Brixadi™ to effective treatment 8–27 days Weekly / Monthly • Double-digit market growth and urgent need for Rx high-quality treatments of OUD Source: 1. Symphony Health Patient Source, 2017 9 Growing Buvidal® evidence base presented at 1-5 conferences and in leading scientific journals Key publications Selected conferences where Buvidal data was presented in 2019 2019 Q1 Q2 Q3 Q4 Global ASAM CPDD ISAM Conferences Orlando San Antonio New Delhi ALBATROS Lisbon Add Paris Lisbon European IOTOD ICDD Conferences Frankfurt Madrid FederSerd SIPaD National Milan Rome Conferences F Add Psych ATHS APSAD London Biarritz Hobart K f Suchtmed SSA Gef-med T Münich Newcastle Frankfurt 1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Frost et al, Addiction, 2019;114(8):1416-1426, 3Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 4Haasen, C, et al, J Subst Abuse Treat. 2017;78:22-29; 5Albayaty M, et al, Adv Ther. 2017 34(2):560-575 10 Additional trials to demonstrate utility and advantages of Buvidal® DEBUT – Depot Evaluation Buprenorphine UNLOC-T – Safety and feasibility of depot buprenorphine Utilization Trial in New South Wales custodial settings ‒ Randomized, open-label, active-controlled study of Buvidal vs ‒ Prospective, non-randomized, open-label, multicenter study in 129 standard of care in 120 adult outpatients with opioid dependence OUD patients treated with Buvidal or methadone in eight prisons. ‒ Study met both primary and secondary objectives ‒ Primary objective to test safety, tolerability, diversion and HEOR • Superior TSQM global satisfaction, p=0.0143 ‒ Secondary objectives to compare efficacy and QoL • Significantly higher TSQM effectiveness and convenience ‒ Positive preliminary results in Q4 2019; resulted in additional domain scores, p<0.0001 resource allocation and scale-up in NSW prisons DEBUT Buvidal® Weekly & UNLOC-T Buvidal® Buvidal® Buvidal® Monthly flexible dosing Weekly Monthly Monthly Screening R Follow-up Screening period E n=1201 BPN SoC n=1201 Methadone Extended safety flexible dosing monitoring Day -28 to -1 Day 1 Week 24 Week 26 Day 0 Day 1 Week 4 Week 16 Week 48 11 Fourth quarter pipeline update PHARMACEUTICALS PHASE 1-2 PHASE 3 REGISTRATION MARKET Buvidal® q1w OPIOID DEPENDENCE MARKET Buvidal® q4w OPIOID DEPENDENCE MARKET Brixadi® q1w OPIOID DEPENDENCE - BRAEBURN1 TENTATIVE APPROVAL Brixadi® q4w OPIOID DEPENDENCE - BRAEBURN1 TENTATIVE APPROVAL CAM2038 q1w CHRONIC PAIN1 PHASE 3 CAM2038 q4w CHRONIC PAIN1 PHASE 3 CAM2029 ACROMEGALY PHASE 3 CAM2029 NEUROENDOCRINE TUMORS PHASE 2 CAM2032 PROSTATE CANCER PHASE 2 CAM4072 GENETIC OBESITY DISORDERS - RHYTHM2 PHASE 2 CAM2043 PULMONARY ARTERIAL HYPERTENSION PHASE 1 CAM4071 ENDOCRINE DISORDER PHASE 1 CAM2047 CINV3 PHASE 1 CAM2048/58 POSTOPERATIVE PAIN & PONV4 - BRAEBURN1 PHASE 1 1. Braeburn holds the rights to North America; 2. Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal®; 3. Chemotherapy-induced nausea and vomiting; 4. Postoperative nausea and vomiting; 12 Significant unmet medical needs in chronic pain market Significant market size Limitations with current chronic pain medications • ~100 million Americans and ~1 million high-risk • Efficacy ~75 million Europeans with CLBP patients • Risks of tolerance, dependency 3 chronic pain1,2 (>99 MME*/day) and respiratory depression – 74 million patients with 61041 • Issues with diversion, misuse, chronic lower back pain (CLBP) abuse and pediatric exposure in 7 major markets in 20183 • Chronic pain estimated to 246848 Buprenorphine attractive but cost US society USD +600 653995 underutilized potential in pain billion per year4 • Effective analgesia with good safety profile and low dependency potential • Currently limited formulation options US EU5 Japan impacts usage Source: 1Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research (2011) https://www.nap.edu/read/13172/chapter/2; 2Pain Alliance Europe https://pae-eu.eu/activities- 2/petition-on-chronic-pain-in-europe; 3Chronic Lower Back Pain. Market Insights, Epidemiology, and Market Forecast-2028, Delveinsight, May 2019. 13 4Gaskin D, Richard P., J. Pain 2012; 13 (8): 715-724. MME: morphine milligram
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