Company Presentation. Pareto Securities Healthcare Conference 7 September 2017

Transcription

1 Company Presentation Pareto Securities Healthcare Conference 7 September 2017

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 2

3 Camurus in short Innovation that delivers Leading technology platform, FluidCrystal Late-stage product pipeline with 10 clinical programs Emerging European commercial organization Strong pharma partners Patient centric product development Long-acting medications for better treatment outcomes and quality of life for patients Focus on attractive, underserved specialty markets 10 CLINICAL STAGE PROGRAMS Entrepreneurial company Experienced management team 70 employees with 48 in R&D Headquarter in Lund, Sweden CASH 413 MILLION SEK END Q MARKET CAP ~4.5 BILLION SEK 3

4 Strong delivery of results over the past year CAM2038 OUD & CHRONIC PAIN NDA submission for CAM2038 for Opioid Use Disorder (OUD) Positive Phase 3 long-term safety results Positive Phase 3 efficacy results Positive Phase 2 opioid blockade results Positive Phase 2 results in opioid dependence and chonic pain Recruitment completed in pivotal Phase 3 chronic pain study OTHER PIPELINE PROGRAMS Positive Phase 2 study results for CAM2029 in acromegaly and NET Start of new Phase 1 study of CAM2047/58 for nausea and pain Positive Phase 1a study of weekly setmelenotide for genetic obesity with Rhythm Completion of stage 1 in building European commercial orgaization 4

5 Building value throughout the medical product life-cycle Cost effective and risk mitigated product development strategy - combining clinically documented APIs with leading and proven technologies Decreased time to market 505(b)(2), hybrid regulatory pathway Deeper market penetration Best-in-class treatment potential Expanding end of cycle sales Strong and extended IP protection 5

6 FluidCrystal injection depot for long-lasting treatment effects ~1500 SUBJECTS HAVE RECEIVED >15,000 INJECTIONS IN CLINICAL TRIALS +400 PATENTS & APPLICATIONS FluidCrystal key attributes Easy and convenient administration Rapid onset & long-acting release Good safety profile Applicable across substance classes Standard manufacturing processes 6

7 Plasma concentration (ng/ml) Plasma concentration (ng/ml) FluidCrystal injection depot for long-acting delivery FluidCrystal injection depot Immediate release octreotide (Sandostatin ) 1000 FC pasireotide FC octreotide 1000 subcutaneous octreotide FC somatostatin ,1 0,1 0, , Time (days) Time (days) Single dose injection at t=0; n=6 (SC); rodent; mean values 7

8 FluidCrystal product can offer enhanced design features over existing depot technologies Example: CAM2029 vs. Sandostatin LAR and Somatuline Autogel CAM , 20 mg ml/ready-to-use/subcutaneous no reconditioning/room temperature Based on FluidCrystal system No reconstitution Small volume Thin needle Sandostatin LAR 10, 20, 30 mg 2.0 ml/reconstitution/intramuscular refrigerated/30-60 min reconditioning Based on PLGA microsphere system Somatuline Autogel 60, 90, 120 mg ml/ready-to-use/subcutaneous refrigerated 30 min reconditioning Self-associated gel Note: 1) Illustrative. Final product configuration may be different. 8

9 Late-stage diversified pipeline 9

10 Value creation through strategic partnerships CAM2038, CAM2048, CAM2058 CAM2029, CAM other products CAM4072 Field Opioid dependence and pain Acromegaly, neuroendocrine tumors and other indications Genetic obesity Scope Exclusive license agreement for North America, with option to China, Japan, Korea, and Taiwan Exclusive, worldwide, collaboration and license agreement Exclusive license to FluidCrystal Injection depot for setmelanotide USD 22 million in upfront license fee received USD 50 million received in upfront, option exercise and development milestones USD 65 million in potential development and sales milestones Financials USD 130 million in total potential development and sales milestones USD 700 million in total potential development and sales milestones Mid to mid-high single digit % royalties on sales Mid teen % royalties on sales Mid to high single digit % royalties on sales New Hope in The Search for Treatment for Obesity, WSJ, August 26,

11 CAM2038 Weekly and monthly buprenorphine depots Changing the treatment paradigm in opioid dependence

12 Why focus on opioid dependence? Large market 2.7 billion USD in (US only) Growing at 23% CAGR Clear unmet need makes opportunities for differentiated new products Growing global public health crisis Largest society burden of all drugs 1 4 million diagnosed patients in the US and Europe, less than half in treatment 2,3 Escalating opioid overdose deaths in the US and Europe High unmet medical need Limited treatment adherence Risks of relapse and overdose Burden and stigma of daily medication Medication diversion and misuse Exposure to children and teenagers Supervision and related treatment costs Inadequate access to treatment >33,000 OPIOID OVERDOSE DEATHS IN THE US ~7000 OVERDOSE DEATHS IN EUROPE Concentrated, accessible target prescriber base ~8,000 US ~7,500 Europe Investment in treatment adds significant value Up to 12 dollars saved for each dollar spent on treatment 5 Source: 1. UNODC, World Drug Report 2015; 2. SAHMSA, National Survey on Drug Use and Health (NSDUH) 2014; 3. EMCDD, European Drug Report Trends and Developments 2017; 4. Hser et al. Harvard Review Psychiatry1 2015; 23: 76-89; 5. Center for Disease Control & Prevention 2016; 6. QuintilesIMS National Sales Perspectives (NSP) June

13 US sales $ billions Large and growing market 3,0 2,5 $0,3 US market dominated by branded products 2,0 1,5 $0,1 $0,1 $0,1 $0,1 $0,2 $0,1 $0,3 $134M in 2016 $1.6B in ,0 0,5 $0,0 $0,8 $1,5 $1,6 $1,7 $1,8 $2,0 $23M in ,0 $0,1 $0,1 $0,1 $0,1 $0,1 $0, buprenorphine buprenorphine/naloxone naloxone naltrexone $296M in 2016 Source: QuintilesIMS National Sales Perspectives (NSP) June

14 CAM2038 individualized treatment of opioid dependence from initiation and stabilization to maintenance treatment Weekly and monthly subcutaneous depots each provided in multiple small volume fixed dosages in prefilled syringes with a safety device, stored at room temperature New to treatment patients Weekly CAM2038 Inititation (induction) Weekly CAM2038 Stabilization Monthly or Weekly CAM2038 Maintenance treatment Patients in treatment Transmucosal buprenorphine 14

15 CAM2038 addresses key unmet medical needs Long-acting treatment effect Rapid and sustained withdrawal suppression Opioid blockade from first dose Adherence to treatment no daily supervision Improved treatment outcomes No diversion, misuse and pediatric exposure 15

16 CAM2038 Development milestones U.S FDA Pre-IND meeting: 13 March 2012 End of Phase II meeting: 24 February 2015 Fast Track Designation: 10 July 2015 Pre-NDA Meeting: 16 March 2017 NDA Submission: 19 July 2017 EMA, Europe CHMP Scientific Advice: 22 October 2015 Pre-MAA with EMA: 19 January 2017 MAA submission under validation TGA, Australia Pre-submission meeting: 17 July 2017 Comprehensive clinical program completed 944 participants across 7 clinical studies Four phase 1/2 studies of pharmacokinetics and pharmacodynamics after single and repeated dosing of CAM2038 Phase 2 opioid blocking study Phase 3 double-blind, doubledummy, active-controlled study Phase 3 long-term safety study 16

17 Comprehensive CAM2038 clinical program Pharmacokinetics Four clinical trials in healthy volunteers and opioid dependent patients Pharmacodynamics A double-blind, randomized within-patient, opioid challenge study in adults with moderate-to-severe opioid use disorder Phase 3 efficacy A 24-week, randomized, double-blind, double-dummy study assessing efficacy and safety of CAM2038 versus daily SL buprenorphine/naloxone Phase 3 long-term safety A 48-week, multinational, open-label study assessing long-term safety and efficacy of CAM

18 Steady-state population PK profiles from data for weekly and monthly CAM2038 versus daily SL BPN Weekly CAM2038 Daily SL BPN Monthly CAM2038 Weekly CAM2038 Population PK analysis and modelling based on data four clinical studies (N=236). Diagnostic testing demonstrated predictive BPN concentrations and good agreement between observed and predicted data percentiles 18

19 Total COWS Score Effective withdrawal suppression Rapid and sustained suppression of withdrawal from the first CAM2038 dose Weekly CAM2038 Injection 1 Weekly CAM2038 Injection 2 CAM mg CAM mg Clinical opiate withdrawal scale (COWS) scores from Phase 2 study (HS ), N=47 Withdrawal COWS Score <5 6 Mild 5-12 Moderate Moderate to Severe Severe >36 BL Treatment Days Source: Walsh S. et al, JAMA Psych

20 Peak Score (mm) Effective blockade of opioid effects Rapid and sustained blockade of opioid effects from the first CAM2038 dose Strong Liking Qualification (Days 1-3) (Days 4-6) (Days 1-3) (Days 4-6) At this moment, my liking for this drug is data from Phase 2 study (HS ), N= Weekly CAM2038 Injection 1 Weekly CAM2038 Injection 2 CAM2038 q1w 24 mg CAM2038 q1w 32 mg Neutral pt. difference Prespecified complete blocking criteria Strong Disliking Hydromorphone (mg, IM) Source: Walsh S. et al, JAMA Psych

21 First head-to-head pivotal efficacy study of a long-acting injection depot versus daily standard treatment with SL BPN/NX Phase 3 randomized, double-blind, double-dummy efficacy study (HS ), N=428 Screening Phase 1: Weekly Visits Phase 2: Monthly Visits Follow-Up 3 Weeks 12 Weeks 12 Weeks 1 Month SL BPN/NX 8-24 mg/day Weekly CAM2038 Placebo SL BPN/NX 8-32 mg/day Monthly CAM2038 Placebo Treatmentseeking adults with opioid use disorder R SL Placebo Weekly CAM mg/week SL Placebo Monthly CAM mg/month 21

22 CONFIDENTIAL Demographics and baseline characteristics representative of treatment seeking populations Study population with high proportion heroin, polydrug and injection use SL BPN/NX (n=215) CAM2038 (n=213) Age, years 38 (10.9)* 39 (11.2)* Male 142 (66%) 121 (57%) White 164 (76%) 159 (75%) Body mass index, kg/m 2 26 (5.6)* 26 (5.0)* Employed full time or part time 72 (34%) 76 (36%) History of any arrest 144 (67%) 130 (61%) Primary opioid of use Heroin 151 (70%) 152 (71%) Prescription opioids 64 (30%) 61 (29%) SL BPN/NX (n=215) CAM2038 (n=213) Injection opioid use 110 (51%) 114 (54%) Non-opioid drug use at screening Total non-opioid drug use 149 (69%) 155 (73%) Amphetamine 32 (15%) 38 (18%) Benzodiazepine 35 (16%) 30 (14%) Cocaine 53 (25%) 53 (25%) Marijuana 64 (30%) 57 (27%) Opioid craving; need to use VAS score (0 100) Clinical opiate withdrawal scale score (0-48) Subjective opiate withdrawal scale score (0-64) * Mean (SD) 76 (24.9)* 77 (25.4)* 12 (6.0)* 12 (5.4)* 31 (16.1)* 32 (15.4)* 22

23 CONFIDENTIAL Study met primary endpoints of non-inferiority for CAM2038 vs. daily SL BPN/NX EMA and FDA primary endpoints in Phase 3 (HS ) study, N=428 CAM2038 vs SL BPN/NX Treatment difference mean (95%CI) Non-inferiority (NI) Non-Inferiority P value EMA: Primary Efficacy Endpoint - Mean % Urine Samples Negative for Illicit Opioids NI margin 10% 6.7% (-0.1%, 13.3%) <0.001 FDA: Primary Efficacy Endpoint - Response Rate 3.4% (-3.5%, 10.4%) NI margin 11% < ,2-0,1 0 0,1 0,2 Favors SL BPN/NX Favors CAM2038 Difference (95% CI) 23

24 CONFIDENTIAL CAM2038 superior to BPN/NX for first secondary endpoint of CDF for percent of no illicit opioid use (FDA) CDF for urine samples + self reports negative for illicit opioids (weeks 4-24) Superiority for CAM2038 versus SL BPN/NX Grace period (weeks) Treatment weeks Superiority P-value CDF a b c CDF = Cumulative distribution function a Secondary endpoint for FDA; b Primary endpoint in RB-US ; c Including 2-week open label phase in RB-US Adjustment for multiplicity was made by a closed testing procedure to preserve family-wise type 1 error at CDF cumulative distribution function 24

25 Clinical data suggest that CAM2038 is safe and effective and may transform the treatment of opioid dependence Efficacy and safety demonstrated versus active control FDA and EMA primary endpoints met in pivotal Phase 3 study CAM2038 superior to daily sublingual buprenorphine for cumulative illicit opioid use (CDF) Craving and withdrawal symptoms effectively suppressed across the study treatment Consistent long-term safety profile and treatment effect Safety profile consistent with shorter term studies and daily sublingual buprenorphine products High treatment retention observed for both new to treatment and transferred patients Opioid blockade from the first administered dose Dose-proportional pharmacokinetics with both weekly and monthly durations Flexible and individualized treatment across all medication assisted treatment phases 25

26 Dissemination of CAM2038 data in publications and at scientific conferences Q1 Q2 Q3 Q4 Q1 Q2 Global Conferences CPDD Jun Montréal,Canada ISAM Oct Abu Dhabi, UAE AAAP 8-11 Dec Florida, USA ASAM Apr San Diego, USA AMERSA 3-5 Nov Washington DC European Conferences IOTOD May Berlin, Germany Lisbon Addictions Oct Lisbon, Portugal EUROPAD May Krakow, Poland National Conferences ALBATROS 31 May 2 Jun Paris, France ATHS Oct Biarritz, France SSA 9-10 Nov Newcastle, UK APSAD Nov Melbourne, Australia Publications Advances in Therapy Albayatny et al, 2017: 34(2), J. Subst. Abuse Treat. Haasen et al, 2017: 78, JAMA Psychiatry Walsh et al, 2017: Published online Publications in progress 26

27 CAM2038 for treatment of chronic pain: Recruitment completed in pivotal Phase 3 study Randomized, double-blind, enriched-enrollment withdrawal design (N est. =340) Screening Transition Open-label titration Double-Blind treatment Follow-Up 2 Weeks 2 Weeks Up to 10 Weeks 12 Weeks 4 weeks Moderate to severe lower back pain, patients on high daily dose of opioids (incl SL BPN) Down-titration of opioid dose and transitioned to IR morphine (only if not on SL BPN) CAM2038 q1w 8-32 mg/week Titrated to effect on a stable dose of CAM2038 R CAM2038 Placebo CAM2038 q1w 8-12 mg/day or CAM2038 q4w mg/day Primary and key secondary endpoints: Average and worst pain intensity as measured by 11-point numerical rating scale 27

28 Global commercialization strategy for CAM m 1.3m opioid problem users in Europe diagnosed opioid dependent in the US 1.3m registered heroin users in China 187k opioid dependent in Australia Braeburn markets Camurus markets Braeburn option right 28

29 Preparing for launch of CAM2038 in Europe UK 148,686 France 161,388 Nordic countries 16,535 Spain 61,954 Germany 77,500 Italy 75,964 Strong rationale for CAM2038 in Europe Specialist market 650,000 patients in treatment High unmet need Ongoing paradigm shift Sizeable health and socio-economic benefits can support pricing and reimbursement Accessible and concentrated prescriber base Planned EU launch during second half of 2018 Patients in opioid dependence treatment by country 29

30 Large interest in CAM2038 among European physicians Country Physicians willingness to prescribe CAM % patients*: q4w q1w N=51 86% 31% 30% N=50 94% 25% 36% N=50 86% 27% 43% N= 48 N=50 96% 22% 39% N= 47 Large markets with high willingness to prescribe weekly and monthly depots Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015 * % patients considered suitable for CAM2038 by surveyed physicians if available on the market 30

31 Building the marketing & sales organization in Europe 2016 EU commercial leadership team in place GMs in early reimbursed markets Pricing, market access, medical affairs 2017 Regional leadership teams early reimbursed markets GMs 2 nd wave markets 2018 Regional leadership teams 2 nd wave markets Full key account teams for CAM2038 launch Internationally experienced leadership team Market access, medical affairs, global commercial strategy, opioid dependence & pain Establishment in key European markets Headcount build up according to launch sequence Ongoing pre-launch activities HEOR, pricing and market access Strategic marketing Medical affairs Policy and education Country operating models 31

32 Anticipated near-term news flow PARTNERS PRODUCT EVENT TIME CAM2038 Opioid dependence MAA validation by EMA NDA acceptance for review by FDA NDA approval (if granted priority review) Q Q Q CAM2038 Chronic pain Phase 3 efficacy results Q CAM2029 Acromegaly & NET* Phase 3 initiation CAM2047 CINV Phase 1 results Q CAM2048 Pain CAM2058 Pain, nausea and vomiting Phase 1 results Phase 1 results Q CAM2043 PAH Phase 1 start Q Weekly setmelanotide Genetic obesity Phase 1 (Part B), results H

33 Camurus positioned for continued value creation De-risked, late stage, differentiated pipeline Multi-billion dollar specialty pharmaceutical markets Opioid addiction, pain, cancer, endocrine disease Strong collaborations with dedicated partners Novartis, Braeburn Pharmaceuticals, Rhythm, Solasia Early project collaborations with global pharma companies Emerging commercial organization Strong, experienced leadership in place Potential levers for future value creation NDA/MAA approvals of CAM2038 in the US/EU Phase 3 programs in pain, acromegaly and NET Advancement of early stage clinical programs Pipeline expansion and business development Anticipated CAM2038 launch in 2018 Braeburn launch US H Camurus launch Europe H Planned geographical expansion 2019 Solid financial position Potential for significant near-term regulatory milestones, and royalty from sales 33

34 Camurus AB, Ideon Science Park, SE Lund, Sweden camurus.com

35 Backup slides 35

36 Experienced and committed management team Fredrik Tiberg, PhD, Prof. President & CEO In Company since: 2002 Holdings: 1,512,551 shares & 130,000 subsc. warrants Education: M.Sc. in Chemical Engineering, PhD in Physical Chemistry, Lund University Previous experience: Professor in Physical Chemistry at Lund University, Institute for Surface Chemistry (Section head), Visiting Professor at Oxford University Fredrik Joabsson, PhD Vice President, Business Development In Company since: 2001 Holdings: 36,391 shares & 20,000 subscription warrants Torsten Malmström, PhD Vice President, Technical Operations In Company since: 2013 Holdings: 36,391 shares & 20,000 subscription warrants Eva Pinotti-Lindqvist Chief Financial Officer In Company since: 2014 Holdings: 36,391 shares & 25,882 subscript. warrants Education: Bachelor s of Science in Economics, Lund University Previous experience: EQL Pharma (CFO), Nordic Drugs (Nordic Market Analyst), Poolia (Finance Consultant) Markus Johnsson, PhD Vice President, Pharmaceutical & Analytical Dev. In Company since: 2003 Holdings: 45,363 shares & 20,000 subscription warrants Rein Piir Vice President, Investor Relations In Company since: 2015 Holdings: 5,275 shares Richard Jameson Chief Commercial Officer In Company since: 2016 Holdings: 16,395 shares & 80,000 subscript. warrants Education: Bachelor s of Science in Applied Biological Sciences from University West of England Previous experience: GM, UK and Nordics for Reckitt Benckiser Pharmaceuticals Ltd ( ) and Area Director Europe, Middle East and Africa for Indivior PLC ( ). Margareta Linden, PhD Vice President, Project Management In Company since: 2004 Holdings: 36,291 shares & 25,000 subscript. warrants Agneta Svedberg Vice President, Clinical & Regulatory Development In Company since: 2015 Holdings: 9,073 shares & 45,000 subscription warrants Urban Paulsson Vice President Corporate Dev.& General Counsel In Company since: 2017 Holdings: 6,500 shares & 75,000 subscript. warrants Education: Master of Law from Lund University Previous experience: More than 20 years experience from the life science industry including as legal counsel at Pharmacia and general counsel for Vitrolife. Partner at law firms Bird & Bird and Nordia Law. Cecilia Callmer Vice President, Human Resources In Company since: 2017 Holdings: 17,650 subscription warrants 36

37 Solid financial position with continued investments in late-stage development programs Revenues Key figures, msek Q2 H1 Q2 H1 FY 2016 Revenues Operating result Cash Licensbetalningar Milstolpesbetalningar Försäljning varor och tjänster Total assets Equity 488, Operating expenses 250,0 200,0 150,0 100,0 50,0 Forskning & utveckling Marknad & försäljning Administration 0,