Transforming treatments by long-acting medications
Fredrik Tiberg, President & CEO 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 Investment highlights
FluidCrystal® • In-house developed with strong IP protection • Validated in 20 clinical trials delivery technology • 1 marketed product and approval processes ongoing
Broad, late-stage • +10 clinical programs in opioid addiction, pain, cancer, obesity, endocrine and cardiovascular disease. R&D pipeline • Potential FDA/EMA/TGA product approvals in 2018
Emerging European • Leadership and key functions in place commercial • Fully operational for 2018 launch Listed on Nasdaq STO (ticker CAMX) organization Market Cap: ~500 MUSD Cash position: 45 MUSD (Q3, 2017) Strong pharma • Novartis, Braeburn Pharmaceuticals, Rhythm… Monthly OPEX: 3 MUSD (2017) • R&D investments, milestones and royalty on sales partnerships Employees: 70 HQ: Lund, Sweden
3 Long-acting medications address key healthcare challenges
4 FluidCrystal® injection depot – in situ gel formation
✓ Easy to administer ✓ Good safety profile ✓ Rapid onset & long-acting release ✓ Standard manufacturing processes ✓ Applicable across substance classes ✓ Unique mixtures of endogenous lipids
WATER INJECTION ABSORPTION DRUG RELEASE +400 PATENTS & APPLICATIONS
LIQUID DRUG PRODUCT ~1500 BEFORE INJECTION: SOLVENT DEPOT BIODEGRADATION SUBJECTS HAVE RECEIVED LIPIDS+SOLVENT+DRUG RELEASE LIQUID CRYSTAL GEL TO COMPLETE RESOLUTION >15,000 INJECTIONS IN CLINICAL TRIALS TIME 5 FluidCrystal® – Tunable long-acting release
FluidCrystal® injection depot Immediate release octreotide (Sandostatin®)
FC pasireotide subcutaneous octreotide 1000 FC octreotide 1000 FC somatostatin 1-14 100 100
10 10
1 1
0,1 0,1
Plasma concentration (ng/mL) concentration Plasma (ng/mL) concentration Plasma 0,01 0,01 0 5 10 15 20 25 30 0 7 14 21 28 Time (days) Time (days)
Single dose injection at t=0; n=6 (SC); rodent; mean values
6 Clinically documented compounds & Validated proprietary technology
7 Diversified late-stage R&D pipeline – FluidCrystal®
8 CAM2038
Weekly and monthly buprenorphine depots Changing the treatment paradigm in opioid dependence Global opioid addiction health crisis 2 Annual US opioid overdose deaths 30 (thousands) 25 • Escalating human crisis 20 • Largest society burden of all drugs1 15 10
• Patients need better access to care and 5
new treatment choices 0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 • Investment in treatment brings 1999 significant value COST OF US OPIOID CRISIS: $500 bn WHITE HOUSE COUNCIL OF ECONOMIC ADVISERS3
Source: 1. UNODC, World Drug Report 2015; 2. Center for Disease Control & Prevention 2016; 3. White House Council of Economic Advisers Analysis 2017. 10 Long-acting treatment of opioid dependence – from Day 1 to maintenance therapy1
1 Individualized treatment 2 Weekly and monthly dosing options 3 Rapid onset and sustained treatment effect from Day 1 4 Enhanced adherence to treatment 5 Safeguards against diversion and misuse
6 Efficacy supported by robust clinical data versus daily standard treatment
Source: 1 CAM2038 is an investigational treatment under review by US, European and Australian regulatory authorities for treatment of opioid use disorder / dependence. 11 CAM2038 demonstrated efficacy and safety vs standard of care
Superiority in % cumulative • CAM2038 met FDA and EMA primary and key opioid abstinence, p=0.004 secondary efficacy endpoints in a pivotal 24-week Phase 3 study 100 Percent urine ‒ Demonstrating non-inferiority and superiority versus samples confirmed by daily standard treatment 80 self-reports negative for illicit opioid use • Sustained suppression of withdrawal and weeks 4-24. cravings 60 100% • Opioid blockade from first dose 40 75%-<100% 50%-<75% • Safety profile comparable to SL buprenorphine 25%-<50% 20 with no unexpected safety findings 1%-<25% 0% ‒ Confirmed in a 48-week Phase 3 safety study 0 CAM2038 SL BUP/NX
12 High acceptability 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 CAM2038 ongoing global approval processes
✓ Recommendation of approval from FDA Advisory Committee ✓ EMA & TGA ✓ NDA submission ✓ TGA acceptance for evaluation MAA approval to FDA of Australian MAA decisions
May 2017 July 2017 Sept 2017 Nov 2017 Jan 2018 Q3/Q4 2018
✓ Positive phase 3 ✓ Priority review ✓ PDUFA date set to long-term safety granted by FDA 19 January 2018 data ✓ MAA validation by EMA
Supported by comprehensive clinical program ✓ 944 participants across 7 clinical studies ✓ Phase 2 opioid blocking study ✓ Four phase 1/2 studies of pharmacokinetics and ✓ Phase 3 double-blind, double-dummy, pharmacodynamics after single and repeated active-controlled study dosing of CAM2038 ✓ Phase 3 long-term safety study
14 Limited competition on long-acting injectable (LAI) opioid dependence market
Long-acting buprenorphine injectables
PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL (US) APPROVAL (EU/Aus)
PDUFA Estimated Braeburn/Camurus CAM2038 Weekly & Monthly Jan. 19, 2018 Q3/Q4 2018
® APPROVED Indivior Sublocade Monthly Nov. 30, 2017
BDSI BPN Depot1
Heron HTX-0032
Long-acting naltrexone injectables
3 APPROVED Alkermes Vivitrol $275M expected 2017 sales 2010
1. Data of first single-ascending dose cohort from Phase I study expected to be released in Q4 2017; 2. No progress updates since 2015. 3. Alkermes Q3 2017 report 15 Global commercialization strategy for CAM2038
ESTIMATED 1.3 million 15 million opioid problem users in Europe1 OPIOID DEPENDENT 2.5 million 1.4 million INDIVIDUALS GLOBALLY1 diagnosed opioid registered heroin users 2 dependent in the US in China4
187,000 opioid dependent in Australia3
Braeburn markets Camurus markets Braeburn option right
Source. 1. Data for 2010 by Degenhardt et al., Addiction, 2014; 109, 1306–1317. 2. EMCDD, European Drug Report 2015 2. SAHMSA, National Survey on Drug Use and Health (NSDUH) – 2014 3. MedicineToday 2015; 16(6 Suppl):10-15 4. Beijing Review, War on drugs, No.28,July 9,2015 16 Prescription volume growth indicate high market potential for long-acting buprenorphine in the US
Total TRx Volume 12 Months ending June1
15 000 13 156 12 035 11 149 25% LAI SHARE 10 327 10 000 9 309 ~$15002 PER MONTH 8 040 CORRESPONDS TO
5 000 Volume (000s) Volume
TRx $3-4 BN
0 2012 Q2 2013 Q2 2014 Q2 2015 Q2 2016 Q2 2017 Q2 MARKET POTENTIAL
buprenorphine/naloxone buprenorphine HCL & generics (Suboxone, Bunavail, Zubsolv & oral generics)
naltrexone (Vivitrol)
Source: 1. Symphony Health, PHAST Integrated Monthly; 2. Based on monthly Sublocade™ price ($1580), Indivior plc; LAI – long acting injectables 17 Significant market potential for CAM2038 in Europe
High physicians’ willingness to prescribe CAM2038 in EU41
86% 94% 96% 86%
n=51 n=50 n=50 n=50 Physicians’ willingness to prescribe CAM2038 q4w q4w q1w q1w 31% q4w q4w 43% Anticipated share of patients 30% 36% q1w 39% q1w 27% 25% 22% on CAM2038 q4w Anticipated share of patients on CAM2038 q1w
Germany UK Italy France 77,500 patients 148,686 patients 75,964 patients 161,388 patients
Market potential for CAM2038 in Europe and Australia estimated to €180m – €250m
Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015 * % patients considered suitable for CAM2038 by surveyed physicians if available on the market. 18 Additional attractive product candidates
PARTNER PRODUCT PRE-CLINICAL PHASE1-2 PHASE 3
CAM2038 q1w / q4w CHRONIC PAIN PHASE 3
CAM2029 ACROMEGALY PHASE 1-2
CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2
CAM2032 PROSTATE CANCER PHASE 1-2
CAM2047 CHEMOTHERAPY INDUCED NAUSEA & PAIN PHASE 1-2
CAM2048/2058 POSTOPERATIVE PAIN & POSTOPERATIVE NAUSEA & PAIN PHASE 1-2
CAM4072 GENETIC OBESITY PHASE 1-2 PHASE 1-2
CAM2043 PULMONARY ARTERIAL HYPERTENSION
Undisclosed internal project candidates
Early stage collaborations with pharma and biotech partners
19 Pipeline products overview – CAM2038 chronic pain
CAM2038 CHRONIC PAIN FORMULATION Weekly and monthly buprenorphine treatment depot based on FluidCrystal® KEY FEATURES • Round the clock pain relief • Rapid and sustained blockade of euphorigenic and sedative opioid effects 1 IN 5 INDIVIDUALS SUFFERING 1 • Flexible and individualized dosing FROM CHRONIC PAIN • HCP administration safeguards against misuse and diversion CHRONIC PAIN ESTIMATED MARKET SIZE Global opioid pain market ~$6 bn1 DEVELOPMENT • Three phase 1/2 trials completed STATUS • Phase 3 efficacy and safety extension study ongoing; ~$560-635bn top-line efficacy results expected Q1 2018 ANNUAL COST TO SOCIETY2 PARTNER Braeburn Pharmaceuticals (North America)
Sources. 1. Current Medical Research & Opinion Vol. 26, No. 5, 2010, 1231–1245; Disease Landscape and Forecast Chronic Pain, Decision Resources 2015; 2. Journal of Pain 2012, 13:715-724. 20 Pipeline products overview – CAM2029
ACROMEGALY & NEUROENDOCRINE TUMORS SOMATOSTATIN ANALOGUE SALES CAM2029 m
FORMULATION Subcutaneous octreotide depot based on FluidCrystal® omatuline sen an ostatin Novartis
KEY • Improved patient convenience
ADVANTAGES • Increased bioavaiability • potential for enhanced treatment efficacy in currently underexposed patients MARKET SIZE Somatostatin analogue market >$2 bn1
DEVELOPMENT • Four phase 1/2 trials successfully completed
STATUS • Novartis currently evaluating new study designs
recently suggested by health authorities
• Ongoing preparations for Phase 3 including additional manufacturing and packaging activities Significant potential in converting PARTNER Novartis (exclusive worldwide license) Sandostatin® LAR ® patients to CAM2029
Sources. 1. GlobalData 2017. 21 New clinical product candidates
CAM4072 GENETIC OBESITY DISORDERS CAM2043 PULMONARY ARTERIAL HYPERTENSION FORMULATION Subcutaneous FC setmelanotide depot FORMULATION Subcutaneous FC treprostinil depot
KEY • Weekly dosing KEY • Weekly dosing ADVANTAGES • Ready-to-use prefilled syringe ADVANTAGES • High patient convenience • Improved patient convenience • No need for extracorporal pumps • Reduced risk of treatment limiting MARKET SIZE Not communicated infusion site pain and local reactions • Low risk of infections and sepsis DEVELOPMENT • Phase 1 study completed, positive STATUS initial data communicated MARKET SIZE PAH market >$5 bn, tresprostinil ~1.2 bn2 • Submission earliest 20191 KEY RESULTS Positive initial phase 1 results met DEVELOPMENT • Phase 1 start Q4 2017 Rhythm’s PK an tolerability criteria. STATUS
PARTNER Rhythm (exclusive worldwide license) KEY RESULTS Preclinical data confirmed target profile
Sources. 1. Form S-1 Rhythm Pharmaceuticals 2017 2. PharmaCircle 2017. 22 Camurus positioned for continued value creation
• De-risked, late stage, differentiated • Potential levers for future value creation pipeline ‒ NDA/MAA approvals of CAM2038 in the US/EU ‒ Multibillion dollar specialty markets ‒ Phase 3 programs in pain, acromegaly and NET ‒ Opioid addiction, pain, cancer, endocrine ‒ Advancement of early stage clinical programs disease ‒ Pipeline expansion and business development • Strong collaborations with dedicated • Anticipated CAM2038 launch in 2018 partners ‒ Braeburn launch US H1 2018 ‒ Novartis, Braeburn Pharmaceuticals, Rhythm, Solasia ‒ Camurus launch Europe Q4 2018 ‒ Early project collaborations with global ‒ Geographical expansion in 2018/19 pharma companies • Solid financial position • Emerging commercial organization ‒ Potential for significant near-term regulatory ‒ Strong, internationally experienced milestone payments, and royalty from sales leadership
23 Thank you!
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] camurus.com Experienced and committed management team
Fredrik Tiberg, PhD, Prof. Education: M.Sc. in Chemical Engineering, PhD in Fredrik Joabsson, PhD Torsten Malmström, PhD President & CEO Physical Chemistry, Lund University Vice President, Business Vice President, Technical Development Operations Previous experience: Professor in Physical In Company since: 2002 Chemistry at Lund University, Institute for Surface In Company since: 2001 In Company since: 2013 Holdings: 1,512,551 shares Chemistry (Section head), Visiting Professor at Holdings: 36,391 shares & Holdings: 36,391 shares & & 130,000 subsc. warrants Oxford University 20,000 subscription warrants 20,000 subscription warrants
Eva Pinotti-Lindqvist Education: Bachelor’s of cience in Economics, Markus Johnsson, PhD Rein Piir Chief Financial Officer Lund University Vice President, Pharma- Vice President, Investor ceutical & Analytical Dev. Relations Previous experience: EQL Pharma (CFO), Nordic In Company since: 2014 Drugs (Nordic Market Analyst), Poolia (Finance In Company since: 2003 In Company since: 2015 Holdings: 36,391 shares & Consultant) Holdings: 45,363 shares & Holdings: 5,275 shares 25,882 subscript. warrants 20,000 subscription warrants
Richard Jameson Education: Bachelor’s of cience in Applied Margareta Linden, PhD Agneta Svedberg Chief Commercial Officer Biological Sciences from University West of England Vice President, Project Vice President, Clinical & Management Regulatory Development Previous experience: GM, UK and Nordics for In Company since: 2016 Reckitt Benckiser Pharmaceuticals Ltd (2010 – In Company since: 2004 In Company since: 2015 Holdings: 16,395 shares & 2013) and Area Director Europe, Middle East and Holdings: 36,291 shares & Holdings: 9,073 shares & 80,000 subscript. warrants Africa for Indivior PLC (2013 – 2016). 25,000 subscript. warrants 45,000 subscription warrants
Urban Paulsson Education: Master of Law from Lund University Cecilia Callmer Vice President Corporate Vice President, Human Dev.& General Counsel Previous experience: More than 20 years Resources experience from the life science industry including as In Company since: 2017 legal counsel at Pharmacia and general counsel for In Company since: 2017 Holdings: 6,500 shares & Vitrolife. Partner at law firms Bird & Bird and Holdings: 17,650 subscription 75,000 subscript. warrants Nordia Law. warrants
25 Major shareholders 31 October 2017
10 LARGEST STAKEHOLDERS SHARES (%)
SANDBERG DEVELOPMENT AB 20 014 978 53,7%
GLADIATOR 1 755 258 4,7%
SWEDBANK ROBUR FONDER 1 546 198 4,2%
TIBERG, FREDRIK 1 512 551 4,1%
CATELLA FONDFÖRVALTNING 1 106 044 3,0%
SEB S.A. CLIENT ASSETS UCITS. 995 783 2,7%
BACKAHILL UTVECKLING AB 877 193 2,4%
FJÄRDE AP FONDEN 797 731 2,1%
ENTER FONDER 623 365 1,7%
GRENSPECIALISTEN FORVALTNING AB 581 536 1,6%
TOTAL 37 281 486 100%
26 Value adding partnerships
CAM2038, CAM2048, CAM2058 CAM2029, CAM4071 + other products CAM4072
Acromegaly, neuroendocrine Field Opioid use disorder (OUD) and pain Genetic obesity tumors and other indications
• Exclusive license agreement for • Exclusive, worldwide, collaboration and • Exclusive license to FluidCrystal® Scope North America; option to China, license agreement Injection depot for setmelanotide Japan, Korea, and Taiwan
• MUSD 20 received in upfront license fee • MUSD 50 received in upfront, option • MUSD 65 in development and • Development milestones, include; exercise and development milestones sales milestones ○ MUSD 35 OUD • MUSD 700 in total potential development • Mid to mid-high single digit % Financials ○ MUSD 21 pain and sales milestones royalties on sales • Mid teen % royalties on sales • Mid to high single digit % royalties on sales “New Hope in The Search for Treatment + MUSD 75 in potential sales for Obesity”, WSJ, August 26, 2016” milestones
27 Recruitment completed in pivotal Phase 3 chronic pain study and safety extension studies of CAM2038. Topline data expected early 2018
Double-blind, enriched-enrollment study in opioid experienced low back pain patients on morphine equivalent doses of 40 mg/day or higher (Nest.=340)
Screening Transition Open-label titration Double-Blind treatment Follow-Up 2 Weeks 2 Weeks Up to 10 Weeks 12 Weeks 4 weeks
CAM2038 q1w 8-32 mg/week CAM2038 Placebo Titrated to effect Moderate to Down-titration on a stable dose of severe lower of opioid CAM2038 back pain, dose and patients on transitioned high daily to IR morphine R dose of opioids (only if not (incl SL BPN) on SL BPN)
CAM2038 q1w 8 -12 mg/day or CAM2038 q4w 64-128 mg/day
Primary and key secondary endpoints: Average and worst pain intensity as measured by 11-point numerical rating scale 28 Dissemination of CAM2038 data in publications and at scientific conferences
2017 2018 Q1 Q2 Q3 Q4 Q1 Q2
ISAM CPDD ISAM AAAP ASAM Global 26-29 Oct 17-22 Jun 26-29 Oct 8-11 Dec 12-15 Apr Abu Dhabi, UAE Conferences Montréal,Canada Abu Dhabi, UAE San Diego, USA San Diego, USA
AMERSA 3-5 Nov Washington DC
European IOTOD Lisbon Addictions EUROPAD Conferences 17-18 May 24-26 Oct 25-27 May Berlin, Germany Lisbon, Portugal Krakow, Poland
National ATHS SSA APSAD Conferences 17-20 Oct 9-10 Nov 12 -15 Nov Biarritz, France Newcastle, UK Melbourne, Australia
Publications Advances in Therapy J. Subst. Abuse Treat. JAMA Psychiatry Albayatny et al, Haasen et al, Walsh et al, Phase 3 publications in progress 2017: 34(2), 560-575 2017: 78, 22-29 2017: Published online
29 Strong rationale for CAM2038 in Europe Nordic and Australia countries 16,535
UK 148,686 • Specialist market with a concentrated prescriber base Germany 77,500 • High unmet medical needs France 161,388 Italy • No significant innovation for more than a decade 75,964 • Paradigm shift in opioid dependence treatment • Pricing and reimbursement supported by sizeable Spain health and socio-economic benefits 61,954 Australia 50,000
Internationally experienced leadership team Ongoing pre-launch activities • Market access, medical affairs, global commercial • HEOR, pricing and market access strategy, opioid dependence & pain • Strategic marketing Establishment in key European markets & Australia • Medical affairs Headcount build-up following to launch sequence • Policy and education • Country operating models 30