Stockholm Corporate Finance Life Science seminar
Camurus Advancing late stage pipeline with high market potential
Company Presentation, March 22, 2017 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
Camurus' Company Presentation 2 LISTED ON Camurus in short NASDAQ STOCKHOLM 3rd DEC, 2015 • Innovation that delivers − Award-winning FluidCrystal® technology − Late-stage, diversified pipeline with 10 clinical programs − Strong, strategic partners − Emerging European commercial organization
• Patient centric product development MARKET CAP − Long-acting medications for better treatment outcomes and quality of life for patients ~440 − Focus on attractive, underserved specialty million USD markets
• Entrepreneurial company culture − Experienced management team CASH POSITION − 64 employees with 45 in R&D 55 − Headquarter in Lund, Sweden million USD END 2016 Camurus' Company Presentation 3 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 Deeper market penetration Expanding end of cycle sales 505(b)(2), hybrid regulatory pathway Best-in-class treatment potential Strong and extended IP protection Value Value Value created created created
0 Time 0 Time 0 Time
Value Value Value Spent Spent Spent
Camurus' Company Presentation 4 Late-stage, diversified clinical pipeline
PARTNERS PRODUCT PRECLINICAL PHASE 1/2 PHASE 3 REGISTRATION
CAM2038 Weekly Opioid dependence
CAM2038 Monthly Opioid dependence
CAM2038 Weekly Chronic pain
CAM2038 Monhly Chronic pain
CAM2029 Neuroendocrine tumours
CAM2029 Acromegaly
CAM2032 Prostate cancer
CAM4071 Not disclosed
CAM2047 CINV*
CAM2048 Pain
CAM2058 Pain, nausea and vomiting
*CINV Chemotherapy nausea and vomiting
Camurus' Company Presentation 5 Leading development in advanced delivery technologies +400 FluidCrystal® injection depot PATENTS & APPLICATIONS FluidCrystal® nanostructures 17 lipid 1 CLINICAL TRIALS WITH FC TECHNOLOGY L 2 FluidCrystal® topical bioadhesive
I2 1 COMMERCIAL PRODUCT
H2
Lα water lipid 2 FluidCrystal® nanoparticles
Camurus' Company Presentation 6 FluidCrystal® injection depot for longer lasting treatment effects
~1500 SUBJECTS HAVE EASY AND CONVENIENT ADMINISTRATION RECEIVED >10,000 INJECTIONS IN CLINICAL TRIALS RAPID ONSET & LONG-ACTING RELEASE
GOOD SAFETY PROFILE
APPLICABLE ACROSS SUBSTANCE CLASSES
STANDARD MANUFACTURING PROCESSES
Camurus' Company Presentation 7 FluidCrystal® – Adaptable long-acting release
Weekly and monthly buprenorphine injections versus daily medication
100
10
1 Plasma Plasma BPN concentration (ng/mL) 0 0 7 14 21 28 Time (days)
FluidCrystal® weekly depot (single dose to steady state) FluidCrystal® monthly depot (single dose, simulated data) FluidCrystal® monthly depot (steady state) Daily sublingual tablets (single dose to steady state)
Camurus' Company Presentation 8 Value creating through strong partnerships
CAM2038, CAM2048, CAM2058 CAM2029, CAM4071 + other products CAM4072
Acromegaly, neuroendocrine Opioid dependence and pain Genetic obesity Field tumours and other indications
• Exclusive license agreement for • Exclusive, worldwide, collaboration • Exclusive license to FluidCrystal® North America, with option to China, and license agreement Injection depot for setmelanotide Scope Japan, Korea, and Taiwan • USD 20 million in upfront license fee • USD 50 million received in upfront, • USD 65 million in potential received option exercise and development development • + USD 130 million in total potential milestones and sales milestones development and sales milestones • USD 700 million in total potential • Mid to mid-high single digit % • Mid teen % royalties on sales development and sales milestones royalties on sales Financials • Mid to high single digit % royalties on “New Hope in The Search for Treatment for sales Obesity”, WSJ, August 26, 2016”
9 Compelling R&D results delivered in 2016
PRODUCT EVENT TIME
CAM2038 Opioid dependence • Positive Phase 3 efficacy results November
• Positive Phase 2 results from opioid challenge study May
• Phase 3 long-term safety study fully enrolled April
CAM2038 Chronic pain • First patient enrolled in Phase 3 efficacy trial September
• Completed enrollment in pivotal Phase 2 chronic pain trial April
CAM2029 Acromegaly & NET* • Positive results from Phase 2 trial in acromegaly and NET July
CAM2032 Prostate cancer • Positive results from Phase 2 trial in prostate cancer June
CAM4071 Not disclosed indication • Phase 1 clinical trial completed June
CAM2047 CINV** • Phase 1 trial started October CAM2048 Pain CAM2058 Pain & nausea and vomiting
*NET: Neuroendocrine tumours **CINV: Chemotherapy induced nausea and vomiting
Camurus' Company Presentation 10 CAM2038: Weekly and monthly buprenorphine depots Changing the treatment paradigm in opioid dependence
11 Opioid dependence – a growing global health problem
33,1 • 33 million people misuse opioids globally US overdose epidemic4 Thousands 28,6 1 Largest society burden of all drugs 24,5 21,3 21,9 19,7 About 4 million diagnosed patients in Europe and the US, 18,9 17,8 2,3 16,8 less than half in treatment (Europe and US ) 15,8 12,9 11,7 10,6 9,5 • Ongoing opioid crisis 7,3 6,0 6,2 33,091 US opioid overdose deaths in 2015, 12,990 from heroin (+23%).
Growing concerns in Europe with at least 6,800 overdose 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 deaths in 20144 5 1000 Overdose deaths in Sweden 900 • A chronic relapsing disease Annual deaths with illicit drugs or opioid pharmaceutics 800 present during forensic examination 700 Opioid-use trajectories show that the disease is chronic with 600 500 less than 30% abstinence achieved over time 400 300 6 Opioid dependence mortality continues to increase over time 200 100 0
Heroin Non-heroin opioids Other drugs
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 2015; 4. Center for Disease Control & Prevention 2016; 5. Toxreg 2016; 6. Hser et al. Harvard Review Psychiatry1 2015; 23: 76-89
Camurus' Company Presentation 12 Large and growing market with high unmet needs
Current standard treatment Important unmet medical needs
• Daily medication with sublingual • Limited medication adherence buprenorphine or methadone ‒ Patients forget or choose not to take daily medications ‒ Increased risk of relapse / overdose • On the World Health Organization’s Essential Medicines List • Suboptimal quality of life • Current oral buprenorphine market ‒ Stigma of daily medication exceeds USD 2 billion ‒ Daily reminders of disease and addiction ‒ Fear of accidental pediatric exposure • Public health impact ‒ Opportunities for diversion, misuse and abuse ‒ Huge healthcare and societal costs
13 Flexible and individualized opioid dependence treatment – across all treatment phases
Weekly and monthly CAM2038 administered as small dose volume subcutaneous (SC) injections by a prefilled syringe with a thin 23G needle
Monthly Weekly Initiation Weekly Maintenance or Weekly CAM2038 CAM2038 Stabilization - induction CAM2038 treatment
14 CAM2038 – gamechanger in opioid dependence treatment
Addresses key unmet medical needs and improves treatment outcomes
Long-acting release and continuous treatment effect
Sustained suppression of withdrawal and blockade of opioid effects
Safeguards against diversion, misuse and accidental pediatric exposure
Reduced number of doses/decisions from 365 to 12 times per year
No daily supervised dosing and related stigma
Improved treatment adherence – dose given is dose taken
15 Robust clinical program for CAM2038 in opioid dependence
Trial no. No. subjects Key results / Study design Status 7 Extended release of BPN suited for once CLINICAL TRIALS 60 healthy volunteers weekly dosing. Dose proportional exposure. 6-8 HS-11-426 Phase 1 COMPLETED under naltrexone block times higher bioavailability versus SL BPN AND UNDER tablets. COMPLETION
Good safety Extended release suited for weekly respective 87 healthy volunteers monthly dosing. 6-8 times higher bioavailability. HS-13-487 Phase 1 and local under naltrexone block tolerability for Acceptability of CAM2038 dosing higher than CAM2038, SL tablets. weekly and Dose proportional extended release further +900 monthly supported by pharmacodynamics results for STUDY HS-07-307 Phase 2 41 patients formulations withdrawal symptoms over time and time to PARTICIPANTS rescue medication. DOSED WITH CAM2038 OR Randomized, placebo controlled opioid PLACEBO HS-14-478 Phase 2 47 patients challenge study of CAM2038 in opioid dependent patients (US).
HS-14-549 Phase 2 Repeat dose pharmacokinetic study of CAM2038 in opioid dependent pain patients (US), Under completion including injections in different subcutaneous injection sites.
Double blind, double dummy Phase 3 efficacy trial of CAM2038 versus sublingual HS-11-421 Phase 3 Positive results buprenorphine (US). N=428 Open label Phase 3 long-term safety trial in patients with opioid dependence (EU, US, HS-14-499 Phase 3 Under completion AUS). N=228
16 CAM2038 delivers rapid and sustained suppression of withdrawal symptoms
Clinical opiate withdrawal scale (COWS) scores from Pivotal Phase 2 study
44 CAM2038 24 mg COWS Withdrawal CAM2038 32 mg Score 12 Weekly CAM2038 Weekly CAM2038 – <5 Injection 1 Injection 2 Mild 5-12 9 Moderate 13-24 Moderate to 25-36 Severe 6 Severe >36 Total COWS COWS Score Total
3
0 BL 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Treatment Days
Camurus' Company Presentation 17 CAM2038 secures blockade of opioid effects
“At this moment, my liking for this drug is” data from Pivotal Phase 2 study
Qualification (Days 1-3) (Days 4-6) (Days 1-3) (Days 4-6) Strong Liking 100
90 CAM2038 q1w 24 mg CAM2038 q1w 32 mg 80 Weekly CAM2038 Weekly CAM2038 Injection 1 Injection 2 70
60 11 pt. difference Prespecified complete blocking Peak Score (mm) Score Peak Neutral 50 criteria
40
Strong Disliking 0 0 6 18 0 6 18 0 6 18 0 6 18 0 6 18 Hydromorphone (mg, IM)
Presentation, S27, ISAM & CSAM-SMCA 2016 Montreal, Canada Oct 20-22, 2016, Sharon L Walsh, Sandra Comer, Michelle Lofwall, Bradley Vince, Debra Kersh, Marion A Coe, Jermaine D Jones, Fredrik Tiberg, Behshad Sheldon, Sonnie Kim. http://www.csam-smca.org/resources-and-documents/past-annual-meeting-presentations/2016-abstracts/
Camurus' Company Presentation 18 Phase 3 study met both FDA and EMA primary endpoints of non-inferiority versus SL BPN/NX – “Standard of Care”(ITT)
Non-Inferiority CAM2038 vs SL BPN/NX 95%CI Non-inferiority (NI) p-value NI margin EMA: 11% Primary Efficacy Endpoint (-0.1%, 13.3%) <0.001 - Mean % Urine Samples Negative for Illicit Opioids
NI margin 10% FDA: Primary Efficacy Endpoint (-3.5%, 10.4%) <0.001 - Response Rate
-0,2 -0,1 0 0,1 0,2
Favors SL BPN/NX Favors CAM2038
Difference (95% CI)
19 Statistical superiority met for CAM2038 versus SL/BPN/NX for key secondary endpoint of CDF for negative urines throughout the study (ITT)
Grace Period Treatment Sampling Superiority Superiority Weeks Weeks Weeks p-value (FDA) p-value (EMA) 0 1-24 2-25 0.006 0.011 1 2-24 3-25 0.005 0.010 3a 4-24 5-25 0.004 0.008 4b 5-24 6-25 0.001 0.003 6c 7-24 8-25 0.001 0.002
a Secondary endpoint for FDA and EMA; b Primary endpoint in RB-US-13-0001; c Including 2-week open label phase in RB-US-13-0001. CDF – cumulative distribution function
20 CAM2038 demonstrated significantly better efficacy versus daily sublingual buprenorphine/naloxone
CAM2038 versus “Standard of Care”
Met both primary and secondary endpoints Efficacy across treatment phases From initiation to maintenance treatment CAM2038 safety profile comparable to daily sublingual buprenorphine/naloxone Fewer SAEs (3.2% versus 6%) No drug overdoses versus 4 overdoses Good local tolerability; no severe AEs Phase 3 results to be presented at CPDD in Montreal, June 19-22, 2017 Data support MAA and NDA submissions to FDA and EMA in mid-2017 Fast Track designation by FDA
Camurus' Company Presentation 21 Global strategy for CAM2038 with build-up of own European commercial organization for opioid use disorder
Rationale Estimated 32 million opioid users globally
Specialist market in EU ~700 000 patients in treatment
CAM2038 addresses high unmet 1.3m opioid problem users need 2.5m 1.3m Sizeable socio-economic diagnosed opioid registered heroin users benefits dependent
On-going paradigm shift
Accessible and concentrated 187k opioid dependent market
Cost efficient roll-out and creation of significant value Braeburn markets Camurus markets Braeburn option right
Transformative new treatment can support pricing strategy and reimbursement on European markets
22 Significant interest in CAM2038 among European physicians
Country Physicians willingness to prescribe CAM20381 % patients*: q4w q1w
31% N=51 86% 30%
36% N=50 94% 25%
43% N= 48 N=50 86% 27%
39% N=50 96% 22% 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 prescribers thought would be prescribed CAM2038 of those currently prescribed medication
23 Building the commercial organization in Europe
2016 2017 2018 • EU commercial leadership • Regional leadership • Regional leadership team in place teams early reimbursed teams 2nd wave markets • GMs in early reimbursed markets • Full key account teams markets • GMs 2nd wave markets for CAM2038 launch • Pricing, market access, medical affairs
Internationally experienced leadership team Pre-launch activities
Specialist pharma leadership HEOR, pricing and market access Market access Strategic marketing Medical affairs Medical affairs Global strategy Policy and education Opioid use disorder & pain Country operating models Stepwise build – right time, right place principles
24 Chronic pain – new potential indication for CAM2038
• About 20% of the population suffer from chronic Painful diabetic neuropathy Fibromyalgia non-cancer pain1 Chronic daily headache • Major chronic pain segments in 20142: ‒ More than 70 million people in the US and Europe an Cancer pain suffer from Postherpetic chronic low back pain Osteoarthritic neralgia • Chronic pain has a detrimental impact on QoL3 pain ‒ For 2/3 the pain inflicting on sleep ‒ 50% report difficulties with household tasks • Global opioid analgesics market worth $22 billion in 2014, anticipated to reach 28 billion in 20212 Rheumatoid Chronic low Arthritic Pain back pain
Chronic Migraine
Sources. 1. Pain Practice 2014, 14, 79–94 2. Disease Landscape and Forecast Chronic Pain, Decision Resources 2015 3. Persistence Market Research 2016 Ongoing phase 3 study in chronic low back pain patients. Randomized, double-blind, placebo-controlled, enriched-enrollment withdrawal design (Nest.=340)
Screening Transition Open-label titration Double-Blind treatment Follow-Up 2 Weeks 2 Weeks Upto 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 on dose and high daily transitioned dose of opioids to IR morphine R (incl SL BPN) (only if not on SL BPN)
CAM2038 q1w 8 -12 mg/day or CAM2038 q4w 64-128 mg/day
Primary and key secondary endpoints: Worst and average pain intensity as measured by 11-point numerical rating scale
Camurus Capital Markets and R&D Day, December 14, 2016 26 CAM2029: Next generation subcutaneous octreotide depot for treatment of NET and acromegaly
27 CAM2029 for treatment of acromegaly and neuroendocrine tumors
Overview of acromegaly and NET Strong market growth over 15 years1
• Acromegaly is a rare, chronic and insidious (USDm) CAGR 2004-2014: hormonal disorder 2 069 Somatuline® : 16% 2 032 1 917 ‒ Occurs when the pituitary gland produces excess ® Sandostatin : 7% 1 802 growth hormone (GH) and insulin-like growth factor-1 1 705 (IGF-1) 1 516
‒ Current gold-standard medical treatment include 1 350 1 300 somatostatin analogues 1 169
998 1 031 • Neuroendocrine tumors (NETs) are malignant 917
neoplasms 695 607 ‒ Somatostatin analogues constitute the current 488 412 standard of safe and effective medical therapy for 339 symptom control ‒ Somatostatin analogues also show anti-tumor effects 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Sandostatin® (Novartis) Somatuline® (Ipsen)
Significant potential in converting Sandostatin® LAR ® patients to CAM2029
Source1. Medtrack Camurus' Company Presentation 28 CAM2029 A new convenient and effective treatment option
CAM2029 overview CAM2029 key attributes
• Ready-to-use, long-acting octreotide for Easy subcutaneous administration treatment of acromegaly and neuroendocrine using prefilled syringe tumors (NETs) Self-administration option with significant • Exclusive partnership with Novartis convenience benefits and cost savings ‒ "Novartis Oncology continues its commitment to developing a new formulation of octreotide through a Increased bioavailability (500%) with potential collaboration with Camurus” for improved treatment efficacy1 • Positive Phase 2 results announced in July 2016 Thin needle and small injection volumes ‒ Well maintained or improved control of disease symptoms and biomarkers when switching from Room temperature stability avoiding cold chain Sandostatin® LAR® distribution and conditioning before use • Phase 3 studied planned to start in 2017 1. Novartis Q2 and H1 Condensed Interim Financial Report 2. Tiberg F, Roberts J, Cervin C, et al. Br J Clin Pharmacol. 2015;80:460-472.
Camurus' Company Presentation 29 Pipeline expansion with new attractive preclinical candidates
PARTNERS PRODUCT STATUS PRECLIN PH 1/2 PH 3 REG
Rhythm preparing to enter CAM4072 Genetic obesity clinical development in 2017
CAM2043 PAH Phase 1 planned to start in 2017
CAM2046 Diabetes Formulation development
Early stage collaborations with Formulation development pharma and biotech partners
Camurus' Company Presentation 30 Extensive clinical news flow expected during 2017
PARTNERS PRODUCT EVENT TIME CAM2038 Opioid dependence Phase 3 results, long-term safety study Q2, 2017 NDA and MAA submissions Mid-2017 CAM2038 Chronic pain Phase 2 results Q2, 2017 Phase 3 efficacy results H2, 2017 CAM2029 Acromegaly & NET Phase 3 start 2017
CAM2047 CINV Phase 1 results Q2, 2017
CAM2048 Pain Phase 1 study results Q2, 2017 CAM2058 Pain, nausea and vomiting Phase 1 study results Phase 2 study start CAM2043 PAH Phase 1 study start H2 2017
Weekly setmelanotide Genetic obesity Phase 1 study start H1 2017
Camurus' company presentation 31 Investment case
• De-risked, late-stage, differentiated pipeline ‒ Opioid addiction, pain, acromegaly and cancer ‒ Attractive multi-billion dollar specialty pharmaceutical markets ‒ Concentrated prescriber audiences and active patient advocacy groups • Strong collaborations with dedicated partners ‒ Novartis, Braeburn Pharmaceuticals, Rhythm, Solasia, R-Pharm US ‒ Early project collaborations with global pharma companies • Several levers for continued value creation ‒ MAA and NDA submissions in opioid dependence ‒ Phase 3 programs in multiple indications ‒ Advances in early stage clinical programs ‒ Growth opportunities via proven innovative technologies • Emerging European commercial organisation ‒ Lean and talented leadership team in place ‒ Extensive pre-launch activities ongoing for CAM2038 • Solid financial position
Camurus' Company Presentation 32 Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] www.camurus.com
33 Solid financial position with increasing investments in late-stage development programs
Revenues
35 30 License payments 2016 2015 25 Key figures, mUSD 20 Milestone payments Q4 Q1-Q4 Q4 Q1-Q4 15 10 Revenues 4.1 12.5 4.0 17.1 Net sales; services 5 and products 0 Operating result -3.9 -12.3 -0,5 -3.3 2012 2013 2014 2015 2016
Cash 56.1 79.0 Operating expenses 35 30 Total assets 70.5 90.0 25 20 Research & dev Equity 62.2 70.6 15 Sales & marketing 10 Administration 5 0 2012 2013 2014 2015 2016
Camurus' Company Presentation 34