Camurus Ab · OMXSTO:CAMX
Camurus Ab — Carnegie NYC (December 2017)
30 slides from Camurus Ab's conference presentation, December 2017
Slide 1: Transforming treatments by long-acting medications
Transforming treatments by long-acting medications Fredrik Tiberg, President & CEO
Slide 2: Forward-looking statements
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-look
Slide 3: Investment highlights
Investment highlights • In-house developed with strong IP protection FluidCrystal® • Validated in 20 clinical trials delivery technology • 1 marketed product and approval processes ongoing • +10 clinical programs in opioid addiction, pain, cancer, Broad, late-stage obesity, endocrine and cardiovascu
Slide 4: Long-acting medications address key healthcare challenges
Long-acting medications address key healthcare challenges 4
Slide 5: FluidCrystal injection depot – in situ gel formation
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 &
Slide 6: FluidCrystal – Tunable long-acting release
FluidCrystal® – Tunable long-acting release FluidCrystal® injection depot Immediate release octreotide (Sandostatin®) FC pasireotide subcutaneous octreotide 1000 FC octreotide 1000 FC somatostatin 1-14 Plasma concentration (ng/mL) Plasma concentration (ng/mL) 100 100 10 10 1 1 0,1 0,1 0,01 0,01 0 5
Slide 7: Clinically documented compounds & validated proprietary technology
Clinically documented compounds & Validated proprietary technology 7
Slide 8: Diversified late-stage R&D pipeline – FluidCrystal
Diversified late-stage R&D pipeline – FluidCrystal® 8
Slide 9: CAM2038 weekly and monthly buprenorphine depots
CAM2038 Weekly and monthly buprenorphine depots Changing the treatment paradigm in opioid dependence
Slide 10: Global opioid addiction health crisis
Global opioid addiction health crisis Annual US opioid overdose deaths2 30 (thousands) 25 • Escalating human crisis 20 15 • Largest society burden of all drugs1 10 • Patients need better access to care and 5 new treatment choices 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 201
Slide 11: Long-acting treatment of opioid dependence
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 r
Slide 12: CAM2038 demonstrated efficacy and safety vs standard of care
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 sampl
Slide 13: High acceptability amongst patients
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
Slide 14: CAM2038 ongoing global approval processes
CAM2038 ongoing global approval processes ✓ Recommendation of approval from FDA Advisory Committee ✓ TGA acceptance for evaluation ✓ EMA & TGA ✓ NDA submission of Australian MAA MAA approval to FDA decisions May 2017 July 2017 Sept 2017 Nov 2017 Jan 2018 Q3/Q4 2018 ✓ Positive phase 3 ✓ Priority revi
Slide 15: Limited competition on long-acting injectable opioid dependence market
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
Slide 16: Global commercialization strategy for CAM2038
Global commercialization strategy for CAM2038 ESTIMATED 1.3 million opioid problem users 15 million in Europe1 OPIOID DEPENDENT 2.5 million INDIVIDUALS GLOBALLY1 1.4 million diagnosed opioid registered heroin users dependent in the US2 in China4 187,000 opioid dependent in Australia3 Braeburn market
Slide 17: Prescription volume growth indicate high market potential in the US
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 11 149 12 035 25% LAI SHARE 10 327 9 309 10 000 ~$15002 PER MONTH TRx Volume (000s) 8 040 CORRESPONDS TO 5 000 $3-4 BN 0 2012 Q2 2013 Q2 2014 Q2 201
Slide 18: Significant market potential for CAM2038 in Europe
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 A
Slide 19: Additional attractive product candidates
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 POSTO
Slide 20: Pipeline products overview – CAM2038 chronic pain
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 SUFFERIN
Slide 21: Pipeline products overview – CAM2029
Pipeline products overview – CAM2029 CAM2029 ACROMEGALY & NEUROENDOCRINE TUMORS SOMATOSTATIN ANALOGUE SALES m omatuline sen FORMULATION Subcutaneous octreotide depot based on FluidCrystal® an ostatin Novartis KEY • Improved patient convenience ADVANTAGES • Increased bioavaiability • potential for en
Slide 22: New clinical product candidates
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 • Hi
Slide 23: Camurus positioned for continued value creation
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, c
Slide 24: Thank you!
Thank you! Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] camurus.com
Slide 25: Experienced and committed management team
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 ex
Slide 26: Major shareholders October 2017
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 UTVE
Slide 27: Value adding partnerships
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 licen
Slide 28: Recruitment completed in pivotal Phase 3 chronic pain study
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 Transit
Slide 29: Dissemination of CAM2038 data in publications and at scientific conferences
Dissemination of CAM2038 data in publications and at scientific conferences 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 ISAM Global CPDD ISAM 26-29 Oct AAAP ASAM 17-22 Jun 26-29 Oct 8-11 Dec 12-15 Apr Conferences Montréal,Canada Abu Dhabi, UAE Abu Dhabi, UAE San Diego, USA San Diego, USA AMERSA 3-5 Nov Washington D
Slide 30: Strong rationale for CAM2038 in Europe and Australia
Strong rationale for CAM2038 in Europe and Australia Nordic countries 16,535 UK • Specialist market with a concentrated prescriber base 148,686 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 dependen