Camurus Ab · OMXSTO:CAMX
Camurus Ab — Carnegie Healthcare Seminar 2016
32 slides from Camurus Ab's conference presentation, Mar 17, 2016
Slide 1: Camurus – a differentiated R&D based pharmaceutical company
Presentation at Carnegie Healthcare Seminar Camurus – a differentiated R&D based pharmaceutical company 17 March 2016 Fredrik Tiberg President & Chief Executive Officer
Slide 2: Camurus in brief
LISTED ON Camurus in brief NASDAQ STOCKHOLM 3rd Dec • Innovation that delivers 2015 − Award-winning FluidCrystal® technology − Broad advancing product pipeline − More than 400 patents and patent applications MARKET CAP • Patient centric product development − Focus on severe and chronic disease ~2.5
Slide 3: Key figures
Key figures Key figures, KSEK 2015 2014 2013 2012 Revenues Revenues 154 799 208 207 197 716 95 204 250 Operating result before items affecting comparability -30 464 62 319 127 316 18 761 200 License payments Operating result -204 104 62 319 127 316 18 761 150 Milestone payments Result for the period
Slide 4: Camurus' value proposition
Camurus’ value proposition LEADING DRUG DELIVERY STRONG STRATEGIC MARKET TECHNOLOGY PIPELINE PARTNERS SIZE Technology platforms FluidCrystal® Injection Depot FluidCrystal® Topical Bioadhesive FluidCrystal® Nanoparticles CAM2038 Opiod dependence CAM2038 Pain CAM2029 Acromegaly CAM2029 Neuroendocrine
Slide 5: Camurus business model
OUR FOCUS Camurus Development and commercialization of business innovative and important model treatments for patients with severe and chronic diseases OWN COMMERCIAL ORGANIZATION RESOURCES VALUE CREATION • Leading formulation technologies PATIENT • New and improved treatment PIPELINE alternatives •
Slide 6: Our development pipeline
Our development pipeline PARTNERS PRODUCT PRECLINICAL PHASE 1/2 PHASE 3 REGISTRATION CAM2038 q1w Opioid dependence CAM2038 q4w Opioid dependence CAM2029 Neuroendocrine tumous CAM2029 Acromegaly CAM2038 q1w Chronic pain CAM2038 q4w Chronic pain CAM2032 Prostate cancer CAM4071 Not disclosed 6
Slide 7: Strategic collaborations with dedicated partners
Strategic collaborations with dedicated partners CAM2029, CAM4071 + other products CAM2038 CAM4072 Field Acromegaly, neuroendocrine tumours Opioid dependence and pain Genetic obesity and other indications • Exclusive, worldwide, collaboration, option • Exclusive license agreement for North • Worldwi
Slide 8: FluidCrystal in three presentations
FluidCrystal® in three presentations FluidCrystal® Injection Depot FluidCrystal® Topical bioadhesive FluidCrystal® Nanoparticles New generation injection depot Extended local delivery of peptide Nanoparticle carrier delivery featuring prefilled syringe and auto- and small molecule at tissue addressi
Slide 9: FluidCrystal Injection Depot for tunable long-acting release
FluidCrystal® Injection Depot for tunable long-acting release Simple handling and easy injection Tunable release – “days to months” Applicable across substance classes Good safety and local tolerability Storage and in-use stability Manufacturing using standard processes 9
Slide 10: Long-acting release of short-lived peptides
Long-acting release of short-lived peptides FluidCrystal® long-acting release Immediate release solution 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 10 15 20 25 3
Slide 11: Effective fast to market development model
Effective fast to market development model Traditional pharmaceutical development model Camurus’ development model Clinical development Clinical development Reuse of data MAA/NDA for API approval process Discovery & Regulatory Formulation- non-clinical according to Ph 1 Ph 2 Ph 3 review Use of prove
Slide 12: Opioid dependence – A growing global health problem
Opioid dependence – A growing global health problem • Largest burden to society of all drugs Have misused prescription opioids ‒ About 70 000 annual overdose deaths globally in US, N=48 million1 ‒ 29 000 deaths in the US alone in 2014 ‒ 56 billion USD in total societal costs in the US Currently abus
Slide 13: Paradigm shift in opioid dependence treatment
Paradigm shift in opioid dependence treatment CAM2038 overview CAM2038 attributes • Weekly and monthly buprenorphine injections for all phases of opioid maintenance treatment • Multiple fixed doses and two durations Reduced number of administrations from 365 to 52 or 12 doses per year • Ready to u
Slide 14: Plasma buprenorphine from CAM2038 versus sublingual tablets
Plasma buprenorphine from CAM2038 versus sublingual tablets 100 Plasma BNP conc (ng/mL) 10 1 0 0 7 14 21 28 Time (days) Conc (q1w 16 mg obs) Conc (q1w 16 mg pred) Conc (q4w 64 mg obs) Conc (q4w 64 mg obs SD) Conc (q4w 64 mg pred SS) Conc (SL BPN 8 mg obs) Conc (SL BPN 8 mg pred) Note: obs = observed
Slide 15: Clinical program for CAM2038 in opioid dependence
Clinical program for CAM2038 in opioid dependence Trial no. HS-11-426 Phase 1 Subjects 60 healthy volunteers Key results / Study design Extended release of BPN suited for once weekly dosing. Dose proportional exposure. 6-8 times higher bioavailability versus SL BPN tablets Status 7 completed and G
Slide 16: Strategy of own commercialisation of CAM2038 in EU
Strategy of own commercialisation of CAM2038 in EU Rationale Overview of market rights and Camurus’ primary markets Favourable market for CAM2038 in Europe Desire for fewer administrations Sizeable socio-economic benefits On-going paradigm shift Accessible market Cost efficient roll-out Braeburn exc
Slide 17: Highly addressable target markets (EU-4)
Highly addressable target markets (EU-4) Country Market structure Physicians willingness to prescribe CAM20381 # OMT patients % buprenorphine Treatment location Specialised centers 77,300 21% and primary health N=51 86% care system n.a. Community health 172,513 Methadone predominant clinics and NHS
Slide 18: Stepwise approach to building a successful commercial organisation
Stepwise approach to building a successful commercial organisation Process of building a successful commercial Fully built out, the European commercial organization for the opioid dependence market in organization will include about 70 to 120 people. Europe has been initiated. Internationally experi
Slide 19: Chronic pain estimated to affect 1.5 billion people globally
Chronic pain estimated to affect 1.5 billion people globally • Chronic pain is a huge global problem ‒ 116 million with chronic pain in the US 116 ‒ 4 times the number of diabetes patients ‒ 560-635 billion USD in annual incremental ~600 billion USD milion suffer from chronic pain in the US1 health
Slide 20: Chronic pain is a significant market opportunity for CAM2038
Chronic pain is a significant market opportunity for CAM2038 Market overview CAM2038 potential advantages • Global market for chronic pain exceeded 20 billion USD, US market 10.8 billion USD in 20121 Around the clock pain relief • Long-acting opioid market is estimated to 4.7 billion USD2 Fast o
Slide 21: Acromegaly and NET showing continuous long-term growth
Acromegaly and NET showing continuous long-term growth Overview of acromegaly and NETs Strong and sustained market growth over 15 years • Acromegaly is a rare, chronic and insidious (USDm) hormonal disorder CAGR 2004-2014: ‒ Occurs when the pituitary gland produces excess Somatuline® : 16% Sandostat
Slide 22: CAM2029 for effective treatment of acromegaly and NET
CAM2029 for effective treatment of acromegaly and NET CAM2029 overview CAM2029 potential advantages • Ready-to-use, long-acting octreotide for treatment of acromegaly and neuroendocrine tumours (NETs) Easy subcutaneous administration using prefilled syringe • Orphan drug designation for acromegaly
Slide 23: Ready for use with smaller needle and lower dose volume
Ready for use with smaller needle and lower dose volume CAM2029 10, 20 mg No reconstitution 0.5 -1.0 mL/ready-to-use/ no reconditioning/room temperature ≥22G Small volume Based on FluidCrystal® system Subcutaneous (12.5mm) Thin needle Sandostatin® LAR® 10, 20, 30 mg 2.0 mL/reconstitution/ 20G
Slide 24: Clinical trials confirm target properties of CAM2029
Clinical trials confirm target properties of CAM2029 Trial no. Subjects Key results / Study design Status HS-05-194 Phase 1 32 volunteers Rapid and long-acting release of octreotide One month suppression of the growth factor IGF-1. Good safety HS-07-291 Phase 1 95 volunteers and local tolerability
Slide 25: Prostate cancer market opportunity
Prostate cancer market opportunity Prostate cancer Global market size (MUSD) • Prostate cancer is an uncontrolled (malignant) 4,000 3,569 3,535 3,485 3,688 3,546 3,540 growth of cells in the prostate gland 3,500 3,265 3,000 • Prostate cancer is the fourth most commonly 2,689 2,808 2,789 2,546 diagno
Slide 26: CAM2032 treatment of prostate cancer
CAM2032 treatment of prostate cancer CAM2032 overview CAM2032 potential advantages • Ready-to-use, long-acting leuprolide product for treatment of prostate cancer • Phase 2 PoC completed Easy subcutaneous administration using prefilled syringe ‒ Clinically significant and effective long-acting sup
Slide 27: Key selection criteria for new product candidates
Key selection criteria for new product candidates High unmet medical need • Meaningful treatment improvements • Better treatment outcomes, QoL and health economy Attractive market • Price and reimbursement • Concentrated prescriber base • Market size • Commercial synergies Technology match • Value c
Slide 28: Promising early phase pipeline
Promising early phase pipeline Project Target indication Status CAM2041 Inflammation & pain Lead formulation selected CAM2046 Diabetes Formulation development CAM2047 Cancer supportive care Lead formulation selected CAM2048 Pain Lead formulation selected CAM2043 Undisclosed Lead formulation selected
Slide 29: Camurus 2016 Anticipated clinical news flow
Camurus 2016 Anticipated clinical news flow CAM2038 CAM2029 CAM2038 CAM2038 CAM2029 Results Phase 2 Results Phase 2 trial Results two Results Phase 3 Start Phase 3 Opioid challenge trial Phase 2 trials efficacy trial Late-stage pipeline Opioid dependence Acromegaly & NET OD & chronic pain Opioid dep
Slide 30: Camurus goals 2016
Camurus goals 2016 • Opioid dependence ‒ Results from two Phase 2 trials, opioid blockade and PK chronic pain ‒ Results from Phase 3 efficacy trial ‒ Manufacturing of first commercial batches of CAM2038 ‒ EU commercial leadership team in place • Chronic pain ‒ Results from Phase 2 study in opioid de
Slide 31: Camurus strategy for growth
Camurus strategy for growth Build own commercialization infrastructure on opioid dependence and accompanying Increase values of markets in Europe technologies and products through Grow and advance strategic partnerships. our product pipeline Strengthen our leading And launch new technology position
Slide 32: Camurus AB, Ideon Science Park, Lund, Sweden
Camutus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] www.camurus.com S camurus®