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Presentation at Carnegie Healthcare Seminar
Fredrik TibergPresident & Chief Executive Officer
Camurus – a differentiatedR&D based pharmaceuticalcompany17 March 2016
Camurus in brief
• Innovation that delivers− Award-winning FluidCrystal® technology − Broad advancing product pipeline− More than 400 patents and patent applications
• Patient centric product development− Focus on severe and chronic disease− Long-acting solutions for better adherence− Easy and convenient administration
• Experienced and merited management− Including inventors and founders− 150 years combined life-science experience
• Entrepreneurial and agile company culture − Clear focus on innovation− Solutions and execution are key
LISTED ON NASDAQ
STOCKHOLM
3rd Dec 2015
MARKET CAP
~2.5billion SEK
CASH POSITION
716million SEKEND 2015
2
Key figures
Key figures, KSEK 2015 2014 2013 2012
Revenues 154 799 208 207 197 716 95 204
Operating result before items affecting comparability -30 464 62 319 127 316 18 761
Operating result -204 104 62 319 127 316 18 761
Result for the period -159 542 48 346 99 235 13 317
Cash flow from operating activities -5 657 69 429 163 064 24 735
Cash 716 096 56 5 3
Total assets 816 349 207 668 111 656 57 405
Earnings per share before dilution, SEK -6,33 2,06 17,01 2,28
Earnings per share after dilution, SEK -6,33 1,92 15,75 2,11
Number of employees at end of period 48 43 36 31
Number of employees in R&D at end of period 35 28 29 25
Equity 640 557 123 457 50 047 40 210
Equity ratio in Group, % 78% 59% 45% 70%
R&D costs as a percentage of operating expenses 83% 77% 71% 76%
0
50
100
150
200
250
2012 2013 2014 2015
Revenues
Licensepayments
Milestonepayments
Net sales;services andproducts
50
100
150
200
2012 2013 2014 2015
Operating expenses
Research & dev
Sales & marketing
Administration
3
Camurus’ value proposition
4
LEADING DRUG DELIVERY TECHNOLOGY
STRONG PIPELINE
STRATEGIC PARTNERS
MARKET SIZE
Technology platformsFluidCrystal® Injection DepotFluidCrystal® Topical BioadhesiveFluidCrystal® Nanoparticles
CAM2038 Opiod dependenceCAM2038 PainCAM2029 AcromegalyCAM2029 Neuroendocrine tumoursCAM2032 Prostate cancer In-house non-clinical projectsPartner projects
Annual sales of products withsame mode of action and indications, excluding pain
USD7bn
5
PATIENT AND
HEALTHCARE NEEDS
NEW PRODUCT
LAUNCHES
PIPELINE GROWTH
AND PROGRESS
VALUE CREATION • New and improved treatment
alternatives• Contributions to society on
local and global levels • Shareholder value
RESOURCES• Leading formulation technologies• Broad development pipeline• Solid patent portfolio• Dynamic and talented people• Wide-ranging expertise
Camurus business model
OUR FOCUSDevelopment and
commercialization of innovative and important
treatments for patients with severe and chronic diseases
OWN COMMERCIAL
ORGANIZATION
DEVELOPMENT AND COMMERCIALIZATION
PARTNERSHIPS
REVENUE STREAMS• License payments
• Royalties• Own sales
5
Our development pipeline
6
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
Strategic collaborations with dedicated partners
7
CAM2029, CAM4071 + other products
• Exclusive, worldwide, collaboration, option and license agreement for CAM2029 and related products
CAM2038
• Exclusive license agreement for North America and option rights in Japan, South Korea, Taiwan and China
• USD 50 million received in upfront, option exercise and development milestones
• USD 700 million in total potential development and sales milestones
• Mid to high single digit % royalties on sales
• USD 20 million in upfront license fee received
• USD 130 million in total potential development and sales milestones
• Mid double digit % royalties on sales
Acromegaly, neuroendocrine tumours and other indications Opioid dependence and pain
Scop
eFi
nanc
ials
Fiel
d
CAM4072
• Worldwide license to use FluidCrystal®Injection depot for setmelanotide
• USD 65 million in potential development and sales milestones
• Mid to mid-high single digit % royalties on sales
Genetic obesity
FluidCrystal® in three presentations
FluidCrystal® Injection Depot FluidCrystal® Topical bioadhesive FluidCrystal® Nanoparticles
New generation injection depotfeaturing prefilled syringe and auto-injector compatibility.
Ready-to-use product designLow burst and long-acting releaseTunable duration
Extended local delivery of peptide and small molecule at tissue surfaces.
Protection of sensitive tissueStrong bioadhesionSustained drug release
Nanoparticle carrier delivery addressing bioavailability limitations for amphiphilic and lipophilic drugs.
High drug payloadsEncapsulation of sensitive drugsEnhanced systemic circulationEnhanced trans-epithelial flux
8
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
Long-acting release of short-lived peptides
CONFIDENTIAL
FluidCrystal® long-acting release Immediate release solution
0,01
0,1
1
10
100
1000
0 5 10 15 20 25 30
Plas
ma
conc
entra
tion
(ng/
mL)
Time (days)
FC pasireotide
FC octreotide
FC somatostatin 1-14
0,01
0,1
1
10
100
1000
0 7 14 21 28
Plas
ma
conc
entra
tion
(ng/
mL)
Time (days)
subcutaneous octreotide
Single dose injection at t=0; n=6 (SC); rodent; mean values
10
Effective fast to market development model
11
Traditional pharmaceutical development model
Established safety profile Documented efficacy
Scalable & proven technology platform
Time and cost effective development is achieved by combining clinically documented active ingredients with proven technology
Clinical development Clinical development
Discovery & non-clinical development
Regulatory review
MAA/NDA approval process
according to abbreviated pöathways
Formulation-optimization
Reuse of data for API
Use of proven technology plattform
Time for development and review ~ 5-8 yrsTime for development and review ~ 10-15 yrs
Ph 1 Ph 2 Ph 3 Phase 3 Ph. 1/2
Camurus’ development model
Opioid dependence – A growing global health problem
• Largest burden to society of all drugs‒ About 70 000 annual overdose deaths globally ‒ 29 000 deaths in the US alone in 2014‒ 56 billion USD in total societal costs in the US‒ Each dollar spent on treatment yields 12 dollar in
savings
• Increasing numbers in treatment‒ 700K in OMT in Europe‒ 1,100K in OMT in the US‒ Growing numbers in treatment,
> 1.5 million in US in 10 years
• Current treatment limitations‒ Limited access to treatment‒ Modest retention in treatment‒ Burdens of daily medication‒ Extensive misuse, abuse and diversion
of current daily medications
Have misused prescription opioidsin US, N=48 million1
Currently abusing painkillers or heroin
N=5 million2
Diagnosed with Dependence
N= 2.5M2
Treated USN=~1,100K
Treated with buprenorphine4
N= ~750K15million
global opiatedependentpopulation4
1.3million
Europeans areproblem opioid
users3
12
Source: 1. National Institute of Drug Abuse; 2. SAHMSA, National Survey on Drug Use and Health (NSDUH) – 2014; 3. EMCDD, European Drug Report Trends and Developments 2015.; 4. UNODC, World Drug Report 2015; 5. WHO, UNAIDS position paper 2004
12:1cost saving on
each dollar spenton treatment5
Paradigm shift in opioid dependence treatment
• Weekly and monthly buprenorphine injections for all phases of opioid maintenance treatment
• Multiple fixed doses and two durations
• Ready to use and easy to inject
• Fast Track designation by FDA for both weekly and monthly products
• Strategic partner for North America in BraeburnPharmaceuticals
• Best-in-class treatment potential
Reduced number of administrations from 365 to 52 or 12 doses per year Safeguard against misuse, abuse and diversionNo risk of accidental pediatric exposureLong-acting release providing continuous treatment effect
Continuous blocking effect of illicit opioids
Flexible doses and durations allow individualized therapy in all OMT phases
CAM2038 attributesCAM2038 overview
13
Plasma buprenorphine from CAM2038 versus sublingual tablets
0
1
10
100
0 7 14 21 28
Plas
ma
BNP
conc
(ng/
mL)
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, pred = predicted, SD = single dose, SS = steady state
14
Clinical program for CAM2038 in opioid dependence
HS-11-426Phase 1 60 healthy volunteers
HS-13-487Phase 1 87 volunteers
HS-07-307 Phase 1/2 41 patients
Trial no. Subjects Key results / Study design Status
Dose proportional extended release further supported by pharmacodynamics results for withdrawal symptoms over time and time to rescue medication
Extended release suited for weekly respective monthly dosing. 6-8 times higher bioavailability. Acceptability of CAM2038 dosing higher than SL tablets.
Extended release of BPN suited for once weekly dosing. Dose proportional exposure. 6-8 times higher bioavailability versus SL BPN tablets
HS-14-478HS-14-549Phase 2
Opioid challenge study of CAM2038 in opioid dependent patients (US)Repeat dose pharmacokinetic study of CAM2038 in opioid dependent pain patients (US), including injections in different subcutaneous injection sites)
OngoingOngoing
HS-11-421 Phase 3HS-07-499
Double blind, double dummy Phase 3 efficacy trial of CAM2038 versus sublingual buprenorphine (US)Open label Phase 3 safety trial in patients with opioid dependence (EU, US, AUS)
Ongoing
Ongoing
Good safety and local tolerability forCAM2038, weekly and monthly formulations
7completed and
ongoingclinical trials
+600people dosed withCAM2038, weekly
and monthlyproducts
15
Strategy of own commercialisation of CAM2038 in EU
Positive market drivers support pricing strategy and reimbursement on European 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
Rationale Overview of market rights and Camurus’ primary markets
Braeburn exclusive markets Braeburn option right Camurus markets
16
Highly addressable target markets (EU-4)
17
Market structure Physicians willingness to prescribe CAM20381Country# OMT patients % buprenorphine Treatment location
Large markets with known demand from physicians
77,300
172,513
163,000
94,376
21%
n.a. Methadone predominant
treatment
66%
15%
Specialised centers and primary health care system
Community health clinics and NHS providers
Specialised centers and GP practices
Servizi Tossicodipendenze (Ser.T.) and private and non-profit organisations
86%N=51
94%N=50
86%N=50
96%N=50
Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015
Stepwise approach to building a successful commercial organisation
Process of building a successful commercial organization for the opioid dependence market in Europe has been initiated.
Internationally experienced Chief Commercial Officer has been appointed.
Fully built out, the European commercial organization will include about 70 to 120 people.
2016• EU leadership team• General managers in early
reimbursed markets
2017• Regional leadership teams
early reimbursed markets• General Managers 2nd
wave markets
2018• Regional leadership teams
on 2nd wave markets• Full key account teams
18
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‒ 4 times the number of diabetes patients‒ 560-635 billion USD in annual incremental
health care costs (US)‒ 100 million chronic pain patients in EU
• Large medical need‒ No or little control over pain ‒ Daily breakthrough pain‒ Impact on overall enjoyment of life. ‒ Depression and inability to sleep
• Opioids are powerful painkillers‒ Prescription drugs are the second-most abused
category of drugs in the US‒ Almost 20 000 people in the US died from overdoses
of prescription opioid pain relievers in 2014.
• Buprenorphine‒ Demonstrated to provide effective relief of a broad
spectrum of pain condition ‒ Partial µ-opioid receptor agonist and κ -antagonist
‒ Ceiling effect on respiratory depression ‒ Higher analgesic potency and lower analgesic
tolerance than morphine
~600billion USD
incremental annualcosts of chronicpain in the US2
116milion suffer from chronic pain in the
US1
100million
Europeans havechronic pain
19
Source. 1. The American Society of Pain Medicine http://www.painmed.org/patientcenter/facts_on_pain.aspx.;2 J. Latham* & B. D. Davis Disability and Rehabilitation, Volume 16, pages 39-44 1994
Chronic pain is a significant market opportunity for CAM2038
• Global market for chronic pain exceeded 20 billion USD, US market 10.8 billion USD in 20121
• Long-acting opioid market is estimated to 4.7 billion USD2
• Butrans® (Purdue) 7-day buprenorphine patch have US sales prediction of about 230 MUSD3
• Endo recently launched BelbucaTM with sales prediction in excess of 250 MUSD4
Around the clock pain reliefFast onset and long acting durationDosing flexibility allow individualized treatmentReduced overdose risk
Good local tolerability versus patches
Minimal risk of diversion and abuse
CAM2038 potential advantagesMarket overview
20
Source: 1. Decision Resources; 2. IMS Health data 2015; 3 Symphony Health; 4. EndoPharmaceutical presentation JP Morgan 2016
Significant potential in converting Sandostatin® LAR ® patients to CAM2029
Acromegaly and NET showing continuous long-term growth
• Acromegaly is a rare, chronic and insidious hormonal disorder‒ Occurs when the pituitary gland produces excess
growth hormone (GH) and insulin-like growth factor-1 (IGF-1)
‒ Treatable in most patients (treatment includes surgery and/or medical treatment)
‒ Current gold-standard medical treatment include somatostatin analogues
• Neuroendocrine tumours (NETs) are rare and malignant neoplasms‒ Somatostatin analogues constitute the current
standard of safe and effective medical therapy for symptom control
‒ Somatostatin analogues also show promising antitumour effects
Overview of acromegaly and NETs Strong and sustained market growth over 15 years
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Sandostatin® (Novartis) Somatuline® (Ipsen)(2)
Sandostatin® : 7%
Somatuline® : 16%
(USDm)CAGR 2004-2014:
2015
21
CAM2029 for effective treatment of acromegaly and NET
• Ready-to-use, long-acting octreotide for treatment of acromegaly and neuroendocrine tumours (NETs)
• Orphan drug designation for acromegaly by EMA
• Exclusive partnership with Novartis –market leader within acromegaly and NETs
• Phase 3 preparations ongoing
• Multiple life-cycle management
Easy subcutaneous administration using prefilled syringeSelf-administration option with significant convenience benefits and cost savingsIncreased bioavailability (500%) with potential for enhanced efficacy in some patients1Thin needle and small injection volumesRoom temperature stability avoiding cold chain distribution and conditioning before use
CAM2029 potential advantagesCAM2029 overview
22 Source: 1. Tiberg F, Roberts J, Cervin C, et al. Br J Clin Pharmacol. 2015;80:460-472.
No reconstitutionCAM2029 10, 20 mg0.5 -1.0 mL/ready-to-use/
no reconditioning/room temperature Based on FluidCrystal® system
Sandostatin® LAR® 10, 20, 30 mg 2.0 mL/reconstitution/
refrigerated/30-60 min reconditioningBased on PLGA microsphere system
Somatuline® Autogel® 60, 90, 120 mg0.2-0.5 mL/ready-to-use/refrigerated
≥ 30 min reconditioningSelf-associated gel
Small volume
Thin needle
≥22G
20G
18G/19G
Subcutaneous(12.5mm)
Intramuscular(40mm)
Deep subcutaneous(20mm)
Note: 1) Illustrative. Final product configuration may be different.
Ready for use with smaller needle and lower dose volume
23
Clinical trials confirm target properties of CAM2029
HS-05-194Phase 1 32 volunteers
HS-07-291Phase 1 95 volunteers
HS-11-411Phase 1 122 volunteers
Trial no. Subjects Key results / Study design Status
and suppression of the IGF-1 growth factor. Dose proportional octreotide exposure with 5 times higher bio-availability compared with Sandostatin LAR 30 mg.
Dose proportional octreotide exposure during repeated dosing of CAM2029 mg.Rapid and long-acting release of octreotide
Rapid and long-acting release of octreotide One month suppression of the growth factor IGF-1.
HS-12-455Phase 2
24 patients(1) in two groups with acromegaly and NETs
CompletedData base lock
Phase 3 Two Phase 3 trials of CAM2029 versus active control, Sandostatin® LAR®, in patients with neuroendocrine tumours (NETs) and acromegaly, respectively (Global) In preparation
Good safety and local tolerability demonstrated in all trials
Randomised multi-centre study of the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2029 in two patients groups with acromegaly and neuroendocrine tumours (NET) previously treated with Sandostatin® LAR®
24
Prostate cancer market opportunity
• Prostate cancer is an uncontrolled (malignant) growth of cells in the prostate gland
• Prostate cancer is the fourth most commonly diagnosed cancer type worldwide, with an estimated 1.1 million people affected in 2012
• Increase in incidence rates, mainly driven by rapidly growing population of men older than 50 years
• The global prostate market is forecasted to grow with a CAGR of 12.4% to 2023
• Current treatment includes gonadotropin-releasing hormone (GnRH) analogues that block testosterone product, resulting in decreased PSA and slow-down of tumour growth and spread
• Mature and large market with opportunities for cost-effectiveness
• Current alternatives all require physician administration
Prostate cancer Global market size (MUSD)
Source: Company information, www.cancerresearchuk.org, Medtrack, GlobalData(1) Lupron 2014 EU sales not reported in Medtrack. 3.4% increase in sales from 2013 to 2014 reported for EU+Canada in Takeda annual report
1,180 1,315
2,546 2,689 2,808 2,789
3,569 3,535 3,4853,688 3,546 3,540
3,265
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
Lupron Depot® Eligard® Zoladex® Decapeptyl®
Treatments for prostate cancer such as Lupron Depot® and Eligard® have increased sales over time in tandem with increased incidence rates
25
CAM2032 treatment of prostate cancer
• Ready-to-use, long-acting leuprolide product for treatment of prostate cancer
• Phase 2 PoC completed‒ Clinically significant and effective long-acting
suppression of testosterone ‒ Good safety and local tolerability
• Phase 2 repeat dose ongoing (incl. comparator drug Eligard®)‒ Results Q2 2016
• Worldwide license rights available
Easy subcutaneous administration using prefilled syringeSelf-administration option with significant convenience and cost benefitsSmall volume, thin needle and auto-injector compatibilityManufacturing by standard processes leadsto low COGS which enables price advantage
CAM2032 potential advantagesCAM2032 overview
26
Key selection criteria for new product candidates
27
High unmet medical need• Meaningful treatment
improvements • Better treatment outcomes,
QoL and health economy
Technology match• Value creation by FluidCrystal®• Technology match • Safety and tolerability
Effective development• 505 (b)(2) registration pathway• Potential for accelerated approval
Attractive market• Price and reimbursement• Concentrated prescriber base• Market size• Commercial synergies
Extended market exclusivity• Approved platform patents• Product specific patent
applications
Promising early phase pipeline
28
Inflammation & painCAM2041
DiabetesCAM2046
Cancer supportive careCAM2047
PainCAM2048
Target indicationProject
UndisclosedCAM2043
Lead formulation selected
Formulation development
Lead formulation selected
Lead formulation selected
Status
Lead formulation selected
CAM4072Partner, Rhythm
Genetic obesity (Prader-Willis syndrome, POMC deficiency) Lead formulation selected
Early phase project evaluations, including three big pharma collaborations
Camurus 2016 Anticipated clinical news flow
29
Late-stagepipeline
Early/mid-stagepipeline
2015 2016 2017
CAM2038Results Phase 2Opioid challenge trial
CAM2029Results Phase 2 trial
CAM2038Results twoPhase 2 trials
CAM2038Results Phase 3 efficacy trial
CAM2029Start Phase 3
Opioid dependence Acromegaly & NET OD & chronic pain Opioid dependence Acromegaly & NET
Partner: Braeburn(North America)
Partner: Novartis(Global)
Partner: Braeburn(North America)
Partner: Braeburn(North America)
Partner: Novartis(Global)
CAM2032Results Phase 2 trial
Prostate cancer
Camurus
CAM4071Results Phase 1 trial
Undisclosed
Partner: Novartis(Global)
Camurus
Prostate cancer
New projectIn clincial trial
Undisclosed
Camurus goals 2016
30
• 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 dependent chronic pain
patients‒ First patients included in Phase 3 chronic pain study
• Acromegaly and NET ‒ Results from Phase 2 study in acromegaly and NET, respectively.‒ GMP manufacturing in final product format completed for start of Phase 3
• Prostate cancer‒ Completed Phase 2 trial in patients with locally advanced prostate cancer
• Start of new projects ‒ At least one new program in clinical trials
Camurus strategy for growth
31
Strengthen our leading technology position through continued innovation and development
Grow and advance our product pipelineAnd launch new products
Increase values of technologies and products through strategic partnerships.
Build own commercialization infrastructure on opioid dependence and accompanying markets in Europe
32
