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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
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Investment highlights
Listed on Nasdaq STO (ticker CAMX)
Market Cap: ~500 MUSD
Cash position: 45 MUSD (Q3, 2017)
Monthly OPEX: 3 MUSD (2017)
Employees: 70
HQ: Lund, Sweden
FluidCrystal®
delivery technology
Broad, late-stage
R&D pipeline
Emerging European
commercial
organization
Strong pharma
partnerships
• In-house developed with strong IP protection
• Validated in 20 clinical trials
• 1 marketed product and approval processes ongoing
• +10 clinical programs in opioid addiction, pain, cancer,
obesity, endocrine and cardiovascular disease.
• Potential FDA/EMA/TGA product approvals in 2018
• Leadership and key functions in place
• Fully operational for 2018 launch
• Novartis, Braeburn Pharmaceuticals, Rhythm…
• R&D investments, milestones and royalty on sales
Long-acting medications address key healthcare
challenges
4
5
FluidCrystal® injection depot – in situ gel formation
+400 PATENTS &
APPLICATIONS
~1500 SUBJECTS HAVE RECEIVED
>15,000 INJECTIONS IN
CLINICAL TRIALS
✓ Good safety profile
✓ Standard manufacturing processes
✓ Unique mixtures of endogenous lipids
✓ Easy to administer
✓ Rapid onset & long-acting release
✓ Applicable across substance classes
TIME
LIQUID DRUG PRODUCT
BEFORE INJECTION:
LIPIDS+SOLVENT+DRUG
WATER
ABSORPTION
SOLVENT
RELEASE
DRUG RELEASE
LIQUID CRYSTAL GEL
INJECTION
DEPOT BIODEGRADATION
TO COMPLETE RESOLUTION
FluidCrystal® injection depot Immediate release octreotide (Sandostatin®)
FluidCrystal® – Tunable long-acting release
0,01
0,1
1
10
100
1000
0 5 10 15 20 25 30
Pla
sm
a c
once
ntr
ation
(n
g/m
L)
Time (days)
FC pasireotide
FC octreotide
FC somatostatin 1-14
0,01
0,1
1
10
100
1000
0 7 14 21 28
Pla
sm
a c
once
ntr
ation
(n
g/m
L)
Time (days)
subcutaneous octreotide
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®
88
Weekly and monthly buprenorphine depots
Changing the treatment paradigm in opioid dependence
CAM2038
10
Global opioid addiction
health crisis
• Escalating human crisis
• Largest society burden of all drugs1
• Patients need better access to care and new treatment choices
• Investment in treatment brings significant value
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25
20
10
15
5
0
19
99
20
00
20
01
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02
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03
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04
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06
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08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
Annual US opioid overdose deaths2
(thousands)
COST OF US OPIOID CRISIS:
$500 bnWHITE 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.
Long-acting treatment of opioid dependence
– from Day 1 to maintenance therapy1
Individualized treatment
Weekly and monthly dosing options
Rapid onset and sustained treatmenteffect from Day 1
Enhanced adherence to treatment
Safeguards against diversion and misuse
Efficacy supported by robust clinical data versus daily standard treatment
11Source: 1 CAM2038 is an investigational treatment under review by US, European and Australian regulatory authorities for treatment of opioid use disorder / dependence.
1
2
3
4
5
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• CAM2038 met FDA and EMA primary and key
secondary efficacy endpoints in a pivotal
24-week Phase 3 study
‒ Demonstrating non-inferiority and superiority versus
daily standard treatment
• Sustained suppression of withdrawal and
cravings
• Opioid blockade from first dose
• Safety profile comparable to SL buprenorphine
with no unexpected safety findings
‒ Confirmed in a 48-week Phase 3 safety study
12
CAM2038 demonstrated efficacy
and safety vs standard of care
0
20
40
60
80
100
CAM2038 SL BUP/NX
100%
75%-<100%
50%-<75%
25%-<50%
1%-<25%
0%
Percent urine
samples confirmed by
self-reports negative
for illicit opioid use
weeks 4-24.
Superiority in % cumulative opioid abstinence, p=0.004
H
“CAM2038 compared to my previously prescribed sublingual buprenorphine treatment”
13
Much worse
Slightly worse
About the same
Slightly better
Much better
83% POSITIVEN=133
High acceptability amongst patients
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CAM2038 ongoing global approval processes
Supported by comprehensive clinical program
✓ 944 participants across 7 clinical studies
✓ Four phase 1/2 studies of pharmacokinetics and pharmacodynamics after single and repeated dosing of CAM2038
✓ Phase 2 opioid blocking study
✓ Phase 3 double-blind, double-dummy, active-controlled study
✓ Phase 3 long-term safety study
May 2017
✓ Positive phase 3
long-term safety
data
July 2017
✓ NDA submission
to FDA
Sept 2017
✓ Priority review
granted by FDA
✓ MAA validation
by EMA
Nov 2017
✓ Recommendation of approval
from FDA Advisory Committee
✓ TGA acceptance for evaluation
of Australian MAA
Jan 2018
✓ PDUFA date set to
19 January 2018
✓ EMA & TGA
MAA approval
decisions
Q3/Q4 2018
15
Limited competition on long-acting injectable (LAI)
opioid dependence market
CAM2038 Weekly & Monthly
Sublocade® Monthly
BPN Depot1
HTX-0032
Vivitrol $275M expected 2017 sales3
PDUFA
Jan. 19, 2018
APPROVED
Nov. 30, 2017
APPROVED
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
Long-acting buprenorphine injectables
Long-acting naltrexone injectables
Braeburn/Camurus
Indivior
BDSI
Heron
Alkermes
PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL (US) APPROVAL (EU/Aus)
Estimated
Q3/Q4 2018
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Global commercialization strategy for CAM2038
Braeburn markets Braeburn option rightCamurus markets
2.5 milliondiagnosed opioid
dependent in the US2
1.3 millionopioid problem users
in Europe1
187,000opioid dependent
in Australia3
1.4 millionregistered heroin users
in China4
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
ESTIMATED
15 millionOPIOID DEPENDENT
INDIVIDUALS GLOBALLY1
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Prescription volume growth indicate high market potential
for long-acting buprenorphine in the US
8 040
9 309 10 327
11 149 12 035
13 156
0
5 000
10 000
15 000
2012 Q2 2013 Q2 2014 Q2 2015 Q2 2016 Q2 2017 Q2
TR
xV
olu
me
(0
00
s)
Total TRx Volume 12 Months ending June1
Source: 1. Symphony Health, PHAST Integrated Monthly; 2. Based on monthly Sublocade™ price ($1580), Indivior plc; LAI – long acting injectables
buprenorphine/naloxone
(Suboxone, Bunavail, Zubsolv & oral generics)buprenorphine HCL & generics
naltrexone (Vivitrol)
25% LAI SHARE
~$15002 PER MONTH
CORRESPONDS TO
$3-4 BN
MARKET POTENTIAL
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Significant market potential for CAM2038 in Europe
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.
High physicians’ willingness to prescribe CAM2038 in EU41
Physicians’ willingness to
prescribe CAM2038
Anticipated share of patients
on CAM2038 q4w
Anticipated share of patients
on CAM2038 q1w
96%
n=50
39%q4w
22%q1w
94%
n=50
36%q4w
25%q1w
86%
n=50
43%q4w
27%q1w
France
161,388 patients
86%
n=51
31%q4w
30%q1w
Germany
77,500 patientsUK
148,686 patients
Italy
75,964 patients
Additional attractive product candidates
PARTNER PRODUCT PRE-CLINICAL PHASE1-2
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PHASE 1-2CAM2029 ACROMEGALY
PHASE 1-2CAM2029 NEUROENDOCRINE TUMORS
PHASE 1-2CAM2032 PROSTATE CANCER
PHASE 1-2
PHASE 1-2CAM2047 CHEMOTHERAPY INDUCED NAUSEA & PAIN
PHASE 1-2CAM2048/2058 POSTOPERATIVE PAIN & POSTOPERATIVE NAUSEA & PAIN
CAM2043 PULMONARY ARTERIAL HYPERTENSION
Undisclosed internal project candidates
Early stage collaborations with pharma and biotech partners
PHASE 1-2CAM4072 GENETIC OBESITY
PHASE 3
PHASE 3CAM2038 q1w / q4w CHRONIC PAIN
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Pipeline products overview – CAM2038 chronic pain
CAM2038
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
• Flexible and individualized dosing
• HCP administration safeguards against misuse and
diversion
MARKET SIZE Global opioid pain market ~$6 bn1
DEVELOPMENT
STATUS• Three phase 1/2 trials completed
• Phase 3 efficacy and safety extension study ongoing;
top-line efficacy results expected Q1 2018
PARTNER Braeburn Pharmaceuticals (North America)
CHRONIC PAIN
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.
1 IN 5 INDIVIDUALS SUFFERING FROM CHRONIC PAIN1
CHRONIC PAIN ESTIMATED
~$560-635bnANNUAL COST TO SOCIETY2
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Pipeline products overview – CAM2029
CAM2029
FORMULATION Subcutaneous octreotide depot based on FluidCrystal®
KEY
ADVANTAGES• Improved patient convenience
• Increased bioavaiability
• potential for enhanced treatment efficacy in currently
underexposed patients
MARKET SIZE Somatostatin analogue market >$2 bn1
DEVELOPMENT
STATUS• Four phase 1/2 trials successfully completed
• Novartis currently evaluating new study designs
recently suggested by health authorities
• Ongoing preparations for Phase 3 including additional
manufacturing and packaging activities
PARTNER Novartis (exclusive worldwide license)
Sources. 1. GlobalData 2017.
SOMATOSTATIN ANALOGUE SALES
Significant potential in converting
Sandostatin® LAR ® patients to CAM2029
m
an ostatin Novartis
omatuline sen
ACROMEGALY & NEUROENDOCRINE TUMORS
CAM4072
FORMULATION Subcutaneous FC setmelanotide depot
KEY
ADVANTAGES• Weekly dosing
• Ready-to-use prefilled syringe
• Improved patient convenience
MARKET SIZE Not communicated
DEVELOPMENT
STATUS• Phase 1 study completed, positive
initial data communicated
• Submission earliest 20191
KEY RESULTS Positive initial phase 1 results met
Rhythm’s PK an tolerability criteria.
PARTNER Rhythm (exclusive worldwide license)
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New clinical product candidates
CAM2043
FORMULATION Subcutaneous FC treprostinil depot
KEY
ADVANTAGES• Weekly dosing
• High patient convenience
• No need for extracorporal pumps
• Reduced risk of treatment limiting
infusion site pain and local reactions
• Low risk of infections and sepsis
MARKET SIZE PAH market >$5 bn, tresprostinil ~1.2 bn2
DEVELOPMENT
STATUS• Phase 1 start Q4 2017
KEY RESULTS Preclinical data confirmed target profile
Sources. 1. Form S-1 Rhythm Pharmaceuticals 2017 2. PharmaCircle 2017.
GENETIC OBESITY DISORDERS PULMONARY ARTERIAL HYPERTENSION
• Potential levers for future value creation
‒ NDA/MAA approvals of CAM2038 in the US/EU
‒ Phase 3 programs in pain, acromegaly and NET
‒ Advancement of early stage clinical programs
‒ Pipeline expansion and business development
• Anticipated CAM2038 launch in 2018
‒ Braeburn launch US H1 2018
‒ Camurus launch Europe Q4 2018
‒ Geographical expansion in 2018/19
• Solid financial position
‒ Potential for significant near-term regulatory milestone payments, and royalty from sales
Camurus positioned for continued value creation
• De-risked, late stage, differentiated pipeline
‒ Multibillion dollar specialty markets
‒ Opioid addiction, pain, cancer, endocrine disease
• Strong collaborations with dedicated partners
‒ Novartis, Braeburn Pharmaceuticals, Rhythm, Solasia
‒ Early project collaborations with global pharma companies
• Emerging commercial organization
‒ Strong, internationally experienced leadership
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Experienced and committed management team
Fredrik Tiberg, PhD, Prof.
President & CEO
In Company since: 2002
Holdings: 1,512,551 shares & 130,000 subsc. warrants
Education: M.Sc. in Chemical Engineering, PhD in
Physical Chemistry, Lund University
Previous experience: Professor in Physical
Chemistry at Lund University, Institute for Surface
Chemistry (Section head), Visiting Professor at
Oxford University
Eva Pinotti-Lindqvist Chief Financial Officer
In Company since: 2014
Holdings: 36,391 shares & 25,882 subscript. warrants
Education: Bachelor’s of cience in Economics,
Lund University
Previous experience: EQL Pharma (CFO), Nordic
Drugs (Nordic Market Analyst), Poolia (Finance
Consultant)
Richard Jameson
Chief Commercial Officer
In Company since: 2016
Holdings: 16,395 shares & 80,000 subscript. warrants
Education: Bachelor’s of cience in Applied
Biological Sciences from University West of England
Previous experience: GM, UK and Nordics for
Reckitt Benckiser Pharmaceuticals Ltd (2010 –
2013) and Area Director Europe, Middle East and
Africa for Indivior PLC (2013 – 2016).
Fredrik Joabsson, PhD Vice President, Business Development
In Company since: 2001Holdings: 36,391 shares & 20,000 subscription warrants
Markus Johnsson, PhD Vice President, Pharma-ceutical & Analytical Dev.
In Company since: 2003Holdings: 45,363 shares & 20,000 subscription warrants
Margareta Linden, PhD Vice President, Project Management
In Company since: 2004Holdings: 36,291 shares & 25,000 subscript. warrants
Torsten Malmström, PhD Vice President, Technical Operations
In Company since: 2013Holdings: 36,391 shares & 20,000 subscription warrants
Rein PiirVice President, Investor Relations
In Company since: 2015Holdings: 5,275 shares
Agneta SvedbergVice President, Clinical & Regulatory Development
In Company since: 2015Holdings: 9,073 shares & 45,000 subscription warrants
Urban PaulssonVice President Corporate Dev.& General Counsel
In Company since: 2017Holdings: 6,500 shares & 75,000 subscript. warrants
Education: Master of Law from Lund University
Previous experience: More than 20 years
experience from the life science industry including as
legal counsel at Pharmacia and general counsel for
Vitrolife. Partner at law firms Bird & Bird and
Nordia Law.
Cecilia CallmerVice President, Human Resources
In Company since: 2017Holdings: 17,650 subscription warrants
25
Major shareholders 31 October 2017
26
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%
Value adding partnerships
CAM2038, CAM2048, CAM2058 CAM2029, CAM4071 + other products CAM4072
Field Opioid use disorder (OUD) and painAcromegaly, neuroendocrine
tumors and other indicationsGenetic obesity
Scope
• Exclusive license agreement for
North America; option to China,
Japan, Korea, and Taiwan
• Exclusive, worldwide, collaboration and
license agreement
• Exclusive license to FluidCrystal®
Injection depot for setmelanotide
Financials
• MUSD 20 received in upfront
license fee
• Development milestones, include;
○ MUSD 35 OUD
○ MUSD 21 pain
• Mid teen % royalties on sales
+ MUSD 75 in potential sales
milestones
• MUSD 50 received in upfront, option
exercise and development milestones
• MUSD 700 in total potential development
and sales milestones
• Mid to high single digit % royalties on sales
• MUSD 65 in development and
sales milestones
• Mid to mid-high single digit %
royalties on sales
“New Hope in The Search for Treatment
for Obesity”, WSJ, August 26, 2016”
27
Double-blind, enriched-enrollment study in opioid experienced low back pain patients on morphine equivalent doses of 40 mg/day or higher (Nest.=340)
Recruitment completed in pivotal Phase 3 chronic pain
study and safety extension studies of CAM2038.
Topline data expected early 2018
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Screening Transition Double-Blind treatment Follow-Up
2 Weeks Up to 10 Weeks 12 Weeks 4 weeks
Moderate tosevere lowerback pain, patients onhigh daily
dose of opioids(incl SL BPN)
CAM2038 q1w8-32 mg/week
Titrated to effecton a stable dose of
CAM2038
CAM2038 Placebo
CAM2038 q1w 8 -12 mg/day orCAM2038 q4w 64-128 mg/day
R
Open-label titration
2 Weeks
Down-titrationof opioid dose and
transitionedto IR morphine
(only if noton SL BPN)
Primary and key secondary endpoints:
Average and worst pain intensity as measured by 11-point numerical rating scale
Dissemination of CAM2038 data in publications and
at scientific conferences
2017 2018
Q1 Q2 Q3 Q4 Q1 Q2
Global
Conferences
European
Conferences
National
Conferences
Publications
ISAM
26-29 Oct
Abu Dhabi, UAE
29
Advances in Therapy
Albayatny et al,
2017: 34(2), 560-575
J. Subst. Abuse Treat.
Haasen et al,
2017: 78, 22-29
JAMA Psychiatry
Walsh et al,
2017: Published online
Phase 3 publications in progress
CPDD
17-22 Jun
Montréal,Canada
ISAM
26-29 Oct
Abu Dhabi, UAE
AMERSA
3-5 Nov
Washington DC
AAAP
8-11 Dec
San Diego, USA
ASAM
12-15 Apr
San Diego, USA
IOTOD
17-18 May
Berlin, Germany
Lisbon Addictions
24-26 Oct
Lisbon, Portugal
EUROPAD
25-27 May
Krakow, Poland
ATHS
17-20 Oct
Biarritz, France
SSA
9-10 Nov
Newcastle, UK
APSAD
12 -15 Nov
Melbourne, Australia
Spain
61,954
France
161,388
UK
148,686Germany
77,500
Nordic countries
16,535
Italy
75,964
30
Strong rationale for CAM2038 in Europe
and Australia
Ongoing pre-launch activities
• HEOR, pricing and market access
• Strategic marketing
• Medical affairs
• Policy and education
• Country operating models
Internationally experienced leadership team
• Market access, medical affairs, global commercial strategy, opioid dependence & pain
Establishment in key European markets & Australia
Headcount build-up following to launch sequence
• Specialist market with a concentrated prescriber base
• High unmet medical needs
• No significant innovation for more than a decade
• Paradigm shift in opioid dependence treatment
• Pricing and reimbursement supported by sizeablehealth and socio-economic benefits
Australia
50,000
