37
Company Presentation Pareto Securities Healthcare Conference 7 September 2017
Company Presentation
Pareto Securities Healthcare Conference7 September 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
2
Camurus in short
Innovation that delivers
‒ Leading technology platform, FluidCrystal®
‒ Late-stage product pipeline with 10 clinical programs
‒ Emerging European commercial organization
‒ Strong pharma partners
Patient centric product development
‒ Long-acting medications for better treatment outcomes and quality of life for patients
‒ Focus on attractive, underserved specialty markets
Entrepreneurial company
‒ Experienced management team
‒ 70 employees with 48 in R&D
‒ Headquarter in Lund, Sweden
10CLINICAL STAGE
PROGRAMS
CASH
413MILLION SEK
END Q2 2017
MARKET CAP
~4.5BILLION SEK
3
Strong delivery of results over the past year
• Positive Phase 2 results in opioiddependence and chonic pain
• Recruitment completed in pivotalPhase 3 chronic pain study
OTHER PIPELINE PROGRAMS
• Positive Phase 2 study results for CAM2029 in acromegaly and NET
CAM2038 – OUD & CHRONIC PAIN
• NDA submission for CAM2038 for Opioid Use Disorder (OUD)
• Positive Phase 3 long-term safety results
• Positive Phase 3 efficacy results
• Positive Phase 2 opioid blockade results
• Start of new Phase 1 study ofCAM2047/58 for nausea and pain
• Positive Phase 1a study of weeklysetmelenotide for genetic obesitywith Rhythm
• Completion of stage 1 in buildingEuropean commercial orgaization
4
Cost effective and risk mitigated product development strategy
- combining clinically documented APIs with leading and proven technologies
Decreased time to market505(b)(2), hybrid regulatory pathway
Deeper market penetrationBest-in-class treatment potential
Expanding end of cycle salesStrong and extended IP protection
Building value throughout the medical product life-cycle
5
FluidCrystal® injection depot
for long-lasting treatment effects
FluidCrystal® key attributes
✓ Easy and convenient administration
✓ Rapid onset & long-acting release
✓ Good safety profile
✓ Applicable across substance classes
✓ Standard manufacturing processes
+400 PATENTS &
APPLICATIONS
~1500 SUBJECTS HAVE
RECEIVED >15,000
INJECTIONS IN
CLINICAL TRIALS
6
FluidCrystal® injection depot Immediate release octreotide (Sandostatin®)
FluidCrystal® injection depot for long-acting delivery
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
7
Example: CAM2029 vs. Sandostatin® LAR® and Somatuline® Autogel®
FluidCrystal® product can offer enhanced design
features over existing depot technologies
8
CAM2029 10, 20 mg1
0.5 -1.0 mL/ready-to-use/subcutaneous
no reconditioning/room temperature
Based on FluidCrystal® system
Sandostatin® LAR® 10, 20, 30 mg 2.0 mL/reconstitution/intramuscular
refrigerated/30-60 min reconditioning
Based on PLGA microsphere system
Somatuline® Autogel® 60, 90, 120 mg0.2-0.5 mL/ready-to-use/subcutaneous
refrigerated ≥ 30 min reconditioning
Self-associated gel
✓No reconstitution
✓Small volume
✓Thin needle
Note: 1) Illustrative. Final product configuration may be different.
Late-stage diversified pipeline
99
Value creation through strategic partnerships
CAM2038, CAM2048, CAM2058 CAM2029, CAM4071 + other products CAM4072
Field Opioid dependence and painAcromegaly, neuroendocrine
tumors and other indicationsGenetic obesity
Scope
• Exclusive license agreement for
North America, with option to
China, Japan, Korea, and Taiwan
• Exclusive, worldwide, collaboration and
license agreement
• Exclusive license to FluidCrystal®
Injection depot for setmelanotide
Financials
• USD 22 million in upfront license
fee received
• USD 130 million in total potential
development and sales milestones
• Mid teen % royalties on sales
• 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 65 million in potential
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”
10
Weekly and monthly buprenorphine depots
Changing the treatment paradigm in opioid dependence
CAM2038
Why focus on opioid dependence?
Growing global public health crisis
• Largest society burden of all drugs1
• 4 million diagnosed patients in the US and Europe, less than half in treatment2,3
• Escalating opioid overdose deaths in the US and Europe
Investment in treatment adds significant value
• Up to 12 dollars saved for each dollar spent on treatment5
High unmet medical need
• Limited treatment adherence
• Risks of relapse and overdose
• Burden and stigma of daily medication
• Medication diversion and misuse
• Exposure to children and teenagers
• Supervision and related treatment costs
• Inadequate access to treatment
Concentrated, accessible target prescriber base
~8,000 US
~7,500 Europe
Large market
• 2.7 billion USD in 20166 (US only)
• Growing at 23% CAGR
• Clear unmet need makes opportunities for differentiated new products
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 2017; 4. Hser et al. Harvard Review Psychiatry1 2015; 23: 76-89; 5. Center for Disease Control & Prevention 2016; 6. QuintilesIMS National Sales
Perspectives (NSP) June 2017
>33,000OPIOID OVERDOSE
DEATHS IN THE US
20154
~7000OVERDOSE
DEATHS IN
EUROPE 20163
12
$0,1 $0,1 $0,1 $0,1 $0,1 $0,1
$0,8
$1,5$1,6
$1,7 $1,8$2,0
$0,1$0,1
$0,3
$0,0
$0,1
$0,1
$0,1
$0,2
$0,3
0,0
0,5
1,0
1,5
2,0
2,5
3,0
2011 2012 2013 2014 2015 2016
US
sale
s $
bill
ions
buprenorphine buprenorphine/naloxone naloxone naltrexone
Large and growing market
$1.6B in 2016
$23M in 2016
$134M in 2016
$296M in 2016
US market dominated by
branded products
Source: QuintilesIMS National Sales Perspectives (NSP) June 2017
13
CAM2038 – individualized treatment of opioid dependence
from initiation and stabilization to maintenance treatment
Weekly and monthly subcutaneous depots – each provided in multiple small volume fixed dosages in prefilled syringes with a safety device, stored at room temperature
”New to treatment” patients
Patients in treatment
Transmucosal
buprenorphine
Inititation
(induction)Stabilization
Maintenance
treatment
Weekly
CAM2038Weekly
CAM2038Monthly
or Weekly
CAM2038
14
CAM2038 addresses key unmet medical needs
Rapid and sustained withdrawal
suppression
Opioid blockade from first
dose
Long-actingtreatment
effect
Adherence to treatment– no daily
supervision
Improved treatment outcomes
No diversion, misuse and
pediatric exposure
15
U.S FDA EMA, Europe
• Pre-IND meeting: 13 March 2012
• End of Phase II meeting: 24 February 2015
• Fast Track Designation: 10 July 2015
• Pre-NDA Meeting: 16 March 2017
• NDA Submission: 19 July 2017
• CHMP Scientific Advice: 22 October 2015
• Pre-MAA with EMA: 19 January 2017
• MAA submission under validation
TGA, Australia
• Pre-submission meeting: 17 July 2017
Comprehensive clinical program completed
✓ 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
CAM2038 Development milestones
16
17
PharmacokineticsFour clinical trials in healthy volunteers and opioid
dependent patients
PharmacodynamicsA double-blind, randomized within-patient, opioid
challenge study in adults with moderate-to-severe
opioid use disorder
Phase 3 efficacyA 24-week, randomized, double-blind, double-dummy
study assessing efficacy and safety of CAM2038
versus daily SL buprenorphine/naloxone
Phase 3 long-term safetyA 48-week, multinational, open-label study assessing
long-term safety and efficacy of CAM2038
Comprehensive CAM2038 clinical program
Weekly CAM2038 – Daily SL BPN Monthly CAM2038 – Weekly CAM2038
Steady-state population PK profiles from data for
weekly and monthly CAM2038 versus daily SL BPN
18
Population PK analysis and modelling based on data four clinical studies (N=236). Diagnostic testing demonstrated
predictive BPN concentrations and good agreement between observed and predicted data percentiles
Rapid and sustained suppression of withdrawal from the first CAM2038 dose
Effective withdrawal suppression
0
3
6
9
12
48
To
tal C
OW
S S
co
re
BL 1 2
Treatment Days
3 4 5 6 7 8 9 10 11 12 13 14
CAM2038 24 mg
CAM2038 32 mg
Weekly CAM2038
Injection 2
Weekly CAM2038
Injection 1Withdrawal COWS Score
– <5
Mild 5-12
Moderate 13-24
Moderate to
Severe
25-36
Severe >36
19
Source: Walsh S. et al, JAMA Psych. 2017
Clinical opiate withdrawal scale
(COWS) scores from Phase 2
study (HS-13-478), N=47
Rapid and sustained blockade of opioid effects from the first CAM2038 dose
Effective blockade of opioid effects
CAM2038 q1w 24 mg
CAM2038 q1w 32 mg
0
40
50
70
80
100
Pe
ak S
co
re (
mm
)
0 6 18
Hydromorphone (mg, IM)
0 6 18 0 6 18 0 6 18 0 6 18
Qualification (Days 1-3) (Days 4-6) (Days 1-3) (Days 4-6)
Weekly CAM2038
Injection 1
60
90
11 pt. difference
Prespecified complete blocking
criteria Neutral
Strong Disliking
Strong Liking
Weekly CAM2038
Injection 2
20
Source: Walsh S. et al, JAMA Psych. 2017
“At this moment, my liking for
this drug is” data from Phase 2
study (HS-13-478), N=47
Phase 3 randomized, double-blind, double-dummy efficacy study (HS-11-421), N=428
First head-to-head pivotal efficacy study of a
long-acting injection depot versus daily standard
treatment with SL BPN/NX
Screening Phase 1: Weekly Visits Phase 2: Monthly Visits Follow-Up
3 Weeks 12 Weeks 12 Weeks 1 Month
Treatment-seeking adults
with opioid use disorder
SL BPN/NX8-24 mg/day
Weekly CAM2038 Placebo
SL BPN/NX8-32 mg/day
Monthly CAM2038 Placebo
SL PlaceboWeekly CAM2038
8-32 mg/week
SL PlaceboMonthly CAM203864-160 mg/month
R
21
22
Demographics and baseline characteristics
representative of treatment seeking populations
CO
NF
IDE
NT
IAL
Study population with high proportion heroin, polydrug and injection use
SL BPN/NX
(n=215)
CAM2038
(n=213)
Age, years 38 (10.9)* 39 (11.2)*
Male 142 (66%) 121 (57%)
White 164 (76%) 159 (75%)
Body mass index, kg/m2 26 (5.6)* 26 (5.0)*
Employed full time or part time 72 (34%) 76 (36%)
History of any arrest 144 (67%) 130 (61%)
Primary opioid of use
Heroin 151 (70%) 152 (71%)
Prescription opioids 64 (30%) 61 (29%)
SL BPN/NX
(n=215)
CAM2038
(n=213)
Injection opioid use 110 (51%) 114 (54%)
Non-opioid drug use at screening
Total non-opioid drug use 149 (69%) 155 (73%)
Amphetamine 32 (15%) 38 (18%)
Benzodiazepine 35 (16%) 30 (14%)
Cocaine 53 (25%) 53 (25%)
Marijuana 64 (30%) 57 (27%)
Opioid craving; need to use VAS
score (0–100)
76 (24.9)* 77 (25.4)*
Clinical opiate withdrawal scale
score (0-48)
12 (6.0)* 12 (5.4)*
Subjective opiate withdrawal scale
score (0-64)
31 (16.1)* 32 (15.4)*
* Mean (SD)
Study met primary endpoints of non-inferiority
for CAM2038 vs. daily SL BPN/NX
CAM2038 vs SL BPN/NXTreatment difference
mean (95%CI) Non-inferiority (NI)
Non-InferiorityP value
EMA:Primary Efficacy Endpoint - Mean % Urine SamplesNegative for Illicit Opioids
6.7% (-0.1%, 13.3%) <0.001
FDA:Primary Efficacy Endpoint - Response Rate
3.4% (-3.5%, 10.4%)<0.001
-0,2 -0,1 0 0,1 0,2
Difference (95% CI)
Favors CAM2038Favors SL BPN/NX
11%
10%
NI margin
NI margin
23
EMA and FDA primary endpoints in Phase 3 (HS-11-421) study, N=428
CO
NF
IDE
NT
IAL
CDF for urine samples + self reports negative for illicit opioids (weeks 4-24)
Superiority for CAM2038 versus SL BPN/NX
24
CAM2038 superior to BPN/NX for first secondary endpoint
of CDF for percent of no illicit opioid use (FDA)
a Secondary endpoint for FDA; b Primary endpoint in RB-US-13-0001; c Including 2-week
open label phase in RB-US-13-0001. Adjustment for multiplicity was made by a closed
testing procedure to preserve family-wise type 1 error at 0.05. CDF – cumulative
distribution function
Grace
period
(weeks)
Treatment
weeks
Superiority
P-value
CDF
0 1-24 0.006
1 2-24 0.005
3a 4-24 0.004
4b 5-24 0.001
6c 7-24 0.001
CO
NF
IDE
NT
IAL
CDF = Cumulative distribution function
Clinical data suggest that CAM2038 is safe and effective and
may transform the treatment of opioid dependence
25
✓ Efficacy and safety demonstrated versus active control
FDA and EMA primary endpoints met in pivotal Phase 3 study
CAM2038 superior to daily sublingual buprenorphine for cumulative illicit opioid use (CDF)
Craving and withdrawal symptoms effectively suppressed across the study treatment
✓ Consistent long-term safety profile and treatment effect
Safety profile consistent with shorter term studies and daily sublingual buprenorphine products
High treatment retention observed for both new to treatment and transferred patients
✓ Opioid blockade from the first administered dose
✓ Dose-proportional pharmacokinetics with both weekly and monthly durations
Flexible and individualized treatment across all medication assisted treatment phases
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
APSAD
12 -15 Nov
Melbourne, Australia
AMERSA
3-5 Nov
Washington DC
AAAP
8-11 Dec
Florida, USA
CPDD
17-22 Jun
Montréal,Canada
ASAM
12-15 Apr
San Diego, USA
ATHS
17-20 Oct
Biarritz, France
SSA
9-10 Nov
Newcastle, UK
ALBATROS
31 May – 2 Jun
Paris, France
IOTOD
17-18 May
Berlin, Germany
Lisbon Addictions
24-26 Oct
Lisbon, Portugal
EUROPAD
25-27 May
Krakow, Poland
26
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
Publications in progress
Randomized, double-blind, enriched-enrollment withdrawal design (Nest.=340)
CAM2038 for treatment of chronic pain:
Recruitment completed in pivotal Phase 3 study
27
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
Global commercialization strategy for CAM2038
Braeburn markets Braeburn option rightCamurus markets
2.5mdiagnosed opioid
dependent in the US
1.3mopioid problem users
in Europe
187kopioid dependent
in Australia
1.3mregistered heroin users
in China
28
Preparing for launch of CAM2038 in Europe
Strong rationale for CAM2038 in Europe
‒ Specialist market
• 650,000 patients in treatment
‒ High unmet need
‒ Ongoing paradigm shift
‒ Sizeable health and socio-economic benefitscan support pricing and reimbursement
‒ Accessible and concentrated prescriber base
‒ Planned EU launch during second half of 2018
Spain
61,954
France
161,388
UK
148,686Germany
77,500
Nordic countries
16,535
Italy
75,964
Patients in opioid dependence treatment by country
29
Large interest in CAM2038 among European
physicians
Country Physicians willingness to prescribe CAM20381 % patients*: q4w q1w
Large markets with high willingness to prescribe weekly and monthly depots
86%
94%
86%
96%N=50
Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015 * % patients considered suitable for CAM2038 by surveyed physicians if available on the market
N= 47
31%
30%
36%
25%
N= 4843%
27%
39%
22%
N=51
N=50
N=50
30
31
Building the marketing & sales organization in Europe
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
Headcount build up according to launch sequence
2016
• EU commercial leadership team in place
• GMs in early reimbursed markets
• Pricing, market access, medical affairs
2017
• Regional leadership teams early reimbursed markets
• GMs 2nd wave markets
2018
• Regional leadership teams 2nd wave markets
• Full key account teams for CAM2038 launch
✓ ✓
Anticipated near-term news flow
32
PARTNERS PRODUCT EVENT TIME
CAM2038 Opioid dependence MAA validation by EMA
NDA acceptance for review by FDA
NDA approval (if granted priority review)
Q3 2017
Q3 2017
Q1 2018
CAM2038 Chronic pain Phase 3 efficacy results Q1 2018
CAM2029 Acromegaly & NET* Phase 3 initiation 2017-18
CAM2047 CINV Phase 1 results Q3 2017
CAM2048 Pain
CAM2058 Pain, nausea and vomiting
Phase 1 results
Phase 1 results
Q3 2017
CAM2043 PAH Phase 1 start Q4 2017
Weekly setmelanotide Genetic obesity Phase 1 (Part B), results H2 2017
32
• 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 H2 2018
‒ Planned geographical expansion 2019
• Solid financial position
‒ Potential for significant near-term regulatory milestones, and royalty from sales
Camurus positioned for continued value creation
• De-risked, late stage, differentiated pipeline
‒ Multi-billion dollar specialty pharmaceutical 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, experienced leadership in place
33
Backup slides
35
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 Science 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 Science 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
36
37
Solid financial position with continued investments
in late-stage development programs
Key figures, mSEK2017 2016
FY
2016
Q2 H1 Q2 H1
Revenues 19.1 36.3 25.8 46.1 113.7
Operating result -58.7 -110.3 -25.9 -50.7 -102.5
Cash 413.4 549.0 508.6
Total assets 570.4 660.3 639.8
Equity 488,9 603.8 564.4
Revenues
Operating expenses
0
50
100
150
200
250
2012 2013 2014 2015 2016
Licens-betalningar
Milstolpes-betalningar
Försäljning varor ochtjänster
0,0
50,0
100,0
150,0
200,0
250,0
2012 2013 2014 2015 2016
Forskning &utveckling
Marknad &försäljning
Administration
