Camurus Capital Markets and R&D Day 2016
Camurus
Advancing late stage pipeline
with high market potential
Presentation, 14 December, 2016
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
2Camurus Capital Markets and R&D Day, December 14, 2016
Camurus’ Capital Markets and R&D Day agenda
Time Topic Presenter
13:00 – 13:30 Registration and coffee
13:30 – 14:45 Welcome and introduction Fredrik Tiberg, CEO and Head R&D
Rein Piir, VP IR
The FluidCrystal® technology Markus Johnsson, VP Pharm. Dev.
Weekly and monthly buprenorphine depots
(CAM2038): Overview and clinical development
update
Peter Hjelmström, Senior Director Medical Affairs
Fredrik Tiberg, CEO and Head R&D
Clinician’s view on long-acting depots for opiod use
disorder – a potential new treatment paradigm
Edward Nunes, MD, Professor of Psychiatry
Columbia University Medical Center
14:45 – 15:00 Q&A Lars Frick, Moderator
15:00 – 15:20 Refreshments
15:20 – 16:45 CAM2038: US market perspectives Behshad Sheldon, CEO Braeburn Pharmaceuticals
CAM2038: EU market perspectives and
commercialisation
Richard Jameson, CCO
Advancing the pipeline: Late and early stage projects
update
Fredrik Tiberg, CEO and Head R&D
Markus Johnsson, VP Pharm. Dev.
16:45 – 17:00 Conclusions and Q&A Lars Frick, Moderator
3Camurus Capital Markets and R&D Day, December 14, 2016
Camurus in brief
• Innovation that delivers
− Award-winning FluidCrystal® technology
− Late-stage, diversified pipeline
− Strong, strategic 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 culture
− Strong, experienced management team
− 63 employees with 45 in R&D
− Agile, passionate, collaborative and
result focused
4
LISTED ON
NASDAQ
STOCKHOLM3rd DEC, 2015
MARKET CAP
~450million USD
CASH POSITION
60million USD
END Q3 2016
Camurus Capital Markets and R&D Day, December 14, 2016
Building value throughout the medical product life-cycle
5
Time and cost-effective development of innovative and differentiated medications
− combining clinically documented APIs with leading and proven technologies
Value
created
Value
Spent
Time
Decreased time to market505(b)(2), hybrid regulatory pathway
0
Value
created
Value
Spent
Time
Deeper market penetrationBest-in-class treatment potential
0
Value
create
d
Value
Spent
Time
Expanding end of cycle salesLong-acting barriers to generics
0
Camurus Capital Markets and R&D Day, December 14, 2016
6
Late-stage, diversified pipeline with block-buster potential
PARTNERS PRODUCT PRECLINICAL PHASE 1/2 PHASE 3 REGISTRATION
CAM2038 Weekly Opioid dependence
CAM2038 Monthly Opioid dependence
CAM2038 Weekly Chronic pain
CAM2038 Monhly Chronic pain
CAM2029 Neuroendocrine tumours
CAM2029 Acromegaly
CAM2032 Prostate cancer
CAM4071 Not disclosed
CAM2047 CINV*
CAM2048 Pain
CAM2058 Pain, nausea and vomiting
Camurus Capital Markets and R&D Day, December 14, 2016
*CINV Chemotherapy nausea and vomiting
7
Pipeline expansion with new attractive preclinical candidates
PARTNERS PRODUCT PRECLIN PH 1/2 PH 3 REG
CAM4072 Genetic obesity
CAM2043 PAH*
CAM2046 Diabetes
STATUS
Rhythm preparing to enter clinical
development in 2017
GLP tox ongoing. Initiation of
clinical development H1 2017
Formulation development
Several early stage collaborations
with pharma partnersFormulation development
Camurus Capital Markets and R&D Day, December 14, 2016
*PAH: Pulmonary arterial hypertension
PRODUCT EVENT TIME
CAM2038 Opioid dependence • Positive top-line pivotal Phase 3 efficacy trial
• Completed enrollment in Phase 3 long-term safety trial
• Positive results from Phase 2 opioid challenge trial
November
April
May
CAM2038 Chronic pain • First patient enrolled in Phase 3 efficacy trial
• Completed enrollment in pivotal Phase 2 chronic pain trial
September
April
CAM2029 Acromegaly & NET* • Positive results from Phase 2 trial in acromegaly and NET July
CAM2032 Prostate cancer • Positive results from Phase 2 trial in prostate cancer June
CAM4071 Not disclosed indication • Phase 1 clinical trial completed June
CAM2047 CINV**
CAM2048 Pain
CAM2058 Pain & nausea and vomiting
• Initiation of clinical Phase I trial October
8
Clinical pipeline highlights in 2016
*NET: Neuroendocrine tumours
**CINV: Chemotherapy induced nausea and vomiting
Camurus Capital Markets and R&D Day, December 14, 2016
9
Year highlight. Positive topline Phase 3 results
Camurus Capital Markets and R&D Day, December 14, 2016
Camurus Capital Markets and R&D Day 2016
FluidCrystal® technology
10
Markus Johnsson, PhD, VP Pharm. Dev.
FluidCrystal® technology
The FluidCrystal® technology is based on
functional liquid crystal nanostructures
FluidCrystal® injection depot
FluidCrystal® topical bioadhesive
FluidCrystal® nanoparticles
water PC
GDO
H2
La
I2
L2
11Camurus Capital Markets and R&D Day, December 14, 2016
12
FluidCrystal® injection depot: How it works
In situ gelling principles
Camurus Capital Markets and R&D Day, December 14, 2016
FluidCrystal® injection depot: How it works
13Camurus Capital Markets and R&D Day, December 14, 2016
FluidCrystal® injection depot: Tuning of release rates
14
In vitro release (37°C) of model drug substance
Camurus Capital Markets and R&D Day, December 14, 2016
Convenience
Treatment
adherence
Efficacy
FluidCrystal® injection depot: Focus on the patient
0
1
10
100
0 7 14 21 28
Pla
sm
a B
PN
concentr
ation (
ng/m
L)
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, SL = sublingual
15Camurus Capital Markets and R&D Day, December 14, 2016
FluidCrystal® injection depot
• Scope
‒ Broadly applicable across molecular classes; small
molecules, peptides and proteins
16
Buprenorphine MW 468 g/mol
Octreotide MW 1019 g/mol
Glucagon-like Peptide 1 MW 3356 g/mol
Broadlyapplicable
Camurus Capital Markets and R&D Day, December 14, 2016
FluidCrystal® injection depot
17
• Safety
‒ Natural (endogenous) lipid components
‒ Biocompatible solvents
‒ Biodegradable liquid crystal matrix
‒ ~1500 subjects have received >10,000 injections in
clinical trials
Phosphatidylcholine (abundant cell membrane lipid)
Glycerol dioleate (first metabolite of standard triglyceride such as olive oil)
Safe
Camurus Capital Markets and R&D Day, December 14, 2016
FluidCrystal® injection depot
• Function
‒ Efficient encapsulation of drugs in liquid crystal
structure
‒ Immediate onset of release
‒ Long-acting treatment, from weeks to months
‒ Tunable release rates by simple means
18
0,01
0,1
1
10
100
1000
0 5 10 15 20 25 30
Pla
sm
a c
oncentr
ation (
ng/m
L)
Time (days)
FC pasireotide
FC octreotide
FC somatostatin 1-14
Single dose injection at t=0; n=6 (SC); rodent; mean values
Effective
Camurus Capital Markets and R&D Day, December 14, 2016
FluidCrystal® injection depot
• Scale
‒ Commercially available high quality sources of key
components
‒ Manufacturing using conventional pharmaceutical
processing steps
‒ Straightforward up-scaling
Compounding Filtration Filling
Scalable
Camurus Capital Markets and R&D Day, December 14, 2016 19
FluidCrystal® injection depot
• Convenience
‒ Compatible with pre-filled syringes
‒ Compatible with injection aid devices such as
autoinjectors
‒ Enabling patient self-administration
Convenient
Camurus Capital Markets and R&D Day, December 14, 2016 20
Active intellectual property strategy supporting FluidCrystal®
• Intellectual property status
‒ 35 patent families
‒ More than 400 approved and/or pending patents
‒ Solid IP position for the FluidCrystal® technology with
patent coverage at least until 2025 and up to 2032
‒ Product-specific patents covering internal and
partnered products
‒ IP portfolio covering all major markets (US, EU-5,
Japan)
21
FluidCrystal® injection depot for longer lasting treatment effects
Long-acting release with weekly and monthly dosing
Good safety and local tolerability
Easy and convenient dosing
Applicable across substance classes
Standard manufacturing processes
~1500SUBJECTS HAVE
RECEIVED >10,000
INJECTIONS IN
CLINICAL TRIALS
22Camurus Capital Markets and R&D Day, December 14, 2016
Camurus Capital Markets and R&D Day 2016
CAM2038
Opioid dependence overview
23
Peter Hjelmström, MD, PhD, Sen. Dir., Medical Affairs
6,0 6,27,3
9,510,6
11,712,9
15,816,8
17,818,9
19,7
21,3 21,9
24,5
28,630,1
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
20
10
20
11
20
12
20
13
20
14
20
15
Opioid dependence is a growing global health problem
• 33 million people misuse opioids globally
‒ Largest society burden of all drugs1
‒ About 4 million diagnosed patients in Europe and the US
‒ About 2 million in treatment (Europe and US2,3)
• Escalating opioid crisis
‒ 207,400 drug related deaths worldwide
• 30,000 US opioid overdose deaths in 2015,
12,990 from heroin (+23%).
• Growing concerns in Europe with at least 6,800
overdose deaths in 20144
• A chronic relapsing disease
‒ Opioid-use trajectories show that the disease is chronic
with less than 30% abstinence achieved over time
‒ Opioid dependence mortality continues to increase over
time6
US overdose epidemic4
Thousands
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 2015; 4. Center for Disease Control & Prevention 2016; 5. Toxreg 2016; 6. Hser et al. Harvard Review Psychiatry 2015; 23: 76-89
24
0
100
200
300
400
500
600
700
800
900
1000
Heroin Non-heroin opioids Other drugs
Opioid deaths in Sweden5
Annual deaths with illicit drugs or opioid pharmaceutics
present during forensic examination
Camurus Capital Markets and R&D Day 2016
Issues with current daily treatments of opioid dependence
• Buprenorphine and methadone has demonstrated efficacy in the treatment of opioid use disorders
‒ Suppress opioid withdrawal symptoms
‒ Reduce craving for opioids
‒ Produce blockade of opioids
• These all lead to reduced illicit drug use
‒ Creates a sustained opportunity to address other psychosocial issues
• Large scientific evidence base of efficacy
• On the World Health Organization’s Essential Medicines List
Camurus Capital Markets and R&D Day, December 14, 2016 25
• Limited treatment adherence with continued illicit opioid use and treatment discontinuations
• Extensive misuse and diversion of medications
• Accidental pediatric exposure
• Safety concerns incl. respiratory depression and overdoses and cardiac events (e.g. methadone)
• Need for daily and often supervised dosing, resulting in inconvenience, stigma and reduced quality of life for patients as well as burdens to the healthcare and criminal justice systems
Medication assisted treatment (MAT) Limitations of medication assisted treatment
Source; 1. Benyamina and Stöver, Heroin Addict Relat Clin Probl 2012; 14(4): 65-80
Potential benefits of a sustained release buprenorphine formulation
• Reduces need for daily dosing and decisions
‒ Convenient for the patient
‒ Less staffing for supervision
• Reduces need for substantial drug supply at home
‒ Reduces risk of overdose, accidental ingestion
‒ Minimizes risk of misuse, abuse, diversion and theft
• Providing more stable blood levels over time
• Physician can be confident that patient has appropriate dose
exposure (adherence)
Camurus Capital Markets and R&D Day, December 14, 2016 26
Camurus Capital Markets and R&D Day 2016
CAM2038
Clinical development update,
Phase 3 results, and pathway
to market registrations
27
Fredrik Tiberg, PhD, CEO and Head R&D
Flexible and individualized opioid dependence treatment– across treatment phases
Treatment initiation
- induction
Weekly CAM2038
Stabilization Weekly
CAM2038Maintenance
treatment
Monthly or Weekly CAM2038
Camurus Capital Markets and R&D Day, December 14, 2016 28
Weekly and monthly CAM2038 are administered as small dose volumesubcutaneous (SC) injections by a prefilled syringe with a thin 23G needle
Development strategy for CAM2038 for opioid dependence
• Demonstrate efficacy and safety for weekly and monthly CAM2038 for opioid dependence treatment
‒ Versus sublingual (SL) buprenorphine/naloxone “Standard of Care”
‒ Across treatment phases – from initiation and early stabilization to longer-term maintenance treatment
‒ Flexible and individualized treatment regimen
• Development program aligned with FDA and EMA/CHMP advices and includes SL buprenorphine and buprenorphine/naloxone as active comparators
‒ Phase 1 pharmacokinetic studies of weekly & monthly CAM2038 versus SL and IV buprenorphine (EU)
‒ Phase 2 opioid challenge study of opioid blocking and withdrawal suppression by weekly CAM2038 (US)
‒ Phase 3 double-dummy, double-blind efficacy study of weekly & monthly CAM2038 versus SL buprenorphine/naloxone (US)
‒ Phase 3 long-term, open-label, safety study of weekly & monthly CAM2038 (EU, AUS, and US)
• Additional studies
‒ Phase 2 pharmacokinetic and pharmacodynamic study of weekly CAM2038 (EU)
‒ Phase 2 pharmacokinetic study of weekly and monthly CAM2038, including different SC injection sites (US)
• Supportive of global market registration approvals
Camurus Capital Markets and R&D Day, December 14, 2016 29
Clinical program for CAM2038 in opioid dependence
HS-11-426 Phase 1 60 healthy volunteers
under naltrexone block
HS-13-487 Phase 1 87 healthy volunteers
under naltrexone block
HS-07-307 Phase 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-14-478 Phase 2
HS-14-549 Phase 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
Positive results
Under completion
HS-11-421 Phase 3
HS-14-499 Phase 3
Double blind, double dummy Phase 3 efficacy trial of CAM2038 versus sublingual
buprenorphine (US)
Open label Phase 3 long-term safety trial in patients with opioid dependence (EU, US,
AUS)
Positive results
Under completion
Good safety
and local
tolerability for
CAM2038,
weekly and
monthly
formulations
7COMPLETED
OR ONGOING
CLINICAL TRIALS
+900STUDY
PARTICIPANTS
DOSED WITH
CAM2038 OR
PLACEBO
30Camurus Capital Markets and R&D Day, December 14, 2016
Pivotal Phase 2 opioid challenge study with weekly CAM2038
• Randomized, multiple-dose opioid challenge
study to assess blockade of subjective opioid
effects by weekly CAM2038 in adults with opioid
use disorder
• N=47
• Treatment with two weekly CAM2038
subcutaneous (SC) injections
• Opioid challenges with randomized
hydromorphone intramuscular (IM) injections
before CAM2038 dosing and on Days 1-3, 4-6,
8-10, and 11-13 of treatment
31
• Visual Analog Scores
‒ Primary: Drug Liking [bipolar scale]
‒ Secondary: Good Effects, High, Bad Effects, Any
Drug Effect, Desire to Use [unipolar scale],
Alertness/Drowsiness [bipolar scale]
• Opioid Withdrawal
‒ Clinical opioid withdrawal scale (COWS)
‒ Objective opioid withdrawal scale (OOWS)
• Pharmacokinetic Outcomes
• Safety Outcomes
Study design Key Primary and Secondary Outcomes
Camurus Capital Markets and R&D Day, December 14, 2016
CAM2038 shows rapid and sustained opioid blockade
“At this moment, my liking for this drug is”
32
Presentation, S27, ISAM & CSAM-SMCA 2016 Montreal, Canada Oct 20-22, 2016, Sharon L Walsh, Sandra Comer, Michelle Lofwall, Bradley Vince, Debra Kersh, Marion A Coe,
Jermaine D Jones, Fredrik Tiberg, Behshad Sheldon, Sonnie Kim. http://www.csam-smca.org/resources-and-documents/past-annual-meeting-presentations/2016-abstracts/
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
Camurus Capital Markets and R&D Day, December 14, 2016
CAM2038 show effective suppression of withdrawal
Effective suppression of clinical opiate withdrawal scale (COWS) scores from treatment initiation
33
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 1
Camurus Capital Markets and R&D Day, December 14, 2016
WithdrawalCOWS
Score
– <5
Mild 5-12
Moderate 13-24
Moderate to
Severe
25-36
Severe >36
Phase 3 efficacy study of weekly and monthly CAM2038
• 24-week, double-blind, double-dummy,
randomized, active-controlled Phase 3 study
‒ Treatment-seeking patients with moderate to severe
opioid use disorder, not currently on medication
assisted treatment (MAT)
‒ Assessed from treatment initiation to maintenance
‒ Non-inferiority and superiority objectives
‒ CAM2038 vs. sublingual buprenorphine/naloxone
BPN/NX – “Standard of Care”
34
• Primary Endpoint
‒ EMA: Negative Urines with NI margin of -11%
‒ FDA: Response Rate* with NI margin of -10%
• Key Secondary Endpoint:
‒ EMA: Cumulative Distribution Function (CDF)
of urines negative for illicit opioids from Week 5 to 25.
(Sampling Weeks)
‒ FDA: CDF of negative urines plus self-reports
negative for illicit opioids from Week 5 to 25
(Sampling Weeks).
‒ Multiple additional secondary and explorative
endpoints: retention; craving, morning cravings,
withdrawal (SOWS and COWS)
Study design Key Primary and Secondary Outcomes
Camurus Capital Markets and R&D Day, December 14, 2016
* Responder defined as displaying negative urine samples, including self-reports, for;
treatment week 12 and month 6, at least 2 of treatment weeks 9, 10 and 11 and 12,
and at least 5 of the 6 samples obtained during treatment weeks 12 through 24.
Comparison between pivotal Phase 3 studies of CAM2038 versus RBP-6000
CAM2038 Phase 3 study (HS-11-421) RBP-6000 Phase 3 study (RB-US-13-0001)
Active controlled study (non-inferiority & superiority
analysis)
Placebo controlled study (superiority analysis)
Primary and key secondary study endpoints were
aligned with EMA/CHMP and FDA advices
The primary endpoint was “the regulatory-agreed
primary endpoint of the study”
Study included treatment initiation (induction) and
early stabilization (double-blind, double-dummy)
Study excluded up to 2 weeks of open-label
treatment initiation (induction) and early stabilization
Primary endpoints included entire treatment period Primary endpoint excluded a 4-week ”Grace Period”
- effectively 6 weeks, including the open label phase
Excluded patients with moderate-to-severe non-opioid
substance use disorders, but allowed positive UDS for
e.g. benzodiazepines, cocaine, methamphetamine,
marijuana.
Excluded patients with substance use disorders (other
than: mild cocaine and cannabis if UDS negative at
screening; mild alcohol or nicotine use disorders).
Camurus Capital Markets and R&D Day, December 14, 2016 35
Abbreviation: UDS, urine drug screen
Pivotal phase 3 study design. Randomized, double-blind, double-dummy study of CAM2038 vs. SL buprenorphine/naloxone (N=428)
Camurus Capital Markets and R&D Day, December 14, 2016 36
Screening Phase 1: Weekly Visits Phase 2: Monthly Visits Follow-Up
3 Weeks 12 Weeks 12 Weeks 1 Month
Opioid dependentpatients seeking
treatment
SL BPN/NX8-24 mg/day
CAM2038 q1w Placebo
SL BPN/NX8-32 mg/day
CAM2038 q4w Placebo
SL PlaceboCAM2038 q1w8-32 mg/week
SL PlaceboCAM2038 q4w
64-160 mg/month
R
Subject demographics in Phase 3 trial, HS-11-421
Camurus Capital Markets and R&D Day, December 14, 2016 37
SL BPN/NX
N=215
CAM2038
N=213
TOTAL
N=428
Mean age 38 39 38
Male / Female 66% / 36% 57% / 43% 61% / 39%
Race
White 76% 75% 76%
Black or African American 22% 22% 22%
Others 1% 3% 2%
Mean height 173 cm 172 cm 172 cm
Mean BMI 26 kg/m2 26 kg/m2 26 kg/m2
Baseline clinical characteristics show representative patient population with significant non-opioid drug use at screening
Camurus Capital Markets and R&D Day, December 14, 2016 38
Participant demographics SL BPN/NX
N=215
CAM2038
N=213
TOTAL
(N=428)
Drug use history
Heroin 70% 71% 71%
Prescription opioid pain relievers 28% 26% 27%
Substance use at screening, e.g.: 55% 60% 58%
Benzodiazepine 16% 14% 15%
Cocaine 25% 25% 25%
Amphetamine 15% 18% 16%
Marijuana 30% 27% 28%
Psychatric disorder history
Anxiety 19% 14% 16%
Attention deficit/hyperactivity disorder 5% 5% 5%
Depression 13% 12% 12%
CAM2038 vs SL BPN/NX 95%CI Non-inferiority (NI)Non-Inferiority
p-value
EMA:Primary Efficacy Endpoint - Mean % Urine SamplesNegative for Illicit Opioids
(-0.1%, 13.3%) <0.001
FDA:Primary Efficacy Endpoint - Response Rate
(-3.5%, 10.4%) <0.001
CAM2038 met both FDA and EMA primary endpoints of non-inferiority versus SL BPN/NX – “Standard of Care”(ITT)
-0,2 -0,1 0 0,1 0,2
Difference (95% CI)
Favors CAM2038Favors SL BPN/NX
11%
10%5%
5%
Camurus Capital Markets and R&D Day, December 14, 2016 39
NI margin
NI margin
CAM2038 vs SL BPN/NX 95%CI Non-inferiority (NI)Superiority
p-value
Study phase 1:Mean % Urine SamplesNegative for Illicit Opioids
(-1.3, 13.1) 0.110
Study phase 2:Mean % Urine SamplesNegative for Illicit Opioids
(1.2, 15.7) 0.023
Non-inferiority shown in phase 1 and superiority in phase 2 versus SL BPN/NX (ITT)
Difference (95% CI)
Favors CAM2038Favors SL BPN/NX
Camurus Capital Markets and R&D Day, December 14, 2016 40
-0,2 -0,1 0 0,1 0,2
5%10%
NI margin
CAM2038 met statistical superiority versus SL/BPN/NX for secondary endpoint of CDF for negative urines +/- self-reports throughout the study (ITT)
Camurus Capital Markets and R&D Day, December 14, 2016 41
Grace Period
Weeks
Treatment
Weeks
Sampling
Weeks
Superiority
p-value (FDA)
Superiority
p-value (EMA)
0 1-24 2-25 0.006 0.011
1 2-24 3-25 0.005 0.010
3a 4-24 5-25 0.004 0.008
4b 5-24 6-25 0.001 0.003
6c 7-24 8-25 0.001 0.002
a Secondary endpoint for FDA and EMA; b Primary endpoint in RB-US-13-0001; c Including 2-week open label phase in RB-US-13-0001).
CDF – cumulative distribution function
CAM2038 was well tolerated with no unexpected safety findings
Camurus Capital Markets and R&D Day, December 14, 2016 42
Treatment emergent adverse events,
TEAEs
SL BPN/NX
N=215
CAM2038
N=213
TOTAL
N=428
Any TEAE 55% 60% 58%
Serious TEAEs 6% 2% 4%
Severe TEAEs 7% 3% 5%
AEs leading to treatment discontinuation 1% 3% 2%
Suspected drug-related TEAEs 30% 33% 31%
TEAEs that resulted in death* 0% 0.5% 0.2%
Drug overdoses 2% 0% 1%
*Not-related, traffic accident
CAM2038 was well tolerated with low frequency of injection site reactions
0
20
40
60
80
100
Mild Moderate Severe
Inje
ction
site
rea
ction
s(%
)
Severity
SL BPN/NX (placebo) CAM2038
Camurus Capital Markets and R&D Day, December 14, 2016 43
Only mild and moderate reactions
% patients with at least one injection site reaction (total injections >5000)
CAM2038 demonstrate non-inferior and superior efficacyacross treatment phases versus daily SL BPN/NX
• Met both FDA and EMA primary endpoints
• Statistical superiority met for the key secondary endpoint of CDF for negative urines, with and without self reports
• Efficacy demonstrated throughout treatment phases
‒ From initiation to maintenance
• CAM2038 safety profile comparable to daily sublingual buprenorphine/naloxone
‒ Fewer SAEs (3.2% vs. 6%)
‒ No opioid overdoses vs four overdoses
• Clinical data support MAA and NDA submissions in mid-2017
44
CAM2038 show robust treatment efficacy
in Phase 3 trial versus Standard of Care Urgent need for new treatments!
Deaths from the drugs are rising sharply in
the U.S.
The number of deaths from heroin overdoses
surged by 23% to 12,990 in 2015, while fatal
overdoses from powerful synthetic opioids such
as fentanyl rose by more than 73% to 9,580,
Centers for Disease Control and Prevention
12,990fatal heroin
overdoses
2015
9,580fatal synthetic
opioid
overdoses
2015MAA – Market Authorisation Application
45
Phase 3 long-term safety trial under completion in Europe, Australia and the United States (N=228, enrolled)
Screening Period Treatment Period Follow-Up
Weeks -3 to -1 4 Weeks
Patients who are new treatment seekers or on
weekly SL BNP prescriptions
Patients who are on monthly SL BNP
prescriptions
Week -3 Week 0
Week 4
Week 48
Up to 48 Weeks
CAM2038 q1w
CAM2038 q4w
Camurus Capital Markets and R&D Day, December 14, 2016
Proceeding towards market approval authorizationsubmissions in Europe and the US
• Regulatory
‒ Fast Track designation for both Weekly and Monthly CAM2038 by US FDA, August 2015
‒ Positive decision for eligibility for centralized procedure for CAM2038 by EMA, October 2016
‒ Pre-MAA meeting with EMA in January 2017
‒ NDA submission to FDA in mid-2017
‒ MAA submission to EMA mid-2017
• Clinical development
‒ Completion of Phase 3 long-term safety and repeat dose PK study
• Presentations and publications
‒ Planned participation and presentations at key conferences and meetings during 2017, including:
‒ Peer reviewed publications
Camurus Capital Markets and R&D Day, December 14, 2016 46
ASAM
6-9 Apr
New Orleans, USA
INRC
9-14 July
Chicago, USA
ISAM
26-29 Oct
Abu Dhabi, UAE
CPDD
17-22 June
Montréal, Canada
AMCP1
27-30 Mar
Colorado, USA
ECNP
2-5 Sep
Paris, France
CAM2038 has potential to improve and transform the treatment of opioid dependence
Weekly & monthly coverage for individualized treatment
Effective suppression of withdrawal and cravings
Rapid and sustained opioid blockade (“complete blockade”)
Documented efficacy across treatment phases; non-inferior/superior to daily SL BPN/NX – “Standard of Care”
Safe and locally tolerable
47
No daily
dosing or
supervision
No accidental
pediatric
exposure
Minimal risk
of misuse and
diversion
Camurus Capital Markets and R&D Day, December 14, 2016
48
Two companies – One team
Camurus Capital Markets and R&D Day, December 14, 2016
• Behshad Sheldon, President & CEO
• Fredrik Tiberg, President & CEO, Head of R&D
• Sonnie Kim, Senior VP Clinical & Medical Affairs
• Margareta Linden, VP Program Management
• Frank Young, EVP Medical and Regulatory
• Agneta Svedberg, VP Clinical and Regulatory
• Craig Brown, SVP, Commercial & Project Man
• Markus Johnsson, VP Pharmaceutical Development
• Sonia Oosman, Director, Clinical Operations
• Torsten Malmström, VP Technical Operations
• Sheila Mathews, Director Regulatory
• Anna-Karin Lindqvist, Senior Dir. Preclinical Research
• Ryan Dannerman, Sen. Dir. Medical Affairs
• Kerstin Strandgården, Sen. Pharmacokineticist
• John Diaz, Ass. Dir. Clinical Ops.
• Hanna Liedman, Medical Writer
• Mathews Adera, Exec. Director Clinical Development
• Peter Hjelmström, Sen. Dir. Medical Affairs
• CMC and Non-Clin Teams
• Michael Chen and Stefan Peterson, Biostatistics,
Consultants
• Investigators, staff and study participants
Camurus Capital Markets and R&D Day 2016
Clinician’s view
Long-acting depots – a potential
new treatment paradigm for OUD
Prof. Edward Nunes, MD, PhD, Columbia Medical School
Prof Edward Nunes, MD PhD
• Prof. Nunes is Professor of Psychiatry at Columbia University Medical School
• Principal Investigator of the Greater New York Node of the National Institute on Drug Abuse (NIDA) Clinical
Trials Network on behavioral and medication treatments for substance dependence and related psychiatric
disorders
• Interests and ongoing studies include treatments for cocaine dependence in general, heroin and other opioid
dependence, for nicotine dependence in general, and for addicted patients with co-occurring psychiatric
disorders including depression, and post-traumatic stress disorder.
• Types of treatment under study include medication treatments (buprenorphine, naltrexone, mirtazapine) as well
as behavioral and psychotherapeutic approaches and computer-delivered treatments.
• Dr. Nunes also studies the challenges involved in implementing evidence-based treatments for substance use
disorders in real-world community-based treatments settings.
• Dr. Nunes also serves on the American Board of Addiction Medicine, Co-Chair of the Columbia/ New York
State Psychiatric Institute’s Institutional Review Board, and has been appointed to the National Advisory
Council on Drug Abuse.
• Clinical investigator on CAM2038 Phase 3 trials HS-11-421 and HS-14-499.
50
Camurus Capital Markets and R&D Day 2016
Q&A session
Moderator, Lars Frick
Camurus Capital Markets and R&D Day 2016
CAM2038
US market perspectives
Behshad Sheldon, President & CEO
Braeburn Pharmaceuticals
Camurus Capital Markets and R&D DayDecember 14, 2016
Behshad Sheldon President and CEO
Braeburn Overview and Vision
• Chronic specialty CNS diseases affect all walks of life
• Novel long-acting injectables and implantables help solve public health crises
• Personalized care with steady blood levels and increased compliance essential for improving patient
clinical outcomes
• Reduced relapse, diversion and abuse meaningfully improve social outcomes
54
Founded in December 2012
Based in Princeton, New Jersey
Apple Tree Partners Company
First FDA Approval in May 2016
Vision:
Experienced Management Team
55
Craig Brown
SVP, Commercial, Project
Management & Manufacturing
David Byram
VP, Market Access &
Governmental Affairs
Frank Young, MD, PhD
EVP, Medical and Regulatory
Behshad Sheldon
President & CEO
David J. McIntyre
CFO
Otsuka Pharmaceuticals, SVP Global Commercial Lead and Board
Member of Otsuka R&D
• Launched and led development and commercialization efforts for Abilify® for 12 years
• Otsuka / Lundbeck landmark $10B CNS co-commercialization deal
Bristol-Myers Squibb / Smithkline Beecham
• Plavix®, Glucophage®, Abilify®, Bactroban
Partner at Apple Tree Partners
HeartWare International: Executive VP, CFO 2005 - 2011; COO global
commercialization phase 2008 - 2011
Baker & McKenzie and KPMG, senior attorney in private practice
specializing in corporate, M&A and ECM
Various senior financial roles in multi-national companies including Coal
& Allied Limited, a publicly traded subsidiary of the Rio Tinto Group
Sonnie Kim, PharmD
SVP, Clinical and Medical Affairs
Large and Growing Markets with High Unmet Needs
Opioid Use Disorder Population Pain Population
• ~13.2mm people in U.S. misuse opioid painkillers and heroin
• ~30,000 opioid overdose deaths per year
• ~100mm people suffer from chronic pain in the U.S.
• ~23mm adults report a lot of daily pain
• Up to ~12 saved for every $1 spent on treatment
• ~$2.0bn sales of buprenorphine
• ~$80 billion annual economic impact
• CDC directive that full agonists are overprescribed for chronic pain –
alternatives needed
• $635bn annual economic impact
Our long acting medications will address markets with ~$870bn annual impact
56
~228mm TRxopioids
analgesics
~6.7mm TRx
buprenorphine
~3mm TRxmethadone
~13.2mm people.
misuse opioid pain
killers and heroin in U.S
~2.6mm diagnosed with
opioid use disorder
~1.1mm treated
~0.7mm patientson buprenorphine
therapy
Our Product Portfolio
57
Product BRBN Rights
Ad
dic
tio
nP
ain
Ph 1 Ph 2 Ph 3 ApvlIndication Form
1 Exclusively sub-licensed to Knight Therapeutics, Inc. in Canada2 Option rights for Japan, China, South Korea, and Taiwan
Compound(s)
Probuphine (6-month) Opioid Addiction Implant US, Canada1Buprenorphine
CAM2038 Weekly Opioid Addiction Injectable North America2Buprenorphine
CAM2038 Monthly Opioid Addiction Injectable North America2Buprenorphine
CAM2038 Weekly Chronic Pain Injectable North America2Buprenorphine
CAM2038 Monthly Chronic Pain Injectable North America2Buprenorphine
Probuphine (6-month) Chronic Pain Implant US, Canada1Buprenorphine
Sch
izo
ph
ren
ia
BB0817 (6-month) Schizophrenia Implant WorldwideRisperidone
BB1216 (6-month)Clinic
readySpasticity Implant WorldwideTizanidine
BB0417 (3-5-day) Post op /Acute Pain Injectable North America2Buprenorphine
+ Granisetron
Sp
asti
cit
y
May 2016
Expected NDA
submission
1H17
Opioid Addiction: A Public Health Epidemic
• US: ~5% of global population,
>80% of opioid prescriptions
• ~4x increase in opioid
prescriptions and opioid
overdoses since 1999
• ~3,900 people daily begin abusing
opioids
• ~30,000 deaths per year from
opioid overdose
• 1 death every ~18 minutes
58
“Deaths from drug overdoses have jumped in nearly every county across the United States, driven largely by an
explosion in addiction to prescription painkillers and heroin”
Lost productivity accounts for an estimated $42 billion annually while
criminal justice accounts for $8.2 billion3*
Opioid abusers are 4× more likely to visit the ER, 11× more likely to visit
a mental health clinic and 12× more likely to be admitted as an inpatient2
Misuse treatment accounts for $2.2 billion annually3*
$944 million has been estimated to be spent on management of medical
complications, with the vast majority relating to the management of HIV
and Hep-C infections3*
The estimated total cost of nonmedical use of prescription opioids in the
US has been estimated at $53.4 billion annually3*
Drug diversion costs payers up to $72.5 billion annually in direct costs and
indirect costs associated with medical complications arising from abuse1
Nonmedical use
and Diversion
Intensive and costly
clinical management
Impact on Productivity
* Based on a 2006 estimate1. Coalition Against Insurance Fraud. Prescription for peril: how insurance fraud finances theft and abuse of addictive prescription drugs.
http://www.insurancefraud.org/downloads/drugDiversion.pdf. Accessed on May 31, 2016
2. Meyer et al., Popul Health Manag 2014;17(6): 2014
3. Hansen R et al., Clin J Pain 2011;27(3): 194-202
Financial Impact of Opioid Use Disorder
Opioid Use Disorder Financial Impact on US Health Plans
1. Ghate SR et al., J Pain palliative care 2010;24: 251-258
The annual direct health care costs for privately insured opioid abusers based on 6 months
prior and post diagnosis is estimated to be 8 times higher than non-abusers
Cost (U
SD
)
Patient numbers n=740 n=2220 n=50,162 n=150,486
Total cost $15,884 $1,830 $13,658 $7,008
$657
$2,034
$5,398
$7,795
$185
$386
$928
$331
$4,159
$8,265
$1,234
$2,473
$4,275
$260
Administrative claims database analysis. Cases were included based on a opioid abuse related ICD-9 code (304.0X, 304.7x, 305.5X, 965.0X) with each patient
matched to 3 controls based on age, gender, geographical region, and employment status. Analysis was conducted over one year
US Buprenorphine Oral Market Continues to Grow
61
• $2 Billion in sales in 2015
• The market continues to grow despite
4 generic competitors
• 11.6 million TRx in 2015
• TRx robust growth continued
• Market grew 1.9x in the past 5 years
• Very concentrated market, with >90+%
of Rx’s from ~6,000 prescribers
+58%+19%
+16%+13%
+12%
Source: TRx IMS NPA; Sales IMS NSP
+8%
Expanding Access to Buprenorphine in the USPolicy update
62
US Surgeon General’s Report
• Substance use disorder (SUD) is a chronic, relapsing disease of the brain and not a moral
weakness
• Treatment gap for individuals with SUD due to lack of screening, stigma, inadequate access
to treatment, and cost of care
• Medication reduces illicit opioid use and improves outcomes, including employment,
criminal justice involvement, and HIV risk
• Explicitly references buprenorphine implant for treatment in stable patients
Expanding Access to Buprenorphine treatment
US Congress: Comprehensive Addiction and Recovery Act (CARA)
• Expanded prescribing privileges to nurse practitioners and physicians assistants (NPs/PAs)
• Authorized HHS to set patient limit
• NPs/PAs can currently treat up to 30 patients for one year
• HHS will write a new rule raising the limit to 100 after NPs/PAs have one year of experience
US Administration: HHS Regulation
• Increased physicians’ patient limit to 275, with qualifications:
• Physicians must have a waiver to treat 100 patients for at least one year and either
• Hold board certification by an accredited entity, or
• Practice in a qualified practice setting (i.e. uses electronic medical records, utilizes the
state PDMPs, and accepts insurance)
• >2200 physicians have filed for increase to 275, ~400K increase in capacity
21st Century Cures Act: SUD Treatment
Bipartisan Congressional bill
• Passed overwhelmingly (House vote: 392-26; Senate vote: 94-5)
• Reflects an enthusiastic congressional climate for biomedical research and innovation
Grant Programs (requiring separate appropriations)
• Authorizes $1 billion ($500 million this year and $500 million next year) for state grants to address
the opioid overdose crisis; first $500 million likely to be appropriated on December 12
• May be used for:
− Training for HCPs on opioid prescribing, pain management, recognizing a substance use
disorder (SUD), and referrals to treatment
− Supporting access to health care services, and other activities
• Provides five-year grants for medical residents and fellows who practice psychiatry and addiction
medicine
• Reauthorizes the Substance Abuse Prevention and Treatment Block Grant at $1.858 billion for
fiscal years 2018-2022
Parity Enforcement
• Requires HHS to convene a public meeting within six months of enactment to produce an action
plan for improved federal and state parity enforcement
Opioid Addiction: Evolution of Continuum of Care
66
Limitations of Current Therapies
CAM2038 Weekly
Oral daily buprenorphine
CAM2038 Weekly
Oral daily buprenorphine
CAM2038 Monthly
Oral daily buprenorphine
CAM2038 Monthly/
Probuphine 6-mo
Oral daily buprenorphine
Daily/Weekly Weekly Monthly Less frequent
Treatment
Options
MD Visits
InitiationInitial
stabilization
Medium-term
stabilization
Long-term
maintenanceTreatment
Stage
• Patients forget or choose not to take daily medications
• Increased risk of relapse / overdose
• Stigma of daily medication
• Daily reminders of disease and addiction
• Fear of accidental pediatric exposure
• Street value leads to creation of "pill mills"
• Opportunities for diversion, misuse and abuse
• High hospitalization costs
Suboptimal medication
compliance impeding outcomes
Suboptimal quality
of lifePublic health impact
Braeburn’s comprehensive suite of products seeks to provide solutions for patients from
initiation of treatment through long-term maintenance
Opioid Addiction: CAM2038 Phase 3 Update
67
Key Phase 3 results Announced Nov. 2016
• Multicenter, randomized double blind, double dummy, active controlled study with 428 patients
• First and only long-acting buprenorphine study vs. current standard of care
• Met both FDA and EMA primary endpoints of non-inferiority vs. SOC (p < 0.001)
• Superiority for secondary endpoint of Cumulative Distribution Function (CDF) of negative urine samples (p = 0.004)
• Few serious adverse events and similar in CAM2038 vs SL BPN / NX (3.2% vs. 6%)
• 4 non-fatal overdoses in SL BPN/NX arm vs 0 in CAM2038 arm
(-0.2%, 13.7%)
Difference (95% CI)
Favors CAM2038Favors SL BPN
Non-inferiority
10%
Non-inferiority
11% 5%
5%
Responder Rate
% Urine Samples Negative
for Illicit Opioids
(-3.5%, 10.4%)
p-valueNon-Inferiority
<0.001
<0.001
Primary Endpoints (FDA and EMA)
CAM2038 met both FDA and EMA primary endpoints of non-inferiority versus the standard of
care in its Phase 3 trials
Probuphine: Model of Execution
Braeburn successfully executed on an aggressive trial schedule and NDA submission
68
1 IMS National Sales Perspective. Dollars MAT March 20152 IMS National Sales Perspective. Dollars Calendar 2014
May 26, 2016:• Approved
June 2016:• Shipped Product
Enrollment of 177 patients
in 4 months far outpaced
typical enrollment schedule
of 6-9 months
Filed NDA within
3 months from
database lock
May 15 2014:• Final FDA advice on
proposed protocol
July 17 2014:• First patient enrolled
June 2015: • Positive topline data
released
FDA Approval Media Coverage
Trade Media Coverage
Buprenorphine implant helps opioid-
dependent patients stay abstinent longer
New Rule Expands Access to
Buprenorphine
First Patients Implanted June 2016
Social Media: Amplifying the Probuphine Story
72
2,507+ mentions
12.6 million+ impressions
Opioid Addiction: Probuphine Sales Evolution Plan
Probuphine
FDA Approval
(May 26, 2016)
Q2 2016 Q3 2016 Q4 2016 Q1 2017
Hiring and training
of clinical educator
field force
6,000 physicians
represent ~90% of
buprenorphine
Rx’s
Top 100 payers
represent ~85% of
buprenorphine
Rx’s
Increase physician
adoption
Support full scale
launch
Build Clinical Educators Team to
Support Medical Affairs Launch
Train & Certify Physicians
Expand Payer Coverage and
Reimbursement
Broaden Distribution Channels
Build Sales Force
46
114
Key Metric/Goal
27 27 25
2,4002,800
73
CMS grants J-code
(J0570)
‘Buy-and-bill’ systemSpecialty pharmacy in
addition to ‘Buy-and-bill’
1
2
3
5
4
Pain: Market Overview
74
Belbuca
Butrans
~228mm TRx Opioids
Analgesics
~6.7mmTRx
Buprenorphine
~3mm TRx Methadone
• 100mm people suffer from chronic pain in the
U.S.
• ~23mm adults report a lot of daily pain
• New guidelines from CDC on opioid painkillers
• Two approved buprenorphine pain drugs
− Butrans (patch)
− Belbuca (film)…
• …only available in low doses
• …risk of abuse and pediatric exposure
No higher-dose oral buprenorphine products used for opioid addiction approved for chronic pain
Buprenorphine: Mechanistic Advantages Over Other Pain Medications
75
Reduced hyperalgesia
Ceiling effect makes overdose unlikely on buprenorphine alone
Potential for fewer side effects
Lower risk of respiratory depression vs. full mu agonists
Possible anti-depressant effect due to kappa antagonist activity
Mu
(analgesia,
euphoria,
respiratory
depression)
Kappa
(dysphoria,
hyperalgesia,
antinorciceptive)
Delta
(minor
analgesia)
ORL1
(spinal
analgesia)
Partial agonist
Strong affinity
Antagonist
Strong affinity
Antagonist
Moderate
affinity
Agonist
Full agonist
Moderate
affinity
Weak agonist
Very Low affinity
Weak agonist
Very low affinity N/A
Mo
rph
ine, o
xyco
do
ne,
fen
tan
yl,
hyd
rom
orp
ho
ne
Bu
pre
no
rph
ine
Key buprenorphine attributes
Pain: Our Portfolio
76
Opioid-naïve
patients
Low, fixed opioid
doses
Flexible medium to
high opioid dosesPost op / acute
Our comprehensive pain management approach
Low-dose CAM2038
Weekly and Monthly Probuphine Implant
Higher dose
CAM2038 Weekly
and Monthly
Low-dose combination
of Buprenorphine and
Granisetron
Our long-acting medications, if approved, will provide steady, around-the-clock therapy, resulting in
improved pain management
• Probuphine 6-month Implant
− First implantable buprenorphine
− Short in-office procedure
• CAM2038 Weekly and Monthly
− Subcutaneous injection
− Fast in-office shot
• Buprenophrine + Granisetron
− Subcutaneous injection
− Fast in-office or in-hospital shot
Physicians View Long-Acting Buprenorphine as a Long-Term Solution to
the Problems Created by Use of Opioids for Pain
77
~82% of all MDs and 94% of MDs with a
high volume of patients would “possibly,”“probably,” or “definitely” prescribe
buprenorphine injection if approved
Key reasons for adoption:
Less abuse
Less diversion
Steadier dose
Limits opioid dependency
Convenience
MDs predict they will prescribe the buprenorphine
injection to 9% of their patients
Buprenorphine Injection Market Share Capture from
Other Prescribed Chronic Pain Treatments
4%
9%2%
3%
Full Opioid Agonists
Anticonvulsants / Antiepileptics
Other Buprenorphine Injections
228mm prescriptions annually
Large market opportunity for Braeburn
2014 Current Target potential
1 Clinic 1 Approved
2 Clinic
3 Approved
4 Clinic 4 Approved
1 Clinic 1 Approved
1 Clinic-Ready 1 Clinic
Approved: 0
Clinic or Clinic-Ready: 1
Approved: 1
Clinic or Clinic-Ready: 8
Approved: 8
Clinic or Clinic-Ready: 1
In-licensed and acquired long-
acting technologies from Titan,
Camurus and Endo
ProNeura Implantable Platform
FluidCrystal Injectable Platform
MedLaunch Implant Platform
Licensing & acquiring new
delivery technologies to drive
future growth
78
Company
Employees
Technologies
Schizophrenia
Pain
Opioid Addiction
Spasticity
Total
Field PersonnelTotal Employees
76
38
2016
7
2014
~200
~150
2017E+
Th
era
pe
uti
c A
rea
sOur Growth Trajectory
Camurus Capital Markets and R&D Day 2016
CAM2038
EU market perspectives
and commercialisation
Richard Jameson, CCO
Opioid dependence in the EU is a significant burden on society
• Estimated 1.3m problem drug users in EU
‒ Largest burden to society of all drugs1
‒ It is estimated that over 70 000 lives were lost to drug overdoses in
Europe in the first decade of the twenty-first century4
‒ Every year drug addiction costs society $18.4bn in UK2
‒ Any drug dependent user not in treatment costs society €31k a year
through crime costs in UK2
• Growing concern with prescription drug dependence in EU
with an estimated 400 000 patients affected5
80
Source: 1. UNODC, World Drug Report 2015; 2. Why treat NTA 2014; 3. EMCDD, European Drug Report Trends and Developments 2015; 4. http://www.emcdda.europa.eu/publications/pods/preventing-overdose-
deaths; 5. Alho, H. and Strydom, M. (2013). “Prevalence of prescription opioid-dependency in Europe and risk factors for abuse.” Presented at the International Society of Addiction Medicine Annual Meeting 2013.
Kuala Lumpur, Malaysia. 21–23 Nov 2013
Camurus Capital Markets and R&D Day 2016
Overview of Medication Assisted Treatment in Europe – a heterogenous treatment system
Medication Assisted Treatment (MAT) Overview
• Approximately 700,000 patients in treatment
‒ 80% patients in EU5 + Nordics
• Methadone now the most common treatment in
EU
• Buprenorphine is accepted as treatment of
choice with a growing patient share
‒ About 250,000 patients on buprenorphine
‒ Largest market shares in France and the Nordics
• Average treatment time in Europe is 3.7 years
but ranges from 2.2 – 5.9 years
‒ Frequently drop out and re-entering in treatment
‒ Majority users and patients have previous treatment
episodes (1 to 4+)
81
MAT at national level (2014)
Methadone67%
Buprenorphine20%
Methadone = Buprenorphine
13%
Camurus Capital Markets and R&D Day 2016
Source: European Drug Report 2014 and 2016; Equator Dec 2012. Note: 1) According to percentage of Buprenorphine
patients according to the European Drug Report Statistical Bulletin 2014, applied on number of patients in OMT
Methadone >50% share
Buprenorphine >50% share
Buprenorphine = Methadone
Camurus Capital Markets and R&D Day 2016 82
Treatment systems in place are concentrated to specialists
77,500
148,686
161,388
75,964
~21%
~66%
~25%
Specialised centers and primary
health care system
Community health clinics and NHS
providers
Specialised centers and GP
practices
Servizi Tossicodipendenze (Ser.T.),
private and non-profit organisations
CountryNumber patients in
treatment 1Treatment model
% patients receiving
buprenorphine3
Specialised Centres
Specialised centers and primary
healthcare system
61,954
16,535
~25%
~6%
~50%
~ 3000
~ 6000
~ 2000
~ 3000
~ 2000
~ 2000
1. ECMDDA 2016 drug report; 2. Internal data; 3. IMS 2014.
Estimated key Rxers 2
Limitations of current treatment
Camurus Capital Markets and R&D Day 2016 83
1. Bell J: Medications in Recovery: Re-Orientating Drug Dependence Treatment. Appendix C - Opioid Substitution Treatment and Its Effectiveness: Review of the Evidence, 2012; 2. Black
2016, An independent review of the impact on employment outcomes of drug or alcohol addiction
Medically assisted treatment (MAT) has
demonstrated effectiveness1,2
However associated with significant
limitations
• Improves public health
• Reduces heroin use
• Improves social functioning
• Redues overdose deaths
• Reduces crime
• Limits spread of blood borne viruses
• Provides value for money for the taxpayer
• Frequent relapses
• Limited adherence − Continued “use on top”
• Misuse, abuse and diversion
• Accidental pediatric exposure
• Stringent treatment rules− Patients drop out of treatment
− Users do not enter treatment
In EU no new interventions in medication assisted treatment for >10 years
A paradigm shift in opioid dependence treatment
• Weekly and monthly buprenorphine injections for
initiation, stabilization and maintenance treatment
• Flexible dosing for individualized treatment
• Ready to use and easy to administer
• Room temperature storage
• Well tolerated, locally and systemically
• Best-in-class treatment potential
Continuous treatment effectReduced number of doses and decisions
from 365 to 52 or 12 times per yearSafeguards against misuse, abuse, diversion
and pediatric exposureNo daily supervised dosing and related
stigma
Improved treatment adherence
– dose given is dose taken
Rapid and sustained opioid blockade
reduces use on top
Key attributesCAM2038 overview
84Camurus Capital Markets and R&D Day 2016
CAM2038 has potential to bring significant values to patients, physicians, payors and society
85
• Less supervision of patients
• Improved patient treatment outcomes
• Reduced burden of diversion, misuse and abuse
• Encouraging users into treatment – reducing
societal costs
• Reduced healthcare utilisation
• Improved outcomes potential for less social
welfare and CJ costs
Clear differentiation with several benefits
Current treatment
Value of
CAM2038CAM 2038
Value
Benefits to health care systems, society and patients suggests that the value CAM2038 can
bring can be realised through robust HEOR and wider value demonstrating programmes
Country Physicians willingness to prescribe CAM20381 % patients*: q4w q1w
86
Majority of clinicians identify patients suitable for CAM2038
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 prescribers thought would be prescribed CAM2038 of those currently prescribed medication
N= 47
31%
30%
36%
25%
N= 4843%
27%
39%
22%
N=51
N=50
N=50
Camurus Capital Markets and R&D Day 2016
CAM2038 addressing unmet need for patients and users
87
Problem
Opioid
Users
Patients
currently
in treatment
Users out of
treatmentUsers starting
new
treatment
journey
Users willing
to enter with
new treatment
option
Users not
Accessing
treatment
Users not entering treatment due to impact on daily life
“Recycling” users entering new patient journey or naïve patients
• Motivated patients ready for change
• Patients in treatment wanting reduced burden of treatment
• Patients struggling with compliance/adherence
Illustrative
Users not
recycling
Rationale for own commercialization of CAM2038 in Europe
88
Positive market drivers support pricing strategy and reimbursement on European markets
Specialist market
~700 000 patients in treatment
CAM2038 addresses unmet need
Sizeable socio-economic benefits
On-going paradigm shift
Accessible and concentrated
market
Cost efficient roll-out and
creation of significant value
Rationale Overview of market rights and Camurus’ primary markets
Braeburn exclusive markets Braeburn option right Camurus markets
Camurus Capital Markets and R&D Day 2016
Building the commercial organization – stage 1 completed
• Strong and internationally experienced leadership
team
‒ Specialist pharma leadership
‒ Market access
‒ Medical affairs
‒ Global strategy
‒ Opioid use disorder & pain
• Stepwise build – right time, right place principles
89
2016
• EU leadership team
• 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
Strategic pre-commercialisation focus 2017
Country operating models
Establish subsidiaries Establish specialist teams Patient access
Strategic marketing & building the brand
Understand the market Awareness Differentiation Communication
Medical affairs
KOL development programs Medical education Building the evidence base
HEOR, pricing and market access
Policy Pricing Market Access HEOR/SEOR
CAM2038 – first step in Camurus commercialisation strategy to create value
• CAM2038 commercial organisation is the
basis for the future expansion of the
portfolio of marketed products
• Retain commercial rights for product
assets within Camurus focus
areas/commercial model
‒ Areas of unmet need and high value
‒ Concentrated treatment systems
‒ Cost efficient roll-out
‒ Potential synergies to leverage existing
infrastructure
• Seek product partnerships
‒ Adjacencies to portfolio
‒ Meets commercial model
91
Product partnerships In-house products
Commercialisation strategy will create value
through in house products and partnerships
Se
cu
re c
om
me
rcia
l rig
hts
Re
tain
co
mm
erc
ial rig
hts
Leverage Camurus commercialisation organisation for roll-out of new product candidates
92Camurus Capital Markets and R&D Day, December 14, 2016
Our vision Provide all patients suffering
from opioid dependence
access to the most effective
treatments for improving
outcomes and quality of life
Advancing the pipeline
Late & early stage projects update
93
Fredrik Tiberg, PhD, CEO and Head R&D
94
Late-stage, diversified pipeline with block-buster potential
PARTNERS PRODUCT PRECLINICAL PHASE 1/2 PHASE 3 REGISTRATION
CAM2038 Weekly Opioid dependence
CAM2038 Monthly Opioid dependence
CAM2038 Weekly Chronic pain
CAM2038 Monhly Chronic pain
CAM2029 Neuroendocrine tumours
CAM2029 Acromegaly
CAM2032 Prostate cancer
CAM4071 Not disclosed
CAM2047 CINV
CAM2048 Pain
CAM2058 Pain & nausea and vomiting
Camurus Capital Markets and R&D Day, December 14, 2016
Chronic pain is a common condition with large impact on qualityof life
• Chronic pain is defined as pain lasting longer
than 3 months
• About 20% of the population suffer from chronic
non-cancer pain1
• Major chronic pain segments in 20142:
‒ More than 70 million people in the US and Europe an
suffer from chronic low back pain
‒ 63 million people suffer from arthritis pain
• Chronic pain has a detrimental impact on QoL3
‒ For 2/3 the pain inflicting on sleep
‒ 50% report difficulties with household tasks
• Global opioid analgesics market worth
$22 billion in 2014, anticipated to reach 28 billion
in 20212
Sources. 1. Pain Practice 2014, 14, 79–94 2. Disease Landscape and Forecast Chronic Pain, Decision Resources 2015 3. Persistence Market Research 2016
Fibromyalgia Chronic daily headache
Cancer pain
Postherpetic neralgia
Chronic low back pain
Chronic Migraine
Rheumatoid Arthritic Pain
Osteoarthritic pain
Painful diabetic neuropathy
Buprenorphine is an effective analgesic with an unique pharmacological profile
• Treating broad spectrum of pain with various etiologies
• Demonstrated analgesic potency at least 30 times higher than that of morphine
• Associated with lower analgesic tolerance – dose escalation and hyper-algesia
• Less constipation than other potent µ-agonists, and does not adversely affect the sphincter of Oddi
• Improved safety versus full µ-agonists with ceiling effect at higher doses minimizes risk of respiratory depression
• Reduced risk of dependence, misuse and diversion corroborated long-acting
96
Buprenorphine offers effective pain treatment with established safety profile and reduced abuse liability
OpioidGI safety –
constipationCNS – Sedation
Respiratory
distress
Immune
suppressionTolerance Addiction Hyperalgesia
Morphine Yes Yes
Oxycodone Yes
Hydromorphone Yes
Fentanyl TD Yes
Methadone
Buprenorphine
TD/SL Limited
Anti-
hyperalgesia
Source: Journal of Pain Research 2015:8 859–87
Ongoing phase 3 study in chronic low back pain patients. Randomized, double-blind, placebo-controlled, enriched-enrollment withdrawal design (Nest.=340)
Camurus Capital Markets and R&D Day, December 14, 2016 97
Screening Transition Double-Blind treatment Follow-Up
2 Weeks Upto 10 Weeks 12 Weeks 4 weeks
Moderate tosevere lowerback pain on
high 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:
Worst and average pain intensity as measured by 11-point
numerical rating scale
Significant potential in converting Sandostatin® LAR ® patients to CAM2029
CAM2029 for treatment of acromegaly and neuroendocrine tumors
• 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)
‒ Current gold-standard medical treatment include
somatostatin analogues
• Neuroendocrine tumors (NETs) are malignant
neoplasms
‒ Somatostatin analogues constitute the current standard of
safe and effective medical therapy for symptom control
‒ Somatostatin analogues also show anti-tumor effects
Overview of acromegaly and NET Strong market growth over 15 years1
Source1. Medtrack
98
2015
1 802
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Sandostatin® (Novartis) Somatuline® (Ipsen)
Sandostatin® : 7%
Somatuline® : 16%
(USDm)
CAGR 2004-2014:
339 412
488
607 695
917 998 1 031
1 169
1 300 1 350
1 516
1 705
1 917
2 032 2 069
Camurus Capital Markets and R&D Day, December 14, 2016
CAM2029 is a convenient, safe and effective treatment option
Camurus Capital Markets and R&D Day, December 14, 2016 99
Easy subcutaneous administration
using prefilled syringe
Self-administration option with significant
convenience benefits and cost savings
Increased bioavailability (500%) with potential for
enhanced treatment efficacy1
Thin needle and small injection volumes
Room temperature stability avoiding cold chain
distribution and conditioning before use
Key attributesCAM2029 overview
1. Novartis Q2 and H1 Condensed Interim Financial Report
2. Tiberg F, Roberts J, Cervin C, et al. Br J Clin Pharmacol. 2015;80:460-472.
• Ready-to-use, long-acting octreotide for
treatment of acromegaly and neuroendocrine
tumors (NETs)
• Exclusive partnership with Novartis
‒ "Novartis Oncology continues its commitment to
developing a new formulation of octreotide through a
collaboration with Camurus”
• Positive Phase 2 results
‒ Control of symptoms and disease markers
• Planned start of Phase 3 in 2017
CAM2029 supported by comprehensive clinical program
HS-05-194
Phase 132 volunteers
HS-07-291
Phase 195 volunteers
HS-11-411
Phase 1122 volunteers
Trial no. Subjects Key results / Study design Status
Rapid and long-acting release of octreotide
and suppression of IGF-1. 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-12-455
Phase 2
12 patients in two
groups with
acromegaly and NETs
Positive results
Phase 3Two Phase 3 trials of CAM2029 versus active control, Sandostatin® LAR®, in patients with
neuroendocrine tumours (NETs) and acromegaly, respectively (Global)
3 trials in preparation,
start in 2017
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®
100Camurus Capital Markets and R&D Day, December 14, 2016
Positive topline Phase 2 results announced in 2016
• Multicenter, randomized study of CAM2029 in
patients with functioning NETs and
acromegaly previously treated with
Sandostatin LAR
• Characterize the PK profile and to assess the
efficacy, safety and tolerability of CAM2029
verus Sandostatin® LAR®
• 16 week study including switch from
Sandostatin® LAR® to CAM2029 after Week 4
Camurus Capital Markets and R&D Day, December 14, 2016 101
• CAM2029 provided high sustained plasma
octreotide exposure in both patient
populations over 4-week dosing interval
• The control of disease biomarkers and
symptoms were maintained or improved
when switching from Sandostatin® LAR®
• Both treatments were well tolerated
• Detailed results to be presented at
international conferences and in a peer
reviewed publication during 2017
Phase 2 study design Topline Phase 2 results for CAM2029
No reconstitutionCAM2029 10, 20 mg
0.5 -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 reconditioning
Based on PLGA microsphere system
Somatuline® Autogel® 60, 90, 120 mg
0.2-0.5 mL/ready-to-use/refrigerated
≥ 30 min reconditioning
Self-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-to-use in prefilled syringe with small needle
102Camurus Capital Markets and R&D Day, December 14, 2016
Early stage pipeline
103
Markus Johnsson, PhD, VP Pharm. Dev.
Camurus Capital Markets and R&D Day, December 14, 2016 104
Selection criteria for growing our pipeline
Unmet medical need
• Patients and prescribers in focus
• Better treatment outcomes; convenience, compliance,health care cost savings
Technology match
• Value creation by use of FluidCrystal®
technology platforms
• Technology fit (solubility, stability, and in vitro and in vivo release)
Expeditious clinical development and market registration
• 505(b)(2) registration pathway
• Accelerated approvals
Patent protection
• Existing platform patents
• Product patent opportunities
Attractive market
• Potential for pricing and reimbursement
• Concentrated customer base, prescribers
• Large market potential
• Commercial synergies
Camurus Capital Markets and R&D Day, December 14, 2016 105
Camurus’ development engine supporting different strategicdirections
Compounds Preclinical assessment Clinical development and commercial strategy
In-house
innovation
Established
APIs
Partner
initiated
Partner
NCEs
Own development & commercialisation
and licensing partnerships
Partner development and commercialisation
supported by Camurus R&D
Camurus development
Early stage projects
Camurus Capital Markets and R&D Day, December 14, 2016 106
Project Product Indication Development
status
Near-term
development
milestone
CAM2047 granisetron FluidCrystal®
injection depot
Prevention of
chemotherapy-induced
nausea and vomiting
(CINV)
Phase 1 ongoing Results Q2 2017
CAM2048 buprenorphine
FluidCrystal® injection
depot
Pain Phase 1 ongoing Results Q2 2017
CAM2058 granisetron /
buprenorphine
FluidCrystal® injection
depot
Pain, nausea and vomiting Phase 1 ongoing Results Q2 2017
CAM2043 treprostinil FluidCrystal®
injection depot
Pulmonary Arterial
Hypertension (PAH)
Pre-clinical Bridging toxicology
program finalized
Q1 2017
CAM2043 is a novel sustained release trepostinil under development for treatment of pulmonary arterial hypertension
• Pulmonary arterial hypertension (PAH) is a
progressive, life-threatening disease
• Orphan indication of 15-50 cases per million
‒ Fewer than 200 treatment centers in the US
• PAH market exceeded 4 billion USD with
aggregated trepostinil product sales of about
1.1 billion in 2015
‒ Remodulin (United Therapeutics) sales of ~$572
million in 2015, ~12% CAGR1
Camurus Capital Markets and R&D Day, December 14, 2016 107
• Limitations of current parenteral treatments
‒ Infusion site pain in 85% of patients
• Treatment limiting in 8% of patients
‒ Infections and sepsis relating to administration by
continuous infusion
‒ Need for extra-corporal pump device limiting
convenience and quality of life
• Requiring programming, drug dilution and filling
with associated complications in 28% of patients
• Pump not water resistant
• Includes meta-cresol preservative
Source: 1. PharmaCircle
CAM2043 has multiple potential treatment benefits versusparenteral infusion for PAH patients
• CAM2043 is a convenient subcutaneous depot
‒ E.g. weekly SC dosing
‒ Individualized treatment
• Steady exposure levels adjustable by dose
‒ In dose range of current products
‒ Maintain efficacy of parenteral products
• Potential for improved local tolerability
‒ Injection site pain and local reactions
‒ Risks of infections and sepsis
‒ No need for meta-cresol preservative
Camurus Capital Markets and R&D Day, December 14, 2016 108
• CAM2043 pharmacokinetic profile
Time (hours)
24 48 72 96 120 144 168
Pla
sm
a T
PN
con
c (
ng
/mL)
0,1
1
10
100
treprostinil SC 22.5mg
treprostinil SC 30 mg
Source: Company data (dog PK)
Camurus Capital Markets and R&D Day 2016
Conclusion
PARTNERS PRODUCT EVENT TIME
CAM2038 Opioid dependence Phase 3 study results, long-term safety trial
NDA & MAA submissions
Q1, 2017
Mid-2017
CAM2038 Chronic pain Phase 2 results
Phase 3 efficacy results
Q1, 2017
H2, 2017
CAM2029 Acromegaly & NET Phase 3 trial initiations, NET & acromegaly 2017
CAM2047 CINV Phase 1 study results Q2, 2017
CAM2048 Pain
CAM2058 Pain, nausea and vomiting
Phase 1 study results
Phase 2 study initiations
Q2, 2017
Q2, 2017
Early partnerships Start of Phase 1 trial for weekly setmelanotide 2017
New program CTA approval 2017
110
Significant news flow expected during 2016-17
Camurus Capital Markets and R&D Day, December 14, 2016
Conclusions
• De-risked, late-stage, differentiated pipeline
‒ Opioid addiction, pain, cancer and acromegaly
‒ Successful Phase 3 study results in addiction
‒ Attractive multi-billion dollar specialty pharmaceutical markets
‒ Concentrated prescriber audiences and active patient advocacy groups
• Strong collaborations with dedicated partners
‒ Novartis, Braeburn Pharmaceuticals, Rhythm, Solasia, R-Pharm US
• Several levers for pipeline and business expansion
‒ New product candidates entering clinical development
‒ Growth opportunities via proven technology platforms and business development
• European commercial organisation
‒ Leadership team established
‒ Pre-launch activities for CAM2038 ongoing
• Solid financial position
111Camurus Capital Markets and R&D Day, December 14, 2016
Camurus Capital Markets and R&D Day 2016
Q&A
Lars Frick
Camurus Capital Markets and R&D Day 2016
Backup slides
Strong financial position and increasing investments in R&D and commercial launch preparations
Key figures, mSEK
2016 2015
Q3 Q1-Q3 Q3 Q1-Q3
Revenues 3.6 9.1 4.4 14.0
Operating result -2.0 -8.0 -0.8 -3.0
Cash 60.1 13.4
Total assets 75.3 25.0
Equity 68.6 12.3
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
115Camurus Capital Markets and R&D Day, December 14, 2016