jefferies 2017 london healthcare conference 2017 london healthcare conference london, uk november...
TRANSCRIPT
Jefferies 2017 London
Healthcare Conference
London, UK
November 15-16, 2017
Company Presentation
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
2
Late-stage pipeline and emerging
European commercial organization
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
‒ Listed on NASDAQ STO (OM-CAMX)
CASH
~45MILLION USD
END Q3 2017
MARKET CAP
470MILLION USD
3
Strong delivery of results during the past year
• Positive Phase 2 opioid blockade results
• Positive Phase 2 results in OUD patients with chronic pain
• Completed patient recruitment to pivotal Phase 3 chronic pain and safety extension study
CAM2038 – OPIOID USE DISORDER (OUD) & CHRONIC PAIN
• Advisory Committee recommendationfor CAM2038 NDA approval
• EMA/TGA validation of MAA submissions
• Priority Review by FDA
• Positive Phase 3 long-term safetystudy results
• Positive Phase 3 efficacy results
OTHER PIPELINE PROGRAMS
• Phase 1 study of CAM2047 and CAM2058 for nausea and pain completed
• Positive initial Phase 1 study results for weekly setmelanotide for genetic obesity disorders
• Positive Phase 2 study results for CAM2029 in acromegaly and NET
4
5
FluidCrystal® injection depot
for longer 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
Time
+400 PATENTS &
APPLICATIONS
~1500 SUBJECTS HAVE RECEIVED
>15,000 INJECTIONS IN
CLINICAL TRIALS
Liquid drug product
formulation before injection:
SPC+GDO+solvent+Drug
Water absorption
Solvent release
Drug release
Liquid Crystal (LC)
Injection
Depot biodegradation to
complete resolution
Diversified, late-stage pipeline
66
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 for OUD
○ MUSD 21 for chronic 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”
7
Weekly and monthly buprenorphine depots
Changing the treatment paradigm in opioid dependence
CAM2038
9
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, Europe and Australia3,4
Investment in treatment adds significant value
• Up to 12 dollars saved for each dollar spent on treatment5
High unmet medical need
• Treatment adherence
• Relapse and overdose
• Burden of daily medication
• Medication diversion and misuse
• Exposure to children and teenagers
• Controls and supervision
• Access to treatment
Concentrated, accessible target prescriber base
~8,000 US
~7,500 Europe
Large, growing market
• 2.7 billion USD in 20166
• 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
7000OPIOID OVERDOSE
DEATHS IN
EUROPE 20153
EACH DAY
>1000RECEIVE EMERGENCY
ROOM TREATMENT DUE
TO NONMEDICAL USE
OF OPIOIDS (US)
Unique characteristics of CAM2038
• Weekly and monthly dosing alternatives
‒ Multiple dose strengths
‒ Small volume doses from 0.16 to 0.64 mL
‒ Thin 23G, ½” needle
• Administered by healthcare provider
‒ Ensuring medication adherence and exposure
‒ Minimizing risk of misuse, abuse, diversion and accidental pediatric exposure
• Allows for individualized dosing
‒ Aligning with current treatment guidelines
‒ Use across all phases of medication assisted treatment (MAT) of opioid dependence
10
CAM2038 – individualized treatment of opioid
dependence across treatment phases
Proposed indication:
For treatment of opioid dependence, including treatment initiation.
”New to treatment” patients
Patients in treatment
Transmucosal
buprenorphine
Inititation
(induction)Stabilization
Maintenance
treatment
Weekly
CAM2038Weekly
CAM2038Monthly
or Weekly
CAM2038
11
Potential to significantly improve opioid dependence
treatment with weekly and monthly depots
Sustained suppression of cravings
and withdrawal
Opioid blockade from
first dose
Reduce burdens of
daily medication
Improve treatment adherence
Significantly reduce illicit opioid use
Minimize risks of diversion, misuse and
pediatric exposure
12
13
CAM2038 development milestones in
opioid dependence
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
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
14
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
CAM2038 clinical program
Drug liking visual analogue scale
15
Sustained withdrawal suppression and opioid blockade
from the first dose – no need for sublingual medication
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
Weekly
CAM2038
Injection 2
Weekly
CAM2038
Injection 1
CAM2038 24 mg
CAM2038 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 8-10) (Days 11-13)
Weekly
CAM2038
Injection 1
60
90
* 11 pt. difference: Prespecified complete blocking criteria
Neutral
Strong
Disliking
Strong
Liking
Weekly
CAM2038
Injection 2
CAM2038 24 mg
CAM2038 32 mg
Clinical opiate withdrawal scale (COWS)
Phase 3 randomized, double-blind, double-dummy efficacy study (HS-11-421), N=428
Head-to-head efficacy study of a long-acting injection
versus daily sublingual buprenorphine/naloxone
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
16
17
Phase 3 study in unstable patients – reflecting
real-world opioid dependence patients
Study with high portions of heroin, poly-drug and injection users
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)
18
CAM2038 met primary and secondary endpoints of
noninferiority and superiority versus daily SL BPN/NX
Noninferiority shown for mean % urines negative for illicit opioids and response rateP<0.001
Superiority demonstrated for key secondary endpoint of percentage weeks abstinent, P=0.004
-0,2 -0,1 0 0,1 0,2
Treatment difference mean (95% CI)
Favors CAM2038Favors SL BPN/NX
10%
11%
NI margin
NI margin
-0.1% 6.7% 13.3%
-3.5% 3.4% 10.4%
EMA:- Mean % Urine Samples Negative for Illicit Opioids
FDA:Primary Endpoint - Response Rate
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.
1 2 3 4 5
Much
Worse
Slightly
Worse
About the
Same
Slightly
Better
Much
Better
19
CAM2038 well tolerated with a low frequency of
injection site adverse events
Mild to moderate local AEs
17%
5%0%
13%6%
0%0
20
40
60
80
100
Mild Moderate Severe
Inje
ctio
nsite
rea
ction
s(%
)
Severity
SL BPN/NX (N=215)
CAM2038 (N=213)
CAM2038 safety profile
Consistent with well established safety profile of SL buprenorphine
Good local tolerability with low frequency of mild to moderate injection site reactions
No unexpected safetyfindings
Transfer from SL BN
High satisfaction indicated by patients transferred from SL BPN to CAM2038 (N=133)
83%
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
20
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
ALBATROS
31 May – 2 Jun
Paris, France
ATHS
17-20 Oct
Biarritz, France
SSA
9-10 Nov
Newcastle, UK
APSAD
12 -15 Nov
Melbourne, Australia
21
Limited competition on long-acting injectable opioid
dependence market
CAM2038 Weekly & Monthly
RBP-6000 Monthly
Buprenorphine Depot1
HTX-0032
Vivitrol $300M expected 2017 sales
PDUFA
Jan. 19, 2018
PDUFA
Nov. 30, 2017
Approved in 2010
for OUD
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.
Long-acting buprenorphine injectables
Long-acting naltrexone
Braeburn/Camurus
Indivior
BDSI
Heron
Alkermes
PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL (US) APPROVAL (EU/Aus)
Estimated
Q3/Q4 2018
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 miilionregistered heroin users
in China4
22Source. 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 million opioid dependent individuals globally1
Cost is driven primarily by expensive catastrophic events
23
OUD is a significant driver of direct costs for
payers in the US
$3 435
$19 333
$0
$5 000
$10 000
$15 000
$20 000
$25 000
Any Patient* OUD Patient
Average Per-Patient Costs (2015)
*Including OUD Patients
690,000OUD INTENSIVE CARE UNIT
ADMISSIONS IN 2015
$92,400MEAN OUD ICU
ADMIT COST IN 2015
$63.8 bnCOSTS TO PAYERS
5.6xHIGHER
COSTS
Sources: Fair Health, The impact of the Opioid Crisis on the Healthcare System, 2016.; Yokell MA, et al. Presentation of Prescription and Nonprescription Opioid Overdoses to US Emergency
Departments, 2014.; Stevens, et al. The critical care crisis of opioid overdoses in the United States, 2017.
24
Prescription volume growth of OUD treatment in the US.
Significant market share expected for long-acting buprenorphine
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. Jefferies, RBC Capital, Numis, Stifel, Merrill Lynch
buprenorphine/naloxone
(Suboxone, Bunavail, Zubsolv & oral generics)buprenorphine HCL & generics
naltrexone (Vivitrol)
ANALYSTS:
$0.8-1.4 bnUS PEAK SALES ESTIMATES FOR
MONTHLY BUPRENORPHINE DEPOT
PRODUCT FOR OUD2
Spain
61,954
France
161,388
UK
148,686Germany
77,500
Nordic countries
16,535
Italy
75,964
25
Preparing for 2018 launch of
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
Headcount build-up following to launch sequence
Strong rationale for CAM2038 in Europe and Australia
• 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 sizeable health and socio-economic benefits
26
Large interest in CAM2038 among physicians and
large patient pool in Europe and Australia
Large markets & high willingness to prescribe depots gives market estimates for depot of €180m-€250m2
Country Physicians willingness to prescribe CAM20381 % patients*: q4w q1w
86%
94%
86%
96%N=50
N= 47
31%
30%
36%
25%
N= 4843%
27%
39%
22%
N=51
N=50
N=50
Patient numbers in EU5, Nordics and Australia
0
50000
100000
150000
200000
No.s in substitution treatment
New entrants to treatment
Estimated no. of buprenorphine
Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015 * % patients considered suitable for CAM2038 by surveyed physicians if available on the market: 2. Europe and Australia
Round-the-clock relief of chronic pain withlimited potential for misuse and diversion
CAM2038
28
Chronic pain is a global health problem with large
impact on patients’ QoL and society
Opioids are highly effective in management of chronic pain, but come at a high price
Side effects, dose escalation, misuse, abuse, diversion, opioid overdoses and pediatric exposure
Over 15,000 US overdose deaths related to prescription pain relievers (2015)6
1 IN 5 INDIVIDUALS SUFFERING FROM CHRONIC PAIN1
The chronic pain global health challenge Opioids for 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. Relieving Pain in America, A Blueprint for Transforming
Prevention, Care, Education and Research. The National Academic Press 2011; 3. Eur J Pain 2006;10:287-333 4. Journal of Pain 2012, 13:715-724; 5. Persistence Market Research 2016; 6. Prescription Opioid
Overdose Data, CDC 7. Symphony Health Solutions, data period: November 2015, January 2016;
~200 MILLION
PEOPLE
SUFFER FROM CHRONIC
PAIN IN EU & US2,3
$ 560-635
BILLIONS
COST TO SOCIETY4
LARGE
NEGATIVE
IMPACT ON
QoL5
• 24% of opioid chronic pain prescriptions were for 90 mg/day or higher morphine equivalent doses in 20157
• Global opioid analgesics market worth 6.2 bn USD1
• New recommendations, updated guidelines and regulations leave many patients without effective treatment alternatives
Buprenorphine has uniqueproperties for pain management
Rational for CAM2038 in treatmentof chronic pain
29
• Category 3 opioid with lowerpotential for dependence
• Provides effective dosedependent pain relief
• 25-100 times more potent thanmorphine
• Favorable safety profile with a ceiling effect on respiratorydepression
• Less dysphoria and no evidence ofhyperalgesia
• Less analgesic tolerance
Round the clock pain relief
Multiple weekly and monthllydoses allow dose titration and individualized treatment
Rapid and sustained blockade ofeuphorigenic and sedativeopioid effects
HCP administration adressesmisuse and diversion issues
A majority of physicians whotreat addiction also treat pain
Clear rational for buprenorphine depots for chronic pain,
further emphasized in high risk/high dose patients
Sources. Anesthesiology 2014; 120:1262-74, J Clin Pharm Ther. 2014 Dec;39(6):577-83
µ-opioid receptor agonist
κ-opioid receptor antagonist
No
activation
BuprenorphineMorphine
Illustrative
Full agonist Partial agonist
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
30
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
Pipeline expansion with additional
attractive early stage candidates
PARTNER PRODUCT PRE-CLINICAL PHASE1-2
31
PHASE 1-2
PHASE 1-2
CAM2029 ACROMEGALY
CAM2029 NEUROENDOCRINE TUMORS
PHASE 1-2CAM2032 PROSTATE CANCER
CAM4072 GENETIC OBESITY
CAM2043 PULMONARY ARTERIAL HYPERTENSION
Undisclosed internal project candidates
Early stage collaborations with pharma and biotech partners
PHASE 1-2PHASE 1-2
PHASE 1-2
PHASE 1-2
CAM2047 CHEMOTHERAPY INDUCED NAUSEA & PAIN
CAM2048/2058 POSTOPERATIVE PAIN & POSTOPERATIVE NAUSEA & PAIN
32
Pipeline products overview – CAM2029
CAM2029
TARGET
INDICATIONS Acromegaly and neuroendocrine tumors
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; 2. GBI Research 2010
Somatostatin analogue sales
Significant potential in converting
Sandostatin® LAR ® patients to CAM2029
33
Pipeline products overview – CAM2047 and CAM2048/58
CAM2047
TARGET
INDICATION
Chemotherapy induced nausea and vomiting
(CINV)
FORMULATION SC granisetron FluidCrystal® depot
KEY ADVANTAGES • ~5-7 days duration to cover both acute and
delayed CINV
• Ready-to-use prefilled syringe
• Room temperature storage
MARKET SIZE $1 bn1 for NK1 and 5HT-3 inhibitors
DEVELOPMENT
STATUS
• Phase 1 completed
• Preparations for Phase 3 ongoing
KEY RESULTS PK and tolerability targets met in Phase 1
PARTNER Partnering strategy under evaluation
CAM2048/58
TARGET
INDICATION
Acute pain (post-operative) and post-operative
nausea and vomiting (PONV)
FORMULATION SC FluidCrystal® depot of buprenorphine (CAM2048)
or buprenorphine/granisetron (CAM2058)
KEY ADVANTAGES • Continuous pain relief ~4 days to cover post-
operative pain (and nausea & vomiting)
• Controlled administration by HCP (no diversion or
misuse)
MARKET SIZE Post-operative pain market >$5 bn2
DEVELOPMENT
STATUS
• Phase 1 completed
• Preparations for Phase 3 ongoing
KEY RESULTS PK and tolerability targets met in Phase 1
PARTNER Braeburn Pharmaceuticals (North America)
CAM2048/58
TARGET
INDICATION
Acute pain (post-operative) and post-operative
nausea and vomiting (PONV)
FORMULATION SC FluidCrystal® depot of buprenorphine (CAM2048)
or buprenorphine/granisetron (CAM2058)
KEY ADVANTAGES • Continuous pain relief ~4 days to cover post-
operative pain (and nausea & vomiting)
• Controlled administration by HCP (no diversion or
misuse)
MARKET SIZE Post-operative pain market >$5 bn2
DEVELOPMENT
STATUS
• Phase 1 completed
• Pivotal study program in prepara
KEY RESULTS PK and tolerability targets met in Phase 1
PARTNER Braeburn Pharmaceuticals (North America)
CAM2048/58
TARGET
INDICATION
Acute pain (post-operative) and post-operative
nausea and vomiting (PONV)
FORMULATION SC FluidCrystal® depot of buprenorphine (CAM2048)
or buprenorphine/granisetron (CAM2058)
KEY ADVANTAGES • Continuous pain relief ~4 days to cover post-
operative pain (and nausea & vomiting)
• Controlled administration by HCP (no diversion or
misuse)
MARKET SIZE Post-operative pain market >$5 bn2
DEVELOPMENT
STATUS
• Phase 1 completed
• Pivotal study program in preparation
KEY RESULTS PK and tolerability targets met in Phase 1
PARTNER Braeburn Pharmaceuticals (North America)
Sources. 1. GlobalData 2017; 2. GBI Research 2010
CAM4072
TARGET
INDICATION
Genetic obesity disorders
FORMULATION Subcutaneous setmelanotide depot based on
FluidCrystal®
KEY
ADVANTAGES
• Weekly dosing
• Ready-to-use prefilled syringe
• Improved patient convenience
MARKET SIZE Not communicated
DEVELOPMENT
STATUS
• Phase 1 results expected Q4 2017
• Submission earliest 20191
KEY RESULTS Positive initial phase 1 results meeting Rhythm’s
PK and tolerability criteria.
PARTNER Rhythm (exclusive worldwide license)
34
Pipeline products overview – CAM4072 and CAM2043
CAM2043
TARGET
INDICATION
Pulmonary arterial hypertension (PAH)
FORMULATION Subcutaneous treprostinil depot based on
FluidCrystal®
KEY
ADVANTAGES
• ~7 days duration
• No need for extracorporal pump and infusion
hoses
• Potential for reduced injection site pain and
local reactions
• Lower risk of infections and sepsis
MARKET SIZE PAH market >$5 bn, tresprostinil ~1.2 bn2
DEV. STATUS • Planned phase 1 start Q4 2017
KEY RESULTS Preclinical target PK profile confirmed
Sources. 1. Form S-1 Rhythm Pharmaceuticals 2017 2. PharmaCircle 2017
• 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
35
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden
[email protected] camurus.com
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
37