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Company presentation
December 2018
Forward-looking statements
This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance.
Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases.
Camurus undertakes no obligation to update forward-looking statements
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3
Investment highlights
Listed on Nasdaq STO (ticker CAMX)
Market Cap: SEK ~4 billion
Cash position: SEK ~216 million (Q3 2018)
Employees: 94
HQ: Lund, Sweden
Regional offices: Cambridge, Mannheim, Paris, Sydney
Unique FluidCrystal®
delivery technology
Broad, late-stage
R&D pipeline
Own commercial
organization
Value adding
partnerships
Experienced management and dedicated teams
• Developed in-house with strong IP protection
• Proven in 20+ clinical trials
• Validated by regulatory approvals
• 10+ clinical programs in opioid addiction, pain,
cancer, obesity, endocrine and CV disease
• 2018 EMA/TGA approvals and FDA decision
• Fully operational for 2019 Buvidal® launches
in Europe and Australia
• Braeburn, Rhythm, Medison, Solasia Pharma…
• Significant near-term milestone payments
4
Broad and diversified product pipeline
4
1. Braeburn holds the rights to North America; 2. Postoperative nausea and vomiting; 3. Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal®
PRODUCT PRECLINICAL PHASE 1-2 PHASE 3 REGISTRATION MARKET
Buvidal® (CAM2038) q1w OPIOID DEPENDENCE1 APPROVED
Buvidal® (CAM2038) q4w OPIOID DEPENDENCE1 APPROVED
CAM2038 q1w CHRONIC PAIN1 PHASE 3
CAM2038 q4w CHRONIC PAIN1 PHASE 3
CAM2029 ACROMEGALY PHASE 1-2
CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2
CAM2032 PROSTATE CANCER PHASE 1-2
CAM2047 CHEMOTHERAPY INDUCED NAUSEA & VOMITING PHASE 1-2
CAM2048/58 POSTOPERATIVE PAIN & PONV1,2 PHASE 1-2
CAM4072 GENETIC OBESITY DISORDERS3 PHASE 1-2
CAM2043 PULMONARY ARTERIAL HYPERTENSION PHASE 1-2
Strong 2018 news flow
5
PRODUCT EVENT TIME
CAM2038 Opioid dependence CRL issued by FDA
NDA resubmitted to the FDA √
Publication of pivotal Phase 3 results in JAMA Int. Med. √
FDA issued PDUFA goal date of 26 December 2018 √
Positive CHMP opinion recommending EU approval √
EU approval √
Australian approval √
US approval decisions
January 2018
May 2018
May 2018
July 2018
Sept 2018
Nov 2018
Nov 2018
Dec 2018
CAM2038 Chronic pain Positive Phase 3 efficacy results √ Sept 2018
CAM2029 Acromegaly / NET Exclusive rights to CAM2029 regained from Novartis √ July 2018
CAM2043 PAH / 2nd indication Positive Phase 1 SAD and MAD results√ May 2018
CAM4072 Genetic obesity First clinical milestone achieved √ Feb 2018
5
Long-acting medications address key healthcare challenges
6
7
Unique FluidCrystal® nanotechnology platform
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
WEEKS / MONTHSHOURS SECONDS
400+ PATENTS &
APPLICATIONS
>2000 SUBJECTS HAVE RECEIVED
~20,000 INJECTIONS IN
20 CLINICAL TRIALS
✓ Easy to administer
✓ Rapid onset & long-acting release
✓ Applicable across substance classes
✓ Good safety and tolerability profile
✓ Unique mixtures of endogenous lipids
✓ Validated by regulatory approvals
Tiberg F, Johnsson M, Jankunec M et al., Chemistry Letters 2012; 41(10): 1090-1092; Tiberg F, Johnsson M., J. Drug Delivery Science Techn. 2011; 21 (1): 101-109.
0,1
1
10
0 7 14 21 28
Pasireotide p
lasm
a c
oncentr
ation (
ng/m
L)
Time (days)
Pasireotide IR 600 ug(SC thigh, n = 94)
Long-acting pasireotide (CAM4071)Immediate-release pasireotide (Signifor®)
Long-acting pasireotide, formulated with FluidCrystal®
Single dose injection at t=0; clinical Phase 1 data, mean values. Tiberg F et al, Poster presentation at ECE, Barcelona, May 2018. 8
0,1
1
10
0 7 14 21 28
Pasireotide p
lasm
a c
oncentr
ation (
ng/m
L)
Time (days)
Pasireotide FluidCrystal20 mg (SC thigh, n = 12)
Clinically documented compounds+
FluidCrystal® technology
9
Weekly and monthly buprenorphine depots
Potential game-changer in opioid dependence treatment
CAM2038
Opioid dependence: an escalating
global health crisis
• Largest societal burden of all drugs1
• Public health epidemic in the US
• Patients need better access to care and new treatment choices
• Investment in treatment brings significant value
Source: 1. UNODC, World Drug Report 2017; 2. Center for Disease Control & Prevention 2018; 3. The Council of Economic
Advisers, November 2017; 4. Frazier at al, 2017, Journal of the American Medical Association; 5. Crow D. Financial Times.com,
accessed on March 13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da
WHITE HOUSE ESTIMATES
US$ 504 billion PRICE TAG FOR US OPIOID CRISIS3
11
Mounting US opioid overdose deaths2
(thousands)
5
10
15
20
25
30
35
40
45
50
* Provisional data
− 1 cause of death for people below 50 in the US
− 30:1 non-fatal to fatal overdoses4
− Recent US life expectancy decline largely
due to opioids5
• Flexible dosing to match patient needs
Enhanced continuum of care with direct
initiation and switching from daily
treatments (‘dose matching’)
• Removes burden and stigma of daily
medication and increases adherence
• HCP administration safeguards against
diversion, misuse and pediatric exposure
• Potential game changer in opioid
dependence treatment
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Buvidal® has a unique and differentiated product profile
SMALL
NEEDLE
LOW
VOLUMES
ROOM TEMP
STORAGE
CLINICAL DATA VS
ACTIVE CONTROL
✓ ✓ ✓23 gauge 0.16 – 0.64 mL
✓
WEEKLY
DOSING
MONTHLY
DOSING
MULTIPLE
DOSES
CHOICE OF
INJECTION
SITES
✓ ✓ ✓ ✓
• Non-inferior and superior efficacy shown in pivotal Phase 3
study versus standard daily SL BPN/NX1
• Effective suppression of withdrawal and cravings1,2,3
• Blockade of opioid effects from the first dose2
• Pharmacokinetic profiles for weekly and monthly dosing4
• Safety profile comparable to SL BPN/NX except for
mild and moderate injection site reactions1
• No opioid overdoses across clinical studies for participants
treated with Buvidal® 1,2,3,5
• High patient satisfaction including versus SL BPN6
Compelling clinical data for Buvidal®
versus daily standard treatment
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1Lofwall et al, JAMA Int. Med. 2018;178(6); 764-773; 2Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 3Haasen C et al, J
Subst Abuse Treat. 2017;78:22-29; 4Albayaty M et al, Adv Ther. 2017 34(2):560-575; 5Lintzeris et al, Drug and alcohol review.
2017;36(S1):47-48, 6Study HS-14-499, data on file. SL BPN: sublingual buprenorphine/naloxone.
H
“CAM2038 compared to my previously prescribed sublingual buprenorphine treatment”
Much worse
Slightly worse
About the same
Slightly better
Much better
83% POSITIVEN=133
High satisfaction amongst patients
Source: Poster presentation ASAM 2018. Phase 3 Long-Term Safety Study HS-14-499, data on file.14
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Long-acting injectables for opioid dependence
treatment on key global markets
Approved Nov 2017
Approved 2010
Source: 1. Indivior, Q2 Financial Results, May 2, 2018; 2. GlobalData 2018
Long-acting buprenorphine injectables
Long-acting naltrexone injectables
Camurus/
Braeburn
Indivior
Alkermes
PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL
US
US
Vivitrol 2017 sales $269M2 US
Europe
Europe
Australia
Australia
N/A
Est. Q3 2019
CAM2038 Weekly & Monthly
Sublocade™ Monthly
PDUFA 26 Dec. 2018
Positive CHMP opinion. Est. Q4 2018
Est. Q4 2018
16
2019: Buvidal® (CAM2028) launches in key global markets
Source. 1. World drug report 2018.
ESTIMATED
34 millionWORLDWIDE
OPIOID USERS 20161
Braeburn Braeburn option rightCamurus 1st entry markets Medison (Israel)Camurus
127,000OPIOID OVERDOSE
DEATHS1
11.2 millionINJECTION
USERS1
5.5 millionWITH HEPATATIS C1
1.2 millionWITH HIV1
Strong market dynamics Braeburn readiness for Q1 ‘19 launch
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• Escalating opioid crisis, high unmet need and high disease awareness
• Opioid addiction market growing+13.9% in scripts over 12 months
• Payers under pressure to increase treatment access due to extreme economic burden – $500 billion
• Strong physician and KOL support for long-acting injections
~11,000 unique patient Rx initiations for injectable buprenorphine
• High patient interest in CAM2038 profile
• Purpose-built infrastructure for specialty pharma
• Quality payer access from launch
• Broad specialty pharmacy network for fast and easy market access
• Reducing Rx process friction
• Benefiting from “fast follower” status
• Simplified doctor/patient interaction
• Experienced team with over 50 specialty drug launches
• Sales force recruitment well advanced
US market opportunity for
CAM2038
1Estimate based on 20% share of US OUD patients, or prescriptions (Symphony Health, PHAST Integrated Monthly).Treatment
retention from study HS-11-421 (data on file) and monthly price of Sublocade™ ($1580). LAI – long acting injectables
Long-acting injectable Rx share of 20% corresponds to ~ USD 3 billion market potential1
Mannheim,
Germany
Paris,
France
Cambridge,
UK
HQ
Lund,
Sweden
Track record of successful commercialization in the opioid dependence market
‒ EU/AUS team of 45 professionals, expanding to 75 in 2019
‒ Extensive experience from the opioid dependence and related specialty areas
‒ Market access, pricing and reimbursement expertise
‒ Strong relationships with KOLs through collaborations
‒ Infrastructure and effective pathways for patient access under development
‒ 85% of patients in treatment are in EU5, Nordics and Australia
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Leading commercialization platform established in
EU and Australia
Sydney
Australia
Northern Europe
Southern Europe
Central Europe
Australia
Regions
Focus on accelerating growth trajectory of Buvidal®
96%
n=52
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Significant market potential for Buvidal® on Camurus’
own markets
Market potential for LAIs in Europe and Australia estimated to €180m – €250 million3
Source: 1. Market access dynamics in opioid addiction, Decision Resources 2015; 2. ECMDDA 2018; 3. Camurus estimate
High physicians’ willingness to prescribe CAM2038 (EU5)1
Physicians’ willingness to prescribe CAM2038 Anticipated share of patients on CAM2038 q4w if available Anticipated share of patients on CAM2038 q1w if available
96%
n=50
39%q4w
22%q1w
94%
n=50
36%q4w
25%q1w
86%
n=50
43%q4w
27%q1w
France
169,700 patients2
86%
n=51
31%q4w
30%q1w
Germany
78,500 patients2
UK
138,400 patients2
Italy
62,800 patients2
Spain
59,200 patients2
37%q4w
22%q1w
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Positive Phase 3 results for CAM2038 in second
indication of chronic pain
Enriched enrollment randomized withdrawal study design
• Primary endpoint change from Week 12 to baseline
‒ 1.03 (95% CI, 0.49 to 1.57; p<0.001) difference to placebo (+rescue)
• Key secondary endpoint of worst pain intensity,
‒ 1.11 (95% CI, 0.49 to 1.57; p<0.001) difference to placebo (+rescue)
• Statistical treatment difference for additional endpoints:
‒ Time to loss of efficacy, p=0.002; patient global impression of change improvement, p<0.001; work productivity and activity impairment subscale, p=0.005
• Favorable safety profile consistent with buprenorphine
‒ Mild to moderate injection site reactions in a minority of subjects
API average pain intensity Research N Reports 2018, Chronic Low Back Pain Market - Global Insights, Growth, Size, Comparative Analysis, Trends and Forecast, 2017-2025. 2. Journal of Pain 2012, 13:715-724.
0
1
2
3
4
5
6
7
8
Baseline End OLT withCAM2038
Averg
a p
ain
inte
nsity s
core
Average pain intensity (API) score decreased 64%
from 7 to 2.5 during CAM2038 open-label titration
64% decrease
in pain score
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Registration program for CAM2038 in chronic
pain targets opioid experienced patients
1 IN 5 INDIVIDUALS SUFFERFROM CHRONIC PAIN1
CHRONIC PAIN ESTIMATED
~US$560-
635bnANNUAL COST TO SOCIETY2
Completion of long-term safety
extension study
Scientific advice/pre-MAA meetings
with health authorities
MAA submissions to EMA and TGA
expected first half of 2020
Focus on high risk, high need
opioid experienced patients
Long-acting octreotide
for acromegaly and NET
CAM2029 update
SOMATOSTATIN ANALOG SALES1
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CAM2029: A next generation long-acting
octreotide entering Phase 3
Source: 1. GlobalData 2017; 2. US weighted average cost for mid-range doses, 2018.
0
250
500
750
1000
1250
1500
1750
2000
2250
2500Somatuline® (Ipsen)Sandostatin® LAR® (Novartis)
mUS$
• Octreotide subcutaneous depot (CAM2029) for acromegaly and neuroendocrine tumors (NET)
‒ FluidCrystal® formulated for patient convenience and controlled release
‒ Potential for improved efficacy – Phase 2 data
‒ Phase 3 program planned to start Q2 2019
• Additional innovative SSA products under development targeting rare endocrine diseases
‒ Preclinical data suggest effective hormonal secretion and tumor growth inhibition and good tolerability – 20 years of strong market growth
– Concentrated prescriber base
– Long-acting SSA US price-range
US$51,000 to US$146,000 WAC/year2
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CAM2029 – Next generation octreotide depot
Note: 1) Illustrative; final product configuration may be different.
Product Product
presentation
Route of
administration
Self-administration
CAM2029 Ready-to-use
prefilled syringe
12.5 mm, ≥22G needle
SC ✓
Sandostatin® LAR® Reconstitution system
(vial, diluent)
40 mm, 20G needle
IM –
Somatuline® Autogel® Ready-to-use
prefilled syringe
20 mm, 18-19G needle
Deep SC –
• Dose proportional long-acting octreotide release suitable for once monthly dosing1
• Rapid and sustained suppression of insulin growth factor-1 (IGF-1) in healthy volunteers1
• Well maintained or improved biochemical control indicated in patients with acromegaly2
• Well maintained or improved symptom control indicated in NET patients2
• Good safety profile and local tolerability1-2
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CAM2029 is supported by data from four clinical studies
Completed clinical trials
✓ Three Phase 1 studies assessing pharmacokinetics (PK), pharmacodynamics (PD) and safety in healthy volunteers (N=249)
✓ One Phase 2 study evaluating PK, disease biomarkers and symptoms in acromegaly and NET patients (N=12)
Source: 1. Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2. Ferone D. Poster Presentation ENDO 2017, Pavel.
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Plans for continued development of CAM2029
✓ Four clinical trials completed in
healthy subjects and patients
characterizing PK, PD and
safety profile (N=249)
Phase 1, SAD
Phase 1, MAD
Phase 1, MAD
Phase 2, MAD❑ Placebo controlled (PC) Phase 3
study in SSA responders (N~80).
❑ Open label, long-term safety
extension in full/partial responders
ACRO Phase 3 LTSE
ACRO Phase 3 PC
H2 2019 2021
❑ Active controlled (AC) Phase 3
study in patients with metastatic,
well or moderately differentiated
NET.
NET Phase 3 AC + LTSE
Camurus positioned for continued value creation
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• Leading FluidCrystal® technology platform used in in-house and in partnership programs and registered products
• Broad and de-risked clinical pipeline targeting unmet needs in multibillion dollar specialty markets
• Multiple levers for value creation including product approvals, partnerships and own commercialization
• Buvidal®/CAM2038 launches in Europe and Australia, and the US (Braeburn)
• Potential for significant near-term milestones, royalty and sales revenues
• 10 year track record of successful product, business and corporate development
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Key financialsSandberg
Development AB
53,2%
Gladiator4,7%
Fredrik Tiberg3,9%
Swedbank Robur Fonder3,1%
Catella Fondforvaltning
2,7%
Fjärde AP-fonden2,3%
Others30,1%
Key Shareholders (30 September 2017)
Listed on Nasdaq STO (ticker CAMX)
Market Cap: SEK ~3.5 billion
Cash position: SEK 216 million (Q3 2018)
Employees: 85
HQ: Lund, Sweden
Regional offices: Cambridge, Mannheim, Paris, Sydney
MSEKQ3
2018
Q3
2017
Q1-Q3
2018
Q1-Q3
2017FY 2017
Net Sales 19.6 12.5 41.5 48.8 54.3
Operating result -56.4 -67.1 -184.0 -177.4 -243.5
Result after tax -43.8 -52.3 -147.5 -138.4 -190.6
Earnings per
share SEK before
and after dilution
-1.14 -1.40 -3.92 -3.71 -5.11
Cash position 216.3 369.7 216.3 369.7 314.5
Experienced and committed management team
Fredrik Tiberg, PhD
President & CEO
In Company since: 2002
Holdings: 1,512,551 shares & 205,000 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 & 33,882 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 & 120,000 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 & 40,000 warrants
Torsten Malmström, PhD Vice President, Technical Operations
In Company since: 2013Holdings: 36,391 shares & 28,000 subscription warrants
Agneta SvedbergVice President, Clinical & Regulatory Development
In Company since: 2015Holdings: 9,073 shares & 70,000 subscription warrants
Urban PaulssonVice President Corporate Dev.& General Counsel
In Company since: 2017Holdings: 6,500 shares & 115,000 warrants
Cecilia CallmerVice President, Human Resources
In Company since: 2017Holdings: 26,000 warrants
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Randomized, double-blind, enriched-enrollment withdrawal design (Nest.=340)
CAM2038 for treatment of chronic pain:
Pivotal Phase 3 study design
31
Screening Transition
2 Weeks
Moderate tosevere lowerback pain, patients onhigh daily
dose of opioids(incl SL BPN)
Double-Blind treatment Follow-Up
Up to 10 Weeks 12 Weeks 4 weeks
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
Open-label titration
R
2 Weeks
Down-titrationof opioid dose and
transitionedto IR
morphine(only if not
on SL BPN)
Primary and key secondary endpoints:
Average and worst pain intensity as measured by 11-point numerical rating scale
