Company presentation
Jefferies London Healthcare Conference 14 November 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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Camurus’ key value drivers
Listed on Nasdaq STO (ticker CAMX)Market Cap: USD ~380 millionCash position: USD ~24 million (Q3 2018)Employees: 85HQ: Lund, SwedenRegional offices: Cambridge, Mannheim, Paris, Sydney
Unique FluidCrystal®delivery technology
Broad, late-stage R&D pipeline
Own commercial organization
Strong partnerships
Experienced management and dedicated teams
• In-house developed with strong IP protection• Validated in +20 clinical trials
• +10 clinical programs in opioid addiction, pain, cancer, obesity, endocrine and CV disease
• EMA/TGA/FDA approvals expected Q4 2018
• Fully operational for planned 2019 launches of Buvidal® (CAM2038) in Europe and Australia
• Braeburn Pharmaceuticals, Rhythm, SolasiaPharma…
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Broad and diversified clinical pipeline
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CAM2038 q1w OPIOID DEPENDENCE REGISTRATION
CAM2038 q4w OPIOID DEPENDENCE REGISTRATION
CAM2038 q1w CHRONIC PAIN PHASE 3
CAM2038 q4w CHRONIC PAIN PHASE 3
CAM2029 ACROMEGALY PHASE 1-2
CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2
CAM2032 PROSTATE CANCER PHASE 1-2
CAM2047 CINV3 PHASE 1-2
CAM2048/58 POSTOPERATIVE PAIN & PONV4 PHASE 1-2
CAM2043 PAH5 PHASE 1-2
CAM4072 GENETIC OBESITY PHASE 1-2
CAM4071 UNDISCLOSED INDICATION PHASE 1-2
PRODUCT PRECLINICAL PHASE 1-2PARTNER PHASE 3 REGISTRATION
1. Rights to North America, 2. Worldwide rights, 3. Chemotherapy induced nausea and vomiting, 4. Postoperative nausea and vomiting, 5. Pulmonary arterial hypertension
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Significant near-term and recent news flow
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PRODUCT EVENT TIMECAM2038 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 √MAA approval, AustraliaMAA approval, EUNDA approval, US
January 2018
May 2018
May 2018
July 2018
Sept. 2018
Q4 2018Q4 2018Q4 2018
CAM2038 Chronic pain Positive top-line Phase 3 efficacy results √Phase 3 long-term safety results
Sept. 2018
H1 2019CAM2029 Acromegaly / NET Exclusive rights to CAM2029 regained from Novartis √
Phase 3 manufacturing preparations completedJuly 2018
Q4 2018CAM2043 PAH / 2nd indication Phase 1 SAD and MAD results √
CTA/IND submission Phase 2 studyMay 2018
Q4 20185
Long-acting medications address key healthcare
challenges
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FluidCrystal® in situ gel formation
LIQUID DRUG PRODUCTFORMULATION 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 IN20 CLINICAL TRIALS
Easy to administer Rapid onset & long-acting release Applicable across substance classes
Good safety and tolerability profile Unique mixtures of endogenous lipids Strong intellectual properties
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): 101-1
0,1
1
10
0 7 14 21 28
pasi
reot
ide
plas
ma
conc
entra
tion
(ng/
mL)
Time (days)
Pasireotide IR 600 ug(SC thigh, n = 94)
Pasireotide FluidCrystal® (CAM4071)Immediate release pasireotide (Signifor®)
FluidCrystal® formulated: Long-acting release of pasireotide – Phase 1 results
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
pasi
reot
ide
plas
ma
conc
entra
tion
(ng/
mL)
Time (days)
Pasireotide FluidCrystal20 mg (SC thigh, n = 12)
Clinically documented compounds+
FluidCrystal® technology
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Weekly and monthly buprenorphine depotsPotential game-changer in opioid dependence treatment
CAM2038
Opioid dependence – escalating global health crisis
• Largest society 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
$504 billion PRICE TAG FOR US OPIOID CRISIS3
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Mounting US opioid overdose deaths2
(thousands)
5
10
15
20
25
30
35
40
45
50
* Provisional data
#1 cause of death for people under 50 in the US30:1 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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CAM2038 has a unique and differentiated product profile1
Source: 1. CAM2038 is an investigational medicinal product and is currently not approved in any market
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 CAM20381,2,3,5
High patient satisfaction including versus SL BPN6
Compelling clinical results for CAM2038 versus daily standard treatment
131Lofwall 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
Recent publications
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
AustraliaN/A
Est. Q3 2019
CAM2038 Weekly & Monthly
Sublocade™ Monthly
PDUFA 26 Dec. 2018
Positive CHMP opinion. Est. Q4 2018
Est. Q4 2018
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2019 launches of CAM2038 (Buvidal®) prepared for the three largest 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 thousandOPIOID 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 highdisease awareness
• Opioid addiction market growing+13.9% in scripts over 12 months
• Payers under pressure to increase treatment accessdue to extreme economic burden – $500 billion
• Strong physician and KOL support for long-actinginjections~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 forCAM2038
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
MannheimGermany
ParisFrance
CambridgeUK
HQLundSweden
• Experienced international leadership in key markets‒ General managers, market access, medical affairs, marketing
• Sales teams in early launch markets (UK, DE, Nordics) ‒ On-boarded and trained
• High pre-launch activity‒ Payer access, medical affairs and marketing‒ Distribution and patient access‒ Country operating models‒ Policy and education‒ Phase 4 studies and
LCM in progress
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Camurus establishing leading commercialization platform in Europe and Australia
SydneyAustralia
Northern Europe
Southern EuropeCentral Europe
Australia
Regions
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
France169,700 patients2
86%n=51
31%q4w
30%q1w
Germany78,500 patients2
UK138,400 patients2
Italy62,800 patients2
Spain59,200 patients2
37%q4w
22%q1w
Positive phase 3 efficacy results
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• Robust statistical significance demonstrated for primary and key secondary efficacy endpoints‒ Primary endpoint: weekly average pain intensity (p-value < 0.001)‒ Key secondary endpoint: weekly worst pain intensity (p-value < 0.001)
• Also statistically significant improvements for e.g.:‒ Time to loss of efficacy (p-value = 0.002)‒ Patient Global Impression of Change-Improvement (p-value < 0.001)‒ Work Productivity and Activity Impairment subscale (p = 0.005)
• Favorable safety profile consistent with the known safety profile of buprenorphine
Strong clinical data for CAM2038 in second potential indication of chronic pain
Source: 1. 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
1 IN 5 INDIVIDUALS SUFFERING FROM CHRONIC PAIN1
CHRONIC PAIN ESTIMATED
~$560-635bnANNUAL COST TO SOCIETY2
Long-acting octreotidefor acromegaly and NET
CAM2029 update
SOMATOSTATIN ANALOGUE SALES1
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Somatostatin analogs market expectedto exceed US$ 3.5 billion in 20241
Source: 1. GlobalData 2017; 2. US weighted average cost for mid-range doses, 2018
02505007501000125015001750200022502500Somatuline® (Ipsen)
Sandostatin® LAR® (Novartis)
mUSD
• 20 years of strong market growth for somatostatin analogues (SSAs) ‒ 12% CAGR
• Use in niche endocrinology and oncology indications‒ Acromegaly‒ Neuroendocrine tumors ‒ Cushing’s disease (pasireotide)
• NET and acromegaly accounted for >80% of the market share for SSAs in 2016‒ Majority of global sales in the US market1
• US prices for long-acting SSAs range from $51,000 to $146,000 WAC / year2
• Small and concentrated prescriber base
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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 syringe12.5 mm, ≥22G needle
SC
Sandostatin® LAR® Reconstitution system(vial, diluent)40 mm, 20G needle
IM –
Somatuline® Autogel® Ready-to-useprefilled syringe20 mm, 18-19G needle
Deep SC –
• Dose proportional long-acting octreotide release supporting 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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Positive results in four clinical studies of CAM2029
Four completed clinical studies 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
CAM2029 status and next steps
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Manufacturing and stability of commercial scale, technical batches
Design of pivotal Phase 3 program
GMP manufacturing of clinical Phase 3 batches
IND/CTA submissions for acromegaly Phase 3 efficacy + safety ext. study
Initiation of Phase 3 NET program
H2 2018 H1 2019 H2 2019
Start clinical development of second innovative long-acting SSA product candidate – new target indication
New SSA program 2019
Camurus positioned for significant value creation
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• Leading FluidCrystal® technology platform used in house and in multiple partnerships with biotech and pharma partners
• Broad and de-risked clinical pipeline targeting multibillion dollar specialty markets
• Multiple levers for value creation including near-term product approvals, partnerships and own commercialization
• Ready for Buvidal® (CAM2038) launches after approvals in Europe and Australia, and the US (Braeburn)
• Potential for significant near-term milestones, royalty and sales revenues
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] camurus.com
Thank you!
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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 billionCash position: SEK 216 million (Q3 2018)Employees: 85HQ: Lund, SwedenRegional offices: Cambridge, Mannheim, Paris, Sydney
MSEK Q3 2018
Q3 2017
Q1-Q3 2018
Q1-Q3 2017 FY 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, PhDPresident & CEO
In Company since: 2002Holdings: 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: 2014Holdings: 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 JamesonChief Commercial Officer
In Company since: 2016Holdings: 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 OperationsIn 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 ResourcesIn 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
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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