Enhanced Delivery Options for Injectables - Sterile Parenteral Drug
Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in...
Transcript of Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in...
Company presentation
January 2019
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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Investment highlights
Listed on Nasdaq STO (ticker CAMX)Market Cap: USD ~280 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• Used in +20 clinical trials and 2 approved products
• +10 clinical programs in opioid addiction, pain, cancer, obesity, endocrine and CV disease
• EMA/TGA approvals (Buvidal®) in Nov 2018. Tentative US approval (Brixadi®) in Dec 2018
• Fully operational for 2019 Buvidal® launches in Europe and Australia
• Braeburn Pharmaceuticals, Rhythm, SolasiaPharma…
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Broad and diversified product pipeline
41. 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 MARKETBuvidal® (CAM2038) q1w OPIOID DEPENDENCE APPROVED
Buvidal® (CAM2038) q4w OPIOID DEPENDENCE 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
Brixadi® (CAM2038) q1w OPIOID DEPENDENCE1 TENTATIVELY APPROVED
Brixadi® (CAM2038) q4w OPIOID DEPENDENCE1 TENTATIVELY APPROVED
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
Demonstrated 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 depotsGame-changer in opioid dependence treatment
Buvidal®/Brixadi™ (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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Buvidal® has an unique 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
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 ODT 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
Estimated Q3 2019
CAM2038 Weekly & Monthly
Sublocade™ Monthly
Tentative approval Dec 2018
Approved Nov 2018
Approved Nov 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
$264 m
GlobalData estimates of opioid dependence market (US, CA, DE, AUS)1
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Significant market potential estimated for CAM2038 (Buvidal®/Brixadi™)
Source: 1. Opioid Use Disorder (OUD): Opportunity Analysis and Forecasts to 2027, GlobalData 2018
• Escalating opioid crisis, high unmet need and high disease awareness
• Pronounced interest from patients, prescribers and payers
• Opioid dependence market predicted to grow by 10.2% CAGR
• Sales estimated to US$ 1.4 billion in 20271
• Long-acting injectables are likely to become the new gold standard of treatment
• >100,000 US patients estimated to be treated with CAM2038 in 20271
2017 2027
Long-acting injectablesDaily medication
US$ 1.8 billion
US$ 4.8 billion
$1.5 billion$3.4 billion
$1.4 billion
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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High HCPs’ willingness to prescribe Buvidal® (EU5)1
Source: 1. Market access dynamics in opioid addiction, Decision Resources 2015.
HCPs’ 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
France169,700patients
86%
n=51
31%q4w
30%q1w
Germany78,800 patients
UK138,400 patients
Italy62,800 patients
Spain59,200 patients
37%q4w
22%q1w
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Patients and users perceive quality of life benefits with Buvidal®
• Makes life easier
• No need for daily medication pick up
• Reduce problem of stigma or privacyrelated to taking medication
• Right dose consistently
1. Gilman et al Patient Preference and Adherence, Vol. 12, 2018, p. 2123-2129
Perceived benefits of depot medications for UK patients & users not in treatment1:
11 6 3 20 11 17 31
3 6 6 9 6 31 40
11 11 6 20 20 31
6 3 11 9 14 57
NeutralDisagree strongly
Agree strongly
1 2 3 4 5 6 7
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Estimated addressable market of ~740,000 patients in EU and Australia
1. EMCDDA 2018 Drug report 2. Camurus estimate 3. Benyamina et al 2013 Heroin Addiction and Related Clinical Problems 14 (4): 65-80. 4. Camurus data on file 2018 Patient qualitative study .
Patients on Bup1 Patients on low dose Methadone ≤30mg2
Patients recycling within a year1
Users out of treatment
due to rules & burden1,3,4
Total addressable
market
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Market potential of long-acting injectables in opioid dependence in EU and Australia
740,0001
patients in addressable market in EU and Australia
20 – 30% suitable for depot
medication2,3,
Average length of treatment ~180 days
Price point comparable
to depot antipsychotic medications
Estimated market size
€200 - €300m for LAIs at peak
1.See previous slide; 2.Market access dynamics in opioid addiction, Decision Resources 2015; 3. Camurus data Simon Kucher and Partners pricing research 2018;
• Wave 1 countries launch ready‒ Subsidiaries established‒ Reimbursement established or in final stage‒ Experience commercial teams in place‒ Wide stakeholder engagement
• Manufacturing completed
• Infrastructure and pathways to ensure patient access well advanced
• 740,000 addressable patients
• Buvidal clearly addresses many of the limitations of daily treatments
• Patients, physician willing to try and prescribe
• Payers differentiate Buvidal from SoC
• Payers attribute value in line with other CNS depot products
Opportunity Readiness
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Buvidal in EU and Australia: launch ready
Focus on accelerating growth trajectory of Buvidal®
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Launch readiness – wave 1 distribution chain
Import/export
licences
Delivery to wholesaler
Delivery to
Clinic/HCP
Manufacture
Delivery to hospital
or retail pharmacy
Clinic ability to
store schedule
drug
Clinic depot administration
capability
4 weeks 3–5 weeks ~24 hours
Strong market dynamics
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• Escalating opioid crisis, high unmet need and high disease awareness
• Opioid addiction market growing+10% 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~2,000 prescribing physicians
• High patient interest in CAM2038 profile
US market opportunity forBrixadi® (CAM2038)
1 Center for Disease Control and Prevention, 2018
TX
OK
OR MN
IA
NY
PA
INCA
HI
CT
NJDE
AK
ME
VTNHMA
RI
MDWV
VA
NC
SCTN
KY
OH
MIWI
IL
MO
AR
LA
MS AL GA
FL
WA
ND
SD
NE
KS
NM
CO
WY
MT
ID
NVUT
AZ
13.6 to 16.011.1 to 13.56.9 to 11.0
(Deaths per 100,000)
16.1 to 18.518.6 to 21.021.1 to 52.0
US overdose deaths 20171
• Tentative approval received for Brixadi® in the US• Final approval for monthly depot subject to
expiration of Sublocade™ exclusivity period up to November 2020
• Weekly Brixadi not blocked by exclusivity and can be approved with own label
• Braeburn committed to making both weekly and monthly Brixadi available to US patients as soon as possible
Braeburn launch ready‒ 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‒ Experienced team with over 50
specialty drug launches
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Camurus’ US partner Braeburn working to address exclusivity issue for monthly Brixadi®
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 octreotides for neuroendocrine tumors (NET) and acromegalyCAM2029 update
SOMATOSTATIN ANALOGUE SALES1
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Next generation long-acting somatostatin analogs (SSAs)
Source: 1. GlobalData 2017; 2. US weighted average cost for mid-range doses, 2018
02505007501000125015001750200022502500Somatuline® (Ipsen)
Sandostatin® LAR® (Novartis)
mUSD• Octreotide SC depot (CAM2029) for acromegaly and neuroendrocrine tumors (NET)‒ FluidCrystal® formulated for ease of administration ‒ Potential for improved efficacy ‒ Phase 3 program to start by mid-2019 (international
advisory team in place)
• Additional FluidCrystal® based SSA products under development for rare diseases‒ Preclinical data suggest effective inhibition of tumor
growth and hormonal secretion and good tolerability - 20 years of strong market growth, 12% CAGR- Small concentrated prescriber base - Long-acting SSA US price-range: $51,000 to
$146,000 WAC / year2
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Need for improved SSA therapies
Source: 1. Colao AM et al, Pituitary 2016; 19: 235–247. 2. Ferolla P et al. J. Endocrine Inv. 2012, 3. Riechelmann RP et al, Ther Adv Med Oncol. 2017 Feb; 9(2): 127–137SSAs, somatostatin analogs; CS, carcinoid syndrome; PFS: progression-free survival.
Dosing Acromegaly NET NET, Carcinoid Syndrome Activity
Biochemical control with
modest response~20-60%1
Symptom control in 50% pts. – CS often refractory3
SSAs are safe and effective, but dose and exposure may
be suboptimal
IM or deep SC dosing with large
bore needlesNo options for
self-administration
Tumor control and PFS – potential for
improved response2
Significant potential for improvement of first generation long-acting octreotide and lanreotide treatments
• Sandostatin® LAR® has very low bioavailability
• Increased evidence that higher plasma somatostatin analog levels can improve efficacy ‒ Only about half of acromegaly patients are
controlled (IGF-1 and GH) • 57% and 67% for octreotide LAR • 47% and 48% for lanreotide depot
‒ Significant room for improvement of symptom and tumor control in patients with GI- NET
• A majority of patients on pasireotide experience increased glucose levels within the first 2-3 weeks of treatment
• Complex reconstitution – prone to handling errors and needle clogging (octreotide and pasireotide)
• Intramuscular or deep subcutaneous injections with large needles (octreotide, lanreotide, pasireotide)
• Inconvenient dosing with need for frequent physician office visits
• No self-administration option for patients
Current drug administration Current clinical efficacy and safety
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CAM2029 aims to address unmet needs of current long-acting SSA treatments
GI, gastrointestinal; NET, neuroendocrine tumors; GH, growth hormone; IGF-1, insulin-like growth factor 1; LAR, long-acting release
• 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
Long-acting treprostinil for treatment of PAH
CAM2043 update
Pulmonary arterial hypertension (PAH) is a rare and severe condition characterized by vascular proliferation and remodeling of the small pulmonary arteries
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PAH: a progressive and life-threatening disease
Source: 1. World Symposium on Pulmonary Hypertension; 2. Adapted from: Hill NS. Pulmonary Hypertension Therapy. Summit Communications, LLC; 2006:9.
Right ventricle Left ventricle
Pulmonary arteries
Enlarged right ventricle
Constricted pulmonary arteries
5th WSPH1 consensus definitions
Pulmonary hypertension
Mean pulmonary artery pressure (mPAP) ≥25 mm Hg
Pulmonary arterial hypertension
Mean pulmonary artery pressure (mPAP) ≥25 mm Hg
Mean pulmonary artery occlusion pressure (PAOP) ≤15 mm Hg
Pulmonary vascular resistance (PVR) >3 Wood units
Normal heart
PAH heart
Limitations with current treatments
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IV and SC infusion pumps• Complex programming and error prone filling • Infusion system complications (in 28% of
patients in controlled clinical studies1) • Infusion site pain in 85% of patients, 32%
needing opioid painkillers2
• Non-aseptic technique can cause blood stream infection and sepsis which may lead to death
• Patient inconvenience:‒ Not water resistant ‒ Back-up pump needed 24 hours a day
Inhaled and oral • Not recommended for patients
with severe PAH (WHO FC IV)• Complex dosing schedules with
inhalation 4 x 3 minutes a day• Sub-efficacious plasma drug
levels during night• Patient inconvenience: daily
cleaning of nebulizer
Prostacyclin drugs are potent in treating PAH but have several limitations
Source: Adapted from ”Recent advances in targeting the prostacyclin pathway in pulmonary arterial hypertension” Eur Respir Rev 2015; 24: 630–641.
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CAM2043 designed as convenient once-weekly subcutaneous treprostinil treatment
Key features• Predictable long-acting delivery of treprostinil over at least 7 days
• FluidCrystal® injection depot technology
• Ready-to-use formulation in prefilled syringe
• Once-weekly subcutaneous dosing
• No need for complex extracorporal pump systems
• No risk of infusion site related infections and sepsis
Key results from completed clinical Phase 1 study Dose proportional, long-acting release of treprostinil Steady state accumulation factor ~2 Acceptable safety profile with no unexpected or serious adverse events
Single dose pharmacokinetic profiles1 Repeat dose pharmacokinetic profiles1
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CAM2043 gives dose dependent and long-acting pharmacokinetics – Phase 1 SAD/MAD study
0,01
0,1
1
10
0 1 2 3 4 5 6 7
Trep
rost
inil
plas
ma
conc
entra
tion
(ng/
mL)
Time (days)
1 mg2.5 mg5 mg10 mg
0,0100
0,1000
1,0000
10,0000
0 1 2 3 4 5 6 7
Trep
rost
inil
plas
ma
conc
entra
tion
(ng/
mL)
Time (days)
First dose
Third dose
Source: 1. Camurus data on file 2018. Maximum dose exposure limited by healthy volunteer study population. Plasma concentration accumulation to steady state =2.
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Safety observations in Phase 1 study
• 57 out of 60 enrolled subjects completed the study • Acceptable safety profile with no serious or unexpected adverse
events reported• All adverse events were resolved during the study, including
injection site reactions (eg pain, swelling and erythema) • No clinically relevant changes in vital signs, ECG or pulse oximetry
or labs observed
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CAM2043: target PAH population
Oral therapy Oral or inhaled therapy
Parenteral therapy
WHO FC II WHO FC III WHO FC IV
CAM2043
Disease severity
• PAH patients (class II-III) switched from oral or inhaled prostacyclin agonist therapy
• Assessing efficacy, pharmacokinetics, safety and tolerability
• Endpoints include exercise capacity, treatment satisfaction and PAH symptoms
• Study to be performed under US IND
A 12-week, open label, flexible dose Phase 2 study of weekly CAM2043 in patients with PAH
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Planned Phase 2 study of CAM2043 in PAH
Potential benefits of CAM2043 in PAH
1. CAM2043 may be introduced earlier in treatment with the potential for improved outcomes1
2. More steady plasma profiles may improve efficacy versus oral and inhaled prostacyclin products
3. Improved convenience for patients with no need for infusion pumps, thus eliminating risks of catheter-related complications and pump user errors
4. No risk of infusion related blood stream infections
5. Enhanced quality of life by not having to worry about pumps and catheters during every day activities like exercising, taking a bath or sleeping
6. Eliminating burdens of pump system management
1 Bartolome S et al, American Journal of Respiratory and Critical Care Medicine 2018;197:A7587.
IMPROVED
SURVIVAL RATES FOR PATIENTS
INITIATING PROSTACYCLIN SC OR IV THERAPY EARLY
< 1 YEAR VS > 1 YEAR
HR 2.35, P>0.011
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Selection of expected milestone events to 2021
2019 2020
Com
mer
cial
R&D
H1 H2 H1 H2
Start CAM2029 Phase 3 ACRO study
Start CAM2029 Phase 3 NET studyStart CAM2043 Phase 2 in PAH
MAA submissions for CAM2038 chronic painBuvidal® UNLOC-T study completed
MAA approval decision for CAM2038 in EU
H1 H2 H1 H2
2021
Buvidal® 1st wave launches in EU and Australia
Buvidal® 2nd wave launches in EU
Buvidal 3rd wave launches in EU and Israel
Buvidal geographic expansion
CAM2038 launch in chronic pain
Continued pipeline progressNew technology licensesCommercial infrastructure built in EU and Australia
Out-licensing of own clinical product candidateIn licensing of complementing commercial asset
Sustained profitabilityThree commercial stage assets
Cor
pora
te
MAA approval for CAM2038 in EU/AUSPhase 3 results CAM2029 ACRO
Potential early US launch of Brixadi1 Expiry of SublocadeUS exclusivity
1Weekly Brixadi only until expiry of Sublocade product exclusivity November 2020 or other early resolution
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® launches after approvals in Europe and Australia• Potential for significant near-term milestones, royalty and sales revenues
Buvidal®
Launch in EU and Australia
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Buvidal® – launch sequence EU/Australia/RoW
WAVE 1 WAVE 2 WAVE 3 WAVE 4
GermanyUK
AustraliaFinlandSwedenDenmarkNorway
ItalySpain
FranceIsrael
BeneluxPortugalGreeceCroatiaIrelandCzechAustriaPoland
RoW
310,000 patients:45% of totalEU/Aus
+299,000 patients89% of totalEU/Aus
+86,000 patients98% of totalEU/Aus
Market shaping
6 January 2019
CO
NFI
DEN
TIAL
Mannheim,Germany
Paris,France
Cambridge,UK
HQLund,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
SydneyAustralia
Northern Europe
Southern EuropeCentral Europe
Australia
Regions
Focus on accelerating growth trajectory of Buvidal®
6 January 2019
CO
NFI
DEN
TIAL
Country # patients in treatment1
Treatment model # target prescribers
Reimbursement Estimated launch
~100,0002 Specialized centers and primary healthcare system ~ 2000 No HTA
Clinical decision Q1 2019
138,000 Community health clinics and NHS providers ~ 3000 No HTA England
Local formulary approval Q1 2019
22,000 Specialized centers and primary healthcare system ~ 2000 Municipalities fund
HTA Norway Q2 Q1-Q2 2019
49,000 Specialized centers and primary healthcare system ~ 500 HTA decision Q2 Q2 2019
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Wave 1 markets: patients concentrated to limited prescriber base & fast HTA/reimbursement approval
1. ECMDDA 2018 drug report 2. Internal data based on ECMDDA & adjusted to account for reporting methodology. 6 January 2019
CO
NFI
DEN
TIAL
Country # patients in treatment1
Treatment model # target prescribers
Reimbursement Estimated launch
62,6862Servizi Tossicodipendenze
(Ser.T.) and private and non-profit organizations
~ 2000 9-12 months Q3-Q4 2019
59,264 Specialized centers ~ 2000 9-12 months Q3-Q4 2019
169,750 Specialized centers and GP practices ~ 4000 9-12 months Q1 2020
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Wave 2 markets: Slower HTA/reimbursement approval process
1. ECMDDA 2018 drug report; 2 likely under reported as not all regions provide data 2. EFPIA Market Access delays Analysis 2018 www.efpia.eu6 January 2019
CO
NFI
DEN
TIAL
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Launch readiness – wave 1 distribution chain
Import/export
licences
Delivery to wholesaler
Delivery to
Clinic/HCP
Manufacture
Delivery to hospital
or retail pharmacy
Clinic ability to
store schedule
drug
Clinic depot administration
capability
4 weeks 3–5 weeks ~24 hours
6 January 2019
CO
NFI
DEN
TIAL
Commercial Supply Buvidal
• Launch batches manufactured September 2018• All specifications for printed packaging material finalized• Printing of all packaging material on-going• Packaging and labeling of commercial batches during November and December (ca 60.000 units)
‒ UK completed
• Materials planned to be shipped to pre-Wholesalers during December/ early Januay in the followingorder: UK, Finland, Germany, Sweden, Denmark and Norway
• Contracts with Kuhn and Nagel for transportation established• Implementation activities on-going at p-WS and WS
6 January 2019
CO
NFI
DEN
TIAL
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• Wave 1 countries launch ready‒ Subsidiaries established‒ Reimbursement in final stages‒ Recruitment of experience teams completed‒ Wide stakeholder engagement
• Manufacturing completed
• Infrastructure and pathways to ensure patient access well advanced
• 740,000 addressable patients
• Buvidal clearly addresses many of the limitations of daily treatments
• Patients, physician willing to try and prescribe
• Payers differentiate Buvidal from SoC
• Payers attribute value in line with other CNS depot products
Opportunity Readiness
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Buvidal in EU and Australia: launch ready
Focus on accelerating growth trajectory of Buvidal®
6 January 2019
CO
NFI
DEN
TIAL
2019 Buvidal Revenues
Revenue Model
• Built from bottom up on patient in treatment/new patient journey basis• Builds share capture from 3 key segments
‒ Transfer from patients on sublingual buprenorphine (266,000 patients on SL bup in region)‒ New patient entrants (191 000 new or re-entering patients in region_‒ Transfer from low dose methadone (<30mg) (estimated 52 000 patients in region)
• Assumes drop out average LOT = ~9 months (as seen in study)• Weekly/monthly split assumptions made based on market research amongst
prescribers• Share capture builds though conservative in year 3 compared to physician/patient
market research
57
CO
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DEN
TIAL
6 January 2019
Buvidal revenue development
58
CO
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TIAL
Launch Date AssumptionsJan 2019 UK De Se Fi DkMar 2019 NoAugust 2019 AusQ4 2019 It SpQ1 2020 Fr
Assumes France full primary care Model from launch
Assume competitor from Q3 2020
6 January 2019
596 January 2019
Buvidal market share capture
CO
NFI
DEN
TIAL
Launch Date AssumptionsJan 2019 UK De Se Fi DkMar 2019 NoAugust 2019 AusQ4 2019 It SpQ1 2020 Fr
Assumes France full primary care Model from launch
Assume competitor from Q3 2020
Pricing
• UK, Germany, Nordics - free pricing, range €9 - €14/day‒ Price supported by cost effective/budget impact modelling‒ Aligns with depot antipsychotics‒ Targeting flat pricing across all SKUs
• Australia – resubmission to PBAC‒ Initial price declined delayed launch though positive post submission meeting, resubmitted December
2018‒ Interim will initiate a patient familiarisation program (PFP) from Feb 2019‒ Patient recruitment as planned, will transfer to paid product August, minimise impact delayed launch
6 January 2019 60
CO
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TIAL
Headcount
Fixed costs 2019
• 30 heads exit 2018, growing 75 heads in place on exit Dec 2019, and 115 exit 2020• Germany – completed• UK – completed • Nordics – 70% completed • Australia – completed • 80% customer facing in country wave 1 markets (UK, DE, Nordics)
CO
NFI
DEN
TIAL
626 January 2019
Organisation
CO
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DEN
TIAL
63
Organisational data – base case
Head Counts End of 2018 End of 2019 End of 2020Total HCs 94 147 187• R&D and Support functions 64 72 72• Commercial team 30 75 115
6 January 2019 64
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Camurus Group structure
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6 January 2019 65
Camurus Inc, USACommercial registration,
43-1648843
Camurus AB, SECommercial registration
556667-9105Nasdaq “CAMX”
Cubosome Inc, USACommercial registration,
43-1648841
Camurus Development, SECommercial registration
556421-1208
Camurus GmbH, GermanyCommercial registration
HRB-727015
Camurus Ltd, UKCommercial registration
10571011
Camurus AS, NorwayCommercial registration,
920 137 253
Camurus Oy, FinlandCommercial registration
2864875-7
Camurus SAS, FranceCommercial registration
838 703 114
Camurus Pty Ltd, AustraliaCommercial registration,
627 784 605
”Camurus SL, Spain” ”Camurus AS, Denmark”
Preparation for incorporationongoing
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] camurus.com
67
Key financials
Listed on Nasdaq STO (ticker CAMX)Market Cap: USD ~280 millionCash position: USD ~24 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
Sandberg Development
AB53,2%
Gladiator4,8%
Fredrik Tiberg3,9%
Swedbank Robur Fonder3,0%
Catella Fondforvaltning
2,6%
Fjärde AP-fonden2,3%
Others30,1%
Key Shareholders (30 November 2018)
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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