j.p. morgan annual healthcare conference 2017
TRANSCRIPT
Company Presentation, January 12, 2016
J.P. Morgan Annual Healthcare Conference 2017
CamurusAdvancing late stage pipeline with high market potential
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 in brief
• Innovation that delivers− Award-winning FluidCrystal® technology − Late-stage, diversified pipeline− 10 clinical programs
− Strong, strategic partners
• Patient centric product development− Long-acting medications for better treatment
outcomes and quality of life for patients− Focus on attractive, underserved specialty
markets
• Entrepreneurial company culture − Strong, experienced management team− 64 employees with 45 in R&D− Agile, passionate and result focused− Headquarter in Lund, Sweden
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LISTED ON
NASDAQ STOCKHOLM
3rd DEC, 2015
MARKET CAP
~450million USD
CASH POSITION
60million USD
END Q3 2016
Building value throughout the medical product life-cycle
Time and cost-effective development of innovative and differentiated medications- combining clinically documented APIs with leading and proven technologies
Value created
Value Spent
Time
Decreased time to market505(b)(2), hybrid regulatory pathway
0
Value created
Value Spent
Time
Deeper market penetrationBest-in-class treatment potential
0
Value created
Value Spent
Time
Expanding end of cycle salesLong-acting barriers to generics
0
4
Leader in lipid science and formulation technologies
The FluidCrystal® technology is based on functional liquid crystal nanostructures
FluidCrystal® injection depot
FluidCrystal® topical bioadhesive
FluidCrystal® nanoparticleswater lipid 2
lipid 1
H2
Lα
I2
L2
5
+400PATENTS &
APPLICATIONS
17CLINICAL
TRIALS WITH FC TECHNOLOGY
FluidCrystal® injection depot for longer lasting treatment effects
Long-acting release with weekly and monthly dosing
Good safety and local tolerability
Easy and convenient dosing
Applicable across substance classes
Standard manufacturing processes
~1500SUBJECTS HAVE
RECEIVED >10,000 INJECTIONS IN
CLINICAL TRIALS
6
FluidCrystal® injection depot: Weekly and monthly SC buprenorphine depots versus daily SL tablets
0
1
10
100
0 7 14 21 28
Plas
ma
BPN
con
cent
ratio
n (n
g/m
L)
Time (days)
Conc (q1w 16 mg obs) Conc (q1w 16 mg pred) Conc (q4w 64 mg obs) Conc (q4w 64 mg obs SD)
Conc (q4w 64 mg pred SS) Conc (SL BPN 8 mg obs) Conc (SL BPN 8 mg pred)
Note: obs = observed, pred = predicted, SD = single dose, SS = steady state, SL = sublingual
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Strong collaborations with strategic partners
CAM2029, CAM4071 + other products
• Exclusive, worldwide, collaboration and license agreement
CAM2038, CAM2048, CAM2058
• Exclusive license agreement for North America, with option to China, Japan, Korea, and Taiwan
• USD 50 million received in upfront, option exercise and development milestones
• USD 700 million in total potential development and sales milestones
• Mid to high single digit % royalties on sales
• USD 20 million in upfront license fee received
• + USD 130 million in total potential development and sales milestones
• Mid double digit % royalties on sales
Acromegaly, neuroendocrine tumours and other indications Opioid dependence and pain
Scop
eFi
nanc
ials
Fiel
d
CAM4072
• Exclusive license to FluidCrystal®Injection depot for setmelanotide
• USD 65 million in potential 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”
Genetic obesity
8
9
Late-stage, diversified pipeline with block-buster potential
PARTNERS PRODUCT PRECLINICAL PHASE 1/2 PHASE 3 REGISTRATION
CAM2038 Weekly Opioid dependence
CAM2038 Monthly Opioid dependence
CAM2038 Weekly Chronic pain
CAM2038 Monhly Chronic pain
CAM2029 Neuroendocrine tumours
CAM2029 Acromegaly
CAM2032 Prostate cancer
CAM4071 Not disclosed
CAM2047 CINV*
CAM2048 Pain
CAM2058 Pain, nausea and vomiting
*CINV Chemotherapy nausea and vomiting
PRODUCT EVENT TIME
CAM2038 Opioid dependence • Positive results from pivotal Phase 3 efficacy trial
• Positive results from Phase 2 opioid challenge trial
• Completed enrollment in Phase 3 long-term safety trial
November
May
April
CAM2038 Chronic pain • First patient enrolled in Phase 3 efficacy trial
• Completed enrollment in pivotal Phase 2 chronic pain trial
September
April
CAM2029 Acromegaly & NET* • Positive results from Phase 2 trial in acromegaly and NET July
CAM2032 Prostate cancer • Positive results from Phase 2 trial in prostate cancer June
CAM4071 Not disclosed indication • Phase 1 clinical trial completed June
CAM2047 CINV**CAM2048 PainCAM2058 Pain & nausea and vomiting
• Phase 1 trial started October
10
R&D highlights in 2016
*NET: Neuroendocrine tumours **CINV: Chemotherapy induced nausea and vomiting
CAM2038: Weekly and Monthly Buprenorphine Injection Depots for Opioid Use Disorder Treatment
11
6,0 6,27,3
9,510,6
11,712,9
15,816,8
17,818,9 19,7
21,3 21,9
24,5
28,630,1
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Opioid dependence is a growing global health problem
• Estimated 32 million opioid users globally1
‒ Largest society burden of all drugs1
‒ About 4 million diagnosed patients in Europe and the US
‒ Less than half in treatment (Europe and US2,3)
• Escalating opioid crisis‒ 207,400 drug related deaths worldwide
• 30,000 US opioid overdose deaths in 2015• Growing concerns in Europe
• A chronic relapsing disease‒ Opioid-use trajectories show that the disease is chronic
with less than 30% abstinence achieved over time‒ Opioid dependence mortality continues to increase
over time6
US overdose epidemic4
Thousands
Source: 1. UNODC, World Drug Report 2015; 2. SAHMSA, National Survey on Drug Use and Health (NSDUH) – 2014; 3. EMCDD, European Drug Report Trends and Developments 2015; 4. Center for Disease Control & Prevention 2016; 5. Toxreg 2016; 6. Hser et al. Harvard Review Psychiatry 2015; 23: 76-89
12
01002003004005006007008009001000
Heroin Non-heroin opioids Other drugs
Opioid deaths in Sweden5Annual deaths with illicit drugs or opioid pharmaceuticspresent during forensic examination
CAM2038 – a paradigm shift in opioid dependence treatment
• Flexible, individualized treatment across treatment phases
• Ready to use and easy to administer
• Room temperature storage
• Well tolerated, locally and systemically
• Best-in-class treatment potential
• Fast Track designation for both weekly and monthly formulations
Continuous treatment effectReduced number of doses and decisions from 365 to 52 or 12 per yearSafeguards against misuse, abuse, diversion and pediatric exposureNo daily supervised dosing and related stigma
Improved treatment adherence– dose given is dose taken
Rapid and sustained opioid blockade reduces use on top
Key attributesCAM2038 overview
13
Flexible and individualized opioid dependence treatment– across treatment stages
Initiation - induction
Weekly CAM2038 Stabilization Weekly
CAM2038Maintenance
treatmentMonthly
or Weekly CAM2038
14
Weekly and monthly CAM2038 are administered as small dose volume subcutaneous (SC) injections by a prefilled syringe with a thin 23G needle
Extensive clinical program for CAM2038 in opioid dependence
HS-11-426 Phase 1 60 healthy volunteers under naltrexone block
HS-13-487 Phase 1 87 healthy volunteersunder naltrexone block
HS-07-307 Phase 2 41 patients
Trial no. No. subjects Key results / Study design Status
Dose proportional extended release further supported by pharmacodynamics results for withdrawal symptoms over time and time to rescue medication.
Extended release suited for weekly respective monthly dosing. 6-8 times higher bioavailability. Acceptability of CAM2038 dosing higher than SL tablets.
Extended release of BPN suited for once weekly dosing. Dose proportional exposure. 6-8 times higher bioavailability versus SL BPN tablets.
HS-14-478 Phase 2HS-14-549 Phase 2
Opioid challenge study of CAM2038 in opioid dependent patients (US). N=47Repeat dose pharmacokinetic study of CAM2038 in opioid dependent pain patients (US), including injections in different subcutaneous injection sites.
Positive resultsUnder completion
HS-11-421 Phase 3
HS-14-499 Phase 3
Double blind, double dummy Phase 3 efficacy trial of CAM2038 versus sublingual buprenorphine (US). N=428Open label Phase 3 long-term safety trial in patients with opioid dependence (EU, US, AUS). N=228
Positive results
Under completion
Good safety and local tolerability forCAM2038, weekly and monthly formulations
7CLINICAL TRIALS
COMPLETED AND UNDER
COMPLETION
+900STUDY
PARTICIPANTS DOSED WITH CAM2038 OR
PLACEBO
15
CAM2038 provides rapid and sustained opioid blockadePivotal Phase 2 study
“At this moment, my liking for this drug is”
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Presentation, S27, ISAM & CSAM-SMCA 2016 Montreal, Canada Oct 20-22, 2016, Sharon L Walsh, Sandra Comer, Michelle Lofwall, Bradley Vince, Debra Kersh, Marion A Coe, Jermaine D Jones, Fredrik Tiberg, Behshad Sheldon, Sonnie Kim. http://www.csam-smca.org/resources-and-documents/past-annual-meeting-presentations/2016-abstracts/
CAM2038 q1w 24 mgCAM2038 q1w 32 mg
0
40
50
70
80
100
Peak
Sco
re (m
m)
0 6 18
Hydromorphone (mg, IM)0 6 18 0 6 18 0 6 18 0 6 18
Qualification (Days 1-3) (Days 4-6) (Days 1-3) (Days 4-6)
Weekly CAM2038Injection 1
60
90
11 pt. difference Prespecified complete blocking
criteria Neutral
Strong Disliking
Strong Liking
Weekly CAM2038Injection 2
CAM2038 also provides complete suppression of withdrawal
Effective suppression of clinical opiate withdrawal scale (COWS) scores from treatment initiation
17
0
3
6
9
12
44
Tota
l CO
WS
Scor
e
BL 1 2
Treatment Days3 4 5 6 7 8 9 10 11 12 13 14
CAM2038 24 mgCAM2038 32 mg
Weekly CAM2038Injection 2
Weekly CAM2038Injection 1
Withdrawal COWSScore
– <5
Mild 5-12
Moderate 13-24
Moderate to Severe
25-36
Severe >36
Phase 3 efficacy study of weekly and monthly CAM2038
• 24-week, double-blind, double-dummy, randomized, active-controlled Phase 3 study‒ Treatment-seeking patients with moderate to severe
opioid use disorder, not currently on medication assisted treatment (MAT)
‒ Assessed from treatment initiation to maintenance ‒ Non-inferiority and superiority objectives‒ CAM2038 vs. sublingual buprenorphine/naloxone
BPN/NX – “Standard of Care”
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• Primary Endpoint‒ EMA: Negative Urines with NI margin of -11%‒ FDA: Response Rate* with NI margin of -10%
• Key Secondary Endpoint: ‒ EMA: Cumulative Distribution Function (CDF)
of urines negative for illicit opioids from Week 5 to 25. (Sampling Weeks)
‒ FDA: CDF of negative urines plus self-reports negative for illicit opioids from Week 5 to 25 (Sampling Weeks).
‒ Multiple additional secondary and explorative endpoints: retention; craving, morning cravings, withdrawal (SOWS and COWS)
Study design Key Primary and Secondary Outcomes
* Responder defined as displaying negative urine samples, including self-reports, for;treatment week 12 and month 6, at least 2 of treatment weeks 9, 10 and 11 and 12,
and at least 5 of the 6 samples obtained during treatment weeks 12 through 24.
CAM2038 vs SL BPN/NX 95%CI Non-inferiority (NI) Non-Inferiorityp-value
EMA:Primary Efficacy Endpoint - Mean % Urine SamplesNegative for Illicit Opioids
(-0.1%, 13.3%) <0.001
FDA:Primary Efficacy Endpoint - Response Rate
(-3.5%, 10.4%) <0.001
CAM2038 met both FDA and EMA primary endpoints of non-inferiority versus SL BPN/NX – “Standard of Care”(ITT)
-0,2 -0,1 0 0,1 0,2
Difference (95% CI)
Favors CAM2038Favors SL BPN/NX
11%
10%5%
5%
19
NI margin
NI margin
Statistical superiority met for CAM2038 versus SL/BPN/NX for secondary endpoint of CDF for negative urines +/- self-reports throughout the study (ITT)
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Grace PeriodWeeks
TreatmentWeeks
Sampling Weeks
Superiorityp-value (FDA)
Superiorityp-value (EMA)
0 1-24 2-25 0.006 0.011
1 2-24 3-25 0.005 0.010
3a 4-24 5-25 0.004 0.008
4b 5-24 6-25 0.001 0.003
6c 7-24 8-25 0.001 0.002
a Secondary endpoint for FDA and EMA; b Primary endpoint in RB-US-13-0001; c Including 2-week open label phase in RB-US-13-0001). CDF – cumulative distribution function
CAM2038 demonstrated non-inferior and superior efficacy across treatment phases versus daily SL BPN/NX
• Met both FDA and EMA primary endpoints• Statistical superiority for the key secondary
endpoint of CDF for negative urines• Efficacy throughout treatment phases
‒ From initiation to maintenance
• CAM2038 safety profile comparable to daily sublingual buprenorphine/naloxone‒ Fewer SAEs (3.2% vs. 6%) ‒ No drug overdoses vs 4 overdoses‒ Good local tolerability; no severe AEs
• Data support MAA/NDA submissions mid-2017
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Robust efficacy versus “Standard of Care”
MAA – Market Authorisation Application
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Global strategy for CAM2038 with build-up of own European commercial organization for opioid use disorder
Braeburn markets Braeburn option rightCamurus markets
Transformative new treatment can support pricing strategy and reimbursement on European markets
Specialist market in EU ~700 000 patients in treatment
CAM2038 addresses high unmet need
Sizeable socio-economic benefits
On-going paradigm shift
Accessible and concentrated market
Cost efficient roll-out and creation of significant value
Rationale Estimated 32 million opioid users globally
Country Physicians willingness to prescribe CAM20381 % patients*: q4w q1w
23
Significant interest in CAM2038 among European physicians
Large markets with high willingness to prescribe weekly and monthly depots
86%
94%
86%
96%N=50
Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015 * % patients prescribers thought would be prescribed CAM2038 of those currently prescribed medication
N= 47
31%30%
36%25%
N= 4843%27%
39%22%
N=51
N=50
N=50
Building the commercial organization in Europe
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2016• EU commercial leadership
team in place• GMs in early reimbursed
markets • Pricing, market access,
medical affairs
2017• Regional leadership teams
early reimbursed markets• GMs 2nd wave markets
2018• Regional leadership teams
2nd wave markets• Full key account teams for
CAM2038 launch
Internationally experienced leadership team
Specialist pharma leadership Market access Medical affairs Global strategy Opioid use disorder & painStepwise build – right time, right place principles
Pre-launch activities
HEOR, pricing and market access Strategic marketing Medical affairs Policy and education Country operating models
CAM2029: Next generation subcutaneous octreotide depot for treatment of NET and acromegaly
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Significant potential in converting Sandostatin® LAR ® patients to CAM2029
CAM2029 for treatment of acromegaly and neuroendocrine tumors
• Acromegaly is a rare, chronic and insidious hormonal disorder‒ Occurs when the pituitary gland produces excess
growth hormone (GH) and insulin-like growth factor-1 (IGF-1)
‒ Current gold-standard medical treatment include somatostatin analogues
• Neuroendocrine tumors (NETs) are malignant neoplasms‒ Somatostatin analogues constitute the current
standard of safe and effective medical therapy for symptom control
‒ Somatostatin analogues also show anti-tumor effects
Overview of acromegaly and NET Strong market growth over 15 years1
2015
Source1. Medtrack
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1 802
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014Sandostatin® (Novartis) Somatuline® (Ipsen)
Sandostatin® : 7%
Somatuline® : 16%
(USDm)CAGR 2004-2014:
339 412
488 607
695
917 998 1 031
1 169 1 300
1 350
1 516
1 705
1 917 2 032 2 069
CAM2029 is a convenient, safe and effective treatment option
• Ready-to-use, long-acting octreotide for treatment of acromegaly and neuroendocrine tumors (NETs)
• Exclusive partnership with Novartis‒ "Novartis Oncology continues its commitment to
developing a new formulation of octreotide through a collaboration with Camurus”
• Positive Phase 2 results announced in July 2016‒ Well maintained control of disease symptoms and
biomarkers in NET and acromegaly patient when switching from Sandostatin® LAR®
‒ Good safety and local tolerability
• Phase 3 studied planned to start in 2017
Easy subcutaneous administration using prefilled syringeSelf-administration option with significant convenience benefits and cost savingsIncreased bioavailability (500%) with potential for enhanced treatment efficacy1Thin needle and small injection volumesRoom temperature stability avoiding cold chain distribution and conditioning before use
CAM2029 key attributesCAM2029 overview
1. Novartis Q2 and H1 Condensed Interim Financial Report2. Tiberg F, Roberts J, Cervin C, et al. Br J Clin Pharmacol. 2015;80:460-472.
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PARTNERS PRODUCT EVENT TIME
CAM2038 Opioid dependence Phase 3 results, long-term safety study
NDA and MAA submissions
Q1, 2017
Mid-2017
CAM2038 Chronic pain Phase 2 results
Phase 3 efficacy results
Q1, 2017
H2, 2017
CAM2029 Acromegaly & NET Phase 3 study initiations, NET & acromegaly 2017
CAM2047 CINV Phase 1 results Q2, 2017
CAM2048 Pain CAM2058 Pain, nausea and vomiting
Phase 1 study resultsPhase 1 study resultsPhase 2 study initiation
Q2, 2017
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Significant clinical news flow expected during 2017
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Pipeline expansion with new attractive preclinical candidates
PARTNERS PRODUCT PRECLIN PH 1/2 PH 3 REG
CAM4072 Genetic obesity
CAM2043 PAH
CAM2046 Diabetes
STATUS
Rhythm preparing to enter clinical development in 2017
Phase 1 planned to start in 2017
Formulation development
Early stage collaborations with pharma and biotech partners
Formulation development
Summary
• De-risked, late-stage, differentiated pipeline‒ Opioid addiction, pain, cancer and acromegaly‒ Successful Phase 3 study results in addiction‒ Attractive multi-billion dollar specialty pharmaceutical markets‒ Concentrated prescriber audiences and active patient advocacy groups
• Strong collaborations with dedicated partners‒ Novartis, Braeburn Pharmaceuticals, Rhythm, Solasia, R-Pharm US‒ Early project collaborations with global pharma companies
• Several levers for pipeline and business expansion‒ New product candidates entering clinical development‒ Growth opportunities via proven technology platforms
as well as strong business development
• European commercial organisation‒ Leadership team established‒ Pre-launch activities for CAM2038 ongoing
• Solid financial position
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Solid financial position with increasing investments in late-stage development programs
Key figures, mUSD2016 2015
Q3 Q1-Q3 Q3 Q1-Q3
Revenues 3.6 9.1 4.4 14.0
Operating result -2.0 -8.0 -0.8 -3.0
Cash 60.1 13.4
Total assets 75.3 25.0
Equity 68.6 12.3
0
50
100
150
200
250
2012 2013 2014 2015
Revenues
Licensepayments
Milestonepayments
Net sales;services andproducts
50
100
150
200
2012 2013 2014 2015
Operating expenses
Research & dev
Sales & marketing
Administration
32