September 8, 2016
Carnegie Small & Mid Cap Seminar 2016
CamurusAdvancing late stage pipeline with high market potential
Fredrik Tiberg, President & CEO
Forward-looking statements
This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements
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Camurus in brief
• Innovation that delivers− Award-winning FluidCrystal® technology
− Broad, advanced and de-risked development pipeline
− Strategic collaborations with strong partners
• Patient centric product development− Long-acting medications for better treatment
outcomes and quality of life for patients
− Meaningful product differentiation and positive pharmacoeconomic impacts
− Focus on attractive specialty markets and disease areas in need of new solutions
• Entrepreneurial company culture − Agile, passionate, collaborative and
result focused
− 60 employees with 43 in R&D
LISTED ON
NASDAQ STOCKHOLM
3rd DEC, 2015
MARKET CAP
~3.5billion SEK
CASH POSITION
549million SEK
END Q2 2016
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Building value throughout the medical product life-cycle
Time and cost effective development by combining clinically documented active ingredients with a strong proven technology
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
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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
L
I2
L2
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+400PATENTS &
APPLICATIONS
16CLINICAL
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
~1400SUBJECTS HAVE
RECEIVED >10,000 INJECTIONS IN
CLINICAL TRIALS
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Strong collaborations with strategic partners
CAM2029, CAM4071 + other products
• Exclusive, worldwide, collaboration, option and license agreement for CAM2029 and related products
CAM2038
• Exclusive license agreement for North America and option rights in Japan, South Korea, Taiwan and China
• 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
• Worldwide license to use 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”, August 26, 2016”
Genetic obesity
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Long-acting release from FluidCrystal® injection depot
FluidCrystal® injection depot Immediate release octreotide (Sandostatin®)
0,01
0,1
1
10
100
1000
0 5 10 15 20 25 30
Pla
sma
conc
entra
tion
(ng/
mL)
Time (days)
FC pasireotide
FC octreotide
FC somatostatin 1-14
0,01
0,1
1
10
100
1000
0 7 14 21 28
Pla
sma
conc
entra
tion
(ng/
mL)
Time (days)
subcutaneous octreotide
Single dose injection at t=0; n=6 (SC); rodent; mean values
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Solid financial position and increasing investments in late-stage development programs
Key figures, kSEK Q2 2016 H1 2016 Q2 2015 H1 2015
Revenues 25,834 45,714 22,686 81,226
Operating result -25,881 -50,739 -31,645 -30,464
Cash 548,983 136,276
Total assets 660,261 210,922
Equity 603,837 106,803
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
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Advancing pipeline of innovative treatment options
PARTNERS PRODUCT PRECLINICAL PHASE 1/2 PHASE 3 REGISTRATION
CAM2038 Weekly Opioid dependence
CAM2038 Monthly Opioid dependence
CAM2029 Neuroendocrine tumours
CAM2029 Acromegaly
CAM2038 Weekly Chronic pain
CAM2038 Monthly Chronic pain
CAM2032 Prostate cancer
CAM4071 Not disclosed
PRODUCT EVENT COMMUNICATED
CAM2038 Opioid dependence Enrollment completed in two Phase 3 trials
Positive results from pivotal Phase 2 opioid challenge trial
April, 2016
May, 2016
CAM2038 Chronic pain Enrollment completed in Phase 2 trial in chronic pain patients April, 2016
CAM2029 Acromegaly & NET Positive topline results from Phase 2 trial in acromegaly and NET July, 2016
CAM2032 Prostate cancer Positive results from Phase 2 trial in prostate cancer June, 2016
CAM4071 Not disclosed indication Phase 1 clinical trial completed
New clinical product candidates Decision to initiate clinical development and trials of two new candidates June, 2016
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Clinical development highlights 2016
Promising product candidates with large potentials
Opioid dependence is a growing global health problem
• About 4 million diagnosed with dependence in the US and in Europe, 15 million globally‒ Largest burden to society of all drugs1
‒ About 2 million in medication assisted treatment in the US and in Europe2,3
‒ 12 dollar saved for each dollar spent on treatment4
• The opioid epidemic‒ 28,647 opioid overdose deaths in the US in 2014,
18,893 from prescription drugs – a fourfold increase in 15 years
‒ Growing concern with prescription drug dependence also in EU
• Limitations of current treatment options‒ Frequent relapses to abuse and limited compliance ‒ Extensive misuse, abuse and diversion ‒ Pediatric exposure‒ Quality of life and mortality‒ Stringent treatment rules and regulations
Deaths of opioid overdoses in the US5
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 WHO, UNAIDS position paper 2004.
”This epidemic is harming too many Americans and their families. But we know that – and your lives affirm – that treatment works and recovery is possible” said President Barack Obama
President’s Budget includes new mandatory funding to help ensure that all Americans who want treatment can get the help they need”
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CAM2038 A paradigm shift in opioid dependence treatment
• Weekly and monthly buprenorphine injections for all phases of opioid maintenance treatment
• Ready to use and easy to inject
• Fast Track designation by FDA for both weekly and monthly products
• Strategic partner for North America in BraeburnPharmaceuticals
• Best-in-class treatment potential
Long-acting release and continuous treatment effectReduced number of administrations from 365 to 52 or 12 doses per yearSafeguard against misuse, abuse and diversionNo risk of accidental pediatric exposure
Sustained blocking of subjective opioid effects
Flexible doses and durations allow individualized therapy in all OMT phases
CAM2038 key attributesCAM2038 overview
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Plasma buprenorphine for CAM2038 versus sublingual tablets
0
1
10
100
0 7 14 21 28
Pla
sma
BP
N c
once
ntra
tion
(ng/
mL)
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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Clinical program for CAM2038 in opioid dependence
HS-11-426 Phase 1 60 healthy volunteers
HS-13-487 Phase 1 87 healthy volunteers
HS-07-307 Phase 2 41 patients
Trial 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)Repeat dose pharmacokinetic study of CAM2038 in opioid dependent pain patients (US), including injections in different subcutaneous injection sites)
Positive top-line resultsEnrolment completed
HS-11-421 Phase 3
HS-14-499 Phase 3
Double blind, double dummy Phase 3 efficacy trial of CAM2038 versus sublingual buprenorphine (US)Open label Phase 3 long-term safety trial in patients with opioid dependence (EU, US, AUS)
Enrolment completed
Enrolment completed
Good safety and local tolerability forCAM2038, weekly and monthly formulations
7COMPLETED
AND ONGOING CLINICAL TRIALS
+900PEOPLE DOSED WITH CAM2038, WEEKLY AND
MONTHLY PRODUCTS OR
PLACEBO
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Strategy of own commercialisation of CAM2038 in Europe
Positive market drivers support pricing strategy and reimbursement on European markets
Favourable market
Improved compliance and quality of life
Sizeable socio-economic benefits
On-going paradigm shift
Accessible and concentrated market
Cost efficient roll-out
Rationale Overview of market rights and Camurus’ primary markets
Braeburn exclusive markets Braeburn option right Camurus markets
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Highly addressable target markets in Europe
Market structure for opioid dependence Physicians willingness to prescribe CAM20381Country# OMT patients % buprenorphine Treatment location
Large markets with known physician demand
77,300
172,513
163,000
94,376
21%
25-30%
66%
15%
Specialised centers and primary health care system
Community health clinics and NHS providers
Specialised centers and GP practices
Servizi Tossicodipendenze (Ser.T.) and private and non-profit organisations
86%N=51
94%N=50
86%N=50
96%N=50
Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015
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Establishment of our commercial organisation
• Building of the commercial organisation for the anticipated launch of CAM2038 on track
• Internationally experienced leadership teamon board
• Engagement initiated with stakeholders to realise optimum product value‒ Politicians, policy makers, payers, prescribers and
patients
• Fully built out, the European commercial organization will include about 70 to 120 people.
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2016• EU leadership team• 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
Pre-launch activities• Publications• Market research• Policy and education• Health economic outcome research• Market access, price & reimbursement
Chronic pain is another significant market opportunity for CAM2038
• Over 200 million people with chronic pain in Europe and the US
• Global market for chronic pain exceeded 20 billion USD, US market 10.8 billion USD in 20121
• Costs estimate to US society is $560-635 billion annually2, exceeding costs of heart disease, cancer and diabetes.
• Clinical Phase 2 trial under completion
• Phase 3 program in preparation‒ Reuse of data from opioid dependence program
Round-the-clock pain reliefLong acting duration Improved treatment complianceReduced overdose riskMinimal risk of misuse, abuse, and diversion
CAM2038 potential advantagesCAM2038 Chronic pain overview
Source: 1 . Decision Resources; 2. IMS Health data 2015
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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 rare and 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
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Sandostatin® (Novartis) Somatuline® (Ipsen)(2)
Sandostatin® : 7%
Somatuline® : 16%
(USDm)CAGR 2004-2014:
2015
Source1. Medtrack
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CAM2029 A convenient, safe and effective treatment option
• Ready-to-use, long-acting octreotide for treatment of acromegaly and neuroendocrine tumours (NETs)
• Orphan drug designation for acromegaly by EMA
• Exclusive partnership with Novartis –market leader within acromegaly and NETs
• Positive Phase 2 results announced by Novartis and Camurus 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 preparations ongoing for 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 efficacts1Thin needle and small injection volumesRoom temperature stability avoiding cold chain distribution and conditioning before use
CAM2029 key attributesCAM2029 overview
Source: 1. Tiberg F, Roberts J, Cervin C, et al. Br J Clin Pharmacol. 2015;80:460-472.
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No reconstitutionCAM2029 10, 20 mg0.5 -1.0 mL/ready-to-use/
no reconditioning/room temperature Based on FluidCrystal® system
Sandostatin® LAR® 10, 20, 30 mg 2.0 mL/reconstitution/
refrigerated/30-60 min reconditioningBased on PLGA microsphere system
Somatuline® Autogel® 60, 90, 120 mg0.2-0.5 mL/ready-to-use/refrigerated
≥ 30 min reconditioningSelf-associated gel
Small volume
Thin needle
≥22G
20G
18G/19G
Subcutaneous(12.5mm)
Intramuscular(40mm)
Deep subcutaneous(20mm)
Note: 1) Illustrative. Final product configuration may be different.
Ready for use with small needle and no need for reconstitution
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Clinical trials confirm target properties of CAM2029
HS-05-194Phase 1 32 volunteers
HS-07-291Phase 1 95 volunteers
HS-11-411Phase 1 122 volunteers
Trial no. Subjects Key results / Study design Status
Rapid and long-acting release of octreotideand suppression of IGF-1. Dose proportional octreotide exposure with 5 times higher bio-availability compared with Sandostatin LAR 30 mg.
Dose proportional octreotide exposure during repeated dosing of CAM2029 mg.Rapid and long-acting release of octreotide
Rapid and long-acting release of octreotide One month suppression of the growth factor IGF-1.
HS-12-455Phase 2
12 patients in two groups with acromegaly and NETs
Positive results
Phase 3 Two Phase 3 trials of CAM2029 versus active control, Sandostatin® LAR®, in patients with neuroendocrine tumours (NETs) and acromegaly, respectively (Global) 3 trials in preparation
Good safety and local tolerability demonstrated in all trials
Randomised multi-centre study of the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2029 in two patients groups with acromegaly and neuroendocrine tumours (NET) previously treated with Sandostatin® LAR®
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Pipeline expansion with new attractive clinical candidates
Inflammation & painCAM2041
DiabetesCAM2046
Cancer supportive careCAM2047
Post operative painCAM2048, CAM2058
Target indicationProject
UndisclosedCAM2043
Lead formulation selected
Formulation development
Lead formulation selectedClinical development start in Q4 2016
Lead formulation selectedClinical development start in Q4 2016
Status
Lead formulation selectedClinical development start in Q3 2017
CAM4072Setmelanotide FC
Genetic obesity (Prader-Willis syndrome, POMC deficiency)
Lead formulation selectedRhythm Inc. preparing for clinical trials
Early phase project evaluations, including three big pharma collaborations
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PARTNERS PRODUCT EVENT TIME
CAM2038 Opioid dependence Results Phase 3 efficacy trial
Results Phase 3 long-term trial
NDA and MAA submissions
Q4, 2016
Q1, 2017
Mid-2017
CAM2038 Chronic pain Start Phase 3 trial
Results Phase 2 trial in chronic pain patients
Results Phase 3 efficacy trial
Q3, 2016
Q4, 2016
H2, 2017
CAM2029 Acromegaly & NET Start Phase 3 trials in patients with acromegaly and NETs 2017
New clinical product candidates Start of Phase 1 trial for CAM2047, CAM2048, and CAM2058 Q4, 2016
Early partnerships Start of Phase 1 trial for weekly setmelanotide 2017
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Significant clinical news flow expected during 2016-17
Summary
• De-risked portfolio of differentiated late-stage assets‒ Opioid addiction, pain, cancer and acromegaly‒ 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 technology platforms
as well as business development
• European commercial organisation‒ Leadership team established‒ Prelaunch activities for CAM2038 initiated
• Solid financial position
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