Presentation at Carnegie Healthcare Seminar

Camurus – a differentiated R&D based pharmaceutical company 17 March 2016

Fredrik Tiberg President & Chief Executive Officer

Camurus in brief • Innovation that delivers

LISTED ON NASDAQ STOCKHOLM

3rd Dec 2015

− Award-winning FluidCrystal® technology − Broad advancing product pipeline − More than 400 patents and patent applications • Patient centric product development

MARKET CAP

− Focus on severe and chronic disease

~2.5

− Long-acting solutions for better adherence

billion SEK

− Easy and convenient administration • Experienced and merited management − Including inventors and founders − 150 years combined life-science experience • Entrepreneurial and agile company culture − Clear focus on innovation − Solutions and execution are key 2

CASH POSITION

716 million SEK END 2015

Key figures Revenues

2015

2014

2013

2012

Revenues

154 799

208 207

197 716

95 204

250

Operating result before items affecting comparability

-30 464

62 319

127 316

18 761

200

Operating result

-204 104

62 319

127 316

18 761

150

Result for the period

-159 542

48 346

99 235

13 317

100

-5 657

69 429

163 064

24 735

50

Cash

716 096

56

5

3

0

Total assets

816 349

207 668

111 656

57 405

Earnings per share before dilution, SEK

-6,33

2,06

17,01

2,28

Earnings per share after dilution, SEK

-6,33

1,92

15,75

2,11

Number of employees at end of period

48

43

36

31

Number of employees in R&D at end of period

35

28

29

25

640 557

123 457

50 047

40 210

100

Equity ratio in Group, %

78%

59%

45%

70%

50

R&D costs as a percentage of operating expenses

83%

77%

71%

76%

Key figures, KSEK

Cash flow from operating activities

License payments Milestone payments Net sales; services and products 2012

2013

2014

2015

Operating expenses 200

Equity

150 Research & dev Sales & marketing Administration

2012

3

2013

2014

2015

Camurus’ value proposition

4

LEADING DRUG DELIVERY TECHNOLOGY

STRONG PIPELINE

Technology platforms FluidCrystal® Injection Depot FluidCrystal® Topical Bioadhesive FluidCrystal® Nanoparticles

CAM2038 Opiod dependence CAM2038 Pain CAM2029 Acromegaly CAM2029 Neuroendocrine tumours CAM2032 Prostate cancer In-house non-clinical projects Partner projects

STRATEGIC PARTNERS

MARKET SIZE

7

USD

bn

Annual sales of products with same mode of action and indications, excluding pain

OUR FOCUS Development and commercialization of innovative and important treatments for patients with severe and chronic diseases

Camurus business model

OWN COMMERCIAL ORGANIZATION

RESOURCES • Leading formulation technologies • Broad development pipeline • Solid patent portfolio • Dynamic and talented people • Wide-ranging expertise

PIPELINE GROWTH AND PROGRESS

PATIENT AND HEALTHCARE NEEDS

NEW PRODUCT LAUNCHES

DEVELOPMENT AND COMMERCIALIZATION PARTNERSHIPS

REVENUE STREAMS • License payments • Royalties • Own sales 5

5

VALUE CREATION • New and improved treatment alternatives • Contributions to society on local and global levels • Shareholder value

Our development pipeline PARTNERS

PRODUCT CAM2038 q1w Opioid dependence

CAM2038 q4w Opioid dependence

CAM2029 Neuroendocrine tumous

CAM2029 Acromegaly

CAM2038 q1w Chronic pain CAM2038 q4w Chronic pain

CAM2032 Prostate cancer

CAM4071 Not disclosed

6

PRECLINICAL

PHASE 1/2

PHASE 3

REGISTRATION

Strategic collaborations with dedicated partners

Opioid dependence and pain

Genetic obesity

Field

CAM4072

Scope

CAM2038

Acromegaly, neuroendocrine tumours and other indications • Exclusive, worldwide, collaboration, option and license agreement for CAM2029 and related products

• Exclusive license agreement for North America and option rights in Japan, South Korea, Taiwan and China

• Worldwide license to use FluidCrystal® Injection depot for setmelanotide

• USD 50 million received in upfront, option exercise and development milestones

• USD 20 million in upfront license fee received

• USD 65 million in potential development and sales milestones

• USD 700 million in total potential development and sales milestones

• USD 130 million in total potential development and sales milestones

• Mid to mid-high single digit % royalties on sales

• Mid to high single digit % royalties on sales

• Mid double digit % royalties on sales

Financials 7

CAM2029, CAM4071 + other products

FluidCrystal® in three presentations

FluidCrystal® Injection Depot

FluidCrystal® Topical bioadhesive

FluidCrystal® Nanoparticles

New generation injection depot featuring prefilled syringe and autoinjector compatibility.

Extended local delivery of peptide and small molecule at tissue surfaces.

Nanoparticle carrier delivery addressing bioavailability limitations for amphiphilic and lipophilic drugs.

Ready-to-use product design Low burst and long-acting release Tunable duration

8

Protection of sensitive tissue Strong bioadhesion Sustained drug release

High drug payloads Encapsulation of sensitive drugs Enhanced systemic circulation Enhanced trans-epithelial flux

FluidCrystal® Injection Depot for tunable long-acting release

Simple handling and easy injection Tunable release – “days to months” Applicable across substance classes Good safety and local tolerability Storage and in-use stability Manufacturing using standard processes

9

Long-acting release of short-lived peptides

FluidCrystal® long-acting release

Immediate release solution

FC pasireotide 1000

FC somatostatin 1-14

Plasma concentration (ng/mL)

Plasma concentration (ng/mL)

subcutaneous octreotide

FC octreotide

1000

100

10

1

0,1

0,01

10

1

0,1

0,01 0

5

10

15

20

25

30

0

Time (days)

7

14

Time (days)

Single dose injection at t=0; n=6 (SC); rodent; mean values

10

100

CONFIDENTIAL

21

28

Effective fast to market development model Traditional pharmaceutical development model

Camurus’ development model

Clinical development

Discovery & non-clinical development

Clinical development

Reuse of data for API Ph 1

Ph 2

Ph 3

Regulatory review

Use of proven technology plattform

Time for development and review ~ 10-15 yrs

Formulationoptimization Ph. 1/2

Phase 3

MAA/NDA approval process according to abbreviated pöathways

Time for development and review ~ 5-8 yrs

Time and cost effective development is achieved by combining clinically documented active ingredients with proven technology Established safety profile

11

Documented efficacy

Scalable & proven technology platform

Opioid dependence – A growing global health problem • Largest burden to society of all drugs ‒ ‒ ‒ ‒

Have misused prescription opioids in US, N=48 million1

About 70 000 annual overdose deaths globally 29 000 deaths in the US alone in 2014 56 billion USD in total societal costs in the US Each dollar spent on treatment yields 12 dollar in savings

Currently abusing painkillers or heroin N=5 million2

12:1

• Increasing numbers in treatment ‒ 700K in OMT in Europe ‒ 1,100K in OMT in the US ‒ Growing numbers in treatment, > 1.5 million in US in 10 years

• Current treatment limitations ‒ ‒ ‒ ‒

1.3 million Europeans are problem opioid users3

Limited access to treatment Modest retention in treatment Burdens of daily medication Extensive misuse, abuse and diversion of current daily medications

Source: 1. National Institute of Drug Abuse; 2. SAHMSA, National Survey on Drug Use and Health (NSDUH) – 2014; 3. EMCDD, European Drug Report Trends and Developments 2015.; 4. UNODC, World Drug Report 2015; 5. WHO, UNAIDS position paper 2004

12

cost saving on each dollar spent on treatment5

15

million

global opiate dependent population4

Diagnosed with Dependence N= 2.5M2 Treated US N=~1,100K

Treated with buprenorphine4 N= ~750K

Paradigm shift in opioid dependence treatment CAM2038 overview • Weekly and monthly buprenorphine injections for all phases of opioid maintenance treatment • Multiple fixed doses and two durations • Ready to use and easy to inject • Fast Track designation by FDA for both weekly and monthly products • Strategic partner for North America in Braeburn Pharmaceuticals • Best-in-class treatment potential

13

CAM2038 attributes

     

Reduced number of administrations from 365 to 52 or 12 doses per year Safeguard against misuse, abuse and diversion No risk of accidental pediatric exposure Long-acting release providing continuous treatment effect Flexible doses and durations allow individualized therapy in all OMT phases Continuous blocking effect of illicit opioids

Plasma buprenorphine from CAM2038 versus sublingual tablets

Plasma BNP conc (ng/mL)

100

10

1

0 0

7

14 Time (days)

21

Conc (q1w 16 mg obs)

Conc (q1w 16 mg pred)

Conc (q4w 64 mg obs)

Conc (q4w 64 mg pred SS)

Conc (SL BPN 8 mg obs)

Conc (SL BPN 8 mg pred)

28

Conc (q4w 64 mg obs SD)

Note: obs = observed, pred = predicted, SD = single dose, SS = steady state

14

Clinical program for CAM2038 in opioid dependence Trial no. HS-11-426 Phase 1

HS-13-487 Phase 1

15

Subjects

Key results / Study design

60 healthy volunteers

87 volunteers

Good safety and local tolerability for CAM2038, weekly and monthly formulations

Status

Extended release of BPN suited for once weekly dosing. Dose proportional exposure. 6-8 times higher bioavailability versus SL BPN tablets



Extended release suited for weekly respective monthly dosing. 6-8 times higher bioavailability. Acceptability of CAM2038 dosing higher than SL tablets.



Dose proportional extended release further supported by pharmacodynamics results for withdrawal symptoms over time and time to rescue medication



HS-07-307 Phase 1/2

41 patients

HS-14-478 HS-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)

Ongoing Ongoing

HS-11-421 Phase 3 HS-07-499

Double blind, double dummy Phase 3 efficacy trial of CAM2038 versus sublingual buprenorphine (US) Open label Phase 3 safety trial in patients with opioid dependence (EU, US, AUS)

Ongoing Ongoing

7 completed and ongoing clinical trials

+600 people dosed with CAM2038, weekly and monthly products

Strategy of own commercialisation of CAM2038 in EU Rationale

Overview of market rights and Camurus’ primary markets

Favourable market for CAM2038 in Europe Desire for fewer administrations Sizeable socio-economic benefits

On-going paradigm shift

Accessible market

Cost efficient roll-out

Braeburn exclusive markets

Braeburn option right

Camurus markets

Positive market drivers support pricing strategy and reimbursement on European markets 16

Highly addressable target markets (EU-4) Country

Market structure # OMT patients

77,300

172,513

163,000

94,376

% buprenorphine

21%

n.a. Methadone predominant treatment

Treatment location

Physicians willingness to prescribe CAM20381

Specialised centers and primary health care system

N=51

Community health clinics and NHS providers

N=50

66%

Specialised centers and GP practices

N=50

15%

Servizi Tossicodipendenze (Ser.T.) and private and non-profit organisations

N=50

Large markets with known demand from physicians 17

Source. 1. Market access dynamics in opioid addiction, Decision Resources 2015

86%

94%

86%

96%

Stepwise approach to building a successful commercial organisation Process of building a successful commercial organization for the opioid dependence market in Europe has been initiated.

Fully built out, the European commercial organization will include about 70 to 120 people.

Internationally experienced Chief Commercial Officer has been appointed.

2016 • EU leadership team • General managers in early reimbursed markets

18

2017 • Regional leadership teams early reimbursed markets • General Managers 2nd wave markets

2018 • Regional leadership teams on 2nd wave markets • Full key account teams

Chronic pain estimated to affect 1.5 billion people globally • Chronic pain is a huge global problem ‒ 116 million with chronic pain in the US ‒ 4 times the number of diabetes patients ‒ 560-635 billion USD in annual incremental health care costs (US) ‒ 100 million chronic pain patients in EU

• Large medical need ‒ ‒ ‒ ‒

No or little control over pain Daily breakthrough pain Impact on overall enjoyment of life. Depression and inability to sleep

~600 billion USD incremental annual costs of chronic pain in the US2

milion suffer from chronic pain in the US1

100 million Europeans have chronic pain

• Buprenorphine

• Opioids are powerful painkillers ‒ Prescription drugs are the second-most abused category of drugs in the US ‒ Almost 20 000 people in the US died from overdoses of prescription opioid pain relievers in 2014.

Source. 1. The American Society of Pain Medicine http://www.painmed.org/patientcenter/facts_on_pain.aspx.; 2 J. Latham* & B. D. Davis Disability and Rehabilitation, Volume 16, pages 39-44 1994

19

116

‒ Demonstrated to provide effective relief of a broad spectrum of pain condition ‒ Partial µ-opioid receptor agonist and κ -antagonist ‒ Ceiling effect on respiratory depression ‒ Higher analgesic potency and lower analgesic tolerance than morphine

Chronic pain is a significant market opportunity for CAM2038 Market overview •

Global market for chronic pain exceeded 20 billion USD, US market 10.8 billion USD in 20121

•

Long-acting opioid market is estimated to 4.7 billion USD2

•

Butrans® (Purdue) 7-day buprenorphine patch have US sales prediction of about 230 MUSD3

•

Endo recently launched BelbucaTM with sales prediction in excess of 250 MUSD4

Source: 1. Decision Resources; 2. IMS Health data 2015; 3 Symphony Health; 4. Endo Pharmaceutical presentation JP Morgan 2016

20

CAM2038 potential advantages

     

Around the clock pain relief Fast onset and long acting duration Dosing flexibility allow individualized treatment Reduced overdose risk Minimal risk of diversion and abuse Good local tolerability versus patches

Acromegaly and NET showing continuous long-term growth Overview of acromegaly and NETs

• 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) ‒ Treatable in most patients (treatment includes surgery and/or medical treatment) ‒ Current gold-standard medical treatment include somatostatin analogues

Strong and sustained market growth over 15 years (USDm) CAGR 2004-2014: Somatuline® : 16% Sandostatin® : 7%

• Neuroendocrine tumours (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 promising antitumour effects

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Sandostatin® (Novartis)

Somatuline® (Ipsen)(2)

Significant potential in converting Sandostatin® LAR ® patients to CAM2029 21

CAM2029 for effective treatment of acromegaly and NET CAM2029 overview • Ready-to-use, long-acting octreotide for treatment of acromegaly and neuroendocrine tumours (NETs)



Easy subcutaneous administration using prefilled syringe

• Orphan drug designation for acromegaly by EMA



Self-administration option with significant convenience benefits and cost savings



Increased bioavailability (500%) with potential for enhanced efficacy in some patients1



Thin needle and small injection volumes



Room temperature stability avoiding cold chain distribution and conditioning before use

• Exclusive partnership with Novartis – market leader within acromegaly and NETs • Phase 3 preparations ongoing • Multiple life-cycle management

22

CAM2029 potential advantages

Source: 1. Tiberg F, Roberts J, Cervin C, et al. Br J Clin Pharmacol. 2015;80:460-472.

Ready for use with smaller needle and lower dose volume

CAM2029 10, 20 mg 0.5 -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 reconditioning Based on PLGA microsphere system

Somatuline® Autogel® 60, 90, 120 mg 0.2-0.5 mL/ready-to-use/refrigerated ≥ 30 min reconditioning Self-associated gel

≥22G Subcutaneous (12.5mm)

20G Intramuscular (40mm)

18G/19G Deep subcutaneous (20mm)

Note: 1) Illustrative. Final product configuration may be different.

23

  

No reconstitution Small volume Thin needle

Clinical trials confirm target properties of CAM2029 Trial no.

Subjects

HS-05-194 Phase 1

32 volunteers

HS-07-291 Phase 1

HS-11-411 Phase 1

24

95 volunteers

122 volunteers

Key results / Study design

Good safety and local tolerability demonstrated in all trials

Status

Rapid and long-acting release of octreotide One month suppression of the growth factor IGF-1.



Dose proportional octreotide exposure during repeated dosing of CAM2029 mg. Rapid and long-acting release of octreotide



and suppression of the IGF-1 growth factor. Dose proportional octreotide exposure with 5 times higher bio-availability compared with Sandostatin LAR 30 mg.



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®

HS-12-455 Phase 2

24 patients(1) in two groups with acromegaly and NETs

Phase 3

Two Phase 3 trials of CAM2029 versus active control, Sandostatin® LAR®, in patients with neuroendocrine tumours (NETs) and acromegaly, respectively (Global)

Completed Data base lock

In preparation

Prostate cancer market opportunity Global market size (MUSD)

Prostate cancer • Prostate cancer is an uncontrolled (malignant) growth of cells in the prostate gland

4,000

• Prostate cancer is the fourth most commonly diagnosed cancer type worldwide, with an estimated 1.1 million people affected in 2012

3,000

• Increase in incidence rates, mainly driven by rapidly growing population of men older than 50 years

1,500

• Mature and large market with opportunities for costeffectiveness • Current alternatives all require physician administration 25

2,500

3,265

2,689 2,808 2,789

2,000 1,180

1,000

1,315

500

Lupron Depot®

Eligard®

Zoladex®

2014

2013

2012

2011

2010

2009

2008

2007

2006

2005

2004

2003

0

2002

• Current treatment includes gonadotropin-releasing hormone (GnRH) analogues that block testosterone product, resulting in decreased PSA and slow-down of tumour growth and spread

2,546

2001

• The global prostate market is forecasted to grow with a CAGR of 12.4% to 2023

3,569 3,535 3,485 3,688 3,546 3,540

3,500

Decapeptyl®

Treatments for prostate cancer such as Lupron Depot® and Eligard® have increased sales over time in tandem with increased incidence rates Source: Company information, www.cancerresearchuk.org, Medtrack, GlobalData (1) Lupron 2014 EU sales not reported in Medtrack. 3.4% increase in sales from 2013 to 2014 reported for EU+Canada in Takeda annual report

CAM2032 treatment of prostate cancer CAM2032 overview • Ready-to-use, long-acting leuprolide product for treatment of prostate cancer • Phase 2 PoC completed ‒ Clinically significant and effective long-acting suppression of testosterone ‒ Good safety and local tolerability

• Phase 2 repeat dose ongoing (incl. comparator drug Eligard®) ‒ Results Q2 2016

• Worldwide license rights available

26

CAM2032 potential advantages



Easy subcutaneous administration using prefilled syringe



Self-administration option with significant convenience and cost benefits



Small volume, thin needle and auto-injector compatibility



Manufacturing by standard processes leads to low COGS which enables price advantage

Key selection criteria for new product candidates High unmet medical need • •

Meaningful treatment improvements Better treatment outcomes, QoL and health economy

Attractive market • • • •

Price and reimbursement Concentrated prescriber base Market size Commercial synergies

Technology match • • •

Value creation by FluidCrystal® Technology match Safety and tolerability

Extended market exclusivity • •

27

Approved platform patents Product specific patent applications

Effective development • •

505 (b)(2) registration pathway Potential for accelerated approval

Promising early phase pipeline Project

Target indication

Status

CAM2041

Inflammation & pain

Lead formulation selected

CAM2046

Diabetes

Formulation development

CAM2047

Cancer supportive care

Lead formulation selected

CAM2048

Pain

Lead formulation selected

CAM2043

Undisclosed

Lead formulation selected

CAM4072

Genetic obesity (Prader-Willis syndrome, POMC deficiency)

Lead formulation selected

Partner, Rhythm

Early phase project evaluations, including three big pharma collaborations

28

Camurus 2016 Anticipated clinical news flow

Late-stage pipeline

CAM2038

CAM2029

CAM2038

CAM2038

CAM2029

Results Phase 2 Opioid challenge trial

Results Phase 2 trial

Results two Phase 2 trials

Results Phase 3 efficacy trial

Start Phase 3

Opioid dependence

Acromegaly & NET

OD & chronic pain

Opioid dependence

Acromegaly & NET

Partner: Braeburn (North America)

Partner: Novartis (Global)

Partner: Braeburn (North America)

Partner: Braeburn (North America)

Partner: Novartis (Global)

2016

2015 Early/mid-stage pipeline

29

2017

CAM2032

CAM4071

New project

Results Phase 2 trial

Results Phase 1 trial

In clincial trial

Prostate cancer

Undisclosed

Undisclosed Prostate cancer

Camurus

Partner: Novartis (Global)

Camurus

Camurus goals 2016 • Opioid dependence ‒ ‒ ‒ ‒

Results from two Phase 2 trials, opioid blockade and PK chronic pain Results from Phase 3 efficacy trial Manufacturing of first commercial batches of CAM2038 EU commercial leadership team in place

• Chronic pain ‒ Results from Phase 2 study in opioid dependent chronic pain patients ‒ First patients included in Phase 3 chronic pain study

• Acromegaly and NET ‒ Results from Phase 2 study in acromegaly and NET, respectively. ‒ GMP manufacturing in final product format completed for start of Phase 3

• Prostate cancer ‒ Completed Phase 2 trial in patients with locally advanced prostate cancer

• Start of new projects ‒ At least one new program in clinical trials

30

Camurus strategy for growth

Strengthen our leading technology position through continued innovation and development

31

Grow and advance our product pipeline And launch new products

Increase values of technologies and products through strategic partnerships.

Build own commercialization infrastructure on opioid dependence and accompanying markets in Europe

32