Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction,...

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Company presentation Jefferies London Healthcare Conference 14 November 2018

Transcript of Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction,...

Page 1: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Company presentation

Jefferies London Healthcare Conference 14 November 2018

Page 2: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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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Page 3: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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Camurus’ key value drivers

Listed on Nasdaq STO (ticker CAMX)Market Cap: USD ~380 millionCash position: USD ~24 million (Q3 2018)Employees: 85HQ: Lund, SwedenRegional offices: Cambridge, Mannheim, Paris, Sydney

Unique FluidCrystal®delivery technology

Broad, late-stage R&D pipeline

Own commercial organization

Strong partnerships

Experienced management and dedicated teams

• In-house developed with strong IP protection• Validated in +20 clinical trials

• +10 clinical programs in opioid addiction, pain, cancer, obesity, endocrine and CV disease

• EMA/TGA/FDA approvals expected Q4 2018

• Fully operational for planned 2019 launches of Buvidal® (CAM2038) in Europe and Australia

• Braeburn Pharmaceuticals, Rhythm, SolasiaPharma…

Page 4: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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Broad and diversified clinical pipeline

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CAM2038 q1w OPIOID DEPENDENCE REGISTRATION

CAM2038 q4w OPIOID DEPENDENCE REGISTRATION

CAM2038 q1w CHRONIC PAIN PHASE 3

CAM2038 q4w CHRONIC PAIN PHASE 3

CAM2029 ACROMEGALY PHASE 1-2

CAM2029 NEUROENDOCRINE TUMORS PHASE 1-2

CAM2032 PROSTATE CANCER PHASE 1-2

CAM2047 CINV3 PHASE 1-2

CAM2048/58 POSTOPERATIVE PAIN & PONV4 PHASE 1-2

CAM2043 PAH5 PHASE 1-2

CAM4072 GENETIC OBESITY PHASE 1-2

CAM4071 UNDISCLOSED INDICATION PHASE 1-2

PRODUCT PRECLINICAL PHASE 1-2PARTNER PHASE 3 REGISTRATION

1. Rights to North America, 2. Worldwide rights, 3. Chemotherapy induced nausea and vomiting, 4. Postoperative nausea and vomiting, 5. Pulmonary arterial hypertension

1

1

1

1

1

2

Page 5: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Significant near-term and recent news flow

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PRODUCT EVENT TIMECAM2038 Opioid dependence CRL issued by FDA √

NDA resubmitted to the FDA √Publication of pivotal Phase 3 results in JAMA Int. Med. √FDA issued PDUFA goal date of 26 December 2018 √Positive CHMP opinion recommending EU approval √MAA approval, AustraliaMAA approval, EUNDA approval, US

January 2018

May 2018

May 2018

July 2018

Sept. 2018

Q4 2018Q4 2018Q4 2018

CAM2038 Chronic pain Positive top-line Phase 3 efficacy results √Phase 3 long-term safety results

Sept. 2018

H1 2019CAM2029 Acromegaly / NET Exclusive rights to CAM2029 regained from Novartis √

Phase 3 manufacturing preparations completedJuly 2018

Q4 2018CAM2043 PAH / 2nd indication Phase 1 SAD and MAD results √

CTA/IND submission Phase 2 studyMay 2018

Q4 20185

Page 6: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Long-acting medications address key healthcare

challenges

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Page 7: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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FluidCrystal® in situ gel formation

LIQUID DRUG PRODUCTFORMULATION BEFORE INJECTION:

SPC+GDO+SOLVENT+DRUG

WATER ABSORPTION

SOLVENT RELEASE

DRUG RELEASE

LIQUID CRYSTAL (LC)

INJECTION

DEPOT BIODEGRADATION TO COMPLETE RESOLUTION

WEEKS / MONTHSHOURS SECONDS

+400 PATENTS &

APPLICATIONS

>2000 SUBJECTS HAVE RECEIVED

~20,000 INJECTIONS IN20 CLINICAL TRIALS

Easy to administer Rapid onset & long-acting release Applicable across substance classes

Good safety and tolerability profile Unique mixtures of endogenous lipids Strong intellectual properties

Tiberg F, Johnsson M, Jankunec M et al., Chemistry Letters 2012; 41(10): 1090-1092; Tiberg F, Johnsson M., J. Drug Delivery Science Techn. 2011; 21 (1): 101-1

Page 8: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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)

Page 9: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Clinically documented compounds+

FluidCrystal® technology

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Page 10: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Weekly and monthly buprenorphine depotsPotential game-changer in opioid dependence treatment

CAM2038

Page 11: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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

Page 12: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

• Flexible dosing to match patient needs. Enhanced continuum of care with direct initiation and switching from daily treatments (‘‘dose matching”)

• Removes burden and stigma of daily medication and increases adherence

• HCP administration safeguards against diversion, misuse and pediatric exposure

• Potential game-changer in opioid dependence treatment

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CAM2038 has a unique and differentiated product profile1

Source: 1. CAM2038 is an investigational medicinal product and is currently not approved in any market

SMALL NEEDLE

LOW VOLUMES

ROOM TEMP. STORAGE

CLINICAL DATA VS. ACTIVE CONTROL

23 gauge 0.16 – 0.64 mL

WEEKLY DOSING

MONTHLY DOSING

MULTIPLE DOSES

CHOICE OF INJECTION

SITES

Page 13: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Non-inferior and superior efficacy shown in pivotal Phase 3 study versus standard daily SL BPN/NX1

Effective suppression of withdrawal and cravings1,2,3

Blockade of opioid effects from the first dose2

Pharmacokinetic profiles for weekly and monthly dosing4

Safety profile comparable to SL BPN/NX except for mild and moderate injection site reactions1

No opioid overdoses across clinical studies for participants treated with CAM20381,2,3,5

High patient satisfaction including versus SL BPN6

Compelling clinical results for CAM2038 versus daily standard treatment

131Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 3Haasen, C, et al, J Subst Abuse Treat. 2017;78:22-29; 4Albayaty M, et al, Adv Ther. 2017 34(2):560-575; 5Lintzeris et al., Drug and alcohol review. 2017;36(S1):47-48, 6Study HS-14-499, data on file. SL BPN sublingual buprenorphine/naloxone

Recent publications

Page 14: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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

Page 15: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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Long-acting injectables for opioid dependence treatment on key global markets

Approved Nov 2017

Approved 2010

Source: 1. Indivior, Q2 Financial Results, May 2, 2018; 2. GlobalData 2018

Long-acting buprenorphine injectables

Long-acting naltrexone injectables

Camurus/Braeburn

Indivior

Alkermes

PRECLINICAL PHASE I PHASE II PHASE III REGISTRATION APPROVAL

US

US

Vivitrol 2017 sales $269M2 US

Europe

Europe

Australia

AustraliaN/A

Est. Q3 2019

CAM2038 Weekly & Monthly

Sublocade™ Monthly

PDUFA 26 Dec. 2018

Positive CHMP opinion. Est. Q4 2018

Est. Q4 2018

Page 16: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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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

Page 17: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Strong market dynamics Braeburn readiness for Q1 ‘19 launch

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• Escalating opioid crisis, high unmet need and highdisease awareness

• Opioid addiction market growing+13.9% in scripts over 12 months

• Payers under pressure to increase treatment accessdue to extreme economic burden – $500 billion

• Strong physician and KOL support for long-actinginjections~11,000 unique patient Rx initiations for injectable buprenorphine

• High patient interest in CAM2038 profile

• Purpose-built infrastructure for specialty pharma• Quality payer access from launch• Broad specialty pharmacy network for fast and

easy market access• Reducing Rx process friction

• Benefiting from “fast follower” status• Simplified doctor/patient interaction

• Experienced team with over 50 specialty drug launches

• Sales force recruitment well advanced

US market opportunity forCAM2038

1Estimate based on 20% share of US OUD patients, or prescriptions (Symphony Health, PHAST Integrated Monthly).Treatment retention from study HS-11-421 (data on file) and monthly price of Sublocade™ ($1580). LAI – long acting injectables

Long-acting injectable Rx share of 20% corresponds to ~ USD 3 billion market potential1

Page 18: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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

Page 19: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

96%n=52

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Significant market potential for Buvidal® on Camurus’ own markets

Market potential for LAIs in Europe and Australia estimated to €180m – €250 million3

Source: 1. Market access dynamics in opioid addiction, Decision Resources 2015; 2. ECMDDA 2018; 3. Camurus estimate

High physicians’ willingness to prescribe CAM2038 (EU5)1

Physicians’ willingness to prescribe CAM2038 Anticipated share of patients on CAM2038 q4w if available Anticipated share of patients on CAM2038 q1w if available

96%n=50

39%q4w

22%q1w

94%n=50

36%q4w

25%q1w

86%n=50

43%q4w

27%q1w

France169,700 patients2

86%n=51

31%q4w

30%q1w

Germany78,500 patients2

UK138,400 patients2

Italy62,800 patients2

Spain59,200 patients2

37%q4w

22%q1w

Page 20: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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

Page 21: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Long-acting octreotidefor acromegaly and NET

CAM2029 update

Page 22: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

SOMATOSTATIN ANALOGUE SALES1

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Somatostatin analogs market expectedto exceed US$ 3.5 billion in 20241

Source: 1. GlobalData 2017; 2. US weighted average cost for mid-range doses, 2018

02505007501000125015001750200022502500Somatuline® (Ipsen)

Sandostatin® LAR® (Novartis)

mUSD

• 20 years of strong market growth for somatostatin analogues (SSAs) ‒ 12% CAGR

• Use in niche endocrinology and oncology indications‒ Acromegaly‒ Neuroendocrine tumors ‒ Cushing’s disease (pasireotide)

• NET and acromegaly accounted for >80% of the market share for SSAs in 2016‒ Majority of global sales in the US market1

• US prices for long-acting SSAs range from $51,000 to $146,000 WAC / year2

• Small and concentrated prescriber base

Page 23: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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CAM2029 – Next generation octreotide depot

Note: 1) Illustrative; final product configuration may be different.

Product Product presentation

Route of administration

Self-administration

CAM2029 Ready-to-use prefilled syringe12.5 mm, ≥22G needle

SC

Sandostatin® LAR® Reconstitution system(vial, diluent)40 mm, 20G needle

IM –

Somatuline® Autogel® Ready-to-useprefilled syringe20 mm, 18-19G needle

Deep SC –

Page 24: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

• Dose proportional long-acting octreotide release supporting once monthly dosing1

• Rapid and sustained suppression of insulin growth factor-1 (IGF-1) in healthy volunteers1

• Well maintained or improved biochemical control indicated in patients with acromegaly2

• Well maintained or improved symptom control indicated in NET patients2

• Good safety profile and local tolerability1-2

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Positive results in four clinical studies of CAM2029

Four completed clinical studies Three Phase 1 studies assessing pharmacokinetics (PK), pharmacodynamics (PD)

and safety in healthy volunteers (N=249) One Phase 2 study evaluating PK, disease biomarkers and symptoms in acromegaly

and NET patients (N=12)

Source: 1. Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2. Ferone D. Poster Presentation ENDO 2017

Page 25: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

CAM2029 status and next steps

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Manufacturing and stability of commercial scale, technical batches

Design of pivotal Phase 3 program

GMP manufacturing of clinical Phase 3 batches

IND/CTA submissions for acromegaly Phase 3 efficacy + safety ext. study

Initiation of Phase 3 NET program

H2 2018 H1 2019 H2 2019

Start clinical development of second innovative long-acting SSA product candidate – new target indication

New SSA program 2019

Page 26: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Camurus positioned for significant value creation

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• Leading FluidCrystal® technology platform used in house and in multiple partnerships with biotech and pharma partners

• Broad and de-risked clinical pipeline targeting multibillion dollar specialty markets

• Multiple levers for value creation including near-term product approvals, partnerships and own commercialization

• Ready for Buvidal® (CAM2038) launches after approvals in Europe and Australia, and the US (Braeburn)

• Potential for significant near-term milestones, royalty and sales revenues

Page 27: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] camurus.com

Thank you!

Page 28: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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Key financialsSandberg

Development AB

53,2%

Gladiator4,7%

Fredrik Tiberg3,9%

Swedbank Robur Fonder3,1%

Catella Fondforvaltning

2,7%

Fjärde AP-fonden2,3%

Others30,1%

Key Shareholders (30 September 2017)

Listed on Nasdaq STO (ticker CAMX)Market Cap: SEK ~3.5 billionCash position: SEK 216 million (Q3 2018)Employees: 85HQ: Lund, SwedenRegional offices: Cambridge, Mannheim, Paris, Sydney

MSEK Q3 2018

Q3 2017

Q1-Q3 2018

Q1-Q3 2017 FY 2017

Net Sales 19.6 12.5 41.5 48.8 54.3

Operating result -56.4 -67.1 -184.0 -177.4 -243.5

Result after tax -43.8 -52.3 -147.5 -138.4 -190.6

Earnings per share SEK before and after dilution

-1.14 -1.40 -3.92 -3.71 -5.11

Cash position 216.3 369.7 216.3 369.7 314.5

Page 29: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

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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Page 30: Company presentation - Camurus · 2018. 11. 27. · • +10 clinical programs in opioid addiction, pain, cancer, obesity, ... Source: Poster presentation ASAM 2018. Phase 3 LongTerm

Randomized, double-blind, enriched-enrollment withdrawal design (Nest.=340)

CAM2038 for treatment of chronic pain:Pivotal Phase 3 study design

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Screening Transition

2 Weeks

Moderate tosevere lowerback pain, patients onhigh daily

dose of opioids(incl SL BPN)

Double-Blind treatment Follow-Up

Up to 10 Weeks 12 Weeks 4 weeks

CAM2038 q1w8-32 mg/week

Titrated to effecton a stable dose of

CAM2038

CAM2038 Placebo

CAM2038 q1w 8 -12 mg/day orCAM2038 q4w 64-128 mg/day

Open-label titration

R

2 Weeks

Down-titrationof opioid dose and

transitionedto IR

morphine(only if not

on SL BPN)

Primary and key secondary endpoints:Average and worst pain intensity as measured by 11-point numerical rating scale