Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in...

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Company presentation January 2019

Transcript of Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in...

Page 1: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Company presentation

January 2019

Page 2: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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 · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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…

Page 4: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 5: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Long-acting medications address key healthcare

challenges

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Page 6: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 7: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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 8: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Clinically documented compounds+

FluidCrystal® technology

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Page 9: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Weekly and monthly buprenorphine depotsGame-changer in opioid dependence treatment

Buvidal®/Brixadi™ (CAM2038)

Page 10: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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 11: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

• 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

Page 12: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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 13: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 14: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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 15: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

$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

Page 16: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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 17: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 18: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 19: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 20: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in 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;

Page 21: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

• 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®

Page 22: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 23: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 24: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

• 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®

Page 25: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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 26: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Long-acting octreotides for neuroendocrine tumors (NET) and acromegalyCAM2029 update

Page 27: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 28: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 29: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

• 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

Page 30: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

• 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.

Page 31: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 32: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Long-acting treprostinil for treatment of PAH

CAM2043 update

Page 33: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 34: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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.

Page 35: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 36: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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.

Page 37: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 38: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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

Page 39: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

• 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

44

Planned Phase 2 study of CAM2043 in PAH

Page 40: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 41: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

46

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

Page 42: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Camurus positioned for significant value creation

47

• 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

Page 43: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

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Page 45: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

50

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

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Page 46: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

51

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

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Page 47: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

52

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

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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

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Page 49: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

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Page 50: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

• 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

55

Buvidal in EU and Australia: launch ready

Focus on accelerating growth trajectory of Buvidal®

6 January 2019

CO

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2019 Buvidal Revenues

Page 52: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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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6 January 2019

Page 53: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Buvidal revenue development

58

CO

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DEN

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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

Page 54: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 55: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

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Page 56: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Headcount

Page 57: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 58: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

Organisation

CO

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Page 59: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 61: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

Page 62: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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)

Page 63: Company presentation - Camurus · 2019. 1. 11. · Market potential of long-acting injectables in opioid dependence in EU and Australia. 740,000. 1. patients in addressable market

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

68