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Page 1: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Company PresentationOctober 2019

Page 2: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

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

2

Page 3: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Unique FluidCrystal®nanotechnologies• In-house developed with strong IP• New generation long-acting depot technology• Validated in +20 clinical trials and byapproved products

Two Phase 3 programsLate-stage pipeline with 10 innovative clinical programs in areas of pain, oncology, endocrine and cardiovasculardisease

3

Company profile

Approved medicinesWeekly and monthly Buvidal®

for the treatment of opioid dependence

Own commercialorganizationFully operational in Europe and Australia

PartnershipsR&D collaborations, licensing and royalty arrangements withnumerous companies

Experiencedmanagement and dedicatedteams

LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP

~ SEK 4 billion EMPLOYEES: 120 HQ: Lund, SwedenREG. OFFICES: Cambridge, Mannheim, Paris, Sydney

Page 4: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

4

Business highlights

• EU and Australian approvals of Buvidal® , weekly and monthly SC buprenorphine depots, in opioid dependence – Launches initiated in 2019

• US tentative approval of Brixadi™ for opioid use disorder – US District Court for the District of Columbia Court ruled that the FDA acted

inconsistently when delaying the full approval of Brixadi™– Remanded the FDA to reconsider, with deliberate speed, Braeburn’s

application for final approval of Brixadi™• Positive Phase 3 results from pivotal randomized study of

CAM2038 for treatment of chronic pain• Pivotal Phase 3 program initiated with CAM2029 octreotide SC

depot in acromegaly • License agreement with Ra Pharma for long-acting formulation

FluidCrystal® zilucoplan for complement C5 mediated disease

Buvidal® launch status• Sales in Finland, Denmark, Sweden, Norway,

Germany, the UK and Australia• Reimbursement in key markets

‒ Australian government supports affordable access to Buvidal® as part of a $40 million package1

• Fully operational commercial infrastructure• First year sales guidance SEK 70-90 million

Source: 1Media Release 25 August 2019, The Hon. Greg Hunt MP, Minister of Health, Minister Assisting the Prime Minister for the Public Service and Cabinet, Australia https://www.health.gov.au/ministers/the-hon-greg-hunt-mp/media/pbs-support-for-end-of-life-care-and-opioid-dependency

Page 5: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Injection of liquidformulationusing prefilled syringe or autoinjector

Slow release of drug

Drug release and biodegradation of gel matrix to full resolution

Encapsulatingliquid crystal gel triggered by water uptake

time

5

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

Good safety and tolerability profile Unique lipid compositions Strong intellectual properties

H2O

drug

bloo

dco

nc.

FluidCrystal® in situ gel formation

Page 6: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

FluidCrystal – Long-acting release of somatostatin analogues

FluidCrystal® injection depotImmediate release octreotide (Sandostatin®)

0,01

0,1

1

10

100

1000

0 5 10 15 20 25 30

Plas

ma

conc

entra

tion

(ng/

mL)

Time (days)

FC pasireotide

FC octreotide

FC somatostatin 1-14

0,01

0,1

1

10

100

1000

0 7 14 21 28

Plas

ma

conc

entra

tion

(ng/

mL)

Time (days)

subcutaneous octreotide

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

6

Page 7: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Relative tumor volumes (PC-3 cell lines) in active and placebo treatment groups

Effect of octreotide and somatostatin FC q4w depots on prostate cancer tumor growth in a mice model

7

0

200

400

600

800

1000

0 7 14 21 28 35 42

2022SOM-L 2022OCT-V 2022SOM-L placeboR

elat

ive

tum

or v

olum

e (%

)

Time (days)

Page 8: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

8

FluidCrystal – Long-acting peptide release

Pasireotide FluidCrystal® (CAM4071)Immediate release pasireotide (Signifor®)

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)

0,1

1

10

0 7 14 21 28

pasi

reot

ide

plas

ma

conc

entra

tion

(ng/

mL)

Time (days)

Pasireotide FluidCrystal 20mg (SC thigh, n = 12)

Single dose injection at t=0; clinical Phase 1 data, mean values. Source: Tiberg, F. et al, Poster presentation at ECE, Barcelona, May 2018

Page 9: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

9

Weekly and monthly buprenorphine depots

Illustration of population pharmacokinetic profiles for Buvidal vs sublingual buprenorphine

Source: Albayaty M, Linden M, Olsson H, Johnsson M, Strandgarden K, Tiberg F. Adv Ther. 2017;34(2):560–575; Buvidal: EPAR - Public assessment report, December 2018. Available at: https://www.ema.europa.eu/en/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf

Population PK analysis and modelling based on data from four clinical studies (N=236). Diagnostic testing demonstrated predictive buprenorphine concentrations and good agreement between observed and predicted data percentiles. Steady state data.

Weekly Buvidal vs. Daily sublingual buprenorphine Weekly vs. Monthly Buvidal

Page 10: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

FluidCrystal – Broadly applicable

Broadly applicable across molecular classes ‒ Peptides & proteins, e.g.:

• somatostatin & analogues• LHRH agonists• MC4 agonists• glucagon & insulin• GLP-1 & analogues• interferons• antibody fragments

‒ Small molecules, e.g.:• opioids• local analgesics• hormones• anti-emetics• prostacyclins

10

Buprenorphine MW 468 g/mol

Octreotide MW 1019 g/molGlucagon-like Peptide 1 MW 3356 g/mol

Page 11: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Buvidal® q1w OPIOID DEPENDENCE

CAM2038 q1w CHRONIC PAIN1

CAM2029 ACROMEGALY

CAM4072 GENETIC OBESITY DISORDERS - RHYTHM2

CAM2043 PULMONARY ARTERIAL HYPERTENSION

Brixadi® q1w OPIOID DEPENDENCE - BRAEBURN1

CAM2048/58 POSTOPERATIVE PAIN & PONV4 - BRAEBURN1

Brixadi® q4w OPIOID DEPENDENCE - BRAEBURN1

Buvidal® q4w OPIOID DEPENDENCE

CAM2038 q4w CHRONIC PAIN1

CAM2029 NEUROENDOCRINE TUMORS

CAM2032 PROSTATE CANCER

CAM2047 CINV3

1Braeburn holds the rights to North America; 2Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal®; 3Chemotherapy-induced nausea and vomiting; 4Postoperative nausea and vomiting;

PRODUCT PHASE 1-2 PHASE 3 REGISTRATION MARKET

MARKET

MARKET

PHASE 3

PHASE 3

PHASE 3

PHASE 2

PHASE 2

PHASE 2

PHASE 1

TENTATIVE APPROVAL

TENTATIVE APPROVAL

PHASE 1

PHASE 1

11

Broad clinical pipeline of innovative investigational medicines

11

Page 12: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Weekly and monthly buprenorphine depotsGame-changer in opioid dependence treatment

Buvidal®/Brixadi™

Page 13: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Opioid dependence – escalating global health crisis

• Largest society burden of all drugs1

• 35 million opioid users worldwide1

• High need for better access to care and new treatment alternatives

• Investment in treatment brings substantial value and saves lives

• Significant limitation with current daily medications

Sources: 1UNODC, World Drug Report 2019; 2.EMCDDA 2018, National Records of Scotland, Centers for Disease Control and Prevention 3Frazier at al, 2017, Journal of the American Medical Association; 4Crow D. Financial Times.com, accessed on March 13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da 13

Mounting opioid overdose deaths2

0

5

10

15

20

25

30

Scotland

USA

SwedenUKFinland

Germany

Australia

Dru

g ov

erdo

se d

eath

s pe

r 100

,000

, age

gro

up 1

5-64

#1 cause of death for people under 50 in the US2,3

Recent US life expectancy decline largely due to opioids4

Page 14: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

• Buvidal® is indicated (EU) for treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents from 16 years

• Individualized dosing for use across treatment phases:initiation, switching from daily medications and long-term maintenance treatment

• Superiority versus daily standard treatment with daily buprenorphine/naloxone included in clinical outcomes

• Removes burdens and stigma of daily medication

• HCP administration safeguards against diversion, misuse and pediatric exposure

• Potential to result in fewer occurrences of opioid overdoses

14

Buvidal® – first long-acting injection treatment of opioid dependence in the EU and Australia

INTERNAL USE ONLY. NOT TO BE CONSIDERED BRIEFING MATERIAL FOR REPRESENTATIVES.Sources: Buvidal Summary of Product Characteristics (SmPC), 2018; European Medicines Agency. Buvidal: EPAR - Public assessment report, December 2018. Available at: https://www.ema.europa.eu/en/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf

Page 15: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

*

15

Buvidal brings unique values to patients and HCPs

23G 0.16 – 0.64 mL

SMALL NEEDLE

LOW VOLUMES

ROOM TEMP.

STORAGEDAY ONE

INITIATIONWEEKLY DOSING

MONTHLY DOSING

MULTIPLE DOSES

CHOICE OF INJECTION

SITESPRODUCT

CLIN. DATA VS ACTIVE CONTROL*

– – – – – – –

– – – – – – – –19G 0.5 – 1.5 mL

20G 3.4 mL

*Based on information in product labels

Page 16: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

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

High Treatment Retention ~70% at 48 weeks2

Blockade of opioid effects from the first dose3

Effective suppression of withdrawal and cravings1,2,3

Safety Profile comparable to SL BPN/NX except for mild and moderate injection site reactions1,2

No Opioid Overdoses reported across clinical studies for participants treated with Buvidal®1,2,3,4,5

High Patient Satisfaction including versus SL BPN2

Positive case-studies6

Growing evidence base for Buvidal®versus daily standard treatment

1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Frost et al, Addiction, 2019;114(8):1416-1426, 3Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 4Haasen, C, et al, J Subst Abuse Treat. 2017;78:22-29; 5Albayaty M, et al, Adv Ther. 2017 34(2):560-575; 6D’Agnone O, Case Reports in Psychiatry, 2019 https://doi.org/10.1155/2019/9381346

16

NEW

Page 17: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

“CAM2038 compared to my previously prescribed sublingual buprenorphine treatment”

Much worse

Slightly worse

About the same

Slightly better

Much better83% POSITIVE

N=133

High treatment satisfaction by patients

Source: Frost et al, Addiction, 2019;114(8):1416-1426 17

Features rated as extremely important or much better (7 on scale 1-7) by majority of patients

Spares regular visits to the pharmacy Prevents others access to my medication Prevents accidental exposure to children Daily medication not required Improves my privacy as a patient Helps me not miss or skip medication dose Allowed to travel with no medication

Page 18: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

The Depot Evaluation Buprenorphine Utilization Trial (DEBUT)

Safety and feasibility of depot buprenorphine in NSW custodial settings (UNLOC-T)

18

‒ Prospective, non-randomized, open-label, case-comparison, multicenter trial in custodial settings

‒ 60 adult prisoners treated with Buvidal® and compared with methadone treated patients. Topline results Q4 2019

‒ Primary objective to test safety, tolerability, diversion and HEOR‒ Secondary objectives to compare efficacy and QoL

‒ Prospective, randomized, open-label, active-controlled, multicenter trial

‒ 120 adult outpatients have been randomized 1:1 to CAM2038 vs SL BNX. Topline results Q4 2019

‒ Primary objective to compare patient satisfaction‒ Secondary objectives QoL, HEOs and other PROs

Ongoing trials to further demonstrate utility and advantages of Buvidal®

DEBUT

Day -28 to -1 Day 1 Week 24

Screening

SC Buvidal® weekly and monthly flexible dosing

Follow-upperiod

Week 26

BPN standard of careat flexible doses

n=1201

R

UNLOC-T

Screening

Day 0 Day 1 Week 16 Week 48Week 4

Extended safetymonitoring

Active follow-up

E

Methadone

Buvidal®Weekly

Buvidal®Monthly

n=1201

Buvidal®Monthly

Page 19: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

19

Global commercialization strategy for Buvidal® (Brixadi™)

Source. 1World drug report 2019.

ESTIMATED

35 millionWORLDWIDE

OPIOID USERS 20161

Braeburn Braeburn option rightCamurus 1st entry markets Medison (Israel)Camurus

Page 20: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

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~740,000 patients estimated suited for treatmentwith Buvidal® in the EU and Australia

1EMCDDA 2018 Drug report 2Camurus estimate 3Benyamina et al 2013 Heroin Addiction and Related Clinical Problems 14 (4): 65-80. 4. Camurus data on file 2018, Patient qualitative study. 5Based on average daily price of USD 10/day and 270 treatment days/patient/year

Buprenorphine treated1

Methadonetreated ≤30 mg,1,2

New treatment journeys

12 months1

Not in treatment due to rules and burden of

daily treatment1,3,4

Total potential

15 percent market penetration corresponds to annual sales of ~ USD 300 million5

Page 21: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Wave 1 markets

Wave 3 marketsWave 2 markets

Wave 4 expansion

Launch sequence

HQLundSweden

CambridgeUK

ParisFrance

MannheimGermany

SydneyAustralia

Preparations in Wave 2-3 markets‒ Launches planned in Austria, Spain, Italy, France

and other EU countries Q4 2019 to Q2 2020• Pricing and reimbursement applications

submitted• Key regional functions onboarded

21

Buvidal® launch in EU & Australia gaining momentum1

Launched in all Wave 1 markets ‒ Finland, Sweden, Denmark, Norway, UK, Germany,

and Australia• Positive pricing and reimbursement decisions

in key markets, including: Norway, Scotland, Australia

• Fully operational teams – 65 heads• Effective supply and distribution

– within 24 hours delivery to clinic

Page 22: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

• Expansion into new markets ‒ Launches Australia and Norway in Q3‒ Wave 2&3 markets from Q4 2019

• Successful HTA review processes‒ Positive reimbursement decisions and recommendations

in Q2, incl. in Norway, Scotland and Australia

• Formulary inclusion and funding release‒ More than 40 formularies in the UK and 35 in Australia

have agreed to include Buvidal® as treatment option

• Medical education, evidence sharing and practical assistance ‒ Regional, national and local symposia, webinars, clinician

road shows, and case study publications

• Very positive feedback from patient and HCPs‒ Improved stability, less burden, more freedom

• High retention with only few dropouts‒ Similar or better than long-term Ph. 3 study

• Initial patient uptake and sales vary by country‒ 160 percent patient growth Q1 to Q2> 20% buprenorphine market share in Finland‒ Primary barrier is market access

• Reimbursement and formulary listing processes

• Significant potential in the custodial setting ‒ Buvidal® introduced in more than 20 prisons in the EU‒ UNLOC-T study under completion in Australia

Drivers of growth Experiences from initial launch markets

22

Key takeaways from initial markets

HTA: Health Technology Assesment

Page 23: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

• Tentative approval Brixadi™ on 21 Dec. 2018• Final approval of monthly product subject to the

expiration of an exclusivity period until November 2020 – unless earlier resolved

• Braeburn initiated court proceedings in April 2019 to overturn exclusivity and seek immediate market approval of Brixadi™ in the US

‒ US District Court for the District of Columbia ruled in July 2019 that the FDA acted inconsistently with precedent by delaying the approval of Brixadi™

‒ The court remanded the FDA to reconsider, with deliberate speed, Braeburn’s application for final approval of Brixadi™

23

Making Brixadi™ available to US patients

23

Scope Opioid dependence and pain

Region • Exclusive license for North America

Financials • USD 24 million received in upfront and development milestone payments

• Costs for pivotal clinical program covered by Braeburn

• Remaining development milestones;– USD 35 million for opioid use disorder– USD 17 Million for chronic pain

• Mid-teen royalty on product sales+ USD 75 million in sales milestones

Partnership with

Page 24: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

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CAM2038 in chronic pain – large market withhigh unmet medical needs

Market opportunity

• 100 million Americans and 75 million Europeans with chronic pain1,2

• 74 million patients with chronic low back pain (CLBP) in 7MM in 20183

• Chronic pain estimated to cost US society USD +600 billion per year4

Medical needaddressed

• Effective round-the-clock pain management, with potential of reduced risks of tolerance, dependency and respiratory depression

• HCP administration can improve treatment adherence and safeguards against diversion, misuse, abuse and child exposure

Key clinicalresults

• CAM2038 met primary and key secondary Phase 3 endpoints in a pivotal enriched-enrollment and randomized withdrawal study – Superiority demonstrated for relief of average and worst pain intensity

compared to placebo (P<0.0001, mITT). – Well tolerated with favorable safety profile

Next steps • Final Clinical Study Report of Phase 3 LTSE study • Regulatory submissions planned for H1 2020

Source: 1Global Industry Analysts, Inc. report 2011; 2Pain Practice 2014, 14, 79-94; 3Chronic Lower Back Pain (CLBP). Market Insights, Epidemiology, and Market Forecast-2028, Delveinsight, May 2019. 4Gaskin D, Richard P., J. Pain 2012; 13 (8): 715-724. MME: morphine milligram equivalent. 7MM – seven major markets

653 99561 04154 945

41 06017 873

27 873105 097

~1 million high-risk CLBP patients

(>99 MME*/day)3

US JapanGermany FranceItaly SpainUK

Page 25: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Improving lives of patients with pituitary and neuroendocrine disorders

CAM2029

Page 26: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Potential for better efficacy• 500% higher bioavailibility vs octreotide LAR1

• Well maintained or improved biochemical and symptom control indicated in acromegaly and NET patients2

Improved patient convenience• Ready-to-use prefilled syringe with option of autoinjector for enhanced convenience

• Fast onset and long-acting release allowsonce monthly dosing

26

CAM2029 could be the first long-acting octreotideanalogue for subcutaneous administration by patients

Additional promising indications• CAM2029 has an attractive target product profile across multipleindications

• Efficacy of octreotide suggested by growing scientific evidence base

>US$ 2.6 billion current somatostatinanalogue market3

20 years of steady market growth at 11% CAGR

Source: 1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2.Pavel M et al, Cancer Chemotherapy and Pharmacology 2019; 83:375–385; 3GlobalData 2019, SSA – somatostatin analog;

Comprehensive clinicaldevelopment program• Phase 3 studies in acromegaly initiated• NET program in progress• Four Phase 1-2 clinical trials completed with positive results

• Orphan designation in the EU

Page 27: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

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Acromegaly management overview

Source: 1. Melmed S, et al., Nat Rev Endocrinol. 2018 Sep;14(9):552-56. Well controlled studies indicate as few as 25% controlled

• Transsphenoidal surgery is standard initial therapy for a majority of patients • First-line medical treatment is first generation long-acting SSAs, octreotide LAR

and lanreotide ATG; with ~ 55% of patients biochemically controlled1

• For partial responders, SSA dose and dose frequency may be increased• Second line therapy includes pasireotide and pegvisomant

Increase SSA dose or frequency of dosing

Second generation SSA• Pasireotide LAR

First-line medical therapy

Partial response

Second-line therapy

GH receptor agonist• Pegvisomant

Combination of first generation SSA and pegvisomant

Addition of dopamine agonist to first generation SSA

Dopamine agonists, e.g. cabergoline, may be attempted in patients with modest biochemical abnormalities

or or

First generation SSA• Octreotide LAR• Lanreotide ATGBiochemical

and MRI confirmed Acromegaly

Surgery55 – 60% 40 – 45%

Not suitable for surgery

Diagnosis

Page 28: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

NET management overview

• Management of NETs patients is complicated given the highly heterogeneous patient population – approach varies with primary site, tumour size, grade and stage1

• For localised tumours, surgical resection is the primary treatment choice2

• However, surgery is not possible in many NETs patients (c. 40 – 50%)3,4

• First generation somatostatin analogues is the first line medical therapy, with highly favorable safety and tolerability profiles

Confirmed Neuroendocrine Tumour

Surgery

Medical Therapy• Somatostatin analogues• Chemotherapy

• Targeted therapies (sunitinib and everolimus)

• Liver-directed therapies • PRRT

40 – 50% 5,6

Incomplete resection

Not suitable for surgery

50 – 60% 5,6

Observationor

1 NANETS Consensus Guidelines for the Management and Treatment of Neuroendocrine Tumors, Pancreas. 2013 May;42(4):557-77; 2 NCCN Guidelines, Neuroendocrine and Adrenal Tumors, Version 1.2019; 3 Stueven AK, et al., Int J Mol Sci. 2019 Jun; 20(12): 3049; 4 Herrera-Martínez AD, et al., Drugs. 2019; 79(1): 21–42; 5 Man D, et al., Cancer Manag Res. 2018; 10: 5629–5638; 6 Analyst Report, Apr 2016 28

Page 29: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

29

CAM2029 –next generation octreotide depot for easy subcutaneous self-administration

Note: 1) New device introduced in 2019 (not shown here)

Product Product presentation

Route of administration

Self-administration

CAM2029 Ready-to-use PFS 12.5 mm, ≥22G needlewith autoinjector option

SC

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

IM –

Somatuline® Autogel®,1 Ready-to-useprefilled syringe20 mm, 18-19G needle

Deep SC –

Page 30: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

• 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

30

Efficacy and tolerability of CAM2029 supported by data from four clinical studies and PK modelling

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: 1Tiberg F, Br J Clin Pharmacol. 2015;80(3):460-72; 2Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019;83(2):75-385

Page 31: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

0

50

100

150

200

250

Day -28 - Day 0 Day 0 - Day 28 Day 28 - Day 56 Day 56 - Day 84

Tim

e w

eigh

ted

aver

age

(% o

f ULN

)

Patient 1 Patient 2 Patient 3Patient 4 Patient 5

IGF-1 in acromegaly patients Flushing and diarrhea in NET patient

31

Phase 2 study indicates improved biochemical and symptom control when switching from octreotide LAR to CAM2029

Analysis of data from Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019; 83(2): 375–385GH, growth hormone; IGF-1, insulin-like growth factor 1; LAR, long-acting release; NET, neuorendocrine tumors

0

0,5

1

1,5

2

Day -28 - Day 0 Day 0- Day 28 Day 28 - Day 56 Day 56 - Day 84

Mon

thly

mea

nnu

mbe

rsym

ptom

s/da

y

Bowel movementsFlushings

Oct-LAR CAM2029 Oct-LAR CAM2029

Page 32: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

32

CAM2029 top-level development program

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 full responders (N~80) Open label, long-term safety extension

(LTSE) in full/partial responders (N~70)

ACRO Phase 3 LTSE

ACRO Phase 3 PC

H2 2019 2021

Active controlled (AC) Phase 3 study in GEP-NET patients with metastatic, well differentiated NET.

NET Phase 3 AC + LTSE

Regulatory submissions

x

x

Page 33: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

• Superior convenience with ready-to-use formulationfor subcutaneous administration‒ No need for reconstitution or mixing, or risk of clogging ‒ Autoinjector under development for enhanced convenience

• Rapid onset and long-acting duration‒ Therapeutic concentrations reached within hours ‒ 4 week duration

• 5-fold higher bioavailability vs Sandostatin® LAR® 1

‒ Potential for improved treatment response

• Potential for improved efficacy‒ Indicated in Phase 2 study in acromegaly and NET

• Safety consistent with known safety profile of octreotide‒ Studies indicate that CAM2029 is well-tolerated systemically and locally

33

CAM2029 summary features

Source: Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019; 83: 375-383..

02505007501000125015001750200022502500Somatuline® (Ipsen)

Sandostatin® LAR® (Novartis)

mUSD

• 20 years of strong market growth ‒ $2.6 billion in global sales 2018~ 12% annual growth rate

Page 34: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

Inhibition of hemolysis following a single dose of zilucoplan FluidCrystal® in cynomolgus monkeys (n=4)

CAM4083: Complement-mediated disordersCAM4072: Genetic disorders of obesity

34

• Zilucoplan FluidCrystal® weekly SC depot‒ Treatment of generalized myasthenia gravis (gMG),

immune-mediated necrotizing myopathy (IMNM), and other serious complement C5 mediated disorders

• Preclinical PoC• Preparations for clinical

development ongoing• Program driven by

Ra Pharma under license agreement with Camurus

• UCB has agreed to acquire Ra Pharma for $2.5 billion1

• Setmelanotid FluidCrystal® weekly SC depot‒ Treatment of POMC deficiency, LEPR deficiency, and

Bardet-Biedl syndrome obesity

• Phase 1b clinical milestone in 2018‒ Plasma half-life ~120 hours ‒ Good tolerability

• Phase 2 study ongoing of CAM4072• Positive Phase 3 results for setmelanotide in

POMC and LEPR deficiency in August 2019• Program driven by Rhythm Pharmaceuticals

under license agreement with Camurus

Progress in partnerships

0

20

40

60

80

100

0 48 96 144 192

% H

emol

ysis

Time (h)

Source: Press release UCB and Ra Pharmaceuticals 10 October 2019

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35

Multiple levers for growth and value creation on short and medium term

Buvidal®/Brixadi™

Pipeline

Corporate

• Establish leadership in opioid dependence treatment with Buvidal® in Europe and Australia

• Support US market approval and launch of Brixadi™ by Braeburn, and continue geographic expansion through partnerships

• Drive late-stage development and to obtain regulatory approvals in chronic pain and acromegaly and NETs in 2 to 4 years

• Growing pipeline of innovative medicines in high unmet medical need areas and large market potential

• Expand the utilization of our FluidCrystal® technology to new applications and therapy areas

• Develop sustained profitability through own sales, partnerships and business development

Page 36: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

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

Thank You

Page 37: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

37

Key figures

Listed on Nasdaq STO (ticker CAMX)Market Cap: ~ SEK 4 billionEmployees: 120HQ: Lund, Sweden, Regional offices: Cambridge, Mannheim, Paris, SydneyAnalyst coverage: Carnegie Investment Bank, Erik Hultgård; Jefferies International, Harry Sephton, Svenska Handelsbanken, Peter Sehested

Contact us Learn more about [email protected] www.camurus.com

SEK million H2 2019Jan-Jul

H2 2018Jan-Jul

FY 2018Jan-Dec

Net Revenue 30.4 22.0 49.3

Operating result -194.2 -127.6 -287.2

Result after tax -155.3 -103.8 -234.7

Cash position 283.1 199.1 134.4

Sandberg Development

46.3%

Gladiator9.8%

Fjärde AP-fonden6.2%

Fredrik Tiberg3.5%

Avanza Pension2.3%

Backahill Utveckling2.3%

Catella fondförvaltning

2.2%

Others27.4%

Key Shareholders (30 September 2019)

Financials (SEK million)

Full year revenue guidance Net revenue SEK 130–160 million, whereof product sales SEK 70–90 million

Page 38: Company Presentation - Camurus · 10. 0. 7. 14. 21. 28. pasireotide plasma concentration (ng/mL) Time (days) Pasireotide FluidCrystal 20 mg (SC thigh, n = 12) Single dose injection

38

Outlook to 2021 – significant news flow expected

2019 2020

Com

mer

cial

R&D

H1 H2 H1 H2

CAM2029 Ph 3 ACRO startDEBUT & UNLOC-T studies fully enrolledCAM2038 Ph 3 long-term safety results

DEBUT study resultsUNLOC-T study resultsCAM2043 Ph 2 start

CAM2038 MAA chronic pain submission CAM2029 Ph 3 NET startCAM4072 Ph 2 results

CAM2029 Ph 3 ACRO fully enrolledCAM2043 Ph 2 results

H1 H2 H1 H2

2021

Buvidal® 1st wave launches in EU and Australia

Buvidal® 2nd wave launches in EU

Buvidal® 3rd wave EU & RoW launches

Buvidal® geographic expansion

CAM2038 launch in chronic pain

Commercial organization fully built-out in EU and AustraliaNew FluidCrystal® technology partnerships

Out-licensing of clinical product candidatesMilestone payments for Brixadi™ approval Leadership in opioid dependence treatment in EU

Sustained profitabilityThree commercial stage assets by end of 2021

Cor

pora

te

CAM2029 ACRO Ph 3 study resultsCAM2029 ACRO NDA /MAA submissionsCAM2043 Ph 3 start

Potential early US Brixadi launch

Expiry of Sublocade®

US exclusivity