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Page 1: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

November 2020

Company presentation

Page 2: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

2

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

Page 3: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

Long-acting medications addressing key healthcare challenges

Page 4: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

4

Experiencedmanagement and dedicatedteams

Corporate highlights

Rapidly growing commercial stage company• Fully operational infrastructure in Europe and Australia

• Buvidal® to date launched in 10 countries• Strong growth of product sales

Market approvalsWeekly and monthly Buvidal® for opioid dependence

PartnershipsR&D collaborations, licensing and royalty arrangements with pharma and biotech companies

Unique FluidCrystal®nanotechnologies• New generation long-acting depot technology

• Validated in +25 clinical trials and by approved products

LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP ~ SEK 10 billion EMPLOYEES: 130 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney

Broad late-stage pipeline• +10 innovative clinical programs in addiction, pain, oncology, endocrine disorders and CV diseases

• Two ongoing Phase 3 studies• Advancing early stage opportunities

Page 5: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

5

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

Easy and convenient administration Rapid onset & long-acting release Applicable across substance classes

Adopted to prefilled syringes and autoinjectors Manufacturing by standard processes Strong intellectual property

H2O

dru

gb

lood

conc

.

Sources:Tiberg F, et al. Chapter in Long Acting Injections and Implants, Advances in Delivery Science and Technology 2012; Tiberg F, et al. OnDrugDelivery2010; Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011.

Camurus‘ FluidCrystal® long-acting release technology has unique properties

Page 6: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

6

FluidCrystal – Long-acting release

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

0,1

1

10

0 7 14 21 28

pas

ireo

tid

e p

lasm

a co

nce

ntr

atio

n (

ng

/mL)

Time (days)

Pasireotide IR 600 ug (SCthigh, n = 94)

0,1

1

10

0 7 14 21 28

pas

ireo

tid

e p

lasm

a co

nce

ntr

atio

n (

ng

/mL)

Time (days)

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

Page 7: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

7

Recent highlights

• Strong improvement of results driven by Buvidal sales growth in EU and Australia since 2019 launch

• Brixadi™under review by FDA for final US approval 1 December 2020

• Two ongoing Phase 3 studies of CAM2029 in acromegaly

• Pivotal Phase 3 study of CAM2029 in NET aligned with FDA

• Positive Phase 2 results for weekly setmelanotide

• MSEK 300 raised in directed share issue

• Arbitration process with Braeburn1

1Camurus press release 15 June 2020 https://mb.cision.com/Main/13456/3134723/1264520.pdf

Positive 2020 outlookExpected FY net revenues1

SEK 340 - 380 millionExpected FY OPEX2

SEK 505 – 525 million

1. Excluding the $35m milestone for final FDA approval of Brixadi™ in he US2. Without regards to the outcome of the ongoing arbitration process

Page 8: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

8

Opioid dependence –escalating global health crisis

• Largest society burden of all drugs1

• 58 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‒ Diversion, misuse, overdosing, poor retention,

burdens and stigma of daily buprenorphine and methadone medications

1United Nations: World drug report 2020; 2Washington Post https://www.washingtonpost.com/health/2020/07/01/coronavirus-drug-overdose/ and ODMAP

Increase of suspected overdoses per month during the pandemic compared to the same month in 20192

Covid-19 causing spike in opioid overdoses in the US

Jan Feb Mar Apr May

-0.3%

+16% +18%

+29%

+42%

Page 9: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

9

Buvidal® – flexible long-acting treatment of opioid dependence

Flexible-dose, weekly and monthly, subcutaneous buprenorphine for treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1

Launch initiated in Europe and Australia in 2019

1BuvidalSummary of Product Characteristics (SmPC), 2018

Page 10: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

10

Buvidal provides significantbenefits to patients and society

• Improved treatment outcomes and patient satisfaction1-3

• Decreased treatment burden and stigma2

• Diminished diversion, misuse and pediatric exposure4

• Reduced treatment costs in the criminal justice system5

1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773;2Frost et al, Addiction, 2019;114(8):1416-1426; 3Lintzeris N, et al., Results of the DEBUT Study, presented at CPDD Virtual Meeting June 22-24, 2020. 4EPAR; 5Dunlop A, et al. Introduction of Long-Acting Depot Buprenorphine in Prison - the UNLOC-T Study. Presented at CPDD Virtual Meeting June 22-24, 2020

“For me, Buvidal is a revelation. I know that as long as I stay on Buvidal I’ve got a chance”Sophie, Buvidal patient in Wales

“CAM2038 compared to my previously prescribed sublingual buprenorphine treatment”

Much worse

Slightly worse

About the same

Slightly better

Much better 83% POSITIVE

N=1332

Page 11: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

11

Buvidal is well differentiated

Long-acting injection treatments for opioid dependence

*Based on information in product labels

PRODUCT WEEKLY DOSING

MONTHLY DOSING

MULTIPLE DOSES

CHOICE OF INJECTION

SITES

SMALL NEEDLE

LOW VOLUMES

ROOM TEMP.

STORAGE

DAY ONE INITIATION

CLIN. DATA VS ACTIVE CONTROL*

LAUNCHED

23G

0.16 – 0.64mL

EU, Australia

– – – –19G

–0.5 – 1.5 mL

– – – US, Canada, Australia

– – – –20G

–3.4 mL

– – – US

Page 12: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

12

REGION PARTNER NO OF PATIENTS PEAK MARKET POTENTIAL

EUAustralia LAUNCH INITIATED IN 2019

~1.3 millionHIGH-RISK

OPIOID USERS1

~€300 million2

North America US PDUFA DATE 1 DEC 2020

>2 millionDIAGNOSED WITH OPIOID USE

DISORDER IN THE US3

$0.6-1.2 billion4, 5

Middle East& North Africa EARLY ACCESS PROGRAMS

INITIATED IN 2020

>300,000WITH OPIOID DEPENDENCE6

€25-75 million5

1European Drug Report 2019; 2Camurus estimate; 3SAMHSA, Results from the 2017 National Survey on Drug Use and Health, Sep. 2018; 4Opioid Use Disorder: Opportunity Analysis and Forecasts to 2027, GlobalData 2018; 5Camurus estimates; 6World Drug Report and NewBridge estimate

Global strategy for Buvidal (Brixadi™)

Page 13: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

13

Strong growth of Buvidal in EU and Australia

Increasing market share‒ Largest markets (Australia, Finland and Norway)

continue to expand‒ Growth accelerating in the UK, Germany and Sweden‒ Covid-19 challenges with prescription authorizations

in Austria, lockdown of parts of Australia, and protracted pricing and reimbursement processes

Estimated more than 12,000 patients in treatment with Buvidal at the end of September

Buvidal now available in 12 countries‒ 10 countries in Europe and Australia‒ 2 countries in MENA with Early Access Programs‒ 2 additional EU launches expected before year end

* Measured by product sales

Product sales by quarter

MSEK

20202019

48.6

30.3

19.5

11.0

75.8

11.3

Q1 Q2 Q3 Q4 Q1 Q2

60

50

40

30

20

10

0

70

80

90

100

Q3

94.3

Page 14: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

14

Austria Launched in May 2020 after law

change allowing injectable treatments for OD5

Norway Launched in Q3 2019 Buvidal now market leader

United Kingdom Scottish government delivers

£1.9m budget to support people in prison on ODT to transfer to Buvidal1

Wales’ government supports treatment with long-acting buprenorphine during Covid2

Germany Physician remuneration system

modified balancing reimbursement for different treatment modalities5

1. https://news.gov.scot/news/supporting-people-affected-by-drug-use; 2. https://gov.wales/wales-roll-out-once-month-injection-recovering-heroin-addicts-help-protect-nhs-staff; 3. https://www.tlv.se/beslut/beslut-lakemedel/begransad-subvention/arkiv/2020-05-19-buvidal-ingar-i-hogkostnadsskyddet-med-begransning.html; 4. https://www.kbv.de/html/1150_45794.php; 5 .Federal law for Austria issued 18 May 2020 Part II 215th regulation: Amendment of the drug regulation

Australia GPs allowed to

prescribe Buvidal from 1 April 2020

Sweden Reimbursement of Buvidal approved by

TLV in May 20203

EU and Australia launch update

Belgium Sales initiated in prison

system during Q3 2020

Finland First market to launch in Q1 2019 Now market leader with >50% share

Denmark KOL support driving change

Iceland Launched in Q4 2020

Page 15: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

15

Benelux >22,000 patients in opioid

dependence treatment1

Launched in BE in Q3 2020 Preparing for NL launch in

Q1 2021

Spain >58,000 patients in ODT1

Preparing for launch in Q4 2020

Italy ~70,000 patients in opioid

dependence treatment1

Pricing and reimbursement discussions

Launch sequenceLaunched Wave 3 marketsWave 2 markets Wave 4 markets

France >179,000 patients in opioid

dependence treatment1

Final regulatory and pricing discussions with authorities

1. European Drug Report 2019, EMCDDA

Wave 2/3 planned countries

Portugal >17,000 patients in ODT1

Preparing for launch in Q4 2020

Switzerland Regulatory approval decision

pending Preparing for launch in 2021

Ireland Launch in Q4 2020

Page 16: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

16

CAM2038 Chronic pain

Pre-submission meeting held with EU Rapporteur

Regulatory submission to EMA delayed to early 2021

Regulatory progress and market expansion

•Regulatory filings Pre-approval received by Swiss

Agency for Therapeutic Products (Swissmedic)

Market authorization application under final review in New Zealand

Line-extension applications and label enhancements with EMA and TGA

•Availability of Buvidal in MENA region Early access programs and regulatory

filings initiated with collaboration partner NewBridge Pharmaceuticals

Growing patient numbers

•Braeburn preparing for US launch Request for final FDA approval of the

NDA for Brixadi accepted by FDA with PDUFA date 1 Dec. 2020

FDA final approval of Brixadi expected 1 Dec 2020 – triggering a $35 million milestone payment to Camurus

Page 17: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

17

Significant opportunity for Brixadi in the US

•US opioid crisis continues to grow‒ Nearly 50,000 fatal opioid overdoses in

the US in 20181

‒ Increasing opioid overdoses during Covid pandemic2

•US opioid use disorder epidemiology:

•Brixadi aligned with current treatmentparadigm‒ Flexibility on posology and doses expected to

resonate with established prescription patterns5

‒ Day 1 treatment initiation and multiple choice of injection sites

1https://www.cdc.gov/drugoverdose/data/statedeaths.html; 2https://www.ama-assn.org/system/files/2020-10/issue-brief-increases-in-opioid-related-overdose.pdf; 3https://www.samhsa.gov/data/report/2018-nsduh-detailed-tables ; 4https://www.soa.org/globalassets/assets/files/resources/research-report/2019/econ-impact-non-medical-opioid-use-pdf; 5Symphony Health Patient Source

40%

26%

34% 7 days Rxmost common

8–27 days Rx

28 days+Rx

Brixadi™ Weekly / Monthly

Brixadi™ Monthly

misusing opioids3

prevalence of OUD4

annual buprenorphine or naltrexone patients51.4m

3.9m

10.3m

Page 18: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

18

Expanding the evidence base throughinvestigator sponsored studies

Study Country Investigator Type Est. patient numbers Status

Understanding NSW Long-acting Opioids in Custody-Treatment (UNLOC-T)

Australia Prof Dunlop(NSW Government)

Two-arm, case-comparison study

129 (Buvidal 67) Reporting

Patient experiences of long-acting SC injectable depot buprenorphine (post-DEBUT qualitative study)

Australia Prof Lubman(Monash Univ)

Qualitative interviews(retrospective)

30 Reporting

Addiction recovery of opioid dependent patients treated with injectable subcutaneous depot buprenorphine (ARIDE)

Germany Prof Schulte(ZIS Hamburg)

Non-interventionalstudy

426 (Buvidal 213) Ongoing

Exploring the potential of long-acting buprenorphine therapy in vulnerable people who use drugs and are homeless

Scotland Prof Matheson(Univ of Stirling)

Qualitative interviews(prospective)

30 Ongoing

Emergency department-initiated buprenorphine and validation network trial (NCT04225598)

USA Prof Gail D’Onofrio, Yale

RCT, open-label 2000 (Brixadi 1000) Ongoing

Medication treatment for OUD in expectant mothers (NCT04212065)

USA Prof Theresa Winhusen, University of Cincinnati

RCT, open-label 300 (Brixadi 150) Ongoing

A comparative effectiveness trial of XR Naltrexone vs XR-BUP with individuals leaving jail (NCT04408313)

USA Dr Michael Gordon, Friends Research Inst.

RCT, open-label 240 (Brixadi 120) Ongoing

Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (NCT04345718)

USA Prof Gavin Bart, Hennepin Healthcare

RCT, open-label 314 (Brixadi 157) Starting

Optimizing Retention, Duration and Discontinuation Strategies for OUD Pharmacotherapy (NCT04464980)

USA Prof Edward Nunes, Columbia University

RCT, open-label 1630 (Brixadi 650) Starting

Σ >2,400 Buvidal/Brixadi patients

Page 19: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

19

Significant opportunity in mid- to late-stage pipeline

Own approved medicines License collaborations Own product candidates

Approved medicines Phase 1 Phase 2 Phase 3 Registration Market

Buvidal® Opioid dependence

Product candidates

Brixadi™ Opioid Dependence1)

CAM2038 Chronic pain

CAM2029 Acromegaly

CAM2029 Neuroendocrine tumors

CAM2032 Prostate cancer

CAM4072 Genetic obesity disorders2)

CAM2043 Pulmonary arterial hypertension

CAM2043 Raynaud’s phenomenon

CAM4071 Endocrine disorders

CAM2047 CINV3)

CAM2048 Postoperative pain1)

Medical device

episil® Oral liquid

1) Braeburn holds the rights to North America2) Developed by Rhythm Pharmaceuticals under a

worldwide license to FluidCrystal®3) CINV – Chemotherapy-induced nausea and vomiting

Page 20: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

20

CAM2029 – long-actingsubcutaneous octreotidein Phase 3 development

•Innovative medicine in late-stage development for rare pitituary and neurendocrine disorders and tumors

•Designed for enhanced efficacy and patient convenience

Page 21: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

21

CAM2029 opportunity addresses key unmet medical needs in the SSA market

•Potential for response rates in acromegaly and NET patients‒ Fast onset and long-acting release‒ ~ 500% higher bioavailability vs octreotide LAR1

•CAM2029 offers simplified dosing and possibility of self-administration‒ Ready-to-use prefilled syringe or autoinjector for self-administration and enhanced patient convenience‒ No need for burdensome clinic visits for dosing

1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2US label; 3Global Data 2020

CAM2029 advantages CAM2029 Sandostatin® LAR (octreotide) Somatuline® Depot (lanreotide)

Convenient device Pre-filled syringeAutoinjector

Powder vial + pre-filled syringe with diluent solution + vial adapter + injection needle

Pre-filled syringe

Thin needle 22G 12.5mm 20G 40mm 18G 20mm

Administration route Subcutaneous Intramuscular, after reconstitution in six steps

Deep subcutaneous, after conditioning

Storage Room temperature Refrigerated, bring to room temperature between 30 – 60 minutes before reconstitution

Refrigerated, conditioning at room temperature for at least 30 minutes before injection

Flexible administration Self-administration option Administration by trained healthcare provider2

Administration by healthcare provider2

US$ 1.6 billion global sales in 20193 US$ 1.3 billion global sales in 20193

SSA market size

US$3billionin 20193

Page 22: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

22

CAM2029 supported by data from four clinical studies

• Dose proportional long-acting octreotide release suitable for once monthly dosing1

• Rapid and sustained suppression of insulin-like growth factor-1 (IGF-1) in HVs

• Well-maintained or improved biochemical control indicated in acromegaly patients2

• Well-maintained or improved symptom control in NET patients2

• Safety and tolerability profile consistent with octreotide LAR1-2

1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-472; 2Pavel M et al, Cancer Chemotherapy and Pharmacology 2019; 83: 375-383.

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)

Page 23: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

23

0,1

1

10

100

0 7 14 21 28

Pla

sma

OC

T c

on

c (n

g/m

L)

Time (days)

CAM2029 20mg q4w NET patients ssOCT LAR 30mg q4w NET patients ss

Phase 2 pilot study indicates good or improved symptom control in NET patients

Pharmacokinetics in NET patients Flushing and diarrhea in NET patients

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 CAM2029Steady-state pharmacokinetic profiles

Page 24: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

24

0

2

4

6

8

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

GH

co

nce

ntr

atio

n (m

g/m

L)

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5

Study also indicates well-maintained or improved biochemical control with CAM2029 in acromegaly

IGF-1 in acromegaly patients Growth hormone (GH) in acromegaly patients

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

Oct-LAR CAM2029

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

eig

hte

d a

vera

ge

(% o

f U

LN)

Patient 1 Patient 2 Patient 3 Patient 4 Patient 5

Oct-LAR CAM2029

ULN

ULN

1.3xULN

Page 25: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

25

•Efficacy trial (HS-18-633)‒ Phase 3, randomized, double-blind, placebo-controlled,

multi-center trial to assess efficacy and safety of CAM2029‒ Regulatory requirements for efficacy data met‒ 78 patients, full SSA responders‒ Primary end-point: Proportion of patients with mean IGF-1

levels ≤ 1x upper limit of normal (ULN) at w22 and w24

Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly

•Long-term safety study (HS-19-647)‒ Phase 3, open-label, single arm, multi-center trial to

assess the long-term safety of CAM2029‒ ≥ 100 patients exposed to CAM2029 for 12 months

• Roll-over patients from HS-18-633 and• ‘New patients’ (partial SSA responders, irradiated patients,

and full SSA responders)

‒ Primary end-point: Characterization of adverse events

HS-18-633

4 - 8 Weeks Day 1

Screening

CAM2029 once monthly

Week 24

Placebo once monthly

N=78, 2:1

R

Rescue with standard of care

Prior treatment with octreotide or lanreotide

Double-blind treatment phase

HS-19-647

4 - 8 Weeks Day 1 Week 24

New patientsN=70

Prior treatment with octreotide or lanreotide

Open-label treatment phase

Screening Roll-over patients from HS-18-633

N=70

Week 52

CAM2029 once monthly

Page 26: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

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NET Phase 3 program aligned with the FDA

Meeting held with the US FDA to align on the pivotal study program for CAM2029 in NET

• Planned Phase 3 study design‒ Randomized, multicenter, open-label, parallel-group, active-controlled trial

• To assess the superiority of treatment with CAM2029 compared to octreotide LAR or lanreotide ATG on progression free survival in patients with metastatic/inoperable, well-differentiated GEP-NET*

‒ Study planned to early 2021 with expected completion in 2024

HS-19-657

Day 1

Screening

CAM2029

Follow-up period

ROption to switch to CAM2029

(if primary endpoint met)

Treatment period

Survival follow-up

* GEP – gastroenteropancreatic; NET – neuroendocrine tumors

Primary endpoint PFS (Progression

Free Survival)Active comparator

Page 27: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

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NET Phase 3

Active controlled Phase 3 study in patients with metastatic, well differen-tiated GEP-NET

CAM2029 study program overview

2019 20212020 2022

ACRO Phase 3 LTSE

Randomized, double-blind, placebo-controlled study in SSA responders

ACRO Phase 3 PCRegulatory

submissionsACRO

Autoinj. PK

ACRO Phase 3 PC ACRO Phase 3 LTSE

Open-label, long-term safety study in partial and full responders

Four clinical trials completed in healthy subjects and patients characterizing PK, PD and safety profile (N=249)

NET Phase 3

PLD Phase 2

PLD Phase 2

Placebo-controlled Phase 2 study in patients with polycystic liver disease (PLD)

Autoinjector PK

PK bridging study of prefilled syringe and autoinjector devices

FDA advisory meeting NET

Page 28: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

28

Significant peak market potential for CAM2029

$60m

$145m

$120m

$180m

$180m

$245m

$240m

$435m$485m

$720m

$720m

$1,015m

NET (US+EU5)Acromegaly (US+EU5)

Profile 1CAM2029 is available as a pre-filled syringe (PFS) device with non-inferior efficacy to current long-acting SSAs, with an assumed penetration of 10–20% in acromegaly, and 10–15% in NET

Profile 2Available both as PFS and as an autoinjector, with non-inferior efficacy to current long-acting SSAs and an assumed penetration of 20–25%

Profile 3Available both as PFS and as an autoinjector, with data suggesting superior efficacy over current long-acting SSAs, and an assumed higher penetration of 30–35%

1Globe Life Sciences reports 2019 and 2020; data on file

$265m

$415m

PLD (US+EU5)

Profile 1 Profile 2 Profile 3 Profile 1 Profile 2 Profile 3 Currently no approved products

Page 29: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

29

Progress in Rhythm collaboration

Long-acting setmelanotide for treatment of genetic obesity disorders Rhythm submitted NDA for daily

setmelanotide in POMC / LEPR deficiency– PDUFA date with priority review 27 November 20201

Positive Phase 2 results for weekly depot (CAM4072) announced in June 20201

• CAM4072 well tolerated• Achieved weight loss comparable to

daily formulation over 12 weeks

Discussion with FDA about the registration path for once-weekly setmelanotide

Weekly setmelanotide (CAM4072) Positive Phase 2 data announced1

1Rhythm Corporate Presentation – October 2020. https://ir.rhythmtx.com/static-files/fd4e0919-4d82-47e0-afe3-8cd9b5151490

Mean through drug concentrations for 20mg and 30mg doses of CAM4072 similar to 3mg daily dose

QD-3mg QW-10mg QW-20mg QW-30mg

Week

Mea

nTh

roug

hC

once

ntra

tion

(ng/

mL)

1 2 3 4 5 6

0

7 8 9 10 11 12

3

6

9

12

Page 30: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

30

Start Phase 2 study of CAM2043 in Raynaud’s phenomenon

Reported and anticipated news flow during 2020/21

Buvidal launched in Austria

2020 2021

Start CAM2029 autoinjector bridging PK study

Results CAM2029 bridging PK study autoinjector

Announcement of strong Buvidal demand during Q1 2020

H2H1

IND CAM2029 Phase 3 study in NET

MAA submission CAM2038 chronic pain to EMA

Final market approval of Brixadi™ in the US

CTA for CAM2043 Phase 2 in RP

GPs allowed to prescribe Buvidal in Australia

Start Phase 2 CAM2029 in PLDBuvidal reimbursed

in Sweden

Request for final market approval to US FDA

Phase 2 results long-acting setmelanotide

Raised FY 2020 guidance

Outcome of arbitration

process

Arbitration process initiated by Braeburn

Completion of Phase 3 efficacy study of CAM2029 in acromegaly

Page 31: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

31

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

Buvidal®/ Brixadi™

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

US market approval and launch of Brixadi™ and continued RoWexpansion of Buvidal

Pipeline

Late-stage development and new regulatory approvals in chronic pain, acromegaly and NET

Grow our pipeline of innovative medicines and expand the use of our FluidCrystal® technology in areas of high unmet need and market potential

Corporate

Continue to build our commercial infrastructure and launch new products

Develop sustained profitability through own sales, partnerships and business development

Page 32: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

32

Camurus AB │ Ideon Science Park, SE-223 70 Lund,

Sweden

P +46 46 286 57 30 │ [email protected] │ camurus.com

Page 33: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

33

Financial overview third quarter 2020

Key figures

MSEK Jul – Sep2020 (2019) Δ

Jan – Sep2020 (2019) Δ

Total revenues 100.3 (40.2) +150% 230.4 (70.6) +226%

whereof product sales 94.3 (19.5) +383% 218.6 (41.8) +423%

OPEX 113.4 (113.0) 0% 332.7 (332.5) 0%

Operating result -23.4 (-77.4) +70% -123.6 (-271.6) +54%

Result for the period -20.3 (-62.7) +68% -101.8 (-218.0) +53%

Result per share, before and after dilution, SEK -0.38 (-1.31) +71% -1.95 (-4.76) +59%

Cash position 475.7 (192.3) +147% 475.7 (192.3) +147%

Q3 Q1-Q3

Page 34: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

34

Shareholders

Shareholders as of 31 October 2020 Number of shares % of capital % of votes

Sandberg Development AB 22,200,692 41.4 41.4

Gladiator 3,433,078 6.4 6.4

Fjärde AP-fonden 3,330,676 6.2 6.2

Avanza Pension 1,733,024 3.2 3.2

Fredrik Tiberg, CEO 1,703,188 3.2 3.2

Svenskt Näringsliv 1,100,000 2.0 2.0

Backahill Utveckling 867,153 1.6 1.6

Lancelot Asset Management 600,000 1.1 1.1

State Street Bank and Trust 553,616 1.0 1.0

Afa Försäkring 550,000 1.0 1.0

Camurus Lipid Research Foundation 505,250 0.9 0.9

Nordnet Pensionsförsäkring 474,642 0.9 0.9

Enter fonder 457,561 0.8 0.8

Hamrins Stiftelse 425,000 0.8 0.8

Grenspecialisten 420,870 0.8 0.8

Other shareholders 15,282,108 28.5 28.5

In total 53,636,858 100.0 100.0

Shareholder distribution

41.4%

6.4%6.2%

3.2%3.2%

2.0%

1.6%

1.1%

1.0%1.0%

0.9%0.9%0.8%0.8%

0,8%

28.5%

Page 35: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

35

Agneta SvedbergVice President, Clinical & Regulatory Development

In Company since: 2015Holdings: 11,341 shares & 75,000 subscription warrants

Fredrik Tiberg, PhDPresident & CEOHead R&DIn Company since: 2002Holdings: 1,703,188 shares & 220,000warrants

Education: M.Sc. in Chemical Engineering, PhD in Physical Chemistry, Lund University

Previous experience: Professor in Physical Chemistry at Lund University, Visiting Professor at Oxford University, Institute for Surface Chemistry (Section head)

Eva Pinotti-Lindqvist Chief Financial Officer

In Company since: 2014Holdings: 45,363 shares & 22,891 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: 20,490 shares & 80,000 warrants

Education: Bachelor’s of Science in Applied Biological Sciences from University West of England

Previous experience: GM, UK & Nordics for Reckitt Benckiser (2010 – 2013) and Area Director Europe, Middle East and Africa for Indivior (2013 – 2016).

Fredrik Joabsson, PhD Chief Business DevelopmentOfficer

In Company since: 2001Holdings: 45,463 shares & 35,000 subscription warrants

Torsten Malmström, PhD Chief Technical Officer

In Company since: 2013Holdings: 45,363 shares & 8,000 subscription warrants

Annette MattssonVice President, Regulatory Affairs

In Company since: 2017Holdings: 375 shares & 25,000 subscription warrants

Urban PaulssonVice President Corporate Dev.& General Counsel

In Company since: 2017Holdings: 8,125 shares & 115,000 warrants

Experienced and committed management team

Peter HjelmströmChief Medical Officer

In Company since: 2016Holdings: - shares & - warrants

Page 36: Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ... Tiberg F, et al. Chapter in Long Acting Injections and Implants, ... Two-arm, case-comparison

36

Braeburn arbitration

•Camurus announced on 15 June that Braeburn has initiated arbitration proceedings in England1

‒ Camurus previously served a notice of material breach questioning Braeburn’s performance primarily relating to:

• Preparations for regulatory approval and commercialization of Brixadi/CAM2038 for OUD in Canada

• Preparations for a separate earlier launch of Brixadi weekly product for the treatment of OUD in the US

• Preparations for regulatory approval and commercialization of Brixadi for the treatment of chronic pain

‒ Braeburn has disputed the validity of the material breach notice‒ The license agreement stipulates a 90 days arbitration process

• The license agreement remain in full force and effect during the arbitration process

•Possible outcomes‒ If the Tribunal finds that Braeburn is in material breach:

• Camurus will be entitled (subject to a 60-day cure period) to terminate the agreement and regain all rights granted to Braeburn

‒ If the Tribunal finds that Braeburn is not in material breach:• The license agreement will remain in full force and effect

1 Camurus press release 15 June 2020 https://mb.cision.com/Main/13456/3134723/1264520.pdf