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March 2021 Company presentation
Transcript

March 2021

Company presentation

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

Long-acting medications addressing key healthcare challenges

4

Experiencedmanagement and dedicatedteams

Corporate highlights

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

• Buvidal® to date available in 15 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 12 billion EMPLOYEES: 136 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

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

loo

dco

nc.

Sources: Tiberg F, et al. Chapter in Long Acting Injections and Implants, Advances in Delivery Science and Technology 2012; Tiberg F, et al. OnDrugDelivery 2010; Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011.

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

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 (n

g/m

L)

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 (n

g/m

L)

Time (days)

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

7

Camurus had a successful 2020

1. Constant exchange rates (CER) December 2019

FY 2020 guidanceExpected FY net revenuesSEK 340 - 380 million,whereof product salesSEK 310 – 340 millionExpected FY OPEX* SEK 505 – 525 million

*Without regard to the outcome of the ongoing arbitration process

•Strong revenue growth – in line with our upgraded 2020 guidance • Net revenue SEK 336 million, up 218% (SEK 351 million, up 227% at CER1),• Product sales SEK 323 million, up 347% (SEK 337 million, up 362% at CER1)• OPEX was SEK 508 million, an increase of 15%

•Successful commercialization of Buvidal• Scalable commercial platform in Europe and Australia • Expansion into new markets• Established the value Buvidal brings to patients, HCPs, payors and society

‒ Growing scientific evidence, including positive results from DEBUT and UNLOC-T clinical trials

•Significant pipeline progress• Progress of Phase 3 studies for CAM2029 in acromegaly • Positive Phase 2 results for weekly FluidCrystal® setmelanotide for treatment of rare

genetic obesity disorders by Rhythm• Progress in the early pipeline has laid the ground for new value-adding clinical

programs

8

Fourth quarter 2020 highlights

•Total revenues up by 201% (213% at CER1)‒ Product sales up by 243% (256% at CER1)

•Patients in treatment with Buvidal® increased to over 15,000‒ More than 200,000 Buvidal doses administered in 2020

•Buvidal approved in Switzerland ‒ Three additional MAAs submitted

•Delay in the US‒ Braeburn received a CRL2 from FDA for the Brixadi™NDA‒ Partial award announced from arbitration process with Braeburn

•New clinical studies‒ First patients treated in Phase 2 study of CAM2043 in Raynaud’s

phenomenon and Phase 1 study of CAM2029 autoinjector‒ Phase 3 study protocol finalized for CAM2029 in NET

•New patents for Buvidal granted in the EU and US

Key figures

1. Constant exchange rates (CER) December 2019 2. CRL – Complete Response Letter

MSEK Oct – Dec2020

Δvs 2019

Jan – Dec2020

Δvs 2019

Total revenues 106 +201% 336 +218%

whereof product sales 104 +243% 323 +347%

OPEX 175 +58% 508 +15%

Operating result -82 +8% -205 +43%

Result for the period -65 +9% -167 +42%

Result per share, before and after dilution, SEK -1.22 +17% -3.18 +49%

Cash position 462 +29% 462 +29%

9

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, risk of overdose, poor retention,

burdens and stigma of daily buprenorphine and methadone medications

1United Nations: World drug report 2020; National Records of Scotland https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/deaths/drug-related-deaths-in-scotland/2019

Escalating overdose deaths

0

200

400

600

800

1 000

1 200

Opioid related deaths in Scotland over the last 10 years2

10

Buvidal® – flexible long-acting treatment of opioid dependence

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

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

Buvidal provides significant benefits to patients and society‒ Improved treatment outcomes and patient satisfaction1-3

‒ Reduced treatment burden and improved quality of life2

‒ Diminished diversion, misuse and pediatric exposure4

‒ Reduced treatment costs in the criminal justice system5

11

60

50

40

30

20

10

0

70

80

90

100

110

Buvidal growth journey

Continued progress in the fourth quarter‒ Invoiced product sales grew by 10% versus Q3 2020,

while the in-market Buvidal sales growth was 33%‒ Double-digit growth in all markets ‒ Largest markets: Australia, Finland, Norway and UK‒ Covid-19 barrier for uptake and delayed pricing and

reimbursement processes

Buvidal available in 15 countries‒ 12 countries in Europe and Australia

• Latest launch in Spain after price and reimbursement decision in December 2020

‒ 3 countries in MENA with Early Access Programs ‒ Preparation for new launches in Wave 3 markets

MSEK

20202019

Q1 Q2 Q3 Q4 Q1 Q2 Q3

49

30

19

11

76

11

94

104

Q4

Product sales by quarter

12

Buvidal scientific evidence base translated into significant patient benefits

Strong science

• 25 peer-reviewed scientific publications – 11 in 2020

• 123 conference presentations – 24 in 2020

Supported claims

• Superior treatment outcome versus daily sublingual buprenorphine

• Flexible, individualized treatment according to patients’ needs

• Improved treament satisfaction and quality of life of patients

Media recognition

• Benefits of Buvidal being recognized by wider society

• Covid-19 highlights advantages of long-acting treatments

“…make available long acting treatments in both community & prison” Nicola Sturgeon, First Minister, Scotland, 21 Jan 2021

13

REGION PARTNER NO OF PATIENTS MARKET POTENTIAL

EUAustralia LAUNCH INITIATED IN 2019

~1.3 millionHIGH-RISK

OPIOID USERS1

~€300 million2

North America

>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™)

14

CAM2038 Chronic pain

Pre-submission meeting held with EU Rapporteur

Regulatory submission to EMA planned in 2021

Buvidal (Brixadi) regulatory progress

•New approval Market authorization approval by

Swissmedic in December 2020

•Regulatory filings Line-extension applications and label

enhancements with EMA and TGA Market authorization application, MAA,

under final review in New Zealand

•Availability of Buvidal in MENA Early access programs ongoing in

three countries MAAs submitted in three MENA

countries in Q4 – priority review received in Saudi Arabia

Further submissions planned in 2021

•Braeburn received CRL in the US Complete response letter (CRL) issued

by FDA for the Brixadi™NDA on1 December 2020‒ Quality related observations during pre-

market inspections of Braeburn’s third-party manufacturer

Braeburn are working with their contract manufacturer to address the CRL issues and resubmit the NDA

A new PDUFA date for the Brixadi™ NDA is expected in H2 2021

15

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 Raynaud’s phenomenon

CAM2043 Pulmonary arterial hypertension

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

16

CAM2029 – octreotide subcutaneous depot in Phase 3 development

•Innovative medicine in late-stage development for rare pituitary disorders and neuroendocrine tumors

•Designed for enhanced efficacy and patient convenience

17

CAM2029 opportunity addresses key unmet medical needs in the SSA market

•Somatostatin analogues (SSAs) are first-line medical therapy in acromegaly and neuroendocrine tumors (NET)

•But there are significant limitations with current SSA treatments‒ Difficult handling & administration‒ Sub-optimal treatment result

•CAM2029 offers simplified dosing and possibility of self-administration‒ Ready-to-use prefilled syringe or

autoinjector for enhanced convenience with option for self-administration

•Potential for improved biochemical and symptom control‒ Fast onset and long-acting release

with 500% higher bioavailability vs octreotide LAR1

‒ Well maintained or improved biochemical and symptom control indicated with CAM2029 in acromegaly and NET patients2

•US$ 2.8 billion• CURRENT SSA MARKET VALUE3

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; 3 GlobalData 2020, excluding pasireotide sales

Somatuline® Autogel®Sandostatin® LAR®

0

500

1000

1500

2000

2500

3000

mUSD

SSA annual sales

Sandostatin® LAR® (octreotide):

Somatuline® Autogel® (lanreotide): CAM2029:

18

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

19

0

2

4

6

8

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

GH

co

nce

ntr

atio

n (

mg

/mL)

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

20

CAM2029 study program overview

PK – pharmacokinetic; PD – pharmacodynamic

2019 20212020 2022

ACRO Phase 3 LTSE

ACRO Phase 3 PCRegulatory

submissionsACRO

Autoinj. PK

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

NET Phase 3

PLD Phase 2

NET Phase 3

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

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

ACRO Phase 3 PC ACRO Phase 3 LTSE

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

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

IND NET Ph. 3

21

•Efficacy trial‒ Phase 3, randomized, double-blind, placebo-controlled,

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

levels ≤ 1x upper limit of normal (ULN) at w22 and w24‒ Study ongoing and recruiting

Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly

•Long-term safety trial‒ Phase 3, open-label, single arm, multi-center trial to

assess the long-term safety and efficacy 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: Safety profile (adverse events)

‒ Study ongoing and recruiting

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

22

GEP-NET Phase 3 trial under start-up

Phase 3, randomized, open-label, active-controlled multi-center trial to assess efficacy and safety of CAM2029 versus octreotide LAR or lanreotide ATG in patients with GEP-NET‒ Approximately 300 patients with GEP-NET randomized 1:1‒ Primary endpoint: superiority of treatment with CAM2029 versus standard of care, as determined by

progression free survival in patients with GEP-NET ‒ Study starting

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

23

CAM2029 update status

•Acromegaly‒ Two phase 3 studies ongoing ‒ On track for NDA/MAA submissions

in late 2022 ‒ Orphan drug designation in the EU

•Neuroendocrine tumor‒ Registration program for GEP-NET

was aligned with FDA and EMA ‒ IND safe to proceed letter received

from FDA for start of Phase 3 trial‒ CTAs in progress

•Polycystic liver disease program‒ FDA interactions ongoing about the clinical

registration program for CAM2029 in PLD‒ Patient reported outcome (PRO) questionnaire in

development

•Autoinjector development ‒ Autoinjector developed ‒ Phase 1 bridging study ongoing‒ Full validation ready in mid-2021

•New indications ‒ CAM2029 is being considered for additional

indications ‒ Go / No Go decision and potential clinical study

start in 2021

“Top selling drug to enter the market will

be Camurus' Octreotide LA”

24

Significant market potential expected for CAM2029

Recent GlobalData report:

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

“Top selling drug to enter the market will

be Camurus' Octreotide LA”

November 2020

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%

Estimates US$210m US+EU5 sales in 2029

in acromegaly

$60m

$145m

$120m

$180m

$180m

$245m

$240m

$435m$485m

$720m

$720m

$1,015m

NET (US+EU5)

$265m

$415m

PLD (US+EU5)Acromegaly (US+EU5)

Profile 1 Profile 2 Profile 3 Currently no approved productsProfile 1 Profile 2 Profile 3

25

Progress in Rhythm collaboration

Long-acting setmelanotide for treatment of genetic obesity disorders Daily setmelanotide in POMC / LEPR

deficiency approved by the FDA on27 November 20201

Positive Phase 2 results for weekly depot (CAM4072) announced in June 20202

• CAM4072 well tolerated• Achieved weight loss comparable to

daily formulation over 12 weeks

Rhythm announced plans to start registration study for weekly setmelanotide in H2 2021

Weekly setmelanotide (CAM4072) Positive Phase 2 data2

1 https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreetm; 2Rhythm Corporate Presentation – November 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 daily 3mg 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

26

Start Phase 2 study of CAM2043 in Raynaud’s phenomenon

Strong news flow during 2020/21 – selected events

2020 2021

Start CAM2029 autoinjector bridging PK study

Results CAM2029 autoinjector PK study

Announcement of strong Buvidal demand

H2H1

Start CAM2029 Phase 3 study in NET

MAA submission CAM2038 chronic pain

Braeburn receives CRL for Brixadi™ in the US

Start Phase 2 CAM2029 in PLD

Phase 2 results long-acting setmelanotide

Raised FY 2020 guidance

Arbitration process initiated by Braeburn

Completion of Phase 3 efficacy study of

CAM2029 in acromegaly

Buvidal third wave market expansion

Phase 2 results CAM2043 in Raynaud’s

Start new in-house clinical program

Brixadi US approval

Buvidal EU/AUS line extension approvals

Publication of DEBUT and

UNLOC-T data

27

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™

Continued RoW expansion

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 growth and profitability through own sales, partnerships, business development and M&A

2828

Outlook 2021

•Full year 2021 guidance*

• Revenue

•SEK 680 – 750 million

• whereof product sales

•SEK 620 – 680 million

• Operating result

•SEK -120 – 0 million

• * Constant exchange rates from January 2021

•Key assumptions: Revenue • Excludes a potential $35m milestone for

final approval of Brixadi in the US• Product sales estimate based on end of

2020 Buvidal patient numbers, a similar uptake as in 2020, and market expansion

• Uncertainty relating to Covid-19 impacts

•Expenses• Incremental R&D investments, including

in CAM2029 Phase 3 programs • Investments in market expansion for

Buvidal with launches in Wave 3 markets• Limited organizational expansion

29

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

Sweden

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

30

Shareholders

Shareholders as of 26 February 2021 Number of shares % of capital % of votes

Sandberg Development AB 22,000,692 40.6 40.6

Fjärde AP-fonden 3,330,676 6.1 6.1

Gladiator 2,833,100 5.2 5.2

Avanza Pension 1,783,876 3.3 3.3

Fredrik Tiberg, CEO 1,696,788 3.1 3.1

Svenskt Näringsliv 1,100,000 2.0 2.0

Didner & Gerge Fonder 1,015,219 1.9 1.9

Backahill Utveckling 826,491 1.5 1.5

Lancelot Avalon 719,038 1.3 1.3

Afa Försäkring 550,000 1.0 1.0

Cancerfonden 510,000 0.9 0.9

Camurus Lipid Research Foundation 505,250 0.9 0.9

State Street Bank and Trust 479,090 0.9 0.9

Enter fonder 457,561 0.8 0.8

Hamrins Stiftelse 425,000 0.8 0.8

Other shareholders 16,002,409 29.7 29.7

In total 54,235,190 100.0 100.0

Shareholder distribution

40.6%

5.6%6.1%

3.5%3.1%

2.0%

1,9%1.5%

1.4%1.0%

0,9%0.9%

1.2%

0.8%

0.8%

29.7%

31

Agneta SvedbergVice President, Clinical & Regulatory Development

In Company since: 2015Holdings:12,000 shares & 50,000 subscription warrants

Fredrik Tiberg, PhDPresident & CEOHead R&DIn Company since: 2002Holdings:1,696,788 shares & 165,000warrants

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:45,124 shares & 17,009 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 & 88,000 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:12,000 subscription warrants

Andrew McLeanVice President Corporate Dev.& Senior Counsel

In Company since: 2021Holdings: -

Experienced and committed management team

Peter HjelmströmChief Medical Officer

In Company since: 2016Holdings: -

32

~740,000 patients estimated suited for treatment with Buvidal in the EU and Australia

1EMCDDA 2018 Drug report 2https://www.aihw.gov.au/reports/alcohol-other-drug-treatment-services/nopsad-2018/contents/introduction%C2%A0 3Camurus estimate 4Benyamina et al 2013 Heroin Addiction and Related Clinical Problems 14 (4): 65-80. 5Camurus data on file 2018, Patient qualitative study. 6Based on average daily price of USD 10/day and 270 treatment days/patient/year

Buprenorphine treated1,2

Methadonetreated ≤30 mg1-3

New treatment journeys

12 months1

Not in treatment due to rules and burden of daily treatment1,4,5

Total potential

15 percent market penetration would correspond to annual sales of ~ SEK 3 billion66

33

Buvidal is well differentiated

Long-acting injection treatments for opioid dependence

*Based on information in product labels

PRODUCTWEEKLY 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 – 0.64 mL

EU, Australia

– – – –19G

–0.5 – 1.5 mL

– – – US, Canada, Australia

– – – –20G

–3.4 mL

– – – US

34

Study met primary endpoint demonstrating superiority for TSQM global satisfaction1

Compelling clinical evidence from head-to-head DEBUT study

•DEBUT – Depot Evaluation Buprenorphine Utilization Trial‒ Randomized, multi-site, open-label, active-controlled study

of Buvidal vs standard of care in 120 adult outpatients with opioid dependence to compare patient reported outcomes (PROs)

‒ Primary endpoint: patient reported TSQM† global satisfaction score

‒ Secondary endpoints (selected): other treatment satisfaction domains, treatment burden, quality of life, opioid related behaviors and general health outcomes

1. Lintzeris N, Dunlop A, Haber P, Lubman D, Graham R, Hutchinson S, Hjelmstrom P, Svedberg A, Peterson S, Tiberg F. Results of the DEBUT Study – A Multisite, Open-Label RCT of Weekly and Monthly Depot Buprenorphine Injections (CAM2038) Vs. Daily Sublingual Therapy Investigating Patient Reported Outcomes in Treatment of Opioid Use Disorder. Presented at The College on Problems of Drug Dependence, (CPDD) Virtual Meeting June 22-24, 2020. † Statistically significant p-value ≤ 0.05TSQM – Treatment satisfaction questionnaire for medication ; SL – sublingual; BPN – buprenorphine; SOC – Standard of Care

Day -28 to -1 Day 1 Week 24

Screening

Buvidal Weekly & Monthly flexible dosing

Follow-upperiod

Week 26

BPN SoCflexible dosing

n=120

R

Scheduled Visit Statistic Buvidal SL BPN SOC†Difference

(Buvidal - SL BPN)p-value

Baseline (Mean) 71.2 73.8 - -

Week 24 (LS Mean) 82.5 74.3 8.2 0.0143

Treatment period (LS Mean) 82.4 73.8 8.6 0.0016

w0 w12 w24

Side Effects Score

w0 w12 w24

Effectiveness Score

* *

40

50

60

70

80

90

100

w0 w12 w24

Mea

n T

SQ

M s

core

Global satisfactionscore

CAM2038SL BPN

* *

w0 w12 w24

Convenience Score

* *

Buvidal

Primary endpoint First secondary endpoints

35

•UNLOC-T – Safety and feasibility of depot buprenorphine in NSW custodial settings‒ Prospective, non-randomized, open-label, multicenter study in

129 OUD patients treated with Buvidal or methadone in 8 prisons

•Results1

‒ The safety profile pf Buvidal was satisfactory with most AEs being mild in severity and no severe treatment related AEs

‒ Treatment retention was high (81% at week 16)‒ Treatment costs with Buvidal was ~1/3 of daily methadone and

~1/10 of daily sublingual buprenorphine‒ Following the study, treatment with depot BPN in NSW prisons

has been expanded rapidly in Australia2

Further studies continue to expand the Buvidal evidence base

•ARIDE – Addiction recovery among opioid-dependent patients treated with injectable subcutaneous depot buprenorphine‒ Non-randomized prospective non-interventional

observational study with control group design (treatment-as-usual, TAU) performed in Germany3

‒ The primary objective is to evaluate quality of life. Secondary objectives include satisfaction, illicit substance use, social participation and cost-effectiveness.

‒ Patient recruitment started in 2020

1. Dunlop A et al. Introduction of Long-Acting Depot Buprenorphine in Prison - the UNLOC-T Study. Presented at The College on Problems of Drug Dependence, (CPDD) Virtual Meeting June 22-24, 2020 ; 2. Roberts J et al. Rapid upscale of depot buprenorphine (CAM2038) in custodial settings during the early COVID-19 pandemic in New South Wales, Australia. Addiction. 2020; Online ahead of print https://doi.org/10.1111/add.15244 there were >8003. Schulte B et al. U. Addiction recovery among opioid-dependent patients treated with injectable subcutaneous depot buprenorphine: Study protocol of a non-randomized prospective observational study (ARIDE) Front Psychiatry 2020; Online ahead of print https://doi.org/10.3389/fpsyt.2020.58086

Screening

Day 0 Day 1 Week 16 Week 48Week 4

Extended safetymonitoring

E

Buvidal weekly Buvidal monthly

n=1201

Methadone

Month 12

Screening

Buvidal weekly & monthly

TAUN=4261

A

Day 1

S


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