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Page 1: Audiocast presentation - Camurus · This presentation contains forward- looking statements that provide our expectations or ... Uppsala, Sweden. SAD. 5-6 Nov Uppsala, Sweden. Fin

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First quarter results 2020

Audiocast presentation7 May 2020

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Forward looking statements

This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance.

Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases.

Camurus undertakes no obligation to update forward-looking statements

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Agenda

• First quarter 2020 overview

• Buvidal progress in EU & Australia

• Pipeline update• Key take-aways• Q&A

3

Fredrik Tiberg, PhDPresident & CEO, Head R&D

Eva Pinotti LindqvistChief Financial Officer

Company participants

Richard JamesonChief Commercial Officer

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Promising first quarter results

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• Accelerated Buvidal uptake delivers strong sales performance

• Continued pipeline progress

• New commercial and R&D collaborations

• Operational excellence across all teams

• Agility and resilience in a challenging and uncertain time

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MSEK 2020 Jan-Mar

2019 Jan-Mar % Δ

Total revenues 49.3 18.5 167%

whereof product sales 48.6 11.0 343%

OPEX 117.3 99.4 18%

Operating result -76.9 -84.4 9%

Result for the period -61.6 -67.6 9%

Result per share, before and after dilution, SEK -1.19 -1.62 27%

Cash position 291.3 406.6 -28%

Financials Quarterly product sales 2019/2020

60

50

40

30

20

10

0

Financial overview

MSEK

20202019

+60%

48.6

Q1 Q2 Q3 Q4 Q1

30.3

19.5

11.311.0

Total revenuesSEK 49.3 million+167%

Product salesSEK 48.6 million+343%

OPEXSEK 117.3 million+18%

Q1

5

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Pipeline

• Recruitment in Phase 3 acromegaly studies temporarily stalled at most sites

• Focus shifted to other time-critical activities, including autoinjector development and new R&D programs

• Phase 2 study start for CAM2043 postponed to H2 2020

Limited negative impact of Covid-19

6

Business operations

• Operations according to plan

• Supply chain largely unaffected

• Situation closely monitored to ensure supply to clinics and patients

• Uncertainty of long-term impact

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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

Source: 1Buvidal Summary of Product Characteristics (SmPC), 2018

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Accelerating uptake of Buvidal

Launched in 7 markets in 2019 7,500 patients in treatment with Buvidal

at the end of March 2020– 90% increase quarter to quarter

Covid-19 highlights Buvidal advantages; catalyst for uptake

Market leader position in Finland and Norway*

Rapid growth in Australia with 3,000 patients on Buvidal end of March

Increasing uptake in Sweden, Germany, UK and Denmark

Increasing use in the criminal justice system

Wide media coverage of Buvidal

10,000

8,000

6,000

4,000

2,000

0

+88%

20202019

Increasing number of patients

Q2 Q3 Q4 Q1Q1

Estimated # patients in treatment with Buvidal at end of quarter

7,500

4,000

2,500

1,300

500

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* Measured by product sales

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Australia GPs allowed to prescribe

Buvidal from 1 April 2020

Norway Outreach services allowing

patient access to Buvidal to mitigate risk of spreading Covid-193

Scotland Government announced

£1.9m budget to support people in prison on OST to switch to Buvidal1

Germany Physician remuneration

system modified to balance reimbursement for different products4

Key access limitations addressed, the foundation for continued growth

9

Wales Wales’ Health Minister

support treatment with long-acting buprenorphine during the ongoing Covid-19 crisis2

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://sykepleien.no/2020/04/leverer-lar-medisiner-pa-dora?cid=sm7786262328; 4. https://www.kbv.de/html/1150_45794.php;

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Market expansion in Wave 2 countries

Benelux >22,000 patients in opioid

dependence treatment1

Preparation for launch

Austria >18,000 patients in opioid

dependence treatment1

Launch ready for Q2 2020

Spain >58,000 patients in

opioid dependence treatment1

Preparation for launch

Italy ~70,000 patients in opioid

dependence treatment1

Pricing and reimbursement discussions

Launch sequenceWave 1 markets Wave 3 marketsWave 2 markets Wave 4 markets

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France >179,000 patients in

opioid dependence treatment1

Final regulatory discussion with authorities

1. European Drug Report 2019, EMCDDA

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Global strategy for Buvidal (Brixadi)

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REGION PARTNER NO OF PATIENTS PEAK MARKET POTENTIAL

EUAustralia

~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 (Israel)

>300,000WITH OPIOID DEPENDENCE6

€25-75 million5

Source: 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;

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Regulatory progress with Buvidal (Brixadi)

New regulatory filings Market authorization application

submitted to the Swiss Agency for Therapeutic Products (Swissmedic)

Market authorization application under review in New Zealand

12

Braeburn preparing for US launch Clear path to final market approval,

after FDA granting Citizen Petition in Nov 2019

Final FDA approval date 1 Dec 2020

All product requirements in place for a successful launch

Braeburn preparing for launch soon after FDA approval

Availability of Buvidal in MENA region Early access programs and

regulatory filings initiated with collaboration partner NewBridgePharmaceuticals

First patients treated with Buvidal

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Growing evidence base for Buvidal

Planned conferences where Buvidal will be presented in 2020

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Key publications1-5

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

2020

Q1 Q2 Q3 Q4

Global Conferences

European Conferences

National Conferences

ASAM2-5 AprVirtual

ALBATROS27-29 Oct

Paris, France

SSA5-6 Nov

Newcastle, UK

K f Suchtmed2-4 Jul

Munich, Germany

DGS konf30 Oct – 1 Nov

Berlin, Germany

CPDD20-24 Jun

Virtual

F Add Psych23-24 Apr

Birmingham, UK

SIPaD18-20 Nov

Sorrento, Italy

ISAM13-16 Nov

Victoria, Canada

IOTOD24-25 Sept

Amsterdam, NL

AAAP10-13 Dec

San Antonio, USA

FederSerDTBD

Napoli, Italy

RCGP MDAP30-31 Jan

London, UK

Encephale22-24 Jan

Paris, France

SFA12-13 Mar

Paris, France

APSAD15-18 Nov

Brisbane, Aus

S Esp San PenTBD

Madrid, Spain

SEPD11-13 June

Seville, Spain

Subforum9-10 May

Mondsee, Aut

Nord Op Sym1-2 Oct

Uppsala, Sweden

SAD5-6 Nov

Uppsala, Sweden

Fin S Add Med5-6 Mar

Helsinki, Finland

LAR konf15-16 Oct

Oslo, Norway

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Generation of real-world evidence

‒ Non-randomized prospective non-interventional observational study with control group design (treatment-as-usual, TAU) performed in Germany

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

‒ Study started in March 2020

ARIDE – Addiction recovery among opioid-dependent patients treated with injectable subcutaneous depot buprenorphine

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‒ Randomized, open-label, active-controlled study of Buvidal vs standard of care in 120 adult outpatients with opioid dependence

‒ Study met primary and secondary endpoints, e.g. showing superior treatment satisfaction by patients

‒ Accepted for presentation at College on Problems of Drug Dependence, CPDD, in June 2020

DEBUT – Depot Evaluation Buprenorphine Utilization Trial

‒ Prospective, non-randomized, open-label, multicenter study in 129 OUD patients treated with Buvidal or methadone in eight prisons.

‒ Met primary and secondary endpoints ‒ Accepted for presentation at College on Problems of

Drug Dependence, CPDD, in June 2020

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

ARIDE

Day 1 Month 12

Screening

Buvidal weekly & monthly

TAUN=4261

A

Day 1

Screening S

NEW

* Sponsor ARIDE study Centre for Interdisciplinary Addiction Research of Hamburg University (ZIS), Department of Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

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Products and pipeline

15

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

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CAM2038 Chronic pain

Pre-submission meeting held with EMA Rapporteurs

Product positioning & pricing studies under completion

Regulatory submission to EMA planned for third quarter 2020

Pipeline update first quarter 2020

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CAM2043 PAH* & Raynaud’s

Granted clinical trial application for Phase 2 study in Raynaud’s phenomenon

Study start moved to H2 2020

Preparations for Phase 2 study in pulmonary arterial hypertension ongoing

CAM2029 Acromegaly & NET*

Ongoing recruitment in ACRO Phase 3 trials – stalled at most clinics due to Covid-19

NET registration program aligned with KOL’s and authorities

Autoinjector development accelerated. Bridging PK study to start Q2-Q3

* NET – Neuroendocrine tumors; PAH – Pulmonary arterial hypertension

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Rhythm collaborationLong-acting setmelanotide for treatment of genetic obesity disorders

Positive Phase 3 data announced for daily setmelanotide in POMC / LEPR deficiency August 20191

Phase 1b clinical milestone achieved‒ Plasma half-life ~120 hours2

‒ Good tolerability

Phase 2 study under completion

Top-line results expected in 2020

Progress in partnerships

17

Ra Pharma collaborationLong-acting zilucoplan for treatment of complement C5 mediated disorders

License agreement signed July 2019

Preparations for clinical development ongoing

Expected to enter start clinical development in H2 2020

Early stage collaborations

Two new research collaborations with international pharmaceutical companies initiated during the first quarter 2020

Source: 1Press release Rhythm Pharmaceuticals 7 August 2019; 2Rhythm Corporate Presentation – January 2020 https://ir.rhythmtx.com/static-files/38f3b5c8-4b34-4fde-935a-2d041bf20696;

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Key take-aways first quarter 2020

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Strong revenue growth

Total revenues of SEK 49.3 million, an increase of 167 % vs Q1 2019

Product sales were SEK 48.6 million, an increase of 343% vs Q1 2019

Product sales increased by 60% compared to previous quarter

Buvidal uptake accelerating

Estimated 7,500 patients in treatment with Buvidal

GPs allowed to prescribe Buvidal in Australia from 1 April 2020

Market authorization application submitted in Switzerland

Pipeline progress

Pre-submission meeting for CAM2038 chronic pain held with EMA rapporteur

Clinical trial application granted for long-acting treprostinil, CAM2043

Two new early stage research collaborations with international pharmaceutical companies initiated

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Outlook 2020 – revenues in the higher interval

Financial Outlook 2020

Expected net revenues*SEK 290 - 330 millionwhereof product sales ofSEK 240 - 280 million

Expected full year OPEXSEK 570 - 610 million

*excluding the $35 million milestone for final FDA approval of Brixadi™in the US

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Camurus’ update on guidance • Full year revenues in the higher end of the interval

— Main drivers of growth are: increasing Buvidal market shares, improved access, expansion into new market and positive clinical data

• Operating costs according to plan —Tracking below but expected to increase as the situation with Covid-19

normalizes and Phase 3 clinical activities are fully resumed

• Next scheduled financial update is 16 July 2020 (Q2 report)

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Q&A

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Shareholders

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Shareholders as of 30 April 2020 Number of shares % of capital % of votesSandberg Development AB 22,200,692 43.0 43.0

Gladiator 3,859,713 7.5 7.5

Fjärde AP-fonden 3,330,676 6.5 6.5

Fredrik Tiberg, CEO 1,703,188 3.3 3.3

Avanza Pension 1,533,263 3.0 3.0

Backahill Utveckling 1,176,491 2.3 2.3

Svenskt Näringsliv 1,100,000 2.1 2.1

Camurus Lipid Research Foundation 505,250 1.0 1.0

Enter fonder 437,561 0.8 0.8

Nordnet Pensionsförsäkring 431,221 0.8 0.8

Carl-Olof och Jenz Hamrins Stiftelse 425,000 0.8 0.8

Grenspecialisten Förvaltning 420,870 0.8 0.8SEB Investment Management 347,872 0.7 0.7Lancelot Asset Management 328,000 0.6 0.6

Other shareholders 13,837,061 26.8 26.8

In total 51,636,858 100.0 100.0

Shareholder distribution

43,0%

7,5%6,5%

3,3%

3,0%2,3%

2,1%

1,0%

0,8%0,8%0,8%0,8%

0,7%

0,6%

26,8%

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Agneta SvedbergVice President, Clinical & Regulatory Development

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

Experienced and committed management team

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Fredrik Tiberg, PhDPresident & CEO

In 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, Institute for Surface Chemistry (Section head), Visiting Professor at Oxford University,

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 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