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Q2 2019 Results 18 July, 2019

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Page 1: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Q2 2019 Results

18 July, 2019

Page 2: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Forward-looking statements

This presentation contains forward-looking statements that provide our expectations or forecasts of future events such as new product developments and regulatory approvals and financial performance. Camurus is providing the following cautionary statement. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements

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Page 3: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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Agenda

Fredrik TibergPresident & CEO, Head R&D

Eva Pinotti LindqvistChief Financial Officer

Second quarter highlights

Buvidal® launch in the EU and Australia

R&D update

Key take-aways

Q&A

Participants

Page 4: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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Camurus in brief

Listed on Nasdaq STO; ticker CAMXMarket Cap: ~ SEK 3.5 billionCash position: ~ SEK 283 million (Q2 ‘19)Employees: 117 HQ: Lund, SwedenRegional Offices: Cambridge, Mannheim, Paris, Sydney

Unique FluidCrystal®nanotechnologies

Own commercial organization

Approved commercial products

Partnerships

Experienced management and dedicated teams

• In-house developed with strong IP • New generation long-acting depot technology• Validated in 20 clinical trials and by approved products

• Launching Buvidal® in Europe and Australia

• Weekly and monthly Buvidal® approved in the EU and Australia for treatment of opioid dependence

• Braeburn, Rhythm, Ra Pharmaeuticals, SolasiaPharma, Medison

Broad, late-stage R&D pipeline

• 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV

Page 5: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Financial overview Q2/H1 2019

5

• Patients treated with Buvidal® increased from ~ 500 to 1,300 across 150 clinics

• Buvidal® launch expanded to Australia and Norway

• Positive reimbursement decisions in key markets

• Phase 3 study of CAM2029 in acromegaly initiated

• GMP manufacturing of CAM2029 IMP completed and released

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

• Fast track 180 days procedure granted for Buvidal® in Israel

• Buvidal® Phase 3 long-term safety results published in Addiction

• License agreement with Ra Pharma for long-acting formulation FluidCrystal® zilucoplan for complement C5 mediated disease

Q2 2019 highlights

MSEK Q2 H2

Net revenue 11.9 (7.3) 30.4 (22.0)

Product sales 11.3 (2.9) 22.3 (5.9)

Op. result -109.8 (-81.2) -194.2 (-127.6)

Result after tax -87.6 (-67.5) -155.3 (-103.8)

Cash 283.1 (199.1)

Q2

Q3

Reiterated 2019 FY guidance Net revenue MSEK 130–160, whereof product sales MSEK 70–90

Page 6: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Buvidal® launch gaining momentum

Buvidal®/Brixadi™ (CAM2038)

Page 7: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

• 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

7

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

INTERNAL USE ONLY. NOT TO BE CONSIDERED BRIEFING MATERIAL FOR REPRESENTATIVES.Source: Buvidal Summary of Product Characteristics (SmPC), 2018

Page 8: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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 Q3 2019 to Q2 2020• Pricing and reimbursement applications • Key functions onboarded

8

Buvidal® launch in EU & Australia gaining momentum1

Launch initiated in all Wave 1 markets ‒ Finland, Sweden, UK, Germany, Denmark,

Norway and Australia• Positive pricing and reimbursement decisions

in key markets, including Australia and Norway • Fully operational teams – 65 heads• Effective supply and distribution

– within 24 hours delivery to clinic

Page 9: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

• Expansion into new markets ‒ Launches initiated in Australia and Norway in Q2‒ Wave 2&3 markets from Q3 2019

• Successful HTA review processes‒ Positive reimbursement decisions and recommendations

in Q2, incl. in Norway and Australia

• Formulary inclusion and funding release‒ 38 formularies in the UK and 25 formularies 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‒ Not reflected in sales due to initial stock-up in Q1‒ Primary barrier is market access

• Reimbursement and formulary listings

• Significant potential in the custodial setting ‒ Buvidal® introduced in 10 correctional facilities in the EU‒ UNLOC-T study progressing in Australia

Drivers of growth Experiences from initial launch markets

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Key takeaways from initial launch markets

HTA: Health Technology Assesment

Page 10: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Finland

POPULATION

5.5 million

HIGH RISK OPIOID USERS1

~14,000IN TREATMENT FOR

OPIOID DEPENDENCE1

~3,300~2,100 ~1,200BUPREN. METHADONE

Status June 2019 Observations

10

~ 490 Buvidal® patients, 60 clinics‒ New to treatment ‒ Conversion from sublingual

buprenorphine, both from film and tablets

‒ Conversions from methadone

> 20% buprenorphine market share

~ 15% of total treated patients

• High initial retention‒ less than 25 patients (<5%)

dropped out since launch

• High acceptance by patients

• Most patients still on weekly depot

• Initial use in criminal justice setting

• Efficacy, misuse and diversion are the main reasons for starting treatment with Buvidal®

Update on Finland – first launch market

Source: 1. EMCDDA 2019, European Drug Report

Page 11: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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-studies published6

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

CO

NFI

DEN

TIAL

11

NEW

Page 12: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Buvidal® scientific communication and data dissemination – strong presence driven by KOL’s

2019Q1 Q2 Q3 Q4

Global Conferences

European Conferences

National Conferences

ASAM4-7 Apr

Orlando, USA

ALBATROS5-7 Jun

Paris, France

SSA7-8 Nov

Newcastle, UK

ICDD19-22 Jun

Madrid, Spain

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K f Suchtmed4-6 Jul

Münich, Germany

Selected conferences where Buvidal® data will be presented

Gef-med T5-6 Dec

Frankfurt, Germany

IOTOD13-14 May

Frankfurt, Germany

Lisbon Add23-25 Oct

Lisbon, Portugal

CPDD15-20 Jun

San Antonio, USA

F Add Psych30 Apr – 1 May

London, UK

ISAM13-16 Nov

New Delhi, India

APSAD10-13 Nov

Hobart, Australia

ATHS1-4 Oct

Biarritz, France

Page 13: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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

‒ 60 adult prisoners treated with Buvidal® compared with 60 matched cases of methadone treated patients

‒ Primary objective to test safety and tolerability, diversion and HEOR

‒ Secondary objectives to compare efficacy and QoL

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

‒ 120 adult outpatients have been randomized 1:1 to CAM2038 vs SL BNX. LPLV Sept. 2019

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

The Depot Evaluation Buprenorphine Utilization Trial (DEBUT)

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

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Continuing building the evidence base

DEBUT

Day -28 to -1 Day 1 Week 24

Screening

SC CAM2038 q1w or q4w at flexible doses

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 14: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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From other drugs

Opioid overdose

Opioid dependence – escalating global health crisis

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

of a 3-year exclusivity period until 30 November 2020 –unless earlier resolved

• Brixadi™ Weekly not blocked by exclusivity and can be approved and launched separately

• Braeburn has initiated court proceedings to overturn exclusivity and seeks immediate market approval of Brixadi™ in the US

• Court hearing at the United States District Court in District of Columbia held on July 15, 2018

• Decision expected later in Q3• Camurus eligible to $35 million on approval of Brixadi®

weekly and monthly depots for treatment of OUD

Source: 1. UNODC, World Drug Report 2017; 2. Center for Disease Control & Prevention 2018; 3. Frazier at al, 2017, Journal of the American Medical Association; 4. Crow D. Financial Times.com, accessed on March 13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da 14

Mounting US opioid overdose deaths2

(thousands)

#1 cause of death for people under 50 in the US30:1 non-fatal to fatal overdoses3

Recent US life expectancy decline largely due to opioids4

Page 15: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Pipeline update

15

Page 16: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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Broad late-stage clinical pipeline

16

CAM2048/58 POSTOPERATIVE PAIN & PONV4 - BRAEBURN1

Buvidal® q1w OPIOID DEPENDENCE

CAM2038 q1w CHRONIC PAIN1

CAM2029 ACROMEGALY

CAM4072 GENETIC OBESITY DISORDERS - RHYTHM2

CAM2043 PULMONARY ARTERIAL HYPERTENSION

Brixadi® q1w OPIOID DEPENDENCE - BRAEBURN1

CAM2047 CINV3

Brixadi® q4w OPIOID DEPENDENCE - BRAEBURN1

Buvidal® q4w OPIOID DEPENDENCE

CAM2038 q4w CHRONIC PAIN1

CAM2029 NEUROENDOCRINE TUMORS

CAM2032 PROSTATE CANCER

CAM4071 UNDISCLOSED INDICATION

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

PHARMACEUTICALS 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

PHASE 1

Page 17: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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CAM2038 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 being compiled• Meetings with health authorities in H2 2019• Regulatory submissions planned for H1 2020

Source: 1. Global Industry Analysts, Inc. report 2011; 2. Pain Practice 2014, 14, 79-94; 3. Chronic Lower Back Pain (CLBP). Market Insights, Epidemiology, and Market Forecast-2028, Delveinsight, May 2019. 4. Gaskin 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 18: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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CAM2029 – Phase 3 study initiation

Market opportunity

• Somatostatin analogue sales 2018: >USD 2.6 billion1

• 20 years of market growth at 20% CAGR• Long-acting SSA US price-range: $51,000 to $146,000 WAC / year2

Medical need addressed

• Enhanced efficacy and response rates in treatment of acromegaly and pain • Easy and convenient dosing, with self-administration option

Key clinicalresults

• Long-acting octreotide release demonstrated3

• High octreotide exposure3

• Rapid and sustained suppression of insulin growth factor-1 (IGF-1)3

• Well maintained or improved biochemical control indicated in patients with acromegaly4

• Well maintained or improved symptom control indicated in NET patients4

Next steps • 24-week, randomized, placebo controlled Phase 3 study to assess efficacy and safety of CAM2029 in patients with acromegaly

• 52-week, open-label Phase 3 safety and tolerability study of CAM2029 in patients with acromegaly

Source: 1. GlobalData 2019; 2. US weighted average cost for mid-range doses, 20183. Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 4. Pavel M et al, Cancer Chemotherapy and Pharmacology 2019; 83:375–385

02505007501000125015001750200022502500Somatuline® (Ipsen)

Sandostatin® LAR®(Novartis)

mUSD

Page 19: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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CAM2029 ACRO Phase 3 program design

The primary objective is to assess the superiority of CAM2029 compared to placebo in biochemical response for IGF-1. The safety and tolerability of CAM2029 will also be assessed, together with patient-reported treatment satisfaction and health-related quality of life parameters

Prior treatment withoctreotide LAR

Prior treatment withlanreotide ATG

CAM2029 once monthly

Placebo once monthly

Rescue with standard of care

Screening phase 4-8 wks Double-blind treatment phase 24 wks

R

New patientsPrior treatment with

octreotide LARor lanreotide ATG

Roll-over patients from trial HS-18-633

CAM2029 once monthly CAM2029 once monthly

24 Weeks 28 Weeks

Screening phase 4-8 wks Open-label treatment phase

Randomized, double-blind phase 3 study of CAM2029 vs. placebo control (HS-18-633)

Open-label phase 3 long‐term safety study (HS-19-647)

Page 20: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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Plans for continued development of CAM2029 for treatment of acromegaly

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

2019 20212020 2022

Open label, long-term safety study

ACRO Phase 3 LTSE

Placebo controlled (PC) Phase 3 study in SSA responders

ACRO Phase 3 PC Regulatory submissions

Page 21: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

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

CAM4083: Complement-mediated disorders CAM4072: Genetic disorders of obesity

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• 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 demonstrated

• Preparations for clinical development ongoing

• Program conducted by Ra Pharmaceuticals under license agreement with Camurus

• 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 progressing

• Program conducted by Rhythm Pharmaceuticals under license agreement with Camurus

Progress in partnerships

Page 22: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Key take-aways – second quarter 2019

Buvidal® / Brixadi™

• Buvidal® launch initiated and expanded into new markets• Patients in treatment with Buvidal® grew from ~500 to 1,300 at 150 clinics• Improved access through price and reimbusement approvals in key markets • Court proceedings in the US with decision expected in Q3 2019

Pipeline • Pivotal Phase 3 program for CAM2029 in acromegaly initiated • Preparation of ”pre-submission” meetings with HAs for CAM2038 in chronic pain• Phase 2 study of weekly setmelanotide by Rhythm in the US • License agreement with Ra Pharma for FluidCrystal® depot of zilucoplan

Financials • Net revenues of MSEK 11.9 (7.3), whereof MSEK 11.3 (2.9) from product sales• Expected full year revenue of MSEK 130-160, with products sales of MSEK 70-90• Cash position end of Q2 MSEK 283.1

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Page 23: Q2 2019 Results - Camurus · 2019. 7. 18. · R&D pipeline • 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV . ... 2015. 2016. 2017. From other

Q&A

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