Company presentation
January 2021 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
Corporate highlights
Rapidly growing commercial Broad late-stage pipeline stage company • +10 innovative clinical programs in • Fully operational infrastructure in Europe addiction, pain, oncology, endocrine and Australia disorders and CV diseases • Buvidal® to date available in 14 countries • Two ongoing Phase 3 studies • Strong growth of product sales • Advancing early stage opportunities
Market approvals Unique FluidCrystal® Partnerships Experienced Weekly and monthly nanotechnologies R&D collaborations, management ® Buvidal for opioid • New generation long-acting licensing and royalty and dedicated dependence depot technology arrangements with teams • Validated in +25 clinical trials pharma and biotech and by approved products companies
LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP ~ SEK 10 billion EMPLOYEES: 136 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney 5 Camurus‘ FluidCrystal® long-acting release technology has unique properties
Easy and convenient administration Adopted to prefilled syringes and autoinjectors Rapid onset & long-acting release Manufacturing by standard processes Applicable across substance classes Strong intellectual property
Injection of liquid formulation Encapsulating Slow release . Drug release and conc using prefilled H2O liquid crystal gel of drug biodegradation of
syringe or triggered by blood gel matrix to full
autoinjector water uptake drug resolution time
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. 6
FluidCrystal – Long-acting release
Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071)
10 10 Pasireotide IR 600 ug (SC Pasireotide FluidCrystal 20 thigh, n = 94) mg (SC thigh, n = 12)
1 1 pasireotide plasma concentration (ng/mL) concentration plasma pasireotide pasireotide plasma concentration (ng/mL) concentration plasma pasireotide 0,1 0,1 0 7 14 21 28 0 7 14 21 28 Time (days) Time (days) 7 Camurus had a successful 2020 despite the challenges
• Strong revenue growth, pipeline advancement and building of shareholder value • Established the significant value Buvidal brings to patients, HCPs, payors and society – as best-in-class treatment • Demonstrated successful commercialization of an innovative medicine across our markets 2020 guidance raised during the year • Expanded into new markets Expected FY net revenues • Accelerated recruitment in two Phase 3 studies of CAM2029 in acromegaly SEK 340 - 380 million, and prepared start of pivotal programs in additional indications whereof product sales SEK 310 – 340 million • Positive Phase 2 results for weekly setmelanotide for treatment of genetic Expected FY OPEX obesity with Rhythm SEK 505 – 525 million • Progress in our early R&D pipeline laid the ground for new value-adding clinical programs 8 Opioid dependence – escalating global health crisis
• Largest society burden of all drugs1 Escalating overdose deaths • 58 million opioid users worldwide1
• High need for better access to care 1 200 and new treatment alternatives 1 000 • Investment in treatment brings substantial 800 value and saves lives 600 • Significant limitation with current daily medications 400 ‒ Diversion, misuse, risk of overdose, poor retention, 200 burdens and stigma of daily buprenorphine and methadone medications 0
Opioid related deaths in Scotland over the last 10 years2
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 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
“For me, Buvidal is a Buvidal provides significant benefits to patients and society revelation. I know that as ‒ Improved treatment outcomes and patient satisfaction1-3 long as I stay on Buvidal ‒ Reduced treatment burden and improved quality of life2 I’ve got a chance” ‒ Diminished diversion, misuse and pediatric exposure4 Sophie, Buvidal patient in Wales ‒ Reduced treatment costs in the criminal justice system5
1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Frost et al, Addicti on, 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. Introduc ti on of Long-Acting Depot Buprenor phi ne in Prison - the UNLOC-T Study. Presente d at CPDD Virtual Meeting June 22-24, 2020 10
Strong growth of Buvidal in EU and Australia
Increasing market shares Product sales by quarter
‒ Largest markets (Australia, Finland and Norway) MSEK 100 continue to expand 94.3 ‒ Growth accelerating in the UK, Germany, 90 80 Sweden, Denmark, Austria, and Belgium 75.8 ‒ Impacts of Covid-19 have been relatively limited 70 and effectively addressed 60 Estimated more than 12,000 patients in 50 48.6 Buvidal treatment end of September 2020 40 30 30.3
Buvidal now available in 14 countries 20 19.5
‒ 12 countries in Europe and Australia, 10 11.0 11.3
latest launch Spain 0 ‒ 2 countries in MENA with Early Access Programs Q1 Q2 Q3 Q4 Q1 Q2 Q3 2019 2020
* Measured by product sales 11
Global strategy for Buvidal (Brixadi™)
REGION PARTNER NO OF PATIENTS MARKET POTENTIAL
EU ~1.3 million ~€300 million2 Australia LAUNCH INITIATED IN 2019 HIGH-RISK OPIOID USERS1
North >2 million $0.6-1.2 billion4, 5 America DIAGNOSED WITH OPIOID USE DISORDER IN THE US3
Middle East 5 & North >300,000 €25-75 million WITH OPIOID DEPENDENCE6 Africa EARLY ACCESS PROGRAMS INITIATED IN 2020
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 12 Regulatory progress and market expansion
•New approval •Braeburn receives CRL in the US CAM2038 Chronic pain Market authorization approval by On the PDUFA date 1 Dec. 2020, Pre-submission meeting Swissmedic in December 2020 Braeburn received a complete held with EU Rapporteur response letter (CRL) from the FDA •Regulatory filings regarding the NDA for Brixadi™ for Regulatory submission Line-extension applications and label treatment of opioid use disorder to EMA planned in 2021 enhancements with EMA and TGA The CRL was related to quality Market authorization application, MAA, deficiencies identified in a pre-approval under final review in New Zealand inspection of Braeburn’s third party manufacturer •Availability of Buvidal in MENA Resolution of manufacturing issue, MAAs submitted in several MENA NDA resubmission and review by FDA countries – priority review granted in • Estimated 2 or 6-month NDA review Saudi Arabia period after resubmission Early access programs ongoing in three countries 13 Significant opportunity in mid- to late-stage pipeline
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 1) Braeburn holds the rights to North America 2) Developed by Rhythm Pharmaceuticals under a CAM4071 Endocrine disorders worldwide license to FluidCrystal® CAM2047 CINV3) 3) CINV – Chemotherapy-induced nausea and vomiting CAM2048 Postoperative pain1)
Medical device episil® Oral liquid
Own approved medicines License collaborations Own product candidates 14
CAM2029 – long-acting subcutaneous octreotide in Phase 3 development
•Innovative medicine in late-stage development for rare pitituary and neurendocrine disorders and tumors •Designed for enhanced efficacy and patient convenience 15 CAM2029 opportunity addresses key unmet medical needs in the SSA market
•Somatostatin analogues (SSAs) are •CAM2029 offers simplified dosing and first-line medical therapy in possibility of self-administration •US$ 2.8 billion acromegaly and NET ‒ Ready-to-use prefilled syringe or •CURRENT SSA autoinjector for enhanced convenience with MARKET VALUE3 •But there are significant limitations option for self-administration with current SSA treatments •Potential for improved biochemical mUSD ‒ Difficult handling & administration and symptom control SSA annual sales 3000 ‒ Sub-optimal treatment result ‒ Fast onset and long-acting release Somatuline® Autogel® 2500 with 500% higher bioavailability vs Sandostatin® LAR® 2000 octreotide LAR1 1500 Sandostatin® LAR® (octreotide): 1000 ‒ Well maintained or improved biochemical and symptom control indicated with 500 CAM2029 in acromegaly and NET patients2 0
Somatuline® Autogel® (lanreotide): CAM2029:
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 16 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
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)
1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-472; 2Pavel M et al, Cancer Chemotherapy and Pharmacology 2019; 83: 375-383. 17 Phase 2 pilot study indicates good or improved symptom control in NET patients
Pharmacokinetics in NET patients Flushing and diarrhea in NET patients
Steady-state pharmacokinetic profiles 100 Oct-LAR CAM2029 2 CAM2029 20mg q4w NET patients ss
day Bowel movements OCT LAR 30mg q4w NET patients ss Flushings 1,5 10 symptoms/ 1
1 number
mean 0,5 Plasma OCT conc (ng/mL)
0,1 Monthly 0 0 7 14 21 28 Day -28 - Day 0 Day 0- Day 28 Day 28 - Day 56 Day 56 - Day 84 Time (days)
Analysis of data from Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019; 83(2): 375–385 GH, growth hormone; IGF-1, insulin-like growth factor 1; LAR, long-acting release; NET, neuorendocrine tumors 18 Study also indicates well-maintained or improved biochemical control with CAM2029 in acromegaly
IGF-1 in acromegaly patients Growth hormone (GH) in acromegaly patients
Oct-LAR CAM2029 Oct-LAR CAM2029 250 8
200 6
150 1.3xULN 4 ULN 100 ULN
2 50 GH concentration (mg/mL)
0 0 Time weighted average (% of ULN) Day -28 - Day 0 Day 0 - Day 28 Day 28 - Day 56 Day 56 - Day 84 Day -28 - Day 0 Day 28 Day 56 Day 84
Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 1 Patient 2 Patient 3 Patient 4 Patient 5
Analysis of data from Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019; 83(2): 375–385 GH, growth hormone; IGF-1, insulin-like growth factor 1; LAR, long-acting release; NET, neuorendocrine tumors 19 Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly
•Efficacy trial (HS-18-633) •Long-term safety study (HS-19-647) ‒ Phase 3, randomized, double-blind, placebo-controlled, ‒ Phase 3, open-label, single arm, multi-center trial to multi-center trial to assess efficacy and safety of CAM2029 assess the long-term safety of CAM2029 ‒ Regulatory requirements for efficacy data met ‒ ≥ 100 patients exposed to CAM2029 for 12 months ‒ 78 patients, full SSA responders • Roll-over patients from HS-18-633 and ‒ Primary endpoint: Proportion of patients with mean IGF-1 • ‘New patients’ (partial SSA responders, irradiated patients, levels ≤ 1x upper limit of normal (ULN) at w22 and w24 and full SSA responders) ‒ Primary endpoint: Characterization of adverse events
HS-18-633 CAM2029 once monthly HS-19-647 Open-label treatment phase
Screening R Screening Roll-over patients Placebo once monthly from HS-18-633 New patients N=70 Prior treatment N=70 with octreotide N=78, 2:1 Prior treatment or lanreotide with octreotide Rescue with standard of care CAM2029 once monthly or lanreotide
4 - 8 Weeks Day 1 Double-blind treatment phase Week 24 4 - 8 Weeks Day 1 Week 24 Week 52 20 NET Phase 3 program aligned with the FDA and EMA
IND submitted to FDA after Type B meeting • 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 initiation early 2021
HS-19-657 CAM2029
Primary endpoint Option to switch to CAM2029 PFS (Progression Screening R (if primary endpoint met) Survival follow-up Free Survival) Active comparator
Day 1 Treatment period Follow-up period
* GEP – gastroenteropancreatic; NET – neuroendocrine tumors 21
CAM2029 study program overview
Regulatory Four clinical trials ACRO Phase 3 PC submissions completed in ACRO healthy subjects ACRO Phase 3 LTSE and patients characterizing PK, PD and safety NET Phase 3 profile (N=249) NET IND submitted PLD Phase 2
Autoinj. PK
2019 2020 2021 2022
ACRO Phase 3 PC ACRO Phase 3 LTSE NET Phase 3 PLD Phase 2 Autoinjector PK Randomized, double- Open-label, long-term Active controlled Phase 3 Placebo-controlled PK bridging study of blind, placebo- safety study in partial study in patients with Phase 2 study in prefilled syringe and controlled study in and full responders metastatic, well differen- patients with polycystic autoinjector devices SSA responders tiated GEP-NET liver disease (PLD) 22 Significant market potential expected for CAM2029
Acromegaly (US+EU5) NET (US+EU5) PLD (US+EU5) Recent GlobalData report:
$1,015m
$415m $245m $720m $720m $180m $145m $180m $435m $485m $265m $120m $240m $60m November 2020 Profile 1 Profile 2 Profile 3 Profile 1 Profile 2 Profile 3 Currently no approved products “Top selling drug to enter the market will Profile 1 Profile 2 Profile 3 be Camurus' CAM2029 is available as a pre-filled syringe Available both as PFS and as an Available both as PFS and as an Octreotide LA” (PFS) device with non-inferi or efficacy to autoinjector, with non-inferior efficacy autoinjector, with data suggesting current long-acting SSAs, with an assumed to current long-acting SSAs and an superior efficacy over current long- penetration of 10–20% in acromegaly, and assumed penetration of 20–25% acting SSAs, and an assumed higher Estimates US$210m 10–15% in NET penetration of 30–35% US+EU5 sales in 2029 in acromegaly
1Globe Life Sciences reports 2019 and 2020; data on file 23
Progress in Rhythm collaboration
Weekly setmelanotide (CAM4072) Positive Phase 2 data announced1
12
Long-acting setmelanotide for treatment ) mL of genetic obesity disorders / ( ng Daily setmelanotide in POMC / LEPR 9 deficiency approved by the FDA on 6 27 November 20201 Concentration
3
Positive Phase 2 results for weekly Through depot (CAM4072) announced in June Mean 20202 0 1 2 3 4 5 6 7 8 9 10 11 12 • CAM4072 well tolerated Week • Achieved weight loss comparable to daily formulation over 12 weeks QD-3mg QW-10mg QW-20mg QW-30mg Discussion with FDA about the Mean through drug concentrations for registration path for once-weekly 20mg and 30mg doses of CAM4072 similar setmelanotide to 3mg daily dose
1 https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceut icals-announces-fda-approval-imcivreet m; 2Rhythm Corporate Presentation – November 2020. https://ir.rhythmtx.com/static-f iles /fd4e0919-4d82-47e0-af e3-8cd9b5151490 24
Strong news flow during 2020/21 – selected events
Announcement Start CAM2029 Start CAM2029 Buvidal third wave of strong Buvidal autoinjector Phase 3 study market expansion demand bridging PK study in NET Start Phase 2 CAM2029 in PLD Raised Publication of Completion of Phase 3 FY 2020 DEBUT and MAA submission efficacy study of guidance UNLOC-T data CAM2038 chronic pain CAM2029 in acromegaly
Phase 2 results Start Phase 2 study of Buvidal EU/AUS Start new in-house long-acting CAM2043 in Raynaud’s line extension clinical program setmelanotide phenomenon approvals Brixadi US approval Arbitration Braeburn receives process initiated CRL for Brixadi™ Results CAM2029 Phase 2 results by Braeburn in the US autoinjector PK study CAM2043 in Raynaud’s
2020 2021 H1 H2 25 Multiple levers for growth and value creation on short and medium term
® Buvidal / Brixadi™ Pipeline Corporate Establish leadership in opioid Late-stage development and new Continue to build our dependence treatment regulatory approvals in chronic commercial infrastructure with Buvidal in Europe, Australia pain, acromegaly and NET and launch new products and MENA Grow our pipeline of innovative Develop sustained profitability US regulatory approval of Brixadi medicines and expand the use of through own sales, partnerships, and continued RoW expansion of our FluidCrystal technology in business development and M&A Buvidal areas of high unmet need and market potential 26
Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden
P +46 46 286 57 30 │ [email protected] │ camurus.com 27
Experienced and committed management team
Fredrik Tiberg, PhD Education: M.Sc. in Chemical Engineering, PhD in Fredrik Joabsson, PhD Torsten Malmström, PhD President & CEO Physical Chemistry, Lund University Chief Business Development Chief Technical Officer Officer Head R&D Previous experience: Professor in Physical In Company since: 2002 Chemistry at Lund University, Visiting Professor at In Company since: 2001 In Company since: 2013 Holdings: 1,696,788 shares Oxford University, Institute for Surface Chemistry Holdings: 45,463 shares & Holdings: 45,363 shares & & 165,000warrants (Section head) 35,000 subscription warrants 8,000 subscription warrants
Eva Pinotti-Lindqvist Education: Bachelor’s of Science in Economics, Annette Mattsson Andrew McLean Chief Financial Officer Lund University Vice President, Regulatory Vice President Corporate Affairs Dev.& Senior Counsel Previous experience: EQL Pharma (CFO), Nordic In Company since: 2014 Drugs (Nordic Market Analyst), Poolia (Finance In Company since: 2017 In Company since: 2021 Holdings: 45,124 shares & Consultant) Holdings: 12,000 subscription Holdings: - 17,009 warrants warrants
Richard Jameson Education: Bachelor’s of Science in Applied Agneta Svedberg Peter Hjelmström Chief Commercial Officer Biological Sciences from University West of Vice President, Clinical & Chief Medical Officer England Regulatory Development In Company since: 2016 Previous experience: GM, UK & Nordics for Reckitt In Company since: 2015 In Company since: 2016 Holdings: 20,490 shares & Benckiser (2010 – 2013) and Area Director Europe, Holdings: 12,000 shares & Holdings: - 88,000 warrants Middle East and Africa for Indivior (2013 – 2016). 50,000 subscription warrants 28
Shareholders
Shareholders as of 30 December 2020 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 22,200,692 40.8 40.8 Fjärde AP-fonden 3,330,676 6.2 6.2 Gladiator 3,095,142 5.7 5.7 Avanza Pension 1,873,132 3.5 3.5 Fredrik Tiberg, CEO 1,653,188 3.1 3.1 29.6% Svenskt Näringsliv 1,100,000 2.0 2.0 40.8%
Backahill Utveckling 826,491 1.5 1.5 0.8% Lancelot Asset Management 682,779 1.3 1.3 0.8% 0.9% Afa Försäkring 550,000 1.0 1.0 0.9%0.9% Cancerfonden 520,000 1.0 1.0 1.0% 1.0% 6.2% Camurus Lipid Research Foundation 505,250 0.9 0.9 5.7% 1.3% 2.0% Nordnet Pensionsförsäkring 462,732 0.9 0.9 3.5% 1.5% 3.1% Didner & Gerge Fonder 461,151 0.9 0.9 Enter fonder 457,561 0.8 0.8 Hamrins Stiftelse 425,000 0.8 0.8 Other shareholders 15,978,555 29.6 29.6 In total 53,922,349 100.0 100.0 29
Financial overview third quarter 2020
Key figures Q3 Q1-Q3 MSEK Jul – Sep Jan – Sep 2020 (2019) Δ 2020 (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% 30 ~740,000 patients estimated suited for treatment with Buvidal in the EU and Australia
Buprenorphine Methadone New treatment Not in treatment due to Total potential treated1,2 treated 30 mg1-3 journeys rules and burden of 12 months1 daily treatment1,4,5 ≤ 15 percent market penetration would correspond to annual sales of ~ SEK 3 billion66
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 31
Buvidal is well differentiated
Long-acting injection treatments for opioid dependence
CHOICE OF ROOM CLIN. DATA WEEKLY MONTHLY MULTIPLE SMALL LOW DAY ONE PRODUCT INJECTION TEMP. VS ACTIVE LAUNCHED DOSING DOSING DOSES NEEDLE VOLUMES INITIATION SITES STORAGE CONTROL*
EU, Australia 23G 0.16 – 0.64 mL
US, Canada, Australia – – – 19G– 0.5 ––1.5 mL – – –
US – – – 20G– 3.4– mL – – –
*Based on information in product labels 32 Compelling clinical evidence from head-to-head DEBUT study
•DEBUT – Depot Evaluation Buprenorphine Study met primary endpoint demonstrating superiority Utilization Trial for TSQM global satisfaction1 Randomized, multi-site, open-label, active-controlled study Difference ‒ Scheduled Visit Statistic Buvidal SL BPN SOC† p-value of Buvidal vs standard of care in 120 adult outpatients with (Buvidal - SL BPN) opioid dependence to compare patient reported outcomes Baseline (Mean) 71.2 73.8 - - (PROs) Week 24 (LS Mean) 82.5 74.3 8.2 0.0143 ‒ Primary endpoint: patient reported TSQM† global satisfaction score Treatment period (LS Mean) 82.4 73.8 8.6 0.0016 ‒ Secondary endpoints (selected): other treatment satisfaction domains, treatment burden, quality of life, Primary endpoint First secondary endpoints opioid related behaviors and general health outcomes Global satisfac tion Convenience Effectiveness Side Effects score Score Score Score 100 Buvidal Weekly & Monthly CAM2038Buvidal flexible dosing 90 SL BPN * * * * * 80 * Screening R Follow-up period 70 60 n=120 BPN SoC 50
flexible dosing MeanTSQM score 40 w0 w12 w24 w0 w12 w24 w0 w12 w24 w0 w12 w24 Day -28 to -1 Day 1 Week 24 Week 26
1. Lintzeris N, Dunlop A, Haber P, Lubma n D, Graham R, Hutchi ns on S, Hjelmstrom P, Svedber g A, Peterson S, Tiberg F. Results of the DEBUT Study – A Multisite, Open-La bel RCT of Weekly and Monthl y Depot Buprenor phi ne Injections (CAM203 8 ) Vs. Daily Sublingual Therapy Investiga ti ng Patient Reporte d Outcome s in Treatme nt of Opioid Use Disorder. Presente d at The College on Problems of Drug Depende nc e, (CPDD) Virtual Meeting June 22-24, 2020. † Statistically significant p-value ≤ 0.05 TSQM – Treatment satisfaction questionnaire for medication ; SL – sublingual ; BPN – buprenor phi ne ; SOC – Standar d of Care 33 Further studies continue to expand the Buvidal evidence base
•UNLOC-T – Safety and feasibility of depot •ARIDE – Addiction recovery among opioid- buprenorphine in NSW custodial settings dependent patients treated with injectable ‒ Prospective, non-randomized, open-label, multicenter study in subcutaneous depot buprenorphine 129 OUD patients treated with Buvidal or methadone in 8 prisons ‒ Non-randomized prospective non-interventional 1 observational study with control group design •Results (treatment-as-usual, TAU) performed in Germany3 The safety profile pf Buvidal was satisfactory with most AEs ‒ ‒ The primary objective is to evaluate quality of life. being mild in severity and no severe treatment related AEs Secondary objectives include satisfaction, illicit ‒ Treatment retention was high (81% at week 16) substance use, social participation and cost- ‒ Treatment costs with Buvidal was ~1/3 of daily methadone and effectiveness. ~1/10 of daily sublingual buprenorphine ‒ Patient recruitment started in March 2020 ‒ Following the study, treatment with depot BPN in NSW prisons has been expanded rapidly in Australia2
Buvidal weekly Buvidal monthly Buvidal weekly & monthly
Screening E Screening SA Methadone Extended safety TAU monitoring 1 n=1201 N=426
Day 0 Day 1 Week 4 Week 16 Week 48 Day 1 Month 12
1. Dunlop A et al. Introduc ti on of Long-Acting Depot Buprenor phi ne in Prison - the UNLOC-T Study. Presente d at The College on Proble ms of Drug Depende nc e, (CPDD) Virtual Meeting June 22-24, 2020 ; 2. Roberts J et al. Rapid upscale of depot buprenor phi ne (CAM203 8 ) 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. Addicti on recovery among opioid-dependent patients treated with injectable subcuta ne ous depot buprenor phi ne: Study protoc ol of a non-randomi zed prospecti ve observati onal study (ARIDE) Front Psychiatry 2020; Online ahead of print https://doi . or g/ 10. 3389/ fps yt. 2020. 58086