Company presentation
Jefferies Virtual London Healthcare Conference 18 November 2020 Presented by Fredrik Tiberg, President & CEO 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
Company profile
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 launched in 10 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 11 billion EMPLOYEES: 130 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney 5
Recent highlights
• Strong improvement of results driven by Buvidal sales growth in EU and Australia since 2019 launch • Brixadi™under review by FDA for final US approval 1 December 2020 • Two ongoing Phase 3 studies of CAM2029 in Positive 2020 outlook acromegaly Expected FY net revenues1 SEK 340 - 380 million • Pivotal Phase 3 study of CAM2029 in NET aligned Expected FY OPEX2 with FDA SEK 505 – 525 million
1. Excluding the $35m milestone for final FDA • Positive Phase 2 results for weekly setmelanotide approval of Brixadi™ in he US 2. Without regards to the outcome of the ongoing • MSEK 300 raised in directed share issue arbitration process • Arbitration process with Braeburn1
1Camurus press release 15 June 2020 https://mb.cision.com/Main/13456/3134723/1264520.pdf 6 Opioid dependence – escalating global health crisis
• Largest society burden of all drugs1 Covid-19 causing spike in opioid overdoses in the US • 58 million opioid users worldwide1 • High need for better access to care +42% and new treatment alternatives +29% • Investment in treatment brings substantial value and saves lives +16% +18% • Significant limitation with current daily medications -0.3% ‒ Diversion, misuse, overdosing, poor retention, burdens and stigma of daily buprenorphine and Jan Feb Mar Apr May methadone medications Increase of suspected overdoses per month during the pandemic compared to the same month in 20192
1United Nations: World drug report 2020; 2Washington Post https://www.washingtonpost.com/health/2020/07/01/coronavirus-drug- overdose/ and ODMAP 7
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
1Buvidal Summary of Product Characteristics (SmPC), 2018 8 Buvidal provides significant benefits to patients and society
• Improved treatment outcomes and patient satisfaction1-3 • Decreased treatment burden and stigma2 • Diminished diversion, misuse and pediatric exposure4 • Reduced treatment costs in the criminal justice system5
“CAM2038 compared to my previously prescribed sublingual buprenorphine treatment” “For me, Buvidal is a Much better 83% revelation. I know that as Slightly better POSITIVE long as I stay on Buvidal 2 About the same N=133 I’ve got a chance”
Slightly worse Sophie, Buvidal patient in Wales
Much worse
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 9
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 10
Strong growth of Buvidal in EU and Australia
Increasing market share Product sales by quarter ‒ Largest markets (Australia, Finland and Norway) continue to expand MSEK 100 ‒ Growth accelerating in the UK, Germany and Sweden 94.3 ‒ Covid-19 challenges with prescription authorizations 90 80 in Austria, lockdown of parts of Australia, and 75.8 protracted pricing and reimbursement processes 70 Estimated more than 12,000 patients in 60 treatment with Buvidal at the end of September 50 48.6 40 Buvidal now available in 12 countries 30 30.3 ‒ 10 countries in Europe and Australia 20 19.5 ‒ 2 countries in MENA with Early Access Programs 10 11.0 11.3 ‒ 2 additional EU launches expected before year end 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2019 2020
* Measured by product sales 11 Regulatory progress and market expansion
•Regulatory filings •Braeburn preparing for US launch CAM2038 Chronic pain Pre-approval received by Swiss Request for final FDA approval of the Pre-submission meeting Agency for Therapeutic Products NDA for Brixadi accepted by FDA held with EU Rapporteur (Swissmedic) with PDUFA date 1 Dec. 2020 Market authorization application FDA final approval of Brixadi expected Regulatory submission under final review in New Zealand 1 Dec 2020 – triggering a $35 million to EMA delayed to early 2021 Line-extension applications and label milestone payment to Camurus enhancements with EMA and TGA •Availability of Buvidal in MENA region Early access programs and regulatory filings initiated with collaboration partner NewBridge Pharmaceuticals Growing patient numbers 12
Significant opportunity for Brixadi in the US
•US opioid crisis continues to grow •Brixadi aligned with current treatment ‒ Nearly 50,000 fatal opioid overdoses in paradigm 1 the US in 2018 ‒ Flexibility on posology and doses expected to ‒ Increasing opioid overdoses during Covid resonate with established prescription patterns5 2 pandemic ‒ Day 1 treatment initiation and multiple choice of injection sites •US opioid use disorder epidemiology:
Brixadi™ Monthly 10.3m misusing opioids3 28 days+ 34% 7 days Rx Rx 40% most common 3.9m prevalence of OUD4
annual buprenorphine or 1.4m naltrexone patients5 26% Brixadi™ 8–27 days Rx Weekly / Monthly
1https://www.cdc.gov/drugoverdose/data/statedeaths.html; 2https://www.ama-assn.org/system/files/2020-10/issue-brief-increases-in-opioid-related-overdose.pdf; 3https://www.samhsa.gov/data/report/2018-nsduh-detailed-tables ; 4https://www.soa.org/globalassets/assets/files/resources/research-report/2019/econ-impact-non-medical-opioid-use-pdf; 5Symphony Health Patient Source 13 Expanding the evidence base through investigator sponsored studies
Study Country Investigator Type Est. patient numbers Status Understanding NSW Long-acting Opioids in Custody- Australia Prof Dunlop Two-arm, case- 129 (Buvidal 67) Reporting Treatment (UNLOC-T) (NSW Government) comparison study Patient experiences of long-acting SC injectable depot Australia Prof Lubman Qualitative interviews 30 Reporting buprenorphine (post-DEBUT qualitative study) (Monash Univ) (retrospective) Addiction recovery of opioid dependent patients treated with Germany Prof Schulte Non-interventional 426 (Buvidal 213) Ongoing injectable subcutaneous depot buprenorphine (ARIDE) (ZIS Hamburg) study Exploring the potential of long-acting buprenorphine therapy Scotland Prof Matheson Qualitative interviews 30 Ongoing in vulnerable people who use drugs and are homeless (Univ of Stirling) (prospective) Emergency department-initiated buprenorphine and USA Prof Gail D’Onofrio, RCT, open-label 2000 (Brixadi 1000) Ongoing validation network trial (NCT04225598) Yale Medication treatment for OUD in expectant mothers USA Prof Theresa Winhusen, RCT, open-label 300 (Brixadi 150) Ongoing (NCT04212065) University of Cincinnati A comparative effectiveness trial of XR Naltrexone vs USA Dr Michael Gordon, RCT, open-label 240 (Brixadi 120) Ongoing XR-BUP with individuals leaving jail (NCT04408313) Friends Research Inst. Exemplar Hospital Initiation Trial to Enhance Treatment USA Prof Gavin Bart, RCT, open-label 314 (Brixadi 157) Starting Engagement (NCT04345718) Hennepin Healthcare Optimizing Retention, Duration and Discontinuation USA Prof Edward Nunes, RCT, open-label 1630 (Brixadi 650) Starting Strategies for OUD Pharmacotherapy (NCT04464980) Columbia University Σ >2,400 Buvidal/Brixadi patients 14 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 15
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 16 CAM2029 opportunity addresses key unmet medical needs in the SSA market
•Potential for response rates in acromegaly and NET patients ‒ Fast onset and long-acting release ‒ ~ 500% higher bioavailability vs octreotide LAR1 •CAM2029 offers simplified dosing and possibility of self-administration ‒ Ready-to-use prefilled syringe or autoinjector for self-administration and enhanced patient convenience ‒ No need for burdensome clinic visits for dosing
CAM2029 advantages CAM2029 Sandostatin® LAR (octreotide) Somatuline® Depot (lanreotide) Convenient device Pre-filled syringe Powder vial + pre-filled syringe Pre-filled syringe Autoinjector with diluent solution + vial adapter SSA market size + injection needle Thin needle 22G 12.5mm 20G 40mm 18G 20mm US$ 3billion Administration route Subcutaneous Intramuscular, after reconstitution Deep subcutaneous, after in six steps conditioning in 20193 Storage Room temperature Refrigerated, bring to room Refrigerated, conditioning at room temperature between 30 – 60 temperature for at least 30 minutes minutes before reconstitution before injection Flexible administration Self-administration option Administration by trained Administration by healthcare healthcare provider2 provider2 US$ 1.6 billion global sales in 20193 US$ 1.3 billion global sales in 20193
1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2US label; 3Global Data 2020 17 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 end-point: 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 end-point: 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 18
NET Phase 3 program aligned with the FDA
Meeting held with the US FDA to align on the pivotal study program for CAM2029 in NET • Planned Phase 3 study design ‒ Randomized, multicenter, open-label, parallel-group, active-controlled trial • To assess the superiority of treatment with CAM2029 compared to octreotide LAR or lanreotide ATG on progression free survival in patients with metastatic/inoperable, well-differentiated GEP-NET* ‒ Study planned to early 2021 with expected completion in 2024
HS-19-657 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 19
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) FDA advisory meeting NET 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) 20
Reported and anticipated news flow during 2020/21
Announcement of strong Start CAM2029 Results CAM2029 Buvidal demand during autoinjector bridging PK study Q1 2020 bridging PK study autoinjector
GPs allowed to prescribe Request for final Start Phase 2 study of MAA submission CAM2038 Buvidal in Australia market approval to CAM2043 in Raynaud’s chronic pain to EMA US FDA phenomenon Buvidal launched in Austria Raised Start Phase 2 Completion FY 2020 Final market approval CAM2029 in of Phase 3 Buvidal reimbursed guidance of Brixadi™ in the US PLD efficacy in Sweden study of CAM2029 in CTA for Arbitration Phase 2 results Outcome of IND CAM2029 acromegaly CAM2043 process initiated long-acting arbitration Phase 3 study Phase 2 in RP by Braeburn setmelanotide process in NET
2020 H1 H2 2021 21 Multiple levers for growth and value creation on short and medium term
® Buvidal / Brixadi™ Pipeline Corporate • Establish leadership in opioid • Late-stage development and • Continue to build our dependence treatment new regulatory approvals in commercial infrastructure with Buvidal® in Europe and chronic pain, acromegaly and and launch new products Australia NET • Achieve sustained profitability • Approval and launch of Brixadi™ in • Grow our pipeline of innovative through own sales, partnerships the US and continued RoW market medicines and expand the use of and business development expansion with Buvidal our FluidCrystal® technology in areas of high unmet need and • Continue develop our strong market potential financial position 22
Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden
P +46 46 286 57 30 │ [email protected] │ camurus.com 23
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% 24
Shareholders
Shareholders as of 31 October 2020 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 22,200,692 41.4 41.4 Gladiator 3,433,078 6.4 6.4 Fjärde AP-fonden 3,330,676 6.2 6.2 Avanza Pension 1,733,024 3.2 3.2 Fredrik Tiberg, CEO 1,703,188 3.2 3.2 28.5% Svenskt Näringsliv 1,100,000 2.0 2.0 41.4%
Backahill Utveckling 867,153 1.6 1.6 0,8% Lancelot Asset Management 600,000 1.1 1.1 0.8% State Street Bank and Trust 553,616 1.0 1.0 0.8% 0.9%0.9% Afa Försäkring 550,000 1.0 1.0 1.0% 1.0% 6.4% Camurus Lipid Research Foundation 505,250 0.9 0.9 6.2% 1.1% 2.0% Nordnet Pensionsförsäkring 474,642 0.9 0.9 3.2% 1.6% 3.2% Enter fonder 457,561 0.8 0.8 Hamrins Stiftelse 425,000 0.8 0.8 Grenspecialisten 420,870 0.8 0.8 Other shareholders 15,282,108 28.5 28.5 In total 53,636,858 100.0 100.0 25
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:1,703,188 shares Oxford University, Institute for Surface Chemistry Holdings:45,463 shares & Holdings:45,363 shares & & 220,000 warrants (Section head) 35,000 subscription warrants 8,000 subscription warrants
Eva Pinotti-Lindqvist Education: Bachelor’s of Science in Economics, Annette Mattsson Urban Paulsson Chief Financial Officer Lund University Vice President, Regulatory Vice President Corporate Affairs Dev.& General Counsel Previous experience: EQL Pharma (CFO), Nordic In Company since: 2014 Drugs (Nordic Market Analyst), Poolia (Finance In Company since: 2017 In Company since: 2017 Holdings:45,363 shares & Consultant) Holdings:375 shares & 25,000 Holdings:8,125 shares & 22,891 warrants subscription warrants 115,000 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:11,341 shares & Holdings: - shares & - warrants 80,000 warrants Middle East and Africa for Indivior (2013 – 2016). 75,000 subscription warrants 26
Global strategy for Buvidal (Brixadi™)
REGION PARTNER NO OF PATIENTS PEAK 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 US PDUFA DATE 1 DEC 2020 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 27
Significant peak market potential for CAM2029
Acromegaly (US+EU5) NET (US+EU5) PLD (US+EU5)
$1,015m
$415m $245m $720m $720m $180m $145m $180m $435m $485m $265m $120m $240m $60m
Profile 1 Profile 2 Profile 3 Profile 1 Profile 2 Profile 3 Currently no approved products
Profile 1 Profile 2 Profile 3 CAM2029 is available as a pre-filled syringe (PFS) Available both as PFS and as an autoinjector, with Available both as PFS and as an autoinjector, with device with non-inferior efficacy to current long- non-inferior efficacy to current long-acting SSAs data suggesting superior efficacy over current long- acting SSAs, with an assumed penetration of and an assumed penetration of 20–25% acting SSAs, and an assumed higher penetration of 10–20% in acromegaly, and 10–15% in NET 30–35%
1Globe Life Sciences reports 2019 and 2020; data on file 28
Braeburn arbitration
•Camurus announced on 15 June that Braeburn has initiated arbitration proceedings in England1 ‒ Camurus previously served a notice of material breach questioning Braeburn’s performance primarily relating to: • Preparations for regulatory approval and commercialization of Brixadi/CAM2038 for OUD in Canada • Preparations for a separate earlier launch of Brixadi weekly product for the treatment of OUD in the US • Preparations for regulatory approval and commercialization of Brixadi for the treatment of chronic pain ‒ Braeburn has disputed the validity of the material breach notice ‒ The license agreement stipulates a 90 days arbitration process • The license agreement remain in full force and effect during the arbitration process •Possible outcomes ‒ If the Tribunal finds that Braeburn is in material breach: • Camurus will be entitled (subject to a 60-day cure period) to terminate the agreement and regain all rights granted to Braeburn ‒ If the Tribunal finds that Braeburn is not in material breach: • The license agreement will remain in full force and effect
1 Camurus press release 15 June 2020 https://mb.cision.com/Main/13456/3134723/1264520.pdf