Second quarter results 2020
Audiocast presentation 16 July 2020 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 3
Agenda
• Second quarter 2020 overview Company participants • Buvidal progress in EU & Australia Fredrik Tiberg, PhD President & CEO, Head R&D • Pipeline update • Key take-aways Eva Pinotti Lindqvist • Revised Outlook 2020 Chief Financial Officer • Q&A Richard Jameson Chief Commercial Officer 4 Continued strong performance in the second quarter 2020
• Continued strong Buvidal sales growth and expansion to second-wave markets • Full-year 2020 net revenue guidance raised • Request for final approval of Brixadi™ submitted to, and accepted by, the US FDA • Arbitration process initiated in England • Recruitment in CAM2029 Phase 3 studies reinitiated after Covid-19 stall • Positive Phase 2 data for Rhythm’s once- weekly drug candidate for obesity disorders
o MSEK 300 raised in directed share issue 5
Financial overview second quarter 2020
Key figures Product sales by quarter
MSEK Q2 2020 (Q2 2019) H1 2020 (H1 2019) MSEK Apr-Jun Δ Jan-Jun Δ 80 75.8 Total revenues 80.9 (11.9) +579% 130.2 (30.4) +328% 70 +56% whereof product sales 75.8 (11.3) +568% 124.4 (22.3) +458% 60
OPEX 102.1 (120.1) -15% 219.4 (219.5) 0% 50 48.6
40 Operating result -23.3 (-109.8) +79% -100.3 (-194.2) +48% +60% 30 30.3 Result for the period -20.0 (-87.6) +77% -81.5 (-155.3) +48% +55% 20 19.5 Result per share, before 11.0 11.3 +73% and after dilution, SEK -0.39 (-1.70) +77% -1.58 (-3.32) +53% 10
Cash position 222.0 (283.1) -22% 222.0 (283.1) -22% 0 Q1 Q2 Q3 Q4 Q1 Q2
2019 2020 6 Opioid dependence – escalating global health crisis
• Largest society burden of all drugs1 Covid-19 causing spike in US opioid overdoses • 58 million opioid users worldwide1 +42% • High need for better access to care and new treatment alternatives +29% • Investment in treatment brings substantial +18% value and saves lives +16% • 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 US suspected overdoses per month during 2020 compared to the same month in 20192
1. United Nations: World drug report 2020; 2. Washington 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
Source: 1Buvidal Summary of Product Characteristics (SmPC), 2018 8
Continued strong growth of Buvidal
•Increasing market share Buvidal sales increased by >50% for the fourth consecutive quarter Approx. 9,500 patients in treatment with Buvidal Covid-19 highlights advantages of long-acting treatment • Catalyst for transition from daily to depot treatment in both outpatient and criminal justice settings, but also limits access to HCPs •Improved market access Reimbursement approved by Swedish TLV Expanded prescriber base in Australia Physician remuneration system changed in Germany •Expansion in second-wave markets initiated Buvidal launched in Austria in May 2020 Belgium, Netherlands, Iceland and Spain next on track Patients in early access programs in MENA region
* Measured by product sales 9 Regulatory progress with Buvidal® (Brixadi™)
•Camurus’ regulatory submissions •Braeburn preparing for US launch Market authorization applications Clear path to final market approval, under review in New Zealand and after FDA granting Citizen Petition in Switzerland Nov. 2019 Line-extension application for label Request for final FDA approval of the enhancements submitted to EMA NDA for Brixadi accepted by FDA with PDUFA date 1 Dec. 2020 •Availability of Buvidal in MENA All product requirements in place for a final approval Market authorization application by FDA final approval of Brixadi Medison under review in Israel expected 1 Dec 2020 – triggering a Early access programs and regulatory $35 million milestone payment to filings initiated with collaboration Camurus partner NewBridge Pharmaceuticals
1. Camurus’ press release 15 June 2020 https://mb.cision.com/Main/13456/3134723/1264520.pdf 10 Growing scientific evidence base for Buvidal Important publications1-6
Presentations at Scientific Conferences in 2020
2020
Q1 Q2 Q3 Q4
International ASAM CPDD AAAP Conferences 2-5 Apr 10-13 Dec Virtual 20-24 Jun San Antonio, USA Virtual ISAM 13-16 Nov Victoria, Canada
European IOTOD Nord Op Sym 24-25 Sept 1-2 Oct Conferences Virtual Uppsala, Sweden
ALBATROS 27-29 Oct Paris, France
National RCGP MDAP SFA Odensee Kon SIPaD RCGP H&J 30-31 Jan 12-13 Mar 6-7 Nov 11-13 Nov 25-26 Nov Conferences London, UK Paris, France Grundlsee, Aut Sorrento, Italy Newcastle, UK
Encephale Fin S Add Med SSA SEPD S Esp San Pen 22-24 Jan 5-6 Mar 5-6 Nov 15-17 Nov 19-21 Nov Paris, France Helsinki, Finland Newcastle, UK Seville, Spain Madrid, Spain
DGS konf Feder SerD J Sociodrog 30 Oct – 1 Nov 18-20 Nov 2-4 Dec 1Chappuy et al,Therapie. 2020 May 18:S0040-5957(20)30096-2; 2Hjelmström Berlin, Germany Rome, Italy Madrid, Spain et al, Drug Dev Ind Pharm 2020;46(1):1-7; 3Frost et al, Addiction, 2019;114(8):1416-1426, 4Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 5Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 6Albayaty et al, Adv Ther. 2017 34(2):560-575; 11 Compelling clinical evidence from head-to-head DEBUT study presented at CPDD
•DEBUT – Depot Evaluation Buprenorphine Study met primary endpoint demonstrating superiority Utilization Trial for TSQM global satisfaction1 Difference ‒ Randomized, multi-site, open-label, active-controlled study 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 satisfaction 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 Mean TSQM 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, 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 ≤ 0.05 TSQM – Treatment satisfaction questionnaire for medication ; SL – sublingual; BPN – buprenorphine; SOC – Standard of Care 12 Buvidal highly cost-effective in the UNLOCT-T study – further studies under way
•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 Germany 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 have expanded rapidly and now include over 640 patients
Buvidal weekly Buvidal monthly Buvidal weekly & monthly
Screening E Screening AS 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, White B, Roberts J, Haber P, Oldmeadow C, Searles A, Cretikos M, Mackson J, Attalla D, Kim S, Murrell T, Doyle M, McEntyre E, Brown L, Howard M, Lintzeris N. 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 13
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 14
Products and 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
Pipeline update second quarter 2020
•CAM2038 Chronic pain •CAM2029 Acromegaly, NET* & PLD* •CAM2043 PAH & Raynaud’s Pre-submission meeting held Recruitment in ACRO Phase 3 trials CTA granted Phase 2 study in with EMA Rapporteurs reinitiated after Covid-19 stall Raynaud’s phenomenon Product positioning & pricing Autoinjector development for clinical Study start delayed to H2 2020 MAA submission to EMA trials completed due to Covid-19 planned for H2 2020 Bridging PK study for autoinjector Preparations for pulmonary planned for H2 2020 arterial hypertension trial NET Phase 3 to start early 2021 ongoing Clinical program for treatment of PLD – new indication – to start Q4 2020
* NET – Neuroendocrine tumors; PLD – Polycystic liver disease 16 New potential indication for CAM2029: Polycystic liver disease (PLD) POTENTIAL PEAK SALES
• Up to 20% of patients with autosomal dominant polycystic $400 kidney disease (ADPKD) develop symptomatic PLD MILLION FOR CAM2029 IN PLD5 • PLD is a rare chronic disorder ‒ Estimated 37,000 target patients with symptomatic PLD in US and EU51 ‒ Continuous increase in the volume and the number of cysts in the liver only or in combination with cysts in the kidneys ‒ Symptoms associated with significantly impaired quality of life ‒ Patients managed in specialized centers ‒ No approved pharmacological treatment for symptomatic PLD ‒ Somatostatin analogues have shown efficacy in recent clinical studies: decreasing liver volume and associated symptoms and improving quality of life of patients with symptomatic PLD2-4
Sources: 1. Globe Life Sciences report 2020; data on file ; 2. Gevers TJ, et al., Liver Int. 2015 May;35(5):1607-14.; 3. Pisani A, et al., Clin Gastroenterol Hepatol. 2016 Jul;14(7):1022-1030.; 4. van Aerts R, et al., Gastroenterology. 2019 Aug;157(2):481-491.; 5. Globe Life Sciences report 2020 and Camurus’ estimate for EU, US and Australia 17
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) 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) 18
Progress in partnerships
•Rhythm collaboration •Ra Pharma collaboration Long-acting setmelanotide for Long-acting zilucoplan for treatment of treatment of genetic obesity disorders complement C5 mediated disorders Rhythm submitted NDA for daily License agreement signed July 2019 setmelanotide in POMC / LEPR UCB acquisition of Ra completed in deficiency – PDUFA date April 2020 1 27 November 2020 Preparations for clinical development Positive Phase 2 results for weekly ongoing depot (CAM4072) announced in Expected to enter start clinical 1 June 2020 development in H2 2020 • CAM4072 well tolerated • Achieved weight loss similar to daily formulation Discussion with FDA about the registration path for once-weekly setmelanotide
Source: 1Rhythm Corporate Presentation – June 2020. https://ir.rhythmtx.com/static-files/fd4e0919-4d82-47e0-afe3-8cd9b5151490 19 Strong results and news flow reported and anticipated during H2 2020
Announcement of strong Start CAM2029 Final market Buvidal demand during autoinjector approval of Q1 2020 bridging PK study Brixadi™ in the US
GPs allowed to prescribe Request for final MAA submission Long-acting Buvidal in Australia market approval to CAM2038 chronic zilucoplan clinical US FDA pain to EMA study start Buvidal launched in Austria Raised Start CAM2043 Results CAM2029 Buvidal reimbursed FY 2020 Phase 2 in Raynaud’s bridging PK study in Sweden guidance phenomenon autoinjector
CTA for Strong Phase 2 results Start Phase 2 IND CAM2029 CAM2043 Q1 report long-acting CAM2029 in PLD Phase 3 study in Phase 2 in RP setmelanotide NET 2020 H1 H2 Q12021 20
Key take-aways second quarter 2020
Financials Buvidal/Brixadi Pipeline progress Total revenues of SEK 80.9 million, Estimated 9,500 patients in Recruitment in CAM2029 Phase 3 up 579 % vs Q2 2019 treatment with Buvidal trials reinitiated after Covid-19 stall Product sales increased by 56% Buvidal launched in Austria in Additional indication for CAM2029, compared to previous quarter May 2020 polycystic liver disease (PLD) Full-year 2020 net revenue Request for final approval of Positive Phase 2 results for once- guidance raised Brixadi accepted by the US FDA weekly setmelanotide in Rhythm – PDUFA date 1 December 2020 collaboration 21
Revised Outlook 2020
• Full year revenue and sales guidance was raised 23 June 2020 •Financial Outlook 2020 • Stronger than expected sales of Buvidal in H1 2020 •Expected net revenues* • Main drivers of growth are: •SEK 340 - 380 million ‒ Improved market access •whereof product sales of ‒ Expansion into new markets ‒ Positive clinical data •SEK 310 - 340 million
• Operating expenses remain as previously communicated •Expected full year OPEX (including a provision for legal costs for the recently initiated SEK 570 - 610 million arbitration process in England) Third quarter report 5 November 2020 • *excluding the $35 million • milestone for final FDA approval of Brixadi™in the US Q&A 23
Shareholders
Shareholders as of 30 June 2020 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 22,200,692 43.0 43.0 Gladiator 3,758,334 7.3 7.3 Fjärde AP-fonden 3,330,676 6.5 6.5 Fredrik Tiberg, CEO 1,703,188 3.3 3.3 Avanza Pension 1,560,185 3.0 3.0 26.7%
Backahill Utveckling 1,176,491 2.3 2.3 0.7% 43.0% Svenskt Näringsliv 1,100,000 2.1 2.1 0.8% 0.8% Camurus Lipid Research Foundation 505,250 1.0 1.0 0.8% 0.9% Lancelot Asset Management 480,000 0.9 0.9 0,8% Nordnet Pensionsförsäkring 451,675 0.8 0.8 1.0% 6.5% 7.3% Enter fonder 437,561 0.8 0.8 2.1% 2.3% 3.0% 425,000 0.8 0.8 Hamrins Stiftelse 3.3% Grenspecialisten Förvaltning 420,870 0.8 0.8 Cancerfonden 380,000 0.7 0.7 Other shareholders 13,706,936 26.7 26.7 In total 51,636,858 100.0 100.0 24
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 Chief Commercial Officer Biological Sciences from University West of Vice President, Clinical & England Regulatory Development In Company since: 2016 Previous experience: GM, UK & Nordics for Reckitt In Company since: 2015 Holdings: 20,490 shares & Benckiser (2010 – 2013) and Area Director Europe, Holdings: 11,341 shares & 80,000 warrants Middle East and Africa for Indivior (2013 – 2016). 75,000 subscription warrants