Camurus Ab · OMXSTO:CAMX
Camurus Ab — Investor Presentation (October 2022)
32 slides from Camurus Ab's investor presentation, October 2022
Slide 1: Company presentation October 2022
Company presentation October 2022
Slide 2: Forward looking statements
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-lo
Slide 3: Long-acting medications addressing key healthcare challenges
3 Long-acting medications addressing key healthcare challenges
Slide 4: Camurus snapshot
4 Camurus snapshot Rapidly growing commercial Strong financial stage company performance Leader in opioid dependence treatment Entering profitability in 2022 with Buvidal weekly and monthly depots Advancing late-stage pipeline Unique FluidCrystal® with blockbuster potential technology platform Prosp
Slide 5: Significant recent progress
5 Significant recent progress Strong financial performance Commercialization execution Pipeline advancement High double-digit year-on-year Leader in long-acting opioid Successful life-cycle management revenue growth dependence treatment in the EU Key programs in registration Profitability
Slide 6: Positive financial development
6 Positive financial development •Revenues1 •Operating results1 MSEK MSEK 1000 400 FY 2022 outlook2 800 200 Total revenue1 SEK 900 to 950 million 600 0 Product sales1 400 SEK 875 to 925 million -200 Operating results 200 SEK -20 to +40 million 0 -400 2019 2020 2021 2022 2019 2020 2021 2022 1Forecast
Slide 7: Leading FluidCrystal extended-release technology
7 Leading FluidCrystal extended-release technology Easy and convenient administration Adopted to prefilled syringes and prefilled pens Rapid onset & long-acting release Manufacturing by standard processes Applicable across substance classes Strong intellectual property Injection of liqui
Slide 8: FluidCrystal – Long-acting release
8 FluidCrystal – Long-acting release Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071) pasireotide plasma concentration (ng/mL) pasireotide plasma concentration (ng/mL) 10 10 Pasireotide IR 600 ug (SC Pasireotide FluidCrystal 20 thigh, n = 94) mg (SC thigh, n = 12) 1 1 0,
Slide 9: Weekly and monthly buprenorphine depots
9 Weekly and monthly buprenorphine depots Population pharmacokinetic profiles for Buvidal vs sublingual buprenorphine Weekly Buvidal vs. Daily sublingual buprenorphine Weekly vs. Monthly Buvidal Population PK model analysis based on data from four clinical studies (N=236). Diagnostic testing demonst
Slide 10: Opioid dependence – escalating global health crisis
10 Opioid dependence – escalating global health crisis Escalating opioid overdose deaths •Largest society burden of all drugs1 US: 100 000 Number of deaths in the US All drugs ‒ 61 million opioid users worldwide1 80 000 ‒ Opioid crisis worsened during COVID-19 pandemic Opioids 60 000 •High need for
Slide 11: Buvidal – game changing opioid dependence treatment
11 Buvidal – game changing opioid dependence treatment Weekly and monthly, subcutaneous buprenorphine for individualized treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1 Demonstrated benefits to patients and
Slide 12: Buvidal sales growth underscores potential
12 Buvidal sales growth underscores potential •Continued strong sales performance •Quarterly product sales ‒ 12 consecutive quarters with double digit growth MSEK ‒ Estimated 30,000 patients in treatment at the end of Q2 250 2020 2021 2022 225 •Strengthening market leadership in established markets
Slide 13: Focus on commercial execution
13 Focus on commercial execution •Launched markets with full access ‒ Facilitating patient uptake • Educating on informed choice and the growing scientific evidence • Ensuring Buvidal offered as a first line treatment option •Launched markets with restrictions ‒ Addressing funding needs and barriers
Slide 14: Substantial growth potential in MENA
14 Substantial growth potential in MENA •Large unmet need1 Buvidal in MENA ‒ Large untreated populations ‒ Early access programs three markets ‒ Future challenging problems to MENA countries ‒ New approvals in Saudi Arabia and Egypt – first ‒ Estimated >3 million opioid users2 and approved treatment
Slide 15: Significant opportunity for Brixadi in the US
15 Significant opportunity for Brixadi™ in the US •High unmet medical need • Brixadi well positioned against competition ‒ Opioid use disorder (OUD) is a health crisis in the US1 ‒ 10 million Americans misuse opioids1 LAI features ‒ 3 million people diagnosed with OUD1 Weekly dosing – – •Opportuni
Slide 16: Buvidal label extension to chronic pain
16 Buvidal label extension to chronic pain •Market authorization applications under review in EU and Australia — CHMP opinion expected in Q4 2022 — TGA approval decision expected H1 2023 •High unmet medical need in chronic pain management — Especially among patients with or high risk of opioid depen
Slide 17: Broad and diversified mid- to late-stage pipeline
17 Broad and diversified mid- to late-stage pipeline Phase 1 Phase 2 Phase 3 Registration CAM2043 CAM2029 CAM2029 Brixadi™ Pulmonary arterial Polycystic liver disease Acromegaly Opioid use disorder (US)1 hypertension CAM2047 CAM2032 CAM2029 CAM2038 Chemotherapy-induced Prostate cancer Gastroenteropa
Slide 18: CAM2029 targeting 3-billion dollar SSA market
18 CAM2029 targeting 3-billion dollar SSA market •Established treatment, with limitations Annual sales of first generation SSAs1 ‒ First generation somatostatin analogs (SSAs) mUSD 3000 regarded as safe and effective ‒ First-line treatment of acromegaly and 2500 neuroendocrine tumors (NET) 2000 ‒ Li
Slide 19: CAM2029 developed in three rare diseases
19 CAM2029 developed in three rare diseases “I do not want to have to live my life circled around my disease” •CAM2029 has potential significant benefits Laura, patient, acromegaly, US ‒ Enhanced octreotide exposure ~500% increase vs. octreotide LAR ‒ Ready-to-use with no need for reconstitution or
Slide 20: CAM2029 extensive clinical program
20 CAM2029 extensive clinical program NDA/MAA ACRO Phase 3 RCT approval decisions ACRO NDA/MAA ACRO Phase 3 LST approval decisions NET GEP-NET Phase 3 RCT ”SORENTO” PLD Phase 2b RCT ”POSITANO” Phase 3 continuation TBD Prefilled pen PK bridge -2022 2023 2024 2025 2026 ACRO Phase 3 RCT ACRO Phase 3 LS
Slide 21: Significant market potential for CAM2029
21 Significant market potential for CAM2029 •Attractive opportunity GlobalData report5 ‒ Highly concentrated target audiences ‒ Differentiated product properties ‒ Switch opportunity from established first-line treatments • CAM2029 peak sales estimates from third party market research1-4 PATIENT EST
Slide 22: CAM2029 recent and upcoming milestones
22 CAM2029 recent and upcoming milestones ACRO NET PLD Completed enrollment H2 2022 Start SORENTO Phase 3 trial Orphan drug designation (US) Topline Phase 3 Est. enrollment completion New PROs developed and efficacy results H1 2023 H1 2023 aligned with FDA NDA and MAA submissions Com
Slide 23: Preparing for CAM2029 commercialization
23 Preparing for CAM2029 commercialization •Using existing infrastructure in Europe and Australia ‒ Focused audience and significant market potential >4 billion SEK across indications1,2 ‒ Established scalable commercial infrastructure •Establishing own US commercial infrastructure ‒ Single largest
Slide 24: Other rare disease opportunities
24 Other rare disease opportunities Setmelanotide SC depot, CAM4072 •Treprostinil SC depot, CAM2043 ‒ Developed by license partner Rhythm ‒ Targeting high medical need in treating ‒ Positive PK and PD results in Phase 2a MAD study Raynaud’s Phenomenon and PAH ‒ Phase 3 trial ongoing in switch patien
Slide 25: Key priorities going forward
25 Key priorities going forward • Strengthen market leading position of Buvidal • Expand to new markets and indications • Advance our R&D Pipeline to new approvals • Grow and diversify through business development • Fully implement our sustainability strategy
Slide 26: Appendix
Appendix Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 │ info@camurus.com │ camurus.com
Slide 27: Key figures second quarter 2022
28 Key figures second quarter 2022 MSEK Apr – Jun Apr – Jun Change Jan – Jun Jan – Jun Change Jan – Dec 2022 2021 2022 2021 2021 Total revenues 227 138 +64% 447 264 +69% 601 whereof product sales 225 137 +65% 427 261 +64% 594 Operating expenses 196 179 +10% 384 315 +22% 628 Operating result 7 -60 N/
Slide 28: Experienced and committed management team
29 Experienced and committed management team Fredrik Tiberg, PhD Education: M.Sc. in Chem. Eng., Lund Institute of Technology, Jon Garay Alonso Education: Bachelor in Business Administration by President & CEO, CSO PhD and Assoc. Prof. Physical Chemistry, Lund University. Chief Financial Officer Uni
Slide 29: Shareholders and analyst coverage
30 Shareholders and analyst coverage Shareholders as of 30 September 2022 Number of shares % of capital % of votes Sandberg Development AB 21,875,692 39.5 39.5 Fjärde AP-fonden 3,502,450 6.3 6.3 Didner & Gerge Fonder 2,572,977 4.7 4.7 Analysts Avanza Pension 2,437,675 4.4 4.4 Carnegie Fredrik Tiberg
Slide 30: Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly
31 Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly •Pivotal randomized, placebo-controlled Phase 3 trial AcroInnova 1 ‒ Rigorous, 24-week, randomized, double-blind, placebo-controlled trial CAM2029 once monthly Controlled ‒ Biomarker response (IGF-1≤1xULN) primary endpoint patients on R
Slide 31: SORENTO Phase 3 trial assesses superiority of CAM2029 versus standard of care
32 SORENTO Phase 3 trial assesses superiority of CAM2029 versus standard of care •Pivotal randomized, active-controlled Phase 3 trial SORENTO ‒ Primary endpoint is superiority in progression free CAM2029 survival, PFS, versus octreotide LAR and lanreotide ATG Option to switch to R ‒ Assessed after 1
Slide 32: CAM2029 Phase 2b trial, POSITANO, started in PLD
33 CAM2029 Phase 2b trial, POSITANO, started in PLD •Significant unmet need with no approved treatment ‒ PLD is a rare, genetic and chronic disorder CAM2029 group 1 ‒ Progressive growth of cysts in the liver R CAM2029 group 2 CAM2029 ‒ Can cause severe symptoms and impaired quality of life N=69 Plac