Camurus Ab · OMXSTO:CAMX
Camurus Ab — Investor Presentation (November 2022)
31 slides from Camurus Ab's investor presentation, November 2022
Slide 1: Improving treatments for patients with severe and chronic diseases
Improving treatments for patients with severe and chronic diseases Company Presentation November 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 performance stage company Entering profitability in 2022 Leader in opioid dependence treatment 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 Entering profi
Slide 6: Strong quarterly financial development
6 Strong quarterly financial development Revenue Operating Result Revenue growth MSEK +57% vs Q3 2021 MSEK 700 688 100 Operating result 600 +65% 50 41 53 +48 MSEK vs Q3 2021 500 418 +48 MSEK Cash position 400 0 -6 +146 MSEK SEK 520 million Q3 -23 300 241 -50 +22% vs Q3 2021 230 200 +57% 154 100 -100
Slide 7: On track for full year profitability
7 On track for full year profitability •Revenues1 •Operating results1 MSEK MSEK 1000 400 FY 2022 outlook 800 200 Total revenue SEK 900 to 950 million 600 0 Product sales 400 SEK 875 to 925 million -200 Operating results 200 SEK 40 to 70 million (increased from SEK -20 to 40 million) 0 -400 2019 2020
Slide 8: Opioid dependence – escalating global health crisis
8 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 b
Slide 9: Buvidal – game changing opioid dependence treatment
9 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 s
Slide 10: Buvidal sales growth underscores potential
10 Buvidal sales growth underscores potential •Leadership in opioid dependence treatment •Quarterly product sales ‒ High double-digit year-on-year sales growth MSEK ‒ Buvidal available in 18 countries in Europe, Australia and the 250 241 225 Middle East ‒ Est. >32,000 patients in treatment at the en
Slide 11: Substantial growth potential in MENA
11 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 12: Market expansion to the US
12 Market expansion to the US •Brixadi1 NDA resubmission status •Ongoing US investigator sponsored studies FDA inspection of Braeburn’s third party manufacturer STUDY EST. PATIENTS Resubmission of Brixadi new drug applications (NDA) for MOMs3 200 opioid use disorder (OUD) Medication Treatment fo
Slide 13: Brixadi well positioned against competition
13 Brixadi well positioned against competition Long-acting injectables features Weekly dosing – – Monthly dosing Multiple doses – – Choice of inj. sites – – Smallest needle (19G) (20G) (23G) Lowest dose volume 0.5–1.5mL 3.4mL 0.16–0.64mL Room temp. storage – – Day one initiation –
Slide 14: Buvidal label extension to chronic pain
14 Buvidal label extension to chronic pain •Market authorization applications under review in EU and Australia — CHMP opinion expected in Q4 2022 or Q1 2023 — TGA approval decision expected H1 2023 •High unmet medical need in chronic pain management — Especially among patients with or high risk of o
Slide 15: Broad and diversified mid- to late-stage pipeline
15 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 16: CAM2029 – octreotide subcutaneous depot in Phase 3 development
16 CAM2029 – octreotide subcutaneous depot in Phase 3 development •Octreotide SC depot under assessment in three, serious rare disease indications • Acromegaly • Gastroenteropancreatic neuroendocrine tumors (GEP-NET) • Polycystic liver disease (PLD) •Designed for enhanced efficacy and patient conven
Slide 17: CAM2029 targeting 3 billion dollar SSA market
17 CAM2029 targeting 3 billion dollar SSA market •SSAs established treatment with limitations Annual sales of first generation SSAs1 ‒ First-line treatment of acromegaly and neuroendocrine mUSD Somatuline® Autogel® (lanreotide) 3000 tumors (NET) Sandostatin® LAR® (octreotide) ‒ Established safety an
Slide 18: CAM2029 extensive clinical program
18 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 19: AcroInnova program for CAM2029 in acromegaly
19 AcroInnova program for CAM2029 in acromegaly •Pivotal randomized, placebo-controlled Phase 3 trial ‒ Rigorous, 24-week, randomized, double-blind, placebo-controlled trial ‒ Primary endpoint biochemical response (IGF-1≤1xULN) ‒ Filling regulatory requirement for efficacy Two Phase 3 trials ongoi
Slide 20: SORENTO program for CAM2029 in NET
20 SORENTO program for CAM2029 in NET •Multinational, randomized, active-controlled Phase 3 trial ‒ Primary endpoint is superiority in progression free survival, PFS, versus octreotide LAR and lanreotide ATG ‒ Assessed after 194 progression events ‒ Multiple patient reported outcomes included in stu
Slide 21: POSITANO program for CAM2029 in PLD
21 POSITANO program for CAM2029 in PLD •Significant unmet need with no approved treatment ‒ PLD is a rare, genetic and chronic disorder ‒ Progressive growth of cysts in the liver, can cause severe symptoms ‒ Estimated ~30,000 patients with symptomatic PLD1 ‒ No approved medical treatment – increased
Slide 22: Significant market potential for CAM2029
22 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 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 Grow and strengthen market leading position of Buvidal Expand to new markets and indications Advance R&D Pipeline to new approvals Grow and diversify through business development
Slide 26: Appendix
Appendix Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 │ [email protected] │ camurus.com
Slide 27: Experienced and committed management team
27 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 28: Shareholders and analyst coverage
28 Shareholders and analyst coverage Shareholders as of 31 October 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 Avanza Pension 2,401,362 4.3 4.3 Analysts Didner & Gerge Fonder 2,332,561 4.2 4.2 Fredrik Tiberg, CEO 1,680
Slide 29: Leading FluidCrystal extended-release technology
29 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 liqu
Slide 30: FluidCrystal – Long-acting release
30 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 31: Weekly and monthly buprenorphine depots
31 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 demons