Camurus Ab · OMXSTO:CAMX
Camurus Ab — Investor Presentation (May 2023)
30 slides from Camurus Ab's investor presentation, May 2023
Slide 1: Improving treatments for patients with severe and chronic diseases
Improving treatments for patients with severe and chronic diseases Company Presentation May 2023
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: Camurus snapshot
3 Camurus snapshot Rapidly growing commercial Strong financial performance stage company Entered 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 Prospe
Slide 4: Significant recent progress and near-term milestones
4 Significant recent progress and near-term milestones Strong financial performance Commercialization execution Pipeline advancement High double-digit year-on-year Leader in long-acting opioid Imminent approval decision for revenue growth dependence treatment in the EU Brixadi in the US Prof
Slide 5: Leading FluidCrystal extended-release technology
5 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 6: FluidCrystal – Long-acting release
6 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 7: Opioid dependence – escalating global health crisis
7 Opioid dependence – escalating global health crisis Escalating opioid overdose deaths •Largest society burden of all drugs1 US: All drugs Number of deaths in the US 100,000 ‒ 61 million opioid users worldwide1 80,000 Opioids ‒ Opioid crisis worsened during COVID-19 pandemic 60,000 •High need for b
Slide 8: Buvidal – game changing opioid dependence treatment
8 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 significant benefits to pa
Slide 9: Buvidal continuing to grow in Europe, Australia and MENA
9 Buvidal continuing to grow in Europe, Australia and MENA •Leader in opioid dependence treatment •Quarterly product sales ‒ Continued high market penetration with Buvidal MSEK 300 • >20% of treated patients in Australia and Nordics 282 267 • UK exceeding 5% patient share (~20% of the buprenorphine
Slide 10: Brixadi approved for treatment of OUD in the US
10 Brixadi™ approved for treatment of OUD in the US •Brixadi1 approved in the US •Large medical need and treatment gap NDA approval of Brixadi by the US FDA 23 May 2023 for the treatment of opioid use disorder (OUD)2 US commercialization by Braeburn under license ~10 million US people misusing o
Slide 11: Recent initiatives to address treatment hurdles in the US
11 Recent initiatives to address treatment hurdles in the US •President Biden’s Unity Agenda1 ‒ Combating opioid epidemic key item $ •Increased funding of treatment2 ‒ Over $6 billion to address opioid epidemic in State of the Union 2022 and 2023 and substance misuse in 2022 •Improved access to trea
Slide 12: US opioid use disorder market expected to grow to >$3.5 billion
12 US opioid use disorder market expected to grow to >$3.5 billion in five years •Forecasted North America opioid use •Expected growth primarily from disorder (OUD) market size1 buprenorphine LAI products2 MUSD MUSD 4000 2000 Buprenorhine * LAI share 2022 Forecasted US sales buprenorphine LAIs Forec
Slide 13: Brixadi and Buvidal – well differentiated
13 Brixadi and Buvidal – well differentiated •Flexible dosing and posology ‒ Weekly and monthly dosing LAI features1 ‒ Multiple dose options (four weekly, three monthly) Weekly dosing – – ‒ Choice of multiple injection sites (buttock, thigh, Monthly dosing abdomen or upper arm) Multiple dose
Slide 14: Broad and diversified mid- to late-stage pipeline
14 Broad and diversified mid- to late-stage pipeline Phase 1 Phase 2 Phase 3 Registration Approved Brixadi™ Opioid use disorder (USA)1 23 May 2023 CAM2038 Chronic pain CAM2029 Acromegaly CAM2029 Gastroenteropancreatic neuroendocrine tumors CAM2029 Polycystic liver disease CAM4072 Genetic obesity dis
Slide 15: Octreotide SC depot
15 Octreotide SC depot CAM2029 under assessment in three serious rare-disease indications • Acromegaly • Gastroenteropancreatic neuroendocrine tumors (GEP-NET) • Polycystic liver disease (PLD) •Designed for enhanced efficacy and patient convenience
Slide 16: CAM2029 targeting USD 3-billion SSA market
16 CAM2029 targeting USD 3-billion 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 and e
Slide 17: CAM2029 Phase 3 programs advancing
17 CAM2029 Phase 3 programs advancing NDA/MAA Phase 3 RCT approval decisions ACRO est. NDA/MAA Phase 3 LST Trial extension approval decisions GEP-NET est. GEP-NET Phase 3 RCT PLD Phase 2/3 RCT Phase 3 continuation Prefilled pen PK bridge -2022 2023 2024 2025 2026 ACRO Phase 3 RCT ACRO Phase 3 LST GE
Slide 18: CAM2029 provides high SSA exposure
18 CAM2029 provides high SSA exposure • ~5x higher octreotide plasma exposure for CAM2029 vs. Sandostatin LAR • CAM2029 octreotide plasma levels in the range of immediate release octreotide Steady state pharmacokinetic profiles 100 CAM2029 20mg q4w (PK model) Sandostatin IR 0.5mg TID (PK model) Sand
Slide 19: CAM2029 provides high SSA exposure
19 CAM2029 provides high SSA exposure • ~5x higher octreotide plasma exposure for CAM2029 vs. Sandostatin LAR • CAM2029 octreotide plasma levels in the range of immediate release octreotide Steady state pharmacokinetic profiles 100 CAM2029 20mg q4w (PK model) CAM2029 20mg q2w (PK model) Sandostatin
Slide 20: ACROINNOVA 1: Phase 3 efficacy trial in acromegaly
20 ACROINNOVA 1: Phase 3 efficacy trial in acromegaly • Pivotal randomized, placebo-controlled Phase 3 trial • Primary endpoint ‒ Rigorous, 24-week, randomized, double-blind, placebo- ‒ Proportion of patients with mean IGF-1 levels ≤1x upper controlled trial of CAM2029 in patients with acromegaly li
Slide 21: ACROINNOVA 2: Phase 3 long-term safety trial in acromegaly
21 ACROINNOVA 2: Phase 3 long-term safety trial in acromegaly • Long-term safety Phase 3 trial • Primary endpoint ‒ 52-week long-term safety, switch and extension trial of ‒ Safety and tolerability of CAM2029 CAM2029 in patients with acromegaly ‒ Filling regulatory requirements for safety exposure •
Slide 22: SORENTO: Largest Phase 3 trial of SSA in NET
22 SORENTO: Largest Phase 3 trial of SSA in NET • Randomized, active-controlled Phase 3 trial • Primary endpoint ‒ Randomized, multi-center, open-label, active-controlled ‒ Superiority in progression free survival, PFS, vs. standard Phase 3 trial of CAM2029 vs. long-acting octreotide or of care (fir
Slide 23: CAM2029 clinical trials status update
23 CAM2029 clinical trials status update Pivotal randomized placebo controlled Subcutaneous Octreotide Randomized Polycystic liver Safety and efficacy and long-term safety trials in acromegaly Efficacy in Neuroendocrine TumOrs TriAl with subcutaneous Octreotide Two Phase 3 trials ongoing, SORENT
Slide 24: Ongoing preparations for launches of CAM2029
24 Ongoing preparations for launches of CAM2029 •Manufacturing •Medical affairs – activities Q1 2023 Commercial manufacturing process ‒ Investigator meeting in the SORENTO study held at the established European NeuroEndocrine Tumor Society (ENETS) Process validation completed meeting 22-24 March
Slide 25: Large market potential for CAM2029
25 Large market potential for CAM2029 •Attractive opportunity GlobalData report5 ‒ Block buster potential in NET ‒ Highly concentrated target audiences ‒ Differentiated product features ‒ Switch opportunity from established first-line treatments • CAM2029 peak sales estimates from third party market
Slide 26: Key take-aways May 2023
26 Key take-aways May 2023 Strong start to the year with robust top and bottom-line growth Buvidal market penetration and expansion continues Significant progress in the late-stage R&D pipeline Brixadi approved in the US for OUD on 23 May 2023 Phase 3 results for CAM2029 late June
Slide 27: Past and expected milestones in 2023
27 Past and expected milestones in 2023 •Advancing the pipeline Topline Phase 3 efficacy results in acromegaly First readout Phase 3 long-term safety study Pre NDA meeting for CAM2029 in acromegaly Completed recruitment in SORENTO study in GEP-NET Completed recruitment in POSITANO study in
Slide 28: Q&A
Q&A Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 │ info@camurus.com │ camurus.com
Slide 29: 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 30: Shareholders and analyst coverage
30 Shareholders and analyst coverage Shareholders as of 30 April Number of shares % of capital % of votes Sandberg Development AB 21,875,692 39.5 39.5 Fjärde AP-fonden 3,116,100 5.6 5.6 Analysts Avanza Pension 2,277,315 4.1 4.1 Carnegie Didner & Gerge Fonder 2,024,044 3.6 3.6 Erik Hultgård Fredrik T