Camurus Ab · OMXSTO:CAMX
Camurus Ab — Investor Presentation (May 2024)
30 slides from Camurus Ab's investor presentation, May 2024
Slide 1: Company presentation May 2024
Company presentation May 2024
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 Unique FluidCrystal® stage company technology platform Leader in opioid dependence treatment Commercially validated, with Buvidal® weekly and monthly depots with a broad range of applications Advancing late-stage pipeline Strong financial performance wit
Slide 4: Significant recent progress
4 Significant recent progress Strong financial performance Commercialization execution Pipeline advancement High year-on-year revenue growth Strengthened leadership in Four Phase 3 studies in rare disease Profitable since 2022 opioid dependence treatment indications SEK 1.1 billion directe
Slide 5: Positive financial development
5 Positive financial development •Revenues •Operating results MSEK MSEK 2,000 600 526 1717 400 Outlook 2024 1,500 Total revenue 200 SEK 1,740 – 1,860 million 957 73 + 33 – 42% excl. one-time 1,000 milestones 2023 0 601 Profit before tax 500 336 -200 -111 SEK 330 – 450 million 106 -205 +131 – 215% ex
Slide 6: FluidCrystal extended-release technology
6 FluidCrystal® extended-release technology Easy and convenient administration Applicable across substance classes Rapid onset & long-acting release Compatible with prefilled syringes, autoinjector Controlled by composition, liquid crystal pens, and other advanced devices phase structure a
Slide 7: Broad and diversified product portfolio and pipeline
7 Broad and diversified product portfolio and pipeline Phase 1 Phase 2 Phase 3 Registration Market Product on the market Buvidal® Opioid dependence Brixadi® Opioid use disorder (USA)1 Pipeline programs CAM2029 Acromegaly CAM2029 Gastroenteropancreatic neuroendocrine tumors CAM2029 Polycystic liver d
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 benefits to patients and s
Slide 9: Towards global leadership in opioid dependence treatment
9 Towards global leadership in opioid dependence treatment •Wide and growing access to Buvidal and Brixadi •Strong growth of Buvidal sales ‒ Available across four continents MSEK 1500 ‒ More than 57,000 in treatment end-March 2024 1299 •Robust Buvidal sales growth ‒ 106% CAGR since first launch in 2
Slide 10: Accelerated growth of Brixadi in the US
10 Accelerated growth of Brixadi in the US •Brixadi launched in the US in September 2023 •Brixadi royalty by quarter ‒ Camurus’ licensee Braeburn responsible for US MSEK commercialization 30 26 ‒ Focused commercial organization of over 100 people 25 •Wide access to Brixadi for the treatment of OUD 2
Slide 11: Buvidal/Brixadi – well differentiated
11 Buvidal/Brixadi – well differentiated •Convenient and flexible administration ‒ Weekly and monthly dosing LAI features2 ‒ Multiple dose strengths (four weekly, three monthly) ‒ Choice of multiple injection sites ‒ Thin needle and small dose volumes Weekly dosing – – Monthly dosing ‒ Room temp
Slide 12: Growing scientific evidence base
12 Growing scientific evidence base Recent key publications1-3 •Strong scientific support for Buvidal/Brixadi ‒ Documenting treatment effectiveness ‒ Positive health economical outcomes ‒ About 160 scientific publications on Buvidal/Brixadi ‒ Ongoing clinical studies exploring new applications •Sele
Slide 13: Octreotide SC depot, CAM2029
13 Octreotide SC depot, CAM2029 CAM2029 is a long-acting octreotide in development for three serious rare disease indications • Acromegaly • Gastroenteropancreatic neuroendocrine tumors (GEP-NET) • Polycystic liver disease (PLD) •Designed for enhanced efficacy and patient convenience vs. current som
Slide 14: CAM2029 designed to address key limitations of current first-generation SRLs
14 CAM2029 designed to address key limitations of current first-generation SRLs Ready-to-use FluidCrystal® technology Rapid onset and long-acting octreotide release1 5-fold octreotide bioavailability vs Sandostatin LAR with potential for improved efficacy1-3 State-of-the-art, pre-filled autoinjector
Slide 15: CAM2029 provides high SRL exposure
15 CAM2029 provides high SRL 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) Sandos
Slide 16: Comprehensive clinical study program for CAM2029
16 Comprehensive clinical study program for CAM2029 21 Oct 2024 NDA filing MAA filing NDA approval 1 Phase 3 RCT ACRO US ACRO EU decision ACRO 5 completed Phase 1 and 2 clinical trials 2 Phase 3 LST Study extension characterizing Est. NDA filing PK, PD and Fully recruited GEP-NET safety in healthy s
Slide 17: Positive results from ACROINNOVA 1
17 Positive results from ACROINNOVA 1 – CAM2029 provided robust biochemical control •ACROINNOVA 1 study design •Superiority achieved •CAM2029 improved ‒ 24-week, randomized, double blind, ‒ Significantly more patients ‒ Treatment convenience placebo-controlled Phase 3 study achieved IGF-1 control wi
Slide 18: Positive interim results from ACROINNOVA 2
18 Positive interim results from ACROINNOVA 2 •ACROINNOVA 2 study design •Improved acromegaly •ACROINNOVA 2 interim results ‒ 52-week, open-label safety study symptoms with CAM2029 ‒ Reinforcing long-term safety and with further extension effectiveness observed in ACROINNOVA 1 •Patient population 1
Slide 19: SORENTO assessing CAM2029 superiority in PFS vs SoC in GEP-NET
19 SORENTO assessing CAM2029 superiority in PFS vs SoC in patients with GEP-NET •Randomized, active-controlled Phase 3 study •Primary endpoint ‒ Randomized, multi-center, open-label, active-controlled Phase 3 ‒ Superiority in progression free survival, PFS, vs. study of CAM2029 vs. long-acting octre
Slide 20: Completed patient recruitment in SORENTO
20 Completed patient recruitment in SORENTO Enrollment of 332 patients across 12 countries exceeding randomization target (302) Largest ever controlled clinical study with somatostatin receptor ligand 80 76 70 332 60 49 patients 50 44 47 randomized 40 31 30 20 16 14 14 15 13 11 12 13 10 8 6 7 10
Slide 21: Clinical Phase 2/3 study in PLD fully recruited
21 Clinical Phase 2/3 study in PLD fully recruited •POSITANO trial to assess efficacy and safety •Large unmet medical need in PLD ‒ 53-week randomized, placebo-controlled, three-arm study ‒ Severe quality-of-life implications for • Randomization of 71 patients completed in Q1 2024 patients with symp
Slide 22: CAM2029 progressing towards market with upcoming key milestones 2024/25
22 CAM2029 progressing towards market with upcoming key milestones 2024/25 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 Po
Slide 23: High market potential for CAM2029 – largest opportunity in GEP-NET
23 High market potential for CAM2029 – largest opportunity in GEP-NET •Attractive specialty pharma opportunity ‒ Blockbuster potential in NET ‒ Highly concentrated target audiences ‒ Differentiated product features ‒ Switch from established first-line treatments • CAM2029 peak sales estimates from t
Slide 24: Building US infrastructure for launch of Oclaiz
24 Building US infrastructure for launch of Oclaiz™ Estimated ~ $1.5 billion market opportunity Key activities • US office established in Princeton, New Jersey • President Camurus US, Behshad Sheldon • Key positions onboarded • In-depth market research • High medical affairs activity • Payor engagem
Slide 25: Significant near-term opportunities
25 Significant near-term opportunities Establish global leadership in opioid dependence treatment US market approval decision for Oclaiz™ (CAM2029) in acromegaly Topline results from SORENTO and POSITANO studies of CAM2029 in GEP-NET and PLD Advancement of new pipeline programs in attractive
Slide 26: Camurus AB contact details
Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 │ [email protected] │ camurus.com
Slide 27: Shareholders and analyst coverage
27 Shareholders and analyst coverage Shareholders as of 30 April 2024 Number of shares % of capital % of votes Sandberg Development AB 21,875,692 38.0 38.0 Fjärde AP-fonden 2,610,766 4.5 4.5 Analysts Avanza Pension 1,835,773 3.2 3.2 Carnegie Swedbank Robur Fonder 1,799,360 3.1 3.1 Erik Hultgård Fred
Slide 28: Experienced and committed management team
28 Experienced and committed management team Fredrik Tiberg, PhD Education: M.Sc. in Chem. Eng., Lund Institute of Technology, PhD Jon Garay Alonso Education: Bachelor in Business Administration by Universidad President & CEO, CSO and Assoc. Prof. Physical Chemistry, Lund University. Chief Financial
Slide 29: ACROINNOVA 1 Phase 3 RCT efficacy and safety trial
29 ACROINNOVA 1 Phase 3 RCT efficacy and safety trial • ACROINNOVA 1 trial design • Primary endpoint: • Secondary endpoints, e.g,: ‒ 24-week, randomized, double ‒ Proportion of patients with mean ‒ Time to loss of IGF-1 response blind, placebo-controlled trial IGF-1 ≤1xULN (week 22 and 24) ‒ IGF-1 a
Slide 30: ACROINNOVA 2 Phase 3 long-term safety and extension trial
30 ACROINNOVA 2 Phase 3 long-term safety and extension trial • ACROINNOVA 2 trial design • Primary endpoint: ‒ 52-week, open-label, long-term safety and extension trial ‒ Long-term safety and tolerability • Patient population • Secondary endpoints: ‒ New patients in trial; IGF-1<2xULN (n=81) ‒ Bioch