Slide 1: Company presentation October 2024
Company presentation October 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 a broad with Buvidal® and Brixadi® weekly and range of applications monthly depots Advancing late-stage pipeline Strong operational a
Slide 4: Strategy for continued value creation
4 Strategy for continued value creation 1.1. Grow Buvidal/Brixadi and expand to new markets 2.2. Grow and advance R&D pipeline to new approvals 3.3. Diversify through business development and partnerships 4.4. Strengthen organization and sustainability agenda Camurus' vision 2027 5x 4 ~50% Sustainab
Slide 5: Significant recent progress
5 Significant recent progress Commercial execution Advancing R&D pipeline Corporate development Global leadership in long-acting Near term catalysts including PDUFA Growing revenues and sustained treatment of opioid dependence date for Oclaiz the 21 October 2024 profitability Robust double-d
Slide 6: Positive financial development
6 Positive financial development •Revenues •Profit before tax MSEK MSEK 2 000 600 549 1717 400 Outlook 2024* 1 500 Total revenue 200 SEK 1,740 – 1,860 million 1 000 956 73 + 33 – 42% excl. one-time milestones 2023 0 601 Profit before tax 500 -112 336 -200 SEK 330 – 450 million -207 +131 – 215% excl.
Slide 7: FluidCrystal extended-release technology
7 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 8: Broad and diversified product portfolio and pipeline
8 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 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: Towards global leadership in long-acting opioid dependence treatment
10 Towards global leadership in long-acting opioid dependence treatment •Wide and growing access to Buvidal and Brixadi •Strong growth of Buvidal sales ‒ Available across four continents MSEK 1500 ‒ More than 53,000 in treatment with Buvidal in Europe 1299 and Australia end-June 2024 •Robust Buvidal
Slide 11: Accelerated growth of Brixadi in the US
11 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 50 commercialization 45 ‒ Focused commercial organization of over 100 people 40 •Wide access to Brixadi for the treatment of OUD +
Slide 12: Buvidal/Brixadi – well differentiated
12 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 13: Growing scientific evidence base
13 Growing scientific evidence base •Strong scientific support for Buvidal/Brixadi Recent key publications1-3 ‒ Documenting effectiveness in different treatment settings ‒ Positive health economical outcomes ‒ More than 160 scientific publications on Buvidal/Brixadi ‒ Ongoing clinical studies explor
Slide 14: Octreotide SC depot, CAM2029
14 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 15: CAM2029 designed to address key limitations of current first-generation SRLs
15 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 16: CAM2029 provides high SRL exposure
16 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 17: Comprehensive clinical study program for CAM2029
17 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 continuation characterizing Est. NDA filing PK, PD and Fully recruited GEP-NET safety in health
Slide 18: Positive results from ACROINNOVA 1
18 Positive results from ACROINNOVA 1 – CAM2029 provided robust biochemical control •ACROINNOVA 1 study design •Superiority achieved •CAM2029 improved ‒ 24-week, randomized, double blind, ‒ 77.2% vs. 37.5% patients with ‒ Treatment convenience placebo-controlled Phase 3 study IGF-1 ≤1 ULN with CAM20
Slide 19: Positive topline results from 52-week Phase 3 ACROINNOVA 2 study
19 Positive topline results from 52-week Phase 3 ACROINNOVA 2 study announced 15 July 2024 •ACROINNOVA 2 study design •Improved acromegaly •ACROINNOVA 2 results ‒ 52-week, open-label safety study symptoms with CAM2029 ‒ Reinforcing long-term safety and with further extension effectiveness in ACROINN
Slide 20: SORENTO assessing CAM2029 superiority in PFS vs SoC in GEP-NET
20 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 21: Completed patient recruitment in SORENTO
21 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 22: Clinical Phase 2/3 study in PLD fully recruited
22 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 23: CAM2029 progressing towards market with upcoming key milestones 2024/25
23 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 24: High market potential for CAM2029 – largest opportunity in GEP-NET
24 High market potential for CAM2029 – largest opportunity in GEP-NET Attractive specialty pharma opportunity ‒ Highly concentrated target audiences ‒ Differentiated product features ‒ Switch from established first-line treatments ‒ Blockbuster potential in GEP-NET alone • CAM2029 peak sales estimat
Slide 25: Establishing US organization for launch of Oclaiz
25 Establishing US organization 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 • Market research and payor engagement • High medical affairs activity •
Slide 26: Significant near-term opportunities
26 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 27: Camurus AB contact details
Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 │ info@camurus.com │ camurus.com
Slide 28: Shareholders and analyst coverage
28 Shareholders and analyst coverage Shareholders as of 30 September 2024 Number of shares % of capital % of votes Sandberg Development AB 20,530,692 35.0 35.2 Fjärde AP-fonden 2,610,766 4.5 4.5 Analysts JP Morgan Chase Bank 2,222,886 3.8 3.8 Carnegie State Street Bank and Trust 2,017,277 3.4 3.5 Er
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: ACROINNOVA 1 Phase 3 RCT efficacy and safety trial
30 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 31: ACROINNOVA 2 Phase 3 long-term safety and extension trial
31 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
Slide 32: FluidCrystal semaglutide to enter clinical development stage
32 FluidCrystal semaglutide to enter clinical development stage Encouraging preclinical product profile to be validated in Phase 1 study aimed to start Q4 2024 PROPERTY TARGET PRODUCT PROFILE (TPP) STATUS OCT 2024 Indication • Type 2 diabetes mellitus and obesity To be confirmed in clinical progra