Camurus Ab · OMXSTO:CAMX
Camurus Ab — Investor Presentation (March 2024)
34 slides from Camurus Ab's investor presentation, March 2024
Slide 1: Company presentation
Company presentation March 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 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 Prosp
Slide 4: Successful 2023 lays foundation for continued profitable growth
4 Successful 2023 lays foundation for continued profitable growth Strengthened leadership in opioid dependence treatment Brixadi™ launched in the US for treatment of opioid use disorder Positive results and progress in three Phase 3 studies NDA submission for Oclaiz™ (CAM2029) in acromegaly Strong f
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 1740 – 1860 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% excl
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, pen-injectors, Controlled by composition, liquid crystal and other advanced devices phase structure and b
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: Buvidal continues to grow in Europe, Australia and MENA
9 Buvidal continues to grow in Europe, Australia and MENA •Sales growth across all markets •Quarterly product sales ‒ Net sales 2023: SEK 1.3 billion; +39% vs 2022 MSEK • Strong performance in key markets in UK, Nordics, Australia 400 366 • Germany, Spain, France growing well from a lower base 346 3
Slide 10: Brixadi launch gains momentum in the US
10 Brixadi™ launch gains momentum in the US •Braeburn responsible for US commercialization • US drug overdose deaths per 100,000 residents2 ‒ Focused commercial organization of over 100 people •Wide access to Brixadi for the treatment of OUD ‒ Available in all 50 US states ‒ High payer coverage – on
Slide 11: Opioid crisis in the US continues
11 Opioid crisis in the US continues •High medical need in the US •Significant treatment gap ~80,000 annual deaths in opioid overdoses1 All drugs ~10 million US people 100 000 misusing opioids2 US overdose deaths 80 000 Opioids US OUD prevalence3 60 000 6–7 million individuals 40 000 2.7 million dia
Slide 12: Brixadi – well differentiated in the US market
12 Brixadi – well differentiated in the US market •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 ‒
Slide 13: Communicating a growing evidence base
13 Communicating a growing evidence base Active scientific conference agenda Recent key publications Q4 2023 Q1/Q2 2024 Q3/Q4 2024 Global ASAM CPDD ISAM 4-7 Apr 16-19 Jun 5-8 Sep Dallas, US Montreal, CA Istanbul, TR European ATHS WADD/SEPD ALBATROS Lisbon Addict. 24-27 Oct 17-20 Apr 5-7 Jun 23-25 Oc
Slide 14: Octreotide SC depot, CAM2029
14 Octreotide SC depot, CAM2029 CAM2029 under development for three serious rare disease indications • Acromegaly • Gastroenteropancreatic neuroendocrine tumors (GEP-NET) • Polycystic liver disease (PLD) •Designed for enhanced efficacy and patient convenience
Slide 15: Somatostatin receptor ligands established treatment
15 Somatostatin receptor ligands established treatment •Wide use of somatostatin receptor ligands (SRLs) ‒ Antisecretory, antiproliferative, and immunomodulatory activity ‒ First-line medical treatment of acromegaly (ACRO) and neuroendocrine tumors (NET)1 ‒ SRLs also used in other fields of endocrin
Slide 16: Key limitations of current SSA therapies
16 Key limitations of current SSA therapies Sandostatin® LAR® Somatuline® Autogel® Mycapssa® First approved 1998 First approved 2007 First approved 2020 POSOLOGY Monthly intramuscular injection POSOLOGY Monthly deep subcutaneous injection POSOLOGY Twice daily (BID) DOSAGE FORM 19-gauge 38mm needle D
Slide 17: CAM2029 designed to address key limitations
17 CAM2029 designed to address key limitations Differentiating features Ready-for-use FluidCrystal® technology Rapid onset and long-acting octreotide release1 5-fold octreotide bioavailability vs Sandostatin LAR with potential for improved efficacy1,2,3 State-of-the-art, pre-filled pen injec
Slide 18: CAM2029 provides high SRL exposure
18 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) Sandosta
Slide 19: Status overview of CAM2029 programs by indication
19 Status overview of CAM2029 programs by indication NDA filing Est. NDA approval 5 completed 1 Phase 3 RCT ACRO decision ACRO Phase 1 and 2 clinical trials 2 Phase 3 LST Study continuation Est. NDA filing characterizing PK, PD and GEP-NET safety in healthy GEP-NET Phase 3 RCT subjects and patients
Slide 20: NDA submission in acromegaly following positive ACROINNOVA Phase 3 results
20 NDA submission in acromegaly following positive ACROINNOVA Phase 3 study results •Key milestones achieved for CAM2029 •Efficacy demonstrated in ACROINNOVA 1 & 21,2 Positive ACROINNOVA 1 Phase 3 results1 • IGF-1 values over time (mean, 95% CI) • Demonstrating superior biochemical control vs plac
Slide 21: CAM2029 has an attractive product profile in acromegaly
21 CAM2029 has an attractive product profile in acromegaly Once-monthly self-administration with prefilled pen • Improved symptom scores* 2 CAM2029 switched from ACROINNOVA 1 change from baseline Improved convenience and treatment satisfaction1,2 Symptom score – 1 CAM2029 new patients in ACROINNOVA
Slide 22: ACROINNOVA 1 Phase 3 RCT efficacy and safety trial
22 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 23: Completed patient recruitment in Phase 3 SORENTO study of CAM2029 in GEP-NET
23 Completed patient recruitment in Phase 3 SORENTO study of CAM2029 in GEP-NET •Enrollment across 12 countries exceeding randomization target (302) 80 76 332 70 patients 60 randomized 49 47 50 44 40 31 30 20 16 14 14 15 13 11 12 13 10 8 10 6 7 2 4 4 4 3 4 4 0 # randomized patients # sites with rand
Slide 24: SORENTO assessing CAM2029 superiority in PFS
24 SORENTO assessing CAM2029 superiority in PFS •Randomized, active-controlled Phase 3 trial •Primary endpoint ‒ Randomized, multi-center, open-label, active-controlled Phase 3 ‒ Superiority in progression free survival, PFS, vs. trial of CAM2029 vs. long-acting octreotide or lanreotide in patients
Slide 25: Clinical Phase 2/3 study in PLD fully recruited
25 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 trial ‒ Severe quality-of-life implications for • Randomization of 71 patients completed in February 2024 patients wit
Slide 26: CAM2029 progressing towards market with key milestones 2024/25
26 CAM2029 progressing towards market with key 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
Slide 27: High market potential for CAM2029 – largest opportunity in GEP-NET
27 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 28: Building commercial infrastructure in the US
28 Building commercial infrastructure in the US US launch preparations Oclaiz™ in acromegaly Key scientific conferences for CAM2029 in 2024 Key activities Q1 2024 Q2 2024 Q3 2024 Q4 2024 • Camurus Inc. fully operational Global ICE AACE2023 ENDO ENEA NANETS • President Camurus US appointed 1-4 March
Slide 29: Strong foundation for continued value creation
29 Strong foundation for continued value creation Buvidal growth in Europe and Australia Positive launch momentum for Brixadi in the US Pipeline progress towards new approvals and launches Establishing a US commercial organization Strong financial position to support sustainable growth
Slide 30: 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 31: Progress towards Camurus' Vision 2027
31 Progress towards Camurus’ Vision 2027 •Status update end-2023 following one year of execution towards the five-year vision 5x 4 ~50% Five-fold revenue growth Establishment Approvals for four R&D Operating margin around 50% (from 2022) of US commercial infrastructure pipeline programs 5x revenue g
Slide 32: Key milestones coming 12 months
32 Key milestones coming 12 months •R&D Pipeline Completed recruitment in POSITANO study in PLD FDA acceptance for review of Oclaiz™NDA MAA submission of CAM2029 in acromegaly to EMA FDA approval of Oclaiz™ in acromegaly Topline results SORENTO study in GEP-NET Topline results POSITANO s
Slide 33: Shareholders and analyst coverage
33 Shareholders and analyst coverage Shareholders as of 31 January 2024 Number of shares % of capital % of votes Sandberg Development AB 21,875,692 38.0 38.0 Fjärde AP-fonden 2,487,654 4.3 4.3 Analysts Avanza Pension 1,714,091 3.0 3.0 Carnegie Swedbank Robur Fonder 1,670,277 2.9 2.9 Erik Hultgård Fr
Slide 34: Experienced and committed management team
34 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