Slide 1: Third quarter 2024 results
Third quarter 2024 results Audiocast presentation 7 November 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: Agenda
3 Agenda • Business highlights Company participants • Financial performance Fredrik Tiberg, PhD • Commercial development President & CEO, CSO • R&D pipeline update Jon Garay Alonso Chief Financial Officer • Key take-aways Richard Jameson • Q&A Chief Commercial Officer
Slide 4: Business highlights
camurus. Business highlights
Slide 5: Strong profitability and operating performance
5 Strong profitability and operating peformance Raised full year outlook Continued commercial execution Advancing R&D pipeline Revenues up 38% YoY* (41% CER) Emerging global leadership in Positive Phase 3 results from to SEK 480 m in Q3 opioid dependence treatment ACROINNOVA 2 Profit before
Slide 6: On track for vision 2027
6 On track for vision 2027 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% Sustainable value crea
Slide 7: Financial performance
Camurus. Financial performance
Slide 8: Strong growth of operating revenue and profit
8 Strong growth of operating revenue and profit Revenue Profit before tax MSEK MSEK Cash position 1400 1342 1314 600 567 SEK 2,751 million +138% vs Q3 2023 1200 500 +40% 1000 400 366 800 Q3 688 300 600 +205 MSEK 480 385 +38% 200 400 165 241 110 100 +92 MSEK 200 38 40 0 0 Q3 YTD Q3 YTD Q3 YTD Q3 YTD
Slide 9: Reported Q3 profit and loss
9 Reported Q3 profit and loss CER YTD CER MSEK Jul – Sep Change Change Jan – Sep Change YTD Change YTD 2024 vs. 2023 vs. 2023 2024 vs. 2023 vs. 2023 Total revenues 480 25% 31% 1,314 -2% -1% excl. one-time milestones/license rev. +38% +41% +40% +40% Gross margin 446 134bps 194bps 1,218 -63bps -34bps
Slide 10: Strong operational cash flow
10 Strong operational cash flow MSEK 2800 2,751 16 45 2,751 Improved FY 2024 Outlook 2750 -6 -3 -2 134 Revenue 2700 SEK 1,810 – 1,880 million 2,567 (increased fr. SEK 1,740 – 1,860 million) 2650 Profit before taxes 2600 SEK 450 – 510 million 2,567 (increased from SEK 330 – 450 million) 2550 2500 Cas
Slide 11: Commercial development
Camurus. Commercial development
Slide 12: Buvidal – in-market growth continues
12 Buvidal – in-market growth continues •Sales growth across all markets •Quarterly reported sales and at CER1 ‒ Net sales Q3 2024 was SEK 421 million; +22% YoY MSEK • At CER, sales grew by 24% YoY and 6% QoQ, respectively 450 421 400 • Est. >56,000 patients in treatment with Buvidal end Q3 2024 400
Slide 13: Solid Brixadi performance in the US
13 Solid Brixadi performance in the US •Continued strong growth of Brixadi •Brixadi royalty by quarter ‒ Net sales grew 39% at CER1, and 30% at reported rate MSEK 58 ‒ A majority of new patients were transferred from 60 sublingual buprenorphine products2 ‒ Remaining patients come from treatment with
Slide 14: Growing scientific evidence base
14 Growing scientific evidence base Selected scientific conference participation in 2024/2025 Recent key publications Q3/Q4 2024 Q1/Q2 2025 Global ISAM ASAM CPDD 5-8 Sep 24-27 Apr 14-18 Jun Istanbul, TR Denver, CO - US New Orleans, US European Lisbon Addict. ISAM ALBATROS 23-25 Oct 26-28 May 10 – 12
Slide 15: R&D update
Camurus. R&D update
Slide 16: Octreotide SC depot, CAM2029
16 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
Slide 17: Acroinnova
Camurus. Acroinnova"
Slide 18: ACROINNOVA program update
18 ACROINNOVA program update • Positive topline Phase 3 results received from ACROINNOVA 2, 15 July 2024 ‒ Safety profile consistent with SoC with no new findings ‒ Enhanced rate of biochemical response (IGF-1≤1xULN) vs SoC at baseline in the overall population1 ‒ Improved symptom scores observed co
Slide 19: SORENTO
camurus. SORENTO™
Slide 20: Phase 3 trial designed to assess superiority with CAM2029 vs first-line treatment
20 Phase 3 trial designed to assess superiority with CAM2029 vs first-line treatment •Primary objective •Primary endpoint ‒ To assess if CAM2029 improves progression free survival with ‒ Superiority in progression free survival, PFS, vs. versus standard of care with octreotide LAR or lanreotide ATG
Slide 21: SORENTO patient recruitment
21 SORENTO patient recruitment Largest randomized study of a somatostatin receptor ligand in GEP-NET Canada Belgium Netherlands Total number of: 44 7 10 4 14 4 332 patients At 79 sites Hungary 14 4 France 31 8 USA Germany Israel Australia 47 13 16 4 13 3 6 2 Spain 76 15 Romania 12 4 # patients Italy
Slide 22: SORENTO status update
22 SORENTO status update • Recent analysis suggests a longer progression free survival (PFS) than expected for the SORENTO patient population • A majority of patients had advanced disease, grade 2 and some grade 3 NETs, at baseline • Based on a better-than-expected tumor control in the study populat
Slide 23: POSITANO
camurus. Positano”
Slide 24: POSITANO trial design
24 POSITANO trial design •Primary objective •Primary endpoint ‒ To evaluate the treatment effect of CAM2029 compared to ‒ Change from baseline to Week 53 in placebo on liver volume in patients with polycystic liver height-adjusted total liver volume disease (PLD) •Secondary endpoints include •Patien
Slide 25: POSITANO status update
25 POSITANO status update • Patient reported symptom outcomes tool (PLD-S) is developed and aligned with FDA • POSITANO randomized 71 patients to 52 weeks of treatment with CAM2029 or placebo, followed by 128 weeks of open label extension with CAM2029 • More than half completed the randomized phase
Slide 26: CAM2029 clinical program overview
26 CAM2029 clinical program overview NDA filing MAA filing 5 completed 1 ACRO US ACRO EU Phase 1 and 2 clinical trials characterizing 2 Study extension Est. NDA filing PK, PD and GEP-NET safety in healthy Fully recruited subjects and patients Study extension Fully recruited Study extension -2023 202
Slide 27: Regulatory update
Camurus. Regulatory update
Slide 28: Regulatory update for CAM2029 NDA in acromegaly
28 Regulatory update for CAM2029 NDA in acromegaly •NDA review progressed during quarter ‒ Labeling well advanced •CRL issued by the FDA relating solely to a cGMP-inspection at a third-party manufacturing facility, pending inspection classification ‒ Timing of inspection precluded resolution by PDUF
Slide 29: Early pipeline
Ccamurus. Early pipeline
Slide 30: Early pipeline activities
30 Early pipeline activities • Preparation of randomized, dose-escalating, multiple dose Phase 1 study of monthly semaglutide in overweight and obese, otherwise healthy participants • Preclinical assessments of additional long-acting GLP-1 receptor agonists have undergone preclinical evaluation with
Slide 31: Strong delivery and raised outlook
31 Strong delivery and raised outlook Robust profitability while investing in pipeline and US operations Solid double-digit growth of Buvidal in Europe and Australia Brixadi launch continues to progress in the US EU MAA review for CAM2029 in acromegaly CTA submitted for clinical study of monthly sem
Slide 32: Q&A
camurus. O&A
Slide 33: Shareholders and analyst coverage
33 Shareholders and analyst coverage Shareholders as of 30 October 2024 Number of shares % of capital % of votes Sandberg Development AB 20,530,692 34.9 35.1 Fjärde AP-fonden 2,715,766 4.6 4.6 Analysts JP Morgan Chase Bank 2,319,995 3.9 4.0 Carnegie State Street Bank and Trust 2,015,841 3.4 3.4 Erik
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
Slide 35: Broad and diversified product portfolio and pipeline
35 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