Slide 1: Full year and fourth quarter 2023 results
Full year and fourth quarter 2023 results Audiocast presentation 15 February 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 • FY 2023 and Q4 highlights Company participants • Financial results & Outlook 2024 Fredrik Tiberg • 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: 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 1,500 200 957 73 1,000 0 601 500 -111 336 -200 -205 106 0 -400 -360 2019 2020 2021 2022 2023 2019 2020 2021 2022 2023
Slide 6: Progress towards Camurus' Vision 2027
6 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 gr
Slide 7: Financial performance and outlook 2024
Financial performance and outlook 2024
Slide 8: Persistent revenue growth and result improvement
8 Persistent revenue growth and result improvement Revenue Operating result Cash position end 2023 MSEK MSEK SEK 1,190 million 2000 600 526 +110% vs 2022 1717 1500 400 Profit before tax FY 2023 +80% +453 MSEK SEK 549 million +476 million vs 2022 Q4 1000 956 200 601 73 19 500 0 375 -18 -29 268 +40% 1
Slide 9: Reported Q4 & FY profit and loss
9 Reported Q4 & FY profit and loss CER CER MSEK Oct – Dec Change Change Full year Change Change 2023 vs. 2022 vs. 2022 2023 vs. 2022 vs. 2022 Total revenues 375 +40% +36% 1 717 +80% +72% out of which milestones/License rev. 0 406 Gross margin 342 +175bps +140bps 1 595 +367bps +353bps % GM excl. mile
Slide 10: Cashflow overview
10 Cashflow overview •Cash position SEK 1.2 billion. No debt. MSEK Directed Share Issue, Jan 2024 • Gross proceeds SEK 1.1 billion • 2 million shares via Accelerated Book Build < 5% dilution • Significantly oversubscribed • High quality international and local institutional investors Cash end Workin
Slide 11: Outlook 2024
11 Outlook 2024 •Full year 2024 guidance • • Revenue • Profit before tax •SEK 1,740 – 1,860 million •SEK 330 – 450 million + 33 – 42% excl. one-time milestones 2023 +131 – 215% excl. one-time milestones 2023 MSEK MSEK 2000 600 1500 406 2023 revenue excl. 2023 profit excl. 1740 400 – one-time impacts
Slide 12: Commercial development
camurus. Commercial development
Slide 13: Buvidal continues to grow in Europe, Australia and MENA
13 Buvidal continues to grow in Europe, Australia and MENA •Sales growth across all markets •Quarterly product sales ‒ Net sales Q4 2023: SEK 366 million; +37% YoY, +6% QoQ MSEK • Strong performance in key markets in UK, Nordics, Australia 400 366 • Germany, Spain, France growing well from a lower b
Slide 14: Brixadi launch gains momentum in the US
14 Brixadi launch gains momentum in the US •Braeburn responsible for US commercialization ‒ Focused commercial organization of over 100 people • Significant treatment gap •Wide access to Brixadi for the treatment of OUD ‒ Available in all 50 US states ~10 million US people misusing opioids2 ‒ High p
Slide 15: Communicating a growing evidence base
15 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 16: R&D update
camurus. R&D update
Slide 17: Octreotide SC depot
17 Octreotide SC depot CAM2029 under development in three serious, rare disease indications • Acromegaly • Gastroenteropancreatic neuroendocrine tumors (GEP-NET) • Polycystic liver disease (PLD) •Designed for enhanced efficacy and patient convenience
Slide 18: Status overview of CAM2029 programs by indication
18 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 19: NDA submission in acromegaly following positive ACROINNOVA Phase 3 study results
19 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 20: CAM2029 has an attractive product profile in acromegaly
20 CAM2029 has an attractive product profile in acromegaly • Higher bioavailability 100 CAM2029 20mg Oct. Conc. (ng/mL) Once-monthly self-administration with prefilled pen 10 Oct LAR 20mg 1 Improved convenience and treatment satisfaction1,2 0.1 0 7 14 21 28 Long-acting release with ~5X octreotide bi
Slide 21: Completed patient recruitment in Phase 3 SORENTO study of CAM2029 in GEP-NET
21 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 22: SORENTO assessing CAM2029 superiority in PFS
22 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 23: Clinical Phase 2/3 study in PLD fully recruited
23 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 24: CAM2029 progressing towards market with key upcoming milestones 2024/25
24 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 25: High market potential for CAM2029 – largest opportunity in GEP-NET
25 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 26: Building commercial infrastructure in the US
26 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 27: Strong foundation for continued value creation
27 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 28: Q&A
camurus. O&A
Slide 29: Key milestones coming months
29 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 30: Shareholders and analyst coverage
30 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 31: Experienced and committed management team
31 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 32: Broad and diversified product portfolio and pipeline
32 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