Slide 1: First quarter 2023 results
First quarter 2023 results Audiocast presentation 10 May 2023
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: Excellent progress in the first quarter
5 Excellent progress in the first quarter Grow Buvidal Advance the R&D pipeline Build and diversify our business Strengthened leadership in LAI Four Phase 3 trials progressing Fourth consecutive profitable quarter, treatments for opioid dependence across three indications net profit SEK 59 m,
Slide 6: Financial performance
camurus. Financial performance
Slide 7: Revenue growth and result improvement
7 Revenue growth and result improvement Revenue Operating result MSEK MSEK 300 284 100 Cash position 74 SEK 586 million +29% 220 +47% vs Q1 2022 200 50 +69 m 126 Q1 5 100 0 -26 0 -50 Q1 2021 Q1 2022 Q1 2023 Q1 2021 Q1 2022 Q1 2023 Product sales Other revenues
Slide 8: Reported Q1 profit and loss
8 Reported Q1 profit and loss CER MSEK Jan – Mar Change Change 2023 vs. 2022 vs. 2022 Total revenues 284 +29% +24% Gross margin 255 +175bps +139bps Marketing and distribution costs -76 +32% +27% Administrative expenses -9 +37% +32% Research and development costs -99 -15% -18% Other operating expense
Slide 9: Strong cash generation – no debt
9 Strong cash generation – no debt •Continued generation of positive cash flow MSEK Capital allocation priorities • Reinvest in our business: ‒ Buvidal market penetration & geographical expansion ‒ CAM2029 development to market • Synergistic inorganic growth opportunities enhancing company value 23
Slide 10: Commercial development
camurus. Commercial development
Slide 11: Buvidal continuing to grow in Europe, Australia and MENA
11 Buvidal continuing to grow in Europe, Australia and MENA •Solid sales growth •Quarterly product sales ‒ Net sales was SEK 282 million; +40% YoY, +6% QoQ MSEK 300 • Continued growth in Australia and Nordics from a high base 282 267 (market share >20% of treated patients) 241 • UK exceeding 5% mark
Slide 12: US approval decision for Brixadi is imminent
12 US approval decision for Brixadi™ is imminent •Brixadi1 NDA under review by US FDA •Large medical need and treatment gap NDA resubmission with Priority Review NDA approval decision by PDUFA date 23 May 2023 ~10 million US people misusing opioids8 US commercialization by Braeburn under licen
Slide 13: Recent initiatives to address treatment hurdles in the US
13 Recent initiatives to address treatment hurdles in the US •President Biden’s Unity Agenda1 ‒ Combating opioid epidemic key item $ •Increased funding of treatment2 ‒ Over $6 billion to address opioid epidemic in State of the Union 2022 and 2023 and substance misuse in 2022 •Improved access to trea
Slide 14: US opioid use disorder market expected to grow to >$3.5 billion
14 US opioid use disorder market expected to grow to >$3.5 billion in five years •Forecasted North America opioid use •Expected growth primarily from disorder (OUD) market size1 buprenorphine LAI products2 MUSD MUSD 4000 2000 Buprenorhine * LAI share 2022 Forecasted US sales buprenorphine LAIs Forec
Slide 15: Brixadi and Buvidal – well differentiated
15 Brixadi and Buvidal – well differentiated •Flexible dosing and posology ‒ Weekly and monthly dosing LAI features1 ‒ Multiple dose options (four weekly, three monthly) Weekly dosing – – ‒ Choice of multiple injection sites (buttock, thigh, Monthly dosing abdomen or upper arm) Multiple dose
Slide 16: R&D pipeline update
camurus. R&D pipeline update
Slide 17: Octreotide SC depot
17 Octreotide SC depot CAM2029 under assessment 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: CAM2029 has blockbuster potential
18 CAM2029 has block buster potential •Somatostatin analog treatments established with limitations •USD 3 billion SSA market ‒ First-line treatment of acromegaly and neuroendocrine tumors ‒ Potential for significant improvements of efficacy and patient Annual sales of first generation SSAs1 convenie
Slide 19: CAM2029 Phase 3 programs advancing
19 CAM2029 Phase 3 programs advancing NDA/MAA Phase 3 RCT approval decisions ACRO est. NDA/MAA Phase 3 LST Trial extension approval decisions GEP-NET est. GEP-NET Phase 3 RCT PLD Phase 2/3 RCT Phase 3 continuation Prefilled pen PK bridge -2022 2023 2024 2025 2026 ACRO Phase 3 RCT ACRO Phase 3 LST GE
Slide 20: ACROINNOVA 1: Phase 3 efficacy trial in acromegaly
20 ACROINNOVA 1: Phase 3 efficacy trial in acromegaly • Pivotal randomized, placebo-controlled Phase 3 trial • Primary endpoint ‒ Rigorous, 24-week, randomized, double-blind, placebo- ‒ Proportion of patients with mean IGF-1 levels ≤1x upper controlled trial of CAM2029 in patients with acromegaly li
Slide 21: CAM2029 clinical trials status update
21 CAM2029 clinical trials status update 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 Two Phase 3 trials ongoing, SORENT
Slide 22: Ongoing preparations for launches of CAM2029
22 Ongoing preparations for launches of CAM2029 •Manufacturing •Medical affairs – activities Q1 2023 Commercial manufacturing process ‒ Investigator meeting in the SORENTO study held at the established European NeuroEndocrine Tumor Society (ENETS) Process validation completed meeting 22-24 March
Slide 23: Key takeaways
23 Key takeaways Strong start to the year with robust top and bottom-line growth Buvidal market penetration and expansion continues Significant progress in the late-stage R&D pipeline FDA approval decision for Brixadi expected in the next two weeks Phase 3 results for CAM2029 late June
Slide 24: Key expected milestones in 2023
24 Key expected milestones in 2023 •Advancing the pipeline Topline Phase 3 efficacy results in acromegaly First readout Phase 3 long-term safety study Pre NDA meeting for CAM2029 in acromegaly Completed recruitment in SORENTO study in GEP-NET Completed recruitment in POSITANO study in PLD
Slide 25: Q&A
camurus. O&A
Slide 26: Key figures first quarter 2023
26 Key figures first quarter 2023 MSEK Jan – Mar Jan – Mar Change Jan – Dec 2023 2022 2022 Total revenues 284 220 29% 956 whereof product sales 202 202 +40% 935 Operating expenses 184 189 -4% 789 Operating result 74 5 69 72 Result for the period 59 -1 60 56 Result per share, after dilution, SEK 1.02
Slide 27: Experienced and committed management team
27 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 28: Shareholders and analyst coverage
28 Shareholders and analyst coverage Shareholders as of 30 April Number of shares % of capital % of votes Sandberg Development AB 21,875,692 39.5 39.5 Fjärde AP-fonden 3,116,100 5.6 5.6 Analysts Avanza Pension 2,277,315 4.1 4.1 Carnegie Didner & Gerge Fonder 2,024,044 3.6 3.6 Erik Hultgård Fredrik T
Slide 29: ACROINNOVA 2: Phase 3 long-term safety trial in acromegaly
29 ACROINNOVA 2: Phase 3 long-term safety trial in acromegaly • Long-term safety Phase 3 trial • Primary endpoint ‒ 52-week long-term safety, switch and extension trial of ‒ Safety and tolerability of CAM2029 CAM2029 in patients with acromegaly ‒ Filling regulatory requirements for safety exposure •
Slide 30: SORENTO: Largest Phase 3 trial of SSA in NET
30 SORENTO: Largest Phase 3 trial of SSA in NET • Randomized, active-controlled Phase 3 trial • Primary endpoint ‒ Randomized, multi-center, open-label, active-controlled ‒ Superiority in progression free survival, PFS, vs. standard Phase 3 trial of CAM2029 vs. long-acting octreotide or of care (fir