Slide 1: Second quarter 2023 results
Second quarter 2023 results Audiocast presentation 18 July 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 • 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 Alberto Pedroncelli Chief Medical Of
Slide 4: Business highlights
camurus. Business highlights
Slide 5: Transformative second quarter with FDA approval
5 Transformative second quarter with FDA approved! Strong commercial execution Pipeline advancement Corporate development Strengthened leadership in LAI FDA approval of Brixadi™ for opioid Record revenue and result treatments for opioid dependence use disorder in the US Sixth consecutive qua
Slide 6: Financial performance
camurus, — Financial performance SF
Slide 7: Strong revenue growth and result
7 Strong revenue growth and result Revenue Operating result MSEK Cash position MSEK 1000 958 500 SEK 654 million 450 +53% vs Q2 2022 400 376 800 674 +114% 300 +438 MSEK 600 200 447 +369 MSEK 100 Q2 400 +197% 7 12 264 0 227 200 137 -60 -100 -86 0 -200 Q2 H1 Q2 H1 Q2 H1 Q2 H1 Q2 H1 Q2 H1 2021 2022 202
Slide 8: Reported Q2 profit and loss
8 Reported Q2 profit and loss CER YTD CER MSEK Apr – Jun Change Change Jan – Jun Change YTD Change YTD 2023 vs. 2022 vs. 2022 2023 vs. 2022 vs. 2022 Total revenues 674 +197% +185% 958 +114% +105% out of which Brixadi milestone 369 369 Gross margin 645 +676bps +689bps 901 +544bps +536bps % GM excludi
Slide 9: Strong cash generation – no debt
9 Strong cash generation – no debt •Continued generation of positive cash flow MSEK 6 27 654 FY 2023 guidance maintained -5 Total revenue and profit before 39 taxes expected in the mid to high end of the interval: 586 Revenue SEK 1,530 – 1,650 million + 60 – 73% vs. 2022 Profit before taxes SEK 425
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 •Sales growth across all markets •Quarterly product sales ‒ Net sales was SEK 305 million; +36% YoY, +8% QoQ MSEK 305 ‒ Est. 42,000 patients in treatment with Buvidal end Q2 300 282 267 •Regulatory and market expansion processes 250 241 225
Slide 12: Brixadi approved in the US
approved in the US! 23 May 2023: “Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery” FDA Commissioner Robert M. Califf, M.D.
Slide 13: Brixadi and Buvidal – well differentiated
13 Brixadi and Buvidal – well differentiated •Convenient and flexible administration ‒ Weekly and monthly dosing LAI features2 ‒ Multiple dose strengths (four weekly, three monthly) Weekly dosing – – ‒ Choice of multiple injection sites Monthly dosing ‒ Thin needle and small dose volumes Mul
Slide 14: Upcoming launch of Brixadi in the US
14 Upcoming launch of Brixadi™ in the US • US launch of Brixadi in September 2023 Positive outlook on BPN LAI market growth2 • Braeburn responsible for commercialization MUSD • Commercial organization and sales force 2000 * * Forecast based Forecasted US sales BPN LAIs on analyst in place * consensu
Slide 15: R&D pipeline update
camurus. R&D pipeline update
Slide 16: Octreotide SC depot
16 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 17: CAM2029 Phase 3 programs advancing
17 CAM2029 Phase 3 programs advancing NDA filing NDA/MAA approval ACRO est. decisions ACRO est. 1 Phase 3 RCT NDA/MAA 2 Phase 3 LST Trial continuation approval decisions GEP-NET est. GEP-NET Phase 3 RCT PLD Phase 2/3 RCT Phase 3 continuation -2022 2023 2024 2025 2026 ACRO Phase 3 RCT ACRO Phase 3 LS
Slide 18: Unmet medical need in acromegaly
18 Unmet medical need in acromegaly •Uncontrolled IGF-1 levels Quality of life of acromegaly patients ‒ Above upper limit of normal (ULN) •Persistent acromegaly symptoms, e.g.; 80 General population (n=12,245) Untreated acromegaly (n=42) ‡ ‒ Fatigue, headache, paresthesia, soft tissue swelling, Trea
Slide 19: ACROINNOVA 1 Phase 3 RCT trial of CAM2029 in acromegaly
19 ACROINNOVA 1 Phase 3 RCT trial of CAM2029 in acromegaly • Primary objective • Key secondary endpoints • Other secondary endpoints ‒ To assess the superiority of ‒ Proportion of patients with mean ‒ Biochemical response (IGF-1 and GH) CAM2029 compared to placebo in IGF- 1 levels ≤ULN at Week 22 an
Slide 20: Octreotide SC depot achieved superiority for IGF-1 and GH response
20 Octreotide SC depot achieved superiority for IGF-1 and GH response Primary and key secondary endpoints met with high statistical significance (ITT) CAM2029- CAM2029 % Placebo % In favor of Placebo In favor of CAM2029 Upper-tailed Placebo % responders responders p-value (95% CI) Primary efficacy e
Slide 21: High statistical difference in time to loss of biochemical response
21 High statistical difference in time to loss of biochemical response (IGF-1>ULN) •Cox regression analysis (ITT): Hazard ratio=0.1; p<0.0001 1 0.9 0.8 0.7 Proportion of responders 0.6 0.5 0.4 0.3 CAM2029 Placebo 0.2 censored 0.1 0 0 4 8 12 16 20 24 28 Weeks ITT – intention-to-treat analysis set.
Slide 22: Improvement in patient reported quality of life scores
22 Improvement in patient reported quality of life (QoL) scores versus standard of care Treatment difference in Acromegaly Quality of Life Questionnaire scores LS Mean of Change AcroQoL Treatment arm Worsening Improving p-value from Baseline CAM2029 4.685 (1.510, 7.861) 0.0038 Total Score Placebo 2.
Slide 23: Key takeaways from ACROINNOVA 1 topline results
23 Key takeaways from ACROINNOVA 1 topline results Met both primary and key secondary endpoints of superiority versus placebo Confirmed by all sensitivity and supportive analyses IGF-1, GH and symptoms were well controlled over time with CAM2029 Improved patient satisfaction and quality of life vers
Slide 24: ACROINNOVA 2 Phase 3 long-term safety and extension trial
24 ACROINNOVA 2 Phase 3 long-term safety and extension trial • Study design • Primary endpoint ‒ 52-week, open-label, long-term safety, switch and ‒ Safety and tolerability of CAM2029 extension trial of CAM2029 in patients with acromegaly ‒ Filling regulatory requirements for safety exposure • Secon
Slide 25: ACROINNOVA 2 Patient demographics by patient group
25 ACROINNOVA 2 Patient demographics by patient group Placebo Rollover CAM2029 Rollover CAM2029 New Full population (N=18) (N=36) (N=81) (N=135) Parameter (unit) Statistics or category n (%) n (%) n (%) n (%) Age (years) Mean (SD) 50.3 (15.4) 56.6 (10.5) 51.8 (11.4) 52.9 (11.9) Min-Max 20-82 35-79 2
Slide 26: ACROINNOVA 2 primary endpoint: Confirmed favorable safety profile
26 ACROINNOVA 2 primary endpoint: Confirmed favorable safety profile Adverse events (AEs) were mostly mild, and none of the serious or severe AEs were related to CAM2029 Placebo Rollover CAM2029 Rollover CAM2029 New Full population (N=18) (N=36) (N=81) (N=135) Category n (%) n (%) n (%) n (%) Any AE
Slide 27: Positive long-term biochemical response in ACROINNOVA 2
27 Positive long-term biochemical response in ACROINNOVA 2 Responder rates (IGF-1≤ULN) after treatment with CAM2029 compared to SoC baseline, or placebo Difference (% and CI) Week 50/52 vs. Responder rates (%) SoC or placebo Overall population ACROINNOVA 2 Significant increase in response rate from
Slide 28: Roll-over patients retain or regain biochemical control
28 Roll-over patients retain or regain biochemical control when treated with CAM2029 •IGF-1 values over time (mean, 95% CI) 2 Mean IGF-1/ULN 1.8 1.6 CAM2029 1.4 1.2 Placebo in ACROINNOVA 1 1 CAM2029 in ACROINNOVA 2 0.8 switched from placebo in ACROINNOVA 1 0.6 0.4 ACROINNOVA 1 ACROINNOVA 2 0.2 0 4 8
Slide 29: Decreasing acromegaly symptom burden over time
29 Decreasing acromegaly symptom burden over time •Change from SoC baseline in Acromegaly Index of Severity Score (6 symptoms)* 2 Acromegaly index of severity overall score, 1 0 CAM2029 in ACROINNOVA 1 and Change from baseline rollover to ACROINNOVA 2 CAM2029, new in ACROINNOVA 2 -1 Placebo in ACROI
Slide 30: Key takeaways from ACROINNOVA 2 interim results
30 Key takeaways from ACROINNOVA 2 interim results Reinforced favorable safety profile over 52-weeks Improved IGF-1 response in the full, partially controlled and treatment naïve population Stable response in controlled patients Improved symptoms versus standard of care at baseline Improved treatmen
Slide 31: Update on CAM2029 clinical programs
31 Update on CAM2029 clinical programs 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, SORENTO
Slide 32: Preparing own commercialization of CAM2029
32 Preparing own commercialization of CAM2029 •Regulatory •Medical affairs – activities Q2 2023 Request for Pre-NDA meeting submitted ‒ ACROINNOVA 1 study design presented at the NDA submission targeted around year end ENDO meeting 15-19 June in Chicago 2023 ‒ SORENTO investigator meeting held i
Slide 33: Key takeaways
33 Key takeaways Transformative quarter with record revenue and earnings Brixadi FDA approved for the treatment of opioid use disorder in the US Strong growth of Buvidal in Europe and Australia Positive Phase 3 results for CAM2029 in acromegaly Camurus Inc. operational in the US
Slide 34: Q&A
camurus. O&A
Slide 35: Key milestones in 2023
35 Key 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 Topline
Slide 36: Shareholders and analyst coverage
36 Shareholders and analyst coverage Shareholders as of 30 June 2023 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 2,333,233 4.2 4.2 Carnegie Fredrik Tiberg, CEO 1,600,000 2.9 2.9 Erik Hultgård State S
Slide 37: Experienced and committed management team
37 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 38: SORENTO: Largest Phase 3 trial of SSA in NET
38 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