Slide 1: Third quarter 2021 results
Third quarter 2021 results Audiocast presentation 4 November 2021
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 • Third quarter results and Company participants full year outlook • Commercial development Fredrik Tiberg, PhD President & CEO, Head R&D • R&D pipeline update • Summary Eva Pinotti-Lindqvist Chief Financial Officer • Q&A Richard Jameson Chief Commercial Officer
Slide 4: Q3 highlights – delivering on strategy
4 Q3 highlights – delivering on strategy Commercial execution under continued pressure of the pandemic Product sales • Double-digit Buvidal® sales growth for the 9th consecutive quarter SEK 152 million • Continued very positive feedback from patients, HCPs and policy makers +61% vs Q3 2020 • Buvidal
Slide 5: Positive financial development continues
5 Positive financial development continues Total revenue Operating expenses Operating results MSEK MSEK MSEK MSEK 500 500 300 200 400 400 +37% +81% 100 300 300 0 200 200 -100 +25% 100 100 -200 0 0 -300 Q3, YTD Q3, YTD Q3, YTD Q3, YTD Q3, YTD Q3, YTD Q3, YTD Q3, YTD Q3, YTD Q2 H12019 2019 Q2 H12020 2
Slide 6: Financial Outlook 2021 revised
6 Financial Outlook 2021 revised* •Reasons for adjustments • Product sales • SEK 575 to 595 million (+78-84% YoY) • Continued impact of the pandemic • previously SEK 620 to 680 million – Lockdowns restricting direct access to health care professionals • Total revenue1 – Extended delays of pricing an
Slide 7: Commercial development
7 Commercial development Richard Jameson
Slide 8: Growing patient numbers and market expansion
8 Growing patient numbers and market expansion •High patient shares and growth in established markets •Quarterly product sales ‒ Over 60% patient share in Finland and ~10-20% shares in Scandinavia, MSEK Australia, Wales and Scotland 2-3 years from launch 200 ‒ Good growth in England and Germany with
Slide 9: Growing scientific evidence base
9 Growing scientific evidence base Key publications in 20211-5 Presentations at Scientific Conferences in 2021 Q1 Q2 Q3 Q4 Global ASAM CPDD ISAM AAAP 22-24 Apr 19-23 Jun 19-21 Nov 9-12 Dec Virtual Virtual Virtual Naples, USA AATOD 10-14 Apr Las Vegas, USA European IOTOD EUROPAD ALBATROS 26-27 Apr 19
Slide 10: Buvidal (Brixadi) key regulatory processes
10 Buvidal (Brixadi) key regulatory processes •Brixadi™ US approval decision •Availability of Buvidal in MENA ‒ FDA acceptance of NDA resubmission ‒ Early access programs ongoing in as a complete class II response on 25 three countries June 2021 ‒ MAAs under review in four MENA ‒ New PDUFA date 15 D
Slide 11: R&D pipeline update
11 R&D pipeline update Fredrik Tiberg
Slide 12: Broad and diversified mid- to late-stage pipeline
12 Broad and diversified mid- to late-stage pipeline Phase 1 Phase 2 Phase 3 Registration Market CAM2043 CAM2029 CAM2038 Brixadi™ Buvidal® Pulmonary arterial Polycystic liver disease Chronic pain Opioid use disorder (US)1 Opioid dependence hypertension CAM2047 CAM2032 CAM2029 episil® oral liquid Che
Slide 13: CAM2029 – octreotide subcutaneous depot in Phase 3 development
13 CAM2029 – octreotide subcutaneous depot in Phase 3 development •Under development for three rare diseases; acromegaly, neuroendocrine tumors and polycystic liver disease •Designed for enhanced efficacy and improved patient convenience
Slide 14: CAM2029 status update
14 CAM2029 status update •Acromegaly •Pen injector developed Estimated EstimatedCAM2029 CAM2029 Two phase 3 studies ongoing Validation for Phase 3 and commercial peak sales peak salespotential potential in the 1 Top-line results in H2 2022 use completed in the US USand andEU5: EU5:1 Pre-laun
Slide 15: Phase 3 RCT assessing superiority of CAM2029 vs standard of care in GEP-NET
15 Phase 3 RCT assessing superiority of CAM2029 vs standard of care in GEP-NET Phase 3, randomized, open-label, active-controlled multi-center trial to assess efficacy and safety of CAM2029 versus standard of care in patients with GEP-NET ‒ Approximately 300 patients with GEP-NET randomized 1:1 ‒
Slide 16: Rhythm to start two Phase 3 trials of weekly formulation of setmelanotide
16 Rhythm to start two Phase 3 trials of weekly formulation of setmelanotide •Weekly setmelanotide for genetic •Phase 3 Switch trial obesity disorders ‒ Randomized, double-blind (13+13 w) Daily formulation of setmelanotide, trial in patients with eg. Bardet-Biedl IMCIVREE™, approved by the FDA Syn
Slide 17: Key take aways, Q3 2021
17 Key take aways, Q3 2021 Commercialization Pipeline advancement Corporate development • 9th consecutive quarter of double- • US approval decision for Brixadi • Continued strong growth and digit Buvidal sales growth 15 December 2021 improved result • Growing scientific evidence base • MAA submissio
Slide 18: Q&A
camurus. O&A