Slide 1: Full year 2021 results
Full year 2021 results Audiocast presentation 16 February 2022
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 • Full year 2021 summary Company participants • Fourth quarter 2021 highlights Fredrik Tiberg, PhD • Commercial development President & CEO, Head R&D • R&D pipeline update Jon Garay Alonso • Key take-aways Chief Financial Officer • Outlook 2022 Richard Jameson • Q&A Chief Commercial Officer
Slide 4: Significant progress during 2021
4 Significant progress during 2021 MSEK 800 Total Revenue 600 •Strong financial performance - on track to profitability +84% ‒ Net revenue SEK 601 million, an increase of 79% versus 2020 400 ‒ Product sales SEK 594 million, an increase of 84% 200 ‒ Operating result SEK -111 million, an improvement o
Slide 5: Q4 highlights
5 Q4 highlights Product sales SEK 181 million • Accelerated sales of Buvidal for treatment of opioid dependence +74% vs Q4 2020 • EMA application for expanded indication to include chronic pain Operating results • Good recruitment progress in CAM2029 Phase 3 ACRO studies SEK -18 million • First pati
Slide 6: Commercial development
6 Commercial development Richard Jameson
Slide 7: Growing patient numbers and market expansion
7 Growing patient numbers and market expansion •Accelerating fourth quarter sales •Quarterly product sales ‒ 19% increase versus previous quarter MSEK ‒ High market shares in established markets 200 2020 2021 181 ‒ Estimated ~25,000 patients in treatment +19% 152 •Market expansion continues 150 137
Slide 8: Positive momentum for Buvidal in the UK
8 Positive momentum for Buvidal in the UK Increasing awareness New funding initiatives UK 10-year drug plan published 6 Dec 20215: • Benefits of Buvidal recognized • Scottish Government initiative £250m by wider society1-3 investment to tackle drug death crisis1 • Powerful patient stories in • Engla
Slide 9: Continued high activity to disseminate scientific evidence base for Buvidal
9 Continued high activity to disseminate scientific evidence base for Buvidal Key publications in 20211-5 Planned scientific conferences in 2022 Q1 Q2 Q3 Q4 Global ASAM CPDD ISAM 31-Mar- 3 Apr 11-15 Jun 4-7 Oct Hollywood, FL, Minneapolis, Valetta, USA USA Malta European Nordic Op Sym. IOTOD ALBATROS
Slide 10: R&D pipeline update
10 R&D pipeline update Fredrik Tiberg
Slide 11: Broad and diversified mid- to late-stage pipeline
11 Broad and diversified mid- to late-stage pipeline Phase 1 Phase 2 Phase 3 Registration CAM2043 CAM2029 CAM2029 Brixadi™ Pulmonary arterial Polycystic liver disease Acromegaly Opioid use disorder (US)1 hypertension CAM2047 CAM2032 CAM2029 CAM2038 Chemotherapy-induced Prostate cancer Gastroenteropa
Slide 12: Buvidal (Brixadi) regulatory progress
12 Buvidal (Brixadi) regulatory progress New approvals and ongoing processes Brixadi™ in the US ‒ Market authorization in Israel adding to approvals ‒ Braeburn issued with new Complete Response in EU, UK, Switzerland, Australia and New Zealand Letter (CRL) for the Brixadi NDA on 15 Dec 2021 ‒ MAAs u
Slide 13: Buvidal for treatment of chronic pain
13 Buvidal for treatment of chronic pain •Buvidal indication expansion ‒ Regulatory submission (type 2-variation) accepted by EMA for extension of Buvidal indication to include chronic pain ‒ CHMP opinion expected in H2 2022 ‒ Submission to TGA in Australia planned for Q1 2022 •High unmet medical ne
Slide 14: CAM2029 – octreotide subcutaneous depot in Phase 3 development
14 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 15: CAM2029 clinical study program overview
15 CAM2029 clinical study program overview ACRO Phase 3 RCT Four completed clinical trials ACRO Phase 3 OLS characterizing PK, PD and safety in healthy GEP-NET Phase 3 RCT ”SORENTO” subjects and patients (N=249) PLD Phase 2/3 RCT ”POSITANO” OLE Prefilled pen PK bridge - 2021 2022 2023 2024 2025 ACRO
Slide 16: CAM2029 in acromegaly
16 CAM2029 in acromegaly Acromegaly CAM2029 opportunity Market potential ‒ Caused by benign pituitary tumor ‒ Ready-to-use injection pen and syringe secreting excess growth hormone allows patient self-administration and CAM2029 peak sales estimate resulting in severe symptoms and improved convenienc
Slide 17: CAM2029 in neuroendocrine tumors
17 CAM2029 in neuroendocrine tumors Neuroendocrine tumors (NET) CAM2029 opportunity Market potential ‒ Chronic, life-limiting disease caused by ‒ Potential for improved tumor and tumors eg, in GI-tract, pancreas and lung symptom control with CAM2029 CAM2029 peak market sales ‒ SSAs first line treatm
Slide 18: CAM2029 in polycystic liver disease
18 CAM2029 in polycystic liver disease Polycystic liver disease (PLD) CAM2029 opportunity Market potential ‒ Chronic disorder characterized by ‒ Ready-to-use prefilled pen or syringe progressive growth of liver cysts for enhanced convenience and patient CAM2029 peak market sales ‒ Can be very burden
Slide 19: First dosing in Phase 3 program for weekly setmelanotide
19 First dosing in Phase 3 program for weekly setmelanotide •Weekly setmelanotide for genetic obesity disorders Weekly formulation of setmelanotide based on Camurus’ FluidCrystal technology Daily formulation of setmelanotide, IMCIVREE™, approved by the FDA in Nov 20201 and EC in Jul 20211,2 •Pha
Slide 20: Key take aways from a positive fourth quarter 2021
20 Key take aways from a positive fourth quarter 2021 Commercialization execution Pipeline advancement Corporate development Tenth consecutive quarter with EMA application for label Continued strong growth and double-digit sales growth extension for Buvidal to include improved result Acceler
Slide 21: Expected key milestones and outlook 2022
21 Expected key milestones and outlook 2022 •Commercialization Market expansion with new regulatory and market access approvals Approval and preparation for launch in chronic pain •Pipeline advancement Start Phase 2/3 POSITANO study of CAM2029 in polycystic liver disease Enrolment completed
Slide 22: Q&A
camurus. O&A
Slide 23: Financials - fourth quarter and full year 2021
23 Financials - fourth quarter and full year 2021 MSEK Oct – Dec Oct – Dec Δ Jan – Dec Jan – Dec Δ 2021 2020 2021 2020 Total revenues 183 106 73% 601 336 79% whereof product sales 181 104 74% 594 323 84% Operating expenses 174 175 -1% 628 508 24% Operating result -18 -82 78% -111 -205 46% Result for
Slide 24: Shareholders
24 Shareholders Shareholders as of 30 December 2021 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 21,875,692 39.9 39.9 Fjärde AP-fonden 3,330,676 6.1 6.1 Avanza Pension 2,723,086 5.0 5.0 Fredrik Tiberg, CEO 1,672,788 3.1 3.1 29,7% Gladiator 1,518,133 2.8 2
Slide 25: Experienced and committed management team
25 Experienced and committed management team Fredrik Tiberg, PhD Education: M.Sc. in Chemical Engineering, PhD in Physical Jon Garay Alonso Education: Bachelor in Business Administration by President & CEO, Head R&D Chemistry, Lund University Chief Financial Officer Universidad Comercial de Deusto.
Slide 26: Phase 3 RCT to assess superiority of CAM2029 vs standard of care in GEP-NET
26 Phase 3 RCT to assess 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 ‒