Slide 1: Second quarter and half-year results 2021
Second quarter and half-year results 2021 Audiocast presentation 15 July 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 • Strategic objectives Company participants • Second quarter and half-year 2021 results Fredrik Tiberg, PhD President & CEO, Head R&D • Commercial development • R&D update Eva Pinotti-Lindqvist Chief Financial Officer • Key take-aways • Q&A Richard Jameson Chief Commercial Officer
Slide 4: Strategic objectives for continued growth
4 Strategic objectives for continued growth Bring new innovative medicines to market approvals to build and diversify our business Establish Buvidal as preferred treatment choice and market leader in the long-acting opioid dependence segment Strategic Drive commercial execution objectives excellence
Slide 5: Continued strong operating performance
5 Continued strong operating performance Executing on commercial objectives Total revenue • Double-digit Q/Q sales growth – limited by effects of the pandemic SEK 138 million • Successful life-cycle management with approvals in three markets +71% vs 2020 • Publication of compelling clinical results
Slide 6: Second quarter and half-year results
6 Second quarter and half-year results Revenue Operating expenses Operating result 2019 2020 2021 MSEK MSEK MSEK MSEK Q2 H1 Q2 H1 Q2 H1 400 140 400 200 120 300 300 100 100 80 200 200 0 60 40 100 100 -100 20 0 00 -200 Q2 H1 Q2 H1 Q2 H1 Q22019 Q1 Q2 H1 2019 Q22020 Q1 Q2 H1 2020 Q22021 Q1 Q2 H1 2021 20
Slide 7: Buvidal – flexible long-acting treatment of opioid dependence
7 Buvidal® – flexible long-acting treatment of opioid dependence Weekly and monthly, subcutaneous buprenorphine for individualized treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1 Buvidal provides significant
Slide 8: Robust Buvidal sales growth continues under pressure by the pandemic
8 Robust Buvidal sales growth continues under pressure by the pandemic •High market penetration in Australia and the Nordics •Product sales SEK 137m; up 80% vs Q2 2020 ‒ Estimated patient market share >60% in Finland and ~10-20% MSEK in Scandinavia and Australia (~80,000 patients in ODT) 160 •Progre
Slide 9: Increasing support for Buvidal and improved access to innovative ODT treatments
9 Increasing support for Buvidal and improved access to innovative ODT treatments •Government initiatives to increase •Growing scientific evidence base funding and improve treatment access ‒ Positive results in peer-reviewed ‒ Scottish government and Public Health scientific journals England allocat
Slide 10: Growing scientific evidence base for Buvidal
10 Growing scientific evidence base for Buvidal Important publications in Q2 20211-3 Presentations at Scientific Conferences in 2021 2021 Q1 Q2 Q3 Q4 International ASAM CPDD ISAM AAAP Conferences 22-24 Apr Virtual 19-23 Jun Virtual 28 Sep – 1 Oct Valetta, Malta 9-12 Dec Naples, USA European IOTOD No
Slide 11: Product and pipeline update
11 Product and pipeline update Phase 1 Phase 2 Phase 3 Registration Market CAM2043 CAM2029 CAM2029 Brixadi™ Buvidal® Pulmonary arterial Polycystic liver disease Acromegaly Opioid use disorder (US)1 Opioid dependence hypertension CAM2047 CAM2032 CAM2029 episil® oral liquid Chemotherapy-induced Prosta
Slide 12: Buvidal (Brixadi) lifecycle management and geographic expansion
12 Buvidal (Brixadi) lifecycle management and geographic expansion •New market approvals •Brixadi™ in the US CAM2038 Chronic pain ‒ Buvidal 160mg monthly dose in the EU, ‒ NDA for treatment of opioid use ‒ Pre-submission meeting UK and Australia disorder resubmitted to then US FDA held with EU Rappo
Slide 13: High unmet need for new treatment options in the US
13 High unmet need for new treatment options in the US Opioid crisis worsened during COVID-19 Escalating overdose deaths pandemic during COVID-19 ‒ Opioid overdose deaths has mounted during the 12 Month-ending Provisional Number pandemic and now exceed > 60,000 per year1 of Drug Overdose Deaths in t
Slide 14: Opportunity for long-acting injectables in US opioid use disorder market
14 Opportunity for long-acting injectables (LAIs) in US opioid use disorder (OUD) market •US market expected to grow1 LAI OUD PRODUCT ‒ Current US market size of USD ~2 billion1 ‒ Expected to grow to USD >3 billion in 2028 mainly WEEKLY DOSING – – driven by transition to LAIs1 MONTHLY DOSING
Slide 15: CAM2029 – octreotide subcutaneous depot in development
15 CAM2029 – octreotide subcutaneous depot in development •For treatment of acromegaly, neuroendocrine tumors (NET), and polycystic liver disease (PLD) •Designed for enhanced efficacy and patient convenience
Slide 16: CAM2029 study program overview
16 CAM2029 study program overview Regulatory ACRO Phase 3 PC submission Four clinical ACRO trials completed Regulatory in healthy ACRO Phase 3 LTSE submission subjects and GEP-NET patients NET Phase 3 characterizing PK, PD and IND NET Ph. 3 PLD Phase 2/3 Ext. treatment period safety (N=249) Autoinj.
Slide 17: CAM2029 update status
17 CAM2029 update status •Acromegaly •Prefilled pen development Estimated CAM2029 ‒ Two phase 3 studies ongoing ‒ Phase 1 bridging study ongoing peak sales potential ‒ Top-line results in 2022 ‒ Results in H2 2021 in the US and EU5:1 ‒ Pre-launch activities initiated ‒ Validation for Phase 3 and com
Slide 18: Recent and anticipated news flow 2021/22
18 Recent and anticipated news flow 2021/22 H1 2021 H2 2021 2022 Buvidal market approval Start CAM2029 Phase 3 in NET Results CAM2029 Phase 3 in New Zealand efficacy study Results CAM2029 bridging Line-extension approvals of PK study with prefilled pen Results CAM2029 Phase 3 Buvidal in
Slide 19: Key takeaways Q2 2021
19 Key takeaways Q2 2021 Commercialization Pipeline advancement Corporate development • Continued significant sales growth • Potential for US approval of • Financed to execute on our of Buvidal in Europe and Australia Brixadi in December 2021 strategic objectives and reach • Successful Buvidal life-
Slide 20: Q&A
camurus. O&A
Slide 21: Financials - second quarter and first half 2021
21 Financials - second quarter and first half 2021 MSEK Apr – Jun Apr – Jun Change Jan – Jun Jan – Jun Change Jan – Dec 2021 2020 2021 2020 2020 Total revenues 138 81 +70% 264 130 103% 336 whereof product sales 137 76 +80% 261 124 110% 323 Operating expenses 179 102 +75% 315 219 44% 508 Operating re
Slide 22: Shareholders
22 Shareholders Shareholders as of 30 June 2021 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 22,000,692 40.3 40.3 Fjärde AP-fonden 3,330,676 6.1 6.1 Avanza Pension 2,506,313 4.6 4.6 Gladiator 1,762,953 3.2 3.2 Fredrik Tiberg, CEO 1,706,788 3.1 3.1 29.1% D
Slide 23: Experienced and committed management team
23 Experienced and committed management team Fredrik Tiberg, PhD Education: M.Sc. in Chemical Engineering, PhD in Physical Eva Pinotti-Lindqvist Education: Bachelor’s of Science in Economics, Lund President & CEO, Head R&D Chemistry, Lund University Chief Financial Officer University In Company sinc
Slide 24: CAM2029 has potential for best-in-class, offering clear advantages over current long-acting SSAs
24 CAM2029 has potential for best-in-class, offering clear advantages over current long-acting SSAs Key Brands Sandostatin® LAR® (octreotide) Somatuline® Autogel® (lanreotide) Signifor® LAR (pasireotide) CAM2029 Presentation Powder in a vial, requiring Pre-filled syringe Powder in a vial, requiring
Slide 25: Outlook 2021 maintained
25 Outlook 2021 maintained •Key assumptions1: Revenue •Full year 2021 guidance* • Excludes a potential $35m milestone for • Revenue final approval of Brixadi in the US • Product sales estimate based on end of •SEK 680 – 750 million 2020 Buvidal patient numbers, a similar • whereof product sales upta