Slide 1: First quarter results 2021
First quarter results 2021 Audiocast presentation 6 May 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 • First quarter 2021 overview Company participants • Commercial development Fredrik Tiberg, PhD • Pipeline update President & CEO, Head R&D • Key take-aways Eva Pinotti-Lindqvist • Q&A Chief Financial Officer Richard Jameson Chief Commercial Officer
Slide 4: Significant progress on key priorities
4 Significant progress on key priorities •Strong commercial development and progress with Buvidal Total revenue • Expansion of the commercial platform in Europe and Australia SEK 126 million • Successful life-cycle management and regulatory approvals +155% vs 2020 • Growing scientific evidence for B
Slide 5: Positive first quarter financial development
5 Positive first quarter financial development Revenue Operating expenses Operating results MSEK MSEK MSEK Q1 2019 Q1 2020 Q1 2021 140 140 0 +16% 120 120 -20 100 100 -40 +155% +66% 80 80 -60 60 60 -80 40 40 -100 20 20 -120 0 0 -140 Q1 2019 Q1 2020 Q1 2021 Q1 2019 Q1 2020 Q1 2021 Product sales Admini
Slide 6: Buvidal – flexible long-acting treatment of opioid dependence
6 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 7: Opioid dependence – worsened global health crisis during pandemic
7 Opioid dependence – worsened global health crisis during pandemic • Largest society burden of all drugs1 Escalating overdose deaths ‒ 58 million opioid users worldwide during COVID-19 • High need for better access to care and 12 Month-ending Provisional Number new treatment alternatives of Drug Ov
Slide 8: Strong growth for Buvidal during challenging period
8 Strong growth for Buvidal during challenging period Product sales 124m SEK; up 156% vs Q1 2020, Product sales by quarter 20% vs last quarter MSEK ‒ Exceptional market penetration in Australia & Nordics 140 124 ‒ Good progress in UK and Germany and smaller markets 120 ‒ COVID-19 remains barrier f
Slide 9: Buvidal launches in Wave 3 markets being prepared
9 Buvidal launches in Wave 3 markets being prepared Netherlands Switzerland ~10,000 patients in opioid 10,000 patients1 dependence treatment1 Marketing approval received Launch expected in Q2 2021 Launch expected in Q2/Q3 2021 France Croatia and Slovenia >179,000 patients1 >8,000 patie
Slide 10: Product and pipeline update
10 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 Buvidal® 160mg episil® oral liquid Chemotherapy
Slide 11: Buvidal (Brixadi) lifecycle management and geographic expansion
11 Buvidal (Brixadi) lifecycle management and geographic expansion •New approvals •Brixadi™ in the US CAM2038 Chronic pain ‒ Market authorization approval in ‒ Complete response letter (CRL) issued ‒ Pre-submission meeting New Zealand by FDA for the Brixadi NDA on held with EU Rapporteur ‒ Approval
Slide 12: CAM2029 – octreotide subcutaneous depot in Phase 3 development
12 CAM2029 – octreotide subcutaneous depot in Phase 3 development •Innovative medicine in late-stage development for the treatment of rare diseases; acromegaly, neuroendocrine tumors and polycystic liver disease •Designed for enhanced efficacy and patient convenience
Slide 13: CAM2029 study program overview
13 CAM2029 study program overview Regulatory ACRO Phase 3 PC submissions Four clinical ACRO trials completed in healthy ACRO Phase 3 LTSE subjects and patients NET Phase 3 characterizing PK, PD and IND NET Ph. 3 PLD Phase 2/3 safety (N=249) Autoinj. PK - 2020 2021 2022 2023 ACRO Phase 3 PC ACRO Phas
Slide 14: CAM2029 update status
14 CAM2029 update status •Acromegaly •Autoinjector development Estimated CAM2029 ‒ Two phase 3 studies ongoing ‒ Prefilled pen available for clinical trials peak sales potential ‒ On track for NDA/MAA submissions ‒ Phase 1 bridging study ongoing in the US and EU5:1 in late 2022 ‒ Orphan drug designa
Slide 15: Recent and anticipated news flow 2021/22
15 Recent and anticipated news flow 2021/22 Start CAM2029 Phase 3 Start CAM2029 Phase 3 efficacy results study in GEP-NET Phase 2/3 in PLD CAM2029 in acromegaly Results CAM2029 Start CAM4072 registration Results CAM2029 Phase 3 long- autoinjector PK study study program (Rhythm) term safety study in
Slide 16: Key strategies for value creation in short and medium term
16 Key strategies for value creation in short and medium term Pipeline advancement • Late-stage development and new regulatory approvals for CAM2038 and CAM2029 • Grow our pipeline of innovative medicines and expand the use of our FluidCrystal® technology in areas of high unmet need and market poten
Slide 17: Q&A
camurus. O&A
Slide 18: Key figures first quarter 2021
18 Key figures first quarter 2021 MSEK Jan – Mar Jan – Mar Change Jan – Dec 2021 2020 2020 Total revenues 126 49 +155% 336 whereof product sales 124 49 +156% 323 Operating expenses 136 117 +16% 508 Operating result -26 -77 +66% -205 Result for the period -22 -62 +64% -167 Result per share, before an
Slide 19: Reiterated Outlook 2021
19 Reiterated Outlook 2021 •Key assumptions: 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 uptak
Slide 20: Shareholders
20 Shareholders Shareholders as of 30 April 2021 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 22,000,692 40.6 40.6 Fjärde AP-fonden 3,330,676 6.1 6.1 Gladiator 2,167,026 4.0 4.0 Avanza Pension 1,794,547 3.3 3.3 Fredrik Tiberg, CEO 1,696,788 3.1 3.1 29.5%
Slide 21: Experienced and committed management team
21 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 Previous experi
Slide 22: Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly
22 Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly •Efficacy trial •Long-term safety trial ‒ Phase 3, randomized, double-blind, placebo-controlled, ‒ Phase 3, open-label, single arm, multi-center trial to multi-center trial to assess efficacy and safety of CAM2029 assess the long-term s
Slide 23: GEP-NET Phase 3 trial under start-up
23 GEP-NET Phase 3 trial under start-up Phase 3, randomized, open-label, active-controlled multi-center trial to assess efficacy and safety of CAM2029 versus octreotide LAR or lanreotide ATG in patients with GEP-NET ‒ Approximately 300 patients with GEP-NET randomized 1:1 ‒ Primary endpoint: super