Camurus Ab · OMXSTO:CAMX
Camurus Ab — Q3 2020 Earnings Presentation
25 slides from Camurus Ab's earnings presentation, Nov 5, 2020
Slide 1: Third quarter results 2020
Third quarter results 2020 Audiocast presentation 5 November 2020
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 2020 results Company participants • Commercial development Fredrik Tiberg, PhD • Pipeline update President & CEO, Head R&D • Key take-aways • Q&A Eva Pinotti Lindqvist Chief Financial Officer Richard Jameson Chief Commercial Officer
Slide 4: Highlights in the third quarter 2020
4 Highlights in the third quarter 2020 • Solid financial performance • Buvidal® growth journey continues • Brixadi™ under review by FDA for final US approval 1 December 2020 • Patient recruitment in Phase 3 acromegaly studies of CAM2029 reinitiated and advancing • CAM2029 pivotal Phase 3 NET study a
Slide 5: Financial overview third quarter 2020
5 Financial overview third quarter 2020 Key figures Product sales by quarter Q3 Q1-Q3 MSEK Jul – Sep Jan – Sep MSEK 2020 (2019) Δ 2020 (2019) Δ 100 94.3 Total revenues 100.3 (40.2) +150% 230.4 (70.6) +226% 90 80 75.8 whereof product sales 94.3 (19.5) +383% 218.6 (41.8) +423% 70 OPEX 113.4 (113.0) 0%
Slide 6: Buvidal growth journey continues
6 Buvidal growth journey continues Product sales increased 383% vs Q3 2019 and 24% (26% CER) vs Q2 2020 ‒ Largest markets (Australia, Finland and Norway) continue to expand ‒ Growth accelerating in the UK, Germany and Sweden ‒ Covid-19 challenges with prescription authorizations in Austria, lockdo
Slide 7: EU and Australia launch update
7 EU and Australia launch update Norway Finland Launched in Q3 2019 First market to launch in Q1 2019 Buvidal now market leader Now market leader with >50% share Denmark Sweden KOL support driving change Reimbursement of Buvidal approved by TLV in May 20203 United Kingdom Scottish gove
Slide 8: Wave 2/3 planned countries
8 Wave 2/3 planned countries Benelux Iceland France >22,000 patients in opioid Launch in Q4 2020 >179,000 patients in opioid dependence treatment1 dependence treatment1 Launched in BE in Q3 2020 Final regulatory and pricing Preparing for NL launch in discussions with authorities Q1 2021
Slide 9: Regulatory progress and market expansion
9 Regulatory progress and market expansion •Regulatory filings •Braeburn preparing for US launch CAM2038 Chronic pain Pre-approval received by Swiss Request for final FDA approval of the Pre-submission meeting Agency for Therapeutic Products NDA for Brixadi accepted by FDA held with EU Rapport
Slide 10: Growing scientific evidence base for Buvidal
10 Growing scientific evidence base for Buvidal Important publications1-6 Presentations at Scientific Conferences in 2020 2020 Q1 Q2 Q3 Q4 International ASAM CPDD AAAP Conferences 2-5 Apr 20-24 Jun 10-13 Dec Virtual Virtual Virtual ISAM 12-14 Nov Virtual European IOTOD Conferences 24-25 Sept Virtual
Slide 11: Products and pipeline
11 Products and pipeline Approved medicines Phase 1 Phase 2 Phase 3 Registration Market Buvidal® Opioid dependence Product candidates Brixadi™ Opioid Dependence1) CAM2038 Chronic pain CAM2029 Acromegaly CAM2029 Neuroendocrine tumors CAM2032 Prostate cancer CAM4072 Genetic obesity disorders2) CAM2043
Slide 12: CAM2029 – long-acting subcutaneous octreotide in Phase 3 development
12 CAM2029 – long-acting subcutaneous octreotide in Phase 3 development •Innovative medicine in late-stage development for rare pitituary and neurendocrine disorders and tumors •Designed for enhanced efficacy and patient convenience
Slide 13: CAM2029 opportunity addresses key unmet medical needs in the SSA market
13 CAM2029 opportunity addresses key unmet medical needs in the SSA market •Potential for response rates in acromegaly and NET patients ‒ Fast onset and long-acting release ‒ ~ 500% higher bioavailability vs octreotide LAR1 •CAM2029 offers simplified dosing and possibility of self-administration ‒ R
Slide 14: Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly
14 Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly •Efficacy trial (HS-18-633) •Long-term safety study (HS-19-647) ‒ 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 CAM202
Slide 15: NET Phase 3 program aligned with the FDA
15 NET Phase 3 program aligned with the FDA Meeting held with the US FDA to align on the pivotal study program for CAM2029 in NET • Planned Phase 3 study design ‒ Randomized, multicenter, open-label, parallel-group, active-controlled trial • To assess the superiority of treatment with CAM2029 comp
Slide 16: CAM2029 study program overview
16 CAM2029 study program overview Regulatory Four clinical trials ACRO Phase 3 PC submissions completed in ACRO healthy subjects ACRO Phase 3 LTSE and patients characterizing PK, PD and safety NET Phase 3 profile (N=249) FDA advisory meeting NET PLD Phase 2 Autoinj. PK 2019 2020 2021 2022 ACRO Phase
Slide 17: Significant peak market potential for CAM2029
17 Significant peak market potential for CAM2029 Acromegaly (US+EU5) NET (US+EU5) PLD (US+EU5) $1,015m $415m $245m $720m $720m $180m $145m $180m $435m $265m $485m $120m $240m $60m Profile 1 Profile 2 Profile 3 Profile 1 Profile 2 Profile 3 Currently no approved products Profile 1 Profile 2 Profile 3
Slide 18: Progress in Rhythm collaboration
18 Progress in Rhythm collaboration Weekly setmelanotide (CAM4072) Positive Phase 2 data1 Long-acting setmelanotide for treatment 12 Mean Through Concentration (ng/mL) of genetic obesity disorders 9 Rhythm submitted NDA for daily setmelanotide in POMC / LEPR 6 deficiency – PDUFA date with priority
Slide 19: Reported and anticipated news flow during 2020/21
19 Reported and anticipated news flow during 2020/21 Announcement of strong Start CAM2029 Results CAM2029 Buvidal demand during autoinjector bridging PK study Q1 2020 bridging PK study autoinjector GPs allowed to prescribe Request for final Final market approval MAA submission CAM2038 Buvida
Slide 20: Multiple levers for growth and value creation on short and medium term
20 Multiple levers for growth and value creation on short and medium term ® Buvidal / Brixadi™ Pipeline Corporate Establish leadership in opioid Late-stage development and new Continue to build our dependence treatment with regulatory approvals in chronic commercial infrastructure Buvidal® in
Slide 21: Update of Outlook FY 2020
21 Update of Outlook FY 2020 • FY net revenue and sales guidance reiterated •Financial Outlook 2020 • FY OPEX guidance reduced • Expected FY net revenues1 ‒ Interval revised from SEK 570 - 610m to SEK 505 – 525m, mainly due to Covid-19 •SEK 340 - 380 million • Updated development timelines, includin
Slide 22: Q&A
camurus. O&A
Slide 23: Shareholders
23 Shareholders Shareholders as of 30 September 2020 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 22,200,692 41.4 41.4 Gladiator 3,572,184 6.7 6.7 Fjärde AP-fonden 3,330,676 6.2 6.2 Fredrik Tiberg, CEO 1,703,188 3.2 3.2 Avanza Pension 1,695,342 3.2 3.2 28
Slide 24: Experienced and committed management team
24 Experienced and committed management team Fredrik Tiberg, PhD Education: M.Sc. in Chemical Engineering, PhD in Fredrik Joabsson, PhD Torsten Malmström, PhD President & CEO Physical Chemistry, Lund University Chief Business Development Chief Technical Officer Head R&D Officer Previous experience:
Slide 25: Braeburn arbitration
25 Braeburn arbitration •Camurus announced on 15 June that Braeburn has initiated arbitration proceedings in England1 ‒ Camurus previously served a notice of material breach questioning Braeburn’s performance primarily relating to: • Preparations for regulatory approval and commercialization of Brix