Camurus Ab · OMXSTO:CAMX
Camurus Ab — Investor Presentation (January 2021)
33 slides from Camurus Ab's investor presentation, January 2021
Slide 1: Company presentation January 2021
Company presentation January 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: Long-acting medications addressing key healthcare challenges
Long-acting medications addressing key healthcare challenges
Slide 4: Corporate highlights
4 Corporate highlights Rapidly growing commercial Broad late-stage pipeline stage company • +10 innovative clinical programs in • Fully operational infrastructure in Europe addiction, pain, oncology, endocrine and Australia disorders and CV diseases • Buvidal® to date available in 14 countries • Two
Slide 5: Camurus' FluidCrystal long-acting release technology has unique properties
5 Camurus‘ FluidCrystal® long-acting release technology has unique properties Easy and convenient administration Adopted to prefilled syringes and autoinjectors Rapid onset & long-acting release Manufacturing by standard processes Applicable across substance classes Strong intellectual p
Slide 6: FluidCrystal – Long-acting release
6 FluidCrystal – Long-acting release Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071) pasireotide plasma concentration (ng/mL) pasireotide plasma concentration (ng/mL) 10 10 Pasireotide IR 600 ug (SC Pasireotide FluidCrystal 20 thigh, n = 94) mg (SC thigh, n = 12) 1 1 0,
Slide 7: Camurus had a successful 2020 despite the challenges
7 Camurus had a successful 2020 despite the challenges • Strong revenue growth, pipeline advancement and building of shareholder value • Established the significant value Buvidal brings to patients, HCPs, payors and society – as best-in-class treatment • Demonstrated successful commercialization of
Slide 8: Opioid dependence – escalating global health crisis
8 Opioid dependence – escalating global health crisis • Largest society burden of all drugs1 Escalating overdose deaths • 58 million opioid users worldwide1 • High need for better access to care 1 200 and new treatment alternatives 1 000 • Investment in treatment brings substantial 800 value and sav
Slide 9: Buvidal – flexible long-acting treatment of opioid dependence
9 Buvidal® – flexible long-acting treatment of opioid dependence Flexible-dose, weekly and monthly, subcutaneous buprenorphine for treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1 Launch initiated in Europe a
Slide 10: Strong growth of Buvidal in EU and Australia
10 Strong growth of Buvidal in EU and Australia Increasing market shares Product sales by quarter ‒ Largest markets (Australia, Finland and Norway) MSEK continue to expand 100 94.3 ‒ Growth accelerating in the UK, Germany, 90 Sweden, Denmark, Austria, and Belgium 80 75.8 ‒ Impacts of Covid-19 have
Slide 11: Global strategy for Buvidal (Brixadi)
11 Global strategy for Buvidal (Brixadi™) REGION PARTNER NO OF PATIENTS MARKET POTENTIAL EU ~1.3 million ~€300 million2 Australia LAUNCH INITIATED IN 2019 HIGH-RISK OPIOID USERS1 North >2 million $0.6-1.2 billion4, 5 America DIAGNOSED WITH OPIOID USE DISORDER IN THE US3 Middle East & North >300,000
Slide 12: Regulatory progress and market expansion
12 Regulatory progress and market expansion •New approval •Braeburn receives CRL in the US CAM2038 Chronic pain Market authorization approval by On the PDUFA date 1 Dec. 2020, Pre-submission meeting Swissmedic in December 2020 Braeburn received a complete held with EU Rapporteur response lette
Slide 13: Significant opportunity in mid- to late-stage pipeline
13 Significant opportunity in mid- to late-stage pipeline Approved medicines Phase 1 Phase 2 Phase 3 Registration Market Buvidal® Opioid dependence Product candidates Brixadi™ Opioid Dependence1) CAM2038 Chronic pain CAM2029 Acromegaly CAM2029 Neuroendocrine tumors CAM2032 Prostate cancer CAM4072 Ge
Slide 14: CAM2029 – long-acting subcutaneous octreotide in Phase 3 development
14 CAM2029 – long-acting subcutaneous octreotide in Phase 3 development •Innovative medicine in late-stage development for rare pitituary and neurendocrine disorders and tumors •Designed for enhanced efficacy and patient convenience
Slide 15: CAM2029 opportunity addresses key unmet medical needs in the SSA market
15 CAM2029 opportunity addresses key unmet medical needs in the SSA market •Somatostatin analogues (SSAs) are first-line medical therapy in •CAM2029 offers simplified dosing and possibility of self-administration •US$ 2.8 billion acromegaly and NET ‒ Ready-to-use prefilled syringe or • CURRENT SSA a
Slide 16: CAM2029 supported by data from four clinical studies
16 CAM2029 supported by data from four clinical studies • Dose proportional long-acting octreotide release suitable for once monthly dosing1 • Rapid and sustained suppression of insulin-like growth factor-1 (IGF-1) in HVs • Well-maintained or improved biochemical control indicated in acromegaly pati
Slide 17: Phase 2 pilot study indicates good or improved symptom control in NET patients
17 Phase 2 pilot study indicates good or improved symptom control in NET patients Pharmacokinetics in NET patients Flushing and diarrhea in NET patients Steady-state pharmacokinetic profiles 100 Oct-LAR CAM2029 2 Monthly mean number symptoms/day CAM2029 20mg q4w NET patients ss Bowel movements Flush
Slide 18: Study also indicates well-maintained or improved biochemical control in acromegaly
18 Study also indicates well-maintained or improved biochemical control with CAM2029 in acromegaly IGF-1 in acromegaly patients Growth hormone (GH) in acromegaly patients Oct-LAR CAM2029 Oct-LAR CAM2029 250 8 Time weighted average (% of ULN) GH concentration (mg/mL) 200 6 150 1.3xULN 4 ULN 100 ULN 2
Slide 19: Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly
19 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 20: NET Phase 3 program aligned with the FDA and EMA
20 NET Phase 3 program aligned with the FDA and EMA IND submitted to FDA after Type B meeting • Phase 3 study design ‒ Randomized, multicenter, open-label, parallel-group, active-controlled trial • To assess the superiority of treatment with CAM2029 compared to octreotide LAR or lanreotide ATG on
Slide 21: CAM2029 study program overview
21 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) NET IND submitted PLD Phase 2 Autoinj. PK 2019 2020 2021 2022 ACRO Phase 3 PC A
Slide 22: Significant market potential expected for CAM2029
22 Significant market potential expected for CAM2029 Acromegaly (US+EU5) NET (US+EU5) PLD (US+EU5) Recent GlobalData report: $1,015m $415m $245m $720m $720m $180m $145m $180m $435m $265m $485m $120m $240m $60m November 2020 Profile 1 Profile 2 Profile 3 Profile 1 Profile 2 Profile 3 Currently no app
Slide 23: Progress in Rhythm collaboration
23 Progress in Rhythm collaboration Weekly setmelanotide (CAM4072) Positive Phase 2 data announced1 Long-acting setmelanotide for treatment 12 Mean Through Concentration (ng/mL) of genetic obesity disorders 9 Daily setmelanotide in POMC / LEPR deficiency approved by the FDA on 6 27 November 20201
Slide 24: Strong news flow during 2020/21 – selected events
24 Strong news flow during 2020/21 – selected events Announcement Start CAM2029 Start CAM2029 Buvidal third wave of strong Buvidal autoinjector Phase 3 study market expansion demand bridging PK study in NET Start Phase 2 CAM2029 in PLD Raised Publication of Completion of Phase 3 FY 2020 DEBUT
Slide 25: Multiple levers for growth and value creation on short and medium term
25 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 regulatory approvals in chronic commercial infrastructure with Buvidal in E
Slide 26: Camurus AB contact details
26 Camurus AB │ Ideon Science Park, SE-223 70 Lund, Sweden P +46 46 286 57 30 │ [email protected] │ camurus.com
Slide 27: Experienced and committed management team
27 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 28: Shareholders
28 Shareholders Shareholders as of 30 December 2020 Number of shares % of capital % of votes Shareholder distribution Sandberg Development AB 22,200,692 40.8 40.8 Fjärde AP-fonden 3,330,676 6.2 6.2 Gladiator 3,095,142 5.7 5.7 Avanza Pension 1,873,132 3.5 3.5 Fredrik Tiberg, CEO 1,653,188 3.1 3.1 29.
Slide 29: Financial overview third quarter 2020
29 Financial overview third quarter 2020 Key figures Q3 Q1-Q3 MSEK Jul – Sep Jan – Sep 2020 (2019) Δ 2020 (2019) Δ Total revenues 100.3 (40.2) +150% 230.4 (70.6) +226% whereof product sales 94.3 (19.5) +383% 218.6 (41.8) +423% OPEX 113.4 (113.0) 0% 332.7 (332.5) 0% Operating result -23.4 (-77.4) +70
Slide 30: ~740,000 patients estimated suited for treatment with Buvidal in the EU and Australia
30 ~740,000 patients estimated suited for treatment with Buvidal in the EU and Australia Buprenorphine Methadone New treatment Not in treatment due to Total potential treated1,2 treated ≤30 mg1-3 journeys rules and burden of 12 months1 daily treatment1,4,5 15 percent market penetration would corresp
Slide 31: Buvidal is well differentiated
31 Buvidal is well differentiated Long-acting injection treatments for opioid dependence CHOICE OF ROOM CLIN. DATA WEEKLY MONTHLY MULTIPLE SMALL LOW DAY ONE PRODUCT INJECTION TEMP. VS ACTIVE LAUNCHED DOSING DOSING DOSES NEEDLE VOLUMES INITIATION SITES STORAGE CONTROL* 23G 0.16 – 0.64 mL
Slide 32: Compelling clinical evidence from head-to-head DEBUT study
32 Compelling clinical evidence from head-to-head DEBUT study •DEBUT – Depot Evaluation Buprenorphine Study met primary endpoint demonstrating superiority Utilization Trial for TSQM global satisfaction1 ‒ Randomized, multi-site, open-label, active-controlled study Scheduled Visit Statistic Buvidal S
Slide 33: Further studies continue to expand the Buvidal evidence base
33 Further studies continue to expand the Buvidal evidence base •UNLOC-T – Safety and feasibility of depot •ARIDE – Addiction recovery among opioid- buprenorphine in NSW custodial settings dependent patients treated with injectable ‒ Prospective, non-randomized, open-label, multicenter study in subc