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Q2 2019 Results
18 July, 2019
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-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include currency exchange rate fluctuations, delay or failure of development projects, loss or expiry of patents, production problems, unexpected contract, patent, breaches or terminations, government-mandated or market-driven price decreases, introduction of competing products, Camurus‘ ability to successfully market products, exposure to product liability claims and other lawsuits, changes in reimbursement rules and governmental laws and interpretation thereof, and unexpected cost increases. Camurus undertakes no obligation to update forward-looking statements
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3
Agenda
Fredrik TibergPresident & CEO, Head R&D
Eva Pinotti LindqvistChief Financial Officer
Second quarter highlights
Buvidal® launch in the EU and Australia
R&D update
Key take-aways
Q&A
Participants
4
Camurus in brief
Listed on Nasdaq STO; ticker CAMXMarket Cap: ~ SEK 3.5 billionCash position: ~ SEK 283 million (Q2 ‘19)Employees: 117 HQ: Lund, SwedenRegional Offices: Cambridge, Mannheim, Paris, Sydney
Unique FluidCrystal®nanotechnologies
Own commercial organization
Approved commercial products
Partnerships
Experienced management and dedicated teams
• In-house developed with strong IP • New generation long-acting depot technology• Validated in 20 clinical trials and by approved products
• Launching Buvidal® in Europe and Australia
• Weekly and monthly Buvidal® approved in the EU and Australia for treatment of opioid dependence
• Braeburn, Rhythm, Ra Pharmaeuticals, SolasiaPharma, Medison
Broad, late-stage R&D pipeline
• 10 clinical programs in addiction, pain, oncology, endocrinology, obesity and CV
Financial overview Q2/H1 2019
5
• Patients treated with Buvidal® increased from ~ 500 to 1,300 across 150 clinics
• Buvidal® launch expanded to Australia and Norway
• Positive reimbursement decisions in key markets
• Phase 3 study of CAM2029 in acromegaly initiated
• GMP manufacturing of CAM2029 IMP completed and released
• Braeburn initiated court proceedings to overturn market exclusivity and seek immediate US market approval of Brixadi™
• Fast track 180 days procedure granted for Buvidal® in Israel
• Buvidal® Phase 3 long-term safety results published in Addiction
• License agreement with Ra Pharma for long-acting formulation FluidCrystal® zilucoplan for complement C5 mediated disease
Q2 2019 highlights
MSEK Q2 H2
Net revenue 11.9 (7.3) 30.4 (22.0)
Product sales 11.3 (2.9) 22.3 (5.9)
Op. result -109.8 (-81.2) -194.2 (-127.6)
Result after tax -87.6 (-67.5) -155.3 (-103.8)
Cash 283.1 (199.1)
Q2
Q3
Reiterated 2019 FY guidance Net revenue MSEK 130–160, whereof product sales MSEK 70–90
Buvidal® launch gaining momentum
Buvidal®/Brixadi™ (CAM2038)
• Buvidal® is indicated (EU) for treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents from 16 years
• Individualized dosing for use across treatment phases:initiation, switching from daily medications and long-term maintenance treatment
• Superiority versus daily standard treatment with daily buprenorphine/naloxone included in clinical outcomes
• Removes burdens and stigma of daily medication
• HCP administration safeguards against diversion, misuse and pediatric exposure
7
Buvidal® – first long-acting treatment of opioid dependence in the EU and Australia
INTERNAL USE ONLY. NOT TO BE CONSIDERED BRIEFING MATERIAL FOR REPRESENTATIVES.Source: Buvidal Summary of Product Characteristics (SmPC), 2018
Wave 1 markets
Wave 3 marketsWave 2 markets
Wave 4 expansion
Launch sequence
HQLundSweden
CambridgeUK
ParisFrance
MannheimGermany
SydneyAustralia
Preparations in Wave 2-3 markets‒ Launches planned in Austria, Spain, Italy, France
and other EU countries Q3 2019 to Q2 2020• Pricing and reimbursement applications • Key functions onboarded
8
Buvidal® launch in EU & Australia gaining momentum1
Launch initiated in all Wave 1 markets ‒ Finland, Sweden, UK, Germany, Denmark,
Norway and Australia• Positive pricing and reimbursement decisions
in key markets, including Australia and Norway • Fully operational teams – 65 heads• Effective supply and distribution
– within 24 hours delivery to clinic
• Expansion into new markets ‒ Launches initiated in Australia and Norway in Q2‒ Wave 2&3 markets from Q3 2019
• Successful HTA review processes‒ Positive reimbursement decisions and recommendations
in Q2, incl. in Norway and Australia
• Formulary inclusion and funding release‒ 38 formularies in the UK and 25 formularies in Australia
have agreed to include Buvidal® as treatment option
• Medical education, evidence sharing and practical assistance ‒ Regional, national and local symposia, webinars, clinician
road shows, and case study publications
• Very positive feedback from patient and HCPs‒ Improved stability, less burden, more freedom
• High retention with only few dropouts‒ Similar or better than long-term Ph. 3 study
• Initial patient uptake and sales vary by country‒ 160 percent patient growth Q1 to Q2‒ Not reflected in sales due to initial stock-up in Q1‒ Primary barrier is market access
• Reimbursement and formulary listings
• Significant potential in the custodial setting ‒ Buvidal® introduced in 10 correctional facilities in the EU‒ UNLOC-T study progressing in Australia
Drivers of growth Experiences from initial launch markets
9
Key takeaways from initial launch markets
HTA: Health Technology Assesment
Finland
POPULATION
5.5 million
HIGH RISK OPIOID USERS1
~14,000IN TREATMENT FOR
OPIOID DEPENDENCE1
~3,300~2,100 ~1,200BUPREN. METHADONE
Status June 2019 Observations
10
~ 490 Buvidal® patients, 60 clinics‒ New to treatment ‒ Conversion from sublingual
buprenorphine, both from film and tablets
‒ Conversions from methadone
> 20% buprenorphine market share
~ 15% of total treated patients
• High initial retention‒ less than 25 patients (<5%)
dropped out since launch
• High acceptance by patients
• Most patients still on weekly depot
• Initial use in criminal justice setting
• Efficacy, misuse and diversion are the main reasons for starting treatment with Buvidal®
Update on Finland – first launch market
Source: 1. EMCDDA 2019, European Drug Report
Non-inferior and superior efficacy demonstrated in pivotal Phase 3 study versus standard daily SL BPN/NX1
High Treatment Retention ~70% at 48 weeks2
Blockade of Opioid Effects from the first dose3
Effective suppression of withdrawal and cravings1,2,3
Safety Profile comparable to SL BPN/NX except for mild and moderate injection site reactions1,2
No Opioid Overdoses reported across clinical studies for participants treated with Buvidal®1,2,3,4,5
High Patient Satisfaction including versus SL BPN2
Positive case-studies published6
Growing evidence base for Buvidal®versus daily standard treatment
1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773; 2Frost et al, Addiction, 2019;114(8):1416-1426, 3Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 4Haasen, C, et al, J Subst Abuse Treat. 2017;78:22-29; 5Albayaty M, et al, Adv Ther. 2017 34(2):560-575; 6D’Agnone O, Case Reports in Psychiatry, 2019 https://doi.org/10.1155/2019/9381346
CO
NFI
DEN
TIAL
11
NEW
Buvidal® scientific communication and data dissemination – strong presence driven by KOL’s
2019Q1 Q2 Q3 Q4
Global Conferences
European Conferences
National Conferences
ASAM4-7 Apr
Orlando, USA
ALBATROS5-7 Jun
Paris, France
SSA7-8 Nov
Newcastle, UK
ICDD19-22 Jun
Madrid, Spain
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K f Suchtmed4-6 Jul
Münich, Germany
Selected conferences where Buvidal® data will be presented
Gef-med T5-6 Dec
Frankfurt, Germany
IOTOD13-14 May
Frankfurt, Germany
Lisbon Add23-25 Oct
Lisbon, Portugal
CPDD15-20 Jun
San Antonio, USA
F Add Psych30 Apr – 1 May
London, UK
ISAM13-16 Nov
New Delhi, India
APSAD10-13 Nov
Hobart, Australia
ATHS1-4 Oct
Biarritz, France
‒ Prospective, non-randomized, open-label, case-comparison, multicenter trial in custodial settings
‒ 60 adult prisoners treated with Buvidal® compared with 60 matched cases of methadone treated patients
‒ Primary objective to test safety and tolerability, diversion and HEOR
‒ Secondary objectives to compare efficacy and QoL
‒ Prospective, randomised, open-label, active-controlled, multicenter trial
‒ 120 adult outpatients have been randomized 1:1 to CAM2038 vs SL BNX. LPLV Sept. 2019
‒ Primary objective to compare patient satisfaction‒ Secondary objectives QoL, HEOs and other PROs
The Depot Evaluation Buprenorphine Utilization Trial (DEBUT)
Safety and feasibility of depot buprenorphine in NSW custodial settings (UNLOC-T)
13
Continuing building the evidence base
DEBUT
Day -28 to -1 Day 1 Week 24
Screening
SC CAM2038 q1w or q4w at flexible doses
Follow-upperiod
Week 26
BPN standard of careat flexible doses
n=1201
R
UNLOC-T
Screening
Day 0 Day 1 Week 16 Week 48Week 4
Extended safetymonitoring
Active follow-up
E
Methadone
Buvidal®Weekly
Buvidal®Monthly
n=1201
Buvidal®Monthly
0
10
20
30
40
50
60
70
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
From other drugs
Opioid overdose
Opioid dependence – escalating global health crisis
• Tentative approval Brixadi™ on 21 Dec. 2018• Final approval of monthly product subject to the expiration
of a 3-year exclusivity period until 30 November 2020 –unless earlier resolved
• Brixadi™ Weekly not blocked by exclusivity and can be approved and launched separately
• Braeburn has initiated court proceedings to overturn exclusivity and seeks immediate market approval of Brixadi™ in the US
• Court hearing at the United States District Court in District of Columbia held on July 15, 2018
• Decision expected later in Q3• Camurus eligible to $35 million on approval of Brixadi®
weekly and monthly depots for treatment of OUD
Source: 1. UNODC, World Drug Report 2017; 2. Center for Disease Control & Prevention 2018; 3. Frazier at al, 2017, Journal of the American Medical Association; 4. Crow D. Financial Times.com, accessed on March 13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da 14
Mounting US opioid overdose deaths2
(thousands)
#1 cause of death for people under 50 in the US30:1 non-fatal to fatal overdoses3
Recent US life expectancy decline largely due to opioids4
Pipeline update
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Broad late-stage clinical pipeline
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CAM2048/58 POSTOPERATIVE PAIN & PONV4 - BRAEBURN1
Buvidal® q1w OPIOID DEPENDENCE
CAM2038 q1w CHRONIC PAIN1
CAM2029 ACROMEGALY
CAM4072 GENETIC OBESITY DISORDERS - RHYTHM2
CAM2043 PULMONARY ARTERIAL HYPERTENSION
Brixadi® q1w OPIOID DEPENDENCE - BRAEBURN1
CAM2047 CINV3
Brixadi® q4w OPIOID DEPENDENCE - BRAEBURN1
Buvidal® q4w OPIOID DEPENDENCE
CAM2038 q4w CHRONIC PAIN1
CAM2029 NEUROENDOCRINE TUMORS
CAM2032 PROSTATE CANCER
CAM4071 UNDISCLOSED INDICATION
1. Braeburn holds the rights to North America; 2. Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal®; 3. Chemotherapy-induced nausea and vomiting; 4. Postoperative nausea and vomiting;
PHARMACEUTICALS PHASE 1-2 PHASE 3 REGISTRATION MARKET
MARKET
MARKET
PHASE 3
PHASE 3
PHASE 3
PHASE 2
PHASE 2
PHASE 2
PHASE 1
TENTATIVE APPROVAL
TENTATIVE APPROVAL
PHASE 1
PHASE 1
PHASE 1
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CAM2038 chronic pain – large market withhigh unmet medical needs
Market opportunity
• 100 million Americans and 75 million Europeans with chronic pain1,2
• 74 million patients with chronic low back pain (CLBP) in 7MM in 20183
• Chronic pain estimated to cost US society USD +600 billion per year4
Medical needaddressed
• Effective round-the-clock pain management, with potential of reduced risks of tolerance, dependency and respiratory depression
• HCP administration can improve treatment adherence and safeguards against diversion, misuse, abuse and child exposure
Key clinicalresults
• CAM2038 met primary and key secondary Phase 3 endpoints in a pivotal enriched-enrollment and randomized withdrawal study – Superiority demonstrated for relief of average and worst pain intensity
compared to placebo (P<0.0001, mITT). – Well tolerated with favorable safety profile
Next steps • Final Clinical Study Report of Phase 3 LTSE study being compiled• Meetings with health authorities in H2 2019• Regulatory submissions planned for H1 2020
Source: 1. Global Industry Analysts, Inc. report 2011; 2. Pain Practice 2014, 14, 79-94; 3. Chronic Lower Back Pain (CLBP). Market Insights, Epidemiology, and Market Forecast-2028, Delveinsight, May 2019. 4. Gaskin D, Richard P., J. Pain 2012; 13 (8): 715-724. MME: morphine milligram equivalent. 7MM – seven major markets
653 99561 04154 945
41 06017 873
27 873105 097
~1 million high-risk CLBP patients
(>99 MME*/day)3
US JapanGermany FranceItaly SpainUK
18
CAM2029 – Phase 3 study initiation
Market opportunity
• Somatostatin analogue sales 2018: >USD 2.6 billion1
• 20 years of market growth at 20% CAGR• Long-acting SSA US price-range: $51,000 to $146,000 WAC / year2
Medical need addressed
• Enhanced efficacy and response rates in treatment of acromegaly and pain • Easy and convenient dosing, with self-administration option
Key clinicalresults
• Long-acting octreotide release demonstrated3
• High octreotide exposure3
• Rapid and sustained suppression of insulin growth factor-1 (IGF-1)3
• Well maintained or improved biochemical control indicated in patients with acromegaly4
• Well maintained or improved symptom control indicated in NET patients4
Next steps • 24-week, randomized, placebo controlled Phase 3 study to assess efficacy and safety of CAM2029 in patients with acromegaly
• 52-week, open-label Phase 3 safety and tolerability study of CAM2029 in patients with acromegaly
Source: 1. GlobalData 2019; 2. US weighted average cost for mid-range doses, 20183. Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 4. Pavel M et al, Cancer Chemotherapy and Pharmacology 2019; 83:375–385
02505007501000125015001750200022502500Somatuline® (Ipsen)
Sandostatin® LAR®(Novartis)
mUSD
19
CAM2029 ACRO Phase 3 program design
The primary objective is to assess the superiority of CAM2029 compared to placebo in biochemical response for IGF-1. The safety and tolerability of CAM2029 will also be assessed, together with patient-reported treatment satisfaction and health-related quality of life parameters
Prior treatment withoctreotide LAR
Prior treatment withlanreotide ATG
CAM2029 once monthly
Placebo once monthly
Rescue with standard of care
Screening phase 4-8 wks Double-blind treatment phase 24 wks
R
New patientsPrior treatment with
octreotide LARor lanreotide ATG
Roll-over patients from trial HS-18-633
CAM2029 once monthly CAM2029 once monthly
24 Weeks 28 Weeks
Screening phase 4-8 wks Open-label treatment phase
Randomized, double-blind phase 3 study of CAM2029 vs. placebo control (HS-18-633)
Open-label phase 3 long‐term safety study (HS-19-647)
20
Plans for continued development of CAM2029 for treatment of acromegaly
Four clinical trials completed in healthy subjects and patients characterizing PK, PD and safety profile (N=249)
Phase 1, SAD
Phase 1, MAD
Phase 1, MAD
Phase 2, MAD
2019 20212020 2022
Open label, long-term safety study
ACRO Phase 3 LTSE
Placebo controlled (PC) Phase 3 study in SSA responders
ACRO Phase 3 PC Regulatory submissions
Inhibition of hemolysis following a single dose of zilucoplan FluidCrystal® in cynomolgus monkeys (n=4)
CAM4083: Complement-mediated disorders CAM4072: Genetic disorders of obesity
21
• Zilucoplan FluidCrystal® weekly SC depot‒ Treatment of generalized myasthenia gravis (gMG),
immune-mediated necrotizing myopathy (IMNM), and other serious complement C5 mediated disorders
• Preclinical PoC demonstrated
• Preparations for clinical development ongoing
• Program conducted by Ra Pharmaceuticals under license agreement with Camurus
• Setmelanotid FluidCrystal® weekly SC depot‒ Treatment of POMC deficiency, LEPR deficiency, and
Bardet-Biedl syndrome obesity
• Phase 1b clinical milestone in 2018‒ Plasma half-life ~120 hours ‒ Good tolerability
• Phase 2 study progressing
• Program conducted by Rhythm Pharmaceuticals under license agreement with Camurus
Progress in partnerships
Key take-aways – second quarter 2019
Buvidal® / Brixadi™
• Buvidal® launch initiated and expanded into new markets• Patients in treatment with Buvidal® grew from ~500 to 1,300 at 150 clinics• Improved access through price and reimbusement approvals in key markets • Court proceedings in the US with decision expected in Q3 2019
Pipeline • Pivotal Phase 3 program for CAM2029 in acromegaly initiated • Preparation of ”pre-submission” meetings with HAs for CAM2038 in chronic pain• Phase 2 study of weekly setmelanotide by Rhythm in the US • License agreement with Ra Pharma for FluidCrystal® depot of zilucoplan
Financials • Net revenues of MSEK 11.9 (7.3), whereof MSEK 11.3 (2.9) from product sales• Expected full year revenue of MSEK 130-160, with products sales of MSEK 70-90• Cash position end of Q2 MSEK 283.1
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Q&A
23