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First quarter results 2020
Audiocast presentation7 May 2020
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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
2
Agenda
• First quarter 2020 overview
• Buvidal progress in EU & Australia
• Pipeline update• Key take-aways• Q&A
3
Fredrik Tiberg, PhDPresident & CEO, Head R&D
Eva Pinotti LindqvistChief Financial Officer
Company participants
Richard JamesonChief Commercial Officer
Promising first quarter results
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• Accelerated Buvidal uptake delivers strong sales performance
• Continued pipeline progress
• New commercial and R&D collaborations
• Operational excellence across all teams
• Agility and resilience in a challenging and uncertain time
5
MSEK 2020 Jan-Mar
2019 Jan-Mar % Δ
Total revenues 49.3 18.5 167%
whereof product sales 48.6 11.0 343%
OPEX 117.3 99.4 18%
Operating result -76.9 -84.4 9%
Result for the period -61.6 -67.6 9%
Result per share, before and after dilution, SEK -1.19 -1.62 27%
Cash position 291.3 406.6 -28%
Financials Quarterly product sales 2019/2020
60
50
40
30
20
10
0
Financial overview
MSEK
20202019
+60%
48.6
Q1 Q2 Q3 Q4 Q1
30.3
19.5
11.311.0
Total revenuesSEK 49.3 million+167%
Product salesSEK 48.6 million+343%
OPEXSEK 117.3 million+18%
Q1
5
Pipeline
• Recruitment in Phase 3 acromegaly studies temporarily stalled at most sites
• Focus shifted to other time-critical activities, including autoinjector development and new R&D programs
• Phase 2 study start for CAM2043 postponed to H2 2020
Limited negative impact of Covid-19
6
Business operations
• Operations according to plan
• Supply chain largely unaffected
• Situation closely monitored to ensure supply to clinics and patients
• Uncertainty of long-term impact
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
Source: 1Buvidal Summary of Product Characteristics (SmPC), 2018
7
8
Accelerating uptake of Buvidal
Launched in 7 markets in 2019 7,500 patients in treatment with Buvidal
at the end of March 2020– 90% increase quarter to quarter
Covid-19 highlights Buvidal advantages; catalyst for uptake
Market leader position in Finland and Norway*
Rapid growth in Australia with 3,000 patients on Buvidal end of March
Increasing uptake in Sweden, Germany, UK and Denmark
Increasing use in the criminal justice system
Wide media coverage of Buvidal
10,000
8,000
6,000
4,000
2,000
0
+88%
20202019
Increasing number of patients
Q2 Q3 Q4 Q1Q1
Estimated # patients in treatment with Buvidal at end of quarter
7,500
4,000
2,500
1,300
500
8
* Measured by product sales
Australia GPs allowed to prescribe
Buvidal from 1 April 2020
Norway Outreach services allowing
patient access to Buvidal to mitigate risk of spreading Covid-193
Scotland Government announced
£1.9m budget to support people in prison on OST to switch to Buvidal1
Germany Physician remuneration
system modified to balance reimbursement for different products4
Key access limitations addressed, the foundation for continued growth
9
Wales Wales’ Health Minister
support treatment with long-acting buprenorphine during the ongoing Covid-19 crisis2
1. https://news.gov.scot/news/supporting-people-affected-by-drug-use; 2. https://gov.wales/wales-roll-out-once-month-injection-recovering-heroin-addicts-help-protect-nhs-staff; 3. https://sykepleien.no/2020/04/leverer-lar-medisiner-pa-dora?cid=sm7786262328; 4. https://www.kbv.de/html/1150_45794.php;
Market expansion in Wave 2 countries
Benelux >22,000 patients in opioid
dependence treatment1
Preparation for launch
Austria >18,000 patients in opioid
dependence treatment1
Launch ready for Q2 2020
Spain >58,000 patients in
opioid dependence treatment1
Preparation for launch
Italy ~70,000 patients in opioid
dependence treatment1
Pricing and reimbursement discussions
Launch sequenceWave 1 markets Wave 3 marketsWave 2 markets Wave 4 markets
10
France >179,000 patients in
opioid dependence treatment1
Final regulatory discussion with authorities
1. European Drug Report 2019, EMCDDA
Global strategy for Buvidal (Brixadi)
11
REGION PARTNER NO OF PATIENTS PEAK MARKET POTENTIAL
EUAustralia
~1.3 millionHIGH-RISK
OPIOID USERS1
~€300 million2
North America
>2 millionDIAGNOSED WITH OPIOID USE
DISORDER IN THE US3
$0.6-1.2 billion4, 5
Middle East& North Africa (Israel)
>300,000WITH OPIOID DEPENDENCE6
€25-75 million5
Source: 1European Drug Report 2019; 2Camurus estimate; 3SAMHSA, Results from the 2017 National Survey on Drug Use and Health, Sep. 2018; 4Opioid Use Disorder: Opportunity Analysis and Forecasts to 2027, GlobalData 2018; 5Camurus estimates; 6World Drug Report and NewBridge estimate;
12
Regulatory progress with Buvidal (Brixadi)
New regulatory filings Market authorization application
submitted to the Swiss Agency for Therapeutic Products (Swissmedic)
Market authorization application under review in New Zealand
12
Braeburn preparing for US launch Clear path to final market approval,
after FDA granting Citizen Petition in Nov 2019
Final FDA approval date 1 Dec 2020
All product requirements in place for a successful launch
Braeburn preparing for launch soon after FDA approval
Availability of Buvidal in MENA region Early access programs and
regulatory filings initiated with collaboration partner NewBridgePharmaceuticals
First patients treated with Buvidal
Growing evidence base for Buvidal
Planned conferences where Buvidal will be presented in 2020
13
Key publications1-5
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
2020
Q1 Q2 Q3 Q4
Global Conferences
European Conferences
National Conferences
ASAM2-5 AprVirtual
ALBATROS27-29 Oct
Paris, France
SSA5-6 Nov
Newcastle, UK
K f Suchtmed2-4 Jul
Munich, Germany
DGS konf30 Oct – 1 Nov
Berlin, Germany
CPDD20-24 Jun
Virtual
F Add Psych23-24 Apr
Birmingham, UK
SIPaD18-20 Nov
Sorrento, Italy
ISAM13-16 Nov
Victoria, Canada
IOTOD24-25 Sept
Amsterdam, NL
AAAP10-13 Dec
San Antonio, USA
FederSerDTBD
Napoli, Italy
RCGP MDAP30-31 Jan
London, UK
Encephale22-24 Jan
Paris, France
SFA12-13 Mar
Paris, France
APSAD15-18 Nov
Brisbane, Aus
S Esp San PenTBD
Madrid, Spain
SEPD11-13 June
Seville, Spain
Subforum9-10 May
Mondsee, Aut
Nord Op Sym1-2 Oct
Uppsala, Sweden
SAD5-6 Nov
Uppsala, Sweden
Fin S Add Med5-6 Mar
Helsinki, Finland
LAR konf15-16 Oct
Oslo, Norway
Generation of real-world evidence
‒ Non-randomized prospective non-interventional observational study with control group design (treatment-as-usual, TAU) performed in Germany
‒ The primary objective is to evaluate the quality of life. Secondary objectives include satisfaction, illicit substance use, social participation and cost-effectiveness.
‒ Study started in March 2020
ARIDE – Addiction recovery among opioid-dependent patients treated with injectable subcutaneous depot buprenorphine
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‒ Randomized, open-label, active-controlled study of Buvidal vs standard of care in 120 adult outpatients with opioid dependence
‒ Study met primary and secondary endpoints, e.g. showing superior treatment satisfaction by patients
‒ Accepted for presentation at College on Problems of Drug Dependence, CPDD, in June 2020
DEBUT – Depot Evaluation Buprenorphine Utilization Trial
‒ Prospective, non-randomized, open-label, multicenter study in 129 OUD patients treated with Buvidal or methadone in eight prisons.
‒ Met primary and secondary endpoints ‒ Accepted for presentation at College on Problems of
Drug Dependence, CPDD, in June 2020
UNLOC-T – Safety and feasibility of depot buprenorphine in NSW custodial settings
ARIDE
Day 1 Month 12
Screening
Buvidal weekly & monthly
TAUN=4261
A
Day 1
Screening S
NEW
* Sponsor ARIDE study Centre for Interdisciplinary Addiction Research of Hamburg University (ZIS), Department of Psychiatry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Products and pipeline
15
Own approved medicines License collaborations Own product candidates
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 Pulmonary arterial hypertension
CAM2043 Raynaud’s phenomenon
CAM4071 Endocrine disorders
CAM2047 CINV3)
CAM2048 Postoperative pain1)
Medical device
episil® Oral liquid
1) Braeburn holds the rights to North America2) Developed by Rhythm Pharmaceuticals under a
worldwide license to FluidCrystal®3) CINV – Chemotherapy-induced nausea and vomiting
CAM2038 Chronic pain
Pre-submission meeting held with EMA Rapporteurs
Product positioning & pricing studies under completion
Regulatory submission to EMA planned for third quarter 2020
Pipeline update first quarter 2020
16
CAM2043 PAH* & Raynaud’s
Granted clinical trial application for Phase 2 study in Raynaud’s phenomenon
Study start moved to H2 2020
Preparations for Phase 2 study in pulmonary arterial hypertension ongoing
CAM2029 Acromegaly & NET*
Ongoing recruitment in ACRO Phase 3 trials – stalled at most clinics due to Covid-19
NET registration program aligned with KOL’s and authorities
Autoinjector development accelerated. Bridging PK study to start Q2-Q3
* NET – Neuroendocrine tumors; PAH – Pulmonary arterial hypertension
Rhythm collaborationLong-acting setmelanotide for treatment of genetic obesity disorders
Positive Phase 3 data announced for daily setmelanotide in POMC / LEPR deficiency August 20191
Phase 1b clinical milestone achieved‒ Plasma half-life ~120 hours2
‒ Good tolerability
Phase 2 study under completion
Top-line results expected in 2020
Progress in partnerships
17
Ra Pharma collaborationLong-acting zilucoplan for treatment of complement C5 mediated disorders
License agreement signed July 2019
Preparations for clinical development ongoing
Expected to enter start clinical development in H2 2020
Early stage collaborations
Two new research collaborations with international pharmaceutical companies initiated during the first quarter 2020
Source: 1Press release Rhythm Pharmaceuticals 7 August 2019; 2Rhythm Corporate Presentation – January 2020 https://ir.rhythmtx.com/static-files/38f3b5c8-4b34-4fde-935a-2d041bf20696;
Key take-aways first quarter 2020
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Strong revenue growth
Total revenues of SEK 49.3 million, an increase of 167 % vs Q1 2019
Product sales were SEK 48.6 million, an increase of 343% vs Q1 2019
Product sales increased by 60% compared to previous quarter
Buvidal uptake accelerating
Estimated 7,500 patients in treatment with Buvidal
GPs allowed to prescribe Buvidal in Australia from 1 April 2020
Market authorization application submitted in Switzerland
Pipeline progress
Pre-submission meeting for CAM2038 chronic pain held with EMA rapporteur
Clinical trial application granted for long-acting treprostinil, CAM2043
Two new early stage research collaborations with international pharmaceutical companies initiated
Outlook 2020 – revenues in the higher interval
Financial Outlook 2020
Expected net revenues*SEK 290 - 330 millionwhereof product sales ofSEK 240 - 280 million
Expected full year OPEXSEK 570 - 610 million
*excluding the $35 million milestone for final FDA approval of Brixadi™in the US
19
Camurus’ update on guidance • Full year revenues in the higher end of the interval
— Main drivers of growth are: increasing Buvidal market shares, improved access, expansion into new market and positive clinical data
• Operating costs according to plan —Tracking below but expected to increase as the situation with Covid-19
normalizes and Phase 3 clinical activities are fully resumed
• Next scheduled financial update is 16 July 2020 (Q2 report)
Q&A
20
Shareholders
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Shareholders as of 30 April 2020 Number of shares % of capital % of votesSandberg Development AB 22,200,692 43.0 43.0
Gladiator 3,859,713 7.5 7.5
Fjärde AP-fonden 3,330,676 6.5 6.5
Fredrik Tiberg, CEO 1,703,188 3.3 3.3
Avanza Pension 1,533,263 3.0 3.0
Backahill Utveckling 1,176,491 2.3 2.3
Svenskt Näringsliv 1,100,000 2.1 2.1
Camurus Lipid Research Foundation 505,250 1.0 1.0
Enter fonder 437,561 0.8 0.8
Nordnet Pensionsförsäkring 431,221 0.8 0.8
Carl-Olof och Jenz Hamrins Stiftelse 425,000 0.8 0.8
Grenspecialisten Förvaltning 420,870 0.8 0.8SEB Investment Management 347,872 0.7 0.7Lancelot Asset Management 328,000 0.6 0.6
Other shareholders 13,837,061 26.8 26.8
In total 51,636,858 100.0 100.0
Shareholder distribution
43,0%
7,5%6,5%
3,3%
3,0%2,3%
2,1%
1,0%
0,8%0,8%0,8%0,8%
0,7%
0,6%
26,8%
Agneta SvedbergVice President, Clinical & Regulatory Development
In Company since: 2015Holdings: 11,341 shares & 75,000 subscription warrants
Experienced and committed management team
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Fredrik Tiberg, PhDPresident & CEO
In Company since: 2002Holdings: 1,703,188 shares & 220,000warrants
Education: M.Sc. in Chemical Engineering, PhD in Physical Chemistry, Lund University
Previous experience: Professor in Physical Chemistry at Lund University, Institute for Surface Chemistry (Section head), Visiting Professor at Oxford University,
Eva Pinotti-Lindqvist Chief Financial Officer
In Company since: 2014Holdings: 45,363 shares & 22,891 warrants
Education: Bachelor’s of Science in Economics, Lund University
Previous experience: EQL Pharma (CFO), Nordic Drugs (Nordic Market Analyst), Poolia (Finance Consultant)
Richard JamesonChief Commercial Officer
In Company since: 2016Holdings: 20,490 shares & 80,000 warrants
Education: Bachelor’s of Science in Applied Biological Sciences from University West of England
Previous experience: GM, UK & Nordics for Reckitt Benckiser (2010 – 2013) and Area Director Europe, Middle East and Africa for Indivior (2013 – 2016).
Fredrik Joabsson, PhD Chief Business DevelopmentOfficer
In Company since: 2001Holdings: 45,463 shares & 35,000 warrants
Torsten Malmström, PhD Chief Technical Officer
In Company since: 2013Holdings: 45,363 shares & 8,000 subscription warrants
Annette MattssonVice President, Regulatory Affairs
In Company since: 2017Holdings: 375 shares & 25,000 subscription warrants
Urban PaulssonVice President Corporate Dev.& General Counsel
In Company since: 2017Holdings: 8,125 shares & 115,000 warrants