Company Presentation - Camurus · 22/1/2020 · Company Presentation. SEB Annual Pharma & Biotech...
Transcript of Company Presentation - Camurus · 22/1/2020 · Company Presentation. SEB Annual Pharma & Biotech...
Company PresentationSEB Annual Pharma & Biotech Seminar22 January 2020 Fredrik Tiberg, President & CEO
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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Long-acting medications address key healthcare challenges
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Unique FluidCrystal®nanotechnologies• In-house developed with strong IP• New generation long-acting depot technology• Validated in 20 clinical trials and byapproved products
Two Phase 3 programs• Late-stage pipeline with 10 innovative clinical programs in addiction, pain, oncology, endocrine and CV disease
• Growing early stage opportunities
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Camurus in brief
Approved medicinesWeekly and monthly Buvidal®
for the treatment of opioiddependence
Own commercialorganizationFully operational in Europe and Australia
PartnershipsR&D collaborations, licensing and royalty arrangements withnumerous companies
Experiencedmanagement and dedicatedteams
LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP
~ SEK 4.8 billion EMPLOYEES: 120 HQ: Lund, SwedenREG. OFFICES: Cambridge, Mannheim, Paris, Sydney
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Camurus 2019 highlights
• Buvidal launch initiated in EU and Australia• Clear path to final US approval of Brixadi™ 1 December 2020
following FDA’s grant of Braeburn’s Citizen Petition • Growing evidence base for Buvidal with new Phase 3 publication
and superiority outcomes in DEBUT study vs standard of care• Start of two Phase 3 studies of CAM2029 in acromegaly• Marketing approval application for CAM2038 in chronic pain
under preparation in the EU• License agreement with Ra Pharma for long-acting zilucoplan • SEK 700 million raised in gross proceeds to drive Buvidal®
launches and late-stage pipeline developments to the market
Buvidal® launch 2019• Sales started in 7 markets in the EU and
Australia• Pricing & reimbursement in key markets‒ Australian government supports affordable
access to Buvidal® as part of a $40 million package
• Fully operational commercial infrastructure • Effective product distribution
First full year sales report 12 February 2020
Injection of liquidformulationusing prefilled syringe or autoinjector
Slow release of drug
Drug release and biodegradation of gel matrix to full resolution
Encapsulatingliquid crystal gel triggered by water uptake
time
6
Easy to administer Rapid onset & long-acting release Applicable across substance classes
Good safety and tolerability profile Unique lipid compositions Strong intellectual properties
H2O
drug
bloo
dco
nc.
FluidCrystal® in situ gel formation
Sources: Tiberg F, et al. Chapter in Long Acting Injections and Implants, Advances in Delivery Science and Technology 2012; Tiberg F, et al. OnDrugDelivery 2010; Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011.
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Weekly and monthly buprenorphine depots
Illustration of population pharmacokinetic profiles for Buvidal vs sublingual buprenorphine
Source: Albayaty M, Linden M, Olsson H, Johnsson M, Strandgarden K, Tiberg F. Adv Ther. 2017;34(2):560–575; Buvidal: EPAR - Public assessment report, December 2018. Available at: https://www.ema.europa.eu/en/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf
Population PK analysis and modelling based on data from four clinical studies (N=236). Diagnostic testing demonstrated predictive buprenorphine concentrations and good agreement between observed and predicted data percentiles. Steady state data.
Weekly Buvidal vs. daily sublingual buprenorphine Weekly vs. monthly Buvidal
Individualized weekly and monthly treatment for opioid dependence
Buvidal® / Brixadi™
Opioid dependence – escalating global health crisis
• Largest society burden of all drugs1
• 35 million opioid users worldwide1
• High need for better access to care and new treatment alternatives
• Investment in treatment brings substantial value and saves lives
• Significant limitation with current daily medications– Diversion, misuse, overdosing, poor retention,
burdens and stigma of daily buprenorphine and methadone medications
Sources: 1UNODC, World Drug Report 2019; 2.EMCDDA 2018, National Records of Scotland, Centers for Disease Control and Prevention 3Frazier at al, 2017, Journal of the American Medical Association; 4Crow D. Financial Times.com, accessed on March 13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da 9
Mounting opioid overdose deaths2
0
5
10
15
20
25
30
Scotland
USA
SwedenUKFinland
Germany
Australia
Dru
g ov
erdo
se d
eath
s pe
r 100
,000
, age
gro
up 1
5-64
#1 cause of death for people under 50 in the US2,3
Recent US life expectancy decline largely due to opioids4
Buvidal® – first long-acting treatment of opioid dependence in the EU and Australia
Flexible-dose, weekly and monthly, subcutaneousbuprenorphine for treatment of opioid dependencewithin a framework of medical, social and phychologicaltreatment in adults and adolescents 16 years or over1
10Source: 1Buvidal Summary of Product Characteristics (SmPC), 2018
*
Less burden and stigma for patients
• Improved convenience and quality of life • Ability to live a more normal life
Safeguard against misuse overdosing and diversion
• Continuous blockade of effect of illicit opioids• Healthcare professional administration safeguards
against diversion, misuse and pediatric exposure
Demonstrated improved treatment outcomes
• Superiority versus standard of care with daily sublingual buprenorphine medications
• High retention in clinical trials and real worlds settings
Suitable for patients across treatment phases
• Individualized dosing for use across treatment phases: initiation, switching from daily medications and long-term maintenance treatment
Objective: Establish Buvidal as a new standard of care in opioid dependence
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Buvidal brings significant values over daily medications
Source: Buvidal Summary of Product Characteristics (SmPC), 2018
*
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Buvidal is well positioned against the competition
*Based on information in product labels
PRODUCT WEEKLY DOSING
MONTHLY DOSING
MULTIPLE DOSES
CHOICE OF INJECTION
SITES
SMALL NEEDLE
LOW VOLUMES
ROOM TEMP.
STORAGE
DAY ONE INITIATION
CLIN. DATA VS ACTIVE CONTROL*
LAUNCHED
23G
0.16 – 0.64mL
EU, AUSTRALIA
– – – – –19G
–0.5 – 1.5 mL
– – US
– – – – –20G
–3.4 mL
– – US
Long-acting injection treatments for opioid dependence
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Global commercialization strategy for Buvidal (Brixadi)
Source. 1World drug report 2019.
ESTIMATED
35 millionWORLDWIDE
OPIOID USERS 20171
Braeburn Braeburn option rightCamurus 1st entry markets Medison (Israel)Camurus
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Buvidal launch gaining momentum in EU & Australia 1
Launch sequence
HQLundSweden
CambridgeUK
ParisFrance
MannheimGermany
SydneyAustralia
Wave 1 markets Wave 3 marketsWave 2 markets Wave 4 expansion
0
10
20
30
40
50
Q1 Q2 Q3
MSE
K
Accumulated product sales YTD
Quarterly product sales
Initial sales Jan-Sept 2019
Launched in seven Wave 1 markets in 2019 ‒ Exceptional performance in Finland with >30% BPN
patient share end Q3 2019‒ Strong start in Norway and Australia after pricing and
reimbursement listings in Q3 2019‒ Accelerating uptake in Germany, Sweden, Denmark
and UK‒ Est. 2,500 patients treated with Buvidal end Q3 2019‒ 73% increase in sales Q3 vs Q2 2019‒ Very positive response by patients and physicians
2020 launches in Wave 2-3 markets‒ Austria, Spain, Italy, Benelux, Portugal, other EU
countries, and MENA following approvals of pricing and reimbursement
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~740,000 patients estimated suited for treatmentwith Buvidal® in the EU and Australia
1EMCDDA 2018 Drug report 2https://www.aihw.gov.au/reports/alcohol-other-drug-treatment-services/nopsad-2018/contents/introduction%C2%A0 3Camurus estimate 4Benyamina et al 2013 Heroin Addiction and Related Clinical Problems 14 (4): 65-80. 5Camurus data on file 2018, Patient qualitative study. 6Based on average daily price of USD 10/day and 270 treatment days/patient/year
Buprenorphine treated1,2
Methadonetreated ≤30 mg1-3
New treatment journeys
12 months1
Not in treatment due to rules and burden of
daily treatment1,4,5
Total potential
15 percent market penetration would correspond to annual sales of ~ SEK 3 billion6
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Growing Buvidal evidence base disseminated at conferences and in renown scientific journals
2019Q1 Q2 Q3 Q4
Global Conferences
European Conferences
National Conferences
Selected conferences where Buvidal data was presented in 2019
ASAMOrlando
ALBATROSParis
SSANewcastle
ICDDMadrid
K f SuchtmedMünich
Gef-med TFrankfurt
IOTODFrankfurt
Lisbon AddLisbon
CPDDSan Antonio
F Add PsychLondon
ISAMNew Delhi
APSADHobart
ATHSBiarritz
SIPaDRome
FederSerdMilan
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
“CAM2038 compared to my previously prescribed sublingual buprenorphine treatment”
Much worse
Slightly worse
About the same
Slightly better
Much better83% POSITIVE
N=133
High treatment satisfaction by patients
Source: Frost et al, Addiction, 2019;114(8):1416-1426 17
Features rated as extremely important or much better (7 on scale 1-7) by majority of patients
Spares regular visits to the pharmacy Prevents others access to my medication Prevents accidental exposure to children Daily medication not required Improves my privacy as a patient Helps me not miss or skip medication dose Allowed to travel with no medication
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Additional trials to demonstrate utility and advantages of Buvidal
DEBUT
Day -28 to -1 Day 1 Week 24
Screening
Buvidal® Weekly & Monthly flexible dosing
Follow-upperiod
Week 26
BPN SoCflexible dosing
n=1201
R
UNLOC-T
Screening
Day 0 Day 1 Week 16 Week 48Week 4
Extended safetymonitoring
E
Methadone
Buvidal®Weekly
Buvidal®Monthly
n=1201
Buvidal®Monthly
‒ Prospective, non-randomized, open-label, case-comparison, multicenter trial in custodial settings
‒ 129 opioid dependent patients in eight prisons treated with Buvidal or methadone. Preliminary results in Q1 2020
‒ Primary objective to test safety, tolerability, diversion and HEOR‒ Secondary objectives to compare efficacy and QoL
‒ Prospective, randomized, open-label, active-controlled, multicenter study of Buvidal versus standard of care in120 adult outpatients with opioid dependence
‒ Study met both primary and secondary objectives• Superior TSQM global satisfaction score, p=0.0143• Significantly higher TSQM effectiveness and
convenience domain scores, p<0.0001
DEBUT – Depot Evaluation Buprenorphine Utilization Trial
Safety and feasibility of depot buprenorphine in NSW custodial settings (UNLOC-T)
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Brixadi™ – significant opportunity in the US
Source: 1. Centers for Disease Control and Prevention
3 434
4 881 6 143
7 288
8 739 9 849
10 790 11 612
12,48213,657
15 055
0
4 000
8 000
12 000
16 000
TRx
Volu
me
(000
s)
Buprenorphine Vivitrol Total
US treatment rates continue to rise• Tentative approval on 21 Dec. 2018• FDA revoked the orphan designation for
Sublocade™• Braeburn has clear pathway to marketing
authorization on December 1, 2020‒ Triggers $35m approval milestone for OUD to Camurus‒ $70m in sales milestones‒ Mid teen royalty on product sales
• Strong and competitive product label and commercial product availability
• All product requirements for successful launch are in place
• Commercial strategy addressed need for reliable, easy access to effective treatment
10%3-year CAGR
Buvidal® q1w OPIOID DEPENDENCE
CAM4072 GENETIC OBESITY DISORDERS - RHYTHM2
CAM2043 PULMONARY ARTERIAL HYPERTENSION
Brixadi® q1w OPIOID DEPENDENCE - BRAEBURN1
CAM2048/58 POSTOPERATIVE PAIN & PONV4 - BRAEBURN1
Brixadi® q4w OPIOID DEPENDENCE - BRAEBURN1
Buvidal® q4w OPIOID DEPENDENCE
CAM2032 PROSTATE CANCER
CAM2047 CINV3
1Braeburn holds the rights to North America; 2Developed by Rhythm Pharmaceuticals under a worldwide license to FluidCrystal®; 3Chemotherapy-induced nausea and vomiting; 4Postoperative nausea and vomiting;
PRODUCT PHASE 1-2 PHASE 3 REGISTRATION MARKET
MARKET
MARKET
CAM2038 q1w CHRONIC PAIN1
CAM2029 ACROMEGALY
CAM2038 q4w CHRONIC PAIN1
CAM2029 NEUROENDOCRINE TUMORS
PHASE 3
PHASE 3
PHASE 3
PHASE 2
PHASE 2
PHASE 2
PHASE 1
TENTATIVE APPROVAL
TENTATIVE APPROVAL
PHASE 1
PHASE 1
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Broad and late-stage pipeline
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CAM2038 in chronic pain – large market with highunmet medical needs
Market opportunity in chronic pain Medical need addressed
• ~100 million Americans and ~75 million Europeans with chronic pain1,2
– 74 million patients with CLBP in 7MM in 20183
– At least 1 million high-risk CLBP patients in 7MM on doses > 99 mg morphine equivalents per day3
• Chronic pain estimated to cost US society USD +600 billion per year4
• 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 clinical results• CAM2038 met primary and key secondary Phase 3
endpoints in a pivotal enriched-enrollment and randomized withdrawal study
Next step • Regulatory submissions planned for H1 2020
Source: 1Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research (2011) https://www.nap.edu/read/13172/chapter/2; 2Pain Alliance Europe https://pae-eu.eu/activities-2/petition-on-chronic-pain-in-europe; 3Chronic Lower Back Pain (CLBP). Market Insights, Epidemiology, and Market Forecast-2028, Delveinsight, May 2019. 4Gaskin D, Richard P., J. Pain 2012; 13 (8): 715-724. MME: morphine milligram equivalent. 7MM – seven major markets
Improving lives of patients with neuroendocrine and pituitary disorders
CAM2029
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Acromegaly and neuroendocrine tumors (NET) combined represent a >$2bn market with a ‘sub-optimal duopoly’
Sources: 1GlobalData 2019 and Recordati Press Release 12 July 2019; 2Globe Life Sciences reports 2019; 3Financial reports and filings, Novartis & Ipsen, 2016–2018SSA – somatostatin analogue
NET
Acro
ESTIMATED
67,000ACROMEGALY & NET PATIENTS
TREATED WITH SSAs IN US / EU52
50,000patients
17,000patients
US$ 2.7 billionCURRENT SSA MARKET VALUE1,3
Sandostatin® LAR ® (octreotide) and Somatuline® Autogel ®
(lanreotide) are first-line medical therapy in acromegaly and NET
02505007501000125015001750200022502500
Somatuline® (Ipsen)
Sandostatin® LAR®(Novartis)
mUSD
Global sales
Significant limitations withcurrent SSA treatments
Difficult handling & administration− Need for regular visits at specialty clinics
or home nursing − IM or deep SC dosing− Large bore needles− No real self-administration option
Sub-optimal treatment response− Significant room for improving efficacy;
disease biomarkers in acromegaly and symptom and tumor control in NETs
Simple administration Potential for self-administration
• Ready-to-use prefilled syringe and autoinjector for enhanced convenience with option to self-administer
Potential for improved biochemicaland symptom control• Limited response with current SSA treatments in
acromegaly; ~25-45% biochemical control3,4
• Significant room for improvement of symptom and tumor control in patients with GI- NET
• Fast onset and long-acting release with500% higher bioavailibility vs octreotideLAR1
• Well maintained or improved biochemical and symptom control indicated with CAM2029 in acromegaly and NET patients2
Strategy: Position CAM2029 as the gold standard somatostatin analogue across acromegaly and NET, offering the most convenient and effective treatment option
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CAM2029, octreotide SC depot, offers clear differentation and addresses the key market unmet needs
Source: 1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2.Pavel M et al, Cancer Chemotherapy and Pharmacology 2019; 83:375–385; 3Carmichael JD, et al., J Clin Endocrinol Metab. 2014 May;99(5):1825-33; 4Melmed S, et al., Nat Rev Endocrinol. 2018 Sep;14(9):552-561
0
50
100
150
200
250
Day -28 - Day 0 Day 0 - Day 28 Day 28 - Day 56 Day 56 - Day 84
Tim
e w
eigh
ted
aver
age
(% o
f ULN
)
Patient 1 Patient 2 Patient 3Patient 4 Patient 5
IGF-1 in acromegaly patients Flushing and diarrhea in NET patient
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Phase 2 study indicates improved biochemical and symptom control when switching from Sandostatin® LAR to CAM2029
Analysis of data from Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019; 83(2): 375–385GH, growth hormone; IGF-1, insulin-like growth factor 1; LAR, long-acting release; NET, neuorendocrine tumors
0
0,5
1
1,5
2
Day -28 - Day 0 Day 0- Day 28 Day 28 - Day 56 Day 56 - Day 84
Mon
thly
mea
nnu
mbe
rsym
ptom
s/da
y
Bowel movementsFlushings
Oct-LAR CAM2029 Oct-LAR CAM2029
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Top-level development program for CAM2029
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 Phase 3 study in SSA responders
ACRO Phase 3 PC Regulatory submissions
ACRO
Active controlled Phase 3 study in patients with metastatic, well differentiated GEP-NET
NET Phase 3
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External market assessment of combined US/EU-5 peak sales for acromegaly and NET1
$60m
$145m
$120m
$180m
$180m
$245m
$240m
$435m$485m
$720m
$720m
$1,015m
Peak Sales for NETPeak Sales for Acromegaly Scenario 1CAM2029 is available as a pre-filled syringe (PFS) device with equivalent efficacy to current long-acting SSAs, with an assumed penetration of 10–20% in Acromegaly, and 10–15% in NET
Scenario 2Available both as PFS and as an autoinjector, with equivalent efficacy to current long-acting SSAs and an assumed penetration of 20–25%
Scenario 3Available both as PFS and as an autoinjector, with data suggesting superior efficacy over current long-acting SSAs, and an assumed higher penetration of 30–35%
Estimated potential peak sales range $300m – $1,260m, depending on product profile
+superiorefficacy
Source: Globe Life Sciences reports 2019; data on file
CAM20294th indication
CAM20293rd indication
Building an endocrinology franchise based on CAM2029 and related SSA assets
CAM2029 octreotide SC depot• Lead indications‒ Acromegaly‒ NET
• Potential additional indications‒ In-depth market assessments
of four prioritized indications
CAM4071 pasireotide SC depotCAM2049 somatostatin SC depot
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CAM2029NET
CAM2029Acromegaly
CAM4071Indication to
be announced
CAM2049Indication to be
announced
Inhibition of hemolysis following a single dose of zilucoplan FluidCrystal® in cynomolgus monkeys (n=4)
Ra Pharma: Complement-mediated disordersRhythm: Genetic disorders of obesity
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• Zilucoplan FluidCrystal SC depot‒ Treatment of generalized myasthenia gravis (gMG),
immune-mediated necrotizing myopathy (IMNM), and other serious complement C5 mediated disorders
• Preclinical PoC• Preparations for clinical
development ongoing• License agreement signed
with Ra Pharma July 2019 • UCB has agreed to acquire
Ra Pharma for $2.5 billionOct. 20192
• Setmelanotid FluidCrystal weekly SC depot‒ Treatment of POMC deficiency, LEPR deficiency, and
Bardet-Biedl syndrome obesity
• Phase 1b clinical milestone achieved‒ Plasma half-life ~120 hours ‒ Good tolerability
• Dose escalating Phase 2 study under completion • Positive Phase 3 data announced for daily
setmelanotide in POMC / LEPR deficiency Aug. 20191
Progress in partnerships
0
20
40
60
80
100
0 48 96 144 192
% H
emol
ysis
Time (h)
Source: 1Press release Rhythm Pharmaceuticals 7 August 2019; 2Press release UCB and Ra Pharmaceuticals 10 October 2019
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Multiple levers for growth and value creation on short and medium term
Buvidal®/Brixadi™
Pipeline
Corporate
• Establish leadership in opioid dependence treatment with Buvidal in Europe and Australia
• Support US market approval and launch of Brixadi by Braeburn, and continue geographic expansion through partnerships
• Drive late-stage development and to obtain regulatory approvals in chronic pain and acromegaly and NETs in 2 to 4 years
• Growing pipeline of innovative medicines in high unmet medical need areas and large market potential
• Expand the utilization of our FluidCrystal technology to new applications and therapy areas
• Develop sustained profitability through own sales, partnerships and business development
Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden [email protected] camurus.com
Thank You
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Key figures, Jan. – Sept.
Listed on Nasdaq STO (ticker CAMX)Market Cap: ~ SEK 4.8 billionEmployees: 130HQ: Lund, Sweden, Regional offices: Cambridge, Mannheim, Paris, SydneyAnalyst coverage: Carnegie Investment Bank, Erik Hultgård; Jefferies International, Harry Sephton, Svenska Handelsbanken, Peter Sehested
Contact us Learn more about [email protected] www.camurus.com
Sandberg Development43.0%
Gladiator8.2%
Fjärde AP-fonden6.3%Fredrik Tiberg
3.3%
Avanza Pension2.9%
Backahill2.3%
Catella2.0%
Svenskt Näringsliv1.4%
Others27.6%
Largest shareholders (31 December 2019)
*Cash flow from operations excl. change in working capital
Full Year Report 2019 to be issued 12 Feb. 2020
Financials Q3 2019MSEK
YTDMSEK
Net revenue 40.2 (19.6) 70.6 (41.5)
– Product sales 19.5 (0.3) 41.8 (6.2)
Operating result -77.4 (-56.4) -271.6 (-184.0)
Result after tax -62.7 (-43.8) -218.0 (-147.5)
Cash flow from operations*
-76.6 (-55.3) -267.7 (-180.5)
Cash 192.3 (216.3) 192.3 (216.3)