Company Presentation October 2019 - Camurus
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Company Presentation October 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
2
LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP
Company profile ~ SEK 4 billion EMPLOYEES: 120 HQ: Lund, Sweden
REG. OFFICES: Cambridge, Mannheim, Paris, Sydney
Unique FluidCrystal® Two Phase 3 programs
nanotechnologies Late-stage pipeline with 10 innovative
• In-house developed with strong IP clinical programs in areas of pain,
• New generation long-acting depot technology oncology, endocrine and cardiovascular
• Validated in +20 clinical trials and by disease
approved products
Approved medicines Own commercial Partnerships Experienced
Weekly and monthly Buvidal® organization R&D collaborations, management
for the treatment of opioid Fully operational in licensing and royalty and dedicated
dependence arrangements with
Europe and Australia
numerous companies teams
3
Business highlights
• EU and Australian approvals of Buvidal® , weekly and monthly
SC buprenorphine depots, in opioid dependence
– Launches initiated in 2019
Buvidal® launch status
• US tentative approval of Brixadi™ for opioid use disorder • Sales in Finland, Denmark, Sweden, Norway,
– US District Court for the District of Columbia Court ruled that the FDA acted Germany, the UK and Australia
inconsistently when delaying the full approval of Brixadi™ • Reimbursement in key markets
– Remanded the FDA to reconsider, with deliberate speed, Braeburn’s ‒ Australian government supports affordable access
application for final approval of Brixadi™ to Buvidal® as part of a $40 million package1
• Positive Phase 3 results from pivotal randomized study of • Fully operational commercial infrastructure
CAM2038 for treatment of chronic pain • First year sales guidance SEK 70-90 million
• Pivotal Phase 3 program initiated with CAM2029 octreotide SC
depot in acromegaly
• License agreement with Ra Pharma for long-acting formulation
FluidCrystal® zilucoplan for complement C5 mediated disease
Source: 1Media Release 25 August 2019, The Hon. Greg Hunt MP, Minister of Health, Minister Assisting the Prime
Minister for the Public Service and Cabinet, Australia https://www.health.gov.au/ministers/the-hon-greg-hunt-
mp/media/pbs-support-for-end-of-life-care-and-opioid-dependency 4
FluidCrystal® in situ gel formation
Easy to administer Good safety and tolerability profile
Rapid onset & long-acting release Unique lipid compositions
Applicable across substance classes Strong intellectual properties
Injection of liquid
formulation Encapsulating Slow release Drug release and
drug blood conc.
using prefilled H2O liquid crystal gel of drug biodegradation of
syringe or triggered by gel matrix to full
autoinjector water uptake resolution
time
5
FluidCrystal – Long-acting release of
somatostatin analogues
Immediate release octreotide (Sandostatin®) FluidCrystal® injection depot
FC pasireotide
subcutaneous octreotide
1000 1000 FC octreotide
FC somatostatin 1-14
Plasma concentration (ng/mL)
Plasma concentration (ng/mL)
100 100
10 10
1 1
0,1 0,1
0,01 0,01
0 7 14 21 28 0 5 10 15 20 25 30
Time (days) Time (days)
Single dose injection at t=0; n=6 (SC); rodent; mean values
6
Effect of octreotide and somatostatin FC q4w depots
on prostate cancer tumor growth in a mice model
Relative tumor volumes (PC-3 cell lines) in active and placebo treatment groups
2022SOM-L 2022OCT-V 2022SOM-L placebo
1000
Relative tumor volume (%)
800
600
400
200
0 7 14 21 28 35 42
0
Time (days)
7
FluidCrystal – Long-acting peptide release
Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071)
10 10
pasireotide plasma concentration (ng/mL)
pasireotide plasma concentration (ng/mL)
Pasireotide IR 600 ug Pasireotide FluidCrystal 20
(SC thigh, n = 94) mg (SC thigh, n = 12)
1 1
0,1 0,1
0 7 14 21 28 0 7 14 21 28
Time (days) Time (days)
Single dose injection at t=0; clinical Phase 1 data, mean values. Source: Tiberg, F. et al, Poster presentation at ECE, Barcelona, May 2018 8
Weekly and monthly buprenorphine depots Illustration of population pharmacokinetic profiles for Buvidal vs sublingual buprenorphine Weekly Buvidal vs. Daily sublingual buprenorphine Weekly vs. Monthly Buvidal 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. 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: 9 https://www.ema.europa.eu/en/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf
FluidCrystal – Broadly applicable
Broadly applicable across molecular classes
‒ Peptides & proteins, e.g.:
• somatostatin & analogues
• LHRH agonists
• MC4 agonists
• glucagon & insulin
• GLP-1 & analogues
• interferons
• antibody fragments
Octreotide MW 1019 g/mol
‒ Small molecules, e.g.: Glucagon-like Peptide 1 MW 3356 g/mol
• opioids
• local analgesics
• hormones
• anti-emetics Buprenorphine MW 468 g/mol
• prostacyclins 10Broad clinical pipeline of innovative
investigational medicines
PRODUCT PHASE 1-2 PHASE 3 REGISTRATION MARKET
Buvidal® q1w OPIOID DEPENDENCE MARKET
Buvidal® q4w OPIOID DEPENDENCE MARKET
Brixadi® q1w OPIOID DEPENDENCE - BRAEBURN1 TENTATIVE APPROVAL
Brixadi® q4w OPIOID DEPENDENCE - BRAEBURN1 TENTATIVE APPROVAL
CAM2038 q1w CHRONIC PAIN1 PHASE 3
CAM2038 q4w CHRONIC PAIN1 PHASE 3
CAM2029 ACROMEGALY PHASE 3
CAM2029 NEUROENDOCRINE TUMORS PHASE 2
CAM2032 PROSTATE CANCER PHASE 2
CAM4072 GENETIC OBESITY DISORDERS - RHYTHM2 PHASE 2
CAM2043 PULMONARY ARTERIAL HYPERTENSION PHASE 1
CAM2047 CINV3 PHASE 1
CAM2048/58 POSTOPERATIVE PAIN & PONV4 - BRAEBURN 1 PHASE 1
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;
11Buvidal®/Brixadi™ Weekly and monthly buprenorphine depots Game-changer in opioid dependence treatment
Opioid dependence – escalating Mounting opioid overdose deaths2
global health crisis
• Largest society burden of all drugs1 30
Drug overdose deaths per 100,000, age group 15-64
Scotland
• 35 million opioid users worldwide1 25
• High need for better access to care 20
USA
and new treatment alternatives
• Investment in treatment brings substantial
15
value and saves lives 10 Australia
Sweden
• Significant limitation with current daily UK
Finland
5
medications Germany
0
#1 cause of death for people under 50 in the US2,3
Recent US life expectancy decline largely
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
due to opioids4
13, 2018, https://www.ft.com/content/d22e742c-e65c-11e7-97e2-916d4fbac0da 13Buvidal® – first long-acting injection treatment
of opioid dependence in the EU and Australia
• 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
• Potential to result in fewer occurrences of opioid overdoses
Sources: Buvidal Summary of Product Characteristics (SmPC), 2018; European Medicines Agency. Buvidal: EPAR - Public assessment report, December 2018. Available at: 14
https://www.ema.europa.eu/en/documents/assessment-report/buvidal-epar-public-assessment-report_en.pdf
INTERNAL USE ONLY. NOT TO BE CONSIDERED BRIEFING MATERIAL FOR REPRESENTATIVES.Buvidal brings unique values to patients and HCPs
CHOICE OF ROOM CLIN. DATA
WEEKLY MONTHLY MULTIPLE SMALL LOW DAY ONE
PRODUCT INJECTION TEMP. VS ACTIVE
DOSING DOSING DOSES NEEDLE VOLUMES INITIATION
SITES STORAGE CONTROL*
*
23G 0.16 – 0.64 mL
– – – –
19G
–
0.5 – 1.5 mL
– – –
– – – –
20G
–
3.4 mL
– – –
*Based on information in product labels 15NEW
Growing evidence base for Buvidal®
versus daily standard treatment
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-studies6
1Lofwallet 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 16
34(2):560-575; 6D’Agnone O, Case Reports in Psychiatry, 2019 https://doi.org/10.1155/2019/9381346High treatment satisfaction by patients
“CAM2038 compared to my previously prescribed
sublingual buprenorphine treatment”
83% Features rated as extremely important
Much better
POSITIVE or much better (7 on scale 1-7) by
Slightly better majority of patients
Spares regular visits to the pharmacy
About the same N=133 Prevents others access to my medication
Prevents accidental exposure to children
Daily medication not required
Slightly worse
Improves my privacy as a patient
Helps me not miss or skip medication dose
Much worse Allowed to travel with no medication
17
Source: Frost et al, Addiction, 2019;114(8):1416-1426Ongoing trials to further demonstrate utility and
advantages of Buvidal®
The Depot Evaluation Buprenorphine Utilization Safety and feasibility of depot buprenorphine
Trial (DEBUT) in NSW custodial settings (UNLOC-T)
‒ Prospective, randomized, open-label, active-controlled, ‒ Prospective, non-randomized, open-label, case-comparison,
multicenter trial multicenter trial in custodial settings
‒ 120 adult outpatients have been randomized 1:1 to ‒ 60 adult prisoners treated with Buvidal® and compared with
CAM2038 vs SL BNX. Topline results Q4 2019 methadone treated patients. Topline results Q4 2019
‒ Primary objective to compare patient satisfaction ‒ Primary objective to test safety, tolerability, diversion and HEOR
‒ Secondary objectives QoL, HEOs and other PROs ‒ Secondary objectives to compare efficacy and QoL
DEBUT SC Buvidal® weekly and UNLOC-T Buvidal® Buvidal® Buvidal®
monthly flexible dosing Weekly Monthly Monthly
Screening Follow-up Screening E
R
period
n=1201 BPN standard of care n=1201 Methadone
at flexible doses Extended safety
Active follow-up
monitoring
Day -28 to -1 Day 1 Week 24 Week 26 Day 0 Day 1 Week 4 Week 16 Week 48
18Global commercialization strategy for Buvidal® (Brixadi™)
ESTIMATED
35 million
WORLDWIDE
OPIOID USERS 20161
Camurus 1st entry markets Camurus Braeburn Braeburn option right Medison (Israel)
Source. 1World drug report 2019.
19~740,000 patients estimated suited for treatment
with Buvidal® in the EU and Australia
Buprenorphine Methadone New treatment Not in treatment due Total potential
treated1
treated ≤30 mg,1,2 journeys to rules and burden of
12 months1 daily treatment1,3,4
15 percent market penetration corresponds to annual sales of ~ USD 300 million5
1EMCDDA 2018 Drug report 2Camurus estimate 3Benyamina et al 2013 Heroin Addiction and Related Clinical Problems 14 (4): 65-80. 4. Camurus data on file 2018, Patient qualitative study. 5Based on
20
average daily price of USD 10/day and 270 treatment days/patient/year1
Buvidal® launch in EU & Australia gaining momentum
Launched in all Wave 1 markets
HQ
Lund ‒ Finland, Sweden, Denmark, Norway, UK, Germany,
Sweden and Australia
• Positive pricing and reimbursement decisions
Cambridge in key markets, including: Norway, Scotland,
UK Australia
Launch sequence
Wave 1 markets • Fully operational teams – 65 heads
Wave 2 markets • Effective supply and distribution
Paris Wave 3 markets – within 24 hours delivery to clinic
France
Wave 4 expansion
Preparations in Wave 2-3 markets
‒ Launches planned in Austria, Spain, Italy, France
Mannheim and other EU countries Q4 2019 to Q2 2020
Germany
• Pricing and reimbursement applications
Sydney submitted
Australia • Key regional functions onboarded
21Key takeaways from initial markets
Experiences from initial launch markets Drivers of growth
• Very positive feedback from patient and HCPs • Expansion into new markets
‒ Improved stability, less burden, more freedom ‒ Launches Australia and Norway in Q3
• High retention with only few dropouts ‒ Wave 2&3 markets from Q4 2019
‒ Similar or better than long-term Ph. 3 study • Successful HTA review processes
• Initial patient uptake and sales vary by country ‒ Positive reimbursement decisions and recommendations
in Q2, incl. in Norway, Scotland and Australia
‒ 160 percent patient growth Q1 to Q2
> 20% buprenorphine market share in Finland • Formulary inclusion and funding release
‒ Primary barrier is market access ‒ More than 40 formularies in the UK and 35 in Australia
have agreed to include Buvidal® as treatment option
• Reimbursement and formulary listing processes
• Medical education, evidence sharing and practical
• Significant potential in the custodial setting assistance
‒ Buvidal® introduced in more than 20 prisons in the EU
‒ Regional, national and local symposia, webinars, clinician
‒ UNLOC-T study under completion in Australia road shows, and case study publications
HTA: Health Technology Assesment 22Making Brixadi™ available to US patients
• Tentative approval Brixadi™ on 21 Dec. 2018
Partnership with
• Final approval of monthly product subject to the
expiration of an exclusivity period until November Scope Opioid dependence and pain
2020 – unless earlier resolved
Region • Exclusive license for North America
• Braeburn initiated court proceedings in April 2019 Financials • USD 24 million received in upfront and
to overturn exclusivity and seek immediate market development milestone payments
approval of Brixadi™ in the US • Costs for pivotal clinical program covered by
Braeburn
‒ US District Court for the District of Columbia ruled in July
2019 that the FDA acted inconsistently with precedent • Remaining development milestones;
– USD 35 million for opioid use disorder
by delaying the approval of Brixadi™ – USD 17 Million for chronic pain
‒ The court remanded the FDA to reconsider, with • Mid-teen royalty on product sales
deliberate speed, Braeburn’s application for final + USD 75 million in sales milestones
approval of Brixadi™
23CAM2038 in chronic pain – large market with
high unmet medical needs ~1 million high-risk
CLBP patients
(>99 MME*/day)3
Market • 100 million Americans and 75 million Europeans with chronic pain1,2
opportunity • 74 million patients with chronic low back pain (CLBP) in 7MM in 20183 27 873
105 097
17 873
• Chronic pain estimated to cost US society USD +600 billion per year4 41 060
Medical need • Effective round-the-clock pain management, with potential of 54 945
addressed reduced risks of tolerance, dependency and respiratory depression 61 041
653 995
• HCP administration can improve treatment adherence and
safeguards against diversion, misuse, abuse and child exposure
Key clinical • CAM2038 met primary and key secondary Phase 3 endpoints in a US Japan
pivotal enriched-enrollment and randomized withdrawal study Germany France
results Italy Spain
– Superiority demonstrated for relief of average and worst pain intensity
compared to placebo (PCAM2029 Improving lives of patients with pituitary and neuroendocrine disorders
CAM2029 could be the first long-acting octreotide
analogue for subcutaneous administration by patients
Improved patient convenience Potential for better efficacy
• Ready-to-use prefilled syringe with option • 500% higher bioavailibility vs octreotide LAR1
of autoinjector for enhanced convenience
• Well maintained or improved biochemical and
• Fast onset and long-acting release allows symptom control indicated in acromegaly and
once monthly dosing NET patients2
Comprehensive clinical Additional
development program promising indications >US$ 2.6 billion
• Phase 3 studies in acromegaly initiated • CAM2029 has an attractive target current somatostatin
• NET program in progress product profile across multiple analogue market3
• Four Phase 1-2 clinical trials completed indications 20 years of steady market
with positive results • Efficacy of octreotide suggested by growth at 11% CAGR
• Orphan designation in the EU growing scientific evidence base
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; 3GlobalData 2019, SSA – somatostatin analog; 26Acromegaly management overview
• Transsphenoidal surgery is standard initial therapy for a majority of patients
• First-line medical treatment is first generation long-acting SSAs, octreotide LAR
and lanreotide ATG; with ~ 55% of patients biochemically controlled1
• For partial responders, SSA dose and dose frequency may be increased
• Second line therapy includes pasireotide and pegvisomant
Diagnosis First-line medical therapy Second-line therapy
Second generation SSA
First generation SSA Partial response
55 – 60% 40 – 45% • Pasireotide LAR
Surgery • Octreotide LAR Increase SSA dose or
Biochemical • Lanreotide ATG frequency of dosing
and MRI GH receptor agonist
confirmed or or
Acromegaly • Pegvisomant
Not suitable for surgery
Dopamine agonists, e.g. Addition of dopamine agonist
cabergoline, may be attempted to first generation SSA
in patients with modest Combination of first generation
biochemical abnormalities SSA and pegvisomant
Source: 1. Melmed S, et al., Nat Rev Endocrinol. 2018 Sep;14(9):552-56. Well controlled studies indicate as few as 25% controlled 27NET management overview
• Management of NETs patients is complicated given the highly heterogeneous patient
population – approach varies with primary site, tumour size, grade and stage1
• For localised tumours, surgical resection is the primary treatment choice2
• However, surgery is not possible in many NETs patients (c. 40 – 50%)3,4
• First generation somatostatin analogues is the first line medical therapy,
with highly favorable safety and tolerability profiles
Medical Therapy
Incomplete • Somatostatin analogues
50 – 60% 5,6
Surgery
resection
• Chemotherapy
Confirmed Neuroendocrine 40 – 50% 5,6 • Targeted therapies (sunitinib
Tumour and everolimus)
Not suitable for surgery
• Liver-directed therapies
• PRRT
or
Observation
1 NANETS Consensus Guidelines for the Management and Treatment of Neuroendocrine Tumors, Pancreas. 2013 May;42(4):557-77; 2 NCCN Guidelines, Neuroendocrine and Adrenal Tumors, Version 1.2019;
3 Stueven AK, et al., Int J Mol Sci. 2019 Jun; 20(12): 3049; 4 Herrera-Martínez AD, et al., Drugs. 2019; 79(1): 21–42; 5 Man D, et al., Cancer Manag Res. 2018; 10: 5629–5638; 6 Analyst Report, Apr 2016 28CAM2029 –next generation octreotide depot for easy
subcutaneous self-administration
Product Product Route of Self-
presentation administration administration
CAM2029 Ready-to-use PFS
12.5 mm, ≥22G needle
SC
with autoinjector option
Sandostatin® LAR® Reconstitution system IM –
(vial, diluent)
40 mm, 20G needle
Somatuline® Autogel®,1 Ready-to-use Deep SC –
prefilled syringe
20 mm, 18-19G needle
Note: 1) New device introduced in 2019 (not shown here) 29Efficacy and tolerability of CAM2029 supported by data from four clinical studies and PK modelling • Dose proportional long-acting octreotide release suitable for once monthly dosing1 • Rapid and sustained suppression of insulin growth factor-1 (IGF-1) in healthy volunteers1 • Well maintained or improved biochemical control indicated in patients with acromegaly2 • Well maintained or improved symptom control indicated in NET patients2 • Good safety profile and local tolerability1-2 Completed clinical trials Three Phase 1 studies assessing pharmacokinetics (PK), pharmacodynamics (PD) and safety in healthy volunteers (N=249) One Phase 2 study evaluating PK, disease biomarkers and symptoms in acromegaly and NET patients (N=12) Source: 1Tiberg F, Br J Clin Pharmacol. 2015;80(3):460-72; 2Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019;83(2):75-385 30
Phase 2 study indicates improved biochemical and symptom
control when switching from octreotide LAR to CAM2029
IGF-1 in acromegaly patients Flushing and diarrhea in NET patient
Oct-LAR CAM2029 Oct-LAR CAM2029
250 2
Bowel movements
Time weighted average (% of ULN)
Monthly mean number symptoms/day
Flushings
200
1,5
150
1
100
0,5
50
0 0
Day -28 - Day 0 Day 0 - Day 28 Day 28 - Day 56 Day 56 - Day 84 Day -28 - Day 0 Day 0- Day 28 Day 28 - Day 56 Day 56 - Day 84
Patient 1 Patient 2 Patient 3
Patient 4 Patient 5
Analysis of data from Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019; 83(2): 375–385
GH, growth hormone; IGF-1, insulin-like growth factor 1; LAR, long-acting release; NET, neuorendocrine tumors 31CAM2029 top-level development program
ACRO Phase 3 PC Regulatory
submissions
ACRO Phase 3 LTSE
Phase 2, MAD
x Placebo controlled (PC) Phase 3 study
Phase 1, MAD in SSA full responders (N~80)
x
Open label, long-term safety extension
(LTSE) in full/partial responders (N~70)
Phase 1, MAD
Phase 1, SAD
Four clinical trials completed in
healthy subjects and patients NET Phase 3 AC + LTSE
characterizing PK, PD and Active controlled (AC) Phase 3
safety profile (N=249) study in GEP-NET patients with
metastatic, well differentiated NET.
H2 2019 2021
32CAM2029 summary features
• Superior convenience with ready-to-use formulation • 20 years of strong market growth
for subcutaneous administration ‒ $2.6 billion in global sales 2018
‒ No need for reconstitution or mixing, or risk of clogging ~ 12% annual growth rate
‒ Autoinjector under development for enhanced convenience
• Rapid onset and long-acting duration mUSD
Somatuline® (Ipsen) 2500
‒ Therapeutic concentrations reached within hours
Sandostatin® LAR® (Novartis) 2250
‒ 4 week duration 2000
1750
• 5-fold higher bioavailability vs Sandostatin® LAR® 1 1500
‒ Potential for improved treatment response 1250
1000
• Potential for improved efficacy 750
500
‒ Indicated in Phase 2 study in acromegaly and NET
250
• Safety consistent with known safety profile of octreotide 0
‒ Studies indicate that CAM2029 is well-tolerated systemically and locally
Source: Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; Pavel M et al, Cancer Chemotherapy and Pharmacology, 2019; 83: 375-383.. 33Progress in partnerships
CAM4072: Genetic disorders of obesity CAM4083: Complement-mediated disorders
• Setmelanotid FluidCrystal® weekly SC depot • Zilucoplan FluidCrystal® weekly SC depot
‒ Treatment of POMC deficiency, LEPR deficiency, and ‒ Treatment of generalized myasthenia gravis (gMG),
Bardet-Biedl syndrome obesity immune-mediated necrotizing myopathy (IMNM), and
other serious complement C5 mediated disorders
• Phase 1b clinical milestone in 2018
‒ Plasma half-life ~120 hours • Preclinical PoC 100
‒ Good tolerability • Preparations for clinical 80
Inhibition of hemolysis
development ongoing
• Phase 2 study ongoing of CAM4072
% Hemolysis
following a single dose of
60
zilucoplan FluidCrystal® in
• Program driven by
• Positive Phase 3 results for setmelanotide in cynomolgus monkeys (n=4)
Ra Pharma under license 40
POMC and LEPR deficiency in August 2019
agreement with Camurus 20
• Program driven by Rhythm Pharmaceuticals
• UCB has agreed to acquire
under license agreement with Camurus 0
Ra Pharma for $2.5 billion1 0 48 96 144 192
Time (h)
Source: Press release UCB and Ra Pharmaceuticals 10 October 2019 34Multiple levers for growth and value creation
on short and medium term
• Establish leadership in opioid dependence treatment
Buvidal®/
with Buvidal® in Europe and Australia
Brixadi™
• Support US market approval and launch of Brixadi™ by Braeburn,
and continue geographic expansion through partnerships
Pipeline • 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
Corporate
to new applications and therapy areas
• Develop sustained profitability through own sales, partnerships
and business development
35Thank You Camurus AB, Ideon Science Park, SE-223 70 Lund, Sweden info@camurus.com camurus.com
Key Shareholders (30 September 2019)
Key figures Catella
Others
27.4%
Sandberg
Development
fondförvaltning 46.3%
2.2%
Backahill Utveckling
2.3%
Financials (SEK million) Avanza Pension
2.3%
H2 2019 H2 2018 FY 2018
SEK million Fredrik Tiberg
Jan-Jul Jan-Jul Jan-Dec Fjärde AP-fonden Gladiator
3.5% 6.2% 9.8%
Net Revenue 30.4 22.0 49.3
Operating result -194.2 -127.6 -287.2
Listed on Nasdaq STO (ticker CAMX)
Result after tax -155.3 -103.8 -234.7 Market Cap: ~ SEK 4 billion
Employees: 120
Cash position 283.1 199.1 134.4
HQ: Lund, Sweden, Regional offices: Cambridge,
Mannheim, Paris, Sydney
Full year revenue guidance Analyst coverage: Carnegie Investment Bank, Erik
Hultgård; Jefferies International, Harry Sephton,
Net revenue SEK 130–160 million, whereof Svenska Handelsbanken, Peter Sehested
product sales SEK 70–90 million
Contact us Learn more about Camurus
ir@camurus.com www.camurus.com
37Outlook to 2021 – significant news flow expected
2019 2020 2021
Commercial
Buvidal® 1st wave launches Buvidal® 2nd wave Buvidal® 3rd wave EU & Buvidal® geographic CAM2038 launch
in EU and Australia launches in EU RoW launches expansion in chronic pain
Potential early US Expiry of Sublocade®
Brixadi launch US exclusivity
H1 H2 H1 H2
CAM2029 Ph 3 ACRO start DEBUT study results CAM2038 MAA chronic CAM2029 Ph 3 ACRO CAM2029 ACRO Ph 3
DEBUT & UNLOC-T studies UNLOC-T study results pain submission fully enrolled study results
R&D
fully enrolled CAM2043 Ph 2 start CAM2029 Ph 3 NET start CAM2043 Ph 2 results CAM2029 ACRO NDA
CAM2038 Ph 3 long-term CAM4072 Ph 2 results /MAA submissions
safety results CAM2043 Ph 3 start
H1 H2 H1 H2
Corporate
Commercial organization fully built-out in EU and Australia Out-licensing of clinical product candidates Sustained profitability
New FluidCrystal® technology partnerships Milestone payments for Brixadi™ approval Three commercial stage
Leadership in opioid dependence treatment in EU assets by end of 2021
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