Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ......
Transcript of Company presentation · 2020. 11. 18. · Company presentation. 2. Forward looking statements. ......
November 2020
Company presentation
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-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
Long-acting medications addressing key healthcare challenges
4
Experiencedmanagement and dedicatedteams
Corporate highlights
Rapidly growing commercial stage company• Fully operational infrastructure in Europe and Australia
• Buvidal® to date launched in 10 countries• Strong growth of product sales
Market approvalsWeekly and monthly Buvidal® for opioid dependence
PartnershipsR&D collaborations, licensing and royalty arrangements with pharma and biotech companies
Unique FluidCrystal®nanotechnologies• New generation long-acting depot technology
• Validated in +25 clinical trials and by approved products
LISTED ON NASDAQ STO; TICKER CAMX MARKET CAP ~ SEK 10 billion EMPLOYEES: 130 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney
Broad late-stage pipeline• +10 innovative clinical programs in addiction, pain, oncology, endocrine disorders and CV diseases
• Two ongoing Phase 3 studies• Advancing early stage opportunities
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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
Easy and convenient administration Rapid onset & long-acting release Applicable across substance classes
Adopted to prefilled syringes and autoinjectors Manufacturing by standard processes Strong intellectual property
H2O
dru
gb
lood
conc
.
Sources:Tiberg F, et al. Chapter in Long Acting Injections and Implants, Advances in Delivery Science and Technology 2012; Tiberg F, et al. OnDrugDelivery2010; Tiberg F, et al. Drug Del. Sci. Tech., 21 (1) 101-109 2011.
Camurus‘ FluidCrystal® long-acting release technology has unique properties
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FluidCrystal – Long-acting release
Immediate release pasireotide (Signifor®) Pasireotide FluidCrystal® (CAM4071)
0,1
1
10
0 7 14 21 28
pas
ireo
tid
e p
lasm
a co
nce
ntr
atio
n (
ng
/mL)
Time (days)
Pasireotide IR 600 ug (SCthigh, n = 94)
0,1
1
10
0 7 14 21 28
pas
ireo
tid
e p
lasm
a co
nce
ntr
atio
n (
ng
/mL)
Time (days)
Pasireotide FluidCrystal 20mg (SC thigh, n = 12)
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Recent highlights
• Strong improvement of results driven by Buvidal sales growth in EU and Australia since 2019 launch
• Brixadi™under review by FDA for final US approval 1 December 2020
• Two ongoing Phase 3 studies of CAM2029 in acromegaly
• Pivotal Phase 3 study of CAM2029 in NET aligned with FDA
• Positive Phase 2 results for weekly setmelanotide
• MSEK 300 raised in directed share issue
• Arbitration process with Braeburn1
1Camurus press release 15 June 2020 https://mb.cision.com/Main/13456/3134723/1264520.pdf
Positive 2020 outlookExpected FY net revenues1
SEK 340 - 380 millionExpected FY OPEX2
SEK 505 – 525 million
1. Excluding the $35m milestone for final FDA approval of Brixadi™ in he US2. Without regards to the outcome of the ongoing arbitration process
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Opioid dependence –escalating global health crisis
• Largest society burden of all drugs1
• 58 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
1United Nations: World drug report 2020; 2Washington Post https://www.washingtonpost.com/health/2020/07/01/coronavirus-drug-overdose/ and ODMAP
Increase of suspected overdoses per month during the pandemic compared to the same month in 20192
Covid-19 causing spike in opioid overdoses in the US
Jan Feb Mar Apr May
-0.3%
+16% +18%
+29%
+42%
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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 and Australia in 2019
1BuvidalSummary of Product Characteristics (SmPC), 2018
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Buvidal provides significantbenefits to patients and society
• Improved treatment outcomes and patient satisfaction1-3
• Decreased treatment burden and stigma2
• Diminished diversion, misuse and pediatric exposure4
• Reduced treatment costs in the criminal justice system5
1Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773;2Frost et al, Addiction, 2019;114(8):1416-1426; 3Lintzeris N, et al., Results of the DEBUT Study, presented at CPDD Virtual Meeting June 22-24, 2020. 4EPAR; 5Dunlop A, et al. Introduction of Long-Acting Depot Buprenorphine in Prison - the UNLOC-T Study. Presented at CPDD Virtual Meeting June 22-24, 2020
“For me, Buvidal is a revelation. I know that as long as I stay on Buvidal I’ve got a chance”Sophie, Buvidal patient in Wales
“CAM2038 compared to my previously prescribed sublingual buprenorphine treatment”
Much worse
Slightly worse
About the same
Slightly better
Much better 83% POSITIVE
N=1332
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Buvidal is well differentiated
Long-acting injection treatments for opioid dependence
*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, Canada, Australia
– – – –20G
–3.4 mL
– – – US
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REGION PARTNER NO OF PATIENTS PEAK MARKET POTENTIAL
EUAustralia LAUNCH INITIATED IN 2019
~1.3 millionHIGH-RISK
OPIOID USERS1
~€300 million2
North America US PDUFA DATE 1 DEC 2020
>2 millionDIAGNOSED WITH OPIOID USE
DISORDER IN THE US3
$0.6-1.2 billion4, 5
Middle East& North Africa EARLY ACCESS PROGRAMS
INITIATED IN 2020
>300,000WITH OPIOID DEPENDENCE6
€25-75 million5
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
Global strategy for Buvidal (Brixadi™)
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Strong growth of Buvidal in EU and Australia
Increasing market share‒ Largest markets (Australia, Finland and Norway)
continue to expand‒ Growth accelerating in the UK, Germany and Sweden‒ Covid-19 challenges with prescription authorizations
in Austria, lockdown of parts of Australia, and protracted pricing and reimbursement processes
Estimated more than 12,000 patients in treatment with Buvidal at the end of September
Buvidal now available in 12 countries‒ 10 countries in Europe and Australia‒ 2 countries in MENA with Early Access Programs‒ 2 additional EU launches expected before year end
* Measured by product sales
Product sales by quarter
MSEK
20202019
48.6
30.3
19.5
11.0
75.8
11.3
Q1 Q2 Q3 Q4 Q1 Q2
60
50
40
30
20
10
0
70
80
90
100
Q3
94.3
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Austria Launched in May 2020 after law
change allowing injectable treatments for OD5
Norway Launched in Q3 2019 Buvidal now market leader
United Kingdom Scottish government delivers
£1.9m budget to support people in prison on ODT to transfer to Buvidal1
Wales’ government supports treatment with long-acting buprenorphine during Covid2
Germany Physician remuneration system
modified balancing reimbursement for different treatment modalities5
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://www.tlv.se/beslut/beslut-lakemedel/begransad-subvention/arkiv/2020-05-19-buvidal-ingar-i-hogkostnadsskyddet-med-begransning.html; 4. https://www.kbv.de/html/1150_45794.php; 5 .Federal law for Austria issued 18 May 2020 Part II 215th regulation: Amendment of the drug regulation
Australia GPs allowed to
prescribe Buvidal from 1 April 2020
Sweden Reimbursement of Buvidal approved by
TLV in May 20203
EU and Australia launch update
Belgium Sales initiated in prison
system during Q3 2020
Finland First market to launch in Q1 2019 Now market leader with >50% share
Denmark KOL support driving change
Iceland Launched in Q4 2020
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Benelux >22,000 patients in opioid
dependence treatment1
Launched in BE in Q3 2020 Preparing for NL launch in
Q1 2021
Spain >58,000 patients in ODT1
Preparing for launch in Q4 2020
Italy ~70,000 patients in opioid
dependence treatment1
Pricing and reimbursement discussions
Launch sequenceLaunched Wave 3 marketsWave 2 markets Wave 4 markets
France >179,000 patients in opioid
dependence treatment1
Final regulatory and pricing discussions with authorities
1. European Drug Report 2019, EMCDDA
Wave 2/3 planned countries
Portugal >17,000 patients in ODT1
Preparing for launch in Q4 2020
Switzerland Regulatory approval decision
pending Preparing for launch in 2021
Ireland Launch in Q4 2020
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CAM2038 Chronic pain
Pre-submission meeting held with EU Rapporteur
Regulatory submission to EMA delayed to early 2021
Regulatory progress and market expansion
•Regulatory filings Pre-approval received by Swiss
Agency for Therapeutic Products (Swissmedic)
Market authorization application under final review in New Zealand
Line-extension applications and label enhancements with EMA and TGA
•Availability of Buvidal in MENA region Early access programs and regulatory
filings initiated with collaboration partner NewBridge Pharmaceuticals
Growing patient numbers
•Braeburn preparing for US launch Request for final FDA approval of the
NDA for Brixadi accepted by FDA with PDUFA date 1 Dec. 2020
FDA final approval of Brixadi expected 1 Dec 2020 – triggering a $35 million milestone payment to Camurus
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Significant opportunity for Brixadi in the US
•US opioid crisis continues to grow‒ Nearly 50,000 fatal opioid overdoses in
the US in 20181
‒ Increasing opioid overdoses during Covid pandemic2
•US opioid use disorder epidemiology:
•Brixadi aligned with current treatmentparadigm‒ Flexibility on posology and doses expected to
resonate with established prescription patterns5
‒ Day 1 treatment initiation and multiple choice of injection sites
1https://www.cdc.gov/drugoverdose/data/statedeaths.html; 2https://www.ama-assn.org/system/files/2020-10/issue-brief-increases-in-opioid-related-overdose.pdf; 3https://www.samhsa.gov/data/report/2018-nsduh-detailed-tables ; 4https://www.soa.org/globalassets/assets/files/resources/research-report/2019/econ-impact-non-medical-opioid-use-pdf; 5Symphony Health Patient Source
40%
26%
34% 7 days Rxmost common
8–27 days Rx
28 days+Rx
Brixadi™ Weekly / Monthly
Brixadi™ Monthly
misusing opioids3
prevalence of OUD4
annual buprenorphine or naltrexone patients51.4m
3.9m
10.3m
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Expanding the evidence base throughinvestigator sponsored studies
Study Country Investigator Type Est. patient numbers Status
Understanding NSW Long-acting Opioids in Custody-Treatment (UNLOC-T)
Australia Prof Dunlop(NSW Government)
Two-arm, case-comparison study
129 (Buvidal 67) Reporting
Patient experiences of long-acting SC injectable depot buprenorphine (post-DEBUT qualitative study)
Australia Prof Lubman(Monash Univ)
Qualitative interviews(retrospective)
30 Reporting
Addiction recovery of opioid dependent patients treated with injectable subcutaneous depot buprenorphine (ARIDE)
Germany Prof Schulte(ZIS Hamburg)
Non-interventionalstudy
426 (Buvidal 213) Ongoing
Exploring the potential of long-acting buprenorphine therapy in vulnerable people who use drugs and are homeless
Scotland Prof Matheson(Univ of Stirling)
Qualitative interviews(prospective)
30 Ongoing
Emergency department-initiated buprenorphine and validation network trial (NCT04225598)
USA Prof Gail D’Onofrio, Yale
RCT, open-label 2000 (Brixadi 1000) Ongoing
Medication treatment for OUD in expectant mothers (NCT04212065)
USA Prof Theresa Winhusen, University of Cincinnati
RCT, open-label 300 (Brixadi 150) Ongoing
A comparative effectiveness trial of XR Naltrexone vs XR-BUP with individuals leaving jail (NCT04408313)
USA Dr Michael Gordon, Friends Research Inst.
RCT, open-label 240 (Brixadi 120) Ongoing
Exemplar Hospital Initiation Trial to Enhance Treatment Engagement (NCT04345718)
USA Prof Gavin Bart, Hennepin Healthcare
RCT, open-label 314 (Brixadi 157) Starting
Optimizing Retention, Duration and Discontinuation Strategies for OUD Pharmacotherapy (NCT04464980)
USA Prof Edward Nunes, Columbia University
RCT, open-label 1630 (Brixadi 650) Starting
Σ >2,400 Buvidal/Brixadi patients
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Significant opportunity in mid- to late-stage pipeline
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
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CAM2029 – long-actingsubcutaneous octreotidein Phase 3 development
•Innovative medicine in late-stage development for rare pitituary and neurendocrine disorders and tumors
•Designed for enhanced efficacy and patient convenience
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CAM2029 opportunity addresses key unmet medical needs in the SSA market
•Potential for response rates in acromegaly and NET patients‒ Fast onset and long-acting release‒ ~ 500% higher bioavailability vs octreotide LAR1
•CAM2029 offers simplified dosing and possibility of self-administration‒ Ready-to-use prefilled syringe or autoinjector for self-administration and enhanced patient convenience‒ No need for burdensome clinic visits for dosing
1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-72; 2US label; 3Global Data 2020
CAM2029 advantages CAM2029 Sandostatin® LAR (octreotide) Somatuline® Depot (lanreotide)
Convenient device Pre-filled syringeAutoinjector
Powder vial + pre-filled syringe with diluent solution + vial adapter + injection needle
Pre-filled syringe
Thin needle 22G 12.5mm 20G 40mm 18G 20mm
Administration route Subcutaneous Intramuscular, after reconstitution in six steps
Deep subcutaneous, after conditioning
Storage Room temperature Refrigerated, bring to room temperature between 30 – 60 minutes before reconstitution
Refrigerated, conditioning at room temperature for at least 30 minutes before injection
Flexible administration Self-administration option Administration by trained healthcare provider2
Administration by healthcare provider2
US$ 1.6 billion global sales in 20193 US$ 1.3 billion global sales in 20193
SSA market size
US$3billionin 20193
22
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 patients2
• Well-maintained or improved symptom control in NET patients2
• Safety and tolerability profile consistent with octreotide LAR1-2
1Tiberg F, Br J Clin Pharmacol. 2015 Sep;80(3):460-472; 2Pavel M et al, Cancer Chemotherapy and Pharmacology 2019; 83: 375-383.
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)
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0,1
1
10
100
0 7 14 21 28
Pla
sma
OC
T c
on
c (n
g/m
L)
Time (days)
CAM2029 20mg q4w NET patients ssOCT LAR 30mg q4w NET patients ss
Phase 2 pilot study indicates good or improved symptom control in NET patients
Pharmacokinetics in NET patients Flushing and diarrhea in NET patients
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 CAM2029Steady-state pharmacokinetic profiles
24
0
2
4
6
8
Day -28 - Day 0 Day 28 Day 56 Day 84
GH
co
nce
ntr
atio
n (m
g/m
L)
Patient 1 Patient 2 Patient 3 Patient 4 Patient 5
Study also indicates well-maintained or improved biochemical control with CAM2029 in acromegaly
IGF-1 in acromegaly patients Growth hormone (GH) in acromegaly patients
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
Oct-LAR CAM2029
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
eig
hte
d a
vera
ge
(% o
f U
LN)
Patient 1 Patient 2 Patient 3 Patient 4 Patient 5
Oct-LAR CAM2029
ULN
ULN
1.3xULN
25
•Efficacy trial (HS-18-633)‒ Phase 3, randomized, double-blind, placebo-controlled,
multi-center trial to assess efficacy and safety of CAM2029‒ Regulatory requirements for efficacy data met‒ 78 patients, full SSA responders‒ Primary end-point: Proportion of patients with mean IGF-1
levels ≤ 1x upper limit of normal (ULN) at w22 and w24
Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly
•Long-term safety study (HS-19-647)‒ Phase 3, open-label, single arm, multi-center trial to
assess the long-term safety of CAM2029‒ ≥ 100 patients exposed to CAM2029 for 12 months
• Roll-over patients from HS-18-633 and• ‘New patients’ (partial SSA responders, irradiated patients,
and full SSA responders)
‒ Primary end-point: Characterization of adverse events
HS-18-633
4 - 8 Weeks Day 1
Screening
CAM2029 once monthly
Week 24
Placebo once monthly
N=78, 2:1
R
Rescue with standard of care
Prior treatment with octreotide or lanreotide
Double-blind treatment phase
HS-19-647
4 - 8 Weeks Day 1 Week 24
New patientsN=70
Prior treatment with octreotide or lanreotide
Open-label treatment phase
Screening Roll-over patients from HS-18-633
N=70
Week 52
CAM2029 once monthly
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NET Phase 3 program aligned with the FDA
Meeting held with the US FDA to align on the pivotal study program for CAM2029 in NET
• Planned 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 progression free survival in patients with metastatic/inoperable, well-differentiated GEP-NET*
‒ Study planned to early 2021 with expected completion in 2024
HS-19-657
Day 1
Screening
CAM2029
Follow-up period
ROption to switch to CAM2029
(if primary endpoint met)
Treatment period
Survival follow-up
* GEP – gastroenteropancreatic; NET – neuroendocrine tumors
Primary endpoint PFS (Progression
Free Survival)Active comparator
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NET Phase 3
Active controlled Phase 3 study in patients with metastatic, well differen-tiated GEP-NET
CAM2029 study program overview
2019 20212020 2022
ACRO Phase 3 LTSE
Randomized, double-blind, placebo-controlled study in SSA responders
ACRO Phase 3 PCRegulatory
submissionsACRO
Autoinj. PK
ACRO Phase 3 PC ACRO Phase 3 LTSE
Open-label, long-term safety study in partial and full responders
Four clinical trials completed in healthy subjects and patients characterizing PK, PD and safety profile (N=249)
NET Phase 3
PLD Phase 2
PLD Phase 2
Placebo-controlled Phase 2 study in patients with polycystic liver disease (PLD)
Autoinjector PK
PK bridging study of prefilled syringe and autoinjector devices
FDA advisory meeting NET
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Significant peak market potential for CAM2029
$60m
$145m
$120m
$180m
$180m
$245m
$240m
$435m$485m
$720m
$720m
$1,015m
NET (US+EU5)Acromegaly (US+EU5)
Profile 1CAM2029 is available as a pre-filled syringe (PFS) device with non-inferior efficacy to current long-acting SSAs, with an assumed penetration of 10–20% in acromegaly, and 10–15% in NET
Profile 2Available both as PFS and as an autoinjector, with non-inferior efficacy to current long-acting SSAs and an assumed penetration of 20–25%
Profile 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%
1Globe Life Sciences reports 2019 and 2020; data on file
$265m
$415m
PLD (US+EU5)
Profile 1 Profile 2 Profile 3 Profile 1 Profile 2 Profile 3 Currently no approved products
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Progress in Rhythm collaboration
Long-acting setmelanotide for treatment of genetic obesity disorders Rhythm submitted NDA for daily
setmelanotide in POMC / LEPR deficiency– PDUFA date with priority review 27 November 20201
Positive Phase 2 results for weekly depot (CAM4072) announced in June 20201
• CAM4072 well tolerated• Achieved weight loss comparable to
daily formulation over 12 weeks
Discussion with FDA about the registration path for once-weekly setmelanotide
Weekly setmelanotide (CAM4072) Positive Phase 2 data announced1
1Rhythm Corporate Presentation – October 2020. https://ir.rhythmtx.com/static-files/fd4e0919-4d82-47e0-afe3-8cd9b5151490
Mean through drug concentrations for 20mg and 30mg doses of CAM4072 similar to 3mg daily dose
QD-3mg QW-10mg QW-20mg QW-30mg
Week
Mea
nTh
roug
hC
once
ntra
tion
(ng/
mL)
1 2 3 4 5 6
0
7 8 9 10 11 12
3
6
9
12
30
Start Phase 2 study of CAM2043 in Raynaud’s phenomenon
Reported and anticipated news flow during 2020/21
Buvidal launched in Austria
2020 2021
Start CAM2029 autoinjector bridging PK study
Results CAM2029 bridging PK study autoinjector
Announcement of strong Buvidal demand during Q1 2020
H2H1
IND CAM2029 Phase 3 study in NET
MAA submission CAM2038 chronic pain to EMA
Final market approval of Brixadi™ in the US
CTA for CAM2043 Phase 2 in RP
GPs allowed to prescribe Buvidal in Australia
Start Phase 2 CAM2029 in PLDBuvidal reimbursed
in Sweden
Request for final market approval to US FDA
Phase 2 results long-acting setmelanotide
Raised FY 2020 guidance
Outcome of arbitration
process
Arbitration process initiated by Braeburn
Completion of Phase 3 efficacy study of CAM2029 in acromegaly
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Multiple levers for growth and value creation on short and medium term
Buvidal®/ Brixadi™
Establish leadership in opioid dependence treatment with Buvidal® in Europe and Australia
US market approval and launch of Brixadi™ and continued RoWexpansion of Buvidal
Pipeline
Late-stage development and new regulatory approvals in chronic pain, acromegaly and NET
Grow our pipeline of innovative medicines and expand the use of our FluidCrystal® technology in areas of high unmet need and market potential
Corporate
Continue to build our commercial infrastructure and launch new products
Develop sustained profitability through own sales, partnerships and business development
32
Camurus AB │ Ideon Science Park, SE-223 70 Lund,
Sweden
P +46 46 286 57 30 │ [email protected] │ camurus.com
33
Financial overview third quarter 2020
Key figures
MSEK Jul – Sep2020 (2019) Δ
Jan – Sep2020 (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% -123.6 (-271.6) +54%
Result for the period -20.3 (-62.7) +68% -101.8 (-218.0) +53%
Result per share, before and after dilution, SEK -0.38 (-1.31) +71% -1.95 (-4.76) +59%
Cash position 475.7 (192.3) +147% 475.7 (192.3) +147%
Q3 Q1-Q3
34
Shareholders
Shareholders as of 31 October 2020 Number of shares % of capital % of votes
Sandberg Development AB 22,200,692 41.4 41.4
Gladiator 3,433,078 6.4 6.4
Fjärde AP-fonden 3,330,676 6.2 6.2
Avanza Pension 1,733,024 3.2 3.2
Fredrik Tiberg, CEO 1,703,188 3.2 3.2
Svenskt Näringsliv 1,100,000 2.0 2.0
Backahill Utveckling 867,153 1.6 1.6
Lancelot Asset Management 600,000 1.1 1.1
State Street Bank and Trust 553,616 1.0 1.0
Afa Försäkring 550,000 1.0 1.0
Camurus Lipid Research Foundation 505,250 0.9 0.9
Nordnet Pensionsförsäkring 474,642 0.9 0.9
Enter fonder 457,561 0.8 0.8
Hamrins Stiftelse 425,000 0.8 0.8
Grenspecialisten 420,870 0.8 0.8
Other shareholders 15,282,108 28.5 28.5
In total 53,636,858 100.0 100.0
Shareholder distribution
41.4%
6.4%6.2%
3.2%3.2%
2.0%
1.6%
1.1%
1.0%1.0%
0.9%0.9%0.8%0.8%
0,8%
28.5%
35
Agneta SvedbergVice President, Clinical & Regulatory Development
In Company since: 2015Holdings: 11,341 shares & 75,000 subscription warrants
Fredrik Tiberg, PhDPresident & CEOHead R&DIn 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, Visiting Professor at Oxford University, Institute for Surface Chemistry (Section head)
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 subscription 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
Experienced and committed management team
Peter HjelmströmChief Medical Officer
In Company since: 2016Holdings: - shares & - warrants
36
Braeburn arbitration
•Camurus announced on 15 June that Braeburn has initiated arbitration proceedings in England1
‒ Camurus previously served a notice of material breach questioning Braeburn’s performance primarily relating to:
• Preparations for regulatory approval and commercialization of Brixadi/CAM2038 for OUD in Canada
• Preparations for a separate earlier launch of Brixadi weekly product for the treatment of OUD in the US
• Preparations for regulatory approval and commercialization of Brixadi for the treatment of chronic pain
‒ Braeburn has disputed the validity of the material breach notice‒ The license agreement stipulates a 90 days arbitration process
• The license agreement remain in full force and effect during the arbitration process
•Possible outcomes‒ If the Tribunal finds that Braeburn is in material breach:
• Camurus will be entitled (subject to a 60-day cure period) to terminate the agreement and regain all rights granted to Braeburn
‒ If the Tribunal finds that Braeburn is not in material breach:• The license agreement will remain in full force and effect
1 Camurus press release 15 June 2020 https://mb.cision.com/Main/13456/3134723/1264520.pdf