company presentation - camurus
TRANSCRIPT
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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
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Experiencedmanagement and dedicatedteams
Corporate highlights
Rapidly growing commercial stage company• Fully operational infrastructure in Europe and Australia
• Buvidal® to date available in 15 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 12 billion EMPLOYEES: 136 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
loo
dco
nc.
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.
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 (n
g/m
L)
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 (n
g/m
L)
Time (days)
Pasireotide FluidCrystal 20mg (SC thigh, n = 12)
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Camurus had a successful 2020
1. Constant exchange rates (CER) December 2019
FY 2020 guidanceExpected FY net revenuesSEK 340 - 380 million,whereof product salesSEK 310 – 340 millionExpected FY OPEX* SEK 505 – 525 million
*Without regard to the outcome of the ongoing arbitration process
•Strong revenue growth – in line with our upgraded 2020 guidance • Net revenue SEK 336 million, up 218% (SEK 351 million, up 227% at CER1),• Product sales SEK 323 million, up 347% (SEK 337 million, up 362% at CER1)• OPEX was SEK 508 million, an increase of 15%
•Successful commercialization of Buvidal• Scalable commercial platform in Europe and Australia • Expansion into new markets• Established the value Buvidal brings to patients, HCPs, payors and society
‒ Growing scientific evidence, including positive results from DEBUT and UNLOC-T clinical trials
•Significant pipeline progress• Progress of Phase 3 studies for CAM2029 in acromegaly • Positive Phase 2 results for weekly FluidCrystal® setmelanotide for treatment of rare
genetic obesity disorders by Rhythm• Progress in the early pipeline has laid the ground for new value-adding clinical
programs
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Fourth quarter 2020 highlights
•Total revenues up by 201% (213% at CER1)‒ Product sales up by 243% (256% at CER1)
•Patients in treatment with Buvidal® increased to over 15,000‒ More than 200,000 Buvidal doses administered in 2020
•Buvidal approved in Switzerland ‒ Three additional MAAs submitted
•Delay in the US‒ Braeburn received a CRL2 from FDA for the Brixadi™NDA‒ Partial award announced from arbitration process with Braeburn
•New clinical studies‒ First patients treated in Phase 2 study of CAM2043 in Raynaud’s
phenomenon and Phase 1 study of CAM2029 autoinjector‒ Phase 3 study protocol finalized for CAM2029 in NET
•New patents for Buvidal granted in the EU and US
Key figures
1. Constant exchange rates (CER) December 2019 2. CRL – Complete Response Letter
MSEK Oct – Dec2020
Δvs 2019
Jan – Dec2020
Δvs 2019
Total revenues 106 +201% 336 +218%
whereof product sales 104 +243% 323 +347%
OPEX 175 +58% 508 +15%
Operating result -82 +8% -205 +43%
Result for the period -65 +9% -167 +42%
Result per share, before and after dilution, SEK -1.22 +17% -3.18 +49%
Cash position 462 +29% 462 +29%
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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, risk of overdose, poor retention,
burdens and stigma of daily buprenorphine and methadone medications
1United Nations: World drug report 2020; National Records of Scotland https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/deaths/drug-related-deaths-in-scotland/2019
Escalating overdose deaths
0
200
400
600
800
1 000
1 200
Opioid related deaths in Scotland over the last 10 years2
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Buvidal® – flexible long-acting treatment of opioid dependence
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
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
Buvidal provides significant benefits to patients and society‒ Improved treatment outcomes and patient satisfaction1-3
‒ Reduced treatment burden and improved quality of life2
‒ Diminished diversion, misuse and pediatric exposure4
‒ Reduced treatment costs in the criminal justice system5
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60
50
40
30
20
10
0
70
80
90
100
110
Buvidal growth journey
Continued progress in the fourth quarter‒ Invoiced product sales grew by 10% versus Q3 2020,
while the in-market Buvidal sales growth was 33%‒ Double-digit growth in all markets ‒ Largest markets: Australia, Finland, Norway and UK‒ Covid-19 barrier for uptake and delayed pricing and
reimbursement processes
Buvidal available in 15 countries‒ 12 countries in Europe and Australia
• Latest launch in Spain after price and reimbursement decision in December 2020
‒ 3 countries in MENA with Early Access Programs ‒ Preparation for new launches in Wave 3 markets
MSEK
20202019
Q1 Q2 Q3 Q4 Q1 Q2 Q3
49
30
19
11
76
11
94
104
Q4
Product sales by quarter
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Buvidal scientific evidence base translated into significant patient benefits
Strong science
• 25 peer-reviewed scientific publications – 11 in 2020
• 123 conference presentations – 24 in 2020
Supported claims
• Superior treatment outcome versus daily sublingual buprenorphine
• Flexible, individualized treatment according to patients’ needs
• Improved treament satisfaction and quality of life of patients
Media recognition
• Benefits of Buvidal being recognized by wider society
• Covid-19 highlights advantages of long-acting treatments
“…make available long acting treatments in both community & prison” Nicola Sturgeon, First Minister, Scotland, 21 Jan 2021
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REGION PARTNER NO OF PATIENTS MARKET POTENTIAL
EUAustralia LAUNCH INITIATED IN 2019
~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 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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CAM2038 Chronic pain
Pre-submission meeting held with EU Rapporteur
Regulatory submission to EMA planned in 2021
Buvidal (Brixadi) regulatory progress
•New approval Market authorization approval by
Swissmedic in December 2020
•Regulatory filings Line-extension applications and label
enhancements with EMA and TGA Market authorization application, MAA,
under final review in New Zealand
•Availability of Buvidal in MENA Early access programs ongoing in
three countries MAAs submitted in three MENA
countries in Q4 – priority review received in Saudi Arabia
Further submissions planned in 2021
•Braeburn received CRL in the US Complete response letter (CRL) issued
by FDA for the Brixadi™NDA on1 December 2020‒ Quality related observations during pre-
market inspections of Braeburn’s third-party manufacturer
Braeburn are working with their contract manufacturer to address the CRL issues and resubmit the NDA
A new PDUFA date for the Brixadi™ NDA is expected in H2 2021
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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 Raynaud’s phenomenon
CAM2043 Pulmonary arterial hypertension
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 – octreotide subcutaneous depot in Phase 3 development
•Innovative medicine in late-stage development for rare pituitary disorders and neuroendocrine tumors
•Designed for enhanced efficacy and patient convenience
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CAM2029 opportunity addresses key unmet medical needs in the SSA market
•Somatostatin analogues (SSAs) are first-line medical therapy in acromegaly and neuroendocrine tumors (NET)
•But there are significant limitations with current SSA treatments‒ Difficult handling & administration‒ Sub-optimal treatment result
•CAM2029 offers simplified dosing and possibility of self-administration‒ Ready-to-use prefilled syringe or
autoinjector for enhanced convenience with option for self-administration
•Potential for improved biochemical and symptom control‒ Fast onset and long-acting release
with 500% higher bioavailability vs octreotide LAR1
‒ Well maintained or improved biochemical and symptom control indicated with CAM2029 in acromegaly and NET patients2
•US$ 2.8 billion• CURRENT SSA MARKET VALUE3
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; 3 GlobalData 2020, excluding pasireotide sales
Somatuline® Autogel®Sandostatin® LAR®
0
500
1000
1500
2000
2500
3000
mUSD
SSA annual sales
Sandostatin® LAR® (octreotide):
Somatuline® Autogel® (lanreotide): CAM2029:
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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
19
0
2
4
6
8
Day -28 - Day 0 Day 28 Day 56 Day 84
GH
co
nce
ntr
atio
n (
mg
/mL)
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
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CAM2029 study program overview
PK – pharmacokinetic; PD – pharmacodynamic
2019 20212020 2022
ACRO Phase 3 LTSE
ACRO Phase 3 PCRegulatory
submissionsACRO
Autoinj. PK
Four clinical trials completed in healthy subjects and patients characterizing PK, PD and safety (N=249)
NET Phase 3
PLD Phase 2
NET Phase 3
Active controlled Phase 3 study in patients with metastatic, well differen-tiated GEP-NET
Randomized, double-blind, placebo-controlled study in SSA responders
ACRO Phase 3 PC ACRO Phase 3 LTSE
Open-label, long-term safety study in partial and full responders
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
IND NET Ph. 3
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•Efficacy trial‒ Phase 3, randomized, double-blind, placebo-controlled,
multi-center trial to assess efficacy and safety of CAM2029 ‒ 78 patients, full SSA responders‒ Regulatory requirements for efficacy data met‒ Primary end-point: Proportion of patients with mean IGF-1
levels ≤ 1x upper limit of normal (ULN) at w22 and w24‒ Study ongoing and recruiting
Two ongoing pivotal Phase 3 studies of CAM2029 in acromegaly
•Long-term safety trial‒ Phase 3, open-label, single arm, multi-center trial to
assess the long-term safety and efficacy 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: Safety profile (adverse events)
‒ Study ongoing and recruiting
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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GEP-NET Phase 3 trial under start-up
Phase 3, randomized, open-label, active-controlled multi-center trial to assess efficacy and safety of CAM2029 versus octreotide LAR or lanreotide ATG in patients with GEP-NET‒ Approximately 300 patients with GEP-NET randomized 1:1‒ Primary endpoint: superiority of treatment with CAM2029 versus standard of care, as determined by
progression free survival in patients with GEP-NET ‒ Study starting
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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CAM2029 update status
•Acromegaly‒ Two phase 3 studies ongoing ‒ On track for NDA/MAA submissions
in late 2022 ‒ Orphan drug designation in the EU
•Neuroendocrine tumor‒ Registration program for GEP-NET
was aligned with FDA and EMA ‒ IND safe to proceed letter received
from FDA for start of Phase 3 trial‒ CTAs in progress
•Polycystic liver disease program‒ FDA interactions ongoing about the clinical
registration program for CAM2029 in PLD‒ Patient reported outcome (PRO) questionnaire in
development
•Autoinjector development ‒ Autoinjector developed ‒ Phase 1 bridging study ongoing‒ Full validation ready in mid-2021
•New indications ‒ CAM2029 is being considered for additional
indications ‒ Go / No Go decision and potential clinical study
start in 2021
“Top selling drug to enter the market will
be Camurus' Octreotide LA”
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Significant market potential expected for CAM2029
Recent GlobalData report:
1Globe Life Sciences reports 2019 and 2020; data on file
“Top selling drug to enter the market will
be Camurus' Octreotide LA”
November 2020
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%
Estimates US$210m US+EU5 sales in 2029
in acromegaly
$60m
$145m
$120m
$180m
$180m
$245m
$240m
$435m$485m
$720m
$720m
$1,015m
NET (US+EU5)
$265m
$415m
PLD (US+EU5)Acromegaly (US+EU5)
Profile 1 Profile 2 Profile 3 Currently no approved productsProfile 1 Profile 2 Profile 3
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Progress in Rhythm collaboration
Long-acting setmelanotide for treatment of genetic obesity disorders Daily setmelanotide in POMC / LEPR
deficiency approved by the FDA on27 November 20201
Positive Phase 2 results for weekly depot (CAM4072) announced in June 20202
• CAM4072 well tolerated• Achieved weight loss comparable to
daily formulation over 12 weeks
Rhythm announced plans to start registration study for weekly setmelanotide in H2 2021
Weekly setmelanotide (CAM4072) Positive Phase 2 data2
1 https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreetm; 2Rhythm Corporate Presentation – November 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 daily 3mg 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
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Start Phase 2 study of CAM2043 in Raynaud’s phenomenon
Strong news flow during 2020/21 – selected events
2020 2021
Start CAM2029 autoinjector bridging PK study
Results CAM2029 autoinjector PK study
Announcement of strong Buvidal demand
H2H1
Start CAM2029 Phase 3 study in NET
MAA submission CAM2038 chronic pain
Braeburn receives CRL for Brixadi™ in the US
Start Phase 2 CAM2029 in PLD
Phase 2 results long-acting setmelanotide
Raised FY 2020 guidance
Arbitration process initiated by Braeburn
Completion of Phase 3 efficacy study of
CAM2029 in acromegaly
Buvidal third wave market expansion
Phase 2 results CAM2043 in Raynaud’s
Start new in-house clinical program
Brixadi US approval
Buvidal EU/AUS line extension approvals
Publication of DEBUT and
UNLOC-T data
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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™
Continued RoW expansion
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 growth and profitability through own sales, partnerships, business development and M&A
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Outlook 2021
•Full year 2021 guidance*
• Revenue
•SEK 680 – 750 million
• whereof product sales
•SEK 620 – 680 million
• Operating result
•SEK -120 – 0 million
• * Constant exchange rates from January 2021
•Key assumptions: Revenue • Excludes a potential $35m milestone for
final approval of Brixadi in the US• Product sales estimate based on end of
2020 Buvidal patient numbers, a similar uptake as in 2020, and market expansion
• Uncertainty relating to Covid-19 impacts
•Expenses• Incremental R&D investments, including
in CAM2029 Phase 3 programs • Investments in market expansion for
Buvidal with launches in Wave 3 markets• Limited organizational expansion
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Camurus AB │ Ideon Science Park, SE-223 70 Lund,
Sweden
P +46 46 286 57 30 │ [email protected] │ camurus.com
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Shareholders
Shareholders as of 26 February 2021 Number of shares % of capital % of votes
Sandberg Development AB 22,000,692 40.6 40.6
Fjärde AP-fonden 3,330,676 6.1 6.1
Gladiator 2,833,100 5.2 5.2
Avanza Pension 1,783,876 3.3 3.3
Fredrik Tiberg, CEO 1,696,788 3.1 3.1
Svenskt Näringsliv 1,100,000 2.0 2.0
Didner & Gerge Fonder 1,015,219 1.9 1.9
Backahill Utveckling 826,491 1.5 1.5
Lancelot Avalon 719,038 1.3 1.3
Afa Försäkring 550,000 1.0 1.0
Cancerfonden 510,000 0.9 0.9
Camurus Lipid Research Foundation 505,250 0.9 0.9
State Street Bank and Trust 479,090 0.9 0.9
Enter fonder 457,561 0.8 0.8
Hamrins Stiftelse 425,000 0.8 0.8
Other shareholders 16,002,409 29.7 29.7
In total 54,235,190 100.0 100.0
Shareholder distribution
40.6%
5.6%6.1%
3.5%3.1%
2.0%
1,9%1.5%
1.4%1.0%
0,9%0.9%
1.2%
0.8%
0.8%
29.7%
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Agneta SvedbergVice President, Clinical & Regulatory Development
In Company since: 2015Holdings:12,000 shares & 50,000 subscription warrants
Fredrik Tiberg, PhDPresident & CEOHead R&DIn Company since: 2002Holdings:1,696,788 shares & 165,000warrants
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:45,124 shares & 17,009 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 & 88,000 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:12,000 subscription warrants
Andrew McLeanVice President Corporate Dev.& Senior Counsel
In Company since: 2021Holdings: -
Experienced and committed management team
Peter HjelmströmChief Medical Officer
In Company since: 2016Holdings: -
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~740,000 patients estimated suited for treatment with 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 billion66
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Buvidal is well differentiated
Long-acting injection treatments for opioid dependence
*Based on information in product labels
PRODUCTWEEKLY 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 – 0.64 mL
EU, Australia
– – – –19G
–0.5 – 1.5 mL
– – – US, Canada, Australia
– – – –20G
–3.4 mL
– – – US
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Study met primary endpoint demonstrating superiority for TSQM global satisfaction1
Compelling clinical evidence from head-to-head DEBUT study
•DEBUT – Depot Evaluation Buprenorphine Utilization Trial‒ Randomized, multi-site, open-label, active-controlled study
of Buvidal vs standard of care in 120 adult outpatients with opioid dependence to compare patient reported outcomes (PROs)
‒ Primary endpoint: patient reported TSQM† global satisfaction score
‒ Secondary endpoints (selected): other treatment satisfaction domains, treatment burden, quality of life, opioid related behaviors and general health outcomes
1. Lintzeris N, Dunlop A, Haber P, Lubman D, Graham R, Hutchinson S, Hjelmstrom P, Svedberg A, Peterson S, Tiberg F. Results of the DEBUT Study – A Multisite, Open-Label RCT of Weekly and Monthly Depot Buprenorphine Injections (CAM2038) Vs. Daily Sublingual Therapy Investigating Patient Reported Outcomes in Treatment of Opioid Use Disorder. Presented at The College on Problems of Drug Dependence, (CPDD) Virtual Meeting June 22-24, 2020. † Statistically significant p-value ≤ 0.05TSQM – Treatment satisfaction questionnaire for medication ; SL – sublingual; BPN – buprenorphine; SOC – Standard of Care
Day -28 to -1 Day 1 Week 24
Screening
Buvidal Weekly & Monthly flexible dosing
Follow-upperiod
Week 26
BPN SoCflexible dosing
n=120
R
Scheduled Visit Statistic Buvidal SL BPN SOC†Difference
(Buvidal - SL BPN)p-value
Baseline (Mean) 71.2 73.8 - -
Week 24 (LS Mean) 82.5 74.3 8.2 0.0143
Treatment period (LS Mean) 82.4 73.8 8.6 0.0016
w0 w12 w24
Side Effects Score
w0 w12 w24
Effectiveness Score
* *
40
50
60
70
80
90
100
w0 w12 w24
Mea
n T
SQ
M s
core
Global satisfactionscore
CAM2038SL BPN
* *
w0 w12 w24
Convenience Score
* *
Buvidal
Primary endpoint First secondary endpoints
35
•UNLOC-T – Safety and feasibility of depot buprenorphine in NSW custodial settings‒ Prospective, non-randomized, open-label, multicenter study in
129 OUD patients treated with Buvidal or methadone in 8 prisons
•Results1
‒ The safety profile pf Buvidal was satisfactory with most AEs being mild in severity and no severe treatment related AEs
‒ Treatment retention was high (81% at week 16)‒ Treatment costs with Buvidal was ~1/3 of daily methadone and
~1/10 of daily sublingual buprenorphine‒ Following the study, treatment with depot BPN in NSW prisons
has been expanded rapidly in Australia2
Further studies continue to expand the Buvidal evidence base
•ARIDE – Addiction recovery among opioid-dependent patients treated with injectable subcutaneous depot buprenorphine‒ Non-randomized prospective non-interventional
observational study with control group design (treatment-as-usual, TAU) performed in Germany3
‒ The primary objective is to evaluate quality of life. Secondary objectives include satisfaction, illicit substance use, social participation and cost-effectiveness.
‒ Patient recruitment started in 2020
1. Dunlop A et al. Introduction of Long-Acting Depot Buprenorphine in Prison - the UNLOC-T Study. Presented at The College on Problems of Drug Dependence, (CPDD) Virtual Meeting June 22-24, 2020 ; 2. Roberts J et al. Rapid upscale of depot buprenorphine (CAM2038) in custodial settings during the early COVID-19 pandemic in New South Wales, Australia. Addiction. 2020; Online ahead of print https://doi.org/10.1111/add.15244 there were >8003. Schulte B et al. U. Addiction recovery among opioid-dependent patients treated with injectable subcutaneous depot buprenorphine: Study protocol of a non-randomized prospective observational study (ARIDE) Front Psychiatry 2020; Online ahead of print https://doi.org/10.3389/fpsyt.2020.58086
Screening
Day 0 Day 1 Week 16 Week 48Week 4
Extended safetymonitoring
E
Buvidal weekly Buvidal monthly
n=1201
Methadone
Month 12
Screening
Buvidal weekly & monthly
TAUN=4261
A
Day 1
S