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Jefferies Virtual Healthcare Conference 1 June 2021
Corporate presentationDelivering better treatments for patients with severe and chronic diseases
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
3
Long-acting medications addressing key healthcare challenges
4
Experiencedmanagement & dedicated teams
Camurus snapshot
Rapidly growing commercial stage company• Fully operational infrastructure in Europe and Australia
• Buvidal® to date available in 15 countries• Strong sales performance and growth
Market approvalsWeekly and monthly Buvidal® for opioid dependence
PartnershipsR&D collaborations, licensing and royalty arrangements with pharmautical 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 11 billion EMPLOYEES: 146 HQ: Lund, Sweden REGIONAL OFFICES: Cambridge, Mannheim, Sydney
Broad late-stage pipeline• +10 innovative clinical programs in addiction, pain, endocrine disorders and oncology
• Three Phase 3 programs• Advancing early- and mid-stage candidates
5
Recent business progress
•Strong commercial execution with Buvidal‒ Expanding sales and commercial infrastructure‒ Initiating diversification and prelaunch preparations for new products
•Advancing pipeline‒ Successful life-cycle management and new regulatory approvals‒ Two ongoing Phase 3 studies of CAM2029 in acromegaly ‒ Phase 3 study of CAM2029 in neuroendocrine tumors (NET) starting‒ Several early-stage clinical programs and partnerships advancing
•Positive financial performance ‒ Strong revenue growth and improved financial results ‒ Solid cash position with no loans‒ On track for profitability in 2022
1Total revenue SEK 680 – 750 million, whereof product sales SEK 620 – 680 million, and the operating result SEK -120 – 0 million excluding a USD 35 million milestone payment on approval of Brixadi™ in the US
6
Opioid dependence – worsened crisis during the pandemic
• Largest society burden of all drugs1
‒ High need for better access to care and new treatment alternatives
‒ Investment in treatment brings substantial value and saves lives
• New funding initiatives‒ President Biden recently issued a US$1.5 billion
initiative for substance use treatment and prevention2
‒ Scottish Government initiative £250m investment to tackle drug death crisis3
• Significant limitations 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; 2www.thenationalcouncil.org/wp-content/uploads/2021/03/American-Rescue-Plan-Act-MH-SUD-Provisions..pdf?daf=375ateTbd56; 3www.gov.scot/news/more-than-gbp-250-million-for-drug-deaths-emergency/
Escalating overdose deaths during COVID-19
12 Month-ending Provisional Number of Drug Overdose Deaths in the US4
0
10 000
20 000
30 000
40 000
50 000
60 000
70 000
80 000
90 000
100 000
Nu
mb
er o
f d
eath
s in
th
e U
S
12 month-ending period
All drugs
Opioids
Start lockdowns
4 https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
7
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
Weekly and monthly, subcutaneous buprenorphine for individualized treatment of opioid dependence within a framework of medical, social and psychological treatment in adults and adolescents 16 years or over1
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
“Buvidal becamemy way out”Justin, Buvidal patient in Australia
8
11
20
30
49
76
94
104
124
Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
20202019 2021
Strong growth for Buvidal despite pandemic challenges
Consistent double-digit quarter-by-quarter growth‒ Exceptional uptake in Australia and the Nordics‒ Progress in the UK, Germany, Spain and other markets‒ COVID-19 remains a barrier on many markets
Buvidal market expansion continues‒ Available in 15 countries in Europe, Australia and MENA‒ P&R applications in new markets‒ 8 launches planned in 2021
Successful life-cycle management and growing scientific evidence ‒ New approvals and important scientific publications‒ Increasing media coverage
;
Product sales by quarter (MSEK)
MENA – Middle East and North Africa; P&R – price and reimbursement
35% Average Q/Qgrowth rate
9
New Zealand ~5,500 patients2,3
Market authorization received PMA initiated
Netherlands ~10,000 patients in opioid
dependence treatment1
Launch expected in Q2 2021
France >179,000 patients1
Positive HEOR assessment by Haute Autorité de Santé
Preparing for launch in Q3 2021
Croatia and Slovenia >8,000 patients1
Preparing for launch Q3 2021
1EMCDDA 2020; 2Office of the Director of Mental Health and Addiction Services Annual Report 2018 and 2019; 3New Zealand Practice Guidelines for Opioid Substitution Treatment 2014
Italy ~70,000 patients1
PMA ongoing
Buvidal market expansion continues
Portugal >17,000 patients1
Preparing for launch in Q2/Q3 2021
Switzerland 10,000 patients1
Marketing approval received Launch expected in Q2/Q3 2021
Launch sequenceWave 1& 2 Launched
Wave 3 marketsWave 4 markets
MENA Early access program in three countries Several regulatory submissions
progressing
10
Buvidal scientific evidence base translated into significant patient benefits
Growing evidence base
• From RCTs to real-life studies• 25 peer-reviewed scientific
publications1
• 123 conference presentations
Strong supported claims
• Superior treatment outcome versus daily sublingual buprenorphine
• Flexible, individualized treatment according to patients’ needs
• Improved treatment satisfaction and quality of life of patients
Increasing media attention
• Benefits of Buvidal recognized by wider society2
• Powerful patient stories in national and regional media3
“…make available long acting treatments in both community & prison” Nicola Sturgeon, First Minister, Scotland, 21 Jan 2021
1Including Lintzeris, N. et al.; JAMA Netw Open 2021 May 3;4(5):e219041; Lofwall et al. JAMA Int. Med. 2018;178(6); 764-773;Frost et al, Addiction, 2019;114(8):1416-1426; and Walsh et al, JAMA Psychiatry 2017;74(9):894-902; 2Including www.gov.scot/publications/update-drugs-policy/; 3Including www.bbc.com/news/uk-scotland-54433312, www.itv.com/news/granada/2021-05-19/the-game-changer-meds-helping-tackle-opioid-addiction;
11
Study met primary endpoint demonstrating superiority for TSQM global satisfaction1
Compelling data from head-to-head DEBUT studySuperior patient satisfaction, reduced treatment burden and higher quality of life
•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, and opioid related behaviors
1. Lintzeris N. et al, JAMA Network Open 2021 May 3;4(5):e219041. * Statistically significant p-value ≤ 0.05TSQM – Treatment satisfaction questionnaire for medication ; SL – sublingual; BPN – buprenorphine; SOC – Standard of Care
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 .01
Treatment period (LS Mean) 82.4 73.8 8.6 .001
w0 w12 w24
Side Effects Score
w0 w12 w24
Effectiveness Score
* *
40
50
60
70
80
90
100
w0 w12 w24
Mea
n TS
QM
sco
re
Global satisfactionscore
CAM2038SL BPN
* *
w0 w12 w24
Convenience Score
* *
Buvidal
Primary endpoint First secondary endpoints
RFollow-up
period
Buvidal Weekly & Monthly
BPN SoC
Day -28 to -1 Week 24
n=120
Flexible dosing
Screening
Day 1 Week 26
12
REGION PARTNER NO OF PATIENTS ESTIMATED PEAK SALES
EUAustralia LAUNCH INITIATED IN 2019
~1.3 millionHIGH-RISK
OPIOID USERS1
€300 million2
North America
>2 millionDIAGNOSED WITH OPIOID USE DISORDER IN THE US3
$600-1,200 million4, 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™)
13
Significant opportunity in mid- to late-stage pipeline
Phase 1 Phase 2 Phase 3 Registration Market
CAM2043Pulmonary arterialhypertension
CAM2029Polycystic liver disease
CAM2029Acromegaly
Brixadi™Opioid use disorder (US)1
Buvidal®Opioid dependence
CAM2047Chemotherapy-inducednausea and vomiting
CAM2032Prostate cancer
CAM2029Neuroendocrine tumors
Buvidal® 160mgOpioid dependence
episil® oral liquidOral mucositis
CAM2048Postoperative pain
CAM2043Raynaud’s phenomenon
CAM2038Chronic pain
CAM4071Endocrine disorders
CAM4072Genetic obesity disorders2
1 Licensed to Braeburn. 2 Licensed to Rhythm Pharmaceuticals
Opioid dependence & Pain
Rare diseases
Oncology & Supportive care
14
CAM2038 Chronic pain‒ Pre-submission meeting
held with EU Rapporteur‒ Regulatory submission
to EMA planned in H2 2021
Buvidal (Brixadi) lifecycle management and geographic expansion
•New approvals‒ Market authorization approval in
Switzerland and New Zealand ‒ Approval of 160mg monthly dose
and direct initiation in Australia‒ Approval of 160mg dose in EU
•Regulatory filings‒ Four MAAs under review in MENA;
Priory Review granted in Saudi Arabia‒ Early access programs ongoing in three
MENA countries‒ Further submissions planned in 2021
•Brixadi™ in the US‒ FDA issued Braeburn a Complete
Response Letter (CRL) for the Brixadi NDA on 1 December 2020
‒ Braeburn has worked with their contract manufacturer to address the CRL issues
‒ Waiting for confirmation of NDA resubmission and new PDUFA date for Brixadi – expected in H2 2021
CHMP - EMA Committee for Medicinal Products for Human Use; MENA – Middle East and North Africa; NDA – New Drug Application; PDUFA – Prescription Drug User Fee Act
15
CAM2029 – octreotide subcutaneous depot in Phase 3 development
•Innovative medicine in late-stage development for the treatment of rare diseases; acromegaly, neuroendocrine tumors and polycystic liver disease.
•Designed for enhanced efficacy and patient convenience
16
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 exposure / treatment response
•CAM2029 offers simplified dosing and possibility of self-administration‒ Ready-to-use prefilled syringe and pen
device for enhanced convenience with option for self-administration
•Potential for improved biochemical, symptom and tumor control‒ 500% higher bioavailability vs octreotide
LAR1
‒ Well maintained or improved biochemical and symptom control indicated with CAM2029 in acromegaly and NET patients2
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
US$ 2.8 billionCURRENT SSA
MARKET VALUE3
Somatuline® Autogel®Sandostatin® LAR®
0
500
1000
1500
2000
2500
3000
mUSD
SSA annual sales
Sandostatin® LAR® (octreotide):
Somatuline® Autogel® (lanreotide):
CAM2029:
17
Three late-stage programs with CAM2029
PK – pharmacokinetic; PD – pharmacodynamic
- 2020 20222021 2023
Regulatory submissions
ACRO
Autoinj. PK
Four clinical trials completed in healthy subjects and patients characterizing PK, PD and safety (N=249)
NET Phase 3
PLD Phase 2/3
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 2/3
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
ACRO Phase 3 LTSE
ACRO Phase 3 PC
18
R
Double-blind treatment phase
Possibility to roll-over to long-term safety study
CAM2029 once monthly
Placebo
4-8 weeksscreening
Week 24Endpoint assessment
N=782:1 Rescue with standard of care
Prior treatment with octreotide or lanreotide
Week 1Open label treatment phase
Roll-over patients from efficacy study
N=70
4-8 weeksScreening
Week 24
CAM2029 once monthly
New patientsN=70
Prior treatment with octreotide or lanreotide
Week 52Week 1
•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 endpoint: 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 endpoint: Safety profile (adverse events)
‒ Study ongoing and recruiting
HS-18-633 HS-19-647
19
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
* GEP – gastroenteropancreatic; NET – neuroendocrine tumors
•Patient population‒ Adult patients with
histologically confirmed advanced (unresectable and/or metastatic) and well-differentiated NET of GEP origin Follow-up period
ROption to switch to CAM2029
(if primary endpoint met)
Treatment period
Survival follow-up
CAM2029
Active comparator
Screening Endpoint assessment
Week 1
20
CAM2029 status and milestones
•Acromegaly Orphan drug designation in the EU Two phase 3 studies ongoing NDA/MAA submissions late 2022 Pre-launch activities initiated
•Neuroendocrine tumor Registration program for GEP-NET
aligned with FDA and EMA
Phase 3 study starting
•Polycystic liver disease program FDA scientific advice meeting PRO questionnaire in development Start Phase 2/3 study
•Prefilled pen development Clinical study ongoing Fully validated for Phase 3 and
commercial use mid-2021
•New indications CAM2029 is being considered for
additional indications Go / No Go decision and potential
clinical study start in 2021
1Globe Life Science market research. Data on file. 2Assuming CAM2029 prefilled pen presentation and efficacy non-inferior to current long-acting SSA-products; 3Assuming CAM2029 prefilled pen presentation and efficacy superior to current long-acting SSA-products; 4No currently available medical treatments
Estimated CAM2029 peak sales potential in the US and EU5:1
US$ 1.1-1.6 billion
Acromegaly2
US$ 120-180 million
Neuroendocrine tumors3
US$ 720-1015 million
Polycystic liver disease4
US$ 265-415 million
21
H2 2021 Results CAM2029 prefilled pen
– autoinjector – PK study
Start CAM2029 Phase 2/3 in PLD
Start CAM4072 Phase 3 program (Rhythm)
Phase 2 results CAM2043 in Raynaud’s phenomenon
MAA submission CAM2038 in chronic pain
Brixadi US approval in opioid use disorder
2022 Results CAM2029 Phase 3
efficacy study
Results CAM2029 Phase 3 long-term safety study
NDA/MAA submission CAM2029 for acromegaly
MAA approval and launch of CAM2038 chronic pain
Recent and anticipated news flow 2021/22
H1 2021 Buvidal market approval
in New Zealand
Line-extension approvals of Buvidal in EU and Australia
Publication of DEBUT and UNLOC-T study data
Sustainability award
Start Phase 3 GEP-NET study
22
Strategies for continued value creation
Commercialization• Establish leadership in opioid
dependence treatment in Europe, Australia and RoW
• Support US launch of Brixadi
• Initiate pre-launch activities in chronic pain and acromegaly
Innovation and pipeline• Advance our late-stage pipeline
programs in neuroscience, endocrinology and oncology
• Continue invest in patient centric innovation and differentiated clinical programs
• Develop our leading FluidCrystal technology platform and partnerships
Corporate development• Expand our commercial footprint
• Deliver on key catalysts for robust, sustained growth
• Develop profitability through own sales, partnerships, business development and M&A
Camurus AB │ Ideon Science Park, SE-223 70 Lund, SwedenP +46 46 286 57 30 │ [email protected] │ camurus.com
Appendix
24
Key figures first quarter 2021
MSEK Jan – Mar 2021
Jan – Mar 2020
Change Jan – Dec 2020
Total revenues 126 49 +155% 336
whereof product sales 124 49 +156% 323
Operating expenses 136 117 +16% 508
Operating result -26 -77 +66% -205
Result for the period -22 -62 +64% -167
Result per share, before and after dilution, SEK -0.40 -1.19 +66% -3.18
Cash position 428 291 +47% 462
25
Positive first quarter financial development
0
20
40
60
80
100
120
140
Q1 2019 Q1 2020 Q1 2021
Product sales
Other revenues
+155%
MSEK
Revenue Operating results
-140
-120
-100
-80
-60
-40
-20
0Q1 2019 Q1 2020 Q1 2021
+66%
MSEK
0
20
40
60
80
100
120
140
Q1 2019 Q1 2020 Q1 2021
AdministrationSales and marketingResearch and development
MSEK
Operating expenses
+16%
26
Shareholders
Shareholders as of 30 April 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 2,167,026 4.0 4.0
Avanza Pension 1,794,547 3.3 3.3
Fredrik Tiberg, CEO 1,696,788 3.1 3.1
Didner & Gerge Fonder 1,517,016 2.8 2.8
Svenskt Näringsliv 1,100,000 2.0 2.0
Backahill Utveckling 826,491 1.5 1.5
Lancelot Avalon 775,000 1,4 1.4
State Street Bank and Trust 545,591 1.0 1.0
Afa Försäkring 531,000 1.0 1.0
Camurus Lipid Research Foundation 505,250 0.9 0.9
Cancerfonden 500,000 0.9 0.9
CBNY – Norges Bank 470,780 0.9 0.9
Enter fonder 457,561 0.8 0.8
Other shareholders 16,017,018 29.5 29.5
In total 54,235,190 100.0 100.0
Shareholder distribution
40.6%
4.0%6.1%
3.3%3.1%2.8%
2,0%
1.5%
1.4%
1.0%
1,0%0.9%0.9%
0.9%
0.8%
29.5%
27
Experienced and committed management team
Agneta SvedbergVP Clinical & Regulatory Dev.
In Company since: 2015Holdings:12,000 shares & 50,000 subscription warrants
Fredrik Tiberg, PhDPresident & CEO, Head R&D
In Company since: 2002Holdings:1,696,788 shares & 165,000 warrants
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: Chief Financial Officer at EQL Pharma, Nordic Market Analyst at Nordic Drugs, Finance Consultant at Poolia
Richard JamesonChief Commercial Officer
In Company since: 2016Holdings:20,490 shares & 88,000 warrants
Education: B.Sc. in Applied Biological Sciences from University West of England
Previous experience: General Manager, UK & Nordics for Reckitt Benckiser (2010 – 2013) and Area Director Europe, Middle East and Africa for Indivior (2013 – 2016).
Fredrik Joabsson, PhD Chief Business Dev. Officer
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 MattssonVP Regulatory Affairs
In Company since: 2017Holdings:12,000 subscription warrants
Andrew McLeanVP Corporate Development& Senior Counsel
In Company since: 2021Holdings: -
Peter Hjelmström, MD, PhDChief Medical Officer
In Company since: 2016Holdings: -
Maria LundqvistHead of Global HR
In Company since: 2021Holdings: -
Education: MD, PhD and Associate Professor from Karolinska Institutet, Postdoctoral fellowship at Yale University
Previous experience: More than 15 years of experience from the pharmaceutical industry, including as Medical Director at Orexo and Head of Clinical Science at Sobi
Education: M.Sc. in Chemistry, PhD in Physical Chemistry, Lund University
Previous experience: More than 20 years of experience in pharmaceutical R&D, business development and alliance management.
Education: Bachelor of Pharmacy, Uppsala University and Business Economics, Lund University
Previous experience: More than 25 years of experience within regulatory affairs, including European RA Director/Global RA Lead at AstraZeneca and Global RA Lead at LEO Pharma.
Education: Bachelor of Laws (LL.B (Hons)), Aberystwyth University and College of Law, Guildford (Law Finals)
Previous experience: General Counsel, Company Secretary & Chief Compliance Officer at Kyowa Kirin International, International Business Lawyer at Recordati SpA, Head of Legal Affairs at Shire Pharmaceuticals
Education: B.Sc: in Business and Economics, Uppsala University
Previous experience: More than 20 years of experience of leadership roles within Human Resources, including HR Director Nordics at Teva Pharmaceuticals and HR positions at Tetra Pak, Vestas and AstraZeneca.
Education: M.Sc. in Chemistry, PhD in Inorganic Chemistry, Lund University
Previous experience: More than 20 years of experience from pharmaceutical R&D including Director Pharmaceutical Development at Zealande Pharma, Director of Development at Polypeptide, Team Manager at AstraZeneca.
Education: M.Sc. In Radiophysics and B.Sc. In Medicine from Lund University, Executive MBA from ExecutiveFoundation Lund
Previous experience: More than 25 years of experience in drug development, incl. as COO at Zealand Pharma, CEO of Cantargia, Senior VP Clinical Development at Genmab.
2828
Reiterated 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
29
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.
Leading FluidCrystal® extended-release technology
CONFIDENTIAL