Leading a New
Paradigm in
Preventative
Cardiovascular Care
Investor
Presentation
November 2021
Forward Looking Statements & Disclaimer
This presentation contains forward-looking statements, such as those relating to the commercial potential of VASCEPA®(VAZKEPA® in Europe), clinical and regulatory efforts and timelines, potential regulatory and pricing approvals, patent litigation, generic product launch, intellectual property, cash flow, research and development, and other statements that are forward-looking in nature and depend upon or refer to future events or conditions, including financial guidance and milestones. These statements involve known and unknown risks, uncertainties and other factors that can cause actual results to differ materially. Investors should not place undue reliance on forward-looking statements, which speak only as of the presentation date of this presentation. Please refer to the "Risk Factors" section in Amarin's most recent Forms 10 -K and 10-Q filed with the SEC and cautionary statements outlined in recent press releases for more complete descriptions of risks in an investment in Amarin.
This presentation is intended for communication with investors and not for drug promotion.
AMARIN, VASCEPA, VAZKEPA and REDUCE-IT are trademarks of Amarin Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark in Europe and other countries and regions and is pending registration in the United States.
AMARIN | 2 |
CardiovascularDisease (CVD) Is an Enormous and Worsening Public Health Burden
US CVD BURDEN | EUROPE CVD BURDEN | INTERNATIONAL CVD BURDEN |
1 stroke, heart attack | ∼50M with CVD | 523M |
or death from CVD | in Europe4 | living with CVD globally6 |
every 13 seconds in the US1 | >$1.0tn | |
$555bn | €210bn | |
estimated economic | ||
annual treatment cost expected | annual spending on CV | burden by 20307 |
to double in 20 years2 | disease management5 | |
38.9M | 3.9M | China alone |
291M with CVD & the | ||
patients on statins3 | People die each year from a | leading cause of death8 |
heart attack or a stroke4
Leading cause of death globally | Increasing prevalence | High and increasing economic burden
1 Heart Disease in the United States: 2020; 2 Cardiovascular Disease: A Costly Burden for America Projections Through 2035; 3 IMS Data: 2020; 4 European Heart Network Report, 2017; 5 ESC CardiovascularRealities 2020 report; 6 IMS Data 7 Global
Burden of Cardiovascular Diseases and Risk Factors, 1990-2019 - 2020 8 WEF-Harvard Global Economic Burden 9 China Cardiovascular Diseases Report2018: anupdated summary - Jan2020
AMARIN | 3 |
Lowering LDL-C Helps But is Not Enough for Many Patients
Controlled LDL-C doesn'teliminate CV risk; P-CVR often remains 25%-35% lowering majoradverse CV events (MACE) shown in CV outcome studies of statin therapies
P-CVR - Persistent Cardiovascular Risk
LDL-C control
25-35%
Persistent risk beyond
LDL-C control
65-75%
Placebo groups from multiple recent trials show high P-CVR despite statin-basedstandard-of-care
14.6% to 34.7% of patients treated for LDL-C butnot for P-CVR experienced a major adverse cardiovascularevent(MACE) in 3-7 Years
30
IMPROVE-IT: 34.7% | ||||||||
of statin-treated patients | ||||||||
had a MACE at | ||||||||
%* | 7 years3 | |||||||
20 | ||||||||
event, | ||||||||
REDUCE-IT®: 28.3% | ||||||||
an | ||||||||
ith | of statin-treated patients | All statin-treated | ||||||
had a MACE at | ||||||||
w | ||||||||
patients had well | ||||||||
Patients | 5 years2 | |||||||
10 | controlled LDL-C | |||||||
levels (ranging from | ||||||||
67-92 mg/dL*) | ||||||||
FOURIER: 14.6% | ||||||||
of statin-treated patients | ||||||||
had a MACE at | ||||||||
3 years1 | ||||||||
0 | Years of | |||||||
follow up | ||||||||
3 | 5 | 7 | ||||||
Cross-trial comparisons are subject to differences in populations, primary
outcomes, and other trial design aspects
AMARIN
Note: FOURIER, REDUCE-IT® and IMPROVE-IT trials evaluated evolocumab, icosapent ethyl and ezetimibe / simvastatin, respectively
* 67 mg/dL is equivalent to 0.8 mmol/L and 92 mg/dL is equivalent to 1.0 mmol/L | 4 |
1. Sabatine MS, et al. N Engl J Med.2017;376(18):1713-1722; 2. BhattDL, et al; for REDUCE-IT® Investigators. N Engl J Med. 2019;380(1):11-22; 3. Cannon CP, et al. N Engl J Med. 2015;372(25):2387-2397 |
CV Drug Development:
A Challenging Endeavor
- Many biopharma abandoned drug development in CV
- Requirements for long-term outcomes studies evaluating thousands of patients take years to fulfill
- Significant costs to fund the commercial infrastructure needed for broad primary care reach
AMARIN
Amarin:
Succeeding in a Challenging Environment
- With REDUCE-IT®, developed the first and only approved medication for reducing cardiovascular risk beyond LDL lowering therapies in certain high-risk, statin- treated, patients
- Received US FDA approval with unanimous Advisory committee positive vote of 16:0
- Received European Medicines Agency (EMA) approval for a broad label in-line with the REDUCE-IT evidence
5
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Amarin Corporation plc published this content on 23 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 November 2021 15:59:09 UTC.