Leading a New Paradigm in
Preventative Cardiovascular Care
Investor Presentation
April 29, 2021
Forward-Looking Statements and Disclaimer
Forward-looking statements
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.
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Recent Updates and Results
Milestones Achieved
- European Commission (EC) authorized marketing of Amarin's VAZKEPA in European Union (Mar'21)
- Medicines and Healthcare Product Regulatory Agency (MHRA) authorized marketing of Amarin's VAZKEPA in England, Scotland and Wales (Apr'21)
- Regulatory authorities in Mainland China and Hong Kong, in response to submission by Amarin's commercial partner, accepted icosapent ethyl for review with decisions expected before end of 2021
- 15 medical societies now recommend use of icosapent ethyl (IPE)
Financial
- Operating spending in United States intentionally slowed to help offset market headwinds of COVID-19 and other factors
- Atypical generic competition in the US accounted for ~9% of icosapent ethyl prescriptions as estimated by Symphony Health in Q1'21
- Net total revenue for Q1'21 was $142.2 million, including $140.8 from net product sales in the U.S. and none from net product sales in Europe where VAZKEPA is expected to launch before the end of Q3'21
- Net product sales in U.S. in Q1'21 were down 3% from prior year due to 1) COVID-19; 2) severe winter weather; 3) generic competition and 4) calendar anomaly reported in Q1'20 which, as expected, was not repeated in Q1'21
- Expense management improved bottom line in Q1'21; profitable excluding non-cash costs
Management Changes
- Transition plans/retirements announced for CEO and general counsel
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Remaining 2021 Priorities
United States
- As impact of COVID-19 on patients avoiding doctors' visits recedes, resume launch and growth of VASCEPA® for persistent cardiovascular risk based on the landmark REDUCE-IT® outcomes study (P-CVR)
Europe
- Pursue market (reimbursement) access on a country-by-country basis using approved label and supporting clinical effectiveness data
- Commence commercial launch pursuant to market access, including expected launch in
Germany before the end of Q3'21
China and Rest of World (RoW)
- Support existing commercial partners, including regulatory support in Middle East and China (approval in China targeted for near end of 2021), and prepare for further international expansion after approval and market access progress in Europe
Other
- Increasingly evaluate and pursue product pipeline opportunities (e.g., ongoing COVID-19 studies) and diversification opportunities
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VASCEPA Is a New Preventative Cardiovascular (CV) Care Treatment Option Beyond LDL-C Lowering
◼ Attacking persistent CV Risk (P-CVR), the risk beyond LDL-C lowering
◼ Aggressive LDL-C ↓↓ "Lower is Better" | ||
Statin | ◼ Statins | |
◼ | Ezetimibe | |
◼ | PCSK9 inhibitors |
◼ Bempedoic acid
Pre-Statin ◼ Modest LDL-C ↓ or HDL-C ↑
◼ Niacin
◼ Fibrates
◼ Bile acid sequestrants
VASCEPA is the only drug proven to reduce persistent CV risk in the population studied (P-CVR)
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Amarin Corporation plc published this content on 29 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 29 April 2021 10:32:09 UTC.