2019;380:11-22. 2020;51(3):282â286. The contents of Amarinâs website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Promotion DisclaimerThis press release is intended for investor relations purposes. https://doi.org/10.1016/S0140-6736(20)31189-2. The drugmaker topped analysts' top- and bottom-line expectations despite challenges from a generic rival and the pandemic. Back. âPrevention and treatment of cardiovascular disease (CVD) is one of the major initiatives promoted by Health China 2030. The levels of EPA and DHA varied markedly from lot to lot in the FODS. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. VASCEPA is covered by most major medical insurance plans. Amarinâs lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Canada, Lebanon and the United Arab Emirates. In premarket trading Tuesday, the shares were advancing 1.18% to $214.85. 2019;380:11-22. Mail; Finance Home. âThe EPA levels achieved in REDUCE-IT were well above levels that can be achieved with diet or with dietary supplements and the clinical results have not been demonstrated by any other agent, reflecting the uniqueness of this FDA-approved prescription therapy.â * âFirst Human Trial of a Loading Dose of Icosapent Ethyl in Patients with COVID-19: Primary Results of the VASCEPA COVID-19 CardioLink-9 Randomized Trialâ â presented on behalf of all authors by Deepak L. Bhatt, M.D., M.P.H., Brigham and Womenâs Hospital, Harvard Medical School, Boston, MA (as described in a separate press release dated December 12, 2020 and related FAQ on Amarinâs website) Highlights: The VASCEPA COVID-19 CardioLink-9 Trial was a randomized, open-label trial enrolling 100 SARS-CoV-2 positive and symptomatic outpatients displaying at least one of the following: fever, cough, sore throat, shortness of breath, myalgia. News; Video; Watchlists; My Portfolio; My Screeners; Tech; Market Data. 14 Ganda OP, Bhatt DL, Mason RP, et al. J Am Heart Assoc. Included in these anticipated expenses are increased costs associated with Amarinâs commercial launch preparations and initial launch in Europe as well as continued U.S. promotional activities, including increased face to face interactions between Amarinâs sales professionals and health care providers and direct-to-consumer advertising in the U.S. after the impact of COVID-19 becomes less pronounced and at-risk patients begin returning to their doctors for non-urgent medical care. Proc Natl Acad Sci U S A. U.S. In 2009, Amarin had fewer than twenty employees. In the complaint, Amarin is seeking remedies including a permanent injunction against the unlawful inducement by Hikma and Health Net of infringing uses of the Hikma generic product, i.e., uses to reduce CV risk as detailed in the patents, and monetary damages in an amount sufficient to compensate Amarin for such infringement. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. Industries. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.2 Significant cardiovascular risk remains after statin therapy. About VASCEPA® (icosapent ethyl) Capsules VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. Cabenuva is provided as a co-pack with two injectable medicines -- ViiV Healthcare's cabotegravir and Johnson & Johnson (NYSE: JNJ) unit Janssen's rilpivirine -- dosed once monthly.This is as an option to replace the current antiretroviral regimen in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Earnings Johnson & Johnson (NYSE: JNJ) (Q4 revenue of $22.48 billion vs. $21.67-billion estimate, adjusted EPS $1.86 vs. $1.82 consensus, FY21 adjusted EPS guidance above consensus) Varian Medical Systems, Inc. (NYSE: VAR) (after the close) Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates See more from BenzingaClick here for options trades from BenzingaThe Week Ahead In Biotech (Jan 24-30): J&J, Lilly to Kickstart Big Pharma Earnings, Amgen FDA Decision and MoreThe Daily Biotech Pulse: Fluidigm's Saliva-Based COVID Test Approved In Europe, China Backs Amarin's Vascepa© 2021 Benzinga.com. Can Bioactive Lipids Inactivate Coronavirus (COVID-19)? Since launch, VASCEPA has been prescribed over ten million times. The stock was down 3.77% to $94.76 premarket Tuesday. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.14 Significant cardiovascular risk remains after statin therapy. âWe intend to build on our strong scientific foundation and medical experience. FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.Forward-Looking Statements This press release contains forward-looking statements, including statements regarding revenue and prescription growth, the impacts of COVID-19, including its future trajectory and effects on non-urgent medical care, the impacts of generic competition, including expected levels of generic supply, changes to U.S. commercial operations, including to spending and promotional levels, plans for commercial and international expansion, including the timing and outcome of regulatory approvals, market access negotiations and commercial launch, R&D and medical outlook, including the timing and results of future studies, market access efforts and indication expansion opportunities, the adequacy of its current cash resources and its 2021 operating expenses. âThis positive CHMP opinion is a significant milestone for Amarin, taking us one step closer to making this important therapy available to millions of patients in the European Union at high risk of cardiovascular events such as heart attacks and strokes. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing. Patients in the VASCEPA arm received a loading dose of 8 g/day for 3 days followed by 4 g/day for 11 days on top of usual care. Faites part de votre opinion et consultez les avis des autres négociateurs et investisseurs en bourse. OPR - OPR Delayed Price. 2017;40:138-148.2 Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. NZX 50 13,120.28-63.41 (-0.48%) NZD/USD 0.7184-0.0042 (-0.58%) ALL ORDS 6,953.90 +14.80 (+0.21%) ⦠Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. Paige Spiranac's IG Photos Show A Bit Too Much. Inflammation resolution: a dual-pronged approach to averting cytokine storms in COVID-19? The lipid mediator protectin D1 inhibits influenza virus replication and improves severe influenza. Am J Cardiol. REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. Join Yahoo Finance and Thrive Global to harness your habits and secure your future. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. In premarket trading Tuesday, the stock was retreating 11.36% to $1.95. EPA, not DHA, prevents fibrosis in pressure overload-induced heart failure: potential role of free fatty acid receptor 4. J Am Coll Cardiol. This list of channels may be updated from time to time on Amarinâs investor relations website and may include social media channels. Lancet. For more information about Amarin, visit www.amarincorp.com.About COVID-19 Current understanding of the biology of COVID-19 is that patients that have or are at high risk for developing atherosclerotic cardiovascular disease (ASCVD) are at higher risk of death and severe effects from infection, and that the morbidity and mortality associated with COVID-19 are due both to the direct toxicity of the virus as well as the bodyâs robust inflammatory response leading to âcytokine stormâ.1,2,3,4Scientific Rationale for Study of VASCEPA in COVID-19 Patients Based on data related to the mechanism of action and effects of VASCEPA, it is hypothesized that VASCEPA may play a potential beneficial role in preventing SARS-CoV-2 infection and to potentially reduce clinical severity in patients infected by the virus.4,5,6The clinical effects of VASCEPA are multi-factorial. Circ Res. Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. Offerings German coronavirus vaccine developer CureVac BV (NASDAQ: CVAC) announced an underwritten public offering of 5 million common shares. Arch Med Res. Patients were randomized to icosapent ethyl 4 g/d plus statin (n=12) or statin alone (n=8) for > 14 weeks. In January 2021, VASCEPA was accepted for introduction into the Hainan Boao Lecheng International Medical Tourism Pilot Zone program. amrn We often see insiders buying up shares in companies that perform well over the long term. Amarin Corporation plc (AMRN) NasdaqGS - NasdaqGS Real-time price. The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the companyâs historical results from its core business operations. Circulation. While Amarin respects the scientific opinions of these clinicians and scientists, Amarin takes no responsibility for those opinions. Amarin Contact InformationInvestor Inquiries:Investor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com (investor inquiries) Solebury Troutamarinir@troutgroup.com Media Inquiries:CommunicationsAmarin Corporation plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media inquiries) CONSOLIDATED BALANCE SHEET DATA (U.S. GAAP) Unaudited * December 31, 2020 December 31, 2019 (in thousands) ASSETS Current Assets: Cash and cash equivalents $186,964 $644,588 Restricted cash 3,915 3,907 Short-term investments 313,969 â Accounts receivable, net 154,574 116,430 Inventory 188,864 76,769 Prepaid and other current assets 30,947 13,311 Total current assets 879,233 855,005 Property, plant and equipment, net 2,016 2,361 Long-term investments 62,469 â Operating lease right-of-use asset 8,054 8,511 Other long-term assets 432 1,074 Intangible asset, net 13,817 15,258 TOTAL ASSETS $966,021 $882,209 LIABILITIES AND STOCKHOLDERSâ EQUITY Current Liabilities: Accounts payable $105,876 $49,950 Accrued expenses and other current liabilities 198,641 139,826 Debt from royalty-bearing instrument â 50,130 Current deferred revenue 2,926 2,342 Total current liabilities 307,443 242,248 Long-Term Liabilities: Long-term deferred revenue 15,706 18,504 Long-term operating lease liability 9,153 9,443 Other long-term liabilities 6,214 3,751 Total liabilities 338,516 273,946 Stockholdersâ Equity: Preferred stock â 21,850 Common stock 290,115 269,173 Additional paid-in capital 1,817,649 1,764,317 Treasury stock (51,082) (35,900)Accumulated deficit (1,429,177) (1,411,177)Total stockholdersâ equity 627,505 608,263 TOTAL LIABILITIES AND STOCKHOLDERSâ EQUITY $966,021 $882,209 * Unaudited as a standalone schedule; copied from consolidated financial statements CONSOLIDATED STATEMENTS OF OPERATIONS DATA (U.S. GAAP) Unaudited * Three Months Ended December 31, Year Ended December 31, (in thousands, except per share amounts) (in thousands, except per share amounts) 2020 2019 2020 2019 Product revenue, net$165,907 $142,044 $607,025 $427,391 Licensing and royalty revenue 1,344 1,233 7,035 2,364 Total revenue, net 167,251 143,277 614,060 429,755 Less: Cost of goods sold 34,769 30,665 131,444 96,019 Gross margin 132,482 112,612 482,616 333,736 Operating expenses: Selling, general and administrative (1) 116,816 96,025 463,312 323,623 Research and development (1) 8,508 11,097 38,959 34,392 Total operating expenses 125,324 107,122 502,271 358,015 Operating income (loss) 7,158 5,490 (19,655) (24,279)Interest income 551 3,074 4,901 8,499 Interest expense (163) (1,439) (2,605) (6,626)Other income (expense), net 54 107 104 (75)Income (loss) from operations before taxes 7,600 7,232 (17,255) (22,481)Provision for income taxes (2,674) (164) (745) (164)Net income (loss) 4,926 7,068 (18,000) (22,645)Earnings (loss) per share Basic$0.01 $0.02 $(0.05) $(0.07)Diluted$0.01 $0.02 $(0.05) $(0.07)Weighted average shares outstanding: Basic 390,661 359,156 381,759 342,538 Diluted 398,963 401,039 381,759 342,538 * Unaudited as a standalone schedule; copied from consolidated financial statements (1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were $424,067 and $297,321 for 2020 and 2019, respectively, and research and development expenses were $32,391 and $29,777, respectively, for the same periods. 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