What changed in this filing

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Item 1. Legal Proceedings

2021-11-03 compared with 2021-08-05 · 131 added, 132 removed, 1405 unchanged (16% of the section changed)

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Refer to Note 5 –

Commitments and Contingencies in the accompanying Notes to the Condensed Consolidated Financial Statements in this Form 10-Q for further details on our legal proceedings during the six months ended June 30, 2021.

Ri sk Factors

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Factors outside of our control make it more difficult for VASCEPA to achieve a level of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary to meet expectations for commercial success.

The continued scale and scope of business interruptions caused by the COVID-19 pandemic and related recovery efforts are uncertain as the impact of the pandemic continues to cause negative effects on our business.

Our current and planned commercialization efforts may not be successful in increasing sales of VASCEPA in the United States and developing sales internationally.

The continued scale, scope and duration of business interruptions caused by the COVID-19 pandemic and related recovery efforts are uncertain as the impact of the pandemic continues to cause negative effects on our business.

Our current and planned commercialization efforts, including our recently announced Go-to-Market strategy, may not be successful in increasing sales of VASCEPA in the United States and developing sales internationally.

Our promotion and supply of VASCEPA is subject to regulatory scrutiny and associated risk.

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Increasing sales of generic versions of VASCEPA could continue to have a material and adverse impact on our revenues and results of operations in the United States.

We are implementing a new Go-to-Market strategy in an effort to accelerate growth of VASCEPA in the United States by shifting reliance on sales force interactions with healthcare professionals to providing managed care and prescription access through an omnichannel platform, and, in connection with this initiative, we reduced our U.S.

field force to approximately 300 sales representatives.

Although we believe this initiative will provide greater access to VASCEPA and ultimately result in an improved expense structure, such efforts are costly to implement, could impact employee morale and make hiring and retaining talented personnel more challenging, and may not result in all or any of the benefits we anticipate.

We continue our development efforts to support commercialization of VASCEPA in major markets outside the United States.

In March 2021 we announced that the European Commission, or the EC, approved the marketing authorization application for icosapent ethyl, under the brand name VAZKEPA (hereafter along with VASCEPA, collectively referred to as VASCEPA), to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides (≥150 mg/dL) and either established cardiovascular disease or diabetes and at least one additional cardiovascular risk factor.

We are in the process of obtaining pricing and reimbursement approvals for VAZKEPA in relevant jurisdictions in Europe.

In September 2021, we launched VAZKEPA in Germany, representing our first European launch of VAZKEPA, and are in the process of obtaining pricing and reimbursement approvals for VAZKEPA in relevant jurisdictions in Europe.

This process is conducted on a country-by-country basis and is time-consuming and complex.

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For example, we have strategic collaborations for the development and commercialization of VASCEPA in Canada, the Middle East and Greater China.

However, we cannot make any guarantees as to the success of these efforts or that our beliefs about the value potential are accurate, and if commercialization plans for VASCEPA do not meet expectations in major markets such as the United States and Europe, our business and prospects could be materially and adversely affected.

However, we cannot make any guarantees as to the success of these efforts or that our beliefs about the value potential are accurate, and if commercialization

plans for VASCEPA do not meet expectations in major markets such as the United States and Europe, our business and prospects could be materially and adversely affected.

The development and commercial time cycle for VASCEPA or other products that we may develop from our research and development efforts could result in delays in our ability to achieve commercial success.

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These dynamics can restrict our ability to respond rapidly to adverse business conditions for VASCEPA.

If development of, or demand for, VASCEPA does not meet expectations, we may not have the ability to effectively shift our resources to the development of alternative products, or do so in a timely manner, without suffering

material adverse effects on our business.

As a result, the lack of alternative markets and products we develop could constrain our ability to generate revenues and achieve profitability.

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Reddy’s Laboratories, Inc., or Dr.

Reddy’s or DRL, and Hikma Pharmaceuticals USA Inc., or Hikma, (formerly known as West-Ward), and certain of their affiliates, or, collectively, the Defendants, that declared as invalid several patents of ours protecting the first FDA-approved use of our drug, for use to reduce severely high triglyceride levels, which is known as the MARINE indication.

Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, (formerly known as West-Ward), and certain of their affiliates, or, collectively, the Defendants, that declared as invalid several patents of ours protecting the first FDA-approved use of our drug, for use to reduce severely high triglyceride levels, which is known as the MARINE indication.

We sought appeals of the Nevada Court judgment up to the United States Supreme Court, but, we were unsuccessful.

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Each generic launch is subject to procurement of adequate product supply.

Once a generic version of VASCEPA is available in the market, whether based on a generic product with primarily a MARINE indication label or REDUCE-IT indication label it is typically used in many U.S.

states to fill a prescription for any use of the drug, subject, in certain circumstances, to state reimbursement law, the potential for patent infringement under certain case law and subject to certain Teva and Apotex settlement agreement terms.

We currently face generic competition from Hikma's and Dr.

Reddy’s generic version of VASCEPA in the United States, and could face increased competition from additional generic entrants in the near term, which could have a material and adverse impact on our revenues and our results of operations.

Once a generic version of a drug is available in the market, the generic version is typically used in many U.S.

states to fill a prescription for any use of the drug, subject, to state reimbursement laws.

Although, in our case, use of generic versions of VASCEPA, whether with primarily a MARINE indication label or REDUCE-IT indication label, could be further subject to the potential for patent infringement under certain case law and subject to certain Teva and Apotex settlement agreement terms, we currently face generic competition from Hikma's and Dr.

Reddy’s generic versions of VASCEPA in the United States, and could face increased competition from additional generic entrants in the near term, which could have a material and adverse impact on our revenues and our results of operations.

There can be no assurance that we will be successful in preventing use of generic versions of VASCEPA in indications for which they have not been approved by U.S.

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In addition, we may need to litigate with such suppliers to protect our rights, which can be costly and distracting to management.

Such circumstances could have a material and adverse impact on our revenues and results of operations directly in the United States and potentially outside of the United States as well if supply costs and availability are affected or promotion and education programs reduced.

Such circumstances

could have a material and adverse impact on our revenues and results of operations directly in the United States and potentially outside of the United States as well if supply costs and availability are affected or promotion and education programs reduced.

* We have limited experience as a company in commercializing VASCEPA outside of the United States and may be unsuccessful in developing sales internationally.

While we have been working internally and with partners to support efforts toward approvals and commercialization outside the United States in light of the REDUCE-IT results and the recent EC approval of VAZKEPA, we may be unsuccessful in expanding our global footprint.

For example, we plan to launch VAZKEPA on our own in the most commercially significant markets in Europe.

For example, we plan to launch VAZKEPA on our own in the most commercially significant markets in Europe and recently launched VAZKEPA in Germany, representing our first European launch of VAZKEPA.

The commercial launch of a new pharmaceutical product is a complex and resource heavy undertaking for a company to manage, and we have no prior experience as a company operating a commercial-stage pharmaceutical business in Europe.

Given the amount of time

and resources, including capital, needed to support regulatory and commercial efforts aimed at international expansion, if we are unsuccessful or delayed in generating revenues overseas, our results of operations could be materially and adversely impacted.

Given the amount of time and resources, including capital, needed to support regulatory and commercial efforts aimed at international expansion, if we are unsuccessful or delayed in generating revenues overseas, our results of operations could be materially and adversely impacted.

Factors that could inhibit our efforts to successfully commercialize VASCEPA include:

the impact the expiration of regulatory exclusivities and entry into the market of additional generic versions of VASCEPA;

our inability to attract and retain adequate numbers of effective sales and marketing personnel;

our inability to attract and retain adequate numbers of effective sales and marketing personnel, particularly in light of our recently announced reduction in force;

our inability to adequately train our sales and marketing personnel and our inability to adequately monitor compliance with these requirements;

the inability of our new sales personnel, to obtain access to or persuade adequate numbers of physicians to prescribe VASCEPA;

if our new Go-to-Market strategy and omnichannel approach does not provide improved managed care and prescription access, or if healthcare providers are reluctant or delayed in shifting to the omnichannel platform;

regulators may impose restrictions on VASCEPA’s conditions for use, distribution or marketing, and may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials, which may be costly or result in label or other use restrictions;

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We are committed to working with the entire healthcare community to ensure continued innovation and to facilitate patient access to needed medicines;

however, if reimbursement of

VASCEPA is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our ability to successfully commercialize VASCEPA outside of the United States may be harmed, which could have a material and negative impact on our overall business.

however, if reimbursement of VASCEPA is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our ability to successfully commercialize VASCEPA outside of the United States may be harmed, which could have a material and negative impact on our overall business.

* Government and commercial payer actions outside the United States have affected and will continue to affect access to and sales of our products

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MACE events were defined as a composite of cardiovascular death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization.

This result was supported by robust demonstrations of efficacy across multiple secondary endpoints.

This result was supported by robust

demonstrations of efficacy across multiple secondary endpoints.

VASCEPA was well tolerated in REDUCE-IT with a safety profile generally consistent with clinical experience associated with omega-3 fatty acids and current U.S.

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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

the scope, effectiveness and strength of product education, marketing and distribution support, including our sales and marketing team;

the scope, effectiveness and strength of product education, marketing and distribution support, including our sales and marketing team and the success of our omnichannel platform;

publicity concerning VASCEPA or competing products;

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FDA-approved labeling that is more closely tied to the patient population studied in a clinical trial could limit use generally and by making reimbursement more difficult.

The continued scale and scope of business interruptions caused by the COVID-19, pandemic are uncertain as the impact of the pandemic continues to cause negative effects on our business.

* The continued scale, scope and duration of business interruptions caused by the COVID-19, pandemic are uncertain as the impact of the pandemic continues to cause negative effects on our business.

The global spread of COVID-19, has created significant volatility, uncertainty and disruption in healthcare, social, supply and economic infrastructures.

The extent to which the coronavirus pandemic impacts our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict or plan around, including:

The extent to which the coronavirus pandemic will continue to impact our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict or plan around, including:

the duration, volatility and scope of the pandemic and the efficacy of recovery efforts;

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the ability to access, secure and otherwise obtain and deliver sufficient and timely commercial or clinical supplies of VASCEPA to meet demand if the production capabilities of suppliers is disrupted;

disruptions in regulatory oversight and actions if regulators and industry professionals are expending significant and unexpected resources addressing COVID-19;

disruptions in regulatory oversight and actions if regulators and industry professionals continue to expend significant and unexpected resources addressing COVID-19;

the availability of coverage and reimbursement from government and health administration authorities, private health insurers and other third-party payors if the system becomes overly strained;

the ability of regulators to complete inspections and reviews of operations and applications, respectively, in a timely manner;

any further or prolonged closures of our and our partners’

any further, prolonged or reinstated closures of our and our partners’

offices, operations and facilities impeding our ability to work together as a company and with our business and healthcare partners.

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In the fourth quarter of 2020 and in early 2021, the impact of COVID-19 worsened in some parts of the United States, with some healthcare professionals again limiting access to face-to-face interactions.

Additionally although we have started to see signs of recovery in light of the availability of vaccines during the second quarter, the number of patient visits to doctors’

Additionally although we have started to see signs of recovery in light of the availability of vaccines during the second and third quarters, the number of patient visits to doctors’

offices and patients undergoing blood testing remains down considerably from pre-COVID-19 levels.

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We hope to be able to maintain our substantial resumption of our business efforts, however, given the dynamics related to COVID-19, there can be no assurance that this will be the case.

While we have supplemented these face-to-face interactions with virtual outreach, these efforts may not be as impactful as traditional, in-person interactions.

While we have supplemented these face-to-face interactions with virtual outreach and our omnichannel platform, these efforts

may not be as impactful as traditional, in-person interactions.

Specifically, access to healthcare professionals through the internet or other channels, may not be as productive as in-person interactions.

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the consistency of findings across cohorts and important subgroups;

safety considerations and risk/benefit considerations (such as related to adverse events such as bleeding and atrial fibrillation generally and in different sub-populations);

safety considerations and risk/benefit considerations (such as those related to adverse events, including bleeding and atrial fibrillation generally and in different sub-populations);

consideration of REDUCE-IT results in the context of other clinical studies;

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On December 12, 2020, we announced at the National Lipid Association Scientific Sessions 2020 positive clinical results from the CardioLink-9 Trial, the first results of a study of VASCEPA in COVID-19 infected outpatients.

Results from the investigator initiated study in Argentina called PREPARE-IT-1 is expected to be presented by the lead trial investigator at the European Society of Cardiology on August 29, 2021.

Results from the investigator initiated study in Argentina called PREPARE-IT-1 were presented by the lead trial investigator at the European Society of Cardiology on August 29, 2021 and the results did not meet the primary and/or other endpoints studied.

Results from the other investigational studies are expected over the next year.

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Thus, despite the size of our sales team, it is not large enough to call upon all physicians and we may not have sufficient sales personnel and resources to maximize the sales potential of VASCEPA.

If we are not successful in maintaining a sales force that is rightsized for our efforts to market and sell VASCEPA in the United States, our anticipated revenues or our expenses could be materially and negatively affected, and we may not obtain profitability, may need to cut back on research and development activities or implement other cost-containment measures, or we may need to raise additional funding that could result in substantial dilution or impose considerable restrictions on our business.

If we are not successful in maintaining a sales force that is rightsized for our efforts to market and sell VASCEPA in the United States, including in light of our new Go-to-Market strategy, including our omnichannel approach and reduced sales force, our anticipated revenues or our expenses could be materially and negatively affected, and we may not obtain profitability, may need to cut back on research and development activities or implement other cost-containment measures, or we may need to raise additional funding that could result in substantial dilution or impose considerable restrictions on our business.

Although substantially all of our sales force personnel have the ability to resume face-to-face customer interactions in a manner consistent with state and local guidance, given the dynamics related to COVID-19, there can be no assurance that/as to when we will be able to substantially resume and sustain our business efforts.

While we have supplemented these face-to-face interactions with virtual outreach, these efforts may not be as successful as traditional, in-person interactions.

While we have supplemented these face-to-face interactions with virtual outreach, including our omnichannel platform, these efforts may not be as successful as traditional, in-person interactions.

Specifically, access to healthcare professionals through digital or other channels, may not be as productive as in-person interactions.

In the United States, in July 2020 we launched our first ever direct-to-consumer promotional campaign regarding VASCEPA demonstrating results in lowering cardiovascular risk in patients with persistent cardiovascular risk in high risk patients.

In September 2020, we launched a new, nationwide television advertisement campaign in connection with our expanded promotional campaign which was further complemented by additional digital, point-of-care and other forms of healthcare professional and patient educational outreach.

educational outreach.

As the impact of COVID-19 on much of the United States worsened in the fourth quarter of 2020, we suspended television-based promotion of VASCEPA as we determined that the cost was not sufficiently justified in light of the COVID-19 pandemic on patient visits to doctors.

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In June 2021, we launched an educational campaign, It's Clear to Me Now , to help physicians and patients learn more about the differentiation between VASCEPA and fenofibrates for CV risk reduction.

There can be no assurance that such promotion will have the intended positive increase in patients asking their healthcare providers regarding VASCEPA or that prescription rates for VASCEPA will increase in the near future or at all from such promotion.

There can be no assurance that the efforts described above will have the intended positive increase in patients asking their healthcare providers regarding VASCEPA or that prescription rates for VASCEPA will increase in the near future or at all from such efforts.

Data on increased product usage from similar promotion of other products suggests that the impact of television-based promotion can be positive and sustained but is rarely immediate in its effect.

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Constitution as applied in the case of our proposed promotion of VASCEPA.

The physicians in the suit regularly treated patients at risk of

cardiovascular disease and, as the complaint contended, have First Amendment rights to receive truthful and non-misleading information from Amarin.

The physicians in the suit regularly treated patients at risk of cardiovascular disease and, as the complaint contended, have First Amendment rights to receive truthful and non-misleading information from Amarin.

The suit was based on the principle that better informed physicians make better treatment decisions for their patients.

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FDA, the U.S.

government, our competitors and other interested parties may not agree on the truthfulness and non-misleading nature of our promotional materials.

government, our competitors and other interested parties may not agree on the truthfulness and non-misleading

nature of our promotional materials.

Federal and state governments or agencies may also seek to find other means to prevent our promotion of unapproved truthful and non-misleading information about VASCEPA.

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Many of these and other existing or potential competitors may have substantially greater financial, technical and human resources than we do and may be better equipped to develop, manufacture and market products.

companies may develop and introduce products and processes competitive with, more efficient than or superior to ours.

These companies may develop and introduce products and processes competitive with, more efficient than or superior to ours.

In addition, other technologies or products may be developed that have an entirely different approach or means of accomplishing the intended purposes of our products, which might render our technology and products noncompetitive or obsolete.

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With a generic version of VASCEPA launched by Hikma in November 2020 and by Dr.

Reddy in June 2021 and with further generic competition anticipated, it may not be viable for us to invest in market education to grow the United States market and our ability to maintain current promotional efforts and attract favorable commercial terms in several aspects of our business will likely be adversely affected as we face increased generic competition, or if we launch our own generic version of VASCEPA.

GlaxoSmithKline plc currently sells Lovaza ® , a prescription-only omega-3 fatty acid indicated for patients with severe hypertriglyceridemia, which was approved by U.S.

Reddy's in June 2021 and with further generic competition anticipated, it may not be viable for us to invest in market education to grow the United States market and our ability to maintain current promotional efforts and attract favorable commercial terms in several aspects of our business will likely be adversely affected as we face increased generic competition, or if we launch our own generic version of VASCEPA.

Woodward Pharma Services LLC currently sells Lovaza ® , which it acquired from GlaxoSmithKline plc in Q3 2021.

Lovaza ® a prescription-only omega-3 fatty acid indicated for patients with severe hypertriglyceridemia, was approved by U.S.

FDA in 2004 and has been on the market in the United States since 2005.

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The study was a randomized, double-blind, placebo-controlled (corn oil), parallel group design that is believed to have enrolled approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for cardiovascular disease randomized 1:1 to either corn oil plus statin or Epanova plus statin, once daily.

On January 13, 2020 following the recommendation of an independent Data Monitoring Committee, AstraZeneca decided to close the STRENGTH trial due to its low likelihood of demonstrating benefit to patients with mixed dyslipidemia who are at increased risk of cardiovascular disease.

cardiovascular disease.

Full data from the STRENGTH trial was presented at the American Heart Association’s, or the AHA's, Scientific Sessions in November 2020, confirming that Epanova failed to meet the primary endpoint of CV risk reduction.

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Patients received 1.8 g omega-3 fatty acids (930 mg EPA and 660 mg DHA) or placebo (corn oil) daily added to standard of care.

unscheduled revascularization, stroke, hospitalization for heart failure or all-cause mortality), nor for the individual components of this endpoint after two years.

Results presented in November 2020 at the American Heart Association’s Scientific Sessions showed no significant differences in cardiovascular events between the treatment groups for the composite primary endpoint (non-fatal MI, unscheduled revascularization, stroke, hospitalization for heart failure or all-cause mortality), nor for the individual components of this endpoint after two years.

In a meta-analysis, presented in 2018 by the Cochrane Foundation and separately as published in JAMA, additional omega-3 studies were evaluated.

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In the first quarter of 2021, Matinas announced topline results from the ENHANCE-IT study, stating that LYPDISO, or MAT9001, did not meet statistical significance over VASCEPA on the primary endpoint of percent change from baseline to end of treatment in triglycerides in the pharmacodynamic, or PD, population.

A key secondary endpoint in ENHANCE-IT was the measurement of eicosapentaenoic acid levels in the blood, which is regarded as a key surrogate marker in determining cardiovascular risk reduction.

A key secondary endpoint in ENHANCE-IT

was the measurement of eicosapentaenoic acid levels in the blood, which is regarded as a key surrogate marker in determining cardiovascular risk reduction.

In ENHANCE-IT, plasma EPA concentrations were significantly higher with LYPDISO vs.

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Although epeleuton failed to meet the primary endpoint to demonstrate effects on liver enzyme elevation, it demonstrated significant reduction of triglycerides, HbA1c and potential for CV risk reduction.

In September 2020, Afimmune announced the start of TRIglyceride And Glucose control with Epeleuton in Metabolic Syndrome Patients, or TRIAGE, a

Phase IIb study of epeleuton in patients with high triglycerides and type 2 diabetes to assess the safety and efficacy of orally administered epeleuton capsules vs placebo in the treatment of hypertriglyceridemia and type 2 diabetes.

Results are expected in the fourth quarter of 2021.

In September 2020, Afimmune announced the start of TRIglyceride And Glucose control with Epeleuton in Metabolic Syndrome Patients, or TRIAGE, a Phase IIb study of epeleuton in patients with high triglycerides and type 2 diabetes to assess the safety and efficacy of orally administered epeleuton capsules vs placebo in the treatment of hypertriglyceridemia and type 2 diabetes.

Results are expected in the third quarter of 2022.

Based on prior communications from the U.S.

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Recent CV outcomes trials and meta-analyses with low and high dose omega-3 fatty acid mixtures containing DHA have not shown substantial benefit in patients receiving contemporary medical therapy, including statins.

Due to failed low dose omega-3 CV outcomes trials, the European regulatory authorities have concluded that omega-3 fatty acid medicines (specifically Lovaza ® /Omacor ® ) at a dose of 1-gram per day are not effective in preventing further events for patients who have had a heart attack.

Due to failed low dose omega-3 CV

outcomes trials, the European regulatory authorities have concluded that omega-3 fatty acid medicines (specifically Lovaza ® /Omacor ® ) at a dose of 1-gram per day are not effective in preventing further events for patients who have had a heart attack.

The STRENGTH trial of an omega-3 mixture studied at 4-grams per day also failed to demonstrate cardiovascular benefit.

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Although any such introduction of a generic version of VASCEPA would also be subject to any litigation settlement terms and patent infringement claims (including any new claims and those that may then be subject to an appeal), pursuing such litigation may be prohibitively costly or could put a substantial constraint on our resources.

On July 9, 2021, President Biden issued an executive order directing the U.S.

FDA to, among other things, continue to clarify and improve the approval framework for generic drugs and identify and address any efforts to impede generic drug competition.

Any significant degree of generic market entry would limit our U.S.

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FTC and a subpoena from the New York Attorney General with respect to practices relating to our supply of the active pharmaceutical ingredient in VASCEPA.

We believe such contact from

the governments may have been prompted by a generic competitor.

We believe such contact from the governments may have been prompted by a generic competitor.

We are cooperating with the agencies.

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Under the settlements, Coromega and Omax agreed to publicly correct their prior statements that wrongly suggested the REDUCE-IT cardiovascular outcomes trial supports the safety and efficacy of omega-3 dietary supplements.

Each dietary supplement company also acknowledged that as a general matter under federal law dietary supplements may be lawfully marketed to supplement the diet, but they cannot be lawfully marketed to treat, mitigate, or prevent disease, such as cardiovascular disease.

dietary supplement company also acknowledged that as a general matter under federal law dietary supplements may be lawfully marketed to supplement the diet, but they cannot be lawfully marketed to treat, mitigate, or prevent disease, such as cardiovascular disease.

Similarly, on August 30, 2017, we filed a lawsuit with the United States International Trade Commission, or the ITC, against manufacturers, importers, and distributors of products containing synthetically produced omega-3 products in ethyl ester or re-esterified triglyceride form that contain more EPA than DHA or any other single component for use in or as dietary supplements.

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The continuing efforts of the U.S.

and foreign governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce healthcare costs may adversely affect our ability to set prices for our products which we believe are fair, and our ability to generate revenues and achieve and maintain profitability.

and foreign governments, insurance

companies, managed care organizations and other payors of healthcare services to contain or reduce healthcare costs may adversely affect our ability to set prices for our products which we believe are fair, and our ability to generate revenues and achieve and maintain profitability.

Specifically, in both the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes to the healthcare system in ways that could affect our ability to sell our products profitably.

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In response, the U.S.

FDA released a final rule on

September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada.

FDA released a final rule on September 24, 2020, which went into effect on November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada.

Further, on November 20, 2020 CMS issued an Interim Final Rule implementing the Most Favored Nation Model, or the MFN Model, under which Medicare Part B reimbursement rates will be calculated for certain drugs and biologicals based on the lowest price drug manufacturers receive in Organization for Economic Cooperation and Development countries with a similar gross domestic product per capita.

The MFN Model regulations mandate participation by identified Part B providers and will apply in all U.S.

The MFN Model regulations mandate participation by identified Part B providers and would have applied to all U.S.

states and territories for a seven-year period beginning January 1, 2021 and ending December 31, 2027.

The Interim Final Rule has not been finalized and is subject to revision and challenge.

On December 28, 2020, a judge in the U.S.

District Court for the Northern District of California granted a preliminary injunction prohibiting CMS from implementing the MFN Model pending completion of the comment and rulemaking process required under the Administrative Procedures Act.

On January 13, 2021, in a separate lawsuit brought by industry groups in the U.S.

District of Maryland, the government defendants entered a joint motion to stay litigation on the condition that the government would not appeal the preliminary injunction granted in the U.S.

District Court for the Norther District of California and that the performance for any final regulation stemming from the Interim Final Rule shall not commence earlier than 60 days after publication of that regulation in the Federal Register.

However, on August 6, 2021, CMS announced a proposed rule to rescind the MFN Model.

Further, authorities in Canada have passed rules designed to safeguard the Canadian drug supply from shortages.

If implemented, importation of drugs from Canada and the MFN Model may materially and adversely affect the price we receive for any of our products and product candidates.

If implemented, importation of drugs from Canada and regulations similar to the MFN Model, or if the MFN Model is reinstated, may materially and adversely affect the price we receive for any of our products and product candidates.

On November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

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For example, proposals are being considered to expand the use of dietary supplements in addition to or in place of drugs in government and private payor plans.

In addition, cost control initiatives could decrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect our profitability.

In addition, cost control initiatives

could decrease the price that we or any potential collaborators could receive for any of our future products and could adversely affect our profitability.

These and similar regulatory dynamics, including the recent entry of generic versions of VASCEPA into the market, and the potential for additional generic versions in the near term, can affect our ability to commercialize VASCEPA on commercially reasonable terms and limit the commercial value of VASCEPA.

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effective January 1, 2019.

The Bipartisan Budget Act of 2018, or the BBA, among other things, amends the ACA to create a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% (an increase from 50% effective as of January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Medicare Part D.

Under the Trump administration, CMS issued regulations that gave states greater flexibility, starting in 2020, in the identification of the essential health benefits benchmarks for non-grandfathered individual and small group market health insurance coverage, including plans sold through the health insurance exchanges established under the ACA.

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On March 10, 2020, the Trump administration sent “principles”

for drug pricing to

Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases.

for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases.

Further, the Trump administration also previously released a “Blueprint”

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In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators.

In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA.

In addition, we may obtain health information from third parties (including research institutions from which we obtain

clinical trial data) that are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA.

Although we are not directly subject to HIPAA –

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FDA approved VASCEPA for use in the MARINE indication in July 2012, U.S.

FDA did not dispute the veracity of the ANCHOR trial data and, in connection with the March 2016 agreement we reached with the U.S.

FDA did not dispute the veracity of the ANCHOR trial data and, in connection with the March 2016 agreement we reached with the

FDA allowing us to promote the results of the ANCHOR study, the U.S.

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Any of these or similar circumstances could adversely affect our ability to gain approval for new indications and affect revenues from the sale of our products.

circumstances where products are approved by a regulatory body for commercialization, the regulatory or legal requirements may change over time, or new safety or efficacy information may be identified concerning a product, which may lead to the withdrawal of a product from the market or similar use restrictions.

Even in circumstances where products are approved by a regulatory body for commercialization, the regulatory or legal requirements may change over time, or new safety or efficacy information may be identified concerning a product, which may lead to the withdrawal of a product from the market or similar use restrictions.

The discovery of previously unknown problems with a clinical trial or product, or in connection with the manufacturer of products, may result in regulatory issues that prevent proposed future approvals of a product and/or restrictions on that product or manufacturer, including withdrawal of an indication or the product from the market, which would have a negative impact on our potential revenue stream.

As we continue to build our infrastructure for commercializing VASCEPA, we may encounter difficulties in managing our growth and expanding our operations successfully.

The process of establishing, maintaining and expanding a commercial infrastructure is difficult, expensive and time-consuming.

* As we continue to build our infrastructure for commercializing VASCEPA, we may encounter difficulties in managing our growth and expanding, or streamlining, our operations successfully.

The process of establishing, maintaining, expanding and streamlining a commercial infrastructure is difficult, expensive and time-consuming.

As a result of the COVID-19 pandemic and the related social distancing, in March 2020, we suspended face-to-face interactions between our sales representatives and healthcare professionals.

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In the fourth quarter of 2020 and in early 2021, the impact of COVID-19 worsened in some parts of the United States, with some physicians again limiting access to face-to-face interactions with our field force personnel.

Accordingly, we have intentionally slowed the hiring of replacements for our open positions which resulted from ordinary turnover.

As we witness our sales representatives increasingly able to resume direct interactions with healthcare professionals, we continue to evaluate our needs and it is our intention to fill a significant number of these positions, provided such replacement is appropriate to meet our business needs.

Accordingly, we have intentionally slowed the hiring of replacements for our open positions which resulted from ordinary turnover and as announced on September 22, 2021 we have reduced our U.S.

field force to approximately 300 sales representatives.

As we observe the results of the new Go-to-Market strategy and witness our sales representatives increasingly able to resume direct interactions with healthcare professionals, we will continue to evaluate our needs and, including the need to fill open positions, or expand or further streamline our sales force, as appropriate to meet our business needs.

Our sales team promotes VASCEPA to a limited group of physicians and other healthcare professionals in select geographies in the United States and is not large enough to call upon all physicians.

In addition to sales force expansion in the United States, we continue to work on our own and with our international partners to support regulatory efforts outside the United States based on REDUCE-IT results.

In addition to sales force reductions and the shift to omnichannel in the United States, we continue to work on our own and with our international partners to support regulatory efforts outside the United States based on REDUCE-IT results.

As our operations expand with the anticipated growth of our product sales, we expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties.

Future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees.

Future growth and streamlining efforts will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate the right number of employees.

For example, in Europe we commenced 2021 with approximately 50 professionals involved in pre-approval and pre-launch planning and other commercial preparation activities, with plans to continue to expand our European staff as deemed appropriate on a country by country basis.

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While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations could have a significant impact on our ability to hire and retain personnel and realize the commercial opportunity of VAZKEPA in Europe.

Our future financial performance and our ability to commercialize VASCEPA and to compete effectively will depend, in part, on our ability to manage our future growth effectively, and such efforts may be disrupted by the COVID-19 protocols.

To that end, we must be able to manage our development efforts effectively, and hire, train, integrate and retain additional management, administrative and sales and marketing personnel and have limited experience managing a commercial organization.

To that end, we must be able to manage our development efforts effectively, and hire, train, integrate and retain an appropriate level of management, administrative and sales and marketing personnel and have limited experience managing a commercial organization.

We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our company.

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We have contractual freedom to source the API for VASCEPA and to procure other services supporting our supply chain.

We have entered into supply agreements with multiple suppliers who also rely on other third-party suppliers to manufacture the API and

other elements necessary for the sale of VASCEPA.

We have entered into supply agreements with multiple suppliers who also rely on other third-party suppliers to manufacture the API and other elements necessary for the sale of VASCEPA.

Our strategy in sourcing API and other components in our supply chain from multiple suppliers has been to expand manufacturing capacity, maintain competitive advantages, and mitigate the risk of reliance on any single supplier.

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costs associated with projected expansion and qualification can be significant.

And, lead-times for supply purchases and capacity expansion are long requiring certain supply related decisions and commitment to be made in advance, for example, prior to commercial launch in China and Europe.

There can be no assurance that the expansion plans of any of our suppliers will be successful.

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This requirement is referred to as process validation.

Process validations includes stability testing, measurement of impurities and testing of other product specifications by validated test methods.

Process validation includes stability testing, measurement of impurities and testing of other product specifications by validated test methods.

FDA does not consider the result of the process validation or required testing to be satisfactory, the commercial supply of VASCEPA may be delayed, or we may not be able to supply sufficient quantities of VASCEPA to meet anticipated demand.

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Under the DCS Agreement, Edding is responsible for development and commercialization activities in the China Territory and associated expenses.

Additionally, Edding is required to conduct clinical trials in the China Territory to secure regulatory approval in certain territories.

Additionally, Edding is

required to conduct clinical trials in the China Territory to secure regulatory approval in certain territories.

In December 2017, Edding commenced a pivotal clinical trial aimed to demonstrate that VASCEPA lowers triglyceride levels and otherwise has beneficial effects in Chinese patients with severe hypertriglyceridemia (TG >500 mg/dL), as we previously demonstrated with VASEPA in the more diverse population studied in the MARINE study.

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Even though such results are similar to the MARINE study, additional clinical development efforts may be necessary in this market to demonstrate the effectiveness of VASCEPA in reducing major adverse cardiovascular events in Chinese patients with persistent cardiovascular risk.

Any development and regulatory efforts in the China Territory may be negatively impacted by the spread of the coronavirus and the unexpected diversion of resources by regulators and industry professionals to address the coronavirus outbreak.

Any development and regulatory efforts in the China Territory may be negatively impacted by heightened political tension between China and the United States, including in connection with COVID-19 and other issues expressed between the countries regarding

trade practices, tariffs and honoring intellectual property rights.

Any development and regulatory efforts in the China Territory may be negatively impacted if the coronavirus pandemic continues or spreads, and if resources by regulators and industry professionals continue to be diverted to address the prolonged coronavirus outbreak.

If Edding is not able to effectively develop and commercialize VASCEPA in the China Territory, we may not be able to generate revenue from the DCS Agreement resulting from the sale of VASCEPA in the China Territory.

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However, if HLS is not able to effectively commercialize VASCEPA in Canada through effective pricing (initially and over time), reimbursement or otherwise we may not be able to generate revenue from the sale of VASCEPA in Canada.

Our efforts to launch VAZKEPA on our own in Europe is a complex undertaking for a company that has not launched a product in Europe and could be subject to significant risks of execution to our successful development and revenue generation of VAZKEPA in Europe.

Our efforts to launch VAZKEPA on our own in Europe is a complex undertaking for a company that, other than our recent launch of VAZKEPA in Germany in September 2021, has not launched a product in Europe and could be subject to significant risks of execution to our successful development and revenue generation of VAZKEPA in Europe.

While various of our suppliers have been inspected and we do not anticipate supply availability limiting our launch in Europe, COVID-19 has limited the ability of suppliers to be inspected and not all of our suppliers have completed all of the requirements of the European regulatory authorities.

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Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products.

Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products.

Arrangements with third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain

the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical products.

In particular, the promotion, sales and marketing of healthcare items and services, as well as a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices.

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Although there are a number of statutory exemptions and regulatory safe harbors protecting certain activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases, or recommendations may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

Our practices may not in all cases meet all of the criteria for safe harbor

protection from anti-kickback liability.

Our practices may not in all cases meet all of the criteria for safe harbor protection from anti-kickback liability.

Violations are subject to significant civil and criminal fines and penalties for each violation, plus up to three times the renumeration involved, imprisonment, and exclusion from government healthcare workers;

the federal civil and criminal false claims laws, including the FCA, which prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making or using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing, or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government.

the federal civil and criminal false claims laws and civil monetary penalties laws, including the FCA, which prohibits, among other things, any person from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making or using, or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing, or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government.

The FCA also permits a private individual acting as a “whistleblower”

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Beginning in 2022, applicable manufacturers also will be required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives;

federal governmental price reporting laws, which require the calculation and reporting of complex pricing metrics in an accurate and timely manner to government programs;

federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

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The distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

In addition, manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying U.S.

FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations.

Federal and state enforcement bodies continue to give regular and close scrutiny to interactions between healthcare companies and healthcare providers, and such scrutiny

often leads to investigations, prosecutions, convictions and settlements in the healthcare industry.

Federal and state enforcement bodies continue to give regular and close scrutiny to interactions between healthcare companies and healthcare providers, and such scrutiny often leads to investigations, prosecutions, convictions and settlements in the healthcare industry.

Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business.

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Depending on the circumstances, failure to meet applicable regulatory requirements can result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in federal and state funded healthcare programs (such as Medicare and Medicaid), contractual damages and the curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws.

Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business.

Any action for violation of these laws, even if successfully

defended, could cause a pharmaceutical manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business.

If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, that person or entity may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

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patents covering or related to the use of VASCEPA in the REDUCE-IT population with terms expiring in 2033 or later;

three additional US patents directed to a pharmaceutical composition comprised of free fatty acids with a term that expires in 2030;

three additional U.S.

patents directed to a pharmaceutical composition comprised of free fatty acids with a term that expires in 2030;

five additional patents related to the use of a pharmaceutical composition comprised of free fatty acids to treat the ANCHOR patient population with a term that expires in 2030 or later;

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In China and the Middle East, we are pursuing such regulatory approvals and subsequent commercialization of VASCEPA with commercial partners.

The European Commission, or EC, approval provides ten years of market protection in the EU.

The EC approval provides ten years of market protection in the EU.

Furthermore, patent protection in Europe includes:

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We may be dependent in some cases upon third-party licensors to pursue filing, prosecution and maintenance of patent rights or applications owned or controlled by those parties, including, for example, under our collaboration with Mochida.

It is possible that

third parties will obtain patents or other proprietary rights that might be necessary or useful to us.

It is possible that third parties will obtain patents or other proprietary rights that might be necessary or useful to us.

In cases where third parties are first to invent a particular product or technology, or first to file after various provisions of the America Invents Act of 2011 went into effect on March 16, 2013, it is possible that those parties will obtain patents that will be sufficiently broad so as to prevent us from utilizing such technology or commercializing our current and future products.

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We anticipate that competitors may from time to time oppose our efforts to obtain patent protection for new technologies or to submit patented technologies for regulatory approvals.

Competitors may seek to oppose our patent applications to delay the approval process or to challenge our granted patents, for example, by requesting a reexamination of our patent at the USPTO, or by filing an opposition in a foreign patent office, even if the opposition or challenge has little or no merit.

opposition in a foreign patent office, even if the opposition or challenge has little or no merit.

For example, one of our patents was revoked in an opposition proceeding in Europe due to a determination of improper claim amendments under a provision of law not applicable in the United States.

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This process includes written and public communication with the patent office.

The process can

also include direct discussions with the patent examiner.

The process can also include direct discussions with the patent examiner.

There can be no assurance that the patent office will accept our arguments with respect to any patent application or with respect to any claim therein.

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The loss of the services of one or more members of senior management could have a material adverse effect on us.

Given our rapidly expanding enterprise coupled with a streamlined management structure, the departure of any key person could have a significant impact and would be potentially disruptive to our business until such time as a suitable replacement is hired.

In April 2021, we announced that John Thero, President and Chief Executive Officer, will retire from his positions as President and Chief Executive Officer and member of the Board of Directors effective August 1, 2021 and will provide phased transitional and consulting services to us thereafter.

The Board of Directors has appointed Karim Mikhail, currently our Senior Vice President, Commercial Head Europe, to succeed Mr.

Thero as our next President and Chief Executive Officer, as well as, a member of the Board of Directors, effective August 1, 2021.

In April 2021, we also announced that Joseph Kennedy will retire from his position as Executive Vice President, General Counsel effective August 1, 2021.

A search has commenced to hire a new General Counsel, with Mr.

Kennedy also intending to support this transition and to provide consulting support on certain legal matters.

Although we anticipate smooth transitions, any such changes to senior management, can be disruptive to operations, including by distracting management from our core business and effective employee productivity.

Given our rapidly expanding enterprise coupled with a streamlined management structure and sales force, the departure of any key person could have a significant impact and would be potentially disruptive to our business until such time as a suitable replacement is hired.

In the third quarter of 2021, John Thero and Joseph Kennedy, our President and Chief Executive Officer, and our Executive Vice President and General Counsel, respectively, retired and we welcomed Karim Mikhail, previously our Senior Vice President, Commercial Head Europe and Jason Marks as our new President and Chief Executive Officer and our new Senior Vice President and Chief Legal Officer, respectively.

Although these transitions have been smooth, any such changes to senior management can be disruptive to operations, including by distracting management from our core business and effective employee productivity.

Furthermore, because of the specialized nature of our business, as our business plan progresses, we will be highly dependent upon our ability to attract and retain qualified scientific, technical and key management personnel.

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It is possible that in the future, whether as a result of a change in law or the practice of any relevant tax authority or as a result of any change in the conduct of our affairs, we could become, or be regarded as having become resident in a jurisdiction other than Ireland.

Should we cease to be an Irish tax resident, we may be subject to a charge to Irish capital gains tax on our assets and the basis on which our income is taxed may also change.

Should we cease to be an Irish tax resident, we may be subject to a charge to Irish capital gains tax on our assets and the basis on which our

income is taxed may also change.

Similarly, if the tax residency of our Irish or UK subsidiaries were to change from their current jurisdiction, they may be subject to a charge to local capital gains tax on their assets and the basis on which their income is taxed may also change.

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gross product sales.

Customers A, B, and C accounted for 27%, 36%, and 30%, respectively, of gross product sales for the three and six months ended June 30, 2021 and 2020, and represented 40%, 34%, and 21%, respectively, of the gross accounts receivable balance as of June 30, 2021.

Customers A, B, and C accounted for 25%, 37%, and 29%, respectively, of gross product sales for the six months ended June 30, 2020, and represented 32%, 38%, and 23%, respectively, of the gross accounts receivable balance as of June 30, 2020.

Customers A, B, and C accounted for 27%, 37%, and 28%, respectively, of gross product sales for the three and nine months ended September 30, 2021 and 2020, and represented 34%, 37%, and 21%, respectively, of the gross accounts receivable balance as of September 30, 2021.

Customers A, B, and C accounted for 25%, 37%, and 30%, respectively, of gross product sales for the nine months ended September 30, 2020, and represented 37%, 32%, and 25%, respectively, of the gross accounts receivable balance as of September 30, 2020.

We expect that we may have customer concentration risk as we enter additional countries.

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For the fiscal years ended December 31, 2020, 2019, and 2018, we reported losses of approximately $18.0 million, $22.6 million, and $116.4 million, and we had an accumulated deficit as of December 31, 2020 of $1.4 billion.

For the three months ended June 30, 2021 and 2020, we reported income of approximately $7.8 million and $4.4 million, respectively, and we had an accumulated deficit as of June 30, 2021 of $1.4 billion.

For the three months ended September 30, 2021 and 2020, we reported losses of approximately $13.2 million and $6.8 million, respectively, and we had an accumulated deficit as of September 30, 2021 of $1.4 billion.

Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs, from general and administrative costs associated with our operations, and costs related to the commercialization of VASCEPA.

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VASCEPA sales are difficult to predict from period to period and as a result, you should not rely on VASCEPA sales results in any period as being indicative of future performance, and sales of VASCEPA may be below the expectation of securities analysts or investors in the future.

We believe that our quarterly and annual results of operations may be affected by a variety of factors, including those risks and uncertainties described in this Part II, Item 1A and the following:

the recent launch of a generic version of VASCEPA, and the potential launch of additional generic versions;

continued and prolonged disruption to our business, or delays in resuming normal business activities from the COVID-19 pandemic;

We believe that our quarterly and annual results of

operations may be affected by a variety of factors, including those risks and uncertainties described in this Part II, Item 1A and the following:

the recent and potential launches of additional generic versions of VASCEPA;

continued and prolonged disruption to our business, or delays in resuming normal business activities, or reinstating restrictions after protocols have been lifted, from the COVID-19 pandemic;

the continuing evolution of the medical community’s and the public’s perception of the REDUCE-IT study results;

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the extent to which coverage and reimbursement for VASCEPA is available from government and health administration authorities, private health insurers, managed care programs and other third-party payers and the timing and extent to which such coverage and reimbursement changes;

the timing, cost and level of investment in our sales and marketing efforts to support VASCEPA sales and the resulting effectiveness of those efforts;

the timing, cost and level of investment in our sales and marketing efforts to support VASCEPA sales, including our recently announced Go-to-Market strategy, and the resulting effectiveness of those efforts;

disruptions or delays in our or our partners’

commercial or development activities, including as a result of political instability, civil unrest, terrorism, pandemics or other natural disasters, such as the recent outbreak of coronavirus;

commercial or development activities, including as a result of political instability, civil unrest, terrorism, pandemics or other natural disasters, such as the coronavirus outbreak;

the timing and ability of efforts outside the United States, to develop, register and commercialize VASCEPA in Europe, China Territory, several Middle Eastern and North African countries, and Canada, for example, including obtaining necessary regulatory approvals, favorable pricing and establishing marketing channels;

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We currently operate with limited resources.

We believe that our cash and cash equivalents balance of $327.0 million and short-term investment balance of $181.9 million as of June 30, 2021 will be sufficient to fund our projected operations for at least 12 months.

We believe that our cash and cash equivalents balance of $222.9 million and short-term investment balance of $256.3 million as of September 30, 2021 will be sufficient to fund our projected operations for at least 12 months.

We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect or fail to achieve positive cash flow.

Depending on the level of cash generated from operations, and depending in part on the rate of prescription growth for VASCEPA, additional capital may be required to support planned VASCEPA promotion and potential VASCEPA promotion beyond which we are currently executing and for commercialization of VAZKEPA in Europe.

If additional capital is required and we are unable to obtain additional capital or satisfactory terms, or at all, we may be forced to delay, limit or eliminate certain promotional activities.

If additional capital is required and we are unable to obtain additional capital on satisfactory terms, or at all, we may be forced to delay, limit or eliminate certain promotional activities.

We anticipate that quarterly net cash outflows in future periods will be variable as a result of the timing of certain items, including our purchases of API, VASCEPA promotional activities from approval by the U.S.

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In addition, the market prices of the securities of many pharmaceutical and medical technology companies have been especially volatile in the past, and this trend is expected to continue in the future.

As of July 30, 2021, we had 395,302,404 common shares outstanding including 395,105,527 shares held as ADSs and 196,877 held as ordinary shares (which are not held in the form of ADSs).

As of October 29, 2021, we had 395,825,887 common shares outstanding including 395,629,060 shares held as ADSs and 196,827 held as ordinary shares (which are not held in the form of ADSs).

There is a risk that there may not be sufficient liquidity in the market to accommodate significant increases in selling activity or the sale of a large block of our securities.

Our ADSs have historically had limited trading volume, which may also result in volatility.

If any of our large investors seek to sell substantial

amounts of our ADSs, particularly if these sales are in a rapid or disorderly manner, or other investors perceive that these sales could occur, the market price of our ADSs could decrease significantly.

If any of our large investors seek to sell substantial amounts of our ADSs, particularly if these sales are in a rapid or disorderly manner, or other investors perceive that these sales could occur, the market price of our ADSs could decrease significantly.

The market price of our ADSs and common shares may also be affected by factors such as:

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However, because our place of central management and control is currently outside of the United Kingdom, we are not subject to the Takeover Code.

As a result, our shareholders are not entitled to the benefit of certain takeover offer

protections provided under the Takeover Code.

As a result, our shareholders are not entitled to the benefit of certain takeover offer protections provided under the Takeover Code.

The following is a brief summary of some of the most important rules of the Takeover Code which, as noted, does not apply to us:

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We cannot assure you that research and discoveries by others will not render some or all of our programs or product candidates uncompetitive or obsolete.

Our business strategy is based in part upon new and unproven technologies to the development of therapeutics to improve cardiovascular health.

Our business strategy is based in part upon new and unproven technologies to the development of therapeutics to improve cardiovascular

We cannot assure you that unforeseen problems will not develop with these technologies or applications or that any commercially feasible products will ultimately be developed by us.

Legal, political and economic uncertainty surrounding the exit of the UK from the EU may be a source of instability in international markets, create significant currency fluctuations, adversely affect our operations in the UK and pose additional risks to our business, revenue, financial condition, and results of operations.

On June 23, 2016, the UK held a referendum in which a majority of the eligible members of the electorate voted to leave the EU, commonly referred to as Brexit.

The UK formally left the EU on January 31, 2020 when the transition period granted by the Withdrawal Agreement ended.

Separately, the EU-UK Trade and Cooperation Agreement was entered into between the UK and the EU on December 24, 2020.

In addition, the UK is negotiating deals in a number of other areas where cooperation with the EU is required, and there is continued uncertainty as to which EU regulations and directives will be replicated into UK domestic law, or replaced, going forward, and when.

Given the recent deal terms and the lack of clarity on future UK laws and regulations and their divergence from, or consistency with, the EU laws and regulations may negatively impact foreign direct investment in the UK, increase costs, depress economic activity and restrict access to capital.

The continued uncertainty concerning the UK’s legal, political and economic relationship with the EU after Brexit may be a source of instability in the international markets, create significant currency fluctuations, and/or otherwise adversely affect trading agreements or similar cross-border co-operation arrangements (whether economic, tax, fiscal, legal, regulatory or otherwise.

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Such a withdrawal from the EU is unprecedented, and it is unclear how the UK’s access to the European single market for goods, capital, services and labor within the EU, or single market, and the wider commercial, legal and regulatory environment, will impact our current and future operations (including business activities conducted by third parties and contract manufacturers on our behalf) and clinical activities in the UK.

In addition to the foregoing, our UK operations support our current and future operations and clinical activities in other countries in the EU and EEA and these operations and clinical activities could be disrupted by the ongoing effects of Brexit, particularly in regards to the specific terms of any trade deal that is reached between the UK and the EU.

We may also face new regulatory costs and challenges that could have an adverse effect on our operations.

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Any delay in commercializing our products in the UK and/or the EU could restrict our ability to generate revenue and achieve and sustain profitability.

The uncertainty around the UK’s future relationship

with the EU continues to cause economic uncertainty which could adversely impact customer confidence resulting in customers reducing their spending budgets on our solutions, which could adversely affect our business, revenue, financial condition, results of operations and could adversely affect the market price of our ADSs.

The uncertainty around the UK’s future relationship with the EU continues to cause economic uncertainty which could adversely impact customer confidence resulting in customers reducing their spending budgets on our solutions, which could adversely affect our business, revenue, financial condition, results of operations and could adversely affect the market price of our ADSs.

Negative economic conditions would likely have a negative effect on our ability to obtain financing on acceptable terms.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Legal Proceedings