What changed in this filing

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Item 1. Legal Proceedings

2022-10-27 compared with 2022-08-03 · 144 added, 135 removed, 1430 unchanged (16% of the section changed)

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Refer to Note 5 –

Commitments and Contingencies in this Quarterly Report for further details on our legal proceedings during the six months ended June 30, 2022.

Commitments and Contingencies in this Quarterly Report for further details on our legal proceedings during the nine months ended September 30, 2022.

Ri sk Factors

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In the United States, VASCEPA is facing increasing competition from generic versions of the drug.

In Europe, VAZKEPA launched in Germany following approval from the central regulatory authority and we are in the process of obtaining relevant pricing approvals in various countries;

In Europe, we are in the process of obtaining relevant pricing approvals in various countries;

however, we may not be successful in obtaining such approvals in a timely manner, or at all and, even if successfully obtained, we may not be successful in commercializing VAZKEPA in Europe or elsewhere.

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 at levels sufficient to meet our expectations for commercial success.

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

Our recently announced cost and organizational restructuring plan may not be successful in addressing current shifts within the Company's U.S.

Our cost reduction and organizational restructuring plan may not be successful in addressing current shifts within the Company's U.S.

business and developing sales internationally.

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In the United States, VASCEPA is facing increasing competition from generic versions of the drug.

In Europe, VAZKEPA launched in Germany following approval from the central regulatory authority and we are in the process of obtaining relevant pricing approvals in various countries;

In Europe, we are in the process of obtaining relevant pricing approvals in various countries;

however, we may not be successful in obtaining such approvals in a timely manner or at all and even if successfully obtained, we may not be successful in commercializing VAZKEPA in Europe or elsewhere.

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In recent years and currently, much of our financial results and revenue has been dependent on our ability to execute our development and commercial strategy for VASCEPA in the United States.

Generic versions of VASCEPA launched in the United States in November 2020, June 2021 and January 2022.

Generic versions of VASCEPA launched in the United States for the 1-gram capsule in November 2020, June 2021, January 2022 and for the 0.5-gram capsule in September 2022.

We expect that VASCEPA could face more competition from generic companies in the United States in the near term in light of the patent litigation rulings against us, applicable only in this territory.

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commercial team from approximately 300 sales representatives to approximately 75 sales representatives.

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

Although this has resulted in an improved expense structure, such efforts could impact employee morale and make hiring and retaining talented personnel more challenging, may not result in all of the cost-savings or other benefits we anticipate and are costly to implement.

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.

In September 2021, we launched VAZKEPA in Germany, representing our first European launch.

We are in the process of obtaining further 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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2.60 mmol/L) and established cardiovascular disease.

In June 2022 HLS Therapeutics Inc., or HLS, entered into Product Listing Agreements with New Brunswick, Northwest Territories and the non-insurance health benefits, for the listing and public reimbursement of VASCEPA on their respective Public Prescription Drug Insurance Plans.

In August 2022, we announced that we discontinued business operations in Germany following the conclusion of negotiations with the National Association of Statutory Health Insurance Funds during which a viable agreement on the reimbursement price of VAZKEPA could not be reached.

Although the matter is now moving to the Arbitration Board for a final decision, and although we plan to resubmit a pricing and reimbursement dossier with new data in Germany once we have a new dossier ready, we may be unable to resume operations, including commercialization efforts, in Germany.

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

As of September 30, 2022, in Canada reimbursement coverage is approximately 70% of publicly covered lives and 95% for private coverage.

Public reimbursement is now available in Ontario, Quebec, Saskatchewan, New Brunswick Northwest Territories and for the Non-Insured Health Benefits program for the First Nations and Inuit people.

We may not be successful in obtaining additional approvals in a timely manner with acceptable terms, or in additional countries.

Our expansion and development of VASCEPA outside the United States is generally not subject to the adverse patent ruling in the United States.

Development outside the United States is primarily based on the second indication approval for VASCEPA in the United States.

Development outside the United States is primarily based on the REDUCE-IT indication approved for VASCEPA in the United States.

That second indication, which we believe has significantly more value potential, is for use of the drug in the reduction of cardiovascular risk in select high-risk patients.

We have been developing VAZKEPA on our own in Europe for the approved cardiovascular risk reduction indication and are exploring possible strategic collaborations in smaller markets within Europe and in other major markets.

We currently have multiple partners for the development and commercialization of VASCEPA in select geographies and intend to assess potential partners to commercialize VASCEPA in other parts of the world.

For example, we have strategic collaborations for the development and

commercialization of VASCEPA in Canada, the Middle East and Greater China.

We currently have multiple partners for the development and commercialization of VASCEPA in select geographies and are assessing potential partners to

commercialize VASCEPA in other parts of the world.

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.

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For example, it took over a decade of preceding product development before we received marketing approval for VAZKEPA in March 2021 from the EC.

Likewise, if we seek to diversify our development programs or product offerings through licensing or acquisitions, such transactions are also time-consuming, may be dilutive to existing shareholdings, and can be disruptive to operations.

These transactions may not be available on favorable terms, or at all.

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On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss.

We intend to appeal the decision of the district court when permitted and also continue to vigorously pursue our ongoing litigation with Health Net, LLC, but cannot predict the outcome or the impact on our business.

On October 13, 2022, the district court granted final judgement on the aspect of the litigation relating to the Company and Hikma.

The Company intends to appeal the decision of the district court now that it is permitted to do so and also intends to continue to vigorously pursue its ongoing litigation with Health Net, but cannot predict the outcome or the impact on its business.

In June 2021, Dr.

Reddy's launched its generic version of VASCEPA with labeling that is substantially similar to labeling of the Hikma generic product.

In addition to ANDAs approved for Hikma and Dr.

Reddy’s, on September 11, 2020, Teva Pharmaceuticals USA, Inc’s., or Teva’s, ANDA was approved by the U.S.

Food and Drug Administration, or U.S.

On June 30, 2021, Apotex Inc.'s, or Apotex's, ANDA was approved by the U.S.

In January 2022, Apotex launched its generic version of VASCEPA with labeling that is substantially consistent with the labeling of the Hikma and Dr.

Reddy's generic product, not the cardiovascular risk reduction indication.

In January 2022, Apotex Inc., or Apotex, launched its generic version of VASCEPA with labeling that is substantially consistent with the labeling of the other generic products.

In September 2022, Teva Pharmaceuticals USA, Inc., or Teva, lauched its generic version of VASCEPA's 0.5-gram capsule with consistent labeling as the other generic products.

The rulings of the Nevada Court and related appeal losses detailed above could permit each of Teva and Apotex to launch a generic version of VASCEPA under certain circumstances pursuant to their respective settlement agreement with us.

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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 these or additional generic entrants in the near term, which could have a material and adverse impact on our revenues and our results of operations.

Reddy’s, Apotex's and Teva's (0.5-gram only) generic versions of VASCEPA in the United States, and could face increased competition from these or 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.

FDA, even if such use is determined to infringe certain of our patent claims.

Reddy and Apotex, we do not have direct visibility into the supply levels of any of the generic companies and we rely on our own experience together with information from third parties, which information may not be reliable.

As such, generic companies could potentially find or develop sources of qualified

VASCEPA supply that are not known to us and that are more efficient or less expensive than our sources.

Although we continue to believe that VASCEPA is difficult to manufacture and that building capacity to manufacture VASCEPA would be time-consuming and expensive for generic companies, we do not have direct visibility into the supply levels of any of the generic companies and we rely on our own experience together with information from third parties, which information may not be reliable.

As such, generic companies could potentially find or develop sources of qualified VASCEPA supply that are not known to us

and that are more efficient or less expensive than our sources.

Furthermore, generic companies could potentially convince suppliers to prioritize supply to the generic companies.

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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 EC approval of VAZKEPA, we may be unsuccessful in expanding our global footprint.

For example, we are launching VAZKEPA on our own in the most commercially significant markets in Europe and launched VAZKEPA in Germany, representing our first European launch.

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.

For example, we are launching VAZKEPA on our own in the most commercially significant markets in Europe.

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

For example, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached with German regulators and we have discontinued our Germany business operations.

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.

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unforeseen costs and expenses associated with operating a new independent sales and marketing organization;

the continued impact from COVID-19 on healthcare providers, patients and personnel which may vary considerably from jurisdiction to jurisdiction, as well as on local restrictions and practices, including the complexities of having to understand and navigate multiple sets of protocols and the accessibility and rates of vaccinations in various geographies.

the continued or resumed impact from COVID-19 on healthcare providers, patients and personnel which may vary considerably from jurisdiction to jurisdiction, as well as on local restrictions and practices, including the complexities of having to understand and navigate multiple and evolving sets of protocols and the accessibility and rates of vaccinations in various geographies.

If we experience one or more of the setbacks described above, we may not be able to pursue international regulatory and commercial efforts in a cost effective manner, or at all, which could cause our stock price to decline.

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In many countries outside the United States, government-sponsored healthcare systems are the primary payors for drugs.

With increasing budgetary constraints and differing views on or challenges in valuing medicines, governments and payors in many

countries are applying a variety of measures to exert downward price pressure.

With increasing budgetary constraints and differing views on or challenges in valuing medicines, governments and payors in many countries are applying a variety of measures to exert downward price pressure.

These measures can include mandatory price controls, price referencing, therapeutic-reference pricing, increases in mandates, incentives for generic substitution and biosimilar usage and government-mandated price cuts.

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REDUCE-IT topline results showed the trial met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance (p<0.001), in MACE in the intent-to-treat patient population with use of VASCEPA 4 grams per day as compared to placebo.

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.

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.

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 and the success of our omnichannel platform;

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

publicity concerning VASCEPA or competing products;

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sufficient third-party coverage or reimbursement for VASCEPA and its prescribed uses, on-label and off-label;

natural disasters, including pandemics such as COVID-19 and political unrest that could inhibit our ability to promote VASCEPA regionally and that could negatively affect product demand by creating obstacles for patients to seek treatment and fill prescriptions;

natural disasters, including pandemics such as COVID-19 and political unrest which could inhibit our ability to promote VASCEPA regionally and which could negatively affect product demand by creating obstacles for patients to seek treatment and fill prescriptions;

new policies or laws affecting VASCEPA sales, such as state and federal efforts to affect drug pricing and provide or remove healthcare coverage that includes reimbursement for prescription drugs;

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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 could make reimbursement more difficult.

*The continued scale, scope and duration of business interruptions caused by the ongoing COVID-19 pandemic and related recovery efforts 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.

*Despite some recent remediation of the negative impacts on our business from the COVID-19 pandemic, the evolving and continued scale, scope and duration of business interruptions caused by the ongoing COVID-19 pandemic and related recovery efforts remain uncertain.

Despite recent improvements, 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 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;

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

governmental, business and individuals’

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ability to access supplies of VASCEPA and the willingness of patients to visit doctors for non-urgent medical examination or to visit labs for blood tests to assess biomarkers such as lipid levels;

our ability to commercialize VASCEPA, including as a result of ongoing travel restrictions, social distancing and other containment measures or the restoration of such measures in areas where such measures have been relaxed;

our ability to commercialize VASCEPA, including if travel restrictions, social distancing and other containment measures are resumed or intensified;

the enrollment or monitoring of patients in clinical trials, particularly at clinical trial sites located in highly impacted jurisdictions and jurisdictions where vaccination rates are low;

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

As variants emerge and as vaccine usage and protocols evolve, face-to-face interactions are challenging for us to predict and the number of patient visits to doctors’

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

Even as the impacts of the pandemic appear to subside, additional variants may emerge and as vaccine usage and protocols evolve, face-to-face interactions may continue to be challenging for us to predict.

The circumstances surrounding COVID-19 vary geographically and vary over time, with continued risk of potential resurgences in COVID-19 cases, and the possibility of reinstitution of protocols, in various geographies as the efficacy of the vaccine on various strains remains uncertain.

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

Although we have a geographically diversified supply chain for VASCEPA and believe we have sufficient inventory on hand at pharmacies throughout the United States and other markets where it is approved for sale, and at various stages of manufacturing with our suppliers, the global spread of the pandemic and containment measures has been unprecedented and could have a negative impact on the availability of VASCEPA at various points in our supply chain, including limiting the ability of new suppliers to be inspected,

which would have a material and adverse effect on our business.

our suppliers, the global spread of the pandemic and containment measures has been unprecedented and could have a negative impact on the availability of VASCEPA at various points in our supply chain, including limiting the ability of new suppliers to be inspected, which would have a material and adverse effect on our business.

The ongoing demand for vaccines, including boosters, and potential for manufacturing facilities and materials to be commandeered under the Defense Production Act of 1950, or equivalent foreign legislation, may make it more difficult to obtain materials or manufacturing slots for the products needed for our commercial product, which could lead to issues with our commercial supply.

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The relationship between the ratio of EPA to arachidonic acid and incidence of events will also be examined.

Results from this study are expected in the second half of 2022, though the study and results are not under the Company's control and may be delayed as a result of COVID-19 impacts.

Results from this study are expected to be presented during the 2022 American Heart Association Scientific Sessions in November 2022.

In November 2020, we announced statistically significant topline results from a Phase 3 clinical trial of VASCEPA, conducted by our partner in China, Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL).

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Results from the investigator sponsored study in Argentina called PREPARE-IT-2 were presented by the lead trial investigator at the American Heart Association Scientific Sessions in November 2021 and the results did not meet the primary and/or other endpoints studied.

Results from the other investigational study, called MITIGATE, are expected during 2022.

Results from the other investigational study, called MITIGATE, are expected during the first half of 2023.

If the outcomes of one or more of these studies do not meet expectations, the perception of existing clinical results of VASCEPA, such as MARINE or REDUCE-IT, or the perceived clinical profile and commercial value of VASCEPA and its regulatory status may suffer.

If this occurs our revenue and business could suffer and our stock price could significantly decline.

*Our recently announced cost and organizational restructuring plan may not be successful in addressing the current shift in the United States business and developing sales internationally.

If we are not successful in our efforts to market and sell VASCEPA in the United States, including from the implementation of our recent cost and organizational restructuring plan, reduced sales force, our anticipated revenues or our expenses could be materially and negatively affected, and we may not maintain profitability in the United States or obtain profitability internationally, 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.

*Our cost reduction and organizational restructuring plan may not be successful in addressing the current shift in the United States business and developing sales internationally.

If we are not successful in our efforts to continue to market and sell VASCEPA in the United States, including from the implementation of our cost reduction and organizational restructuring plan announced in June 2022, reduced sales force, our anticipated revenues or our expenses could be materially and negatively affected, and we may not maintain profitability in the United States or obtain profitability internationally, 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.

Given the dynamics related to COVID-19, we cannot predict our ability to effectively sustain business efforts, or how those efforts will be impacted in the long term.

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In May 2015, we and a group of independent physicians filed a lawsuit against the U.S.

FDA seeking a federal court declaration that would permit us and our agents to promote to healthcare professionals the use of VASCEPA in the ANCHOR population and promote on the potential of VASCEPA to reduce the risk of cardiovascular disease so long as the promotion is truthful and non-misleading.

non-misleading.

This use of VASCEPA at issue reflected recognized medical practice at the time but was not approved by the U.S.

and was thus not covered by then U.S.

FDA and was thus not covered by then U.S.

FDA-approved labeling for the drug.

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by Hikma in November 2020, Dr.

Reddy's in June 2021 and Apotex in January 2022, and with the potential for further generic versions being launched, it may not be viable for us to continue to invest in market education to grow the 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.

Reddy's in June 2021, Apotex in January 2022 and Teva for the 0.5-gram capsule only in September 2022, and with the potential for further generic versions being launched, it may not be viable for us to continue to invest in market education to grow the 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 the third quarter of 2021.

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In April 2022, Kowa Research Institute announced the decision to not continue the PROMINENT study as the primary endpoint was unlikely to be met.

Results of the PROMINENT trial are scheduled to be presented at the 2022 American Heart Association Scientific Session in November 2022.

During 2018, two outcomes studies were completed of omega-3 mixtures which both failed to achieve their primary endpoints of cardiovascular risk reduction and two meta-analyses were published showing that omega-3 mixtures of are not effective in lowering cardiovascular risk.

Results of these failed outcomes studies, as described below and analysis, while not done with VASCEPA, may negatively affect sales of VASCEPA if omega-3 mixtures are broadly viewed as ineffective.

Results and analyses of these failed outcomes studies, as described below, while not done with VASCEPA, may negatively affect sales of VASCEPA if omega-3 mixtures are broadly viewed as ineffective.

For example, results of one of these two studies, the VITamin D and OmegA-3 TriaL, or VITAL, as announced immediately before the presentation of REDUCE-IT results at the 2018 Scientific Sessions of the AHA on November 10, 2018, failed to achieve its primary endpoint of lowering cardiovascular events.

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

Similar to the VITAL and ASCEND studies, most of the studies in these omega-3 meta-analyses were of

omega-3 mixtures, including DHA, and most were studies of relatively low doses of omega-3 as is associated with dietary supplementation and/or they studied relatively low risk patient populations.

Similar to the VITAL and ASCEND studies, most of the studies in these omega-3 meta-analyses were of omega-3 mixtures, including DHA, and most were studies of relatively low doses of omega-3 as is associated with dietary supplementation and/or they studied relatively low risk patient populations.

The exception was the JELIS study, conducted in Japan, of highly pure EPA which showed a positive outcome benefit but had significant limitations in its application to a wider population.

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

Results presented in November 2020 at the AHA’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 component of this endpoint after 2 years.

Matinas BioPharma, Inc., or Matinas, is developing an omega-3-based therapeutic (MAT9001 also known as LYPDISO) for the treatment of severe hypertriglyceridemia and mixed dyslipidemia.

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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 third quarter of 2022.

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.

The trial completed in May 2022 and results are expected in the fourth quarter of 2022.

Based on prior communications from the U.S.

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Generic versions of VASCEPA made available in the market, even if based on a MARINE indication, are often used to fill a prescription for any intended use of the drug.

If any approved ANDA filers are able to supply the product in significant commercial

quantities, generic companies could introduce generic versions of VASCEPA in the market, as did Hikma in November 2020, Dr.

Reddy's in June 2021 and Apotex in January 2022.

If any approved ANDA filers are able to supply the product in significant commercial quantities, generic companies could introduce generic versions of VASCEPA in the market, as did Hikma in November 2020, Dr.

Reddy's in June 2021, Apotex in January 2022 and Teva for the 0.5-gram capsule only in September 2022.

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.

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The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and long-term financial commitments to ensure sufficient capacity is available when needed.

One of the generic competitors which has filed a lawsuit against us claiming we have engaged in anticompetitive practices related to our building of adequate supply for our needs and, in activities we believe were prompted by the generic competitor, government agencies are investigating our business as it relates to the supply of the active pharmaceutical ingredient in VASCEPA.

One of our generic competitors has filed a lawsuit against us claiming we have engaged in anticompetitive practices related to our building of adequate supply for our needs and government agencies are investigating our business as it relates to the supply of the active pharmaceutical ingredient in VASCEPA.

Consumer lawsuits with similar allegations have also been filed.

This dynamic could interfere with our business plans.

This dynamic and resulting regulatory scrutiny could be costly for us and could negatively and materially interfere with our business plans.

The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, often requires considerable advanced planning and necessitates long-term financial commitments to ensure sufficient capacity is available when needed.

We have invested over a decade of resources and expenses to develop with our third-party, active pharmaceutical ingredient supply chain the technical knowhow, manufacturing processes and related regulatory approvals that have helped enable our suppliers to supply our clinical and commercial needs globally.

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Such investigations can be lengthy, costly and could materially affect and disrupt our business.

We cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on our business.

We cannot predict when these investigations will be resolved, the outcome

of the investigations or their potential impact on our business.

If a government determines that we have violated antitrust law, we could be subject to significant civil fines and penalties.

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We cannot be sure physicians and other providers will view the U.S.

FDA approval, pharmaceutical grade purity and proven efficacy and safety of

VASCEPA as having a superior therapeutic profile to unproven and loosely regulated omega-3 fatty acid dietary supplements.

FDA approval, pharmaceutical grade purity and proven efficacy and safety of VASCEPA as having a superior therapeutic profile to unproven and loosely regulated omega-3 fatty acid dietary supplements.

In addition, the U.S.

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FDA on the topic of synthetically produced omega-3 products through the citizen’s petition process and otherwise.

In addition, to the extent the net price of VASCEPA after insurance and offered discounts is significantly higher than the prices of commercially available omega-3 fatty acids marketed by other companies as dietary supplements (through the lack of coverage by insurers or otherwise), physicians and pharmacists may recommend these retail alternatives instead of writing or filling prescriptions for VASCEPA or patients may elect on their own to take commercially available omega-3 fatty acids.

In addition, to the extent the net price of VASCEPA to patients after insurance and offered discounts is significantly higher than the prices of commercially available omega-3 fatty acids marketed by other companies as dietary supplements (through the lack of coverage by insurers or otherwise), physicians and pharmacists may recommend these retail alternatives instead of writing or filling prescriptions for VASCEPA or patients may elect on their own to take commercially available omega-3 fatty acids.

Also, insurance plans may increasingly impose policies that directly or indirectly favor supplement use over VASCEPA.

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In some foreign countries, including major markets in Europe, the pricing of prescription pharmaceuticals is subject to governmental control.

In these countries, pricing negotiations with individual governmental authorities can take six to 12 months or longer after the receipt of regulatory marketing approval for a product.

The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time.

In certain European countries, securing product reimbursement is a requisite to

commercial launch.

In these countries, pricing negotiations with individual governmental authorities can take six to 12 months or longer after the receipt of regulatory marketing approval for a product, and is not always successful.

For example, after the conclusion of negotiations with the National Association of Statutory Health Insurance Funds, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached, and the matter is now moving to the Arbitration Board for a final decision.

As a result of the negotiation outcome, we have discontinued our German operations as of September 1, 2022.

Further, in certain European countries, securing product reimbursement is a requisite to commercial launch.

To obtain reimbursement or pricing approval in some countries, we may be required to conduct a pharmacoeconomic study that compares the cost-effectiveness of VASCEPA to other available therapies.

Such pharmacoeconomic studies can be costly and the results uncertain.

The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted at this time.

Our business could be harmed if reimbursement of our products is unavailable, delayed or limited in scope or amount or if pricing is set at unsatisfactory levels.

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As discussed above, in June 2020, we received a CID from the DOJ informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver programs during the period from January 1, 2015 to the present violated the U.S.

Anti-Kickback Statute and the U.S.

Anti-Kickback

Statute and the U.S.

FCA in relation to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa America.

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In addition, all of the above factors may also apply to any regulatory approval for VASCEPA obtained in territories outside the United States.

In Europe, for example, restrictions regarding off-label promotion are in some ways more stringent than in the United

States, including restrictions covering certain communications with shareholders.

In Europe, for example, restrictions regarding off-label promotion are in some ways more stringent than in the United States, including restrictions covering certain communications with shareholders.

Given our inexperience with marketing and commercializing products outside the United States, in certain territories we may need to rely on third parties, such as our partners in Canada, China and the Middle East, to assist us in dealing with any such issues and we will have limited or no control over such partners.

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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.

Specifically, in the United States and in 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.

For example, on August 2, 2011, the Budget Control Act of 2011, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals for spending reductions.

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Among other things, the Executive Order also directs HHS to provide a report on actions to combat excessive pricing of prescription drugs, enhance the domestic drug supply chain, reduce the price that the federal government pays for drugs, and address price gouging in the industry;

and directs the FDA to work with states and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and the FDA's implementing regulations.

and directs the FDA to work with states and Indian Tribes that propose to develop section

804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, and the FDA's implementing regulations.

FDA released such implementing regulations 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.

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The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers.

Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation of the rule

until January 1, 2026.

Pursuant to court order, the removal and addition of the aforementioned safe harbors were delayed and recent legislation imposed a moratorium on implementation of the rule until January 1, 2026.

In August 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law.

The IRA includes several provisions that will impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries.

The effect of IRA on our business and the healthcare industry in general is not yet known.

Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the Biden administration may reverse or otherwise change these measures, both the Biden administration and Congress have indicated that they will continue to seek new legislative measures to control drug costs.

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Federal law requires that any company that participates in the Medicaid Drug Rebate program also participate in the Public Health Service’s 340B drug pricing program in order for federal funds to be available for the manufacturer’s drugs under Medicaid and Medicare Part B.

The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no more than the 340B “ceiling price”

The 340B program requires participating manufacturers to agree to charge statutorily defined covered entities no

more than the 340B “ceiling price”

for the manufacturer’s covered outpatient drugs.

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In the case of our Medicaid pricing data, if we become aware that our reporting for a prior quarter was incorrect, or has changed as a result of recalculation of the pricing data, we are obligated to resubmit the corrected data for up to three years after those data originally were due.

Such restatements and recalculations increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate program and could result in an overage or underage in

our rebate liability for past quarters.

Such restatements and recalculations increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate program and could result in an overage or underage in our rebate liability for past quarters.

Price recalculations also may affect the ceiling price at which we are required to offer our products under the 340B program or could require us to issue refunds to 340B covered entities.

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Further, on June 14, 2018, U.S.

Court of Appeals for the Federal Circuit ruled that, due to Congressional appropriations riders that prohibited the HHS from paying out more in risk corridor

payments than it collected, HHS was not required to pay more than $12.0 billion in ACA risk corridor payments owed to insurers under the risk corridor formula.

Court of Appeals for the Federal Circuit ruled that, due to Congressional appropriations riders that prohibited the HHS from paying out more in risk corridor payments than it collected, HHS was not required to pay more than $12.0 billion in ACA risk corridor payments owed to insurers under the risk corridor formula.

On November 6, 2018, the Federal Circuit declined to rehear the case en banc.

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Supreme Court.

Supreme Court granted the writ of certiorari on July 2, 2021 and oral arguments were held on November 30, 2021.

The Court's decision should be released in the coming months.

On June 15, 2022, the Supreme Court unanimously reversed the Court of Appeals' decision, holding that HHS's 2018 and 2019 reimbursement rates for 340B hospitals were contrary to

the statute and unlawful.

We continue to review developments impacting the 340B program.

It is unclear how these developments could affect covered hospitals who might purchase our future products and affect the rates we may charge such facilities for our approved products in the future, if any.

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We and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security).

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.

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The new standard contractual clauses may also impact our business as companies based in Europe may be reluctant to utilize the new clauses to legitimize transfers of personal information to third countries given the burdensome requirements of transfer impact assessments and the substantial obligations that the new standard contractual clauses impose upon exporters.

Failure to comply with the requirements of the GDPR, and the related national data protection laws of the EEA Member States may result in restrictions against regulatory approval in the EEA or substantial fines for breaches of the data protection rules.

Failure to comply with the requirements of the GDPR, and the related

national data protection laws of the EEA Member States may result in restrictions against regulatory approval in the EEA or substantial fines for breaches of the data protection rules.

The GDPR may impose additional responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with these and/or new data protection rules.

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FDA-approved VASCEPA label or our settlement.

we are found to have promoted VASCEPA outside the terms of the litigation settlement or in violation of what federal or state government may determine to be acceptable, we may become subject to significant government fines and other related liability, such as under the FDCA, the FCA, or other theories of liability.

If we are found to have promoted VASCEPA outside the terms of the litigation settlement or in violation of what federal or state government may determine to be acceptable, we may become subject to significant government fines and other related liability, such as under the FDCA, the FCA, or other theories of liability.

Government may also seek to hold us responsible for the non-compliance of our former co-promotion partner, Kowa America, or our commercialization partners outside the United States or other third-parties that we retain to help us implement our business plan.

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Clinical trials that we or potential partners conduct may not provide sufficient safety and efficacy data to obtain the requisite regulatory approvals for product candidates.

The failure of clinical trials to

demonstrate safety and efficacy for our desired indications could harm the development of that product candidate as well as other product candidates, and our business and results of operations would suffer.

The failure of clinical trials to demonstrate safety and efficacy for our desired indications could harm the development of that product candidate as well as other product candidates, and our business and results of operations would suffer.

For example, during the public advisory committee meeting held by U.S.

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Any reliance on suppliers may involve several risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules, reliability and quality.

Any unanticipated disruption to future contract manufacture caused by problems at suppliers could delay shipment of products, increase our cost of goods sold and/or result in lost sales.

Any unanticipated disruption to future contract manufacture caused by problems at suppliers could delay

shipment of products, increase our cost of goods sold and/or result in lost sales.

If our suppliers were unable to supply us with adequate volumes of active pharmaceutical ingredient, API, (drug substance) or encapsulated bulk product (drug product), it would have a material adverse effect on our ability to continue to commercialize VASCEPA.

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FDA or another regulatory authority.

delays associated with the verification of a new third-party manufacturer could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget.

The delays associated with the verification of a new third-party manufacturer could negatively affect our ability to develop product candidates or commercialize our products in a timely manner or within budget.

Furthermore, a third-party manufacturer may possess technology related to the manufacture of our product candidate that such third-party manufacturer owns independently.

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FDA or similar foreign regulatory bodies.

For example, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold, the U.S.

For example, since March 2020 when foreign and domestic inspections of facilities were largely placed on hold, the

FDA has been working to resume routine surveillance, bioresearch monitoring and pre-approval inspections on a prioritized basis.

Since April 2021, the U.S.

FDA has conducted limited inspections and employed remote interactive evaluations, using risk management methods, to meet user fee commitments and goal dates.

Ongoing travel restrictions and other uncertainties continue to impact oversight operations both domestic and abroad and it is unclear when standard operational levels will resume.

In April 2021, the U.S.

FDA resumed inspections, but on a limited basis, and employed remote interactive evaluations, using risk management methods, to meet user fee commitments and goal dates.

Lasting impacts from travel restrictions and continued uncertainties continue to impact oversight operations both domestic and abroad and it is unclear when standard operational levels will resume.

FDA is continuing to complete mission-critical work, prioritize other higher-tiered inspectional needs (e.g., for-cause inspections), and carry out surveillance inspections using risk-based approaches for evaluating public health.

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The Chinese National Medical Products Administration, or NMPA, has accepted for review the new drug application for VASCEPA, submitted by Edding, based on the results from the Phase 3 clinical trial and the results from our prior studies of VASCEPA.

We expect to receive a decision from the NMPA in Mainland China in the second half of 2022.

On February 23, 2022 the Hong Kong Department of Health completed their

evaluation and approved the use of VASCEPA under the REDUCE-IT indication.

Edding has communicated that they still anticipate an approval could be achieved before year-end in China.

On February 23, 2022 the Hong Kong Department of Health completed their evaluation and approved the use of VASCEPA under the REDUCE-IT indication.

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.

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In February 2020, HLS launched VASCEPA in Canada, with strong initial uptake before the impact of COVID-19 pandemic.

In July 2020, Patented Medicine Prices Review Board confirmed VASCEPA price is compliant with current guidelines, and CADTH recommended reimbursement for VASCEPA in Canada in secondary prevention population.

In June 2022 HLS entered into Product Listing Agreements with New Brunswick, Northwest Territories and the non-insured health benefits, for the listing and public reimbursement of VASCEPA on their respective Public Prescription Drug Insurance Plans.

In July 2020, Patented Medicine Prices Review Board confirmed VASCEPA price is compliant with current guidelines, and CADTH recommended reimbursement for

VASCEPA in Canada in secondary prevention population.

As of September 30, 2022, reimbursement coverage is approximately 70% of publicly covered lives and 95% for private coverage.

Public reimbursement is now available in Ontario, Quebec, Saskatchewan, New Brunswick Northwest Territories and for the Non-Insured Health Benefits program for the First Nations and Inuit people.

Coverage of patients with established cardiovascular disease represents a substantial portion of VASCEPA’s approved label in Canada.

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 and support commercialization of 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 or otherwise commercialized 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 and support commercialization of VAZKEPA on our own in Europe is a complex undertaking for a company that, other than our launch of VAZKEPA in Germany in September 2021 (where operations were subsequently discontinued) and the launch of VAZKEPA in the UK in October 2022, has not launched or otherwise commercialized 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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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.

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.

The applicable federal and state healthcare laws and regulations laws that may affect our ability to operate include, but are not limited to:

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Anti-Kickback Statute constitutes a false or fraudulent claim under the FCA.

When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.

When an entity is determined to have violated

the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs.

Pharmaceutical and other healthcare companies also are subject to other federal false claims laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs;

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We are cooperating with the government.

We cannot predict when these investigations will be resolved, the outcome of the investigations or their potential impact on our business.

We cannot predict

when these investigations will be resolved, the outcome of the investigations or their potential impact on our business.

Such investigations can be lengthy, costly and could materially affect and disrupt our business.

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Specifically, in recent years there have been multiple settlements resulting out of government claims challenging the legality of their patient assistance programs under a variety of federal and state laws.

It is possible that we may make grants to independent charitable foundations that help financially needy patients with their premium,

co-pay, and co-insurance obligations.

It is possible that we may make grants to independent charitable foundations that help financially needy patients with their premium, co-pay, and co-insurance obligations.

If we choose to do so, and if we or our vendors or donation recipients are deemed to fail to comply with relevant laws, regulations or evolving government guidance in the operation of these programs, we could be subject to damages, fines, penalties, or other criminal, civil, or administrative sanctions or enforcement actions.

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For example, on December 31, 2020, CMS published a new rule, effective January 1, 2023, requiring manufacturers to ensure the full value of co-pay assistance is passed on to the patient or these dollars will count toward the Average Manufacturer Price and Best Price calculation of the drug.

On May 21, 2021, PhRMA sued the HHS in the U.S.

District Court for the District of Columbia, to stop the implementation of the rule claiming that the rule contradicts federal law surrounding Medicaid rebates.

On May 17, 2022, the U.S.

District Court for the District of Columbia granted the Pharmaceutical Research and Manufacturers of America's, or PhRMA, motion for summary judgment invalidating the accumulator adjustment rule.

Although a number of these and other proposed measures may require authorization through additional legislation to become effective, and the current U.S.

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We may in the future discover the existence of products that infringe patents that we own or that have been licensed to us.

If we were to initiate legal proceedings against a third party to stop such an infringement, such proceedings could be costly and time

consuming, regardless of the outcome.

If we were to initiate legal proceedings against a third party to stop such an infringement, such proceedings could be costly and time consuming, regardless of the outcome.

No assurances can be given that we would prevail, and it is possible that, during such a proceeding, our patent rights could be held to be invalid, unenforceable or both.

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On January 4, 2022, the district court hearing the case granted Hikma's motion to dismiss.

We intend to appeal the decision of the district court when permitted and also intend to continue to vigorously pursue our ongoing litigation with Health Net, LLC, but cannot predict the outcome or the impact on our business.

On October 13, 2022, the district court granted final judgement on the aspect of the litigation relating to the Company and Hikma.

intends to appeal the decision of the district court now that it is permitted to do so and also intends to continue to vigorously pursue its ongoing litigation with Health Net, but cannot predict the outcome or the impact on its business.

Patent litigation is a time-consuming and costly process.

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In addition to our patent portfolio and strategy, we will also rely upon trade secrets and know-how to help protect our competitive position.

We rely on trade secrets to protect technology in cases when we believe patent protection is not appropriate or

We rely on trade secrets to protect technology in cases when we believe patent protection is not appropriate or obtainable.

However, trade secrets are difficult to protect.

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Such outlook and estimates are based on estimates, assumptions and the judgment of management.

Because of the inherent nature of estimates, including during the uncertainty of the European launch and COVID-19’s impact on our business, we have suspended providing net revenue guidance and there could be significant differences between our estimates and the actual amount of product demand.

Because of the inherent nature of estimates, including during the uncertainty of our European launch and the impact from U.S.

generic competition, we have suspended providing net revenue guidance and there could be significant differences between our estimates and the actual amount of product demand.

If we fail to realize or if we change or update any element of our publicly disclosed financial guidance as we have done in the past or other expectations about our business and initiative change, our stock price could decline in value.

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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 25%, 38%, and 31%, respectively, of gross product sales for the six months ended June 30, 2022, and represented 41%, 33%, and 21%, respectively, of the gross accounts receivable balance as of June 30, 2022.

Customers A, B, and C accounted for 27%, 36%, and 30%, respectively, of gross product sales for the six months ended June 30, 2021, 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 26%, 36%, and 31%, respectively, of gross product sales for the nine months ended September 30, 2022, and represented 41%, 32%, and 22%, respectively, of the gross accounts receivable balance as of September 30, 2022.

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

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 and 2019, we reported net losses of approximately $18.0 million and $22.6 million, and we had an accumulated deficit as of December 31, 2021 of $1.4 billion.

For the three months ended June 30, 2022 and 2021, we reported losses of approximately $70.0 million and income of approximately $7.8 million, respectively, and we had an accumulated deficit as of June 30, 2022 of $1.5 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.

For the three months ended September 30, 2022 and 2021, we reported losses of approximately $5.1 million and $13.2 million, respectively, and we had an accumulated deficit as of September 30, 2022 of $1.5 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.

Additionally, as a result of our significant expenses relating to research and development and to commercialization, we expect to continue to incur significant operating losses for an indefinite period.

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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:

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;

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We currently operate with limited resources.

We believe that our cash and cash equivalents balance of $228.0 million and short-term investment balance of $85.2 million as of June 30, 2022 will be sufficient to fund our projected operations for at least 12 months.

We believe that our cash and cash equivalents balance of $240.5 million and short-term investment balance of $63.2 million as of September 30, 2022 will be sufficient to fund our projected operations for at least 12 months from the issuance date of our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report.

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.

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The effect of any such tax reform is uncertain.

As we continue to expand internationally, we will be subject to varied and complex tax regimes, and the tax laws of one jurisdiction may impact our expansion to or operations in other jurisdictions.

As we continue to expand internationally, we will be subject to varied and complex tax regimes, and the tax laws of one jurisdiction may

impact our expansion to or operations in other jurisdictions.

Additionally, new, changed, modified, or newly interpreted or applied tax laws could increase our partners’

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As we expand the scale of our business activities, any changes in the taxation of such activities may increase our effective tax rate and harm our business, financial condition, and results of operations.

The IRA was enacted into law on August 16, 2022.

Included in the IRA was a provision to implement a 15% corporate alternative minimum tax on corporations whose average annual adjusted financial statement income during the most recently-completed three-year period exceeds $1.0 billion.

This provision is effective for tax years beginning after December 31, 2022.

We are in the process of evaluating the provisions of the IRA.

Risks Related to Ownership of our ADSs and Common Shares

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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 29, 2022, we had 403,205,514 common shares outstanding including 403,021,687 shares held as ADSs and 183,827 held as ordinary shares (which are not held in the form of ADSs).

As of October 21, 2022, we had 403,828,955 common shares outstanding including 383,347,128 shares held as ADSs and 20,481,827 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.

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to obtain 100% control of us.

Accordingly, acceptances of 90% of our outstanding ordinary shares/ADSs will likely be a condition in any takeover offer to acquire us, not 50% as is more common in tender offers for corporations organized under Delaware law.

Accordingly, acceptances of 90% of our

outstanding ordinary shares/ADSs will likely be a condition in any takeover offer to acquire us, not 50% as is more common in tender offers for corporations organized under Delaware law.

By contrast, a scheme of arrangement, the successful completion of which would result in a bidder obtaining 100% control of us, requires the approval of a majority of shareholders voting at the meeting and representing 75% of the ordinary shares voting for approval.

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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

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

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.

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These developments, or the perception that any of them could occur, may have a significant adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global market liquidity and limit the ability of key market participants to operate in certain financial markets.

In particular, it could also lead to a period of considerable uncertainty in relation to the UK financial and banking markets, as well as on the regulatory process in Europe.

In particular, it could also lead to a period of considerable uncertainty

in relation to the UK financial and banking markets, as well as on the regulatory process in Europe.

Asset valuations, currency exchange rates and credit ratings may also be subject to increased market volatility.

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While we may seek additional funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all.

There can be no assurance that we will be able to access equity or credit markets in order to finance our current operations or expand development programs for VASCEPA, or that there will not be deterioration in financial markets and confidence in economies, particularly in light of the continued volatility attributed to COVID-19.

We may also have to scale back or further restructure our operations.

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As a result of these risks, we may not be able to achieve the expected benefits of any such transaction or collaboration or deliver the value thereof to our shareholders.

If we are unsuccessful in consummating any such transaction or collaboration, we may be required to reevaluate our business only after we have incurred substantial expenses and devoted significant management time and resources.

If we are unsuccessful in consummating any such transaction or collaboration, we may be

required to reevaluate our business only after we have incurred substantial expenses and devoted significant management time and resources.

*We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, including in Europe, and record inflation.

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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