What changed in this filing

/stocks — the workspaceLOADING

Item 1. Legal Proceedings

2024-05-01 compared with 2023-11-01 · 251 added, 431 removed, 820 unchanged (45% of the section changed)

1 unchanged sentence

In the ordinary course of business, we are from time to time involved in lawsuits, claims, investigations, proceedings, and threats of litigation relating to intellectual property, commercial arrangements and other matters.

Information regarding reportable legal proceedings is contained in “Item 3.

Legal Proceedings”

of our Annual Report.

Refer to Note 5 –

Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three and nine months ended September 30, 2023, and updates any descriptions of previously reported legal proceedings in which there have been material developments during such period.

The discussion of legal proceedings included within Note 5 –

Commitments and Contingencies is incorporated into this Item 1 by reference.

Information regarding reportable legal proceedings is contained in “Item 3.

Legal Proceedings” of our Annual Report.

Refer to Note 5 – Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three months ended March 31, 2024, and updates to any descriptions of previously reported legal proceedings in which there have been material developments during such period.

The discussion of legal proceedings included within Note 5 – Commitments and Contingencies is incorporated into this Item 1 by reference.

Ri sk Factors

1 unchanged sentence

Because our actual results may differ materially from any forward-looking statements that we make or that are made on our behalf, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our ability to successfully commercialize VASCEPA and VAZKEPA, collectively referred to as VASCEPA, our capital resources, the progress and timing of our clinical programs, the safety and efficacy of our product candidates, risks associated with regulatory filings, the potential clinical benefits and market potential of our product candidates, commercial market estimates, future development efforts, patent protection, effects of healthcare reform, reliance on third parties effects of tax reform, and other risks set forth below.

Except where denoted with an “*”, these risk factors have not been materially updated from our Annual Report on 10-K for the year ended December 31, 2022 filed with the SEC on March 1, 2023, or our Annual Report.

Except where denoted with an “*”, these risk factors have not been materially updated from our Annual Report on 10-K for the fiscal year ended December 31, 2023 filed with the SEC on February 29, 2024, or our Annual Report.

Summary Risk Factors

2 unchanged sentences

• we are substantially dependent upon VASCEPA ® (icosapent ethyl), its commercialization in the United States and its development, launch and commercialization in Europe and other major markets;

In the United States, we face increasing competition from generic drug companies in the near term and our revenues and results could continue to be materially and adversely affected.

In Europe, we are seeking 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.

The commercial value of VASCEPA outside the United States may be smaller than we anticipate, including if we are unable to secure favorable product pricing and reimbursement levels, which vary from country to country.

• in the United States, we compete with and may face increasing competition from generic drug companies and our revenues and results could continue to be materially and adversely affected;

• we are seeking 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 major markets outside the United States;

• the commercial value of VASCEPA outside the United States may be smaller than we anticipate, particularly if we are unable to secure favorable product pricing and reimbursement levels, which vary from country to country.

If we are unable to realize product reimbursement rates at reasonable price levels, or at all, patient access to VASCEPA may be limited;

• 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 achieve commercial success;

Our recently announced Organizational Restructuring Program, or ORP, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S.

• our Organizational Restructuring Program, or ORP, effected in July 2023 and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S.

business and establishing a more significant international footprint;

• the manufacture, supply and commercialization, including promotional activities, of VASCEPA is subject to regulatory scrutiny;

We may not be able to compete effectively against our competitors’

pharmaceutical products, including generic products.

• we may not be able to compete effectively against our competitors’ pharmaceutical products, including generic products.

In addition, we face competition from omega-3 fatty acids that are marketed by other companies as non-prescription dietary supplements, subjecting us to non-prescription competition and consumer substitution;

• our supply of product for the commercial market and clinical trials is dependent upon relationships with third-party manufacturers and suppliers, including manufacturers and suppliers who may require us to comply with burdensome minimum purchase commitments, which may be greater than our supply needs;

Our dependence on third parties in the distribution channel from our manufacturers to patients subjects us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments.

• our dependence on third parties in the distribution channel from our manufacturers to patients subject us to risks that limit our profitability and could limit our ability to supply VASCEPA to large market segments;

• we have limited experience commercializing VASCEPA outside the United States, and we may not be successful in building an infrastructure, including a sales force, that can navigate the regulatory and other dynamics outside of the United States.

4 unchanged sentences

There can be no assurance that any of these applications will issue patents, and even if patent protection is obtained, it may be insufficient to minimize competition or support our commercialization efforts;

If we are no longer able to meet the listing requirements of the NASDAQ Global Market, our stock may be delisted.

• our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program (which is subject to shareholder and UK court approval), may not be implemented in a timely manner or at all, or may not have the expected results;

• if we are no longer able to meet the listing requirements of the NASDAQ Stock Market, our stock may be delisted.

The summary risk factors described above should be read together with the text of the full risk factors below and in the other information set forth in our Annual Report and this Quarterly Report on Form 10-Q, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC.

7 unchanged sentences

Our financial condition and the success of our company will be materially adversely affected, we may have to further restructure our current operations, and our business prospects will be limited, if we experience any negative developments relating to VASCEPA.

For example, in the first quarter of 2020, the U.S.

In the first quarter of 2020, the U.S.

District Court for the District of Nevada issued a ruling in favor of two generic drug companies, Dr.

5 unchanged sentences

Although we are exploring ways to broaden our development and commercial pipeline, such efforts are likely to be time consuming, costly and may utilize resources that could otherwise be focused on commercializing VASCEPA.

It took over a decade of preceding product development before we received marketing approval for VAZKEPA in March 2021 from the European Commission, or the EC.

It took over a decade of product development before we received marketing approval for VAZKEPA in March 2021 from the European Commission, or 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 may be initially disruptive to operations.

3 unchanged sentences

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

*In the United States, we face increasing competition from generic drug companies in the near term and our revenues and results of operations could continue to be materially and adversely affected.

In the United States, we compete with and may face increasing competition from generic drug companies and our revenues and results of operations could continue to be materially and adversely affected.

Following the ANDA litigation rulings against the Company, generic versions of VASCEPA began launching in the United States in November 2020, and several generic versions are currently available, including for both the 0.5-gram and 1-gram capsules, and we expect that VASCEPA could face more competition from generic companies in the United States.

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.

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.

Generally, once a generic version of a drug is available in the market, the generic version is typically used by pharmacies across the U.S.

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

to fill prescriptions for any use of the drug, subject to state substitution laws.

Although, we intend to vigorously defend our intellectual property rights related to VASCEPA, 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 the U.S.

1 unchanged sentence

Given the changing dynamic in the U.S.

market, in 2022 we initiated cost and organizational restructuring plans which reduced our U.S.

commercial team from approximately 300 sales representatives to approximately 75 sales representatives by the end of 2022, and in July 2023 all remaining sales force positions in the U.S.

were eliminated and our overall headcount was reduced by 30% as part of our Organizational Restructuring Program, or ORP.

market at the time, we initiated cost and organizational restructuring plans which resulted in eliminating our U.S.

sales force, while maintaining our managed care and trade organization to support our U.S.

commercial efforts, and our overall headcount was reduced by 30% as part of our ORP.

Although these initiatives are expected to 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 of the cost savings or other benefits we anticipate, and are costly to implement.

Furthermore, such efforts may reduce our ability to expand use of VASCEPA.

In Europe, we are seeking 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.

We continue our development efforts to support commercialization of VASCEPA in major markets outside the United States, particularly in light of the level of competition, including from generic products, in the United States, and as part of our ORP, we intend to redesign our commercial infrastructure in Europe and work on generating revenues in other international markets as well.

This process is conducted on a country-by-country basis and is time consuming and complex, and, even though the EC approved the marketing authorization for VAZKEPA in March 2021, and we have received positive national pricing and reimbursement decisions in certain countries, including, England and Wales, Spain, Sweden and Finland, there is no guarantee that we will be able to negotiate and obtain further reimbursement and pricing terms on favorable terms, or at all, in the other countries where we are pursuing commercialization.

We are seeking 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 major markets outside the United States.

We continue our development efforts to support commercialization of VASCEPA in major markets outside the United States, particularly in light of the level of competition, including from generic products, in the United States, and as part of our ORP, we redesigned our commercial infrastructure in Europe.

This process is conducted on a country-by-country basis and is time consuming and complex, and, even though the EC approved the marketing authorization for VAZKEPA in March 2021, and we have received positive national pricing and reimbursement decisions in various countries, there is no guarantee that we will be able to negotiate and obtain further reimbursement and pricing terms on favorable terms, or at all, in the other countries where we are pursuing commercialization.

Further, successful progress or pricing terms in one country may not be indicative of our outcomes in other jurisdictions.

For example, although the UK’s National Institute for Health and Care Excellence, or NICE, announced final guidance for reimbursement for VAZKEPA® and use across the National Health Service, or NHS, in England and Wales, we decided to discontinue 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.

The Arbitration Board process concluded without an agreement in November 2022 and although we plan to resubmit a pricing and reimbursement dossier with new data in Germany, we may be unable to resume commercial operations in Germany.

5 unchanged sentences

However, we cannot make any guarantees as to the success of these efforts or that our beliefs about the value potential are accurate, or that we will be able to rely upon these third parties;

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.

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

The commercial value of VASCEPA outside the United States may be smaller than we anticipate, particularly if we are unable to secure favorable product pricing and reimbursement levels, which vary from country to country.

If we are unable to realize product reimbursement rates at reasonable price levels, or at all, patient access to VASCEPA may be limited.

There can be no assurance as to the market for VASCEPA outside the United States, and we may face challenges in successfully achieving market opportunities available to us.

Despite having received EC approval to commercialize VAZKEPA in Europe and approval elsewhere around the world, applicable regulatory agencies may impose restrictions on the product’s conditions for use, distribution or marketing, and in some cases may impose ongoing requirements for post-market surveillance, post-approval studies or clinical trials, any of which could limit the market opportunity, or our ability to capitalize on such opportunity, for VASCEPA.

Further, securing adequate reimbursement is critical for commercial success of any therapeutic, and pricing and reimbursement levels of medications in markets outside the United States can be unpredictable and vary considerably on a country-by-country basis.

4 unchanged sentences

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

In November 2022, the Arbitration Board process concluded without an agreement.

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

In November 2022, the Arbitration Board process concluded without an agreement and although we plan to resubmit a pricing and reimbursement dossier with new data in Germany, we may be unable to resume commercial operations in Germany.

Further, in countries outside the U.S., 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.

3 unchanged sentences

If the pricing and reimbursement levels of VASCEPA are lower than we anticipate, then affordability of, and market access to, VASCEPA may be adversely affected and thus market potential in these territories would suffer.

We, or our partners, may even choose to not proceed with marketing VASCEPA in a market, even after obtaining all necessary regulatory approval, due to negative commercial dynamics.

We, or our partners, may choose to not proceed with marketing VASCEPA in a market, even after obtaining all necessary regulatory approval, due to negative commercial dynamics.

Further, with regard to any indications for which we may gain approval in territories outside the United States, the number of actual patients with the condition included in such approved indication may be smaller than we anticipate.

12 unchanged sentences

• our inability to adequately train our sales and marketing personnel and our inability to adequately monitor compliance with applicable regulatory and other legal requirements;

the inability to obtain access to or persuade adequate numbers of physicians to prescribe or patients to use VASCEPA, particularly in light of our elimination of all U.S.

sales force positions in July 2023 as part of our ORP;

• the inability to obtain access to or persuade adequate numbers of physicians to prescribe or patients to use VASCEPA;

• overestimating the addressable market for VASCEPA;

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;

• 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;

• complexities and challenges in connection with pricing and reimbursement, including our ability to secure adequate reimbursement coverage, which in Europe is almost exclusively covered through public national funding, and not individual private insurance companies;

2 unchanged sentences

• unforeseen costs and expenses associated with operating a new independent sales and marketing organization outside of the United States.

any lingering or resumed impact from COVID-19 on healthcare providers, patients and personnel.

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.

5 unchanged sentences

These pressures are intensified where our products are subject to competition, including from generics.

Refer to “

Business - Government Regulation –

Pharmaceutical Pricing and Reimbursement ”

in our Annual Report on Form 10-K for the year ended December 31, 2022 for further details.

Refer to “ Item 1.

Business - Government Regulation – Pharmaceutical Pricing and Reimbursement ” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 for further details.

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

11 unchanged sentences

Outside of the United States, we expect countries will continue to take actions to reduce their drug expenditures.

International reference pricing, or IRP, has been widely used by many countries outside the United States to control costs based on an external benchmark of a product’s price in other countries.

IRP policies can change quickly and frequently and may not reflect differences in the burden of disease, indications, market structures, or affordability differences across countries or regions.

7 unchanged sentences

Factors outside of our control may make it more difficult for VASCEPA to achieve market acceptance by physicians, patients, healthcare payors and others in the medical community at levels sufficient to achieve commercial success.

In January 2013, we launched VASCEPA based on the U.S.

FDA approval of our MARINE indication, for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (TG ³

500 mg/dL) hypertriglyceridemia.

Guidelines for the management of very high triglyceride levels suggest that the primary goal of reducing triglyceride levels in this patient population is reduction in the risk of acute pancreatitis.

A secondary goal for this patient population is to reduce CV risk.

The effect of VASCEPA on the risk for

pancreatitis in patients with severe hypertriglyceridemia has not been determined and our U.S.

FDA-approved labeling and promotional efforts state this fact.

In December 2019, the U.S.

FDA approved another indication and label expansion for VASCEPA as an adjunct to statin therapy to reduce the risk of MACE events in adult patients with elevated TG levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease, or our REDUCE-IT indication.

FDA approval for this indication and expanded label for VASCEPA, we may not meet expectations for market acceptance by physicians, patients, healthcare payors and others in the medical community for this approved use, especially in light of generic competition.

If VASCEPA does not achieve an adequate level of acceptance, we may not generate product revenues sufficient to become profitable, or, even if we do achieve profitability, we may not be able to generate consistent profitability.

The degree of market acceptance of VASCEPA for its approved indications and uses or otherwise will depend on a number of factors, including:

We may be unable to increase or maintain market acceptance by physicians, patients, healthcare payors and others in the medical community, especially in light of generic competition.

If VASCEPA does not achieve an adequate level of acceptance, we

may not generate product revenues sufficient to become profitable, or, even if we do achieve profitability, we may not be able to generate consistent profitability.

The degree of market acceptance of VASCEPA will depend on a number of factors, including:

• the impact of and outcome of adjudicated, settled and pending patent litigation;

14 unchanged sentences

• 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;

the actual and perceived efficacy of the product and the prevalence and severity of any side effects and warnings in VASCEPA’s approved labeling internationally.

• the actual and perceived efficacy of the product and the prevalence and severity of any side effects and warnings in VASCEPA’s approved labeling internationally.

Any one or more of the above factors could have a negative impact on our ability to successfully commercialize VASCEPA, which would in turn have a negative impact on our financial condition.

Additional data or related interpretations that are generated or arise over time related to REDUCE-IT might not meet expectations, and the perception of REDUCE-IT results and VASCEPA revenue potential may suffer and our stock price may decline.

While the U.S.

FDA approved the expanded label for VASCEPA for the REDUCE-IT indication in 2019, additional data assessment by international regulatory authorities or otherwise could yield additional information to inform greater understanding of study outcome, which information could impact the perception of VASCEPA.

Additional data assessment by international regulatory authorities or otherwise could yield additional information to inform greater understanding of study outcome, which information could impact the perception of VASCEPA.

Such data or interpretations may not be favorable for us.

4 unchanged sentences

It is possible the scope of subsequent regulatory approvals, if any, could likewise differ based on the same data.

interpretations of data, or new data, could impact public and medical community perception of the totality of the efficacy and safety data from REDUCE-IT.

Conflicting interpretations of data, or new data, could impact public and medical community perception of the totality of the efficacy and safety data from REDUCE-IT.

Regulatory authorities and medical guideline committees outside of the United States and Europe may consider the following additional factors, which could lead to evaluations of the totality of the efficacy and safety data from REDUCE-IT that differ from those of the U.S.

10 unchanged sentences

FDA or the EC, the U.S.

FDA or the EC could re-evaluate its conclusions as to the safety and efficacy of VASCEPA.

FDA or the EC could reevaluate its conclusions as to the safety and efficacy of VASCEPA.

Likewise, if additional data or analyses released from time to time do not meet expectations, the perception of REDUCE-IT results and the perceived and actual value of VASCEPA may suffer.

In these instances our revenue and business could suffer and our stock price could significantly decline.

Ongoing clinical trials or new clinical data involving VASCEPA and similar moderate-to-high doses of eicosapentaenoic acid or icosapent ethyl could adversely impact public perception of VASCEPA’s clinical profile and the commercial and regulatory prospects of VASCEPA.

Ongoing trials of moderate-to-high doses of VASCEPA and icosapent ethyl, or a similar eicosapentaenoic acid product, could render new or adverse information on the effects of VASCEPA and its commercial and regulatory prospects.

For example, the Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy–Statin and EPA (RESPECT-EPA;

Any new clinical data or analysis of existing data from clinical trials involving VASCEPA and similar moderate-to-high doses of eicosapentaenoic acid or icosapent ethyl could adversely impact public perception of VASCEPA’s clinical profile and the commercial and regulatory prospects of VASCEPA.

Analysis of data from trials of moderate-to-high doses of VASCEPA and icosapent ethyl, or a similar eicosapentaenoic acid product, could render new or adverse information on the effects of VASCEPA and its commercial and regulatory prospects.

The Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy–Statin and EPA (RESPECT-EPA;

UMIN Clinical Trials Registry number, UMIN000012069) is a study examining Japanese patients with chronic coronary artery disease receiving LDL-C lowering treatment by statin therapy.

1 unchanged sentence

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.

China’s National Medical Products Administration, or NMPA, approved VASCEPA as an adjunct to diet to reduce the levels of triglyceride in adult patients suffering from severe hypertriglyceridemia (≥500mg/dL) and Edding is now working towards securing National Reimbursement Drug Listing for VASCEPA in Mainland China under the REDUCE-IT indication.

Even though such results from these trials were positive, additional clinical development efforts may be necessary in these markets to demonstrate the effectiveness of VASCEPA, which may be costly to pursue, or may not produce the desired or expected results.

If the outcomes of any study involving VASCEPA and icosapent ethyl is unfavorable, 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, or perceptions about the potential for VASCEPA, including as a treatment for broader indications, may suffer.

China’s National Medical Products Administration, or NMPA, approved VASCEPA as an adjunct to diet to reduce the levels of triglyceride in adult patients suffering from severe hypertriglyceridemia (≥500mg/dL) and in October 2023 Edding submitted a regulatory filing to the NMPA which, if approved, would secure National Reimbursement Drug Listing for VASCEPA in Mainland China under the REDUCE-IT indication.

Even though the results from these trials were positive, additional clinical development efforts may be necessary in these markets to demonstrate the effectiveness of VASCEPA, which may be costly to pursue, or may not produce the desired or expected results.

If the outcomes of any new studies involving VASCEPA and icosapent ethyl, or further analysis of existing trial data, is unfavorable, 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, or perceptions about the potential for VASCEPA, including as a treatment for broader indications, may suffer.

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

*Our recently announced organizational restructuring programs and cost reduction plans, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S.

Our ORP effected in July 2023, and any similar efforts we may undertake in the future, may not be successful in mitigating risks and challenges associated with our U.S.

business and establishing a more significant international footprint.

If we are not successful in our efforts to continue to market and sell VASCEPA in the United States, including following our recently announced ORP that eliminated all remaining sales force positions in the United States, with the managed care and trade organization remaining to support U.S.

commercial efforts, and approximately 30% of non-sales positions, our anticipated revenues or

our expenses could be materially adversely affected, and we may not maintain profitability in the United States or obtain profitability internationally.

If we are not successful in our efforts to continue to market and sell VASCEPA in the United States, including following our ORP announced in July 2023 which eliminated all remaining sales force positions in the United States, with the managed care and trade organization remaining to support U.S.

commercial efforts, and approximately 30% of non-sales positions, our anticipated revenues or our expenses could be materially adversely affected, and we may not maintain profitability in the United States or obtain profitability internationally.

Further, we may need to cut back on research and development activities or we may need to 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 promotional initiatives have had to adjust over the last several years, given the impact of COVID-19 and international instability, which efforts have been costly and require considerable resources.

Shifts from traditional face-to-face interactions to mostly virtual outreach, specifically, access to healthcare professionals through digital or other channels, were not as productive as in-person interactions in promoting use of VASCEPA and prior to the recently announced ORP, we had been pursuing increased face-to-face interactions with targeted health care professionals as protocols have eased and travel has resumed to pre-pandemic levels.

The manufacture, supply and commercialization, including promotional activities, of VASCEPA is subject to regulatory scrutiny.

3 unchanged sentences

FDA-approved products for uses that have not been approved by the U.S.

Companies that market drugs for off-label uses or indications have been subject to related costly litigation, criminal penalties and civil liability under the FDCA and the FCA.

Companies that market drugs for off-label uses or indications have been subject to related costly litigation, criminal penalties and civil liability under the FDCA and the False Claims Act, or FCA.

However, case law over the last several years has called into question the extent to which the U.S.

3 unchanged sentences

As a result of a lawsuit that we and a group of independent physicians filed against the U.S.

FDA in 2015, we were granted preliminary relief through the court’s declaratory judgment that confirmed we may engage in truthful and non-misleading speech promoting the off-label use of VASCEPA to healthcare professionals, i.e., to treat patients with persistently high triglycerides, and that such speech may not form the basis of a misbranding action under the FDCA.

FDA did not appeal the court’s ruling and ultimately settled this litigation under terms by which the U.S.

FDA and the U.S.

government agreed to be bound by the conclusions from the federal court order that we may engage in truthful and non-misleading speech promoting the off-label use of VASCEPA and that certain statements and disclosures that we proposed to make to healthcare professionals were truthful and non-misleading.

As part of the settlement, given, as expressed in the court’s opinion, that the dynamic nature of science and medicine is that knowledge is ever-advancing and that a statement that is fair and balanced one day may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired, we agreed that we bear the responsibility to ensure that our communications regarding off-label use of VASCEPA remain truthful and non-misleading, consistent with the federal court ruling.

While we believe we are now permitted under applicable law to more broadly promote VASCEPA, the U.S.

FDA-approved labeling for VASCEPA did not change as a result of this litigation and settlement, and neither government nor other third-party coverage or reimbursement to pay for the off-label use of VASCEPA promoted under the court declaration was required.

Promotional activities in the biotechnology and pharmaceutical industries generally are subject to considerable regulatory scrutiny and, may be subject to enhanced scrutiny to ensure that our promotion remains within the scope covered by the settlement.

Promotional activities in the biotechnology and pharmaceutical industries generally are subject to considerable regulatory scrutiny.

For example, we were recently the subject of two civil investigative demands, or CIDs, from the U.S.

Federal Trade Commission and a subpoena from the New York Attorney General, or the Investigations.

Although we are cooperating with the government and completed document production in mid-2023, we cannot predict when these investigations will be resolved, the outcome of the Investigations or their potential impact on our business.

In addition, we may be subject to enhanced scrutiny to ensure that our promotion remains within the scope covered by the settlement.

Under the settlement, we remain responsible for ensuring our speech is truthful and non-misleading, which is subject to a considerable amount of judgment.

2 unchanged sentences

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.

In June 2020, we received a civil investigative demand, or CID, from the U.S.

Department of Justice, or the DOJ, informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program during the period from January 1, 2015 to the present violated the U.S.

Anti-Kickback Statute and the U.S.

Civil False Claims Act, or the FCA, in relation to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa Pharmaceuticals America, Inc., or Kowa America.

Similarly, in March 2021, the United States Federal Trade Commission, or the FTC, issued a CID to us in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA.

The New York State attorney general similarly issued a subpoena to us regarding the same subject matter on which the FTC CID is focused.

The inquiries require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods.

Although 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.

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

If the government determines that we have violated the U.S.

Anti-Kickback Statute, the FCA or antitrust regulations, we could be subject to significant civil and criminal fines and penalties.

If our promotional activities or other operations are found to be in violation of any law or governmental regulation through existing or new interpretations, we may be subject to prolonged litigation, penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations.

If our promotional activities or other operations are found to be in violation of any law or governmental regulation through existing or new interpretations or as a result of the findings of the Investigations, we may be subject to prolonged litigation, penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations.

Also, if governmental parties or our competitors view our claims as misleading or false, we could be subject to liability based on fair competition-based statutes, such as the Lanham Act.

Any allegations that our promotional activities are not truthful or misleading, even allegations without merit, could cause reputational harm and adversely affect our ability to operate our business and our results of operations.

We may not be able to compete effectively against our competitors’

pharmaceutical product, including generic products.

We may not be able to compete effectively against our competitors’ pharmaceutical products, including generic products.

8 unchanged sentences

by companies such as Hikma, Dr.

Reddy's, Apotex and Teva all of which have greater resources than us, and with the potential for further generic versions being launched possibly in the near term, 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.

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.

We also face considerable competition in the United States from branded products and generic versions of competing branded products and formulations, including Lovaza ® , Tricor, ® Trilipix ® and Niaspan ® , all of which have multiple generic competing versions.

2 unchanged sentences

FDA approval to reduce CV risk on top of statin therapy.

For a more detailed discussion of our competitors, and potential competing drugs in development, in the United States and the rest of the world, see our discussion in " Item 1.

Business - Competition" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Further, drugs in development that are expected to compete with VASCEPA if they are ultimately approved and commercialized, and the perceived safety and efficacy of such commercialized drugs or drug products, could have a negative impact on the perceived safety and efficacy of VASCEPA.

1 unchanged sentence

FDA, including communications in connection with its review of the ANCHOR indication for VASCEPA, it is our understanding that the U.S.

FDA is not prepared to approve any therapy for treatment of CV risk based on biomarker modification without cardiovascular outcomes study data, with the potential exception of therapies which lower LDL-cholesterol, depending on the circumstances.

In particular, it is our understanding that the U.S.

9 unchanged sentences

FDA-approved, prescription-only status, and EPA-only purity and stability of VASCEPA or U.S.

FDA’s stringent regulatory oversight, as significant advantages versus omega-3 dietary supplements regardless of clinical study results and other scientific data.

Consistent with the competitive landscape in the United States, our competitors outside of the United States include large, well-established and experienced pharmaceutical companies, specialty and generic pharmaceutical companies, marketing companies, and specialized cardiovascular treatment companies and we have limited experience as a company self-commercializing a product outside of the United States.

3 unchanged sentences

As generic competitors seek to compete with VASCEPA in the United States and elsewhere, we could face additional challenges to our patents and additional patent litigation.

The FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, or the Hatch-Waxman Amendments, permits the U.S.

FDA to approve ANDAs for generic versions of brand name drugs like VASCEPA.

We refer to the process of generic drug applications as the ANDA process.

The ANDA process permits competitor companies to obtain marketing approval for a drug product with the same active ingredient, dosage form, strength, route of administration, and labeling as the approved brand name drug, but without having to conduct and submit clinical studies to establish the safety and efficacy of the proposed generic product.

In place of such clinical studies, an ANDA applicant needs to submit data demonstrating that its product is bioequivalent to the brand name product, usually based on pharmacokinetic studies.

As an alternate path to U.S.

FDA approval for modifications of products previously approved by the U.S.

FDA, an applicant may submit a new drug application, or NDA, under Section 505(b)(2) of the FDCA (enacted as part of the Hatch-Waxman Amendments).

This statutory provision permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference from the owner of the data.

The Hatch-Waxman Amendments permit the applicant to rely upon the U.S.

FDA findings of safety and effectiveness of a drug that has obtained U.S.

FDA approval based on preclinical or clinical studies conducted by others.

In addition to relying on U.S.

FDA prior findings of safety and effectiveness for a referenced drug product, the U.S.

FDA may require companies to perform additional preclinical or clinical studies to support approval of the modification to the referenced product.

If an application for a generic version of a branded product or a Section 505(b)(2) application relies on a prior U.S.

FDA finding of safety and effectiveness of a previously-approved product including an alternative strength thereof, the applicant is required to certify to the U.S.

FDA concerning any patents listed for the referenced product in the U.S.

FDA publication called “Approved Drug Products with Therapeutic Equivalence Evaluations,”

otherwise known as the “Orange Book.”

Specifically, the applicant must certify in the application that:

there is no patent information listed for the reference drug;

the listed patent has expired for the reference drug;

the listed patent for the reference drug has not expired, but will expire on a particular date and approval is sought after patent expiration;

the listed patent for the reference drug is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of the product for which the ANDA or 505(b)(2) NDA is submitted.

The Hatch-Waxman Amendments require an applicant for a drug product that relies, in whole or in part, on the U.S.

FDA’s prior approval of VASCEPA, to notify us of its application, a “paragraph IV”

notice, if the applicant is seeking to market its product prior to the expiration of the patents that both claim VASCEPA and are listed in the Orange Book.

A bona fide paragraph IV notice may not be given under the Hatch-Waxman Amendments until after the generic company receives from the U.S.

FDA an acknowledgement letter stating that its ANDA is sufficiently complete to permit a substantive review.

The paragraph IV notice is required to contain a detailed factual and legal statement explaining the basis for the applicant’s opinion that the proposed product does not infringe our patents, that the relevant patents are invalid, or both.

After receipt of a valid notice, the branded product manufacturer has the option of bringing a patent infringement suit in federal district court against any generic company seeking approval for its product within 45 days from the date of receipt of each notice.

If such a suit is commenced within this 45-day period, the Hatch-Waxman Amendments provide for a 30-month stay on U.S.

FDA’s ability to give final approval to the proposed generic product, which period begins on the date the paragraph IV notice is received.

Generally, during a period of time in which generic applications may be submitted for a branded product based on a product’s regulatory exclusivity status, if no patents are listed in the Orange Book before the date on which a complete ANDA application for a product (excluding an amendment or supplement to the application) is submitted, an ANDA application could be approved by U.S.

FDA without regard to a stay.

For products entitled to five-year exclusivity status, the Hatch-Waxman Amendments provide that an ANDA application may be submitted after four years following U.S.

FDA approval of the branded product if it contains a certification of patent invalidity or non-infringement to a patent listed in the Orange Book.

In such a case, the 30-month stay runs from the end of the five-year exclusivity period.

Statutory stays may be shortened or lengthened if either party fails to cooperate in the litigation and it may be terminated if the court decides the case in less than 30 months.

If the litigation is resolved in favor of the ANDA applicant before the expiration of the 30-month period, the stay will be immediately lifted and the U.S.

FDA’s review of the application may be completed.

Such litigation is often time-consuming and costly and may result in generic competition if such patents are not upheld or if the generic competitor is found not to infringe such patents.

In addition to the ANDA patent litigation described above, we could face patent litigation related to the patents filed in the Orange Book related to the REDUCE-IT study.

A three-year period of exclusivity under the Hatch-Waxman Amendments is generally granted for a drug product that contains an active moiety that has been previously approved, such as when the application contains reports of new clinical investigations (other than bioavailability studies) conducted by the sponsor that were essential to approval of the application.

Accordingly, we received three-year exclusivity in connection with the approval of our sNDA for REDUCE-IT study

Such three-year exclusivity protection precluded the U.S.

FDA from approving a marketing application for an ANDA, a product candidate that the U.S.

FDA views as having the same conditions of approval as VASCEPA (for example, the same indication and/or other conditions of use), or a 505(b)(2) NDA submitted to the U.S.

FDA with VASCEPA as the reference product until such protection expired on December 13, 2022, three years from the date of U.S.

FDA approval of the REDUCE-IT sNDA.

We could face patent litigation related to the patents filed in the Orange Book related to the REDUCE-IT study, particularly given that the three-year period of exclusivity under the Hatch-Waxman Amendments expired on December 13, 2022, which exclusivity would have precluded the U.S.

FDA from approving a marketing application for an ANDA for a product candidate that the U.S.

FDA viewed as having the same conditions of approval as VASCEPA.

We may also face challenges to the validity of our patents through a procedure known as inter partes review.

3 unchanged sentences

We cannot predict the outcome of the pending lawsuits, any appeals, or any subsequently filed lawsuits or inter partes review.

Generally, if an ANDA filer meets the approval requirements for a generic version of VASCEPA to the satisfaction of the U.S.

FDA under its ANDA, U.S.

FDA may grant tentative approval to the ANDA during a Hatch-Waxman 30-month stay period and during the Hatch-Waxman 36-month regulatory exclusivity period.

A tentative approval is issued to an ANDA applicant when its application is approvable prior to the expiration of any exclusivities applicable to the branded, reference listed drug product.

A tentative approval does not allow the applicant to market the generic drug product and postpones the final ANDA approval until applicable exclusivity protections have expired.

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 Hikma, Dr.

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 Hikma, Dr.

Reddy's, Apotex and Teva have done.

14 unchanged sentences

The active pharmaceutical ingredient in VASCEPA is difficult and time consuming to manufacture, and 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 active pharmaceutical ingredient, or API, with our third-party supplier, and to otherwise build our supply chain, improve our technical knowhow, establish manufacturing processes and obtain related regulatory approvals to help enable our suppliers to supply our clinical and commercial needs globally.

We have invested over a decade of resources and expenses to develop this active pharmaceutical ingredient, or API, with our third-party suppliers, and to otherwise build our supply chain, improve our technical knowhow, establish manufacturing processes and obtain related regulatory approvals to help enable our suppliers to meet our clinical and commercial needs globally.

Despite such efforts, the stability of the supply chain is largely out of our control and is subject to market and supply volatility and the actions of third parties.

1 unchanged sentence

In April 2021, Dr.

Reddy’s filed a complaint against us in the United States District Court District of New Jersey (case no.

2:21-cv-10309) alleging various antitrust violations stemming from alleged anticompetitive practices related to the supply of API of VASCEPA.

Damages sought include recovery for alleged economic harm to Dr.

Reddy’s, payors, and consumers, treble damages and other costs and fees.

Injunctive relief against the alleged violative activities is also being sought by Dr.

Reddy’s.

Consumer group lawsuits followed claiming similar violations and alleging that such alleged violations resulted in higher prices to consumers.

addition, in February 2023, Hikma filed a complaint against us in the United States District Court District of New Jersey (case no.

3:23-cv-01016) making allegations consistent with the Dr.

In addition, in February 2023 and March 28, 2024, Hikma and Teva respectively, filed complaints against us in the United States District Court District of New Jersey (case nos.

23-cv-01016 and 24-cv-04341, respectively) making allegations consistent with the Dr.

Reddy's complaint.

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

In addition, as noted above, we have also received a CID from the U.S.

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

The government inquiries require us to produce documents and answer related questions relevant to specified time periods.

We are cooperating with the agencies.

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.

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

VASCEPA is a prescription-only omega-3 fatty acid product.

5 unchanged sentences

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.

In addition, the U.S.

FDA has not yet enforced to the full extent of its regulatory authority what we view as illegal claims made by certain omega-3 fatty acid product manufacturers to the extent we believe appropriate under applicable law and regulations, for example, claims that certain of such chemically-altered products are dietary supplements and that certain of such products reduce triglyceride levels or could reduce CV risk.

FDA approval, pharmaceutical grade purity and proven efficacy and safety of VASCEPA as having a superior therapeutic profile to omega-3 fatty acid dietary supplements, which are subject to less stringent regulatory oversight.

Also, for over a decade, subject to certain limitations, the U.S.

4 unchanged sentences

In addition, the net price of VASCEPA to patients even after insurance reimbursement and offered discounts could be 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.

Physicians and pharmacists may recommend these dietary supplement 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.

VASCEPA pricing might not be sufficient for healthcare providers or patients to elect VASCEPA over alternative treatments that may be perceived as less expense or more convenient to access.

If healthcare providers or patients favor dietary supplements over prescribing VASCEPA, we may be constrained in how we price our product or VASCEPA’s market acceptance may be less than expected, which would have a negative impact on our revenues and results of operations.

If healthcare providers or patients favor dietary supplements over prescribing VASCEPA, we may be constrained in how we price VASCEPA or VASCEPA’s market acceptance may be less than expected, which would have a negative impact on our revenues and results of operations.

Our products and marketing efforts are subject to extensive post-approval government regulation.

14 unchanged sentences

FDA inspection and must continue to adhere to the U.S.

FDA’s pharmaceutical current good manufacturing practice requirements, or cGMPs.

Application holders must obtain U.S.

2 unchanged sentences

FDA and state agencies for compliance with cGMP requirements.

In addition, under the Food and Drug Omnibus Reform Act of 2022, or FDORA, sponsors of approved drugs and biologics must provide six months’

notice to the FDA of any changes in marketing status, such as the withdrawal of a drug, and failure to do so could result in the FDA placing the product on a list of discontinued products, which would revoke the product’s ability to be marketed.

For certain commercial prescription drug products, manufacturers and other parties involved in the supply chain must also meet chain of distribution requirements and build electronic, interoperable systems for product tracking and tracing and for notifying the U.S.

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

In addition, under the Food and Drug Omnibus Reform Act of 2022, or FDORA, sponsors of approved drugs and biologics must provide six months’ notice to the U.S.

FDA of any changes in marketing status, such as the withdrawal of a drug, and failure to do so could result in the U.S.

FDA placing the product on a list of discontinued products, which would revoke the product’s ability to be marketed.

We participate in the U.S.

6 unchanged sentences

Depending on the circumstances, failure to meet post-approval requirements can result in criminal prosecution, fines or other penalties, injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, or refusal to allow us to enter into supply contracts, including government contracts.

We may also be held responsible for the non-compliance of our partners, such as our former co-promotion partner Kowa America.

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.

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

The New York State attorney general similarly issued a subpoena to us regarding the same subject matter on which the FTC CID is focused.

The inquiries require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods.

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

If the government determines that we have violated the U.S.

Anti-Kickback Statute, the FCA or antitrust regulations, we could be subject to significant civil and criminal fines and penalties, and our reputation may be harmed.

In addition, even if we comply with U.S.

FDA and other requirements, new information regarding the safety or effectiveness of a product could lead the U.S.

FDA to modify or withdraw a product approval.

Newly discovered or developed safety or effectiveness data may require changes to a drug’s approved labeling and marketing, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures.

We may also be held responsible for the non-compliance of our partners, over whom we have limited or no control.

Adverse regulatory action, whether pre- or post-approval, can potentially lead to product liability claims and increase our product liability exposure.

3 unchanged sentences

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.

Legislative or regulatory reform of the healthcare system in the United States and foreign jurisdictions may affect our ability to profitably sell VASCEPA.

The success of our product candidates, if approved, depends on the availability of coverage and adequate reimbursement from third-party payors.

We cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we may develop.

Our ability to commercialize VASCEPA or any future products successfully, alone or with collaborators, will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers and other third-party payors.

1 unchanged sentence

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.

Refer to “

Business - Government Regulation –

Pharmaceutical Pricing and Reimbursement " in our Annual Report on Form 10-K for the year ended December 31, 2022 for further details.

For example, the Inflation Reduction Act, or IRA, recently was enacted in the United States in an effort to manage certain drug prices, which includes provisions such as a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, the imposition of new manufacturer financial liability on most drugs in Medicare Part D, permitting the U.S.

government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, requiring companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay until January 1, 2032 the implementation of the HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge.

This could have an adverse impact on our future revenues.

Refer to “ Item 1.

Business - Government Regulation – Pharmaceutical Pricing and Reimbursement " in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 for further details.

In addition, it is time-consuming and expensive for us to go through the process of seeking coverage and reimbursement from Medicare and private payors.

Our products may not be considered cost effective, and government and third-party private health insurance coverage and reimbursement may not be available to patients for any of our future products or sufficient to allow us to sell our products on a competitive and profitable basis.

Our results of operations could be adversely affected by ACA and by other healthcare reforms that may be enacted or adopted in the future.

Our results of operations could be adversely affected by the Affordable Care Act, or ACA, and by other healthcare reforms that may be enacted or adopted in the future.

In addition, increasing emphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products.

3 unchanged sentences

If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

We participate in the Medicaid Drug Rebate program, the 340B drug pricing program, and the VA’s FSS pricing program.

Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available to the states for our drugs under Medicaid and Medicare Part D.

6 unchanged sentences

The issuance of the final regulation has increased and will continue to increase our costs and the complexity of compliance, has been and will continue to be time-consuming to implement, and could have a material adverse effect on our results of operations, particularly if CMS challenges the approach we take in our implementation of the final regulation.

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”

for the manufacturer’s covered outpatient drugs.

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.

These 340B covered entities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients.

The 340B ceiling price is calculated using a statutory formula based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program, and in general, products subject to Medicaid price reporting and rebate liability are also subject to the 340B ceiling price calculation and discount requirement.

Any additional future changes to the definition of average manufacturer price and the Medicaid rebate amount under the ACA, other legislation, or in regulation could affect our 340B ceiling price calculations and negatively impact our results of operations.

Any additional future changes to the definition of average manufacturer price and the Medicaid

rebate amount under the ACA, other legislation, or in regulation could affect our 340B ceiling price calculations and negatively impact our results of operations.

The Health Resources and Services Administration, or HRSA, which administers the 340B program, issued a final regulation regarding the calculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge covered entities, which became effective on January 1, 2019.

10 unchanged sentences

We cannot assure you that our submissions will not be found by CMS or HRSA to be incomplete or incorrect.

In order to be eligible to have our products paid for with federal funds under the Medicaid and Medicare Part D programs and purchased by certain federal agencies and grantees, as noted above, we participate in the VA’s FSS pricing program.

As part of this program, we are obligated to make our products available for procurement on an FSS contract under which we must comply with standard government terms and conditions and charge a price that is no higher than the statutory Federal Ceiling Price, or FCP, to four federal agencies (the VA, U.S.

2 unchanged sentences

The FCP is based on the Non-Federal Average Manufacturer Price, or Non-FAMP, which we calculate and report to the VA on a quarterly and annual basis.

Pursuant to applicable law, knowing provision of false information in connection with a Non-FAMP filing can subject a

manufacturer to significant penalties for each item of false information.

Pursuant to applicable law, knowing provision of false information in connection with a Non-FAMP filing can subject a manufacturer to significant penalties for each item of false information.

These obligations also contain extensive disclosure and certification requirements.

16 unchanged sentences

In addition, we may confront limitations in, or exclusions from, insurance coverage for our products, particularly as generic competition intensifies.

If we fail to successfully secure and maintain reimbursement coverage for our approved drugs or are significantly delayed in doing so, we may have difficulty achieving market acceptance of our approved drugs and investigational drug candidates for which we obtain approval, and our business may be harmed.

If we fail to successfully secure and

maintain reimbursement coverage for our approved drugs or are significantly delayed in doing so, we may have difficulty achieving market acceptance of our approved drugs and investigational drug candidates for which we obtain approval, and our business may be harmed.

Congress has enacted healthcare reform and may enact further reform, which could adversely affect the pharmaceutical industry as a whole, and therefore could have a material adverse effect on our business.

7 unchanged sentences

If any such changes were to be imposed, they could adversely affect the operation of our business.

Refer to “

Business - Government Regulation –

United States Healthcare Reform and Legislation " in our Annual Report on Form 10-K for the year ended December 31, 2022 for further details.

Refer to “ Item 1.

Business - Current and Future Legislation" and "Item 1.

Business – United States Healthcare Reform and Legislation " in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 for further details.

There has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.

1 unchanged sentence

Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, and review the relationship between pricing and manufacturer patient programs.

The Inflation Reduction Act of 2022, or IRA, includes several provisions that may impact our business to varying degrees, including provisions that that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby effectively eliminating the coverage gap, impose new manufacturer financial liability on all drugs in Medicare Part D, allow the U.S.

government to negotiate Medicare Part B and Part D pricing for certain high-cost 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 until January 1, 2032 the implementation of the HHS rebate rule that that would have limited the fees that pharmacy benefit managers can charge.

Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition.

If a product receives multiple orphan designations or has multiple approved indications, it may not qualify for the orphan drug exemption.

In August 2023, the government selected the first 10 drugs to be put through the

Medicare drug price negotiation program, which is currently the subject of several constitutional challenges.

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

In addition, President Biden has issued multiple executive orders that have sought to reduce prescription drug costs.

In February 2023, HHS also issued a proposal in response to an October 2022 executive order from President Biden that includes a proposed prescription drug pricing model that will test whether targeted Medicare payment adjustments will sufficiently incentivize manufacturers to complete confirmatory trials for drugs approved through FDA’s accelerated approval pathway.

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.

The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect:

11 unchanged sentences

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 –

other than with respect to providing certain employee benefits –

we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

Although we are not directly subject to HIPAA – other than with respect to providing certain employee benefits – we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.

In addition, state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts.

1 unchanged sentence

and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.

Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.

operating results and business.

Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information.

Claims that we have violated individuals’

privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our operating results and business.

Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our operating results and business.

European data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.

The REDUCE-IT cardiovascular outcomes trial was conducted in part through clinical sites in the EEA.

As a result, we are subject to additional privacy restrictions.

The collection and use of personal health data in the EU and the UK is governed by the provisions of the GDPR, and its UK equivalent, collectively referred to as GDPR.

The GDPR imposes several requirements relating to the legal basis for processing personal data which may include the consent of the individuals to whom the personal data relates, the

information provided to the individuals and the security and confidentiality of the personal data.

The GDPR also imposes strict rules on the transfer of personal data out of the EEA to third countries, including the United States.

A decision by the Court of Justice of the European Union, or CJEU, in 2020 invalidated the EU-U.S.

Privacy Shield Framework, which was one of the primary mechanisms used by U.S.

companies to import personal information from Europe in compliance with the GDPR's cross-border data transfer restrictions, and raised questions about whether the EC's Standard Contractual Clauses, or SCCs, one of the primary alternatives to the Privacy Shield, can lawfully be used for personal information transfers from Europe to the United States or most other countries.

Furthermore, on June 4, 2021, the EC issued new forms of standard contractual clauses for data transfers from controllers or processors in the EEA, or otherwise subject to the GDPR, to controllers or processors established outside the EEA, and not subject to the GDPR.

The new forms of standard contractual clauses have replaced the standard contractual clauses that were adopted previously under the Data Protection Directive.

They require a case-by-case assessment of the law in the recipient country to ensure it provides “essentially equivalent”

protections to safeguard the transferred personal data as the EEA, and require businesses to adopt supplementary measures if such standard is not met.

The new SCCs do not apply to the UK, but the UK Information Commissioner’s Office has published its own transfer mechanism, the International Data Transfer Agreement, or UK IDTA, which entered into force on March 21, 2022, and enables data transfers originating from the UK.

It requires a similar assessment of the data protection provided in the importer’s country.

In July 2023, the European Commission adopted its adequacy decision for the EU-U.S.

Data Privacy Framework, or the Framework, the successor of the EU-U.S.

Privacy Shield framework.

On the basis of the new adequacy decision, personal data can flow from the EU to U.S.

companies participating in the Framework, without having to put in place additional data protection safeguards.

The UK government also established the UK-U.S.

Data Bridge for the UK Extension to the Data Privacy Framework that allows certified US companies to receive UK personal data through the Framework.

However, the validity of the Framework has already been challenged in European courts.

We will be required to transition to the new forms of transfer mechanisms and doing so will require significant effort and cost.

The new transfer mechanisms 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 or the UK GDPR, and the related national data protection laws of the EEA Member States or the UK may result in substantial fines.

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.

We are subject to European data protection regulations, where we collect and use personal data relating to Europe, including in relation to our personnel in the European Economic Area, or the EEA, or in the United Kingdom, or the UK.

This regulatory regime includes the European Union General Data Protection Regulation, or the EU GDPR, and the UK equivalent of the same, or the UK GDPR (collectively referred to as the GDPR in this Quarterly Report on Form 10-Q), as well as other national data protection legislation in force in relevant EU and EEA member states and the UK (including the UK Data Protection Act 2018 in the UK), which govern the collection, use, storage, disclosure, transfer, or other processing of personal data (including health data processed in the context of clinical trials):

(i) regarding individuals in the EU, EEA and UK;

and/or (ii) carried out in the context of the activities of our establishment in any EU and EEA member state or the UK.

Currently, the EU GDPR and UK GDPR remain largely aligned.

The GDPR imposes several requirements on companies that process personal data, including requirements relating to the processing of health and other sensitive data, legal basis for processing personal data which may include obtaining the consent of the individuals to whom the personal data relates, providing detailed information to individuals about how their personal data is used, notification of personal data breaches to data protection authorities and individuals, and implementing safeguards to protect the security and confidentiality of the personal data.

The GDPR also imposes strict rules on the transfer of personal data out of the EEA and UK to third-party countries, including the United States in certain circumstances, unless a derogation exists or a valid GDPR transfer mechanism (e.g., the European Commission approved Standard Contractual Clauses, or SCCs, and the UK International Data Transfer Agreement/Addendum, or UK IDTA) have been put in place.

Where relying on the SCCs /UK IDTA for data transfers, we may also be required to carry out transfer impact assessments to assess whether the recipient is subject to local laws which allow public authority access to personal data.

Any inability to transfer personal data from the EEA and UK to the United States in compliance with data protection laws may impede our business operations and may adversely affect our business and financial position.

The UK government has introduced a Data Protection and Digital Information Bill, or Data Reform Bill, into the UK legislative process to reform the UK’s data protection regime, and if passed, the final version of the Data Reform Bill may have the effect of further altering the similarities between the UK and EEA data protection regimes and threaten the UK international transfers adequacy decision from the European Commission, which may lead to additional compliance costs for us and could increase our overall risk.

It is unclear how UK data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the UK will be regulated in the long term.

Failure to comply with the requirements of the GDPR and related national data protection laws of the EEA Member States or the UK may result in substantial fines of up to €20 million or 4% of a company’s global annual revenues for the preceding financial year, whichever is higher.

Moreover, the GDPR grants data subjects and consumer associations the right to claim material and non-material damages resulting from infringement of the GDPR.

The GDPR imposes additional responsibility and liability in relation to personal data that we process, where such processing is subject to the GDPR and we may be required to put in place additional mechanisms ensuring compliance with these and/or new data protection rules.

This may be costly, onerous and adversely affect our business, financial condition, prospects and results of operations.

Although the EU GDPR and the UK GDPR currently impose substantially similar obligations, it is possible that over time the UK GDPR could become less aligned with the EU GDPR.

In addition, EEA Member States have adopted national laws to supplement the EU GDPR, which may partially deviate from the EU GDPR, and the competent authorities in the EEA Member States may interpret EU GDPR obligations slightly differently from country to country, such that we do not expect to operate in a uniform legal landscape in the EEA and UK with respect to data protection regulations.

The potential of the respective provisions and enforcement of the EU GDPR and UK GDPR further diverging in the future creates additional regulatory challenges and uncertainties for us.

The lack of clarity on future UK laws and regulations and their interaction with EU laws and regulations could add legal risk, uncertainty, complexity and compliance cost to the handling of European personal data and our privacy and data security compliance programs could require us to amend our processes and procedures to implement different compliance measures for the UK and the EEA.

FDA, other regulatory agencies and industry organizations strictly regulate the promotional claims that may be made about prescription products and promotional efforts such as speaker programs.

If we or our partners are found to have improperly promoted uses, efficacy or safety of VASCEPA or otherwise are found to have violated the law or applicable regulations, we may become subject to significant fines and other liability.

The government may seek to find means to prevent our promotion of truthful and non-misleading information beyond the current court ruling and litigation settlement or seek to find violations of other laws or regulations in connection with the promotional efforts we undertake on our own or through third parties.

The government may seek to find means to prevent our promotion of truthful and non-misleading information beyond the current court ruling and litigation settlement or seek to find

violations of other laws or regulations in connection with the promotional efforts we undertake on our own or through third parties.

FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products.

In particular, in general, the U.S.

government’s position has been that a product may not be promoted for uses that are not approved by the U.S.

FDA as reflected in the product’s approved labeling.

In general, the U.S.

government’s position has been that a product may not be promoted for uses that are not approved by the U.S.

FDA as reflected in the product’s approved labeling.

The Federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion.

5 unchanged sentences

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.

The 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.

In addition, incentives exist under applicable laws that encourage competitors, employees and physicians to report violations of rules governing promotional activities for pharmaceutical products.

These incentives could lead to so-called “whistleblower lawsuits”

as part of which such persons seek to collect a portion of moneys allegedly overbilled to government agencies due to, for example, promotion of pharmaceutical products beyond labeled claims.

These incentives could also lead to suits that we have mischaracterized a competitor’s product in the marketplace and we may, as a result, be sued for alleged damages to our competitors.

These incentives could lead to so-called “whistleblower lawsuits” as part of which such persons seek to collect a portion of moneys allegedly overbilled to government agencies due to, for example, promotion of pharmaceutical products beyond labeled claims.

These incentives could also lead to suits that we have mischaracterized a competitor’s product in the marketplace and we may, as a result, be sued for alleged damages to our competitors.

Such lawsuits, whether with or without merit, are typically time-consuming and costly to defend.

Such suits may also result in related shareholder lawsuits, which are also costly to defend.

For example, the June 2020 CIDs from the DOJ informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program violated the U.S.

Anti-Kickback Statute and from the FCA relating to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa America, as well as the March 2021 CID from the FTC in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods.

The subpoena from the New York State attorney general covers the same subject matter on which the FTC CID is focused.

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

If the government determines that we have violated the U.S.

Anti-Kickback Statute, the FCA or antitrust regulations, we could be subject to significant civil and criminal fines and penalties.

We may not be successful in developing and receiving regulatory approval for VASCEPA in other jurisdictions or marketing future products if we cannot meet the extensive regulatory requirements of regulatory agencies such as for quality, safety, efficacy and data privacy.

15 unchanged sentences

• compliance with laws and regulations related to patient data privacy;

government or regulatory delays or “clinical holds”

requiring suspension or termination of a trial;

• government or regulatory delays or “clinical holds” requiring suspension or termination of a trial;

• political instability or other social or government protocols affecting our clinical trial sites.

Even if we obtain positive results from our efforts to seek regulatory approvals, from early stage preclinical studies or clinical trials, we may not achieve the same success in future efforts.

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.

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.

In connection with U.S.

FDA’s review of REDUCE-IT data and sNDA in 2019, the agency determined that an interaction between mineral oil and statins leading to decreased absorption of statins cannot be excluded when the two are co-administered as could have been the case in some patients in REDUCE-IT and that, in the agency’s view, indirect evidence suggested the presence of a potential inhibitory effect on statin absorption by mineral oil.

FDA’s review of REDUCE-IT data and the supplemental New Drug Application, or sNDA, in 2019, the agency determined that an interaction between mineral oil and statins leading to decreased absorption of statins cannot be excluded when the two are co-administered as could have been the case in some patients in REDUCE-IT and that, in the agency’s view, indirect evidence suggested the presence of a potential inhibitory effect on statin absorption by mineral oil.

However, U.S.

FDA’s exploratory analysis indicated that the effect of LDL cholesterol values on the time to the primary endpoint was numerically small and unlikely to change the overall conclusion of treatment benefit.

FDA’s exploratory analysis indicated that the effect of low-density lipoprotein, or LDL cholesterol values on the time to the primary endpoint was numerically small and unlikely to change the overall conclusion of treatment benefit.

FDA then relied on this assessment and all data available to it to approve a new indication statement and labeling based on REDUCE-IT results.

This matter illustrates that concerns such as this may arise in the future that could affect our product development, regulatory reviews or the public perception of our products and our future prospects, including REDUCE-IT results.

Any approvals that are obtained may be limited in scope, may require additional post-approval studies or may require the addition of labeling statements, including boxed warnings, focusing on product safety that could affect the commercial potential for

our product candidates.

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.

9 unchanged sentences

If we are successful in obtaining sufficient approvals and adequate pricing and reimbursement levels in major markets in Europe and elsewhere, we will need to ensure that our operations are adequate to support a commercial launch and continued promotion.

We intend to redesign our commercial infrastructure in Europe to better align with pricing and reimbursement status and commercial potential and will be operating with streamlined teams in Europe and elsewhere outside the United States and will need to expand internally and we expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties.

We redesigned our commercial infrastructure in Europe to better align with pricing and reimbursement status and commercial potential.

We will be operating with streamlined teams in Europe and elsewhere outside the United States;

however, we will anticipate the need to expand internally and expect that we will need to manage additional relationships with various collaborative partners, suppliers and other third parties as we progress in Europe and elsewhere outside the United States.

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.

5 unchanged sentences

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.

Our life-cycle management, in large part, currently depends on our ability to develop, obtain regulatory approval and commercialize a fixed-dose combination of VASCEPA and yet to be disclosed statins.

Specifically, our drug development efforts are subject to the risks and uncertainties inherent in any drug development program.

Due to the risks and uncertainties involved in progressing through development and bioequivalence or even potential additional trials (as may be required by specific regulatory agencies), and the time and cost involved in obtaining regulatory approvals, we cannot reasonably estimate the timing, completion dates and costs, or range of costs, of our drug development program, or of the successful development of any particular fixed-dose combination.

The potential success of any fixed-dose combination will depend on a number of factors, including the following:

Our ability to successfully manufacture a combination of VASCEPA and a statin;

Our ability to maintain a supply of necessary statin for use in the fixed-dose combination;

Our ability to obtain regulatory approvals for any and all markets in which we intend to commercialize a fixed-dose combination of VASCEPA and a statin;

Our ability to obtain payor acceptance and market access for a fixed-dose combination product of VASCEPA and a statin;

Our ability to achieve market acceptance of a fixed-dose combination of VASCEPA and a statin.

*The lasting results of business interruptions caused by the COVID-19 pandemic and related recovery efforts remain uncertain.

Despite the end of the COVID-19 pandemic, there may continue to be significant volatility, uncertainty and disruption in healthcare, social, supply and economic infrastructures in its wake.

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 lasting results and any resurgence of the pandemic, including on:

economic and political activity and our supply chain;

patients, healthcare providers and business partners, including patients’

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;

changes in patients’

and healthcare providers’

behavior and practices regarding face to face visits may have on our commercialization efforts, including whether virtual interactions will be as impactful as traditional, in-person interactions;

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

Our business is depending on successful life-cycle management efforts.

Our drug development efforts are subject to the risks and uncertainties inherent in any drug development program.

of any particular derivative, combination or next generation product candidate.

The potential success of any derivative, combination or next generation product candidate will depend on a number of factors, including the scope of and our success with manufacturing, obtaining regulatory approvals and achieving sufficient (or any) levels of market acceptance if approved.

Risks Related to Our Reliance on Third Parties

34 unchanged sentences

This bargaining power has required us to bear increasingly higher discounts in the sale of VASCEPA.

In addition, payors have broad latitude to change individual products’

formulary position or to implement other barriers that inhibit patients from receiving therapies prescribed by their healthcare professionals.

In addition, payors have broad latitude to change individual products’ formulary position or to implement other barriers that inhibit patients from receiving therapies prescribed by their healthcare professionals.

These payor barriers include requirements that patients try another drug before VASCEPA, known as step edits, and the requirement that prior authorization be obtained by a healthcare provider after a prescription is written before a patient will be reimbursed by their health plan for the cost of a VASCEPA prescription.

Further, pharmacy benefit managers implement plans that act as disincentives for VASCEPA use, such as increasingly higher deductibles.

One practical impact of higher deductibles is that they may cause patients to delay filling prescriptions for asymptomatic, chronic care medications such as hypertriglyceridemia earlier in the year, until patients meet their deductible and the cost of VASCEPA is then borne more by their insurance carrier.

One practical impact of higher deductibles is that they may cause patients to delay filling prescriptions for asymptomatic, chronic care medications such as hypertriglyceridemia, for which VASCEPA may be prescribed, earlier in the year, until patients meet their deductible and the cost of VASCEPA is then borne more by their insurance carrier.

Collectively, these dynamics adversely affect our profitability for the sale of VASCEPA and could increase over time further impacting our operating results.

5 unchanged sentences

FDA and similar foreign regulatory bodies and must be conducted in accordance with the U.S.

FDA’s cGMPs and comparable requirements of foreign regulatory bodies.

There are a limited number of manufacturers that operate under these cGMPs as well as the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, or ICH, regulations and guidelines, that are both capable of manufacturing VASCEPA and willing to do so.

3 unchanged sentences

FDA review and pre-approval of the manufacturing process and procedures in accordance with the U.S.

FDA’s cGMPs.

Any new facility may be subject to a pre-approval inspection by the U.S.

2 unchanged sentences

In either scenario, our clinical trials or commercial distribution could be delayed significantly as we establish alternative supply sources.

In some cases, the technical skills required to manufacture our products or product candidates

may be unique or proprietary to the original third-party manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.

In some cases, the technical skills required to manufacture our products or product candidates may be unique or proprietary to the original third-party manufacturer and we may have difficulty, or there may be contractual restrictions prohibiting us from, transferring such skills to a back-up or alternate supplier, or we may be unable to transfer such skills at all.

In addition, if we are required to change a third-party manufacturer for any reason, we will be required to verify that the new third-party manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations.

7 unchanged sentences

There are comparable foreign requirements under ICH guidelines.

In addition, the impact of past COVID-19 restrictions could continue to affect the ability of regulatory agencies to conduct facility inspections in a timely manner and may affect the timing of further approvals.

This review may be costly and time consuming and could delay or prevent the launch of a product.

Furthermore, the U.S.

13 unchanged sentences

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

Edding has successfully undertaken clinical trials and approval initiatives under our arrangement with them, including the announcement of statistically significant positive topline results from Edding’s Phase 3 clinical trial of VASCEPA and has obtained approval for VASCEPA in Hong Kong under the REDUCE-IT indication and in Mainland China under the MARINE indication.

In October 2023, Edding submitted for the approval of the REDUCE-IT indication in Mainland China.

3 unchanged sentences

If Edding is not able to effectively commercialize VASCEPA in the China Territory, we may not be able to generate revenue from our agreement with Edding resulting from the sale of VASCEPA in the China Territory.

We are party to arrangements with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries, with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada, with CSL Seqirus, or CSL, to commercialize and distribute VASCEPA in Australia and New Zealand, Lotus Pharmaceuticals, or Lotus, to commercialize and distribute VASCEPA in several countries in Southeast Asia and Neopharm (Israel)

1996 Ltd., or Neopharm, to distribute VASCEPA in Israel.

Although Biologix is currently actively commercializing VASCEPA in the United Arab Emirates, Lebanon, Kuwait and Saudi Arabia, and HLS is currently commercializing VASCEPA in Canada, we are completely reliant on these third parties to secure approval and successfully commercialize the product in those markets, which markets can be complex and challenging.

We are party to arrangements with Biologix FZCo, or Biologix, to register and commercialize VASCEPA in several Middle Eastern and North African countries, with HLS Therapeutics Inc., or HLS, to register, commercialize and distribute VASCEPA in Canada, with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VASCEPA in Australia and New Zealand, Lotus Pharmaceuticals, or Lotus, to register, commercialize and distribute VASCEPA in several countries in Southeast Asia and Neopharm (Israel) 1996 Ltd., or Neopharm, to distribute VASCEPA in Israel.

Although Biologix is currently actively commercializing VASCEPA in the United Arab Emirates, Lebanon, Kuwait and Saudi Arabia, and HLS is currently commercializing VASCEPA in Canada, we are completely reliant on these third parties to successfully commercialize the product in those markets, which markets can be complex and challenging.

If Edding, Biologix, HLS, CSL, Lotus or Neopharm, or other third parties who we rely on for development and commercialization of VASCEPA, do not successfully carry out their contractual obligations or meet expected deadlines, our recourse and remedies against these parties is limited.

3 unchanged sentences

In order for our partners to market and sell VASCEPA in any country outside of the United States for any indication, it will be necessary to obtain regulatory approval from the appropriate regulatory authorities.

The requirements and timing for regulatory approval, which may include conducting clinical trials, vary widely from country to country and may in some cases be different than or more rigorous than requirements in the United States.

The requirements and timing for regulatory approval, which may include conducting clinical trials, vary widely from country to country and may in some cases be different than

or more rigorous than requirements in the United States.

Any failure by us or our partners to obtain approval for VASCEPA in non-U.S.

6 unchanged sentences

Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.

Refer to “

Business - Government Regulation - Fraud and Abuse Laws and Data Regulation " in our Annual Report on Form 10-K for the year ended December 31, 2022 for further details.

Refer to “ Item 1.

Business - Government Regulation - Fraud and Abuse Laws and Data Regulation " in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 for further details.

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.

3 unchanged sentences

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.

For example, the June 2020 CIDs from the DOJ informing us that the DOJ is investigating whether aspects of our promotional speaker programs and copayment waiver program violated the U.S.

Anti-Kickback Statute, and from the FCA relating to the sale and marketing of VASCEPA by us and our previous co-marketing partner, Kowa America, as well as the March 2021 CID from the FTC in connection with the FTC’s investigation of whether we have engaged in, or are engaging in, anticompetitive practices or unfair methods of competition relating to VASCEPA require us to produce documents and answer written questions, or interrogatories, relevant to specified time periods;

as does the subpoena from the New York State attorney general regarding the same subject matter on which the FTC CID is focused.

As noted, we are cooperating with the government, but 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.

2 unchanged sentences

The failure to comply with any of these laws or regulatory requirements subjects entities to possible legal or regulatory action.

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.

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.

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.

1 unchanged sentence

In the U.S., to help patients afford our approved product, we utilize programs to assist them, including patient assistance programs and co-pay coupon programs for eligible patients.

Government enforcement agencies have shown increased interest in pharmaceutical companies’

product and patient assistance programs, including reimbursement support services, and a number of investigations into these programs have resulted in significant civil and criminal settlements.

In addition, at least one insurer has directed its network pharmacies to no longer accept co-pay coupons for certain specialty drugs the insurer identified.

Our co-pay coupon programs could become the target of similar insurer actions.

In addition, in November 2013, the CMS issued guidance to the issuers of qualified health plans sold through the ACA’s marketplaces encouraging such plans to reject patient cost-sharing support from third parties and indicating that the CMS intends to monitor the provision of such support and may take regulatory action to limit it in the future.

The CMS subsequently issued a rule requiring individual market qualified health plans to accept third-party premium and cost-sharing payments from certain government-related entities.

In September 2014, the Office of Inspector General of the HHS issued a Special Advisory Bulletin warning manufacturers that they may be subject to sanctions under the federal anti-kickback statute and/or civil monetary penalty laws if they do not take appropriate steps to exclude Part D beneficiaries from using co-pay coupons.

Accordingly, companies exclude these Part D beneficiaries from using co-pay coupons.

Government enforcement agencies have shown increased interest in pharmaceutical companies’ product and patient assistance programs, including reimbursement support services, and a number of investigations into these programs have resulted in significant civil and criminal settlements.

It is possible that changes in insurer policies regarding co-pay coupons and/or the introduction and enactment of new legislation or regulatory action could restrict or otherwise negatively affect these patient support programs, which could result in fewer patients using affected products, and therefore could have a material adverse effect on our sales, business, and financial condition.

22 unchanged sentences

Our success depends in part on our ability to obtain and maintain intellectual property protection for our drug candidates, technology and know-how, and to operate without infringing the proprietary rights of others.

Refer to “ Item 1.

Business - Patents, Proprietary Technology, Trade Secrets" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 for further details.

We plan to vigorously defend our rights under issued patents, however such defense activities can be costly to pursue and may not have the desired results.

12 unchanged sentences

Any such competition could undermine sales, marketing and collaboration efforts for VASCEPA, and thus reduce, perhaps materially, the revenue potential for VASCEPA.

Even if we are successful in enforcing our issued patents, we may incur substantial costs and divert management’s time and attention in pursuing these proceedings, which could have a material adverse effect on us.

Patent litigation is costly and time consuming, and we may not have sufficient resources to bring these actions to a successful conclusion.

15 unchanged sentences

Furthermore, third parties may attempt to submit publications for consideration by the patent office during examination of our patent applications.

Providing such additional evidence and publications could prolong the patent office’s review of our applications and result in us incurring additional costs.

We cannot be certain what commercial value any granted patent in our patent estate will provide to us.

6 unchanged sentences

If the estimates we make, or the assumptions on which we rely, in preparing our projected guidance prove inaccurate, our actual results may vary from those reflected in our projections and accruals.

In January 2023, we disclosed our 2023 financial outlook.

Such outlook is based on estimates, assumptions and the judgment of management at such time.

Subsequently, in July 2023, we announced an Organizational Restructuring Program, which will have a significant effect on our results for 2023 and future years.

In January 2024, we reiterated our belief that current cash and investments and other assets are adequate to support continued operations, including the share repurchase program.

This and similar statements are based on estimates, assumptions and the judgment of management at such time.

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

4 unchanged sentences

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 and sales force and the changes to our Board and our recent hiring of a new Chief Executive Officer, 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.

Given our rapidly expanding enterprise coupled with a streamlined management structure and sales force and the changes to our Board and senior management team during 2023, 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.

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.

1 unchanged sentence

We may have difficulty identifying, attracting and integrating new executives to replace any such losses.

As we pursue commercialization efforts in Europe, we need to rapidly hire employees and ensure that they are well trained and working cohesively with core values which are consistent with our existing operations and which, we believe, help improve our position for success.

In the United States, where we have recently eliminated all sales force positions, employees are increasingly being recruited by other companies.

The current and potential threat of generic competition and our recent reductions in force, including as part of our Organizational Restructuring Program announced in July 2023, can create employee uncertainty which could lead to increased employee turnover.

The current and potential threat of generic competition and our recent reductions in force, including as part of our ORP announced in July 2023, can create employee uncertainty which could lead to increased employee turnover.

There is intense competition for qualified personnel in the areas of our activities.

1 unchanged sentence

The failure to recruit key scientific, technical and management personnel would be detrimental to our ability to implement our business plan.

Our internal computer systems, or those of our third‑party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our commercial, research and development and other programs.

Despite the implementation of security measures, our internal computer systems and those of our third‑party clinical research organizations and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures.

Any such incident could cause interruptions in our operations or a material disruption of our programs.

4 unchanged sentences

The number and complexity of these threats continue to increase over time.

In June 2019, a report published by security researchers claimed that a database belonging to one of our vendors containing information about individuals who use or have expressed interest in VASCEPA was accessible to unauthorized users.

For example, in June 2019, a report published by security researchers claimed that a database belonging to one of our vendors containing information about individuals who use or have expressed interest in VASCEPA was accessible to unauthorized users.

Although we were informed that such breach did not include social security numbers or credit card information, a more material breach could occur in the future.

7 unchanged sentences

As we outsource more of our information systems to vendors, engage in more electronic transactions with payors and patients, and rely more on cloud-based information systems, the related security risks will increase and we will need to expend additional resources to protect our technology and information systems.

In addition, there can be no assurance that our internal information technology systems or those of our third-party contractors, or our consultants’

efforts to implement adequate security and control measures, will be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks or insider threat attacks which could result in financial, legal, business or reputational harm.

In addition, there can be no assurance that our internal information technology systems or those of our third-party contractors, or our consultants’ efforts to implement adequate security and control measures, will be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, security breach, industrial espionage attacks or insider threat attacks which could result in financial, legal, business or reputational harm.

We are subject to potential product liability.

7 unchanged sentences

Under current UK legislation, a company incorporated in England and Wales, or which is centrally managed and controlled in the UK, is regarded as resident in the UK for taxation purposes.

Under current Irish legislation, a company is regarded as resident for tax purposes in Ireland if it is centrally managed and controlled in Ireland, or, in certain circumstances, if it is incorporated in Ireland.

Under current Irish legislation, a company is regarded as resident for tax purposes in Ireland if it is centrally managed and controlled in Ireland, or, in

certain circumstances, if it is incorporated in Ireland.

Up to December 31, 2019, where a company was treated as tax resident under the domestic laws of both the UK and Ireland, then the provisions of article 4(3) of the Double Tax Agreement, or DTA, between the UK and Ireland provided that such enterprise would be treated as resident only in the jurisdiction in which its place of effective management is situated.

We have at all times sought to conduct our affairs in such a way so as to be solely resident in Ireland for tax purposes by virtue of having our place of effective management situated in Ireland.

These rules regarding determination of tax residence changed effective January 1, 2020, when a modified Ireland-UK DTA came into effect pursuant to the OECD’s Multilateral Instrument, or MLI.

Under the modified Ireland-UK DTA, from January 1, 2020, we would be solely tax resident in Ireland and not tax resident in the UK if we continued to be centrally managed and controlled in Ireland and if it were mutually agreed between the Irish and UK tax authorities under the MLI “tie-breaker rule”

that we are solely tax resident in Ireland.

These rules regarding determination of tax residence changed effective January 1, 2020, when a modified Ireland-UK DTA came into effect pursuant to the Organisation for Economic Co-operation and Development's, or OECD’s, Multilateral Instrument, or MLI.

Having made the relevant submission under the amended provisions, we received confirmation effective January 1, 2020 of the mutual agreement of Irish and UK tax authorities that we are solely tax resident in Ireland for the purposes of the modified DTA.

3 unchanged sentences

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.

Our and our subsidiaries’

income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or the IRS, and state tax authorities.

Our and our subsidiaries’ income tax returns are periodically examined by various tax authorities, including the Internal Revenue Service, or the IRS, and state tax authorities.

For example, the IRS began an examination of our 2018 U.S.

5 unchanged sentences

gross product sales.

Customers A, B, and C accounted for 30%, 36%, and 29%, respectively, of gross product sales for the nine months ended September 30, 2023, and represented 37%, 37%, and 22%, respectively, of the gross accounts receivable balance as of September 30, 2023.

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.

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

Customers A, B, and C accounted for 28%, 35%, and 29%, respectively, of gross product sales for the three months ended March 31, 2024, and represented 37%, 31%, and 22%, respectively, of the gross accounts receivable balance as of March 31, 2024.

Customers A, B, and C accounted for 29%, 38%, and 27%, respectively, of gross product sales for the three months ended March 31, 2023, and represented 36%, 40%, and 20%, respectively, of the gross accounts receivable balance as of March 31, 2023.

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

There can be no guarantee that we will be able to sustain our accounts receivable or gross sales levels from our key customers.

6 unchanged sentences

We had an accumulated deficit as of December 31, 2023 of $1.6 billion.

For the nine months ended September 30, 2023 and 2022, we reported losses of approximately $53.3 million and $106.7 million, respectively, and we had an accumulated deficit as of September 30, 2023 of $1.6 billion.

For the three months ended March 31, 2024 and 2023, we reported losses of approximately $10.0 million and $16.5 million, respectively, and we had an accumulated deficit as of March 31, 2024 of $1.6 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.

1 unchanged sentence

Because of the numerous risks and uncertainties associated with developing and commercializing pharmaceutical products, we are unable to predict the magnitude of these future losses.

Our historic losses, combined with expected future losses, have had and will continue to have an adverse effect on our cash resources, shareholders’

deficit and working capital.

Our historic losses, combined with expected future losses, have had and will continue to have an adverse effect on our cash resources, shareholders’ deficit and working capital.

We may never generate sufficient revenue to achieve a steady state of profitability.

14 unchanged sentences

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

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

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

• the level of demand for VASCEPA, due to changes in prescriber sentiment, quarterly changes in distributor purchases, and other factors;

• 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 payors 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 our cost and reorganization efforts, including our Organizational Restructuring Program announced in July 2023, 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 coronavirus pandemic;

• the timing, cost and level of investment in our sales and marketing efforts to support VASCEPA sales, and our cost and reorganization efforts, including our ORP announced in July 2023, 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 coronavirus pandemic;

• additional developments regarding our intellectual property portfolio and regulatory exclusivity protections, if any;

• outcomes of litigation and other legal proceedings;

lasting impacts from the COVID-19 pandemic;

• our ongoing regulatory dialogue.

2 unchanged sentences

We currently operate with limited resources.

We believe that our cash and cash equivalents balance of $270.8 million and short-term investment balance of $49.8 million as of September 30, 2023 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 believe that our cash and cash equivalents balance of $213.9 million and short-term investment balance of $94.2 million as of March 31, 2024 will be sufficient to fund our projected operations, including the share repurchase program, 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.

13 unchanged sentences

Tax law and policies in the United States and Ireland are unsettled and may be subject to significant change, including based on adjustments in political perspectives and administration shifts.

In the United States and internationally, how to tax entities with international operations, like us, has been subject to significant re-evaluation.

In the United States and internationally, the method of taxation of entities with international operations, like us, has been subject to significant reevaluation.

We believe we developed VASCEPA in and from Ireland based on understanding of applicable requirements.

4 unchanged sentences

Similarly, a change in our Irish tax residence could materially affect our ability to obtain and maintain profitability, if otherwise achievable.

Changes in tax law and tax rates, particularly in the United States and Ireland, could also impact our assessment of

deferred taxes.

Changes in tax law and tax rates, particularly in the United States and Ireland, could also impact our assessment of deferred taxes.

Any change in our assessment of the realizability or the timing for realizing deferred taxes could have a negative impact our future profitability.

4 unchanged sentences

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’

and our compliance, operating and other costs, as well as the costs of our products.

Additionally, new, changed, modified, or newly interpreted or applied tax laws could increase our partners’ and our compliance, operating and other costs, as well as the costs of our products.

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.

2 unchanged sentences

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

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

We do not expect the tax provisions of the IRA to have a material impact.

Risks Related to Ownership of our ADSs and Common Shares

*If we are no longer able to meet the listing requirements of the NASDAQ Global Market, our stock may be delisted.

The NASDAQ Global Market, or NASDAQ, on which our ADSs are listed and traded, has listing requirements that include a $1.00 minimum closing bid price requirement.

NASDAQ will issue a deficiency notice if an issuer is in violation of a listing standard for a period of 30 consecutive days.

We received a deficiency letter in October 2023, as our ADSs have traded below $1.00 for 30 consecutive days.

Such deficiency letter does not result in the immediate delisting of our ADSs and we are provided a compliance period of 180 calendar days to regain compliance with NASDAQ's minimum bid price requirement.

If we are to remain out of compliance, NASDAQ may elect, subject to any potential additional cure periods, to initiate a process that could delist our common shares from trading on the NASDAQ.

Our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program (which is subject to shareholder and UK court approval), may not be implemented in a timely manner or at all, or may not have the expected results.

The implementation of our announced share repurchase agreement is conditional upon shareholder and UK court approval, as required under UK company law.

We received shareholder approval during our annual general meeting of shareholders in April 2024.

Although we are now proceeding with the requisite court process to undertake a reduction of capital in order to create the necessary distributable profits for the funding of the repurchases, which process could be completed by the end of the second quarter of 2024, with share repurchases commencing shortly thereafter;

however, we cannot guarantee that the share repurchase program will receive court approval in a timely manner or at all.

Further, the share repurchase program and other efforts to return capital to shareholders may not have the anticipated effect or increase shareholder value in the long term.

If we are no longer able to meet the listing requirements of the NASDAQ Stock Market, our stock may be delisted.

The NASDAQ Stock Market, or NASDAQ, on which our ADSs are listed and traded, has listing requirements that include a $1.00 minimum closing bid price requirement.

NASDAQ will issue a deficiency notice if an issuer is in violation of a listing standard for a period of 30 business consecutive days.

Such deficiency letter does not result in the immediate delisting of an issuer as there is a period of 180 calendar days from the deficiency notice to regain compliance with NASDAQ's minimum bid price requirement.

If an issuer is unable to comply with NASDAQ's minimum bid price requirement after this 180-day calendar period, NASDAQ may elect, subject to any potential additional cure periods, to initiate a process that could delist the issuer from trading on the NASDAQ.

We received a deficiency letter from NASDAQ in October 2023, as our ADSs had traded below $1.00 for 30 consecutive business days.

In January 2024, we regained compliance with the NASDAQ listing requirements as our ADSs had traded above $1.00 for 10 consecutive business days.

Should such a delisting occur, it would adversely impact the liquidity and price of our ADSs and would impede our ability to raise capital.

2 unchanged sentences

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 October 27, 2023, we had 408,291,815 common shares outstanding, including 387,902,637 shares held as ADSs and 20,389,178 held as ordinary shares (which are not held in the form of ADSs).

As of April 26, 2024, we had 410,868,659 common shares outstanding, including 402,066,926 shares held as ADSs and 8,801,733 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.

Our planned share repurchase program, which is subject to requisite shareholder and UK High Court approval under UK law, would, if implemented, reduce the number of shares outstanding and could result in reduced trading volumes.

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.

2 unchanged sentences

• litigation and regulatory developments in the United States affecting our VASCEPA promotional rights, and regulatory developments in other countries;

actual or potential medical results relating to our products or our competitors’

• actual or potential medical results relating to our products or our competitors’ products;

• interim failures or setbacks in product development;

2 unchanged sentences

• period-to-period variations in our results of operations.

Further, the long-term effects of the UK's departure from the EU, or Brexit, remain uncertain and may have a negative effect on global economic conditions, financial markets and our business, which could reduce the price of our ADSs and common shares.

In particular, ongoing uncertainty related to Brexit and the long-term relationship between the UK and the EU could lead to a period of

disruption in the UK financial and banking markets, as well as on the regulatory process in Europe, which could cause the broader global financial markets to experience significant volatility.

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

Lack of clarity about future UK laws and regulations as the United Kingdom determines which EU rules and regulations to replace or replicate could decrease foreign direct investment in the UK, increase costs, disrupt our business, depress economic activity and restrict our access to capital, any of which could negatively impact the price of our ADSs and common shares.

Actual or potential sales of our common shares by our employees, including members of our senior management team, pursuant to pre-arranged stock trading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons could be viewed negatively by other investors.

In accordance with the guidelines specified under Rule 10b5-1 under the Exchange Act and our policies regarding stock transactions, a number of our directors and employees, including members of our senior management team, have adopted and may continue to adopt pre-arranged stock trading plans to sell a portion of our common stock that they beneficially own.

Generally, sales under such plans by members of our senior management team and directors require public filings.

Actual or potential sales of our ADSs by such persons could cause the price of our ADSs to fall or prevent it from increasing for numerous reasons.

A substantial amount of our ADSs becoming available (or being perceived to become available) for sale in the public market could cause the market price of our ADSs to fall or prevent it from increasing.

Also, actual or potential sales by such persons could be viewed negatively by other investors.

If we were to be characterized as a passive foreign investment company there could be adverse consequences to U.S.

corporation will be classified as a passive foreign investment company, or PFIC, for U.S.

federal income tax purposes for any taxable year, if either (i) 75% or more of its gross income for such year consists of certain types of “passive”

income or (ii) 50% or more of the value of its assets (determined on the basis of a quarterly average) during such year produce or are held for the production of passive income.

federal income tax purposes for any taxable year, if either (i) 75% or more of its gross income for such year consists of certain types of “passive” income

or (ii) 50% or more of the value of its assets (determined on the basis of a quarterly average) during such year produce or are held for the production of passive income.

Passive income generally includes dividends, interest, royalties, rents, annuities, net gains from the sale or exchange of property producing such income and net foreign currency gains.

18 unchanged sentences

You should be aware, however, that the voting rights of ADSs are also governed by the provisions of a deposit agreement with our depositary bank.

Under English law, subject to certain exceptions and disapplications, each shareholder generally has preemptive rights to subscribe on a proportionate basis to any issuance of ordinary shares or rights to subscribe for, or to convert securities into,

ordinary shares for cash.

• Under English law, subject to certain exceptions and disapplications (including, without limitation, the disapplication by at least 75% of the shareholders who vote (in person or by proxy)), each shareholder generally has preemptive rights to subscribe on a proportionate basis to any issuance of ordinary shares or rights to subscribe for, or to convert securities into, ordinary shares for cash.

law, shareholders generally do not have preemptive rights unless specifically granted in the certificate of incorporation or otherwise.

2 unchanged sentences

law, generally only majority shareholder approval is required to amend the certificate of incorporation or to approve other significant transactions.

In the United Kingdom, takeovers may be structured as takeover offers or as schemes of arrangement.

• In the UK, takeovers may be structured as takeover offers or as schemes of arrangement.

Under English law, a bidder seeking to acquire us by means of a takeover offer would need to make an offer for all of our outstanding ordinary shares/ADSs.

If acceptances are not received for 90% or more of the ordinary shares/ADSs under the offer, under English law, the bidder cannot complete a “squeeze out”

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.

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.

If acceptances are not received for 90% or more of the ordinary shares/ADSs (and 90% of the voting rights carried by those ordinary shares/ADSs) under the offer, under English law, the bidder cannot complete a “squeeze out” to obtain 100% control of us.

Accordingly, acceptances of 90% of our outstanding ordinary shares/ADSs (and 90% of the voting rights) 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.

• Under English law and our Articles of Association, shareholders and other persons whom we know or have reasonable cause to believe are, or have been, interested in our shares may be required to disclose information regarding their interests in our shares upon our request, and the failure to provide the required information could result in the loss or restriction of rights attaching to the shares, including prohibitions on certain transfers of the shares, withholding of dividends and loss of voting rights.

Comparable provisions generally do not exist under U.S.

The quorum requirement for a shareholders’

meeting is a minimum of two shareholders entitled to vote at the meeting and present in person or by proxy or, in the case of a shareholder which is a corporation, represented by a duly authorized officer (although the marketplace rules of the Nasdaq Stock Market require that shareholders holding at least one-third of our outstanding shares of voting stock are present at the meeting or by proxy).

law, a majority of the shares eligible to vote must generally be present (in person or by proxy) at a shareholders’

meeting in order to constitute a quorum.

The minimum number of shares required for a quorum can be reduced pursuant to a provision in a company’s certificate of incorporation or bylaws, but typically not below one-third of the shares entitled to vote at the meeting.

• The quorum requirement for a shareholders’ meeting is a minimum of two shareholders entitled to vote at the meeting and present in person or by proxy or, in the case of a shareholder which is a corporation, represented by a duly authorized officer (although the marketplace rules of the Nasdaq Stock Market require that shareholders holding at least one-third of our outstanding shares of voting stock are present at the meeting or by proxy).

law, a majority of the shares eligible to vote must generally be present (in person or by proxy) at a shareholders’ meeting in order to constitute a quorum.

Shareholder protections found in provisions under the UK City Code on Takeovers and Mergers, or the Takeover Code, do not apply to us.

We believe that our place of central management and control is not currently in the UK (or the Channel Islands or the Isle of Man) for the purposes of the jurisdictional criteria of the Takeover Code.

Accordingly, we believe that we are not currently subject to the Takeover Code and, as a result, our shareholders are not currently entitled to the benefit of certain takeover offer protections provided under the Takeover Code, including the rules regarding mandatory takeover bids.

In the event that this changes, or if the interpretation and application of the Takeover Code by the Panel on Takeovers and Mergers, or Takeover Panel, changes (including changes to the way in which the Takeover Panel assesses the application of the Takeover Code to English companies whose shares are listed outside of the UK), the Takeover Code may apply to us in the future.

The Takeover Code provides a framework within which takeovers of certain companies organized in the United Kingdom are regulated and conducted.

2 unchanged sentences

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:

In connection with a potential offer, if following an approach by or on behalf of a potential bidder, the company is “the subject of rumor or speculation”

or there is an “untoward movement”

in the company’s share price, there is a requirement for the potential bidder to make a public announcement about a potential offer for the company, or for the company to make a public announcement about the potential offer.

When a person or group of persons who are treated as “acting in concert”

with each other (a) acquires interests in shares carrying 30% or more of the voting rights of a company (which percentage is treated by the Takeover Code as the level at which effective control is obtained) or (b) increases the aggregate percentage interest they have when they are already interested in not less than 30% and not more than 50%, they must make a cash offer to all other shareholders at the highest price paid by them in the 12 months before the offer was announced.

When interests in shares of any class representing 10% of shares of that class have been acquired for cash by an offeror (i.e., a bidder) during the offer period (i.e., broadly speaking, the period after the potential offer has been made public) and within 12 months prior to commencement of the offer period, the offer must be in cash or be accompanied by a cash alternative for all shareholders of that class at the highest price paid by the offeror in that period.

Further, if an offeror acquires any interest in shares for cash during the offer period, the offer for the shares must be in cash or accompanied by a cash alternative at a price at least equal to the price paid for such shares during the offer period.

If after an announcement is made, the offeror acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the value of the offer, the offer must be increased accordingly.

• In connection with a potential offer, if following an approach by or on behalf of a potential bidder, the company is “the subject of rumor or speculation” or there is an “untoward movement” in the company’s share price, there is a requirement for the potential bidder to make a public announcement about a potential offer for the company, or for the company to make a public announcement about the potential offer.

• When any person acquires, whether by a series of transactions over a period of time or not, an interest in shares which (taken together with shares already held by that person and an interest in shares held or acquired by persons acting in concert with him or her) carry 30% or more of the voting rights of a company that is subject to the Takeover Code, that person is generally required to make a mandatory offer to all the holders of any class of equity share capital or other class of transferable securities carrying voting rights in that company to acquire the balance of their interests in the company.

• When any person who, together with persons acting in concert with him or her, is interested in shares representing not less than 30% but does not hold more than 50% of the voting rights of a company that is subject to the Takeover Code, and such person, or any person acting in concert with him or her, acquires an additional interest in shares which increases the percentage of shares carrying voting rights in which he or she is interested, then such person is generally required to make a mandatory offer to all the holders of any class of equity share capital or other class of transferable securities carrying voting rights of that company to acquire the balance of their interests in the company.

• A mandatory offer triggered in the circumstances described in the preceding two paragraphs above must be in cash (or be accompanied by a cash alternative) and at not less than the highest price paid within the preceding 12 months to acquire any interest in shares of that class in the company by the person required to make the offer or any person acting in concert with him or her.

• In relation to a voluntary offer (i.e., any offer which is not a mandatory offer), when interests in shares of any class representing 10% or more of shares of that class have been acquired for cash by an offeror (i.e., a bidder) and any person acting in concert with it during the offer period (i.e., broadly speaking, the period after the potential offer has been made public) and within 12 months prior to commencement of the offer period, the offer must be in cash or be accompanied by a cash alternative for all shareholders of that class at not less than the highest price paid for any interest in shares of that class by the offeror or any person acting in concert with it in that period.

Further, if an offeror or any person acting in concert with it acquires any interest in shares for cash during the offer period, the offer for that class of shares must be in cash or accompanied by a cash alternative at a price at not less than the highest price paid by the offeror or any person acting in concert with it for shares of that class acquired during the offer period.

• If after an announcement of a firm intention to make an offer is made and before the offer closes for acceptance, the offeror or any person acting in concert with them acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the then current value of the offer, the offer must be increased to not less than the highest price paid for the interest in shares so acquired.

• The offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company.

Favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the financial adviser to the offeree.

• Special or favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the independent adviser to the offeree.

• All shareholders must be given the same information.

The directors of those parties issuing takeover circulars must include statements taking responsibility for the contents thereof.

• Each document published in connection with an offer by or on behalf of the offeror or offeree must state that the directors of the offeror or the offeree, as the case may be, accept responsibility for the information contained therein and that, to the best of their knowledge and belief (having taken all reasonable care to ensure that such is the case) the information contained therein is in accordance with the facts and does not omit anything likely to affect the import of such information.

• Profit forecasts, quantified financial benefits statements and asset valuations must be made to specified standards and must be reported on by professional advisers.

1 unchanged sentence

• Actions during the course of an offer (or even before if the board of the offeree company is aware that an offer is imminent) by the offeree company, which might frustrate the offer are generally prohibited unless shareholders approve these plans (or the bidder consents to the proposed course of action).

Frustrating actions would include, for example, issuing new shares, lengthening the notice period for directors under their service contract or agreeing to sell off material parts of the target group, to the extent such actions are not in the ordinary course of the offeree company's business.

• Stringent requirements are laid down for the disclosure of dealings in relevant securities during an offer, including the prompt disclosure of positions and dealing in relevant securities by the parties to an offer and any person who is interested (directly or indirectly) in 1% or more of any class of relevant securities.

Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer.

In addition, the offeree company’s employee representatives and pension scheme trustees have the right to have a separate opinion on the effects of the offer on employment and pension schemes appended to the offeree board of directors’

circular or published on a website.

• Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer.

shareholders may not be able to enforce civil liabilities against us.

11 unchanged sentences

person that owns directly, indirectly or by attribution, 10% or more of the voting power of our outstanding shares may be subject to U.S.

income taxation at ordinary income tax rates on all or a portion of our undistributed earnings and profits attributable to “subpart F income.”

Such 10% holder may also be taxable at ordinary income tax rates on any gain realized on a sale of ordinary shares or ADS, to the extent of our current and accumulated earnings and profits attributable to such shares.

income taxation at ordinary income tax rates on all or a portion of our undistributed earnings and profits attributable to “subpart F income.” Such 10% holder may also be taxable at ordinary income tax rates on any gain realized on a sale of ordinary shares or ADS, to the extent of our current and accumulated earnings and profits attributable to such shares.

The CFC rules are complex and U.S.

5 unchanged sentences

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.

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.

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.

The UK left the EU on January 31, 2020, but remained in the EU’s customs union and single market for a transitional period that expired on December 31, 2020.

Although the UK entered into a trade and cooperation agreement with the EU, which was provisionally applicable since January 1, 2021 and formally applicable since May 1, 2021, the UK-EU TCA, that provides for, among other things, the free movement of goods between the United Kingdom and the EU, continued legal uncertainty and potentially divergent national laws and regulations in areas not specifically addressed in the UK-EU TCA may continue to affect trade and other interactions between the UK and the EU.

In addition, UK service suppliers no longer benefit from automatic access to the entire EU single market and free movement of goods is subject to increased bureaucracy.

The loss of these benefits could impact the attractiveness of the UK as a global business and financial center, which may have an adverse effect on the rate of economic growth in the UK and the EU.

On a greater macroeconomic level, ongoing uncertainty related to Brexit and the UK’s legal, political and economic relationship with the EU 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 cooperation arrangements whether economic, tax, fiscal, legal, regulatory or otherwise.

These developments 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.

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

The long-term effects of Brexit are currently unknown and will depend on the evolution of any agreements (or lack thereof) that the UK makes to retain access to the EU markets.

Such a withdrawal from the EU is unprecedented, and it remains 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 long-term 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.

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

The impact of the terms of the recent trade deal between the UK and EU are uncertain.

Since the regulatory framework in the UK covering quality, safety and efficacy of pharmaceutical products, clinical trials, marketing authorization, commercial sales and distribution of pharmaceutical products is derived from EU directives and regulations, Brexit could materially impact the future regulatory regime with respect to the commercialization of our products in the UK.

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.

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

7 unchanged sentences

Debt financing, if available, may involve agreements that include burdensome covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional funds

through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, VASCEPA or product candidates beyond the rights we have already relinquished, or grant licenses on terms that are not favorable to us.

Potential business combinations or other strategic transactions may disrupt our business or divert management’s attention.

If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, VASCEPA or product candidates beyond the rights we have already relinquished, or grant licenses on terms that are not favorable to us.

Potential business combinations or other strategic transactions may disrupt our business or divert management’s attention.

On a regular basis, we explore potential business combination transactions, including an acquisition of us by a third party, exclusive licenses of VASCEPA or other strategic transactions or collaborations with third parties.

6 unchanged sentences

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 re-evaluate 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.

Our business, financial condition and results of operations could be materially and adversely affected by any negative impact on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen.

Economic uncertainty in various global markets, including the U.S.

and Europe, caused by political instability and conflict, such as Russia's invasion of Ukraine and current armed conflict in Israel and the Gaza Strip, and economic challenges caused by the COVID-19 pandemic, have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions, which have caused record inflation globally.

Economic uncertainty in various global markets, including the U.S., Europe and the Middle East, caused by political instability and conflict, such as Russia's invasion of Ukraine and current armed conflict in Israel and the Gaza Strip, and economic challenges caused by pandemics or other health crises, such as the recent COVID-19 pandemic, have led to market disruptions, including significant volatility in commodity prices, credit and capital market instability and supply chain interruptions, which have caused record inflation globally.

Although, to date, our business has not been materially impacted by these global economic and geopolitical conditions, it is impossible to predict the extent to which our operations will be impacted in the short and long term, or the ways in which such instability could impact our business and results of operations.

2 unchanged sentences

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