What changed in this filing

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Item 1. Legal Proceedings

2023-08-02 compared with 2023-05-03 · 134 added, 141 removed, 1075 unchanged (20% of the section changed)

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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.

“Item 3.

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

Legal Proceedings”

of our Annual Report includes a discussion of our current legal proceedings.

of our Annual Report.

Refer to Note 5 –

Commitments and Contingencies in this Quarterly Report for further details on our current legal proceedings.

Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three and six months ended June 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.

Ri sk Factors

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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 reimbursement levels, which can vary from country to country.

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

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.

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 previous cost reduction and organizational restructuring 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 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.

business and establishing a more significant international footprint.

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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.

We are currently, and may continue to be, substantially dependent on third parties for our international efforts, and

we may not be successful in negotiating or establishing relationships with business partners to support and maintain control over our international activities.

We are currently, and may continue to be, substantially dependent on third parties for our international efforts, and we may not be successful in negotiating or establishing relationships with business partners to support and maintain control over our international activities.

We are dependent on patents, proprietary rights and confidentiality obligations of our employees, agents, business partners and third parties to protect the commercial value and potential of VASCEPA.

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Reddy's, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, that declared as invalid several patents of ours protecting the first U.S.

FDA-approved use of our drug, to reduce severely high triglyceride levels, or the MARINE indication.

FDA-approved use of our drug, to reduce severely high triglyceride levels, or the MARINE indication, or the ANDA litigation.

We were unsuccessful in our appeals and our stock price was adversely and materially impacted by the ruling, the results of the appeals process and the introduction of generic competition.

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*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.

Following the patent litigation rulings against us, 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.

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.

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states to fill a prescription 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 U.S.

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.

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

Given the changing dynamic in the U.S.

market, 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.

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

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.

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.

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.

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 England and Wales, 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 countries where we are pursuing commercialization.

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 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.

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

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, or we may face challenges in successfully achieving market opportunities available to us.

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

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

For example, after the conclusion of negotiations with the National Association of Statutory Health Insurance Funds, a viable agreement on the reimbursement price of VAZKEPA in Germany could not be reached.

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We may be unsuccessful in expanding our global footprint.

We are launching VAZKEPA on our own in the most commercially significant markets in Europe.

We are launching VAZKEPA on our own in the most commercially significant markets in Europe, and intend to redesign our commercial infrastructure in Europe.

The commercial launch of a new pharmaceutical product is a complex and resource heavy undertaking for a company to manage and may be impacted by decisions by and interactions with local regulators.

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

our inability to attract and retain adequate numbers of effective sales and marketing personnel and senior management, particularly in light of our recent reductions in force and turnover on the management team;

our inability to attract and retain adequate numbers of effective sales and marketing personnel and senior management, particularly in light of our recent reductions in force, including our ORP announced in July 2023, and turnover on the management team;

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 of our sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe or patients to use VASCEPA;

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;

overestimating the addressable market for VASCEPA;

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

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

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.

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Drugs remain heavily scrutinized for cost containment.

As a result, payors are becoming more restrictive regarding the use of biopharmaceutical products and scrutinizing the prices of these products while requiring a higher level of clinical evidence to support the benefits such products bring to patients and

the broader healthcare system.

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

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

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

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Similarly, fiscal constraints may also affect the extent to which countries are willing to approve new and innovative therapies and/or allow access to new technologies.

The dynamics and developments discussed above serve to create pressure on the pricing and potential usage of our products and the industry.

The dynamics and developments discussed above serve to create pressure on the pricing and potential usage of products throughout the pharmaceutical industry, including VASCEPA.

Given the diverse interests in play among payors, biopharmaceutical manufacturers, policy makers, healthcare providers and independent organizations, if and whether the parties involved can achieve alignment on the matters discussed above remains unclear and the outcome of any such alignment is difficult to predict.

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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 

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.

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

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

natural disasters, pandemics, international conflicts and political unrest, all of which could negatively impact our supply chain or inhibit our ability to promote VASCEPA regionally and which could negatively affect product demand by creating obstacles for patients to seek treatment and fill prescriptions;

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

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FDA or the EC, the U.S.

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

FDA or the EC could re-evaluate 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.

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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.

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.

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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.

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 the implementation of our cost reduction and organizational restructuring plan, 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 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.

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 we have been pursuing increased face-to-face interactions with targeted health care professionals as protocols have eased and travel has resumed to more stable levels.

Such efforts are costly and there can be no assurance that they will result in an increase in VASCEPA prescriptions and sales in the near future, or at all.

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.

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There are many pharmaceutical companies, biotechnology companies, public and private universities and research organizations actively engaged in the research and development of products that may be similar to our product.

We expect that the number of companies seeking to develop products and therapies similar to VASCEPA will increase.

We expect that the number of companies seeking to develop products and therapies similar to VASCEPA may increase.

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

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

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

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

Our competitors include large, well-established pharmaceutical and generic companies, specialty and generic pharmaceutical sales and marketing companies, and specialized cardiovascular treatment companies.

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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.”

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.

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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

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.

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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 results.

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.

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

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

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.

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FDA enforcement activity, to make claims that suggest or imply treatment of cardiovascular disease.

These factors enable dietary supplements to compete with VASCEPA.

We may not be successful in such efforts, or such efforts may prove too costly to be effective.

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).

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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 6 months’

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.

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Similar requirements exist in many of these areas in other countries.

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.

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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 B.

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.

Those rebates are based on pricing data reported by us on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug Rebate program.

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Our failure to comply with these price reporting and rebate payment obligations could negatively impact our financial results.

The ACA made significant changes to the Medicaid Drug Rebate program.

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively the ACA, made significant changes to the Medicaid Drug Rebate program.

CMS issued a final regulation, which became effective in 2016, to implement the changes to the Medicaid Drug Rebate program under the ACA.

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Significant civil monetary penalties can be applied if we are found to have knowingly submitted any false pricing information to CMS, or if we fail to submit the required price data on a timely basis.

Such conduct also could be grounds for CMS to terminate our Medicaid drug rebate agreement, in which case federal payments may not be available under Medicaid or Medicare Part B for our covered outpatient drugs.

Such conduct also could be grounds for CMS to terminate our Medicaid drug rebate agreement, in which case federal payments may not be available under Medicaid or Medicare Part D for our covered outpatient drugs.

Significant civil monetary penalties also can be applied if we are found to have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price.

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 B programs and purchased by certain federal agencies and grantees, as noted above, we participate in the VA’s FSS pricing program.

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.

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The rebates are calculated as the difference between the annual Non-FAMP and FCP.

We are required to list our covered products on a Tricare Agreement in order for these products to be eligible for DOD formulary inclusion.

We are required to list our covered products on a Tricare Agreement in order for

these products to be eligible for DOD formulary inclusion.

If we overcharge the government in connection with our FSS contract or Tricare Agreement, whether due to a misstated FCP or otherwise, we are required to refund the difference to the government.

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Increasingly, third-party payors are challenging the prices charged for medical products and services.

Some third-party payor benefit packages restrict reimbursement, charge copayments to patients, or do not provide coverage for specific drugs or drug classes.

Some third-party payor benefit packages restrict reimbursement, charge copayments to patients, or do not provide coverage for specific drugs, uses, or drug classes.

In addition, certain U.S.-based healthcare providers are moving toward a managed care system in which such providers contract to provide comprehensive healthcare services, including prescription drugs, for a fixed cost per person.

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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.

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:

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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.

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.

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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.

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.

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The process of establishing, maintaining, expanding and streamlining a commercial infrastructure is difficult, expensive and time consuming, particularly when such efforts need to adapt to changing market and business dynamics.

We implemented cost and organizational restructuring plans, which included a reduction to our U.S.

commercial team to approximately 75 sales representatives by the end of 2022.

Our sales team promotes VASCEPA to a targeted group of physicians and other healthcare professionals in select geographies in the United States who recognize the potential benefit to patients, and this team is not large enough to call upon a sufficient number of physicians.

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

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.

Although we are preparing for growth in Europe and elsewhere by expanding our infrastructure, we are operating with streamlined teams 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.

In 2022 we implemented cost and organizational restructuring plans, which included a reduction to our U.S.

commercial team 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 ORP.

As a result, we do not have a sales team to promote VASCEPA to physicians and other healthcare professionals in the United States, and will rely on only our managed care and trade organization to support sales of VASCEPA in the United States.

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

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.

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.

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

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

Despite recent improvements, the ongoing presence of COVID-19 has created significant volatility, uncertainty and disruption in healthcare, social, supply and economic infrastructures.

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

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

governmental, business and individuals’

actions taken in response to the pandemic;

the impact of the pandemic on economic and political activity and our supply chain;

the effect on patients, healthcare providers and business partners, including patients’

*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.

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;

the impact that changes in patients’

changes in patients’

and healthcare providers’

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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.

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

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

Risks Related to Our Reliance on Third Parties

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costs associated with projected expansion and qualification can be significant, and lead-times for supply purchases and capacity expansion are long requiring certain supply related decisions and commitment to be made in advance of commercial launch, including in China and various European countries.

Our aggregate capacity to produce API is dependent upon the continued qualification of our API suppliers and, depending on the ability of existing suppliers to meet our supply demands, and the ability to qualify any new suppliers.

If no additional API supplier is approved by the U.S.

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Certain of our agreements with our suppliers include minimum purchase obligations and limited exclusivity provisions.

These purchases are generally made on the basis of rolling 12-month forecasts which in part are binding on us and the balance of which are subject to adjustment by us subject to certain limitations.

These purchases are generally made on the basis of rolling 12-month forecasts which in part are binding on us and the balance of which are

subject to adjustment by us subject to certain limitations.

Certain of our agreements also include contractual minimum purchase commitments regardless of the rolling 12-month forecasts.

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These parties exercise a substantial amount of bargaining power over us given their control over large segments of the market for VASCEPA.

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

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’

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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.

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

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

Consolidation among these industry participants could increase the pressure on us from these market dynamics.

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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 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.

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.

We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process will produce our product according to the specifications previously submitted to or approved by the U.S.

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This would increase our reliance on such third-party manufacturer or require us to obtain a license from such third-party manufacturer in order to have another third-party manufacturer manufacture our products or product candidates.

In addition, in the case of the third-party manufacturers that supply our product candidates, changes in manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer.

In addition, in the case of the third-party manufacturers that supply our product candidates, changes in manufacturers often involve changes in manufacturing procedures and

processes, which could require that we conduct bridging studies between our prior clinical supply used in our clinical trials and that of any new manufacturer.

We may be unsuccessful in demonstrating the comparability of clinical supplies which could require the conduct of additional clinical trials.

There are comparable foreign requirements under ICH guidelines.

In addition, certain past COVID-19 restrictions have affected Regulatory Agencies' ability to conduct facility inspections and may affect the timing of further approvals.

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.

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This requirement is referred to as process validation.

Process validation includes stability testing,

measurement of impurities and testing of other product specifications by validated test methods.

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

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

On March 27, 2020, former President Trump signed into law the CARES Act in response to the COVID-19 pandemic.

Throughout the COVID-19 pandemic, there has been public concern over the availability and accessibility of critical medical products, and the CARES Act enhances U.S.

FDA’s existing authority with respect to drug shortage measures.

Under the CARES Act, we must have in place a risk management plan that identifies and evaluates the risks to the supply of approved drugs for certain serious diseases or conditions for each establishment where the drug or API is manufactured.

The risk management plan will be subject to U.S.

FDA review during an inspection.

If we experience shortages in the supply of our marketed products, our results could be materially impacted.

FDA and similar foreign regulatory bodies may also implement new requirements, or change their interpretation and enforcement of existing requirements, for manufacture, packaging or testing of products at any time.

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FDA or similar foreign regulatory bodies.

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

FDA has been working to resume pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections.

Should the U.S.

FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the U.S.

FDA does not determine a remote interactive evaluation to be adequate, the agency has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed.

During the COVID-19 public health emergency, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications.

Regulatory authorities outside the U.S.

may adopt similar restrictions or other policy measures in response to the ongoing COVID-19 pandemic and may experience delays in their regulatory activities.

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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 with anticipated approval in Mainland China expected by midyear 2023.

Submission for the approval of the REDUCE-IT indication in Mainland China is planned by the end of 2023.

However, Edding may be required to undertake clinical development efforts in these markets, or Edding may face challenges or be unsuccessful in pursuing commercial launch.

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

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

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

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 and with CSL Seqirus, or CSL, to commercialize and distribute VASCEPA in Australia and New Zealand.

Further, any development and regulatory efforts in the China Territory may be negatively impacted by the lingering effects of the coronavirus pandemic.

Any development and regulatory efforts in the China Territory may be negatively impacted by heightened political tension between China and the United States, including issues expressed between the countries regarding trade practices, tariffs and honoring intellectual property rights.

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 and Lotus Pharmaceuticals, or Lotus, to commercial and distribute VASCEPA in several countries in Southeast Asia.

Although Biologix is currently actively commercializing VASCEPA in the United Arab Emirates and Lebanon, 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.

Further, development and commercialization across the Middle East and North Africa is subject to similar risks as in the China Territory, and has been negatively impacted by COVID-19 and the destabilized local economies in the region.

If Edding, Biologix, HLS or CSL, 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.

If Edding, Biologix, HLS, CSL or Lotus, 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.

Our efforts to launch and support commercialization of VAZKEPA on our own in Europe is a complex undertaking for a company that, other than our launch of VAZKEPA in Germany in September 2021 (where operations were subsequently discontinued) and the launch of VAZKEPA in certain countries in the fourth quarter of 2022, including the UK in October 2022, has not launched or otherwise commercialized a product in Europe and could be subject to significant risks of execution to our successful development and revenue generation of VAZKEPA in Europe.

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Refer to “

Business - Government Regulation - Fraud and Abuse Laws and Data Regulation " for further details.

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.

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.

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If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be delayed in obtaining regulatory approvals for our product candidates and may be delayed in our efforts to successfully commercialize our product candidates for targeted diseases.

In addition, investigator initiated trials, or IITs, which are scientific research that is initiated, sponsored, and conducted by an independent investigator(s) and/or institution(s) not affiliated with us, are being, and additional IITs, may be conducted involving potential product candidates.

The investigator, sponsor, and/or investigator/sponsor remains responsible for conception, design, data analysis, publication, and compliance with applicable law.

Investigator initiated trials can contribute towards enhancing the understanding of products (such as mechanism of action) and sparking new ideas for further research;

however, IITs are generally not supported by pharmaceutical companies for the purposes of generating data that can lead to product labelling changes.

Even if an IIT has positive results, additional studies, along with regulatory agency guidance and approval, would be required to advance a pharmaceutical product to the next stage of development and new potential labelling changes or indications.

If we are unable to confirm or replicate the results from an IIT or if negative results are obtained, we would likely be further delayed or prevented from advancing further clinical development.

Further, if the data proves to be inadequate compared to the firsthand knowledge we might have gained had the IIT been sponsored and conducted by us, then our ability to design and conduct any future clinical trials ourselves may be adversely affected.

Negative results in IITs could have a material adverse effect on our efforts to obtain regulatory approval for such product candidates and the public perception of such product candidates.

In addition, third parties that are investigating product candidates which have not been provided by us may seek and obtain regulatory approval of product candidates before we do, which may adversely affect our development strategy and eligibility for certain exclusivities for which we may otherwise be eligible.

Risks Related to Our Intellectual Property

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On November 30, 2020, we filed a patent infringement lawsuit against Hikma for making, selling, offering to sell and importing generic icosapent ethyl capsules in and into the United States in a manner that we allege has induced the infringement of patents covering the use of VASCEPA to reduce specified CV risk.

On January 25, 2021, we expanded the scope of this patent infringement lawsuit to include a health care insurance provider, Health Net, LLC.

On January 25, 2021, we expanded the scope of this patent infringement lawsuit to include a healthcare insurance provider, Health Net, LLC.

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

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We entered into a settlement agreement with Health Net, LLC on December 26, 2022.

The Company will continue to consider its legal options against parties similarly situated to Health Net and Hikma and acting in concert with either by making or selling any drug product or component thereof covered by the subject patents, or inducing others to do the same.

The Company intends to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of these lawsuits or any subsequently filed lawsuits.

The Company intends to continue to vigorously enforce its intellectual property rights relating to VASCEPA, but cannot predict the outcome of these lawsuits or any subsequently filed lawsuits.

Patent litigation is a time-consuming and costly process.

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Several of our patent applications contain claims that are based upon what we believe are unexpected and favorable findings from our clinical trials.

However, our pending patent applications may not be granted or, if they grant, that they will prevent competitors from competing with VASCEPA.

However, our pending patent applications may not be granted or, if they are granted, there is no certainty that they will prevent competitors from competing with VASCEPA.

Securing patent protection for a product is a complex process involving many legal and factual questions.

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In January 2023, we disclosed our 2023 financial outlook.

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

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.

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

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

Given our rapidly expanding enterprise coupled with a streamlined management structure and sales force and the changes to our Board and the recently announced departure of our 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 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.

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.

As we continue to expand our commercialization efforts, particularly on a global scale, we may experience continued or increased turnover among members of our senior management team.

As we continue to expand our commercialization efforts globally we may experience continued or increased turnover among members of our senior management team.

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

As we expand 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, employees are increasingly being recruited by other companies.

While our business remains focused on continued promotion of VASCEPA in the United States, and expansion in Europe, the current and potential threat of generic competition and our recent reductions in force can create employee uncertainty which could lead to increased employee turnover.

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

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.

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

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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 had 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.

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.

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gross product sales.

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.

Customers A, B, and C accounted for 21%, 39%, and 31%, respectively, of gross product sales for the three months ended March 31, 2022, and represented 29%, 37%, and 28%, respectively, of the gross accounts receivable balance as of March 31, 2022.

Customers A, B, and C accounted for 30%, 36%, and 28%, respectively, of gross product sales for the six months ended June 30, 2023, and represented 39%, 34%, and 22%, respectively, of the gross accounts receivable balance as of June 30, 2023.

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

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

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We have not yet reached sustained profitability.

For the fiscal year ended December 31, 2022 and 2020, we reported net losses of approximately $105.8 million and $18.0 million, respectively.

For the fiscal years ended December 31, 2022 and 2020, we reported net losses of approximately $105.8 million and $18.0 million, respectively.

For the fiscal year ended December 31, 2021, we reported net income of approximately $7.7 million.

We had an accumulated deficit as of December 31, 2022 of $1.5 billion.

For the three months ended March 31, 2023 and 2022, we reported losses of approximately $16.5 million and $31.6 million, respectively, and we had an accumulated deficit as of March 31, 2023 of $1.5 billion.

For the six months ended June 30, 2023 and 2022, we reported losses of approximately $34.0 million and $101.5 million, respectively, and we had an accumulated deficit as of June 30, 2023 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.

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We have been generating product revenue from sales of VASCEPA since January 2013, but we may not be able to generate sufficient revenue to achieve a steady state of profitability.

Our ability to generate profits on sales of VASCEPA is subject to the market acceptance and commercial success of VASCEPA and our ability to manufacture commercial quantities of VASCEPA through third parties at acceptable cost levels, and may also depend upon our ability to effectively market and sell VASCEPA through our strategic collaborations.

Our ability to generate profits on sales of VASCEPA is subject to the market acceptance and commercial

success of VASCEPA and our ability to manufacture commercial quantities of VASCEPA through third parties at acceptable cost levels, and may also depend upon our ability to effectively market and sell VASCEPA through our strategic collaborations.

Even though VASCEPA has been approved by the U.S.

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Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year, and VASCEPA prescription figures will likely fluctuate from month to month.

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

VASCEPA sales are difficult to predict from period to period and as a result, you should not rely on VASCEPA sales results in any period as being indicative of future performance.

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

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

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, for example, including obtaining necessary regulatory approvals, favorable pricing and establishing marketing channels;

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;

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the extent to which coverage and reimbursement for VASCEPA is available from government and health administration authorities, private health insurers, managed care programs and other third-party 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 recent cost reduction plan, and the resulting effectiveness of those efforts;

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’

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outcomes of litigation and other legal proceedings;

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

lasting impacts from the COVID-19 pandemic;

our ongoing regulatory dialogue.

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We currently operate with limited resources.

We believe that our cash and cash equivalents balance of $191.4 million and short-term investment balance of $113.0 million as of March 31, 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 $233.0 million and short-term investment balance of $79.9 million as of June 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 have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect or fail to achieve positive cash flow.

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the timing, amount and consistency of revenue generated from the commercial sale of VASCEPA;

the costs associated with commercializing VASCEPA in the United States and sales force sizing, and for commercializing VAZKEPA in Europe, including hiring experienced professionals, and for additional regulatory approvals internationally, if any, the cost and timing of securing commercial supply of VASCEPA and the timing of entering into any new strategic collaboration with others relating to the commercialization of VASCEPA, if at all, and the terms of any such collaboration;

the costs associated with commercializing VASCEPA in the United States, and for commercializing VAZKEPA in Europe, including hiring experienced professionals, and for additional regulatory approvals internationally, if any, the cost and timing of securing commercial supply of VASCEPA and the timing of entering into any new strategic collaboration with others relating to the commercialization of VASCEPA, if at all, and the terms of any such collaboration;

continued costs associated with litigation and other legal proceedings and governmental inquiries;

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

As of April 30, 2023, we had 407,687,476 common shares outstanding including 387,307,491 shares held as ADSs and 20,379,985 held as ordinary shares (which are not held in the form of ADSs).

As of July 31, 2023, we had 407,909,197 common shares outstanding, including 387,502,130 shares held as ADSs and 20,407,067 held as ordinary shares (which are not held in the form of ADSs).

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

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corporation will be treated as owning its proportionate share of the assets and earning its proportionate share of the income of any other corporation in which it owns, directly or indirectly, no more than 25% (by value) of the stock.

Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, 2022 and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future.

Based on certain estimates of our gross income and gross assets, the latter determined by reference to the expected value of our ADSs and ordinary shares, we believe that we will not be classified as a PFIC for the taxable year ended December 31, 2022 and we do not expect to be treated as a PFIC in any future taxable year for the foreseeable future.

However, because PFIC status is based on our income, assets and activities for the entire taxable year, which we expect may vary substantially over time, it is not possible to determine whether we will be characterized as a PFIC for any taxable year until after the close of the taxable year.

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

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

protections provided under the Takeover Code.

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

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

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courts predicated upon the civil liability provisions of the federal securities laws of the United States.

We have been advised by our English solicitors that there is doubt as to the enforceability in England in original actions, or in actions for

enforcement of judgments of U.S.

We have been advised by our English solicitors that there is doubt as to the enforceability in England in original actions, or in actions for enforcement of judgments of U.S.

courts, of civil liabilities to the extent predicated upon the federal securities laws of the United States.

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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.

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.

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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.

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.

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

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

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

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

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

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

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

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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.

The extent and duration of these market disruptions, whether as a result

of the military conflict between Russia and Ukraine, geopolitical tensions, record inflation or otherwise, are impossible to predict, but could be substantial.

The extent and duration of these market disruptions, whether as a result of the military conflict between Russia and Ukraine, geopolitical tensions, record inflation or otherwise, are impossible to predict, but could be substantial.

Any such disruptions may also magnify the impact of other risks described in this report.

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