What changed in this filing

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Item 1. Legal Proceedings

2024-07-31 compared with 2024-05-01 · 61 added, 56 removed, 1015 unchanged (10% of the section changed)

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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.

Refer to Note 5 – Commitments and Contingencies in this Quarterly Report for any legal proceedings that became reportable during the three and six months ended June 30, 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.

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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 fiscal year ended December 31, 2023 filed with the SEC on February 29, 2024, 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 year ended December 31, 2023 filed with the SEC on February 29, 2024, or our Annual Report.

Summary Risk Factors

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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;

• 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;

• our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program, 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.

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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.

Although these initiatives reduced operating costs by $50.0 million annually, 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.

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

We have strategic collaborations for the development and commercialization of VASCEPA in Canada, the Middle East, Australia, New Zealand, Greater China, South Korea and many markets in Southeast Asia, and Israel.

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;

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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.

Results from this study were presented during the 2022 American Heart Association Scientific Sessions in November 2022 and were consistent with the evidence from the REDUCE-IT study.

Results from this study were presented during the 2022 American Heart Association Scientific Sessions in November 2022 and published online in the journal Circulation in June 2024 and were consistent with the evidence from the REDUCE-IT study.

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 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.

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 and was approved on June 28, 2024, following approval Edding is working to 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 and safety 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.

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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.

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.

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

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With generic versions of VASCEPA launched in the U.S.

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.

by companies that could 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.

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.

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

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

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

Reddy's, Apotex and Teva have done.

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, Teva and others have done.

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

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

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.

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

23-cv-01016, 24-cv-04341 and 24-cv-07041, respectively) making allegations consistent with the Dr.

Reddy's complaint.

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FDA has expressly permitted dietary supplement manufacturers that sell supplements containing the omega-3 fatty acids EPA and/or DHA to make the following qualified health claim directly to consumers:

Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.

Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk

of coronary heart disease.

Such companies are not, however, permitted, based on U.S.

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Third-party payors decide which products and services they will cover and the conditions for such coverage.

For example, a large national pharmacy benefit manager, or PBM, recently notified the Company that, effective July 1, 2024, the PBM intends to no longer cover VASCEPA as the exclusive icosapent ethyl product for its commercial national formularies and will be transitioning VASCEPA to not covered.

While this decision does not impact VASCEPA coverage within Medicare Part D formularies of the PBM, the PBM's decision not to cover VASCEPA as the exclusive icosapent ethyl product for its commercial formularies will limit our ability to market and sell VASCEPA.

Third-party payors also establish reimbursement rates for those products and services.

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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.

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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.

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.

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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.

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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.

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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 derivative, combination or next generation product candidate.

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 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.

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We require supply capacity to support our direct and indirect commercialization of VASCEPA.

We are also committed to providing supply to our commercial partners and distributors in Australia and New Zealand, Canada, China, the Middle East and North Africa, South Korea and Southeast Asia, and Israel, and we anticipate potential additional supply requirements as we pursue commercial opportunities in other countries.

We are also committed to providing supply to our commercial partners and distributors in Australia and New Zealand, Canada, China, the Middle East and North Africa, South Korea and Southeast Asia, Greece and Israel, and we anticipate potential additional supply requirements as we pursue commercial opportunities in other countries.

The resources of our suppliers vary and are limited;

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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.

Further, PBMs may 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, 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.

PBMs also have discretion to no longer cover the Company's products.

For example, a large national PBM recently notified the Company that effective July 1, 2024, the PBM intends to no longer cover VASCEPA as the exclusive icosapent ethyl product for its commercial national formularies, as further discussed above.

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

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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.

any new manufacturer.

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

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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 have expanded our VASCEPA commercialization activities outside of the United States through several contractual arrangements in territories including China, the Middle East, North Africa, Canada and, most recently, Australia, New Zealand, South Korea and Southeast Asia, and Israel.

We continue to assess other opportunities to develop VASCEPA commercialization outside of the United States through similar arrangements.

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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.

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

In June 2024, Edding received approval for the REDUCE-IT indication in Mainland China.

However, Edding may face challenges or be unsuccessful in commercial launch.

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

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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.

If Edding, Biologix, HLS, CSL, Lotus, Neopharm or Vianex, 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 the launch of VAZKEPA in certain countries in the last two years, 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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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 healthcare insurance provider, Health Net, LLC.

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

On October 13, 2022, the district court granted final judgement and the Company is appealing (Fed.

23-1169 filed November 21, 2022) the decision of the district court but cannot predict the outcome or the impact on its business.

On January 4, 2022, the district court for the District of Delaware granted a motion to dismiss our lawsuit for failure to state a claim.

Thereafter, we appealed the district court dismissal to the Court of Appeals for the Federal Circuit.

On June 25, 2024, the Federal Circuit issued a decision reversing the district court's ruling, finding that our allegations against Hikma plausibly state a claim alleging Hikma actively induced infringement of the asserted patents.

The case will return to the district court and proceed accordingly but we cannot predict the outcome or the impact on its business.

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

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

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

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

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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 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.

Given our rapidly expanding enterprise coupled with a streamlined management structure and sales force, the resignation of our CEO in 2024 and turnover on the 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.

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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

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.

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gross product sales.

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.

Customers A, B, and C accounted for 28%, 34%, and 29%, respectively, of gross product sales for the six months ended June 30, 2024, and represented 40%, 30%, and 21%, respectively, of the gross accounts receivable balance as of June 30, 2024.

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.

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

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We had an accumulated deficit as of December 31, 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.

For the six months ended June 30, 2024 and 2023, we reported losses of approximately $8.4 million and $34.0 million, respectively, and we had an accumulated deficit as of June 30, 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.

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We currently operate with limited resources.

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 believe that our cash and cash equivalents balance of $215.9 million and short-term investment balance of $90.7 million as of June 30, 2024 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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Risks Related to Ownership of our ADSs and Common Shares

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.

Our efforts to return capital to our shareholders and increase shareholder value, including our share repurchase program, 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.

We received court approval to undertake a reduction of capital in order to create the necessary distributable profits for the funding of the repurchases in May 2024.

We have not commenced any share repurchases to date, but we will continue to monitor business and market conditions.

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.

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

We received an additional deficiency letter in May 2024, as our ADSs had traded below $1.00 for 30 consecutive business days and to date continue to trade below $1.00.

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

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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 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).

As of July 26, 2024, we had 411,171,121 common shares outstanding, including 402,356,734 shares held as ADSs and 8,814,387 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.

Our planned share repurchase program, 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.

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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.

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.

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.

In addition, a non-U.S.

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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).

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.

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

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

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

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

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

What changed 10-Q

Item 1. Legal Proceedings