Content analysis
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H.S. sophomore Avg
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New words:
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Removed:
allocable, Amitiza, amortizing, anesthesia, annualized, automatically, biopharmaceutical, capped, CIA, cleaning, distancing, Dohme, ephedrine, ertapenem, ES, escrow, evolved, exchanged, globe, Horizon, Hospira, hypotension, Invanz, labeled, led, LIDODERM, Mallinckrodt, MEGACE, methodology, multiplying, notified, occurring, prospectively, quarantine, realizing, refund, remeasure, renewed, rotation, safely, seller, Sharp, speed, stream, subsumed, sulfate, Sweden, temperature, tender, tendered, travel, validly
Financial report summary
?Competition
Eagle Pharmaceuticals • Spectrum Pharmaceuticals • Royalty Pharma • La Jolla Pharmaceutical • Curis • Protara Therapeutics • Zevra Therapeutics • Ironwood Pharmaceuticals Inc - Ordinary Shares • Mallinckrodt • Zosano PharmaRisks
- We operate in a highly competitive industry.
- If other pharmaceutical companies use litigation and regulatory means to obtain approval for generic, biosimilar, OTC or other competing versions of our products, our sales may suffer.
- If pharmacies or outsourcing facilities produce compounded versions of our products, our sales may suffer.
- If we fail to successfully identify and develop additional branded and generic pharmaceutical products, obtain and maintain exclusive marketing rights for our branded and generic products or fail to introduce branded and generic products on a timely basis, our revenues, gross margin and operating results may decline.
- The success of our acquisition and licensing strategy is subject to uncertainty and acquisitions or licenses may reduce our earnings, be difficult to integrate, not perform as expected or require us to obtain additional financing.
- We may decide to sell assets, which could adversely affect our prospects and opportunities for growth.
- The availability of third-party reimbursement for our products is uncertain, and we may find it difficult to maintain current price levels. Additionally, the market may not accept those products for which third-party reimbursement is not adequately provided, and government-led efforts may seek to legislate or otherwise effect lower prices for our products.
- We may experience pricing pressure on our products due to social or political pressures, which would reduce our revenue and future profitability.
- Our business is highly dependent upon market perceptions of us, our brands and the safety and quality of our products and similar products, and may be adversely impacted by negative publicity or findings.
- Our business and financial condition may be adversely affected by existing or future legislation and regulations.
- Our customer concentration may adversely affect our financial condition and results of operations.
- We are currently dependent on outside manufacturers for the manufacture of a significant amount of our products; therefore, we have and expect to continue to have limited control of the manufacturing process and related costs. Certain of our manufacturers currently constitute the sole source of one or more of our products.
- We are dependent on third parties to supply raw materials used in our products and to provide services for certain core aspects of our business. Any interruption, mistake or failure by suppliers, distributors and collaboration partners to meet their obligations pursuant to various agreements with us could have a material adverse effect on our business, financial condition, results of operations and cash flows.
- We have limited experience in manufacturing biologic products and may encounter difficulties in our manufacturing processes, which could materially adversely affect our results of operations or delay or disrupt the manufacture and supply of those products which are reliant upon our manufacturing operations.
- The DEA limits the availability of the active ingredients used in many of our products as well as the production of these products, and, as a result, our procurement and production quotas may not be sufficient to meet commercial demand or complete clinical trials.
- If we are unable to retain our key personnel and continue to attract additional professional staff, we may be unable to maintain or expand our business.
- Our operations could be disrupted if our information systems fail or are not upgraded or are subject to cyber-attacks.
- The risks related to our global operations may adversely impact our revenues, results of operations and financial condition.
- Widespread health problems, including the recent global coronavirus, could materially and adversely affect our business.
- Supply chain and other manufacturing disruptions could negatively impact our businesses.
- We may be impacted by the effects of climate change and encounter challenges implementing sustainability-related measures.
- We are subject to risks and uncertainties associated with the Chapter 11 Cases.
- Delays in the Chapter 11 Cases may increase the risks of our being unable to confirm and consummate the Plan and increase our costs associated with the Chapter 11 Cases.
- The RSA is subject to significant conditions and milestones that may be difficult for us to satisfy.
- If the RSA is terminated, our ability to confirm and consummate the Plan could be adversely affected.
- Even if the Plan is consummated, we may not be able to achieve our goals or continue as a going concern.
- Our ability to prosecute the Chapter 11 Cases and confirm and consummate the Plan may be contested by third parties.
- In certain instances, a chapter 11 case may be converted to a case under chapter 7 of the Bankruptcy Code.
- Termination of our exclusive right to file a chapter 11 plan and the exclusive right to solicit acceptances could result in other parties in interest filing plans of reorganization, which could than under the Plan result in significant litigation and expenses.
- As a result of the Chapter 11 Cases, our historical financial information may not be indicative of our future performance.
- We may be subject to claims that will not be discharged in the Chapter 11 Cases, which could have a material adverse effect on our business, financial condition, results of operations and cash flows.
- The pursuit of the Chapter 11 Cases has consumed, and will continue to consume, a substantial portion of the time and attention of our management, which could have a material adverse effect on our business, financial condition, results of operations and cash flows, and could cause us to experience increased levels of employee attrition.
- Our current operations and future growth may require significant additional capital, and the amount and terms of our indebtedness could impair our ability to fund our capital requirements. Our current sources of financing may be insufficient to fund our cash requirements through emergence from bankruptcy.
- We may be unable to comply with restrictions imposed by the Cash Collateral Order.
- Aspects of the Chapter 11 Cases limit the flexibility of our management team in running our business.
- The trading prices of our securities have been volatile, and investments in our securities could decline in value.
- We have no plans to pay regular dividends on our ordinary shares or to conduct ordinary share repurchases.
- Our business and operations could be negatively affected by shareholder activism, which could cause significant expenses, hinder our business strategy and impact our share price.
- Our ordinary shares are quoted on the over-the-counter market, and thus may have a limited market and lack of liquidity.
- We believe it is likely that our ordinary shares will continue to decrease in value as a result of the Chapter 11 Cases.
- We are regularly the subject of material legal proceedings, including significant lawsuits, product liability claims, governmental investigations and product recalls, any of which could have a material adverse effect on our company.
- We may not have and may be unable to obtain or maintain insurance adequate to cover potential liabilities.
- Public concern around the abuse of opioids or other products including, without limitation, law enforcement concerns over diversion or marketing practices, regulatory efforts to combat abuse and litigation could result in costs to our business and damage our reputation.
- Our ability to fund our operations, maintain adequate liquidity and meet our financing obligations is reliant on our operations, which are subject to significant risks and uncertainties.
- We have significant goodwill and other intangible assets. Consequently, potential impairments of goodwill and other intangibles may significantly impact our profitability.
- We have a substantial amount of indebtedness which could adversely affect our financial position and prevent us from fulfilling our obligations under such indebtedness, which may require us to refinance all or part of our then-outstanding indebtedness. Any refinancing of this substantial indebtedness could be at significantly higher interest rates. Additionally, we have a significant amount of floating rate indebtedness and an increase in interest rates would increase the cost of servicing our indebtedness. Despite our current level of indebtedness, we may still be able to incur substantially more indebtedness and increase the associated risks.
- We may not realize the anticipated benefits from our strategic actions.
- Agreements between branded and generic pharmaceutical companies are facing increased government scrutiny.
- We are subject to various laws, court orders and regulations pertaining to the marketing of our products and services.
- The pharmaceutical industry is heavily regulated, which creates uncertainty about our ability to bring new products to market and imposes substantial compliance costs on our business.
- Our reporting and payment obligations under Medicaid and other governmental drug pricing programs are complex and may involve subjective decisions. Any failure to comply with those obligations could subject us to penalties and sanctions.
- Decreases in the degree to which individuals are covered by healthcare insurance could result in decreased use of our products.
- If our manufacturing facilities are unable to manufacture our products or we interruptions in the manufacturing process due to regulatory or other factors, it could have a material adverse effect on our business, financial condition, results of operations and cash flows.
- Non-U.S. regulatory requirements vary, including with respect to the regulatory approval process, and failure to obtain regulatory approval or maintain compliance with requirements in non-U.S. jurisdictions would prevent or impact the marketing of our products in those jurisdictions.
- If pharmaceutical companies are successful in limiting the use of generics through their legislative, regulatory and other efforts, our sales of generic products may suffer.
- New tariffs and evolving trade policy between the U.S. and other countries, including China, could have a material adverse effect on our business, financial condition, results of operations and cash flows.
- We are subject to information privacy and data protection laws that include penalties for noncompliance. Our failure to comply with various laws protecting the confidentiality of personal information, patient health information or other data could result in penalties and reputational damage.
- Our ability to protect and maintain our proprietary and licensed technology, which is vital to our business, is uncertain.
- Our competitors or other third parties may allege that we are infringing their intellectual property, forcing us to expend substantial resources litigation, the outcome of which is uncertain. Any unfavorable outcome of such litigation, including losses related to “at-risk” product launches, could have a material adverse effect on our business, financial condition, results of operations and cash flows.
- Future changes to tax laws could materially adversely affect us.
- The IRS may not agree with the conclusion that we should be treated as a non-U.S. corporation for U.S. federal income tax purposes.
- The effective rate of taxation upon our results of operations is dependent on multi-national tax considerations.
- The IRS and other taxing authorities may continue to challenge our tax positions and we may not be able to successfully maintain such positions.
- Our ability to use tax attributes to offset U.S. taxable income may be limited.
- We are incorporated in Ireland and Irish law differs from the laws in effect in the U.S. and may afford less protection to, or otherwise adversely affect, our shareholders.
- Any attempts to take us over will be subject to Irish Takeover Rules and subject to review by the Irish Takeover Panel.
- We are an Irish company and it may be difficult to enforce judgments against us or certain of our officers and directors.
Management Discussion
- Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
- This section omits discussions about 2021 items and comparisons between 2022 and 2021. Such discussions can be found in Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2022.
- The discussions in this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our audited Consolidated Financial Statements and the related Notes thereto. Except for the historical information contained in this report, including the following discussion, this report contains forward-looking statements that involve risks and uncertainties. See “Forward-Looking Statements” beginning on page i of this report.