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Our referral sources are not contractually obligated to refer patients to us and may refer their patients to other providers.
−Removed: Our growth and profitability depends, in part, on our ability to establish and maintain close working relationships with these patient referral sources and to increase awareness and acceptance of the benefits of home infusion by our referral sources and their patients.
+Added: Our growth and profitability depend, in part, on our ability to establish and maintain close working relationships with these patient referral sources and to increase awareness and acceptance of the benefits of home infusion by our referral sources and their patients.
Our loss of, or failure to maintain, existing relationships or our failure to develop new referral relationships could have a material adverse effect on our business and consolidated financial condition, results of operations, and cash flows.
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Any changes to these relationships, including, but not limited to, the loss of a manufacturer relationship, drug shortages or changes in pricing, could have an adverse effect on our business and financial results.
+Added: For example, in October 2024, we received notice of a manufacturer’s intention to significantly reduce the spread at which we procure a certain therapy relative to drug reference prices beginning in early 2025, which is expected to negatively impact gross profit by approximately $60 million to $70 million dollars in 2025.
Some pharmaceutical manufacturers attempt to limit the number of preferred distributors that may market certain of their pharmaceutical products.
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A disruption in pharmaceutical and medical supply could adversely impact our business.
−Removed: For the year ended December 31, 2023, approximately 72% of our pharmaceutical and medical supply purchases were from four vendors.
+Added: For the year ended December 31, 2024, approximately 58% of our pharmaceutical and medical supply purchases were from three vendors.
Most of the pharmaceuticals that we purchase are available from multiple sources, and we believe they are available in sufficient quantities to meet our needs and the needs of our patients.
1 unchanged sentence
Should a supply disruption result in our inability to obtain especially high margin drugs and compound components necessary for patient care, our consolidated financial statements could be negatively impacted.
+Added: In addition, there is currently significant uncertainty with respect to trade policies, treaties, tariffs and customs duties and taxes.
+Added: If tariffs, trade restrictions or trade barriers are expanded, increased or interpreted by a court or governmental agency to apply to more of our products, then our exposure to future taxes and duties on such imported products and components could be significant and could have a material effect on our financial results.
A shortage of qualified registered nursing staff, pharmacists and other professionals could adversely affect our ability to attract, train and retain qualified personnel and could increase operating costs.
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As a result of such older drugs losing patent protection and being replaced by generic substitutes, new and less expensive delivery methods (such as when an infusion or injectable drug is replaced with an oral drug) or additional products that are added to a therapeutic class, increase price competition among competing manufacturers’ products in that therapeutic category.
−Removed: We have experienced a decrease in revenue and net income as a result of the withdrawal from the market of a drug related to the treatment of pre-term labor and the introduction of an oral alternative drug related to the treatment of ALS.
In such cases, manufacturers have the ability to increase drug acquisition costs or lower the selling price of replaced products.
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Our acquisitions resulted in significant goodwill reported on our financial statements.
−Removed: Goodwill results when the purchase price exceeds the fair value of the net identifiable tangible and intangible assets acquired.
+Added: Goodwill results when the purchase price exceeds the fair value of the identifiable tangible and intangible assets and liabilities acquired.
We may not realize the full value of this goodwill.
1 unchanged sentence
The Company completes its goodwill impairment test annually in the fourth quarter on a qualitative basis.
−Removed: If the fair value is more likely than not less than the carrying value, a quantitative assessment would be performed.
+Added: If the fair value is more likely than not less than the carrying value, a quantitative assessment will be performed.
When evaluating goodwill for potential impairment on a quantitative basis, we compare the fair value of our reporting units to their respective carrying amounts.
5 unchanged sentences
A significant change in, or noncompliance with, governmental regulations and other legal requirements could have a material adverse effect on our reputation and profitability.
−Removed: We operate in complex, highly regulated environments and could be materially and adversely affected by changes to applicable legal requirements including the related interpretations and enforcement practices, new legal requirements and/or any failure to comply with applicable regulations.
+Added: We operate in complex, highly regulated environments and could be materially and adversely affected by changes to applicable legal requirements including related interpretations and enforcement practices, new legal requirements and/or any failure to comply with applicable regulations.
Our home infusion and alternate site infusion businesses are subject to numerous federal, state and local regulations including licensing and other requirements for pharmacies and reimbursement arrangements.
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In addition, from time to time, CMS revises the reimbursement systems used to reimburse healthcare providers, which may result in reduced Medicare payments.
+Added: Most recently, the Inflation Reduction Act of 2022 (the “IRA”) granted CMS the authority to negotiate drug prices under Medicare Part D, with price controls taking effect in 2026.
+Added: In August 2024, CMS announced the results of its first round of drug price negotiations, which included a 66% reduction from 2023 list price for one therapy in our portfolio.
+Added: The manufacturer of this therapy subsequently informed us in October 2024 of its intent to significantly reduce our procurement spread relative to drug reference prices beginning in early 2025.
+Added: The direct and indirect impact IRA-mandated price negotiations and future CMS determinations is expected to negatively impact our results of operations.
For the year ended December 31, 2024, 12% of our revenue was derived from reimbursement by direct federal and state programs such as Medicare and Medicaid.
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Further, many states have taken steps to reduce coverage and/or enroll Medicaid recipients in managed care programs.
−Removed: The current economic environment has increased the budgetary pressures on many states, and these budgetary pressures have resulted, and likely will continue to result, in decreased spending, or decreased spending growth, for Medicaid programs and the Children’s Health Insurance Program in many states.
+Added: The current economic environment has increased the budgetary pressures on many states, and these budgetary pressures have resulted, and will likely continue to result, in decreased spending, or decreased spending growth, for Medicaid programs and the Children’s Health Insurance Program in many states.
In some cases, Third-Party Payers rely on all or portions of Medicare payment systems to determine payment rates.
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The risks associated with third-party payers and the inability to collect outstanding accounts receivable could have a material adverse effect on our liquidity, cash flows and results of operations.
+Added: For example, in the first quarter of 2024, Change Healthcare, a subsidiary of UnitedHealth Group, experienced a cybersecurity incident that disrupted its operations, causing us to disconnect from certain Change Healthcare applications until the end of the quarter, preventing us from processing claims for services and reducing our cash flows from operations in the first quarter of 2024.
+Added: The majority of previously unprocessed claims were recognized in the second quarter of 2024.
+Added: While we have substantially addressed the backlog and resumed normal billing operations as of the fourth quarter of 2024, we continue to evaluate the impact of the incident on our broader revenue cycle management processes.
We are subject to pricing pressures and other risks involved with Third-Party Payers.
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We cannot predict the impact of changing requirements on compounding pharmacies.
−Removed: Compounding pharmacies are closely monitored by federal and state governmental agencies.
+Added: The operation of compounding pharmacies are regulated by federal and state governmental agencies.
We believe that our compounding is performed in safe environments, and we have clinically appropriate policies and procedures in place.
−Removed: We only compound pursuant to a patient-specific prescription and do so in compliance with USP 797 standards.
−Removed: The DQSA amended the FDCA to grant the FDA additional authority to regulate and monitor the manufacturing of compounded pharmaceutical drugs .
+Added: We do not believe that our current compounding practices qualify us as an outsourcing facility because we only compound pursuant to a patient-specific prescription and do so in compliance with the applicable United States Pharmacopeia, Chapter 797 (“USP 797”) standards and applicable state pharmacy laws.
+Added: Should state regulators or the FDA disagree, or should our business practices change to qualify us as an outsourcing facility, there is risk of regulatory action and/or increased resources required to comply with federal requirements imposed pursuant to the Drug Quality & Safety Act (“DQSA”) on outsourcing facilities that could significantly increase our costs or otherwise affect our results of operations.
+Added: Furthermore, we cannot predict the overall impact of increased scrutiny on compounding pharmacies.
+Added: The (“DQSA”) amended the Federal Drug & Cosmetic Act (“FDCA”) to grant the FDA additional authority to regulate and monitor the manufacturing of compounded pharmaceutical drugs.
In 2013, Congress passed the DQSA, which creates a new category of compounding facilities called outsourcing facilities that are regulated by the FDA.
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Title II of this measure, known as the Drug Supply Chain Security Act (“DSCSA”), established requirements in November 2013 to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain.
−Removed: These requirements included a 10-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” The law’s track and trace requirements are applicable to manufacturers, wholesalers, repackagers and dispensers (e.g., pharmacies) of prescription drugs.
+Added: These requirements included a 10-year timeline culminating in the building of "an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” The law’s track and trace requirements are applicable to manufacturers, wholesalers, re-packagers and dispensers (e.g., pharmacies) of prescription drugs.
The Company is currently materially compliant with the DSCSA provisions currently in effect.
−Removed: The Company also expects to be materially compliant with the additional provisions of DSCSA, which requires the electronic receipt and exchange of transaction information (with specific product identifiers for each package) and transaction statements, by the November 2023 effective date.
+Added: As an eligible trading partner, the Company believes it is materially compliant with the additional provisions of DSCSA, which requires the electronic receipt and exchange of transaction information (with specific product identifiers for each package) and transaction statements.
+Added: Please note that the FDA has issued an exemption from the enhanced drug distribution security requirements of section 582 of the FDCA for eligible trading partners until November 27, 2025.
These regulatory measures, future DSCSA regulatory measures and the potential for increased DSCSA enforcement by the FDA could increase pharmacy costs.
Noncompliance with these regulations could have an adverse impact on our reputation and profitability.
−Removed: We do not believe that our current compounding practices qualify us as an outsourcing facility and, therefore, we continue to operate consistently with USP 797 standards and applicable state pharmacy laws.
−Removed: Should state regulators or the FDA disagree, or should our business practices change to qualify us as an outsourcing facility, there is risk of regulatory action and/or increased resources required to comply with federal requirements imposed pursuant to the DQSA on outsourcing facilities that could significantly increase our costs or otherwise affect our results of operations.
−Removed: Furthermore, we cannot predict the overall impact of increased scrutiny on compounding pharmacies.
Risks Relating to Our Indebtedness
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Risks Relating to Our Common Stock
−Removed: Provisions of our corporate governance documents could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management, even if beneficial to our stockholders.
+Added: Provisions of our corporate governance documents could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our current management, even if it is beneficial to our stockholders.
Our third amended and restated certificate of incorporation contains provisions that could make it more difficult for a third party to acquire us, even if doing so might be beneficial to our stockholders.
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• provide that any amendment, alteration, rescission or repeal of our bylaws or certificate of incorporation by our stockholders will require the affirmative vote of the holders of at least 66 2∕3% of the voting power of all the then-outstanding shares of our stock entitled to vote thereon, voting together as a single class.
−Removed: These and other provisions in our certificate of incorporation, bylaws and Delaware law could make it more difficult for shareholders or potential acquirers to obtain control of our Board of Directors or initiate actions that are opposed by our then-current Board, including delay or impede a merger, tender offer or proxy contest involving the Company.
+Added: These and other provisions in our certificate of incorporation, bylaws and Delaware law could make it more difficult for shareholders or potential acquirers to obtain control of our Board of Directors or initiate actions that are opposed by our then-current Board, including delaying or impeding a merger, tender offer or proxy contest involving the Company.
The existence of these provisions could negatively affect the price of our common stock and limit opportunities to realize value in a corporate transaction.
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We cannot guarantee that our stock repurchase program will be fully implemented or that it will enhance long-term stockholder value.
−Removed: In February 2023, the Board of Directors approved a new stock repurchase program authorizing the repurchase of up to $250 million of our common stock.
−Removed: In December 2023, the Board of Directors approved an increase to its stock repurchase program authorization from $250 million to $500 million.
+Added: In January 2025, the Board of Directors approved a new stock repurchase program authorizing the repurchase of up to $500 million of our common stock.
The repurchase program does not have an expiration date, and we are not obligated to repurchase a specified number or dollar value of shares, on any particular timetable or at all.
3 unchanged sentences
Pending and future litigation could subject us to significant monetary damages and/or require us to change our business practices.
−Removed: We employ pharmacists, dieticians, nurses and other healthcare professionals.
+Added: We employ pharmacists, dietitians, nurses and other healthcare professionals.
We are subject to liability for negligent acts, omissions, or injuries occurring at any of our clinics or caused by any of our employees.
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Various aspects of our business may subject us to litigation and liability for damages.
−Removed: For example, a prescription drug dispensing error could result in a patient receiving the wrong or incorrect amount of medication, leading to personal injury or death.
+Added: For example, a prescription drug dispensing error could result in a patient receiving the wrong amount of medication, which could lead to personal injury or death.
Our business and consolidated financial statements could suffer if we pay damages or defense costs in connection with a claim that is outside the scope of any applicable contractual indemnity or insurance coverage.
−Removed: Our insurance coverage also includes property liability, cyber liability, clinical trials liability, crime liability, auto liability, workers’ compensation, employers’ liability, executive liability policies (employment practices liability, fiduciary liability, directors’ and officers’ liability), umbrella/excess liability and general liability with varying limits.
+Added: Our insurance coverage also includes property and business interruption liability, cyber liability, clinical trials liability, crime liability, auto liability, intercompany transit liability, workers’ compensation, employers’ liability, executive liability policies (employment practices liability, fiduciary liability, directors’ and officers’ liability), umbrella/excess liability and general liability with varying limits.
We cannot assure that the insurance we maintain will satisfy claims made against us or that insurance coverage will continue to be available to us at commercially reasonable rates, in adequate amounts or on satisfactory terms or at all.
1 unchanged sentence
Any claims made against us, regardless of their merit or eventual outcome, could damage our reputation and business.
−Removed: Our insurance coverage also includes fire, property damage and general liability with varying limits.
−Removed: We cannot assure that the insurance we maintain will satisfy claims made against us or that insurance coverage will continue to be available to us at commercially reasonable rates, in adequate amounts or on satisfactory terms.
−Removed: Any claims made against us, regardless of their merit or eventual outcome, could damage our reputation and business.
Pressures relating to downturns in the economy could adversely affect our business and consolidated financial statements.
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Adverse economic conditions could also cause employers to stop offering, or limit, healthcare coverage, or modify program designs, shifting more costs to the individual and exposing us to greater credit risk from patients or the discontinuance of therapy.
−Removed: The general levels of inflation and specific inflationary pressures that we have experienced in areas such as labor, transportation and medical supplies may continue to persist due to events outside of our control, for example, the COVID-19 pandemic and other potential pandemic events, supply chain disruptions, and the broader macro-economic environment.
−Removed: The sustained or continued rise of inflation may adversely impact our business operations, financial condition and results of operations.
+Added: General levels of inflation and specific inflationary pressures may impact areas such as labor, transportation and medical supplies and may persist due to events outside of our control, for example, potential pandemic events, supply chain disruptions, and the broader macroeconomic environment.
+Added: The rise of inflation may adversely impact our business operations, financial condition and results of operations.
Acquisitions, strategic investments and strategic relationships involve certain risks.
1 unchanged sentence
Acquisitions may entail numerous risks, including difficulties in assessing values for acquired businesses, intangible assets and technologies, difficulties in the assimilation of acquired operations and products, diversion of management’s attention from other business concerns, assumption of unknown material liabilities of acquired companies, amortization of acquired intangible assets that could reduce future reported earnings, and potential loss of clients or key employees of acquired companies.
−Removed: We may not be able to successfully fully integrate the operations, personnel, services or products that we have acquired or may acquire in the future.
+Added: We may not be able to successfully integrate the operations, personnel, services or products that we have acquired or may acquire in the future.
Strategic investments may also entail some of the risks described above.
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However, we may not be able to maintain these relationships or develop new strategic alliances.
−Removed: Cybersecurity risks could compromise our information and expose us to liability, which may harm our ability to operate effectively and may cause harm to our business and reputation.
+Added: Our business depends on our information systems.
+Added: A cyber-attack, security breach or our inability to effectively integrate, manage and keep our information systems secure and operational could disrupt our operations.
Cybersecurity refers to the combination of technologies, processes and procedures established to protect information technology systems and data from unauthorized access, attack, or damage.
The Company relies on its information systems to provide security for processing, transmitting, and storing confidential information about patients, customers, and personnel, such as names, addresses and other individually identifiable information protected by HIPAA and other privacy laws.
+Added: Cybersecurity risks could compromise our information and expose us to liability, which may harm our ability to operate effectively and may cause harm to our business and reputation.
Cyber incidents can result from deliberate attacks or unintentional events.
1 unchanged sentence
Compliance with changes in privacy and information security laws and with rapidly evolving industry standards may result in the Company incurring significant expense due to increased investment in technology and the development of new operational processes.
−Removed: We have not experienced any known attacks on our information technology systems that compromised any confidential information.
−Removed: We maintain our information technology systems with safeguard protections against cyber-attacks including passive intrusion protection, firewalls and virus detection software.
+Added: We may experience interruptions, delays and outages in service and availability from time to time, including infrastructure changes, human or software errors, upgrade disruptions and capacity constraints.
+Added: We have not experienced any material known attacks on our information technology systems that compromised any confidential information.
+Added: We maintain our information technology systems with safeguards against cyber-attacks including passive intrusion protection, firewalls and virus detection software.
In addition, we provide our employees with extensive training on best ways to protect our patient information, including, among others, avoiding phishing emails and sharing access to sensitive information on a need-only basis.
3 unchanged sentences
If personal information or protected health information is improperly accessed, tampered with or disclosed as a result of a security breach, we may incur significant costs to notify, and mitigate potential harm to the affected individuals, and we may be subject to sanctions and civil or criminal penalties if we are found to be in violation of the privacy or security rules under HIPAA or other federal or state laws protecting confidential personal information.
−Removed: In addition, a security breach of our information technology systems could damage our reputation, subject us to liability claims or regulatory penalties for compromised personal information and could have a material adverse effect on our business, financial condition, and results of operations.
+Added: In addition, a security breach of our information technology systems could damage our reputation, subject us to liability claims or regulatory penalties for compromised personal information and could have a materially adverse effect on our business, financial condition, and results of operations.
Our business is dependent on the services provided by third-party information technology vendors.
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Acts of God, such as major weather disturbances, could disrupt our business.
−Removed: We operate in a network of prescribers, providers, patients and facilities that can be negatively impacted by local weather disturbances and other force majeure events.
+Added: Acts of God, such as major weather disturbances, natural disasters, or other force majeure events, could disrupt our operations, supply chain, and the services we provide to patient.
+Added: Our business relies on a network of prescribers, providers, patients and facilities that can be negatively impacted by local weather disturbances and other force majeure events.
For example, in anticipation of major weather events, patients with impaired health may be moved to alternate sites.
After a major weather event, availability of electricity, clean water and transportation can impact our ability to provide service in patients’ homes.
−Removed: Similarly, such events could impact key suppliers or vendors, disrupting the services or materials they provide to us.
+Added: Additionally, such events could impact key suppliers or vendors, disrupting the services or materials they provide to us.
Climate change, or legal, regulatory or market measures to address climate change, could adversely affect our business and results of operations.
1 unchanged sentence
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.