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● our success depends on our ability to develop and/or acquire and commercialize additional pharmaceutical products;
−Removed: ● our BAQSIMI ® , Primatene MIST ® , glucagon, epinephrine, lidocaine, phytonadione, and enoxaparin products collectively represent a significant portion of our net revenues;
+Added: ● our BAQSIMI ® , Primatene MIST ® , glucagon, epinephrine, and lidocaine, products collectively represent a significant portion of our net revenues;
if the sales volume or pricing of these products decline, or if we are unable to satisfy market demand for these products, this could have a material adverse effect on our business, financial position and results of operations;
● our actual financial and operating results could differ materially from any expectations or guidance provided by us concerning future results;
−Removed: ● our success depends on the integrity of our supply chain, including multiple single source suppliers, the disruption of which could negatively impact our business;
+Added: ● our success depends on the integrity of our supply chain, including multiple single source suppliers, and reliance on a third party for the manufacture of BAQSIMI ® the disruption of which could negatively impact our business;
● our ability to develop new products and additional revenue streams depends upon a variety of factors including being able to invest ongoing revenue and borrow funds or raise additional capital when needed;
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● because a portion of our manufacturing takes place in China, a significant disruption in the construction or operation of our manufacturing facility in China, political unrest in China, tariffs, impacts of outbreaks of health epidemics, or changes in social, political, trade, health, economic, environmental, or climate-related conditions or in laws, regulations and policies governing foreign trade could materially and adversely affect our business, financial condition and results of operations;
−Removed: ● we may be exposed to product liability claims and may not be able to obtain or maintain adequate
−Removed: product liability insurance;
+Added: ● we may be exposed to product liability claims and may not be able to obtain or maintain adequate product liability insurance;
● we are exposed to risks related to our international operations and failure to manage these risks may adversely affect our operating results and financial condition;
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If health, safety, or environmental concerns arise with respect to a product, we may be forced to withdraw it from the market and be exposed to greater liability, including product liability lawsuits.
−Removed: For example, as a result of environmental concerns over the use of chlorofluorocarbons, or CFCs, the FDA, issued a final rule in 2009, that required the phase-out of the CFC formulation of our Primatene MIST ® product by the end of 2011.
−Removed: As a result, in order to resume selling Primatene MIST ® we had to develop a formulation of the product that uses hydrofluoroalkane, or HFA, as the propellant, and obtain FDA approval for the modified product, which took a significant amount of time and was not re-launched until December 2018.
There can be no guarantee that our investment in research and development activities will result in FDA approval or produce commercially viable new products.
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Necessary regulatory approvals may not be obtained in a timely manner, if at all, and we may not be able to produce and market such products successfully and profitably.
−Removed: For example, we filed an ANDA, for our enoxaparin product in March 2003, but FDA approval was not granted until September 2011 due to delays caused largely by the FDA’s requirement that we perform immunogenicity studies and the receipt of an FDA warning letter and FDA Import Alert by the supplier of the starting material for our enoxaparin product.
−Removed: Following FDA approval, we became involved in litigation with Momenta Pharmaceuticals, Inc.
−Removed: and Sandoz Inc., which further delayed the commercial launch of our enoxaparin product until January 2012.
Delays in any part of the process, or our inability to obtain regulatory approval of our products, including litigation with competitors and regulatory compliance of our suppliers and contractors, could adversely affect our operating results by restricting or delaying our introduction of new products, which could adversely impact our ability to market a prospective product.
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If we are unable to cost-effectively maintain an adequate flow of successful generic and proprietary products and new indications and/or delivery methods for existing products sufficient to cover our substantial research and development costs and the decline in sales of older products that either become subject to generic competition, or are displaced by competing products or therapies, it could have a material adverse effect on our business, financial condition or results of operations.
−Removed: Our BAQSIMI ® , Primatene MIST ® , glucagon, epinephrine, lidocaine, phytonadione, and enoxaparin products collectively represent a significant portion of our net revenues.
+Added: Our BAQSIMI ® , Primatene MIST ® , glucagon, epinephrine, and lidocaine products collectively represent a significant portion of our net revenues.
If the sales volume or pricing of these products decline, or if we are unable to satisfy market demand for these products, they could have a material adverse effect on our business, financial position and results of operations.
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Sales from our lidocaine products represented 8%, 8%, and 9% of our total net revenues for the years ended December 31, 2025, 2024, and 2023, respectively.
−Removed: Sales from our phytonadione product represented 6%, 7%, and 10% of our total net revenues for the years ended December 31, 2024, 2023, and 2022, respectively, and sales of our enoxaparin product represented 3%, 5%, and 7% of our total net revenues for the years ended December 31, 2024, 2023, and 2022, respectively.
−Removed: We have experienced declining revenue from enoxaparin and some of our other existing products in the past.
−Removed: If the sales volume or pricing of enoxaparin continues to decline, or if the sales volume or pricing of lidocaine and phytonadione declines, or if we are unable to satisfy market demand for these products, our business, financial position and results of operations could be materially and adversely affected, and the market value of our common stock could decline.
−Removed: For example, our enoxaparin product continues to see increased competition in the market, which could result in declining per unit prices as well as lower market share due to intense pricing competition in the pharmaceutical industry.
−Removed: We have experienced significant declines in the per unit pricing and gross margins attributable to our enoxaparin product since its commercial launch.
−Removed: Our BAQSIMI ® , Primatene MIST ® , glucagon, epinephrine, lidocaine, phytonadione, and enoxaparin products could be rendered obsolete or negatively impacted by numerous factors, many of which are beyond our control, including:
+Added: We have experienced declining revenue from glucagon and some of our other existing products in the past.
+Added: If the sales volume or pricing of glucagon and epinephrine multi-dose vial continues to decline, or if the sales volume or pricing of lidocaine declines, or if we are unable to satisfy market demand for these products, our business, financial position and results of operations could be materially and adversely affected, and the market value of our common stock could decline.
+Added: For example, our glucagon and our epinephrine multi-dose vial products continue to see increased competition in the market, which could result in declining per unit prices as well as lower market share due to intense pricing competition in the pharmaceutical industry.
+Added: We have experienced significant declines in the per unit pricing and gross margins attributable to our glucagon product since its commercial launch.
+Added: Our BAQSIMI ® , Primatene MIST ® , glucagon, epinephrine, and lidocaine, products could be rendered obsolete or negatively impacted by numerous factors, many of which are beyond our control, including:
● decreasing average sales prices;
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Our research and development expense was $85.8 million, $73.9 million, and $73.7 million for the years ended December 31, 2025, 2024, and 2023, respectively.
−Removed: As noted elsewhere herein, ongoing revenue from current operations is a critical component of being able to adequately fund ongoing research and development efforts in our product pipeline.
+Added: As noted elsewhere herein, ongoing revenue from current operations is a critical component of being able to adequately fund ongoing research and development efforts in our product
We may also fund our research and development using borrowed funds or funds raised through the capital markets.
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If any one, or all, of these sources become unavailable, our research and development projects may become delayed or negatively impacted.
−Removed: Our success depends on the integrity of our supply chain, including multiple single source suppliers, the disruption of which could negatively impact our business.
+Added: Our success depends on the integrity of our supply chain, including multiple single source suppliers, and reliance on a third party for the manufacture of BAQSIMI ® , the disruption of which could negatively impact our business.
Some of our products are the result of complex manufacturing processes, and some require highly specialized raw materials, and BAQSIMI ® relies on CMOs.
Because our business requires outsourcing in some instances, we are subject to inherent uncertainties related to product safety, availability and security.
+Added: We depend on CMOs and suppliers to perform manufacturing activities effectively and on a timely basis for our API and drug products.
+Added: These third parties are independent entities subject to their own unique operational and financial risks that are out of our control.
For some of our key raw materials, components and APIs used in certain of our products, we have only a single, external source of supply, and alternate sources of supply may not be readily available.
−Removed: For example, in 2009, we purchased heparin USP as the starting material for producing our enoxaparin product exclusively from a single source supplier and, in 2009, this supplier received a warning letter from the FDA and was the subject of an FDA Import Alert.
−Removed: The resulting shortage of heparin USP resulted in significant delays to the FDA approval process for our enoxaparin product.
−Removed: There are no guarantees our supplier will not receive warning letters in the future or that we will be able to replace this single source supplier with an alternate supplier on a commercially reasonable and timely basis, or at all, to prevent a shortage of heparin USP.
−Removed: Subsequently, we received FDA approval to make heparin USP from crude heparin using processes at our ANP and IMS facilities.
−Removed: In 2023, our API supplier for medroxyprogesterone discontinued making the active ingredient, which resulted in a halt in sales of the product after the third quarter of 2023.
+Added: For example, in 2023, our API supplier for medroxyprogesterone discontinued making the active ingredient, which resulted in a halt in sales of the product after the third quarter of 2023.
We were only able to relaunch this product in September 2024 following FDA qualification of our subsidiary ANP to manufacture this API.
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However, if market demand decreases or if market supply surpasses demand, whether because of macroeconomic factors, pharmaceutical industry volatility, or deficiencies specific to our customers, we may not be able to reduce manufacturing expenses or overhead costs proportionately.
−Removed: For example, a significant portion of our manufacturing capacity in our facility in Éragny-sur-Epte, France is utilized for the manufacturing of insulin API for MannKind, and a significant portion of our manufacturing capacity in Rancho Cucamonga is utilized for the manufacture of enoxaparin.
+Added: For example, a significant portion of our manufacturing capacity in our facility in Éragny-sur-Epte, France is utilized for the manufacturing of insulin API for MannKind, and, until recently, a significant portion of our manufacturing capacity in Rancho Cucamonga was utilized for the manufacture of enoxaparin.
We have amended our supply agreement with MannKind, or the Supply Agreement and our option purchase agreement with MannKind, or the Option Agreement, multiple times to modify and extend the annual minimum purchase commitments under the Supply Agreement and the Option Agreement.
This lowers the annual minimum quantities and lowers the production levels at AFP.
−Removed: Mannkind will not be purchasing RHI for the next two years as they are in the process of qualifying our upgraded RHI, which uses our internally produced inclusion bodies made at AFP.
+Added: Mannkind will not be purchasing RHI for at least the next two years as they are in the process of qualifying our upgraded RHI, which uses our internally produced inclusion bodies made at AFP.
If an increase in supply outpaces the increase in market demand, or if demand decreases, such as a further reduction in sales of insulin API for MannKind, the resulting oversupply could adversely impact our sales and result in the underutilization of our manufacturing capacity, high inventory levels, changes in revenue mix and rapid price erosion, which would lower our margins and adversely impact our financial results.
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This intensely competitive environment requires an ongoing, extensive search for technological innovations and the ability to market products effectively, including the ability to communicate the effectiveness, safety and value of our products to healthcare professionals in private practice, group practices and managed care organizations.
−Removed: Our competitors
−Removed: vary depending upon product categories and, within each product category, upon dosage strengths and upon drug-delivery systems.
+Added: Our competitors vary depending upon product categories and, within each product category, upon dosage strengths and upon drug-delivery systems.
Based on total assets, annual revenues and market capitalization, we are smaller than many of our national and international competitors with respect to both our generic and proprietary pharmaceutical products and product candidates.
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Our current and future indebtedness has and may continue to adversely affect our operating results and cash flows.
−Removed: The acquisition of BAQSIMI ® was financed with proceeds of the senior secured term loan, or the Wells Fargo Term Loan, provided by the syndicated credit agreement, or the Credit Agreement, by and among the Company, certain subsidiaries of the Company, as guarantors, certain lenders, and Wells Fargo Bank, National Association, or Wells Fargo, as Administrative Agent (in such capacity, Agent), Swing line Lender and L/C Issuer.
+Added: The acquisition of BAQSIMI ® was financed with proceeds of the senior secured term loan, or the Wells Fargo Term Loan, provided by the syndicated credit agreement, or the Credit Agreement, by and among the Company, certain subsidiaries of the Company, as guarantors, certain lenders, and Wells Fargo Bank, National Association, or Wells
+Added: Fargo, as Administrative Agent (in such capacity, Agent), Swing line Lender and L/C Issuer.
The material increase in our indebtedness as a result of the Credit Agreement and the 2.00% Convertible Senior Notes due 2029, or the 2029 Convertible Notes, has and may continue to adversely affect our operating results, cash-flows and our ability to use cash generated from operations as we satisfy our materially increased underlying interest and principal payment obligations under the Credit Agreement and the 2029 Convertible Notes, as applicable.
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Our ability to refinance our existing or future indebtedness will depend on the capital markets and our financial condition at such time.
−Removed: We may not be able to engage in any of these activities or engage in these
−Removed: activities on desirable terms, which could result in a default under the Credit Agreement, the 2029 Convertible Notes or future indebtedness.
+Added: We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default under the Credit Agreement, the 2029 Convertible Notes or future indebtedness.
If we fail to make required payments under our existing or future indebtedness, we would be in default under the terms of these agreements.
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However, we may not have enough available cash on hand or be able to obtain financing at the time we are required to make repurchases of the 2029 Convertible Notes surrendered therefor or pay cash with respect to the 2029 Convertible Notes being converted or at their respective maturity.
−Removed: In addition, our ability to repurchase the 2029 Convertible Notes or to pay cash upon conversions of the 2029 Convertible Notes or at their maturity may be limited by law, regulatory authority or agreements governing our future
−Removed: indebtedness.
+Added: In addition, our ability to repurchase the 2029 Convertible Notes or to pay cash upon conversions of the 2029 Convertible Notes or at their maturity may be limited by law, regulatory authority or agreements governing our future indebtedness.
Our failure to repurchase the 2029 Convertible Notes at a time when the repurchase is required by the Indenture or to pay cash upon the conversion of the 2029 Convertible Notes or at their maturity as required by the Indenture would constitute a default under the Indenture.
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Upon such event, if one or more holders elect to convert their 2029 Convertible Notes, we would be required to settle a portion or all of the conversion obligation in cash, which could adversely affect our liquidity.
−Removed: In addition, even if holders of the 2029 Convertible Notes do not elect to convert their 2029 Convertible Notes, we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of such 2029 Convertible Notes as a current rather than long-term liability, which would result in a material reduction of our net working capital.
+Added: In addition, even if holders of the 2029 Convertible Notes do not elect to convert their 2029 Convertible Notes,
+Added: we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of such 2029 Convertible Notes as a current rather than long-term liability, which would result in a material reduction of our net working capital.
If we fail to obtain exclusive marketing rights for our generic pharmaceutical products or fail to introduce these generic products on a timely basis, our revenues, gross margin and operating results may decline significantly.
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As patents and exclusivities protecting a brand name product expire, the first manufacturer to receive regulatory approval for a generic version of the product is generally able to achieve significant market penetration.
−Removed: Therefore, our ability to increase or
−Removed: maintain revenues and profitability in our generics business is largely dependent on our success in challenging patents and developing non-infringing formulations of proprietary products.
+Added: Therefore, our ability to increase or maintain revenues and profitability in our generics business is largely dependent on our success in challenging patents and developing non-infringing formulations of proprietary products.
As competing manufacturers receive regulatory approvals on generic products or as brand manufacturers launch generic versions of their products (for which no separate regulatory approval is required), market share, revenues and gross profit typically decline, often significantly and rapidly.
Accordingly, the level of market share, revenue and gross profit attributable to a particular generic product normally is related to the number of competitors in that product’s market and the timing of that product’s regulatory approval and launch, in relation to competing approvals and launches.
−Removed: For example, enoxaparin is currently marketed by Sanofi, under the brand name Lovenox ® .
−Removed: Sanofi also markets its authorized generic enoxaparin product through its subsidiary, Winthrop.
−Removed: Fresenius Kabi USA, Apotex Corp., Zydus Pharmaceuticals USA Inc., Sandoz, Meithael Pharmaceuticals, Inc., and others also either market or plan to market a generic version of enoxaparin.
−Removed: Other companies may have received FDA approval of enoxaparin but have not launched the product, while other companies have filed ANDAs for enoxaparin with the FDA.
−Removed: The presence of these current and prospective competitive products has had, and may continue to have, an adverse effect on our market share, revenue and gross profit from our enoxaparin product.
−Removed: Since the commercial launch of our enoxaparin product, we have experienced significant declines in sales volume, per unit pricing and gross margins attributable to this product.
+Added: For example, glucagon is also marketed by Viatris, Inc., Cipla Limited, Lupin Pharmaceuticals, Inc., and others also either market or plan to market a generic version of glucagon.
+Added: Other companies may have received FDA approval of glucagon but have not launched the product, while other companies may have filed ANDAs for glucagon with the FDA.
+Added: The presence of these current and prospective competitive products has had, and may continue to have, an adverse effect on our market share, revenue and gross profit from our glucagon product.
+Added: Since the commercial launch of our glucagon product, we have experienced significant declines in sales volume, per unit pricing and gross margins attributable to this product.
Consequently, we must continue to develop and introduce new generic products in a timely and cost-effective manner to maintain our revenues and gross margins.
−Removed: We may have fewer opportunities to launch significant generic products in the future, as the number and size of proprietary products that are subject to patent challenges is expected to decrease in the next several years compared to historical levels.
+Added: We may have fewer opportunities to launch significant generic products in the future, as the number and size of proprietary products that are subject to patent challenges is expected to decrease in the next several
+Added: years compared to historical levels.
Additionally, as new competitors enter the market, there may be increased pricing pressure on certain products, which may result in lower gross margins.
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The sale of authorized generics adversely impacts the market share of a generic product that has been granted 180-day exclusivity.
−Removed: For example, as mentioned above, Sanofi currently markets an authorized generic enoxaparin product through its subsidiary, Winthrop.
−Removed: This is a significant source of competition for us because brand companies do not face any regulatory barriers to introducing authorized generics of their products.
Because authorized generics may be sold during our exclusivity periods, if any, they can materially decrease the profits that we could otherwise receive as an exclusive marketer of a generic alternative.
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While these FDA improvements are expected to benefit our generic product pipeline, they will also benefit competitors that seek to launch products in established generic markets where we currently offer products.
−Removed: If the market for a reference brand product, such as Lovenox ® , significantly declines, sales or potential sales of our generic and biosimilar products and product candidates may suffer and our business would be materially impacted.
+Added: If the market for any of our reference brand products significantly declines, sales or potential sales of our generic and biosimilar products and product candidates may suffer and our business would be materially impacted.
Proprietary products face competition on numerous fronts as technological advances are made or new products are introduced.
−Removed: As new products are approved that compete with the reference proprietary product to our generic products and generic or biosimilar product candidates, such as Lovenox ® , which is the reference brand product for our enoxaparin product, sales of the reference brand products may be significantly and adversely impacted and may render the reference brand product obsolete.
+Added: As new products are approved that compete with the reference proprietary product to our generic products and generic or biosimilar product candidates, sales of the reference brand products may be significantly and adversely impacted and may render the reference brand product obsolete.
In addition, brand companies may pursue life cycle management strategies that also impact our generic products.
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● the product labeling approved by the FDA for our products and for competing products;
−Removed: ● the willingness of third-party payers to reimburse for our prescription products and the level of any reimbursement provided for our prescription products;
+Added: ● the willingness of third-party payers to reimburse for our prescription products and the level of any
+Added: reimbursement provided for our prescription products;
● the willingness of pharmacy chains to stock our new products;
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The group purchasing organizations with which we have relationships may have relationships with manufacturers that sell competing products, and such group purchasing organizations may earn higher margins from these competing products or combinations of competing products or may prefer products other than ours for other reasons.
−Removed: If we are unable to maintain our group purchasing organization relationships, sales of our
−Removed: products and revenue could decline.
+Added: If we are unable to maintain our group purchasing organization relationships, sales of our products and revenue could decline.
Consolidation in the health care industry could lead to demands for price concessions or for the exclusion of some suppliers from certain of our markets, which could have an adverse effect on our business, financial condition or results of operations.
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These customers are continuing to undergo significant consolidation.
−Removed: Sales to three of these customers for the years ended December 31, 2024, 2023, and 2022, respectively, accounted for approximately 64%, 60%, and 62% of our total net revenues, respectively.
+Added: Sales to three of these customers for the years ended December 31, 2025, 2024, and 2023, respectively, accounted for approximately 65%, 64%, and 60% of our total
+Added: net revenues, respectively.
Such consolidation has provided and may continue to provide them with additional purchasing leverage, and consequently may increase the pricing pressures that we face.
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At the same time, the traditional model for distribution of pharmaceutical products is also undergoing disruption as a result of the entry or potential entry of new competitors and significant mergers among key industry participants.
−Removed: For example, in 2020 Amazon launched its pharmaceutical distribution business.
−Removed: In addition, several major hospital systems in the United States formed a nonprofit company that will provide U.S.
−Removed: hospitals with a number of generic drugs.
These changes to the traditional supply chain could lead to our customers having increased negotiation leverage and to additional pricing pressure and price erosion.
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We do not carry key man life insurance on any key personnel.
−Removed: Competition among pharmaceutical companies
−Removed: for qualified employees is intense, and the ability to attract and retain qualified individuals is critical to our success.
+Added: Competition among pharmaceutical companies for qualified employees is intense, and the ability to attract and retain qualified individuals is critical to our success.
We have experienced attrition among our executive officers in the past, and any future loss of key members of our organization or any inability to continue to attract high-quality employees may delay or prevent the achievement of major business objectives.
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Also, to the extent we hire personnel from competitors, we may be subject to allegations that we have improperly solicited, or that they have divulged proprietary or other confidential information, or that their former employers own their inventions or work product.
−Removed: Our business may be adversely affected by challenging macroeconomic conditions globally resulting from pandemics or other public health outbreaks.
−Removed: Pandemics or other extended public health outbreaks or emergencies could adversely affect economies and financial markets globally and nationally, including inflationary pressures and changes in interest rates, which could continue to decrease spending and adversely affect demand for our products and harm our business and results of operations.
−Removed: To the extent macroeconomic uncertainty persists or macroeconomic conditions worsen, we may experience a continuing adverse effect on the demand for some of our products.
−Removed: The degree of impact of any pandemic and the related challenging macroeconomic conditions on our business will depend on several factors, such as the duration and the extent of the pandemic, as well as actions taken by governments, businesses, and consumers in response to the pandemic and the challenging macroeconomic conditions globally.
−Removed: Macroeconomic conditions may continue to worsen leading to changes in monetary policy and other responses from governmental bodies, infections may resurge and cause closures or supply disruptions, each of which alone or in combination with others, would have a negative impact on our business, financial condition and operating results.
+Added: Our business may be adversely affected by challenging macroeconomic conditions globally.
+Added: General conditions in the global economy and in the global financial markets could adversely affect our results of operations, and the overall demand for our products.
+Added: Downturns in economic conditions and recessions, including inflationary pressures and changes in interest rates could continue to decrease spending and adversely affect demand for our products and harm our business and results of operations.
+Added: A severe or prolonged economic downturn or political disruption could result in a variety of risks to our business, including weakened demand for our products and our ability to raise additional capital when needed on acceptable terms, if at all.
+Added: A weak or declining economy or political disruption could also strain our manufacturers or suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our products.
+Added: Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the political or economic climate and financial market conditions could adversely impact our business.
We may be exposed to product liability claims and may not be able to obtain or maintain adequate product liability insurance.
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We plan to regularly review potential acquisitions of technologies, products and businesses complementary to our business.
−Removed: For example, in 2023 we acquired BAQSIMI ® from Lilly.
+Added: For example, in 2023 we acquired BAQSIMI ® from Eli Lilly & Company.
Acquisitions typically entail many risks and could result in difficulties in integrating operations, personnel, technologies and products.
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Furthermore, there may be overlap between our products or customers and the companies that we acquire that may create conflicts in relationships or other commitments detrimental to the integrated businesses.
−Removed: If we are unable to successfully integrate technologies, products, businesses or personnel that we acquire, we could incur significant impairment charges or other adverse financial consequences.
+Added: If we are unable to successfully integrate technologies, products, businesses or personnel that we acquire, we could incur significant impairment charges or other adverse financial
+Added: consequences.
Identifying, executing and realizing attractive returns on acquisitions is highly competitive and involves a high degree of uncertainty.
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In the future, we may enter into transactions to acquire other businesses, products or technologies or enter into strategic partnerships, including licensing.
−Removed: If we do identify suitable acquisition or partnership candidates, we may not be able to
−Removed: make such acquisitions or partnerships on favorable terms, or at all.
+Added: If we do identify suitable acquisition or partnership candidates, we may not be able to make such acquisitions or partnerships on favorable terms, or at all.
Any acquisitions or partnerships we make may not strengthen our competitive position, and these transactions may be viewed negatively by customers or investors.
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Subject to the agreements governing our existing debt or otherwise, some of these transactions may be financed with our additional borrowings.
−Removed: We may suffer a loss of key employees, customers or
−Removed: suppliers, loss of revenues, increases in costs or other difficulties in connection with these transactions.
+Added: We may suffer a loss of key employees, customers or suppliers, loss of revenues, increases in costs or other difficulties in connection with these transactions.
Other transactions may advance future cash flows from some of our businesses, thereby yielding increased short-term liquidity, but consequently resulting in lower cash flows from these operations over the longer term.
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Our business and operations have been impacted in the past, and may be impacted in the future, in the event of system breach or failure.
−Removed: We, our collaborators, third-party providers, distributors, customers and other contractors utilize information technology systems and networks to transmit, store and otherwise process electronic data in connection with our business activities, including our supply chain processes, operations and communications including, in some cases, our clinical data and business proprietary information, and electronic data interchange, on purchase orders, invoices, chargebacks, among other things.
−Removed: We, and our collaborators, third-party providers, distributors and other contractors, also collect, transmit, store and otherwise process certain data relating to individuals, including about our personnel, business partners, and others, which may be subject to applicable data protection, security and privacy laws and regulations that require adoption of minimum information security standards.
+Added: We and our third-party service providers and other third parties with whom we do business, including our collaborators, third-party providers, distributors, customers and other contractors utilize information technology systems and networks to transmit, store and otherwise process electronic data in connection with our business activities, including our supply chain processes, operations and communications including, in some cases, our clinical data and business proprietary information, and electronic data interchange, on purchase orders, invoices, chargebacks, among other things.
+Added: We and such third parties, including our collaborators, third-party service providers, distributors and other contractors, also collect, transmit, store and otherwise process certain data relating to individuals, including about our personnel, business partners, and others, which may be subject to applicable data protection, security and privacy laws and regulations that require adoption of minimum information security standards.
The cost of compliance with applicable data protection, security and privacy laws and regulations have increased and may increase in the future.
−Removed: Despite our implementation of security measures to protect the confidentiality, integrity, and availability of the systems, networks and data within our control from various threats (e.g., cyber-attacks, system breaches, malware, viruses, hacking, fraudulent use, social engineering attacks, phishing attacks, ransomware attacks, credential-stuffing attacks, denial-of-service attacks, unauthorized access, insider threats, accidental disclosures, intellectual property theft and economic espionage, exploitable vulnerabilities, defects or bugs in our or our third-party providers’ systems, natural disasters, war, terrorism, telecommunications and electrical outages, breakdowns, damage, interruptions), we have experienced and may continue to experience cyber-attacks of varying degrees from time to time.
−Removed: For example, in the first quarter of 2022, our Chinese subsidiary, ANP, was subject to a security incident that resulted in a temporary disruption to some of its internal computer systems.
−Removed: We worked with ANP to improve and implement additional security measures to its systems and networks.
−Removed: We incurred minimal costs to respond to the ANP incident.
−Removed: In addition, in the second quarter of 2020, we were subject to a security incident that resulted in a temporary disruption to some of our internal computer systems.
−Removed: In response to this incident, we engaged a third-party forensic expert to investigate, and determined that cyber criminals illegally obtained certain personal information of certain current and former employees.
−Removed: We notified affected individuals and regulators, as we deemed was required or appropriate.
−Removed: We incurred minimal cost to respond to this incident.
−Removed: Our systems and networks and the systems and networks of third parties that support us and our services may be breached or disrupted due to the threats described above or otherwise.
−Removed: The size and complexity of our systems may make them potentially vulnerable to breakdown or interruption, whether due to computer viruses or other causes,
−Removed: which may result in loss of data or the impairment of production and other supply chain processes, adversely affecting our business.
+Added: Despite our implementation of security measures to protect the confidentiality, integrity, and availability of the systems, networks and data within our control from various threats (e.g., threats of cyber-attacks, system breaches, and other security breaches and incidents, malware, viruses, hacking, fraudulent use, social engineering attacks, phishing attacks, ransomware attacks, credential-stuffing attacks, denial-of-service attacks, unauthorized access, insider threats, accidental disclosures, intellectual property theft and economic espionage, exploitable vulnerabilities, defects or bugs in our or our third-party service providers’ systems, natural disasters, war, terrorism, telecommunications and electrical outages, breakdowns, damage, outages, interruptions, and other cyber-events), we and certain of our third-party service providers have experienced and may continue to experience cyber-attacks, outages, interruptions, and other cyber-events of varying degrees from time to time.
+Added: For example, in the past we have been subject to security incidents that resulted in a temporary disruption to some of its internal computer systems.
+Added: Our systems and networks and the systems and networks of our third-party service providers, have been, and in the future may be, breached or disrupted due to the threats described above or otherwise.
+Added: The size and complexity of our systems may make them potentially vulnerable to breakdown or interruption, whether due to computer viruses or other causes, which may result in loss of data or the impairment of production and other supply chain processes, adversely affecting our business.
Techniques used to sabotage or obtain unauthorized access to systems and networks are constantly evolving and, in some instances, are not identified until or after they are launched against a target.
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We and our third-party service providers who may be operating with personnel in remote work environments may have increased security risks, due to increased use of home Wi-Fi networks and virtual private networks, as well as increased disbursement of physical machines.
−Removed: Also, due to political uncertainty and military actions such as Russia’s invasion of Ukraine or conflicts in the Middle East, we and our third-party providers are vulnerable to heightened risks of cyber threats and cyber-attacks from or affiliated with nation-state actors, including attacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products and services.
+Added: Also, due to political uncertainty and military actions, we and our third-party service providers are vulnerable to heightened risks of cyber threats and cyber-attacks from or affiliated with nation-state actors, including attacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our products and services.
While we implement security measures designed to reduce these risks, there is no guarantee that these measures will be adequate to safeguard all systems and networks.
−Removed: Any failure to maintain performance, reliability, security and availability of our systems and networks may result in accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our data, including personal information.
−Removed: In addition, potential legal, regulatory, contractual, financial, operational, and reputational harm may arise from the accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our systems, networks, or data, including data which is transmitted, stored or otherwise processed by us or by collaborators, third-party providers, distributors and other contractors on our behalf.
+Added: Any failure of ourselves or our third-party service providers to maintain performance, reliability, security and availability of our systems and networks, or other systems or networks on which our data is stored or processed, may result in accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our data, including personal information.
+Added: In addition, potential legal, regulatory, contractual, financial, operational, and reputational harm may arise from the accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our systems, networks, or data, including data which is transmitted, stored or otherwise processed by us or by third parties, including collaborators, third-party service providers, distributors, and other contractors on our behalf.
● The accidental or unlawful loss, unavailability, or alteration of clinical trial data from completed or ongoing clinical trials for any of our product candidates could affect our ability to operate, result in delays in our development and regulatory approval efforts, and significantly increase our costs to recover or reproduce the data.
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There can be no assurance that we will be successful in preventing security incidents nor that we will be successful in mitigating their effects, despite the implementation of security measures for systems, networks and data within our control.
−Removed: Similarly, there can be no assurance that our collaborators, third-party providers, distributors and other contractors will be successful in protecting our data on their systems or in protecting other systems upon which we may rely.
+Added: Similarly, there can be no assurance that our collaborators, third-party service providers, distributors and other contractors will be successful in protecting our data on their systems or in protecting other systems upon which we may rely.
Furthermore, breach notification laws are not consistent among jurisdictions, and compliance and other measures in the event of a security incident could result in a substantial cost and diversion of resources and distract management and technical personnel in efforts to investigate or correct the security incident, address and eliminate vulnerabilities and prevent future security incidents, and remediate the security incident, which repairing systems and responding to claims of damages for actual or asserted contract breaches.
Any such security incident could have a material adverse effect on our business and prospects.
−Removed: Although we maintain cyber insurance coverage that may cover certain of our losses in connection with a security
−Removed: incident, we cannot be certain our insurance coverage will be adequate for losses actually incurred, that insurance will continue to be available to us on commercially reasonable terms (if at all) or that any insurer will not deny coverage as to any future claim.
+Added: Although we maintain cyber insurance coverage that may cover certain of our losses in connection with a security incident, we cannot be certain our insurance coverage will be adequate for losses actually incurred, that insurance will continue to be available to us on commercially reasonable terms (if at all) or that any insurer will not deny coverage as to any future claim.
The successful assertion of one or more large claims against us that exceed available insurance coverage, the occurrence of changes in our insurance policies, including premium increases or the imposition of large deductible or co-insurance requirements, or denials of coverage, could have a material adverse effect on our business, including our financial condition, results of operations and reputation.
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and other countries.
−Removed: Satisfaction of all regulatory requirements, which typically takes years for drugs that require regulatory approval in ANDAs, NDAs, biological license applications, or BLAs, or biosimilar applications is dependent upon the type, complexity and novelty of the product candidate and requires the expenditure of substantial resources for research (including qualification of suppliers and their supplied materials), development, in vitro and in vivo (including nonclinical and clinical trials) studies, manufacturing process development and commercial scale up.
+Added: Satisfaction of all regulatory requirements, which typically takes years for drugs that require regulatory approval in ANDAs, NDAs, biological license applications, or BLAs, or biosimilar applications is dependent upon the type, complexity and novelty of the product candidate and requires the expenditure of substantial resources for research (including qualification of suppliers and their supplied materials), development, in vitro and in vivo (including nonclinical and clinical trials)
+Added: studies, manufacturing process development and commercial scale up.
Some of our products are drug-device combination products that are regulated as drug products by the FDA, with consultation from the FDA’s Center for Device and Radiological Health.
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Further, the terms of approval of any applications may be more restrictive than our expectations and could affect the marketability of our products.
−Removed: The FDA also has the authority to revoke or suspend approvals of previously approved products for cause, to debar companies and individuals from participating in the approval process for ANDAs, to request recalls of allegedly violative products, to seize allegedly violative products, to obtain injunctions that may, among other things, close
−Removed: manufacturing plants that are not operating in conformity with cGMP and stop shipments of potentially violative products and to prosecute companies and individuals for violations of the FFDCA.
+Added: The FDA also has the authority to revoke or suspend approvals of previously approved products for cause, to debar companies and individuals from participating in the approval process for ANDAs, to request recalls of allegedly violative products, to seize allegedly violative products, to obtain injunctions that may, among other things, close manufacturing plants that are not operating in conformity with cGMP and stop shipments of potentially violative products and to prosecute companies and individuals for violations of the FFDCA.
One of our API suppliers discontinued manufacturing an API included in one of our commercial products.
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Delays in our development programs could significantly increase our product development costs and delay product commercialization.
−Removed: The commencement of clinical trials on our product candidates may be delayed for several reasons, including but not limited to delays in demonstrating sufficient pre-clinical safety required to obtain regulatory clearance to commence a
−Removed: clinical trial, reaching agreements on acceptable terms with prospective contract research organizations, clinical trial sites and licensees, manufacturing and quality assurance release of a sufficient supply of a product candidate for use in our clinical trials, delays in recruiting sufficient subjects for a clinical trial and/or obtaining institutional review board approval to conduct a clinical trial at a prospective clinical site.
+Added: The commencement of clinical trials on our product candidates may be delayed for several reasons, including but not limited to delays in demonstrating sufficient pre-clinical safety required to obtain regulatory clearance to commence a clinical trial, reaching agreements on acceptable terms with prospective contract research organizations, clinical trial sites and licensees, manufacturing and quality assurance release of a sufficient supply of a product candidate for use in our clinical trials, delays in recruiting sufficient subjects for a clinical trial and/or obtaining institutional review board approval to conduct a clinical trial at a prospective clinical site.
Once a clinical trial has begun, it may be delayed, suspended or terminated by us or by regulatory authorities for a variety of reasons, including without limitation ongoing discussions with regulatory authorities regarding the scope or design of our clinical trials, a determination by us or regulatory authorities that continuing a trial presents an unreasonable health risk to participants, failure to conduct clinical trials in accordance with regulatory requirements, lower than anticipated recruitment or retention rate of patients in clinical trials, inspection of the clinical trial operations or trial sites by regulatory authorities, the imposition of a clinical hold by the FDA, lack of adequate funding to continue clinical trials and/or negative or unanticipated results of clinical trials.
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If data from third-party testing identifies a safety or efficacy concern, such data could adversely affect our or another licensee’s development of such product.
−Removed: There is significant risk that our products could fail to show anticipated results in nonclinical testing and/or clinical studies and, as a result, we may elect to discontinue the development of a product for a particular indication or
+Added: There is significant risk that our products could fail to show anticipated results in nonclinical testing and/or clinical studies and, as a result, we may elect to discontinue the development of a product for a particular indication or altogether.
A failure to obtain requisite regulatory approvals or to obtain approvals of the scope requested may delay or preclude us from marketing our products or limit the commercial use of the products, and would have a material adverse effect on our business, financial condition and results of operations.
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We also have plans to develop synthetic APIs.
−Removed: Our ongoing trials and studies may not be successful or regulators may not agree with our conclusions regarding the preclinical studies and clinical trials we have conducted to date or approve the use of such synthetic APIs.
+Added: Our ongoing trials and studies may not be successful or regulators may
+Added: not agree with our conclusions regarding the preclinical studies and clinical trials we have conducted to date or approve the use of such synthetic APIs.
If we are unable to obtain approval from the FDA or other regulatory agencies for our product candidates or synthetic APIs, we will not be able to market such product candidates and our ability to achieve profitability may be materially impaired.
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The commercial success of our NDA product candidates will depend in significant measure on the scope of the indication(s) and claims that the FDA approves for such products.
−Removed: The scientific foundation of our NDA product candidates will be based on our various proprietary technologies and the
−Removed: commercial success of these product candidates will depend in significant measure upon our ability to obtain FDA approval of labeling describing such products’ indication(s) and expected features or benefits.
+Added: The scientific foundation of our NDA product candidates will be based on our various proprietary technologies and the commercial success of these product candidates will depend in significant measure upon our ability to obtain FDA approval of labeling describing such products’ indication(s) and expected features or benefits.
Failure to achieve FDA approval of product labeling containing adequate information on features or benefits will prevent or substantially limit our advertising and promotion of such features in order to differentiate our proprietary technologies from those products that already exist in the market.
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The process for bringing a biosimilar product to market is uncertain and may be drawn out for an extended period of time.
−Removed: Approval of biosimilar applications may be delayed by exclusivity on the BLA for the reference product for up to 12 years.
+Added: Approval of biosimilar applications may be delayed by exclusivity on the BLA
+Added: for the reference product for up to 12 years.
Biosimilar applicants are also subjected to a patent resolution process that will require biosimilar applicants to share the contents of their application and information concerning its manufacturing processes with counsel for the company holding the BLA for the reference drug and to engage in a patent litigation process that could delay or prevent the commercial launch of a product for many years.
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Our competitive advantage in this area will depend on our success in demonstrating to the FDA that platform technology provides a level of scientific assurance that facilitates determinations of interchangeability, reduces the need for expensive clinical or other testing and raises the scientific quality requirements for our competitors to demonstrate that their products are highly similar to a brand product.
−Removed: Our ability to succeed will depend in part on our ability to invest in new programs and develop data in a timeframe that enables the FDA to consider our approach as the FDA begins to
−Removed: implement the new law.
+Added: Our ability to succeed will depend in part on our ability to invest in new programs and develop data in a timeframe that enables the FDA to consider our approach as the FDA begins to implement the new law.
BLA holders will develop strategies and precedents for delaying or impeding approvals of biosimilar products and determinations of interchangeability.
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Where approval of the drug product and device is sought under a single application, the increased complexity of the review process may delay approval.
−Removed: Some of the drug delivery devices utilized in our products and product candidates are provided by single source unaffiliated third-party companies.
+Added: Some of the drug delivery devices utilized in our products and product candidates are provided by single source
+Added: unaffiliated third-party companies.
We are dependent on the sustained cooperation and effort of those third-party companies both to supply the devices and to maintain regulatory compliance with the FDA quality system regulations applicable to medical device, and, in some cases, to conduct the studies required for approval or other regulatory clearance of the devices.
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Approval by the FDA does not ensure approval by regulatory or payor authorities in other countries or jurisdictions, and approval by one regulatory or payor authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
−Removed: However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the
−Removed: regulatory approval process in others.
+Added: However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others.
For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries.
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This clinical trial portal and database is maintained by the EMA in collaboration with the European Commission and the EU Member States.
−Removed: Information on the conduct and results of each clinical trial carried out in the EU is made publicly available.
+Added: Information on the conduct and
+Added: results of each clinical trial carried out in the EU is made publicly available.
In addition, this database is complementary to the database established for pharmacovigilance (Regulation (EC) No 726/2004 with respect to centrally authorized medicinal products).
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Uncertainty in the regulatory framework and future legislation can lead to disruption in the execution of international multi-center clinical trials, the monitoring of adverse events through pharmacovigilance programs, the evaluation of the benefit-risk profiles of new medicinal products, and determination of marketing authorization across different jurisdictions.
−Removed: There could also be disruption to the supply and distribution as well as the import/export both of active
−Removed: pharmaceutical ingredients and finished product.
+Added: There could also be disruption to the supply and distribution as well as the import/export both of active pharmaceutical ingredients and finished product.
Such a disruption could create supply difficulties for ongoing clinical trials and may damage the integrity of the pharmacovigilance database for the safety of new products.
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Failure to obtain timely or adequate pricing or formulary placement for our products or obtaining such pricing or placement at unfavorable pricing could adversely impact revenue.
−Removed: In addition to formulary tier co-pay differentials, private health insurance companies and self-insured employers have been raising co-payments required from beneficiaries, particularly for proprietary pharmaceuticals and biotechnology products.
+Added: In addition to formulary tier co-pay differentials, private health insurance companies and self-insured employers have been raising co-payments required from
+Added: beneficiaries, particularly for proprietary pharmaceuticals and biotechnology products.
Private health insurance companies also are increasingly imposing utilization management tools, such as requiring prior authorization for a proprietary product if a generic product is available or requiring the patient to first fail on one or more generic products before permitting access to a proprietary medicine.
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For our approved products, modifications, enhancements, or changes in manufacturing processes and sites may require supplemental FDA approval, which may be subject to a lengthy application process or which we may be unable to obtain.
−Removed: All facilities of Amphastar and our subsidiaries are periodically subject to inspection by the FDA and other governmental entities, and operations at these facilities could be interrupted or halted if the FDA or another governmental entity deems such inspections as unsatisfactory.
+Added: All facilities of Amphastar, our subsidiaries and our CMOs and suppliers are periodically subject to inspection by the FDA and other governmental entities, and operations at these facilities could be interrupted or halted if the FDA or another governmental entity deems such inspections as unsatisfactory.
For example, our facilities in Rancho Cucamonga, CA, Éragny Sur Epte, France, and Nanjing, China have previously been subject to FDA cGMP inspections since 2019 as well as pre-approval, routine and other inspections by the FDA, state, and other regulatory authorities and may be again in the future per applicable law.
−Removed: Products manufactured in our facilities must be made in a manner consistent with cGMP or similar standards in each territory in which we manufacture.
−Removed: Compliance with such standards requires substantial expenditures of time, money and effort in such areas as production and quality control to ensure full technical compliance.
−Removed: Failure to comply with cGMP or with other state, federal, or foreign requirements may result in unanticipated compliance expenditures, total or partial suspension of production or distribution, suspension of review of applications submitted for approval of our product candidates, termination of ongoing research, disqualification of data
−Removed: derived from studies on our products and/or enforcement actions such as recall or seizure of products, injunctions, civil penalties and criminal prosecutions of the company and company officials.
−Removed: Any suspension of production or distribution would require us to engage contract manufacturing organizations to manufacture our products or to accept a hiatus in marketing our products.
−Removed: Any contract manufacturing organization we engage will require time to learn our methods of production and to scale up to full production of our products in accordance with cGMP requirements.
−Removed: Any delays caused by the transfer of manufacturing to a contract manufacturing organization may have a material adverse effect on our results of operations.
−Removed: Additionally, any contract manufacturing organization that we engage will be subject to the same cGMP regulations as us, and any failure on their part to comply with FDA or other governmental regulations will result in similar consequences.
+Added: Compliance with cGMP standards requires substantial expenditures of time, money and effort in such areas as production and quality control to ensure full technical compliance.
+Added: Failure to comply with cGMP or with other state, federal, or foreign requirements may result in unanticipated compliance expenditures, total or partial suspension of production or distribution, suspension of review of applications submitted for approval of our product candidates, termination of ongoing research, disqualification of data derived from studies on our products and/or enforcement actions such as recall or seizure of products, injunctions, civil penalties and criminal prosecutions of the company and company officials.
+Added: There can be no assurance that we will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections.
Our operations are subject to environmental, health and safety and other laws and regulations, with which compliance is costly and which exposes us to penalties for non-compliance.
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There can be no assurance that we will be able to acquire adequate supplies of HFCs for current and future commercialization of our products as a result of the AIM Act or other similar statutes and regulations.
−Removed: Moreover, changes to the ingredients of our proprietary and generic products requires FDA approval and there can be no assurance that we will be able to obtain such approval or the timing of such approval.
+Added: Moreover, changes to the ingredients of our proprietary and generic products require FDA approval and there can be no assurance that we will be able to obtain such approval or the timing of such approval.
The Affordable Care Act and certain legislation and regulatory proposals may increase our costs of compliance and negatively impact our profitability over time.
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It is unclear how this Supreme Court decision, future litigation, or healthcare measures promulgated by the current administration will impact our business, financial condition and results of operations.
−Removed: Complying with any new legislation or changes in healthcare regulation could be time-intensive and expensive, resulting in material adverse effect on our business.
+Added: Complying with any new legislation or changes in healthcare regulation could be time-intensive and expensive, resulting in a material adverse effect on our business.
In addition, there have been a number of other legislative and regulatory proposals aimed at changing the pharmaceutical industry.
For example, in November 2013, Congress passed the Drug Quality and Security Act, or the DQSA.
−Removed: DQSA establishes federal pedigree tracking standards requiring drugs to be labeled and tracked at the lot level, preempts state drug pedigree requirements, and, since November 27, 2024, requires all supply-chain stakeholders to participate in an electronic, interoperable prescription drug track and trace system.
+Added: The DQSA establishes federal pedigree tracking standards requiring drugs to be labeled and tracked at the lot level, preempts state drug pedigree requirements, and, since November 27, 2024, requires all supply-chain stakeholders to participate in an electronic, interoperable prescription drug track and trace system.
The DQSA also establishes new requirements for drug wholesale distributors and third-party logistics providers, including licensing requirements in states that had not previously licensed such entities.
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Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than it receives on the sale of products, which could have a material impact on our business.
−Removed: In July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at increasing competition for prescription drugs.
−Removed: In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, manufacturers are required to pay higher rebates on brand-name drugs once a patient reaches
−Removed: their out-of-pocket spending limit, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes.
−Removed: Various industry stakeholders, including pharmaceutical companies and the Pharmaceutical Research and Manufactures of America, have initiated lawsuits against the federal government asserting that the price negotiation provision of the Inflation Reduction Act are unconstitutional.
+Added: In August 2022, Congress passed the Inflation Reduction Act of 2022 (the “IRA”), which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, manufacturers are required to pay higher rebates on brand-name drugs once a patient reaches their out-of-pocket spending limit, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes.
+Added: Only high-expenditure single-source drugs that have been approved for at least 7 years (11 years for single-source biologics) can qualify for negotiation, with the negotiated price taking effect two years after the selection year.
+Added: For 2026, CMS selected 10 high-cost Medicare Part D drugs in 2023 and the negotiated maximum fair price for each drug has been announced.
+Added: CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027.
+Added: For 2028, up to an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, up to 20 additional Part B or Part D drugs will be selected.
+Added: Various industry stakeholders have initiated lawsuits against the federal government asserting that the price negotiation provision of the Inflation Reduction Act are unconstitutional.
+Added: Further, the current administration has issued executive orders focused on decreasing prescription drug prices, including directing the Secretary of Health and Human Services to establish a mechanism through which American patients can buy drugs directly from manufacturers who sell at a most-favored-nation (“MFN”) price and directing the U.S.
+Added: Trade Representative and Secretary of Commerce to take action to ensure foreign countries are not engaged in practices that purposefully and unfairly undercut market prices and drive price hikes in the United States.
+Added: The One Big Beautiful Bill Act (the “OBBB Act”), which was signed into law in July 2025, includes provisions that will impact the U.S.
+Added: healthcare system in various ways, including by cuts to Medicaid and introducing new participant work and eligibility requirements for Medicaid coverage, which are expected to significantly change the administration and applicability of Medicaid coverage.
+Added: In November 2025, CMS announced a voluntary initiative called the GENEROUS Model (GENErating cost Reductions fOr U.S.
+Added: Medicaid Model) to introduce the option of most-favored-nation pricing to the Medicaid program, whereby a drug manufacturer may voluntarily offer supplemental rebates to participating state Medicaid programs for a manufacturer’s covered outpatient drugs.
+Added: We cannot predict the full impact of these initiatives, executive orders, and new laws focused on reducing prescription drug prices or increasing domestic drug manufacturing capacity, or other measures that may be implemented by the current administration related to drug pricing, drug supply chain and manufacturing in the United States.
The impact of these judicial challenges, legislative, executive, and administrative actions, including future healthcare measures and agency rules implemented by the government on us and the pharmaceutical industry as a whole is unclear.
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For example, in September 2020, the Governor of California signed legislation that brings California one step closer to establishing its own generic drug label, which could have significant impact on the generic drug industry and generic drug pricing.
−Removed: A number of states are also considering or have recently enacted state drug price transparency and reporting laws that could substantially increase our compliance burdens and expose us to greater liability under such state laws.
+Added: A number of states are also
+Added: considering or have recently enacted state drug price transparency and reporting laws that could substantially increase our compliance burdens and expose us to greater liability under such state laws.
Additionally, we encounter similar regulatory and legislative issues in most other countries.
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While the GDPR applies uniformly across the EU, each EU member state is permitted to issue nation-specific data protection legislation, which has created inconsistencies on a country-by country basis.
−Removed: The United Kingdom may introduce legislation reforming the UK GDPR in 2025, which could result in further inconsistencies requiring us to
−Removed: modify our compliance measures and incur costs.
+Added: The United Kingdom made certain modifications to its data protection regime in the UK Data (Use and Access) Act 2025, which could require us to modify our compliance measures and incur costs.
The European Commission issued an adequacy decision to the United Kingdom under the GDPR on June 28, 2021, pursuant to which personal information generally may be transferred from the EU to the United Kingdom without restriction;
−Removed: however, this adequacy decision is subject to a four-year “sunset” period, meaning that the adequacy decision will last until June 27, 2025, unless the European Commission renews it.
+Added: however, this adequacy decision requires renewal in 2025.
The European Commission may intervene at any time with respect to its adequacy decision.
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Furthermore, there will be increasing scope for divergence in application, interpretation and enforcement of the data protection law as between the United Kingdom and European Economic Area.
−Removed: The United Kingdom has introduced legislation that, if enacted, would result in its data protection and regulatory scheme diverging from the GDPR.
In addition, U.S.
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The CCPA gives California residents, among other things, expanded rights to access and require deletion of their personal information, opt out of certain personal information sharing, and receive detailed information about how their personal information is used.
−Removed: The CCPA also provides for civil penalties for violations, as well as a private right of action for certain data breaches that may increase data breach litigation.
+Added: The CCPA also
+Added: provides for civil penalties for violations, as well as a private right of action for certain data breaches that may increase data breach litigation.
The CCPA was expanded substantially on January 1, 2023 when the California Privacy Rights Act of 2020, or the CPRA, which was approved by California voters in November 2020, became fully operative.
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Florida, Montana, Oregon and Texas have enacted similar laws that went into effect in 2024;
−Removed: Tennessee, Delaware and Iowa have enacted similar laws that go into effect in 2025;
−Removed: and Indiana has enacted a similar law that will go into effect in 2026.
+Added: Tennessee, Delaware, Iowa, Maryland, Minnesota, Nebraska, New Hampshire, and New Jersey have enacted similar laws that went into effect in 2025;
+Added: and Indiana, Kentucky, and Rhode Island have enacted similar laws that go into effect in 2026.
Similar laws have been proposed in other states and at the federal level, reflecting a trend toward more stringent data protection, security and privacy legislation in the U.S.
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Further, several states have enacted laws that provide additional protection to consumer health data, including Washington, which enacted the My Health, My Data Act, which, among other things, provides for a private right of action, and Nevada and Connecticut, which have enacted similar laws.
+Added: Additionally, the U.S.
+Added: Department of Justice recently issued a final rule that took effect in April 2025, which places limitations, and in some cases prohibitions, on certain transfers of sensitive personal data to business partners located in certain “countries of concern” or with other specified links to such countries.
Responsibilities and liabilities under, and other potential impacts of, the GDPR, the UK GDPR, the CCPA, and other U.S.
−Removed: state laws are significant, and we may be required to put in place additional measures designed to comply with these regimes.
+Added: laws are significant, and we may be required to put in place additional measures designed to comply with these regimes.
We may also publicly post privacy policies and other documentation regarding our collection, use, storage, transmission, transfer, and other processing of personal information.
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Additionally, other jurisdictions are considering new or expanded laws or regulations relating to privacy, security and data protection.
+Added: We expect laws, regulations, industry standards and other obligations worldwide relating to privacy, data protection, and cybersecurity to continue to evolve, and that there will continue to be new, modified, and re-interpreted laws, regulations, standards, and other obligations in these areas.
+Added: For example, the Network and Information Security Directive II, or NIS2, adopted in 2023, aims to enhance cybersecurity across critical infrastructure and essential services in the EU.
+Added: It expands the scope of the 2016 NIS Directive to include additional sectors while enforcing stricter governance and accountability requirements.
+Added: NIS2 requires all 27 EU member states to issue implementing legislation by October 2024;
+Added: however, several EU member states have not finalized their respective legislation and guidance.
With laws, regulations and other obligations relating to privacy, security and data protection imposing new and relatively burdensome obligations, which may be inconsistent between jurisdictions or in conflict with each other due to differing applications and interpretations, and with substantial uncertainty over further interpretation and application of these and other obligations, we may face challenges in addressing their requirements, putting in place additional compliance mechanisms and making necessary changes to our policies, contracts and practices, and may incur significant costs and expenses in an effort to do so.
Additionally, if we or third parties we work with, such as our third-party providers, violate applicable laws or regulations or our policies, such violations may also put our data at risk and could in turn have an adverse effect on our business.
−Removed: Any failure or perceived failure by us or our service providers to
−Removed: comply with our applicable policies or notices relating to privacy, security or data protection, our contractual or other obligations to third parties, or any of our other legal obligations relating to privacy, security or data protection, may result in public criticism, governmental investigations or enforcement actions, litigation, claims and other proceedings, and could result in significant fines, penalties, and other liability.
+Added: Any failure or perceived failure by us or our service providers to comply with our applicable policies or notices relating to privacy, security or data protection, our contractual or other obligations to third parties, or any of our other legal obligations relating to privacy, security or data protection, may result in public criticism, governmental investigations or enforcement actions, litigation, claims and other proceedings, and could result in significant fines, penalties, and other liability.
Additionally, defending against any claims, litigation, regulatory proceedings, or other proceedings can be costly, time-consuming and may require significant financial and personnel resources.
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The regulations regarding reporting and payment obligations with respect to Medicare and/or Medicaid reimbursement and rebates and other governmental programs are complex.
−Removed: Because our processes for these calculations and the judgments involved in making these calculations involve, and will continue to involve, subjective decisions and complex
−Removed: methodologies, these calculations are subject to the risk of errors.
+Added: Because our processes for these calculations and the judgments involved in making these calculations involve, and will continue to involve, subjective decisions and complex methodologies, these calculations are subject to the risk of errors.
In addition, they are subject to review and challenge by the applicable governmental agencies, and it is possible that such reviews could result in material changes.
1 unchanged sentence
The final rule attempts to provide drug manufacturers with the regulatory guidance necessary to ensure proper calculation and reporting of drug product and pricing information.
−Removed: Specifically, the final rule attempts to clarify the definition of what constitutes a manufacturer’s “best price” and aligns it, where appropriate, to the definition of “Average Manufacturer Price”, which is used to calculate drug rebates.
+Added: Specifically, the final rule attempts to clarify the definition of what constitutes a manufacturer’s “best price” and aligns it, where appropriate, to the definition of “Average Manufacturer Price”, which is
+Added: used to calculate drug rebates.
Notwithstanding the final rule’s guidance, a number of state and federal government agencies have continued to conduct investigations of manufacturers’ reporting practices with respect to Average Wholesale Prices, or AWP, in which reports of inflated AWP may lead to excessive payments for prescription drugs.
21 unchanged sentences
The laws that may affect our ability to operate include:
−Removed: ● the federal Anti-kickback statue, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or
−Removed: service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
+Added: ● the federal Anti-kickback statue, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
● federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;
−Removed: ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
+Added: ● the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new
+Added: federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;
● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and their respective implementing regulations, impose requirements on certain covered healthcare providers, health plans, and healthcare clearinghouses as well as their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, relating to the privacy, security, and transmission of individually identifiable health information;
9 unchanged sentences
The federal false claims laws have been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers or formulary managers on the other.
−Removed: Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe
−Removed: harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor.
+Added: Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor.
Most states also have statutes or regulations similar to the federal anti-kickback law and federal false claims laws, which apply to items and services covered by Medicaid and other state programs, or, in several states, apply regardless of the type of payer.
27 unchanged sentences
The scope and enforcement of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations.
−Removed: Federal or state regulatory
−Removed: authorities might challenge our current or future activities under these laws.
+Added: Federal or state regulatory authorities might challenge our current or future activities under these laws.
Any such challenge could have a material adverse effect on our reputation, business, results of operations and financial condition.
20 unchanged sentences
● disruptions in the construction of the manufacturing facility;
−Removed: ● interruptions to our operations in China or the inability of our manufacturing facility to produce adequate quantities of raw materials or APIs to meet our needs as a result of natural catastrophic events or other causes beyond our control such as power disruptions or widespread disease outbreaks, including the recent outbreaks that impact animal-derived products, such as the importation of pig-derived crude heparin from countries impacted by the African swine flu, and the COVID-19 pandemic, which resulted in import and export
−Removed: complications, and otherwise cause shortages in the supply of raw materials or cause disruptions in our manufacturing capability ;
+Added: ● interruptions to our operations in China or the inability of our manufacturing facility to produce adequate quantities of raw materials or APIs to meet our needs as a result of natural catastrophic events or other causes beyond our control such as power disruptions or widespread disease outbreaks, including the recent outbreaks that impact animal-derived products, such as the importation of pig-derived crude heparin from countries impacted by the African swine flu, and the COVID-19 pandemic, which resulted in import and export complications, and otherwise cause shortages in the supply of raw materials or cause disruptions in our manufacturing capability ;
● product supply disruptions and increased costs as a result of heightened exposure to changes in the policies of the Chinese government, political unrest or unstable economic conditions in China;
● the imposition of additional tariffs, export controls or other trade barriers as a result of changes in social, political, and economic conditions or in laws, regulations, and policies governing foreign trade, including U.S.
−Removed: and foreign export controls such as U.S.
−Removed: controls, increasing controls impacting the ability to send certain products and technology, specifically related to semi-conductor manufacturing and supercomputing worldwide (including a prohibition on exports, reexports, and transfers to and within China without an export license, and the addition of new China-based entities to certain U.S.
−Removed: restricted party lists including the Entity List and Unverified List, trade sanctions and import laws and regulations, tariffs on various imports from China and by the Chinese government on certain U.S.
−Removed: goods including those previously implemented (including additional 10% tariffs levied on imports of Chinese-origin items into the United States as of February 4, 2025) and additional tariffs that have been proposed by the U.S.
−Removed: government (including additional 25% tariffs proposed on imports of pharmaceutical products into the United States, among other proposed tariffs), the implementation, scope, and duration of which remain uncertain;
−Removed: ● the imposition of retaliatory trade measures by China or other countries in response to new or escalated tariffs, export controls, or other trade measures by the United States, which may affect the availability and/or price of materials used in our supply chain, and the implementation, scope, and duration of which remain uncertain;
+Added: export controls impacting the ability to send certain products and technology, specifically related to semi-conductor manufacturing and supercomputing (including a prohibition on exports, reexports, and transfers to and within China without an export license, and the addition of new China-based entities to certain U.S.
+Added: restricted party lists including the Entity List and Unverified List, trade sanctions and import laws and regulations, tariffs on various imports into the U.S.
+Added: from China including those previously implemented and additional tariffs that may in the future be implemented by the U.S.
+Added: government (including on imports of pharmaceutical products into the United States currently under investigation by the U.S.
+Added: Department of Commerce, among other potential tariffs), the implementation, scope, and duration of which remain uncertain;
+Added: ● the imposition of retaliatory trade measures by China or other countries in response to new or escalated tariffs, export controls, or other trade measures by the United States (including those previously implemented by China and other countries, such as tariffs on U.S.-origin items and export controls on certain rare earth materials), which may affect the availability and/or price of materials used in our supply chain, and the implementation, scope, and duration of which remain uncertain;
● the nationalization or other expropriation of private enterprises or intellectual property by the Chinese government, which could result in the total loss of our investment in China;
−Removed: ● interruptions to our manufacturing or business operations resulting from geo-political actions, including war and terrorism, such as the war in Ukraine and the Middle East conflict, natural disasters including earthquakes, typhoons, floods, and fires, or outbreaks of health epidemics or outbreaks in livestock or animals that impact or restrict importation, use, or distribution of animal-derived products.
+Added: ● interruptions to our manufacturing or business operations resulting from geo-political actions, global conflicts, natural disasters including earthquakes, typhoons, floods, and fires, or outbreaks of health epidemics or outbreaks in livestock or animals that impact or restrict importation, use, or distribution of animal-derived products.
Any of these matters could materially and adversely affect our business and results of operations.
34 unchanged sentences
Market uncertainty and instability in Europe or Asia could intensify or spread further, particularly if ongoing stabilization efforts prove insufficient.
−Removed: Continuing or worsening economic instability could adversely affect sales of our
+Added: Continuing or worsening economic instability could adversely affect sales of our products.
Continued turmoil in the geopolitical environment in many parts of the world may also affect the overall demand for our products.
Although we do not believe that our business, financial condition, results of operations and prospects have been significantly adversely affected by economic and political uncertainty in Europe, Asia or other countries to date, deterioration of such conditions may harm our business, financial condition, results of operations and prospects in the future.
−Removed: A prolonged period of economic uncertainty or a downturn may also significantly affect financing markets, the availability of capital and the terms and conditions of financing arrangements, including the overall cost of financing.
+Added: A prolonged period of economic uncertainty or a downturn may also significantly affect financing markets, the availability of capital and the terms and conditions of financing arrangements, including the
+Added: overall cost of financing.
Circumstances may arise in which we need, or desire, to raise additional capital, and such capital may not be available on commercially reasonable terms, or at all.
11 unchanged sentences
There is a possibility that the United States could continue to impose greater restrictions on international trade and significant increases in tariffs on goods imported into the United States.
−Removed: In September 2018, the U.S.
−Removed: Trade Representative (the “USTR”) enacted a tariff on the import of other Chinese products, with a combined import value of approximately $200 billion.
−Removed: Since that time USTR has modified these tariff rates and imposed tariffs on additional goods.
−Removed: As of February 4, 2025, the U.S.
−Removed: government has imposed an additional tariff of 10% on the import of almost all Chinese-origin items, and further tariffs have been proposed on additional products, including pharmaceutical products, in an amount of 25% or greater.
−Removed: Tariffs on imports of APIs and starting materials used in our products, or retaliatory trade measures taken by China or other countries, including restricted access to APIs or starting materials used in our products, causing us to raise prices or make changes to our products, could materially harm our business, financial condition and results of operations.
+Added: For example, since September 2018, the U.S.
+Added: Trade Representative (the “USTR”) enacted Section 301 tariffs on certain commodities from certain U.S.
+Added: trading partners, most prominently China and Brazil, affecting hundreds of billions of dollars of imports.
+Added: In addition, between February 4, 2025 and February 23, 2026, the U.S.
+Added: government imposed “fentanyl-related” tariffs of 10% to 35% on the import of almost all Chinese-, Mexican-, and Canadian-origin items with an exception for items qualifying for duty-free treatment under the U.S.-Mexico-Canada Agreement, as well as additional “reciprocal” tariffs of 10% to 125% on certain products of most other U.S.
+Added: trading partners, including China, after April 2025, with exemptions for certain pharmaceutical products, semiconductors, and consumer electronics.
+Added: Since March 2025, the U.S.
+Added: government has also implemented new Section 232 tariffs of 10% to 50% on various commodities based on findings by the U.S.
+Added: government that imports of these items threaten to impair U.S.
+Added: national security, including with regard to imports of certain articles of steel and aluminum;
+Added: passenger vehicles, trucks, and automotive components;
+Added: certain articles of copper;
+Added: and timber, lumber, and certain article of wood.
+Added: Following a Supreme Court ruling on February 20, 2026, the U.S.
+Added: government ceased collecting the fentanyl-related and reciprocal tariffs on February 24, 2026.
+Added: On the same day, the U.S.
+Added: government implemented a “temporary import surcharge” under authorities provided in Section 122 of the Trade Acts of 1974, currently set at 15% and scheduled to last for a period of 150 days.
+Added: This temporary import surcharge, like the reciprocal tariffs preceding it, excludes certain items, including pharmaceutical products, certain electronics, and other items specified in Annexes to the President’s February 20, 2026 executive order “Imposing a Temporary Import Surcharge to Address Fundamental International Payments Problems.” These trade policies, including applicable items, tariff rates, countries, and exceptions, are subject to change.
+Added: Additional tariffs may in the future also be implemented by the U.S.
+Added: government (including on imports of pharmaceutical products into the United States, which are currently under Section 232 investigation by the U.S.
+Added: Department of Commerce), the implementation, scope, and duration of which remain uncertain.
+Added: Tariffs on imports of APIs and starting materials used in our products, or retaliatory trade measures taken by China or other countries, which could potentially include restricted access to APIs or starting materials used in our products, could result in us needing to raise prices, make changes to our products, or otherwise materially harm our business, financial condition and results of operations.
Further, the continued threats of tariffs, trade restrictions, and trade barriers could have a generally disruptive impact on the global economy and, therefore, negatively impact our sales.
Given the focus of the U.S.
−Removed: government on issues related to China, including the imposition of new restrictions on exports related to semi-conductor manufacturing and supercomputing, the imposition of outbound investment controls affecting U.S.
+Added: government on issues related to China, including the imposition of additional restrictions on exports related to semi-conductor manufacturing and supercomputing, the imposition of outbound investment controls affecting U.S.
persons’ ability to invest in certain enterprises in China, and the addition of entities based in China to various restricted party lists, along with uncertainty regarding how the U.S.
−Removed: or foreign governments will act with respect to tariffs, international trade agreements and policies, a trade war, further governmental action related to tariffs or international trade policies, or additional tax or other regulatory changes in the future could occur and could directly and adversely impact our financial results and results of operations.
+Added: or foreign governments will act with respect to tariffs, international trade
+Added: agreements and policies, a trade war, further governmental action related to tariffs or international trade policies, or additional tax or other regulatory changes in the future could occur and could directly and adversely impact our financial results and results of operations.
We are subject to various governmental export control and trade sanctions laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate these controls.
1 unchanged sentence
Department of Commerce, and our activities may be subject to trade and economic sanctions, including those administered by the United States Department of the Treasury’s Office of Foreign Assets Control, or OFAC (collectively, “Trade Controls”).
−Removed: As such, a license may be required to export or re-export our
−Removed: products, or provide related services, to certain countries and end-users, and for certain end-uses.
+Added: As such, a license may be required to export or re-export our products, or provide related services, to certain countries and end-users, and for certain end-uses.
The process for obtaining necessary licenses may be time-consuming or unsuccessful, potentially causing delays in sales or losses of sales opportunities and these licenses may not be issued.
4 unchanged sentences
The Chinese government has exercised, and continues to exercise, substantial control over virtually every sector of the Chinese economy through regulation and state ownership.
−Removed: Our ability to conduct our proposed manufacturing operations in China may be harmed by changes in its laws and regulations, including those relating to taxation, import and export tariffs and other trade restrictions, environmental regulations, land use rights, property ownership and other matters.
+Added: Our ability to conduct our proposed manufacturing operations in China may be harmed by changes in its laws and regulations, including those relating to taxation, tariffs and other trade restrictions, environmental regulations, land use rights, property ownership and other matters.
We believe that our operations in China are in material compliance with all applicable legal and regulatory requirements.
32 unchanged sentences
● comprehensive financial sanctions against major Russian banks (including SWIFT cut off);
−Removed: ● designation of individuals and entities involved in Russian military activities;
+Added: ● designation of individuals and entities seen to support Russian military activities;
● additional designations of Russian individuals including but not limited to those with significant business interests and government connections;
−Removed: ● enhanced export controls and trade sanctions targeting Russia’s imports of a wide range of goods and services as a whole, including potentially tighter controls on exports and reexports of items previously subject to only a low level of control, stricter licensing policy with respect to issuing export licenses, increased restrictions on services, and/or increased use of “end-use” controls to block or impose licensing requirements on exports.
+Added: ● enhanced export controls and trade sanctions targeting Russia’s imports of a wide range of goods and services as a whole, including potentially tighter controls on exports and reexports of items previously subject to only a low level of control, stricter licensing policy with respect to issuing export licenses, increased restrictions on services, and/or increased use of additional “end-use” controls to block or impose licensing requirements on exports.
Although we do not export any items to Russia, depending on the extent and breadth of any new sanctions or export controls, it is possible that our business, results of operations and financial condition could be adversely affected.
12 unchanged sentences
We may not be granted patents for any of our pending patent applications or any patent applications that we may file in the future and our issued patents may not be upheld if challenged.
−Removed: Further, we may not be able to detect an unauthorized use of our intellectual property rights if a competitor
−Removed: uses our intellectual property confidentially, in-house, with no public disclosure.
+Added: Further, we may not be able to detect an unauthorized use of our intellectual property rights if a competitor uses our intellectual property confidentially, in-house, with no public disclosure.
uses a first inventor to file system in which, assuming the other requirements for patentability are met, the first inventor to file a patent application is entitled to receive a patent (rather than the first to invent as was the case under prior U.S.
29 unchanged sentences
For example, we have been involved in patent litigation and antitrust litigation related to our sales of enoxaparin and other products, including albuterol.
−Removed: For further details, see the section titled Litigation in Note 20 in the accompanying “Notes to Consolidated Financial Statements” in this Annual Report on Form 10-K.
The protracted litigations involved, and may continue to involve, large legal expenses and the diversion of management’s time and effort away from the business.
Any future adverse determinations in a judicial or administrative proceeding or failure to obtain necessary licenses, whether in these litigations or in other litigations, could result in substantial monetary damage awards and could prevent us from manufacturing and selling our products, which could have a material and adverse effect on our financial condition.
−Removed: There may also be situations where we use our business judgment and decide to market and sell products, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts, which situation is commonly referred to as an at-risk launch.
+Added: There may also be situations where we use our business judgment and decide to market and sell products, notwithstanding the fact that allegations of patent infringement(s) have not been finally resolved by the courts, a situation commonly referred to as an at-risk launch.
The risk involved in doing so can be substantial because the remedies available to the owner of a patent for infringement may include, among other things, damages measured by the profits lost by the patent owner and not necessarily by the profits earned by the infringer as well as injunctive relief, which would halt our ability to market and sell such products altogether.
13 unchanged sentences
Any patents we have obtained, or will obtain in the future, may be challenged, invalidated or circumvented.
−Removed: Moreover, the USPTO or any other governmental agency, as well as third parties, may commence interference, opposition or other related third-party proceedings involving our patents or patent applications.
+Added: Moreover, the USPTO or any other governmental agency, as well as third parties, may commence interference,
+Added: opposition or other related third-party proceedings involving our patents or patent applications.
Any challenge to, or invalidation or circumvention of, our patents or patent applications would be costly, would require significant time and attention of our management, could cause a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.
4 unchanged sentences
These parties may breach or terminate these agreements, and we may not have adequate remedies for such breaches.
−Removed: Furthermore, these agreements may not provide meaningful protection for our trade secrets, know-how, or other confidential or proprietary information and technologies or result in the effective
−Removed: assignment to us of intellectual property, and may not provide an adequate remedy in the event of unauthorized use or disclosure of confidential information or other breaches of the agreements.
+Added: Furthermore, these agreements may not provide meaningful protection for our trade secrets, know-how, or other confidential or proprietary information and technologies or result in the effective assignment to us of intellectual property, and may not provide an adequate remedy in the event of unauthorized use or disclosure of confidential information or other breaches of the agreements.
Despite our efforts to protect our trade secrets, know-how, and our other confidential and proprietary information and technologies, we or our collaboration partners, board members, employees, consultants, contractors, or scientific and other advisors may unintentionally or willfully disclose our proprietary information to competitors.
14 unchanged sentences
We have entered into confidentiality agreements with our executives and key consultants.
−Removed: However, we do not have, and are not planning to enter into, any confidentiality agreements with our non-executive directors because they have a fiduciary duty of confidentiality as directors.
+Added: However, we do not have, and are not planning to enter into, any confidentiality agreements with our non-executive directors because they have a
+Added: fiduciary duty of confidentiality as directors.
Our former board members, employees or consultants who are currently employed at, or associated with, one of our competitors may unintentionally or willfully disclose our proprietary technology or information.
4 unchanged sentences
Any such issuances would result in dilution to our existing stockholders and could cause our stock price to fall.
−Removed: In addition, we have registered approximately 16.0 million shares subject to options and RSUs outstanding or reserved
−Removed: for future issuance under our equity compensation plans.
+Added: In addition, we have registered approximately 15.1 million shares subject to options and RSUs outstanding or reserved for future issuance under our equity compensation plans.
If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.
24 unchanged sentences
We have a pledging policy to restrict the pledging of shares by our executive officers and directors, which was created in 2021 and most recently amended in 2025.
−Removed: The policy prohibits our executive officers and directors from entering into any transaction whereby the executive officer or director, directly or indirectly, pledges, hypothecates, or otherwise encumbers more than twenty-five (25) percent of shares of common stock held by the individual or more than five (5) percent of our total outstanding shares of common stock as of the date of the transaction, whichever is lower, as collateral for indebtedness.
+Added: The policy prohibits our executive officers and directors from entering into any transaction whereby the executive officer or director, directly or indirectly, pledges, hypothecates, or otherwise encumbers more than forty (40) percent of shares of common stock held by the individual or more than ten (10) percent
+Added: of our total outstanding shares of common stock as of the date of the transaction, whichever is lower, as collateral for indebtedness.
This restriction extends to any hedging or similar transaction designed to decrease the risks associated with holding our securities.
31 unchanged sentences
● establishing advance notice procedures and requirements for stockholders to nominate candidates for election as directors or to bring matters before meetings of stockholders.
−Removed: These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current
−Removed: management by making it more difficult for stockholders to replace members of our Board of Directors, which is responsible for appointing the members of our management.
+Added: These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors, which is responsible for appointing the members of our management.
Furthermore, our amended and restated certificate of incorporation provides that unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for:
17 unchanged sentences
Additionally, as a result of any future global economic downturn, our third-party payers may delay or be unable to satisfy their reimbursement obligations.
−Removed: Sales of our principal products are dependent, in part, on the availability and extent of reimbursement from third-party payers, including government programs such as Medicare and Medicaid and private payer healthcare and insurance programs.
+Added: Sales of our principal products are dependent, in part, on the availability and
+Added: extent of reimbursement from third-party payers, including government programs such as Medicare and Medicaid and private payer healthcare and insurance programs.
A reduction in the availability or extent of reimbursement from government and/or private payer healthcare programs could have a material adverse effect on the sales of our products, our business and results of operations.
20 unchanged sentences
Our results of operations and, in some cases, cash flows may in the future be adversely affected by certain movements in exchange rates.
−Removed: We also expect that certain exchange rates may be more volatile than normal as a result of the Russian invasion of Ukraine and related events, the Middle East conflict, and uncertain macroeconomic conditions.
+Added: We also expect that certain exchange rates may be more volatile than normal as a result of political and civil unrest, global conflicts, tariff policies, supply chain disruptions, heightened inflationary pressures, and fluctuating interest rates, as well as other uncertain macroeconomic conditions.
From time to time, we may implement currency hedges intended to reduce our exposure to changes in foreign currency exchange rates.
4 unchanged sentences
A number of factors may adversely affect the labor force available to us or increase labor costs, including high employment levels and government regulations.
−Removed: A sustained labor shortage or increased turnover rates within our employee base could lead to increased costs, such as increased overtime to meet demand and increased wage rates to attract and retain employees, and could negatively affect our ability to efficiently operate our manufacturing and distribution facilities and overall business.
+Added: A sustained labor
+Added: shortage or increased turnover rates within our employee base could lead to increased costs, such as increased overtime to meet demand and increased wage rates to attract and retain employees, and could negatively affect our ability to efficiently operate our manufacturing and distribution facilities and overall business.
If we are unable to hire and retain employees capable of performing at a high-level, or if mitigation measures we may take to respond to a decrease in labor availability, such as overtime and third-party outsourcing, have negative effects, our business could be adversely affected.
An overall labor shortage, lack of skilled labor, increased turnover or labor inflation could have a material adverse impact on our business, financial condition or operating results.
+Added: Complications with the design or implementation of our new enterprise resource planning system could adversely impact our business and operations.
+Added: We rely extensively on information systems and technology to manage our business and summarize operating results.
+Added: We are in the process of a multi-year implementation of a new global enterprise resource planning (“ERP”) system.
+Added: The ERP system is designed to accurately maintain the Company’s financial records, enhance operational functionality and provide timely information to the Company’s management team related to the operation of the business and is intended to replace our existing operating and financial systems.
+Added: The ERP system implementation process has required, and will continue to require, the investment of significant personnel and financial resources.
+Added: We may not be able to successfully implement the ERP system without experiencing delays, increased costs and other difficulties.
+Added: If we are unable to successfully design and implement the new ERP system as planned, our financial positions, results of operations and cash flows could be negatively impacted.
+Added: Additionally, if we do not effectively implement the ERP system as planned or the ERP system does not operate as intended, and accordingly, the effectiveness of our internal control over financial reporting could be adversely affected or our ability to assess those controls adequately could be further delayed.
Failure to maintain adequate internal controls or to implement new or improved controls could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.
1 unchanged sentence
Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with GAAP.
−Removed: We may not be able to complete our evaluation, testing
−Removed: and any required remediation in a timely fashion.
+Added: We may not be able to complete our evaluation, testing and any required remediation in a timely fashion.
During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective.
24 unchanged sentences
For example, in 2022 the U.S.
−Removed: government enacted the Inflation Reduction Act of 2022, which imposes a 1% excise tax on certain stock repurchases (including potentially pursuant to
−Removed: our stock repurchase program) and a 15% alternative minimum tax on adjusted financial statement income.
−Removed: In addition, beginning in 2022, the Tax Cuts and Jobs Act of 2017 eliminated the option to deduct research and development expenditures currently and requires taxpayers to capitalize and amortize them over five or fifteen years, and this requirement may impact our effective tax rate and our cash tax liability in future years.
−Removed: Further, may countries, and organizations such as the Organization for Economic Cooperation and Development have proposed implementing changes to existing tax laws, including a proposed 15% global minimum tax that has been and is being adopted by several countries, with implementation beginning in 2024.
+Added: government enacted the Inflation Reduction Act of 2022, which imposes a 1% excise tax on certain stock repurchases (including potentially pursuant to our stock repurchase program) and a 15% alternative minimum tax on adjusted financial statement income.
+Added: In addition, the OBBB Act was signed into law on July 4, 2025 and introduced significant changes to U.S.
+Added: federal tax law.
+Added: We are continuing to evaluate the full impact of the OBBB Act on us.
+Added: Further, many countries, and organizations such as the Organization for Economic Cooperation and Development have proposed implementing changes to existing tax laws (“Pillar 2”), including a proposed 15% global minimum tax that has been and is being adopted by several countries.
+Added: The United States has withdrawn support for Pillar 2, but the G7 and the U.S.
+Added: Treasury Department announced an agreement that the U.S.
+Added: international tax regime will operate “side-by-side” with Pillar 2 rules.
+Added: We are continuing to monitor the enactment and implementation of Pillar 2 legislation, and the impact on our financial position and results of operations.
In addition to income taxes in the United States, we are subject to income taxes in many foreign jurisdictions.
7 unchanged sentences
Furthermore, due to shifting economic and political conditions, tax policies or rates in various jurisdictions may be subject to significant change.
−Removed: Additionally, increases in our effective tax rate as a result of a change in the mix of earnings in countries with differing statutory tax rates, changes in our overall profitability, changes in the valuation of deferred tax assets and liabilities, the results of audits and the examination of previously filed tax returns by various taxing authorities and continuing assessments of our tax exposures could impact our tax liabilities and affect our income tax expense, which could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.
+Added: Additionally, increases in our effective tax rate as a result of a change in the mix of earnings in countries with differing
+Added: statutory tax rates, changes in our overall profitability, changes in the valuation of deferred tax assets and liabilities, the results of audits and the examination of previously filed tax returns by various taxing authorities and continuing assessments of our tax exposures could impact our tax liabilities and affect our income tax expense, which could have a material adverse effect on our business, financial position and results of operations and could cause the market value of our common stock to decline.
We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
22 unchanged sentences
● the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
−Removed: ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, capital commitments or achievement of significant milestones;
+Added: ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures,
+Added: capital commitments or achievement of significant milestones;
● changes in, or termination of our agreements with our business partners;
8 unchanged sentences
● major changes in our Board of Directors or management or departures of key personnel;
−Removed: ● our overall effective tax rate, including impacts caused by any reorganization in our corporate structure, and any new legislation or regulatory developments, including the Tax Act;
+Added: ● our overall effective tax rate, including impacts caused by any reorganization in our corporate structure, and any new legislation or regulatory developments, including the OBBB Act;
● changes in accounting principles;
7 unchanged sentences
If we fail to meet or exceed such expectations for these or any other reasons, our business could be materially adversely affected and our stock price could fluctuate or decline substantially.
−Removed: In addition, if the market for pharmaceutical company stocks or the stock market in general, experiences a loss of
−Removed: investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, operating results or financial condition.
+Added: In addition, if the market for pharmaceutical company stocks or the stock market in general, experiences a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, operating results or financial condition.
The trading price of our common stock might also decline in reaction to events that affect other companies in our industry even if these events do not directly affect us.
21 unchanged sentences
We may become involved in litigation that may materially adversely affect us.
−Removed: From time to time, we may be involved in a variety of claims, lawsuits, investigations and proceedings relating to securities laws, product liability, patent infringement, contract disputes and other matters relating to various claims that arise in the normal course of our business in addition to governmental and other regulatory investigations and proceedings.
+Added: From time to time, we may be involved in a variety of claims, lawsuits, investigations and proceedings relating to securities laws, product liability, patent infringement, contract disputes, employment-related claims, and other matters relating to various claims that arise in the normal course of our business in addition to governmental and other regulatory investigations and proceedings.
For example, former employees have filed claims against us under California’s Private Attorneys General Act, or PAGA.
PAGA allows an aggrieved staff member to bring a lawsuit on behalf of other current and former staff members for labor code violations.
−Removed: In addition, third parties may, from time to time, assert claims against us in the form
−Removed: of letters and other communications.
−Removed: Such matters can be time-consuming, divert management’s attention and resources, cause us to incur significant expenses or liability and/or require us to change our business practices.
+Added: In addition, third parties may, from time to time, assert claims against us in the form of letters and other communications.
+Added: Such matters can be time-consuming, divert management’s attention and resources, cause us to incur significant expenses in defense and/or attorneys’ costs or liability and/or require us to change our business practices.
Because of the potential risks, expenses and uncertainties of litigation, we may, from time to time, settle disputes, even where we have meritorious claims or defenses, by agreeing to settlement agreements.
4 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.