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● our success depends on our ability to develop and/or acquire and commercialize additional pharmaceutical products;
−Removed: ● our Primatene Mist ® , glucagon, lidocaine, phytonadione, and enoxaparin products collectively represent a significant portion of our net revenues;
−Removed: if the sales volume or pricing of our Primatene Mist ® , glucagon, lidocaine, phytonadione, and enoxaparin 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;
+Added: ● our Primatene MIST ® , glucagon, epinephrine, lidocaine, phytonadione, and enoxaparin products collectively represent a significant portion of our net revenues;
+Added: if the sales volume or pricing of our Primatene MIST ® , glucagon, epinephrine, lidocaine, phytonadione, and enoxaparin 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;
● our success depends on the integrity of our supply chain, including multiple single source suppliers, the disruption of which could negatively impact our business;
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● sales of our products may be adversely affected by the continuing consolidation of our customer base;
−Removed: ● our business may be adversely affected by the ongoing COVID-19 pandemic or other epidemics;
● we depend upon our key personnel, the loss of whom could adversely affect our operations.
If we fail to attract and retain the talent required for our business, our business could be materially harmed;
+Added: ● our business may be adversely affected by the ongoing COVID-19 pandemic and the related challenging macroeconomic conditions globally;
● 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, impact of outbreaks of health epidemics, such as the COVID-19 pandemic, 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;
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All of our products must receive regulatory approval and meet (and continue to comply with) regulatory standards and requirements, including continued safety and efficacy standards.
−Removed: If health or safety 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.
+Added: 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.
For example, as a result of environmental concerns over the use of chlorofluorocarbons, or CFCs, the FDA, issued a final rule on January 16, 2009, that required the phase-out of the CFC formulation of our Primatene MIST ® product by December 31, 2011.
13 unchanged sentences
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 Primatene Mist ® , glucagon, lidocaine, phytonadione, and enoxaparin products collectively represent a significant portion of our net revenues.
−Removed: If the sales volume or pricing of our glucagon, lidocaine, phytonadione, and enoxaparin 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.
+Added: Our Primatene MIST ® , glucagon, epinephrine, lidocaine, phytonadione, and enoxaparin products collectively represent a significant portion of our net revenues.
+Added: If the sales volume or pricing of our glucagon, epinephrine, lidocaine, phytonadione, and enoxaparin 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.
Sales from our Primatene MIST ® product represented 17%, 17%, and 15% of our total net revenues for the years ended December 31, 2022, 2021, and 2020, respectively.
−Removed: Sales from our glucagon product, which we launched in February 2021 represented 11% of our total net revenues for the year ended December 31, 2021.
+Added: Sales from our glucagon product, which we launched in February 2021 represented 11% and 11% of our total net revenues for the years ended December 31, 2022 and 2021, respectively.
+Added: Sales from our epinephrine product represented 15%, 13%, and 7% of our total net revenues for the years ended December 31, 2022, 2021, and 2020, respectively.
Sales from our lidocaine products represented 11%, 10%, and 12% of our total net revenues for the years ended December 31, 2022, 2021, and 2020, respectively.
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We have experienced significant declines in the per unit pricing and gross margins attributable to our enoxaparin product since its commercial launch.
−Removed: Our Primatene Mist ® , glucagon, lidocaine, phytonadione, and enoxaparin products could be rendered obsolete or negatively impacted by numerous factors, many of which are beyond our control, including:
+Added: Our 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:
● decreasing average sales prices;
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● changes in third-party reimbursement practices;
+Added: ● changes in applicable environmental law;
● product liability claims;
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Any factor adversely affecting the sale of these products may cause our revenues to decline, and we may not be able to achieve and maintain profitability.
−Removed: We have incurred losses in the past and we may operate at a loss in future years while continuing to invest in developing new products.
−Removed: Although we achieved net income in the years ended December 31, 2021, 2020 and 2019, we may incur operating and net losses and negative cash flow from operations in the future.
−Removed: Our business may generate operating losses if we do not successfully commercialize our product candidates, maintain sales of and profits from existing products, and generate sufficient revenues to support our level of operating expenses, especially as we continue our investment in developing new products.
−Removed: Because of the numerous risks and uncertainties associated with our commercialization efforts and future product development, we are unable to predict whether we will be able to maintain profitability.
Our ability to develop new products and additional revenue streams depends upon our ability to invest ongoing revenue, borrow funds or raise additional capital when needed.
−Removed: Developing a single product in the pharmaceutical industry is a very expensive proposition with no certainty of
−Removed: regulatory clearance or commercial success.
+Added: Developing a single product in the pharmaceutical industry is a very expensive proposition with no certainty of regulatory clearance or commercial success.
Considerable amounts are invested into the research and development process.
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Likewise, the ability to borrow funds at an attractive rate is another factor in being able to fund research and development activities.
−Removed: Finally, being able to access the raise additional funds through the capital markets is another factor in being able to fund research and development.
+Added: Finally, being able to access the raise additional funds through the capital markets on favorable terms, if at all, particularly during times of market volatility, changes in the interest rate environment, and general economic instability, is another factor in being able to fund research and development.
If any one, or all, of these sources become unavailable, our research and development projects may become delayed or negatively impacted.
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We have invested significantly in our manufacturing capacity in order to vertically integrate our business, contain the costs of raw materials and reduce the risks imposed by relying on third-party single source suppliers.
−Removed: We currently own and operate facilities that manufacture raw materials and APIs for our products and product candidates and those of our customers and partners, including insulin API for MannKind.
+Added: We currently own and operate facilities that manufacture raw materials and APIs for our products and product candidates and those of our
+Added: customers and partners, including insulin API for MannKind.
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
−Removed: 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 a significant portion of our manufacturing capacity in Rancho Cucamonga is utilized for the manufacture of enoxaparin.
In November 2016, we amended our supply agreement with MannKind, or the Supply Agreement and our option purchase agreement with MannKind, or the Option Agreement, to modify and extend the annual minimum purchase commitments under the Supply Agreement and the Option Agreement to cover calendar years 2014 through 2023.
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In addition, in order to offset fixed manufacturing overhead costs and utilize our current facilities and personnel, it may at times be in our best interest to continue to produce and sell products that are not profitable in the near term, although this would negatively impact our gross margins.
−Removed: Additionally, we are in the process of building significant capacity to make finished products at our ANP facility.
−Removed: This capacity is intended to be used to supply finished pharmaceutical products to China and other markets outside of the US.
−Removed: However, there is no guarantee that we will sell enough finished pharmaceutical products to take advantage of this new manufacturing capacity.
We face significant competition in the pharmaceutical industry with respect to both our proprietary and generic drugs, which may result in others developing or commercializing products before or more successfully than we do, which could significantly limit our growth and materially and adversely affect our financial results.
The majority of our marketed products are generic products.
−Removed: We face and will face significant competition for our products and product candidates from pharmaceutical companies that focus on the generic injectable and inhalation markets such as Pfizer, Inc., Sagent Pharmaceuticals, Inc., Akorn, Inc., Sandoz Inc., Viatris Inc., Fresenius Kabi USA, Nexus Pharmaceuticals, Apotex Corp., Amneal Biosciences, American Regent, Inc., Hikma Pharmaceuticals USA, Par Pharmaceuticals, Cipla USA Inc., Meitheal Pharmaceuticals, Dr, Reddy’s Laboratories, Inc.
−Removed: and Teva Pharmaceutical Industries Ltd.
+Added: We face and will face significant competition for our products and product candidates from pharmaceutical companies that focus on the generic injectable and inhalation markets such as Pfizer, Inc., Sagent Pharmaceuticals, Inc., Akorn, Inc., Sandoz Inc., Viatris Inc., Fresenius Kabi USA, Nexus Pharmaceuticals, Apotex Corp., Amneal Biosciences, American Regent, Inc., Hikma Pharmaceuticals USA, Par Pharmaceuticals, Cipla USA Inc., Meitheal Pharmaceuticals, Dr, Reddy’s Laboratories, Inc., Eli Lilly and Co., and Teva Pharmaceutical Industries Ltd.
Competition in the generic pharmaceutical industry has increased as producers of branded products have entered the business by creating generic drug subsidiaries, purchasing generic drug companies, or licensing their products to generic manufacturers prior to patent expiration and/or as their patents expire.
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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, Amazon.com has made initial moves to develop a pharmaceutical distribution business.
−Removed: Also, the consolidation resulting from the merger between CVS Health and Aetna, if completed, is expected to create a vertically integrated organization with increased control over the physician and pharmacy networks and, ultimately, over which medicines are sold to patients.
−Removed: In addition, several major hospital systems in the United States announced a plan to form a nonprofit company that will provide U.S.
+Added: For example, in 2020 Amazon.com launched its pharmaceutical distribution business.
+Added: In addition, several major hospital systems in the United States formed a nonprofit company that will provide U.S.
hospitals with a number of generic drugs.
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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.
−Removed: 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.
+Added: Competition among pharmaceutical companies for qualified employees is intense, and the ability to attract and retain qualified individuals is critical to our success.
+Added: We have experienced attrition among our executive officers in the past, and any future loss of key members of our
+Added: organization or any inability to continue to attract high-quality employees may delay or prevent the achievement of major business objectives.
Our productivity may be adversely affected if we do not integrate or train our new employees quickly and effectively.
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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 the ongoing COVID-19 pandemic or other epidemics.
−Removed: The ongoing COVID-19 pandemic, including the recent Omicron variant, has continued to impact worldwide economic activity and financial markets.
−Removed: While three vaccines have received Emergency Use Authorization from the FDA, the COVID-19 pandemic remains a challenge to our business until it is abated.
+Added: Our business may be adversely affected by the ongoing COVID-19 pandemic and the related challenging macroeconomic conditions globally.
+Added: The ongoing COVID-19 pandemic, including the emergence of variants, has continued to impact worldwide economic activity and financial markets, and remains a potential challenge to our business until it is abated.
Mass and rapid production of the vaccines, for example, has placed increased pressure on the availability of supplies that are also used in our products, such as glass vials and needles.
−Removed: The COVID-19 pandemic is imposing additional burdens on our business to comply with regulations imposed by the State of California.
The COVID-19 pandemic may also disrupt the operations of our customers, suppliers and partners for an indefinite period of time, including as a result of travel restrictions and/or business shutdowns, all of which could negatively impact our business and results of operations, including cash flows.
Disruptions to our manufacturing partners and suppliers could result in disruption to the production of our products and failure to satisfy demand.
−Removed: More generally, the outbreak of COVID-19 could adversely affect economies and financial markets globally and nationally, potentially leading to an economic downturn, which could decrease spending and adversely affect demand for our products and harm our business and results of operations.
−Removed: Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact to our business as a result of its global economic impact, including any recession that has occurred or may occur in the future.
−Removed: Specifically, difficult macroeconomic conditions, increased and prolonged unemployment or a decline in business confidence as a result of the COVID-19 pandemic, could have a continuing adverse effect on the demand for some of our products.
−Removed: The degree of impact of the COVID-19 pandemic 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, all of which continue to evolve and remain uncertain at this time.
+Added: More generally, the ongoing COVID-19 pandemic could continue to adversely affect economies and financial markets globally and nationally, including inflationary pressures and changes in interest rates, which could decrease spending and adversely affect demand for our products and harm our business and results of operations.
+Added: To the extent macroeconomic uncertainty persists or the COVID-19 pandemic or macroeconomic conditions worsen, we may experience a continuing adverse effect on the demand for some of our products.
+Added: The degree of impact of the COVID-19 pandemic and the related challenging macroeconomic conditions globally 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, all of which continue to evolve and remain uncertain at this time.
As a result of the consequences of the COVID-19 pandemic, FDA has issued various COVID-19 related guidance documents applicable to biopharmaceutical manufacturers and clinical trial sponsors.
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These and future guidance documents and regulatory requirements, including future legislation, may require us to develop and implement new policies and procedures, make significant adjustments to our clinical trials, or increase the amount time and resources needed for regulatory compliance, which may impact our clinical development plans and timelines.
−Removed: Some of our ongoing clinical trials have experienced short term interruptions in the recruitment of patients due to the COVID-19 pandemic, as hospitals prioritize their resources toward the COVID-19 pandemic and governments impose travel restrictions.
+Added: Some of our ongoing clinical trials have experienced short term interruptions in the recruitment of patients due to the COVID-19 pandemic, as hospitals prioritized their resources toward the COVID-19 pandemic and governments imposed travel restrictions.
Additionally, protocols at certain clinical sites have changed which could slow down the pace of clinical trials while also increasing their cost.
These conditions may in turn delay spending and delay the results of these trials.
−Removed: Additionally, certain suppliers delayed shipments to us in 2020.
+Added: Additionally, certain suppliers delayed shipments to us in 2021 and 2022.
These delays may have been caused by manufacturing disruptions due to the COVID-19 pandemic.
−Removed: None of these delays caused delays in our manufacturing, but future delays could cause manufacturing disruptions at our factories.
−Removed: It is not possible at this time to estimate the complete impact that the COVID-19 pandemic could have on our business, as the impact will depend on future developments, which are highly uncertain and cannot be predicted.
−Removed: Infections may resurge or become more widespread and the limitation on our ability to travel and timely sell and distribute our products, as well as any closures or supply disruptions, may be extended for longer periods of time, all of which would have a negative impact on our business, financial condition and operating results.
−Removed: We will continue to monitor the impact of the COVID-19 pandemic on all aspects of our business.
+Added: For example, in the first quarter of 2022, increases in COVID-19 cases in Shanghai, China, led to shutdowns and delays at the ports in Shanghai, which led to temporary delays in shipping certain APIs and starting materials.
+Added: Future shutdowns could have an adverse impact on our operations.
+Added: However, the extent of the impact of any future shutdown or delay is highly uncertain and difficult to predict.
+Added: Shanghai’s delays did not ultimately cause delays in our manufacturing, but future delays could cause manufacturing disruptions at our factories.
+Added: Any of the negative impacts of the ongoing COVID-19 pandemic and the related challenging macroeconomic conditions, including, among others, those described above, alone or in combination with others, may have a material adverse effect on our business and operations, results of operations, financial condition, and cash flows.
+Added: It is not possible at this time to estimate the complete impact that the COVID-19 pandemic and the related challenging economic conditions could have
+Added: on our business, as the impact will depend on future developments, which are highly uncertain and cannot be predicted.
+Added: Macroeconomic conditions may continue to worsen leading to changes in monetary policy and other responses from governmental bodies, infections may resurge or become more widespread and the limitation on our ability to travel and timely sell and distribute our products, as well as any closures or supply disruptions, may be enacted or extended for longer periods of time, each of which alone or in combination with others, would have a negative impact on our business, financial condition and operating results.
+Added: We will continue to monitor the impact of the COVID-19 pandemic and the related challenging macroeconomic conditions on all aspects of 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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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, including personal information, clinical data and business proprietary information, in connection with our business activities, including our supply chain processes, operations and communications.
−Removed: The collection, use, transmission, transfer, storage and processing of personal information, including about our personnel, business partners, and others, may be subject to applicable data protection, security and privacy laws, and regulations that require adoption of minimum information security standards.
+Added: 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, or EDI, on purchase orders, invoices, chargebacks, among other things.
+Added: 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.
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 and bugs, natural disasters, war, terrorism, acts of vandalism, telecommunications and electrical outages, breakdowns, damage, interruptions), risks remain, and 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 these threats.
−Removed: The size and complexity of our systems and networks may make them potentially vulnerable to breakdown or interruption, whether due to computer viruses or other causes, which may result in the loss of data or the impairment of production and other supply chain processes, adversely affecting our business.
−Removed: Techniques used to sabotage or obtain unauthorized access to systems and networks are constantly evolving and may not be identified until or after they are launched against us or our third-party providers.
+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., 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.
+Added: 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 their internal computer systems.
+Added: We worked with ANP to improve and implement additional security measures to their systems and networks.
+Added: We have incurred costs to respond to the ANP incident.
+Added: 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.
+Added: 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.
+Added: We notified affected individuals and regulators, as we deemed was required or appropriate.
+Added: We have incurred cost to respond to this incident, and we expect to continue to incur cost to support our efforts to enhance our security measures.
+Added: 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 these threats.
+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.
+Added: 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.
We and our third-party providers may be unable to anticipate these techniques, discover threats and react in a timely manner, or implement adequate preventative or mitigating measures.
−Removed: Further, these types of security incidents have become more prevalent.
+Added: Further, system breaches, malware, ransomware, computer hacking, and insider threats have become more prevalent.
For example, companies have experienced an increase in phishing and social engineering attacks from third parties in connection with working remotely as a result of the ongoing COVID-19 pandemic.
We and our third-party providers who may be operating 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: 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, especially with an increased number of employees working remotely.
−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: Potential legal, regulatory, contractual, financial, operational, or reputational harm may arise from any such security incident that results in the accidental or unlawful destruction, damage, loss, unavailability, alteration, impairment, misuse, unauthorized disclosure of, or unauthorized access to our systems, network, 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: Also, due to political uncertainty and military actions associated with Russia’s invasion of Ukraine, 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: 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.
+Added: Any failure to maintain performance, reliability, security and availability of our systems and networks may result in accidental or
+Added: 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 collaborators, third-party 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.
−Removed: ● Any such security incident may require costly response and remediation efforts, trigger notification obligations under breach notification laws or contractual notification requirements, result in time consuming, distracting and expensive litigation or adverse regulatory action arising from or related to such an incident, damage our reputation, and result in significant additional expense to implement further data protection measures.
+Added: ● Any security incident may require costly response and remediation efforts, trigger notification obligations under breach notification laws or contractual notification requirements, result in litigation or adverse regulatory action arising from or related to such an incident or event, damage our reputation, and result in significant additional expense to implement further data protection measures.
Integrating the systems and data of any acquired entity may increase these risks due to unforeseen threats and vulnerabilities.
−Removed: ● Similarly, any such security incident experienced by our collaborators, third-party providers, distributors and other contractors may hinder our product development, supply chain, other business operations, or our regulatory and contractual obligations to others and could also give rise to litigation or adverse regulatory action.
−Removed: We have experienced and may continue to experience cyberattacks of varying degrees from time to time.
−Removed: 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 have incurred costs to respond to this incident, and we expect to continue to incur costs to support our efforts to enhance our security measures.
+Added: ● Similarly, any security incident experienced by our collaborators, third-party providers, distributors and other contractors may hinder our product development, supply chain, other business operations, or our regulatory and contractual obligations to others and could also give rise to litigation or adverse regulatory action.
+Added: In an effort to ensure appropriate oversight of cyber security issues and risks, management now updates the Board of Directors on cyber security matters on a quarterly basis, and the Board of Directors has assigned oversight of cyber security to the Audit Committee.
+Added: Additionally, the Company has a security training and compliance program, which employees with access to information technology, must complete annually or more often, if deemed necessary or appropriate.
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 and networks or in protecting other systems and networks upon which we may rely.
−Removed: 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 expenditure of significant financial or other resources 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.
−Removed: Any such security incident or could have a material adverse effect on our business and prospects.
+Added: 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: 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.
+Added: Any such security incident could have a material adverse effect on our business and prospects.
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.
+Added: We have incurred losses in the past and we may operate at a loss in future years while continuing to invest in developing new products.
+Added: Although we achieved net income in the years ended December 31, 2022, 2021 and 2020, we may incur operating and net losses and negative cash flow from operations in the future.
+Added: Our business may generate operating losses if we do not successfully commercialize our product candidates, maintain sales of and profits from existing products, and generate sufficient revenues to support our level of operating expenses, especially as we continue our investment in developing new products.
+Added: Because of the numerous risks and uncertainties associated with our commercialization efforts and future product development, we are unable to predict whether we will be able to maintain profitability.
Risks Relating to Regulatory Matters
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In addition, in the event we are successful in developing product candidates for distribution and sale in other countries, we would become subject to regulation in such countries.
−Removed: Such foreign regulations and product approval requirements are expected to be time
−Removed: consuming and expensive as well.
+Added: Such foreign regulations and product approval requirements are expected to be time consuming and expensive as well.
We may encounter delays or agency rejections during any stage of the regulatory review and approval process based upon a variety of factors, including without limitation the failure to provide clinical data demonstrating compliance with the FDA’s requirements for safety, efficacy and quality.
15 unchanged sentences
In addition, data obtained from trials and studies are susceptible to varying interpretations, and regulators may not interpret our data as favorably as we do, which may delay, limit or prevent regulatory approval.
−Removed: Success in preclinical studies and early clinical trials does not ensure that subsequent clinical trials will generate the same or similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate.
+Added: Success in preclinical studies and
+Added: early clinical trials does not ensure that subsequent clinical trials will generate the same or similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate.
A number of companies in the pharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in Phase 3 clinical trials, even after seeing promising results in earlier clinical trials.
17 unchanged sentences
Protocol amendments may require us to resubmit protocols to institutional review boards for reexamination or renegotiate terms with contract research organizations and study sites and investigators, all of which may adversely impact the costs or timing of or our ability to successfully complete a trial.
−Removed: Clinical trials required by the FDA for approval of our products may not produce the results we need to move forward in product development or to submit or obtain approval of an NDA.
+Added: Clinical trials required by the FDA for approval of our products may not produce the results we need to move forward in
+Added: product development or to submit or obtain approval of an NDA.
Success in pre-clinical testing and early phase clinical trials does not assure that late phase clinical trials will be successful.
29 unchanged sentences
In addition, delays in approvals or rejections of marketing applications in the U.S.
−Removed: or other countries may be based upon many factors, including regulatory requests for additional analyses, reports, data, preclinical studies and clinical trials, regulatory questions regarding different interpretations of data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our product candidates or other products.
+Added: or other countries may be based upon many factors, including regulatory requests for additional analyses, reports, data, preclinical studies and clinical trials,
+Added: regulatory questions regarding different interpretations of data and results, changes in regulatory policy during the period of product development and the emergence of new information regarding our product candidates or other products.
Also, regulatory approval for any of our product candidates may be withdrawn.
5 unchanged sentences
If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for fast track designation.
−Removed: The FDA has broad discretion whether or not to grant
−Removed: this designation.
+Added: The FDA has broad discretion whether or not to grant this designation.
Even if we believe a particular product candidate is eligible for this designation, we cannot assure you that the FDA would decide to grant it.
25 unchanged sentences
The statutory standards for determining biosimilarity and interchangeability are broad and subject to change, and the FDA has broad discretion to determine the nature and extent of product characterization, nonclinical testing and clinical testing on a product-by-product basis.
−Removed: Products approved based on biosimilarity without an FDA determination of interchangeability may not be substitutable
−Removed: at the retail pharmacy level.
+Added: Products approved based on biosimilarity without an FDA determination of interchangeability may not be substitutable at the retail pharmacy level.
Some states have passed laws limiting pharmacy substitution to biosimilar products that the FDA has determined to be interchangeable, as well as restrictions on the substitution of interchangeable biosimilar products.
12 unchanged sentences
These drug-device combination products are particularly complex, expensive and time-consuming to develop due to the number of variables involved in the final product design, including ease of patient and doctor use, establishing clinical efficacy, reliability and cost of manufacturing, regulatory approval requirements and standards and other important factors.
−Removed: We will be responsible for any regulatory filings arising from this collaboration and, although we have significant in-house and external regulatory expertise, we have never prepared or submitted an NDA to the FDA for a drug-device combination product.
+Added: We will be responsible for any regulatory filings arising from this collaboration and, although we have significant in-house and external regulatory
+Added: expertise, we have never prepared or submitted an NDA to the FDA for a drug-device combination product.
Our product candidates intended for use with such drug delivery, or expanded indications that we may seek for our products used with such devices, may not be approved or may be substantially delayed in receiving approval if the devices do not gain and/or maintain their own regulatory approvals or clearances.
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Also, Commission Delegated Regulation (EU) No 357/2014 on post-authorization efficacy studies specifies the situations in which such studies may be required.
−Removed: Post-authorization efficacy studies may be required where concerns relating to some aspects of efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed, or where the understanding of the disease, the clinical methodology or the use of the
−Removed: medicinal product under real-life conditions indicate that previous efficacy evaluations might have to be revised significantly.
+Added: Post-authorization efficacy studies may be required where concerns relating to some aspects of efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed, or where the understanding of the disease, the clinical methodology or the use of the medicinal product under real-life conditions indicate that previous efficacy evaluations might have to be revised significantly.
Brexit is also expected to disrupt the operation of pre- and post-authorization clinical trial infrastructure.
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Our ability to successfully commercialize our products may depend in part on the availability of reimbursement for and insurance coverage of our prescription products from government health administration authorities, private health insurers and other third-party payers and administrators, including Medicaid and Medicare.
−Removed: Third-party payers and administrators, including state Medicaid programs and Medicare, have been challenging the prices charged for pharmaceutical products.
+Added: Third-party payers and administrators, including state Medicaid programs and Medicare, have been challenging the prices charged for
+Added: pharmaceutical products.
Government and other third-party payers increasingly are limiting both coverage and the level of reimbursement for new drugs.
24 unchanged sentences
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.
−Removed: From June 14, 2021 through June 22, 2021, our Amphastar facility in Rancho Cucamonga, California was subject to a pre-approval inspection by the FDA.
−Removed: The inspection included a review of our corrective actions taken from the previous cGMP inspection in February 2019, as well as a review of the data supporting our pending applications.
−Removed: The inspections resulted in multiple observations on Form 483.
−Removed: We fully responded to those observations on July 14, 2021.
−Removed: We believe that our responses to the observations have satisfied the requirements of the FDA
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.
1 unchanged sentence
Because we own and operate real property, various environmental laws also may impose liability on us for the costs of cleaning up and responding to hazardous substances that may have been released on our property, including releases unknown to us.
−Removed: These environmental laws and regulations also could require us to pay for environmental remediation and response costs at third-party locations where we dispose of or recycle hazardous substances.
+Added: These environmental laws
+Added: and regulations also could require us to pay for environmental remediation and response costs at third-party locations where we dispose of or recycle hazardous substances.
The costs of complying with these various environmental requirements, as they now exist or as may be altered in the future, could adversely affect our financial condition and results of operations.
1 unchanged sentence
This phase out caused us to discontinue sales of the CFC version of our Primatene MIST ® product subsequent to December 31, 2011 and write off our inventory for the product, which had an adverse effect on our financial results.
+Added: Similarly, on December 27, 2020, the American Innovation in Manufacturing Act of 2020, or AIM Act, was enacted.
+Added: The AIM Act directs the United States Environmental Protection Agency to address usage of hydrofluorocarbons, or HFC, by reducing production and consumption of certain HFCs.
+Added: One of our products, Primatene MIST ® , utilizes HFCs subject to the AIM Act’s reduction mandate.
+Added: Moreover, many of our inhalation pipeline assets use HFCs subject to the AIM Act’s reduction mandate.
+Added: 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.
+Added: 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.
The Affordable Care Act and certain legislation and regulatory proposals may increase our costs of compliance and negatively impact our profitability over time.
1 unchanged sentence
The Affordable Care Act made extensive changes to the delivery of health care in the United States.
−Removed: We expect that the rebates, discounts, taxes and other costs resulting from the Affordable Care Act over time will have a negative effect
−Removed: on our expenses and profitability in the future.
+Added: We expect that the rebates, discounts, taxes and other costs resulting from the Affordable Care Act over time will have a negative effect on our expenses and profitability in the future.
Furthermore, the Independent Payment Advisory Board created by the Affordable Care Act to reduce the per capita rate of growth in Medicare spending could potentially limit access to certain treatments or mandate price controls for our products.
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however, we anticipate that it will have an adverse effect on our results of operations.
−Removed: There has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between
−Removed: pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
−Removed: For example, in 2020, HHS and CMS under the Trump administration issued final rules that were expected to impact, among others, price reductions from pharmaceutical manufacturers to plan sponsors under Part D, fee arrangements between pharmacy benefit managers and manufacturers, manufacturer price reporting requirements under the Medicaid Drug Rebate Program, including regulations that affect manufacturer-sponsored patient assistance programs subject to pharmacy benefit manager accumulator programs and Best Price reporting related to certain value-based purchasing arrangements.
−Removed: Multiple lawsuits have been brought against the HHS challenging various aspects of the rules.
−Removed: The impact of these lawsuits as well as legislative, executive, and administrative actions of the Biden administration on us and the pharmaceutical industry as a whole is currently unknown.
−Removed: Further, in January 2021, President Biden issued an executive order to initiate a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which also instructs certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare.
−Removed: Under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs will be eliminated.
+Added: There has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
+Added: For example, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs will be eliminated.
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.
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 response to this executive order, the HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and potential legislative policies that Congress could pursue to advance these principles.
−Removed: In November 2021, the Biden administration also announced a prescription drug plan in Build Back Better framework, which proposes allowing Medicare to negotiate prescription drug prices, imposing a tax penalty if drug companies increase their prices faster than inflation, and directly lowering out-of-pocket costs for seniors.
−Removed: Congress is considering legislation that addresses these proposals which, if passed, could have significant impact on prices of prescription drugs covered by Medicare.
+Added: 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, 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.
The impact of these legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the Biden administration on us and the pharmaceutical industry as a whole is unclear.
13 unchanged sentences
We collect, process, use, store, transmit and transfer personal information from individuals located in the EU in connection with our business.
−Removed: The collection, processing, storage, transmission, transfer and use of personal information
−Removed: in the EU are governed by the provisions of the General Data Protection Regulation ((EU) 2016/679), or the GDPR.
+Added: The collection, processing, storage, transmission, transfer and use of personal information in the EU are governed by the provisions of the General Data Protection Regulation ((EU) 2016/679), or the GDPR.
This legislation imposes requirements relating to having legal bases for processing personal information relating to identifiable individuals and transferring such information outside of the European Economic Area, to third countries that have not been found to provide adequate protection to such personal information, including to the U.S., providing details to those individuals regarding the processing of their personal information, keeping personal information secure, having data processing agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in respect of their personal information, reporting security breaches involving personal information to the competent national data protection authority and affected individuals, appointing data protection officers, conducting data protection impact assessments and record-keeping.
16 unchanged sentences
Aspects of the CCPA and CPRA, and their interpretation and enforcement remain uncertain.
−Removed: The potential effects of the CCPA and CPRA are far-reaching and may require us to modify our data processing practices and policies and to incur substantial costs and expenses in an effort to comply.
+Added: The potential effects of the CCPA and CPRA are far-
+Added: reaching and may require us to modify our data processing practices and policies and to incur substantial costs and expenses in an effort to comply.
The CCPA and CPRA could mark the beginning of a trend toward more stringent data protection, security and privacy legislation in the U.S.
The CCPA has prompted a number of proposals for federal and state privacy legislation.
−Removed: For example, in March 2021, Virginia enacted the Virginia Consumer Data Protection Act, or CDPA, a comprehensive privacy statute that becomes effective on January 1, 2023 and shares similarities with the CCPA and the CPRA, but also imposes security and assessment requirements for businesses.
+Added: For example, in March 2021, Virginia enacted the Virginia Consumer Data Protection Act, or CDPA, a comprehensive privacy statute that became effective on January 1, 2023 and shares similarities with the CCPA and the CPRA, but also imposes security and assessment requirements for businesses.
In addition, on July 7, 2021, Colorado enacted the Colorado Privacy Act, or CPA, which closely resembles the CDPA.
−Removed: The CPA and CDPA will be enforced by the respective states’ Attorney General and district attorneys.
+Added: Also, in March 2022, Utah enacted the Utah Consumer Privacy Act, which becomes effective on December 31, 2023, and in May 2022, Connecticut enacted the Act Concerning Personal Data and Online Monitoring, which becomes effective on July 1, 2023, both of which differ from the CPRA, CDPA, and CPA.
+Added: These new state privacy laws will be enforced by the respective states’ Attorney General and/or district attorneys.
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.
1 unchanged sentence
We may also publicly post privacy policies and other documentation regarding our collection, use, storage, transmission, transfer and other processing of personal information.
−Removed: Although we endeavor to comply with our public policies and
−Removed: documentation, we may at times fail to do so or be alleged to have failed to do so.
+Added: Although we endeavor to comply with our public policies and documentation, we may at times fail to do so or be alleged to have failed to do so.
Moreover, despite our efforts, we may not be successful in achieving compliance if our employees or contractors fail to comply with our published policies and documentation.
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Such pressures have increased as a result of the Medicare Prescription Drug Improvement and Modernization Act of 2003, or the MMA, due to the enhanced purchasing power of the private sector plans that negotiate on behalf of Medicare beneficiaries.
−Removed: In 2020, HHS and CMS under the Trump administration issued final rules that were expected to impact, among others, price reductions from pharmaceutical manufacturers to plan sponsors under Part D, fee arrangements between pharmacy benefit managers and manufacturers, manufacturer price reporting requirements under the Medicaid Drug Rebate Program, including regulations that affect manufacturer-sponsored patient assistance programs subject to pharmacy benefit manager accumulator programs and Best Price reporting related to certain value-based purchasing arrangements.
−Removed: Multiple lawsuits have been brought against the HHS challenging various aspects of the rules.
−Removed: Among other legislative proposals on prescription drug pricing, in November 2021, the Biden administration also announced a prescription drug plan in Build Back Better framework, which proposes allowing Medicare to negotiate prescription drug prices, imposing a tax penalty if drug companies increase their prices faster than inflation, and directly lowering out-of-pocket costs for seniors.
−Removed: Congress is considering legislation that addresses these proposals which, if passed, could have significant impact on prices of prescription drugs covered by Medicare.
−Removed: The impact of these legislative, executive, and administrative
−Removed: actions and any future healthcare measures and agency rules implemented by the Biden administration on us and the pharmaceutical industry as a whole is unclear.
+Added: For example, in November 2021, the Biden administration also announced a prescription drug plan in Build Back Better framework, which proposes allowing Medicare to negotiate prescription drug prices, imposing a tax penalty if drug companies increase their prices faster than inflation, and directly lowering out-of-pocket costs for seniors.
+Added: 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, 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: The impact of these legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the Biden administration on us and the pharmaceutical industry as a whole is unclear.
The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our approved products.
−Removed: Our epinephrine prefilled syringe is marketed without FDA approval and may be subject to enforcement actions by the FDA.
−Removed: Our epinephrine prefilled syringe prescription product is marketed without FDA approval.
−Removed: This product, like many other prescription drugs on the market that have not been formally evaluated as being effective by the FDA, contains active ingredients that were first marketed prior to the enactment of the Federal Food, Drug, and Cosmetic Act, or FFDCA.
−Removed: The FDA has assessed this product in a program known as the “Prescription Drug Wrap-Up” and has stated that this drug cannot be lawfully marketed unless they comply with certain “grandfather” exceptions to the definition of “new drug” in the FFDCA.
−Removed: These exceptions have been strictly construed by FDA and by the courts, and the FDA has stated that it is unlikely that any of the unapproved prescription drugs on the market, including of our drug, qualify for the exceptions.
−Removed: At any time, the FDA may require that our unapproved prescription drug be submitted for approval and may direct us to recall this product and/or cease marketing the product until they are approved.
−Removed: The FDA may also take enforcement actions based on our marketing of this unapproved product, including but not limited to the issuance of an untitled letter or a warning letter, judicial action seeking an injunction, product seizure and/or civil or criminal penalties.
−Removed: The enforcement posture could change at any time and our ability to market such drugs could terminate with little or no notice.
−Removed: Moreover, if our competitors seek and obtain approval and market FDA-approved prescription products that compete against our unapproved prescription product, we would be subject to a higher likelihood that the FDA may seek to take action against our unapproved product.
−Removed: Such competitors have brought and may bring claims against us alleging unfair competition or related claims.
−Removed: As a result of our meetings with the FDA in 2009, we decided to discontinue all of our products that were subject to the Prescription Drug Wrap-Up program, with the exception of epinephrine in vial form.
−Removed: These products were all produced at our subsidiary, IMS.
−Removed: During the third quarter of 2010, the FDA requested that we reintroduce several of the withdrawn products to help address a national drug shortage, while we prepared and filed applications for approval of the products.
−Removed: Between August and October 2010, we reintroduced our epinephrine prefilled syringes.
−Removed: In February 2017, the FDA requested that we discontinue the manufacturing and distribution of our epinephrine injection, USP vial product, which had been marketed under the “grandfather” exception to the “FDA’s Prescription Drug Wrap-Up program”.
−Removed: We discontinued selling this product in the second quarter of 2017.
−Removed: In April 2020, the FDA granted approval of our Epinephrine Injection USP 30mg/mL Multiple Dose Vial, and we launched the product in May 2020.
−Removed: The FDA granted approval of our Atropine Sulfate Injection 0.1mg/mL in the 10mL Luer-Jet ® Prefilled Syringe in October 2020, our Dextrose Injection 50% in the 50mL Luer-Jet ® Prefilled Syringe in March 2021 and our Morphine Sulfate Injection USP, 1mh/mL 30mL in April 2021.
−Removed: Our only unapproved product currently on the market is epinephrine prefilled syringes.
−Removed: For the years ended December 31, 2021, 2020, and 2019, we recorded net revenues of $27.8 million, $13.2 million, and $13.9 million, respectively, for epinephrine prefilled syringes.
−Removed: We filed an NDA for our epinephrine prefilled syringes in order to mitigate all risk associated with the marketing of unapproved drug products.
−Removed: Prior to the approval of our NDA submission, we continue to operate in compliance with the FDA Compliance Policy Guide, CPG Sec.
−Removed: 440.100 Marketed New Drugs Without Approved NDAs and ANDAs.
−Removed: In 2020, the HHS announced that termination of the FDA Unapproved Drugs Initiative (UDI), citing that the Compliance Policy Guide (CPG) issued with the UDI was “linked to prescription drug price increases and shortages” and announced its withdrawal.
−Removed: However, under the Biden administration, in May 2021, HHS and FDA, each under new leadership, jointly issued a withdrawal-of-the-termination notice, withdrawing the prior HHS notice of termination issued under the Trump administration, citing multiple legal and factual inaccuracies.
−Removed: New guidance from the agency is anticipated in the future.
−Removed: The long-term impact of this policy and other measures promulgated by the Biden administration on our business remains unclear.
Our reporting and payment obligations under the Medicare and/or Medicaid drug rebate programs and other governmental purchasing and rebate programs are complex and may involve subjective decisions that could change as a result of new business circumstances, new regulatory guidance or advice of legal counsel.
8 unchanged sentences
These investigations could have a material adverse effect on our business, financial position and results of operations.
−Removed: For example, under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs will be eliminated.
+Added: Under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs will be eliminated.
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 November 2021, the Biden administration also announced a prescription drug plan in Build Back Better framework, which proposes allowing Medicare to negotiate prescription drug prices, imposing a tax penalty if drug companies increase their prices faster than inflation, and directly lowering out-of-pocket costs for seniors.
−Removed: As part of the No Surprises Act and the Consolidated Appropriations Act of 2021, the Biden administration has issued an interim final rule that requires private insurers to report prescription drug costs to the federal government.
+Added: 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, 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.
The impact of these legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the Biden administration on us and the pharmaceutical industry as a whole is unclear.
−Removed: Any governmental agencies that have commenced, or may commence, an investigation of our business relating to the sales, marketing, pricing, quality or manufacturing of pharmaceutical products could seek to impose, based on a claim of violation of fraud and false claims laws or otherwise, civil and/or criminal sanctions, including fines, penalties and possible exclusion from federal health care programs including Medicare and/or Medicaid.
+Added: Any governmental agencies that have commenced, or may commence, an investigation of our business relating to the sales, marketing, pricing, quality or manufacturing of pharmaceutical products could seek to impose, based on a claim of
+Added: violation of fraud and false claims laws or otherwise, civil and/or criminal sanctions, including fines, penalties and possible exclusion from federal health care programs including Medicare and/or Medicaid.
Some of the applicable laws may impose liability even in the absence of specific intent to defraud.
9 unchanged sentences
Although our policy is to refrain from statements that could be considered off-label promotion of our products, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion.
−Removed: In addition, the off-label use of our products may
−Removed: increase the risk of product liability claims.
+Added: In addition, the off-label use of our products may increase the risk of product liability claims.
Product liability claims are expensive to defend and could divert our management’s attention, result in substantial damage awards against us and harm our reputation.
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Dealing with investigations can be time- and resource-consuming and can divert management’s attention from the business.
−Removed: Additionally, if a healthcare provider settles an investigation with the DOJ or other law enforcement agencies, we may be forced to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement.
+Added: Additionally, if a healthcare provider
+Added: settles an investigation with the DOJ or other law enforcement agencies, we may be forced to agree to additional onerous compliance and reporting requirements as part of a consent decree or corporate integrity agreement.
Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.
9 unchanged sentences
While we have implemented numerous risk mitigation measures to comply with such regulations in this complex operating environment, we cannot guarantee that we will be able to effectively mitigate all operational risks.
−Removed: have developed and instituted a corporate compliance program, we cannot guarantee that we, our employees, our consultants or our contractors are or will be in compliance with all potentially applicable U.S.
+Added: While we have developed and instituted a corporate compliance program, we cannot guarantee that we, our employees, our consultants or our contractors are or will be in compliance with all potentially applicable U.S.
federal and state regulations and/or laws, all potentially applicable foreign regulations and/or laws and/or all requirements of the corporate integrity agreement.
26 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 ongoing COVID-19 pandemic, which has resulted in and may in the future result in , business closures, transportation restrictions, import and export complications, and otherwise cause shortages in the supply of raw materials or cause disruptions in our manufacturing capability ;
−Removed: ● 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;
−Removed: ● the imposition of tariffs 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 the tariffs previously implemented and additional tariffs that have been proposed by the U.S.
+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 ongoing COVID-19 pandemic, which has resulted in and may in the future result in , business closures, transportation restrictions, import and export complications, and otherwise cause shortages in the supply of raw materials or cause disruptions in our manufacturing capability ;
+Added: ● 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, including China’s policies with respect to COVID-19;
+Added: ● 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.
+Added: and foreign export controls such as U.S.
+Added: controls preventing the export of a wide-range of items to Russia, new controls impacting the ability to send certain products and technology, specifically related to semi-conductor manufacturing and supercomputing to 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, the tariffs previously implemented and additional tariffs that have been proposed by the U.S.
government on various imports from China and by the Chinese government on certain U.S.
1 unchanged sentence
● 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, natural disasters including earthquakes, typhoons, floods, and fires, or outbreaks of health epidemics such as coronavirus, 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, including war and terrorism such as the war in Ukraine, 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,
+Added: or distribution of animal-derived products.
Any of these matters could materially and adversely affect our business and results of operations.
These interruptions or failures could impair our ability to operate our business, impede the commercialization of our product candidates or delay the introduction of new products, impact our product quality, or impair our competitive position.
−Removed: We are actively monitoring and assessing the ongoing impact of the COVID-19 pandemic.
+Added: We are actively monitoring and assessing the ongoing impact of the COVID-19 pandemic on our business.
This includes evaluating the impact on our employees, suppliers, and logistics providers as well as evaluating governmental actions being taken to curtail the spread of the virus.
−Removed: While the Chinese government has been relaxing work restrictions, at this time, it is unclear if the Chinese government will reinstate restrictions or if further restrictions will be put into place by the government in response to new variants.
+Added: For example, in the first quarter of 2022, increases in COVID-19 cases in Shanghai, China, led to shutdowns and delays at the ports in Shanghai.
+Added: However, the extent of any future shutdown or delay is highly uncertain and difficult to predict.
Any material adverse effect on our employees, suppliers, and logistics providers could have a material adverse effect on our manufacturing operations in China or the supply of raw materials or APIs originating from China.
2 unchanged sentences
For example, we have suppliers in Asia and Europe, and we own manufacturing facilities in Nanjing, China, and Éragny-sur-Epte, France.
−Removed: As a result, a significant portion of our operations is conducted by and/or rely on entities outside the markets in which our products are sold, and, accordingly,
−Removed: we import a substantial number of products into such markets.
+Added: As a result, a significant portion of our operations is conducted by and/or rely on entities outside the markets in which our products are sold, and, accordingly, we import a substantial number of products into such markets.
We may, therefore, be denied access to our customers or suppliers or denied the ability to ship products from any of our sites as a result of a closing of the borders of the countries in which we sell our products, or in which our operations are located, due to economic, legislative, political and military conditions in such countries.
12 unchanged sentences
● tariffs and trade barriers, export regulations and other regulatory and contractual limitations on our ability to sell our products;
−Removed: ● changes in social, political, and economic conditions or in laws, regulations and policies governing foreign trade, manufacturing, development and investment both domestically as well as in other countries and jurisdictions into which we manufacture or sell our products;
+Added: ● changes in social, political, and economic conditions or in laws, regulations and policies governing foreign trade, manufacturing, development and investment both domestically as well as in other countries and
+Added: jurisdictions into which we manufacture or sell our products;
● exposure to liabilities under both U.S.
24 unchanged sentences
The APHIS within the USDA has regulatory oversight over certain animals and animal-derived products that could pose a risk to domestic agriculture.
−Removed: Recently, USDA has increased its African swine flu surveillance efforts, including additional testing and enhanced restrictions on importation of certain porcine products from affected countries, like China.
+Added: Recently, USDA has
+Added: increased its African swine flu surveillance efforts, including additional testing and enhanced restrictions on importation of certain porcine products from affected countries, like China.
In February 2020, we received a notice of non-renewal of our permit to import or transport crude heparin USP from one of our third-party heparin supplies in China due to the recent outbreak of the African swine flu in China, requiring additional information on the processing flow providing all treatment parameters and times for the porcine heparin material.
6 unchanged sentences
There is currently significant uncertainty about the future relationship between the United States and various other countries, most significantly China, with respect to trade policies, treaties, government regulations and tariffs.
−Removed: 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
−Removed: into the United States.
+Added: 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.
In September 2018, the U.S.
4 unchanged sentences
Although the United States and China signed a phase one trade deal on January 15, 2020, given the relatively fluid regulatory environment in China and the United States and the focus that the current U.S.
−Removed: Administration has shown on issues related to China along with uncertainty regarding how the U.S.
+Added: Administration has shown on issues related to China, including the imposition of new restrictions on exports related to semi-conductor manufacturing and supercomputing and the addition of entities based in China to various restricted party lists, along with uncertainty regarding how the U.S.
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.
19 unchanged sentences
For example, we may have to resort to administrative and court proceedings to enforce the legal protections under law or contract.
−Removed: However, since Chinese administrative and court authorities have
−Removed: significant discretion in interpreting and implementing statutory and contract terms, it may be more difficult to evaluate the outcome of administrative and court proceedings and our level of legal protection in China compared to other legal systems.
+Added: However, since Chinese administrative and court authorities have significant discretion in interpreting and implementing statutory and contract terms, it may be more difficult to evaluate the outcome of administrative and court proceedings and our level of legal protection in China compared to other legal systems.
Such uncertainties, including the inability to enforce our contracts and intellectual property rights, could materially and adversely affect our business and operations.
24 unchanged sentences
● designations of individuals and entities involved in Russian military activities;
−Removed: ● enhanced export controls and trade sanctions targeting Russia's imports of technological goods as a whole, including potentially tighter controls on exports and reexports of dual-use items, stricter licensing policy
−Removed: with respect to issuing export licenses, and/or increased use of "end-use"
−Removed: controls to block or impose licensing requirements on exports.
−Removed: We currently sell API indirectly to Russian customers.
+Added: ● enhanced export controls and trade sanctions targeting Russia's imports of a wide range of goods 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, and/or increased use of “end-use” controls to block or impose licensing requirements on exports.
+Added: We currently sell APIs indirectly to Russian customers.
The imposition of enhanced export controls and economic sanctions on transactions with Russia and Russian entities by the U.S., the U.K., and/or the EU could prevent us from selling our products to Russian customers.
19 unchanged sentences
In addition, we may be subject to a third-party pre-issuance submission of prior art to the U.S.
−Removed: Patent and Trademark Office, or USPTO, or become involved in opposition, derivation, reexamination, inter parties review or interference proceedings challenging our patent rights or the patent rights of others.
+Added: Patent and Trademark
+Added: Office, or USPTO, or become involved in opposition, derivation, reexamination, inter parties review or interference proceedings challenging our patent rights or the patent rights of others.
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third party patent rights.
28 unchanged sentences
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.
−Removed: 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.
+Added: Any future adverse determinations in a judicial
+Added: 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.
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.
5 unchanged sentences
The success of our proprietary products depends in part on our ability to obtain, maintain and enforce patents and trademarks, and to protect trade secrets, know-how and other proprietary information and technologies.
−Removed: Our ability to commercialize any proprietary product successfully will largely depend upon our ability to obtain and maintain patents
−Removed: of sufficient scope to prevent third parties from developing substantially equivalent products.
+Added: Our ability to commercialize any proprietary product successfully will largely depend upon our ability to obtain and maintain patents of sufficient scope to prevent third parties from developing substantially equivalent products.
In the absence of patent and trade secret protection, competitors may adversely affect our proprietary products business by independently developing and marketing substantially equivalent products.
15 unchanged sentences
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.
−Removed: In addition, we may not be able to detect any unauthorized disclosure of our trade secrets, know-how and our other confidential and proprietary information and technologies if such disclosure was conducted confidentially without public disclosure.
+Added: In addition, we may not be able to detect any unauthorized
+Added: disclosure of our trade secrets, know-how and our other confidential and proprietary information and technologies if such disclosure was conducted confidentially without public disclosure.
There is a risk that our trade secrets, know-how, and other confidential and proprietary information and technologies could have been, or could, in the future, be shared by any of our former employees with, and be used to the benefit of, any company that competes with us.
41 unchanged sentences
In 2021, the outstanding UBS AG credit line was transferred to UBS Utah due to a UBS organizational change.
−Removed: As of February 16, 2022, the total outstanding UBS combined credit lines were $17.6 million, which consisted of $11.0 million from UBS Utah plus $6.6 million transferred from UBS AG.
−Removed: The credit lines are secured by a pledge of 2,582,898 shares of our common stock currently held by APCL.
+Added: As of February 16, 2023, the total outstanding UBS combined credit lines were $11.0 million.
+Added: The UBS credit lines are secured by a pledge of 1,750,000 shares of our common stock currently held by APCL.
Interest on the loans accrues at market rates.
16 unchanged sentences
As a result of this policy, Drs.
−Removed: Zhang and Luo reduced their total number of pledged shares to 3,182,898 in February 2022 from 8,582,898 in February 2021.
+Added: Zhang and Luo reduced their total number of pledged shares to 2,350,000 in May 2022 from 3,182,898 in February 2022, and 8,582,898 in February 2021.
If the price of our common stock declines, Drs.
−Removed: Zhang and Luo may be forced by these financial institutions to provide additional collateral for the loans or to sell shares of our common stock held by them in order to remain within the margin limitations imposed under the terms of their loans.
+Added: Zhang and Luo may be forced by these financial institutions to provide additional collateral for the loans or to sell shares of our common stock held by them in order to remain within the
+Added: margin limitations imposed under the terms of their loans.
Furthermore, the pledged shares of our common stock may be acquired and sold by the lenders.
7 unchanged sentences
In addition, our existing loan agreements restrict, and any future indebtedness may restrict, our ability to pay dividends.
−Removed: Investors seeking cash dividends should not purchase our
−Removed: common stock.
+Added: Investors seeking cash dividends should not purchase our common stock.
Accordingly, realization of a gain on your investment will depend on the appreciation of the price of our common stock, which may never occur.
10 unchanged sentences
These provisions include:
−Removed: ● authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
+Added: ● authorizing the issuance of undesignated preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
● prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
2 unchanged sentences
● establishing a classified Board of Directors, whereby only one-third of the members of our Board of Directors are elected at one time;
−Removed: ● providing that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum.
+Added: ● providing that vacancies on our board of directors may be filled only by a majority of directors then in office;
+Added: ● advance notice procedures apply for stockholders to nominate candidates for election as directors or to bring matters before an annual meeting of stockholders.
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.
1 unchanged sentence
(i) any derivative action or proceeding brought on our behalf; (ii) any action asserting a breach of fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; (iii) any action asserting a claim arising pursuant to any provision of the DGCL, our amended and restated certificate of incorporation, or our amended and restated bylaws;
−Removed: or (iv) any action
−Removed: asserting a claim against us that is governed by the internal affairs doctrine.
+Added: or (iv) any action asserting a claim against us that is governed by the internal affairs doctrine.
This provision is not intended to apply to actions arising under the Securities Act or the Exchange Act, or any claim for which the federal courts have exclusive jurisdiction.
19 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.
+Added: 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 COVID-19 pandemic, and uncertain macroeconomic conditions.
From time to time, we may implement currency hedges intended to reduce our exposure to changes in foreign currency exchange rates.
−Removed: However, any such hedging strategies may not be successful, and any of our unhedged foreign exchange exposures will continue to be subject to market fluctuations.
+Added: However, any such hedging strategies may not be successful, and any of our unhedged foreign exchange exposures will continue to be
+Added: subject to market fluctuations.
These risks 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.
1 unchanged sentence
Our business is sensitive to general economic conditions, both inside and outside the U.S.
−Removed: Slower global economic growth, credit market crises, high levels of unemployment, reduced levels of capital expenditures, government deficit reduction, sequestration and other austerity measures and other challenges affecting the global economy adversely affects us and our distributors, customers and suppliers.
+Added: Slower global economic growth, credit market crises, high levels of unemployment, reduced levels of capital expenditures, government deficit reduction, changes in inflation and interest rate environments, sequestration and other austerity measures and other challenges affecting the global economy adversely affects us and our distributors, customers and suppliers.
It is uncertain how long these effects will last or whether economic and financial trends will worsen or improve.
3 unchanged sentences
If slower growth in the global economy or in any of the markets we serve continues for a significant period, if there is significant deterioration in the global economy or such markets or if improvements in the global economy don’t benefit the markets we serve, our business and financial statements could be adversely affected.
−Removed: Additionally, as a result of any future global economic downturn, our third-party payers may delay or be unable to
−Removed: satisfy their reimbursement obligations.
+Added: Additionally, as a result of any future global economic downturn, our third-party payers may delay or be unable to satisfy their reimbursement obligations.
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.
24 unchanged sentences
Our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our controls are documented, designed or operating.
−Removed: In addition, we may encounter problems or delays in completing the implementation of any requested
−Removed: improvements and receiving a favorable attestation by our independent registered public accounting firm.
+Added: In addition, we may encounter problems or delays in completing the implementation of any requested improvements and receiving a favorable attestation by our independent registered public accounting firm.
In the event that our Chief Executive Officer, Chief Financial Officer, or independent registered public accounting firm determines that our internal control over financial reporting is not effective as defined under Section 404, we could be subject to one or more investigations or enforcement actions by state or federal regulatory agencies, stockholder lawsuits, breaches of the covenants under our credit facilities, or other adverse actions requiring us to incur defense costs, pay fines, make settlements or seek judgments, which may adversely affect investor perceptions and potentially result in a decline in our stock price.
7 unchanged sentences
These or other changes in accounting principles could adversely affect our financial results.
−Removed: See Note 2 of the Notes to Financial Statements in Part II - Item 8 of this Annual Report on Form 10-K for information regarding the effect of new accounting pronouncements on our financial statements.
+Added: See Note 2 of the Notes to Consolidated Financial Statements in Part II - Item 8 of this Annual Report on Form 10-K for information regarding the effect of new accounting pronouncements on our financial statements.
Any difficulties in implementing these pronouncements could cause us to fail to meet our financial reporting obligations, which could result in regulatory discipline and harm investors’ confidence in us.
2 unchanged sentences
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes.
−Removed: We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, as discussed in greater detail in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
+Added: We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, as discussed in greater detail in the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” the results of which form the basis for making judgments about the carrying values
+Added: of assets and liabilities that are not readily apparent from other sources.
Our operating results may be adversely affected if our assumptions change or if actual circumstances differ from those in our assumptions, which could cause our operating results to fall below the expectations of securities analysts and investors, resulting in a decline in our stock price.
8 unchanged sentences
Changes in income tax laws, tax rulings and other factors may have a significantly adverse impact on our effective tax rate and 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.
−Removed: On December 22, 2017, the U.S.
+Added: Changes in tax laws, tax rulings, or the way in which such laws and rulings are interpreted or implemented, could adversely affect our effective tax rate and tax expense.
+Added: For example, on December 22, 2017, the U.S.
government enacted the Tax Act, which includes significant changes to the taxation of business entities.
4 unchanged sentences
As future guidance is issued, we may make adjustments to amounts that we have previously recorded that may materially impact our financial statements in the period in which the adjustments are made.
+Added: In addition, in 2022 the U.S.
+Added: government enacted the Inflation Reduction Act, 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.
In addition to income taxes in the United States, we are subject to income taxes in many foreign jurisdictions.
2 unchanged sentences
The final determination of any tax audits or related litigation could be materially different from our historical income tax provisions and accruals.
−Removed: In addition, tax laws are dynamic and subject to change as evidenced by the Tax Act.
+Added: In addition, tax laws are dynamic and subject to change as evidenced by the Tax Act and the Inflation Reduction Act.
As new laws are passed and new interpretations of the law are issued or applied, our provision for income taxes may be affected.
43 unchanged sentences
This variability and unpredictability could result in our failing to meet our revenue, billings or operating results expectations or those of securities analysts or investors for any period.
−Removed: addition, a significant percentage of our operating expenses are fixed in nature and based on forecasted revenue trends.
+Added: In addition, a significant percentage of our operating expenses are fixed in nature and based on forecasted revenue trends.
Accordingly, in the event of revenue shortfalls, we are generally unable to mitigate the negative impact on operating results in the short term.
16 unchanged sentences
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
−Removed: We intend to invest resources to comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities.
+Added: We intend to invest resources to comply
+Added: with evolving laws, regulations and standards, and this investment may result in increased general and administrative expenses and a diversion of management’s time and attention from revenue-generating activities to compliance activities.
If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business may be adversely affected.
22 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.