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• If physicians and patients do not continue to accept INGREZZA or do not accept any of our other products, or our sales and marketing efforts are not effective, we may not generate sufficient revenue.
−Removed: • Governmental and third-party payors may impose additional sales and pharmaceutical pricing controls on our products, further limit coverage and/or reimbursement for our products or make decisions that adversely impact the status of our products for governmental reimbursement that could negatively impact our product revenues and impact or delay sustained profitability.
+Added: • Government and third-party payors may impose additional sales and pharmaceutical pricing controls on our products, further limit coverage and/or reimbursement for our products or make decisions that adversely impact the status of our products for government reimbursement that could negatively impact our product revenues and impact or delay sustained profitability.
• Our business could be adversely affected by the effects of health pandemics or epidemics, which could also cause significant disruption in the operations of third-party manufacturers, contract research organizations, or CROs, or other third parties upon whom we rely.
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• We currently have no manufacturing capabilities.
−Removed: If third-party manufacturers of INGREZZA, ONGENTYS, or any of our other products, or any of our product candidates fail to devote sufficient time and resources to our concerns, or if their performance is substandard, our clinical trials and product introductions may be delayed, and our costs may rise.
+Added: If third-party manufacturers of INGREZZA or any of our other products, or any of our product candidates fail to devote sufficient time and resources to our concerns, or if their performance is substandard, our clinical trials and product introductions may be delayed, and our costs may rise.
• We currently depend on a limited number of third-party suppliers.
−Removed: The loss of these suppliers, or delays or problems in the supply of INGREZZA, ONGENTYS, or any of our other products, could materially and adversely affect our ability to successfully commercialize INGREZZA, ONGENTYS, or any of our other products.
+Added: The loss of these suppliers, or delays or problems in the supply of INGREZZA or any of our other products, could materially and adversely affect our ability to successfully commercialize INGREZZA or any of our other products.
• We license some of our core technologies and drug candidates from third parties.
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In addition, many health care practitioners have adopted telehealth for patient interactions, which may impact the ability of the health care practitioner to screen for and diagnose tardive dyskinesia.
−Removed: Further, during the COVID-19 pandemic, the use of physician telehealth services increased significantly, fueled by an expansion of coverage and reimbursement from government and other payors.
−Removed: The limitations that telehealth places on the ability to conduct a thorough visual and physical examination may impact the ability of providers to screen for movement disorders, leading to potentially fewer patients to be diagnosed and referred for treatment.
−Removed: The ultimate impact of the COVID-19 pandemic, including any lasting effects on the way we conduct our business, is highly uncertain and subject to continued change.
−Removed: If we fail to maintain successful marketing, sales and reimbursement capabilities, our product revenues may suffer.
*If physicians and patients do not continue to accept INGREZZA or do not accept any of our other products, or our sales and marketing efforts are not effective, we may not generate sufficient revenue.
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If the medical community, patients and payors do not continue to accept our products as being safe, effective, superior and/or cost-effective, we may not generate sufficient revenue.
−Removed: *Governmental and third-party payors may impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products or impose policies and/or make decisions regarding the status of our products that could limit our product revenues and delay sustained profitability.
+Added: *Government and third-party payors may impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products or impose policies and/or make decisions regarding the status of our products that could limit our product revenues and delay sustained profitability.
Our ability to continue to commercialize INGREZZA successfully or any of our other products, will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available.
1 unchanged sentence
These payors’ efforts could decrease the price that we receive for any products we may develop and sell in the future.
−Removed: Assuming we obtain coverage for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.
+Added: Assuming we obtain coverage for a given product by a third-party payor, the resulting reimbursement rates may not be adequate or may require co-payments that patients find unacceptably high.
Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs.
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Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
−Removed: For example, governmental authorities could make a decision that adversely impacts the status of one of our products, which could impact the eligibility and/or the amount of government reimbursement for that product.
+Added: For example, government authorities could make a decision that adversely impacts the status of one of our products, which could impact the eligibility and/or the amount of government reimbursement for that product.
As a pharmaceutical manufacturer, we are subject to various federal statutes and regulations requiring the reporting of price data and the subsequent provision of concessions to certain purchasers/payors, including state Medicaid programs.
73 unchanged sentences
These risks and uncertainties impact all of our clinical programs and any of the clinical, regulatory or operational events described above could change our planned clinical and regulatory activities.
−Removed: In addition, due to the impact of the COVID-19 pandemic, clinical site initiation and new patient enrollment has been negatively impacted.
Additionally, any of these events described above could result in suspension of a program and/or obviate any filings for necessary regulatory approvals.
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Ongoing geopolitical turmoil and continuing military action in the region, together with widening sanctions imposed on Russia, have caused us to suspend all planned clinical trial activities in Russia and Ukraine.
−Removed: Alternative clinical trial sites that would fully and timely compensate for our planned clinical trial activities in Ukraine and Russia are not available and we may need to find other countries in which to conduct such activities.
−Removed: Our planned clinical development timelines for valbenazine and luvadaxistat could be significantly delayed, which would increase our development costs and delay the development and/or regulatory approval process of such product candidates and jeopardize our ability to commence product sales and generate revenues.
+Added: Alternative clinical trial sites that would fully and timely replace our planned clinical trial activities in Ukraine and Russia have been challenging to obtain.
+Added: Our planned clinical development timelines for valbenazine and luvadaxistat have been significantly delayed, which has increased our development costs and delayed the development and/or regulatory approval process of such product candidates and could jeopardize our ability to commence product sales and generate revenues.
*We depend on our current collaborators for the development and commercialization of several of our products and product candidates and may need to enter into future collaborations to develop and commercialize certain of our product candidates.
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The successful commercialization of ONGENTYS is subject to many risks, including a number of factors that are outside our control.
−Removed: We may be unable to train our employees and effectively communicate with potential prescribers;
−Removed: health care practitioners may not prescribe ONGENTYS;
+Added: We may be unable to convince payors to reimburse for ONGENTYS;
and patients may be unwilling to use ONGENTYS if insurance coverage is not provided or reimbursement is inadequate.
In the first quarter of 2023, we provided notice to terminate our license to commercialize ONGENTYS.
+Added: The termination is anticipated to be effective in December 2023.
Use of our approved products or those of our collaborators could be associated with side effects or adverse events.
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We may encounter difficulties with managing our growth, which could adversely affect our results of operations.
−Removed: As of March 31, 2023, we had approximately 1,300 full-time employees.
+Added: As of June 30, 2023, we had approximately 1,350 full-time employees.
Although we have substantially increased the size of our organization, we may need to add additional qualified personnel and resources, especially with the recent increase in the size of our sales force.
Our current infrastructure may be inadequate to support our development and commercialization efforts and expected growth.
−Removed: Future growth will impose significant added responsibilities on our organization, including the need to identify, recruit, maintain and integrate additional employees, and may take time away from running other aspects of our business, including development and commercialization of our product candidates.
+Added: Future growth will impose significant added responsibilities on our organization, including the need to identify, recruit, maintain and integrate additional employees and create and expand new processes and procedures and may be costly and take time away from running other aspects of our business, including development and commercialization of our product candidates.
Our future financial performance and our ability to commercialize INGREZZA and any of our other products, or any of our product candidates that receive regulatory approval in the future, will partially depend on our ability to manage any future growth effectively.
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Furthermore, recruiting and retaining qualified scientific personnel to perform research and development work in the future, along with personnel with experience marketing and selling pharmaceutical products, is critical to our success.
−Removed: We may be unable to attract and retain personnel on acceptable terms given effects of the COVID-19 pandemic, as well as the competition among biotechnology, pharmaceutical and health care companies, universities and non-profit research institutions for experienced scientists and individuals with experience marketing and selling pharmaceutical products.
+Added: We may be unable to attract and retain personnel on acceptable terms given the competition among biotechnology, pharmaceutical and health care companies, universities and non-profit research institutions for experienced scientists and individuals with experience marketing and selling pharmaceutical products.
We may face particular retention challenges in light of the recent rapid growth in our personnel and infrastructure and the perceived impact of those changes upon our corporate culture.
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*We currently have no manufacturing capabilities.
−Removed: If third-party manufacturers of INGREZZA, ONGENTYS, or any of our other products, or any of our product candidates fail to devote sufficient time and resources to our concerns, or if their performance is substandard, our clinical trials and product introductions may be delayed, and our costs may rise.
+Added: If third-party manufacturers of INGREZZA or any of our other products, or any of our product candidates fail to devote sufficient time and resources to our concerns, or if their performance is substandard, our clinical trials and product introductions may be delayed, and our costs may rise.
We have in the past utilized, and intend to continue to utilize, third-party manufacturers to produce the drug compounds we use in our clinical trials and for the commercialization of our products.
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Establishing internal commercial manufacturing capabilities would require significant time and resources, and we may not be able to timely or successfully establish such capabilities.
−Removed: Consequently, we depend on, and will continue to depend on, several contract manufacturers for all production of products for development and commercial purposes, including INGREZZA and ONGENTYS.
−Removed: If we are unable to obtain or retain third-party manufacturers, we will not be able to develop or commercialize our products, including INGREZZA and ONGENTYS.
+Added: Consequently, we depend on, and will continue to depend on, several contract manufacturers for all production of products for development and commercial purposes, including INGREZZA.
+Added: If we are unable to obtain or retain third-party manufacturers, we will not be able to develop or commercialize our products, including INGREZZA.
The manufacture of our products for clinical trials and commercial purposes is subject to specific FDA regulations, including current Good Manufacturing Practice regulations.
−Removed: Our third-party manufacturers, including BIAL and its suppliers, might not comply with FDA regulations relating to manufacturing our products for clinical trials and commercial purposes or other regulatory requirements now or in the future.
+Added: Our third-party manufacturers might not comply with FDA regulations relating to manufacturing our products for clinical trials and commercial purposes or other regulatory requirements now or in the future.
Our reliance on contract manufacturers also exposes us to the following risks:
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We do not have control over third-party manufacturers’ compliance with these regulations and standards.
−Removed: Our current dependence upon third parties for the manufacture of our products may reduce our profit margin, if any, on the sale of INGREZZA, ONGENTYS, or any of our other products, or our future products and our ability to develop and deliver products on a timely and competitive basis.
+Added: Our current dependence upon third parties for the manufacture of our products may reduce our profit margin, if any, on the sale of INGREZZA or any of our other products, or our future products and our ability to develop and deliver products on a timely and competitive basis.
*We currently depend on a limited number of third-party suppliers.
−Removed: The loss of these suppliers, or delays or problems in the supply of INGREZZA, ONGENTYS, or any of our other products, could materially and adversely affect our ability to successfully commercialize INGREZZA, ONGENTYS, or any of our other products.
+Added: The loss of these suppliers, or delays or problems in the supply of INGREZZA or any of our other products, could materially and adversely affect our ability to successfully commercialize INGREZZA or any of our other products.
The manufacture of pharmaceutical products requires significant expertise and capital investment, including the development of process controls required to consistently produce the active pharmaceutical ingredients, or API, the finished drug product and packaging in sufficient quantities while meeting detailed product specifications on a repeated basis.
−Removed: Manufacturers of pharmaceutical products may encounter difficulties in production, such as difficulties with production costs and yields, process controls, quality control and quality assurance, including testing of stability, impurities and impurity levels and other product specifications by validated test methods, compliance with strictly enforced United States, state and non-United States regulations, and disruptions or delays caused by man-made or natural disasters, pandemics or epidemics, or other business interruptions, including, for example, the COVID-19 pandemic and the conflict between Russia and Ukraine.
+Added: Manufacturers of pharmaceutical products may encounter difficulties in production, such as difficulties with production costs and yields, process controls, quality control and quality assurance, including testing of stability, impurities and impurity levels and other product specifications by validated test methods, compliance with strictly enforced United States, state and non-United States regulations, and disruptions or delays caused by man-made or natural disasters, pandemics or epidemics, or other business interruptions.
We depend on a limited number of suppliers for the production and packaging of INGREZZA and its API.
If our third-party suppliers for INGREZZA encounter these or any other manufacturing, quality or compliance difficulties, we may be unable to meet commercial demand for INGREZZA, which could materially and adversely affect our ability to successfully commercialize INGREZZA.
−Removed: In addition, under the terms of our agreement with BIAL, although we are responsible for the management of all ONGENTYS commercialization activities, we rely on BIAL and its suppliers to supply all drug product for the commercialization of ONGENTYS.
−Removed: BIAL relies on third-party contract manufacturers to produce ONGENTYS.
−Removed: These contract manufacturers may encounter difficulties in achieving volume production, quality control, or quality assurance.
−Removed: As a result, these contract manufacturers may not be able to adequately produce ONGENTYS in commercial quantities when required, which may impact our ability to deliver ONGENTYS on a timely basis.
In addition, if our suppliers fail or refuse to supply us with INGREZZA or its API for any reason, it would take a significant amount of time and expense to qualify a new supplier.
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If there are delays in qualifying new suppliers or facilities or if a new supplier is unable to meet FDA or a similar international regulatory body’s requirements for approval, there could be a shortage of INGREZZA, which could materially and adversely affect our ability to successfully commercialize INGREZZA.
−Removed: If BIAL is unable or refuses to supply us with ONGENTYS drug product for any reason, or does not meet FDA or international regulators’ requirements for approval, we have limited opportunity to qualify a new supplier.
−Removed: This could materially and adversely affect our ability to successfully commercialize ONGENTYS.
The independent clinical investigators and contract research organizations that we rely upon to conduct our clinical trials may not be diligent, careful or timely, or may make mistakes in the conduct of our trials.
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*If the market opportunities for our products and product candidates are smaller than we believe they are, our expected revenues may be adversely affected, and our business may suffer.
−Removed: Certain of the diseases that INGREZZA, ONGENTYS and our other product candidates are being developed to address are in underserved and underdiagnosed populations.
+Added: Certain of the diseases that INGREZZA and our other product candidates are being developed to address are in underserved and underdiagnosed populations.
Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who will seek treatment utilizing our products or product candidates, may not be accurate.
−Removed: If our estimates of the prevalence or number of patients potentially on therapy prove to be inaccurate, the market opportunities for INGREZZA, ONGENTYS and our other product candidates may be smaller than we believe they are, our prospects for generating expected revenue may be adversely affected and our business may suffer.
+Added: If our estimates of the prevalence or number of patients potentially on therapy prove to be inaccurate, the market opportunities for INGREZZA and our other product candidates may be smaller than we believe they are, our prospects for generating expected revenue may be adversely affected and our business may suffer.
*We license some of our core technologies and drug candidates from third parties.
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In the second quarter of 2022, we entered into separate, privately negotiated transactions with certain holders of the 2024 Notes to repurchase $210.8 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of $279.0 million in cash.
−Removed: As of March 31, 2023, $170.4 million aggregate principal amount of the 2024 Notes remained outstanding.
+Added: As of June 30, 2023, $170.4 million aggregate principal amount of the 2024 Notes remained outstanding.
We may also incur additional indebtedness to meet future financing needs.
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Since our inception, we have incurred significant net losses and negative cash flow from operations.
−Removed: As of March 31, 2023, we had an accumulated deficit of $483.4 million as a result of historical operating losses.
+Added: As of June 30, 2023, we had an accumulated deficit of $387.9 million as a result of historical operating losses.
We received FDA approval for INGREZZA for tardive dyskinesia in April 2017 and for ONGENTYS for Parkinson’s disease in April 2020.
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However, we have not yet obtained regulatory approvals for any other product candidates.
−Removed: Even if we continue to succeed in commercializing INGREZZA, or if we successfully commercialize ONGENTYS or are successful in developing and commercializing any of our other product candidates, we may not be able to sustain profitability.
+Added: Even if we continue to succeed in commercializing INGREZZA, or are successful in developing and commercializing any of our other product candidates, we may not be able to sustain profitability.
We also expect to continue to incur significant operating and capital expenditures as we:
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Our quarterly revenues, expenses and operating results have fluctuated in the past and are likely to fluctuate significantly in the future.
−Removed: Our financial results are unpredictable and may fluctuate, for among other reasons, due to seasonality and timing of customer purchases and commercial sales of INGREZZA, royalties from out-licensed products, the impact of Medicare Part D coverage, including redesign of the Part D benefit enacted as part of the Inflation Reduction Act, our achievement of product development objectives and milestones, clinical trial enrollment and expenses, research and development expenses and the timing and nature of contract manufacturing, contract research payments, fluctuations in our effective tax rate, and disruptions caused by man-made or natural disasters or public health pandemics or epidemics or other business interruptions, including, for example, the COVID-19 pandemic and the conflict between Russia and Ukraine.
+Added: Our financial results are unpredictable and may fluctuate, for among other reasons, due to seasonality and timing of customer purchases and commercial sales of INGREZZA, royalties from out-licensed products, the impact of Medicare Part D coverage, including redesign of the Part D benefit enacted as part of the Inflation Reduction Act, our achievement of product development objectives and milestones, clinical trial enrollment and expenses, research and development expenses and the timing and nature of contract manufacturing, contract research payments, fluctuations in our effective tax rate, and disruptions caused by man-made or natural disasters or public health pandemics or epidemics or other business interruptions, including, for example, the conflict between Russia and Ukraine.
Because a majority of our costs are predetermined on an annual basis, due in part to our significant research and development costs, small declines in revenue could disproportionately affect financial results in a quarter.
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Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us.
−Removed: For example, Tax Cut and Jobs Act of 2017, the Coronavirus Aid, Relief, and Economic Security Act and the Inflation Reduction Act enacted many significant changes to the United States tax laws.
+Added: For example, the Tax Cuts and Jobs Act of 2017, the Coronavirus Aid, Relief, and Economic Security Act and the Inflation Reduction Act enacted many significant changes to the United States tax laws.
Future guidance from the Internal Revenue Service and other tax authorities with respect to such legislation may affect us, and certain aspects of such legislation could be repealed or modified in future legislation.
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• developments concerning new and existing collaboration agreements;
−Removed: • announcements of technological innovations or new therapeutic products by us or others;
+Added: • announcements of technological innovations or new therapeutic products by us or others, including our competitors;
• general economic and market conditions, including economic and market conditions affecting the biotechnology industry;
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• potential litigation matters and developments in existing litigation matters, such as the ANDA litigation matters;
−Removed: • government regulation;
+Added: • government regulation, including the Inflation Reduction Act;
• government and third-party payor coverage and reimbursement;
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We have entered into agreements for the distribution of INGREZZA with a limited number of specialty pharmacy providers and distributors, and all of our product sales of INGREZZA are to these customers.
−Removed: Four of these customers represented approximately 81% of our total product revenue for the three months ended March 31, 2023 and approximately 79% of our accounts receivable balance as of March 31, 2023.
+Added: Four of these customers represented approximately 91% of our total product revenue for the six months ended June 30, 2023 and approximately 96% of our accounts receivable balance as of June 30, 2023.
If any of these significant customers becomes subject to bankruptcy, is unable to pay us for our products or is acquired by a company that wants to terminate the relationship with us, or if we otherwise lose any of these significant customers, our revenue, results of operations and cash flows would be adversely affected.
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• the cost involved in filing and pursuing patent applications, enforcing patent claims, or engaging in interference proceedings or other patent litigation;
+Added: • costs associated with securing adequate coverage and reimbursement for our products;
• competing technological and market developments;
8 unchanged sentences
In the second quarter of 2022, we entered into separate, privately negotiated transactions with certain holders of the 2024 Notes to repurchase $210.8 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of $279.0 million in cash.
−Removed: As of March 31, 2023, $170.4 million aggregate principal amount of the 2024 Notes remained outstanding.
+Added: As of June 30, 2023, $170.4 million aggregate principal amount of the 2024 Notes remained outstanding.
Additional equity or debt financing might not be available on reasonable terms, if at all.
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*Enacted health care reform, drug pricing measures and other recent legislative initiatives could adversely affect our business.
−Removed: The business and financial condition of pharmaceutical and biotechnology companies are affected by the efforts of governmental and third-party payors to contain or reduce the costs of health care and to lower drug prices.
−Removed: In the United States, comprehensive drug pricing legislation has been enacted by the Federal government to implement government control over the pricing of prescription pharmaceuticals.
+Added: The business and financial condition of pharmaceutical and biotechnology companies are affected by the efforts of government and third-party payors to contain or reduce the costs of health care and to lower drug prices.
+Added: In the United States, comprehensive drug pricing legislation enacted by the Federal government implements, for the first time, government control over the pricing of certain prescription pharmaceuticals.
Moreover, in some foreign jurisdictions, pricing of prescription pharmaceuticals is also subject to government control.
−Removed: Additionally, other federal and state legislation impose obligations on manufacturers of pharmaceutical products, among others, related to disclosure of new drug products introduced to the market and increases in drug prices above a specified threshold.
−Removed: For example, in August 2022, President Biden signed into law the Inflation Reduction Act of 2022, or the IRA, which, among other things, (1) directs the Secretary of the U.S.
−Removed: Department of Health and Human Services, or HHS, to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare, (2) redesigns the Medicare Part D prescription drug benefit to lower patient out-of-pocket costs and increase manufacturer liability and (3) requires drug manufacturers to pay rebates on drugs whose prices increase greater than the rate of inflation.
+Added: Additionally, other federal and state laws impose obligations on manufacturers of pharmaceutical products, among others, related to disclosure of new drug products introduced to the market and increases in drug prices above a specified threshold.
+Added: For example, in August 2022, President Biden signed into law the Inflation Reduction Act of 2022, or the IRA, which, among other things:
+Added: (1) directs the Secretary of the U.S.
+Added: Department of Health and Human Services, or HHS, to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare;
+Added: (2) redesigns the Medicare Part D prescription drug benefit to lower patient out-of-pocket costs and increase manufacturer liability;
+Added: and (3) requires drug manufacturers to pay rebates on drugs whose prices increase greater than the rate of inflation.
The IRA also extends enhanced subsidies for individuals purchasing health insurance coverage in the ACA marketplaces through plan year 2025 and eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost to $2,000 and through a newly established manufacturer discount program.
−Removed: These provisions will take effect progressively starting in 2023, although they may be subject to legal challenges.
+Added: The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.
+Added: HHS has issued and updated and will continue to issue and update guidance as these programs are implemented.
+Added: These provisions take effect progressively starting in 2023, although aspects of the law are subject to legal challenges.
It is currently unclear how the IRA will be implemented;
however, it is likely to have a significant impact on the pharmaceutical industry and prescription drug pricing.
−Removed: While the IRA targets high-expenditure drugs that have been on the market for several years without generic or biosimilar competition, we believe we will qualify for the small biotech manufacturer exception that is set to expire in 2029.
+Added: While the IRA targets high-expenditure drugs that have been on the market for several years without generic or biosimilar competition, we believe we will qualify for the small biotech exception from negotiation that is set to expire in 2029.
However, the qualification for this exception is subject to various requirements and there is no assurance that we will continue to qualify for this exemption in the future.
4 unchanged sentences
These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in 2013 and, due to subsequent legislative amendments to the statute, including the Infrastructure Investment and Jobs Act and Consolidated Appropriations Act of 2023, will remain in effect until 2032.
−Removed: Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequestration.
The American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several providers, including hospitals and cancer treatment centers, increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
−Removed: At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
+Added: At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including Prescription Drug Affordability Boards, price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
The implementation of these cost containment measures may prevent us from being able to generate revenue, attain sustained profitability or commercialize our drugs, particularly since the majority of our current revenue is derived from federal healthcare programs, including Medicare and Medicaid.
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Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access.
−Removed: The business and financial condition of pharmaceutical and biotechnology companies may be affected by the efforts of governmental and third-party payors to contain or reduce the costs of health care and to lower drug prices.
+Added: The business and financial condition of pharmaceutical and biotechnology companies may be affected by the efforts of government and third-party payors to contain or reduce the costs of health care and to lower drug prices.
In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives, including the Inflation Reduction Act, enacted in 2022.
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While we may be entitled to damages if our third-party service providers fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award.
−Removed: Although to our knowledge we, or the third parties upon who we rely, have not experienced any material incident or disruption to date, we and our vendors have been the target of cybersecurity incidents of this nature and expect them to continue.
+Added: Although to our knowledge we, or the third parties upon who we rely, have not experienced any incident or disruption to date that is material to us, we and our vendors have been, either directly or indirectly, the target of cybersecurity incidents and expect them to continue.
While we have implemented security measures to protect our data security and information technology systems, such measures may not prevent such events.
−Removed: If we (or a third party upon whom we rely) experience a security breach or are perceived to have experienced a security breach, we may experience adverse consequences.
+Added: Furthermore, while we have implemented and are planning to implement redundancies to avoid interruptions to our operations, not all potential events can be anticipated and interruptions to our operations could lead to decreased productivity.
+Added: The cyber threat landscape is continually changing, and we will continue to adapt and change our cyber program to manage and mitigate associated risks.
+Added: If we (or a third party upon whom we rely) experience a security breach, ransomware attack or are perceived to have experienced a security breach, we may experience adverse consequences.
Such consequences may include:
7 unchanged sentences
monetary fund diversions;
−Removed: interruptions in our operations (including availability of data);
−Removed: financial loss;
+Added: interruptions in our operations (including availability of data, loss of connectivity to our network or internet);
+Added: financial loss (including decreased productivity resulting from interruptions in our operations);
and other similar harms.
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These claims might be made directly by consumers, health care providers, pharmaceutical companies or others selling our products.
−Removed: We have product liability insurance coverage for our clinical trials in the amount of $45.0 million per occurrence and $45.0 million in the aggregate.
−Removed: In addition, we have product liability insurance related to the sale of INGREZZA and ONGENTYS in the amount of $45.0 million per occurrence and $45.0 million in the aggregate.
+Added: We have product liability insurance coverage for both our clinical trials as well as related to the sale of INGREZZA and ONGENTYS in amounts consistent with customary industry practices.
However, our insurance may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer.
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Any of these events could have a material adverse effect on our reputation, business, financial condition or results of operations.
−Removed: The following exhibits are filed as part of, or incorporated by reference into, this report:
−Removed: 3.1 Description:
−Removed: Certificate of Incorporation, as amended
−Removed: Incorporated by reference to Exhibit 3.1 of the Company’s Quarterly Report on Form 10-Q filed on November 5, 2018
−Removed: 3.2 Description:
−Removed: Bylaws, as amended
−Removed: Incorporated by reference to Exhibit 3.1 of the Company's Current Report on Form 8-K filed on February 10, 2023
−Removed: 4.1 Description:
−Removed: Form of Common Stock Certificate
−Removed: Incorporated by reference to the Company’s Registration Statement on Form S-1 (Registration No.
−Removed: 4.2 Description:
−Removed: Indenture, dated as of May 2, 2017, by and between the Company and U.S.
−Removed: Bank National Association, as Trustee
−Removed: Incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed on May 2, 2017
−Removed: 4.3 Description:
−Removed: First Supplemental Indenture, dated as of December 22, 2021, by and between the Company and U.S.
−Removed: Bank National Association, as Trustee
−Removed: Incorporated by reference to Exhibit 4.3 of the Company’s Annual Report on Form 10-K filed on February 11, 2022
−Removed: 4.4 Description:
−Removed: Form of Note representing the Company’s 2.25% Convertible Notes due 2024
−Removed: Incorporated by reference to Exhibit 99.1 of the Company’s Current Report on Form 8-K filed on May 2, 2017
−Removed: 10.1+ Description:
−Removed: Employment Agreement dated October 28, 2014 between the Company and Darin Lippoldt
−Removed: 10.2** Description:
−Removed: Collaboration and License Agreement dated January 8, 2023 between Voyager Therapeutics, Inc.
−Removed: and the Company
−Removed: 10.3 Description:
−Removed: Stock Purchase Agreement dated January 8, 2023 between Voyager Therapeutics, Inc.
−Removed: and the Company
−Removed: 10.4 Description:
−Removed: Amended and Restated Investor Agreement dated January 8, 2023 between Voyager Therapeutics, Inc.
−Removed: and the Company
−Removed: 31.1 Description:
−Removed: Certification of Chief Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934
−Removed: 31.2 Description:
−Removed: Certification of Chief Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934
−Removed: 32* Description:
−Removed: Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
−Removed: Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
−Removed: 101.INS Description:
−Removed: Inline XBRL Instance Document.
−Removed: – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
−Removed: 101.SCH Description:
−Removed: Inline XBRL Taxonomy Extension Schema Document.
−Removed: 101.CAL Description:
−Removed: Inline XBRL Taxonomy Extension Calculation Linkbase Document.
−Removed: 101.DEF Description:
−Removed: Inline XBRL Taxonomy Extension Definition Linkbase Document.
−Removed: 101.LAB Description:
−Removed: Inline XBRL Taxonomy Extension Label Linkbase Document.
−Removed: 101.PRE Description:
−Removed: Inline XBRL Taxonomy Extension Presentation Linkbase Document.
−Removed: 104 Description:
−Removed: Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibit 101)
−Removed: ______________
−Removed: + Management contract or compensatory plan or arrangement.
−Removed: * These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C.
−Removed: Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of Neurocrine Biosciences, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.
−Removed: ** Certain information in this exhibit has been omitted pursuant to Item 601 of Regulation S-K.
−Removed: Except as specifically noted above, the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K have a Commission File Number of 000-22705.
−Removed: Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
−Removed: NEUROCRINE BIOSCIENCES, INC.
−Removed: /s/ Matthew C.
−Removed: Chief Financial Officer
−Removed: (Duly authorized officer and Principal Financial Officer)
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.