Neurocrine Biosciences NBIX

Neurocrine Biosciences reports $206.5 million net income for Q3 2026

Form
10-Q
Filed
Importance
Notable
  1. Revenue of $1.12 billion for the three months ended Sep 30, 2026
  2. Net income of $206.5 million for the three months ended Sep 30, 2026
  3. Diluted EPS of $1.96 for the three months ended Sep 30, 2026
  4. Cash and equivalents of $641.5 million as of Sep 30, 2026

Written from the 10-Q on EDGAR. AI can make mistakes. Check the filing.

Get an email when Neurocrine Biosciences files

Only major filings: results, leadership changes, listing notices and other major events, each with the plain-English summary when we have one or the key facts and the EDGAR link. Routine insider filings never email. Confirm once; unsubscribe in one click.

What changed

25 changes since the June 2026 10-Q

Compared with the 10-Q 0000914475-26-000037, filed Jul 31, 2026.

  1. New Risk factors

    • We may not successfully integrate Soleno Therapeutics, Inc. (Soleno) or realize the anticipated benefits…

    • Because the development of our product candidates is subject to a substantial degree of technological uncertainty, we may not succeed in developing any of our product candidates, which could adversely affect our…

    From the filings

    Now

    • We may not successfully integrate Soleno Therapeutics, Inc. (Soleno) or realize the anticipated benefits of the acquisition, which could adversely affect our business and financial condition. • Because the development of our product candidates is subject to a substantial degree of technological uncertainty, we may not succeed in developing any of our product candidates, which could adversely affect our business and financial condition. • Our clinical trials may be delayed for safety or other reasons, or fail to demonstrate the safety and efficacy of our product candidates, which could prevent or significantly delay their regulatory approval.
  2. New Legal proceedings

    New legal mention

    In September 2026, we received a notice from Alvogen, Inc. (Alvogen) that it had filed an ANDA with the FDA seeking approval of a generic version of VYKAT XR (diazoxide choline).

    From the filings

    Now

    In September 2026, we received a notice from Alvogen, Inc. (Alvogen) that it had filed an ANDA with the FDA seeking approval of a generic version of VYKAT XR (diazoxide choline).
  3. New Legal proceedings

    New legal mention

    We filed suit in the U.S. District Court for the District of Delaware in October 2026 against Alvogen.

    From the filings

    Now

    We filed suit in the U.S. District Court for the District of Delaware in October 2026 against Alvogen.
  4. New Legal proceedings

    New legal mention

    The complaint alleged that by filing their ANDA, Alvogen infringed certain of our patents covering VYKAT XR and seeks to prevent Alvogen from selling a generic version of VYKAT XR.

    From the filings

    Now

    The complaint alleged that by filing their ANDA, Alvogen infringed certain of our patents covering VYKAT XR and seeks to prevent Alvogen from selling a generic version of VYKAT XR.
  5. New Legal proceedings

    New legal mention

    The filing of the suit triggered a statutory 30 -month stay of FDA approval of Alvogen's ANDA in addition to the existing New Product and Orphan Drug Exclusivities which expire in March 2028 and March 2032, respectively.

    From the filings

    Now

    The filing of the suit triggered a statutory 30 -month stay of FDA approval of Alvogen's ANDA in addition to the existing New Product and Orphan Drug Exclusivities which expire in March 2028 and March 2032, respectively.
  6. New Legal proceedings

    New legal mention

    On August 28, 2026, Lead Plaintiff filed an amended complaint which added additional causes of action for alleged violations of Sections 11, 12(a)(2), and 15 of the Securities Act of 1933, as amended.

    From the filings

    Now

    On August 28, 2026, Lead Plaintiff filed an amended complaint which added additional causes of action for alleged violations of Sections 11, 12(a)(2), and 15 of the Securities Act of 1933, as amended.
  7. New Legal proceedings

    New legal mention

    Lead Plaintiff's opposition to the motion to dismiss is due on December 18, 2026, and Defendants must file a reply by January 29, 2027.

    From the filings

    Now

    Lead Plaintiff's opposition to the motion to dismiss is due on December 18, 2026, and Defendants must file a reply by January 29, 2027.
  8. Changed Financial statements

    Net income up 43% from Jun 30

    $207M, was $144M.

    From the filings

    Before

    $144M

    Now

    $207M
  9. Changed Financial statements

    Revenue up 17% from Jun 30

    $1.1B, was $959M.

    From the filings

    Before

    $959M

    Now

    $1.1B
  10. Changed Risk factors

    • We face intense competition, and if we are unable to compete effectively, the demand for our products may…

    Drops "• We may not successfully integrate Soleno Therapeutics. Inc. (Soleno) or realize the…".

    From the filings

    Before

    • We face intense competition, and if we are unable to compete effectively, the demand for our products may be reduced. • 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. • We may not successfully integrate Soleno Therapeutics. Inc. (Soleno) or realize the anticipated benefits of the acquisition. which could adversely affect our business and financial condition. • Because the development of our product candidates is subject to a substantial degree of technological uncertainty, we may not succeed in developing any of our product candidates, which could adversely affect our business and financial condition. • Our clinical trials may be delayed for safety or other reasons, or fail to demonstrate the safety and efficacy of our product candidates, which could prevent or significantly delay their regulatory approval.

    Now

    • We face intense competition, and if we are unable to compete effectively, the demand for our products may be reduced. • 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.
  11. Changed Risk factors

    * We may not be able to successfully commercialize VYKAT XR.

    Adds "For example, in August 2026, certain PWS patient advocacy organizations issued a…".

    From the filings

    Before

    * We may not be able to successfully commercialize VYKAT XR. In the second quarter of 2026, we acquired Soleno and its commercial product, VYKAT XR, which was approved by the FDA in March 2025 for the treatment of hyperphagia in adults and pediatric patients four years of age and older with PWS. The successful commercialization of VYKAT XR depends on the extent to which healthcare providers, patients and payors accept and adopt VYKAT XR, and we do not know whether our expectations or estimates in this regard, or those of investors or securities analysts, will be accurate. To generate demand for VYKAT XR, we will need to continue to educate healthcare providers on its clinical utility, benefits, risks, dosing and monitoring. Our ability to generate revenue from VYKAT XR will also depend on our ability to obtain and maintain coverage and adequate reimbursement from payors. PWS is a rare disease, and if our estimates of the prevalence of PWS, the number of patients who may benefit from treatment with VYKAT XR, the number of healthcare providers willing to prescribe VYKAT XR, or the number of patients willing to stay on treatment prove to be incorrect, the market opportunity for VYKAT XR may be smaller than we believe it is. VYKAT XR may also compete with therapeutic products in various stages of clinical development for the treatment of PWS, including hyperphagia, as well as drugs approved for other indications, such as appetite suppression. In addition, adverse events, safety concerns, product complaints or other safety-related reports regarding VYKAT XR, including serious adverse events reported after commercialization, could adversely affect market acceptance, result in regulatory scrutiny, require changes to the approved labeling for VYKAT XR, or cause patients or caregivers to discontinue use of VYKAT XR or healthcare providers to be reluctant to prescribe or continue prescribing VYKAT XR. If commercialization of VYKAT XR and future sales are less successful…

    Now

    * We may not be able to successfully commercialize VYKAT XR. In the second quarter of 2026, we acquired Soleno and its commercial product, VYKAT XR, which was approved by the FDA in March 2025 for the treatment of hyperphagia in adults and pediatric patients four years of age and older with PWS. The successful commercialization of VYKAT XR depends on the extent to which healthcare providers, patients and payors accept and adopt VYKAT XR, and we do not know whether our expectations or estimates in this regard, or those of investors or securities analysts, will be accurate. To generate demand for VYKAT XR, we will need to continue to educate healthcare providers on its clinical utility, benefits, risks, dosing and monitoring. Our ability to generate revenue from VYKAT XR will also depend on our ability to obtain and maintain coverage and adequate reimbursement from payors. PWS is a rare disease, and if our estimates of the prevalence of PWS, the number of patients who may benefit from treatment with VYKAT XR, the number of healthcare providers willing to prescribe VYKAT XR, or the number of patients willing to stay on treatment prove to be incorrect, the market opportunity for VYKAT XR may be smaller than we believe it is. VYKAT XR may also compete with therapeutic products in various stages of clinical development for the treatment of PWS, including hyperphagia, as well as drugs approved for other indications, such as appetite suppression. In addition, adverse events, safety concerns, product complaints or other safety-related reports regarding VYKAT XR, including serious adverse events reported after commercialization, could adversely affect market acceptance, result in regulatory scrutiny, require changes to the approved labeling for VYKAT XR, or cause patients or caregivers to discontinue use of VYKAT XR or healthcare providers to be reluctant to prescribe or continue prescribing VYKAT XR. For example, in August 2026, certain PWS patient advocacy organizations…
  12. Changed Risk factors

    * If healthcare providers and patients do not continue to accept our commercial products, or our sales and…

    Adds "public perception regarding these products, including publicity regarding reported…".

    From the filings

    Before

    * If healthcare providers and patients do not continue to accept our commercial products, or our sales and marketing efforts are not effective, we may not generate sufficient revenue. The commercial success of our commercial products, INGREZZA, CRENESSITY and VYKAT XR, will depend upon the acceptance of these products as safe and effective by the medical community and patients. The market acceptance of our commercial products could be affected by a number of factors, including: • the availability of healthcare payor coverage and adequate reimbursement for the products; • the success of existing competitor products addressing our target markets or the emergence of equivalent or superior products; and Patient advocacy organizations and other patient communities are important across our commercial portfolio in supporting disease awareness and patient and caregiver education. These activities may be particularly significant for CRENESSITY and VYKAT XR given the rare disease nature of those indications, where education and awareness among relatively small patient and caregiver communities can affect patient identification and access to information about available treatments. 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.

    Now

    * If healthcare providers and patients do not continue to accept our commercial products, or our sales and marketing efforts are not effective, we may not generate sufficient revenue. The commercial success of our commercial products, INGREZZA, CRENESSITY and VYKAT XR, will depend upon the acceptance of these products as safe and effective by the medical community and patients. The market acceptance of our commercial products could be affected by a number of factors, including: • the availability of healthcare payor coverage and adequate reimbursement for the products; • public perception regarding these products, including publicity regarding reported adverse events or other safety concerns; • the success of existing competitor products addressing our target markets or the emergence of equivalent or superior products; and Patient advocacy organizations and other patient communities are important across our commercial portfolio in supporting disease awareness and patient and caregiver education. These activities may be particularly significant for CRENESSITY and VYKAT XR given the rare disease nature of those indications, where education and awareness among relatively small patient and caregiver communities can affect patient identification and access to information about available treatments. Statements or communications by patient advocacy organization, clinicians or others concerning the safety, efficacy or appropriate use of our products may influence perceptions and treatment decisions within these communities, including where such statements or communications relate to adverse event reports for which a causal relationship to the applicable product has not been established. 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.
  13. Changed Risk factors

    * Government and third-party payors may impose sales and pharmaceutical pricing controls on our products or…

    Adds "models using international drug"; drops "if finalized,".

    From the filings

    Before

    * 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 our products, INGREZZA, CRENESSITY and VYKAT XR, will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available. The continuing efforts of government and third-party payors to contain or reduce the costs of healthcare and the price of prescription drugs through various means may impact our revenues. These payors' efforts could decrease the price that we receive for any products we may develop and sell in the future. 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 healthcare providers, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the out-of-pocket cost of our products. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available regardless of whether they are approved by the FDA for that particular use. Coverage decisions by payors for our competitors' products may also impact coverage for our products. Government authorities and other third-party payors are developing increasingly sophisticated methods of controlling healthcare costs, such as…

    Now

    * 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 our products, INGREZZA, CRENESSITY and VYKAT XR, will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available. The continuing efforts of government and third-party payors to contain or reduce the costs of healthcare and the price of prescription drugs through various means may impact our revenues. These payors' efforts could decrease the price that we receive for any products we may develop and sell in the future. 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 healthcare providers, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the out-of-pocket cost of our products. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available regardless of whether they are approved by the FDA for that particular use. Coverage decisions by payors for our competitors' products may also impact coverage for our products. Government authorities and other third-party payors are developing increasingly sophisticated methods of controlling healthcare costs, such as…
  14. Changed Risk factors

    We may encounter difficulties integrating Soleno, retaining key employees, maintaining relationships with…

    Adds "as amended,"; drops "Sections 10(b) and 20(a) of".

    From the filings

    Before

    We may encounter difficulties integrating Soleno, retaining key employees, maintaining relationships with healthcare providers, patients, payors, suppliers, specialty pharmacies, distributors and other business partners, or maintaining the commercialization and regulatory strategy for VYKAT XR. We also have assumed, and may become responsible for, liabilities and risks relating to Soleno that may not have been identified or fully quantified in due diligence, including product liability, regulatory, commercial, employment, contract, tax, intellectual property, securities and other claims or proceedings. For example, on March 6, 2026, a purported stockholder of Soleno filed a putative federal securities class action against Soleno and certain members of Soleno's management alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and SEC Rule 10b-5 on behalf of a putative class of purchasers of Soleno stock during a purported class period of March 26, 2025 through November 4, 2025, inclusive. Defense of or any adverse resolution of this action or any similar or related matters could result in substantial costs, damages, indemnification obligations, settlement payments or diversion of management's attention.

    Now

    We may encounter difficulties integrating Soleno, retaining key employees, maintaining relationships with healthcare providers, patients, payors, suppliers, specialty pharmacies, distributors and other business partners, or maintaining the commercialization and regulatory strategy for VYKAT XR. We also have assumed, and may become responsible for, liabilities and risks relating to Soleno that may not have been identified or fully quantified in due diligence, including product liability, regulatory, commercial, employment, contract, tax, intellectual property, securities and other claims or proceedings. For example, on March 6, 2026, a purported stockholder of Soleno filed a putative federal securities class action against Soleno and certain members of Soleno's management alleging violations of the Securities Exchange Act of 1934, as amended, and SEC Rule 10b-5 on behalf of a putative class of purchasers of Soleno stock during a purported class period of March 26, 2025 through November 4, 2025, inclusive.An amended complaint subsequently filed in this action also alleges violations of the Securities Act of 1933, as amended. Defense of or any adverse resolution of this action or any similar or related matters could result in substantial costs, damages, indemnification obligations, settlement payments or diversion of management's attention.
  15. Changed Risk factors

    * Use of our approved products or those of our collaborators could be associated with side effects or…

    Adds "Monitoring"; drops "Reporting".

    From the filings

    Before

    * Use of our approved products or those of our collaborators could be associated with side effects or adverse events. As with most pharmaceutical products, use of our approved products or those of our collaborators could be associated with side effects or adverse events which can vary in severity (from minor adverse reactions to death) and frequency (infrequent or prevalent). Side effects or adverse events associated with the use of our products or those of our collaborators may be observed at any time, including after a product is commercialized, and reports of any such side effects or adverse events may negatively impact demand for our or our collaborators' products or affect our or our collaborators' ability to maintain regulatory approval for such products. With respect to VYKAT XR, since it became commercially available, serious adverse events in patients taking VYKAT XR have been reported to FDA through the FDA Adverse Event Reporting System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). Although reports in AEMS do not establish that a drug caused an adverse event and may be attributable to the patient's underlying disease, other medications or other factors, these reports could negatively impact demand for VYKAT XR, result in regulatory scrutiny or cause patients or caregivers to discontinue use of VYKAT XR or healthcare providers to be reluctant to prescribe or continue prescribing VYKAT XR. Side effects or other safety issues associated with the use of our approved products or those of our collaborators could require us or our collaborators to modify or halt commercialization of these products or expose us to product liability lawsuits which will harm our business. We or our collaborators may be required by regulatory agencies to conduct additional studies regarding the safety and efficacy of our products which we have not planned or anticipated. Furthermore, there can be no assurance that we or our collaborators will resolve any issues…

    Now

    * Use of our approved products or those of our collaborators could be associated with side effects or adverse events. As with most pharmaceutical products, use of our approved products or those of our collaborators could be associated with side effects or adverse events which can vary in severity (from minor adverse reactions to death) and frequency (infrequent or prevalent). Side effects or adverse events associated with the use of our products or those of our collaborators may be observed at any time, including after a product is commercialized, and reports of any such side effects or adverse events may negatively impact demand for our or our collaborators' products or affect our or our collaborators' ability to maintain regulatory approval for such products. With respect to VYKAT XR, since it became commercially available, serious adverse events in patients taking VYKAT XR have been reported to FDA through the FDA Adverse Event Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). In its quarterly report published in September 2026 of newly identified safety signals, the FDA identified fluid retention as a potential safety signal for VYKAT XR and stated that it is evaluating the need for regulatory action. Although reports in AEMS and the FDA's identification of a potential safety signal do not establish that a drug caused an adverse event and such events may be attributable to the patient's underlying disease, other medications or other factors, these reports and the FDA's evaluation of the potential safety signal could negatively impact demand for VYKAT XR, result in additional regulatory scrutiny or cause patients or caregivers to discontinue use of VYKAT XR or healthcare providers to be reluctant to prescribe or continue prescribing VYKAT XR. Side effects or other safety issues associated with the use of our approved products or those of our collaborators could result in changes to product labeling or requirements to implement…
  16. Changed Risk factors

    * International trade policies, including tariffs, sanctions and trade barriers may adversely affect our…

    Adds "presidential administration has imposed tariffs"; drops "Additionally, recent policy discussions have included potential targeted tariffs or…".

    From the filings

    Before

    International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects. We operate in a global economy, and our business depends on a global supply chain for the development, manufacturing, and distribution of our products, and for the advancement of our development programs. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. We source and procure APIs, precursor chemicals, and specialized equipment from international suppliers, with substantial reliance on foreign contract manufacturers in Europe. Tariff policies, particularly those affecting pharmaceutical products, could increase our costs and reduce our profitability. Additionally, recent policy discussions have included potential targeted tariffs or other trade measures specifically aimed at pharmaceutical products and ingredients as part of broader healthcare cost control or national security initiatives. In April 2025, the U.S. Department of Commerce initiated an investigation on imports of pharmaceuticals and pharmaceutical ingredients, which may result in the current U.S. presidential administration taking actions to impose tariffs on the pharmaceutical industry. The U.S. presidential administration also indicated that it may impose a 100% tariff on any branded or patented pharmaceutical product, unless a company is building a pharmaceutical manufacturing plant in the U.S. The specific impact of the investigation and announcements to enact substantial tariffs on patented pharmaceutical products remain uncertain at this time but could negatively impact our business and operations. Unlike consumer goods, pharmaceuticals face unique…

    Now

    * International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects. We operate in a global economy, and our business depends on a global supply chain for the development, manufacturing, and distribution of our products, and for the advancement of our development programs. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. We source and procure APIs, precursor chemicals, and specialized equipment from international suppliers, with substantial reliance on foreign contract manufacturers in Europe. Tariff policies, particularly those affecting pharmaceutical products, could increase our costs and reduce our profitability. The U.S. presidential administration has imposed tariffs on imports of certain patented pharmaceutical products and associated ingredients, subject to varying rates and exemptions. Although these tariffs have not had a material impact on our business, financial condition or results of operations to date, the imposition of new tariffs or changes to existing tariff rates or exemptions could negatively affect our business and operations. Unlike consumer goods, pharmaceuticals face unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly. New or increased tariffs on pharmaceutical imports could cause our production costs to rise, and it would be difficult and costly to qualify alternative sources within another country with a lower tariff rate or within the U.S., as developing and qualifying alternative sources typically requires substantial time, investment, and regulatory approvals. Unlike many industries, our ability to pass…
  17. Changed Risk factors

    * Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial…

    Adds "and other third parties with whom we do business,"; drops "and".

    From the filings

    Before

    * Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations. Our business could be adversely affected by conditions in the U.S. and global economies, the U.S. and global financial markets and adverse geopolitical and macroeconomic developments, including potential future disruptions in access to bank deposits due to bank failures, tariffs and trade barriers, government shutdowns and the resulting effects on regulatory agencies, geopolitical tensions, and military conflicts. General business and economic conditions that could affect our business, financial condition or results of operations include fluctuations in economic growth, inflation and interest rates, debt and equity capital markets, liquidity of the global financial markets, the availability and cost of credit, investor and consumer confidence, and the strength of the economies in which we, our manufacturers and suppliers, and our collaborators operate. A weak or declining global economy due to geopolitical tensions or tariffs and trade barriers could also strain our suppliers and manufacturers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

    Now

    * Unfavorable geopolitical and macroeconomic developments could adversely affect our business, financial condition or results of operations. Our business could be adversely affected by conditions in the U.S. and global economies, the U.S. and global financial markets and adverse geopolitical and macroeconomic developments, including potential future disruptions in access to bank deposits due to bank failures, tariffs and trade barriers, government shutdowns and the resulting effects on regulatory agencies, geopolitical tensions, and military conflicts. General business and economic conditions that could affect our business, financial condition or results of operations include fluctuations in economic growth, inflation and interest rates, debt and equity capital markets, liquidity of the global financial markets, the availability and cost of credit, investor and consumer confidence, and the strength of the economies in which we, our manufacturers and suppliers, and our collaborators operate. A weak or declining global economy due to geopolitical tensions or tariffs and trade barriers could also strain our suppliers, manufacturers and other third parties with whom we do business, possibly resulting in supply, development or other operational disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current geopolitical tensions, economic climate and financial market conditions could adversely impact our business.
  18. New MD&A

    • Announced that Eiry W. Roberts, M.D., who previously served as Neurocrine's Chief Medical Officer (CMO)…

    New paragraph in MD&A.

    From the filings

    Now

    • Announced that Eiry W. Roberts, M.D., who previously served as Neurocrine's Chief Medical Officer (CMO) and most recently as a Strategic Advisor, has rejoined the Company's executive management team as CMO.
  19. New MD&A

    • Initiated Phase 2 clinical study evaluating the efficacy, safety, tolerability, and pharmacokinetics of…

    New paragraph in MD&A.

    From the filings

    Now

    • Initiated Phase 2 clinical study evaluating the efficacy, safety, tolerability, and pharmacokinetics of NBI-1117567, an investigational M1/M4 (M1-preferring) selective muscarinic agonist being developed as an adjunctive therapy for cognitive impairment in Alzheimer's disease.
  20. Changed MD&A

    • Initiated a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIM-'1008, an…

    Adds "a"; drops "NBIP-2118 in adult participants. NBIP-2118 is".

    From the filings

    Before

    • Initiated Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-2118 in adult participants. NBIP-2118 is an investigational corticotropin-releasing factor 2 receptor (CRF 2 ) peptide agonist and a potential first-in-class therapy for obesity.

    Now

    • Initiated a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIM-'1008, an investigational therapy being developed for rheumatoid arthritis and other immune-mediated diseases.
  21. Changed MD&A

    • Initiated a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'1968, an…

    Adds "a"; drops "NBIP-2118 in adult participants. NBIP-2118 is".

    From the filings

    Before

    • Initiated Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-2118 in adult participants. NBIP-2118 is an investigational corticotropin-releasing factor 2 receptor (CRF 2 ) peptide agonist and a potential first-in-class therapy for obesity.

    Now

    • Initiated a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity.
  22. New MD&A

    • Announced publication of the KINECT-PRO™ Phase 4 open-label study results demonstrating that treatment…

    New paragraph in MD&A.

    From the filings

    Now

    • Announced publication of the KINECT-PRO™ Phase 4 open-label study results demonstrating that treatment with once-daily INGREZZA capsules resulted in substantial and sustained improvements in patient-reported quality of life and functionality, alongside improvements in clinician-rated TD movement severity. Improvements were observed regardless of underlying psychiatric diagnosis or baseline TD movement severity, including among participants with clinician-rated mild TD movements. The manuscript appears in CNS Spectrums.
  23. New MD&A

    • Presented research advancing the understanding of Prader-Willi syndrome and real-world experience with…

    New paragraph in MD&A.

    From the filings

    Now

    • Presented research advancing the understanding of Prader-Willi syndrome and real-world experience with VYKAT XR at the Foundation for Prader-Willi Research Symposium & Family Conference.
  24. Changed MD&A

    For the third quarter and first nine months of 2025, the effective tax rate varied from the federal and…

    Adds "third"; drops "second".

    From the filings

    Before

    For the second quarter and first six months of 2025, the effective tax rate varied from the federal and state statutory rates primarily due to credits generated for research activities, certain nondeductible expenses, excess tax benefits related to stock-based compensation, fluctuations in state effective tax rates, and losses in foreign and domestic jurisdictions for which no tax benefit was recorded as management cannot conclude that it is more likely than not that the tax benefit of such losses will be realized in the future.

    Now

    For the third quarter and first nine months of 2025, the effective tax rate varied from the federal and state statutory rates primarily due to credits generated for research activities, certain nondeductible expenses, excess tax benefits related to stock-based compensation, fluctuations in state effective tax rates, and valuation allowances recorded in certain foreign and domestic state jurisdictions for tax benefits that management cannot conclude are more likely than not to be realized in the future. In addition, the effective tax rate for the third quarter of 2025 reflects increased tax expense related to foreign operations and the enactment of the One Big Beautiful Bill Act (OBBBA).
  25. Changed MD&A

    Borrowings under the 2026 Credit Facility bear interest at variable rates, and changes in interest rates…

    Adds "Borrowings under the 2026 Credit Facility bear interest at variable rates, and changes…"; drops "10".

    From the filings

    Before

    Refer to Note 10 to the condensed consolidated financial statements for additional information regarding our significant collaboration and license agreements.

    Now

    Borrowings under the 2026 Credit Facility bear interest at variable rates, and changes in interest rates would affect interest expense on any outstanding borrowings. As of September 30, 2026, no borrowings were outstanding under the 2026 Credit Facility. Refer to Note 5 to the condensed consolidated financial statements for additional information regarding the 2026 Credit Facility.
Show the redline

Section by section. Added words and removed words against the earlier filing.

Cover page 2 changes

3 unchanged paragraphs

For the quarterly period ended June September 30, 2026

19 unchanged paragraphs

The number of outstanding shares of the registrant's common stock, par value $0.001 per share, was 101,649,181 101,218,643 as of July 22, October 26, 2026.

2 unchanged paragraphs

Financial statements 133 changes

3 unchanged paragraphs

Noncurrent inventory 149.1 —

Equity investments 147.3 120.8

Cash and cash equivalents $ 332.4 641.5 $ 713.0

Available-for-sale debt securities 57.4 96.4 767.4

Other current assets 39.4 34.5 115.8

Total current assets 1,637.5 2,008.2 2,522.7

Noncurrent inventory 177.7 —

Noncurrent available-for-sale debt securities 91.9 51.8 1,063.0

Right-of-use assets 448.0 437.2 455.4

Equity investments 95.0 120.8

Property and equipment, net 90.5 92.2 89.8

Intangible assets, net 2,226.0 2,191.0 4.7

Deferred tax assets 8.9 11.8 320.3

Other noncurrent assets 59.3 61.9 48.7

Total assets $ 5,359.1 5,627.4 $ 4,631.5

2 unchanged paragraphs

Accounts payable and accrued liabilities $ 808.3 923.4 $ 674.3

Other current liabilities 66.2 61.2 69.1

Total current liabilities 874.5 984.6 743.4

Deferred tax liabilities 91.5 105.0 —

Noncurrent operating lease liabilities 401.8 392.3 415.3

Other noncurrent liabilities 297.7 266.8 219.7

Total liabilities 1,665.5 1,748.7 1,378.4

2 unchanged paragraphs

Common stock, $ 0.001 par value; 220.0 shares authorized; 101.6 101.3 and 100.1 shares issued and outstanding, respectively

Additional paid-in capital 2,964.4 3,035.8 2,792.2

Accumulated other comprehensive income 5.1 4.4 13.1

Total stockholders' equity 3,693.6 3,878.7 3,253.1

Total liabilities and stockholders' equity $ 5,359.1 5,627.4 $ 4,631.5

4 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Net product sales $ 954.3 $ 682.0 $ 1,765.3 $ 1,245.7

Collaboration revenues 4.7 5.5 8.2 14.4

Total revenues 959.0 687.5 1,773.5 1,260.1

Research and development 326.7 244.3 622.9 507.5

Selling, general, and administrative 439.7 286.3 758.2 562.8

Amortization of acquired intangible assets 16.4 1.0 16.5 2.0

Net product sales $ 1,119.0 $ 789.9 $ 2,884.3 $ 2,035.6

Collaboration revenues 3.7 5.0 11.9 19.4

Total revenues 1,122.7 794.9 2,896.2 2,055.0

Cost of revenues, excluding amortization of acquired intangible assets 23.2 10.3 36.9 18.5 26.6 13.0 63.5 31.5

Research and development 351.8 250.0 974.7 757.5

Acquired in-process research and development 1.5 — 22.7 0.1 11.7 0.3 34.4 0.4

Selling, general, and administrative 366.3 291.6 1,124.5 854.4

Amortization of acquired intangible assets 35.0 1.0 51.5 3.0

1 unchanged paragraph

Total operating expenses 807.5 541.9 1,428.6 1,090.9

Operating income 151.5 145.6 344.9 169.2

Other income (expense):

Interest expense ( 2.9 ) — ( 2.9 ) —

Unrealized gain (loss) on equity investments 1.2 ( 6.7 ) 26.5 ( 37.3 )

Investment income and other, net 12.4 20.6 40.5 42.3

Total other income, net 10.7 13.9 64.1 5.0

Total operating expenses 791.4 555.9 2,220.0 1,646.8

Operating income 331.3 239.0 676.2 408.2

Other (expense) income:

Interest expense ( 0.3 ) — ( 3.2 ) —

Unrealized (loss) gain on equity investments ( 52.3 ) 30.6 ( 25.8 ) ( 6.7 )

Investment income and other, net 5.0 22.2 45.5 64.5

Total other (expense) income, net ( 47.6 ) 52.8 16.5 57.8

1 unchanged paragraph

Provision for income taxes 17.8 52.0 66.7 58.8

Net income $ 144.4 $ 107.5 $ 342.3 $ 115.4

Unrealized gain (loss) on available-for-sale debt securities, net of tax 4.1 2.7 ( 8.6 ) 4.4

Comprehensive income $ 149.1 $ 111.0 $ 334.3 $ 122.1

Basic $ 1.43 $ 1.09 $ 3.40 $ 1.16

Diluted $ 1.39 $ 1.06 $ 3.30 $ 1.13

Provision for income taxes 77.2 82.3 143.9 141.1

Net income $ 206.5 $ 209.5 $ 548.8 $ 324.9

Foreign currency translation adjustments, net of tax 0.6 0.8 0.6 2.3 ( 0.1 ) 1.6 0.5 3.9

Unrealized (loss) gain on available-for-sale debt securities, net of tax ( 0.6 ) ( 0.9 ) ( 9.2 ) 3.5

Comprehensive income $ 205.8 $ 210.2 $ 540.1 $ 332.3

Basic $ 2.03 $ 2.11 $ 5.43 $ 3.27

Diluted $ 1.96 $ 2.04 $ 5.26 $ 3.19

1 unchanged paragraph

Diluted 104.2 101.0 103.8 101.8

Basic 101.6 99.4 101.0 99.0 100.8 99.3

Diluted 105.2 102.5 104.3 102.0

4 unchanged paragraphs

Retained Earnings (Accumulated Deficit)

2 unchanged paragraphs

Balance at March 31, 2026

Net income — — — — 144.4 144.4

Other comprehensive income, net of tax

Stock-based compensation expense — — 65.0 — — 65.0

Issuances of common stock under benefit plans, net of tax 1.1 — 82.1 — — 82.1 ( 0.1 ) — — — ( 10.0 ) ( 10.0 )

1 unchanged paragraph

Balance at March 31, 2025

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

6 unchanged paragraphs

1 unchanged paragraph

2 unchanged paragraphs

1 unchanged paragraph

2 unchanged paragraphs

4 unchanged paragraphs

2 unchanged paragraphs

1 unchanged paragraph

2 unchanged paragraphs

and 53 more changes in the filing

Note 1: Organization and Significant Accounting Policies 11 changes

10 unchanged paragraphs

In connection with the merger, the vesting of certain outstanding Soleno equity awards was accelerated as of the acquisition date and each vested Soleno equity award became entitled to receive cash consideration. The purchase price for the acquisition included $ 67.4 million related to the settlement of outstanding Soleno equity awards attributable to pre-combination service. In addition, we recognized stock-based compensation expense of $ 60.1 million during the second quarter and first six months of 2026 related to the acceleration of outstanding Soleno equity awards attributable to post-combination service that were settled in cash.

25 unchanged paragraphs

Transaction costs, which were comprised primarily of financial advisory and legal fees, totaled $ 33.1 million during the second quarter and first six months of 2026 and were included in selling, general, and administrative expenses. No transaction costs were incurred during the second quarter and first six months of 2025.

1 unchanged paragraph

The results of operations of Soleno have been included in the condensed consolidated statements of income and comprehensive income beginning on the acquisition date. For the third quarter of 2026 and from the acquisition date through June September 30, 2026, total net revenues and net loss attributable to Soleno were $ 54.4 106.7 million and $ 52.2 161.1 million, respectively. inclusive Soleno contributed net income of $ 104.7 17.1 million in for the third quarter of 2026 and a net loss of $ 35.1 million from the acquisition date through September 30, 2026. These results included $ 59.7 million and $ 163.3 million, respectively, of acquisition-related expenses and amortization of expense associated with the VYKAT XR fair-value step up, step-up and amortization of the acquired intangible asset related to the VYKAT XR developed product rights. for VYKAT XR.

2 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Revenues $ 998.4 $ 720.2 $ 1,907.5 $ 1,292.8

Net income (loss) $ 203.4 $ 67.7 $ 395.0 $ ( 57.9 )

Revenues $ 1,122.7 $ 860.9 $ 3,030.2 $ 2,153.7

Net income (loss) $ 204.3 $ 199.7 $ 599.4 $ 141.8

3 unchanged paragraphs

(iii) t he reallocation of acquisition-related compensation costs, including stock-based compensation expense associated with accelerated Soleno equity awards attributable to post-combination service and transaction transaction-related cash bonuses payable paid to certain Soleno employees, from the historical three and six month periods ended June 30, 2026, in which such costs were recognized to the periods period in which they would have been recognized assuming the acquisition had occurred on January 1, 2025;

(iv) the reallocation of non-recurring acquisition-related transaction costs incurred by Neurocrine and Soleno from the historical three and six month periods ended June 30, 2026, in which such costs were recognized to the periods period in which they would have been recognized assuming the acquisition had occurred on January 1, 2025;

2 unchanged paragraphs

Note 3: Fair Value Measurements 18 changes

6 unchanged paragraphs

Equity investments 147.3 147.3 — 120.8 120.8 —

Cash and cash equivalents $ 332.4 641.5 $ 332.4 641.5 $ — $ 713.0 $ 713.0 $ —

Available-for-sale debt securities 149.3 148.2 — 149.3 148.2 1,830.4 — 1,830.4

Equity investments 95.0 95.0 — 120.8 120.8 —

3 unchanged paragraphs

As of June September 30, 2026 and December 31, 2025, we held available-for-sale debt securities with a total fair value of $ 139.6 144.1 million and $ 335.1 million, respectively, that were in unrealized loss positions totaling $ 0.7 1.2 million and $ 0.6 million, respectively. Available-for-sale debt securities that had been in unrealized loss positions for longer than twelve months were not significant as of June September 30, 2026 or December 31, 2025. Unrealized losses on available-for-sale debt securities are primarily caused by changes in interest rates. Our investments in available-for-sale debt securities are of high credit quality, and we do not intend to sell these investments and it is not more likely than not that we will be required to sell these investments before their maturity.

Accrued interest receivables on available-for-sale debt securities totaled $ 3.1 1.7 million and $ 20.5 million, respectively, as of June September 30, 2026 and December 31, 2025 and are included in other current assets on the condensed consolidated balance sheets. We do not measure an allowance for credit losses for accrued interest receivables. For the purposes of identifying and measuring an impairment, accrued interest is excluded from both the fair value and amortized cost basis of the debt security. Uncollectible accrued interest receivables associated with an impaired debt security are reversed against interest income upon identification of the impairment.

2 unchanged paragraphs

Customer A 34 % 41 %

Customer B 26 % 29 %

Customer C 28 % 15 %

Customer A 36 % 41 %

Customer B 24 % 28 %

Customer C 29 % 17 %

1 unchanged paragraph

Customer A 38 % 41 %

Customer B 29 % 31 %

Customer C 23 % 16 %

Customer A 48 % 41 %

Customer B 21 % 31 %

Customer C 20 % 16 %

1 unchanged paragraph

Note 4: Goodwill and Intangible Assets 9 changes

3 unchanged paragraphs

Additions in connection with the acquisition of Soleno Therapeutics, Inc. in May 2026 494.6

1 unchanged paragraph

Balance as of March 31, 2026 6.0

Additions in connection with the acquisition of Soleno Therapeutics, Inc. 494.6

Balance as of June September 30, 2026

4 unchanged paragraphs

Total intangible assets, net $ 2,226.0 2,191.0 $ 4.7

1 unchanged paragraph

The following table presents approximate future annual amortization expense for our finite-lived intangible assets as of June September 30, 2026.

1 unchanged paragraph

2026 (6 months remaining)

2026 (3 months remaining)

Thereafter $ 1,595.1 1,595.2

Note 5: Debt 4 changes

1 unchanged paragraph

Borrowings under the 2026 Credit Facility bear interest, at the Company's option, at a rate based on either an alternate base rate plus an applicable margin or a Term Secured Overnight Financing Rate (SOFR), risk-free rate, or other applicable benchmark rate plus an applicable margin, in each case determined under the credit agreement. We are also required to pay a commitment fee on the unused portion of the revolving commitments. The initial Term SOFR borrowing under the 2026 Credit Facility bears interest at an all-in rate of 4.90 %, consisting of a Chicago Mercantile Exchange Term SOFR reference rate of 3.65 % plus an applicable margin of 1.25 %. The initial commitment fee rate is 0.15 % per annum.

On May 14, 2026, we borrowed $ 600.0 million under the 2026 Credit Facility. In June 2026, we repaid $ 600.0 million of principal and paid $ 2.7 million of accrued interest related to the repayment. In the condensed consolidated statements of cash flows, proceeds from and repayments of borrowings under the 2026 Credit Facility are presented within financing activities net of debt issuance costs paid to lenders. and debt issuance costs paid to third parties, including certain reimbursed third-party costs, are presented separately as financing cash outflows. Repayments of borrowings under the 2026 Credit Facility are presented as within financing cash outflows. activities. As of June September 30, 2026, no borrowings were outstanding and we had $ 1.0 billion of available borrowing capacity under the 2026 Credit Facility, subject to continued compliance with the covenants and other conditions to borrowing under the credit agreement.

In connection with the 2026 Credit Facility, we incurred $ 6.7 million of financing costs, which were deferred as assets and are being amortized to interest expense over the term of the facility. As of June September 30, 2026, unamortized deferred financing costs were $ 6.5 6.1 million and were included in other noncurrent assets in the condensed consolidated balance sheet as of June September 30, 2026. In addition, interest expense associated with the 2026 Credit Facility totaled $ 2.9 0.3 million and $ 3.2 million, respectively, for each of the second third quarter and first six nine months of 2026. including $ 0.2 million related to the amortization of deferred financing costs.

The credit agreement contains customary affirmative and negative covenants, including limitations on indebtedness, liens, investments, restricted payments and certain other transactions, as well as financial covenants requiring us to maintain a maximum total net leverage ratio and a minimum consolidated interest coverage ratio. The obligations under the credit agreement are guaranteed by certain of our subsidiaries and secured by liens on substantially all assets of the Company and the subsidiary guarantors, subject to customary exceptions. As of June September 30, 2026, we were in compliance with the covenants under the credit agreement.

Note 6: Leases 18 changes

3 unchanged paragraphs

Operating lease cost $ 31.2 $ 33.0

Sublease income ( 1.9 ) ( 1.7 )

Net operating lease cost $ 29.3 $ 31.3

Operating lease cost $ 47.3 $ 49.0

Sublease income ( 2.9 ) ( 2.6 )

Net operating lease cost $ 44.4 $ 46.4

Cash paid for amounts included in the measurement of operating lease liabilities $ 27.6 42.8 $ 18.7 28.2

1 unchanged paragraph

9.4 years 10.4 years

9.2 years 10.1 years

2 unchanged paragraphs

The following table presents approximate future non-cancelable minimum lease payments under operating leases and sublease income as of June September 30, 2026.

1 unchanged paragraph

2026 (6 months remaining)

Thereafter 306.9 ( 2.0 )

2026 (3 months remaining)

Thereafter 307.0 ( 2.0 )

Total operating lease payments (sublease income) 583.1 567.6 $ ( 19.1 18.1 )

1 unchanged paragraph

Total operating lease liabilities 461.6 451.8

Less current operating lease liabilities included in other current liabilities 59.8 59.5

Noncurrent operating lease liabilities $ 401.8 392.3

Note 7: Supplemental Financial Information 40 changes

1 unchanged paragraph

(in millions) June 30,

Raw materials $ 39.9 $ 35.7

Total inventory 253.3 69.0

(in millions) September 30,

Raw materials $ 38.8 $ 35.7

Work in process 70.1 67.7 19.2

Finished goods 143.3 137.3 14.1

Total inventory 243.8 69.0

1 unchanged paragraph

Inventory $ 104.2 $ 69.0

Noncurrent inventory 149.1 —

Total inventory $ 253.3 $ 69.0

Inventory $ 66.1 $ 69.0

Noncurrent inventory 177.7 —

Total inventory $ 243.8 $ 69.0

Prior to FDA approval of CRENESSITY in December 2024, all costs related to its manufacturing were expensed as R&D in the period incurred. As a result, our physical inventories as of June September 30, 2026 and December 31, 2025 included active pharmaceutical product with no cost basis. Costs related to the manufacturing of bulk drug product, finished bottling, and other labeling activities that occurred post-FDA approval are included in the inventory values as of June September 30, 2026 and December 31, 2025.

As of June September 30, 2026, noncurrent inventory consisted of VYKAT XR inventory acquired in the Soleno acquisition that, based on management's current demand forecasts, was expected to be realized after June September 30, 2027. Refer to Note 2 for additional information regarding the acquired inventory and related fair-value step-up.

In addition, in connection with the acquisition of Soleno in May 2026, we recorded a step-up in the fair value of work in process and finished goods inventory for VYKAT XR of $ 41.5 million and $ 126.7 million, respectively. The fair value step-up adjustment is being amortized to cost of revenues as the acquired inventory is sold. We recognized expense of $ 3.0 6.3 million of expense and $ 9.3 million, respectively, related to the amortization of the fair value fair-value step-up during the second third quarter and first six nine months of 2026.

1 unchanged paragraph

(in millions) June 30,

(in millions) September 30,

Prepaid income taxes $ 121.8 117.6 $ 94.0

Prepaid development costs 66.1 60.4 55.6

Other prepaid expenses 29.2 34.4 21.1

Total prepaid expenses $ 217.1 212.4 $ 170.7

1 unchanged paragraph

(in millions) June 30,

(in millions) September 30,

Sales rebates and reserves $ 292.1 316.2 $ 226.0

2 unchanged paragraphs

Accrued employee related costs 123.2 169.3 128.8

Current branded prescription drug fee 42.9 45.0 45.3

Accounts payable and other accrued liabilities 142.0 150.5 104.9

Total accounts payable and accrued liabilities $ 808.3 923.4 $ 674.3

1 unchanged paragraph

(in millions) June 30,

(in millions) September 30,

2 unchanged paragraphs

Total other noncurrent liabilities $ 297.7 266.8 $ 219.7

1 unchanged paragraph

(in millions) June 30,

Cash and cash equivalents $ 332.4 $ 264.0

(in millions) September 30,

Cash and cash equivalents $ 641.5 $ 340.2

1 unchanged paragraph

Total cash, cash equivalents, and restricted cash $ 338.9 648.0 $ 272.0 348.2

3 unchanged paragraphs

Cash paid for income taxes $ 88.2 111.3 $ 72.5 73.6

1 unchanged paragraph

Right-of-use assets acquired through operating leases $ 2.6 $ 3.4 —

Note 8: Stockholders' Equity 3 changes

2 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

2 unchanged paragraphs

As of June September 30, 2026, we had $ 266.3 174.2 million remaining under the 2025 Repurchase Program.

Note 9: Earnings per Share 14 changes

1 unchanged paragraph

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Net income - basic and diluted $ 144.4 $ 107.5 $ 342.3 $ 115.4

Net income - basic and diluted $ 206.5 $ 209.5 $ 548.8 $ 324.9

1 unchanged paragraph

Effect of dilutive securities 3.2 2.0 3.0 2.5

Diluted 104.2 101.0 103.8 101.8

Basic $ 1.43 $ 1.09 $ 3.40 $ 1.16

Diluted $ 1.39 $ 1.06 $ 3.30 $ 1.13

Basic 101.6 99.4 101.0 99.0 100.8 99.3

Effect of dilutive securities 3.6 3.1 3.3 2.7

Diluted 105.2 102.5 104.3 102.0

Basic $ 2.03 $ 2.11 $ 5.43 $ 3.27

Diluted $ 1.96 $ 2.04 $ 5.26 $ 3.19

Shares excluded from diluted per share amounts because their effect would have been anti-dilutive 4.8 6.3 4.5 4.8 2.4 3.3 3.8 4.3

Note 10: Collaboration and License Agreements 6 changes

2 unchanged paragraphs

NBI-1117567 is an investigational oral M1-preferring muscarinic agonist in development as a potential treatment for Alzheimer's cognition. In connection with the U.S. Food and Drug Administration's acceptance of our investigational new drug application for a Phase 2 study of NBI-1117567 for the treatment of Alzheimer's cognition in August 2026, we expensed a milestone payment of $ 10.0 million as research and development (R&D) in the third quarter of 2026.

NBI-1117570 is a dual M1/M4 muscarinic agonist in development as a potential treatment for schizophrenia and other psychiatric indications. In connection with the initiation of a Phase 2 clinical study for NBI-1117570 in schizophrenia in March 2026, we expensed a milestone payment of $ 22.5 million as research and development R&D in the first quarter of 2026.

1 unchanged paragraph

Under the terms of the agreement, Nxera may be entitled to receive potential future payments of up to $ 2.48 2.5 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the future net sales of any collaboration product.

4 unchanged paragraphs

In October 2024, we provided Takeda with written notice of termination of the license under the 2020 Takeda Agreement with respect to certain D-amino acid oxidase (DAAO) inhibitors, including the license to develop and commercialize luvadaxistat, and GPR139 agonists, including NBI-1065846, which became effective in April 2025.

9 unchanged paragraphs

Under the terms of the agreement, Xenon may be entitled to receive potential future payments of up to $ 1.66 1.7 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the future net sales of any collaboration product. Xenon retains the right to elect to co-develop one product in a major indication, pursuant to which Xenon would receive a mid-single digit percentage increase in royalties earned on the future net sales of such product in the U.S. and we and Xenon would equally share in the development costs of such product in the applicable indication, except where such development costs relate solely to the regulatory approval of such product outside the U.S.

12 unchanged paragraphs

Under the terms of the 2023 Voyager Agreement, Voyager may be entitled to receive potential future payments of up to $ 6.13 6.1 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the future net sales of any collaboration product, subject to certain co-development and co-commercialization rights retained by Voyager.

4 unchanged paragraphs

Note 11: Segment Reporting and Disaggregation of Relevant Expense Captions 28 changes

4 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

INGREZZA net product sales $ 716.5 $ 624.4 $ 1,373.3 $ 1,169.6

CRENESSITY net product sales 183.5 53.2 336.8 67.7

Total revenues 959.0 687.5 1,773.5 1,260.1

INGREZZA net product sales $ 801.5 $ 686.6 $ 2,174.8 $ 1,856.2

CRENESSITY net product sales 210.8 98.1 547.6 165.8

VYKAT XR net product sales 54.3 106.7 — 54.3 161.0 —

Total revenues 1,122.7 794.9 2,896.2 2,055.0

Cost of revenues, excluding amortization of acquired intangible assets 23.2 10.3 36.9 18.5 26.6 13.0 63.5 31.5

1 unchanged paragraph

External research and development 168.5 120.6 316.5 228.5

Payroll and benefits 115.4 72.2 199.9 147.2

Milestones 0.3 15.1 22.9 60.5

External research and development 192.0 141.8 508.5 370.3

Payroll and benefits 106.6 74.6 306.5 221.8

Milestones 10.0 1.0 32.9 61.5

1 unchanged paragraph

Total research and development 326.7 244.3 622.9 507.5

Selling, general, and administrative 439.7 286.3 758.2 562.8

Amortization of acquired intangible assets 16.4 1.0 16.5 2.0

Total research and development 351.8 250.0 974.7 757.5

Acquired in-process research and development 1.5 — 22.7 0.1 11.7 0.3 34.4 0.4

Selling, general, and administrative 366.3 291.6 1,124.5 854.4

Amortization of acquired intangible assets 35.0 1.0 51.5 3.0

1 unchanged paragraph

Interest expense 2.9 — 2.9 —

Unrealized (gain) loss on equity investments

Interest expense 0.3 — 3.2 —

Unrealized loss (gain) on equity investments 52.3 ( 30.6 ) 25.8 6.7

2 unchanged paragraphs

(1) Other revenues primarily consist of royalties earned on AbbVie Inc. net sales of elagolix and Tanabe Pharma Corporation (formerly Mitsubishi Tanabe Pharma Corporation) net sales of valbenazine. Other revenues also included net product sales of Neurocrine Group Limited (formerly Diurnal Group plc) for periods prior to its sale on January 21, 2026.

1 unchanged paragraph

Legal proceedings 3 changes

In March 2025, we received a notice from Zydus Lifesciences Global FZE (Zydus FZE) that it had filed an abbreviated new drug application or (ANDA) with the FDA seeking approval of a generic version of INGREZZA SPRINKLE (valbenazine). The ANDA contained a Paragraph IV Patent Certification alleging that certain of our patents covering INGREZZA SPRINKLE are invalid and/or will not be infringed by Zydus FZE's importation, manufacture, use or sale of the medicine for which the ANDA was submitted. We filed suit in the U.S. District Court for the District of Delaware in April 2025 against Zydus Pharmaceuticals (USA) Inc. and its affiliates Zydus FZE, Zydus Worldwide DMCC (entity subsequently dismissed), Zydus Lifesciences Limited, and Zydus Healthcare (USA) LLC (entity subsequently dismissed) (collectively, Zydus). The complaint alleged that by filing their ANDAs, Zydus infringed certain of our patents covering INGREZZA SPRINKLE and sought to prevent Zydus from selling a generic version of INGREZZA SPRINKLE. We also filed suit in the U.S. District Court for the District of New Jersey in April 2025 against Zydus on a similar factual basis seeking to prevent Zydus from selling a generic version of INGREZZA SPRINKLE and this case was dismissed in favor of continued prosecution of the Delaware proceeding against the same entities.

In September 2026, we received a notice from Alvogen, Inc. (Alvogen) that it had filed an ANDA with the FDA seeking approval of a generic version of VYKAT XR (diazoxide choline). The ANDA contained a Paragraph IV Patent Certification alleging that certain of our patents covering VYKAT XR are invalid and/or will not be infringed by Alvogen's importation, manufacture, use or sale of the medicine for which the ANDA was submitted. We filed suit in the U.S. District Court for the District of Delaware in October 2026 against Alvogen. The complaint alleged that by filing their ANDA, Alvogen infringed certain of our patents covering VYKAT XR and seeks to prevent Alvogen from selling a generic version of VYKAT XR. The filing of the suit triggered a statutory 30 -month stay of FDA approval of Alvogen's ANDA in addition to the existing New Product and Orphan Drug Exclusivities which expire in March 2028 and March 2032, respectively.

On March 6, 2026, the City of Pontiac Police and Fire Retirement System, a purported stockholder of Soleno, filed a putative class-action complaint for violations of the Federal securities laws against Soleno and certain members of Soleno's management in the U.S. District Court for the Northern District of California. The plaintiff alleges claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and SEC Rule 10b-5 on behalf of a putative class of purchasers of Soleno's common stock during a purported class period of March 26, 2025 through November 4, 2025, inclusive. On June 25, 2026, the Court appointed a Lead Plaintiff. Lead Plaintiff's consolidated complaint is due On August 28, 2026, Lead Plaintiff filed an amended complaint which added additional causes of action for alleged violations of Sections 11, 12(a)(2), and 15 of the Securities Act of 1933, as amended. On October 30, 2026, Defendants filed a joint motion to dismiss. Lead Plaintiff's opposition to the motion to dismiss is due October 30, on December 18, 2026, and Defendants must file a reply by January 29, 2027. A hearing date on the motion to dismiss has not yet been scheduled.

3 unchanged paragraphs

MD&A 107 changes

The following Management's Discussion and Analysis of Financial Condition and Results of Operations section contains forward-looking statements, which involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in Part II, Item 1A under the caption "Risk Factors." The interim financial statements and this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2025 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, which are contained in our Annual Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Report on Form 10-Q for the three months ended March 31, June 30, 2026.

5 unchanged paragraphs

• Total net product sales for the first six nine months of 2026 increased $519.6 $848.7 million, or 41.7%, to $1.77 $2.9 billion, primarily reflecting increased net product sales of CRENESSITY, which was launched in the U.S. as a first-in-class FDA-approved treatment of CAH in December 2024, increased net product sales of INGREZZA, driven by volume growth in total prescriptions and record new prescriptions on strong patient demand, and the inclusion of VYKAT XR net product sales following the acquisition of Soleno in May 2026.

1 unchanged paragraph

• In May 2026, we entered into a $1.0 billion senior secured revolving credit facility (the 2026 Credit Facility). In June 2026, we repaid $600.0 million of principal that was borrowed under the 2026 Credit Facility in May 2026. As of June September 30, 2026, we had $1.0 billion of available borrowing capacity under the 2026 Credit Facility. We may use borrowings under the 2026 Credit Facility for general corporate purposes and other purposes permitted by the credit agreement. Our ability to borrow under the 2026 Credit Facility is subject to the satisfaction of customary conditions, including compliance with the covenants contained in the credit agreement.

1 unchanged paragraph

• Announced that Eiry W. Roberts, M.D., who previously served as Neurocrine's Chief Medical Officer (CMO) and most recently as a Strategic Advisor, has rejoined the Company's executive management team as CMO.

3 unchanged paragraphs

• Initiated Phase 2 clinical study evaluating the efficacy, safety, tolerability, and pharmacokinetics of NBI-1117567, an investigational M1/M4 (M1-preferring) selective muscarinic agonist being developed as an adjunctive therapy for cognitive impairment in Alzheimer's disease.

2 unchanged paragraphs

• Initiated a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIM-'1008, an investigational therapy being developed for rheumatoid arthritis and other immune-mediated diseases.

• Initiated a Phase 1 first-in-human clinical study evaluating the safety and tolerability of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist being developed as a therapy for obesity.

1 unchanged paragraph

• Announced publication of the KINECT-PRO™ Phase 4 open-label study results demonstrating that treatment with once-daily INGREZZA capsules resulted in substantial and sustained improvements in patient-reported quality of life and functionality, alongside improvements in clinician-rated TD movement severity. Improvements were observed regardless of underlying psychiatric diagnosis or baseline TD movement severity, including among participants with clinician-rated mild TD movements. The manuscript appears in CNS Spectrums.

4 unchanged paragraphs

• Presented research advancing the understanding of Prader-Willi syndrome and real-world experience with VYKAT XR at the Foundation for Prader-Willi Research Symposium & Family Conference.

4 unchanged paragraphs

Revenues $ 959.0 $ 687.5 $ 1,773.5 $ 1,260.1

Operating expenses 807.5 541.9 1,428.6 1,090.9

Operating income 151.5 145.6 344.9 169.2

Other income 10.7 13.9 64.1 5.0

Provision for income taxes 17.8 52.0 66.7 58.8

Results of Operations for the Three and Six Nine Months Ended June September 30, 2026 and 2025 (in millions, except per share data)

September 30, Nine Months Ended

(in millions, except per share data)

Revenues $ 1,122.7 $ 794.9 $ 2,896.2 $ 2,055.0

Operating expenses 791.4 555.9 2,220.0 1,646.8

Operating income 331.3 239.0 676.2 408.2

Other (expense) income (47.6) 52.8 16.5 57.8

Provision for income taxes 77.2 82.3 143.9 141.1

2 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

4 unchanged paragraphs

Collaboration revenues 4.7 5.5 8.2 14.4

Collaboration revenues 3.7 5.0 11.9 19.4

3 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Cost of revenues, excluding amortization of acquired intangible assets $ 23.2 26.6 $ 10.3 13.0 $ 36.9 63.5 $ 18.5 31.5 as a % of total revenues 2.4 % 1.6 % 2.1 2.2 % 1.5 %

Compared with the comparable periods last year, the increase primarily reflected increased total net product sales, increased royalties on net product sales of CRENESSITY, $3.0 million of and increased expense related to the amortization of the acquisition-date fair value fair-value step-up of VYKAT XR inventory acquired through the acquisition of Soleno in May 2026. and $2.0 million of acquisition related expenses, including $1.8 million of stock-based compensation expense related to Soleno equity awards for which vesting was accelerated in connection with The acquisition of Soleno in May 2026. The acquired fair value fair-value step-up is expected to be recognized in cost of revenues as the acquired inventory is sold over approximately four to six years following the acquisition date.

2 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Late stage $ 71.5 $ 38.8 $ 137.3 $ 74.1

Early stage 30.1 16.7 56.0 38.4

Research and discovery 66.9 65.1 123.2 116.0

Milestones 0.3 15.1 22.9 60.5

Payroll and benefits 115.4 72.2 199.9 147.2

Facilities and other 42.5 36.4 83.6 71.3

Total research and development $ 326.7 $ 244.3 $ 622.9 $ 507.5 as a % of total revenues 34.1 % 35.5 % 35.1 % 40.3 %

Late stage $ 82.5 $ 52.2 $ 219.8 $ 126.3

Early stage 37.8 16.1 93.8 54.5

Research and discovery 71.7 73.5 194.9 189.5

Milestones 10.0 1.0 32.9 61.5

Payroll and benefits 106.6 74.6 306.5 221.8

Facilities and other 43.2 32.6 126.8 103.9

Total research and development $ 351.8 $ 250.0 $ 974.7 $ 757.5 as a % of total revenues 31.3 % 31.5 % 33.7 % 36.9 %

1 unchanged paragraph

Compared with the comparable periods last year, the increase primarily reflected the progression of the Phase 3 programs for direclidine in schizophrenia and osavampator in major depressive disorder (MDD). and direclidine in schizophrenia.

1 unchanged paragraph

Compared with the comparable periods last year, the increase primarily reflected increased investments in the Phase 1 2 program for NBIP-01435 NBI-1065890 in CAH, TD, the Phase 2 1 program for NBI-1065890 NBIP-01435 in TD, CAH, and our early-stage obesity and immunology programs, partially offset by the progression of the Phase 2 program for NBI-1117567 in Alzheimer's cognition to late-stage in the second quarter of 2026 and decreased investments in certain early-stage psychiatry and neurology programs.

1 unchanged paragraph

Compared with the comparable periods last year, the increase change primarily reflected continued investments to expand our discovery and preclinical programs across therapeutic areas and modalities, including endocrinology and metabolic disease (including obesity) and immunology, and expanding our capabilities in biologics (including peptides and antibodies) and gene therapy.

1 unchanged paragraph

June 30, Six Months Ended

September 30, Nine Months Ended

5 unchanged paragraphs

Compared with the comparable periods last year, the increase primarily reflected higher headcount to support our expanded clinical pipeline and discovery and preclinical programs across therapeutic areas and modalities, including endocrinology and metabolic disease (including obesity) and immunology, expanding our capabilities in biologics (including peptides and antibodies) and gene therapy. In addition, the third quarter and $23.1 million first nine months of 2026 also reflected acquisition-related expenses including of $8.9 million and $32.0 million, respectively. Acquisition-related expenses for the first nine months of 2026 included $18.1 million of stock-based compensation expense related to Soleno equity awards for which vesting was accelerated in connection with the acquisition of Soleno in May 2026.

3 unchanged paragraphs

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Acquired in-process research and development $ 1.5 11.7 $ — 0.3 $ 22.7 34.4 $ 0.1 0.4 as a % of total revenues 0.2 1.0 % — % 1.3 1.2 % — %

Compared with the comparable periods last year, the increase reflected increased payments for upfront fees in connection with our collaborations and license agreements.

1 unchanged paragraph

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Selling, general, and administrative $ 439.7 $ 286.3 $ 758.2 $ 562.8 as a % of total revenues 45.8 % 41.6 % 42.8 % 44.7 %

Selling, general, and administrative $ 366.3 $ 291.6 $ 1,124.5 $ 854.4 as a % of total revenues 32.6 % 36.7 % 38.8 % 41.6 %

Compared with the comparable periods last year, the increase primarily reflected continued investment in our commercial organization supporting INGREZZA growth and the launch of CRENESSITY and VYKAT XR, including the recent expansion of our INGREZZA and CRENESSITY sales teams in the first quarter of 2026. In addition, the third quarter and $96.8 million first nine months of 2026 also reflected $9.7 million and $106.5 million, respectively, or acquisition-related expenses. including Acquisition-related expenses for the first nine months of 2026 included $40.2 million of stock-based compensation expense related to Soleno equity awards for which vesting was accelerated in connection with the acquisition of Soleno in May 2026.

1 unchanged paragraph

June 30, Six Months Ended

September 30, Nine Months Ended

1 unchanged paragraph

Amortization of acquired intangible assets $ 16.4 35.0 $ 1.0 $ 16.5 51.5 $ 2.0 3.0 as a % of total revenues 1.7 3.1 % 0.1 % 0.9 1.8 % 0.2 0.1 %

Compared with the comparable periods last year, the increase primarily reflected amortization of intangible assets acquired through the acquisition of Soleno in May 2026. The estimated fair value of the acquired intangible assets, which relates to developed product rights for VYKAT XR and is being amortized straight line over a useful life of 16 years, was $2.24 $2.2 billion as of the acquisition date.

1 unchanged paragraph

June 30, Six Months Ended

September 30, Nine Months Ended

2 unchanged paragraphs

Other Income (Expense)

June 30, Six Months Ended

Compared with The comparable periods last year, the change first nine months of 2026 reflected a pre-tax gain, net of transaction costs, recognized on the sale of Neurocrine Group Limited in January 2026.

Other (Expense) Income

September 30, Nine Months Ended

1 unchanged paragraph

Interest expense $ (2.9) $ — $ (2.9) $ —

Unrealized gain (loss) on equity investments

Investment income and other, net 12.4 20.6 40.5 42.3

Total other income, net $ 10.7 $ 13.9 $ 64.1 $ 5.0

Interest expense $ (0.3) $ — $ (3.2) $ —

Unrealized (loss) gain on equity investments (52.3) 30.6 (25.8) (6.7)

Investment income and other, net 5.0 22.2 45.5 64.5

Total other (expense) income, net $ (47.6) $ 52.8 $ 16.5 $ 57.8

2 unchanged paragraphs

2 unchanged paragraphs

3 unchanged paragraphs

1 unchanged paragraph

2 unchanged paragraphs

1 unchanged paragraph

1 unchanged paragraph

1 unchanged paragraph

16 unchanged paragraphs

1 unchanged paragraph

2 unchanged paragraphs

and 27 more changes in the filing

Controls and procedures 2 changes

3 unchanged paragraphs

An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of any changes to our internal control over financial reporting that occurred during the quarter ended June September 30, 2026, and that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

There were no significant changes in our internal controls over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the quarter ended June September 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Risk factors 23 changes

13 unchanged paragraphs

• We currently depend on a limited number of third-party suppliers. The loss of these suppliers, or delays or problems in the supply of our commercial products or our product candidates, could materially and adversely affect our ability to successfully develop or commercialize our commercial products or any of our product candidates.

6 unchanged paragraphs

• Our credit facility imposes operating and financial restrictions on us, and our failure to comply with its covenants or satisfy our obligations under the facility could adversely affect our business and financial condition.

7 unchanged paragraphs

In the second quarter of 2026, we acquired Soleno and its commercial product, VYKAT XR, which was approved by the FDA in March 2025 for the treatment of hyperphagia in adults and pediatric patients four years of age and older with PWS. The successful commercialization of VYKAT XR depends on the extent to which healthcare providers, patients and payors accept and adopt VYKAT XR, and we do not know whether our expectations or estimates in this regard, or those of investors or securities analysts, will be accurate. To generate demand for VYKAT XR, we will need to continue to educate healthcare providers on its clinical utility, benefits, risks, dosing and monitoring. Our ability to generate revenue from VYKAT XR will also depend on our ability to obtain and maintain coverage and adequate reimbursement from payors. PWS is a rare disease, and if our estimates of the prevalence of PWS, the number of patients who may benefit from treatment with VYKAT XR, the number of healthcare providers willing to prescribe VYKAT XR, or the number of patients willing to stay on treatment prove to be incorrect, the market opportunity for VYKAT XR may be smaller than we believe it is. VYKAT XR may also compete with therapeutic products in various stages of clinical development for the treatment of PWS, including hyperphagia, as well as drugs approved for other indications, such as appetite suppression. In addition, adverse events, safety concerns, product complaints or other safety-related reports regarding VYKAT XR, including serious adverse events reported after commercialization, could adversely affect market acceptance, result in regulatory scrutiny, require changes to the approved labeling for VYKAT XR, or cause patients or caregivers to discontinue use of VYKAT XR or healthcare providers to be reluctant to prescribe or continue prescribing VYKAT XR. If commercialization of VYKAT XR and future sales are less successful than anticipated by us or our investors or securities analysts, our stock price could decline and our business may be harmed.

In addition, adverse events, safety concerns, product complaints or other safety-related reports regarding VYKAT XR, including serious adverse events reported after commercialization, could adversely affect market acceptance, result in regulatory scrutiny, require changes to the approved labeling for VYKAT XR, or cause patients or caregivers to discontinue use of VYKAT XR or healthcare providers to be reluctant to prescribe or continue prescribing VYKAT XR. For example, in August 2026, certain PWS patient advocacy organizations issued a statement regarding serious adverse events reported through the FDA's Adverse Event Reporting System (AEMS) in patients taking VYKAT XR and encouraged increased awareness of risks and monitoring considerations when initiating treatment. Although the statement noted that the adverse event reports do not establish whether VYKAT XR caused the reported events, the statement and related publicity could adversely affect perceptions of the safety of VYKAT XR, influence treatment decisions or otherwise reduce demand for VYKAT XR. If commercialization of VYKAT XR and future sales are less successful than anticipated by us or our investors or securities analysts, our stock price could decline and our business may be harmed.

7 unchanged paragraphs

• public perception regarding these products;

• public perception regarding these products, including publicity regarding reported adverse events or other safety concerns;

2 unchanged paragraphs

Patient advocacy organizations and other patient communities are important across our commercial portfolio in supporting disease awareness and patient and caregiver education. These activities may be particularly significant for CRENESSITY and VYKAT XR given the rare disease nature of those indications, where education and awareness among relatively small patient and caregiver communities can affect patient identification and access to information about available treatments. Statements or communications by patient advocacy organization, clinicians or others concerning the safety, efficacy or appropriate use of our products may influence perceptions and treatment decisions within these communities, including where such statements or communications relate to adverse event reports for which a causal relationship to the applicable product has not been established.

33 unchanged paragraphs

Legislators, policymakers, and payors may continue to propose and implement cost-containing measures to keep healthcare costs down. For example, in April 2025, the President issued an executive order that, among other things, directed specified agency heads to develop a Center for Medicare and Medicaid Innovation (CMMI) model that enables the Medicare program to obtain better value for high-cost prescription drugs and biological products. In May 2025, the President issued another executive order directing the administration to take immediate steps to end global freeloading and take additional aggressive action should drug manufacturers fail to offer American consumers the Most-Favored Nation (MFN) price. In December 2025, the Centers for Medicare & Medicaid Services (CMS) issued proposed regulations that if finalized, would create CMMI demonstrations that would institute MFN-level models using international drug pricing in the information to establish benchmarks for calculating manufacturer rebates for certain drugs covered under Medicare Part D B and Part D. In September 2026, CMS finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a mandatory model for certain Medicare Part B markets. At present, given drugs that will use an international pricing benchmark in calculating manufacturer rebates and is scheduled to begin in January 2027. The demonstrations are proposed rules that may or may Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model for certain Medicare Part D drugs has not be been finalized. or implemented , There is remains uncertainty as to how these and other potential legal and regulatory changes may impact our business. However, if implemented, t hese policies could reduce or limit the prices we are able to charge for our products and product candidates that we may successfully develop and for which we may obtain regulatory approval or the level of reimbursement available for our products from governmental authorities or third-party payors. Further, in January 2026, the President released The Great Healthcare Plan, a proposal which calls on Congress to codify the administration's MFN drug-pricing agreements with manufacturers and potentially extend MFN pricing to additional manufacturers. In addition, the One Big Beautiful Bill Act (OBBBA) is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding and limiting provider taxes used to fund the program. The OBBBA also narrowed access to the Patient Protection and Affordable Care Act (ACA) marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits, which expired at the end of 2025. These changes, along with other provisions of the OBBBA, are anticipated to reduce the number of Americans with health insurance. Further, an increasing number of countries use prices for medicinal products established in other countries as "reference prices" to help determine the price of the product in their own territory. Consequently, a downward trend in prices of medicinal products in some countries could contribute to similar downward trends elsewhere, including in the U.S.

3 unchanged paragraphs

We also have assumed, and may become responsible for, liabilities and risks relating to Soleno that may not have been identified or fully quantified in due diligence, including product liability, regulatory, commercial, employment, contract, tax, intellectual property, securities and other claims or proceedings. For example, on March 6, 2026, a purported stockholder of Soleno filed a putative federal securities class action against Soleno and certain members of Soleno's management alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and SEC Rule 10b-5 on behalf of a putative class of purchasers of Soleno stock during a purported class period of March 26, 2025 through November 4, 2025, inclusive. inclusive.An amended complaint subsequently filed in this action also alleges violations of the Securities Act of 1933, as amended. Defense of or any adverse resolution of this action or any similar or related matters could result in substantial costs, damages, indemnification obligations, settlement payments or diversion of management's attention.

25 unchanged paragraphs

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. Geopolitical tensions could also affect our ability to obtain supplies of our investigational products, which could cause delays or otherwise disrupt our clinical trials and research and development efforts. Some of our suppliers and research and development collaborators and other third parties with whom we do business, including consultants and service providers, are located in China, exposing us to the possibility of supply, development or other operational disruption in the event of changes to the laws, rules, regulations, and policies of the governments of the U.S. or China. Any such changes to laws or the adoption of tariffs, export controls, investment, licensing or procurement restrictions or other restrictions could impact our ability to contract with or maintain relationships with certain Chinese biotechnology companies or other third parties, cause delays, or have other adverse effects on the development of certain of our research, programs. development or other business activities.

14 unchanged paragraphs

We are transforming our research and development strategies to include the development of biologics, including peptides, proteins, antibodies, conjugates, gene therapies and nucleic acid-based therapeutics. As a company, we do not have experience successfully developing and commercializing biologics and our current infrastructure may be inadequate to support the expected growth and transformation of processes, personnel, and technologies required for these new programs. We have hired employees with expertise in these modalities, but we will need to hire additional qualified personnel and expand our management, administrative, and technical staff to support the research and development organization. If we are unable to identify, recruit and integrate additional employees with the requisite skills, or effectively manage our transformation activities, the development of our biologic product candidates may not be successful, or be delayed or paused indefinitely. Gene therapies, in particular, may entail additional safety and development risks because they often require specialized administration (including intravenous administration) and may cause serious adverse events, including immune or inflammatory reactions, which could delay, suspend or terminate clinical development. Pre-existing immunity or immunity that develops after dosing may limit eligible patients and may prevent repeat dosing, which could reduce effectiveness and limit commercial adoption. Additionally, the manufacture of biologics and cognate their associated delivery devices are more complex than the manufacture of small molecule therapies. We currently have no manufacturing capabilities for biologic product candidates and or devices and rely on third-party manufacturers. We may encounter delays in production and delivery of our biologic product candidates and devices by our third-party manufacturers or other vendors, which would result in corresponding delays to our development and commercialization of such biologic candidates. In addition, the regulatory requirements in the U.S. and in other countries governing biologics are evolving and the FDA or comparable foreign regulatory authorities may change the requirements, or identify different regulatory pathways, for approval for any of our biologic candidates. As a result, we may be required to change our regulatory strategy or to modify our applications for regulatory approval, which could delay and impair our ability to complete the preclinical and clinical development and manufacture of, and obtain regulatory approval for, our biologic candidates. We have made, and expect to continue making, substantial investments in our research and development personnel and facilities, as well in external innovation to support our expansion into the development of our biologics. If any of these risks occur and we fail to successfully develop or commercialize our biologic product candidates, we may not realize a return on our investments which could have an adverse effect on our results of operations and financial condition.

3 unchanged paragraphs

As with most pharmaceutical products, use of our approved products or those of our collaborators could be associated with side effects or adverse events which can vary in severity (from minor adverse reactions to death) and frequency (infrequent or prevalent). Side effects or adverse events associated with the use of our products or those of our collaborators may be observed at any time, including after a product is commercialized, and reports of any such side effects or adverse events may negatively impact demand for our or our collaborators' products or affect our or our collaborators' ability to maintain regulatory approval for such products. With respect to VYKAT XR, since it became commercially available, serious adverse events in patients taking VYKAT XR have been reported to FDA through the FDA Adverse Event Reporting Monitoring System (AEMS), formerly the FDA Adverse Event Reporting System (FAERS). In its quarterly report published in September 2026 of newly identified safety signals, the FDA identified fluid retention as a potential safety signal for VYKAT XR and stated that it is evaluating the need for regulatory action. Although reports in AEMS and the FDA's identification of a potential safety signal do not establish that a drug caused an adverse event and such events may be attributable to the patient's underlying disease, other medications or other factors, these reports and the FDA's evaluation of the potential safety signal could negatively impact demand for VYKAT XR, result in additional regulatory scrutiny or cause patients or caregivers to discontinue use of VYKAT XR or healthcare providers to be reluctant to prescribe or continue prescribing VYKAT XR. Side effects or other safety issues associated with the use of our approved products or those of our collaborators could result in changes to product labeling or requirements to implement risk mitigation measures, require us or our collaborators to modify or halt commercialization of these products or expose us to product liability lawsuits which will harm our business. We or our collaborators may be required by regulatory agencies to conduct additional studies regarding the safety and efficacy of our products which we have not planned or anticipated. Furthermore, there can be no assurance that we or our collaborators will resolve any issues related to any product related adverse events to the satisfaction of the FDA or any regulatory agency in a timely manner or ever, which could harm our business, prospects and financial condition.

56 unchanged paragraphs

In May 2026, we entered into a five-year, $1.0 billion senior secured revolving credit facility. As of June September 30, 2026, no amounts were outstanding under the facility. Any future borrowings under the facility would bear interest at variable rates, which could increase our debt service costs if interest rates rise. Our obligations under the facility are secured by substantially all of our assets, subject to customary exceptions and exclusions, and our material domestic subsidiaries are required to guarantee our obligations and grant security interests in substantially all of their assets, subject to customary exceptions and exclusions. The credit agreement contains customary affirmative and negative covenants and quarterly financial covenants, including a maximum total net leverage ratio and a minimum consolidated interest coverage ratio.

50 unchanged paragraphs

The market prices for securities of biotechnology and pharmaceutical companies historically have been highly volatile, and the market for these securities has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. For example, the applicability of the Medicare drug price negotiation provisions in the IRA negatively affected investor sentiment and resulted in significant volatility. Furthermore, especially as we and our market capitalization have grown, the price of our common stock has been increasingly affected by quarterly and annual comparisons with the valuations and recommendations of the analysts who cover our business. If our results do not meet these analysts' forecasts, the expectations of our investors or the financial guidance we provide to investors in any period, which is based on assumptions that may be incorrect or that may change from quarter to quarter, the market price of our common stock could decline. Over the course of the last 12 months, the price of our common stock has ranged from approximately $122 per share to approximately $181 $186 per share.

27 unchanged paragraphs

In October 2024, our Board of Directors authorized a share repurchase program to repurchase up to $300 million of our common stock and we subsequently entered into an accelerated share repurchase (ASR) transaction to repurchase the entirety of this authorized amount. The purchase period for this ASR transaction ended in February 2025 and an aggregate of 2.3 million shares were delivered to us at an average repurchase price of $131.83 per share. Additionally, in February 2025, our Board of Directors authorized a share repurchase program under which we may repurchase up to $500 million of our common stock (of which $266.3 $174.2 million remained available for additional repurchases as of June September 30, 2026). This subsequent share repurchase authorization was in addition to the $300 million accelerated share repurchase program that was announced in October 2024 and completed in early February 2025. Our share repurchases may change from time to time, and we can provide no assurance that we will repurchase shares of our common stock at favorable prices, in particular amounts, or at all, and any repurchases may not enhance long-term stockholder value or prove to be the best use of our cash. If our Board of Directors authorizes any additional share repurchase programs, it could affect the trading price of our stock and increase volatility.

47 unchanged paragraphs

Any sales of our product once commercialized outside the U.S. will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. Additionally, because of our U.S. and international operations, we are also subject to anti-corruption laws and regulations, in the U.S. and internationally, including but not limited to the U.S. Foreign Corrupt Practices (FCPA), the U.K. Bribery Act 2010, and other applicable anti-bribery and corruption laws. Anti-corruption laws are interpreted broadly and prohibit corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity. It is illegal to pay, offer to pay or authorize the payment of anything of value to any foreign government official, government staff member, political party, or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. The FCPA also imposes accounting standards and requirements on publicly traded U.S. corporations and their foreign affiliates, which are intended to prevent the diversion of corporate funds to the payment of bribes and other improper payments. Recent years have seen substantial increase in the global enforcement of anti-corruption laws. Our operations outside the U.S. could increase the risk of such violations. Although we maintain compliance controls, policies and procedures designed to comply with applicable anti-corruption laws, there is a risk that acts by our employees, agents, consultants, collaborators or other third-party service providers may violate these laws and that we could be held responsible for such acts. Our business is also heavily regulated and involves significant interaction with foreign officials. In many countries outside the U.S., independent clinical investigators conducting our clinical trials and prescribers of our products are employed by government entities, and purchasers themselves can be government entities. As such, our interactions with such investigators, prescribers and purchasers may be subject to regulation under the FCPA, as well as other similar under anti-corruption laws and/or regulations enacted by other countries. Failure to comply with these laws, where applicable, can result in significant penalties, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal and equivalent foreign healthcare programs, and additional reporting requirements and regulatory oversight, any of which could adversely affect our ability to operate our business and our results of operations.

2 unchanged paragraphs

We source and procure APIs, precursor chemicals, and specialized equipment from international suppliers, with substantial reliance on foreign contract manufacturers in Europe. Tariff policies, particularly those affecting pharmaceutical products, could increase our costs and reduce our profitability. Additionally, recent policy discussions have included potential targeted tariffs or other trade measures specifically aimed at pharmaceutical products and ingredients as part of broader healthcare cost control or national security initiatives. In April 2025, The U.S. Department of Commerce initiated an investigation presidential administration has imposed tariffs on imports of pharmaceuticals and certain patented pharmaceutical products and associated ingredients, which may result in the current U.S. presidential administration taking actions subject to impose varying rates and exemptions. Although these tariffs on the pharmaceutical industry. The U.S. presidential administration also indicated that it may impose have not had a 100% tariff material impact on any branded our business, financial condition or patented pharmaceutical product, unless a company is building a pharmaceutical manufacturing plant in the U.S. The specific impact results of the investigation and announcements operations to enact substantial date, the imposition of new tariffs on patented pharmaceutical products remain uncertain at this time but or changes to existing tariff rates or exemptions could negatively impact affect our business and operations. Unlike consumer goods, pharmaceuticals face unique regulatory constraints that make rapid supply chain adjustments particularly difficult and costly. Should New or increased tariffs be imposed specifically targeting on pharmaceutical imports could cause our production costs could to rise, and it would be difficult and costly to qualify alternative sources within another country with a lower tariff rate or within the U.S., as developing and qualifying alternative sources typically requires substantial time, investment, and regulatory approvals.

1 unchanged paragraph

Current or future tariffs will may also result in increased research and development expenses, including with respect to increased costs associated with APIs, raw materials, laboratory equipment and research materials and components. Trade restrictions affecting the import of materials necessary for clinical trials could result in delays to our development timelines. Increased development costs and extended development timelines could place us at a competitive disadvantage compared to companies operating in regions with more favorable trade relationships and could reduce investor confidence and negatively impact our business, results of operations, financial condition and growth prospects.

7 unchanged paragraphs

Cyber-attacks, malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and availability of our sensitive information and information technology systems, and those of the third parties with whom we work. Such threats continue to rise, are increasingly difficult to detect, and come from a variety of sources, including traditional computer "hackers," threat actors, "hacktivists," organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors (also referred to as APTs). Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third parties with whom we work are vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, which could materially disrupt our systems and operations, as well as our ability to conduct clinical trials.

Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, we and the third parties with whom we work are vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, which could materially disrupt our systems and operations, as well as our ability to conduct clinical trials.

14 unchanged paragraphs

Our business could be adversely affected by conditions in the U.S. and global economies, the U.S. and global financial markets and adverse geopolitical and macroeconomic developments, including potential future disruptions in access to bank deposits due to bank failures, tariffs and trade barriers, government shutdowns and the resulting effects on regulatory agencies, geopolitical tensions, and military conflicts. General business and economic conditions that could affect our business, financial condition or results of operations include fluctuations in economic growth, inflation and interest rates, debt and equity capital markets, liquidity of the global financial markets, the availability and cost of credit, investor and consumer confidence, and the strength of the economies in which we, our manufacturers and suppliers, and our collaborators operate. A weak or declining global economy due to geopolitical tensions or tariffs and trade barriers could also strain our suppliers, and manufacturers and other third parties with whom we do business, possibly resulting in supply, development or other operational disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current geopolitical tensions, economic climate and financial market conditions could adversely impact our business.

20 unchanged paragraphs

Laws in Europe regarding privacy, data protection, information security and the processing of personal data have also been significantly reformed and continue to undergo reform. For example, the EU's General Data Protection Regulation (EU GDPR) and the UK's GDPR (UK GDPR) (collectively, GDPR) impose strict requirements for processing the personal data of individuals located, respectively, within the European Economic Area (EEA) and the UK, and the Swiss Federal Act on Data Protection similarly applies to the collection and processing of personal data, including health-related information, in

Laws in Europe regarding privacy, data protection, information security and the processing of personal data have also been significantly reformed and continue to undergo reform. For example, the EU's General Data Protection Regulation (EU GDPR) and the UK's GDPR (UK GDPR) (collectively, GDPR) impose strict requirements for processing the personal data of individuals located, respectively, within the European Economic Area (EEA) and the UK, and the Swiss Federal Act on Data Protection similarly applies to the collection and processing of personal data, including health-related information, in Switzerland. The GDPR provides for enhanced data protection obligations for processors and controllers of personal data, including, for example, obligations relating to: processing health and other sensitive data; obtaining consent of individuals; providing notice to individuals regarding data processing activities; responding to data subject requests; taking certain measures when engaging third-party processors; notifying data subjects and regulators of data breaches; and implementing safeguards to protect the security and confidentiality of personal data. The GDPR imposes substantial fines for breaches of data protection requirements. For example, under the GDPR, such fines can be up to four percent of global revenue or 20 million euros under the EU GDPR / 17.5 million pounds sterling under the UK GDPR, whichever is greater in either case, and also allow for private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as EU regulations governing clinical trial data and other healthcare data, could require us to change our business practices or lead to government enforcement actions, private litigation or significant penalties against us and could have a material adverse effect on our business, financial condition or results of operations.

7 unchanged paragraphs

Unregistered sales of stock 5 changes

1 unchanged paragraph

The following table presents information relating to purchases of our common stock during the second third quarter of 2026.

5 unchanged paragraphs

April 2026 76,015 $ 131.53 76,015 $ 266,310,935

July 2026 — $ — — $ 266,310,935

August 2026 145,799 $ 154.32 145,799 $ 243,811,773

September 2026 472,398 $ 147.27 472,398 $ 174,240,133

1 unchanged paragraph

Other information 15 changes

During the period from April July 1, 2026 to June September 30, 2026, our officers (as defined in Rule 16a-1(f) under the Exchange Act) and/or directors adopted or terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below:

2 unchanged paragraphs

Eric Benevich Adoption

Chief Commercial Officer

Matthew Abernethy Adoption

Chief Financial Officer

George Morrow Adoption

William Rastetter Adoption 9/3/2026 X

Julie Cooke Adoption 8/31/2026 X 15,686 3/31/2027

Chief Human Resource Officer

Richard Pops Adoption 8/27/2026 X 15,000 5/21/2027

Gary Lyons Adoption 8/18/2026 X 15,000 5/22/2027

David Boyer Adoption 8/11/2026 X 4,512 5/18/2028

Chief Corporate Affairs Officer

Sanjay Keswani Adoption 8/7/2026 X 11,200 1/30/2027

Chief Medical Officer (through Sep. 25, 2026)

3 unchanged paragraphs

Exhibits 9 changes

9 unchanged paragraphs

10.1 Description: Form of Tender and Support Agreement

Reference: Incorporated by reference to Exhibit 10.1 of the Company's Current Report on Form 8-K filed on April 6, 2026.

10.2* Description: Credit Agreement, dated May 14, 2026, among Neurocrine Biosciences, Inc., JPMorgan Chase Bank, N.A., as administrative agent, and the lenders party thereto.

Reference: Incorporated by reference to Exhibit 10.1 of the Company's Current Report on Form 8-K filed on May 18, 2026.

10.3+ Description: Neurocrine Biosciences, Inc. 2025 Equity Incentive Plan, as amended

Description: Neurocrine Biosciences, Inc. 2018 Employee Stock Purchase Plan, as amended and restated

Description: Amended and Restated Employment Agreement dated November 2, 2026 between the Company and Eiry W. Roberts, M.D.

16 unchanged paragraphs

Dated: July 30, 2026

Dated: November 2, 2026

4 unchanged paragraphs

Unchanged: Notes to the financial statements, Note 12: Sale of Neurocrine Group Limited, Forward-looking statements, Market risk

Compared by code from the two filings' text and XBRL. Not advice.

The reading, claim by claim

From the filing's financial data, not stated in its text

From this 10-Q's financial data (XBRL) for the quarter ended September 30, 2026

  • The 10-Q is available under accession number 0000914475-26-000054.
  • For the quarter ended September 30, 2026, NEUROCRINE BIOSCIENCES INC reported revenue of $1.1 billion.
  • The company recorded a net income of $206.5 million.
  • Operating margin was 29.5%, and net margin was 18.4%.
  • Revenue for the quarter was 41.2% higher than the same period a year earlier.

Similar companies

Companies of similar size in SIC 2836 and related industry codes: the same peer list as the financial tables.

Data on this page was fetched . The filing on SEC.gov is the record.