Financial Data and Key Metrics Changes - Neurocrine Biosciences reported net product sales of $682 million for Q2 2025, reflecting a 17% year-over-year growth [11] - The company refined its net sales guidance for INGREZZA to a range of $2.5 billion to $2.55 billion, accounting for anticipated double-digit volume gains [14] - The company has $1.8 billion in cash and a strong balance sheet to support its commercial and clinical development strategies [15] Business Line Data and Key Metrics Changes - INGREZZA sales reached $624 million in Q2 2025, with a record number of new patient starts, representing 15% sequential growth and 8% year-over-year growth [16] - KRONESTIV achieved net sales of $53 million in Q2 2025, growing from $15 million in Q1 2025, indicating strong early adoption [12][19] Market Data and Key Metrics Changes - The company has expanded Medicare formulary coverage for INGREZZA to approximately 70% of Medicare beneficiary lives in the TD market, improving patient access [17] - Over 75% of all dispensed prescriptions for KRONESTIV in Q2 were reimbursed, indicating strong market acceptance [19] Company Strategy and Development Direction - Neurocrine aims to solidify its position as a leading neurology-focused enterprise by investing in advancing and expanding its pipeline [10] - The company is focused on enhancing payer access and market share for INGREZZA through strategic investments [6][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of both INGREZZA and KRONESTIV, driven by strong market access initiatives [6][10] - The company anticipates continued revenue contribution from both products, enabling further investment in R&D and patient support [10] Other Important Information - The company has initiated multiple Phase III programs within a single calendar year, showcasing a robust clinical pipeline [9] - The recent ENDO conference highlighted the company's progress and the positive reception of its products among clinicians [7][20] Q&A Session Summary Question: Guidance adjustment and pricing dynamics - Management explained that the adjustment in guidance was primarily due to a change in pricing assumptions, moving from flat pricing expectations to a projected 5% price decline for the year [30][32] Question: KRONESTIV launch dynamics - Management noted that the adoption of KRONESTIV has been steady and consistent, with no significant bolus effect from prior clinical trials [36][40] Question: Prescribing concentration and treatment dynamics - Management indicated that the patient population for CAH is not highly concentrated, allowing for broader adoption across various prescribers [44][46] Question: Transition to formulary-driven reimbursement - Management stated that while some health plans may conduct formulary reviews, many will continue to reimburse KRONESTIV as a non-formulary product [94] Question: Reauthorization and patient authorization patterns - Management reported that patients typically receive authorization for six or twelve prescriptions, with a pattern emerging for reauthorization [108]

Financial Data and Key Metrics Changes - The company reported net product sales of $682 million for Q2 2025, representing a 17% year-over-year growth [9] - INGREZZA sales reached $624 million in Q2, showing a 15% sequential growth and an 8% year-over-year increase [14] - KRONESTIV sales grew from $15 million in Q1 2025 to $53 million in Q2 2025, reflecting strong early adoption [10] - The company has refined its net sales guidance for INGREZZA to a range of $2.5 billion to $2.55 billion, accounting for anticipated double-digit volume gains [12] Business Line Data and Key Metrics Changes - The INGREZZA franchise continues to show solid growth, with record new patient starts and total prescriptions [14] - KRONESTIV has been well received, with over 75% of all dispensed prescriptions reimbursed in Q2 [18] - The company has seen a significant increase in Medicare formulary coverage for INGREZZA, now covering approximately 70% of Medicare beneficiary lives in the TD market [15] Market Data and Key Metrics Changes - The company noted that less than half of the estimated 800,000 TD patients have been diagnosed, indicating a substantial market opportunity [16] - The adoption of KRONESTIV is widespread across both pediatric and adult patients, with a slight trend towards pediatric patients [19] Company Strategy and Development Direction - The company aims to solidify its position as a leading neurology-focused enterprise by investing in advancing and expanding its pipeline [9] - The strategic investments in market access and sales force expansion are expected to drive long-term growth for both INGREZZA and KRONESTIV [11][14] - The company is focused on diversifying its neuroscience pipeline, with multiple Phase III programs initiated within a single calendar year [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the INGREZZA franchise due to market access initiatives [5] - The company anticipates that the strong performance in the first half of the year will enable further investments in R&D and commercial strategies [9] - Management acknowledged the dynamic nature of the business and the need to adjust guidance based on pricing and volume expectations [30] Other Important Information - The company has a strong balance sheet with $1.8 billion in cash, positioning it well for continued growth [13] - The clinical pipeline includes multiple Phase III programs, with anticipated data readouts in 2027 and 2028 [22] Q&A Session Summary Question: How is the company triangulating the guidance adjustments? - The company adjusted the top end of guidance due to a change in pricing assumptions, moving from flat pricing expectations to a negative 5% price decline for the year [30] Question: Can you discuss the dynamics at clinics regarding KRONESTIV? - The company noted steady and consistent adoption of KRONESTIV, with no significant bolus effect from prior clinical trials [36][40] Question: What metrics can be shared regarding prescribing concentration for KRONESTIV? - The company estimates that around 15% of the total CAH patient population flows through a small number of accredited centers, indicating room for growth in community endocrinologists [44][46] Question: What is the reimbursement process for KRONESTIV? - The company reported a high rate of reimbursement for KRONESTIV, with over 75% of dispensed prescriptions reimbursed, and noted that many patients do not need to go on free goods programs [93] Question: How does the company view the implications of the IRA? - The company aims to maximize patient access to INGREZZA and is preparing for the new pricing environment that will come with the IRA [82][84]

Financial Performance - Total Neurocrine net product sales reached $682 million in Q2 2025, representing a 21% quarter-over-quarter (QoQ) growth and a 17% year-over-year (YoY) growth compared to Q1 2025 and Q2 2024, respectively [11] - INGREZZA net product sales were $624 million in Q2 2025, reflecting a 15% QoQ growth and an 8% YoY growth compared to Q1 2025 and Q2 2024, respectively [11] - CRENESSITY net product sales amounted to $53 million in Q2 2025, including 664 total new patient enrollment forms [11] - The company narrowed INGREZZA net sales guidance for 2025 to $2.50 - $2.55 billion, reflecting double-digit volume growth partially offset by a lower net price due to expanded access [7, 11] - Cash and investments totaled approximately $1.8 billion as of June 30, 2025 [7] Research and Development - The company initiated all Phase 3 registrational programs for osavampator (AMPA PAM) for MDD and NBI-'568 (Selective M4 Agonist) for schizophrenia [11] - A Phase 1 study was initiated for NBIP-'1435, a long-acting CRF-1 receptor antagonist, for the potential treatment of classic CAH [11] - Phase 2 studies are expected to be initiated for NBI-'568 in bipolar mania and NBI-'570 (Selective Dual M1 / M4 Agonist) for schizophrenia [11] - Top-line data is expected to be reported in Q4 2025 for the Phase 3 study of valbenazine for dyskinetic cerebral palsy and the Phase 2 study of NBI-'770 (NMDA NR2B NAM) for the treatment of MDD [11] Pipeline and Portfolio - The company has a pipeline of 12 programs, including the first biologic program NBIP-'1435 [8] - The company expects Phase 1 muscarinic agonist results for NBI-'567 (Selective M1 Agonist), NBI-'569 (Selective M4 Agonist), and NBI-'570 [11]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 NEUROCRINE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 6027 Edgewood Bend Court San Diego ...

Exhibit 99.1 Neurocrine Biosciences Reports Second Quarter 2025 Financial Results Achieved Total Net Product Sales of $682 Million Representing 17% Year-Over-Year Growth INGREZZA (valbenazine) Second-Quarter 2025 Net Product Sales of $624 Million and Narrows 2025 Net Product Sales Guidance to $2.5 - $2.55 Billion ® CRENESSITY (crinecerfont) Second-Quarter 2025 Net Product Sales of $53 Million with 664 Total New Patient Enrollment Start Forms ® SAN DIEGO, July 30, 2025 – Neurocrine Biosciences, Inc. (Nasdaq: ...

Achieved Total Net Product Sales of $682 Million Representing 17% Year-Over-Year Growth INGREZZA® (valbenazine) Second-Quarter 2025 Net Product Sales of $624 Million and Narrows 2025 Net Product Sales Guidance to $2.5 - $2.55 Billion CRENESSITY® (crinecerfont) Second-Quarter 2025 Net Product Sales of $53 Million with 664 Total New Patient Enrollment Start Forms SAN DIEGO, July 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the second quarter en ...

Investors with an interest in Medical - Drugs stocks have likely encountered both Catalyst Pharmaceutical (CPRX) and Neurocrine Biosciences (NBIX) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.There are plenty of strategies for discovering value stocks, but we have found that pairing a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system produces the best returns. The proven Zacks Rank puts an e ...

Core Insights - Neurocrine Biosciences, Inc. announced significant variability in glucocorticoid treatment regimens for patients with classic congenital adrenal hyperplasia (CAH), highlighting the complexity of managing the condition over a lifetime [1][2][4] Treatment Patterns and Findings - The CAHtalog registry analysis included data from 98 patients, revealing that 88.9% experienced at least one health state change, with 58.7% undergoing three or more changes during a median observation period of 8.6 years [3][5] - Most patients were exposed to supraphysiologic doses of glucocorticoids and/or elevated androstenedione levels at least once, indicating ongoing challenges in achieving long-term disease control [8][10] Implications for Future Treatment - The analysis emphasizes the need for advanced therapeutic options to manage CAH effectively, as current glucocorticoid treatments often require high doses that can lead to significant complications [6][12] - CRENESSITY (crinecerfont), a new treatment option, aims to reduce ACTH and adrenal androgens through a non-glucocorticoid mechanism, potentially allowing for more physiologic glucocorticoid dosing [14][15]

Core Insights - Neurocrine Biosciences presented new data from the Phase 3 CAHtalyst studies showing that CRENESSITY® (crinecerfont) leads to significant improvements in weight-related outcomes for patients with classic congenital adrenal hyperplasia (CAH) [1][2][5] Group 1: Study Overview - The Phase 3 CAHtalyst program is the largest interventional clinical trial for classic CAH, involving 285 patients (103 pediatric and 182 adult) [2][12] - The studies included a double-blind, placebo-controlled period followed by an open-label period where all patients received CRENESSITY [2][12] Group 2: Weight-Related Outcomes - Adult patients treated with CRENESSITY showed a mean BMI reduction of 0.8 kg/m² compared to a 0.4 kg/m² reduction in the placebo group at Month 12 [4][6] - 39% of adult patients on CRENESSITY achieved over a 5% weight reduction, compared to 14% in the placebo group [4][6] - Pediatric patients on CRENESSITY maintained reductions in BMI standard deviation scores (SDS) through Week 52, while those on placebo saw an increase [6][4] Group 3: Insulin Resistance Improvements - Significant reductions in insulin resistance were observed in both adult and pediatric patients treated with CRENESSITY compared to placebo [5][6] - The mean HOMA-IR score decreased more significantly in the CRENESSITY group than in the placebo group [6][7] Group 4: Safety Profile - CRENESSITY demonstrated a favorable safety profile, with common side effects being mild to moderate and not leading to discontinuation of the drug [8][20] - Common side effects in children included headache and stomach pain, while adults reported fatigue and headache [8][22] Group 5: Regulatory and Market Context - Data from the CAHtalyst studies supported the FDA approval of CRENESSITY in December 2024 [15] - CRENESSITY is positioned to evolve the standard of care for classic CAH by allowing for reduced glucocorticoid doses while maintaining or improving androgen control [2][16]

"Results from the pivotal CAHtalyst clinical trial program continue to reinforce the critical role of CRENESSITY in the management of classic congenital adrenal hyperplasia," said Sanjay Keswani, M.D., Chief Medical Officer, Neurocrine Biosciences. "These one-year data show the lasting ability of CRENESSITY to effectively manage the ACTH and adrenal steroid imbalances in adults while allowing for lower, more physiologic steroid dosing and improved clinical outcomes." The Phase 3 CAHtalyst Adult study was pa ...