Financial Data and Key Metrics Changes - INGREZZA net sales for Q3 2023 reached approximately $1.34 billion, reflecting a 29% year-over-year growth, with an updated guidance range of $1.82 billion to $1.84 billion for the full year [83][101] - Non-GAAP diluted earnings per share for the quarter were reported at $1.54, with over $1.5 billion in cash at the end of the quarter [83] Business Line Data and Key Metrics Changes - The diagnosis rate for tardive dyskinesia (TD) has increased from low single digits to around 35% of the prevalent population, indicating significant progress but still leaving about two-thirds of the estimated 600,000 TD patients undiagnosed [85][114] - The initial rollout of INGREZZA for Huntington's disease (HD) Chorea has shown encouraging early feedback, although it is still in the early stages of market introduction [86][104] Market Data and Key Metrics Changes - Approximately 20% of the eligible patient population for VMAT2 inhibitors are currently being treated, with half of the diagnosed patients not receiving any treatment [3][114] - The addressable population for Huntington's disease and Chorea is estimated at around 20,000 to 25,000, with only about 20% currently treated with a VMAT2 inhibitor [125] Company Strategy and Development Direction - The company is focusing on expanding its pipeline and investing in research and development, particularly in areas such as neuroscience, neuropsychiatry, and congenital adrenal hyperplasia (CAH) [2][24] - The upcoming Analyst Day on December 5th will focus on R&D strategy and the burden of disease in CAH, highlighting the potential of crinecerfont as a new standard of care [66][134] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued strong growth driven by the expanded sales team and ongoing marketing efforts for INGREZZA, particularly in the long-term care segment [93][136] - The company is optimistic about the potential of crinecerfont to change the treatment paradigm for congenital adrenal hyperplasia, with plans for NDA submission next year [130][134] Other Important Information - The company has developed a new INGREZZA sprinkles formulation to cater to patients who have difficulty swallowing capsules, which has been accepted as a new drug application by the FDA [133] - The company is committed to maintaining its leadership in movement disorders and tardive dyskinesia while exploring additional indications for INGREZZA [162][192] Q&A Session Summary Question: Can you discuss the dynamics of the long-term care facility effort and its contribution to revenue? - Management noted that the long-term care segment is growing nicely and is becoming a meaningful contributor to revenue, with the sales team effectively driving diagnosis and treatment [9][185] Question: What are the expectations for the upcoming R&D Day? - The R&D Day will focus on the company's strategy and vision, with no new data expected to be unveiled during the event [66][67] Question: How is the company planning to address the market opportunity for Huntington's disease? - The company is targeting neurology specialists and centers of excellence for Huntington's disease to drive treatment rates, with a focus on both newly diagnosed and previously untreated patients [148][178]

Open-Label Treatment (one year) OpenLabel Extension* Participants randomized to placebo will receive crinecerfont during open-label treatment Objective Evaluate the efficacy, safety and tolerability of crinecerfont in adults with classic CAH Crinecerfont is investigational and not approved in any country *The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per participant for the open-label extension CAHtalystTM Adult and Pediatric S ...

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 September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0-22705 NEUROCRINE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdicti ...

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q2 2023 Earnings Conference Call August 1, 2023 8:00 AM ET Company Participants Todd Tushla - VP, IR Kevin Gorman - CEO Matt Abernethy - CFO Eiry Roberts - Chief Medical Officer Eric Benevich - Chief Commercial Officer Kyle Gano - Chief Business Development & Strategy Officer Conference Call Participants Paul Matteis - Stifel Tazeen Ahmad - Bank of America Anupam Rama - JPMorgan Phil Nadeau - TD Cowen Jay Olson - Oppenheimer Leon Wang - Barclays Marc Goodman - Leer ...

[Part I. Financial Information](index=3&type=section&id=Part%20I.%2E%20Financial%20Information) The company's financial statements for the period ended June 30, 2023, show increased assets and net income, driven by higher product sales despite a significant R&D expense [Item 1. Financial Statements](index=3&type=section&id=Item%201%2E%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2023, show a significant increase in total assets to $2.61 billion from $2.37 billion at year-end 2022, with net income of $18.9 million, a turnaround from a net loss of $3.0 million in the same period of 2022, driven primarily by higher product sales, despite a significant one-time expense for acquired in-process research and development [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets increased to $2.61 billion, driven by growth in debt securities, accounts receivable, and equity investments, while total liabilities rose to $760.1 million and total stockholders' equity grew to $1.85 billion from $1.71 billion at the end of 2022 Condensed Consolidated Balance Sheet Highlights (in millions) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $160.2 | $262.9 | | Total current assets | $1,496.6 | $1,453.5 | | Total assets | $2,613.1 | $2,368.7 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $582.5 | $537.7 | | Total liabilities | $760.1 | $660.9 | | Total stockholders' equity | $1,853.0 | $1,707.8 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) For the second quarter of 2023, the company reported net income of $95.5 million, a significant improvement from a net loss of $16.9 million in Q2 2022, with the six-month period showing net income of $18.9 million compared to a net loss of $3.0 million year-over-year, primarily fueled by a 27% increase in net product sales for the quarter, though the six-month result was impacted by a $143.9 million charge for acquired in-process R&D Three Months Ended June 30, (in millions, except per share data) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net product sales | $446.3 | $352.0 | | Total revenues | $452.7 | $378.2 | | Total operating expenses | $379.1 | $323.5 | | Operating income | $73.6 | $54.7 | | Net income (loss) | $95.5 | $(16.9) | | Diluted EPS | $0.95 | $(0.18) | Six Months Ended June 30, (in millions, except per share data) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | Net product sales | $861.6 | $657.0 | | Total revenues | $873.1 | $688.8 | | Acquired in-process R&D | $143.9 | $0.0 | | Total operating expenses | $913.7 | $631.0 | | Operating income (loss) | $(40.6) | $57.8 | | Net income (loss) | $18.9 | $(3.0) | | Diluted EPS | $0.19 | $(0.03) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash from operating activities was $54.4 million, a decrease from $97.6 million in the prior-year period, with cash used in investing activities at $168.0 million, primarily for purchases of debt and equity securities, and cash from financing activities at $11.1 million, a significant shift from a $270.3 million use of cash in 2022 which included a large repurchase of convertible senior notes Six Months Ended June 30, (in millions) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash from operating activities | $54.4 | $97.6 | | Net cash from investing activities | $(168.0) | $(0.2) | | Net cash from financing activities | $11.1 | $(270.3) | | **Change in cash, cash equivalents and restricted cash** | **$(102.5)** | **$(172.9)** | [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, extensive collaboration and license agreements, debt and equity instruments, and other financial details, with a key event in Q1 2023 being the expanded collaboration with Voyager Therapeutics, involving a $175.0 million upfront payment, of which $143.9 million was expensed as acquired in-process R&D, and the company also provided notice to terminate its license agreement for ONGENTYS with BIAL, effective December 2023 - In Q1 2023, the company entered into a new collaboration with Voyager Therapeutics, paying **$175.0 million** upfront, which included a stock purchase and resulted in a **$143.9 million** charge for acquired in-process R&D[44](index=44&type=chunk) - The company has potential future milestone payment obligations of up to **$2.6 billion** to Heptares, **$1.9 billion** to Takeda, **$1.7 billion** to Idorsia, **$1.7 billion** to Xenon, **$1.3 billion** from the 2019 Voyager agreement, and **$6.1 billion** from the 2023 Voyager agreement[22](index=22&type=chunk)[27](index=27&type=chunk)[31](index=31&type=chunk) - The company provided BIAL with a written notice of termination for the license agreement to commercialize ONGENTYS in the United States and Canada, with the termination expected to be effective in December 2023[47](index=47&type=chunk) - As of June 30, 2023, **$170.4 million** in aggregate principal amount of the 2.25% convertible senior notes due 2024 remained outstanding[78](index=78&type=chunk)[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the strong financial performance in the first half of 2023 to the continued growth of INGREZZA net product sales, which increased 30% year-over-year, despite operating expenses rising due to a $143.9 million IPR&D charge from the Voyager partnership and increased investment in commercial initiatives and clinical programs, with the company's liquidity remaining strong, holding over $1.3 billion in cash, cash equivalents, and marketable securities, believed to be sufficient to fund operations for at least the next 12 months [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Total revenues for the six months ended June 30, 2023, increased to $873.1 million from $688.8 million in the prior year, driven by a 30% rise in INGREZZA sales, offset by a significant increase in operating expenses, primarily a $143.9 million IPR&D expense related to the Voyager agreement, with SG&A expenses also growing due to continued investment in commercial initiatives for INGREZZA, and other income increasing significantly, reflecting unrealized gains on the Voyager equity investment and higher interest income Net Product Sales (in millions) | Product | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | INGREZZA | $850.1 | $652.2 | | Other | $11.5 | $4.8 | | **Total** | **$861.6** | **$657.0** | - The increase in total net product sales was primarily driven by higher INGREZZA prescriptions due to increased customer demand and commercial activities[92](index=92&type=chunk) - A **$143.9 million** IPR&D expense was recognized in Q1 2023 in connection with the upfront fee for the expanded strategic partnership with Voyager[102](index=102&type=chunk) - SG&A expenses increased for the six months of 2023, reflecting continued investment in commercial initiatives, including the branded direct-to-consumer INGREZZA advertising campaign and an expanded salesforce[103](index=103&type=chunk) - The change in other income for the first six months of 2023 was primarily due to an increase in the fair value of the equity investment in Voyager and increased interest income[104](index=104&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2023, the company held $1.32 billion in total cash, cash equivalents, and marketable securities, with working capital at $914.1 million, and management believes existing capital resources are sufficient to fund requirements for at least the next 12 months, with material future cash requirements including potential collaboration milestone payments up to $16.9 billion, lease payments for a new corporate headquarters, and repayment of the remaining $170.4 million of convertible senior notes due in 2024 Financial Condition (in millions) | Metric | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Total cash, cash equivalents and marketable securities | $1,319.3 | $1,288.7 | | Total working capital | $914.1 | $915.8 | - Cash flows from operating activities decreased in the first six months of 2023 compared to 2022, primarily due to higher upfront payments for the Voyager partnership, partially offset by increased INGREZZA sales[110](index=110&type=chunk) - The company has potential future milestone payments of up to **$16.9 billion** related to its various collaboration and license agreements[114](index=114&type=chunk) - The company has entered into a lease for a new four-building campus facility in San Diego which will serve as its new corporate headquarters[116](index=116&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to interest rate risk through its investment portfolio of low-risk, investment-grade debt securities, with the primary objective to preserve principal and maintain liquidity, and management states that a 1% unfavorable change in interest rates as of June 30, 2023, would not have had a material effect on the fair value of its investment portfolio - The company's investment portfolio consists of low-risk, investment-grade debt securities with maturities up to three years, which are subject to interest rate risk[123](index=123&type=chunk) - A hypothetical **1%** unfavorable change in interest rates on June 30, 2023, would not have materially affected the fair value of the investment portfolio[123](index=123&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=Item%204%2E%20Controls%20and%20Procedures) Based on an evaluation as of June 30, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level, with no significant changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, these controls - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of the end of the quarter[129](index=129&type=chunk) - No significant changes in internal control over financial reporting were identified during the quarter ended June 30, 2023[130](index=130&type=chunk) [Part II. Other Information](index=25&type=section&id=Part%20II%2E%20Other%20Information) This section details ongoing legal disputes, key operational and financial risks, and other corporate disclosures [Item 1. Legal Proceedings](index=25&type=section&id=Item%201%2E%20Legal%20Proceedings) The company is involved in patent litigation against several pharmaceutical companies, including Teva, Lupin, Sandoz, and Zydus, that have filed Abbreviated New Drug Applications (ANDAs) seeking to market generic versions of INGREZZA, with the lawsuits alleging that the patents covering INGREZZA are invalid or will not be infringed, and the consolidated cases in the District of Delaware are scheduled for trial on January 2, 2024 - The company has filed lawsuits against multiple generic drug manufacturers (Teva, Lupin, Crystal, Sandoz, Zydus) that submitted ANDAs for generic versions of INGREZZA[132](index=132&type=chunk)[133](index=133&type=chunk) - The legal proceedings allege that the ANDA filers' Paragraph IV certifications, which claim certain INGREZZA patents are invalid or not infringed, are incorrect[132](index=132&type=chunk) - The consolidated cases are being heard in the U.S. District Court for the District of Delaware, with a trial currently scheduled for January 2, 2024[133](index=133&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A%2E%20Risk%20Factors) The company faces significant risks, including its ability to successfully commercialize INGREZZA, potential pricing pressures from government and third-party payors, and intense competition, with other key risks involving the uncertainty of clinical trial outcomes, dependence on collaborators like AbbVie, reliance on third-party manufacturing, and the ability to protect its intellectual property, particularly in light of ongoing generic challenges, and the potential impact of healthcare reform, such as the Inflation Reduction Act, and cybersecurity threats also highlighted as major concerns - The company's success is highly dependent on the continued successful commercialization of INGREZZA and securing adequate third-party reimbursement[138](index=138&type=chunk) - The Inflation Reduction Act of 2022 (IRA) introduces government price negotiation for certain Medicare drugs, which could significantly impact the pharmaceutical industry, though the company believes it will qualify for a small biotech exception until 2029[211](index=211&type=chunk)[212](index=212&type=chunk) - The company faces intense competition for INGREZZA from Teva's AUSTEDO and off-label use of other medications[150](index=150&type=chunk) - The company is dependent on a limited number of specialty pharmacy providers and distributors, with four customers representing approximately **91%** of total product revenue for the first six months of 2023[196](index=196&type=chunk) - The conflict between Russia and Ukraine has impacted planned clinical trial sites, causing significant delays and increased costs for the development of valbenazine and luvadaxistat[158](index=158&type=chunk) [Item 5. Other Information](index=51&type=section&id=Item%205%2E%20Other%20Information) During the second quarter of 2023, two company executives, David W. Boyer (Chief Corporate Affairs Officer) and William H. Rastetter (Chair of the Board), adopted Rule 10b5-1 trading plans for the sale of company securities - David W. Boyer, Chief Corporate Affairs Officer, adopted a Rule 10b5-1 plan on May 31, 2023, to sell **11,590** shares[251](index=251&type=chunk) - William H. Rastetter, Chair of the Board, adopted a Rule 10b5-1 plan on May 31, 2023, to sell shares related to the exercise of a stock option[250](index=250&type=chunk)[251](index=251&type=chunk) [Item 6. Exhibits](index=52&type=section&id=Item%206%2E%20Exhibits) This section lists the exhibits filed as part of the quarterly report, including the company's Certificate of Incorporation, Bylaws, debt indentures, equity incentive plan, and required CEO/CFO certifications

Financial Data and Key Metrics Changes - The company reported Q1 2023 sales of INGREZZA at $410 million, achieving a 36% year-over-year growth with a record number of new patient starts [12][30][10] - The company maintained its SG&A and R&D expense guidance, with an expected step down in SG&A spending for the remainder of the year [31] Business Line Data and Key Metrics Changes - INGREZZA's performance was strong, with record sales and new patient starts, indicating strong adherence and persistence among patients [7][12][30] - The company announced the return of commercialization rights for ONGENTYS to BIAL due to significant commercial challenges in the Parkinson's adjunctive therapeutic category [8][29] Market Data and Key Metrics Changes - Approximately one-third of patients have been diagnosed with tardive dyskinesia (TD), but only about half of those diagnosed are offered treatment with VMAT2 inhibitors [33] - The company is seeing growth across all segments, including psychiatry, neurology, and long-term care (LTC), following the expansion of its sales force [72] Company Strategy and Development Direction - The company is focused on executing its clinical portfolio, with several Phase 2 and Phase 3 readouts expected later in the year, including the PDUFA date for valbenazine for Huntington's disease [9][15] - The company is transitioning towards biologics and large molecules, while maintaining a strong focus on orally active small molecules for psychiatric conditions [53][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth momentum entering Q2, reiterating guidance for 2023 despite potential headwinds from customer order timing [10][12] - The management highlighted the importance of educational efforts to improve diagnosis and treatment rates for TD and plans to apply similar strategies for Crinecerfont in congenital adrenal hyperplasia (CAH) [13][104] Other Important Information - The company is on track for multiple data readouts in Q4 2023, including studies for Crinecerfont and muscarinic agonists [35][128] - The company is preparing for the potential introduction of valbenazine for Huntington's disease chorea, addressing a significant unmet need in the market [88] Q&A Session Summary Question: How do you see the growth of INGREZZA progressing in upcoming quarters? - Management indicated strong fundamentals and momentum entering Q2, with a focus on patient diagnosis and treatment [7][10] Question: Can you comment on the inventory build for INGREZZA? - The inventory build was around $10 million, attributed to timing of customer orders at the end of the quarter [38][48] Question: What is the current split of prescriptions coming from neurologists versus psychiatrists? - The current estimate is an 80-20 split, with slight variations from quarter to quarter [42] Question: What are the expectations for the Crinecerfont studies? - The company is focused on demonstrating a broad range of robust data to support the benefit-risk profile of Crinecerfont [104][119] Question: How is the company addressing the potential for functional unwinding in CAH patients? - The company believes there is significant unmet need and plans to support education and data dissemination to address patient concerns [104][105]

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 March 31, 2023 or 12780 El Camino Real San Diego, CA (Address of principal executive office) 33-0525145 (IRS Employer Identification No.) 92130 (Zip Code) (858) 617-7600 (Registrant's telephone number, including area code) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHA ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________to__________ Commission file number 0-22705 NEUROCRINE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware 33-0525145 (State or other jur ...

Financial Performance & Guidance - 2022 INGREZZA net product sales reached $1.428 billion[18] - The company anticipates 2023 INGREZZA net product sales to be in the range of $1.67 billion to $1.77 billion (Tardive Dyskinesia Only)[2, 167] - Non-GAAP net income for 2022 was $343 million, with diluted earnings per share at $3.47, representing an 83% year-over-year growth[15] - Cash and investments as of December 31, 2022, totaled approximately $1.3 billion[2] Research & Development - Non-GAAP R&D expense for 2022 was $406 million, driven by an expanded portfolio[15] - The company expects GAAP R&D expenses for 2023 to be between $550 million and $580 million[18] - The company has 12 programs currently in mid-to-late-stage studies[2] Key Milestones & Activities - Potential sNDA approval of Valbenazine for the treatment of Chorea Associated with Huntington Disease, with a PDUFA date of August 20[8] - Anticipate several mid-to-late-stage data readouts in the second half of 2023, including registrational data for Crinecerfont in Congenital Adrenal Hyperplasia (CAH) in adults and pediatrics[8] - Initiated Phase 2 study of NBI-1117568, a selective M4 agonist, for the treatment of Schizophrenia in Q3[8] Market Opportunity - Approximately 600,000 people in the U S are affected by Tardive Dyskinesia (TD), with 70% remaining undiagnosed[2, 65, 66]

Financial Data and Key Metrics Changes - Neurocrine reported INGREZZA sales growth of over $350 million in 2022, with expectations for 2023 sales between $1.67 billion to $1.77 billion, reflecting approximately 20% year-over-year growth at the midpoint [11][12][16] - The company ended 2022 with over $1.2 billion in cash and used $280 million to retire a significant portion of its convertible debt [12] - SG&A and R&D expenses are projected to exceed $1.4 billion in 2023, with an anticipated SG&A leverage of around 300 basis points [12][13] Business Line Data and Key Metrics Changes - INGREZZA's performance in 2022 showed year-over-year growth exceeding 30% for four consecutive quarters, indicating strong execution by commercial and medical affairs teams [15] - The majority of growth in 2023 is expected to come from the psychiatry and neurology business segments, which are more developed compared to other segments [16] Market Data and Key Metrics Changes - Approximately 600,000 people in the U.S. are living with tardive dyskinesia (TD), with seven out of ten remaining undiagnosed [15][82] - The long-term care (LTC) segment is a new area for INGREZZA, with an estimated 10% to 15% of TD patients in LTC settings, but tangible sales impact is expected to take a few more quarters [18][63] Company Strategy and Development Direction - The company plans to continue expanding its sales force and direct-to-consumer advertising to increase awareness and treatment of TD [7][8] - Neurocrine has a diversified pipeline with multiple mid and late-stage clinical programs, including treatments for Huntington's disease and congenital adrenal hyperplasia [9][20][21] - The company is focused on advancing its research and development efforts to ensure a consistent flow of new products [9][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2023, driven by an underdeveloped TD market and ongoing marketing initiatives [12][19] - The company is preparing for the potential launch of valbenazine for Huntington's disease, with a PDUFA date set for August 2023 [20] - Management acknowledged the challenges in the LTC segment but remains confident in the potential for growth as education and awareness improve [63] Other Important Information - The company is investing in a range of modalities, including small molecules and gene therapy, to provide treatments for serious diseases in neuroscience [25] - Neurocrine is actively working with partners to navigate legislative changes affecting Medicare price negotiations, which could impact long-term strategies [73] Q&A Session Summary Question: Guidance assumptions for 2023 - Management expects over $300 million in year-over-year growth for INGREZZA, with the top end of guidance reflecting acceleration in new patients [28] Question: Net price per script for INGREZZA - The net revenue per script in Q4 was in the $5,400 range, with expectations for a net price increase of 3% to 4% in 2023 [36] Question: Impact of COVID-19 telemedicine mandates - Telemedicine mandates will last for two years post-emergency health order expiration, with no expected changes in 2023 [41] Question: Market opportunity in congenital adrenal hyperplasia (CAH) - There are approximately 20,000 to 30,000 people in the U.S. with CAH, and the company sees significant potential for its investigational treatment crinecerfont [47] Question: Differentiation of valbenazine in Huntington's disease - Valbenazine is expected to have a differentiated profile due to its simpler dosing regimen and lack of food effect compared to competitors [77][78] Question: Long-term care segment operational hurdles - The LTC segment presents unique challenges, requiring close collaboration with care centers to educate staff on TD [63] Question: Insights on tardive dyskinesia treatment duration - Compliance with INGREZZA has been better than expected, with ongoing efforts to improve diagnosis and treatment rates among TD patients [82]