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, 2022 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) Q3 2022 Earnings Conference Call November 1, 2022 8:00 AM ET Company Participants Todd Tushla - VP of IR Kevin Gorman - CEO Matt Abernethy - CFO Eric Benevich - Chief Commercial Officer Eiry Roberts - Chief Medical Officer Kyle Gano - Chief Business Development & Strategy Officer Conference Call Participants Tazeen Ahmad - Bank of America Paul Matteis - Stifel Phil Nadeau - Cowen & Company Neena Bitritto-Garg - Citi Anupam Rama - JPMorgan Brian Abrahams - RBC Capit ...

Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Todd Tushla - Vice President of Investor Relations Kevin Gorman - Chief Executive Officer Matt Abernethy - Chief Financial Officer Eiry Roberts - Chief Medical Officer Eric Benevich - Chief Commercial Officer Kyle Gano - Chief Business Development and Strategy Officer Conference Call Participants Phil Nadeau - Cowen & Company Leonid Timashev - RBC Capital Markets Paul Matteis - Stifel T ...

Financial Performance - INGREZZA net product sales for Q2 2022 reached $349.6 million, a 32% increase from $264.8 million in Q2 2021[92]. - Total net product sales for the first half of 2022 were $657.0 million, up 32% from $497.8 million in the same period last year[92]. - Collaboration revenues for Q2 2022 totaled $26.2 million, compared to $22.1 million in Q2 2021, driven by milestone revenue from MTPC's DYSVAL launch[93]. - For the three months ended June 30, 2022, the net loss was $16.9 million compared to a net income of $42.3 million for the same period in 2021, primarily due to a $70.0 million loss on extinguishment related to convertible senior notes repurchase[107]. Expenses and Losses - Total research and development expenses for the first half of 2022 were $238.1 million, significantly higher than $148.0 million in the same period last year[98]. - Sales, general and administrative expenses for Q2 2022 were $182.8 million, up from $143.2 million in Q2 2021, reflecting increased investment in commercial initiatives[104]. - The company recognized a $70.0 million loss on extinguishment related to the repurchase of $210.8 million of convertible senior notes in Q2 2022[105]. Cash Flow and Capital - Total cash, cash equivalents, and marketable securities decreased to $1,053.5 million as of June 30, 2022, down from $1,272.0 million as of December 31, 2021[109]. - Cash flows from operating activities for the six months ended June 30, 2022, were $97.6 million, a decrease from $190.5 million in the same period of 2021[110]. - Cash flows from financing activities included the repurchase of $210.8 million aggregate principal amount of convertible senior notes for $279.0 million in cash during the second quarter of 2022[113]. - The company anticipates significant future capital requirements, including potential payments of up to $10.8 billion upon achieving certain event-based milestones related to collaboration and license agreements[115]. Working Capital and Debt - Total working capital as of June 30, 2022, was $733.6 million, slightly up from $727.0 million as of December 31, 2021[109]. - Total debt outstanding decreased by $210.8 million to $170.4 million after the repurchase of approximately 55% of total debt in Q2 2022[89]. Legal Matters - The company filed multiple lawsuits against Teva Pharmaceuticals and its affiliates, as well as Zydus Pharmaceuticals and others, in the United States District Court for the District of Delaware, with trials scheduled for January 2, 2024[131][132][133]. - The lawsuits aim to prevent the sale of generic versions of INGREZZA, indicating the company's focus on protecting its intellectual property[132]. - The company believes that none of the ongoing legal claims will have a material adverse effect on its business or financial condition[134]. Research and Development - The FDA accepted the IND application for NBI-1117568 for schizophrenia, with a $30.0 million milestone expense anticipated in Q3 2022[89]. - The company suspended clinical trial activities in Russia and Ukraine due to the ongoing conflict, impacting certain development efforts[90]. Investments and Facilities - The company is investing in new campus facilities and scientific equipment, with a $7.6 million increase in capital expenditures compared to the previous year[112]. - The company has secured a lease agreement for a new four-building campus facility in San Diego, California, which will serve as its corporate headquarters upon completion[119]. Accounts Receivable - The company reported an increase in accounts receivable due to extended customer payment terms attributed to the expansion of its distribution network[111].

| --- | --- | --- | --- | --- | |---------------------------------------------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | Advancing | | | | | | Life-Changing Discoveries in Neuroscience | | | | | | Q1 2022 Corporate Presentation | | | | | | May 4, 2022 Nasdaq: NBIX | | | | | | | | | | | Safe Harbor Statement and Non-GAAP Financial Measures 2 In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncert ...

Financial Data and Key Metrics Changes - Neurocrine Biosciences reported strong Q1 performance with INGREZZA sales totaling $303 million, marking a significant achievement in a typically challenging quarter [11] - The company exited Q1 with a record number of new patients, reflecting an improving external environment and benefits from commercial initiatives [12] - The gross to net guidance for Q1 was around $5,300 per script, with an expectation of $5,400 per TRx for the full year, indicating a 2% headwind in Q1 [30] Business Line Data and Key Metrics Changes - The INGREZZA franchise experienced over 30% year-over-year growth in Q1, driven by improved healthcare professional access and effective execution by field teams [14] - The company expanded its sales force by 140 representatives, which is expected to benefit growth in the latter half of the year [14][15] - The management noted that while Q2 is expected to show sequential growth, the percentage increase may be lower than in previous years due to the strong performance in Q1 [12][15] Market Data and Key Metrics Changes - The company highlighted that approximately 85% of the estimated 600,000 people living with tardive dyskinesia (TD) remain undiagnosed or untreated, indicating a significant market opportunity [17] - The external environment has improved, but challenges remain, particularly in adapting to remote healthcare delivery [7] Company Strategy and Development Direction - Neurocrine is focused on expanding the INGREZZA franchise and advancing its clinical pipeline, including filing a supplemental NDA for INGREZZA in Huntington's disease [8][20] - The company is committed to increasing awareness and treatment of TD through significant commercial investments and an expanded sales force [17] - The management emphasized the importance of adapting to the evolving healthcare landscape, including the integration of telemedicine [56] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the trajectory of INGREZZA and the ability to treat more TD patients, despite the challenges posed by the conflict in Ukraine [110] - The company is looking forward to a wealth of data readouts in 2023, indicating a strong pipeline and growth potential [111] Other Important Information - The company received regulatory approval for valbenazine in Japan for the treatment of tardive dyskinesia, which is expected to support its launch plans [20] - The humanitarian crisis in Ukraine has impacted some clinical programs, but the company is implementing contingency plans to mitigate these effects [24][110] Q&A Session Summary Question: Can you provide context around compliance improvement this quarter? - Management noted a less significant decline in refill rates from Q4 to Q1, attributed to improved management of the reauthorization process and a better access environment [30] Question: Was there any impact from inventory during the quarter? - Management reported no significant swings in inventory and described the quarter as clean from that regard [32] Question: How is the split between psychiatrists and neurologists in terms of scripts? - Historically, the split has been about 80% psychiatry and 20% neurology, with efforts to better penetrate the neurology segment through an expanded sales team [35] Question: What are the plans for ONGENTYS given its commercial performance? - Management acknowledged lower-than-expected sales for ONGENTYS but emphasized positive feedback from prescribers and plans to continue focusing on neurologists [41][44] Question: What are the key drivers for new patient starts? - The company identified increased awareness, improved healthcare professional access, and direct-to-consumer campaigns as key drivers for new patient starts [71] Question: How does the company differentiate its M4 program from competitors? - The M4 program is a highly selective orthosteric agonist, with potential advantages over competitors, and the company is considering a range of other indications [107]

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, 2022 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 jurisdiction o ...

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, 2021 ☐ 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 Data and Key Metrics Changes - The 2022 net sales guidance for INGREZZA is projected to be between $1.25 billion and $1.35 billion, marking the first time the company has provided annual sales guidance [14][19] - The GAAP operating expense range for 2022 is estimated to be between $1.1 billion and $1.15 billion, with a significant increase in sales force expansion and direct-to-consumer advertising [19][20] Business Line Data and Key Metrics Changes - INGREZZA's Q4 performance showed a total prescription growth of 8% sequentially and 32% year-over-year, marking the third consecutive quarter of growth during the pandemic [23][27] - The company has expanded its sales force to over 350 members, focusing on psychiatry, neurology, and long-term care [29] Market Data and Key Metrics Changes - The total addressable market for tardive dyskinesia (TD) in the U.S. is estimated at 600,000 patients, with only about 25% currently diagnosed [108][110] - The use of antipsychotics continues to grow, leading to an increase in the TD patient population, with 70 million prescriptions written in the past year [115][116] Company Strategy and Development Direction - The company aims to accelerate growth through a combination of expanding its sales force and enhancing its commercial initiatives, including a direct-to-consumer advertising campaign [17][29] - The R&D pipeline includes 12 mid- to late-stage clinical programs, with plans to submit a supplemental new drug application for valbenazine for Huntington's disease in the second half of 2022 [34][35] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the external environment improving, which is expected to positively impact patient access and sales [28][69] - The company acknowledges the challenges posed by COVID-19 but believes that the reopening of clinics and increased patient visits will drive growth in the latter half of 2022 [9][16] Other Important Information - The company is focused on addressing the unmet medical needs in neurology and psychiatry, with a strong emphasis on innovative therapies [42][100] - The company plans to continue exploring business development opportunities to enhance its pipeline and market presence [99] Q&A Session Summary Question: Can you give us some sense of what would be proof of concept for essential tremor? - The proof-of-concept study includes several endpoints, with a primary focus on tremor amplitude measured by accelerometer, and a statistically significant difference is sought [48] Question: How does the demand growth for INGREZZA compare to pre-COVID levels? - Prior to the pandemic, the company experienced a growth trajectory of a couple of hundred million dollars per year, and a 20% midpoint growth in guidance aligns with that performance [51][52] Question: Is your guidance impacted by inventory stocking for INGREZZA? - The guidance reflects underlying demand for INGREZZA sales, and inventory fluctuations are expected to net out over the year [56][58] Question: What are the expectations for long-term care opportunities? - Long-term care represents a significant incremental opportunity, with several million people in facilities potentially treated with antipsychotics that cause TD [103][104] Question: How fast is the total addressable TD market growing? - The TD population is growing due to the increased use of antipsychotics, with estimates rising from around 500,000 to 600,000 patients over the past five years [116]

J.P. Morgan Healthcare Conference January 2022 Safe Harbor Statement 2 In addition to historical facts, this presentation contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: the benefits to be derived from our products and product candidates; the value our products and/or our product candidates may bring to patients; the continued success of INGREZZA; our financial and operating performance, including ...