On October 31, 2023 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the third quarter ended September 30, 2023, raised 2023 net sales guidance for INGREZZA, and announced an Analyst Day to be held in New York City on December 5th (Press release, Neurocrine Biosciences, OCT 31, 2023, View Source [SID1234636546]).
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"With INGREZZA sales continuing to grow, an expanded indication to treat chorea associated with Huntington’s disease, and positive Phase 3 results in congenital adrenal hyperplasia, Neurocrine remains well positioned to build a leading neuroscience-focused company," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We look forward to sharing more insight into our R&D portfolio and strategy at our December Analyst Day."
Three Months Ended
September 30,
Nine Months Ended
September 30,
(unaudited, in millions, except per share data)
2023
2022
2023
2022
Revenues:
Net Product Sales
$ 491.8
$ 379.3
$ 1,353.4
$ 1,036.3
Collaboration Revenue
7.0
8.6
18.5
40.4
Total Revenues
$ 498.8
$ 387.9
$ 1,371.9
$ 1,076.7
GAAP Research and Development (R&D)
$ 142.2
$ 107.7
$ 427.5
$ 345.8
Non-GAAP R&D
$ 125.0
$ 92.8
$ 372.7
$ 302.2
GAAP Selling, General and Administrative (SG&A)
$ 204.2
$ 186.3
$ 668.7
$ 569.8
Non-GAAP SG&A
$ 169.7
$ 158.1
$ 563.4
$ 483.8
GAAP Net Income
$ 83.1
$ 68.5
$ 102.0
$ 65.5
GAAP Earnings Per Share – Diluted
$ 0.82
$ 0.69
$ 1.01
$ 0.67
Non-GAAP Net Income
$ 156.1
$ 106.7
$ 232.3
$ 218.5
Non-GAAP Earnings Per Share – Diluted
$ 1.54
$ 1.08
$ 2.31
$ 2.22
(unaudited, in millions)
September 30,
2023
December 31,
2022
Total Cash, Cash Equivalents and Marketable Securities
$ 1,549.8
$ 1,288.7
Third Quarter INGREZZA Net Product Sales Highlights:
INGREZZA third quarter 2023 net product sales were $486 million and grew 29% vs. the third quarter 2022 driven by prescription demand
Continued high level of new patient scripts generated in the third quarter of 2023
Third Quarter Financial Highlights:
Third quarter 2023 GAAP net income and earnings per share of $83 million and $0.82, respectively, compared with $69 million and $0.69, respectively, for third quarter 2022
Third quarter 2023 non-GAAP net income and earnings per share of $156 million and $1.54, respectively, compared with $107 million and $1.08, respectively, for third quarter 2022
Differences in third quarter 2023 GAAP and non-GAAP operating expenses compared with third quarter 2022 driven by:
Increased R&D expense in support of an expanded and advancing clinical portfolio including preclinical investments in VMAT2, crinecerfont, and our muscarinic compounds
Increased SG&A expense primarily due to ongoing commercial initiatives supporting INGREZZA growth including the expanded indication to treat chorea associated with Huntington’s disease
At September 30, 2023, the Company had cash, cash equivalents and marketable securities of approximately $1.5 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.
Recent Events:
In August 2023, the FDA approved INGREZZA for the treatment of adults with chorea associated with Huntington’s disease.
In September 2023, the Company announced the FDA accepted its New Drug Application (NDA) for INGREZZA oral granules, a new sprinkle formulation of INGREZZA capsules for oral administration. The agency set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
In September 2023, the Company announced positive top-line data from the Phase 3 CAHtalyst clinical study of crinecerfont in adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD). The study met its primary as well as important key secondary endpoints.
In October 2023, the Company announced positive top-line data from the Phase 3 CAHtalyst clinical study of crinecerfont in pediatrics with CAH due to 21-hydroxylase deficiency (21-OHD). The study met both its primary and key secondary endpoint.
Updated 2023 INGREZZA Sales Guidance and Operating Expense Guidance:
Range
(in millions)
Low
High
INGREZZA Net Product Sales 1
$ 1,820
$ 1,840
GAAP R&D Expense 2
$ 560
$ 570
Non-GAAP R&D Expense 3
$ 490
$ 500
GAAP and Non-GAAP IPR&D 4
$ 144
$ 144
GAAP SG&A Expense 5
$ 870
$ 890
Non-GAAP SG&A Expense 3
$ 740
$ 760
1. INGREZZA sales guidance for fiscal 2023 reflects expected sales of INGREZZA.
2. GAAP R&D guidance includes amounts for milestones that are probable of achievement or have been achieved.
3. Non-GAAP guidance adjusted primarily to exclude estimated non-cash stock-based compensation expense of $70 million in R&D and $125 million in SG&A.
4. IPR&D guidance reflects acquired in-process research and development once significant collaboration and licensing arrangements have been completed. IPR&D guidance includes $143.9 million associated with the new strategic collaboration with Voyager.
5. SG&A guidance range reflects increased spend following INGREZZA expanded indication to treat chorea associated with Huntington’s disease and positive Phase 3 results in CAH.
Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.