On May 3, 2023 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the first quarter ended March 31, 2023 and provided an update on its 2023 financial guidance (Press release, Neurocrine Biosciences, MAY 3, 2023, View Source [SID1234630935]).
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"INGREZZA’s first quarter results highlight the steady progress we are making to help improve the lives of patients living with tardive dyskinesia, yet we still have a tremendous opportunity to help even more patients for many years to come," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are executing well across our clinical portfolio and anticipate several important milestones in the months ahead including the August 20th PDUFA date for valbenazine for the treatment of chorea associated with Huntington disease. In addition, we remain on-track for top-line data in the second half of this year for several investigational programs, including crinecerfont for the treatment of pediatric and adult congenital adrenal hyperplasia."
Three Months Ended
March 31,
(unaudited, in millions, except per share data)
2023
2022
Revenues:
Product sales, net
$ 415.3
$ 305.0
Collaboration revenue
5.1
5.6
Total revenues
$ 420.4
$ 310.6
GAAP Research and Development (R&D)
$ 139.5
$ 102.2
Non-GAAP R&D
$ 125.7
$ 89.7
GAAP Selling, General and Administrative (SG&A)
$ 242.7
$ 200.7
Non-GAAP SG&A
$ 216.6
$ 176.2
GAAP net (loss) income
$ (76.6)
$ 13.9
GAAP (loss) earnings per share – diluted
$ (0.79)
$ 0.14
Non-GAAP net (loss) income
$ (49.5)
$ 29.7
Non-GAAP (loss) earnings per share – diluted
$ (0.51)
$ 0.30
(unaudited, in millions)
March 31,
2023
December 31,
2022
Total cash, cash equivalents and marketable securities
$ 1,139.2
$ 1,288.7
First Quarter INGREZZA Net Product Sales Highlights:
INGREZZA first quarter 2023 net product sales were $410 million and grew 36% compared vs. the first quarter 2022
Record number of new patients received therapy during the first quarter of 2023
First Quarter Financial Highlights:
First quarter 2023 GAAP net loss and loss per share of $77 million and $0.79, respectively, compared with first quarter 2022 GAAP net income and earnings per share of $14 million and $0.14, respectively
First quarter 2023 non-GAAP net loss and loss per share of $50 million and $0.51, respectively, compared with first quarter 2022 non-GAAP net income and earnings per share of $30 million and $0.30, respectively
Differences in first quarter 2023 GAAP and non-GAAP operating expenses compared with first quarter 2022 driven by:
Acquired In-Process R&D (IPR&D) expense of $144 million in first quarter 2023 associated with expansion of strategic partnership with Voyager Therapeutics, Inc. (Voyager)
Increased R&D expense in support of an expanded and advancing clinical portfolio
Increased SG&A expense primarily due to ongoing commercial initiatives, including the deployment of the expanded salesforce in April 2022
At March 31, 2023, the Company had cash, cash equivalents and marketable securities of approximately $1.1 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:
On January 8, 2023, we entered into a new strategic collaboration with Voyager, which became effective on February 21, 2023, to acquire the worldwide rights to Voyager’s GBA1 gene therapy program for Parkinson’s disease and other GBA1-mediated diseases and three gene therapy programs directed to rare central nervous system targets for up-front consideration of $175 million.
In the first quarter of 2023, we provided BIAL with written notice of termination of the license agreement to commercialize and market ONGENTYS (opicapone), an approved adjunctive therapy for patients with Parkinson’s disease, in the United States and Canada. We determined that continued commercialization of ONGENTYS is unsustainable. The termination is anticipated to be effective in December 2023. ONGENTYS is an important, safe and effective adjunctive treatment option for Parkinson’s disease patients. We intend to work with BIAL to ensure an orderly transition of the commercialization of ONGENTYS and to ensure patients have continued access to ONGENTYS.
Reiterated 2023 INGREZZA Sales and Updated Operating Expense Guidance:
Range
(in millions)
Low
High
INGREZZA Net Product Sales 1
$ 1,670
$ 1,770
GAAP R&D expense 2
$ 550
$ 580
Non-GAAP R&D expense 5
$ 495
$ 525
GAAP and Non-GAAP IPR&D3
$ 144
$ 144
GAAP SG&A expense 4
$ 850
$ 870
Non-GAAP SG&A expense 5
$ 730
$ 750
1.
INGREZZA sales guidance for fiscal 2023 reflects expected sales of INGREZZA in tardive dyskinesia only.
2.
GAAP R&D guidance reflects the progression of the Company’s pipeline including multiple compounds in mid- to late-phase clinical development, meaningful investments in the muscarinic portfolio and expanded pre-clinical research efforts. GAAP R&D guidance includes amounts for milestones that are probable of achievement or have been achieved.
3.
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.
4.
GAAP SG&A guidance reflects the continued investment in the expanded commercial organization to support INGREZZA and to support the anticipated approval for valbenazine to treat patients with chorea associated with Huntington disease.
5.
Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $55 million in R&D and $120 million in SG&A.
2023 Expected Pipeline Milestones and Key Activities
Program
Indication
2023 Milestones / Key Activities
Valbenazine*
(Selective VMAT2 Inhibitor)
Chorea in Huntington Disease
PDUFA Aug. 20, 2023
Crinecerfont
(CRF1 Receptor Antagonist)
Congenital Adrenal Hyperplasia (Adult)
Top-Line Registrational Data in Early Q4 2023
Congenital Adrenal Hyperplasia (Pediatric)
Top-Line Registrational Data in Early Q4 2023
NBI-921352**
(Selective NaV1.6 Channel Blocker)
Focal Onset Seizure in Adults
Top-Line Phase 2 Data in Q4 2023
NBI-1065846†
(GPR-139 Agonist)
Anhedonia in Major Depressive Disorder
Top-Line Phase 2 Data in Q4 2023
NBI-1117570‡
(Dual M1/ M4 Agonist)
Treatment of Schizophrenia
Initiate Phase 1 Study
New Chemical Entity
or Entities
Indication(s) TBD
Initiate at Least One Phase 1 Study
Key: VMAT2 = Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing Factor Type 1; NaV1.6 = Sodium Channel, Voltage-Gated; M1 / M4 = M1 / M4 Muscarinic Receptor; GPR = Orphan G Protein Coupled Receptor
Neurocrine Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia; ** In-Licensed from Xenon Pharmaceuticals; † Partnered with Takeda Pharmaceutical Company Limited; ‡ In-Licensed from Sosei Group Corporation
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.