Neurocrine Biosciences Reports Second Quarter 2024 Financial Results and Raises 2024 INGREZZA Sales Guidance
Neurocrine Biosciences (NBIX) reported strong Q2 2024 financial results, with INGREZZA net product sales reaching $580 million, a 32% year-over-year increase. The company raised its 2024 INGREZZA sales guidance to $2.25 - $2.3 billion. Total revenues for Q2 were $590.2 million, up from $452.7 million in Q2 2023. GAAP net income was $65 million ($0.63 per share), while Non-GAAP net income was $169 million ($1.63 per share). The company maintains a strong cash position of $1.68 billion. Neurocrine also announced FDA Priority Review for crinecerfont in congenital adrenal hyperplasia and positive Phase 2 data for NBI-1065845 in major depressive disorder. CEO Kevin Gorman will retire in October, to be succeeded by Kyle Gano.
Neurocrine Biosciences (NBIX) ha riportato forti risultati finanziari per il secondo trimestre del 2024, con le vendite nette del prodotto INGREZZA che hanno raggiunto $580 milioni, segnando un incremento del 32% rispetto all'anno precedente. La società ha alzato le previsioni di vendita per l'INGREZZA nel 2024 a $2.25 - $2.3 miliardi. Le entrate totali per il secondo trimestre sono state di $590.2 milioni, in aumento rispetto ai $452.7 milioni del secondo trimestre del 2023. L'utile netto GAAP è stato di $65 milioni ($0.63 per azione), mentre l'utile netto Non-GAAP è stato di $169 milioni ($1.63 per azione). L'azienda mantiene una solida posizione di cassa di $1.68 miliardi. Neurocrine ha anche annunciato la Revisione Prioritaria da parte della FDA per crinecerfont nella iperplasia surrenale congenita e dati positivi della Fase 2 per NBI-1065845 nel disturbo depressivo maggiore. Il CEO Kevin Gorman si ritirerà in ottobre, e sarà succeduto da Kyle Gano.
Neurocrine Biosciences (NBIX) reportó sólidos resultados financieros para el segundo trimestre de 2024, con las ventas netas de productos INGREZZA alcanzando los $580 millones, un aumento del 32% en comparación con el año anterior. La compañía elevó su guía de ventas de INGREZZA para 2024 a $2.25 - $2.3 mil millones. Los ingresos totales para el segundo trimestre fueron de $590.2 millones, en comparación con los $452.7 millones del segundo trimestre de 2023. La utilidad neta GAAP fue de $65 millones ($0.63 por acción), mientras que la utilidad neta No-GAAP fue de $169 millones ($1.63 por acción). La empresa mantiene una sólida posición de efectivo de $1.68 mil millones. Neurocrine también anunció la Revisión Prioritaria por parte de la FDA para crinecerfont en hipoplasia adrenal congénita y datos positivos de la Fase 2 para NBI-1065845 en trastorno depresivo mayor. El CEO Kevin Gorman se retirará en octubre y será sucedido por Kyle Gano.
Neurocrine Biosciences(NBIX)는 2024년 2분기 강력한 재무 실적을 보고했습니다. INGREZZA의 순제품 판매가 5억 8천만 달러에 달하여 전년 대비 32% 증가했습니다. 회사는 2024년 INGREZZA 판매 가이드를 22억 5천만 - 23억 달러로 상향 조정했습니다. 2분기 총 수익은 5억 9천만 달러로, 2023년 2분기의 4억 5천 2백 7십만 달러에서 증가했습니다. GAAP 순이익은 6천5백만 달러(주당 0.63달러)였으며, 비GAAP 순이익은 1억 6천9백만 달러(주당 1.63달러)였습니다. 회사는 16억 8천만 달러의 강력한 현금 보유고를 유지하고 있습니다. Neurocrine은 또한 선천성 부신 과형성증에 대한 crinecerfont의 FDA 우선 검토와 주요 우울 장애에 대한 NBI-1065845의 긍정적인 2상 데이터를 발표했습니다. CEO Kevin Gorman은 10월에 은퇴할 예정이며, Kyle Gano가 그의 후임이 될 것입니다.
Neurocrine Biosciences (NBIX) a annoncé de solides résultats financiers pour le deuxième trimestre 2024, avec des ventes nettes de produits INGREZZA atteignant 580 millions de dollars, soit une augmentation de 32 % par rapport à l'année précédente. La société a relevé ses prévisions de ventes pour l'INGREZZA à 2,25 - 2,3 milliards de dollars pour 2024. Les revenus totaux pour le deuxième trimestre se sont élevés à 590,2 millions de dollars, contre 452,7 millions de dollars au deuxième trimestre 2023. Le bénéfice net GAAP était de 65 millions de dollars (0,63 dollar par action), tandis que le bénéfice net Non-GAAP s'élevait à 169 millions de dollars (1,63 dollar par action). L'entreprise maintient une solide position de trésorerie de 1,68 milliard de dollars. Neurocrine a également annoncé l'examen prioritaire par la FDA pour le crinecerfont dans l'hyperplasie surrénale congénitale et des données positives de phase 2 pour le NBI-1065845 dans le trouble dépressif majeur. Le PDG Kevin Gorman prendra sa retraite en octobre et sera remplacé par Kyle Gano.
Neurocrine Biosciences (NBIX) hat starke Finanzergebnisse für das zweite Quartal 2024 gemeldet, mit INGREZZA-Nettoverkaufszahlen von 580 Millionen Dollar, was einem Anstieg von 32% im Vergleich zum Vorjahr entspricht. Das Unternehmen hat die Verkaufsprognose für INGREZZA 2024 auf 2,25 - 2,3 Milliarden Dollar angehoben. Die Gesamteinnahmen für das zweite Quartal betrugen 590,2 Millionen Dollar, ein Anstieg von 452,7 Millionen Dollar im zweiten Quartal 2023. Der GAAP-Reingewinn betrug 65 Millionen Dollar (0,63 Dollar pro Aktie), während der Non-GAAP-Reingewinn 169 Millionen Dollar (1,63 Dollar pro Aktie) betrug. Das Unternehmen verfügt über eine starke Liquiditätsposition von 1,68 Milliarden Dollar. Neurocrine gab auch eine FDA-Prioritätsprüfung für crinecerfont bei kongenitaler adrenaler Hyperplasie und positive Phase-2-Daten für NBI-1065845 bei majorer Depression bekannt. CEO Kevin Gorman wird im Oktober in den Ruhestand gehen und von Kyle Gano nachfolgen.
- INGREZZA Q2 net product sales grew 32% year-over-year to $580 million
- 2024 INGREZZA sales guidance raised to $2.25 - $2.3 billion
- Total Q2 revenues increased to $590.2 million from $452.7 million in Q2 2023
- Non-GAAP net income rose to $169 million from $126 million in Q2 2023
- FDA granted Priority Review for crinecerfont in congenital adrenal hyperplasia
- Positive Phase 2 data reported for NBI-1065845 in major depressive disorder
- GAAP net income decreased to $65 million from $96 million in Q2 2023
- $50 million charge associated with settlement of convertible senior notes conversions
- $20 million loss from changes in fair value of equity security investments
- $14 million leased office space impairment charge
Neurocrine Biosciences' Q2 2024 results demonstrate strong performance and positive momentum. INGREZZA net product sales of
The company's financial health appears solid, with
However, investors should note the increase in both R&D and SG&A expenses. While these investments are necessary for future growth, they have impacted the bottom line. GAAP net income decreased to
The company's pipeline progress, including positive Phase 2 data for NBI-1065845 in major depressive disorder and the FDA's priority review for crinecerfont in congenital adrenal hyperplasia, bodes well for future growth potential. However, investors should closely monitor the upcoming Phase 2 data readouts for NBI-1117568 and luvadaxistat in Q3, as these results could significantly impact the company's future prospects.
Neurocrine Biosciences' pipeline developments are particularly noteworthy. The positive topline data from the Phase 2 SAVITRI™ study for NBI-1065845 in major depressive disorder (MDD) is a significant milestone. This AMPA positive allosteric modulator represents a novel approach to treating MDD, potentially offering hope for patients who haven't responded to traditional antidepressants.
The FDA's acceptance and priority review grant for crinecerfont NDAs in both adult and pediatric congenital adrenal hyperplasia (CAH) patients is a major advancement. With PDUFA dates set for December 29 and 30, 2024, this could potentially lead to a new treatment option for CAH, a rare genetic disorder with current therapies.
The initiation of multiple Phase 1 and 2 studies, including NBI-1070770 for MDD and several muscarinic receptor modulators (NBI-1117567, NBI-1076968) for various CNS indications, demonstrates a robust and diverse clinical pipeline. These compounds target novel mechanisms of action, potentially addressing unmet needs in neurological and psychiatric disorders.
However, it's important to note that many of these programs are still in early stages. The upcoming Phase 2 data readouts for NBI-1117568 in schizophrenia and luvadaxistat in cognitive impairment associated with schizophrenia will be critical in assessing the potential of these compounds. Positive results could significantly enhance the company's pipeline value, while negative outcomes could lead to program terminations and impact investor confidence.
Neurocrine Biosciences' market position appears to be strengthening, particularly in the tardive dyskinesia (TD) and Huntington's disease chorea markets with INGREZZA. The planned expansion of the INGREZZA psychiatry and long-term care sales teams indicates a strategic move to accelerate diagnosis and treatment rates, potentially leading to further market penetration and sales growth.
The launch of the new sprinkle formulation of INGREZZA is a smart line extension strategy. This new formulation could improve patient compliance and potentially expand the addressable patient population, particularly among those with swallowing difficulties.
The company's pipeline diversification into areas like major depressive disorder, schizophrenia and congenital adrenal hyperplasia demonstrates a strategic approach to expanding its market presence beyond movement disorders. If successful, this could significantly broaden Neurocrine's revenue streams and reduce reliance on INGREZZA.
However, investors should be aware of potential market challenges. The implementation of the Inflation Reduction Act could impact pricing strategies in the future, although INGREZZA's qualification for the Specified Small Manufacturer Exception provides some near-term protection.
The upcoming CEO transition from Kevin Gorman to Kyle Gano in October 2024 is a significant change. While Dr. Gano's experience as Chief Business Development and Strategy Officer suggests a smooth transition, any leadership change can bring uncertainty. Investors should monitor how this transition affects the company's strategic direction and execution capabilities.
INGREZZA® (valbenazine) Second Quarter Net Product Sales of
INGREZZA® (valbenazine) 2024 Net Product Sales Guidance Raised to
Top-Line Phase 2 Data Readouts for NBI-'568 and Luvadaxistat Remain On Track in Q3
"At Neurocrine, we are energized by the tremendous opportunity we see to help many more patients, and we are encouraged by our recent progress, including INGREZZA's continued success in treating tardive dyskinesia and Huntington's disease chorea and the FDA's decision to grant Priority Review for crinecerfont to treat congenital adrenal hyperplasia," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are in the process of building our endocrinology team and expanding the INGREZZA salesforce, positioning our company for continued strong growth in the years ahead."
Kevin
Financial Highlights
Three Months Ended June 30, | Six Months Ended June 30, | ||||||
(unaudited, in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
Revenues: | |||||||
Net Product Sales | $ 583.8 | $ 446.3 | $ 1,092.8 | $ 861.6 | |||
Collaboration Revenue | 6.4 | 6.4 | 12.7 | 11.5 | |||
Total Revenues | $ 590.2 | $ 452.7 | $ 1,105.5 | $ 873.1 | |||
GAAP Research and Development (R&D) | $ 191.1 | $ 145.8 | $ 350.5 | $ 285.3 | |||
Non-GAAP R&D | $ 175.3 | $ 122.0 | $ 317.7 | $ 247.7 | |||
GAAP Selling, General and Administrative (SG&A) | $ 242.0 | $ 221.8 | $ 485.1 | $ 464.5 | |||
Non-GAAP SG&A | $ 200.7 | $ 177.1 | $ 416.3 | $ 393.7 | |||
GAAP Net Income | $ 65.0 | $ 95.5 | $ 108.4 | $ 18.9 | |||
GAAP Earnings Per Share – Diluted | $ 0.63 | $ 0.95 | $ 1.04 | $ 0.19 | |||
Non-GAAP Net Income | $ 168.9 | $ 125.7 | $ 293.7 | $ 76.2 | |||
Non-GAAP Earnings Per Share – Diluted | $ 1.63 | $ 1.25 | $ 2.83 | $ 0.76 | |||
(unaudited, in millions) | June 30, 2024 | December 31, 2023 | |||||
Total Cash, Cash Equivalents and Marketable Securities | $ 1,676.7 | $ 1,719.1 |
INGREZZA Net Product Sales Highlights
- INGREZZA second quarter 2024 net product sales were
and grew$580 million 32% compared to the second quarter 2023 - Year-over-year growth driven by strong underlying patient demand and improvement in gross-to-net dynamics
Other Key Financial Highlights
- Differences in second quarter 2024 GAAP and Non-GAAP operating expenses compared with second quarter 2023 were driven by:
- Increased R&D expense in support of an expanded and advancing clinical portfolio including investments in muscarinic compounds, gene therapy programs and second generation VMAT2 inhibitors. R&D expense for the second quarter 2024 includes
for development milestones achieved under our collaborations with Nxera Pharma$27 million UK Limited (Nxera, formerly known as Sosei Heptares), Takeda Pharmaceutical Company Limited (Takeda) and Voyager Therapeutics, Inc. (Voyager) - Increased SG&A expense includes incremental investment in crinecerfont-related headcount, crinecerfont-related pre-launch activities, and continued investment in INGREZZA. GAAP SG&A expense also includes impairment charges of
associated with leased office space that has been vacated as we continue to occupy our new campus facility$14 million
- Increased R&D expense in support of an expanded and advancing clinical portfolio including investments in muscarinic compounds, gene therapy programs and second generation VMAT2 inhibitors. R&D expense for the second quarter 2024 includes
- Second quarter 2024 GAAP net income and earnings per share were
and$65 million , respectively, compared with$0.63 and$96 million , respectively, for second quarter 2023$0.95 - Second quarter 2024 Non-GAAP net income and earnings per share were
and$169 million , respectively, compared with$1.63 and$126 million , respectively, for second quarter 2023$1.25 - Differences in second quarter 2024 GAAP and Non-GAAP net income compared with second quarter 2023 driven by:
- Higher INGREZZA net sales and improved operating margin
- Second quarter 2024 includes
charge associated with the settlement of convertible senior notes conversions (Non-GAAP adjustment)$50 million - Second quarter 2024 includes
loss from changes in fair value of equity security investments compared to$20 million gain the second quarter 2023 (Non-GAAP adjustment)$37 million - Second quarter 2024 includes
of development milestones expense achieved under collaborations$27 million - Second quarter 2024 includes
leased office space impairment charge (Non-GAAP adjustment)$14 million
- At June 30, 2024, the Company had cash, cash equivalents and marketable securities totaling approximately
.7 billion which reflects the$1 payment to fully retire our convertible senior notes$309 million
A reconciliation of GAAP to Non-GAAP financial results can be found in Table 3 and Table 4 at the end of this news release.
Recent Developments
- Announced Kevin Gorman, Ph.D., will retire as Chief Executive Officer on October 11, 2024. Kyle Gano, Ph.D., currently Neurocrine's Chief Business Development and Strategy Officer, will succeed him in the CEO role. Dr. Gano will also join the Company's Board of Directors at that time, and Dr.
Gorman will continue to serve on the Company's Board. - Announced positive topline data for the Phase 2 SAVITRI™ study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD). NBI-1065845 is an investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development as a potential treatment for patients with MDD who have not benefited from treatment with at least one antidepressant in their current episode of depression.
- Announced FDA accepted New Drug Applications (NDAs) and granted Priority Review for crinecerfont for adult and pediatric patients with congenital adrenal hyperplasia (CAH). The agency set Prescription Drug User Fee (PDUFA) target actions dates of December 29, 2024 for the capsule formulation and December 30, 2024 for the oral solution formulation.
- At the Endocrine Society Annual Meeting (ENDO 2024), presented new Phase 3 clinical study data from the CAHtalyst™ registrational studies of crinecerfont in pediatric and adult patients with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. In parallel, announced that the primary study results from the CAHtalyst™ registrational studies of crinecerfont in pediatric and adult patients with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency have been published in The New England Journal of Medicine.
- Initiated Phase 2 study of NBI-1070770 in adults with major depressive disorder. NBI-1070770 is a novel, selective and orally active, negative allosteric modulator (NAM) of the NR2B subunit-containing N-methyl-D-aspartate (NMDA NR2B) receptor.
- Initiated Phase 1 study of NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of neurological and neuropsychiatric conditions.
- Initiated Phase 1 study of NBI-1076968 in healthy adult participants. NBI-1076968 is an investigational, oral, M4 subtype-selective muscarinic antagonist for the potential treatment of movement disorders.
- Received notification from the Centers for Medicare and Medicaid Services that INGREZZA qualified for the Specified Small Manufacturer Exception pertaining to the Part D redesign of the Inflation Reduction Act.
- Settled the convertible senior notes due May 15, 2024 in full in cash upon maturity.
- Announced planned expansion of the INGREZZA psychiatry and long-term care sales teams to better serve patients by accelerating the number of people who are diagnosed and treated for tardive dyskinesia and chorea associated with Huntington's disease.
- Launched new sprinkle formulation of INGREZZA® (valbenazine) capsules for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.
Raised 2024 Net Sales Guidance and Updated Expense Guidance
Range | |||
(in millions) | Low | High | |
INGREZZA Net Product Sales 1 | $ 2,250 | $ 2,300 | |
GAAP R&D Expense 2 | $ 665 | $ 695 | |
Non-GAAP R&D Expense 3 | $ 600 | $ 630 | |
GAAP and Non-GAAP IPR&D 4 | $ 9 | $ 9 | |
GAAP SG&A Expense 5 | $ 955 | $ 975 | |
Non-GAAP SG&A Expense 3, 5 | $ 830 | $ 850 |
1. | INGREZZA sales guidance reflects expected net product sales of INGREZZA in tardive dyskinesia and chorea associated with Huntington's disease. |
2. | GAAP R&D guidance includes |
3. | Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of approximately |
4. | Acquired in-process R&D (IPR&D) is included in guidance once significant collaboration and licensing arrangements have been completed. |
5. | SG&A guidance range reflects expense for ongoing commercial initiatives supporting INGREZZA growth including the announced planned expansion of the psychiatry and long-term care sales teams and pre-launch commercial activities for crinecerfont. |
2024 Pipeline Milestones and Key Activities
Program | Indication | Milestones / Key Activities |
NBI-1065845* (AMPA Potentiator) | Inadequate Response in Major Depressive Disorder | Reported Positive Top-Line Phase 2 Data; Conducting End of Phase 2 Meeting with FDA; Initiating Phase 3 Studies in 2025 |
Crinecerfont (CRF1 Receptor Antagonist) | Congenital Adrenal Hyperplasia (Pediatric and Adult) | Priority Review with PDUFA Dates Set for December 29 and 30, 2024 |
NBI-1117568** (M4 Agonist) | Schizophrenia | Top-Line Phase 2 Data in Q3'24 |
Luvadaxistat* (DAAO Inhibitor) | Cognitive Impairment Associated with Schizophrenia | Top-Line Phase 2 Data in Q3'24 |
NBI-1070770* (NMDA NR2B NAM) | Major Depressive Disorder | Phase 2 Study Ongoing; Top-Line Data in 2025 |
NBI-1065890 (Selective VMAT2 Inhibitor) | CNS Indications | Phase 1 Study Ongoing |
NBI-1117569** (M4-Prefering Agonist) | CNS Indications | Phase 1 Study Ongoing |
NBI-1117570** (M1/M4 Dual Agonist) | CNS Indications | Phase 1 Study Ongoing |
NBI-1117567** (M1 Agonist) | CNS Indications | Phase 1 Study Ongoing |
NBI-1076986 (M4 Antagonist) | Movement Disorders | Phase 1 Study Ongoing |
Key: AMPA = alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid; CFR1 = Corticotropin-Releasing Factor Type 1; M4 = M4 Muscarinic Receptor; DAAO = d-amino acid oxidase; NMDA NR2B NAM = n-methyl-d-aspartate Receptor Subtype 2B Negative Allosteric Modulator; VMAT2 = Vesicular Monoamine Transporter 2; M1 = M1 Muscarinic Receptor
Neurocrine Biosciences Partners: * Partnered with Takeda Pharmaceutical Company Limited; ** In-Licensed from Nxera Pharma
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 800-445-7795 (US) or 785-424-1699 (International) using the conference ID: NBIX. The webcast and accompanying slides can also be accessed at approximately 8:00 a.m. Eastern Time 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.
About Neurocrine Biosciences
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)
NEUROCRINE BIOSCIENCES, NEUROCRINE and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. The Neurocrine logo is a trademark of Neurocrine Biosciences, Inc.
Non-GAAP Financial Measures
In addition to the financial results and financial guidance that are provided in accordance with accounting principles generally accepted in
Forward-Looking Statements
In addition to historical facts, this press release 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 our future revenues, expenses, or profits; our collaborative partnerships; expected future clinical and regulatory milestones; and the timing of the initiation and/or completion of our clinical, regulatory, and other development activities and those of our collaboration partners. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA; risks that the crinecerfont New Drug Applications (NDAs) may not obtain regulatory approval, such approval may be delayed, or may not receive the benefits associated with priority review; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; and other risks described in our periodic reports filed with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law.
TABLE 1 | |||||||
NEUROCRINE BIOSCIENCES, INC. | |||||||
Three Months Ended | Six Months Ended | ||||||
(in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
Revenues: | |||||||
Net product sales | $ 583.8 | $ 446.3 | $ 1,092.8 | $ 861.6 | |||
Collaboration revenue | 6.4 | 6.4 | 12.7 | 11.5 | |||
Total revenues | 590.2 | 452.7 | 1,105.5 | 873.1 | |||
Operating expenses: | |||||||
Cost of revenues | 9.2 | 11.5 | 16.7 | 20.0 | |||
Research and development | 191.1 | 145.8 | 350.5 | 285.3 | |||
Acquired in-process research and development | 2.5 | — | 8.5 | 143.9 | |||
Selling, general and administrative | 242.0 | 221.8 | 485.1 | 464.5 | |||
Total operating expenses | 444.8 | 379.1 | 860.8 | 913.7 | |||
Operating income (loss) | 145.4 | 73.6 | 244.7 | (40.6) | |||
Other (expense) income: | |||||||
Unrealized (loss) gain on equity securities | (19.9) | 37.3 | (18.3) | 39.5 | |||
Charges associated with convertible senior notes | (49.7) | — | (138.4) | — | |||
Investment income and other, net | 22.8 | 10.7 | 45.1 | 19.4 | |||
Total other (expense) income, net | (46.8) | 48.0 | (111.6) | 58.9 | |||
Income before provision for income taxes | 98.6 | 121.6 | 133.1 | 18.3 | |||
Provision for (benefit from) income taxes | 33.6 | 26.1 | 24.7 | (0.6) | |||
Net income | $ 65.0 | $ 95.5 | $ 108.4 | $ 18.9 | |||
Earnings per share, basic | $ 0.64 | $ 0.98 | $ 1.08 | $ 0.19 | |||
Earnings per share, diluted | $ 0.63 | $ 0.95 | $ 1.04 | $ 0.19 | |||
Weighted average common shares outstanding, basic | 100.8 | 97.6 | 100.3 | 97.4 | |||
Weighted average common shares outstanding, diluted | 103.9 | 100.2 | 103.8 | 100.3 |
TABLE 2 | |||
NEUROCRINE BIOSCIENCES, INC. | |||
(in millions) | June 30, 2024 | December 31, 2023 | |
Cash, cash equivalents and marketable securities | $ 1,038.9 | $ 1,031.6 | |
Other current assets | 630.9 | 575.4 | |
Total current assets | 1,669.8 | 1,607.0 | |
Deferred tax assets | 419.5 | 362.6 | |
Debt securities available-for-sale | 637.8 | 687.5 | |
Right-of-use assets | 262.9 | 276.5 | |
Equity security investments | 143.6 | 161.9 | |
Property and equipment, net | 80.1 | 70.8 | |
Intangible assets, net | 33.5 | 35.5 | |
Other noncurrent assets | 57.8 | 49.6 | |
Total assets | $ 3,305.0 | $ 3,251.4 | |
Convertible senior notes | $ — | $ 170.1 | |
Other current liabilities | 398.5 | 484.7 | |
Total current liabilities | 398.5 | 654.8 | |
Noncurrent operating lease liabilities | 256.2 | 258.3 | |
Other noncurrent long-term liabilities | 141.1 | 106.3 | |
Stockholders' equity | 2,509.2 | 2,232.0 | |
Total liabilities and stockholders' equity | $ 3,305.0 | $ 3,251.4 | |
TABLE 3 | |||||||
NEUROCRINE BIOSCIENCES, INC. | |||||||
Three Months Ended | Six Months Ended | ||||||
(in millions, except per share data) | 2024 | 2023 | 2024 | 2023 | |||
GAAP net income 1 | $ 65.0 | $ 95.5 | $ 108.4 | $ 18.9 | |||
Adjustments: | |||||||
Stock-based compensation expense - R&D | 15.8 | 23.8 | 32.8 | 37.6 | |||
Stock-based compensation expense - SG&A | 27.3 | 44.7 | 54.8 | 70.8 | |||
Charges associated with convertible senior notes 2 | 49.7 | — | 138.4 | — | |||
Impairment charges associated with leased properties 3 | 14.0 | — | 14.0 | — | |||
Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | 1.8 | 1.8 | |||
Changes in fair value of equity security investments 4 | 19.9 | (37.3) | 18.3 | (39.5) | |||
Other | 0.1 | 0.2 | 0.3 | 0.4 | |||
Income tax effect related to reconciling items 5 | (23.8) | (2.1) | (75.1) | (13.8) | |||
Non-GAAP net income | $ 168.9 | $ 125.7 | $ 293.7 | $ 76.2 | |||
Diluted earnings per share: | |||||||
GAAP | $ 0.63 | $ 0.95 | $ 1.04 | $ 0.19 | |||
Non-GAAP | $ 1.63 | $ 1.25 | $ 2.83 | $ 0.76 |
1. | Three and six months ended June 30, 2024 reflect |
2. | Reflects charges associated with the settlement of convertible senior notes conversions. |
3. | Reflects impairment charges associated with leased office space that has been vacated as the Company continues to occupy its new campus facility. |
4. | Reflects periodic fluctuations in the fair values of the Company's equity security investments. |
5. | Estimated income tax effect of Non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration any valuation allowance and adjustments to exclude tax benefits or expenses associated with charges associated with convertible senior notes and non-cash stock-based compensation. |
TABLE 4 | |||||||
NEUROCRINE BIOSCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP EXPENSES (unaudited) | |||||||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP cost of revenues | $ 9.2 | $ 11.5 | $ 16.7 | $ 20.0 | |||
Adjustments: | |||||||
Non-cash amortization related to acquired intangible assets | 0.9 | 0.9 | 1.8 | 1.8 | |||
Non-GAAP cost of revenues | $ 8.3 | $ 10.6 | $ 14.9 | $ 18.2 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP R&D | $ 191.1 | $ 145.8 | $ 350.5 | $ 285.3 | |||
Adjustments: | |||||||
Stock-based compensation expense | 15.8 | 23.8 | 32.8 | 37.6 | |||
Non-GAAP R&D | $ 175.3 | $ 122.0 | $ 317.7 | $ 247.7 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP SG&A | $ 242.0 | $ 221.8 | $ 485.1 | $ 464.5 | |||
Adjustments: | |||||||
Stock-based compensation expense | 27.3 | 44.7 | 54.8 | 70.8 | |||
Impairment charges associated with leased properties | 14.0 | — | 14.0 | — | |||
Non-GAAP SG&A | $ 200.7 | $ 177.1 | $ 416.3 | $ 393.7 | |||
Three Months Ended | Six Months Ended | ||||||
(in millions) | 2024 | 2023 | 2024 | 2023 | |||
GAAP other (expense) income, net | $ (46.8) | $ 48.0 | $ (111.6) | $ 58.9 | |||
Adjustments: | |||||||
Charges associated with convertible senior notes | 49.7 | — | 138.4 | — | |||
Changes in fair value of equity security investments | 19.9 | (37.3) | 18.3 | (39.5) | |||
Other | 0.1 | 0.2 | 0.3 | 0.4 | |||
Non-GAAP other income, net | $ 22.9 | $ 10.9 | $ 45.4 | $ 19.8 | |||
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SOURCE Neurocrine Biosciences, Inc.
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