Neurocrine Biosciences Q2 2024 Financial Results & Increased INGREZZA Sales Guidance

Neurocrine Biosciences, Inc. has released its financial results for the second quarter of 2024, highlighting substantial growth and strategic progress. The company's net product sales for INGREZZA® (valbenazine) in the second quarter amounted to $580 million, reflecting a 32% increase compared to the same period in the previous year. This growth is attributed to strong patient demand and improved gross-to-net dynamics. Consequently, the company has raised its 2024 net product sales guidance for INGREZZA to a range of $2.25 to $2.3 billion.

Kevin Gorman, Ph.D., the CEO of Neurocrine Biosciences, expressed his enthusiasm for the company's continued success. He emphasized the company's commitment to expanding its reach, particularly in treating tardive dyskinesia and Huntington's disease chorea. Gorman also announced his planned retirement in October, with Kyle Gano, Ph.D., set to succeed him as CEO. Gorman expressed confidence in the company's future under Gano's leadership.

Financial highlights for the second quarter of 2024 included notable differences between GAAP and Non-GAAP operating expenses compared to the previous year. These differences were primarily driven by increased research and development (R&D) expenses to support the company’s expanding clinical portfolio, including investments in muscarinic compounds, gene therapy programs, and second-generation VMAT2 inhibitors. The R&D expense for the second quarter included $27 million for development milestones achieved through collaborations with Nxera Pharma UK Limited, Takeda Pharmaceutical Company Limited, and Voyager Therapeutics, Inc.

Additionally, selling, general, and administrative (SG&A) expenses increased due to investments related to crinecerfont, a new drug for congenital adrenal hyperplasia, and continued investment in INGREZZA. GAAP SG&A expenses also included impairment charges of $14 million for vacated office space as the company moved to a new campus facility.

The company reported a GAAP net income of $65 million and earnings per share of $0.63 for the second quarter of 2024, compared to $96 million and $0.95, respectively, for the same period in 2023. On a Non-GAAP basis, net income was $169 million, with earnings per share of $1.63, compared to $126 million and $1.25, respectively, in the previous year. The differences between GAAP and Non-GAAP net income were attributed to higher INGREZZA net sales, improved operating margins, and several adjustments, including a $50 million charge for the settlement of convertible senior notes and a $20 million loss from changes in the fair value of equity security investments.

As of June 30, 2024, Neurocrine Biosciences held approximately $1.7 billion in cash, cash equivalents, and marketable securities. This total reflects a $309 million payment to fully retire convertible senior notes.

Recent developments include the initiation of Phase 2 and Phase 1 studies for various compounds targeting major depressive disorder and other neurological and neuropsychiatric conditions. The company's investigational drugs, such as NBI-1065845 and NBI-1070770, are in development stages aimed at offering new therapeutic options for patients with unmet needs.

Moreover, the FDA has accepted New Drug Applications (NDAs) for crinecerfont and granted Priority Review for treating congenital adrenal hyperplasia in both adults and pediatric patients. New Phase 3 clinical study data for crinecerfont was presented at the Endocrine Society Annual Meeting, further establishing its potential efficacy.

Neurocrine Biosciences continues to make strategic moves to expand its market presence and pipeline. The company has launched a new sprinkle formulation of INGREZZA for the treatment of tardive dyskinesia and Huntington’s disease chorea and plans to expand its sales teams in psychiatry and long-term care sectors.

With a focus on addressing complex neurological, neuroendocrine, and neuropsychiatric conditions, Neurocrine Biosciences remains committed to advancing its diverse portfolio and achieving milestones that could significantly impact patient care.