Neurocrine Biosciences, Inc. (NBIX), a leading neuroscience-focused biopharmaceutical company, approaches the buy point amid growing market enthusiasm. The stock has surged more than 19% over the past six months and nearly 42% over the past year.
One factor fueling this optimism is NBIX's flagship product, INGREZZA®, which targets tardive dyskinesia, a movement disorder associated with certain antipsychotic medications, and its diagnosis rates have been rising. INGREZZA’s launch in 2017 has brought attention to this lesser-known condition.
Moreover, Neurocrine's early-stage initiatives targeting muscarinic receptors in the brain have captured investor interest. This research could potentially lead to new treatments for various movement disorders, schizophrenia, and other central nervous system conditions.
Now, let’s delve deeper into NBIX’s fundamentals and growth prospects:
Promising Recent Developments
On May 8, NBIX announced the initiation of its Phase 1 first-in-human clinical study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in adult participants. NBI-1117567 is an oral, investigational, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of psychiatric and neurological disorders.
On April 30, NBIX announced that the FDA approved INGREZZA® SPRINKLE capsules, introducing a new oral granules version of INGREZZA® capsules prescribed for treating adults with tardive dyskinesia and chorea linked to Huntington's disease. INGREZZA SPRINKLE offers an alternative option, particularly beneficial for individuals experiencing dysphagia or having difficulty with swallowing.
Also, Neurocrine reported positive topline data for its Phase 2 SAVITRI™ study on April 23. This was a randomized, double-blind, placebo-controlled dose-finding trial designed to evaluate the efficacy and safety of NBI-1065845 in adults 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) for the potential treatment for patients with MDD who have not responded adequately to at least one antidepressant during their current episode of depression.
Furthermore, in the same month, NBIX and Sentia Medical Sciences Inc. extended their research collaboration to discover novel, long-acting corticotropin-releasing factor (CRF) receptor antagonist peptide therapeutics.
The partnership will continue to leverage Sentia’s proprietary peptide-based platform and Neurocrine’s drug development expertise in CRF biology to develop, manufacture, and commercialize medicines with the potential to treat various hypothalamic-pituitary-adrenal (HPA) axis-modulated diseases.
In March, Neurocrine announced the initiation of its Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational compound NBI-1065890 in healthy adult subjects.
NBI-1065890 is a next-generation, highly potent, internally discovered, oral, selective vesicular monoamine transporter-2 (VMAT2) inhibitor for the potential treatment of certain neurological and neuropsychiatric conditions.
Moreover, NBIX is well-poised to become a leader in neuroscience, with the recent New Drug Application submissions for crinecerfont and optimistic Phase 2 results for NBI-'845 (a potential first-in-class medication for major depressive disorder).
Solid First-Quarter 2024 Financial Results
For the first quarter that ended March 31, 2024, NBIX’s revenues increased 22.6% year-over-year to $515.30 million. That surpassed the analysts’ estimate of $512.01 million. Its net product sales rose 22.7% year-over-year to $509 million, and INGREZZA net product sales were $506 million, up 23% from the prior year’s quarter.
The year-over-year growth in INGREZZA product sales was driven by solid underlying patient demand and improvement in gross-to-net dynamics. In addition, Neurocrine’s non-GAAP net income and earnings per share were $124.80 million and $1.20, compared to non-GAAP net loss and loss per share of $49.50 million and $0.51 in the first quarter of 2023, respectively.
Furthermore, as of March 31, 2024, the company’s total cash, cash equivalents and marketable securities came in at $1.91 billion, compared to $1.72 billion as of December 31, 2023.
Optimistic Analyst Expectations
Analysts expect NBIX’s revenue to increase 20.9% year-over-year to $547.13 million for the second quarter ending June 2024. The consensus EPS estimate of $1.49 for the current quarter indicates an improvement of 19.3% year-over-year. Moreover, Neurocrine has topped consensus revenue and EPS estimates in three of the trailing four quarters, which is remarkable.
Additionally, NBIX’s revenue and EPS for the fiscal year (ending December 2024) are expected to grow 17.7% and 54.8% year-over-year to $2.22 billion and $5.98, respectively. For the fiscal year 2025, Street expects the company’s revenue and EPS to increase 14.4% and 22.9% from the previous year to $2.54 billion and $7.34, respectively.
Pharma Industry’s Favorable Trends And Dynamics
The growing population worldwide, aging demographics, and increasing prevalence of chronic diseases are boosting the demand for pharmaceutical products and healthcare services. Furthermore, regulatory agencies are increasingly implementing expedited review pathways and flexible approval processes to accelerate innovation and access to new treatments.
According to Statista, the revenue in the pharmaceuticals market is projected to reach $1.16 trillion in 2024. In global comparison, the U.S. is expected to generate the highest revenue of $636.90 billion this year. Looking ahead, the revenue in this sector is expected to grow at a CAGR of 6.2% from 2024 to 2028, resulting in a market volume of $1.47 trillion by 2028.
Moreover, biopharmaceutical advancements, growing adoption of precision medicine approaches, increasing investments in specialty drugs targeting specific diseases or patient populations, and orphan drugs for rare diseases are key trends shaping the pharma sector.
As per IQVIA, U.S. medicines spending is projected to grow 4 to 7% through 2028. This growth will be fueled by the adoption of newly launched innovative products, with an average of 50-55 new medicines launching per year over the next five years, such as those in oncology or with orphan status, alongside a few traditional therapies in diabetes, neurology, and obesity.
Accelerating Profitability
NBIX’s trailing-12-month gross profit margin of 68.54% is 21.7% higher than the 56.34% industry average. Likewise, the stock’s trailing-12-month EBIT margin and levered FCF margin of 23.73% and 36.29% are significantly higher than the industry average of 0.53%, respectively.
Moreover, the stock’s trailing-12-month net income margin of 18.65% compared to the industry average of negative 5.52%. Its trailing-12-month ROCE, ROTC, and ROTA of 18.16%, 12.36%, and 10.65% favorably compared to the respective industry averages of negative 40.87%, negative 20.89%, and negative 29.54%.
Bottom Line
Neurocrine reported outstanding first-quarter 2024 results, with revenue exceeding analyst expectations. The neuroscience-focused biopharmaceutical company’s INGREZZA® net product sales were a significant contributor, posting a 23% year-over-year growth, driven by solid patient demand and improvements in gross-to-net-dynamics.
NBIX’s CEP, Kevin Gorman, Ph.D., highlighted the continued need for treatment for patients with tardive dyskinesia, expressing confidence in the company's lead product, INGREZZA.
For the fiscal year 2024, the company expects INGREZZA net product sales to range from $2.10 to $2.20 billion.
Moreover, Neurocrine is actively pursuing strategic initiatives to develop medicines to alleviate the burden of debilitating diseases and disorders. This includes their ongoing research and development (R&D) efforts to create new effective treatments for neurological, neuroendocrine, and neuropsychiatric conditions.
Wells Fargo analyst Mohit Bansal maintained a Buy rating on NBIX, with a price target of $170. Mohit Bansal has given a Buy rating due to several factors indicating a solid business foundation and bright future developments for Neurocrine. The company’s flagship product, INGREZZA, has been a robust performer, contributing to operating margin expansion and serving as a solid base for the business.
Furthermore, according to the analyst, Neurocrine is actively preparing to launch crinecerfont, its upcoming new drug, with management expressing confidence in its chances for priority review by the FDA. Bansal also highlights the company's proactive approach to ensuring study quality, which bodes well for future clinical trials.
Considering these factors, it could be wise to scoop up shares of NBIX for potential gains.
