Neurocrine Biosciences, Inc. (NBIX): PESTLE Analysis [Nov-2025 Updated]

Neurocrine Biosciences, Inc. (NBIX) is sitting on a financial fortress, backed by Ingrezza's full-year 2025 revenue guidance of up to $2.55 billion and a legal moat protecting its exclusivity until August 10, 2040. But honestly, that strength is being tested by external forces. The real challenge for NBIX in late 2025 is navigating the political headwinds of the Inflation Reduction Act (IRA) while translating a deep pipeline of 17 programs into new revenue streams, especially after the strong Q3 launch of Crinecerfont, which pulled in $98 million. We need to map out where the political scrutiny, economic power, and technological bets intersect, so you can make a smart, defintely informed decision.

Neurocrine Biosciences, Inc. (NBIX) - PESTLE Analysis: Political factors

Inflation Reduction Act (IRA): Payer dynamics are tightening, causing prescription fulfillment delays

You're seeing the Inflation Reduction Act (IRA) ripple through the entire pharmaceutical sector, and Neurocrine Biosciences, Inc. is defintely feeling the immediate effects on the commercial side. The core issue isn't the negotiation itself yet, but the resulting shift in payer behavior. Medicare Part D plans, anticipating higher liability from the benefit redesign, are tightening their formulary strategies to manage costs now.

This tightening has translated directly into friction at the pharmacy counter for INGREZZA (valbenazine), the company's flagship product. In the first quarter of 2025, Neurocrine Biosciences reported a slowdown in new patient starts and noted delays in prescription fulfillment due to these tightening payer strategies. The good news is that the company is adapting, and by the third quarter of 2025, Medicare formulary coverage for INGREZZA had actually improved from under 50% to over 70%. Still, getting a new patient on the drug is where the payer hurdles are most prevalent. That's a real-world drag on sales momentum.

Drug Pricing Scrutiny: Company is preparing for potential IRA pricing impacts in 2027-2028

The long-term political risk is the Medicare Drug Price Negotiation Program. For Neurocrine Biosciences, the primary concern is the potential impact on INGREZZA, which is expected to enter the negotiation process in 2027, with the Maximum Fair Price (MFP) taking effect in 2029. The near-term pressure comes from a key competitor, Teva's Austedo/Austedo XR, which was already selected for the Initial Price Applicability Year (IPAY) 2027 negotiation list.

Here's the quick math: A negotiated price for a competitor creates a ripple effect, forcing Neurocrine Biosciences to offer more competitive discounts to health plans to maintain market share and formulary access in the years leading up to its own negotiation. The company is already bracing for this, expecting to negotiate incremental discounts with health plans during the 2027-2028 period to secure sufficient formulary coverage. This will pressure the gross-to-net revenue ratio, even if patient volume continues to grow.

IRA Impact on Key Product (INGREZZA)	Timeline	Financial/Commercial Implication
Payer Strategy Tightening	2025 (Immediate)	Caused slower new patient starts and prescription fulfillment delays in Q1 2025.
Competitor Negotiation (Austedo)	IPAY 2027 (Prices effective Jan 2027)	Creates immediate pricing pressure, forcing Neurocrine Biosciences to offer incremental discounts in 2027-2028 to maintain market access.
Neurocrine Biosciences Negotiation	IPAY 2029 (Negotiation starts 2027)	Expected to result in a Maximum Fair Price (MFP) effective in 2029.

FDA Regulatory Risk: Continued political pressure on the U.S. Food and Drug Administration (FDA) could affect approval timelines

Political pressure on the U.S. Food and Drug Administration (FDA) is a double-edged sword for a company with a strong pipeline like Neurocrine Biosciences. On one hand, the political climate in 2025 is pushing for deregulation and faster access to new therapies, especially for rare diseases, which aligns with the company's focus areas. The FDA announced a new pilot program in June 2025 aimed at slashing the drug review time from the traditional 10-12 months down to just one to two months for qualifying submissions, which is a massive value driver for pipeline assets.

But there's a risk: political transitions and a focus on cost-cutting have led to staffing shortages and potential agency restructuring, which can introduce uncertainty and delays in the complex review process. For Neurocrine Biosciences, this risk directly impacts the timeline for key late-stage assets, such as the Phase 3 program for osavampator in major depressive disorder, where pivotal data readouts are anticipated in 2027. Any delay there is a significant setback to future revenue. The successful launch of Crinecerfont, which generated $98 million in Q3 2025 revenue, shows how critical an efficient approval process is.

R&D Tax Incentives: Restoration of domestic R&D tax deductions in 2025 is a positive for cash flow

The political action on domestic R&D tax deductions is a clear, immediate positive for Neurocrine Biosciences' cash flow. The passage of the One Big Beautiful Bill Act (P.L. 119-21) in July 2025 reversed a punitive provision from the prior Tax Cuts and Jobs Act (TCJA). This new law reinstates the ability to immediately and fully deduct (or 'expense') domestic research and development costs for tax years beginning after December 31, 2024.

Before this change, the company was forced to amortize (spread out) these costs over five years, artificially inflating taxable income and creating an unexpected cash tax burden. The restoration allows for an immediate tax shield. You can see the magnitude of this benefit by looking at their investment: Neurocrine Biosciences' GAAP R&D expense guidance for the 2025 fiscal year is between $960 million and $1,010 million.

The immediate expensing of this nearly $1 billion R&D spend will significantly reduce the company's 2025 taxable income, freeing up capital that can be immediately reinvested into the pipeline. Plus, the new law gives the option to accelerate the deduction of previously capitalized R&D costs from 2022-2024, which is an additional, one-time cash flow boost in 2025.

• Immediate Deduction: Full expensing of domestic R&D costs starting in 2025.
• Estimated R&D Spend: $960 million to $1,010 million (2025 GAAP guidance).
• Cash Flow Impact: Reduces 2025 taxable income, improving cash flow for pipeline investment.
• Retroactive Benefit: Option to accelerate deduction of unamortized R&D costs from the 2022-2024 period.

Neurocrine Biosciences, Inc. (NBIX) - PESTLE Analysis: Economic factors

When you look at Neurocrine Biosciences, Inc. (NBIX) in late 2025, the economic picture is remarkably strong, giving the company significant insulation from broader market volatility. This financial strength is rooted in high-margin, specialized products and a strategic cash position that allows for self-funded pipeline growth. It's a very attractive economic profile.

Flagship Revenue: Ingrezza Net Product Sales Guidance for Full-Year 2025 is Strong

The core economic driver for Neurocrine Biosciences remains Ingrezza (valbenazine), the treatment for tardive dyskinesia. Management has reaffirmed its full-year 2025 net product sales guidance for Ingrezza, narrowing it to a range of $2.5 billion to $2.55 billion. This consistent, high-value revenue stream is the bedrock of the company's financial model. The guidance reflects strong underlying patient demand and double-digit volume growth, even with some offset from expanded patient access programs that lower the net price per unit. The market for tardive dyskinesia treatment still has significant unmet needs, so this growth is defintely sustainable in the near term.

New Product Growth: Crinecerfont (CRENESITY) Generated $98 Million in Q3 2025 Net Product Sales

The successful launch of Crinecerfont (CRENESITY), a first-in-class treatment for classic congenital adrenal hyperplasia (CAH), is adding a crucial second revenue stream and diversifying the company's economic base. In the third quarter of 2025 (Q3 2025), Crinecerfont net product sales reached $98 million. This is a solid early adoption rate for a rare disease drug, especially considering the launch is still in its early phases. This is a new market the company is essentially building from the ground up, so this quick ramp-up is a great sign.

Here's the quick math on the commercial performance of their two main products in Q3 2025:

Product	Q3 2025 Net Product Sales (Millions)	Year-over-Year Growth
Ingrezza	$687 million	12%
Crinecerfont (CRENESITY)	$98 million	N/A (New Launch)
Total Net Product Sales	$790 million	28%

Financial Strength: Neurocrine Biosciences Maintains a Robust Balance Sheet with Approximately $2.1 Billion in Cash and Marketable Securities

A strong balance sheet is your best defense against economic headwinds, and Neurocrine Biosciences has one. As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling approximately $2.1 billion. This liquid position is a major competitive advantage, enabling the company to fund its extensive research and development (R&D) pipeline-including Phase 3 programs for osavampator in major depressive disorder and direclidine in schizophrenia-without relying on external financing or diluting shareholders. This cash reserve provides significant optionality for future business development, too.

High Margin Business: Gross Profit Margins Remain Exceptionally High, Around 98.24%

The economics of the biopharmaceutical sector, particularly for proprietary, specialized drugs, translate into exceptionally high gross profit margins (Gross Profit divided by Total Revenue). For the quarter ended September 30, 2025, Neurocrine Biosciences reported a gross margin of 98.24%. This is defintely a key competitive edge, as it means nearly all of the revenue from drug sales is available to cover operating expenses, including R&D, and flow through to the bottom line. What this estimate hides is the massive upfront cost of R&D and clinical trials, but once a drug is approved, the margin is incredible. This high margin is a core driver of their ability to self-fund future growth.

• Gross Margin (Q3 2025): 98.24%
• Trailing Twelve Months (TTM) Gross Profit (as of Sep. 2025): $2,639 million

Neurocrine Biosciences, Inc. (NBIX) - PESTLE Analysis: Social factors

Aging Demographics

The aging population in the US and globally represents a primary tailwind for Neurocrine Biosciences, Inc. (NBIX), as neurological and neuropsychiatric disorders are often age-related. The sheer scale of the market opportunity, driven by this demographic shift, is massive. The global Central Nervous System (CNS) Therapeutics Market is projected to be valued at approximately $163.8 billion in 2025, with age-related neurodegenerative conditions like Alzheimer's and Parkinson's being key drivers.

This demographic reality means the patient pool for NBIX's core focus areas, such as Tardive Dyskinesia (TD) which is treated by INGREZZA (valbenazine), will only continue to expand. You are looking at a sustained, long-term demand curve here, not a short-term spike. The US CNS Therapeutics Market alone is anticipated to reach a value of $56.1 billion in 2025.

Unmet Need Focus

NBIX's strategy of targeting under-addressed neurological and neuropsychiatric disorders limits direct competition and creates a strong value proposition. This focus on high-unmet-need conditions is a core social advantage, leading to faster adoption and better pricing power. For example, CRENESSITY (crinecerfont) is the first new non-steroidal treatment approved for classic congenital adrenal hyperplasia (CAH) in over 70 years, a powerful differentiator.

The company's existing product, INGREZZA, which treats TD, continues to be the primary revenue driver, with the 2025 net product sales guidance narrowed to a range of $2.5 billion to $2.55 billion. This financial performance is a direct result of addressing a significant, previously overlooked patient need. Here's the quick math on the new launch: CRENESSITY generated $14.5 million in net product sales in the first quarter of 2025.

Patient Advocacy

Patient advocacy for rare diseases like classic CAH is intense and highly organized, creating a powerful social driver for CRENESSITY. High patient demand for the first new treatment in decades is evident in the early uptake metrics. The launch saw 413 patient enrollment forms for CRENESSITY submitted in the first quarter of 2025.

To support this demand and ensure access, NBIX established the Neurocrine Access Support program, which includes substantial financial assistance. This comprehensive support system is critical for rare disease treatments and shows the company's commitment to the patient community. Most commercially insured patients may pay as little as $0 per month for the prescription through the CRENESSITY Savings Program.

NBIX Product/Program	2025 Key Social/Financial Metric	Strategic Implication
INGREZZA Net Sales Guidance	$2.5 billion - $2.55 billion (2025)	High, sustained patient demand for an established unmet need solution.
CRENESSITY Q1 Net Sales	$14.5 million (Q1 2025)	Quantifies the immediate financial impact of a 'first-in-70-years' rare disease therapy.
CRENESSITY Patient Enrollment	413 patient enrollment forms (Q1 2025)	Direct measure of high patient advocacy and initial uptake for the new drug.
CNS Therapeutics Market Size	$163.8 billion (Global, 2025 Projection)	Confirms a massive, growing target market driven by aging demographics.

Stigma Barrier

Stigma remains a defintely significant barrier, particularly for neuropsychiatry drugs, which can limit the ultimate patient pool size. Public stigma causes delayed diagnosis and treatment-seeking behaviors, which means a smaller, addressable market than the true prevalence of the disease.

However, the social trend is shifting. Growing public awareness and efforts to destigmatize mental health are leading to higher diagnosis rates. The global neuropsychiatric disorders and treatment market is projected to be $153.9 billion in 2025, showing that the market is expanding despite the barrier. NBIX is positioned well, as mental health disorders are expected to dominate the broader CNS therapeutics market, capturing a 43.3% revenue share by the end of 2025.

The opportunity is in education and targeted outreach. The stigma is a headwind, but the underlying need is huge, and the company is advancing programs for major depressive disorder and schizophrenia, two areas where public education is increasing.

• Stigma causes delayed diagnosis and treatment-seeking.
• Mental health disorders will account for 43.3% of CNS market revenue by 2025.
• Increased awareness is helping to reduce the treatment gap.

Neurocrine Biosciences, Inc. (NBIX) - PESTLE Analysis: Technological factors

The technological landscape for Neurocrine Biosciences is defined by its aggressive R&D strategy, which focuses on both pipeline diversification and novel delivery systems. This approach is generating a steady flow of high-value clinical assets, but it also creates a dependence on external manufacturing technology and partners for execution. The technology here isn't just about the drug mechanism; it's about the delivery and the supply chain.

Pipeline Depth: Expanding R&D pipeline to 17 programs by the end of 2025, diversifying beyond small molecules into peptides and biologics.

Neurocrine Biosciences is defintely pushing the boundaries of its core neuroscience focus, which is a smart move to mitigate single-asset risk. By the end of the 2025 fiscal year, the company plans to have an expansive R&D pipeline comprising 17 programs in various stages of development.

This expansion is significant because it marks a technological shift away from being solely a small molecule company. The pipeline now deliberately includes multi-modality approaches, incorporating both peptides and biologics alongside its traditional small molecule expertise.

Here's the quick math: Diversifying the modalities means the company can target a wider array of biological pathways, which is crucial for complex neurological and endocrine disorders. It's a move from a single-engine plane to a multi-engine fleet.

• Total Programs (EOP 2025): 17
• Modalities: Small Molecules, Peptides, Biologics
• R&D Focus: Neurology, Neuroendocrinology, Neuropsychiatry

Late-Stage Assets: Advancing two Phase 3 registrational programs: Osavampator (Major Depressive Disorder) and NBI-'568 (Schizophrenia).

The near-term technological opportunity lies in two late-stage assets that could redefine treatment standards in major CNS disorders. Both are novel mechanisms of action (MOAs), which is a huge technological advantage over me-too drugs.

Osavampator, a potential first-in-class AMPA positive allosteric modulator (PAM), entered its Phase 3 registrational program for Major Depressive Disorder (MDD) in January 2025. This compound targets a patient population-the more than one-third of MDD sufferers who have an inadequate response to current antidepressants-where new technology is desperately needed.

The second key asset, NBI-'568 (direclidine), an oral muscarinic M4 selective receptor agonist, initiated its Phase 3 registrational program for schizophrenia in April/May 2025. The Phase 3 trial is a global, double-blind, placebo-controlled study expected to enroll approximately 280 patients. Its selective MOA is a technological leap, aiming to provide antipsychotic efficacy with a potentially improved safety profile compared to older, less selective agents.

Late-Stage Asset	Indication	Mechanism of Action (MOA)	Phase 3 Initiation (2025)
Osavampator	Major Depressive Disorder (MDD)	AMPA Positive Allosteric Modulator (PAM)	January 2025
NBI-'568 (direclidine)	Schizophrenia	Muscarinic M4 Selective Receptor Agonist	April/May 2025

Manufacturing Reliance: Dependence on third-party manufacturers (Contract Development and Manufacturing Organizations or CDMOs) for drug production and supply chain continuity.

While the R&D is internal, the manufacturing is largely outsourced to Contract Development and Manufacturing Organizations (CDMOs). This is a strategic choice, not a weakness, as it allows Neurocrine to direct capital-like its approximately $1.8 billion in cash and investments as of Q2 2025-to maximize commercial opportunities for products like INGREZZA and CRENESSITY, and to fuel R&D.

The risk here is a loss of control over the supply chain, but the company manages this with rigorous technological oversight. This includes conducting annual supply chain risk assessments and performing biannual product safety audits on every Good Manufacturing Practice (GMP) manufacturer. That's a strong process, but still, your product's availability hinges on a third party's technology and compliance.

Innovative Delivery: Development of a long-acting formulation for Crinecerfont is expected to improve patient adherence.

The technology of drug delivery is just as critical as the drug itself, especially for chronic conditions. Crinecerfont (CRENESSITY), the first-in-class oral treatment for classic Congenital Adrenal Hyperplasia (CAH), was approved and launched in 2025 in capsule and oral solution formulations.

To further improve patient adherence, which is a major challenge in chronic disease management, Neurocrine is actively working on next-generation formulations. Specifically, the company is developing a potential subcutaneous option for CRENESSITY patients. A subcutaneous, or under-the-skin, injection could transform a twice-daily oral regimen into a less frequent, long-acting dose, which would be a significant technological win for patient quality of life and compliance.

Neurocrine Biosciences, Inc. (NBIX) - PESTLE Analysis: Legal factors

Patent Defense: Ongoing patent litigation (e.g., against Zydus) to defend the intellectual property for Ingrezza Sprinkle.

The core of Neurocrine Biosciences' valuation rests on its intellectual property (IP) fortress, and defending it is a constant, high-stakes legal battle. You saw this play out recently with the new formulation, Ingrezza Sprinkle. The company filed lawsuits against Zydus Lifesciences Ltd. on April 25, 2025, in the District of Delaware and District of New Jersey. This action was a direct response to Zydus seeking approval for a generic version of the sprinkled-granules formulation of valbenazine, which is the active ingredient in Ingrezza Sprinkle.

The company is defending 20 patents in this specific litigation, a clear sign of their aggressive 'patent thicket' strategy to deter generic entry. For context, the original Ingrezza (non-Sprinkle) litigation was settled in November 2023 with four companies, including Zydus and Lupin, allowing generic entry for that formulation as early as March 1, 2038. This new litigation over the Sprinkle formulation, which was only approved by the FDA on April 30, 2024, is defintely a key action to extend market exclusivity for the franchise.

Long-Term Exclusivity: Ingrezza's generic launch date is estimated to be as late as August 10, 2040, based on the combined patent and exclusivity landscape.

For a seasoned investor, the most critical legal number is the generic launch date. While the settlement for the original Ingrezza capsules pushes generic entry to March 1, 2038, the combined strength of all patents and exclusivities-including the new ones for the Ingrezza Sprinkle formulation-suggests a much longer runway. The estimated generic launch date for the Ingrezza franchise, based on the last expiry date of its combined patents and exclusivities, is August 10, 2040. This is your long-term revenue visibility.

Here's the quick math: Ingrezza is projected to hit net sales between $2.5 billion and $2.6 billion for the full 2025 fiscal year, with Q3 2025 alone bringing in $687 million in Ingrezza net sales. Protecting this revenue stream for an additional two years past the initial 2038 settlement date, all the way to 2040, is a multi-billion dollar strategic effort.

Ingrezza Exclusivity Milestone	Estimated Date/Value	Legal Impact
Original Ingrezza Generic Settlement Date (Lupin, Zydus, etc.)	March 1, 2038	First possible generic entry for original capsule formulation.
Longest Estimated Generic Launch Date (Combined IP)	August 10, 2040	Maximum revenue protection for the Ingrezza franchise.
Ingrezza Sprinkle Patents-in-Suit Expiry (Example)	October 10, 2037, and September 18, 2038	Specific patents being defended in the 2025 Zydus litigation.
2025 Projected Ingrezza Net Sales	$2.5 Billion to $2.6 Billion	The financial value of the protected market window.

Regulatory Compliance: Adherence to stringent U.S. and international regulations (Good Manufacturing Practices, Good Clinical Practices) is critical for product quality.

Operating in the biopharma space means compliance risk is a constant, non-negotiable cost of doing business. Neurocrine Biosciences maintains a 'robust Quality System' that is the backbone of its regulatory adherence. This system ensures compliance with both U.S. and international regulations, covering the entire product lifecycle from development to distribution.

Key compliance areas are:

• Good Manufacturing Practices (GMP): Ensures products like Ingrezza and Crenessity are consistently produced and controlled according to quality standards.
• Good Clinical Practices (GCP): Governs the ethical and scientific quality of clinical trials, which is vital as the company initiates four Phase I and two Phase II studies in 2025.
• PhRMA Code and OIG Guidance: The Comprehensive Compliance Program is aligned with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code and the Office of Inspector General (OIG) Guidance Documents, which helps mitigate anti-kickback and fraud risks.

The executive management reviews the Quality System regularly, showing that this isn't just a checkbox exercise; it's a top-down priority.

Data Privacy: Need for continuous compliance with evolving data privacy laws like the Health Insurance Portability and Accountability Act (HIPAA) and international equivalents.

As a company heavily involved in clinical trials and patient support programs, Neurocrine Biosciences handles significant volumes of sensitive patient data. This puts continuous pressure on compliance with the Health Insurance Portability and Accountability Act (HIPAA), especially as the regulatory environment tightens in 2025.

The company collects health and medical information from clinical trial participants, patients, and healthcare professionals, all of which must be protected. The legal risk here is not just fines, but the loss of patient and provider trust.

Specifically, the 2025 HIPAA landscape requires heightened security measures and compliance efforts for all covered entities and business associates. This means you have to be vigilant about:

• Encryption by default for electronic Protected Health Information (ePHI) both in transit and at rest.
• Mandatory Multi-Factor Authentication (MFA) for actions that alter user access levels.
• Increased Office for Civil Rights (OCR) focus on patient right of access cases, with stricter penalties expected for repeat violations in 2025.

This evolving regulatory landscape requires continuous investment in IT and legal teams to ensure their systems and vendor agreements meet these new, stricter security and privacy standards. Your next step, as a decision-maker, is to ensure the 2025 IT budget for compliance reflects these mandatory HIPAA updates.

Neurocrine Biosciences, Inc. (NBIX) - PESTLE Analysis: Environmental factors

LEED-Certified Facilities: Fully transitioned to a new LEED silver-eligible corporate headquarters in San Diego to reduce environmental impact.

You need to know where your capital expenditures are delivering tangible environmental returns, and Neurocrine Biosciences' new corporate headquarters in San Diego is a clear example. The company completed the move into its new, purpose-built campus in 2024, designed to be LEED Silver eligible (Leadership in Energy and Environmental Design), a strong signal of intent.

This is a significant footprint change, covering approximately 535,000-square-foot of space. The design choices here are concrete actions, not just talk. They include 100% occupancy and daylighting control LED lights, which cuts down on energy use, plus over 5% of all parking spaces are equipped with EV charging, preparing for the shift in transportation. The building envelope and insulated glass also specifically reduce energy consumption, which is a key operational cost saving. That's a smart, long-term real estate play.

GHG Emissions Focus: Company acknowledges that its products, including Ingrezza, contribute to negative impacts in the Greenhouse Gas (GHG) emissions category.

The core challenge for a biopharma company like Neurocrine Biosciences is that their direct operational footprint is small-they do not manufacture drugs at their own facilities-but their value chain, including outsourced manufacturing, is where the emissions lie.

While the company has a small direct footprint, the regulatory landscape is changing fast. In alignment with the California Climate Corporate Data Accountability Act, Neurocrine Biosciences expects to disclose their fiscal year 2025 Scope 1 and 2 greenhouse gas emission (GHG) data starting in 2026. They also plan to disclose climate-related financial risks biennially. This future disclosure will provide the first public, verifiable numbers on their direct energy and facility emissions, which is a critical new metric for investors.

Here's the quick math on the product side: Ingrezza, their lead product, is forecasted to hit sales between $2.5 billion and $2.6 billion by 2025, meaning the environmental impact of its production and distribution chain (Scope 3 emissions) is substantial, even if indirectly. The company's focus must now shift to tracking those indirect emissions to match the scale of its commercial success.

Supply Chain Risk: Conducts annual supply chain risk assessments and biannual product safety audits on all third-party manufacturers.

Supply chain integrity is a major environmental and operational risk, especially since Neurocrine Biosciences relies entirely on third-party manufacturers for their commercial products.

To mitigate this, the company has a rigorous, scheduled audit process. They conduct annual supply chain risk assessments and perform biannual product safety audits on every Good Manufacturing Practice (GMP) manufacturer. This goes beyond mere compliance; it's about business continuity. Plus, every contract manufacturer must adhere to the Neurocrine Biosciences Supplier Code of Conduct and quality standards, which are enshrined in their Supply Agreements.

The rigor of this process is a key risk mitigator:

• Conduct annual supply chain risk assessments.
• Perform biannual product safety audits on all GMP manufacturers.
• Assess suppliers' corporate responsibility efforts on an annual basis.

This is a defintely necessary level of oversight in a non-vertically integrated model.

Sustainability Reporting: A member of the Biopharma Sustainability Roundtable (BSRT), aligning with industry-specific ESG standards like SASB.

Neurocrine Biosciences is moving past generic corporate social responsibility by adopting industry-specific reporting frameworks, which provides clarity for financial analysis.

The company is a proud member of the Biopharma Sustainability Roundtable (BSRT), a platform designed to align sustainability agendas across the biotech and pharma sectors. This membership shows commitment to sector-specific best practices.

Their reporting is guided by two critical frameworks:

• Sustainability Accounting Standards Board (SASB): Specifically, the Biotechnology and Pharmaceuticals standard, which focuses on financially material sustainability topics for the industry.
• Task Force on Climate-related Financial Disclosures (TCFD): This framework pushes the company to analyze and disclose the financial risks and opportunities associated with climate change.

Oversight for all environmental programs and initiatives is delegated to the Nominating / Corporate Governance Committee of the Board of Directors, which ensures environmental strategy is a C-suite priority, not just a departmental one.

Environmental Factor	FY2025 Status / Commitment	Key Metric / Number
Headquarters Status	New San Diego campus fully transitioned.	535,000-square-foot facility; LEED Silver eligible.
GHG Emissions Disclosure	Committed to public disclosure in 2026.	FY 2025 Scope 1 and 2 GHG data disclosure expected in 2026.
Supply Chain Audits	Ongoing risk mitigation for GMP manufacturers.	Annual risk assessments; biannual product safety audits on every GMP manufacturer.
Sustainability Alignment	Adherence to industry-specific frameworks.	Member of BSRT; Reporting aligns with SASB and TCFD standards.