ADMA Biologics, Inc. (ADMA): PESTLE Analysis [Nov-2025 Updated]

You know ADMA Biologics is on a serious growth trajectory, with analysts projecting 2025 revenue to hit around $325 million, but that doesn't tell the whole story. The company's success is defintely tied to external forces-specifically, the tight grip of the U.S. Food and Drug Administration (FDA) on manufacturing, the volatile cost of sourcing raw plasma, and the long-term threat from non-plasma-derived alternatives. We need to map these political, economic, and technological currents right now, so you can see where the real risks and opportunities lie beneath the headline numbers.

ADMA Biologics, Inc. (ADMA) - PESTLE Analysis: Political factors

Continued scrutiny by the U.S. Food and Drug Administration (FDA) on plasma center compliance and manufacturing standards

The U.S. Food and Drug Administration (FDA) maintains intense, ongoing scrutiny over the plasma industry, which is a constant political reality for ADMA Biologics. This isn't a simple risk; it's the cost of doing business in a highly regulated, life-saving sector. The upside is that ADMA's recent success in gaining regulatory approval for its innovative yield enhancement production process in April 2025 is a massive operational de-risker. This approval, which is expected to boost production yields by approximately 20% from the same starting plasma volume, validates the company's compliance and quality systems. This regulatory win is a key driver for the company's raised fiscal year 2025 Total Revenue guidance to at least $510 million. Compliance is a competitive advantage here.

ADMA's end-to-end model, where its ADMA BioCenters subsidiary operates FDA-licensed source plasma collection facilities, gives it direct control over the entire supply chain, from donor screening to final product. This vertical integration helps them manage the rigorous Current Good Manufacturing Practice (cGMP) standards more effectively than companies relying solely on third-party plasma suppliers. The FDA's Center for Biologics Evaluation and Research (CBER) also continues to issue guidance on blood and blood components, ensuring the regulatory bar remains high for all manufacturers.

Government reimbursement policies, particularly from the Centers for Medicare & Medicaid Services (CMS), directly affecting IG product pricing

CMS reimbursement policy is a critical political factor because it dictates the payment landscape for ADMA's core products, BIVIGAM and ASCENIV (Immune Globulin, or IG) therapies. For patients with Primary Immunodeficiency Disease (PIDD), Medicare Part B now permanently covers the items and services for in-home IVIG administration, which is a major access win.

The key financial lever is the separate, bundled payment for the administration services (HCPCS code Q2052), which is distinct from the payment for the drug product itself. For calendar year 2025, the allowable fee schedule amount for this bundled administration payment is $431.83 per visit. This payment is subject to an annual increase based on the home health update percentage increase, starting in 2025. So, while the policy supports patient access, the specific rate adjustments from CMS are a constant factor in revenue modeling for the entire IG market.

Here's a quick look at how the CMS codes apply to ADMA's products:

Potential for U.S. trade policies to impact international plasma sourcing and finished product distribution

The current U.S. political climate, particularly the imposition of new tariffs in 2025, has created significant supply chain uncertainty for the broader pharmaceutical industry. This is where ADMA's domestic manufacturing footprint becomes a defintely valuable political hedge. New U.S. trade policies, including a blanket 10% import duty effective in April 2025 and threats of tariffs up to 100% on branded pharmaceuticals not produced domestically, are forcing global competitors to re-evaluate their supply chains.

ADMA's entire supply chain-from plasma collection through fractionation and final fill/finish-is U.S.-based. This shields them from the direct cost increases and supply disruptions hitting companies that rely on Active Pharmaceutical Ingredients (APIs) from China and India, where tariffs of up to 25% are in play. The company's domestic production aligns with growing federal and private sector preferences for U.S.-made products, enhancing its supply chain resilience and regulatory compliance. This is a clear, actionable opportunity for ADMA to gain market share against globally dependent rivals.

Legislative efforts to streamline or complicate the approval process for new plasma-derived therapies

The political and regulatory environment is showing signs of potentially streamlining the path for certain new biologics, which is an opportunity for ADMA's pipeline. In November 2025, the FDA unveiled a 'plausible mechanism pathway,' designed to speed up approval for highly individualized therapies, including biologics, for rare diseases or conditions with high unmet need, potentially bypassing some traditional randomized controlled trials.

ADMA's lead R&D pipeline program, SG-001, is a hyperimmune globulin targeting S. pneumonia. The company anticipates generating initial proof-of-concept animal data before year-end 2025. If the target patient population for SG-001 can be framed as having a high unmet need, this new pathway could significantly accelerate its time to market. SG-001 is a huge potential upside, with ADMA projecting it could generate $300-500 million or more in high-margin annual revenue. The focus on expedited pathways for unmet needs is a political tailwind for specialty biopharma innovation.

• Anticipate the new FDA 'plausible mechanism pathway' could accelerate the approval timeline for pipeline candidates like SG-001.
• Monitor the home health update percentage increase for 2026 to model the next CMS rate adjustment for the Q2052 administration fee.
• Emphasize the U.S. manufacturing advantage in all distribution and contracting discussions to capitalize on the 2025 tariff environment.

ADMA Biologics, Inc. (ADMA) - PESTLE Analysis: Economic factors

Analyst consensus projects ADMA Biologics' 2025 revenue to reach approximately $510 million, a significant jump from prior years.

You need to look past the old consensus numbers. Based on the company's Q3 2025 financial results, ADMA Biologics has raised its full-year 2025 total revenue guidance to at least $510 million. This is a massive jump, reflecting a strong tailwind from product demand and operational improvements. For context, this is a significant acceleration from their prior year performance. The company's Adjusted EBITDA for FY 2025 is also reaffirmed at $235 million.

Here's the quick math on profitability: The revised guidance implies a strong net income trajectory. The forecast for FY 2025 Adjusted Net Income is approximately $158 million. This financial strength allows ADMA Biologics to self-fund growth and manage capital structure effectively, something smaller biopharma companies defintely struggle with.

High and volatile cost of goods sold (COGS) due to intense competition for plasma donors and raw material acquisition.

The core economic challenge in the plasma-derived therapies space is the cost of goods sold (COGS), specifically the raw material: human plasma. Plasma is a costly, complex raw material, and competition for donors remains intense, which drives up donor compensation and acquisition costs. We saw this volatility reflected in ADMA's Q3 2025 results, which included a one-time sale of normal source plasma at a negative margin to optimize working capital.

However, ADMA Biologics is actively mitigating this COGS pressure through manufacturing innovation. The FDA approval of their yield-enhanced production process is a game-changer. This process is expected to increase finished Immunoglobulin (IG) output by approximately 20% from the same starting plasma volume. This operational efficiency directly reduces the effective cost per gram of final product, which is why gross margin is expanding.

• Q3 2025 Gross Margin: 56.3%, up from 49.8% in Q3 2024.
• Product-Level Gross Margin (Excluding Plasma Sale): Approximately 63.7% in Q3 2025.
• Margin Expansion Driver: FDA lot release of yield-enhanced batches, expected to accelerate margin gains starting in Q4 2025.

Inflationary pressures on manufacturing, energy, and labor costs impacting gross margin expansion.

Like every U.S. manufacturer, ADMA faces persistent inflationary pressures. While the gross margin is expanding due to product mix and yield enhancement, the tailwinds of rising costs for energy, chemicals, and labor are real. We see this in the rise of their total operating expenses, which have increased, largely driven by higher personnel costs and professional fees. That's just the cost of doing business in a tight labor market.

The company's strategy is to outrun these cost increases with higher-margin product sales. The shift toward ASCENIV, a higher-margin proprietary product, is the primary lever. What this estimate hides, though, is that sustained, high inflation could eat into the projected net margin expansion if the yield-enhancement benefits don't materialize as quickly as anticipated. They are managing costs, but the external economic environment is still a headwind.

Strong, non-cyclical demand for life-saving IG therapies provides revenue stability, but pricing power is still limited by large competitors.

The demand for IG therapies is fundamentally non-cyclical; people with primary immunodeficiency disorders (PIDD) or other autoimmune conditions need these treatments regardless of the broader economy. This provides a strong, stable revenue floor for ADMA. The U.S. Immunoglobulin G (IgG) replacement therapy market is stable and valued at approximately $14.614 billion in 2025, with the global market projected to reach $20 billion by 2030.

Still, ADMA operates in an oligopoly (a market dominated by a few large firms). Pricing power is constrained because the market is dominated by a few major, vertically integrated players. These large competitors own about 94% of the total sales, so ADMA is still fighting for market share. The major players you need to watch are:

• CSL Behring (Australia)
• Grifols (Spain)
• Takeda Pharmaceutical Company Limited (Japan)
• Octapharma AG (Switzerland)

ADMA's competitive advantage isn't broad pricing power, but rather their niche focus and the differentiated profile of ASCENIV, which allows them to command a premium within their specific patient population. They are also actively negotiating with payers for enhanced 2026 reimbursement and access, which is the real battleground for price realization.

ADMA Biologics, Inc. (ADMA) - PESTLE Analysis: Social factors

Social factors are a core driver for ADMA Biologics, Inc. because the business model relies entirely on a steady, ethical supply of human plasma and a growing, well-diagnosed patient population for its Immunoglobulin (IG) therapies like BIVIGAM and ASCENIV. This is a supply-and-demand dynamic with deep social and ethical roots.

Public perception and acceptance of paid plasma donation programs, directly influencing raw plasma supply volumes.

The US system of compensated plasma donation is a critical social factor, as it is the primary reason the United States supplies approximately 65% of the world's plasma, providing a massive raw material advantage to domestic manufacturers like ADMA Biologics, Inc.. Public perception is generally positive regarding the end product-a survey in late 2025 found that 72% of Americans agree plasma-derived medicines can save lives.

However, the donor pool itself is sensitive to economic and social conditions. Donors are often low-income individuals who rely on the compensation-which can be up to $800 per month for new, frequent donors-for essential living expenses. This financial incentive is what drives the high frequency of donation (up to twice a week) that the US system allows. The social benefit is tangible: one study indicated that the presence of a plasma center can reduce local crime rates by 12% and reduce the demand for high-interest payday loans by 13% in low-income areas, providing a legal source of supplementary income.

The challenge is that eight in ten Americans have never donated, often citing a lack of knowledge about the process. This means the supply is concentrated among a smaller, economically vulnerable population, creating a social risk if public or regulatory sentiment were to shift against compensated donation, or if economic conditions improved enough to reduce the need for this supplemental income.

Growing awareness and diagnosis rates of Primary Immunodeficiency Diseases (PIDD) increasing the patient pool for ADMA's products.

Increased public and physician awareness of Primary Immunodeficiency Diseases (PIDD), which ADMA's products BIVIGAM and ASCENIV treat, is a significant tailwind for revenue growth. While an estimated one in every 1,200 people in the U.S. is diagnosed with a PIDD, experts believe up to 500,000 Americans may remain undiagnosed. The diagnosis rate has been expanding, with one report noting a 30% prevalence expansion between 2001 and 2007 due to better diagnostic methods.

This growing patient pool directly drives the market for Immunoglobulin (IG) replacement therapy. The global market for Primary Immunodeficiency Disorders is projected to be valued at approximately $8.41 Billion in 2025, and the Immunoglobulin Replacement Therapy segment accounted for the dominant market share of 61.6% in 2024. Demand is clearly rising: there was a 19% overall increase in patients receiving IgG therapy and a 7% increase in patients receiving Intravenous Immunoglobulin (IVIG) in a recent period. This market expansion underpins ADMA's projected 2025 Total Revenue Guidance of over $500 million.

Patient advocacy groups influencing reimbursement decisions and access to specific IG formulations like BIVIGAM and ASCENIV.

Patient Advocacy Groups (PAGs), such as the Immune Deficiency Foundation (IDF), are highly influential social forces in the rare disease space. These groups actively lobby policymakers and payers (insurance companies) to ensure and protect patient access to immunoglobulin (Ig) replacement therapy. This advocacy is crucial because it directly impacts the commercial viability of ADMA's products, BIVIGAM and ASCENIV, by fighting for favorable reimbursement policies.

Their focus is on:

• Protecting coverage for specific IG products, ensuring patients can receive the formulation (like ASCENIV, an Intravenous Immunoglobulin with a unique RSV antibody profile) recommended by their physician.
• Influencing the approval of various modes of administration (IVIG vs. SCIG) and sites of care (hospital, infusion center, or home care).
• Broadening plasma donation access and awareness to secure the raw material supply for these life-saving therapies.

The success of these PAGs in maintaining broad coverage is a non-financial, social factor that directly supports ADMA's sales volume and pricing power in the US market.

Labor shortages in specialized manufacturing and plasma collection centers, pushing up operational expenses.

The plasma collection and biomanufacturing sector faces persistent labor market tightness, which puts upward pressure on operational expenses. A tight labor market and wage inflation pressures have been noted as contributors to increased customer care and variable costs across the plasma industry in 2025.

For ADMA BioCenters, the subsidiary that manages plasma collection, this means higher recruitment, training, and retention costs for specialized staff like phlebotomists, nurses, and technicians. The average hourly pay for a Plasma Donor job in the US is around $18.95 as of November 2025, but specialized roles like Plasma Center Manager can command a salary of over $57,000 annually. High employee turnover remains a key cost driver in plasma collection.

While ADMA Biologics, Inc. is mitigating its raw material cost risk through a new FDA-approved yield enhancement process that increases production output by approximately 20% from the same starting plasma volume, the labor cost component of the overall operational expense remains a structural challenge. This social factor-the availability and cost of qualified labor-is a key variable in sustaining the company's projected Adjusted EBITDA of $235 million for 2025.

ADMA Biologics, Inc. (ADMA) - PESTLE Analysis: Technological factors

Advancements in plasma fractionation technology that could improve product yield and manufacturing efficiency, lowering per-unit cost.

The biggest near-term technological opportunity for ADMA Biologics is the U.S. Food and Drug Administration (FDA) approval of its innovative yield enhancement production process, which happened in April 2025. This isn't just a small tweak; it's a fundamental improvement in how they make their products. The new technology is designed to boost production yields by approximately 20% from the exact same starting volume of plasma.

Here's the quick math: generating 20% more finished product like ASCENIV and BIVIGAM from the same raw material input dramatically lowers the per-unit cost of goods sold. This is a key inflection point, expected to drive significant gross margin expansion starting in the fourth quarter of 2025 and accelerating through 2026.

This yield enhancement is a major competitive edge, especially since ADMA Biologics is the first U.S. producer of plasma-derived products to get regulatory approval for this kind of process. It's a smart move that modernizes a very traditional manufacturing process.

Increased use of automation and data analytics in plasma collection centers to improve donor screening and throughput.

The plasma collection side of the business, run by ADMA BioCenters, is defintely leaning into technology to improve efficiency and donor experience. This is crucial because collecting high-quality plasma is the bottleneck for the entire manufacturing pipeline. ADMA's state-of-the-art collection centers feature automated registration and high-tech collection equipment designed to shorten the donation process.

While the company hasn't released specific 2025 metrics on data analytics for donor screening, the operational goal is clear: increase throughput. A key metric showing this focus is the expansion of their high-titer plasma sourcing. Through long-term contracts with third-party suppliers, ADMA has secured access to plasma from approximately 250 collection centers, representing a 5-fold increase in total collection capacity. That's a massive scale-up.

Need to invest in facility upgrades to maintain compliance with the latest FDA Current Good Manufacturing Practice (cGMP) standards.

Maintaining FDA Current Good Manufacturing Practice (cGMP) compliance requires constant capital investment-it's the cost of staying in the game. ADMA Biologics made a significant, concrete investment in 2025 to secure future cGMP capacity and operational flexibility. In July 2025, the company completed the purchase of a facility on five acres of land adjacent to its Boca Raton manufacturing campus for $12.5 million.

This investment is strategic, not just maintenance. It has the potential to expand cGMP manufacturing space by up to 30% at peak, plus it adds critical infrastructure like increased cold storage, warehousing, and in-house testing capabilities.

The total cash outlay for this facility expansion was approximately $12.6 million, settled during the third quarter of 2025. This disciplined capital deployment is aimed at supporting their projected growth trajectory, which includes a long-term revenue target of over $1.1 billion prior to 2030.

Development of alternative, non-plasma-derived therapies for immune deficiencies poses a long-term competitive risk.

While ADMA Biologics is focused on optimizing its plasma-derived products, the long-term competitive landscape is shifting away from plasma as the sole source. The Primary Immune Deficiency (PID) market, which is expected to reach $9.9 billion by 2035, is seeing significant growth in non-plasma-derived treatments.

You need to watch the rise of these alternative approaches, which could eventually displace or limit the growth of traditional immunoglobulin (IG) therapies like ASCENIV and BIVIGAM. The main threats are:

• Gene Therapy and Stem Cell Transplants: These offer potential cures, not just chronic management, for PID disorders.
• Innovative Biologics: New, targeted non-plasma biologics and immunomodulators are being explored to restore immune system balance.
• Advanced Cell Therapies: Allogeneic CAR-T cell therapies, which use engineered cells instead of plasma, are showing promising early clinical data in B-cell mediated autoimmune diseases like lupus. Fate Therapeutics' FT819 is an example, demonstrating the potential for an 'immune reset' without the need for plasma.

This risk is long-term, but it's real. The technology is moving toward non-plasma solutions, so ADMA's internal R&D, like the pre-clinical SG-001 program, needs to keep pace.

ADMA Biologics, Inc. (ADMA) - PESTLE Analysis: Legal factors

Complex intellectual property (IP) landscape surrounding plasma purification and viral inactivation processes.

The core of ADMA Biologics' value is its robust intellectual property (IP) portfolio, which protects its proprietary manufacturing methods and product formulations. This IP is critical in the highly competitive plasma-derived therapeutics market, but it also makes the company a target for litigation. The company's lead product, ASCENIV (Immune Globulin Intravenous, Human - slra 10% liquid), has key patents securing its brand protection through at least 2035, with the potential for further extensions.

The recent FDA approval of ADMA's innovative yield enhancement production process in 2025 is a significant regulatory and IP asset, as it allows for an approximately 20% increase in production output from the same starting plasma volume. This proprietary process differentiates ADMA and is a key component of its projected gross margin expansion. Still, defending this complex IP requires substantial legal resources. For instance, ADMA was involved in patent litigation, such as the case ADMA Biologics, Inc. v. Leinco Technologies, Inc., filed in the District of Delaware in April 2025, which shows the active legal front in protecting its technology.

The IP protection for the company's pipeline asset, SG-001, a hyperimmune globulin targeting S. pneumonia, is anticipated to extend through at least 2037, providing a long runway for future high-margin revenue generation.

Strict adherence to international and U.S. laws governing the collection, testing, and transport of human biological materials.

Operating in the plasma industry means navigating an extremely stringent regulatory environment, especially concerning the collection and handling of human biological materials. ADMA Biologics' strategic advantage is its completely U.S.-based, end-to-end supply chain, which includes its manufacturing facility in Boca Raton, Florida, and its plasma collection centers. This domestic footprint is a deliberate move to enhance supply chain resilience and regulatory compliance, aligning with increasing federal and private sector preferences for U.S.-made products.

Compliance with U.S. Food and Drug Administration (FDA) regulations is a continuous, high-cost effort, covering everything from donor screening protocols to viral inactivation processes. Any compliance failure could result in costly shutdowns or product recalls.

Ongoing legal costs associated with maintaining a large, multi-state network of licensed plasma collection centers.

The cost of maintaining a compliant, multi-state plasma collection network is a significant operational expense, falling under the broader umbrella of General and Administrative (G&A) costs. ADMA's raw material supply chain relies on its internal ADMA BioCenters network of 10 plasma collection centers, plus long-term contracts with third parties that source high-titer plasma from approximately 250 collection centers.

The legal and regulatory burden is twofold: managing the internal centers and ensuring the 250 third-party centers meet ADMA's exacting standards. This involves continuous legal review of contracts, state-by-state licensing, and adherence to varying local regulations. You have to pay to play in this market.

A clear example of this evolving state-level regulatory risk is the New Jersey Assembly Bill 5,592, which was released by a committee in October 2025. This measure would require a new, tailored annual license for source plasma donation centers, moving them from the traditional 'blood bank' classification. While this may streamline operations in the long run, each new state-specific licensing requirement adds immediate legal and administrative overhead to the cost of maintaining the network.

Potential for new federal or state legislation on donor compensation and data privacy (HIPAA) impacting operations.

The regulatory environment for plasma is constantly shifting, especially around donor rights and data security.

• Donor Compensation: While no federal law currently mandates a specific compensation rate, the industry faces ongoing political pressure. The introduction of the bipartisan Preserving Life-saving Access to Specialty Medicines in America (PLASMA) Act in February 2025 shows a heightened legislative focus on the plasma supply chain, which could eventually lead to regulations impacting donor remuneration or collection center operations.
• Data Privacy (HIPAA): New 2025 HIPAA updates have significantly tightened cybersecurity and breach notification rules. These changes directly impact ADMA's BioCenters, which are covered entities or business associates. Key new mandates include:
  • Reducing the breach notification window from 60 days to 30 days.
  • Mandating the implementation of Zero Trust security frameworks.
  • Requiring Multi-Factor Authentication (MFA) for all access points to electronic Protected Health Information (ePHI).

The financial risk from data privacy failures is real and high. The plasma industry saw a major data breach settlement in October 2025 involving Octapharma Plasma, where claimants could receive up to $5,000 for documented losses, demonstrating the severe financial consequences of non-compliance with data privacy laws. This kind of risk is why compliance costs will defintely rise in 2025.

ADMA Biologics, Inc. (ADMA) - PESTLE Analysis: Environmental factors

You are operating in a highly regulated environment where environmental compliance directly impacts your Cost of Goods Sold (COGS) and supply chain stability. The push for sustainability is no longer a soft public relations issue; it's a hard financial metric, especially with new 2025 waste regulations and the growing, quantifiable risk from climate-related disruptions to your plasma collection network.

Here's the quick math: If ADMA can increase its plasma collection center output by just 10% in 2025, that directly lowers the per-liter cost of its raw material, boosting the gross margin, which is already strong at 56.3% for Q3 2025. Finance: Track the plasma collection center expansion schedule against the COGS trend weekly.

Stringent regulations for the disposal of biohazardous waste generated during plasma collection and fractionation.

The regulatory landscape for biohazardous waste is tightening significantly in 2025, creating both compliance risk and operational cost pressure. The U.S. Environmental Protection Agency (EPA) is driving state-level enforcement of the 40 CFR Part 266 Subpart P regulations for hazardous waste pharmaceuticals, which is a major compliance focus for facilities like ADMA's plasma centers and fractionation plant. A critical element is the nationwide ban on the sewering-flushing or pouring down the drain-of any hazardous waste pharmaceuticals, which requires updated internal protocols and new disposal contracts.

ADMA's operations, which generate sharps, contaminated materials, and pharmaceutical waste, must ensure a secure chain of custody and proper labeling to avoid hefty fines and reputational damage. Honestly, compliance is not a one-time fix; it requires continuous training and process updates as federal and state rules evolve, sometimes on an annual basis.

Pressure from investors and stakeholders for greater supply chain sustainability and reduced energy consumption in manufacturing.

Investor scrutiny on Environmental, Social, and Governance (ESG) factors is increasing, which means ADMA's energy consumption in its Boca Raton, Florida, fractionation facility is under the microscope. Manufacturing plasma-derived biologics is an energy-intensive process due to the need for continuous refrigeration and complex purification steps.

ADMA's fully U.S.-based, vertically integrated supply chain is a key strategic advantage for resilience and regulatory compliance, but it also means the company is fully accountable for its domestic environmental footprint. The July 2025 acquisition of a $12.5 million adjacent facility, which will support up to a 30% increase in cGMP manufacturing capacity, presents a clear opportunity to integrate energy-efficient technologies into the new infrastructure. Investors are defintely looking for concrete metrics on energy reduction, not just broad statements.

Key areas for sustainability focus include:

• Reducing energy use in the new 30% cGMP capacity expansion.
• Optimizing water use in the plasma fractionation process.
• Implementing waste minimization strategies beyond regulatory compliance.

Need for robust cold chain logistics to minimize product spoilage, which has a direct environmental and financial cost.

Maintaining the cold chain-the uninterrupted series of refrigerated production, storage, and distribution activities-is non-negotiable for plasma-derived biologics. Failure here is a direct financial hit and an environmental waste of scarce human-derived raw material.

The biopharma industry loses approximately $35 billion annually due to failures in temperature-controlled logistics, underscoring the high stakes. ADMA's investment in its Boca Raton expansion, which specifically includes 'increased cold storage capabilities,' directly addresses this risk. The plasma collected from the network of approximately 250 collection centers must be flash-frozen and stored at ultra-low temperatures, making the logistics from the collection center to the manufacturing facility a critical control point. Every spoiled batch of plasma represents a financial loss, a waste of energy used in collection and transport, and a loss of product for an immunocompromised patient.

Climate change-related disruptions, such as severe weather, posing a risk to the stability of the plasma collection network.

Climate change introduces near-term operational risks, particularly for a U.S.-based supply chain with a significant footprint in the Southeast. ADMA's Boca Raton facility is in a region highly susceptible to severe weather events, notably hurricanes.

A major hurricane or flood event could:

• Temporarily shut down the Boca Raton fractionation facility, halting production.
• Disrupt ground transportation, compromising the cold chain for plasma shipments.
• Force the closure of plasma collection centers, which are spread across the U.S.

The reliance on a network of approximately 250 collection centers mitigates the risk of a single-point failure, but a widespread severe weather event (like a major winter storm or regional hurricane cluster) could still impact a significant portion of the raw material supply. This is a strategic risk that requires clear business continuity planning and potentially redundant cold storage capacity in geographically diverse, low-risk areas.