ADMA BIOLOGICS, INC.

Previous wording

We and certain of our directors and officers have been named as defendants in a securities class action lawsuit. This litigation, and any similar or related proceedings that may be filed in the future, could result in substantial costs, divert management’s attention and resources from our business, and may have a material adverse effect on our business, financial condition, results of operations and cash flows.

Current wording

We and certain of our directors and officers have been named as defendants in a securities class action lawsuit and in derivative actions. This lawsuit and these actions, and any similar or related proceedings that may be filed in the future, could result in substantial costs, divert management’s attention and resources from our business, and may have a material adverse effect on our business, financial condition, results of operations and cash flows.

Previous wording

Our business may be adversely affected by a pandemic, epidemic, or outbreak of an unknown or emerging infections disease.

Current wording

Our business may be adversely affected by a pandemic, epidemic, or outbreak of an unknown or emerging infectious disease.

Previous wording

Although we are utilizing our FDA-approved fill/finish suite that we built at the Boca Facility for a portion of our finished drug product and although we receive raw material plasma from our ADMA BioCenters plasma collection facilities, we also intend to continue to utilize third parties to supplement our fill/finish process for final drug product and to supply high-titer RSV plasma. Any failure by us, our contract fill/finishers, or other third parties involved in the process for producing our products or product candidates to comply with the applicable manufacturing and regulatory requirements, including quality requirements, could place us and themat risk of regulatory enforcement actions, recalls and other adverse consequences, could adversely impact our products or product candidates, and could adversely impact patients receiving our products or product candidates, which may negatively impact our business and our ability to produce and supply products to meet commercial and clinical needs.

Current wording

Although we are utilizing our FDA-approved fill/finish suite that we built at the Boca Facility for a portion of our finished drug product and although we receive raw material plasma from our ADMA BioCenters plasma collection facilities, we also intend to continue to utilize third parties to supplement our fill/finish process for final drug product and to supply high-titer RSV plasma. Any failure by us, our contract fill/finishers, or other third parties involved in the process for producing our products or product candidates to comply with the applicable manufacturing and regulatory requirements, including quality requirements, could place us and them at risk of regulatory enforcement actions, recalls and other adverse consequences, could adversely impact our products or product candidates, and could adversely impact patients receiving our products or product candidates, which may negatively impact our business and our ability to produce and supply products to meet commercial and clinical needs.

Previous wording

Our market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate. In particular, the size and growth of the overall U.S. IVIG and source plasma markets and the potential market opportunity for our products and product candidates, including anS. pneumoniae hyperimmune globulin, are subject to significant variables that can be difficult to measure, estimate or quantify.

Current wording

Our market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates that may not prove to be accurate. In particular, the size and growth of the overall U.S. IVIG and source plasma markets and the potential market opportunity for our products and product candidates, including an S. pneumoniae hyperimmune globulin, are subject to significant variables that can be difficult to measure, estimate or quantify.

Previous wording

We and our suppliers and contractors may be unable to comply with our specifications, cGMP requirements and with other FDA, state, and foreign regulatory requirements for commercial and clinical supply. They and us may need to maintain certain licenses that we or they may not be able to maintain. The FDA and other regulatory authorities are authorized to perform inspections (remotely and in person) of our and our suppliers’ facilities, including the Boca Facility. The FDA and other regulatory authorities also may inspect and approve our and our third-parties’ facilities before they may be used for commercial production. If we or our suppliers are not able to comply with the applicable regulatory requirements, we or they may be subject to regulatory enforcement actions, which can materially impact our business. For instance, at the end of such an inspection, the FDA could issue a Form 483 Notice of Inspectional Observations, which could cause the FDA to not approve the use of the facility and cause us to modify certain activities identified during the inspection. Following such inspections, the FDA may issue an untitled letter as an initial correspondence that cites violations that do not meet the threshold of regulatory significance of a warning letter. FDA guidelines also provide for the issuance of warning letters for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action. FDA also may issue warning letters and untitled letters in connection with events or circumstances unrelated to an FDA inspection. Depending on the seriousness of any findings, we or our suppliers may be subject to additional significant enforcement or other actions and events, may need to undertake product recalls, may have a disruption in the supply of commercial or clinical product, or may need to modify or repeat studies, which could have a material impact on our business.

Current wording

We and our suppliers and contractors may be unable to comply with our specifications, cGMP requirements and with other FDA, state, and foreign regulatory requirements for commercial and clinical supply. We and they may need to maintain certain licenses that we or they may not be able to maintain. The FDA and other regulatory authorities are authorized to perform inspections (remotely and in person) of our and our suppliers’ facilities, including the Boca Facility. The FDA and other regulatory authorities also may inspect and approve our and our third-parties’ facilities before they may be used for commercial production. If we or our suppliers are not able to comply with the applicable regulatory requirements, we or they may be subject to regulatory enforcement actions, which can materially impact our business. For instance, at the end of such an inspection, the FDA could issue a Form 483 Notice of Inspectional Observations, which could cause the FDA to not approve the use of the facility and cause us to modify certain activities identified during the inspection. Following such inspections, the FDA may issue an untitled letter as an initial correspondence that cites violations that do not meet the threshold of regulatory significance of a warning letter. FDA guidelines also provide for the issuance of warning letters for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action. FDA also may issue warning letters and untitled letters in connection with events or circumstances unrelated to an FDA inspection. Depending on the seriousness of any findings, we or our suppliers may be subject to additional significant enforcement or other actions and events, may need to undertake product recalls, may have a disruption in the supply of commercial or clinical product, or may need to modify or repeat studies, which could have a material impact on our business.

Previous wording

Ouroperations, including the Boca Facility, our new real estate in Boca Raton, Florida and our plasma collection facilities, are vulnerable to natural disasters (including as a result of climate change), such as interruption by fires, weather related events such as hurricanes, earthquakes, wind and rain, other acts of God or force majeure events, electric power loss, telecommunications failure, equipment failure and breakdown including the disruption or misalignment of specialized laboratory machinery, cyberattacks on our operations and information technology systems as well as the systems of our customers, suppliers and related entities, human error, employee issues, global health occurrences such as a pandemic, global and economic uncertainty, war, terrorism, geopolitical conditions and emergencies, product liability claims and events beyond our control. While we maintain several insurance policies with reputable carriers that provide partial coverage for a variety of these risks, including replacing or rebuilding a part of our facilities, these policies are subject to the insurance carriers’ final determination of compensation to us and we may not have adequate coverage if we need to rebuild or replace our inventory, infrastructure, business income or our entire facilities. In addition, our disaster recovery plans for our facilities may not be adequate and we do not have an alternative manufacturing facility or contractual arrangements with other manufacturers in the event of a casualty to or destruction of any of our facilities. If we are required to rebuild or relocate any of our facilities, a substantial investment in improvements and equipment would be necessary. We carry only a limited amount of business interruption insurance, which may not sufficiently compensate us for losses that may occur. As a result, any significant business interruption could adversely affect our business, financial condition and results ofoperations.

Current wording

Our operations, including the Boca Facility, our real estate in Boca Raton, Florida acquired in July 2025 and our plasma collection facilities, are vulnerable to natural disasters (including as a result of climate change), such as interruption by fires, weather related events such as hurricanes, earthquakes, wind and rain, other acts of God or force majeure events, electric power loss, telecommunications failure, equipment failure and breakdown including the disruption or misalignment of specialized laboratory machinery, cyberattacks on our operations and information technology systems as well as the systems of our customers, suppliers and related entities, human error, employee issues, global health occurrences such as a pandemic, global and economic uncertainty, war, terrorism, geopolitical conditions and emergencies, product liability claims and events beyond our control. While we maintain several insurance policies with reputable carriers that provide partial coverage for a variety of these risks, including replacing or rebuilding a part of our facilities, these policies are subject to the insurance carriers’ final determination of compensation to us and we may not have adequate coverage if we need to rebuild or replace our inventory, infrastructure, business income or our entire facilities. In addition, our disaster recovery plans for our facilities may not be adequate and we do not have an alternative manufacturing facility or contractual arrangements with other manufacturers in the event of a casualty to or destruction of any of our facilities. If we are required to rebuild or relocate any of our facilities, a substantial investment in improvements and equipment would be necessary. We carry only a limited amount of business interruption insurance, which may not sufficiently compensate us for losses that may occur. As a result, any significant business interruption could adversely affect our business, financial condition and results of operations.

Previous wording

We and certain of our directors and officers have been named as defendants in a securities class action lawsuit. This litigation, and any similar or related proceedings that may be filed in the future, could result in substantial costs, divert management’s attention and resources from our business, andmay have a material adverse effect on our business, financial condition, results of operations and cash flows.

Current wording

We and certain of our directors and officers have been named as defendants in a securities class action lawsuit and in derivative actions. This lawsuit and these actions, and any similar or related proceedings that may be filed in the future, could result in substantial costs, divert management’s attention and resources from our business, and may have a material adverse effect on our business, financial condition, results of operations and cash flows.

Previous wording

On July 10, 2026, a putative securities class action lawsuit, Mazzarino v. ADMA Biologics, Inc. et al., Case No. 2:26-cv-06918 (D.N.J.), was filed against us and certain of our directors and officers. The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder and seeks monetary damages in an unspecified amount. The litigation remains at a preliminary stage. We believe that the claims asserted in the lawsuit are without merit and we intend to vigorously defend against the action.

Current wording

On July 10, 2026, a putative securities class action lawsuit,Mazzarino v. ADMA Biologics, Inc. et al., Case No. 2:26-cv-06918 (D.N.J.), was filed against us and certain of our directors and officers. The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder and seeks monetary damages in an unspecified amount. The litigation remains at a preliminary stage. Additionally, there were derivative actions filed on the same conduct as alleged in the Mazzarino action that the Court subsequently consolidated into one action, bearing the captionIn re Adma Biologics, Inc. Stockholder Derivative Litigation, Lead Case No. 2:26-cv-10811-ES-AME. We have also received three demands to date for the inspection of books and records pursuant to Section 220 of the Delaware General Corporation Law, based on the allegations and claims set forth in the Mazzarino class action. We believe that the claims asserted in the class and derivative lawsuits are without merit, and we intend to vigorously defend against the actions.

Previous wording

The ultimate outcome of the litigation is inherently uncertain, and there can be no assurance that we will prevail. Regardless of the merits or ultimate outcome of the proceeding, defending against litigation can be costly and time-consuming and may divert the attention and resources of management and other personnel from the operation of our business. Any such litigation or proceedings may result in substantial defense costs, damages, settlement amounts, fines, penalties, reputational harm, increased regulatory scrutiny or other adverse consequences.

Current wording

The ultimate outcomes of the litigation matters are inherently uncertain, and there can be no assurance that we will prevail. Regardless of the merits or ultimate outcome of the proceedings, defending against litigation can be costly and time-consuming and may divert the attention and resources of management and other personnel from the operation of our business. Any such litigation or proceedings may result in substantial defense costs, damages, settlement amounts, fines, penalties, reputational harm, increased regulatory scrutiny or other adverse consequences.

Previous wording

At this time, we cannot reasonably estimate the ultimate outcome of the litigation or the amount of any potential loss associated with the matter. If we are required to incur significant defense costs, enter into a settlement, pay damages or otherwise incur liabilities relating to the litigation, or if our insurance coverage is unavailable or insufficient to cover such costs, our business, financial condition, results of operations and cash flows could be materially adversely affected.

Current wording

At this time, we cannot reasonably estimate the ultimate outcomes of the litigation matters or the amount of any potential loss associated with the matters. If we are required to incur significant defense costs, enter into a settlement, pay damages or otherwise incur liabilities relating to the litigation matters, or if our insurance coverage is unavailable or insufficient to cover such costs, our business, financial condition, results of operations and cash flows could be materially adversely affected.

Previous wording

We may be unable to successfully expand our manufacturing processes to fulfill demand for our products orincrease our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from the FDA.

Current wording

We may be unable to successfully expand our manufacturing processes to fulfill demand for our products or increase our production capabilities through the addition of new equipment, including if we do not obtain requisite approval from the FDA.

Previous wording

For the six months ended June 30, 2026 and 2025, two customers, BioCare, Inc. (“BioCare”) and Priority Healthcare Distribution, Inc. d/b/a CuraScript SD Specialty Distribution (“Curascript”), represented an aggregate of approximately 67% and 72%, respectively, of our consolidated revenues.

Current wording

For the nine months ended September 30, 2026 and 2025, two customers, BioCare, Inc. (“BioCare”) and Priority Healthcare Distribution, Inc. d/b/a CuraScript SD Specialty Distribution (“Curascript”), represented an aggregate of approximately 69% and 72%, respectively, of our consolidated revenues.

Previous wording

As of June 30, 2026, BioCare and Curascript represented an aggregate of approximately 81% of our consolidated accounts receivable. As of December 31, 2025, BioCare and CuraScript represented an aggregate of approximately 87% of our consolidated accounts receivable.

Current wording

As of September 30, 2026, BioCare and Curascript represented an aggregate of approximately 84% of our consolidated accounts receivable. As of December 31, 2025, BioCare and CuraScript represented an aggregate of approximately 87% of our consolidated accounts receivable.

Previous wording

Our success depends upon the quality of our products. Quality management plays an essential role in meeting customer requirements, preventing defects, improving our products and services and assuring the safety and efficacy of our products. Our future success depends on our ability to maintain and continuously improve our quality management program. A quality or safety issue may result in failure to obtain product approval, adverse inspection reports, warning letters, product recalls or seizures, voluntary or involuntary withdrawals, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, patient injury, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses. The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products. We may elect, in the interest of public safety, to voluntarily withdraw our products from the market for labeled adverse events or for other reasons. For example, during the three and six months ended June 30, 2025, as a precautionary measure, we voluntarily withdrew three lots of BIVIGAM and we recorded a reduction to revenue of $0.2 million and $4.0 million, respectively, for credits issued to customers for the related product returns. Recalls or withdrawals of any of our products could divert managerial and financial resources which could have an adverse effect on our financial condition and results of operations. An inability to address a quality or safety issue by us or by a third-party vendor in an effective and timely manner may also cause negative publicity or a loss of customer confidence in us or our current or future products, which may result in the loss of current or future sales and difficulty in successfully commercializing our current products and launching new products.

Current wording

Our success depends upon the quality of our products. Quality management plays an essential role in meeting customer requirements, preventing defects, improving our products and services and assuring the safety and efficacy of our products. Our future success depends on our ability to maintain and continuously improve our quality management program. A quality or safety issue may result in failure to obtain product approval, adverse inspection reports, warning letters, product recalls or seizures, voluntary or involuntary withdrawals, monetary sanctions, injunctions to halt manufacture and distribution of products, civil or criminal sanctions, costly litigation, patient injury, refusal of a government to grant approvals and licenses, restrictions on operations or withdrawal of existing approvals and licenses. The FDA and similar foreign governmental authorities have the authority to require the recall of commercialized products. We may elect, in the interest of public safety, to voluntarily withdraw our products from the market for labeled adverse events or for other reasons. For example, during the three and nine months ended September 30, 2025, as a precautionary measure, we voluntarily withdrew three lots of BIVIGAM and we recorded a reduction to revenue of $0.2 million and $4.0 million, respectively, for credits issued to customers for the related product returns. Recalls or withdrawals of any of our products could divert managerial and financial resources which could have an adverse effect on our financial condition and results of operations. An inability to address a quality or safety issue by us or by a third-party vendor in an effective and timely manner may also cause negative publicity or a loss of customer confidence in us or our current or future products, which may result in the loss of current or future sales and difficulty in successfully commercializing our current products and launching new products.

Previous wording

Our current product development portfolio consists primarily of label expansion activities for ASCENIV, as well as expanding our IP estate with patents issued for S. pneumoniae hyperimmune immune globulin. We have initiated small-scale preclinical activities to potentially expand our current portfolio through new product development efforts. If we are not successful in developing or acquiring additional products and product candidates, we will have to depend on our ability to continue to generate revenues from ASCENIV, BIVIGAM, Nabi-HB, intermediates, contract manufacturing and plasma attributable to the operations of ADMA BioCenters to support our operations.

Current wording

Our current product development portfolio consists primarily of label expansion activities for ASCENIV, as well as expanding our IP estate with patents issued forS. pneumoniae hyperimmune immune globulin. We have initiated small-scale preclinical activities to potentially expand our current portfolio through new product development efforts. For example, we successfully completed production of a pilot-scale batch and are conducting animal studies for ourS. pneumoniae hyperimmune globulin program, SG-001. We intend to incorporate the October 2026 FDA feedback into the final clinical protocol and advance preparations for an IND submission for SG-001. If we are not successful in developing or acquiring additional products and product candidates, we will have to depend on our ability to continue to generate revenues from ASCENIV, BIVIGAM, Nabi-HB, intermediates, contract manufacturing and plasma attributable to the operations of ADMA BioCenters to support our operations.

Previous wording

On the JPM Closing Date, we entered into the JPM Credit Agreement (see “Liquidity and Capital Resources”). The JPM Credit Agreement provides for a total of $300 million in senior secured credit facilities (the “JPM Credit Facilities”) of which $198.1 million is outstanding as of June 30, 2026. The JPM Credit Facilities have a maturity date of August 5, 2028.

Current wording

On the JPM Closing Date, we entered into the JPM Credit Agreement (see “Liquidity and Capital Resources”). The JPM Credit Agreement provides for a total of $300 million in senior secured credit facilities (the “JPM Credit Facilities”) of which $197.2 million is outstanding as of September 30, 2026. The JPM Credit Facilities have a maturity date of August 5, 2028.

Previous wording

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological and business practice change. Our current products and any future product we may develop will have to compete with other marketed therapies, and certain of such therapies may be available at prices lower than our products. By way of example, beginning in the second half of 2025 and continuing into the first quarter of 2026, new FDA-approved IVIG products, and other pharmaceutical products which compete with certain IVIG product uses, entered the market with aggressive pricing tactics, including extended payment terms, rebates and discounts, raw material plasma supply increased and finished goods inventory across the distribution network increased. This created competitive intensity and distribution recalibration across the industry which, if continued, could impact our future results. In addition, other companies may pursue the development of pharmaceuticals that target the same diseases and conditions that we are targeting. We face competition from pharmaceutical and biotechnology companies in the United States and abroad. In addition, companies pursuing different but related fields represent substantial competition. Many of these organizations competing with us have substantially greater financial resources, larger research and development staffs and facilities, longer product development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do. These organizations also compete with us to attract qualified personnel and parties for acquisitions, joint ventures or other collaborations.

Current wording

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological and business practice change. Our current products and any future product we may develop will have to compete with other marketed therapies, and certain of such therapies may be available at prices lower than our products. By way of example, beginning in the second half of 2025 and continuing in 2026, new FDA-approved non-ADMA IVIG products, and other pharmaceutical products which compete with certain IVIG product uses entered the market with aggressive pricing tactics, including extended payment terms, rebates and discounts, raw material plasma supply increased and finished goods inventory across the distribution network increased. This has created competitive intensity and distribution recalibration across the industry which, if continued, could impact our future results. In addition, other companies may pursue the development of pharmaceuticals that target the same diseases and conditions that we are targeting. We face competition from pharmaceutical and biotechnology companies in the United States and abroad. In addition, companies pursuing different but related fields represent substantial competition. Many of these organizations competing with us have substantially greater financial resources, larger research and development staff and facilities, longer product development history in obtaining regulatory approvals and greater manufacturing and marketing capabilities than we do. These organizations also compete with us to attract qualified personnel and parties for acquisitions, joint ventures or other collaborations.

Previous wording

We have engaged a third-party firm to assist the Company with the development and deployment of an AI tool, ADMAlytics, to improve efficiencies across our supply chain, production, and commercial operations. This tool has been used to assist with activities including plasma pool composition and identifying other manufacturing efficiencies to streamline certain operational processes. While we have successfully implemented ADMAlytics in certain aspects of our commercial manufacturing and expanded its use throughout fiscal year 2025 and into 2026, the development, implementation, and ongoing use of AI technologies involve inherent risks. While ADMA has not experienced any issues to date, these risks include potential data inaccuracies, flawed assumptions, system errors, cybersecurity vulnerabilities, unintended outcomes, and difficulties in integrating AI-driven insights into complex and highly regulated manufacturing and operational environments. If ADMAlytics fails to perform as intended or produces unreliable or biased outputs, our reputation could be harmed and we could be subject to legal exposure, which could adversely affect our business, results of operations, and financial condition.

Current wording

We have engaged a third-party firm to assist the Company with the development and deployment of an AI tool, ADMAlytics, to improve efficiencies across our supply chain, production, and commercial operations. This tool has been used to assist with activities including plasma pool composition and identifying other manufacturing efficiencies to streamline certain operational processes. While we have successfully implemented ADMAlytics in certain aspects of our commercial manufacturing and expanded its use throughout fiscal years 2025 and 2026, the development, implementation, and ongoing use of AI technologies involve inherent risks. While ADMA has not experienced any issues to date, these risks include potential data inaccuracies, flawed assumptions, system errors, cybersecurity vulnerabilities, unintended outcomes, and difficulties in integrating AI-driven insights into complex and highly regulated manufacturing and operational environments. If ADMAlytics fails to perform as intended or produces unreliable or biased outputs, our reputation could be harmed and we could be subject to legal exposure, which could adversely affect our business, results of operations, and financial condition.

Previous wording

Additionally, the ability of the FDA and other federal, state and local business regulatory agencies to review and approve products and product candidates can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and to accept the payment of user fees, as well as statutory, regulatory, and policy changes. Average review times at the FDA and other federal, state and local business regulatory agencies have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for products and product candidate submissions to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including in December 2018, January 2019 and most recently October 2025, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections at domestic and foreign manufacturing facilities from March 2020 until July 2021. Also, in 2025, there was an FDA reduction in force. If a prolonged government shutdown or regulatory agency disruption reoccurs, or in the event the FDA has an insufficient amount of staff, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, conduct evaluations and inspections and other reporting requirements which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain capital that may be necessary in order to properly capitalize and continue our operations.

Current wording

Additionally, the ability of the FDA and other federal, state and local business regulatory agencies to review and approve products and product candidates can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and to accept the payment of user fees, as well as statutory, regulatory, and policy changes. Average review times at the FDA and other federal, state and local business regulatory agencies have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for products and product candidate submissions to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, over the last several years, including in December 2018, January 2019 and most recently in October 2025, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections at domestic and foreign manufacturing facilities from March 2020 until July 2021. Also, in 2025, there was an FDA reduction in force. If a prolonged government shutdown or regulatory agency disruption reoccurs, or in the event the FDA has an insufficient amount of staff, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, conduct evaluations and inspections and other reporting requirements which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain capital that may be necessary in order to properly capitalize and continue our operations.

Previous wording

Plasma is a raw material that is susceptible to damage and contamination and may contain human pathogens, any of which would render the plasma unsuitable as raw material for further manufacturing. For instance, improper storage of plasma, by us or third-party suppliers, may require us to destroy some of our raw material. If unsuitable plasma is not identified and discarded prior to the release of the plasma to the manufacturing process, it may be necessary to discard intermediate or finished product made from that plasma or to recall any finished product released to the market, resulting in a charge to cost of product revenue. The manufacture of our plasma products is an extremely complex process of fractionation, purification, testing, filling and finishing. Our products can become non-releasable or otherwise fail to meet our stringent specifications or regulatory agencies’ specifications through a failure in one or more of these process steps. We may detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with cGMP or other regulations. Such an event of noncompliance would likely result in our determination that the implicated products should not be released or maybe replaced or withdrawn from the market and therefore should be destroyed. Once manufactured, our plasma-derived products must be handled carefully and kept at appropriate temperatures. Our failure, or the failure of third parties that supply, test, ship or distribute our products or product components to properly care for our products, may require that those products be destroyed. Even if handled properly, biologics may form or contain particulates or have other issues or problems after storage which may require products to be destroyed or recalled. While we expect to write off certain amounts of raw materials and work-in-process inventory in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our expectations and the reserves we have established for these purposes. Such write-offs or losses and other costs could cause material fluctuations in our results of operations. Product or component quality issues may also result in regulatory enforcement actions, liability, corrective actions and recalls, among other actions, as described in our 2025 10-K.

Current wording

Plasma is a raw material that is susceptible to damage and contamination and may contain human pathogens, any of which would render the plasma unsuitable as raw material for further manufacturing. For instance, improper storage of plasma, by us or third-party suppliers, may require us to destroy some of our raw material. If unsuitable plasma is not identified and discarded prior to the release of the plasma to the manufacturing process, it may be necessary to discard intermediate or finished product made from that plasma or to recall any finished product released to the market, resulting in a charge to cost of product revenue. The manufacture of our plasma products is an extremely complex process of fractionation, purification, testing, filling and finishing. Our products can become non-releasable or otherwise fail to meet our stringent specifications or regulatory agencies’ specifications through a failure in one or more of these process steps. We may detect instances in which an unreleased product was produced without adherence to our manufacturing procedures or plasma used in our production process was not collected or stored in a compliant manner consistent with cGMP or other regulations. Such an event of noncompliance would likely result in our determination that the implicated products should not be released or may be replaced or withdrawn from the market and therefore should be destroyed. Once manufactured, our plasma-derived products must be handled carefully and kept at appropriate temperatures. Our failure, or the failure of third parties that supply, test, ship or distribute our products or product components to properly care for our products, may require that those products be destroyed. Even if handled properly, biologics may form or contain particulates or have other issues or problems after storage which may require products to be destroyed or recalled. While we expect to write off certain amounts of raw materials and work-in-process inventory in the ordinary course of business due to the complex nature of plasma, our processes and our products, unanticipated events may lead to write-offs and other costs materially in excess of our expectations and the reserves we have established for these purposes. Such write-offs or losses and other costs could cause material fluctuations in our results of operations. Product or component quality issues may also result in regulatory enforcement actions, liability, corrective actions and recalls, among other actions, as described in our 2025 10-K.

Previous wording

The JPM Credit Facilities provide for total senior secured loans in an aggregate principal amount of $300.0 million, of which $198.1 million is currently outstanding as of June 30, 2026. The borrowing under the JPM Credit Facilities currently bears interest at a rate equal to approximately 6.12% per annum, which reflects the one-month term SOFR rate; provided, however, that upon, and during the continuance of, an event of default, the interest rate will automatically increase by an additional 200 basis points. We are currently required to make (i) payments of interest for our revolving facility, at quarterly, one-month or three-month intervals, depending upon the type of borrowing, during the remaining term of the JPM Credit Facilities, with all principal and unpaid interest due at maturity, and (ii) principal under our term loan facility, in accordance with and on the dates specified in the amortization schedule set forth in the JPM Credit Agreement, through the JPM Term Maturity Date. In addition, our monthly interest rate obligation under our revolving facility is subject to rising interest rates. The JPM Credit Facilities are subject to acceleration pursuant to the JPM Credit Agreement, including upon an event of default. All of our obligations under the JPM Credit Facilities are secured by a first-priority lien and security interest in substantially all of our and our subsidiaries’ tangible and intangible assets, including intellectual property, and all of the equity interests in our subsidiaries.

Current wording

The JPM Credit Facilities provide for total senior secured loans in an aggregate principal amount of $300.0 million, of which $197.2 million is currently outstanding as of September 30, 2026. The borrowing under the JPM Credit Facilities currently bears interest at a rate equal to approximately 6.19% per annum, which reflects the one-month term SOFR rate; provided, however, that upon, and during the continuance of, an event of default, the interest rate will automatically increase by an additional 200 basis points. We are currently required to make (i) payments of interest for our revolving facility, at quarterly, one-month or three-month intervals, depending upon the type of borrowing, during the remaining term of the JPM Credit Facilities, with all principal and unpaid interest due at maturity, and (ii) principal under our term loan facility, in accordance with and on the dates specified in the amortization schedule set forth in the JPM Credit Agreement, through the JPM Term Maturity Date. In addition, our monthly interest rate obligation under our revolving facility is subject to rising interest rates. The JPM Credit Facilities are subject to acceleration pursuant to the JPM Credit Agreement, including upon an event of default. All of our obligations under the JPM Credit Facilities are secured by a first-priority lien and security interest in substantially all of our and our subsidiaries’ tangible and intangible assets, including intellectual property, and all of the equity interests in our subsidiaries.

Previous wording

As of July 31, 2026, most of our 223,984,680 outstanding shares of common stock, were available for sale in the public market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements. Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, could cause the market price of our common stock to decline or adversely affect demand for our common stock.

Current wording

As of October 30, 2026, most of our 221,854,389 outstanding shares of common stock were available for sale in the public market, subject to certain restrictions with respect to sales of our common stock by our affiliates, either pursuant to Rule 144 under the Securities Act, or under effective registration statements. Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, could cause the market price of our common stock to decline or adversely affect demand for our common stock.

Previous wording

Our Boardis authorized to issue “blank check” preferred stock, with designations, rights and preferences as theymay determine. Accordingly, our Board may in the future, without stockholder approval, issue shares of preferred stock with dividend, liquidation, conversion, voting or other rights that could adversely affect thevoting power or other rights ofthe holders of our common stock. This type of preferred stock could also be issued to discourage, delay, or prevent a change in our control. The ability to issue “blank check” preferred stock is a traditional anti-takeover measure. This provision in our charter documents makes it difficult for a majority stockholder to gain control of our company. Provisions like this may be beneficial to our management and our Board in a hostile tender offer and may have an adverse impact on stockholders who may want to participate in such a tender offer.

Current wording

Our Board is authorized to issue “blank check” preferred stock, with designations, rights and preferences as they may determine. Accordingly, our Board may in the future, without stockholder approval, issue shares of preferred stock with dividend, liquidation, conversion, voting or other rights that could adversely affect the voting power or other rights of the holders of our common stock. This type of preferred stock could also be issued to discourage, delay, or prevent a change in our control. The ability to issue “blank check” preferred stock is a traditional anti-takeover measure. This provision in our charter documents makes it difficult for a majority stockholder to gain control of our company. Provisions like this may be beneficial to our management and our Board in a hostile tender offer and may have an adverse impact on stockholders who may want to participate in such a tender offer.

Previous wording

During the three and six months ended June 30, 2026, in addition to the shares repurchased under the ASR Agreement, we repurchased 2,723,659 and 3,055,207 shares of common stock under the Repurchase Program at a total cost of $25.1 million and $30.2 million, respectively.

Current wording

During the three and nine months ended September 30, 2026, in addition to the shares repurchased under the ASR Agreement, we repurchased 2,722,563 and 5,777,770 shares of common stock under the Repurchase Program at a total cost of $25.1 million and $55.3 million, respectively.

Previous wording

On March 2, 2026, we entered into the ASR Agreement with JPMorgan to repurchase $125.0 million of shares of our common stock under the Repurchase Program. During the three and six months ended June 30, 2026, we received 4,337,879 and 10,760,487 shares of common stock, respectively, pursuant to the terms of the ASR Agreement.

Current wording

On March 2, 2026, we entered into the ASR Agreement with JPMorgan to repurchase $125.0 million of shares of our common stock under the Repurchase Program. During the three and nine months ended September 30, 2026, we received 0 and 10,760,487 shares of common stock, respectively, pursuant to the terms of the ASR Agreement.

Previous wording

The table below reflects shares of common stock we repurchased during the second quarter of 2026:

Current wording

The table below reflects shares of common stock we repurchased during the third quarter of 2026: