What changed in this filing

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Item 1A. Risk Factors

2026-03-09 compared with 2025-03-07 · 46 added, 26 removed, 587 unchanged (11% of the section changed)

22 unchanged sentences

RISKS RELATED TO OUR BUSINESS

Unfavorable global and national economic conditions and events, including, but not limited to increased inflation, rising interest rates, supply chain disruptions, labor conditions, pandemics and public health crises and international conflicts, could affect our future access to liquidity and materially adversely affect our results of operations and financial condition.

Global and national economic conditions and events, including, but not limited to increased inflation, changes in interest rates, tariffs, supply chain disruptions, labor conditions, pandemics and public health crises and international conflicts, could affect our future access to liquidity and materially adversely affect our results of operations and financial condition.

Our business and results of operations could be adversely affected by changes in global or national economic conditions.

These conditions include, but are not limited to, increased inflation, high and rising interest rates, supply chain disruptions, labor conditions, significant natural disasters (including as a result of climate change), the negative impacts from pandemics and public health crises (such as the COVID-19 pandemic) and the negative impacts resulting from political and military conflict, trade and other international disputes, including the ongoing conflicts in Eastern Europe and the Middle East.

These conditions include, but are not limited to, increased inflation, changes in interest rates, tariffs, supply chain disruptions, labor conditions, significant natural disasters (including as a result of climate change), the negative impacts from pandemics and public health crises (such as the COVID-19 pandemic) and the negative impacts resulting from political and military conflict, trade and other international disputes (including the conflict between Russia and Ukraine and conflicts and instability in the Middle East and Venezuela).

These conditions have had a significant adverse impact on economic and market conditions around the world, including the United States.

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In the longer term, there could be significant new regulatory actions and other events that could limit our activities and investment opportunities or change the functioning of the capital markets, and there is the possibility of a severe worldwide economic downturn.

Inflation rates have increased recently to levels not seen in decades.

Inflation rates have fluctuated in recent periods.

If our costs, in particular costs related to clinical trial expenses and/or employee-related expenses, were to become subject to significant inflationary pressures, it may adversely impact our business, operating results and financial condition.

In response to inflationary pressures, the Federal Reserve raised the benchmark federal funds rate in 2022 and 2023, which led to the increases in interest rates in the credit markets.

Although the Federal Reserve lowered the benchmark federal funds rate in September 2024 and November 2024, it may raise the federal funds rate in the future, which would likely lead to higher interest rates in the credit markets and the possibility of slowing economic growth.

Although the Federal Reserve lowered the benchmark federal funds rate in 2024 and 2025, it could raise the federal funds rate in the future impacting interest rates in the credit markets and the possibility of slowing economic growth.

Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may further increase economic uncertainty and heighten these risks.

Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience increases in the near future (especially if inflation rates continue to rise) on our operating costs, including our labor costs and research and development costs, due to supply chain constraints, ongoing effects of the COVID-19 pandemic, the ongoing conflicts in Eastern Europe and the Middle East and employee availability and wage increases.

Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience increases in the future on our operating costs, including our labor costs and research and development costs, due to supply chain constraints, ongoing international conflicts and employee availability and wage increases.

The United States and other countries have recently begun imposing new tariffs on international trade.

While pharmaceuticals have been largely exempt from these recently imposed U.S.

tariffs, such exemptions may be removed in the future, which could have a material adverse effect on our business.

An adverse development regarding our products could have a material and adverse impact on our future revenues and profitability.

Our product portfolio currently includes six brands:

Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol and Vibativ.

Our product portfolio currently includes seven brands:

Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol, Vibativ and Talicia.

A product contamination or other safety or regulatory issues, such as a failure to meet certain FDA reporting requirements involving our products, could negatively impact us and possibly lead to a product recall.

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We have a manufacturing relationship with one packager who has provided finished supplies of Kristalose for commercial and sampling purposes since 2022.

If the manufacturing or packaging facilities are unable to produce useable or marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Kristalose.

If the manufacturing or packaging facilities are unable to produce usable or marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Kristalose.

In 2018, the manufacturer of Vaprisol informed us that they would no longer be able to provide the product following the manufacturing of one final batch which is providing us with a multi-year supply.

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Once these FDA Form 483 related issues are satisfactorily resolved, we will then resubmit our application for their facility to the FDA for approval.

Meanwhile, we have been working with them to support a special, interim supply of compounded product for critically ill patients, which they introduced to the market in late 2023.

If we are unable to produce additional marketable inventory in sufficient quantities, in the required time frame, we could suffer an inability to meet demand for Vaprisol.

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to Cumberland in August 2023.

The supply of Talicia is complex.

The product’s manufacture and supply is overseen by Talicia Holding, Inc., who delivers the product to our warehouse facilities.

In addition, all manufacturers of our products and product candidates must comply with current good manufacturing practices, ("GMPs"), enforced by the FDA through its facilities inspection program.

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If we do not successfully identify and acquire rights to products or if we do not successfully integrate acquired product brands into our operations, our growth opportunities may be limited.

We have added six products to our portfolio of brands through acquisitions.

We have added seven products to our portfolio of brands through acquisitions.

Our business strategy is to continue to acquire rights to FDA-approved products as well as pharmaceutical product candidates in the late stages of development.

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If we experience difficulties in hiring and retaining personnel in key positions, we could suffer from delays in product development, loss of customers and sales and diversion of management resources, which could adversely affect operating results.

In addition, we have recently observed an overall tightening and increasingly competitive labor market.

Our business could be adversely affected by an inability to retain personnel or upward pressure on wages as a result of the competitive labor market.

The size of our organization and our potential growth may lead to difficulties in managing operations.

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• greater scrutiny in advertising and promotion;

• the development and introduction of competitive products into the market.

Certain regulatory changes or decisions could make it more difficult for us to sell our products and could have a material adverse effect on our business, results of operations, financial condition and cash flows.

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In previous years, legislation has been introduced in Congress that, if enacted, would permit more widespread re-importation of drugs from foreign countries into the U.S., which may include re-importation from foreign countries where the drugs are sold at lower prices than in the U.S.

Such legislation, or similar regulatory changes, if enacted, could decrease the price we receive for any approved products which, in turn, could materially and adversely affect our operating results and our overall financial condition.

Through Executive Order, “ Lowering Drug Pricing By Once Again Putting Americans First,” the Trump Administration instructed the Secretary of Health and Human Services to take steps to streamline and improve the Importation Program under Section 804 of the Federal Food, Drug and Cosmetic Act to ease the State approval process.

Such legislation, or similar regulatory changes, if enacted, could increase competition and decrease the price we receive for any approved products which, in turn, could materially and adversely affect our operating results and our overall financial condition.

Legislative and regulatory changes affecting pricing of pharmaceutical products could materially and adversely affect our operating results and our overall financial condition.

The Federal government appears likely to continue efforts to lower the price of pharmaceutical products.

The Trump Administration’s April 15, 2025 “Lowering Drug Pricing By Once Again Putting Americans First,” instructed Federal agencies to take several steps intended to lower the price of prescription drugs, including directing the Secretary of Health and Human Services to implement rulemaking for implementation of a payment model to improve the ability of the Medicare program to obtain better value for high-cost prescription drugs and biologicals covered by Medicare;

and directing the OMB Director, the Assistant to the President for Domestic Policy, and the Assistant to the President for Economic Policy to coordinate with the Secretary for Health and Human Services to provide recommendations on how best to ensure that drug manufacturers pay accurate Medicaid drug rebates, promote innovation in Medicaid drug payment methodologies, link payments for drugs to value, and support States in ongoing drug spending.

In addition, following up on a May 12, 2025 Executive Order, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” in October 2025, the Trump Administration launched TrumpRx.com, a government-operated website intended to provide opportunities for patients to purchase certain drugs from participating manufacturers at discounted prices.

The One Big Beautiful Bill Act (“OBBBA”) signed July 4, 2025 also included provisions designed to lower the price of drugs by requiring most-favored-nation pricing to match the lower price of international drugs in some cases.

These changes related to the costs and reimbursement of pharmaceutical products continue to be dynamic and it is difficult to accurately predict the nature of final legislative and regulatory pricing initiatives.

It is possible that policy changes governing drug pricing could materially and adversely affect our operating results and our overall financial condition.

We must comply with the CREATES Act.

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If we fail to accurately report this information, we could suffer severe penalties.

We must comply with healthcare fraud and abuse laws and regulations.

We are subject to Federal laws intended to combat fraud and waste such as the Anti-Kickback Statute, False Claims Act, and Medicare and Medicaid laws and regulations.

Many states have analogous laws which may be broader than their Federal counterparts, including state licensure laws, fraud and abuse laws, and Medicaid requirements.

Compliance with these regulatory requirements can increase operating costs, and thereby adversely affect our financial performance.

Also, the life science industry is heavily regulated and the governing laws and regulations are often ambiguous and subject to significant enforcement agency direction in pursuing alleged violations, which makes certainty of compliance challenging.

Our failure to comply with health care fraud and abuse laws and regulations could adversely affect our financial performance and operations.

If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

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These changes may lead to additional costs and increase our overall risk exposure.

We may be subject to laws and regulations governing our use of Artificial Intelligence.

The use of Artificial Intelligence (“AI”) in health care, and particularly the drug development process, continues to increase and evolve.

While there currently is no Federal law governing the use of AI in health care or otherwise, several states and Federal agencies use existing regulations to govern the use of AI and enforce related privacy violations, and it is possible that governing legislation and regulations may be forthcoming given that President Trump has issued multiple AI-related Executive Orders, including an AI Action Plan on July 23, 2025 through Executive Order, “Promoting the Export of the American AI Technology Stock,” and a December 11, 2025 Executive Order, “Ensuring a National Policy Framework for Artificial Intelligence.”

The FDA has indicated its intention to regulate the use of AI by drug manufacturers through multiple announcements, including its January 2025 draft guidance “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” and its January 2026 “Guiding Principles of Good AI Practice in Drug Development,” which establishes ten (10) high-level guiding principles concerning future use and regulation of AI by pharmaceutical manufacturers.

As with privacy and security laws, we cannot predict the ultimate result of proposals to govern and regulate AI and any related enforcement actions, or the potential costs any compliance obligations may have on us.

Violation of any applicable AI-related laws or regulations could have a material adverse effect on our business, financial condition and operating results.

RISKS RELATING TO INTELLECTUAL PROPERTY

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Our total assets include intangible assets related to our acquisitions.

As of December 31, 2024, intangible assets relating to products, which are being amortized, represented approximately 24 percent of our total assets.

As of December 31, 2025, intangible assets relating to products, which are being amortized, represented approximately 18% of our total assets.

We may never realize the value of these assets.

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We anticipate that our drug discovery and development efforts and related expenditures will increase as we focus on the studies, including clinical trials prior to seeking regulatory approval, that are required before we can sell a drug product.

The development of drug products will require us to spend significant funds on research, development, testing, obtaining regulatory approvals, manufacturing and marketing.

We cannot be certain whether or when we will achieve profitability because of the significant uncertainties relating to our ability to generate commercially successful drug products.

The development of drug products will require us to spend significant funds on research, development, testing, obtaining regulatory approvals, manufacturing and marketing.We cannot be certain whether or when we will achieve profitability because of the significant uncertainties relating to our ability to generate commercially successful drug products.

Even if we are successful in obtaining regulatory approvals for manufacturing and commercializing additional drug products, we may incur losses if our drug products do not generate significant revenues.

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Our officers, directors, and principal shareholders, acting as a group, could significantly influence corporate actions.

As of December 31, 2024, our officers and directors control approximately 44.41 percent of our common stock.

As of December 31, 2025, our officers and directors control approximately 42.1% of our common stock.

Acting together, these shareholders could significantly influence any matter requiring approval by our shareholders, including the election of directors and the approval of mergers or other business combinations.

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The market price of our common stock may fluctuate substantially.

The price for the shares of our common stock sold in our initial public offering was determined by negotiation between the representatives of the underwriters and us.

This price may not have reflected the market price of our common stock following our initial public offering.

Moreover, the market price of our common stock might decline below current levels.

The market price of our common stock may decline below current levels.

In addition, the market price of our common stock is likely to be highly volatile and may fluctuate substantially.

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There is a risk that one or more of our current service providers, manufacturers and other partners may encounter difficult economic circumstances, which would directly affect our ability to attain our operating goals on schedule and on budget.

The equity and lending markets have been and will most likely continue to be negatively impacted for an unknown period of time due to global events such as the COVID-19 pandemic, increased inflation and the U.S.

government’s response thereto.

The equity and lending markets have been and will most likely continue to be negatively impacted for an unknown period of time due to global events.

If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud.

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and (iv) impairing our ability to provide equity incentives to our employees.

Some provisions of our third amended and restated charter, bylaws and Tennessee law may inhibit potential acquisition bids that you may consider favorable.

Some provisions of our fourth amended and restated charter, bylaws and Tennessee law may inhibit potential acquisition bids that you may consider favorable.

Our corporate documents contain provisions that may enable our board of directors to resist a change in control of our company even if a change in control were to be considered favorable by you and other shareholders.

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• No cumulative voting.

These and other provisions contained in our third amended and restated charter and bylaws could delay or discourage transactions involving an actual or potential change in control of us or our management, including transactions in which our shareholders might otherwise receive a premium for their shares over then current prices, and may limit the ability of shareholders to remove our current management or approve transactions that our shareholders may deem to be in their best interests and, therefore, could adversely affect the price of our common stock.

These and other provisions contained in our fourth amended and restated charter and bylaws could delay or discourage transactions involving an actual or potential change in control of us or our management, including transactions in which our shareholders might otherwise receive a premium for their shares over then current prices, and may limit the ability of shareholders to remove our current management or approve transactions that our shareholders may deem to be in their best interests and, therefore, could adversely affect the price of our common stock.

In addition, we are subject to control share acquisitions provisions and affiliated transaction provisions of the Tennessee Business Corporation Act, the applications of which may have the effect of delaying or preventing a merger, takeover or other change in control of us and therefore could discourage attempts to acquire our company.

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DEBT-RELATED RISKS

Our Revolving Credit Agreement impose restrictive and financial covenants on us.

Our Revolving Credit Agreement imposes restrictive and financial covenants on us.

Our failure to comply with these covenants could trigger events that would have a material adverse effect on our business.

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Our Revolving Credit Agreement contains specified quarterly financial maintenance covenants.

As of December 31, 2024, we were in compliance with the Borrowing Base financial covenant of the Revolving Credit Agreement and associated amendments.

As of December 31, 2025, we were in compliance with Minimum Fixed Charge Coverage Ratio financial covenant, along with the Borrowing Base Requirements of the Revolving Credit Agreement and associated amendments.

However, we can make no assurance that we will be able to comply with the restrictive and financial covenants contained in the Revolving Credit Agreement in the future.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors