CPIX

New in FY2025

• These risk factors and uncertainties include, but are not limited to the following: RISKS RELATED TO OUR BUSINESS 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.
• 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).
• Inflation rates have fluctuated in recent periods.
• 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.
• 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.
• Our product portfolio currently includes seven brands: Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol, Vibativ and Talicia.
• 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.
• Talicia : 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.
• We have added seven products to our portfolio of brands through acquisitions.
• As of December 31, 2025, we had 93 employees.
• Even after regulatory approval, certain developments may decrease demand for our products, including the following: • the re-review of products that are already marketed; • new scientific information and evolution of scientific theories; • the recall or loss of marketing approval of products that are already marketed; • changing government standards or public expectations regarding safety, efficacy or labeling changes; • greater scrutiny in advertising and promotion; and • the development and introduction of competitive products into the market.
• 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 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.
• 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.
• As of December 31, 2025, intangible assets relating to products, which are being amortized, represented approximately 18% of our total assets.
• 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.
• As of December 31, 2025, our officers and directors control approximately 42.1% of our common stock.
• The market price of our common stock may decline below current levels.
• 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.
• Some provisions of our fourth amended and restated charter, bylaws and Tennessee law may inhibit potential acquisition bids that you may consider favorable.

and 4 more.

Gone since FY2024

• These risk factors and uncertainties include, but are not limited to the following: 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.
• 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.
• Inflation rates have increased recently to levels not seen in decades.
• 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 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.
• Our product portfolio currently includes six brands: Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol and Vibativ.
• 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.
• 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.
• We have added six products to our portfolio of brands through acquisitions.
• 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.
• As of December 31, 2024, we had 91 employees.
• Even after regulatory approval, certain developments may decrease demand for our products, including the following: • the re-review of products that are already marketed; • new scientific information and evolution of scientific theories; • the recall or loss of marketing approval of products that are already marketed; • changing government standards or public expectations regarding safety, efficacy or labeling changes; and • greater scrutiny in advertising and promotion.
• 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.
• As of December 31, 2024, intangible assets relating to products, which are being amortized, represented approximately 24 percent of our total assets.
• 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.
• As of December 31, 2024, our officers and directors control approximately 44.41 percent of our common stock.
• 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 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.
• Some provisions of our third amended and restated charter, bylaws and Tennessee law may inhibit potential acquisition bids that you may consider favorable.
• 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.
• DEBT-RELATED RISKS Our Revolving Credit Agreement impose restrictive and financial covenants on us.
• 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, 2024, we did not have any outstanding interest rate swap contracts.