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What changed in CUMBERLAND PHARMACEUTICALS INC's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of CUMBERLAND PHARMACEUTICALS INC's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+369 added−370 removedSource: 10-K (2026-03-09) vs 10-K (2025-03-07)

Top changes in CUMBERLAND PHARMACEUTICALS INC's 2025 10-K

369 paragraphs added · 370 removed · 292 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

143 edited+41 added−49 removed175 unchanged
Biggest changeDuring 2024, we worked with them to prepare the submissions for the approval of each brand there. They are currently pursuing the approval of Vibativ in their country. We have executed a license and distribution agreement with HongKong WinHealth Pharma Group Co. Limited (“WinHealth”) for our Caldolor and Acetadote brands in China and Hong Kong.
Biggest changeWe have executed a license and distribution agreement with WinHealth Pharma Group Co. Limited (“WinHealth”) for our Caldolor and Acetadote brands in China and Hong Kong. Under the terms of the agreement, WinHealth will provide development milestone payments and purchase supplies of the products following their registration in China.
Our primary target markets are hospital acute care, gastroenterology and oncology. These medical specialties are characterized by relatively concentrated prescriber bases that we believe can be served effectively by small, targeted sales forces. We promote our approved products through our hospital, field and oncology sales divisions in the United States.
Our primary target markets are hospital acute care, gastroenterology and oncology. These medical specialties are characterized by relatively concentrated prescriber bases that we believe can be served effectively by relatively small, targeted sales forces. We promote our approved products through our hospital, field and oncology sales divisions in the United States.
These studies included data on a shortened infusion time and pre-surgical administration of the product. To address our Phase IV commitment to the FDA, these studies also included evaluation of the product for the reduction of fever in hospitalized children and the treatment of pain in children undergoing tonsillectomy surgeries.
The studies included data on a shortened infusion time and pre-surgical administration of the product. To address our Phase IV commitment to the FDA, these studies also included evaluation of the product for the reduction of fever in hospitalized children and the treatment of pain in children undergoing tonsillectomy surgeries.
Clinical Development Our clinical development personnel are responsible for: • Creating and executing clinical development strategies, including protocol design and statistical analysis plans; • Designing, implementing and monitoring clinical trials, including site selection and patient recruitment; • Managing clinical data collection, biostatistical analysis and real-world evidence generation; • Conducting post-marketing surveillance and safety monitoring; • Cross-functional collaboration with research partners.
Clinical Development Our clinical development personnel are responsible for: • Creating and executing clinical development strategies, including protocol design and statistical analysis plans; • Designing, implementing and monitoring clinical trials, including site selection and patient recruitment; • Managing clinical data collection, biostatistical analysis and real-world evidence generation; • Conducting post-marketing surveillance and safety monitoring; and • Cross-functional collaboration with research partners.
Regulatory and Quality Affairs Our internal regulatory and quality affairs team is responsible for: • Managing the full regulatory lifecycle from IND submissions through NDA approvals, including post-marketing commitments and supplemental applications for label expansions and product improvements; • Developing and executing global regulatory strategies, including health authority interactions and submissions across international markets; • Implementing comprehensive quality systems , including pharmacovigilance, QMS oversight, and compliance monitoring of third-party providers with GMP, GLP, and GCP requirements; • Evaluating regulatory risk profiles for product acquisitions and maintaining regulatory intelligence to inform strategic planning; • Overseeing document control systems, change management and customer complaint processes.
Regulatory and Quality Affairs Our internal regulatory and quality affairs team is responsible for: • Managing the full regulatory lifecycle from IND submissions through NDA approvals, including post-marketing commitments and supplemental applications for label expansions and product improvements; • Developing and executing global regulatory strategies, including health authority interactions and submissions across international markets; • Implementing comprehensive quality systems , including pharmacovigilance, QMS oversight, and compliance monitoring of third-party providers with GMP, GLP, and GCP requirements; • Evaluating regulatory risk profiles for product acquisitions and maintaining regulatory intelligence to inform strategic planning; and • Overseeing document control systems, change management and customer complaint processes.
Professional Affairs Our professional affairs team supports our clinical and regulatory initiatives through: • Key opinion leader engagement and medical/scientific advisory boards; • Medical information and scientific communications management; • Publication planning and execution; • Healthcare provider education and support. PROFESSIONAL AND MEDICAL AFFAIRS Our medical team provides in-house medical information support for our marketed products.
Professional Affairs Our professional affairs team supports our clinical and regulatory initiatives through: • Key opinion leader engagement and medical/scientific advisory boards; • Medical information and scientific communications management; • Publication planning and execution; and • Healthcare provider education and support. PROFESSIONAL AND MEDICAL AFFAIRS Our medical team provides in-house medical information support for our marketed products.
Such factors include, but are not limited to: 32 • The possible or assumed future results of operations, including the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; • The impact of macroeconomic conditions, including inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in monetary policy, volatile market conditions, financial institution instability, as well as geopolitical instability and the ongoing conflicts outside the U.S., on our operations; • Our competitive position and competitors, including the size and growth potential of the markets for our products and product candidates; • The success, cost and timing of our product acquisition and development activities and clinical trials; and our ability to successfully commercialize our product candidates; • Product efficacy or safety concerns, whether or not based on scientific evidence, resulting in product withdrawals, recalls, regulatory action on the part of the FDA (or international counterparts) or declining sales; • The performance of our third-party suppliers and manufacturers which impacts our supply chain and could create business shutdowns or product shortages; and the retention of key scientific and management personnel; • The impact on our business, financial condition and results of operations from the effects of a pandemic or the outbreak of an infectious disease in the United States and worldwide and resulting governmental and societal responses; • Challenges to our patents and the introduction of generic versions of our products and product candidates, which could negatively impact our ability to commercialize and sell our products and product candidates and decrease sales a result of market exclusivity; • Changes in reimbursement available to us, including changes in Medicare and Medicaid payment levels and availability of third-party insurance coverage and the effects of future legislation or regulations, including changes to regulatory approval of new products, licensing and patent rights, environmental protection and possible drug re-importation legislation; • Interruptions and breaches of our computer and communications systems, and those of our vendors, including computer viruses, hacking and cyber-attacks, that could impair our ability to conduct business and communicate internally and with our customers, or result in the theft of trade secrets or other misappropriation of assets, or otherwise compromise privacy of sensitive information belonging to us, our customers or other business partners; and • Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the Securities and Exchange Commission.
Such factors include, but are not limited to: • The possible or assumed future results of operations, including the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; • The impact of macroeconomic conditions, including inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in monetary policy, volatile market conditions, financial institution instability, as well as geopolitical instability and the ongoing conflicts outside the U.S., on our operations; • Our competitive position and competitors, including the size and growth potential of the markets for our products and product candidates; • The success, cost and timing of our product acquisition and development activities and clinical trials; and our ability to successfully commercialize our product candidates; • Product efficacy or safety concerns, whether or not based on scientific evidence, resulting in product withdrawals, recalls, regulatory action on the part of the FDA (or international counterparts) or declining sales; • The performance of our third-party suppliers and manufacturers which impacts our supply chain and could create business shutdowns or product shortages; and the retention of key scientific and management personnel; • The impact on our business, financial condition and results of operations from the effects of a pandemic or the outbreak of an infectious disease in the United States and worldwide and resulting governmental and societal responses; • Challenges to our patents and the introduction of generic versions of our products and product candidates, which could negatively impact our ability to commercialize and sell our products and product candidates and decrease sales a result of market exclusivity; 34 • Changes in reimbursement available to us, including changes in Medicare and Medicaid payment levels and availability of third-party insurance coverage and the effects of future legislation or regulations, including changes to regulatory approval of new products, licensing and patent rights, environmental protection and possible drug re-importation legislation; • Interruptions and breaches of our computer and communications systems, and those of our vendors, including computer viruses, hacking and cyber-attacks, that could impair our ability to conduct business and communicate internally and with our customers, or result in the theft of trade secrets or other misappropriation of assets, or otherwise compromise privacy of sensitive information belonging to us, our customers or other business partners; and • Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the Securities and Exchange Commission.
Newer branded agents are also available, including: • Ceftaroline fosamil (brand name Teflaro ® ), an injectable antibiotic manufactured and sold by Allergan; • Ceftolozane/Tazobactam (brand name Zerbaxa ® ), a combination cephalosporin and beta-lactamase inhibitor manufactured and sold by Merck; • Omadacycline (brand name Nuzyra ® ), a new tetracycline approved in October 2018 and sold by Paratek Pharmaceuticals Inc.; 25 • Dalbavancin (brand name Dalvance ® ), an injectable antibiotic manufactured and sold by Allergan; • Oritavancin (brand name Orbactiv ® ), an injectable antibiotic manufactured and sold by Melinta; and • Ceftobripole (brand name Zevetera), an injectable antibiotic registered in 2024 by Basilea.
Newer, branded agents are also available, including: • Ceftaroline fosamil (brand name Teflaro ® ), an injectable antibiotic manufactured and sold by Allergan; • Ceftolozane/Tazobactam (brand name Zerbaxa ® ), a combination cephalosporin and beta-lactamase inhibitor manufactured and sold by Merck; • Omadacycline (brand name Nuzyra ® ), a new tetracycline approved in October 2018 and sold by Paratek Pharmaceuticals Inc.; • Dalbavancin (brand name Dalvance ® ), an injectable antibiotic manufactured and sold by Allergan; • Oritavancin (brand name Orbactiv ® ), an injectable antibiotic manufactured and sold by Melinta; and • Ceftobripole (brand name Zevetera), an injectable antibiotic registered in 2024 by Basilea.
Acetaminophen overdose continues to be a leading cause of poisonings reported by hospital emergency departments in the U.S., and Acetadote became a standard of care for treating this potentially life-threatening condition. 2 Acetadote received U.S. FDA approval as an orphan drug, which provided seven years of marketing exclusivity from the date of approval. That exclusivity has since expired.
Acetaminophen overdose continues to be a leading cause of poisonings reported by hospital emergency departments in the U.S., and Acetadote became a standard of care for treating this potentially life-threatening condition. Acetadote received U.S. FDA approval as an Orphan Drug, which provided seven years of marketing exclusivity from the date of approval. That exclusivity has since expired.
Following its issuance, the 508 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2030. On August 25, 2015, the USPTO issued U.S. Patent number 9,114,068 (the “068 Caldolor Patent”) which is assigned to us. The claims of the 068 Caldolor Patent include methods of treating pain using intravenous ibuprofen.
Following its issuance, the 508 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2030. 20 On August 25, 2015, the USPTO issued U.S. Patent number 9,114,068 (the “068 Caldolor Patent”) which is assigned to us. The claims of the 068 Caldolor Patent include methods of treating pain using intravenous ibuprofen.
We have two Phase II clinical programs underway evaluating our ifetroban product candidate in 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.
We have two Phase II clinical programs evaluating our ifetroban product candidate in 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.
CET has also established and manages the Nashville Life Sciences Center , which serves as an incubator for Middle Tennessee’s emerging biomedical industry. The Life Sciences Center provides offices, laboratory space, and equipment to early-stage companies looking to develop their technologies and products. We maintain the Cumberland Pharmaceuticals formulation and testing laboratory at the CET Life Sciences Center.
CET also established and manages the Nashville Life Sciences Center, which serves as an incubator for Middle Tennessee’s emerging biomedical industry. The Life Sciences Center provides offices, laboratory space and equipment to early-stage companies looking to develop their technologies and products. We maintain the Cumberland Pharmaceuticals formulation and testing laboratory at the CET Life Sciences Center.
The FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug's identity, strength, quality and purity. 26 The sponsor of the drug typically conducts human clinical trials in three sequential phases, but the phases may overlap.
The FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug's identity, strength, quality and purity. The sponsor of the drug typically conducts human clinical trials in three sequential phases, but the phases may overlap.
We also added pre-surgery dosing for Caldolor, and recently included newborns to the patients who can benefit from the product. • Selectively adding complementary brands. In addition to our product development activities, we are also seeking to acquire approved brands or late-stage development product candidates to continue to build our portfolio.
We also added pre-surgery dosing for Caldolor, and more recently included newborns to the patients who can benefit from the product. • Selectively adding complementary brands. In addition to our product development activities, we are also seeking to acquire approved brands or late-stage development product candidates to continue to build our portfolio.
CET partners with academic research institutions to identify and support the progress of promising new product candidates, which Cumberland can further develop and commercialize. 8 Specifically, we are seeking long-term, sustainable growth by: • Supporting and expanding the use of our marketed products.
CET partners with academic research institutions to identify and support the progress of promising new product candidates, which Cumberland can further develop and commercialize. Specifically, we are seeking long-term, sustainable growth by: • Supporting and expanding the use of our marketed products.
Our Vaprisol product has a proven day-one response rate to normalize serum sodium levels in hyponatremic patients and move them out of the Intensive Care Unit as efficiently as possible. 5 Vaprisol is supported by our hospital sales division.
Our Vaprisol product has a proven day-one response rate to normalize serum sodium levels in hyponatremic patients and move them out of the Intensive Care Unit as efficiently as possible. Vaprisol is supported by our hospital sales division.
The other competing product is Samsca ® (an oral tolvaptan product sold by Otsuka Pharmaceutical Company). There are also several generic versions of tolvaptan sold by other companies. Vibativ ® Vibativ is a potent, once-daily, injectable antibiotic for the treatment of certain gram-positive infections.
The other competing product is Samsca ® (an oral tolvaptan product sold by Otsuka Pharmaceutical Company). There are also several generic versions of tolvaptan sold by other companies. 25 Vibativ ® Vibativ is a potent, once-daily, injectable antibiotic for the treatment of certain gram-positive infections.
A number of pharmaceutical and other health care companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. 31 HIPAA and Other Data Protection Laws In the United States, we and our collaborators are subject to numerous federal and state privacy and security laws and regulations, including the Health Insurance Portability and Accountability Act of 1996.
A number of pharmaceutical and other health care companies have been prosecuted under these laws for allegedly inflating drug prices they report to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product. 32 HIPAA and Other Data Protection Laws In the United States, we and our collaborators are subject to numerous federal and state privacy and security laws and regulations, including the Health Insurance Portability and Accountability Act of 1996.
The 356 Acetadote Patent is scheduled to expire in May 2026, which includes a 270-day patent term adjustment granted by the USPTO. Following the issuance of the 356 Acetadote Patent, we received separate Paragraph IV certification notices from InnoPharma, Inc.
The 356 Acetadote Patent is scheduled to expire in May 2026, which includes a 270-day patent term adjustment granted by the USPTO. 18 Following the issuance of the 356 Acetadote Patent, we received separate Paragraph IV certification notices from InnoPharma, Inc.
It is sold by Allergan, Inc. and Ironwood Pharmaceuticals, Inc. 24 • Plecanatide (brand name Trulance ® ), an oral product indicated for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.
It is sold by Allergan, Inc. and Ironwood Pharmaceuticals, Inc. • Plecanatide (brand name Trulance ® ), an oral product indicated for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.
In addition to coordinating the call center, our clinical/regulatory group generates medical information letters, provides informational memos to our sales forces and assists with ongoing training for the sales forces. 15 CLINICAL DEVELOPMENT AND STUDY RESULTS Vibativ Clinical Manuscripts Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections.
In addition to coordinating the call center, our clinical/regulatory group generates medical information letters, provides informational memos to our sales forces and assists with ongoing training for the sales forces. 14 CLINICAL DEVELOPMENT AND STUDY RESULTS Vibativ Clinical Manuscripts Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections.
Cumberland developed and obtained U.S. FDA approval for Acetadote, and then introduced the product through our hospital sales force. Acetadote is typically used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter and prescription pain-relieving and fever-reducing products.
Cumberland developed and obtained U.S. FDA approval for Acetadote and then introduced the product through our hospital sales division. Acetadote is typically used in hospital emergency departments to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter and prescription pain-relieving and fever-reducing products.
The United States Patent and Trademark Office (the “USPTO”) issued us a series of patents associated with our Acetadote product. These patents are discussed in Part I, Item I – “ Business - Trademarks and Patents ” – of this Form 10-K. The FDA has approved several abbreviated new drug applications (“ANDA”) filed by various generics companies referencing Acetadote.
The United States Patent and Trademark Office (the “USPTO”) has issued Cumberland a series of patents associated with our Acetadote product. These patents are discussed in Part I, Item I – “ Business - Trademarks and Patents ” – of this Form 10-K. The FDA has approved several abbreviated new drug applications (“ANDA”) filed by various generics companies referencing Acetadote.
During 2024, we worked to support our existing international partners, conclude unproductive arrangements and identify new companies to represent our products in select additional territories. 11 BUSINESS DEVELOPMENT Since inception, we have had an active business development initiative focused on acquiring rights to marketed products and product candidates that fit our strategy and target markets.
During 2025, we worked to support our existing international partners, conclude unproductive arrangements and identify new companies to represent our products in select additional territories. 11 BUSINESS DEVELOPMENT Since inception, we have had an active business development initiative focused on acquiring rights to marketed products and product candidates that fit our strategy and target markets.
While the time and cost of completing these steps and obtaining FDA approval can vary dramatically depending on the drug, it can take many years and cost millions of dollars for a novel drug. 27 Section 505(b) New Drug Applications An NDA may be submitted under different methods, a 505(b)(1), 505(b)(2) or 505(j).
While the time and cost of completing these steps and obtaining FDA approval can vary dramatically depending on the drug, it can take many years and cost millions of dollars for a novel drug. 28 Section 505(b) New Drug Applications An NDA may be submitted under different methods, a 505(b)(1), 505(b)(2) or 505(j).
An applicant may not be assessed more than five prescription drug program fees for a fiscal year for prescription drug products identified in a single approved application. 29 Under section 736(d)(1)(A) of the FD&C Act, an applicant may qualify for a waiver of or reduction in application or program fees if the waiver or reduction is necessary to protect the public health.
An applicant may not be assessed more than five prescription drug program fees for a fiscal year for prescription drug products identified in a single approved application. 30 Under section 736(d)(1)(A) of the FD&C Act, an applicant may qualify for a waiver of or reduction in application or program fees if the waiver or reduction is necessary to protect the public health.
We are also supplementing our acquisitions and late-stage development activities with the early-stage product development activities at CET. • Leveraging our infrastructure through co-promotion partnerships. We believe that our commercial infrastructure can help drive prescription volume and product sales. We also look for strategic partners that can complement our capabilities and enhance opportunities for our brands.
We are also supplementing our acquisitions and late-stage development activities with the early-stage product development activities at CET. • Leveraging our infrastructure through co-promotion partnerships. We believe that our commercial infrastructure can help drive prescription volume and product sales. We also look for select partners that can complement our capabilities and enhance opportunities for our brands.
We continue to strategically review our brands, pipeline and capabilities, as well as our international partners. We believe that it is prudent to continually evaluate our product portfolio, partners, and organization in order to ensure a proper focus and the needed supporting capabilities. International Partners D.B. Pharm Korea Co., Ltd. (“D.B.
We continue to strategically review our brands, pipeline and capabilities, as well as our international partners. We believe that it is prudent to continually evaluate our product portfolio, partners and organization to ensure a proper focus and the needed supporting capabilities. International Partners D.B. Pharm Korea Co., Ltd. (“D.B.
MSSA and MRSA are important disease-causing pathogens in these cases. While many recently introduced antibiotics are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug-resistant, Vibativ was specifically designed to kill drug-resistant bacteria.
MSSA and MRSA are important disease-causing pathogens in these cases. While many recently introduced antibiotics are quickly losing the ability to fight the bacteria they were designed to kill because those bacteria have become drug-resistant, Vibativ was specifically designed to kill drug-resistant bacteria.
Caldolor South Korea Marketed R-Pharm JSC Vibativ Russia and CIS Marketed Tabuk Pharmaceuticals Vibativ Saudi Arabia and Jordan Registration PiSA Pharmaceutical Caldolor Mexico Registration SciClone Pharmaceuticals, Inc. Vibativ China and Hong Kong Registration D.B. Pharm Korea Co., Ltd. Vaprisol & Vibativ South Korea Registration WinHealth Pharma Group Co.
Caldolor South Korea Marketed R-Pharm JSC Vibativ Russia Marketed Tabuk Pharmaceuticals Vibativ Saudi Arabia and Jordan Marketed PiSA Pharmaceutical Caldolor Mexico Approved SciClone Pharmaceuticals, Inc. Vibativ China and Hong Kong Approved D.B. Pharm Korea Co., Ltd. Vaprisol & Vibativ South Korea Registration WinHealth Pharma Group Co.
Meanwhile, our clinical team is developing a pipeline of new product candidates to address poorly met medical needs. We also pursue opportunities to acquire additional marketed brands, as well as late-stage development product candidates in our target medical specialties. We are supplementing these activities with the earlier-stage product development at Cumberland Emerging Technologies ("CET"), our majority-owned subsidiary.
Meanwhile, our clinical team is developing a pipeline of new product candidates to address poorly met medical needs. We also pursue opportunities to acquire additional marketed brands, and late-stage development product candidates in our target medical specialties. We are supplementing these activities with the earlier-stage product development at Cumberland Emerging Technologies ("CET"), our majority-owned subsidiary.
There are multiple manufacturers of injectable NAC products that are based on our old formulation. 23 Caldolor ® Caldolor is marketed for the treatment of pain and fever, primarily in a hospital or surgery center setting.
There are multiple manufacturers of injectable NAC products that are based on our old formulation. 22 Caldolor ® Caldolor is marketed for the treatment of pain and fever, primarily in a hospital or surgery center setting.
In 2023, the FDA approved expanded labeling for Caldolor to include use in infants 3 to 6 months old. The safety and efficacy of Caldolor has now been established for the treatment of pain and fever in pediatric patients aged 3 months and older.
In 2023, the FDA approved expanded labeling for Caldolor to include use in infants. The safety and efficacy of Caldolor has now been established for the treatment of pain and fever in pediatric patients aged 3 months and older.
We currently own six products approved by the FDA in the United States. We are also building international partnerships to bring our medicines to patients in other countries. Additionally, we look for opportunities to expand our brands into new patient populations through clinical trials, new product presentations and our support of select, investigator-initiated studies.
We currently own rights to seven products approved by the FDA in the United States. We are also building international partnerships to bring our medicines to patients in other countries. Additionally, we look for opportunities to expand our brands into new patient populations through clinical trials, new product presentations and our support of select, investigator-initiated studies.
We also believe that we can increase market share for Kristalose through our co-promotion and marketing initiatives. • Oncology market: In early 2022, we formed a new oncology sales force to promote our Sancuso brand. This organization targets key oncologists and clinics across the U.S. and is comprised of both inside and field-based sales professionals.
We also believe that we can increase market share for Kristalose through our co-promotion and marketing initiatives. • Oncology market: We formed a new oncology sales force to promote our Sancuso brand. This organization targets key oncologists and clinics across the U.S. and is comprised of both inside and field-based sales professionals.
Pharm”) has licensed our Caldolor product for the South Korean market, and they obtained regulatory approval for Caldolor in their country. During 2024, D.B. Pharm continued to purchase supplies of Caldolor and distributed the brand in South Korea. We have also entered into agreements with D.B. Pharm to register and commercialize our Vaprisol and Vibativ brands in their country.
Pharm”) has licensed our Caldolor product for the South Korean market, and they obtained regulatory approval for Caldolor in their country. In 2025, D.B. Pharm continued to purchase supplies of Caldolor and distributed the brand in South Korea. We have also entered into agreements with D.B. Pharm to register and commercialize our Vaprisol and Vibativ brands in their country.
For more information about the risks, uncertainties, and other factors that could affect our future results, please refer to Item 1A, Risk Factors, included herein. 33
For more information about the risks, uncertainties, and other factors that could affect our future results, please refer to Item 1A, Risk Factors, included herein. 35
During 2023, we expanded the sales division as we work to deliver Sancuso to more cancer patients, helping them tolerate their chemotherapy treatments. Our commercial executives conduct ongoing analyses to evaluate marketing campaigns and promotional programs in support of our brands.
We subsequently expanded the sales division as we work to deliver Sancuso to more cancer patients, helping them tolerate their chemotherapy treatments. Our commercial executives conduct ongoing analyses to evaluate marketing campaigns and promotional programs in support of our brands.
Additional Testing Program Cumberland entered into a non-clinical evaluation agreement, to test one of our products against bacterial strains and subsequently, in vivo animal models utilizing the preclinical services program funded by the Division of Microbiology and Infectious Diseases (“DMID”), which is part of the National Institute of Allergy and Infectious Diseases (“NIAID”), an institute of the National Institutes of Health (“NIH”), which is part of the Department of Health and Human Services (“HHS”), an agency of the U.S. government.
Additional Testing Program Cumberland entered into a non-clinical evaluation agreement to test one of our products bacterial strains and subsequently, in vivo animal models utilizing the preclinical services program funded by the Division of Microbiology and Infectious Diseases, which is part of the National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, which is part of the Department of Health and Human Services, an agency of the U.S. government.
Our strategy has been to focus our hospital sales team on select, high-priority accounts. 9 • Gastroenterology market: We promote Kristalose through a dedicated field sales team addressing a targeted group of physicians who are existing and potential large prescribers of the product.
Our strategy has been to focus our hospital sales team on select, high-priority accounts. • Gastroenterology market: We promote Kristalose and Talicia through a dedicated field sales team addressing a targeted group of physicians who are existing and potential large prescribers of the products.
Under policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA (currently PDUFA VII - effective September 30, 2022), the FDA has a target timeline of 10 months in which to complete its initial review of a standard NDA and respond to the applicant.
Under policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA (currently PDUFA VII - effective October 1, 2022), the FDA has a target timeline of 10 months in which to complete its initial review of a standard NDA and respond to the applicant.
PRODUCTS Products Indication Status Acetadote ® Acetaminophen Poisoning Marketed Caldolor ® Pain and Fever Marketed Kristalose ® Chronic and Acute Constipation Marketed Sancuso ® Nausea and Vomiting Associated with Chemotherapy Marketed Vaprisol ® Euvolemic and Hypervolemic Hyponatremia Approved Vibativ ® Serious Bacterial Infections Marketed Acetadote ® Acetadote is an intravenous formulation of N-acetylcysteine, indicated for the treatment of liver toxicity associated with acetaminophen poisoning.
PRODUCTS Products Indication Status Acetadote ® Acetaminophen Poisoning Marketed Caldolor ® Pain and Fever Marketed Kristalose ® Chronic and Acute Constipation Marketed Sancuso ® Nausea and Vomiting Associated with Chemotherapy Marketed Vaprisol ® Euvolemic and Hypervolemic Hyponatremia Approved Vibativ ® Serious Bacterial Infections Marketed Talicia ® H. pylori Infection Marketed 2 Acetadote ® Acetadote is an intravenous formulation of N-acetylcysteine, indicated for the treatment of liver toxicity associated with acetaminophen poisoning.
We are not aware of any approved injectable products indicated for the treatment of fever in the U.S. other than Caldolor and Ofirmev. There are, however, numerous drugs available to physicians to reduce fevers in hospital settings via oral and rectal administration to the patient, including ibuprofen, acetaminophen and aspirin. These drugs are manufactured by numerous pharmaceutical companies.
We are not aware of any approved injectable products indicated for the treatment of fever in the U.S. other than Caldolor and Ofirmev. There are, however, numerous drugs available to physicians to reduce fevers in hospital settings via oral and rectal administration to the patient, including ibuprofen, acetaminophen and aspirin.
In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidate in patients with 1) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) Idiopathic Pulmonary Fibrosis (“IPF”), the most common form of progressive fibrosing interstitial lung disease.
We also have Phase II clinical programs underway evaluating our ifetroban product candidate in patients with 1) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) Idiopathic Pulmonary Fibrosis (“IPF”), the most common form of progressive fibrosing interstitial lung disease.
We continue to build a network of established international partners with the needed regulatory and commercial capabilities to register and provide our medicines to patients in their countries. Our portfolio of brands approved for marketing by the U.S.
We have also established a network of international partners with the needed regulatory and commercial capabilities to register and provide our medicines to patients in their countries. Our portfolio of brands approved for marketing by the U.S.
During 2023, we completed the transition of Sancuso from Kyowa Kirin to Cumberland, including the NDA transfer, and expanded our oncology sales division to further support the brand. We also successfully transferred manufacture of the product to a new facility.
Following our acquisition of Sancuso, we completed the transition of the product from Kyowa Kirin to Cumberland, including the NDA transfer, and expanded our oncology sales division to further support the brand. We also successfully transferred manufacture of the product to a new facility.
We also had manufacturing arrangements with a packager who provided finished supplies of the product for commercial and sampling purposes during 2024. 18 Sancuso ® As part of the acquisition of Sancuso, we obtained an initial supply of finished goods inventory.
We also had manufacturing arrangements with a packager who provided finished supplies of the product for commercial and sampling purposes during 2025. 17 Sancuso ® As part of the acquisition of Sancuso, we obtained an initial supply of finished goods inventory.
We renewed our agreement with Foxland in 2022. CET University Collaboration Agreements Through CET, we collaborate with a select group of academic research institutions located in the Mid-South region of the U.S. to identify, co-develop and seek grant funding for promising biomedical technologies emerging from those research institutions.
CET University Collaboration Agreements Through CET, we collaborate with a select group of academic research institutions located in the Mid-South region of the U.S. to identify, co-develop and seek grant funding for promising biomedical technologies emerging from those research institutions.
We then launched Caldolor and continue to promote the product in the U.S. through our hospital sales force. 3 We completed a series of Phase IV studies to gather additional data to support our Caldolor product. Those clinical trials involved another 1,000 adult and pediatric patients.
We then launched Caldolor and continue to promote the product in the U.S. through our hospital sales division. We completed a series of Phase IV studies to gather additional data to support our Caldolor product. Those clinical trials involved an additional 1,000 adult and pediatric patients.
Competitive factors directly affecting our markets include but are not limited to: • product attributes such as efficacy, safety, ease-of-use and cost-effectiveness; • brand awareness and recognition driven by sales, marketing and distribution capabilities; • intellectual property and other exclusivity rights; • availability of resources to build and maintain developmental and commercial capabilities; • successful business development activities; • extent of third-party reimbursements, insurance coverage; and • establishment of advantageous collaborations to conduct development, manufacturing or commercialization efforts.
Competitive factors directly affecting our markets include but are not limited to: • product attributes such as efficacy, safety, ease-of-use and cost-effectiveness; • brand awareness and recognition driven by sales, marketing and distribution capabilities; • product access in the changing healthcare marketplace through contracting and partnerships; • intellectual property and other exclusivity rights; • availability of resources to build and maintain developmental and commercial capabilities; • successful business development activities; • extent of third-party reimbursements, insurance coverage; and • establishment of advantageous collaborations to conduct development, manufacturing or commercialization efforts.
In particular, forward-looking statements include, among other things, statements regarding our intent, belief or expectations, and can be identified by the use of terminology such as “may,” “will,” “expect,” “believe,” “intend,” “plan,” “estimate,” “should,” “seek,” “anticipate” and other comparable terms or the negative thereof.
All statements other than statement of historical facts may be forward-looking statements. In particular, forward-looking statements include, among other things, statements regarding our intent, belief or expectations, and can be identified by the use of terminology such as “may,” “will,” “expect,” “believe,” “intend,” “plan,” “estimate,” “should,” “seek,” “anticipate” and other comparable terms or the negative thereof.
Caldolor Newborn Study, Clinical Manuscripts and Other Studies We previously received FDA approval for the use of Caldolor in pediatric patients 6 months of age and older. Caldolor is the first and only injectable NSAID approved for use in children.
Caldolor Clinical Manuscripts We previously received FDA approval for the use of Caldolor in pediatric patients 6 months of age and older. Caldolor is the first and only injectable NSAID approved for use in children.
In 2024, we also highlighted our investment in our employees through our continuing education programs, employee development initiatives and employee recognition awards. We reported that women represented 49% of Cumberland’s workforce and 27% of our employees were minorities. Through our sustainability initiatives, we will continue to identify and address critical industry issues, monitor relevant guidelines and utilize best practices.
We also highlighted our investment in our employees through our continuing education programs, employee development initiatives and employee recognition awards. We reported women represented 50% of Cumberland’s workforce and 30% of our employees were minorities. Through our sustainability initiatives, we will continue to identify and address critical industry issues, monitor relevant guidelines and utilize best practices.
Food and Drug Administration (“FDA”) includes: • Acetadote ® ( acetylcysteine ) injection, for the treatment of acetaminophen poisoning; • Caldolor ® ( ibuprofen ) injection, for the treatment of pain and fever; • Kristalose ® ( lactulose ) for oral solution, a prescription laxative, for the treatment of constipation; • Sancuso ® ( granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; • Vaprisol ® ( conivaptan ) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and • Vibativ ® ( telavancin ) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.
Food and Drug Administration ("FDA") includes: • Acetadote ® ( acetylcysteine ) injection, for the treatment of acetaminophen poisoning; • Caldolor ® ( ibuprofen ) injection, for the treatment of pain and fever; • Kristalose ® ( lactulose ) oral solution, a prescription laxative for the treatment of constipation; • Sancuso ® ( granisetron ) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; • Vaprisol ® ( conivaptan ) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; • Vibativ ® ( telavancin ) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and • Tacilia ® ( omeprazole, amoxicillin and rifabutin ) oral capsule, for the treatment of H. pylori infection.
BACKLOG Due to the relatively short lead-time required to fill orders for our products, backlog of orders is not considered material to our business. EMPLOYEES As of December 31, 2024 we had 91 employees.
BACKLOG Due to the relatively short lead-time required to fill orders for our products, backlog of orders is not considered material to our business. EMPLOYEES As of December 31, 2025, we had 93 employees.
Upon this condition, in accordance with the License and Supply agreement with Perrigo, we began to supply Perrigo with our Authorized Generic. On January 7, 2013, Perrigo announced initial distribution of our Authorized Generic acetylcysteine injection product. 20 On March 19, 2013, the USPTO issued U.S. Patent number 8,399,445 (the “445 Acetadote Patent”) which is assigned to us.
Upon this condition, in accordance with the License and Supply agreement with Perrigo, we began to supply Perrigo with our Authorized Generic. On January 7, 2013, Perrigo announced initial distribution of our Authorized Generic acetylcysteine injection product. On March 19, 2013, the USPTO issued U.S. Patent number 8,399,445 (the “445 Acetadote Patent”) which expired in August 2025.
In 2023, we announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of our Vibativ product in children 2 to 17 years of age.
A new publication in Antimicrobial Agents and Chemotherapy detailed the results of the first clinical study investigating the safety and pharmacokinetics of our Vibativ product in children 2 to 17 years of age.
Total revenue by customer for each customer representing 10% or more of consolidated gross revenues are summarized below for the year ended December 31, 2024: 2024 Customer 1 29% Customer 2 26% Customer 3 21% 10 INTERNATIONAL PARTNERSHIPS We have established our own capabilities to support the commercialization of our products in the U.S.
Total revenue by customer for each customer representing 10% or more of consolidated gross revenues are summarized below for the year ended December 31, 2025: 2025 Customer 1 27% Customer 2 25% Customer 3 22% 10 INTERNATIONAL PARTNERSHIPS We have established our own capabilities to support the commercialization of our products in the U.S.
The agreement with the manufacturer of Sancuso was assigned to us and there were additional goods supplied to us during 2022. The production was moved to one of the manufacturer’s other facilities. During 2022, that new facility was approved by the FDA to manufacture and supply Sancuso.
The agreement with the manufacturer of Sancuso was assigned to us and there were additional goods supplied to us during 2022. The production was moved to one of the manufacturer’s other facilities. During 2022, that new facility was approved by the FDA to manufacture and supply Sancuso. We received supplies of the product from the new facility in 2023.
Distribution Like many pharmaceutical companies, we engage a third-party with appropriate facilities and logistical expertise to support the U.S. distribution of our products. In 2024, Cardinal Health Specialty Solutions exclusively handled our U.S. product logistics activities, including warehousing, shipping, and various other customer activities.
Our contract manufacturer for Vibativ continued to provide supplies of the product in 2025. Distribution Like many pharmaceutical companies, we engage a third-party with appropriate facilities and logistical expertise to support the U.S. distribution of our products. In 2025, Cardinal Health Specialty Solutions exclusively handled our U.S. product logistics activities, including warehousing, shipping, and various other customer activities.
Our 2024 sustainability metrics noted that during that year we provided 3.9 million patient doses of our brands, while safely disposing of nearly 12,480 pounds of expired and damaged goods. We had no product recalls and no clinical trials terminated due to failure to practice good clinical standards.
Our 2025 sustainability metrics noted that during that year we provided nearly 5 million patient doses of our brands, while safely disposing of over 5,500 pounds of expired and damaged goods. We had no product recalls and no clinical trials terminated due to failure to practice good clinical standards.
Caldolor ® We have agreements with multiple manufacturers for the supply of Caldolor and during 2024, we obtained commercial supplies from three of these manufacturers for our international and domestic Caldolor requirements. Kristalose ® We have an agreement for the purchase of Kristalose API with an international supplier.
Caldolor ® We have agreements with multiple manufacturers for the supply of Caldolor and during 2025, we obtained commercial supplies from three of these manufacturers for our international and domestic Caldolor requirements. Kristalose ® We have an agreement for the purchase of Kristalose active pharmaceutical ingredient (“API”) with an international supplier.
In connection with the FDA’s approval of Acetadote, we committed to certain post-marketing activities for the product. Completion of our first Phase IV commitment resulted in the FDA’s approval of expanded labeling for the product for use in pediatric patients.
In connection with the FDA’s approval of Acetadote, we committed to certain post-marketing activities for the product. Completion of our first Phase IV commitment resulted in the FDA’s approval of expanded labeling for Acetadote’s use in pediatric patients. Completion of our second Phase IV commitment resulted in further revised labeling for the product with FDA approval of additional safety data.
We seek to protect our proprietary information by requiring our employees, consultants, contractors and other advisors to execute agreements providing for protection of our confidential information upon commencement of their employment or engagement.
We seek to protect our proprietary information by requiring our employees, consultants, contractors and other advisors to execute agreements providing for protection of our confidential information upon commencement of their employment or engagement. We also require confidentiality agreements from entities to which we provide our confidential information or materials.
We have since transferred the product’s manufacturing to a new facility. Our new manufacturing partner is working with the FDA to address several Form 483 and warning letter issues in a timely manner. We next expect to file for the approval to manufacture branded Vaprisol once all FDA issues at the new site are resolved.
Our new manufacturing partner is working with the FDA to address several Form 483 and warning letter issues in a timely manner. We next expect to file for the approval to manufacture branded Vaprisol once all FDA issues at the new site are resolved. Vibativ ® Vibativ is an FDA-approved injectable anti-infective.
Demand for the product increased in 2020 during the pandemic, and we worked to support the expanded use of the product in hospitals and clinics during the health care crisis. During 2021, we shipped all remaining inventory of the product and notified the FDA that supplies of the product are not currently available.
Demand for the product increased during the pandemic, and we worked to support the expanded use of the product in hospitals and clinics during the health care crisis. We shipped all remaining inventory of the product and notified the FDA that supplies of the product are not currently available. We have since transferred the product’s manufacturing to a new facility.
We received supplies of the product from the new facility in 2023 and began shipping the Cumberland-packaged product during 2024. Vaprisol ® As part of the acquisition of Vaprisol, we obtained a significant existing supply of raw material inventory. We reached an agreement during 2020 with a new manufacturer to provide us with long-term supplies of the product.
We continued to receive supplies of the Cumberland-packaged product during 2024. Vaprisol ® As part of the acquisition of Vaprisol, we obtained a significant existing supply of raw material inventory. We reached an agreement during 2020 with a new manufacturer to provide us with long-term supplies of the product.
The study suggests Vibativ is a safe and viable option for pediatric patients ages 2 to 17 who require systemic antibiotics for the treatment of a known or suspected bacterial infection, including those with MRSA or another S. aureus pathogen.
The study suggests Vibativ is a safe and viable option for pediatric patients ages 2 to 17 who require systemic antibiotics for the treatment of a known or suspected bacterial infection, including those with MRSA or another S. aureus pathogen. In February 2025, Vibativ received marketing approval in China through our partner SciClone.
The claims of the 400 Caldolor Patent include composition and methods of treating pain and fever using intravenous ibuprofen. Following its issuance, the 400 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in March 2032.
The claims of the 400 Caldolor Patent include composition and methods of treating pain and fever using intravenous ibuprofen. Following its issuance, the 400 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in March 2032. We also have an additional patent application related to Caldolor pending with the USPTO.
The joint venture will focus on acquiring, developing, registering, and commercializing development stage and commercial stage biopharmaceuticals for China, Hong Kong and other Asian markets. R-Pharma JSC (“R Pharm”) has licensed our Vibativ product for a territory that includes Russia and a number of adjacent countries in Eastern Europe.
The joint venture will focus on acquiring, developing, registering and commercializing development stage and commercial stage biopharmaceuticals for China, Hong Kong and other Asian markets. R-Pharma JSC (“R Pharm”) has licensed our Vibativ product for a territory that includes Russia. R-Pharm is one of the leading multinational pharmaceutical organizations based in Russia.
Kristalose ® Kristalose is a dry powder crystalline prescription formulation of lactulose indicated for the treatment of constipation. The U.S. constipation therapy market includes various prescription and over the counter, or OTC, products.
These drugs are manufactured by numerous pharmaceutical companies. 23 Kristalose ® Kristalose is a dry powder crystalline prescription formulation of lactulose indicated for the treatment of constipation. The U.S. constipation therapy market includes various prescription and over the counter, or OTC, products.
Patent number 7,531,623 (the “623 Vibativ Patent”) is listed in the FDA Orange Book and is scheduled to expire in January 2027 and includes composition of matter claims that encompass the Vibativ drug substance as well as methods for preparing the Vibativ drug substance. Remaining Products We have no issued patents for our Sancuso, Vaprisol or Kristalose products.
Patent number 7,531,623 (the “623 Vibativ Patent”) is listed in the FDA Orange Book and is scheduled to expire in January 2027 and includes composition of matter claims that encompass the Vibativ drug substance as well as methods for preparing the Vibativ drug substance.
Our products face competition from other branded products, generics and alternate medical treatments. Our task is to position each brand to feature its competitive advantages, implement a well thought out marketing plan and provide focused sales, field based medical and other tactical support.
Our products face competition from other branded products, generics and alternate medical treatments. Our task is to position each brand to feature its competitive advantages, implement a well thought out marketing plan and provide focused sales, field-based medical and other tactical support. Acetadote ® Acetadote is our injectable formulation of N-acetylcysteine ( “ NAC”) for the treatment of acetaminophen overdose.
Alternative oral treatments must be taken several times (day and night) to deliver the same therapeutic doses. In early 2022, we assumed full commercial responsibility for the product in the U.S. – including its marketing, promotion, distribution, manufacturing and medical support activities.
Alternative oral treatments must be taken several times (day and night) to deliver the same therapeutic doses. We entered into an agreement with Kyowa Kirin to acquire the U.S. assets and rights to Sancuso. We then assumed full commercial responsibility for the product in the U.S. – including its marketing, promotion, distribution, manufacturing and medical support activities.
We are currently advancing two Phase II clinical programs evaluating ifetroban:1) treatment of Systemic Sclerosis (scleroderma), a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, and 2) treatment of Idiopathic Pulmonary Fibrosis (IPF), the most common form of progressive fibrosing interstitial lung disease (PF-ILD).
We have two Phase II clinical programs evaluating our ifetroban product candidate in 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.
Newer agents are often reserved for two reasons: they are valuable in the treatment of patients that fail to respond to generics and it is considered good practice to conserve the use of these agents to reduce the risk of resistance. antimicrobial resistance, which is considered a global public health threat by the Center for Disease Control and Prevention (“CDC”).
Newer agents are often reserved for two reasons: they are valuable in the treatment of patients that fail to respond to generics and it is considered good practice to conserve the use of these agents to reduce the risk of resistance.
On November 3, 2017, we became aware of a Paragraph IV certification notice from Exela Pharma Sciences, LLC challenging the 356, 445, 061, 738 and 028 Acetadote Patents on the basis of non-infringement. 21 Caldolor ® We have an exclusive, worldwide license to clinical data for intravenous ibuprofen from Vanderbilt University, in consideration for royalty obligations related to Caldolor.
On February 3, 2026, we became aware of a Paragraph IV certification notice from Avet Pharmaceuticals Inc. challenging the 738 and 028 Acetadote Patents on the basis of non-infringement and/or invalidity. Caldolor ® We have an exclusive, worldwide license to clinical data for intravenous ibuprofen from Vanderbilt University, in consideration for royalty obligations related to Caldolor.
We also have additional patent applications related to Caldolor pending with the USPTO. 22 Vibativ ® We own numerous U.S. patents and related international patents for Vibativ. These patents were acquired in our November 2018 acquisition of certain product rights, intellectual property and related assets of Vibativ from Theravance. U.S.
Vibativ ® We own numerous U.S. patents and related international patents for Vibativ. These patents were acquired in our November 2018 acquisition of certain product rights, intellectual property and related assets of Vibativ from Theravance. U.S.
Vibativ ® In November 2018, the Company announced an agreement to acquire the Vibativ assets and assume global responsibility for the brand including the related marketing, distribution, manufacturing and regulatory activities. In early 2021, we introduced the Cumberland-packaged product, which is supported by our hospital sales force. Vibativ is a patented, FDA-approved injectable anti-infective.
The Company reached an agreement to acquire the Vibativ assets and assume global responsibility for the brand including the related marketing, distribution, manufacturing and regulatory activities. We then introduced the Cumberland-packaged product, which is supported by our hospital sales force.
We are also working with a network of select international partners to register our products and make them available to patients in their countries. We will continue to support our partners’ registration and commercialization efforts in their respective territories. The acquisition of Vibativ resulted in several new international partners and market opportunities. • Managing our operations with financial discipline.
We are also working with a network of established international partners to register our products and make them available to patients in their countries. We will continue to support our partners’ registration and commercialization efforts in their respective territories.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe believe that our subcontractors and vendors take precautionary measures to prevent problems that could affect our business operations as a result of failure or disruption to their information systems. However, there is no guarantee such efforts will be successful in preventing a disruption, and it is possible that we may be impacted by information system failures.
Biggest changeHowever, there is no guarantee such efforts will be successful in preventing a disruption, and it is possible that we may be impacted by information system failures. The occurrence of any information system failures could result in interruptions, delays, loss or corruption of data and cessations or interruptions in the availability of these systems.
In addition, changes impacting any of our products in areas such as competition, lack of market acceptance or demand, government regulation, intellectual property, reimbursement and manufacturing could have an adverse impact on our future revenues and profitability including: • Changes in intellectual property protection available for our products or competing treatments; • Any unfavorable publicity concerning us, our products, or the markets for these products such as information concerning product contamination or other safety issues in any of our product markets, whether or not directly involving our products; • Perception by physicians and other members of the healthcare community of the safety or efficacy of our products or competing products; • Regulatory developments related to our marketing and promotional practices or the manufacture or continued use of our products; 35 • The prices of our products relative to other drugs or competing treatments; • The impact of current or additional generic competitors; • The availability and level of third-party reimbursement for sales of our products; • The continued availability of adequate supplies of our products to meet demand: • Weakened demand for our products; and • Unforeseen or serious adverse effects outside of those specified in current product labeling being attributed to any of our approved products.
In addition, changes impacting any of our products in areas such as competition, lack of market acceptance or demand, government regulation, intellectual property, reimbursement and manufacturing could have an adverse impact on our future revenues and profitability including: • Changes in intellectual property protection available for our products or competing treatments; • Any unfavorable publicity concerning us, our products, or the markets for these products such as information concerning product contamination or other safety issues in any of our product markets, whether or not directly involving our products; • Perception by physicians and other members of the healthcare community of the safety or efficacy of our products or competing products; • Regulatory developments related to our marketing and promotional practices or the manufacture or continued use of our products; • The prices of our products relative to other drugs or competing treatments; • The impact of current or additional generic competitors; • The availability and level of third-party reimbursement for sales of our products; • The continued availability of adequate supplies of our products to meet demand: • Weakened demand for our products; and • Unforeseen or serious adverse effects outside of those specified in current product labeling being attributed to any of our approved products.
Furthermore, any system failure, accident or security breach that causes interruptions in our operations could result in a material disruption of our drug development programs. 43 While we continue to invest in data protection and information technology, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions.
Furthermore, any system failure, accident or security breach that causes interruptions in our operations could result in a material disruption of our drug development programs. While we continue to invest in data protection and information technology, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions.
Our employees have been trained to submit accurate and correct pricing information to payors. If, despite the training, our employees provide incorrect or fraudulent information, then we will be subject to various administrative and judicial investigations and litigation. “Formulary” practices of third-party payors could adversely affect our competitive position.
Our employees have been trained to submit accurate and correct pricing information to payors. If, despite the training, our employees provide incorrect or fraudulent information, then we will be subject to various administrative and judicial investigations and litigation. 43 “Formulary” practices of third-party payors could adversely affect our competitive position.
In addition, if we choose to issue shares of our stock as consideration for any acquisition, dilution to our shareholders could result. We may be required to modify our business practices, pay fines and significant expenses or experience other losses due to governmental investigations or other enforcement activities.
In addition, if we choose to issue shares of our stock as consideration for any acquisition, dilution to our shareholders could result. 48 We may be required to modify our business practices, pay fines and significant expenses or experience other losses due to governmental investigations or other enforcement activities.
If our third-party manufacturers do not comply with these requirements, we could be subject to fines and civil penalties; suspension of production or distribution; suspension or delay in product approval; product seizure or recall; and withdrawal of product approval. 37 We are dependent on a variety of other third parties.
If our third-party manufacturers do not comply with these requirements, we could be subject to fines and civil penalties; suspension of production or distribution; suspension or delay in product approval; product seizure or recall; and withdrawal of product approval. We are dependent on a variety of other third parties.
Further consolidation or financial difficulties could also cause our customers to reduce the amounts of our products that they purchase, adversely impacting our business, financial condition and results of operations. 41 Our CET joint initiative may not result in our gaining access to commercially viable products.
Further consolidation or financial difficulties could also cause our customers to reduce the amounts of our products that they purchase, adversely impacting our business, financial condition and results of operations. Our CET joint initiative may not result in our gaining access to commercially viable products.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. We may be involved in lawsuits to protect or enforce our trademarks or for allegedly infringing the trademark rights of others, which could be costly and time consuming.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. 56 We may be involved in lawsuits to protect or enforce our trademarks or for allegedly infringing the trademark rights of others, which could be costly and time consuming.
If we are unable to successfully integrate any acquired brands, both current and future, these product acquisitions may not be beneficial to us in the long term. Our ifetroban product candidates have not been approved for sale and may never be successfully commercialized.
If we are unable to successfully integrate any acquired brands, both current and future, these product acquisitions may not be beneficial to us in the long term. 42 Our ifetroban product candidates have not been approved for sale and may never be successfully commercialized.
A long-term inability to meet demand for our products could result in impairment of our brands overall future and the carrying value of the assets associated with our brands. 36 Acetadote: We have an agreement with one manufacturer to provide commercial supply of Acetadote.
A long-term inability to meet demand for our products could result in impairment of our brands overall future and the carrying value of the assets associated with our brands. Acetadote: We have an agreement with one manufacturer to provide commercial supply of Acetadote.
As a result, we may not commercialize or continue to commercialize a product that has obtained regulatory approval. 45 Any approved drug product that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community.
As a result, we may not commercialize or continue to commercialize a product that has obtained regulatory approval. Any approved drug product that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community.
If we are unable to obtain any needed additional funding, we may be required to reduce the scope of, delay, or eliminate some or all of, our planned research, development and commercialization activities or to license to third parties the rights to develop and/or commercialize products or technologies that we would otherwise seek to develop and/or commercialize ourselves or on terms that are less attractive than they might otherwise be, any of which could materially harm our business. 53 We might also seek to sell assets or rights in one or more commercial products or product development programs.
If we are unable to obtain any needed additional funding, we may be required to reduce the scope of, delay, or eliminate some or all of, our planned research, development and commercialization activities or to license to third parties the rights to develop and/or commercialize products or technologies that we would otherwise seek to develop and/or commercialize ourselves or on terms that are less attractive than they might otherwise be, any of which could materially harm our business. 58 We might also seek to sell assets or rights in one or more commercial products or product development programs.
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.
Our failure to comply with our reporting and payment obligations under the Medicaid Drug Rebate program and other governmental programs could negatively impact our financial results. 49 We may be subject to foreign, federal, and state data privacy and security laws, and failure to protect our information systems against security breaches, service interruptions, or misappropriation of data could disrupt operations, compromise sensitive data, and expose us to liability, possibly causing our business and reputation to suffer.
Our failure to comply with our reporting and payment obligations under the Medicaid Drug Rebate program and other governmental programs could negatively impact our financial results. 53 We may be subject to foreign, federal, and state data privacy and security laws, and failure to protect our information systems against security breaches, service interruptions, or misappropriation of data could disrupt operations, compromise sensitive data, and expose us to liability, possibly causing our business and reputation to suffer.
We cannot currently predict the specific outcome or impact on our business of such regulatory and legislative initiatives. 48 We must comply with the Foreign Corrupt Practices Act.
We cannot currently predict the specific outcome or impact on our business of such regulatory and legislative initiatives. We must comply with the Foreign Corrupt Practices Act.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. We are subject to stringent government regulation. All of our products face regulatory challenges. 52 RISKS RELATED TO OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our operating results are likely to fluctuate from period to period.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. We are subject to stringent government regulation. All of our products face regulatory challenges. 57 RISKS RELATED TO OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our operating results are likely to fluctuate from period to period.
Some provisions of our third 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.
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.
This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. 55 We may not be able to maintain our listing on the NASDAQ Global Select Market (“NASDAQ”), which could have a material adverse effect on us and our stockholders.
This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. 60 We may not be able to maintain our listing on the NASDAQ Global Select Market (“NASDAQ”), which could have a material adverse effect on us and our stockholders.
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.
Any future decision to declare or pay dividends will be at the sole discretion of our Board of Directors. 56 DEBT-RELATED RISKS Our Revolving Credit Agreement impose 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.
Any future decision to declare or pay dividends will be at the sole discretion of our Board of Directors. 61 DEBT-RELATED RISKS 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.
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. 47 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.
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. 50 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.
These risk factors and uncertainties include, but are not limited to the following: 34 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 risk factors and uncertainties include, but are not limited to the following: 36 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.
Our focus on acquisitions as a growth strategy has created intangible assets whose amortization could negatively affect our results of operations. 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.
Our focus on acquisitions as a growth strategy has created intangible assets whose amortization could negatively affect our results of operations. Our total assets include intangible assets related to our acquisitions. As of December 31, 2025, intangible assets relating to products, which are being amortized, represented approximately 18% of our total assets.
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. We do not plan to conduct basic research or preclinical product development, except to the extent of our investment in CET.
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. We do not plan to conduct basic research or preclinical product development, except to the extent of our investment in CET.
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).
Manufacturers of our products must be unable to comply with GMP requirements and with other FDA, state, and foreign regulatory requirements. We have no control over our manufacturers’ compliance with these regulations and standards.
These requirements include quality control, quality assurance, and the maintenance of records and documentation. Manufacturers of our products must be unable to comply with GMP requirements and with other FDA, state, and foreign regulatory requirements. We have no control over our manufacturers’ compliance with these regulations and standards.
We must comply with the Physician Payment Sunshine Act. We are required to comply with the United States Physician Payment Sunshine Act, which requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals.
We are required to comply with the United States Physician Payment Sunshine Act, which requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals. Manufacturers are required to report this information annually to The Centers for Medicare & Medicaid Services ("CMS").
If we cannot successfully defend ourselves against the product liability claim, we may incur substantial liabilities. Liability claims may result in decreased demand for our products; injury to our reputation; withdrawal of clinical trial participants; significant litigation costs; substantial monetary awards to or costly settlement with patients; product recalls; loss of revenue; and the inability to commercialize our product candidates.
Liability claims may result in decreased demand for our products; injury to our reputation; withdrawal of clinical trial participants; significant litigation costs; substantial monetary awards to or costly settlement with patients; product recalls; loss of revenue; and the inability to commercialize our product candidates.
We may need to continue to expand our managerial, operational, financial and other resources in order to increase our marketing efforts with regard to our currently marketed products, continue our business development and product development activities and commercialize our product candidates.
As of December 31, 2025, we had 93 employees. We may need to continue to expand our managerial, operational, financial and other resources in order to increase our marketing efforts with regard to our currently marketed products, continue our business development and product development activities and commercialize our product candidates.
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.
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 fluctuated in recent periods.
Any of these factors may, individually or as a group, have a material adverse effect on our business and results of operations. These or other similar risks could adversely affect our revenue and profitability. As we continue to develop internationally, our exposure to these factors will increase.
Any of these factors may, individually or as a group, have a material adverse effect on our business and results of operations. These or other similar risks could adversely affect our revenue and profitability.
Despite these policies, procedures and systems, we cannot assure you that we will collect and report all data accurately. If we fail to accurately report this information, we could suffer severe penalties.
Despite these policies, procedures and systems, we cannot assure you that we will collect and report all data accurately. If we fail to accurately report this information, we could suffer severe penalties. We must comply with healthcare fraud and abuse laws and regulations.
Like many companies in our industry, we have from time to time received inquiries and other types of information requests from government authorities. 46 While the ultimate outcomes of investigations and legal proceedings are difficult to predict, adverse resolutions or settlements of those matters could result in, among other things: • significant damage awards, fines, penalties or other payments, and administrative remedies, such as exclusion and/or debarment from government programs, or other rulings that preclude us from operating our business in a certain manner; • changes and additional costs to our business operations to avoid risks associated with such litigation or investigations; • product recalls; • reputational damage and decreased demand for our products; and • expenditure of significant time and resources that would otherwise be available for operating our business.
While the ultimate outcomes of investigations and legal proceedings are difficult to predict, adverse resolutions or settlements of those matters could result in, among other things: • significant damage awards, fines, penalties or other payments, and administrative remedies, such as exclusion and/or debarment from government programs, or other rulings that preclude us from operating our business in a certain manner; • changes and additional costs to our business operations to avoid risks associated with such litigation or investigations; • product recalls; • reputational damage and decreased demand for our products; and • expenditure of significant time and resources that would otherwise be available for operating our business. 49 RISKS RELATING TO GOVERNMENT REGULATION Virtually all aspects of our business activities are regulated by government agencies.
We may decide not to commercialize one of our drug candidates once it obtains regulatory approval if we determine that commercialization of that product would require more capital and time than we are willing to invest.
As we continue to develop internationally, our exposure to these factors will increase. 47 We may decide not to commercialize one of our drug candidates once it obtains regulatory approval if we determine that commercialization of that product would require more capital and time than we are willing to invest.
We have established formal policies or procedures for prohibiting or monitoring this conduct, but we cannot assure you that our employees or other agents will not engage in such conduct for which we might be held responsible. If our employees or other agents are found to have engaged in such practices, we could suffer severe penalties.
We have established formal policies or procedures for prohibiting or monitoring this conduct, but we cannot assure you that our employees or other agents will not engage in such conduct for which we might be held responsible.
Confidentiality agreements can be breached, though, and we might not have adequate remedies for any breach. Also, others could acquire or independently develop similar technology. We may depend on certain licensors for the maintenance and enforcement of intellectual property rights and have limited, if any, control over the amount or timing of resources that our licensors devote on our behalf.
Also, others could acquire or independently develop similar technology. 55 We may depend on certain licensors for the maintenance and enforcement of intellectual property rights and have limited, if any, control over the amount or timing of resources that our licensors devote on our behalf.
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.
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.
Our Revolving Credit Agreement contains specified quarterly financial maintenance covenants. 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.
Sales of a substantial number of shares of our common stock in the public market or the perception that these sales may occur could cause the market price of our common stock to decline.
In addition, the market price of our common stock is likely to be highly volatile and may fluctuate substantially. Sales of a substantial number of shares of our common stock in the public market or the perception that these sales may occur could cause the market price of our common stock to decline.
The market for our common stock may be affected by the reports financial analysts publish about us. If one of the analysts covering us downgrades our stock, its price could decline rapidly and significantly. Securities analysts covering our common stock may discontinue coverage.
Research analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports. The market for our common stock may be affected by the reports financial analysts publish about us. If one of the analysts covering us downgrades our stock, its price could decline rapidly and significantly.
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. We must comply with the CREATES Act.
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.
Competition from generic equivalents could result in a decrease in revenues of our branded pharmaceuticals or result in a material impairment of our intangible assets or the acceleration of amortization on our non-impaired intangible assets and may have a material adverse impact on our revenues, financial condition, results of operations and cash flows.
Competition from generic equivalents could result in a decrease in revenues of our branded pharmaceuticals or result in a material impairment of our intangible assets or the acceleration of amortization on our non-impaired intangible assets and may have a material adverse impact on our revenues, financial condition, results of operations and cash flows. 41 Any attempt by us to expand the potential market for any of our products is subject to limitations.
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 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.
Switching or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.
Switching or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new third party commences work.
Not all foreign jurisdictions may represent attractive opportunities for our products due to pricing, competitive, regulatory or other factors. In certain foreign jurisdictions, we have licensed the right to market some of our products to third parties. These third parties are responsible for seeking and maintaining regulatory approval for the products in their respective jurisdictions.
In addition, we have largely obtained regulatory approval to market our products in the United States. Not all foreign jurisdictions may represent attractive opportunities for our products due to pricing, competitive, regulatory or other factors. In certain foreign jurisdictions, we have licensed the right to market some of our products to third parties.
In addition, we may find it necessary to initiate litigation to protect our trade secrets, to enforce our intellectual property rights and to determine the scope and validity of any proprietary rights of others.
In addition, we may find it necessary to initiate litigation to protect our trade secrets, to enforce our intellectual property rights and to determine the scope and validity of any proprietary rights of others. Any such litigation, or the failure to obtain any necessary licenses or other rights, could materially and adversely affect our business.
Manufacturers are required to report this information annually to The Centers for Medicare & Medicaid Services ("CMS"). In addition, some states require reporting information concerning payments to health care providers or other transfers of value by drug manufacturers beyond the requirements of the Federal Sunshine Act.
In addition, some states require reporting information concerning payments to health care providers or other transfers of value by drug manufacturers beyond the requirements of the Federal Sunshine Act.
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.
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.
Many of our competitors have significantly greater financial and marketing resources than we do. Additional competitors may enter our markets. 38 The pharmaceutical industry is characterized by constant and significant investment in new product development, which can result in rapid technological change. The introduction of new products could substantially reduce our market share or render our products obsolete.
The pharmaceutical industry is characterized by constant and significant investment in new product development, which can result in rapid technological change. The introduction of new products could substantially reduce our market share or render our products obsolete.
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.
Our future growth depends on our ability to identify, acquire rights and successfully integrate new brands into our operations. 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.
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.
Our security measures may be inadequate to prevent security breaches and our business operations could be materially adversely affected by federal and state fines and penalties, legal claims or proceedings, cancellation of contracts and loss of customers if security breaches are not prevented.
Our security measures may be inadequate to prevent security breaches and our business operations could be materially adversely affected by federal and state fines and penalties, legal claims or proceedings, cancellation of contracts and loss of customers if security breaches are not prevented. 46 We believe that our subcontractors and vendors take precautionary measures to prevent problems that could affect our business operations as a result of failure or disruption to their information systems.
We have experienced, and may continue to experience, growth and increased expenses in the scope of our operations in connection with the continued marketing and development of our products.
We have experienced, and may continue to experience, growth and increased expenses in the scope of our operations in connection with the continued marketing and development of our products. Our financial performance will depend, in part, on our ability to manage any such growth and expenses of the current organization effectively.
Since we rely on third parties to manufacture our products, GMP requirements directly affect our third party manufacturers and indirectly affect us. The manufacturing facilities of our third-party manufacturers are continually subject to inspection by such governmental agencies, and manufacturing operations could be interrupted or halted in any such facilities if such inspections prove unsatisfactory.
The manufacturing facilities of our third-party manufacturers are continually subject to inspection by such governmental agencies, and manufacturing operations could be interrupted or halted in any such facilities if such inspections prove unsatisfactory. Our third-party manufacturers are subject to periodic inspection by the FDA to assure such compliance.
Furthermore, our competitors may independently develop similar technologies or duplicate technology developed by us in a manner that does not infringe our patents or other intellectual property.
Furthermore, our competitors may independently develop similar technologies or duplicate technology developed by us in a manner that does not infringe our patents or other intellectual property. As a result of these factors, our patent rights may not provide any commercially valuable protection from competing products.
We may become subject to litigation or governmental investigations in the United States and foreign jurisdictions that may arise from the conduct of our business.
We may become subject to litigation or governmental investigations in the United States and foreign jurisdictions that may arise from the conduct of our business. Like many companies in our industry, we have from time to time received inquiries and other types of information requests from government authorities.
Our failure to follow FDA rules and guidelines relating to promotion and advertising may cause the FDA to suspend or withdraw an approved product from the market, require a recall or payment of fines, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our business.
Our failure to follow FDA rules and guidelines relating to promotion and advertising may cause the FDA to suspend or withdraw an approved product from the market, require a recall or payment of fines, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our business. 45 Our business and operations would suffer in the event of system failures, security breaches, including any cybersecurity incidents, adverse events or other disruptions within our information technology infrastructure at our corporate headquarters; or in the event of intellectual property infringement.
Additional barriers for competitors seeking to enter the market include the time and cost associated with the development, regulatory approval and manufacturing of a similar product formulation.
We seek to secure and extend marketing exclusivity for our products through a variety of means, including FDA exclusivity and patent rights. Additional barriers for competitors seeking to enter the market include the time and cost associated with the development, regulatory approval and manufacturing of a similar product formulation.
We may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States. 51 Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, some of our confidential information could be disclosed during this type of litigation.
We may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States.
We face an inherent risk of product liability lawsuits related to the testing of our product candidates and the commercial sale of our products. An individual may bring a liability claim against us if one of our product candidates or products causes, or appears to have caused, an injury.
An individual may bring a liability claim against us if one of our product candidates or products causes, or appears to have caused, an injury. If we cannot successfully defend ourselves against the product liability claim, we may incur substantial liabilities.
As of December 31, 2024, we did not have any outstanding interest rate swap contracts.
As of December 31, 2025, we did not have any outstanding interest rate swap contracts. 62 Item 1B. Unresolved Staff Comments. None.
Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to review and approve new products and otherwise affect the FDA’s ability to perform routine functions.
As with our other products, if Caldolor is not accepted in the marketplace, it could have an adverse impact on our future revenues and profitability. 38 Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to review and approve new products and otherwise affect the FDA’s ability to perform routine functions.
Competitive pressures could reduce our revenues and profits. The pharmaceutical industry is intensely competitive. Our strategy is to target differentiated products in specialized markets. However, this strategy does not relieve us from competitive pressures and can entail distinct competitive risks. Certain of our competitors do not aggressively promote their products in our markets.
As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. 40 Competitive pressures could reduce our revenues and profits. The pharmaceutical industry is intensely competitive. Our strategy is to target differentiated products in specialized markets. However, this strategy does not relieve us from competitive pressures and can entail distinct competitive risks.
This significant concentration of share ownership may adversely affect the trading price of our common stock because many investors perceive disadvantages to owning stock in companies with controlling shareholders. Research analysts may not continue to provide or initiate coverage of our common stock or may issue negative reports.
The interests of this group may not always coincide with our interests or the interests of other shareholders and may prevent or delay a change in control. This significant concentration of share ownership may adversely affect the trading price of our common stock because many investors perceive disadvantages to owning stock in companies with controlling shareholders.
These activities are also regulated by various agencies of the states and localities in which our products are sold. For more information, see “ Business—Government Regulation" in Part I, Item 1 of this Form 10-K. Like all pharmaceutical manufacturers, we are subject to regulation by the FDA under the Federal Food, Drug and Cosmetic Act ("FDCA").
Environmental Protection Agency, ("EPA"), as well as by comparable agencies in foreign countries. These activities are also regulated by various agencies of the states and localities in which our products are sold. For more information, see “ Business—Government Regulation" in Part I, Item 1 of this Form 10-K.
The extent to which these product candidates will be reimbursed by the U.S. government or third-party payors is also currently unknown.
The extent to which these product candidates will be reimbursed by the U.S. government or third-party payors is also currently unknown. As a result of the foregoing and other factors, we do not know the extent to which our product candidates will contribute to our future growth.
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.
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.
In addition to patents, we rely upon trade secrets, unpatented proprietary know-how and continuing technological innovation where we do not believe patent protection is appropriate or attainable. For example, the manufacturing process for Kristalose involves substantial trade secrets and proprietary know-how.
If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected. In addition to patents, we rely upon trade secrets, unpatented proprietary know-how and continuing technological innovation where we do not believe patent protection is appropriate or attainable.
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.
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. 44 The size of our organization and our potential growth may lead to difficulties in managing operations.
If we are unable to continue to obtain marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Vibativ. Sancuso : As part of the acquisition of Sancuso in January 2022, we obtained an initial supply of finished goods inventory and work in progress.
In 2020, we completed the transfer of Vibativ manufacturing activities to a new supplier. If we are unable to continue to obtain marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Vibativ.
We may also experience delays associated with future required Phase IV clinical studies potentially resulting from, among other factors, difficulty enrolling patients.
Expansion of the market for our products may be subject to certain limitations. In the past, these limitations have included FDA required Phase IV commitments. We may also experience delays associated with future required Phase IV clinical studies potentially resulting from, among other factors, difficulty enrolling patients.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations.
Any failure to implement required new or improved controls, or difficulties encountered in their implementation could cause us to fail to meet our reporting obligations.
RISKS RELATING TO GOVERNMENT REGULATION Virtually all aspects of our business activities are regulated by government agencies. The manufacturing, processing, formulation, packaging, labeling, distribution, promotion and sampling, advertising of our products, and disposal of waste products arising from such activities are subject to governmental regulation.
The manufacturing, processing, formulation, packaging, labeling, distribution, promotion and sampling, advertising of our products, and disposal of waste products arising from such activities are subject to governmental regulation. These activities are regulated by one or more of the FDA, the Federal Trade Commission, ("FTC"), the Consumer Product Safety Commission, the U.S. Department of Agriculture and the U.S.
Any such litigation, or the failure to obtain any necessary licenses or other rights, could materially and adversely affect our business. 44 We license our products globally; therefore, we may have exposure to foreign regulatory requirements and fluctuations in foreign currency exchange rates.
We license our products globally; therefore, we may have exposure to foreign regulatory requirements and fluctuations in foreign currency exchange rates.
As we grow, we may not be able to secure sales personnel or organizations that are adequate in number or expertise to successfully market and sell our products. This risk would be accentuated if we acquire products in areas outside of our current focus areas since our sales forces specialize in our existing areas.
This risk would be accentuated if we acquire products in areas outside of our current focus areas since our sales forces specialize in our existing areas.
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. The interests of this group may not always coincide with our interests or the interests of other shareholders and may prevent or delay a change in control.
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.
An increase in promotional activity in our markets could result in large shifts in market share, adversely impacting us. Our competitors may sell or develop drugs that are more effective and useful or less costly than ours, and they may be more successful in manufacturing and marketing their products.
Our competitors may sell or develop drugs that are more effective and useful or less costly than ours, and they may be more successful in manufacturing and marketing their products. Many of our competitors have significantly greater financial and marketing resources than we do. Additional competitors may enter our markets.
The FDA may require an approved NDA for any drug product marketed under the enforcement policy if new information reveals questions about the drug’s safety and effectiveness. All drugs must be manufactured in conformity with GMP, and drug products subject to an approved NDA must be manufactured, processed, packaged, held and labeled in accordance with information contained in the NDA.
The FDA has the authority to withdraw existing NDA approvals and to review the regulatory status of products marketed under the enforcement policy. The FDA may require an approved NDA for any drug product marketed under the enforcement policy if new information reveals questions about the drug’s safety and effectiveness.
Our financial performance will depend, in part, on our ability to manage any such growth and expenses of the current organization effectively. 42 We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product or product candidate and may have to limit its commercialization.
We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product or product candidate and may have to limit its commercialization. We face an inherent risk of product liability lawsuits related to the testing of our product candidates and the commercial sale of our products.
All new drugs must be the subject of an FDA-approved new drug application, ("NDA"), before they may be marketed in the United States. The FDA has the authority to withdraw existing NDA approvals and to review the regulatory status of products marketed under the enforcement policy.
Like all pharmaceutical manufacturers, we are subject to regulation by the FDA under the Federal Food, Drug and Cosmetic Act ("FDCA"). All new drugs must be the subject of an FDA-approved new drug application, ("NDA"), before they may be marketed in the United States.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe also work with third parties from time to time to assist us in identification, assessment and management of cybersecurity risks. For additional informant and a description of the risks from cybersecurity threats that may materially affect us and how they may do so, refer to Part I, Item 1A. Risk Factors. Governance.
Biggest changeWe also work with third parties from time to time to assist us in identification, assessment and management of cybersecurity risks. For additional informant and a description of the risks from cybersecurity threats that may materially affect us and how they may do so, refer to Part I, Item 1A. Risk Factors. 63 Governance.
They participates in cybersecurity incident response efforts and directs the company’s response to cybersecurity incidents. 58 Our Board of Directors addresses the company’s cybersecurity risk management as part of its general oversight function. The Board of Directors has access to various reports, summaries or presentations related to cybersecurity threats, risk, and mitigation.
They participates in cybersecurity incident response efforts and directs the company’s response to cybersecurity incidents. Our Board of Directors addresses the company’s cybersecurity risk management as part of its general oversight function. The Board of Directors has access to various reports, summaries or presentations related to cybersecurity threats, risk, and mitigation.

Item 2. Properties

Properties — owned and leased real estate

1 edited+1 added−0 removed2 unchanged
Biggest changeItem 2. Properties. As of December 31, 2024, we leased approximately 16,903 rentable square feet of space at the Broadwest development in Nashville, Tennessee for our corporate headquarters. The lease commencement date occurred in October 2022 with a term of 157 months leased through November 2035. We believe these facilities are adequate to meet our current needs for office space.
Biggest changeItem 2. Properties. As of December 31, 2025, we leased approximately 16,903 rentable square feet of space at the Broadwest development in Nashville, Tennessee for our corporate headquarters. The lease commencement date occurred in October 2022 with a term of 157 months leased through November 2035. We believe these facilities are adequate to meet our current needs for office space.
Added
Item 3. Legal Proceedings. None. Item 4. Mine Safety Disclosures. Not applicable. 64 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

5 edited+0 added−1 removed1 unchanged
Biggest changeIn January 2019, the Company’s Board of Directors established the current $10.0 million repurchase program to replace the prior authorizations. We repurchased 339,200 and 402,143 shares of common stock for approximately $0.6 million and $0.7 million during the years ended December 31, 2024 and 2023, respectively.
Biggest changeIn January 2019, the Company’s Board of Directors established the current $10.0 million repurchase program to replace the prior authorizations. We repurchased 58,947 and 339,200 shares of common stock for approximately $0.3 million and $0.6 million during the years ended December 31, 2025 and 2024, respectively. There was no repurchase activity during the fourth quarter of 2025. Item 6. Reserved.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock, no par value, has been traded on the Nasdaq Global Select Market since August 11, 2009 under the symbol “CPIX.” As of March 4, 2025, we had 93 shareholders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock, no par value, has been traded on the Nasdaq Global Select Market since August 11, 2009 under the symbol “CPIX.” As of March 4, 2026, we had 87 shareholders of record of our common stock.
The graph assumes an initial investment of $100 on December 31, 2018, and that all dividends were reinvested. 60 Purchases of Equity Securities The Company currently has a share repurchase program to repurchase up to $10.0 million of our common stock pursuant to Rule 10b-18 of the Securities Exchange Act of 1934, as amended.
The graph assumes an initial investment of $100 on December 31, 2020, and that all dividends were reinvested. 65 Purchases of Equity Securities The Company currently has a share repurchase program to repurchase up to $10.0 million of our common stock pursuant to Rule 10b-18 of the Securities Exchange Act of 1934, as amended.
Performance Graph The stock performance graph below illustrates a comparison of the total cumulative stockholder return on our common stock since December 31, 2019 to the Nasdaq Composite and a composite of ten Nasdaq Pharmaceutical and Specialty Pharmaceutical Stocks which most closely compare to our Company - Avadel Pharmaceuticals plc, Harrow Health, Inc., Eagle Pharmaceuticals, Inc., Assertio Holdings, Inc., HLS Therapeutics Inc., EyePoint Pharmaceuticals, Inc., Eton Pharmaceuticals, Inc., Theratechnologies Inc. and Talphera, Inc.
Performance Graph The stock performance graph below illustrates a comparison of the total cumulative stockholder return on our common stock since December 31, 2020, to the Nasdaq Composite and a composite of eight Nasdaq Pharmaceutical and Specialty Pharmaceutical Stocks which most closely compare to our Company - Avadel Pharmaceuticals plc, Eagle Pharmaceuticals, Inc., Assertio Holdings, Inc., HLS Therapeutics Inc., EyePoint Pharmaceuticals, Inc., Eton Pharmaceuticals, Inc., Theratechnologies Inc. and Talphera, Inc.
This excludes shareholders whose shares are held by brokers and other institutions on behalf of shareholders. The closing price of our common stock on the Nasdaq Global Select Market on March 4, 2025 was $6.05 per share. Dividend Policy We have not declared or paid any cash dividends on our common stock.
This excludes shareholders whose shares are held by brokers and other institutions on behalf of shareholders. The closing price of our common stock on the Nasdaq Global Select Market on March 4, 2026 was $3.67 per share. Dividend Policy We have not declared or paid any cash dividends on our common stock.
Removed
The following table summarizes the activity, by month, during the fourth quarter of 2024: Period Total Number of Shares (or Units) Purchased Average Price Paid per Share (or Unit) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs October 29,404 $1.31 29,404 $2,491,306 November 17,908 $1.21 17,908 $2,469,705 December 16,800 $2.17 16,800 $2,433,312 Total 64,112 Item 6.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

47 edited+15 added−16 removed31 unchanged
Biggest changeFair value is determined through various valuation techniques including quoted market prices, third-party independent appraisals and discounted cash flow models, as considered necessary. 66 RESULTS OF OPERATIONS Year ended December 31, 2024 compared to year ended December 31, 2023 The following table presents the statements of operations for the years ended December 31, 2024 and 2023: Years ended December 31, 2024 2023 Change Net revenues $ 37,867,945 $ 39,552,507 $ (1,684,562) Costs and expenses: Cost of products sold 6,585,972 6,066,611 519,361 Selling and marketing 17,023,023 18,451,765 (1,428,742) Research and development 4,816,206 5,834,229 (1,018,023) General and administrative 11,126,901 10,651,915 474,986 Amortization and impairment 4,748,252 8,102,648 (3,354,396) Total costs and expenses 44,300,354 49,107,168 (4,806,814) Operating loss (6,432,409) (9,554,661) 3,122,252 Interest income 334,444 286,854 47,590 Other income — 2,828,871 (2,828,871) Other income - settlement — 475,000 (475,000) Other income - gain on insurance proceeds 237,089 346,800 (109,711) Interest expense (605,508) (667,861) 62,353 Loss before income taxes (6,466,384) (6,284,997) (181,387) Income tax benefit (expense) 22,669 (45,769) 68,438 Net loss $ (6,443,715) $ (6,330,766) $ (112,949) The following table summarizes net revenues for the years presented: Years ended December 31, 2024 2023 Change Products: Kristalose $ 15,315,259 $ 15,981,850 $ (666,591) Sancuso 9,005,129 8,096,788 908,341 Vibativ 7,160,125 8,812,692 (1,652,567) Caldolor 4,959,385 4,333,923 625,462 Acetadote 185,182 458,759 (273,577) Omeclamox (3,075) 20,030 (23,105) Vaprisol (174,538) 151,336 (325,874) RediTrex 90,237 (341,886) 432,123 Other 1,330,241 2,039,015 (708,774) Total net revenues $ 37,867,945 $ 39,552,507 $ (1,684,562) Net revenues.
Biggest changeFair value is determined through various valuation techniques including quoted market prices, third-party independent appraisals and discounted cash flow models, as considered necessary. 71 RESULTS OF OPERATIONS Year ended December 31, 2025 compared to year ended December 31, 2024 The following table presents the statements of operations for the years ended December 31, 2025 and 2024: Years ended December 31, 2025 2024 Change Net revenues $ 44,521,431 $ 37,867,945 $ 6,653,486 Costs and expenses: Cost of products sold 6,667,207 6,585,972 81,235 Selling and marketing 19,098,153 17,023,023 2,075,130 Research and development 5,566,498 4,816,206 750,292 General and administrative 11,946,909 11,126,901 820,008 Amortization and impairment 4,034,657 4,748,252 (713,595) Total costs and expenses 47,313,424 44,300,354 3,013,070 Operating loss (2,791,993) (6,432,409) 3,640,416 Interest income 476,748 334,444 142,304 Other income - gain on insurance proceeds — 237,089 (237,089) Interest expense (495,990) (605,508) 109,518 Loss before income taxes (2,811,235) (6,466,384) 3,655,149 Income tax (expense) benefit (40,256) 22,669 (62,925) Equity in loss of investee (13,220) — (13,220) Net loss $ (2,864,711) $ (6,443,715) $ 3,579,004 The following table summarizes net revenues for the years presented: Years ended December 31, 2025 2024 Change Products: Sancuso $ 11,907,141 $ 9,005,129 $ 2,902,012 Kristalose 10,542,793 15,315,259 (4,772,466) Vibativ 9,484,874 7,160,125 2,324,749 Caldolor 4,659,457 4,959,385 (299,928) Talicia 3,311,235 — 3,311,235 Acetadote 508,169 185,182 322,987 Vaprisol (18,346) (174,538) 156,192 RediTrex 11,391 90,237 (78,846) Omeclamox (10,436) (3,075) (7,361) Other 4,125,153 1,330,241 2,794,912 Total net revenues $ 44,521,431 $ 37,867,945 $ 6,653,486 Net revenues.
You should review the “Risk Factors” section of this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis. 61 EXECUTIVE SUMMARY We are a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription pharmaceutical products.
You should review the “Risk Factors” section of this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis. 66 EXECUTIVE SUMMARY We are a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription pharmaceutical products.
On May 6, 2024, the Company entered into a First Amendment to the Loan Agreement which provides an alternative to the financial covenant by delivering to the lender a borrowing base certificate and complying with certain borrowing base requirements which set forth a maximum revolver amount equal to the lessor of (a) up to $20 million or (b) the sum of the Company's cash balances and eligible accounts receivable.
On May 6, 2024, the Company entered into the First Amendment to the Loan Agreement which provided an alternative to the financial covenant by delivering to the lender a borrowing base certificate and complying with certain borrowing base requirements which set forth a maximum revolver amount equal to the lessor of (a) up to $20 million or (b) the sum of the Company's cash balances and eligible accounts receivable.
Changes in our estimates would be recorded in our statement of operations in the period of the change. Non-current inventories consist of active pharmaceutical ingredients which typically have an extended life and selected finished good products with an extended life longer than one year. 65 Income Taxes We provide for deferred taxes using the asset and liability approach.
Changes in our estimates would be recorded in our statement of operations in the period of the change. Non-current inventories consist of active pharmaceutical ingredients which typically have an extended life and selected finished good products with an extended life longer than one year. 70 Income Taxes We provide for deferred taxes using the asset and liability approach.
The contingent consideration liability represents the fair value of the royalty payments of up to 20% of future net sales as part of the Vibativ acquisition. 4. The contingent consideration liability represents the fair value of the royalty payments of up to 10% of future net sales as part of the Sancuso acquisition. 5.
The contingent consideration liability represents the fair value of the royalty payments of up to 5% of future net sales as part of the Vibativ acquisition. 4. The contingent consideration liability represents the fair value of the royalty payments of up to 10% of future net sales as part of the Sancuso acquisition. 5.
The estimated inventory obsolescence amounts are calculated based upon specific review of the inventory expiration dates and the quantity on-hand at December 31, 2024, in comparison to our expected inventory usage. The amount of actual inventory obsolescence and unmarketable inventory could differ (either higher or lower) in the near term from the estimated amounts.
The estimated inventory obsolescence amounts are calculated based upon specific review of the inventory expiration dates and the quantity on-hand at December 31, 2025, in comparison to our expected inventory usage. The amount of actual inventory obsolescence and unmarketable inventory could differ (either higher or lower) in the near term from the estimated amounts.
A portion of our research and development costs is variable based on the number of trials, study sites, number of patients and the cost per patient in each of our clinical programs. We continue to fund our ongoing clinical initiatives associated with our pipeline products. General and administrative .
A portion of our research and development costs is variable based on the number of trials, study sites, number of patients and the cost per patient in each of our clinical programs. We continue to fund our ongoing clinical initiatives associated with our pipeline products.
A change in our rebate estimate of one percentage point would have impacted net sales by approximately $0.6 million for the years ended December 31, 2024 and 2023. A change in our product return estimate of one percentage point would have impacted net sales by $0.4 million for the years ended December 31, 2024 and 2023.
A change in our rebate estimate of one percentage point would have impacted net sales by approximately $0.6 million for the years ended December 31, 2025 and 2024. A change in our product return estimate of one percentage point would have impacted net sales by $0.4 million for the years ended December 31, 2025 and 2024.
Our principal differences are related to the timing of deductibility of certain items such as depreciation, amortization and expense for options issued to nonemployees. Deferred tax assets and liabilities are measured using management’s estimate of tax rates expected to apply to taxable income in the years in which management believes those temporary differences are expected to be recovered or settled.
Our principal differences are related to the timing of deductibility of certain items such as depreciation, amortization and expense for options issued to non-employees. Deferred tax assets and liabilities are measured using management’s estimate of tax rates expected to apply to taxable income in the years in which management believes those temporary differences are expected to be recovered or settled.
We are dedicated to our mission of working together to provide unique products that improve the quality of patient care. Our commercial portfolio includes six branded products approved for marketing by the FDA.
We are dedicated to our mission of working together to provide unique products that improve the quality of patient care. Our commercial portfolio includes seven branded products approved for marketing by the FDA.
These shares sold at a volume weighted average price of $5.4688 per share for aggregate gross proceeds of $5,468,800. On February 14, 2025, the Company increased the maximum aggregate offering amount of the shares of the Company’s common stock issuable under the Sales Agreement with H.C.
These shares sold at a volume weighted average price of $5.4688 per share for aggregate gross proceeds of $5,468,800. On February 14, 2025, the Company increased the maximum aggregate offering amount of the shares of the Company’s common stock issuable in the ATM program under the Sales Agreement with H.C.
The initial revolving line of credit is up to $20 million, with the ability for Cumberland to increase the amount to $25 million, under certain conditions. It has a three year term expiring on October 1, 2026. The interest rate is based on Benchmark (Term SOFR) plus a spread of 2.75%.
The initial revolving line of credit was up to $20 million, with the ability for Cumberland to increase the amount to $25 million, under certain conditions. It had a three year term expiring on October 1, 2026. The interest rate is based on Benchmark (Term SOFR) plus a spread of 2.75%.
At December 31, 2024 and December 31, 2023, all our investments had original maturities of less than ninety days and as a result were classified as cash equivalents.
At December 31, 2025 and December 31, 2024, all our investments had original maturities of less than ninety days and as a result were classified as cash equivalents.
Cumberland is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of our assets.
Cumberland was initially subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of our assets.
Of the accounts receivable allowances and our sales related accruals, our accrual for product returns and rebates represents the majority of the balance. Sales related accrued liabilities for rebates, product returns, service fees, and administrative fees totaled $7.8 million and $7.6 million as of December 31, 2024 and 2023, respectively.
Of the accounts receivable allowances and our sales related accruals, our accrual for product returns and rebates represents the majority of the balance. Sales related accrued liabilities for rebates, product returns, service fees, and administrative fees totaled $7.8 million each as of December 31, 2025 and 2024.
Our financial statements reflect accounts receivable allowances of $1.1 million and $0.6 million at December 31, 2024 and 2023, respectively, for chargebacks and early pay discounts for products.
Our financial statements reflect accounts receivable allowances of $0.9 million and $1.1 million at December 31, 2025 and 2024, respectively, for chargebacks and early pay discounts for products.
These amounts are based on the $15.3 million line of credit assuming the current $15.3 million balance outstanding on December 31, 2024 is consistently outstanding through maturity of October 2026. Interest and unused line of credit payments are due and payable quarterly in arrears. 3.
These amounts are based on the $5.2 million line of credit assuming the current $5.2 million balance outstanding on December 31, 2025 is consistently outstanding through maturity of October 2027. Interest and unused line of credit payments are due and payable quarterly in arrears. 3.
Of these amounts, our estimated liability for fee for services represented $1.5 million and $1.4 million, respectively, while our accrual for product returns totaled $2.7 million and $2.6 million, respectively.
Of these amounts, our estimated liability for fee for services represented $1.8 million and $1.5 million, respectively, while our accrual for product returns totaled $3.0 million and $2.7 million, respectively.
Wainwright”) on March 20, 2024, in order to allow the Company to sell shares at market prices. The Company did not issue any shares under its ATM program during the year ended December 31, 2024. On February 5, 2025, the Company utilized the Sales Agreement with H. C. Wainwright and sold 1,000,000 shares of Cumberland’s common shares.
Wainwright”) on March 20, 2024, in order to allow the Company to sell shares at market prices. On February 5, 2025, the Company utilized the Sales Agreement with H. C. Wainwright and sold 1,000,000 shares of Cumberland’s common shares under the ATM program.
Our business development team identifies, evaluates and negotiates product acquisition, licensing and co-promotion agreements. Our product development team creates proprietary formulations, manages our clinical studies, prepares our FDA submissions and staffs our medical call center. Our quality and manufacturing professionals oversee the manufacturing, release and shipment of our products.
Our product development team creates proprietary formulations, manages our clinical studies, prepares our FDA submissions and staffs our medical call center. Our quality and manufacturing professionals oversee the manufacturing, release and shipment of our products.
Other revenue, which is a component of net revenues, includes non-refundable upfront payments and milestone payments under licensing agreements along with grant and rental income. Other revenue was approximately 3.5% of net revenues in 2024 and 5.2% in 2023.
Other revenue, which is a component of net revenues, includes non-refundable upfront payments and milestone payments under licensing agreements, contract services, grant funding programs and rental income. Other revenue was approximately 9.3% of net revenues in 2025 and 3.5% in 2024.
Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability of our brands. 62 2024 Highlights Below is a list of our Company’s highlights from 2024.
Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability of our brands. 67 2025 Highlights Listed below are our Company’s 2025 highlights.
Additionally, we recently completed a Phase II study in patients with cardiomyopathy associated with Duchenne muscular dystrophy, a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.
Additionally, we recently completed a Phase II study in patients with cardiomyopathy associated with Duchenne muscular dystrophy, a rare, fatal, genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles. Next steps include meeting with the FDA to determine next steps associated with the product’s development and commercialization.
The following table reflects our sales-related accrual activity for the periods indicated below: 2024 2023 Balance, January 1 $ 7,579,783 $ 8,347,214 Current provision 20,235,610 22,184,661 Actual product returns and credits issued (19,981,182) (22,952,092) Balance, December 31 $ 7,834,211 $ 7,579,783 64 The allowances for chargebacks and discounts and sales related accruals for rebates, fee for service and product returns are determined on a product-by-product basis.
The following table reflects our sales-related accrual activity for the periods indicated below: 2025 2024 Balance, January 1 $ 7,834,211 $ 7,579,783 Current provision 17,917,675 20,235,610 Actual product returns and credits issued (17,977,807) (19,981,182) Balance, December 31 $ 7,774,079 $ 7,834,211 69 The allowances for chargebacks and discounts and sales related accruals for rebates, fee for service and product returns are determined on a product-by-product basis.
Research and development costs for the year ended December 31, 2024, were $4.8 million, compared to $5.8 million in the prior year, representing a decrease of $1.0 million due primarily to reduced FDA fees, salaries and consulting expenses.
Research and development costs for the year ended December 31, 2025, were $5.6 million, compared to $4.8 million in the prior year, representing an increase of $0.8 million due primarily to increased FDA fees and manufacturing costs.
The following table summarizes our liquidity and working capital as of the years ended December 31: 2024 2023 Cash and cash equivalents $ 17,964,184 $ 18,321,624 Total cash and cash equivalents $ 17,964,184 $ 18,321,624 Working capital (current assets less current liabilities) $ 4,830,429 $ 7,732,161 Current ratio (multiple of current assets to current liabilities) 1.2 1.3 Revolving line of credit availability $ 4,723,830 $ 7,215,856 The following table summarizes our net changes in cash and cash equivalents for the years ended December 31: 2024 2023 Cash provided by (used in): Operating activities $ (612,186) $ 6,093,821 Investing activities 57,842 (105,695) Financing activities 196,904 (7,424,472) Net decrease in cash and cash equivalents $ (357,440) $ (1,436,346) The net $0.4 million decrease in cash and cash equivalents for the year ended December 31, 2024, was attributable to cash used in operating activities offset by cash provided by financing and investing activities.
The following table summarizes our liquidity and working capital as of the years ended December 31: 2025 2024 Cash and cash equivalents $ 11,444,693 $ 17,964,184 Total cash and cash equivalents $ 11,444,693 $ 17,964,184 Working capital (current assets less current liabilities) $ 315,348 $ 4,830,429 Current ratio (multiple of current assets to current liabilities) 1.0 1.2 Revolving line of credit availability $ 9,759,267 $ 4,723,830 The following table summarizes our net changes in cash and cash equivalents for the years ended December 31: 2025 2024 Cash provided by (used in): Operating activities $ 4,932,522 $ (612,186) Investing activities (4,706,497) 57,842 Financing activities (6,745,516) 196,904 Net decrease in cash and cash equivalents $ (6,519,491) $ (357,440) The net $6.5 million decrease in cash and cash equivalents for the year ended December 31, 2025, was attributable to cash used in financing and investing activities offset by cash provided by operating activities.
As noted above, we continue to repurchase shares of our common stock, as discussed in Part II, Item 5, "Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities", of this Form 10-K. 70 The net $1.4 million decrease in cash and cash equivalents for the year ended December 31, 2023, was attributable to cash provided by operating activities offset by cash used in investing and financing activities.
As noted above, we continue to repurchase shares of our common stock, as discussed in Part II, Item 5, "Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities", of this Form 10-K.
This 14.4% increase in Caldolor revenue for the year ended December 31, 2024, w as impacted by an increase in international shipments. There was no Vaprisol revenue for the year ended December 31, 2024, as Cumberland is currently out of commercial inventory of the product. Net revenue was negatively impacted by various sales deduction adjustments.
There was no Vaprisol revenue for the year ended December 31, 2025, as Cumberland is currently out of commercial inventory of the product. Net revenue was negatively impacted by various sales deduction adjustments. Acetadote revenue included net sales of our branded product and our share of net sales from our Authorized Generic.
Our financing activities included payments of $3.3 million of contingent consideration for Vibativ and Sancuso, a pay down on our line of credit of $3.4 and $0.7 million in cash used to repurchase shares of our common stock.
Cash used in financing activities of $6.7 million was primarily due to $10.0 million payments on our line of credit, payments of $1.7 million of contingent consideration for Vibativ and Sancuso, $0.3 million in cash used to repurchase shares of our common stock, partially offset by $5.3 million proceeds from the ATM offering.
We have established the capabilities needed to acquire, develop and commercialize branded pharmaceuticals in the U.S. We believe we can leverage this existing infrastructure to support new products and our expected growth. Our management team consists of pharmaceutical industry veterans with significant experience in their areas of responsibility.
We believe we can leverage this existing infrastructure to support new products and our expected growth. Our management team consists of pharmaceutical industry veterans with significant experience in their areas of responsibility. Our business development team identifies, evaluates and negotiates product acquisition, licensing and co-promotion agreements.
Other Revenue. Other revenue decreased from 2023 when milestone payments of $1 million associated with our Vibativ product were recorded. Cost of products sold . Cost of products sold for the year ended December 31, 2024, were $6.6 million compared to $6.1 million in the prior year, an increase of $0.5 million.
Other revenue was $4.1 million for the year ended December 31, 2025, an increase of $2.8 million compared to the year ended December 31, 2024, primarily due to milestone payments recorded of $3.1 million in payments from our international partners. Cost of products sold .
The components of the statements of operations discussed above reflect the following impacts from Sancuso: Financial Impact of Sancuso Years ended December 31, 2024 2023 Net revenue $ 9,005,132 $ 8,096,788 Cost of products sold (1) 856,608 1,214,826 Royalty and operating expenses 3,777,160 3,375,823 Sancuso contribution $ 4,371,364 $ 3,506,139 (1) The Sancuso inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2022.
The components of the statements of operations discussed above reflect the following impacts from Sancuso: Financial Impact of Sancuso Years ended December 31, 2025 2024 Net revenue $ 11,907,141 $ 9,005,132 Cost of products sold (1) 600,663 856,608 Royalty and operating expenses 4,080,157 3,777,160 Sancuso contribution $ 7,226,321 $ 4,371,364 (1) The Sancuso inventory included in the costs of product sold was acquired and paid for by Cumberland as part of the acquisition of the brand during 2022. 75 LIQUIDITY AND CAPITAL RESOURCES Our primary sources of liquidity are cash flows provided by our operations, the amounts borrowed and available under our line of credit and the cash proceeds from our initial public offering of common stock that was completed in August 2009 and the cash proceeds from utilizing our ATM program in February 2025.
These medical specialties are characterized by relatively concentrated prescriber bases that we believe can be served effectively by small, targeted sales forces. We promote our approved products through our hospital, field and oncology sales divisions in the United States and are building a network of international partners to register and provide our medicines to patients in their countries.
We promote our approved products through our hospital, field and oncology sales divisions in the United States and are building a network of international partners to register and provide our medicines to patients in their countries. We have established the capabilities needed to acquire, develop and commercialize branded pharmaceuticals in the U.S.
Acetadote revenue included net sales of our branded product and our share of net sales from our Authorized Generic. For the year ended December 31, 2024, the Acetadote net revenue was $0.2 million, as compared to $0.5 million from the prior year period. This decrease results from lower sales for our Authorized Generic.
For the year ended December 31, 2025, the Acetadote net revenue was $0.5 million, as compared to $0.2 million from the prior year period. This increase resulted primarily higher sales for our Authorized Generic. We discontinued the product Omeclamox-Pak in 2025. Net revenue was positively impacted by various sales deduction adjustments. Other Revenue.
The gross margin for the years ended December 31, 2024 and 2023, were 82.6% and 84.7%, respectively. Selling and marketing . Selling and marketing expense for the year ended December 31, 2024, were $17.0 million compared to $18.5 million in the prior year, which was a decrease of $1.4 million.
Cost of products sold for the year ended December 31, 2025 and 2024, was $6.7 million and $6.6 million remaining consistent year over year. The gross margin for the years ended December 31, 2025 and 2024, were 85.0% and 82.6%, respectively. Selling and marketing .
Amortization. Amortization expense represent the ratable use of our capitalized intangible assets including product and license rights, patents, trademarks and patent defense costs. Amortization for 2024 totaled approximately $4.7 million which is a decrease of $3.4 million due to a $3.3 million write down of our Omeclamox intangible assets for the year ended December 31, 2023. Income taxes .
General and administrative expenses for the year ended December 31, 2025, were $11.9 million compared to $11.1 million in the prior year. The increase was due to higher compensation expenses. Amortization. Amortization expense represent the ratable use of our capitalized intangible assets including product and license rights, patents, trademarks and patent defense costs.
Sancuso revenue was $9.0 million compared to $8.1 million in the prior year, an increase of $0.9 million or 11.2% for the year ended December 31, 2024. This increase in net revenue was impacted by an improvement in product returns in 2024.
This increase in net revenue was primarily impacted by increased shipments, as well as improvement in product returns in 2025. Vibativ revenue increased to $9.5 million for the year ended December 31, 2025, compared to $7.2 million in the same prior year period. The increase was the result of increased shipments of the product, including the product’s new 4-Pak presentation.
Cash provided by operating activities of $6.1 million is primarily due to an increase in accounts payable and other accrued liabilities of $3.7 million, and a $3.4 million decrease in accounts receivable, partially offset by a decrease in non-cash contingent consideration of $1.3 million.
Cash provided by operating activities of $4.9 million was primarily driven by a $6.7 million increase in accounts payable and other current liabilities, a $0.5 million increase in other long‑term liabilities, and a $1.1 million non‑cash add‑back adjustment to net loss.
The primary driver of the increase was higher salary costs. 68 The components of the statements of operations discussed above reflect the following impacts from Vibativ: Financial Impact of Vibativ Years ended December 31, 2024 2023 Net revenue (1) $ 7,161,413 $ 9,812,692 Cost of products sold (2) 1,829,824 1,423,399 Royalty and operating expenses 1,754,411 2,379,939 Vibativ contribution $ 3,577,178 $ 6,009,354 (1) 2023 net revenue includes a $1,000,000 payment to Cumberland related to a settlement agreement of milestone payments.
For the year ended December 31, 2024, we recognized a gain of $0.2 million for a payout earned on a company owned insurance policy. 74 The components of the statements of operations discussed above reflect the following impacts from Vibativ: Financial Impact of Vibativ Years ended December 31, 2025 2024 Net revenue (1) $ 12,474,564 $ 7,161,413 Cost of products sold (2) 1,557,617 1,829,824 Royalty and operating expenses 3,333,416 1,754,411 Vibativ contribution $ 7,583,531 $ 3,577,178 (1) 2025 net revenue includes a $2,975,000 milestone payment and $14,690 for other product related revenue.
Vibativ revenue decreased to $7.2 million for the year ended December 31, 2024, compared to $8.8 million in the same prior year period. The decrease was the result of decreased shipments of the product and higher product returns. Caldolor revenue was $5.0 million during the year ended December 31, 2024, compared to $4.3 million in the same period last year.
Caldolor revenue was $4.7 million during the year ended December 31, 2025, compared to $5.0 million in the same period last year. This decrease in Caldolor revenue for the year ended December 31, 2025, w as impacted by a delay in fulfilling an international order.
Net revenues for the year ended December 31, 2024, were approximately $37.9 million compared to $39.6 million for the year ended December 31, 2023. As detailed in the table above, net revenue increased during 2024 for two of our marketed products: Sancuso and Caldolor.
As detailed in the table above, the increase in net revenues was due to the growth in sales during 2025 for four marketed products: Sancuso, Vibativ, Talicia and Acetadote. 72 Sancuso revenue was $11.9 million compared to $9.0 million in the prior year, an increase of $2.9 million or 32.2% for the year ended December 31, 2025.
The Broadwest contractual cash obligation began upon commencement in October 2022 and CET began May 2023.
The other investment liability represents the remaining amount due to THI. 6. Talicia co-commercialization represents the obligation of up to $2 million for distributing, marketing and sales related costs. 7. The Broadwest contractual cash obligation began upon commencement in October 2022 and CET began May 2023.
Minimum Product Purchase Requirements Our manufacturing and supply agreements do not require minimum annual purchase obligations. 71 Contractual cash obligations The following table summarizes our contractual cash obligations as of December 31, 2024: Payments Due by Year Contractual obligations (1) Total 2025 2026 2027 2028 2029 and after Line of credit (2) $ 15,276,170 $ — $ 15,276,170 $ — $ — $ — Estimated interest on debt (2) 1,904,747 1,088,427 816,320 — — — Vibativ contingent consideration liability payments (3) 3,242,999 381,989 474,553 512,466 481,680 1,392,311 Sancuso contingent consideration liability payments (4) 1,516,000 332,594 336,884 325,578 204,427 316,517 Operating leases (5) 8,268,382 836,100 909,910 934,180 740,791 4,847,401 Total (1) $ 30,208,298 $ 2,639,110 $ 17,813,837 $ 1,772,224 $ 1,426,898 $ 6,556,229 1.
Minimum Product Purchase Requirements Our manufacturing and supply agreements do not require minimum annual purchase obligations. 77 Contractual cash obligations The following table summarizes our contractual cash obligations as of December 31, 2025: Payments Due by Year Contractual obligations (1) Total 2026 2027 2028 2029 2030 and after Line of credit (2) $ 5,240,733 $ — $ 5,240,733 $ — $ — $ — Estimated interest on debt (2) 607,597 347,198 260,399 — — — Vibativ contingent consideration liability payments (3) 3,630,598 774,215 550,857 520,534 517,591 1,267,401 Sancuso contingent consideration liability payments (4) 1,273,000 413,181 336,415 206,788 189,214 127,402 Other investment liability (5) 2,000,000 2,000,000 — — — — Talicia co-commercialization (6) 10,000,000 2,000,000 2,000,000 2,000,000 2,000,000 2,000,000 Operating leases (7) 7,432,282 909,910 934,180 740,791 650,766 4,196,635 Total (1) $ 30,184,210 $ 6,444,504 $ 9,322,584 $ 3,468,113 $ 3,357,571 $ 7,591,438 1.
General and administrative expenses for the year ended December 31, 2024, were $11.1 million compared to $10.7 million in the prior year.
Net revenues for the year ended December 31, 2025, were approximately $44.5 million compared to $37.9 million for the year ended December 31, 2024.
Income taxes totaled $22,669 as a benefit for the year ended December 31, 2024, and $45,769 tax expense for the year ended December 31, 2023. Other income. For the year ended December 31, 2024, we recognized a gain of $0.2 million for a payout earned on a company owned insurance policy.
Income taxes expense was $40,256 for the year ended December 31, 2025, compared to a $22,669 tax benefit for the year ended December 31, 2024. Other income (loss). For the year ended December 31, 2025, we recorded a slight loss on the investment related to THI based on the operating results of that company and our 30% ownership position.
This decrease was primarily a result of a decrease in marketing expenses associated with royalty costs and promotional spending. Research and development .
Selling and marketing expense for the year ended December 31, 2025, was $19.1 million compared to $17.0 million in the prior year, which was an increase of $2.1 million. This increase was primarily a result of an increase in royalty expenses and other costs associated with the increase in product sales. 73 Research and development .
OFF-BALANCE SHEET ARRANGEMENTS During 2024 and 2023 we did not engage in any off-balance sheet arrangements. 72 RECENT ACCOUNTING PRONOUNCEMENTS Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments-Credit Losses,” which changes the impairment model for most financial assets and certain other instruments.
OFF-BALANCE SHEET ARRANGEMENTS During 2025 and 2024 we did not engage in any off-balance sheet arrangements. 78 RECENT ACCOUNTING PRONOUNCEMENTS Recent Accounting Pronouncements In November 2023, the Financial Accounting Standards Board ("FASB") issued final guidance in Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which is intended to improve transparency of segment disclosures, primarily through expanded disclosures for significant segment expenses.
Removed
Next steps include further data analysis and completion of a full study report in preparation for an end-of-Phase-II meeting with the FDA to determine next steps associated with the product’s development and commercialization. Our primary target markets are hospital acute care, gastroenterology and oncology.
Added
Our primary target markets are hospital acute care, gastroenterology and oncology. These medical specialties are characterized by relatively concentrated prescriber bases that we believe can be served effectively by small, targeted sales forces.
Removed
For more information, please see Part I, Item I, Business of this Form 10-K. • Announced the publication of new real-world outcomes research involving 150,000 patients, which compared our Caldolor ® (ibuprofen) injection to its key competitor – ketorolac.
Added
For more information, please see Part I, Item 1, Business of this Form 10-K. • Progressed our clinical development programs for ifetroban announcing breakthrough top-line study results from our Duchenne muscular dystrophy (DMD) study and presented them at two national DMD conferences. • Expanded our commercial portfolio adding Talicia ® , an FDA-approved therapy for the treatment of Helicobacter pylori infection, strengthening our gastroenterology franchise and further diversifying our base of marketed products. • Announced the publication of a peer-reviewed manuscript evaluating Caldolor ® (ibuprofen) injection in older adult patients, demonstrating that Caldolor provided effective pain control with a favorable safety profile and was associated with reduced opioid use in the post-operative setting.
Removed
The results provided compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions and also improved healthcare utilization. • Shared a Caldolor ® Special Report, which was published in Anesthesiology News , General Surgery News and Pharmacy Practice News that presented the growing amount of data supporting the use of Caldolor as a standard of care for the treatment of pain and fever.
Added
The findings further support Caldolor’s role as a non-opioid option for pain management. • Achieved an important reimbursement milestone for Caldolor ® , with a CMS issued J-code associated with an established reimbursement price, strengthening its billing pathway and supporting broader hospital adoption. • Continued to advance and expand Vibativ ® internationally, receiving regulatory approval in China and launching the product in Saudi Arabia, extending access to this important antibiotic in global markets. • Received regulatory approval for our ibuprofen product in Mexico, further expanding the product’s international footprint and supporting access to treatment for patients in Latin America. • Expanded U.S. market access for Vibativ ® through new national group purchasing agreements, including contracts with Premier, Inc. and Vizient, improving availability across hospital systems and strengthening the product’s commercial positioning in acute care settings. 68 CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES Accounting Estimates and Judgments The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period.
Removed
The results demonstrated that the product is a safe and effective treatment for pain and fever in adults, children and infants as young as 3 months of age. • Announced the FDA approval of a supplemental New Drug Application for Acetadote ® , our IV treatment for preventing or lessening liver injury after ingestion of potentially toxic quantities of acetaminophen.
Added
Talicia revenue was $3.3 million for the year ended December 31, 2025. Talicia is a new product added in the fourth quarter of 2025 resulting from our co-commercialization agreement associated with the product.
Removed
The new, streamlined approach reduces the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions without compromising the effectiveness of Acetadote.
Added
Kristalose revenue was $10.5 million for the year ended December 31, 2025, compared to $15.3 million for the year ended December 31, 2024, primarily as a result of decreased shipments of the product associated with increased generic substitution. In fourth quarter of 2025, we introduced our crystalline lactulose Authorized Generic product with initial distribution.
Removed
By simplifying the dosing regimen, health care providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes. • Introduced our newly Cumberland-packaged Sancuso ® , supported by our expanded oncology sales division, after successfully transferring its supply to a new facility that previously received FDA approval for manufacturing the product there. • Helped advance the submissions for the approval of Vibativ ® in China and Saudi Arabia. • Progressed our clinical trials evaluating ifetroban for patients with Systemic Sclerosis, Duchenne muscular dystrophy and Idiopathic Pulmonary Fibrosis. • Received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the use of ifetroban for the treatment of Duchenne muscular dystrophy heart disease, reflecting its potential significance in treating this devastating condition. • Continued our corporate share repurchase initiative, with a group of our board members also purchasing shares through trading plans in order to add to their holdings in the Company. 63 CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES Accounting Estimates and Judgments The preparation of condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period.
Added
The following table shows the primary components of our research and development expenses for the years ended December 31: 2025 2024 External research and development expenses Clinical development $ 1,782,600 $ 1,454,584 Regulatory expenses 1,523,868 1,092,691 Other external 62,419 53,037 Total external expenses 3,368,887 2,600,312 Internal research and development expenses Personnel costs 1,997,309 2,014,389 Other internal 200,302 201,505 Total internal expenses 2,197,611 2,215,894 Total research and development expenses $ 5,566,498 $ 4,816,206 General and administrative .
Removed
These increases were mainly offset by decreases in net product sales of Kristalose and Vibativ. 67 Kristalose revenue decreased by $0.7 million, compared to December 31, 2023, primarily as a result of decreased shipments of the product.
Added
Amortization for 2025 totaled approximately $4.0 million which is a decrease of $0.7 million compared to the same prior year period primarily attributable to an additional amortization expense in 2024 related to the reduction in the valuation of the Acetadote assets. Income taxes .
Removed
Omeclamox-Pak had no sales for the years ended December 31, 2024 and 2023 as Cumberland is currently out of commercial inventory of this product. The packager for our Omeclamox-Pak product encountered financial difficulties and currently is under new management and is reorganizing. We discontinued the product RediTrex in 2023. Net revenue was positively impacted by various sales deduction adjustments.
Added
Cash used in investing activities of $4.7 million is primarily due to the $2.0 million investment in Talicia and the $2.5 million payments related to the Kindos project.
Removed
For the year ended December 31, 2023, we recognized a $2.8 million refund of FDA fees for the periods of 2023 and 2022 to further our product research efforts.
Added
These major sources of cash inflow were partially offset by a $5.2 million increase in accounts receivable and a $0.2 million increase in other current assets and other assets.
Removed
In addition, in 2023 we recognized a gain of $0.5 million to settle a manufacturing dispute and a gain of $0.3 million for a payout earned on a company owned insurance policy. 69 LIQUIDITY AND CAPITAL RESOURCES Our primary sources of liquidity are cash flows provided by our operations, the amounts borrowed and available under our line of credit and the cash proceeds from our initial public offering of common stock that was completed in August 2009.
Added
With the ATM offering in February 2025, the repurchase of our common stock ceased in January 2025. 76 The net $0.4 million decrease in cash and cash equivalents for the year ended December 31, 2024, was attributable to cash used in operating activities offset by cash provided by financing and investing activities.
Removed
Cash used in investing activities of $0.1 million was the result of additions of intangibles and property and equipment offset by life insurance proceeds received.
Added
On November 18, 2025, the Company entered into the First Amendment to the Revolving Credit Note and Second Amendment to the Credit Loan Agreement. The Amendment provides for a principal available for borrowing of up to $15 million. The Company has the right to request an increase of up to an additional $10 million.
Removed
For trade and other receivables, held-to-maturity debt securities, loans and other instruments, companies will be required to use a new forward-looking “expected loss” model that generally will result in the earlier recognition of allowances for losses.
Added
The aggregate principal funding amount remains unchanged of up to $25 million. The Company is subject to a financial covenant, maintenance of a Minimum Fixed Charge Coverage Ratio determined on a quarterly basis, along with Borrowing Base Requirements, as defined. The Amendment extends the maturity date to October 1, 2027.
Removed
For available-for-sale debt securities with unrealized losses, companies will measure credit losses in a manner similar to what they do today, except that the losses will be recognized as allowances rather than as reductions in the amortized cost of the securities.
Added
The guidance is effective for annual periods beginning in 2024 and interim periods beginning in 2025. With the Company having only one segment, the adoption, effective January 1, 2024, did not have a material impact on the Company’s consolidated financial statements.
Removed
Companies will have to disclose additional information, including information they use to track credit quality by year of origination for most financing receivables. Companies will apply the ASU’s provisions as a cumulative-effect adjustment, if any, to accumulated deficit as of the beginning of the first reporting period in which the guidance is adopted.
Added
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("Update 2023-09"), which expands income tax disclosure requirements to include additional information related to the rate reconciliation of our effective tax rates to statutory rates as well as additional disaggregation of taxes paid.
Removed
Related to ASU No. 2016-13 discussed above, in May 2019, the FASB issued ASU 2019-05, "Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief" which provides transition relief for ASU 2016-13 by providing entities with an alternative to irrevocably electing the fair value option for eligible financial assets measured at amortized cost upon adoption of the new credit losses standard.
Added
The amendments in Update 2023-09 also remove disclosures related to certain unrecognized tax benefits and deferred taxes. Update 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. We adopted Update 2023-09 effective for this annual report for the year ended December 31, 2025 on a prospective basis.
Removed
Certain eligibility requirements must be met and the election must be applied on an instrument-by-instrument basis. The election is not available for either available-for-sale or held-to-maturity debt securities. We adopted both ASU 2016-13 and ASU 2019-05 on January 1, 2023. The adoption of ASU 2016-13 and ASU 2019-05 did not have a material impact on the Company’s consolidated financial statements.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

3 edited+0 added−0 removed4 unchanged
Biggest changeThe Company did not have any investments in marketable securities at December 31, 2024. The interest rate risk related to borrowings under our line of credit is based on a benchmark (Term SOFR) plus a spread of 2.75%. As of December 31, 2024, we had $15.3 million in borrowings outstanding under our revolving line of credit.
Biggest changeThe Company did not have any investments in marketable securities at December 31, 2025. The interest rate risk related to borrowings under our line of credit is based on a benchmark (Term SOFR) plus a spread of 2.75%. As of December 31, 2025, we had $5.2 million in borrowings outstanding under our revolving line of credit.
We believe our exposure to foreign currency fluctuation is minimal as our purchases in foreign currency have a maximum exposure of 90 days based on invoice terms with a portion of the exposure being limited to 30 days based on the due date of the invoice. Foreign currency exchange losses were immaterial for 2024 and 2023.
We believe our exposure to foreign currency fluctuation is minimal as our purchases in foreign currency have a maximum exposure of 90 days based on invoice terms with a portion of the exposure being limited to 30 days based on the due date of the invoice. Foreign currency exchange losses were immaterial for 2025 and 2024.
Neither a five percent increase nor decrease from current exchange rates would have had a material effect on our operating results or financial condition. 73
Neither a five percent increase nor decrease from current exchange rates would have had a material effect on our operating results or financial condition. 79

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