What changed in this filing

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Item 1. Business

2026-03-09 compared with 2025-03-07 · 199 added, 217 removed, 738 unchanged (36% of the section changed)

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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.

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.

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.

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.

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• Caldolor ® ( ibuprofen ) injection, for the treatment of pain and fever;

• Kristalose ® ( lactulose ) for oral solution, a prescription laxative, for the treatment of constipation;

• 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;

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• 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;

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.

• Tacilia ® ( omeprazole, amoxicillin and rifabutin ) oral capsule, for the treatment of H.

pylori infection.

In addition to these commercial brands, we have announced breakthrough results in a clinical study of our ifetroban product candidate in patients with cardiomyopathy associated with Duchenne muscular dystrophy (“DMD”).

This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.

We then completed and submitted a clinical study report to the FDA and began interactions to determine their remaining development requirements.

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.

Investigational new study applications have been cleared by the FDA enabling us to launch clinical studies in each of these areas.

Additionally, we recently completed a Phase II study in patients with cardiomyopathy associated with Duchenne muscular dystrophy (“DMD”), a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.

Next steps for this DMD Program 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.

Cumberland has built core competencies for the acquisition, development and commercialization of pharmaceutical products in the U.S.

and we believe we can leverage this existing infrastructure to support our continued growth.

Cumberland has built core competencies for the acquisition, development, registration and commercialization of pharmaceutical products in the U.S.

We believe we can leverage this existing infrastructure to support our continued growth.

Our management team consists of pharmaceutical industry veterans with experience in business development, product development, regulatory, manufacturing, sales, marketing and finance.

Our business development team identifies, evaluates, and negotiates product acquisition, licensing and co-promotion agreements.

Our business development team identifies, evaluates and negotiates product acquisition, licensing and co-promotion arrangements.

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 brands.

Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability and delivery of our products.

Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability and delivery of our products, both domestically and internationally.

Sustainability Metrics

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As one of the largest biopharmaceutical companies founded and headquartered in the Mid-South, we hold ourselves to the highest standards of ethical practices and understand the importance of recognizing and addressing our impact on our constituents, our community and the environment.

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.

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.

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.

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.

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These filings are also available to the public at www.sec.gov ..

Products Indication Status

Acetaminophen Poisoning Marketed

Pain and Fever Marketed

Chronic and Acute Constipation Marketed

Nausea and Vomiting Associated with Chemotherapy Marketed

Euvolemic and Hypervolemic Hyponatremia Approved

Serious Bacterial Infections Marketed

Acetaminophen Poisoning

Pain and Fever

Chronic and Acute Constipation

Nausea and Vomiting Associated with Chemotherapy

Euvolemic and Hypervolemic Hyponatremia

Serious Bacterial Infections

pylori Infection

Acetadote is an intravenous formulation of N-acetylcysteine, indicated for the treatment of liver toxicity associated with acetaminophen poisoning.

Cumberland developed and obtained U.S.

FDA approval for Acetadote, and then introduced the product through our hospital sales force.

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.

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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.

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.

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As a result, dosing guidance was included for patients weighing over 100 kg, and new language was added to alert health care providers that, in certain clinical situations, therapy should be extended for some patients.

In 2024, the FDA approved a supplemental New Drug Application for Acetadote, adding a simplified dosing regimen for the product prescribing information.

In November 2024, the FDA also approved a supplemental New Drug Application for Acetadote, adding a simplified dosing regimen for the product prescribing information.

This newly approved dosing regimen simplifies the administration of Acetadote by combining the first two bags of the standard regimen into a single, slower infusion.

This streamlined approach has been implemented in hospitals across multiple countries and demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions without compromising the effectiveness of Acetadote.

The United States Patent and Trademark Office (the “USPTO”) issued us a series of patents associated with our Acetadote product.

This streamlined approach has been implemented in hospitals across multiple countries and has been shown to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions without compromising the effectiveness of Acetadote.

The FDA subsequently provided three years exclusivity for this new dosing regimen based on the supporting clinical data that the Company submitted.

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.

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An Appeals Court affirmed the District Court ruling in the Company’s favor upholding Cumberland’s Acetadote patent and expressly rejected the validity challenge.

During 2024, we continued to distribute our Acetadote brand, however our Authorized Generic product is now distributed through Padagis US LLC (formerly a division of Perrigo Company).

Caldolor, our intravenous formulation of ibuprofen, was the first injectable product approved in the U.S.

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We then launched Caldolor and continue to promote the product in the U.S.

through our hospital sales force.

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 another 1,000 adult and pediatric patients.

These studies included data on a shortened infusion time and pre-surgical administration of the product.

Those clinical trials involved an additional 1,000 adult and pediatric patients.

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.

We then received FDA approval for the use of Caldolor in pediatric patients 6 months of age and older.

In early 2018, we completed and filed the application for FDA approval of a next generation Caldolor product featuring an improved presentation and formulation which was approved in January 2019.

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During our clinical studies we found that the product delivered its best results when dosed prior to surgery, reducing both patients’ pain as well as their need for opiates.

We also announced an agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor in Mexico.

Under the terms of the agreement, Cumberland will be responsible for providing the product dossier and supplies.

PiSA will be responsible for obtaining regulatory approval for the product in Mexico and introducing it to the new market.

PiSA expects to provide the product in both 400- and 800-milligram vials.

In 2023, the FDA approved expanded labeling for Caldolor to include use in infants 3 to 6 months old.

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.

With this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is delivered through injection.

Also in 2023, we announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in infants.

Published in the journal Pediatric Drugs , the results support the FDA’s approval of Caldolor in patients 3 to 6 months of age.

In 2024, we announced the release of a Special Report evaluating the growing amount of current data supporting the use of Caldolor as a standard of care for the treatment of pain and fever in adults, children and infants.

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Additionally in 2024, we announced the publication of new real-world outcomes research comparing Caldolor to its key competitor – ketorolac – in 150,000 patients.

Published in Frontiers of Pain Research , the results provided compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions and also improved healthcare utilization.

Published in Frontiers of Pain Research, the results provided compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions and improved health care utilization.

In 2025, we announced publication of our study investigating Caldolor in older patients.

The analysis evaluated the safety and efficacy of Caldolor for the management of pain and fever in patients 60 years of age and older.

It marks an important advancement in pain management for older individuals, as it is one of the first studies specifically evaluating our product in this vulnerable population.

In late 2025, the Centers for Medicare & Medicaid Services (CMS) issued a permanent J-Code for Caldolor.

This important reimbursement milestone enhances access, simplifies hospital billing and further supports Caldolor’s role as a standard of care for pain and fever management.

During 2025, we distributed both the vial and the ready-to-use premixed bag presentations of Caldolor.

We supported the brand through our hospital sales division and group of medical science liaisons.

Kristalose is a prescription laxative administered orally for the treatment of acute and chronic constipation.

An innovative, dry powder crystalline formulation of lactulose, Kristalose is designed to enhance patient acceptance and compliance.

It is the only prescription laxative available in pre-measured powder packets.

It is the only branded prescription laxative available in pre-measured powder packets.

Kristalose dissolves easily in 4 ounces of water, offering patients a virtually taste-free, grit-free and essentially calorie-free alternative to lactulose syrups.

We conducted a preference study which indicated that 77% of patients surveyed prefer the taste, consistency and portability of Kristalose over similar products in syrup forms.

We acquired the assets and exclusive rights to Kristalose through a series of transactions, then assembled a dedicated field sales force which re-launched the product as a Cumberland brand.

We acquired the assets and exclusive rights to Kristalose through a series of transactions, then assembled a dedicated field sales division which re-launched the product as a Cumberland brand.

We directed our sales efforts to physicians who are the most prolific writers of prescription laxatives, including gastroenterologists and internists.

We supplemented this personal promotion with telemarketing campaigns to expand our reach and support of the product.

Using preference data as a cornerstone of our marketing efforts, we repositioned the brand, enhancing patient affordability through a coupon program and expanded managed care coverage for the product.

Using preference data as a cornerstone of our marketing efforts, we then repositioned the brand, enhancing patient affordability through a coupon program and expanded managed care coverage for the product.

We added a co-promotion partner, Poly Pharmaceuticals, who is promoting Kristalose to physician targets not covered by our field sales forces.

We then added another partner, Foxland Pharmaceuticals, Inc., who is repackaging Kristalose and featuring it with additional new physician targets.

The Kristalose award-winning marketing campaign was refreshed for 2022 to support increased engagement with our customers.

We also expanded patient support for the brand – and it was added to the GoodRx platform in 2022.

During 2023, we continued to support Kristalose through our field sales force as well as our partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals, Inc.

We have found that the brand performs best in states where we have Medicaid coverage, such as Texas, New York and Wisconsin.

We also learned that Kristalose is now covered on certain Virginia, Louisiana and Maine Medicaid plans.

We are implementing a special initiative to increase our presence and share of voice in these states and believe that this new coverage is contributing to the growth of the product.

At the end of 2021, we entered into an agreement with Kyowa Kirin to acquire the U.S.

assets and rights to Sancuso (granisetron transdermal system), an FDA-approved oncology supportive care medicine.

This transaction closed in January 2022.

The Kristalose award-winning marketing campaign was designed to support increased engagement with our customers.

Substitution by pharmacists dispensing generic alternatives in place of Kristalose prescriptions has historically impacted the brand.

During 2025, substitution rates increased with the entry of new generic competitors.

As a result, we are implementing targeted initiatives to protect the product’s market position and support its growth.

During 2025, we continued to support Kristalose through our field sales division, as well as our partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals, Inc.

Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment for their cancer.

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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.

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.

Kyowa Kirin retained international rights, continuing to deliver the product to address oncology patients’ needs throughout the rest of the world.

In January 2022, we began shipments of the product and formed a new sales force, Cumberland Oncology, to support the brand.

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.

As we began shipments of the product, we also formed a new sales division, Cumberland Oncology, to feature the brand with medical professionals treating cancer patients.

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.

Following FDA approval of that site, we introduced our newly Cumberland-packaged product in 2024, supported by our expanded oncology sales division.

We continued to support Sancuso in 2025 through our oncology sales division.

We acquired the assets and rights to Vaprisol, a prescription brand indicated to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia.

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Vaprisol is supported by our hospital sales division.

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.

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We next expect to file for the approval to manufacture branded Vaprisol once all FDA issues at the new site are resolved.

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.

Vibativ is an FDA-approved injectable anti-infective.

It is designed to treat serious infections due to Staphylococcus aureus (“S.

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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.

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.

The molecule of an existing antibiotic to which bacteria had developed a resistance, vancomycin, was altered by adding a lipophilic (fat-loving) component and a hydrophilic (water-loving) component.

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Further, in clinical trials, Vibativ demonstrated superior cure rates of patients with hospital-acquired bacterial pneumonia.

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.

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.

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.

The results of the study suggest that a single dose of Vibativ is safe in children, and they experience reduced exposure to Vibativ, compared with the same body weight-based dosing in adults.

In 2025, we announced the availability of the Vibativ 4-Vial Starter Pak through a new supply arrangement with Vizient Inc., making it accessible to their health care providers nationwide.

As the country’s largest provider-driven health care performance improvement company, Vizient serves more than 65% of the nation’s acute care providers, including 97% of academic medical centers and 35% of the non-acute market.

Through this agreement, Vizient members now have access to Vibativ’s new 4-vial configuration, which supports flexible treatment initiation in both inpatient and outpatient settings for this potentially life-saving therapy.

Additionally, we announced that Vibativ was added to a national group purchasing agreement with Premier, Inc., in 2025.

The product additional allows Premier members to purchase Vibativ, in the 12-vial carton and 4-vial Starter Pak.

Premier is a leading health care improvement company, uniting an alliance of approximately 4,350 U.S.

hospitals and 325,000 other providers and organizations to transform health care.

With integrated data and analytics, collaboratives, supply chain solutions, consulting and other services, Premier enables better care and outcomes at a lower cost.

With expanded access, Premier member health care providers now have greater flexibility in ordering Vibativ for both inpatient and outpatient settings.

While we remain focused on promoting Vibativ in the U.S.

market, we are building a network of other established companies to bring Vibativ to patients in their countries and territories.

In 2022, we announced a new partnership with Saudi Arabia-based Tabuk Pharmaceutical to introduce Vibativ into the Middle East.

The arrangement provides Tabuk exclusive rights to distribute Vibativ in Saudi Arabia and Jordan, with the option to expand into other countries in the region.

We recently began shipping Vibativ to Tabuk in preparation for their launch of the product in Saudi Arabia.

Additionally, D.B.

Pharm, our partner in South Korea who also distributes Caldolor, is awaiting the approval of Vibativ in their country.

Meanwhile, our Vibativ partner for the Chinese market, SciClone Pharmaceuticals, had their approval application in China accepted for review in September 2021.

We have since been supporting SciClone and their requests associated with review of that submission.

They recently obtained that approval and believe that there is significant potential for Vibativ in their country.

During 2025, Vibativ was supported by our hospital sales division, national accounts group and team of medical science liaison.

Talicia was approved by the FDA for marketing in the U.S.

for the treatment of Helicobacter pylori ( H.

pylori) infection in adults.

Talicia is a combination of three approved drug products - omeprazole, a proton pump inhibitor, which prevents the secretion of hydrogen ions increasing the pH of the stomach, plus amoxicillin and rifabutin, antibiotics.

It is administered to patients orally in the form of fixed-dose, all-in-one capsules.

Talicia is the only all-in-one treatment for H.

pylori and is now listed as a first-line therapy option in the 2024 American College of Gastroenterology (ACG) clinical guidelines.

The product is patent protected through 2042 and received eight years of U.S.

market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.

In 2025, we announced arrangements with RedHill Biopharma Ltd.

(“RedHill”) to jointly commercialize Talicia, therefore adding the brand as the newest addition to our commercial product portfolio.

We also formed a new company with RedHill named Talicia Holdings, Inc.

(“THI”), which holds the worldwide rights and assets associated with the brand.

The new company provides operational support with responsibility for the product’s marketing, manufacturing, regulatory, medical and supply chain functions.

Through a co-commercialization agreement, we assumed responsibility for the distribution and sale of Talicia in the U.S.

Cumberland records Talicia product sales and equally shares Talicia’s net revenues.

We also provide an annual investment to cover certain distribution, marketing and sales costs.

Cumberland is responsible for the sales promotion for Talicia through our established field sales division to increase the number of patients benefiting from Talicia.

Ifetroban Clinical Studies

Ifetroban is a selective thromboxane-prostanoid receptor (“TPr”) antagonist that has been dosed in over 1,400 subjects, demonstrating safety and well-tolerated profiles in both healthy volunteers and various patient populations.

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).

The FDA has cleared investigational new study applications for both indications, enabling the launch of clinical studies in each area.

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 skeletal, heart and lung muscles.

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 the development and commercialization pathway.

We have also completed pilot Phase II studies in patients with 1) Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure, 2) Portal Hypertension associated with chronic liver disease and 3) Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.

No significant safety issues were identified with ifetroban use in these patient populations.

Multiple additional pilot studies of ifetroban are also currently in progress, including several investigator-initiated preclinical and clinical trials.

Following is detailed information about our clinical programs evaluating ifetroban:

Duchenne Muscular Dystrophy (“DMD”)

In February of 2025, we announced positive top-line results from our Phase II study of oral ifetroban (Dyscorban ® ) for treating cardiomyopathy associated with DMD.

The study marks a breakthrough as the first successful Phase II study specifically targeting the cardiac complications in DMD patients.

Cardiomyopathy is the leading cause of death in DMD patients, and elevated levels of TPr and its ligand, isoprostanes, are found in these patients.

The trial enrolled 41 DMD patients who received either low-dose ifetroban (100 mg per day), high-dose ifetroban (300 mg per day) or placebo.

The study’s primary endpoint was improvement in left ventricular ejection fraction (“LVEF”).

Key findings include:

1) high-dose ifetroban treatment resulted in an overall 3.3% improvement in LVEF;

2) the high-dose ifetroban group showed a 1.8% increase in LVEF, while the placebo group showed an expected decline of 1.5%;

3) compared with propensity-matched natural history controls, the difference was more pronounced, with high-dose treatment providing a significant 5.4% overall improvement in LVEF, as control patients experienced a 3.6% decline and 4) both doses were well-tolerated, with no serious drug-related events.

Preclinical studies by our Vanderbilt collaborators demonstrated TPr blockade by ifetroban prevented cardiac dysfunction and improved mortality in several animal models of muscular dystrophy.

These results, published in the Journal of the American Heart Association, suggest TPr activation contributes to DMD cardiomyopathy and blockade with ifetroban may serve as a novel therapeutic for DMD patients.

The FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for ifetroban for the treatment of cardiomyopathy associated with DMD.

If approved, it would be the first therapy specifically indicated for the heart disease associated with DMD.

Cumberland was awarded over $1 million in federal funding to support this clinical trial, the first DMD study awarded FDA Orphan Product Development funding.

Due to the COVID-19 pandemic’s impact on clinical research in 2020, the FDA awarded a supplemental grant to support the study.

Systemic Sclerosis (“SSc”)

We are developing ifetroban oral capsules under the brand name Vasculan ® for treating Systemic sclerosis.

SSc has the highest case-specific mortality of any rheumatic disorder, with 50% of patients dying or developing major internal organ complications within three years of diagnosis.

While several medications treat SSc-associated skin disease, no universally effective treatment exists for improving affected internal organ function, including the cardiovascular system.

Cardiac involvement in SSc is often underestimated due to its subtle and atypical presentation.

Despite cardiovascular events contributing to elevated mortality in later disease stages, overt signs typically indicate advanced disease, including myocardial or pericardial inflammation, heart failure and pulmonary arterial hypertension (“PAH”).

Our Vanderbilt collaborators completed preclinical studies demonstrating that TPr blockade with ifetroban prevents cardiac fibrosis and can restore cardiac function in PAH animal models.

The FDA cleared our IND application for a 34-subject Phase II trial evaluating 12 months of oral ifetroban (Vasculan) in patients with diffuse cutaneous SSc, and those with SSc-associated PAH.

The study is currently enrolling patients.

Idiopathic Pulmonary Fibrosis (“IPF”)

In January 2024, we launched our FIGHTING FIBROSIS trial, a Phase II clinical study evaluating ifetroban for Progressive Fibrosing Interstitial Lung Diseases (“PF-ILDs”).

The study is designed to enroll approximately 128 patients across more than 20 U.S.

medical centers of excellence to evaluate the safety, tolerability and efficacy of oral ifetroban in IPF patients, the most common form of PF-ILD.

This program is supported by studies published by our Vanderbilt collaborators which demonstrated ifetroban could both prevent and enhance resolution of lung fibrosis in multiple preclinical models.

Future Development

Our immediate focus is completing the Company-sponsored studies, analyzing their final data, and announcing top-line results.

The comprehensive evaluation will inform our strategy for the registration pathway for ifetroban, Cumberland’s first new chemical entity.

We continue to believe ifetroban has significant potential to benefit patients with orphan diseases representing substantial unmet medical needs.

We have been evaluating our ifetroban product candidate in a series of clinical studies.

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.

Investigational new drug applications have been cleared by the FDA enabling us to launch clinical studies in each of these areas.

In February 2025, we announced positive top-line results from our completed Phase II study (CPI-IFE-007, the FIGHT DMD trial) 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.

The study enrolled 41 DMD patients who received either low-dose ifetroban (100 mg per day), high-dose ifetroban (300 mg per day), or placebo.

High-dose ifetroban treatment resulted in a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo.

When compared to propensity-matched natural history controls, the difference was even more pronounced, with high-dose treatment providing a statistically significant 5.4% overall improvement in LVEF (p=0.002), as control patients experienced a 3.6% decline in LVEF.

Both doses of ifetroban were well tolerated with no serious drug-related adverse events.

All subjects who completed the 12-month treatment period opted into the open-label extension, with long-term follow-up continuing through Month 24 and Month 36 assessments.

Ifetroban received Orphan Drug Designation and Rare Pediatric Drug Designation for DMD in November 2024.

Fast Track Designation was granted in February 2026.

An End-of-Phase 2 meeting was held with FDA in September 2025, and a subsequent Type C meeting was held in January 2026 to continue regulatory pathway discussions.

The Systemic Sclerosis study (CPI-IFE-004) closed to enrollment in February 2025.

The diffuse cutaneous SSc cohort met its target enrollment goal of 20 patients who completed the 12-month treatment period.

The SSc-associated Pulmonary Arterial Hypertension cohort enrolled 9 of the targeted 14 subjects before study closure.

Cardiac imaging analysis is complete, and topline results for the diffuse cutaneous arm are expected by the end of the first quarter of 2026.

The Idiopathic Pulmonary Fibrosis study (CPI-IFE-008, the FIGHTING FIBROSIS trial) is actively enrolling, with over 70 subjects enrolled across 17 activated sites.

A safety interim analysis was completed in November 2025 evaluating the first 25% of patients completing 12 weeks of treatment;

the independent committee concluded no new safety signals were identified and no changes in study conduct were needed.

We have also completed a pilot Phase II study involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure, 2) patients with Portal Hypertension associated with chronic liver disease and 3) patients with Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.

There were no significant safety issues identified with the use of ifetroban in these patients.

Based on the results from our completed and ongoing studies, we are pursuing ifetroban registration for DMD-associated cardiomyopathy as our lead indication, with the IPF and SSc programs providing additional potential indications for our first new chemical entity.

GROWTH STRATEGY

Cumberland’s growth strategy involves maximizing the potential of our existing brands, while continuing to build a portfolio of differentiated products.

We currently own six products approved by the FDA in the United States.

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.

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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 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.

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For example, we have secured pediatric approval of Acetadote and Caldolor and expanded the labeling for both brands accordingly.

We also added pre-surgery dosing for Caldolor, and recently included newborns to the patients who can benefit from the product.

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.

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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 also look for select partners that can complement our capabilities and enhance opportunities for our brands.

For example, our co-promotion partnerships have allowed us to expand the support for Kristalose across the United States.

• Building an international contribution to our business.

We have established our own commercial capabilities, including three sales divisions, that focus on the U.S.

market for our products.

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 hold the worldwide rights to all our brands except for Sancuso, as we acquired only the U.S.

rights for that product.

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.

The acquisition of Vibativ resulted in several new international partners and market opportunities.

The acquisition of Vibativ resulted in several new international partners and market opportunities with growing approvals of the product in other countries.

• Managing our operations with financial discipline.

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and is comprised of sales professionals with substantial experience in the hospital market.

Independent market data continues to indicate that the majority of pharmaceutical promotional spending is directed toward large, outpatient markets on drugs intended for chronic use rather than short-term, hospital use.

We believe the hospital market is underserved and highly concentrated, and that it can be penetrated effectively by a small, dedicated sales force without large-scale promotional activity.

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• 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.

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.

Because the market for gastrointestinal diseases is broad in patient scope, yet relatively narrow in physician base, we believe it provides opportunities that can be penetrated with a modest-sized sales force.

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• Oncology market:

In early 2022, we formed a new oncology sales force to promote our Sancuso brand.

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.

During 2023, we expanded the sales division as we work to deliver Sancuso to more cancer patients, helping them tolerate their chemotherapy treatments.

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.

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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:

Customer 1 29 %

Customer 2 26 %

Customer 3 21 %

INTERNATIONAL PARTNERSHIPS

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We have entered into a series of agreements to establish an international network, which is summarized in the table below and includes information on our primary partners:

International Partner Product(s) Territory Status

Phebra Pty Ltd Acetadote & Caldolor Australia Marketed

International Partner

Phebra Pty Ltd

Acetadote & Caldolor

Pharm Korea Co., Ltd.

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

Tabuk Pharmaceuticals

Saudi Arabia and Jordan

PiSA Pharmaceutical

SciClone Pharmaceuticals, Inc.

Vibativ China and Hong Kong Registration

China and Hong Kong

Pharm Korea Co., Ltd.

Vaprisol & Vibativ South Korea Registration

Vaprisol & Vibativ

WinHealth Pharma Group Co.

Acetadote & Caldolor China and Hong Kong Development

Acetadote & Caldolor

China and Hong Kong

Our international commercialization agreements include a license to one or more Cumberland products for a specific territory as noted in the table above.

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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.

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

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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.

In 2025, D.B.

Pharm continued to purchase supplies of Caldolor and distributed the brand in South Korea.

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Pharm to register and commercialize our Vaprisol and Vibativ brands in their country.

During 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.

We 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.

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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.

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.

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SciClone Pharmaceuticals (Holdings) Limited (“SciClone”) has licensed our Vibativ product for sale and distribution in China and several adjacent countries.

In February 2021, SciClone completed an initial public offering and listing of their shares on the Hong Kong stock exchange.

In June 2021, SciClone submitted an application to the Chinese regulatory authority for the approval of Vibativ in that country.

In October 2021, SciClone informed us that the filing was accepted by the regulatory agency for review.

We have since been supporting SciClone and their requests associated with review of that submission.

They recently obtained that approval and believe that there is significant potential for Vibativ in their country.

In March 2022, we established distribution for our Vibativ product in the Middle East through a partnership with Tabuk Pharmaceutical Manufacturing Company (“Tabuk”).

In early 2025, they obtained approval and began preparations for the launch of Vibativ in their country.

We established distribution for our Vibativ product in the Middle East through a partnership with Tabuk Pharmaceutical Manufacturing Company (“Tabuk”).

Through our partnership, Tabuk will introduce the product in Saudi Arabia, Jordan and potentially other countries in the Middle East.

They have ordered initial supplies of Vibativ and are currently planning the launch of the product in Saudi Arabia.

In October 2022, we announced an agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor in Mexico.

Under the terms of the agreement, Cumberland will be responsible for providing the product dossier and supplies.

PiSA will be responsible for obtaining regulatory approval for the product in Mexico and introducing it to the new market.

In 2024, they competed the submission of the approval dossier to Mexico’s regulatory agency, for the product’s registration in that country.

In 2025, we supported Tabuk’s launch of Vibativ in Saudi Arabia, as they began to provide the potentially life-saving treatment to patients in their country.

We have entered into an agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor in Mexico.

Under the terms of the agreement, Cumberland is responsible for providing the product dossier and supplies.

PiSA is responsible for obtaining regulatory approval for the product in Mexico and introducing it to the new market.

In 2025, the product received regulatory approval in Mexico, and preparations for the launch of the product there are now underway.

Poly Co-Promotion Agreement

We entered into a co-promotion arrangement with Poly Pharmaceuticals, Inc.

(“Poly”) for our Kristalose product in 2017.

Poly is a privately held U.S.

(“Poly”) for our Kristalose product Poly is a privately held U.S.

specialty pharmaceutical company that is featuring Kristalose to an expanded number of physicians.

Poly’s sales organization is more than doubling the number of nationwide physicians that are reached with the Kristalose brand message.

In 2019, we extended our co-promotion arrangement with Poly.

Poly’s sales organization is more than doubling the number of nationwide physicians who are reached with the Kristalose brand message.

2R and Foxland Agreements

In 2018, we entered into another co-promotion arrangement related to our Kristalose product.

We have also entered into another co-promotion arrangement related to our Kristalose product.

We have agreements with 2R Investments, LLC and with Foxland Pharmaceuticals, Inc.

(“Foxland”) to package, distribute and promote an unbranded generic form of our Kristalose product to physician targets that we do not cover.

We renewed our agreement with Foxland in 2022.

CET University Collaboration Agreements

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CET has been able to help secure federal small business grant funding to support these various projects.

CET has also established and manages the Nashville Life Sciences Center , which serves as an incubator for Middle Tennessee’s emerging biomedical industry.

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.

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Nearly 30 life science companies exist today because of CET, including a vibrant group of current tenants at the Life Sciences Center as well as a growing number of successful graduates.

During 2024 there were two key developments among the programs CET is supporting.

First, enrollment concluded and top-line results have become available for the MENDING Trial, a Phase II investigator-initiated study evaluating the safety and efficacy of a new treatment for delirium in critically ill patients.

The study was conducted in partnership with Vanderbilt University Medical Center and funded by the National Institute of Health (“NIH”).

The MENDING Trial enrolled 97 critically ill patients who were admitted to the Vanderbilt Intensive Care Unit (“ICU”) for treatment of respiratory failure or shock and treated 39 who, while in the ICU, developed delirium.

Delirious patients received twice-daily IV treatment or placebo and were evaluated over the course of 14 days.

The primary endpoint for this study was the safety of this new treatment.

The study also evaluated patient days without delirium or coma.

Additional endpoints included ventilator-free days;

hospital-free days;

drug exposure for antipsychotics, opioids, and sedatives;

and cognitive function.

The MENDING Trial successfully demonstrated that the new treatment was well-tolerated in these ICU patients diagnosed with delirium.

In addition the new treatment was associated with 1) a reduction in days with delirium;

2) reduced use of antipsychotics, opioids, and sedatives;

and 3) a decrease in delirious patients experiencing comas.

While the efficacy results were not statistically significant given the limited number of patients treated, the findings are considered clinically meaningful by physician investigators involved in the study and support continued development.

Delirium is characterized as a serious alteration in mental state which may present with confusion, poor attention or lack of awareness.

Additionally, delirium is the most common presentation of neurologic dysfunction in critically ill patients and affects between 30-75% of patients admitted to the ICU.

Development of delirium is associated with several poor outcomes including increased length of hospital stays, long-term cognitive deficits, additional hospital costs, impaired quality of life and mortality.

Despite the prevalence and impact of delirium, there are currently no FDA-approved therapeutics for the prevention or treatment of delirium, highlighting an unmet medical need for these patients.

Second, CET entered into a Development Agreement with Octapharma AG ("Octapharma") for a new product designed to locate sites of internal bleeding.

In exchange for an option to worldwide rights to the technology, Octapharma will provide development funding.

With the option exercise, Octapharma will also provide milestone payments and royalties on product sales.

Most clinically significant internal bleeding occurs in the gastrointestinal (GI) tract, especially the lower tract.

Intestinal hemorrhage ranks among conditions having the highest number of all-cause readmissions and among the most common causes of nonmalignant mortality.

Current treatment for GI hemorrhage begins with identifying the bleeding site through diagnostic testing.

Colonoscopy is the recommended first-line diagnostic procedure, while computed tomographic angiography is advised for a subset of high-risk patients who are unlikely to tolerate bowel preparation.

Both angiography and tagged red blood cell scintigraphy – older, less commonly used tests – require a minimum rate of active bleeding for accurate results.

Diagnosis using colonoscopy is also more challenging without active bleeding or when excessive bleeding obscures the visual field.

The new technology represents a paradigm shift as it identifies the naturally formed clot at the injured vessels, allowing for the potential to pinpoint GI bleeding sites even if bleeding has ceased temporarily.

The product is designed as a proprietary radiochemical preparatory kit for generating a medical imaging agent for injection.

It has been developed through a collaboration between CET, researchers at Vanderbilt University Medical Center and Cold Springs Diagnostics, Inc.

The development has been supported by an NIH grant awarded to CET under the STTR program.

The next steps include scaling up the drug formulation and conducting the additional preclinical testing needed to file and obtain clearance for an Investigational New Drug application, paving the way for an initial clinical study.

CLINICAL AND REGULATORY AFFAIRS

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aureus pathogen.

Caldolor Newborn Study, Clinical Manuscripts and Other Studies

In February 2025, Vibativ received marketing approval in China through our partner SciClone.

Caldolor Clinical Manuscripts

We previously received FDA approval for the use of Caldolor in pediatric patients 6 months of age and older.

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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.

In September 2025, our partner PiSA received marketing authorization in Mexico for IV ibuprofen under the trade name IVIRET, representing further international expansion of this product.

Ifetroban Phase II Studies

We have been evaluating our ifetroban product candidate in a series of clinical studies.

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.

Investigational new study applications have been cleared by the FDA enabling us to launch clinical studies in each of these areas.

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 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.

Investigational new drug applications have been cleared by the FDA enabling us to launch clinical studies in each of these areas.

The study enrolled 41 DMD patients who received either low-dose ifetroban (100 mg per day), high-dose ifetroban (300 mg per day), or placebo.

High-dose ifetroban treatment resulted in a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo.

Both doses of ifetroban were well tolerated with no serious drug-related adverse events.

All subjects who completed the 12-month treatment period opted into the open-label extension, with long-term follow-up continuing through Month 24 and Month 36 assessments.

Ifetroban received Orphan Drug Designation and Rare Pediatric Drug Designation for DMD in November 2024.

Fast Track Designation was granted in February 2026.

An End-of-Phase 2 meeting was held with FDA in September 2025, and a subsequent Type C meeting was held in January 2026 to continue regulatory pathway discussions.

The Systemic Sclerosis study (CPI-IFE-004) closed to enrollment in February 2025 and topline results for the diffuse cutaneous arm are expected by the end of the first quarter of 2026.

The Idiopathic Pulmonary Fibrosis study (CPI-IFE-008, the FIGHTING FIBROSIS trial) is actively enrolling, with over 70 subjects enrolled across 17 activated sites.

A safety interim analysis was completed in November 2025 evaluating the first 25% of patients completing 12 weeks of treatment;

the independent committee concluded no new safety signals were identified and no changes in study conduct were needed.

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Additional pilot studies of ifetroban are underway, including several investigator-initiated trials.

We are awaiting results from the studies underway before deciding on the best development path for the registration of ifetroban, our first new chemical entity.

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.

The NIAID contractors completed these studies and prepared a manuscript for submission to a scientific journal for publication.

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.

The results of this testing program were published in July 2024 in Antimicrobial Agents and Chemotherapy, demonstrating rapid in vitro activity of telavancin against Bacillus anthracis and in vivo protection against inhalation anthrax infection in the rabbit model.

CORPORATE DEVELOPMENT

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We have an agreement with one manufacturer, who provided commercial supplies of Acetadote in 2025.

We did encounter a shortage of Acetadote in 2025 due to delays in the manufacture, serialization and delivery of orders from our supplier.

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.

We have an agreement for the purchase of Kristalose API with an international supplier.

We have an agreement for the purchase of Kristalose active pharmaceutical ingredient (“API”) with an international supplier.

We also had manufacturing arrangements with a packager who provided finished supplies of the product for commercial and sampling purposes during 2025.

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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 and began shipping the Cumberland-packaged product during 2024.

We received supplies of the product from the new facility in 2023.

We continued to receive supplies of the Cumberland-packaged product during 2024.

As part of the acquisition of Vaprisol, we obtained a significant existing supply of raw material inventory.

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This additional presentation is designed to overcome a barrier at smaller hospitals and infusion centers that use less of the product at a time, allowing them to better manage their costs and the workflow associated with the product.

Our contract manufacturer for Vibativ continued to provide supplies of the product in 2025.

Like many pharmaceutical companies, we engage a third-party with appropriate facilities and logistical expertise to support the U.S.

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On March 19, 2013, the USPTO issued U.S.

Patent number 8,399,445 (the “445 Acetadote Patent”) which is assigned to us.

The claims of the 445 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation to treat patients with acetaminophen overdose.

On April 8, 2013, the 445 Acetadote Patent was listed in the FDA Orange Book.

The 445 Acetadote Patent is scheduled to expire in August 2025.

Following the issuance of the 445 Acetadote Patent we received separate Paragraph IV certification notices from Perrigo, Sagent Pharmaceuticals, Inc., and Mylan challenging the 445 Acetadote Patent on the basis of non-infringement, unenforceability and/or invalidity.

Patent number 8,399,445 (the “445 Acetadote Patent”) which expired in August 2025.

On June 10, 2013, we became aware of a Paragraph IV certification notice from Akorn, Inc.

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On February 18, 2014, the USPTO issued U.S.

Patent number 8,653,061 (the “061 Acetadote Patent”) which is assigned to us.

The claims of the 061 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation to treat patients with acetaminophen overdose.

Following its issuance, the 061 Acetadote Patent was listed in the FDA Orange Book.

The 061 Acetadote Patent is scheduled to expire in August 2025.

Patent number 8,653,061 (the “061 Acetadote Patent”) which expired in August 2025.

On May 13, 2014, the USPTO issued U.S.

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On November 3, 2017, we became aware of a Paragraph IV certification notice from Exela Pharma Sciences, LLC challenging the 356, 445, 738 and 028 Acetadote Patents on the basis of non-infringement.

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.

We have an exclusive, worldwide license to clinical data for intravenous ibuprofen from Vanderbilt University, in consideration for royalty obligations related to Caldolor.

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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 additional patent applications related to Caldolor pending with the USPTO.

We also have an additional patent application related to Caldolor pending with the USPTO.

We own numerous U.S.

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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.

Seven Talicia patents are listed in the FDA Orange Book, the last of which is scheduled to expire in May 2042.

Six of the listed patents include claims that encompass the Talicia drug product.

Talicia received eight years of U.S.

market exclusivity under its Qualified Infectious Disease Product designation, which is scheduled to expire in November 2027.

Remaining Products

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• 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;

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MiraLax was converted to an OTC product in February 2007 and recently, the FDA rescinded the approval of the generic prescription polyethylene glycol 3350 products.

Prescriptions for our Kristalose product are often substituted and filled by one of these generic products.

During the first quarter of 2025, a generic crystalline lactulose product was approved for PAI Pharma, and the product became available during the second quarter of the year.

Sancuso is the only transdermal patch FDA approved for the management of chemotherapy-induced nausea and vomiting (“CINV”).

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While there are no other transdermal products available to treat CINV, there is a large number of generic and branded oral products as well as a limited number of injectables.

Cumberland considers the oral branded products to be the most important competition including Akynzeo;

Cumberland considers the oral branded products to be the most important competition including Akynzeo ® (manufactured by Helsinn Therapeutics);

Emend ® Oral (manufactured by Merck);

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Zuplenz ® (a branded version of Ondansetron marketed by Par Pharmaceuticals, Inc.) and Kytril ® (a branded version of injectable granisetron hydrochloride manufactured by Roche Pharmaceuticals Inc.).

Talicia is a unique three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin -class antibacterial, and rifabutin, a rifamycin antibacterial indicated for the treatment of H.

pylori in adults.

All three drugs are contained in each capsule.

Talicia is administrated by four (4) capsules three times per day with food for 14 days.

The primary competition consists of a variety of regimens including dual, triple, and quadruple therapy combinations of antibiotics and acid reducers.

Most of these regimens require multiple prescriptions, copays, and dosing schedules, and all constituents are generic, with the acid reducer often being a separate OTC.

Branded, prepackaged combination products includes Voquezna ® Triple Pak ® (vonoprozan/amoxicillin/clarithromycin) and Voquezna Dual Pak ® manufactured and sold by Phathom Pharmaceuticals.

Antibiotic resistance and patient compliance are the biggest challenges to eradicating H.

Talicia has zero to minimal resistance to its two antimicrobial components and does not contain clarithromycin.

Its all-in-one formulation supports patient compliance as it only requires one prescription and one bottle of medication.

Talicia is also listed as a first-line empiric treatment option for H.

pylori in the 2024 American College of Gastroenterology Guidelines.

Vaprisol is a patented, prescription brand indicated to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia.

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Once the NDA is validated and accepted for filing, the FDA begins an in-depth review of the NDA.

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.

The review process and the PDUFA goal date may be extended by two months to address deficiencies, or by three months if the FDA requests or if the NDA sponsor otherwise provides additional information or clarification regarding information already provided in the submission at any time during the review clock period.

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Prior to submitting a marketing application for its drug, a sponsor that plans to request a rare pediatric disease PRV may request rare pediatric disease designation.

On November 6, 2024, the FDA granted Rare Pediatric Disease Designation to Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy.

Section 505(j) abbreviated new drug applications

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The Cures Act enhances the FDA’s ability to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

Specifically, the Cures Act enables us to work with the FDA in the development of new biomarkers, clinical outcome assessments, surrogate endpoints and patient reported outcomes.

It allows for the use of data summaries (rather than full clinical trials for approval) as well as the use of real-world evidence to support approval of new indications of approved medical products, or to help satisfy post-approval study requirements for marketed products.

Post Approval Activities

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

What changed 10-K

Item 1. Business