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Item 1. Business

2025-03-07 compared with 2024-03-13 · 213 added, 208 removed, 742 unchanged (36% of the section changed)

Cumberland Pharmaceuticals Inc.

(“Cumberland,” the “Company,” or as used in the context of “we,” “us,” or “our”), is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription pharmaceutical products.

We are dedicated to providing innovative products that improve the quality of care for patients and address poorly met medical needs.

("Cumberland," the "Company," or as used in the context of "we," "us," or "our"), is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription pharmaceuticals.

We are dedicated to our mission of working together to provide unique products that improve the quality of patient care.

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 while we continue to build 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.

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.

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

• Omeclamox ® -Pak , ( omeprazole, clarithromycin, amoxicillin ) oral, for the treatment of Helicobacter pylori ( H.

pylori ) infection and related duodenal ulcer disease;

• 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 1) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, 2) 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 and 3) patients with Idiopathic Pulmonary Fibrosis (“IPF”), the most common form of progressive fibrosing interstitial lung disease.

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.

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.

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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 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.

During the year we took a fresh look at our mission statement and refined it to better capture the spirit of what we do each day at Cumberland.

Our mission is now:

working together to provide unique products that improve the quality of patient care.

In designing this statement, we considered several factors.

First, we wanted our mission to address the constituencies we serve, which include patients in need of care, as well as health care providers, our employees, shareholders, partners and community.

We also sought to reflect Cumberland’s culture, where teamwork is prized, emphasized and expected – in order to achieve our goals.

Next, it needed to demonstrate our focus on developing, acquiring and distributing differentiated brands.

And finally, we wanted to emphasize that the patient is at the core of everything we do.

Our collective efforts are directed at providing unique products that serve as better alternatives for poorly met medical needs.

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 2023 sustainability metrics reveal that during that year we provided 3 million patient doses of our products, while safely disposing of nearly 6,000 pounds of expired and damaged products.

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.

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Additional Information

We were incorporated in 1999 and have been headquartered in Nashville, Tennessee since inception.

We were incorporated as a Tennessee corporation in 1999 and have been headquartered in Nashville, Tennessee since inception.

During 2009, we completed an initial public offering of our common shares and listing on the Nasdaq stock exchange.

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Chronic and Acute Constipation Marketed

Omeclamox ® -Pak

pylori Infection and Related Duodenal Ulcer Disease Approved

Nausea and Vomiting Associated with Chemotherapy Marketed

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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.

Acetaminophen overdose continues to be a leading cause of poisonings reported by hospital emergency departments in the U.S., and Acetadote has become a standard of care for treating this potentially life-threatening condition.

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.

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The FDA subsequently approved updated labeling for Acetadote revising the product’s indication and providing new dosing guidance for specific patient populations.

As a result, dosing guidance is now 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.

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.

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.

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By ruling in Cumberland’s favor, the court upheld the validity of the patent that encompasses our EDTA-free formulation.

The court also granted a permanent injunction preventing challengers from marketing a generic version of our proprietary Acetadote product formulation before the expiration of Cumberland’s patent in

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

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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.

The new, premixed presentation provides health care professionals a formulation that is easy to administer, helping manage the treatment of patient pain and fever, while reducing opioid consumption.

The new, premixed presentation provides health care professionals with a formulation that is easy to administer, helping manage the treatment of patient pain and fever, while reducing opioid consumption.

It is provided in a pre-mixed bag containing 800 mg of ibuprofen in a 200 mL patented low sodium formulation for injection that is ready to use.

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In November 2021, the FDA approved our submission to expand the labeling for Caldolor to include administration of the product prior to surgery.

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

During 2022, we distributed both the vial and the ready-to-use premixed bag presentations of Caldolor.

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.

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

In addition, we reported that we expect Caldolor will be eligible for special Medicare reimbursement under the new Non-Opioids Prevent Addiction in the Nation Act (the “NOPAIN Act”), which was enacted as part of the Consolidated Appropriations Act of 2023.

The NOPAIN Act requires Medicare to provide separate and more favorable reimbursement for non-opioid products that are used to manage pain during surgeries conducted in hospital outpatient departments or ambulatory surgical centers.

In the Medicare Hospital Outpatient Prospective Payment System Proposed Rule, the Centers for Medicare and Medicaid Services (“CMS”) requested that manufacturers with potentially applicable non-opioid products submit comments and supporting clinical evidence regarding products that should be eligible for separate payment.

We submitted a comment letter along with the requisite clinical information to the CMS in September of 2023 explaining why Caldolor should be included and separately reimbursed.

We now await further information from CMS expected this year, including the potential new reimbursement level for Caldolor.

The Act is scheduled to go into effect in early 2025 and will initially apply to those products that are furnished between January 1st, 2025 and January 1st, 2028.

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.

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.

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.

During 2024, we distributed both the vial and the ready-to-use premixed bag presentations of Caldolor.

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

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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.

New York state recently added Kristalose to its Medicaid formulary, and we are implementing a special initiative to increase our presence and share of voice in the state.

We believe that this new coverage is contributing to the growth of the product.

Omeclamox ® -Pak

Many ulcers of the gastrointestinal tract are caused by an infection from the Helicobacter pylori (“H.

pylori”) bacterium.

Omeclamox-Pak is a branded prescription product used for the treatment of these infections and the related duodenal ulcer disease.

This innovative product combines three well-known and widely prescribed medications:

omeprazole, clarithromycin and amoxicillin.

Omeclamox-Pak was the first FDA-approved triple therapy combination medication to contain omeprazole as the proton pump inhibitor, which works to decrease the amount of acid the stomach produces.

Clarithromycin and amoxicillin are both antibiotic agents that hinder the growth of the H.

pylori bacteria.

Interaction of these agents allows the stomach lining to heal effectively.

The medications are packaged together on convenient daily dosing cards, making it simple to follow the twice a day dosing before meals.

We acquired the assets and exclusive rights to Omeclamox-Pak through a series of transactions and re-launched the product as a Cumberland brand supported by our field sales force.

The packager for Omeclamox-Pak encountered financial difficulties in 2020 due to the impact of COVID-19, and their operations are currently suspended.

As a result, we depleted our inventory of the product and notified the FDA that the product is currently unavailable.

That facility is now under new ownership and new management.

We are awaiting resumption of their operations, while also exploring other alternatives to restart the product’s packaging.

Given the delay in identifying a packager for Omeclamox-Pak, as a precaution, the Company has taken a non-cash write down of the related intangible asset of $ 3.3 million.

The financial statements reflect this adjustment.

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.

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– including its marketing, promotion, distribution, manufacturing and medical support activities.

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

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.

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We also successfully transferred manufacture of the product to a new facility.

Following FDA approval of that site, we have now received new supplies of Cumberland-packaged product, which we will begin shipping this year.

Following FDA approval of that site, we introduced our newly Cumberland-packaged product in 2024, supported by our expanded 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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Our new manufacturing partner is working with the FDA to address several Form 483 and warning letter issues in a timely manner.

Meanwhile, we have been working with them to support a special, interim supply of compounded product for critically ill patients, which we introduced to the market in late 2023 and will begin selling in early 2024.

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

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.

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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.

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

They are working toward the approval and believe that there is significant potential for Vibativ in their country.

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

Ifetroban Clinical Studies

Ifetroban is a selective thromboxane-prostanoid receptor (“TPr”) antagonist dosed in nearly 1,400 subjects and found to be safe and well tolerated in healthy volunteers and various patient populations.

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

We have three 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, 2) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy , a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles and 3) 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.

We 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.

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.

Following is more information about the clinical programs in which we are evaluating ifetroban:

Systemic Sclerosis (“SSc”)

We have initiated the clinical development of ifetroban oral capsules under the brand name Vasculan ® for the treatment of Systemic sclerosis , also called scleroderma.

It’s a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, including the heart, as well as vascular dysfunction.

SSc has a high morbidity and 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.

Although several medications are used to treat the skin disease associated with SSc, there is no universally effective treatment to improve the function of affected internal organs including the cardiovascular system.

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

Despite the cardiovascular events associated with its elevated mortality at later stages of the disease, overt signs are suggestive of advance disease including myocardial or pericardial inflammation, heart failure and pulmonary arterial hypertension (“PAH”).

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

The FDA cleared our IND application to evaluate 12 months of oral ifetroban (Vasculan) in a 34-subject phase II trial entitled, A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients with Diffuse Cutaneous Systemic Sclerosis or Systemic Sclerosis-Associated Pulmonary Arterial Hypertension.

This study is well underway and includes patients with diffuse cutaneous SSc, as well as those with pulmonary arterial hypertension associated with their SSc.

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”)

We also initiated the clinical development of oral ifetroban under the brand name Dyscorban ® for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy, a rare and fatal disease caused by a genetic defect which leads to inexorable muscle damage.

Cardiomyopathy is the leading cause of death in DMD patients.

TPr and its ligand, isoprostanes, are found to have increased in DMD patients.

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 cleared Cumberland’s IND application to evaluate 12 months of oral ifetroban (Dyscorban) in a Phase II study entitled, A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study with an Open-Label Extension to Determine the Safety, Pharmacokinetics and Efficacy of Oral Ifetroban in Subjects with Duchenne Muscular Dystrophy .

With medical centers across the U.S.

screening patients, our clinical study is enrolling those with 48 ambulatory and non-ambulatory DMD, 7 years of age and older with stable cardiac function.

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

As a result of the COVID-19 pandemic and its global impact on clinical research in 2020, the FDA awarded a supplemental grant in support of our Phase II DMD study.

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 September 2021, our Board of Directors approved a new clinical program for the use of ifetroban to treat Progressive Fibrosing Interstitial Lung Diseases (“PF-ILDs”).

Nonclinical studies are complete, and the resulting manuscript was prepared and submitted for publication in 2021.

In May 2023, we announced that the FDA cleared the IND application for a Phase II study in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.

As a result, we are in the process of initiating our FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S.

This Phase II clinical trial will study the safety, tolerability and efficacy of oral ifetroban in patients with IPF.

Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.

Other Ifetroban Programs

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

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

Our plan going forward is to complete each of our Company-sponsored studies, analyze their final data, announce top-line results and decide on the best development path for the registration of ifetroban, which we continue to believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.

FDA Fee Waivers

During 2023, the FDA informed us that it had granted two barrier-to-innovation waivers that would result in refunds totaling approximately $2.8 million that we had previously paid for prescription drug program fees.

The FDA granted each waiver after concluding that Cumberland met the statutory criteria based on the innovation associated with its ifetroban clinical development programs, as the funds could be better used to advance those studies.

We received both refunds in June 2023.

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.

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 feature seven products approved by the FDA in the United States.

We are also continuing to explore international partnerships to bring our medicines to patients in other countries.

Additionally, we look for opportunities to expand our products into additional patient populations through clinical trials, new presentations and our support of select, investigator-initiated studies.

We actively pursue opportunities to acquire additional marketed products as well as late-stage development product candidates in our target medical specialties.

Our clinical team is developing a pipeline of new product candidates to address poorly met medical needs.

We are supplementing these activities with the earlier-stage drug development at Cumberland Emerging Technologies (“CET”), our majority-owned subsidiary.

CET partners with academic research institutions to identify and support the progress of promising new product candidates, which Cumberland could further develop and commercialize.

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.

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.

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:

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

We will continue to explore such opportunities to bring our products to new patient populations.

• Selectively adding complementary brands.

In addition to our product development activities, we are also seeking to acquire products or late-stage development product candidates to continue to build a portfolio of complementary brands.

We focus on under-promoted, FDA-approved drugs as well as late-stage development products that can improve patient care.

We will continue to target product acquisition candidates that are competitively differentiated, have valuable intellectual property or other protective features, and allow us to leverage our existing infrastructure.

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 seek under-promoted, FDA-approved drugs as well as late-stage development products that can improve patient care.

We will continue to target product acquisition candidates that are competitively differentiated and have valuable intellectual property or other protective features.

Our acquisitions of Vibativ and Sancuso are examples of the implementation of this strategy.

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We believe it is important to build a pipeline of innovative new product opportunities, as we are doing through our ifetroban Phase II development programs.

We are also supplementing our acquisitions and late-stage development activities with early-stage drug development activities with CET.

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 look for strategic 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 and Sancuso across the U.S.

We also look for strategic 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, to cover the U.S.

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

market for our products.

We are also building a network of select international partners to register our products and make them available to patients in their countries.

We will continue to develop and expand our network of international partners while supporting our partners’ registration and commercialization efforts in their respective territories.

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.

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We continually work to manage our expenses in line with our revenues, to deliver positive cash flow from operations.

We remain in a strong financial position, with favorable gross margins and a strong balance sheet.

We seek to maintain favorable gross margins and a strong balance sheet.

SALES AND MARKETING

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• Hospital market:

We promote Caldolor, Vaprisol, Acetadote and Vibativ through our dedicated hospital sales division.

We promote Caldolor and Vibativ through our dedicated hospital sales division.

This organization targets key hospitals across the U.S.

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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 under-served and highly concentrated, and that it can be penetrated effectively by a small, dedicated sales force without large-scale promotional activity.

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.

Our established position in the hospital market provided the rationale for adding Vibativ as our first infectious disease product that complements our hospital product line.

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• Gastroenterology market:

We promote Kristalose and Omeclamox-Pak through a dedicated field sales team addressing a targeted group of physicians who are large prescribers of the products.

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.

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.

We also believe that we can increase market share for these products through our sales and marketing activities.

We also believe that we can increase market share for Kristalose through our co-promotion and marketing initiatives.

• Oncology market:

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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 cancer patients, helping them tolerate their chemotherapy treatments.

The division is comprised of 12 individuals, including four inside reps.

This group can be expanded through additional personnel or augmented through co-promotion partners.

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.

The evaluations include development of product profiles, testing of the profiles against the needs of the market, determining what additional product information or development work is needed to effectively market the products and preparing financial forecasts.

We utilize professional branding and packaging as well as promotional items to support our products, including direct mail, sales brochures, journal advertising, educational and reminder leave-behinds, patient educational pieces, coupons and product sampling.

We utilize professional branding and packaging as well as promotional items to support our products, including direct mail, promotional aides, journal advertising, educational and reminder leave-behinds, patient educational pieces, coupons and product sampling.

We also regularly attend select medical meetings and trade shows to expand the awareness of our products.

Our national accounts team is responsible for key large buyers and related marketing programs.

This team maintains relationships with our wholesaler customers as well as with third-party payors, such as group purchasing organizations, pharmacy benefit managers, hospital buying groups, outpatient centers, state and federal government purchasers, and health insurance companies.

We also maintain relationships with our wholesaler customers, third-party payors, group purchasing organizations, pharmacy benefit managers, hospital buying groups, outpatient centers, state and federal government purchasers, and health insurance companies.

MATERIAL CUSTOMERS

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Caldolor South Korea Marketed

Sandor Medicaids Pvt.

Caldolor India Marketed

R-Pharm JSC Vibativ Russia and CIS Marketed

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WinHealth Pharma Group Co.

Acetadote China and Hong Kong Development

Acetadote & Caldolor China and Hong Kong Development

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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During 2024, we worked with them to prepare the submissions for the approval of each brand there.

They are currently awaiting the approval of Vibativ in their country.

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.

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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 Pharma”) has licensed our Vibativ product for a territory that includes Russia and a number of adjacent countries in Eastern Europe.

R-Pharma is one of the leading multinational pharmaceutical organizations based in Russia.

Headquartered in Moscow and focusing on a wide breadth of therapeutic areas in the specialty and hospital care markets, R-Pharma generates $1 billion in annual revenue.

R-Pharma has registered Vibativ in Russia and during 2023, continued to purchase supplies of the product for that market.

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-Pharm is one of the leading multinational pharmaceutical organizations based in Russia.

Headquartered in Moscow, R-Pharm focuses on a wide breadth of therapeutic areas in the specialty and hospital care markets.

R-Pharm has registered Vibativ in Russia and during 2024, continued to purchase supplies of the product for that market.

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 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 are working toward the approval, responding to regulatory inquiries, and believe that there is significant potential for Vibativ in their country.

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”).

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

They are currently updating their product approval in Saudi Arabia with new manufacturing information.

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.

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

They are currently preparing their submission for the approval of Caldolor in their country.

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

Poly Co-Promotion Agreement

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We renewed our agreement with Foxland in 2022.

Nordic License Agreement

In July 2022, we entered into an amendment to our agreement with Nordic Pharma (“Nordic”) that addressed the responsibilities and financial arrangements regarding our license to Nordic’s methotrexate line of products for the U.S.

Our line of prefilled methotrexate syringes, marketed under the brand name RediTrex in the U.S., was covered by the license.

As of July 1, 2023, Nordic has assumed responsibility for the product in the U.S.

Following the return of the license, Nordic will provide us with a royalty on their future sales of the products through April 2035.

The companies will continue to collaborate on any transition and the ongoing commercialization of the product line.

Cumberland transferred the marketing authorization associated with the RediTrex product line to Nordic.

They returned the 180,000 shares we issued to them that were associated with the license and refunded the $1 million we paid them following the brand’s approval in the U.S.

Nordic has also issued a credit note in favor of Cumberland in the amount of $1 million for the unpaid milestone payment due from us which was associated with our launch of the product line.

CET University Collaboration Agreements

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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

We have in-house capabilities for the management of our clinical, professional and regulatory affairs.

Our team develops and manages our clinical trials, prepares regulatory submissions, manages ongoing product-related regulatory responsibilities and manages our medical information call center.

Team members have been responsible for devising the regulatory and clinical strategies for all our products as well as obtaining FDA approvals for Acetadote and Caldolor brands.

We maintain robust in-house capabilities for the management of clinical, regulatory and quality affairs, demonstrating our commitment to excellence in drug development and compliance.

Our experienced team develops and manages clinical trials, prepares regulatory submissions, oversees product-related regulatory responsibilities and operates our medical information center.

This team has successfully devised regulatory and clinical strategies for our product portfolio, including obtaining FDA approvals for Acetadote and Caldolor brands.

Clinical Development

Our clinical development personnel are responsible for:

• creating clinical development strategies;

• designing, implementing and monitoring our clinical trials;

• creating case report forms and other study-related documents;

• analyzing efficacy and safety data obtained from clinical trials for subsequent submissions and approval of new drugs.

• 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.

Regulatory and Quality Affairs

Our internal regulatory and quality affairs team is responsible for:

• preparing and submitting INDs for clearance to begin patient studies;

• preparing and submitting NDAs and fulfilling post-approval marketing commitments;

• maintaining investigational and marketing applications through the submission of appropriate reports;

• submitting supplemental applications for additional label indications, product line extensions and manufacturing improvements;

• evaluating regulatory risk profiles for product acquisition candidates, including compliance with manufacturing, labeling, distribution and marketing regulations;

• monitoring applicable third-party service providers for quality and compliance with current Good Manufacturing Practices (“GMPs”), Good Laboratory Practices (“GLPs”), and Good Clinical Practices (“GCPs”), and performing periodic audits of such vendors;

• maintaining systems for document control, product and process change control and customer complaints.

• 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.

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

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aureus pathogen.

Caldolor Newborn Study and Clinical Manuscripts

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.

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The results of this study support the growing body of evidence that demonstrates Caldolor is a safe therapeutic option available to practitioners for the treatment of fever and pain in infants, children and adults.

In 2024, we announced the publication of new real-world outcomes research involving 150,000 patients, which compared our Caldolor to its key competitor – ketorolac.

The results provided compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions and also improved healthcare utilization.

Additionally, in March of 2024, a Caldolor Special Report 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.

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.

Ifetroban Phase II Studies

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

common form of progressive fibrosing interstitial lung disease.

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.

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.

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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”), 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.

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.

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We also had manufacturing arrangements with a packager who provided finished supplies of the product for commercial and sampling purposes during 2024.

Omeclamox ® -Pak

The packager for Omeclamox-Pak encountered financial difficulties in 2020 due to the impact of COVID-19, and their operations are currently suspended.

As a result, we depleted our inventory of the product and notified the FDA that the product is currently unavailable.

That facility is now under new ownership and new management.

We are awaiting resumption of their operations, while also exploring other alternatives to restart the product’s packaging.

With uncertain future cash flows, the Board of Directors approved the write-down of the intangible assets related to the product.

As part of the acquisition of Sancuso, we obtained an initial supply of finished goods inventory.

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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 will begin shipping the Cumberland-packaged product during 2024.

We received supplies of the product from the new facility in 2023 and began shipping 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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Our new manufacturing partner is working with the FDA to address several Form 483 and warning letter issues in a timely manner.

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

They have successfully produced Vaprisol in their facility and we look forward to relaunching the brand once the FDA clears our submission to manufacture it in the new facility.

Meanwhile, our partner is providing a special supply of compounded product in support of critically ill patients.

Through our acquisition of Vibativ, we obtained a multi-year supply of raw material, work in process and finished goods inventory.

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We completed the transfer of the product’s manufacturing activities to a new supplier and received FDA approval for that facility.

During 2024, we launched a new, smaller package for our Vibativ product.

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.

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 December 11, 2014 and March 3, 2015, we became aware of Paragraph IV certification notices from Aurobindo Pharma Limited and Zydus Pharmaceuticals (USA) Inc., respectively, challenging the 356, 445, 061 and 738 Acetadote Patents on the basis of non-infringement.

On February 10, 2015, the USPTO issued U.S.

Patent number 8,952,065 (the “065 Acetadote Patent”) which is assigned to us.

The claims of the 065 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation to treat patients with acute liver failure.

The 065 Acetadote Patent is scheduled to expire in August 2025.

On September 30, 2015, the United States District Court for the Northern District of Illinois, Eastern Division (“District Court”) ruled in our favor in our lawsuit against Mylan for infringement of the 445 Acetadote Patent.

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On September 22, 2015, the USPTO issued U.S.

Patent number 9,138,404 (the “404 Caldolor Patent”) which is assigned to us.

Patent number 9,138,404 (the “404 Caldolor Patent”) which is

assigned to us.

The claims of the 404 Caldolor Patent include methods of treating pain in critically ill patients with intravenous ibuprofen.

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Following its issuance, the 284 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2029.

On November 7, 2023, the USPTO issued U.S.

Patent number 11,806,400 (the “400 Caldolor Patent”) which is assigned to us.

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 additional patent applications related to Caldolor pending with the USPTO.

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These patents were acquired in our November 2018 acquisition of certain product rights, intellectual property and related assets of Vibativ from Theravance.

Two Vibativ patents are listed in the FDA Orange Book.

Patent number 7,531,623 (the “623 Vibativ Patent”) 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.

We are the owner of U.S.

Patent number 7,608,282 (the “282 Sancuso Patent”) for Sancuso.

This patent was acquired in our December 2021 acquisition, which closed in January 2022.

The patent is of certain product rights, intellectual property and related assets of Sancuso from Kyowa Kirin, Inc.

The 282 Sancuso Patent is listed in the FDA Orange Book and is scheduled to expire in January 2025.

The 282 Sancuso Patent includes composition of matter claims that encompass the Sancuso drug product as well as methods of using Sancuso for treatment and/or prophylaxis.

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 Vaprisol, Omeclamox-Pak or Kristalose products.

We have no issued patents for our Sancuso, Vaprisol or Kristalose products.

We have multiple granted patents relating to our ifetroban products and patent applications pending with the USPTO.

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Our branded Acetadote now competes with both the EDTA-free Authorized Generic Acetadote distributed by Paddock and Perrigo along with generic Acetadote products that contain EDTA.

Manufacturers of the old Acetadote formulation include:

Akorn, AuroMedics Pharma, Fresenius Kabi and Sagent Pharmaceuticals.

There are multiple manufacturers of injectable NAC products that are based on our old formulation.

Caldolor is marketed for the treatment of pain and fever, primarily in a hospital or surgery center setting.

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• Oliceridine injection (brand name Olinvyk ® ), is an opioid agonist, a new chemical entity in the acute surgical postoperative pain market, sold by Trevena, Inc.;

• Bupivacaine injectable suspension (brand name Exparel ® ), product sold by Pacira Pharmaceuticals, Inc., along with two additional bupivacaine products, Xaracoll and Posimir,which were more recently approved;

• Bupivacaine injectable suspension (brand name Exparel ® ), a product sold by Pacira Pharmaceuticals, Inc., along with two additional bupivacaine products, Xaracoll and Posimir, which were more recently approved;

• Acetaminophen and ibuprofen combination injection (brand name Combogesic ® ), is a combination of acetaminophen and ibuprofen approved by the U.S.

FDA in October 2023, and is sold by Hikma Pharmaceuticals PLC.

• Suzetrigine oral tablets (brand name Journavx ® ), a product sold by Vertex Pharmaceuticals, Inc., a non-opioid pain signal inhibitor approved by the U.S.

FDA in January 2025.

We are aware of other product candidates in development to treat acute pain, including injectable NSAIDs, novel opioids, new formulations of existing therapies and extended release anesthetics.

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and was recently approved by the FDA.

• Vibrant Gastro (brand name Vibrant ® ) an orally administered drug-free capsule to enhance colonic motility via mechanical stimulation of the colon.

There are several hundred OTC products used to treat constipation marketed by numerous pharmaceutical and consumer health companies.

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• 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;

• Ceftobripole (brand name Zevetera), an injectable antibiotic registered in 2024 by Basilea.

We are also aware of a number of other novel antibiotics that are currently in development.

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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”).

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”).

GOVERNMENT REGULATION

The development of new pharmaceutical products can be a long, expensive and risky process.

There is no assurance we will obtain successful study results or secure the needed market approvals for our pipeline product candidates.

There is no assurance we will obtain successful study results or secure the market approvals needed for our pipeline product candidates.

Governmental authorities in the U.S.

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and (3) adequacy of manufacturing methods to assure the drug's identity, strength, quality and purity.

The FDA and associated regulations detail the requirements at each step.

The FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition.

Those mechanisms include accelerated approval, fast track and priority reviews and the newer designation, breakthrough therapy.

The sponsor of the drug typically conducts human clinical trials in three sequential phases, but the phases may overlap.

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The FDA may order the partial, temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients.

The institutional review board ("IRB"), or ethics committee (outside of the U.S.), of each clinical site generally must approve the clinical trial design and patient informed consent and may also impose other conditions or require the clinical trial at that site to be halted, either temporarily or permanently, for failure to comply with the IRB's requirements.

Each clinical site that conducts a trial must obtain institutional review board ("IRB"), or ethics committee (outside of the U.S.), approval of the clinical trial design and patient-informed consent , and may also impose other conditions or require the clinical trial at that site to be halted, either temporarily or permanently, for failure to comply with the IRB's requirements.

The results of the nonclinical and clinical trials, together with detailed information on the manufacturing and composition of the product and proposed labeling, are submitted to the FDA in the form of an NDA for marketing approval.

The NDA undergoes a 60-day validation review period before it is accepted for filing.

The FDA and associated regulations detail the requirements at each step.

The FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition.

Those mechanisms include accelerated approval, fast track and priority reviews, and the newer designation, breakthrough therapy.

If the NDA is found to be incomplete, it will not be accepted.

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If not, a complete response letter will be sent to applicants indicating that the review cycle for an application is complete and that the application is not ready for approval.

The complete response letter will describe the specific deficiencies that the agency has identified in an application and what changes must be made before the application can be approved, with no implication regarding

whether the application will ultimately be approved.

An approval letter authorizes commercial marketing of the drug for the proposed indication(s) under study.

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Acetadote was entitled to marketing exclusivity until January 2011 for the treatment of this approved indication.

We also received orphan drug designation for Ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy in 2024.

Rare pediatric disease designation and priority review vouchers (“PRV”)

The rare pediatric disease PRV program aims to incentivize drug development for rare pediatric diseases.

To be eligible for a voucher, the drug should be (1) approved for a rare pediatric disease and (2) treat or prevent a serious or life-threatening manifestation of the disease or condition that affects children.

These serious or life-threatening manifestations may be the manifestations that primarily affect children, but they are not required to be, so long as the approved indication is clinically meaningful to pediatric patients with the disease or condition.

Under this voucher program, a sponsor who receives an approval for a drug or biological product for a rare pediatric disease may qualify for a voucher that can be redeemed to receive priority review for a different product.

The sponsor may also transfer or sell the voucher to another sponsor.

FDA awards rare pediatric disease PRVs to sponsors of rare pediatric disease products that are approved and meet certain criteria.

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.

Section 505(j) abbreviated new drug applications

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The annual fee is allocated to companies based on their previous calendar-year market share using sales data that the government agencies that purchase the pharmaceuticals will provide to the Treasury Department.

Although we participate in governmental programs that subject us to this fee, our sales volume in such programs is less than $10 million, with the first $5 million of sales being exempt from the fee.

Although we participate in government programs that subject us to this fee, our sales volume in such programs is less than $10 million, with the first $5 million of sales being exempt from the fee.

This fee has not had a material impact and is not expected to have a material impact on our results of operations.

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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.

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.

Under this provision, the FDA considers the following questions in determining whether to grant a public health waiver or reduction in user fees:

(1) Does the product protect the public health?

and (2) Is the waiver or reduction necessary to continue an activity that protects the public health?

In addition, an applicant may qualify for a waiver or reduction in application or program fees when the assessment of the fees would present a significant barrier to innovation because of limited resources available to the applicant or other circumstances.

Under section 736(a)(1)(F) of the FD&C Act, a human drug application for a product that has been designated as a drug for a rare disease or condition (referred to as an orphan drug) under section 526 of the FD&C Act is not subject to an application fee unless the human drug application includes an indication for other than a rare disease or condition.

Physician Payments Sunshine Act:

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Under the Medicaid Drug Rebate program, we currently are required to provide rebates for covered outpatient drugs that are dispensed to Medicaid beneficiaries.

In addition, we also are required to participate in the Public Health Service’s 340B drug pricing program, which requires us to agree to

charge no more than a designated ceiling price for covered outpatient drugs that are dispensed to community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients.

In addition, we also are required to participate in the Public Health Service’s 340B drug pricing program, which requires us to agree to charge no more than a designated ceiling price for covered outpatient drugs that are dispensed to community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients.

Product Serialization:

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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.

Build Back Better Act and Other Proposed Legislation:

The Build Back Better Act (“BBBA”) was introduced in the 117 th Congress and included provisions that were intended to lower the price of prescription drugs, including granting the Medicare program the authority to negotiate prescription drug prices and imposing tax penalties on drug manufacturers if the price of drugs increases too rapidly.

Ultimately the BBBA was not enacted, however, future legislative initiatives are likely to include provisions targeted at containing costs in the prescription drug market.

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