What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-09 compared with 2024-11-08 · 124 added, 265 removed, 158 unchanged (71% of the section changed)

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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 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 Phase II clinical studies in each of these areas.

Cumberland has built core competencies for the acquisition, development and commercialization of pharmaceutical products, and we believe we can leverage this existing infrastructure to support our growth.

In addition to these commercial brands, we recently completed a Phase II study 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.

The 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.

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.

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.

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

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

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

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.

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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.

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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 are also working with a network of established international partners to register our products and make them available to patients in their countries.

We will continue to support our partners’ registration and commercialization efforts in their respective territories.

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RECENT DEVELOPMENTS

State Medicaid Coverage for Kristalose Grows

We continue to see that Kristalose, our prescription-strength laxative, performs best in states where we have Medicaid coverage, such as Texas, New York and Wisconsin.

The product is now also covered on certain Virginia, Louisiana and Maine Medicaid plans.

We are encouraged to see the positive impact on our business as more states provide favorable Medicaid coverage for Kristalose and we will continue working to increase awareness in those states.

New WHO Report Highlights Need for Antibiotics like Vibativ

A new report from the World Health Organization ("WHO") found that antimicrobial resistance is an urgent global health and socioeconomic crisis.

Further, the worldwide rise in antibiotic resistance poses a significant threat, diminishing the efficacy of many common antibiotics against widespread bacterial infections.

Unlike many antibiotics that are losing the battle to fight bacteria, Vibativ’s unique dual method of action was specifically designed to address drug-resistant bacteria and we therefore believe it has the potential to help many patients amid the growing resistance crisis.

Vibativ can serve as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from infections including the flu and COVID-19.

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

aureus) and other Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus (MSSA ).

Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

Expanded Patient Support for Sancuso

During the third quarter of 2024 we launched a new sampling program for our oncology support medication, Sancuso, that broadens access to the product, allowing more patients to try it and experience its benefits.

We also introduced a new HUB services capability to provide enhanced patient support, ensuring patients receive comprehensive assistance throughout their treatment journey.

Vaprisol Supply Update

Demand for our Vaprisol product increased in 2020 during the COVID-19 pandemic, and we worked to support the expanded use of the product in hospitals and clinics during the health care crisis.

In 2021, we distributed all remaining inventory of the Vaprisol product we possessed and subsequently notified the FDA that supplies of the product are not currently available.

We have since transferred the manufacturing of the product to a new facility.

Our new manufacturing and distribution partner is working with the FDA to address several Form 483 issues in a timely manner.

As we await FDA approval for making the branded product there, our manufacturer is providing a special supply of compounded product in support of critically ill patients.

The companies share in the sales of this compounded product.

Vaprisol is the first and only intravenously administered vasopressin receptor antagonist.

It is used to raise serum sodium levels in hospitalized patients with hyponatremia, the most common electrolyte disorder among such patients.

Federal NOPAIN Act

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

This Act requires Centers for Medicare and Medicaid Services (“CMS”) to provide separate reimbursement for non-opioid products that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers.

The NOPAIN Act applies, in part, to products that are indicated to provide analgesia, without acting upon the body’s opioid receptors.

The reimbursement for non-opioid pain alternatives under the NOPAIN Act will apply to those products that are furnished between January 1, 2025, and January 1, 2028.

Cumberland submitted comments to CMS in July 2023 and July 2024, arguing, among other things, that Caldolor meets the statutory requirements for separate payment under the NOPAIN Act because the U.S.

Food and Drug Administration (“FDA”) approved Caldolor for a general acute pain indication that encompasses use for the reduction of postoperative pain based on clinical studies in patients with postoperative pain.

On November 1, 2024, CMS announced a list of products for separate payment under the NOPAIN Act through their Calendar Year 2025 Medicare Outpatient Prospective Payment System (“OPPS”) Ruling .

The list does not include Caldolor.

CMS concluded that Caldolor and certain other products do not qualify for separate payment under the NOPAIN Act because “there is no mention of post-operative or post-surgical use in the FDA-approved indications.”

The Company was surprised and disappointed with this determination, as the majority of Caldolor’s use is associated with surgery and the FDA approval of the product’s pain indication was based on studies of patients with post-surgical pain.

Furthermore, CMS’s November 1 list of products eligible for separate payment under the NOPAIN Act does not appear to add any new pharmaceuticals.

Cumberland does not believe that CMS’s determination regarding Caldolor is consistent with the intent of the NOPAIN legislation.

We are evaluating our potential options, and next initiatives for continuing to seek separate payment for Caldolor.

FDA Approves Acetadote ® sNDA

Cumberland previously announced the FDA approval of a supplemental New Drug Application for Acetadote ® , our IV treatment for preventing or lessening liver injury after ingestion of potentially toxic quantities of acetaminophen.

Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in the United States.

Each year, thousands of individuals experience accidental or intentional acetaminophen poisoning, leading to serious liver damage.

The new 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 effectiveness.

By simplifying the dosing regimen, health care providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes.

New Study Compares Caldolor ® (ibuprofen injection) to ketorolac

We also announced the publication of new real-world outcomes research involving 150,000 patients, which compared our Caldolor ® (ibuprofen) injection to its key competitor – ketorolac – in both adult and pediatric populations.

The study, published in Frontiers of Pain Research , provided compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions (ADRs) and improved health care utilization when compared to ketorolac.

This extensive, retrospective, payer database analysis evaluated the records of over 17 million patients who had received either Caldolor or ketorolac.

Ultimately, 31,046 Caldolor and 124,184 ketorolac adult patients were selected and compared for ADRs and subsequent health care resource utilization, which includes inpatient, outpatient and emergency department visits as well as all procedures and prescriptions during the follow up time of 29 days.

An additional 5,579 pediatric patients were identified in each arm and compared in a separate claims analysis.

Key findings reveal that, in adults, Caldolor was associated with a 45% reduction in renal dysfunction (p<0.001) and a 78% decrease in hematuria rates (p<0.001) when compared to ketorolac.

Notably, patients also experienced fewer gastrointestinal complications as well as reduced headaches, nausea and abdominal pain.

Among pediatric patients, the results showed Caldolor was associated with a 51-65% lower rate of ADRs, including headache and nausea, with 95% confidence intervals supporting clinical significance.

Caldolor also demonstrated a positive impact on health care resource utilization (HCRU) when compared to ketorolac, with decreased emergency room and outpatient visits, as well as a shortened hospital length of stay for both adults and children.

These findings underscore Caldolor’s potential to improve patient care by reducing their treatment complications, while also delivering potential saving for health care systems through decreased hospital readmissions and shortened treatment times.

Ifetroban Clinical Studies

We have been evaluating our ifetroban product candidate, a selective thromboxane-prostanoid receptor antagonist, in a series of clinical studies.

It has now been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in healthy volunteers and various patient populations.

We have three Phase II clinical programs underway evaluating our ifetroban product candidate in patients with 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, 2) cardiomyopathy associated with Duchenne Muscular Dystrophy, a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart, and lung muscles and 3) Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.

This third program is our newest, with enrollment now underway.

We expect to close two of these ifetroban studies this year.

We recently applied for two FDA designations for our Duchenne Muscular Dystrophy product candidate:

1) Orphan Drug Designation , which is granted to products that show promise in the treatment, prevention or diagnosis of rare – or orphan – diseases;

such designation can result in a number of benefits associated with the FDA review process including exclusivity after approval of the product.

2) Rare Pediatric Disease Designation , which is given to products intended to prevent or treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age.

Upon FDA approval, this designation may result in a priority review voucher from the FDA for a different product.

Cumberland subsequently was informed by the FDA that both the Orphan Drug Designation and the Rare Pediatric Disease Designation requests for this candidate have been granted.

In February, we announced positive top-line results from the Phase II study evaluating our ifetroban product candidate in patients with Duchenne muscular dystrophy (DMD).

This marks a breakthrough for these patients, as it is the first successful Phase II study specifically targeting the cardiac complications of their condition.

These study results were selected for a late-breaking presentation in March at the Muscular Dystrophy Association’s Clinical & Scientific Conference.

That platform allowed us to share our promising results with the global DMD community, including leading researchers, clinicians and patient advocates who are working tirelessly to improve outcomes for those affected by this devastating disease.

The next steps for our DMD program include further data analysis and completion of a full study report in preparation for an end-of-Phase-2 meeting with the FDA to determine the requirements for the product’s approval.

We have been evaluating our ifetroban product candidate in a Phase II clinical programs evaluating our ifetroban product candidate in patients with Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs.

Enrollment in the study is now complete, and we are monitoring the clinical sites in preparation to lock the database and begin evaluating the study.

We expect to announce top-line results from this study later this year.

In addition, we have a Phase II clinical program underway in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.

Patient enrollment is now underway in medical centers across the U.S.

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.

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.

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

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

International Agreements

During the third quarter of 2024, PiSA Pharmaceutical, our partner for Caldolor in Mexico, submitted a dossier to COFEPRIS, Mexico’s equivalent to the FDA, for the product’s approval in that country.

Meanwhile, we continue to support our international partners in their efforts to register Vibativ in their countries.

In late 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.

Tabuk has obtained the final approvals needed to commercialize Vibativ in Saudi Arabia and has now begun ordering the product in preparation for its launch planned for this year.

Also in 2022, we entered into an agreement with D.B.

We continue to support our international partners in their efforts to register Vibativ ® in their countries.

We recently learned that our potent antibiotic Vibativ received approval from the regulatory authorities in China.

That milestone provides us with access to the world’s second-largest pharmaceutical market – and we look forward to the launch of our product there.

We previously announced a new partnership with Saudi Arabia-based Tabuk Pharmaceutical to introduce Vibativ into the Middle East.

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

Tabuk has obtained the final approvals needed to commercialize Vibativ in Saudi Arabia.

In late 2024, we began shipping Vibativ there and completed the needed product training to launch the product in that country.

We also entered into an agreement with D.B.

Pharm to register and commercialize our Vibativ product in South Korea.

Pharm also distributes our Caldolor product there.

They filed for the approval of Vibativ in November 2022 and we have been supporting their efforts through the review process of their application in the country.

The Korean regulatory authorities did not approve the submission, and indicated that additional manufacturing information will be required, which we will work with D.B.

Pharm to address.

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 the review of that submission.

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

CET Program Developments

Through our work at CET, we continue to build a long-term pipeline of innovative new biopharmaceutical products.

CET represents a joint initiative among Cumberland Pharmaceuticals Inc., Vanderbilt University, the state-supported Launch Tennessee and an international partner – WinHealth Pharma.

CET’s mission is to bring biomedical technologies and products conceived at Vanderbilt and other regional research centers to the marketplace.

There have been two recent developments among the programs CET is supporting.

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.

Additionally, CET has 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.

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

We have pursued our mission by building a portfolio of FDA-approved brands with outstanding safety and efficacy profiles that can make a difference in patients’ lives.

We continue to build our portfolio of innovative and differentiated products through a multifaceted strategy that includes the development of new candidates, as well as the acquisition of established brands.

We will remain focused on those efforts and look forward to future opportunities to carry out our mission and report on our progress throughout the remainder of the

year and beyond.

They have filed for the approval of Vibativ and we have been supporting their efforts through the review process of their application in the country.

The Korean regulatory authorities did not approve the initial submission, and indicated that additional manufacturing information will be required.

We will work with D.B.

Pharm to address the additional requirements.

Additionally, in late 2024, PiSA Pharmaceutical, our partner for Caldolor in Mexico, completed and submitted a dossier to COFEPRIS, Mexico’s equivalent to the FDA, for the product’s approval in that country.

The pharmaceutical industry is characterized by intense competition and rapid innovation.

Our continued success in developing and commercializing pharmaceutical products will depend, in part, upon our ability to compete against existing and future products in our target markets.

Competitive factors directly affecting our markets include but are not limited to:

• product attributes such as efficacy, safety, ease-of-use and cost-effectiveness;

• brand awareness and recognition driven by sales, marketing and distribution capabilities;

• intellectual property and other exclusivity rights;

• availability of resources to build and maintain developmental and commercial capabilities;

• successful business development activities;

• extent of third-party reimbursements, insurance coverage;

• establishment of advantageous collaborations to conduct development, manufacturing or commercialization efforts.

Our products face competition from other branded products, generics and alternate medical treatments.

Our task is to position each brand to feature its competitive advantages, implement a well-thought-out marketing plan and provide focused sales, field-based medical and other tactical support.

Kristalose is a dry powder crystalline prescription formulation of lactulose indicated for the treatment of constipation.

constipation therapy market includes various prescription and over the counter, or OTC, products.

There are several branded prescription products which we believe are our primary competitors including Amitiza ® , Movantik ® , Linzess ® and Vibrant ® .

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

MiraLax ® (polyethylene glycol 3350), previously a prescription product, was indicated for the treatment of constipation and manufactured and marketed by Bayer.

MiraLax was converted to an OTC product and as a result the FDA rescinded the approval of the generic prescription polyethylene glycol 3350 products.

There are also other lactulose products available in the U.S.

including Constulose, Enulose and Generalac, as well as several generics.

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, available from PAI Pharma.

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

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

tariffs, such exemptions may be removed in the future.

We continue to monitor and evaluate the impacts of tariffs on our business and the results of our operations.

We are entering an exciting time for our Company.

We remain in the early stages of capitalizing on numerous opportunities and expect our momentum to continue.

Our ongoing success can be driven by growth from our approved brands, expanded international partnerships, progress in our clinical development programs and the potential addition of select acquisitions.

We will remain focused on our efforts and look forward to future opportunities to carry out our mission and report on our progress throughout the remainder of the year and beyond.

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

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RESULTS OF OPERATIONS

Three months ended September 30, 2024 compared to the three months ended September 30, 2023

The following table presents the unaudited interim statements of operations for continuing operations for the three months ended September 30, 2024 and 2023:

Three months ended September 30,

Three months ended March 31, 2025 compared to the three months ended March 31, 2024

The following table presents the unaudited interim statements of operations for continuing operations for the three months ended March 31, 2025 and 2024:

Three months ended March 31,

2025 2024 Change

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Total costs and expenses 10,421,108 10,366,951 54,157

Operating loss (1,694,432) (1,866,603) 172,171

Operating income (loss) 1,291,947 (1,869,250) 3,161,197

Interest income 125,709 96,746 28,963

Other income - settlement — 475,000 (475,000)

Other income - insurance proceeds 237,089 346,800 (109,711)

Interest expense (163,802) (118,526) (45,276)

Loss before income taxes (1,525,527) (1,056,281) (469,246)

Income (loss) before income taxes 1,253,854 (1,891,030) 3,144,884

Income tax expense (5,670) (11,442) 5,772

Net loss $ (1,536,969) $ (1,063,219) $ (473,750)

Net income (loss) $ 1,248,184 $ (1,902,472) $ 3,150,656

The following table summarizes net revenues by product for the periods presented:

Three months ended September 30,

Three months ended March 31,

2025 2024 Change

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Net revenues.

Net revenues for the three months ended September 30, 2024, were $9.1 million compared to $10.1 million for the three months ended September 30, 2023.

As detailed in the table above, net revenue increased for two of our marketed products during the third quarter of 2024, Sancuso and Caldolor.

Kristalose revenue was $3.6 million for the third quarter of 2024 and $3.9 million for the same period in the prior year.

The decrease was the result of higher sales deductions.

Net revenues for the three months ended March 31, 2025, were $11.7 million compared to $8.5 million for the three months ended March 31, 2024.

As detailed in the table above, net revenue increased for three of our marketed products during the first quarter of 2025, Kristalose, Sancuso and Acetadote.

Kristalose revenue was $3.5 million for the first quarter of 2025 and $3.2 million for the same period in the prior year.

The increase was the result of sales to our co-promotion partner.

Acetadote revenue includes net sales of our Acetadote brand and our share of net sales from our Authorized Generic.

During the third quarter of 2024, there was a decrease of $0.1 million in the product's revenue when compared to the prior year period due to a decline in shipments.

There were no Vaprisol branded product sales for the third quarter of 2024 as Cumberland is currently out of inventory of the product as we await FDA approval on a new manufacturer.

During the first quarter of 2025, there was an increase of $0.1 million in the product's revenue when compared to the prior year period due to an increase in sales of our Authorized Generic.

There were no Vaprisol branded product sales for the first quarter of 2025 as Cumberland is currently out of inventory of the product as we await FDA approval on a new manufacturer.

The amount represents charges for product returns.

Caldolor revenue was $1.3 million for the third quarter of 2024, compared to $1.2 million for the third quarter of 2023.

The increase results from higher international sales.

Vibativ revenue was $1.0 million for the three months ended September 30, 2024, and $2.8 million for the same prior year period.

Caldolor revenue was $1.3 million for the first quarter of 2025, compared to $1.5 million for the first quarter of 2024.

The decrease results from higher international sales in 2024.

Vibativ revenue was $1.4 million for the three months ended March 31, 2025, and $1.6 million for the same prior year period.

The decrease in net revenue of the product was due to lower sales volume.

Sancuso revenue was $2.6 million for the third quarter of 2024, compared to $1.9 million for the third quarter of 2023 resulting in an increase of $0.7 million.

The increase resulted primarily from increased sales volume, along with lower sales deductions associated with the product.

Other revenue was $0.6 million for the three months ended September 30, 2024, compared to $0.3 million for the three months ended September 30, 2023.

The increase relates to the development funding received from Octapharma in the third quarter of 2024.

Sancuso revenue was $2.3 million for the first quarter of 2025, compared to $1.8 million for the first quarter of 2024 resulting in an increase of $0.4 million.

The increase resulted primarily from increased shipments as well as lower sales deductions associated with the product for the first quarter of 2025.

Other revenue was $3.1 million for the three months ended March 31, 2025, compared to $0.3 million for the three months ended March 31, 2024.

The increase results from a $3 million milestone payment received associated with the approval of Vibativ for the Chinese market.

Cost of products sold .

Co st of products sold for the third quarter of 2024 and 2023 were $1.3 million and $1.8 million, respectively.

Cost of products sold, as a percentage of net revenues, were 14.6% during the three months ended September 30, 2024, compared to 17.5% during the three months ended September 30, 2023.

The decrease is primarily due to the mix of domestic and international products sold.

Co st of products sold for the first quarter of 2025 and 2024 were $1.4 million and $1.6 million, respectively.

Cost of products sold, as a percentage of net revenues, were 12.2% during the three months ended March 31, 2025, compared to 18.5% during the three months ended March 31, 2024.

The favorable percentage decrease is primarily due to milestone payments and higher international sales in 2024 which typically incur higher cost of goods sold as a percentage relative to the lower international revenue on a per unit basis.

Selling and marketing .

Selling and marketing expense for the third quarter of 2024 decreased $0.3 million compared to the same period last year.

This decrease is primarily attributable to a decline in personnel and the related compensation.

Selling and marketing expenses for the first quarter of 2025 were nominally increased by $0.1 million compared to the same period last year.

Research and development .

Research and development costs for the third quarter of 2024 were $1.3 million compared to $1.9 million for the same period in 2023.

The decrease is primarily due to a portion of our research and development costs is variable as we continue to fund the ongoing clinical initiatives associated with our pipeline product candidates.

Research and development costs for the first quarter of 2025 were $1.3 million compared to $1.2 million for the same period in 2024.

The increase is primarily due to a portion of our research and development costs is variable as we continue to fund the ongoing clinical initiatives associated with our pipeline product candidates.

These variable costs depend on the number of active trials, study sites and patients as well as the cost per patient in each of our clinical programs.

In addition, FDA fees are lower in 2024.

General and administrative .

General and administrative expense for the third quarter of 2024 was $2.7 million compared to $2.3 million for the same period in 2023.

The increase is due to higher salaries and contract labor costs.

General and administrative expense for the first quarter of 2025 was $2.5 million compared to $2.4 million for the same period in 2024.

The increase is due to higher compensation expenses.

The components of the statements of operations discussed above reflect the following impacts from Vibativ:

Financial Impact of Vibativ Three months ended September 30,

Financial Impact of Vibativ Three months ended March 31,

Net revenue (1)

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Vibativ contribution $ 3,593,949 $ 849,953

(1) Net revenue includes $1,288 related to other income received.

(1) Net revenue includes $2,975,000 related to a milestone payment received in the three months ended March 31, 2025 and $1,288 related to other income received in the three months ended March 31, 2024.

(2) The Vibativ inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2018.

The components of the statements of operations discussed above reflect the following impacts from Sancuso:

Financial Impact of Sancuso Three months ended September 30,

Financial Impact of Sancuso Three months ended March 31,

Net revenue $ 2,256,294 $ 1,827,769

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Amortization expense is the ratable use of our capitalized intangible assets including product and license rights, patents, trademarks and patent defense costs.

Amortization for the three months ended September 30, 2024 and 2023, totaled approximately $1.1 million and $1.2 million, respectively.

Income taxes .

Income tax expense for the three months ended September 30, 2024 and for the three months ended September 30, 2023 was $0.01 million.

RESULTS OF OPERATIONS

Nine months ended September 30, 2024 compared to the nine months ended September 30, 2023

The following table presents the unaudited interim statements of operations for continuing operations for the nine months ended September 30, 2024 and 2023:

Nine months ended September 30,

2024 2023 Change

Net revenues $ 27,432,376 $ 30,199,441 $ (2,767,065)

Costs and expenses:

Cost of products sold 4,609,499 4,536,628 72,871

Selling and marketing 12,800,469 13,692,535 (892,066)

Research and development 3,523,535 4,569,476 (1,045,941)

General and administrative 7,800,435 7,212,731 587,704

Amortization 3,288,808 3,563,493 (274,685)

Total costs and expenses 32,022,746 33,574,863 (1,552,117)

Operating loss (4,590,370) (3,375,422) (1,214,948)

Interest income 227,777 205,854 21,923

Other income — 2,828,871 (2,828,871)

Other income - settlement — 475,000 (475,000)

Other income - insurance proceeds 237,089 346,800 (109,711)

Interest expense (382,247) (489,069) 106,822

Loss before income taxes (4,507,751) (7,966) (4,499,785)

Income tax expense (34,327) (20,813) (13,514)

Net loss $ (4,542,078) $ (28,779) $ (4,513,299)

The following table summarizes net revenues by product for the periods presented:

Nine months ended September 30,

2024 2023 Change

Kristalose $ 10,935,702 $ 12,313,321 $ (1,377,619)

Sancuso 6,624,102 5,736,981 887,121

Vibativ 5,087,983 6,785,592 (1,697,609)

Caldolor 3,586,199 3,316,866 269,333

Acetadote 144,973 440,071 (295,098)

Omeclamox-Pak (2,574) 28,832 (31,406)

Vaprisol (128,684) 39,866 (168,550)

RediTrex 71,350 (254,108) 325,458

Other revenue 1,113,325 1,792,020 (678,695)

Total net revenues $ 27,432,376 $ 30,199,441 $ (2,767,065)

Net revenues.

Net revenues for the nine months ended September 30, 2024, were $27.4 million compared to $30.2 million for the nine months ended September 30, 2023, a decrease of $2.8 million.

Kristalose revenue was $10.9 million during the first nine months of 2024, compared to $12.3 million for the prior year period.

Revenue decreased due to the result of timing of shipments to one of our co-promotion partners.

Acetadote revenue includes net sales of our Acetadote brand and our share of net sales from our Authorized Generic.

During the nine months ended September 30, 2024, there was a decrease of $0.3 million in the product's revenue when compared to the prior year period due to a decrease in shipments.

Sancuso revenue was $6.6 million for the nine months ended September 30, 2024, compared to $5.7 million for the same period last year.

The increase resulted primarily from reduced sales deductions for product returns.

Vibativ revenue was $5.1 million for the nine months ended September 30, 2024, compared to $6.8 million for the prior year period.

The decrease in net revenue of the product was the result of lower sales volume in 2024.

There were no Vaprisol branded product sales for the nine months ended September 30, 2024 and 2023.

The sales of our compounded product for the current year-to-date period was offset by normal sales deduction adjustments.

Omeclamox-Pak had no sales for the nine months ended September 30, 2024, as Cumberland is currently out of commercial inventory of this product.

The packager for our Omeclamox-Pak product encountered financial difficulties and currently is under new management and a reorganization.

Caldolor revenue was $3.6 million for the nine months ended September 30, 2024, an increase of $0.3 million over the same period in 2023.

Higher international revenue is driving the increase.

Other revenue was $1.1 million for the nine months ended September 30, 2024, representing a $0.7 million decrease from the same period in 2023, as a result of a settlement recognized in 2023.

Cost of products sold .

Co st of products sold for the first nine months of 2024 were $4.6 million, consistent when compared to $4.5 million for the first nine months of 2023.

Selling and marketing .

Selling and marketing expense for the nine months ended September 30, 2024, decreased $0.9 million compared to the prior year period.

This decrease is primarily attributable to the timing of the expenditures.

Research and development .

Research and development costs were $3.5 million for the first nine months of 2024 compared to $4.6 million for the same period last year.

A portion of our research and development costs is variable as we continue to fund the ongoing clinical initiatives associated with our pipeline product candidates.

These variable costs depend on the number of active trials, study sites and patients as well as the cost per patient in each of our clinical programs.

The year over year reduction results from lower FDA fees and consulting expenses in 2024.

General and administrative .

General and administrative expense for the nine months ended September 30, 2024, increased to $7.8 million compared to $7.2 million during the nine months ended September 30, 2023.

The increase is due to higher salaries and contract labor costs.

The components of the statements of operations discussed above reflect the following impacts from Vibativ:

Financial Impact of Vibativ Nine months ended September 30,

Net revenue (1)

$ 5,089,271 $ 7,785,592

Cost of products sold (2)

1,060,584 1,081,001

Royalty and operating expenses 1,378,848 1,738,568

Vibativ contribution $ 2,649,839 $ 4,966,023

(1) Net revenue includes $1,288 related to other income received.

(2) The Vibativ inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2018.

Financial Impact of Vibativ Since Acquisition

Net revenue (1)

Cost of products sold (2)

Royalty and operating expenses 10,295,977

Vibativ contribution $ 30,155,381

(1) Net revenue includes a $1,000,000 payment to Cumberland related to a settlement agreement of milestone payments and $1,288 of other income.

(2) The Vibativ inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2018.

Financial Impact of Sancuso Nine months ended September 30,

Net revenue $ 6,624,103 $ 5,736,981

Cost of products sold (1)

691,358 886,041

Royalty and operating expenses 2,601,815 2,183,209

Sancuso contribution $ 3,330,930 $ 2,667,731

(1) The Sancuso inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2022.

The acquired inventory was completely sold by the end of the second quarter 2024.

Financial Impact of Sancuso Since Acquisition

Net revenue $ 28,276,494

Cost of products sold (1)

Royalty and operating expenses 10,179,664

Sancuso contribution $ 14,647,046

(1) The Sancuso inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2022.

The acquired inventory was completely sold by the end of the second quarter 2024.

Amortization.

Amortization expense is the ratable use of our capitalized intangible assets including product and license rights, patents, trademarks and patent defense costs.

Amortization for the nine months ended September 30, 2024, and nine months ended September 30, 2023, totaled approximately $3.3 million and $3.6 million, respectively.

The decrease was attributable to a reduction to the valuation of Omeclamox acquisition recognized in December 2023.

Amortization for the three months ended March 31, 2025 and 2024, totaled approximately $1.0 million and $1.1 million, respectively.

Income taxes .

Income tax expense for the nine months ended September 30, 2024, was $0.03 million, compared to the income tax expense recognized for the nine months ended September 30, 2023 of $0.02 million.

As of September 30, 2024, we had approximately $51.9 million in federal net operating loss carryforwards including approximately $44.1 million of net operating loss carryforwards resulting from the exercise of nonqualified stock options that have historically been used to significantly offset income tax obligations.

We expect to continue to pay minimal income taxes during 2024 and beyond, through the continued utilization of these net operating loss carryforwards, on any taxable income generated from our operations.

Income tax expense for the three months ended March 31, 2025 and for the three months ended March 31, 2024 was $0.01 million.

LIQUIDITY AND CAPITAL RESOURCES

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We believe that our internally generated cash flows, existing working capital and our line of credit will be adequate to finance internal growth, finance business development initiatives, and fund capital expenditures for the foreseeable future.

The following table summarizes our liquidity and working capital as of September 30, 2024 and December 31, 2023:

September 30, 2024 December 31, 2023

The following table summarizes our liquidity and working capital as of March 31, 2025 and December 31, 2024:

March 31, 2025 December 31, 2024

Cash and cash equivalents $ 15,108,413 $ 17,964,184

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Revolving line of credit availability $ 14,759,267 $ 4,723,830

The following table summarizes our net changes in cash and cash equivalents for the nine months ended September 30, 2024 and September 30, 2023:

Nine months ended September 30,

The following table summarizes our net changes in cash and cash equivalents for the three months ended March 31, 2025 and March 31, 2024:

Three months ended March 31,

Net cash provided by (used in):

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Financing activities (5,526,102) 2,421,694

Net decrease in cash and cash equivalents $ (856,870) $ (1,250,005)

The net $0.9 million decrease in cash and cash equivalents for the nine months ended September 30, 2024, was primarily attributable to cash used in operating activities partially offset by cash provided by financing and investing activities.

Cash used in operating activities totaled $2.5 million for the nine months ended September 30, 2024, primarily due to the $4.5 million net loss, a $1.6 million increase in accounts receivable, a $0.7 million decrease in accounts payable and other accrued liabilities, a $0.9 million decrease in non-cash contingent consideration and a $0.4 million decrease in other long-term liabilities.

This was partially offset by a $3.4 million increase in depreciation and amortization expense, a $1.1 million decrease in inventory and a $1.0 million decrease in other current assets and other assets.

Cash provided by financing activities totaled $1.6 million for the nine months ended September 30, 2024, primarily due to $3.3 million borrowings net on our line of credit, partially offset by the $1.3 million used for the payment of royalties on sales of Vibativ and Sancuso and the $0.5 million in cash used to repurchase shares of our common stock.

Net increase (decrease) in cash and cash equivalents $ (2,855,771) $ 226,861

The net $2.9 million decrease in cash and cash equivalents for the three months ended March 31, 2025, was primarily attributable to $6.8 million of cash used in financing and investing activities, partially offset by $3.9 million of cash provided by operating activities.

Cash provided by operating activities totaled $3.9 million for the three months ended March 31, 2025, primarily due to the $1.2 million net income, adjusted by adding back a $1.2 million decrease in accounts receivable, a $1.0 million decrease in inventory, $0.3 million in amortization of operating lease right-of-use assets and $1.0 million in depreciation and amortization expense, partially offset by deducting a $0.2 million decrease in operating lease liability and a $0.6 million decrease in accounts payable and other current liabilities.

Cash used in financing activities totaled $5.5 million for the three months ended March 31, 2025, primarily due to $10.0 million in payments on our line of credit, $0.5 million for cash settlement of contingent consideration, and $0.2 million in cash used to repurchase shares of our common stock, partially offset by $5.3 million in proceeds from our ATM offering.

Debt Agreement

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OFF-BALANCE SHEET ARRANGEMENTS

During the nine months ended September 30, 2024 and 2023, we did not engage in any off-balance sheet arrangements.

During the three months ended March 31, 2025 and 2024, we did not engage in any off-balance sheet arrangements.

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-Q

Item 2. Management’s Discussion and Analysis