What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-07 compared with 2025-08-08 · 183 added, 130 removed, 262 unchanged (54% 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 recently completed a Phase II study in patients with cardiomyopathy associated with Duchenne muscular dystrophy (“DMD”).

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

pylori infection.

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

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

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

We also have Phase II clinical programs underway evaluating our ifetroban product candidate in patients with 1) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) Idiopathic Pulmonary Fibrosis (“IPF”), the most common form of progressive fibrosing interstitial lung disease.

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

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

Cumberland has built core competencies for the acquisition, development and commercialization of pharmaceutical products in the U.S., and 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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Cumberland’s growth strategy involves maximizing the potential of our existing brands, while continuing to build a portfolio of differentiated products.

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

We currently own rights to seven products approved by the FDA in the United States.

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

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RECENT DEVELOPMENTS

New Product Added to Commercial Product Portfolio

We recently announced arrangements with RedHill Biopharma Ltd.

(“RedHill”) to jointly commercialize Talicia ® , adding the brand to our commercial product portfolio.

The FDA-approved oral capsule is indicated for the treatment of Helicobacter pylori ( H.

pylori ) infection in adults, a bacterial infection and leading risk factor for gastric cancer.

Talicia net revenues were $8 million in 2024.

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

RedHill has assigned all its Talicia related assets to the new company for a 70% ownership position.

Cumberland will provide $4 million in investment capital over a two-year period and receive ownership of the 30% remaining shares.

Cumberland and RedHill have equal board seats and voting rights in the new company, and these arrangements will enable Cumberland to participate in the value it helps create in the brand.

RedHill has also assigned to the new company the international rights to Talicia including existing international licensing agreements, and Cumberland will therefore also benefit from those arrangements, through its 30% ownership.

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

Cumberland will record Talicia product sales and equally share Talicia’s net revenues.

We will also provide an annual investment of up to $2 million to cover certain distribution, marketing and sales costs.

Cumberland will lead the sales promotion for Talicia and will leverage our established field national sales division, which has been detailing Kristalose, to increase the number of patients benefiting from Talicia.

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

Talicia is the only all-in-one treatment containing omeprazole, amoxicillin and rifabutin, and is now recommended as a first-line therapy in the American College of Gastroenterology (ACG) clinical guidelines.

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

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

International Agreements

During the third quarter of 2025, we announced the launch of Vibativ ® in Saudi Arabia.

The product launch follows an agreement with Tabuk Pharmaceutical Manufacturing Company 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 October 2025, our ibuprofen injection product received regulatory approval in Mexico.

We previously announced our partnership with PiSA Farmaceutica, a well-established Mexican pharmaceutical firm.

Under the agreement, PiSA is provided with the exclusive supply and distribution rights for the ibuprofen product in the Mexican market while Cumberland provides regulatory and manufacturing support.

PiSA plans to introduce the product in 800 mg vials, making it accessible for a variety of clinical uses in Mexican healthcare facilities.

Additionally, we previously announced that 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.

Vibativ ® 4-Vial Starter Pak Now Available for Vizient Providers

Earlier this year, we announced the availability of the Vibativ (telavancin) 4-Vial Starter Pak through a new supply arrangement with Vizient Inc., making it accessible to their healthcare providers nationwide.

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

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

Vibativ ® Added to Premier National Group Purchasing Agreement

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

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

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

hospitals and 325,000 other providers and organizations.

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

Ifetroban Clinical Studies

In June 2025, breakthrough findings from our Phase II FIGHT DMD trial, evaluating our ifetroban product candidate in patients with Duchenne muscular dystrophy ("DMD"), were presented at the Parent Project Muscular Dystrophy Annual Conference .

The findings demonstrated that high-dose ifetroban delivered a 5.4% improvement in cardiac function in patients with DMD.

The presentation also included additional biomarker data indicating reduced cardiac damage, which correlated with the clinical findings.

These results position ifetroban as a potential treatment for DMD cardiomyopathy—the leading cause of death in these patients and a critical unmet medical need affecting 90% of DMD patients by age 18.

The top-line FIGHT DMD study findings were also selected for a late-breaking presentation at the Muscular Dystrophy Association’s Clinical & Scientific Conference in March 2025.

In June 2025, we completed the comprehensive analysis of the study results, completed our clinical study report and submitted it to the FDA along with a request for an end-of-Phase 2 meeting.

Following the FDA’s prompt response, we are scheduled to meet with them this fall to discuss our clinical program and development pathway.

Meanwhile, we have been evaluating our ifetroban product candidate in a Phase II clinical program in patients with Systemic Sclerosis or scleroderma.

This year, we announced positive top-line results from our FIGHT DMD clinical trial.

The study evaluated ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease – the leading cause of death in DMD patients.

It marks a breakthrough for these patients, as it is the first successful Phase 2 study specifically targeting the cardiac complications of their condition.

Ifetroban has been studied in over 1,400 subjects across multiple clinical trials, demonstrating a well-established safety profile.

The trial enrolled 41 DMD patients who received either low dose ifetroban (150 mg per day), high dose ifetroban (300 mg per day) or placebo.

The study's primary endpoint was an improvement in the heart's left ventricular ejection fractions (LVEF).

Key findings included:

• High dose ifetroban treatment resulted in an overall 3.3% improvement in LVEF;

• The high dose ifetroban group showed an increase in 1.8% in LVEF, while the study placebo group showed an expected decline in LVEF of 1.5%;

• When compared with propensity matched natural history controls, the difference was even more pronounced, with the high dose treatment providing a significant 5.4% overall improvement in LVEF, as the control patients experienced a 3.6% decline in LVEF;

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

The top-line findings from our FIGHT DMD study were featured as a late-breaking presentation at the Muscular Dystrophy Association's Clinical & Scientific Conference in March 2025 and subsequently presented at the Parent Project Muscular Dystrophy Annual Conference in June 2025.

Following these presentations, we completed our comprehensive analysis and submitted the clinical study report to the FDA with a request for an end-of-Phase 2 meeting.

This meeting took place in September 2025, where we discussed remaining clinical development and manufacturing requirements.

The FDA has recommended a follow-up meeting, which we are currently planning.

Meanwhile, we have been evaluating our ifetroban product candidate in a Phase II clinical program in patients with Systemic Sclerosis (SSc) or scleroderma.

Enrollment in the study was completed this year, and we are monitoring the clinical sites in preparation to lock the database and begin evaluating the results.

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

We look forward to announcing top-line findings from this study this year.

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

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

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

Vibativ ® 4-Vial Starter Pak Now Available for Vizient Providers

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

Pharmacokinetic Analysis Reinforces Vibativ ® Dosing Strategies

A comprehensive new pharmacokinetic analysis of Vibativ was published in Antimicrobial Agents and Chemotherapy in June 2025.

The analysis utilizes data from over 1,200 patients across varied demographics and comorbidity profiles.

The findings support optimized dosing strategies for patients with different infection severities and renal function levels, reinforcing Vibativ’s critical role in treating life-threatening gram-positive infections.

New Study Features Caldolor ® (ibuprofen injection) for Older Patients

In May 2025, we announced the publication of our study investigating Caldolor (intravenous ibuprofen) in Clinical Therapeutics , demonstrating the product’s safety and efficacy for managing post-operative pain in patients 60 years of age and older.

The analysis, encompassing over 1,000 older patients from our comprehensive post-surgical studies, represents the first such evaluation in this vulnerable population, where traditional pain management options such as opioids carry increased risk.

The analysis was performed using data from four prospective clinical studies in which Caldolor was administered for the treatment of pain and/or fever in hospitalized patients.

The efficacy analysis included 591 patients from two placebo-controlled trials, with safety assessed across all 1,041 patients.

Caldolor treatment resulted in a 24% reduction in pain at rest (p=0.008) and a 20% reduction in pain with movement (p=0.001) between 6- and 24-hours post-surgery compared with placebo.

The study showed that Caldolor treatment led to a 23.2% reduction in total post-operative morphine requirement (p=0.031) compared with placebo.

The incidence of adverse events was lower in Caldolor-treated patients compared to placebo (55% vs 90% in older patients).

Pain management in older patients presents unique challenges due to their increased sensitivity to opioid analgesics and higher risk of side effects.

Nearly one-third of all ambulatory surgeries are performed on older patients, yet this population is often underrepresented in clinical trials, highlighting an important medical need addressed in this study.

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

Qureight Partnership for AI-Enhanced IPF Trial

In May 2025, we announced a partnership with Qureight Ltd., a core imaging laboratory developing deep-learning image analytics based in Cambridge U.K., to enhance the outcome and output of data from our FIGHTING FIBROSIS™ clinical trial.

The partnership will utilize Qureight's advanced, deep-learning image analytics tools for complex lung disease applications to provide deeper insights into treatment efficacy and disease progression in Cumberland's IPF clinical program.

Under this partnership, Qureight's AI-driven analytics technologies will be used to quantify changes in multiple imaging biomarkers, using computed tomography (CT) data from study patients.

Qureight's quantitative deep learning-based tools will precisely measure changes in the volume of patients' fibrotic, vascular and airway lung compartments, allowing a more detailed investigation of ifetroban's modulation of both lung structure and function.

The collaboration leverages Qureight's expertise in IPF and quantitative imaging biomarkers to support Cumberland's evaluation of crucial primary and secondary study endpoints.

International Agreements

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

We previously announced 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 have also shared 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 training to launch the product in that country.

Following completion of our ongoing studies and FDA feedback, we will determine the optimal regulatory pathways for ifetroban, our first new chemical entity.

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

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

• intellectual property and other exclusivity rights;

• intellectual property and other exclusive rights;

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

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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 ("OTC") products.

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 ® .

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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.

On April 16, 2025, the U.S.

Department of Commerce announced an investigation under Section 232 of the Trade Expansion Act of 1962 into imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items.

The investigation will examine the impact of these imports on U.S.

national security culminating in a decision by the President whether to take action to remedy any identified threats, including by imposing additional tariffs.

The statute provides that the Commerce Department report must be completed within 270 days of initiation of the investigation and that the President must decide whether to act within 90 days of receiving the report.

Based on the trade deal reached between the U.S.

and the European Union in late July 2025, a 15 percent tariff will be imposed on imported medicines from Europe into the U.S.

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

We have entered an exciting time for our Company.

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RESULTS OF OPERATIONS

Three months ended June 30, 2025 compared to the three months ended June 30, 2024

The following table presents the unaudited interim statements of operations for continuing operations for the three months ended June 30, 2025 and 2024:

Three months ended June 30,

Three months ended September 30, 2025 compared to the three months ended September 30, 2024

The following table presents the unaudited interim statements of operations for continuing operations for the three months ended September 30, 2025 and 2024:

Three months ended September 30,

2025 2024 Change

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Interest income 131,583 69,190 62,393

Other income - insurance proceeds — 237,089 (237,089)

Interest expense (109,699) (137,374) 27,675

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

Three months ended June 30,

Three months ended September 30,

2025 2024 Change

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Net revenues.

Net revenues for the three months ended June 30, 2025, were $10.8 million compared to $9.8 million for the three months ended June 30, 2024.

As detailed in the table above, net revenue increased primarily due to four of our marketed products during the second quarter of 2025 - Sancuso, Vibativ, Caldolor and Acetadote.

Kristalose revenue was $2.8 million for the second quarter of 2025 and $4.1 million for the same period in the prior year.

The decrease was the result of lower sales volume.

The net revenues for the three months ended September 30, 2025, were $8.3 million compared to $9.1 million for the three months ended September 30, 2024.

Kristalose revenue was $1.2 million for the third quarter of 2025 and $3.6 million for the same period in the prior year.

The decrease was the result of lower sales volume primarily due to a delay in shipments of our Authorized Generic product, in addition to increased generic substitution.

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

During the second quarter of 2025, there was an increase of $0.2 million in the product's revenue when compared to the prior year period due to an increase of our branded and Authorized Generic sales.

There were no Vaprisol branded product sales for the second 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 normal sales deduction adjustments.

Caldolor revenue was $1.6 million for the second quarter of 2025, compared to $0.8 million for the second quarter of 2024.

The increase results from higher international sales in 2025.

Vibativ revenue was $2.7 million for the three months ended June 30, 2025, and $2.5 million for the same prior year period.

The increase in net revenue of the product was due to higher sales volume.

Sancuso revenue was $3.1 million for the second quarter of 2025, compared to $2.2 million for the second quarter of 2024 resulting in an increase of $0.9 million.

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

Other revenue was $0.5 million for the three months ended June 30, 2025, compared to $0.2 million for the three months ended June 30, 2024.

The increase results from payments received for a research contract.

During the third 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 our Authorized Generic sales.

There were no Vaprisol branded product sales for the third 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 adjustments of deductions from previous sales of the product.

Caldolor revenue was $0.9 million for the third quarter of 2025, compared to $1.3 million for the third quarter of 2024.

The decrease was primarily due to a delay in the manufacturing and shipment of an international order for the product.

Vibativ revenue was $2.6 million for the three months ended September 30, 2025, and $1.0 million for the same prior year period.

The increase in net revenue of the product was due to higher sales volumes, including growing shipments of the product's 4-Pak.

Sancuso revenue was $3.2 million for the third quarter of 2025, compared to $2.6 million for the third quarter of 2024 resulting in an increase of $0.6 million.

The increase resulted primarily from increased shipments as well as lower sales deductions associated with the product.

Other revenue was $0.3 million for the three months ended September 30, 2025, compared to $0.6 million for the three months ended September 30, 2024.

The decrease was primarily due to less CET revenues for the period.

Cost of products sold .

Cost of products sold for the second quarter of 2025 and 2024 were $2.0 million and $1.7 million, respectively.

Cost of products sold, as a percentage of net revenues, were 18.6% during the three months ended June 30, 2025, compared to 17.4% during the three months ended June 30, 2024.

The unfavorable percentage increase is primarily due to higher international sales in 2025 which typically incur higher cost of goods sold as a percentage relative to the lower international revenue on a per unit basis.

The cost of products sold for the third quarter of 2025 and 2024 were $1.0 million and $1.3 million, respectively.

Cost of products sold, as a percentage of net revenues, were 11.9% during the three months ended September 30, 2025, compared to 14.6% during the three months ended September 30, 2024.

The favorable percentage decrease is primarily due to the higher international sales in 2024, which typically have lower gross margin.

Selling and marketing .

Selling and marketing expenses for the second quarter of 2025 were similar when compared to the same period last year.

The selling and marketing expenses for the third quarter of 2025 and 2024, were similar at $4.4 million for both periods.

Research and development .

Research and development costs for the second quarter of 2025 were $1.5 million compared to $1.1 million for the same period in 2024.

The increase is primarily due to a portion of our research and development costs that are 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 research and development costs for the three months ended September 30, 2025 and 2024, were similar at $1.3 million for both periods.

General and administrative .

General and administrative expense for the second quarter of 2025 was $2.9 million compared to $2.8 million for the same period in 2024.

The increase is due to higher compensation expenses.

The general and administrative expense for the third quarter of 2025 was $2.6 million compared to $2.7 million for the same period in 2024.

The decrease is due to lower corporate life insurance expense.

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

Financial Impact of Vibativ Three months ended June 30,

Financial Impact of Vibativ Three months ended September 30,

Net revenue (1)

$ 2,613,143 $ 1,029,301

Cost of products sold (2)

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Vibativ contribution $ 1,466,851 $ 494,995

(1) Net revenue includes $14,689 related to additional international training revenue.

(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 June 30,

Financial Impact of Sancuso Three months ended September 30,

Net revenue $ 3,240,947 $ 2,607,559

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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 three months ended June 30, 2025 and 2024, totaled approximately $1.0 million and $1.1 million, respectively.

The 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, 2025 and 2024, totaled approximately $1.0 million and $1.1 million, respectively.

Income taxes .

Income tax expense for the three months ended June 30, 2025 and for the three months ended June 30, 2024 was less than $0.01 million for each year.

The income tax expense for the three months ended September 30, 2025, and for the three months ended September 30, 2024 was less than $0.01 million for each year.

Research and Development Expenses

The following table shows the primary components of our research and development expenses for the three months ended September 30, 2025 and 2024.

Research and Development Expenses Three months ended September 30,

External research and development expenses

Clinical development

$ 322,959 $ 385,517

Regulatory expenses

357,020 364,521

Other external

10,730 12,335

Total external expenses

690,709 762,373

Internal research and development expenses

Personnel costs 509,550 477,596

Other internal

53,108 66,126

Total internal expenses

562,658 543,722

Total research and development expenses

$ 1,253,367 $ 1,306,095

RESULTS OF OPERATIONS

Six months ended June 30, 2025 compared to the six months ended June 30, 2024

The following table presents the unaudited interim statements of operations for continuing operations for the six months ended June 30, 2025 and 2024:

Six months ended June 30,

Nine months ended September 30, 2025 compared to the nine months ended September 30, 2024

The following table presents the unaudited interim statements of operations for continuing operations for the nine months ended September 30, 2025 and 2024:

Nine months ended September 30,

2025 2024 Change

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Interest income 384,781 227,777 157,004

Other income - insurance proceeds — 237,089 (237,089)

Interest expense (383,048) (382,247) (801)

Income (loss) before income taxes 524,318 (2,982,224) 3,506,542

Loss before income taxes (1,419,058) (4,507,751) 3,088,693

Income tax expense (17,011) (34,327) 17,316

Net income (loss) $ 512,977 $ (3,005,109) $ 3,518,086

Net loss $ (1,436,069) $ (4,542,078) $ 3,106,009

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

Six months ended June 30,

Nine months ended September 30,

2025 2024 Change

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Net revenues.

Net revenues for the six months ended June 30, 2025, were $22.6 million compared to $18.3 million for the six months ended June 30, 2024, an increase of $4.2 million.

Kristalose revenue was $6.2 million during the first six months of 2025, compared to $7.3 million for the prior year period.

Revenue decreased due to the result of lower sales volume.

The net revenues for the nine months ended September 30, 2025, were $30.8 million compared to $27.4 million for the nine months ended September 30, 2024, an increase of $3.4 million.

Kristalose revenue was $7.4 million during the first nine months of 2025, compared to $10.9 million for the prior year period.

The decrease was the result of lower sales volume primarily due to a delay in shipments of our Authorized Generic product, in addition to increased generic substitution..

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

During the six months ended June 30, 2025, there was an increase of $0.2 million in the product's revenue when compared to the prior year period due to an increase in sales for our Authorized Generic.

Sancuso revenue was $5.4 million for the six months ended June 30, 2025, compared to $4.0 million for the same period last year.

The increase resulted primarily from increased sales and reduced sales deductions.

Vibativ revenue was $4.1 million for the six months ended June 30, 2025, and the six months ended June 30, 2024.

There were no Vaprisol branded product sales for the six months ended June 30, 2025 and the amounts noted were for normal sales deduction adjustments.

Revenue for the six months ended June 30, 2024, were related to the sales of our compounded product.

Omeclamox-Pak had no sales for the six months ended June 30, 2025 and 2024, as Cumberland is currently out of commercial inventory of this product.

The amounts noted resulted from normal distribution adjustments.

Caldolor revenue was $2.9 million for the six months ended June 30, 2025, an increase of $0.6 million over the same period in 2024 primarily due to international shipments.

Other revenue was $3.6 million for the six months ended June 30, 2025, representing a $3.1 million increase from the same period in 2024, as a result of a milestone payment received in 2025.

During the nine months ended September 30, 2025, there was an increase of $0.3 million in the product's revenue when compared to the prior year period due to an increase in sales for our Authorized Generic.

Sancuso revenue was $8.6 million for the nine months ended September 30, 2025, compared to $6.6 million for the same period last year.

The increase resulted primarily from increased shipments, as well as lower sales deductions associated with the product.

Vibativ revenue was $6.7 million for the nine months ended September 30, 2025, and $5.1 million for the nine months ended September 30, 2024.

The increase in net revenue of the product was due to higher sales volumes, including growing shipments of the product's 4-Pak.

There were no Vaprisol branded product sales for the nine months ended September 30, 2025 and 2024.

The amount represents adjustments of deductions from previous sales of the product.

Omeclamox-Pak had no sales for the nine months ended September 30, 2025 and 2024.

The amount represents adjustments of deductions from previous sales of the product.

Caldolor revenue was $3.8 million for the nine months ended September 30, 2025, an increase of $0.2 million over the same period in 2024 primarily due to an increase in international shipments.

Other revenue was $3.9 million for the nine months ended September 30, 2025, representing a $2.8 million increase from the same period in 2024, primarily as a result of a milestone payment received in 2025.

Cost of products sold .

Co st of products sold for the first six months of 2025 were $3.4 million, consistent when compared to $3.3 million for the first six months of 2024.

The c o st of products sold for the first nine months of 2025 was $4.4 million, consistent with the $4.6 million for the first nine months of 2024.

Selling and marketing .

Selling and marketing expense for the six months ended June 30, 2025, increased $0.1 million compared to the prior year period.

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

The selling and marketing expense for the nine months ended September 30, 2025, increased $0.1 million compared to the prior year period.

This slight increase is primarily attributable to the timing of the expenditures.

Research and development .

Research and development costs were $2.8 million for the first six months of 2025 compared to $2.2 million for the same period last year.

The research and development costs were $4.0 million for the first nine months of 2025 compared to $3.5 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.

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General and administrative .

General and administrative expense for the six months ended June 30, 2025, increased to $5.3 million compared to $5.1 million during the six months ended June 30, 2024.

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

The general and administrative expenses for the nine months ended September 30, 2025, was $7.9 million compared to $7.8 million during the nine months ended September 30, 2024.

This slight increase is due to higher salary expense in 2025.

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

Financial Impact of Vibativ Six months ended June 30,

Financial Impact of Vibativ Nine months ended September 30,

Net revenue (1)

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Vibativ contribution $ 6,448,285 $ 2,649,839

(1) Net revenue includes $2,975,000 related to a milestone payment received in 2025.

(1) Net revenue includes $2,989,689 related to a milestone payment received in 2025 along with other product related revenue.

(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.

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(2) A portion of 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 Six months ended June 30,

Financial Impact of Sancuso Nine months ended September 30,

Net revenue $ 8,616,353 $ 6,624,103

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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 six months ended June 30, 2025, and six months ended June 30, 2024, totaled approximately $2.0 million and $2.2 million, respectively.

The 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, 2025, and nine months ended September 30, 2024, totaled approximately $3.0 million and $3.3 million, respectively.

The decrease was attributable to a reduction to the valuation of the Acetadote intangible asset recognized in December 2024.

Income taxes .

Income tax expense for the six months ended June 30, 2025, was $0.01 million, compared to the income tax expense recognized for the six months ended June 30, 2024, of $0.02 million.

As of June 30, 2025, 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.

The income tax expense for the nine months ended September 30, 2025, was $0.02 million, compared to $0.03 million for the nine months ended September 30, 2024.

As of September 30, 2025, we held approximately $52.6 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 2025 and beyond, through the continued utilization of these net operating loss carryforwards, on any taxable income generated from our operations.

Research and Development Expenses

The following table shows the primary components of our research and development expenses for the nine months ended September 30, 2025 and 2024.

Research and Development Expenses Nine months ended September 30,

External research and development expenses

Clinical development

$ 1,235,616 $ 1,062,209

Regulatory expenses

1,072,175 734,460

Other external

39,425 36,700

Total external expenses

2,347,216 1,833,369

Internal research and development expenses

Personnel costs 1,524,960 1,548,660

Other internal

144,666 141,506

Total internal expenses

1,669,626 1,690,166

Total research and development expenses

$ 4,016,842 $ 3,523,535

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 June 30, 2025 and December 31, 2024:

June 30, 2025 December 31, 2024

The following table summarizes our liquidity and working capital as of September 30, 2025 and December 31, 2024:

September 30, 2025 December 31, 2024

Cash and cash equivalents $ 15,196,745 $ 17,964,184

2 unchanged sentences

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 six months ended June 30, 2025 and June 30, 2024:

Six months ended June 30,

The following table summarizes our net changes in cash and cash equivalents for the nine months ended September 30, 2025 and September 30, 2024:

Nine months ended September 30,

Net cash provided by (used in):

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Net decrease in cash and cash equivalents $ (2,767,439) $ (856,870)

The net $1.9 million decrease in cash and cash equivalents for the six months ended June 30, 2025, was primarily attributable to $6.6 million of cash used in financing and investing activities, partially offset by $4.7 million of cash provided by operating activities.

Cash provided by operating activities totaled $4.7 million for the six months ended June 30, 2025, primarily due to the $0.5 million net income, adjusted by adding back $1.8 million due to a decrease in inventory, $2.1 million expense in depreciation and amortization, $1.4 million due to a decrease in accounts receivable, $0.6 million expense in amortization of operating lease right-of-use assets and $0.6 million due to a decrease in other current assets and other assets, partially offset by deducting $2.0 million due to a decrease in accounts payable and other current liabilities and $0.4 million decrease in operating leases liabilities.

The net $2.8 million decrease in cash and cash equivalents for the nine months ended September 30, 2025, was primarily attributable to $7.7 million of cash used in financing and investing activities, partially offset by $4.9 million of cash provided by operating activities.

Cash provided by operating activities totaled $4.9 million for the nine months ended September 30, 2025, primarily due to the $1.4 million net loss, adjusted by adding back $3.1 million expense in depreciation and amortization, $2.4 million due to a decrease in inventory, $1.3 million due to a decrease in accounts receivable, $0.9 million expense in deduction in the carrying amount of right-of-use assets and $0.8 million due to a decrease in other current assets and other assets, partially offset by deducting $1.3 million due to a decrease in accounts payable and other current liabilities and a $0.7 million decrease in operating leases liabilities.

Cash used in investing activities totaled $1.6 million which was the result of $1.4 million paid for investments in manufacturing as well as an increase in fixed assets and intangible assets.

Cash used in financing activities totaled $5.7 million for the six months ended June 30, 2025, primarily due to $10.0 million in payments on our line of credit, $0.7 million for cash settlement of contingent consideration, and $0.3 million in cash used to repurchase shares of our common stock, partially offset by $5.3 million in proceeds from our ATM offering.

Cash used in financing activities totaled $6.1 million for the nine months ended September 30, 2025, primarily due to $10.0 million in payments on our line of credit, $1.0 million for cash settlement of contingent consideration, and $0.3 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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It has a three year term expiring on October 1, 2026.

The interest rate is based on Benchmark (Term SOFR) plus a spread of 2.75%.

The interest rate is based on Benchmark (Term SOFR) plus 2.75%.

Cumberland is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis.

2 unchanged sentences

OFF-BALANCE SHEET ARRANGEMENTS

During the six months ended June 30, 2025 and 2024, we did not engage in any off-balance sheet arrangements.

During the nine months ended September 30, 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