What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-08 compared with 2025-11-07 · 105 added, 279 removed, 166 unchanged (70% of the section changed)

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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”).

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

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

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GROWTH STRATEGY

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

Cumberland’s current growth strategy, prior to closing the transaction with Apotex Inc., involves maximizing the potential of our existing brands, while continuing to build a portfolio of differentiated products.

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.

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

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

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

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

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 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.

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

The study design includes both an interim safety analysis, as well as an interim efficacy analysis.

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

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

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.

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 exclusive 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 for PAI Pharma, and the product became available during the second quarter of the year.

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 impact of tariffs on our business and the results of our operations.

Strategic Transaction

We recently announced a Strategic Transaction with Apotex, the largest Canadian-based pharmaceutical company to integrate our branded U.S.

commercial businesses.

Under the terms of the agreement, Apotex will acquire our portfolio of FDA-approved brands for $100 million in cash consideration, subject to our shareholders’ approval and certain other customary closing conditions.

Apotex agreed that, in the event, that prior to the two-year anniversary of the closing of the Transaction, Apotex, or its affiliates is awarded a contract by the United States Department of Health and Human Services (or any division thereof) for the supply of Vibativ for certain specified uses, then Apotex must provide a milestone payment to the Company, subject to the terms and conditions set forth in the Agreement, including the achievement of certain net sales associated with such contract.

At the closing of the Transaction, Cumberland intends to enter into a transition services agreement with Apotex, pursuant to which Cumberland will provide Apotex and its affiliates certain transition services following the date of the closing of the Transaction in accordance with the terms and conditions set forth in the transition services agreement.

As consideration for the provision of the transition services, Apotex and its affiliates will pay Cumberland $150,000 per month plus reimbursement of certain pre-approved pass-through costs.

In addition to the Asset Purchase Agreement, Apotex will also make a one-time payment to Cumberland on the one-year anniversary of the closing of the Transaction to reimburse Cumberland for finished goods inventory received by Apotex in the Transaction in an aggregate amount of $ 9 million, less finished goods inventory sold by Cumberland on behalf of Apotex under the transition services agreement to be entered into in connection with the closing of the Transaction.

This Transaction is designed to unlock value and sharpen our focus on advancing our pipeline of differentiated product candidates designed to address unmet medical needs.

Following the closing of the Transaction, we will retain our development programs, as well as our majority ownership in Cumberland Emerging Technologies.

This positions Cumberland to then operate with the profile of a development-stage biopharmaceutical organization.

Fast Track Designation from the FDA

During the first quarter of 2026, the FDA granted Fast Track Designation for our ifetroban candidate product, targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients.

This designation is intended to accelerate the development and review of therapies addressing serious conditions with unmet medical needs.

Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process.

The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA.

Promotional Launch of Talicia ®

In February 2026, we announced the launch of our national sales promotion for Talicia, under our co-commercialization agreement with Talicia Holding Inc., which we jointly own with RedHill Biopharma.

Under this agreement, we assumed responsibility for the distribution and sales promotion of the brand in the U.S.

As part of the launch, we are utilizing our existing field sales division which also promotes Kristalose, with supporting marketing initiatives designed to increase awareness among gastroenterologists and other prescribers.

New Sancuso ® Website

In March 2026, we announced the launch of the new Sancuso website, which is designed to provide health care professionals and patients with enhanced access to educational resources, clinical information and expert insights related to the prevention of chemotherapy-induced nausea and vomiting.

The website also features the brand’s key message :

“Sancuso – the Difference between Life and Living” .

Expanded Indication for Caldolor ®

In April 2026, we announced approval from the FDA for an expanded indication for Caldolor.

The indication now includes the management of postoperative pain.

This approval enhances the clinical utility of Caldolor and supports its role in non-opioid, and opioid-sparing pain management strategies.

With this update, Caldolor is indicated for use in adult and pediatric patients ages 3 months and older for:

• Management of mild to moderate pain, including postoperative pain

• Management of moderate to severe pain, including postoperative pain, as an adjunct to opioid analgesics

• Reduction of fever

This expanded labeling further broadens Caldolor’s use across perioperative and acute care settings.

On April 2, 2026, President Trump issued a proclamation under Section 232 of the Trade Expansion Act of 1962, significantly imposing new tariffs on patented pharmaceuticals and pharmaceutical ingredients.

We are carefully assessing how these new rules may affect our operations and supply chains.

It appears that the tariffs will not apply to our products that are not patented, and that our products originating in Europe and India may involve a low tariff rate based on trade agreements between the U.S.

and those countries.

We have entered 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.

While we continue to operate our commercial business, we are also planning to implement the transformational transaction with Apotex , following a decision by our shareholders to approve it and satisfaction of the other conditions to closing.

We look forward to the opportunity to increase the focus on our pipeline of new medicines that address unmet medical needs for patients.

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

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RESULTS OF OPERATIONS

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,

Three months ended March 31, 2026 compared to the three months ended March 31, 2025

The following table presents the unaudited interim statements of operations for continuing operations for the three months ended March 31, 2026 and 2025:

Three months ended March 31,

2026 2025 Change

7 unchanged sentences

Total costs and expenses 12,260,609 10,421,108 1,839,501

Operating loss (1,965,260) (1,694,432) (270,828)

Operating income (loss) (3,129,292) 1,291,947 (4,421,239)

Interest income 78,031 125,709 (47,678)

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

Interest expense (85,839) (163,802) 77,963

Loss before income taxes (1,943,376) (1,525,527) (417,849)

Income (loss) before income taxes (3,137,100) 1,253,854 (4,390,954)

Income tax expense (3,871) (5,670) 1,799

Net loss $ (1,949,046) $ (1,536,969) $ (412,077)

Co-commercialization investment loss (146,080) — (146,080)

Net income (loss) $ (3,287,051) $ 1,248,184 $ (4,535,235)

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

Three months ended September 30,

Three months ended March 31,

2026 2025 Change

Kristalose $ 1,180,934 $ 3,632,258 $ (2,451,324)

Sancuso 2,928,634 2,256,294 672,340

Vibativ 2,118,295 1,378,066 740,229

Caldolor 867,013 1,271,252 (404,239)

Acetadote 96,597 21,374 75,223

Vaprisol 600 (135,765) 136,365

Omeclamox-Pak (3,127) (18) (3,109)

RediTrex 4,434 36,950 (32,516)

Other revenue 306,510 624,204 (317,694)

Total net revenues $ 8,292,362 $ 9,085,826 $ (793,464)

Net revenues.

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 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 .

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 .

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 .

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 .

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 September 30,

Net revenue (1)

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

Cost of products sold (2)

286,983 233,938

Royalty and operating expenses 859,309 300,368

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 September 30,

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

Cost of products sold (1)

145,251 135,233

Royalty and operating expenses 989,864 1,071,764

Sancuso contribution $ 2,105,832 $ 1,400,562

(1) The Sancuso inventory included in the costs of product sold during 2024 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.

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 .

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

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

Net revenues $ 30,842,780 $ 27,432,376 $ 3,410,404

Costs and expenses:

Cost of products sold 4,425,863 4,609,499 (183,636)

Selling and marketing 12,889,458 12,800,469 88,989

Research and development 4,016,842 3,523,535 493,307

General and administrative 7,909,996 7,800,435 109,561

Amortization 3,021,412 3,288,808 (267,396)

Total costs and expenses 32,263,571 32,022,746 240,825

Operating loss (1,420,791) (4,590,370) 3,169,579

Interest income 384,781 227,777 157,004

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

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

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

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

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

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

Nine months ended September 30,

2025 2024 Change

Talicia 1,916,481 — 1,916,481

Kristalose 981,483 3,484,310 (2,502,827)

Sancuso 8,616,353 6,624,102 1,992,251

Vibativ 6,678,374 5,087,983 1,590,391

Caldolor 965,564 1,307,439 (341,875)

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Net revenues.

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..

The total net revenues for the three months ended March 31, 2026, were $9.1 million compared to $11.7 million for the three months ended March 31, 2025.

However, the 2025 revenues included a $3.0 million milestone payment associated with the approval of Vibativ in China.

Sancuso revenue was $2.9 million for the first quarter of 2026, compared to $2.3 million for the first quarter of 2025 primarily due to higher sales volume of the product.

Vibativ revenue was $2.1 million for the three months ended March 31, 2026, compared to $1.4 million for the same prior year period, due to higher sales volumes, including growing shipments of the product's 4-Pak presentation.

Talicia revenue was $1.9 million for the three months ended March 31, 2026.

Shipments of the brand began in October 2025, and therefore there were no product sales during the prior year period.

Kristalose revenue was $1.0 million for the first quarter of 2026 compared to $3.5 million for the same period in the prior year.

The decrease was the result of lower sales volume primarily due to the timing of shipments to one of our co-promotion partners, in addition to increased generic substitution.

Caldolor revenue was $1.0 million for the first quarter of 2026, compared to $1.3 million for the first quarter of 2025.

The decrease was primarily due to the timing of international shipments for the product.

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, 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.

During the first quarter of 2026, there was a decrease of $0.1 million in the product's revenue when compared to the prior year period due to being out of inventory for both presentations of the product.

There was no Vaprisol revenue for the three months ended March 31, 2026 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 $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.

Other revenue was $0.2 million for the three months ended March 31, 2026, compared to $3.1 million for the three months ended March 31, 2025.

The decrease was primarily due to a milestone payment received in the first quarter of 2025.

Cost of products sold .

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.

The cost of products sold for the first quarter of 2026 and 2025 were $1.9 million and $1.4 million, respectively.

Cost of products sold, as a percentage of net revenues, were 21.2% during the three months ended March 31, 2026, compared to 12.2% during the three months ended March 31, 2025.

The percentage increase is primarily due to the impact of a $3.0 million milestone payment received in 2025.

Selling and marketing .

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.

The selling and marketing expenses for the first quarter of 2026 and 2025, were $5.1 million and $4.2 million, respectively.

The increase is primarily due to the costs associated with the addition of Talicia.

Research and development .

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.

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 March 31, 2026 and 2025, were $1.5 million and $1.3 million, respectively.

A portion of our research and development costs is variable based on the number of trials, study sites, number of patients and the cost per patient in each of our clinical programs.

General and administrative .

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 general and administrative expense for the first quarter of 2026 was $2.6 million similar to $2.5 million for the same period in 2025.

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

Financial Impact of Vibativ Nine months ended September 30,

Financial Impact of Vibativ Three months ended March 31,

Net revenue (1)

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Vibativ contribution $ 949,249 $ 3,593,949

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

(1) Net revenue for 2025 includes $2,975,000 related to a milestone payment 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 12,715,218

Vibativ contribution $ 37,531,005

(1) Net revenue includes a $1,000,000 payment to Cumberland related to a settlement agreement of milestone payments, $15,978 of other income and $2,975,000 related to a milestone payment.

(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 Nine months ended September 30,

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

Cost of products sold (1)

442,955 691,358

Royalty and operating expenses 2,930,585 2,601,815

Sancuso contribution $ 5,242,813 $ 3,330,930

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

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

Financial Impact of Sancuso Since Acquisition

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

Financial Impact of Sancuso Three months ended March 31,

Net revenue $ 2,928,634 $ 2,256,294

2 unchanged sentences

Sancuso contribution $ 1,886,267 $ 1,182,501

(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.

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.

Amortization for the three months ended March 31, 2026 and 2025, totaled approximately $1.2 million and $1.0 million, respectively.

Income taxes .

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.

The income tax expense for the three months ended March 31, 2026, and for the three months ended March 31, 2025 was minimal for each year.

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,

The following table shows the primary components of our research and development expenses for the three months ended March 31, 2026 and 2025.

Research and Development Expenses Three months ended March 31,

External research and development expenses

Clinical development $ 500,745 $ 412,222

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

Regulatory expenses 408,208 357,700

1,072,175 734,460

Other external 15,799 13,674

39,425 36,700

Total external expenses 924,752 783,596

2,347,216 1,833,369

Internal research and development expenses

1 unchanged sentence

Other internal 56,090 55,474

144,666 141,506

Total internal expenses 533,684 511,480

1,669,626 1,690,166

Total research and development expenses $ 1,458,436 $ 1,295,076

$ 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 September 30, 2025 and December 31, 2024:

September 30, 2025 December 31, 2024

The following table summarizes our liquidity and working capital as of March 31, 2026 and December 31, 2025:

March 31, 2026 December 31, 2025

Cash and cash equivalents $ 11,007,245 $ 11,444,693

2 unchanged sentences

Revolving line of credit availability $ 9,759,267 $ 9,759,267

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,

The following table summarizes our net changes in cash and cash equivalents for the three months ended March 31, 2026 and March 31, 2025:

Three months ended March 31,

Net cash provided by (used in):

3 unchanged sentences

Net decrease in cash and cash equivalents $ (437,448) $ (2,855,771)

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 $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.

The net $0.4 million decrease in cash and cash equivalents for the three months ended March 31, 2026, was primarily attributable to $0.8 million of cash used in financing activities and $0.1 million of cash used in investing activities, partially offset by $0.4 million of cash provided by operating activities.

Cash provided by operating activities totaled $0.4 million for the three months ended March 31, 2026, primarily due to a $2.7 million decrease in accounts receivable, a $1.3 million increase in depreciation and amortization expense, a $0.7 million decrease in inventory and a $0.4 million decrease in other assets.

These cash inflow items were partially offset by the $3.3 million net loss and $1.3 million due to a decrease in accounts payable and other current liabilities.

Cash used in investing activities totaled $0.1 million which was the result of an increase in cash surrender value of life insurance policies and additions to intangible assets.

Cash used in financing activities totaled $0.8 million for the three months ended March 31, 2026, primarily due to $0.7 million for cash settlement of contingent consideration and $0.1 million in cash used to repurchase shares of our common stock.

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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This facility provides for an aggregate principal funding amount of up to $25 million.

The initial revolving line of credit is up to $20 million, with the ability for Cumberland to increase the amount to $25 million, under certain conditions.

It has a three year term expiring on October 1, 2026.

The initial revolving line of credit was up to $20 million, with the ability for Cumberland to increase the amount to $25 million, under certain conditions.

It had a three year term expiring on October 1, 2026.

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

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

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

Borrowings under the line of credit are collateralized by substantially all of our assets.

On May 6, 2024, the Company entered into a First Amendment to the Loan Agreement which provides an alternative to the financial covenant by delivering to the lender a borrowing base certificate and complying with certain borrowing base requirements which set forth a maximum revolver amount equal to the lessor of (a) up to $20 million or (b) the sum of the Company's cash balances and eligible accounts receivable.

On May 6, 2024, the Company entered into a First Amendment to the Loan Agreement which provided an alternative to the financial covenant by delivering to the lender a borrowing base certificate and complying with certain borrowing base requirements which set forth a maximum revolver amount equal to the lessor of (a) up to $20 million or (b) the sum of the Company's cash balances and eligible accounts receivable.

On November 18, 2025, the Company entered into the First Amendment to the Revolving Credit Note and Second Amendment to the Credit Loan Agreement.

The Amendment provides for a principal available for borrowing of up to $15 million.

The Company has the right to request an increase of up to an additional $10 million.

The aggregate principal funding amount remains unchanged of up to $25 million.

The Company is subject to a financial covenant, maintenance of a Minimum Fixed Charge Coverage Ratio determined on a quarterly basis, along with Borrowing Base Requirements, as defined.

The Amendment extends the maturity date to October 1, 2027.

OFF-BALANCE SHEET ARRANGEMENTS

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

During the three months ended March 31, 2026 and 2025, 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