What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-08 compared with 2025-05-09 · 203 added, 93 removed, 189 unchanged (61% of the section changed)

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We promote our approved products through our hospital, field and oncology sales divisions in the United States.

We continue to build a network of established international partners with the needed regulatory and commercial capabilities to register and provide our medicines to patients in their countries.

We have built a network of established international partners with the needed regulatory and commercial capabilities to register and provide our medicines to patients in their countries.

Our portfolio of brands approved for marketing by the U.S.

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

The next steps for this DMD Program include further data analysis and completion of a full study report in preparation for an end-of-Phase-II meeting with the FDA to determine next steps associated with the product’s development and commercialization.

In addition to these commercial brands, we recently completed a Phase II study in patients with cardiomyopathy associated with Duchenne muscular dystrophy (“DMD”).

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

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.

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

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

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

Our product development team creates proprietary formulations, manages our clinical studies, prepares our FDA submissions and staffs our medical call center.

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• Building an international contribution to our business.

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

rights for that product.

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

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RECENT DEVELOPMENTS

FDA Approves Acetadote ® sNDA

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

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

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

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

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

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

New Study Compares Caldolor ® (ibuprofen injection) to ketorolac

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

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

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

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

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

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

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

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

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

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

Ifetroban Clinical Studies

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

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

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

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

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

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

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

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

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

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

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.

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.

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

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.

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

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.

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.

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

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

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 product training to launch the product in that country.

We also entered into an agreement with D.B.

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

Pharm also distributes our Caldolor product there.

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

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

We will work with D.B.

Pharm to address the additional requirements.

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

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

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

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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, or OTC, products.

constipation therapy market includes various prescription and over the counter ("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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Prescriptions for our Kristalose product are often substituted and filled by one of these generic products.

During the first quarter of 2025, a generic crystalline lactulose product was approved, available from PAI Pharma.

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.

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

We are entering an exciting time for our Company.

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 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.

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RESULTS OF OPERATIONS

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

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

Three months ended March 31,

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,

2025 2024 Change

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Total costs and expenses 11,584,841 10,875,537 709,304

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

Operating loss (747,478) (1,026,688) 279,210

Interest income 127,489 61,841 65,648

Interest expense (109,547) (126,347) 16,800

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

Loss before income taxes (729,536) (1,091,194) 361,658

Income tax expense (5,671) (11,443) 5,772

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

Net loss $ (735,207) $ (1,102,637) $ 367,430

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

Three months ended March 31,

Three months ended June 30,

2025 2024 Change

4 unchanged sentences

Acetadote 193,546 43,396 150,150

Omeclamox-Pak (5,387) (1,615) (3,772)

Vaprisol (14,621) (1,581) (13,040)

Omeclamox-Pak (752) (941) 189

RediTrex 3,244 (1,156) 4,400

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Net revenues.

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

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

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

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

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.

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

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

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

The amount represents charges for product returns.

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

The decrease results from higher international sales in 2024.

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

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

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

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

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

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

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.

Cost of products sold .

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

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

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

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.

Selling and marketing .

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

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

Research and development .

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

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

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.

General and administrative .

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

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

Financial Impact of Vibativ Three months ended March 31,

Financial Impact of Vibativ Three months ended June 30,

Net revenue $ 2,701,854 $ 2,454,481

$ 4,353,066 $ 1,605,489

Cost of products sold (1)

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Vibativ contribution $ 1,387,485 $ 1,304,891

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

(1) 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 March 31,

Financial Impact of Sancuso Three months ended June 30,

Net revenue $ 3,119,110 $ 2,188,776

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(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.

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 March 31, 2025 and 2024, totaled approximately $1.0 million and $1.1 million, respectively.

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

Income taxes .

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

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.

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,

2025 2024 Change

Net revenues $ 22,550,418 $ 18,346,550 $ 4,203,868

Costs and expenses:

Cost of products sold 3,437,103 3,286,486 150,617

Selling and marketing 8,455,627 8,402,989 52,638

Research and development 2,763,475 2,217,440 546,035

General and administrative 5,337,930 5,125,055 212,875

Amortization 2,011,814 2,210,518 (198,704)

Total costs and expenses 22,005,949 21,242,488 763,461

Operating loss 544,469 (2,895,938) 3,440,407

Interest income 253,198 158,587 94,611

Interest expense (273,349) (244,873) (28,476)

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

Income tax expense (11,341) (22,885) 11,544

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

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

Six months ended June 30,

2025 2024 Change

Kristalose $ 6,238,609 $ 7,303,444 $ (1,064,835)

Sancuso 5,375,405 4,016,544 1,358,861

Vibativ 4,079,920 4,059,970 19,950

Caldolor 2,895,733 2,314,947 580,786

Acetadote 345,195 123,599 221,596

Vaprisol (15,221) 7,081 (22,302)

Omeclamox-Pak (6,139) (2,556) (3,583)

RediTrex 2,897 34,400 (31,503)

Other revenue 3,634,019 489,121 3,144,898

Total net revenues $ 22,550,418 $ 18,346,550 $ 4,203,868

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.

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.

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.

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.

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.

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.

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

Financial Impact of Vibativ Six months ended June 30,

Net revenue (1)

$ 7,054,920 $ 4,059,970

Cost of products sold (2)

889,117 826,646

Royalty and operating expenses 1,184,369 1,078,480

Vibativ contribution $ 4,981,434 $ 2,154,844

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

(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 11,855,909

Vibativ contribution $ 36,064,154

(1) Net revenue includes a $1,000,000 payment to Cumberland related to a settlement agreement of milestone payments, $1,288 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 Six months ended June 30,

Net revenue $ 5,375,405 $ 4,016,544

Cost of products sold (1)

297,704 556,125

Royalty and operating expenses 1,940,721 1,530,051

Sancuso contribution $ 3,136,980 $ 1,930,368

(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

Net revenue $ 36,032,927

Cost of products sold (1)

Royalty and operating expenses 13,295,730

Sancuso contribution $ 19,004,013

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

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

Amortization.

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

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

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.

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 March 31, 2025 and December 31, 2024:

March 31, 2025 December 31, 2024

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

June 30, 2025 December 31, 2024

Cash and cash equivalents $ 16,087,281 $ 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 three months ended March 31, 2025 and March 31, 2024:

Three months ended March 31,

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,

Net cash provided by (used in):

2 unchanged sentences

Financing activities (5,676,899) 2,112,119

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

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

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

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

Net decrease in cash and cash equivalents $ (1,876,903) $ (985,178)

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.

Cash used in investing activities totaled $0.9 million which was the result of $0.8 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.

Debt Agreement

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OFF-BALANCE SHEET ARRANGEMENTS

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

During the six months ended June 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