What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-08-09 compared with 2024-05-10 · 207 added, 103 removed, 168 unchanged (65% of the section changed)

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Cumberland Pharmaceuticals Inc.

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

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

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

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These medical specialties are characterized by relatively concentrated prescriber bases that we believe can be served effectively by small, targeted sales forces.

We promote our approved products through our hospital, field and oncology sales divisions in the United States, while we continue to build a network of international partners to register and provide our medicines to patients in their countries.

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

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

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

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

Investigational new study applications (“INDs”) 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 U.S.

commercialization of pharmaceutical products, and we believe we can leverage this existing infrastructure to support our growth.

Investigational new study applications ("INDs") have been cleared by the FDA enabling us to launch Phase II clinical studies in each of these areas.

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

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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Our quality and manufacturing professionals oversee the manufacturing, release and shipment of our brands.

Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability and delivery of our product.

Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability and delivery of our products.

GROWTH STRATEGY

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

We also 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.

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

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

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

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

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

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

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

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

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

• Leveraging our infrastructure through co-promotion partnerships.

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market for our products.

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

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

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

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

The acquisition of Vibativ resulted in several new international partners and market opportunities.

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RECENT DEVELOPMENTS

Caldolor Special Report

We are implementing a strategy to increase awareness of our products and their attributes throughout the medical community.

In March, a Special Report featuring Caldolor was published in Anesthesiology News, General Surgery News and Pharmacy Practice News .

This new publication presented the growing amount of data supporting the use of our Caldolor (ibuprofen) injection as a standard of care for the treatment of pain and fever.

The reports noted that as part of a comprehensive developmental plan, our intravenous ibuprofen was studied in various treatment areas, including surgical pain, fever and nonsurgical acute pain.

The results, which are highlighted in the report, demonstrate that the product is a safe and effective treatment for pain and fever in adults, children and infants as young as 3 months of age.

Pain management has become one of the most common health care problems.

As this Special Report states, comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control, while minimizing the need for opioids.

A non-steroidal anti-inflammatory drug, such as Caldolor, can provide a cornerstone for many treatment paradigms, and we are encouraged by the substantial database emerging from our studies in patients of all ages.

Federal NOPAIN Act

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

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

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

As a result, we expect that the NOPAIN Act will affect Medicare reimbursement for Caldolor, our non-opioid analgesic injection product.

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

It is anticipated that in 2024, Centers for Medicare & Medicaid Services (“CMS”) will issue regulations implementing the NOPAIN Act and detailing the conditions for, and amount of, the separate reimbursement.

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

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

We now await information from CMS regarding the reimbursement status and price for the product.

New Manufacturing & Supplies of Sancuso

After acquiring U.S.

rights to Sancuso, we successfully completed the transition from Kyowa Kirin to Cumberland in 2023, including the NDA transfer.

A new facility was approved by the FDA for Sancuso and we have completed the manufacturing of Cumberland-packaged product there.

We will begin shipping these new supplies of our Cumberland-branded product this year.

We are supporting the product through our expanded oncology sales division to help cancer patients by addressing certain side effects associated with their chemotherapy treatments.

Vaprisol Supply Update

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

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

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

Our new manufacturing and distribution partner, Nephron Pharmaceuticals (“Nephron”), is working with the FDA to address several Form 483 and warning letter issues in a timely manner.

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

The companies will share in the sales of this compounded product.

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

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

Omeclamox-Pak Supply Update

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

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

As we have not been able to identify an alternative site to package the product, we decided to discontinue it and expense the remaining brand intangible assets in late 2023.

Kristalose Covered on Wisconsin Medicaid Plans

We have found that Kristalose, our prescription-strength laxative, performs best in states where we have Medicaid coverage.

Wisconsin recently added Kristalose to its Medicaid formulary, and we are implementing a special initiative to announce this development in that market.

We also have Medicaid coverage for the brand in New York state and Texas, two of the largest states for the product.

Kristalose Recommended for Opioid-induced Constipation

We recently launched a campaign featuring the American Gastroenterological Association’s (“AGA”) guidelines that include Kristalose as a first-line treatment option for opioid-induced constipation.

As the guidelines state, “Constipation is by far the most common and debilitating gastrointestinal effect of opioids, and some degree of constipation is near universal in patients taking opioid medications.” We believe the AGA’s recommendation will support the use of Kristalose in those patients.

New Study Supports Vibativ as an Effective Treatment for Anthrax Infections

In June, Antimicrobial Agents and Chemotherapy published a study evaluating Vibativ (telavancin) as a novel therapeutic against anthrax inhalation, the most dangerous form of those infections.

Researchers were particularly interested in finding alternatives to current antibiotics in case anthrax bacteria become resistant to them.

Researchers tested telavancin against 17 different anthrax strains in the lab to determine how well it could stop their growth.

Additionally, they tested telavancin in rabbits that were infected with a deadly dose of airborne anthrax spores and compared telavancin’s effectiveness to another antibiotic (levofloxacin) and a placebo.

The results showed that:

Telavancin was very effective at killing all the anthrax strains tested in the lab.

In the rabbit study, all the animals treated with telavancin survived.

Telavancin was better at clearing anthrax from the blood and organs than levofloxacin.

Based on these results, the researchers concluded that telavancin could potentially be an effective new treatment option for anthrax infections, especially if current antibiotics become less effective due to resistance.

Antimicrobial resistance continues to pose a significant challenge in the treatment of bacterial infections, necessitating the development of new antibiotic therapies.

While many recently introduced antibiotics are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug-resistant, Vibativ was specifically designed to kill drug-resistant bacteria.

International Agreements

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

Tabuk has obtained approval for Vibativ in Saudi Arabia and we are now in discussions with them regarding their plans for the product in that country.

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

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

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

In April 2024, we terminated our license and commercialization agreement with Verity Pharmaceuticals for Vibativ in Puerto Rico due to material default.

Ifetroban Clinical Studies

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

We also completed a pilot Phase II study involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure 2) patients with Portal Hypertension associated with chronic liver disease and 3) patients with Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.

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

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

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

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

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

We expect to hear back on both applications this year.

We have also completed a pilot Phase II study involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure, 2) patients with Portal Hypertension associated with chronic liver disease and 3) patients with Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.

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

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

We are dedicated to our mission of working together to provide unique products that improve the quality of patient care – which we have pursued by building a portfolio of FDA-approved brands with outstanding safety and efficacy profiles that can make a difference in patients’ lives.

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

Federal NOPAIN Act

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

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

As a result, we expected that the NOPAIN Act would affect Medicare reimbursement for Caldolor, our non-opioid analgesic injection product.

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

It is anticipated that in late 2024, the Centers for Medicare & Medicaid Services (“CMS”) will issue regulations implementing the NOPAIN Act and detailing the conditions for, and amount of, the separate reimbursement.

In July 2023, Medicare Hospital Outpatient Prospective Payment System (“OPPS”) Proposed Rule , CMS requested that manufacturers with potentially applicable non-opioid products submit comments and supporting clinical evidence regarding products that they believe should be eligible for separate payment.

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

In July 2024 Medicare OPPS Proposed Rule, CMS proposed that, in 2025, several drugs that were previously eligible for separate payment via existing CMS policies continue to be eligible for separate payment in the hospital outpatient setting under the CAA of 2023 and solicited comments on whether there are additional drugs or biologicals that meet the statutory definition.

In response, we plan to submit a comment letter along with the requisite information in September 2024 and will then await information from CMS regarding the reimbursement status and price for Caldolor in the CY 2025 OPPS Final Rule.

New Manufacturing & Supplies of Sancuso

After acquiring U.S.

rights to Sancuso, we successfully completed the transition from Kyowa Kirin to Cumberland in 2023, including the NDA transfer.

A new facility was approved by the FDA for Sancuso and we have completed the manufacturing of Cumberland-packaged product there.

We began shipping these new supplies of our Cumberland-branded product this summer.

We continue to support the product through our expanded oncology sales division to help cancer patients by addressing certain side effects associated with their chemotherapy treatments.

Vaprisol Supply Update

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

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

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

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

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

The companies will share in the sales of this compounded product.

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

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

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

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

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

Our resulting, diversified product line has enabled us to weather external challenges while our team remains responsive to the evolving market.

We look forward to future opportunities to carry out our mission throughout the remainder of the year and beyond.

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

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

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RESULTS OF OPERATIONS

Three months ended March 31, 2024 compared to the three months ended March 31, 2023

The following table presents the unaudited interim statements of operations for continuing operations for the three months ended March 31, 2024 and 2023:

Three months ended March 31,

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

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

Three months ended June 30,

2024 2023 Change

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Total costs and expenses 10,875,537 10,866,018 9,519

Operating loss (1,869,250) (1,531,678) (337,572)

Operating income (loss) (1,026,688) 22,859 (1,049,547)

Interest income 61,841 57,061 4,780

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Interest expense (126,347) (192,635) 66,288

Loss before income taxes (1,891,030) 179,224 (2,070,254)

Income (loss) before income taxes (1,091,194) 869,091 (1,960,285)

Income tax expense (11,443) (6,937) (4,506)

Net loss $ (1,902,472) $ 172,286 $ (2,074,758)

Net income (loss) $ (1,102,637) $ 862,154 $ (1,964,791)

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

Three months ended March 31,

Three months ended June 30,

2024 2023 Change

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Net revenues.

Net revenues for the three months ended March 31, 2024, were $8.5 million compared to $9.2 million for the three months ended March 31, 2023.

Kristalose revenue of $3.2 million for the first quarter of 2024, compared to $4.3 million for the same period in the prior year.

The decrease was primarily the result of timing of shipments to one of our co-promotion partners.

Net revenues for the three months ended June 30, 2024, were $9.8 million compared to $10.9 million for the three months ended June 30, 2023.

Kristalose revenue of $4.1 million for the second quarter of 2024, was similar to the same period in the prior year.

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

During the first quarter of 2024, there was a decrease of $0.09 million in the product's revenue when compared to the prior year period due to a decrease in shipments.

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

The revenue stated represents our share of sales of the compounded product.

Caldolor revenue was $1.5 million for the first quarter of 2024, which was $0.5 million, or 57.3%, higher than the first quarter of 2023 primarily due to increased international shipments.

Vibativ revenue was $1.6 million for the three months ended March 31, 2024, a decrease of $0.2 million from the same prior year period.

The slight decrease in net revenue of the product was the result of wholesaler buying patterns.

Sancuso revenue was $1.8 million for the first quarter of 2024, compared to $1.9 million for the first quarter of 2023.

The decline resulted primarily from decreased sales volume, offset by improved pricing of the product.

Omeclamox-Pak had no sales for the first quarter of 2024, as Cumberland has discontinued the sale of the product.

Net revenue for the three months ended March 31, 2024, reflects sales deduction adjustments.

There were no RediTrex sales in the first quarter of 2024, as Cumberland concluded our distribution of the product effective June 30, 2023.

Net revenue for the three months ended March 31, 2024, reflects sales deduction adjustments.

Other revenue was $0.3 million for the three months ended March 31, 2024, compared to $0.2 million for the three months ended March 31, 2023.

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

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

The revenue stated represents our share of sales of the compounded product offset by expired product returns.

Caldolor revenue was $0.8 million for the second quarter of 2024, compared to $1.2 million for the second quarter of 2023 primarily due to decreased international shipments in the current quarter.

Vibativ revenue was $2.5 million for the three months ended June 30, 2024, an increase of $0.3 million from the same prior year period.

The increase in net revenue of the product was the result of international shipments and the introduction of our 4-pak carton.

Sancuso revenue was $2.2 million for the second quarter of 2024, compared to $1.9 million for the second quarter of 2023 resulting in an increase of $0.3 million.

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

Other revenue was $0.2 million for the three months ended June 30, 2024, compared to $1.3 million for the three months ended June 30, 2023.

The prior year period included two $500,000 milestone payments associated with Vibativ.

Cost of products sold .

Co st of products sold for the first quarter of 2024 and 2023 were $1.6 million and $1.3 million, respectively.

Cost of products sold, as a percentage of net revenues, were 18.5% during the three months ended March 31, 2024, compared to 13.6% during the three months ended March 31, 2023.

The increase is primarily due to international sales having higher manufacturing costs as a percent of sales.

Co st of products sold for the second quarter of 2024 and 2023 were $1.7 million and $1.5 million, respectively.

Cost of products sold, as a percentage of net revenues, were 17.4% during the three months ended June 30, 2024, compared to 14.0% during the three months ended June 30, 2023.

The increase is primarily due to the mix of products sold.

Selling and marketing .

Selling and marketing expense for the first quarter of 2024 decreased $0.1 million compared to the same period last year.

This decrease is primarily attributable to accrual adjustments.

Selling and marketing expense for the second quarter of 2024 decreased $0.4 million compared to the same period last year.

This decrease is primarily attributable to the timing of advertising costs and accrual adjustments.

Research and development .

Research and development costs for the first quarter of 2024 and 2023 were $1.2 million and $1.5 million, respectively.

Research and development costs for the second quarter of 2024 and 2023 were relatively the same at $1.1 million.

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 decrease in research and development costs for the first quarter of 2024 resulted from a decrease in study costs accruals.

General and administrative .

General and administrative expense for the first quarter of 2024 remained consistent with $2.4 million compared to $2.5 million for the same period in 2023.

General and administrative expense for the second quarter of 2024 was $2.8 million compared to $2.4 million for the same period in 2023.

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

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

Financial Impact of Vibativ Three months ended March 31,

Financial Impact of Vibativ Three months ended June 30,

Net revenue $ 2,454,481 $ 3,147,826

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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 $ 2,188,776 $ 1,916,966

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

Amortization for the three months ended March 31, 2024 and 2023, totaled approximately $1.1 million and $1.2 million, respectively.

The decline in amortization expense resulted from the write down of Omeclamox Pak intangible assets as we discontinued the sales of the product in late 2023.

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

The decrease in amortization expense resulted from the write down of Omeclamox-Pak intangible assets as we discontinued the sales of the product in late 2023.

Income taxes .

Income tax expense for the three months ended March 31, 2024, was comparable to the income tax expense for the three months ended March 31, 2023.

As of March 31, 2024, we had approximately $52.1 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.

Income tax expense for the three months ended June 30, 2024, was comparable to the income tax expense for the three months ended June 30, 2023.

RESULTS OF OPERATIONS

Six months ended June 30, 2024 compared to the six months ended June 30, 2023

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

Six months ended June 30,

2024 2023 Change

Net revenues $ 18,346,550 $ 20,113,515 $ (1,766,965)

Costs and expenses:

Cost of products sold 3,286,486 2,771,038 515,448

Selling and marketing 8,402,989 8,949,393 (546,404)

Research and development 2,217,440 2,644,708 (427,268)

General and administrative 5,125,055 4,868,876 256,179

Amortization 2,210,518 2,388,319 (177,801)

Total costs and expenses 21,242,488 21,622,334 (379,846)

Operating loss (2,895,938) (1,508,819) (1,387,119)

Interest income 158,587 107,251 51,336

Other income — 2,828,871 (2,828,871)

Interest expense (244,873) (378,988) 134,115

Income (loss) before income taxes (2,982,224) 1,048,315 (4,030,539)

Income tax expense (22,885) (13,875) (9,010)

Net income (loss) $ (3,005,109) $ 1,034,440 $ (4,039,549)

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

Six months ended June 30,

2024 2023 Change

Kristalose $ 7,303,444 $ 8,425,846 $ (1,122,402)

Sancuso 4,016,544 3,803,759 212,785

Vibativ 4,059,970 3,996,013 63,957

Caldolor 2,314,947 2,161,356 153,591

Acetadote 123,599 320,019 (196,420)

Vaprisol 7,081 39,866 (32,785)

Omeclamox-Pak (2,556) 5,544 (8,100)

RediTrex 34,400 (131,552) 165,952

Other revenue 489,121 1,492,664 (1,003,543)

Total net revenues $ 18,346,550 $ 20,113,515 $ (1,766,965)

Net revenues.

Net revenues for the six months ended June 30, 2024, were $18.3 million compared to $20.1 million for the six months ended June 30, 2023, a decrease of $1.8 million.

Kristalose revenue was $7.3 million during the first six months of 2024, compared to $8.4 million for the prior year period.

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

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

During the six months ended June 30, 2024, there was a decrease of $0.2 million in the product's revenue when compared to the prior year period due to a decrease in shipments.

Sancuso revenue was $4.0 million for the six months ended June 30, 2024, compared to $3.8 million for the same period last year.

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

Vibativ revenue was $4.1 million for the six months ended June 30, 2024, compared to $4.0 million for the same period last year.

The increase in net revenue of the product was the result of international shipments in 2024.

There was $0.01 million of Vaprisol revenue for the six months ended June 30, 2024 related to the sales of our compounded product.

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

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

Caldolor revenue was $2.3 million for the six months ended June 30, 2024, a $0.2 million increase over the same period in 2023.

Higher international revenue is driving the increase.

Other revenue was $0.5 million for the six months ended June 30, 2024, representing a $1.0 million decrease from the same period in 2023, as a result of a settlement recognized in 2023.

Cost of products sold .

Co st of products sold for the first six months of 2024 were $3.3 million, an increase of $0.5 million compared to the same period last year due to higher international sales with corresponding higher cost of goods.

Selling and marketing .

Selling and marketing expense for the six months ended June 30, 2024, decreased $0.5 million compared to the prior year period.

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

Research and development .

Research and development costs were $2.2 million for the first six months of 2024 compared to $2.6 million for the same period last year.

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

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

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

General and administrative .

General and administrative expense for the six months ended June 30, 2024, increased to $5.1 million compared to $4.9 million during the six months ended June 30, 2023.

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)

$ 4,059,970 $ 4,996,013

Cost of products sold 826,646 517,313

Royalty and operating expenses 1,078,480 1,116,627

Vibativ contribution $ 2,154,844 $ 3,362,073

(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.

Financial Impact of Vibativ Since Acquisition

Net revenue (1)

Cost of products sold (2)

Royalty and operating expenses 9,995,609

Vibativ contribution $ 29,660,386

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

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

Financial Impact of Sancuso Six months ended June 30,

Net revenue $ 4,016,544 $ 3,803,759

Cost of products sold (1)

556,125 571,306

Royalty and operating expenses 1,530,051 1,822,804

Sancuso contribution $ 1,930,368 $ 1,409,649

(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.

Financial Impact of Sancuso Since Acquisition

Net revenue $ 25,668,935

Cost of products sold (1)

Royalty and operating expenses 9,107,900

Sancuso contribution $ 13,246,484

(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.

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, 2024, and six months ended June 30, 2023, totaled approximately $2.2 million and $2.4 million, respectively.

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

Income taxes .

Income tax expense for the six months ended June 30, 2024, was $0.02 million, comparable to the income tax expense recognized for the six months ended June 30, 2023.

As of June 30, 2024, we had approximately $52.1 million in federal net operating loss carryforwards including approximately $44.1 million of net operating loss carryforwards resulting from the exercise of nonqualified stock options that have historically been used to significantly offset income tax obligations.

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

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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, 2024 and December 31, 2023:

March 31, 2024 December 31, 2023

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

June 30, 2024 December 31, 2023

Cash and cash equivalents $ 17,336,446 $ 18,321,624

2 unchanged sentences

Revolving line of credit availability $ 3,908,408 $ 7,215,856

The following table summarizes our net changes in cash and cash equivalents for the three months ended March 31, 2024 and March 31, 2023:

Three months ended March 31,

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

Six months ended June 30,

Net cash provided by (used in):

2 unchanged sentences

Financing activities 2,112,119 (5,054,775)

Net increase (decrease) in cash and cash equivalents $ 226,861 $ (3,371,804)

The net $0.2 million decrease in cash and cash equivalents for the three months ended March 31, 2024, was primarily attributable to cash provided by financing activities partially offset by used in operating activities.

Cash used by operating activities totaled $2.1 million for the three months ended March 31, 2024, primarily is due to the result of $1.9 million net loss, a $1.1 million increase in account receivable, and a $0.6 million in accounts payable and other current liabilities, partially offset by the add back of $1.4 million depreciation and amortization expense and stock base compensation expense of $0.1 million.

Cash provided by financing activities totaled $2.4 million for the three months ended March 31, 2024, is primarily due to $3.3 million borrowings net on line of credit, partially offset by the $0.6 million used for the payment of a Sancuso milestone, plus royalties on sales of Vibativ and Sancuso, and the $0.2 million in cash used to repurchase shares of our common stock.

Net decrease in cash and cash equivalents $ (985,178) $ (1,508,884)

The net $1.0 million decrease in cash and cash equivalents for the six months ended June 30, 2024, was primarily attributable to cash used in operating activities partially offset by cash provided by financing activities.

Cash used in operating activities totaled $3.0 million for the six months ended June 30, 2024, primarily is due to the result of $3.0 million net loss, a $1.9 million decrease in accounts payable and other current liabilities and a $1.9 million increase in account receivable partially offset by a $2.3 million increase in depreciation and amortization expense and a $1.2 million decrease in inventories.

Cash provided by financing activities totaled $2.1 million for the six months ended June 30, 2024, primarily due to $3.3 million borrowings net on our line of credit, partially offset by the $0.8 million used for the payment of a Sancuso milestone, plus royalties on sales of Vibativ and Sancuso and the $0.4 million in cash used to repurchase shares of our common stock.

Debt Agreement

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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 (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 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.

OFF-BALANCE SHEET ARRANGEMENTS

During the three months ended March 31, 2024 and 2023, we did not engage in any off-balance sheet arrangements.

During the six months ended June 30, 2024 and 2023, 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