What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-05-10 compared with 2023-11-13 · 121 added, 269 removed, 150 unchanged (72% of the section changed)

18 unchanged sentences

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

Our primary markets are hospital acute care, gastroenterology and oncology.

Our primary target markets are hospital acute care, gastroenterology and oncology.

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, oncology and field sales forces in the United States.

We have also established international partnerships and are continuing to build a network of companies outside the U.S.

to register and provide our medicines to patients in their countries.

Our portfolio of FDA approved brands includes:

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.

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

Food and Drug Administration (“FDA”) includes:

• Acetadote ® ( acetylcysteine ) injection, for the treatment of acetaminophen poisoning;

1 unchanged sentence

• Kristalose ® ( lactulose ) for oral solution, a prescription laxative, for the treatment of constipation;

• Omeclamox ® -Pak , ( omeprazole, clarithromycin, amoxicillin ) for the treatment of Helicobacter pylori ( H.

pylori ) infection and related duodenal ulcer disease;

• Sancuso ® ( granisetron) transdermal system, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;

• Sancuso ® ( granisetron ) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;

• Vaprisol ® ( conivaptan ) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia;

• Vibativ ® ( telavancin ) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.

In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidates for patients with cardiomyopathy associated with 1) Duchenne Muscular Dystrophy (“DMD”), a fatal, genetic neuromuscular disease and 2) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by fibrosis of the skin and internal organs.

In June 2023, we received FDA clearance to proceed directly to a Phase II study for patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.

We are now entering into agreements with medical centers around the country and look forward to initiating the trial.

Cumberland has built core competencies in the acquisition, development and commercialization of pharmaceutical products in the U.S.

– and we believe we can leverage this existing infrastructure to support our continued growth both domestically and internationally.

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.

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

1 unchanged sentence

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

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

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.

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.

GROWTH STRATEGY

Cumberland’s growth strategy involves maximizing the success of our existing brands while continuing to add differentiated products.

We have built our portfolio of FDA approved products through both development and acquisition.

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

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

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

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

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

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

We 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.

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

CET partners with academic research institutions to identify and support the progress of promising new product candidates, which Cumberland could further develop and commercialize.

CET partners with academic research institutions to identify and support the progress of promising new product candidates, which Cumberland can further develop and commercialize.

Specifically, we are seeking long-term, sustainable growth by:

3 unchanged sentences

We also added pre-surgery dosing for Caldolor, and recently included newborns to the patients who can benefit from the product.

We will continue to explore such opportunities to bring our products to new patient populations.

• Selectively adding complementary brands.

In addition to our product development activities, we are also seeking to acquire products or late-stage development product candidates to continue to build a portfolio of complementary brands.

We focus on under-promoted, FDA-approved drugs as well as late-stage development products that can improve patient care.

We will continue to target product acquisition candidates that are competitively differentiated, have valuable intellectual property or other protective features, and allow us to leverage our existing infrastructure.

In addition to our product development activities, we are also seeking to acquire approved brands or late-stage development product candidates to continue to build our portfolio.

We seek under-promoted, FDA-approved drugs as well as late-stage development products that can improve patient care.

We will continue to target product acquisition candidates that are competitively differentiated and have valuable intellectual property or other protective features.

Our acquisitions of Vibativ and Sancuso are examples of the implementation of this strategy.

• Progressing our clinical pipeline and incubating future product opportunities at CET.

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

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

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.

• Leveraging our infrastructure through co-promotion partnerships.

We believe that our commercial infrastructure can help drive prescription volume and product sales.

We look for strategic partners that can complement our capabilities and enhance opportunities for our brands.

We also look for strategic partners that can complement our capabilities and enhance opportunities for our brands.

For example, our co-promotion partnerships have allowed us to expand the support for Kristalose across the U.S.

• Building an international contribution to our business.

We have established our own commercial capabilities, including three sales divisions, to cover the U.S.

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

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 partners’ registration and commercialization efforts in their respective territories.

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.

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

1 unchanged sentence

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

We remain in a strong financial position, with favorable gross margins and a strong balance sheet.

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

RECENT DEVELOPMENTS

New Vibativ Pediatric Study Publication

In October 2023, we announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of our Vibativ injection in children 2 to 17 years of age.

Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia as well as complicated skin and skin structure infections caused by certain gram-positive bacteria in adults.

This is the first reported study evaluating Vibativ in pediatric patients.

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

The results of this study suggest that a single dose of Vibativ is safe in children and they experience reduced exposure to Vibativ, compared with the same body weight-based dosing in adults.

New Bank Credit Facility

On September 5, 2023, Cumberland entered into a new Revolving Credit Loan Agreement with Pinnacle Bank for a three-year term.

The agreement provides for an aggregate principal funding amount of up to $25 million.

It provides an initial revolving credit line with $20 million of availability, and the ability of Cumberland to increase the amount to $25 million under certain conditions.

The interest rate is based on Benchmark (Term SOFR), plus a spread of 2.75%, and is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis.

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

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.

2 unchanged sentences

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, 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.

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.

Caldolor is approved by the FDA for use in adults and pediatric patients 3 months and older for the management of mild to moderate pain as a sole therapy, and for the management of moderate to severe pain as an adjunct to an opioid.

A series of published clinical studies have demonstrated that Caldolor significantly reduces patient pain, while also significantly reducing patients’ need for opioids.

Ifetroban Clinical Studies

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

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

Patient enrollment is well underway in two company sponsored Phase II clinical programs to evaluate ifetroban in Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs;

and the Cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”), a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.

Cumberland is sponsoring the FIGHT DMD™ trial, a multicenter, randomized, placebo-controlled Phase II study evaluating the safety, pharmacokinetics and efficacy of two doses of oral ifetroban for the treatment of the cardiomyopathy associated DMD.

The trial is evaluating 12 months of oral ifetroban in 24 subjects with early-stage cardiomyopathy and 24 subjects with advanced-stage heart disease across 10 U.S.

centers that specialize in DMD cardiomyopathy.

The safety and efficacy endpoints include left ventricular ejection fraction using cardiac MRI, pulmonary function, quantitative muscle strength, daily activity and quality of life measures.

The FDA Orphan Product Division awarded Cumberland $1 million in funding under its Orphan Products Grants Program to support this trial.

This was the first DMD trial awarded such funding.

In June 2023, we presented results from an interim analysis for the FIGHT DMD TM trial at the 29th annual Parent Project Muscular Dystrophy Conference in Dallas, Texas.

The interim analysis was conducted on data from 25 patients with DMD who completed six of the 12 total months of treatment and assessments.

Both doses of ifetroban were reported well tolerated in DMD participants ages 7 years of age or older.

There was also a positive trend in leg muscle strength, but no statistically significant differences have been identified at this point.

In May 2023, we announced that the FDA has cleared the Investigational New Drug Application for a Phase II study in patients with Idiopathic Pulmonary Fibrosis (“IPF”), the most common form of progressive fibrosing interstitial lung disease.

As a result, we are initiating our FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S.

This Phase II clinical trial will study the safety, tolerability and efficacy of oral ifetroban in patients with IPF.

Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.

We have also completed Phase II clinical programs with ifetroban in patients with Hepatorenal Syndrome, Portal Hypertension and Aspirin Exasperated Respiratory Disease.

Additional preclinical and pilot clinical studies of ifetroban are underway, including several investigator-initiated trials.

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

Sancuso Acquisition and Approval of New Manufacturing Plant

In early 2022, Cumberland acquired the U.S.

rights to the FDA-approved oncology-supportive care medicine Sancuso from Kyowa Kirin, Inc., the U.S.

affiliate of Japan-based Kyowa Kirin Co., Ltd.

Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment.

We assumed commercial responsibility for the product in the U.S.

– including its marketing, promotion, distribution, manufacturing and medical support activities – early last year and, as of September 2023, have fully completed the transition of Sancuso to Cumberland.

In late 2022, the FDA approved moving the product’s manufacturer to a new facility, and the production of supplies for Cumberland at that plant is planned for the fourth quarter of 2023.

In June 2023, we launched an expanded oncology sales division comprised of both field-based and inside sales personnel to feature the product.

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.

International Agreements

During the third quarter of 2022, we signed a new agreement with PiSA Pharmaceutical (“PiSA”) for the exclusive supply and distribution of our ibuprofen injection product in Mexico.

Cumberland will be responsible for sharing the U.S.

dossier and providing product supply, while PiSA will be responsible for obtaining the regulatory approval and then commercializing the product in Mexico.

PiSA expects to provide the product in both 400- and 800-milligram vials.

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

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

In late 2022, we announced a new partnership with Saudi Arabia-based Tabuk Pharmaceutical to introduce Vibativ into the Middle East.

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

Tabuk is in the process of updating the Vibativ registration in Saudi Arabia with new manufacturing information as they also prepare for the launch in that country.

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.

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

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

Pharm also distributes our Caldolor product in South Korea.

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

Pharm also distributes our Caldolor product there.

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

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

Pharm to address.

Meanwhile, our Vibativ partner for the Chinese market, SciClone Pharmaceuticals, had their approval application in China accepted for review in September 2021.

1 unchanged sentence

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

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.

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

Meanwhile, we are working with Nephron to provide interim supplies of a special compounded conivaptan product to the market in support of critically ill patients.

The companies will share in the sales of this compounded product, which is expected to be manufactured and released in the fourth quarter of 2023.

We then expect to file for the approval to manufacture branded Vaprisol once all FDA issues at the Nephron site are resolved.

SEC Settlement

On September 27, 2023, the U.S.

Securities and Exchange Commission (the “SEC”) finalized the settlement of an administrative proceeding involving certain instances where some directors and officers of the Company were late in filing public reports regarding changes in their stock ownership pursuant to Section 16(a) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and that the Company did not make the needed disclosure concerning these late filings in its Annual Report on Form 10-K as outlined in Item 405 of Regulation S-K.

Without admitting or denying the allegations, the Company agreed to pay a $200,000 civil penalty to the SEC and to commit to the timely filing of such needed disclosures in the future.

The Company does not expect this matter to materially impact its business or operations.

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.

We are awaiting availability of those operations, while also exploring other alternatives to restart the product’s packaging.

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

To fulfill this mission we are building a 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.

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

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

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

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

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

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

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

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

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.

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

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

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

CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

9 unchanged sentences

RESULTS OF OPERATIONS

Three months ended September 30, 2023 compared to the three months ended September 30, 2022

The following table presents the unaudited interim statements of operations for continuing operations for the three months ended September 30, 2023 and 2022:

Three months ended September 30,

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,

2024 2023 Change

9 unchanged sentences

Interest income 96,746 50,190 46,556

Other income - settlement 475,000 — 475,000

Other income - insurance proceeds 346,800 — 346,800

Other income — 1,847,065 (1,847,065)

Interest expense (118,526) (186,353) 67,827

3 unchanged sentences

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

Three months ended September 30,

Three months ended March 31,

2024 2023 Change

10 unchanged sentences

Net revenues.

Net revenues for the three months ended September 30, 2023, were $10.1 million compared to $11.4 million for the three months ended September 30, 2022.

As noted in the table above, net revenue increased during the quarter for three of our marketed products:

Vibativ, Caldolor and Acetadote.

Kristalose revenue of $3.9 million for the third quarter of 2023, ended the quarter at the same level as the prior year period.

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.

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

During the third quarter of 2023, there was an increase of $0.02 million in the product's revenue when compared to the prior year period due to an increase in shipments.

There was no Vaprisol revenue for the third quarter of 2023 as Cumberland is currently out of inventory of the product.

We await FDA approval on a new manufacturer.

Caldolor revenue was $1.2 million for the third quarter of 2023, which was $0.2 million higher than the third quarter of 2022 primarily due to increased international shipments.

Vibativ revenue was $2.8 million for the three months ended September 30, 2023, an increase of $0.9 million from the same prior year period.

The increase in net revenue of the product was the result of successful implementation of a series of new initiatives in support of the brand as well as a decline in product returns.

Sancuso revenue was $1.9 million for the third quarter of 2023, compared to $4.0 million for the third quarter of 2022.

The decline resulted primarily from deductions from sales including managed care rebates.

Omeclamox-Pak had no sales for the third quarter of 2023, as Cumberland is currently out of commercial inventory of this product.

The packager for our Omeclamox-Pak product encountered financial difficulties in 2020.

Net revenue for the three months ended September 30, 2023, reflects sales deduction adjustments.

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

Net revenue for the three months ended September 30, 2023, reflects sales deduction adjustments.

Other revenue was $0.3 million for the three months ended September 30, 2023, compared to $0.5 million for the three months ended September 30, 2022.

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.

Cost of products sold .

Co st of products sold for the third quarter of 2023 and 2022 were $1.8 million and $2.2 million, respectively.

Cost of products sold, as a percentage of net revenues, were 17.5% during the three months ended September 30, 2023, compared to 19.5% during the three months ended September 30, 2022.

The improvement in cost of products sold is primarily due to the availability of new lower cost inventory and less inventory write-downs.

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.

Selling and marketing .

Selling and marketing expense for the third quarter of 2023 increased $0.6 million compared to the same period last year.

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

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.

Research and development .

Research and development costs for the third quarter of 2023 and 2022 were $1.9 million and $1.7 million, respectively.

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

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 larger research and development costs for the third quarter of 2023 resulted from an increase in these study costs.

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 third quarter of 2023 was $2.3 million compared to $2.2 million for the same period in 2022.

The increase was primarily due to the settlement of an administrative proceeding with the U.S.

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.

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

Financial Impact of Vibativ Three months ended September 30,

Financial Impact of Vibativ Three months ended March 31,

Net revenue $ 1,605,489 $ 1,848,187

5 unchanged sentences

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

Financial Impact of Sancuso Three months ended September 30,

Financial Impact of Sancuso Three months ended March 31,

Net revenue $ 1,827,769 $ 1,886,793

6 unchanged sentences

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, 2023 and 2022, totaled approximately $1.2 million and $1.5 million, respectively.

The decline in amortization expense resulted from adjustments to the useful life of Sancuso as determined by the valuation of the product in December 2022.

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.

Income taxes .

Income tax expense for the three months ended September 30, 2023, was comparable to the income tax expense for the three months ended September 30, 2022.

As of September 30, 2023, we had approximately $53.2 million in federal net operating loss carryforwards including approximately $44 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 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.

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.

Other income.

In the third quarter of 2023, we recognized a gain of $0.5 million to settle a manufacturing dispute and a $0.3 million for a payout earned on a company owned insurance policy.

RESULTS OF OPERATIONS

Nine months ended September 30, 2023 compared to the nine months ended September 30, 2022

The following table presents the unaudited interim statements of operations for continuing operations for the nine months ended September 30, 2023 and 2022:

Nine months ended September 30,

2023 2022 Change

Net revenues $ 30,199,441 $ 32,887,269 $ (2,687,828)

Costs and expenses:

Cost of products sold 4,536,628 6,468,212 (1,931,584)

Selling and marketing 13,692,535 13,281,511 411,024

Research and development 4,569,476 5,283,083 (713,607)

General and administrative 7,212,731 6,672,442 540,289

Amortization 3,563,493 4,609,146 (1,045,653)

Total costs and expenses 33,574,863 36,314,394 (2,739,531)

Operating loss (3,375,422) (3,427,125) 51,703

Interest income 205,854 52,709 153,145

Other income 2,828,871 — 2,828,871

Other income - settlement 475,000 — 475,000

Other income - insurance proceeds 346,800 611,330 (264,530)

Interest expense (489,069) (406,539) (82,530)

Loss before income taxes (7,966) (3,169,625) 3,161,659

Income tax expense (20,813) (20,700) (113)

Net loss $ (28,779) $ (3,190,325) $ 3,161,546

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

Nine months ended September 30,

2023 2022 Change

Kristalose $ 12,313,321 $ 11,418,673 $ 894,648

Sancuso 5,736,981 10,756,411 (5,019,430)

Vibativ 6,785,592 6,008,005 777,587

Caldolor 3,316,866 3,075,355 241,511

Vaprisol 39,866 (252,059) 291,925

Acetadote 440,071 337,685 102,386

Omeclamox-Pak 28,832 31,925 (3,093)

RediTrex (254,108) 238,712 (492,820)

Other revenue 1,792,020 1,272,562 519,458

Total net revenues $ 30,199,441 $ 32,887,269 $ (2,687,828)

Net revenues.

Net revenues for the nine months ended September 30, 2023, were $30.2 million compared to $32.9 million for the nine months ended September 30, 2022, a decrease of $2.7 million.

Kristalose revenue was $12.3 million during the first nine months of 2023, compared to $11.4 million for the prior year period.

Revenue increased due to an overall increase in units shipped during 2023.

Sancuso revenue was $5.7 million for the nine months ended September 30, 2023, compared to $10.8 million for the same period last year.

The decline resulted primarily from deductions from sales including product returns and managed care rebates.

Vibativ revenue was $6.8 million for the nine months ended September 30, 2023, compared to $6.0 million for the same period last year.

The increase in net revenue of the product was the result of successful implementation of a series of new initiatives in support of the brand as well as a decline in product returns.

There was no Vaprisol revenue for the first nine months of 2023 as Cumberland is currently out of commercial inventory of the product.

Net revenue was positively impacted by various sales adjustments.

Omeclamox-Pak had no sales for the nine months ended September 30, 2023, 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.

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

There was a $0.1 million increase in the product's revenue for the nine months ended September 30, 2023, when compared to the prior year period as a result of a decrease in product returns in 2023.

Caldolor revenue was $3.3 million for the first three quarters of 2023, a $0.2 million increase over 2022.

Higher international revenue is driving the increase.

Other revenue was $1.8 million for the nine months ended September 30, 2023, representing a $0.5 million increase from the same period in 2022, as a result of two milestone payments recognized in 2023.

Cost of products sold .

Co st of products sold for the first nine months of 2023 were $4.5 million, a decrease of $1.9 million compared to the same period last year due to the availability of new lower cost inventory and fewer inventory write downs.

Selling and marketing .

Selling and marketing expense for the nine months ended September 30, 2023, increased $0.4 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 $4.6 million for the first nine months of 2023 compared to $5.3 million for the same period last year.

The primary reason for this decline is $0.7 million in reduced FDA fees.

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 nine months ended September 30, 2023, increased to $7.2 million compared to $6.7 million during the nine months ended September 30, 2022.

In 2023, we experienced an increase in deferred compensation, hiring expenses and the settlement of an administrative proceeding with the U.S.

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

Financial Impact of Vibativ Nine months ended September 30,

Net revenue (1)

$ 7,785,592 $ 6,158,005

Cost of products sold (2)

1,081,001 2,433,061

Royalty and operating expenses 1,738,568 484,057

Vibativ contribution $ 4,966,023 $ 3,240,887

(1) 2023 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 Vibativ Since Acquisition

Net revenue (1)

Cost of products sold (2)

Royalty and operating expenses 8,275,758

Vibativ contribution $ 26,462,211

(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.

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

Financial Impact of Sancuso Nine months ended September 30,

Net revenue $ 5,736,981 $ 11,106,411

Cost of products sold (1)

886,041 1,134,670

Royalty and operating expenses 2,183,209 3,135,140

Sancuso contribution $ 2,667,731 $ 6,836,601

(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 $ 19,292,584

Cost of products sold (1)

Royalty and operating expenses 6,385,235

Sancuso contribution $ 10,477,708

(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 nine months ended September 30, 2023, and nine months ended September 30, 2022, totaled approximately $3.6 million and $4.6 million, respectively.

The decrease was attributable to the valuation of the Sancuso acquisition completed in December 2022.

Income taxes .

Income tax expense for the nine months ended September 30, 2023, was $0.02 million, similar to the income tax expense recognized for the nine months ended September 30, 2022.

Other income.

In 2023, we recognized a $2.8 million refund of FDA fees for the periods of 2022 and 2023 to further the development of our new product candidates.

We recognized a gain of $0.5 million in the third quarter of 2023 associated with a manufacturing dispute settlement as well as expected proceeds of $0.3 million for a payout associated with a company owned insurance policy.

LIQUIDITY AND CAPITAL RESOURCES

2 unchanged sentences

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, 2023 and December 31, 2022:

September 30, 2023 December 31, 2022

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

March 31, 2024 December 31, 2023

Cash and cash equivalents $ 18,548,485 $ 18,321,624

2 unchanged sentences

Revolving line of credit availability $ 3,915,856 $ 7,215,856

The following table summarizes our net changes in cash and cash equivalents for the nine months ended September 30, 2023 and September 30, 2022:

Nine months ended September 30,

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,

Net cash provided by (used in):

3 unchanged sentences

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

The net $1.3 million decrease in cash and cash equivalents for the nine months ended September 30, 2023, was primarily attributable to cash used in investing and financing activities partially offset by cash provided by operating activities.

Cash provided by operating activities totaled $5.1 million for the nine months ended September 30, 2023, primarily the result of the add backs of non-cash expenses including depreciation, amortization and share-based compensation expense totaling $4.0 million.

It also resulted from a decrease of accounts receivable of $0.9 million, a decrease in inventory of $0.4 million and an increase of net accounts payable and other current liabilities of $1.9 million.

It was partially offset by a decrease in non-cash contingent consideration of $1.0 million, an increase in other assets of $0.4 million and a decrease of $0.3 million in other long-term liabilities.

Cash used in investing activities of $0.4 million for the nine months ended September 30, 2023, was the result of additions to property and equipment and intangibles.

Financing activities use of cash totaled $5.9 million for the nine months ended September 30, 2023, and included the repayments on our line of credit of $3.3 million, the $0.6 million in cash used to repurchase shares of our common stock and the $2.1 million used for the payment of a Sancuso milestone, plus royalties on sales of Vibativ and Sancuso.

The $7.5 million decrease in cash and cash equivalents for the nine months ending September 30, 2022, was primarily attributable to cash used in investing and partially offset by cash provided by operating and financing activities.

Cash provided by operating activities totaled $4.8 million for the nine months ending September 30, 2022, primarily the result of the add back of non-cash expenses of depreciation, amortization and share-based compensation expense totaling $5.1 million.

It also resulted from decreases in inventory of $1.3 million, decrease in other assets of $4.4 million and increases in accounts payable and other liabilities of $8.8 million.

This was partially offset by accounts receivable increasing by $8.2 million, mainly from the addition of Sancuso sales, and the decrease in long-term liabilities of $2.5 million.

Cash used in investing activities for the nine months ending September 30, 2022, was the result of the acquisition of Sancuso.

Our financing activities for the nine months ending September 30, 2022, included the increase in our line of credit of $2.7 million partially offset by the $0.9 million in cash used to repurchase shares of our common stock as well as the $1.1 million used for the payment of royalties for sales of Vibativ and Sancuso.

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.

Debt Agreement

6 unchanged sentences

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.

OFF-BALANCE SHEET ARRANGEMENTS

During the nine months ended September 30, 2023 and 2022, we did not engage in any off-balance sheet arrangements.

During the three months ended March 31, 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