What changed in this filing

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Item 1. Business

2023-03-13 compared with 2022-03-11 · 193 added, 133 removed, 861 unchanged (27% of the section changed)

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We are dedicated to providing innovative products that improve the quality of care for patients and address poorly met medical needs.

Our primary target markets are hospital acute care, gastroenterology, rheumatology 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, field and oncology sales divisions in the United States and are establishing 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 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.

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• 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.

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

pylori ) infection and related duodenal ulcer disease;

• RediTrex ® ( methotrexate ) injection, for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as well as disabling psoriasis;

• 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, 2) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by fibrosis of the skin and internal organs and 3) Aspirin-Exacerbated Respiratory Disease (“AERD”), a severe form of asthma.

Cumberland has built core competencies in both the development and commercialization of pharmaceutical products.

We have established the capabilities needed to acquire, develop and commercialize branded pharmaceuticals in the U.S.

and believe we can leverage this existing infrastructure to support our expected growth.

In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidate for patients with cardiomyopathy associated with 1) Duchenne Muscular Dystrophy (“DMD”), a fatal, genetic neuromuscular disease, 2) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by fibrosis of the skin and internal organs and 3) Aspirin-Exacerbated Respiratory Disease (“AERD”), a severe form of asthma.

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

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

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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In early 2020, the U.S.

declared a health care emergency following the outbreak of SARS-CoV-2, a novel strain of coronavirus that causes COVID-19, a respiratory illness.

The Company has managed through the resulting pandemic, continuing to operate our business – keeping facilities open and our organization intact.

declared a health care emergency following the outbreak of SARS-CoV-2, a novel strain of coronavirus that causes COVID-19.

The Company managed through the resulting pandemic, continuing to operate our business – keeping facilities open and our organization intact.

We moved quickly to ensure the health and safety of our team.

We also maintained our ongoing compliance with the many laws and regulations that apply to us as a publicly traded pharmaceutical company.

Throughout the pandemic, Cumberland has faced the same challenges affecting other companies that rely on hospital admissions and patient visits to drive revenue.

Throughout the pandemic, Cumberland faced the same challenges affecting other companies that rely on hospital admissions and patient visits to drive revenue.

Our clinical studies were also impacted, as fewer patients sought elective surgeries and our access to medical facilities was substantially limited.

We carefully monitored our supply chain, including the flow of raw materials and the batches of finished products emerging from the facilities that manufacture our products.

Several of our brands were negatively impacted by the lockdowns and postponement of physician office visits and elective procedures.

However, we are fortunate to have a diversified product portfolio that includes other brands that have delivered a strong performance during the pandemic.

Despite the challenges of operating during a pandemic, Cumberland has remained committed to our mission of providing innovative products that improve the quality of care for patients and address poorly met medical needs.

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

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

We are prepared for and look forward to future opportunities to carry out our mission.

Overall, we have been able to continue the delivery of our products while addressing the interests of our shareholders, employees, partners and community.

In July 2021, we released our second annual Sustainability Report (the “2020 Sustainability Report”), which details Cumberland’s activities pertaining to our environmental, social and governance (“ESG”) matters.

After issuing our inaugural ESG Report the prior year (the “2019 Sustainability Report”), we remain committed to sustainability and to maintaining transparency of our corporate operations.

We welcomed a return to a more typical operating environment as 2022 progressed, following the economic and societal effects of the pandemic.

We were encouraged to see enrollment in our clinical trials resume, patient procedures return to more customary levels and access for our sales representatives improve as they gained more face-to-face meetings with medical professionals.

In 2022, we continued to expand our product portfolio, starting the year with the announcement of our Sancuso acquisition from the U.S.

affiliate of Japan-based Kyowa Kirin.

With significant contributions from Sancuso, we experienced strong year-over-year revenue growth.

Throughout the year we continued our mission, delivering our products to improve patient care, while also addressing the interests of our shareholders, employees, partners and community.

New Headquarters

In late October 2022, we opened our new headquarter offices at the Broadwest campus in the Vanderbilt/West End corridor of Nashville.

Our move into the new state-of-the-art facilities will enable the Company to accommodate our growth, support our team, and better serve our international base of customers and partners.

Sustainability Report

In August 2022, we released our second annual Sustainability Report (the “2021 Sustainability Report”), which detailed Cumberland’s activities pertaining to our environmental, social and governance matters.

We issued our inaugural Sustainability Report in 2019 and remain committed to sustainability and to maintaining transparency of our corporate operations.

As the largest biopharmaceutical company founded and headquartered in the Mid-South, we hold ourselves to the highest standards of ethical practices and understand the importance of recognizing and addressing our impact on our constituents, the community and the environment.

The 2020 Sustainability Report notes that during that year we provided nearly 2.5 million patient doses of our products, safely disposed of over 4,000 pounds of expired and damaged products and had no product recalls.

The 2021 Sustainability Report noted that during that year we provided nearly 2.5 million patient doses of our products, safely disposed of over 6,000 pounds of expired and damaged products and had no product recalls.

We also had no Company brands listed on the FDA’s MedWatch Safety Alerts for Human Medical Products, no Company product issues identified by the FDA’s Adverse Event Reporting System and no clinical trials terminated due to failure to practice good clinical standards.

The 2020 Sustainability Report also highlights our investment in our employees through our continuing education programs, employee development initiatives and employee recognition awards.

The 2021 Sustainability Report also highlighted our investment in our employees through our continuing education programs, employee development initiatives and employee recognition awards.

We reported that women represented 44% of Cumberland’s workforce and 15% of our employees were minorities.

Through our sustainability initiatives, we will continue to identify and address critical industry issues, monitor relevant guidelines and utilize best practices.

Cybersecurity

The Company has taken appropriate steps to monitor an adequate level of cybersecurity.

The Company is insured against cyber attacks and has appropriate detection and mitigation controls in place.

Additional Information

We were incorporated in 1999 and have been headquartered in Nashville, Tennessee since inception.

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It is provided in a pre-mixed bag containing 800 mg of ibuprofen in a 200 mL patented low sodium formulation for injection that is ready to use.

It is the first and only FDA-approved pre-mixed bag of ibuprofen.

It is the first and only

FDA-approved pre-mixed bag of ibuprofen.

Caldolor is still available as an 800 mg/8mL single–dose vial for dilution in addition to the ready-to-use bag.

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Unfortunately, the launch was impacted by the COVID-19 pandemic and the resulting postponement of elective surgeries.

Nonetheless, we expect an improved performance of the product after the pandemic abates and more accounts gain access to the new presentation.

During 2021, we distributed both the vial and the ready-to-use premixed bag presentations of Caldolor.

In November 2021, the FDA approved our submission to expand the labeling for Caldolor to include administration of the product prior to surgery.

During our clinical studies we found that the product delivered its best results when dosed prior to surgery, reducing both patient pain as well as their need for opiates.

During 2022, we distributed both the vial and the ready-to-use premixed bag presentations of Caldolor.

We also announced an agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor in Mexico.

Under the terms of the agreement, Cumberland will be responsible for providing the product dossier and supplies.

PiSA will be responsible for obtaining regulatory approval for the product in Mexico and introducing it to the new market.

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

Kristalose is a prescription laxative administered orally for the treatment of acute and chronic constipation.

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During 2022, we continued to support Kristalose through our field sales force as well as our partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals, Inc.

The Kristalose award-winning marketing campaign was refreshed for 2022 to support increased engagement with our customers.

We also expanded patient support for the brand and it was added to the GoodRx platform during the year.

Omeclamox-Pak ®

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We acquired the assets and exclusive rights to Omeclamox-Pak through a series of transactions and re-launched the product as a Cumberland brand supported by our field sales force.

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

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

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

We have entered into an exclusive license and supply agreement to register and commercialize a methotrexate product line in the United States.

RediTrex is a new line of pre-filled syringes specifically designed for ease of handling and dosing accuracy for the subcutaneous administration of methotrexate in patients with arthritis and psoriasis.

The packager for Omeclamox-Pak encountered financial difficulties due to the impact of COVID-19.

They are under new management and are in the process of a reorganization.

Discussions with the packager are ongoing.

We entered into an exclusive license and supply agreement to register and commercialize a methotrexate product line in the United States.

RediTrex is a line of pre-filled syringes specifically designed for ease of handling and dosing accuracy for the subcutaneous administration of methotrexate in patients with arthritis and psoriasis.

RediTrex treats patients with severe, active rheumatoid arthritis, and polyarticular juvenile idiopathic arthritis who have difficulty tolerating or responding to orally delivered methotrexate.

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Due to the pandemic, we delayed the national launch of the product, which was then implemented during the fourth quarter of 2021.

During 2022, we entered into two amendments to our agreement with Nordic Pharma, who had provided us with a license for the U.S.

rights associated with our RediTrex line.

Pursuant to these amendments, in exchange for financial consideration, Nordic may assume responsibility for distributing the methotrexate products in the U.S.

after June 30, 2023.

At the end of 2021, we entered into an agreement with Kyowa Kirin to acquire the U.S.

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– including its marketing, promotion, distribution, manufacturing, and medical support activities.

Kyowa Kirin will retain international rights, continuing to deliver the product to address oncology patients’ needs throughout the rest of the world.

Kyowa Kirin retained international rights, continuing to deliver the product to address oncology patients’ needs throughout the rest of the world.

In January 2022, we began shipments of the product and formed a new sales force, Cumberland Oncology, to support the brand.

During this past year, we completed the transition of Sancuso from Kyowa Kirin to Cumberland.

We have already seen Sancuso quickly become one of our most important brands and a significant contributor to our business.

We acquired the assets and rights to Vaprisol, a prescription brand indicated to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia.

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

We have transferred manufacturing of the product to a new manufacturing facility, and await the submission and FDA approval for the new facility before resuming shipments.

We are also exploring alternatives for providing an interim supply to the market while awaiting the needed approval.

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

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

Meanwhile, we are working with them to support a special, interim supply of compounded product for critically ill patients, while awaiting the needed facility approval to relaunch Vaprisol.

In November 2018, the Company announced an agreement to acquire the Vibativ assets and assume global responsibility for the brand including the related marketing, distribution, manufacturing and regulatory activities.

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Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

Vibativ can serve as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from infections including the flu and COVID-19.

Vibativ can serve as a potentially life-saving treatment in patients with hospital-acquired and ventilator-associated pneumonia resulting from infections including the flu, RSV and COVID-19.

Pneumonia caused by secondary bacterial infections is common among patients with viral respiratory infections.

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The molecule of an existing antibiotic to which bacteria had developed a resistance, vancomycin, was altered by adding a lipophilic (fat-loving) component and a hydrophilic (water-loving) component.

The lipophilic addition increases Vibativ’s ability to penetrate the cell wall and inhibits the formation of new cell walls (the development of new and/or additional cell walls is the most common way that bacteria become resistant to drugs).

The lipophilic addition

increases Vibativ’s ability to penetrate the cell wall and inhibits the formation of new cell walls (the development of new and/or additional cell walls is the most common way that bacteria become resistant to drugs).

The hydrophilic addition increases Vibativ’s penetration into tissue – so it is able to attack infections that are not reachable by other antibiotics.

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Further, in clinical trials, Vibativ demonstrated superior cure rates of patients with hospital-acquired bacterial pneumonia.

While we remain focused on promoting Vibativ in the U.S.

market, we are building a network of other established companies to bring Vibativ to patients in their countries and territories.

In March 2022, we announced the launch of Vibativ in Puerto Rico through a partnership with Verity Pharmaceuticals, who has a particular strength and experience in that market.

Also in March 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.

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

We have since been supporting SciClone and their requests associated with review of that submission.

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

Ifetroban Clinical Studies

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

Follows is more information about the clinical programs in which we are evaluating ifetroban:

Following is more information about the clinical programs in which we are evaluating ifetroban:

Aspirin-Exacerbated Respiratory Disease (“AERD”)

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approved pharmaceutical treatment for AERD.

Preclinical studies at Harvard revealed that ifetroban blocks all features of the asthma reaction triggered by aspirin highlighting the important role of TPr in AERD.

Our Harvard collaborators were awarded a $5 million National Institutes of Health grant to evaluate oral ifetroban in approximately 45 AERD patients undergoing aspirin desensitization in a phase II clinical trial.

Patient enrollment in this trial is well underway.

Researchers at Brigham and Women’s Hospital have completed an investigator-initiated study evaluating the impact of ifetroban on the aspirin desensitization process in patients with AERD.

This single center study closed early due to poor patient accrual and exhausted funding.

The researchers found no statistical difference in the dose of aspirin needed to provide an increase in an extended version of the patient’s total nasal symptom score.

The researchers are pursuing a publication of the full study results.

It should be noted that the results from this investigator study were inconsistent with the previously published preclinical findings that demonstrated ifetroban blockade inhibited all features of aspirin reactions in a model of AERD.

It also differs in design from our corporate-sponsored AERD studies.

We completed an initial Phase II clinical study at several U.S.

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A follow-on phase II study designed to evaluate the safety and efficacy of eight weeks of oral ifetroban entitled, A Phase 2 Multicenter, Double-blind, Randomized, Placebo- Controlled Trial to Evaluate Oral Ifetroban in Subjects with Symptomatic Aspirin Exacerbated Respiratory Disease (“AERD”) , was then initiated.

The study is progressing with patient enrollment ongoing at multiple U.S.

The patient enrollment in that study is now closed, and we are awaiting the completion of the data analysis and availability of top line study results.

Systemic Sclerosis (“SSc”)

Next, we initiated the clinical development of ifetroban oral capsules under the brand name Vasculan ® for the treatment of Systemic sclerosis , also called scleroderma.

We have also initiated the clinical development of ifetroban oral capsules under the brand name Vasculan ® for the treatment of Systemic sclerosis , also called scleroderma.

It’s a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, including the heart, as well as vascular dysfunction.

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Our Vanderbilt collaborators completed preclinical studies demonstrating TPr blockade with ifetroban prevents cardiac fibrosis and can restore cardiac function in animal models of PAH.

The FDA cleared our IND application to evaluate 12 months of oral ifetroban (Vasculan) in a 34-subject phase II trial entitled, A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients with Diffuse Cutaneous Systemic Sclerosis or Systemic Sclerosis-Associated Pulmonary Arterial Hypertension.

Enrollment in this study is also well underway and includes patients with diffuse cutaneous SSc, as well as those with pulmonary arterial hypertension associated with their SSc.

The FDA cleared our Investigational New Drug (IND) application to evaluate 12 months of oral ifetroban (Vasculan) in a 34-subject phase II trial entitled, A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients with Diffuse Cutaneous Systemic Sclerosis or Systemic Sclerosis-Associated Pulmonary Arterial Hypertension.

Enrollment in this study is well underway and includes patients with diffuse cutaneous SSc, as well as those with pulmonary arterial hypertension associated with their SSc.

Duchenne Muscular Dystrophy (“DMD”)

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These results, published in the Journal of the American Heart Association, suggest TPr activation contributes to DMD cardiomyopathy and blockade with ifetroban may serve as a novel therapeutic for DMD patients.

The FDA cleared Cumberland’s application to evaluate 12 months of oral ifetroban (Dyscorban) in a Phase II study entitled, A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study with an Open-Label Extension to Determine the Safety, Pharmacokinetics and Efficacy of Oral Ifetroban in Subjects with Duchenne Muscular Dystrophy .

The FDA cleared Cumberland’s IND application to evaluate 12 months of oral ifetroban (Dyscorban) in a Phase II study entitled, A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study with an Open-Label Extension to Determine the Safety, Pharmacokinetics and Efficacy of Oral Ifetroban in Subjects with Duchenne Muscular Dystrophy .

With medical centers across the U.S.

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As a result of the COVID-19 pandemic and its global impact on clinical research in 2020, the FDA awarded a supplemental grant in support of our Phase II DMD study.

Progressive Fibrosing Interstitial Lung diseases (“PF-ILDs”)

During 2022, patient enrollment in this DMD study continued.

Progressive Fibrosing Interstitial Lung Diseases

In September 2021, our Board of Directors approved a new clinical program for the use of ifetroban to treat Progressive Fibrosing Interstitial Lung Diseases (“PF-ILDs”).

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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.

New Hospital Product Candidate

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A Phase II study has been initiated and patient enrollment is complete.

We have also completed the clinical study report, filed it with the FDA and are now determining the next steps for this program.

We have also completed the clinical study report, filed it with the FDA and continue to consider any next steps for this program.

GROWTH STRATEGY

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

We currently feature eight, including Sancuso, FDA products approved for sale in the United States.

Through our international partners, we are also working to bring our medicines to patients in their countries.

We currently feature eight products approved by the FDA in the United States.

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

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

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We continue to evaluate our products following their FDA approval to determine if additional clinical data could expand their market and use.

We will continue to explore opportunities for label expansion to bring our products to new patient populations.

As examples, we have secured pediatric approval, expanding the labeling for both our Acetadote and Caldolor brands.

For example, we have secured pediatric approval of Acetadote and Caldolor and are expanding the labeling for both brands accordingly.

We also recently further expanded the labeling for Caldolor to allow its use prior to surgery.

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

• Selectively adding complementary brands.

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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.

Our acquisition of Vibativ and Sancuso are examples of this strategy.

Progressing clinical pipeline and incubate 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.

Our acquisition of Sancuso is an example 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 through 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.

CET partners with universities and other research organizations to develop promising, early-stage product candidates, which Cumberland has the opportunity to further develop and commercialize.

• Leveraging our infrastructure through co-promotion partnerships.

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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 our network of international partners while supporting our partners’ registration and commercialization efforts in their respective territories.

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

For example, we have new partnerships Tabuk Pharmaceutical for Vibativ in Saudi Arabia and PiSA Pharmaceutical for Caldolor in Mexico.

• Managing our operations with financial discipline.

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

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

We remain in a strong financial position, with favorable gross margins and positive cash flow from operations.

SALES AND MARKETING

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Our strategy has been to focus our hospital sales team on select, high-priority accounts.

Gastroenterology and rheumatology market:

We promote Kristalose, Omeclamox-Pak and RediTrex through a dedicated field sales team addressing a targeted group of physicians who are large prescribers of the products.

Because the markets for gastrointestinal and rheumatology diseases are broad in patient scope, yet relatively narrow in physician base, we believe they provide opportunities that can be penetrated with a modest sized sales force.

We believe that we can increase market share for these products through our sales and marketing activities.

Gastroenterology market:

We promote Kristalose and Omeclamox-Pak through a dedicated field sales team addressing a targeted group of physicians who are large prescribers of the products.

Because the market for gastrointestinal diseases is broad in-patient scope, yet relatively narrow in physician base, we believe it provides opportunities that can be penetrated with a modest-sized sales force.

We also believe that we can increase market share for these products through our sales and marketing activities.

Oncology market:

In early 2022, we formed a new oncology sales force to promote our Sancuso brand.

This division is initially comprised of seven individuals who formerly supported Sancuso for Kyowa Kirin.

This organization targets key oncologists and clinics across the U.S.

and is comprised of both insider and field based sales professionals.

This initial group can be expanded through additional personnel or augmented through a co-promotion partner.

and is comprised of both inside and field-based sales professionals.

The division is initially comprised of seven individuals who formerly supported Sancuso for Kyowa Kirin.

This initial group can be expanded through additional personnel or augmented through co-promotion arrangements.

Our commercial executives conduct ongoing analyses to evaluate marketing campaigns and promotional programs in support of our brands.

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Our national accounts team is responsible for key large buyers and related marketing programs.

This team maintains relationships with our wholesaler customers as well as with third-party payors such as group purchasing organizations, pharmacy benefit managers, hospital buying groups, out-patient centers, state and federal government purchasers and health insurance companies.

This team maintains relationships with our wholesaler customers as well as with third-party payors such as group purchasing organizations, pharmacy benefit managers, hospital buying groups, outpatient centers, state and federal government purchasers, and health insurance companies.

MATERIAL CUSTOMERS

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International Partner Product(s) Territory Status

Phebra Pty Ltd Acetadote Australia and New Zealand Marketed

Phebra Pty Ltd Acetadote & Caldolor Australia Marketed

DB Pharm Korea Co., Ltd.

Caldolor South Korea Marketed

Seqirus (a CSL company) Caldolor Australia and New Zealand Marketed

Sandor Medicaids Pvt.

Caldolor India, Pakistan, Bangladesh and Nepal Marketed

Caldolor India Marketed

GerminMED Caldolor Qatar Marketed

R-Pharm JSC Vibativ Russia Marketed

Tabuk Pharmaceuticals, Inc.

Vibativ Saudi Arabia and Jordan Registration

PiSA Pharmaceutical Caldolor Mexico Registration

SciClone Pharmaceuticals, Inc.

Vibativ China and Hong Kong Registration

DB Pharm Korea Co., Ltd.

Vibativ & Vaprisol South Korea Registration

WinHealth Pharma Group Co.

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• Remitting any upfront, regulatory and sales milestone payments;

• Providing the transfer price for supplies of product;

• Providing the transfer price for supplies of the product;

• Calculating and paying any royalties, as applicable.

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• Sharing our marketing strategy, experience and materials for the brand;

• Manufacturing and providing finished product for sale.

• Manufacturing and providing the finished product for sale.

During 2022, we worked to support our existing international partners, conclude unproductive arrangements and identify new companies to represent our products in select additional territories.

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We have continued to build our product portfolio of complementary, niche brands largely through product acquisitions and late-stage development of product candidates.

Our primary targets are under-promoted, FDA - approved drugs with existing brand recognition and late-stage development product candidates that address unmet or poorly met medical needs in the hospital acute care and gastroenterology, rheumatology and oncology markets.

We believe that by focusing mainly on approved or late-stage products, we can minimize the significant risk, cost and time associated with drug development.

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WinHealth has established partnerships with international companies that include Boehringer-Ingelheim, Janssen, Novartis, Pfizer and Roche, generating several hundred million dollars in sales annually.

In August 2020, we entered into an agreement with WinHealth Investment (Singapore) Ltd creating WHC Biopharmaceuticals, Pte.

In August 2020, we entered into an agreement with WinHealth Investment (Singapore) Ltd.

creating WHC Biopharmaceuticals, Pte.

The joint venture will focus on acquiring, developing, registering, and commercializing development stage and commercial stage biopharmaceuticals for China, Hong Kong and other Asian markets.

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R-Pharma is one of the leading multinational pharmaceutical organizations based in Russia.

Headquartered in Moscow and focusing in a wide breadth of therapeutic areas in the specialty and hospital care markets, R-Pharma generates $1 billion in annual revenue.

Headquartered in Moscow and focusing on a wide breadth of therapeutic areas in the specialty and hospital care markets, R-Pharma generates $1 billion in annual revenue.

R-Pharma has registered Vibativ in Russia and during 2022, continued to purchase supplies of the product for that market.

In late 2021 we entered into a new agreement with R-Pharma for the terms associated with the supply of Vibativ for greater Russian territory.

SciClone Pharmaceuticals (Holdings) Limited (“SciClone”) has licensed our Vibativ product for sale and distribution in China and several adjacent countries.

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In June 2021, SciClone submitted an application to the Chinese regulatory authority for the approval of Vibativ in that country.

In October 2021, we were informed by SciClone that the filing was accepted by the regulatory agency for review.

SciClone expects a review period of up to twelve months for their application and believes that the potential for Vibativ in China may be significant.

In October 2021, SciClone informed us that the filing was accepted by the regulatory agency for review.

SciClone is in the review period of their application and believes that the potential for Vibativ in China may be significant.

In August 2021, we signed an agreement with Verity Pharmaceuticals International Limited (“Verity”) to license and commercialize our Vibativ product in Puerto Rico.

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They have a particular strength and experience in the Puerto Rican market.

In March 2022, we established distribution for our Vibativ product in the Middle East through a partnership with Tabuk Pharmaceutical Manufacturing Company.

Through our partnership, Tabuk will introduce the product in Saudi Arabia, Jordan and potentially other countries in the Middle East.

In October 2022, we announced an agreement with PiSA Pharmaceutical for the registration and commercialization of Caldolor in Mexico.

Under the terms of the agreement, Cumberland will be responsible for providing the product dossier and supplies.

PiSA will be responsible for obtaining regulatory approval for the product in Mexico and introducing it to the new market.

Verity Co-Promotion Agreement

In April 2022, we entered into an agreement with Verity Pharmaceuticals International Limited (“Verity”) for the national co-promotion of Sancuso®.

Verity is a specialty pharmaceutical company that agreed to utilize its established oncology commercial organization to co-promote Sancuso throughout the United States.

Verity was to provide sales representation in the U.S.

market for an initial three-year term, with an option to extend for an additional two years.

In January 2023, we sent a 30-day notice of default to Verity due to failure of the parties to reach agreement regarding fundamental elements of the agreement, including targets and detailing obligations, among other items.

As a result, the agreement t erminated effective February 25, 2023.

We hope to work with Verity to seek a new arrangement for their continued co-promotion of Sancuso.

Poly Co-Promotion Agreement

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Poly’s sales organization is more than doubling the number of nationwide physicians that are reached with the Kristalose brand message.

During 2019, we extended our co-promotion arrangement with Poly.

In 2019, we extended our co-promotion arrangement with Poly.

2R and Foxland Agreements

During 2018, we entered into another co-promotion arrangement related to our Kristalose product.

In 2018, we entered into another co-promotion arrangement related to our Kristalose product.

We have agreements with 2R Investments, LLC and with Foxland Pharmaceuticals, Inc.

to package, distribute and promote an authorized generic form of our Kristalose product to physician targets that we do not cover.

("Foxland") to package, distribute and promote an authorized generic form of our Kristalose product to physician targets that we do not cover.

We renewed our agreement with Foxland in 2022.

Nordic License Agreement

We acquired the exclusive U.S.

rights to Nordic Group B.V.'s injectable methotrexate product line.

The product line is approved for patient use in various European countries.

Cumberland has registered and is commercializing the methotrexate products under the brand name RediTrex.

The products are designed for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis, severe psoriatic arthritis, and severe disabling psoriasis.

Following the FDA approval for RediTrex, we began introducing the product line during 2020 and commenced the full national launch in October 2021.

In July 2022, we entered into an amendment to our agreement with Nordic Pharma (“Nordic”) that addresses the responsibilities and financial arrangements regarding our license to Nordic’s methotrexate line of products for the U.S.

Our line of prefilled methotrexate syringes, marketed under the brand name RediTrex in the U.S., is covered by the license.

Based on the amendment, Nordic may assume responsibility for commercializing the methotrexate products in the U.S.

after June 30, 2023.

We will continue to distribute and support the RediTrex product line during a transition period until then.

Following the return of the license, Nordic will provide us with a royalty on their future sales of the products through April 2035.

The companies will continue to collaborate on any transition and the ongoing commercialization of the product line.

Cumberland transferred the marketing authorization associated with the RediTrex product line to Nordic.

Nordic returned the 180,000 shares we issued to them that were associated with the license and refunded the $1 million we paid them following the brand’s approval in the U.S.

Nordic has also issued a credit note in favor of Cumberland in the amount of $1 million for the unpaid milestone payment due from us which was associated with our launch of the product line.

Clinigen Strategic Dissolution Agreement

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to identify, co-develop and seek grant funding for promising biomedical technologies emerging from those research institutions.

CET is collaborating with Vanderbilt University, the University of Mississippi, the University of Tennessee Research Foundation, Louisiana State University, and the Medical University of South Carolina.

CET has entered into a series of agreements to access and collaborate on the development of innovative product candidates.

CET is collaborating with Vanderbilt University and other regional academic research institutions and has entered into a series of agreements to access and collaborate on the development of innovative product candidates.

These arrangements enable CET to team with university-based researchers to advance their scientific discoveries and breakthroughs by designing new product candidates to improve patient care and address unmet medical needs.

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• creating case report forms and other study-related documents;

• analyzing efficacy and safety data obtained from clinical trials for subsequent submissions and approval of new drugs.

Regulatory and Quality Affairs

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• monitoring applicable third-party service providers for quality and compliance with current Good Manufacturing Practices ("GMPs"), Good Laboratory Practices ("GLPs"), and Good Clinical Practices ("GCPs"), and performing periodic audits of such vendors;

• maintaining systems for document control, product and process change control, customer complaint.

• maintaining systems for document control, product and process change control and customer complaints.

PROFESSIONAL AND MEDICAL AFFAIRS

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We have been evaluating our ifetroban product candidate in a series of clinical studies.

We have three Phase II clinical programs underway evaluating our ifetroban product candidates in 1) Aspirin-Exacerbated Respiratory Disease, a severe form of asthma, 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 3) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy , a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.

We have three Phase II clinical programs underway evaluating our ifetroban product candidate in 1) Aspirin-Exacerbated Respiratory Disease, a severe form of asthma, 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 3) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy , a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.

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

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Enrollment in our clinical studies was interrupted during 2021 and 2020 due to the COVID-19 pandemic.

Many of our clinical study sites have reopened and resumed screening of patients for potential enrollment into our studies.

In 2022, many of our clinical study sites have reopened and resumed screening of patients for potential enrollment into our studies.

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

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A Phase II study has been initiated and patient enrollment completed.

We have completed the study report, filed it with the FDA and are now determining the next steps for this product development program.

We have completed the study report, filed it with the FDA and continue to consider next steps for this product development program.

Additional Testing Program

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Initial annual grants by the Foundation have been and remain consistent with the historic level of contributions made by Cumberland Pharmaceuticals.

During 2021, we provided approximately $25,000 in cash contributions to the Foundation.

Cumberland Health and Wellness Political Action Committee

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We have an agreement for the purchase of Kristalose API with an international supplier.

We also had manufacturing relationships with two packagers who provided finished supplies of the product for commercial and sampling purposes during 2021.

We will continue with one of those facilities in 2022.

We also had manufacturing arrangements with a packager who provided finished supplies of the product for commercial and sampling purposes during 2022.

Omeclamox-Pak ®

During 2020, the packager for Cumberland’s Omeclamox-Pak product encountered financial difficulties due to the economic impact of COVID-19, and their operations suspended.

Cumberland is awaiting resumption of those operations while also exploring other alternatives to restart the product’s packaging.

We informed the FDA of a shortage of the Omeclamox-Pak in October 2020, and have not provided a date for the availability of new inventory.

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

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

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

In 2016, we entered into an agreement to acquire the exclusive U.S.

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Our licensor is responsible for providing us the packaged and labeled commercial supply of the product.

During 2022, we entered into two amendments to our agreement with Nordic Pharma.

Pursuant to the amendments, in exchange for financial consideration, Nordic may assume responsibility for distributing the methotrexate products in the U.S.

after June 30, 2023.

As part of the acquisition of Sancuso, we obtained an initial supply of finished goods inventory.

The agreement with the manufacturer of Sancuso was assigned to us and there are additional lots planned for 2022 which will provide us with additional supplies.

The agreement with the manufacturer of Sancuso was assigned to us and there were additional goods supplied to us during 2022.

The production is in the process of being moved to one of the manufacturer’s other facilities.

Data is being developed to support the transfer which will require FDA approval.

In late 2022, that new facility was approved by the FDA to manufacture and supply Sancuso.

As part of the acquisition of Vaprisol, we obtained a significant existing supply of raw material inventory.

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We informed the FDA that supplies of the product are not currently available and are awaiting approval for that new facility.

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

Meanwhile, we are working with them to support a special, interim supply of compounded product for critically ill patients, while awaiting the needed facility approval to relaunch Vaprisol.

Through our acquisition of Vibativ, we obtained a multi-year supply of raw material, work in process and finished goods inventory.

As a result of the agreement, we are now responsible for the future manufacture of the product and completed the transfer of the product’s manufacturing activities to a new supplier and received FDA approval for that facility.

As a result of the agreement, we are now responsible for the future manufacturing of the product.

We completed the transfer of the product’s manufacturing activities to a new supplier and received FDA approval for that facility.

Like many pharmaceutical companies, we engage a third-party with appropriate facilities and logistical expertise to support the U.S.

distribution of our products.

In 2021, Cardinal Health Specialty Solutions has exclusively handled our U.S.

In 2022, Cardinal Health Specialty Solutions exclusively handled our U.S.

product logistics activities, including warehousing, shipping, and various other customer activities.

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We also require confidentiality agreements from entities to which we provide our confidential information or materials.

We developed a new formulation of Acetadote (acetylcysteine) Injection as part of a Phase IV commitment in response to a request by the FDA to evaluate the reduction of ethylene diamine tetraacetic acid ("EDTA") from the product's formulation.

product's formulation.

In April 2012, the USPTO issued U.S.

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Following its issuance, the 284 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2029.

We also have additional patent applications related to Caldolor which are pending with the USPTO.

We also have additional patent applications related to Caldolor pending with the USPTO.

We own numerous U.S.

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These patents were acquired in our November 2018 acquisition of certain product rights, intellectual property and related assets of Vibativ from Theravance.

Three Vibativ patents are listed in the FDA Orange Book.

Two Vibativ patents are listed in the FDA Orange Book.

Patent number 7,531,623 (the “623 Vibativ Patent”) is scheduled to expire in January 2027 and includes composition of matter claims that encompass the Vibativ drug substance as well as methods for preparing the Vibativ drug substance.

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Remaining Products

We have no issued patents for our Vaprisol, RediTrex, Omeclamox-Pak and Kristalose products.

We have no issued patents for our Vaprisol, RediTrex, Omeclamox-Pak or Kristalose products.

We have multiple granted patents relating to our ifetroban products and patent applications pending with the USPTO.

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Our branded Acetadote now competes with both the EDTA free Authorized Generic Acetadote distributed by Paddock and Perrigo along with generic Acetadote products that contain EDTA.

Manufactures of the old Acetadote formulation include:

Manufacturers of the old Acetadote formulation include:

Akorn, AuroMedics Pharma, Fresenius Kabi and Sagent Pharmaceuticals.

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• IV acetaminophen (brand name Ofirmev ®) , an injectable analgesic product is sold by Mallinckrodt plc, and there are also generic versions from different manufacturers available;

• Bupivacaine injectable suspension (brand name Exparel ® ), product sold by Pacira Pharmaceuticals, Inc., two additional bupivacaine products, Xaracoll and Posimir, were recently approved;

• IV meloxicam (brand name Anjeso™), a once a day injectable COX-2 preferential NSAID manufactured by Baudax Bio which was recently approved by the FDA.

• Bupivacaine injectable suspension (brand name Exparel ® ), product sold by Pacira Pharmaceuticals, Inc., two additional bupivacaine products, Xaracoll and Posimir, were more recently approved.

We are aware of other product candidates in development to treat acute pain including injectable NSAIDs, novel opioids, new formulations of existing therapies and extended release anesthetics.

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Each patch delivers up to 5 days of treatment with granisetron, a standard of care for CINV, through the skin.

Recommended treatment suggests the patch be applied 24 to 48 hours prior to chemotherapy treatment and remain in place for 5 days.

Recommended treatment suggests the patch be applied 24 to 48 hours prior to chemotherapy treatment and remain in place for five days.

While there are no other transdermal products available to treat CINV, there are a large number of generic and branded oral products as well as a limited number of injectables.

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If not, a complete response letter will be sent to applicants indicating that the review cycle for an application is complete and that the application is not ready for approval.

The complete response letter will describe the specific deficiencies that the agency has identified in an application and what changes must be made before the application can be approved, with no implication regarding whether the application will ultimately be approved.

whether the application will ultimately be approved.

An approval letter authorizes commercial marketing of the drug for the proposed indication(s) under study.

While the FDA's PDUFA 2021 Performance Report showed a continued increase in the percentage of first-cycle approval letters for new molecular entities rising from 56% for FY 2009 to preliminary reports of 100% for FY 2021, we cannot be certain that timely first-cycle approvals will be maintained by the FDA.

The time and cost of completing these steps and obtaining FDA approval can vary dramatically depending on the drug.

However, to complete these steps for a novel drug can take many years and cost millions of dollars.

While the time and cost of completing these steps and obtaining FDA approval can vary dramatically depending on the drug, it can take many years and cost millions of dollars for a novel drug.

Section 505(b) New Drug Applications

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Generally new studies are required to provide data on the proposed change.

Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs which have a new dosage form, strength, route of administration, formulation or indication or combination drugs.

Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration, formulation or indication or combination drugs.

Marketing exclusivity for a 505(b)(2) submission is three years.

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Section 505(j) abbreviated new drug applications

An ANDA is a type of NDA where approval of a generic drug is based on demonstrating comparability to an innovator drug product (the RLD or Reference Listed Drug).

An abbreviated new drug application ("ANDA") is a type of NDA where approval of a generic drug is based on demonstrating comparability to an innovator drug product (the RLD or Reference Listed Drug).

Applications are "abbreviated" because they generally don't include preclinical and clinical data to establish safety and effectiveness.

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Physician Payments Sunshine Act:

The PPACA also includes provisions known as the Physician Payments Sunshine Act, or Sunshine Act, which require manufacturers of pharmaceuticals and medical devices covered under Medicare and Medicaid to record any transfers of value to physicians and teaching hospitals and to report this data to the Centers for Medicare and Medicaid Services, or CMS, for aggregation and subsequent public disclosure.

The PPACA also includes provisions known as the Physician Payments Sunshine Act, or Sunshine Act, which requires manufacturers of pharmaceuticals and medical devices covered under Medicare and Medicaid to record any transfers of value to physicians and teaching hospitals and to report this data to the Centers for Medicare and Medicaid Services, or CMS, for aggregation and subsequent public disclosure.

Under the Sunshine Act, beginning August 1, 2013, we have collected data regarding reportable transfers of value and have reported such data to CMS.

Failure to report appropriate data may result in civil or criminal fines and/or

Failure to report appropriate data may result in civil or criminal fines and/or penalties.

In addition to the Federal Sunshine Act, similar reporting requirements have also been enacted on the state level requiring transparency of interactions with health care professionals.

Medicaid Rebate Rate:

Under the Medicaid Drig Rebate probram we currently are required to provide rebates for covered outpatient drugs that are dispensed to Medicaid beneficiaries.

In addition, we also are required to participate in the Public Health Service's 340B drug pricing program, which requires us to agree to charge no more than a designated ceiling price for covered outpatient drugs that are dispensed to community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients.

Under the Medicaid Drug Rebate program we currently are required to provide rebates for covered outpatient drugs that are dispensed to Medicaid beneficiaries.

entities that receive health services grants from the Public Health Service, as well as hospitals that serve a disproportionate share of low-income patients.

Product Serialization:

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The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision-making process.

The Cures Act enhances FDA's ability to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

Specifically, the Cures Act enables us to work with FDA in the development of new biomarkers, clinical outcome assessments, surrogate endpoints, and patient reported outcomes.

It allows for the use of data summaries rather than full clinical trials for approval and the use of real world evidence to support approval of new indications of approved medical products, or to help satisfy post-approval study requirements for marketed products.

The law builds on the FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in the FDA's decision-making process.

The Cures Act enhances the FDA's ability to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

Specifically, the Cures Act enables us to work with the FDA in the development of new biomarkers, clinical outcome assessments, surrogate endpoints, and patient reported outcomes.

It allows for the use of data summaries (rather than full clinical trials for approval) as well as the use of real-world evidence to support approval of new indications of approved medical products, or to help satisfy post-approval study requirements for marketed products.

Build Back Better Act and Other Proposed Legislation:

The Build Back Better Act ("BBBA") was introduced in the 117 th Congress and included provisions that were intended to lower the price of prescription drugs, including granting the Medicare program the authority to negotiate prescription drug prices and imposing tax penalties on drug manufacturers if the price of drugs increase too rapidly.

Ultimately the BBBA was not enacted, however, future legislative initiatives are likely to include provisions targeted at containing costs in the presccription drug market.

Ultimately the BBBA was not enacted, however, future legislative initiatives are likely to include provisions targeted at containing costs in the prescription drug market.

Post Approval Activities

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market (following FDA approval of the NDA), the FDA continues to address drug production, distribution, and use.

FDA activities are based on ensuring drug safety and effectiveness, and address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, physician advertising and direct-to-consumer advertising.

FDA activities are based on ensuring drug safety and effectiveness.

They address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, physician advertising and direct-to-consumer advertising.

If we amend the NDA for an FDA approved product, such as adding safety or efficacy labeling claims, promoting those new claims, making certain manufacturing changes or product enhancements, we will need FDA review and approval before the change can be implemented.

While physicians may use products for indications that have not been approved by the FDA, we may not label or promote the product for an indication that has not been approved.

Securing FDA approval for new indications, product enhancements, and manufacturing and labeling changes may require us to conduct additional clinical trials under FDA's IND regulations.

Securing FDA approval for new indications, product enhancements, and manufacturing and labeling changes may require us to conduct additional clinical trials under the FDA's IND regulations.

Even if such studies are conducted, they are still subject to the same requirements and timelines as an original NDA.

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The agency collects those reports through MedWatch and uses its FDA Adverse Event Reporting System (FAERS) to store and analyze them.

Because some events may

occur after the use of a drug for reasons unrelated to the product, the FDA reviews the events to assess which ones may indicate a problem with that particular drug.

Because some events may occur after the use of a drug for reasons unrelated to the product, the FDA reviews the events to assess which ones may indicate a problem with that particular drug.

They then use information gleaned from the surveillance data to determine a course of action.

They might recommend a change in drug labeling to alert users to a potential problem, or, perhaps, to require the manufacturer to study the observed association between the drug and the adverse event.

They might recommend a change in drug labeling to alert users to a potential problem, or perhaps, require the manufacturer to study the observed association between the drug and the adverse event.

In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state and federal laws have been applied to restrict certain marketing practices in the pharmaceutical industry in recent years.

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In addition to these U.S.

laws, we are subject to similar laws that govern our marketing practices and financial arrangements with heath care providers and otherwise are intended to prohibit illicit kickbacks and bribery, including the Foreign Corrupt Practices Act.

laws, we are subject to similar laws that govern our marketing practices and financial arrangements with health care providers and otherwise are intended to prohibit illicit kickbacks and bribery, including the Foreign Corrupt Practices Act.

Federal False Claims Act

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As of December 31, 2022, we had 85 employees.

We believe that our future will depend in part on our continued ability to attract, hire, and retain qualified personnel, including hospital and field sales personnel in particular.

We believe that our future will depend in part on our continued ability to attract, hire, and retain qualified personnel, including hospital oncology and field sales personnel in particular.

To that end, we work with qualified search firms to identify talent, we measure and adjust compensation levels to remain competitive and we work closely with team members to support their success.

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• Changes in national or regional economic conditions, including changes in interest rates and the availability and the cost of capital to us;

• The extent of the impact of the novel coronavirus (COVID-19) pandemic, including the duration and any recurrence of the COVID-19 pandemic, the duration and scope of related government orders and restrictions, the impact on our employees, and the extent of the impact of the COVID-19 pandemic on overall demand for our key products;

• The impact of the COVID-19 pandemic on our suppliers, including any disruptions and inefficiencies in the supply chain for our products;

• The impact of a pandemic, epidemic or outbreak of a contagious disease, such as the novel coronavirus (COVID-19) pandemic, including any recurrence of the COVID-19 pandemic, the impact on our employees, the extent of the impact on overall demand for our key products and the impact on our suppliers, including any disruptions and inefficiencies in the supply chain for our products;

• Our competitive position and competitors, including the size and growth potential of the markets for our products and product candidates;

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• Changes in reimbursement available to us, including changes in Medicare and Medicaid payment levels and availability of third-party insurance coverage and the effects of future legislation or regulations, including changes to regulatory approval of new products, licensing and patent rights, environmental protection and possible drug re-importation legislation;

other misappropriation of assets, or otherwise compromise privacy of sensitive information belonging to us, our customers or other business partners;

• Interruptions and breaches of our computer and communications systems, and those of our vendors, including computer viruses, hacking and cyber-attacks, that could impair our ability to conduct business and communicate internally and with our customers, or result in the theft of trade secrets or other misappropriation of assets, or otherwise compromise privacy of sensitive information belonging to us, our customers or other business partners;

• Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the Securities and Exchange Commission.

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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-K

Item 1. Business