What changed in this filing

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Item 1. Business

2021-03-12 compared with 2020-03-20 · 213 added, 191 removed, 697 unchanged (37% of the section changed)

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

Our primary target markets are hospital acute care and gastroenterology.

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

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

Cumberland is dedicated to providing innovative products that improve the quality of care for patients and address unmet or poorly met medical needs.

We promote our approved products through our hospital and field sales forces in the United States and are establishing a network of international partners to bring our medicines to patients in their countries.

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

We promote our approved products through our hospital and field sales forces in the United States and are establishing a network of international partners to register and provide our medicines to patients in their countries.

Our portfolio of FDA approved brands include:

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

Additionally, we have Phase II clinical programs underway evaluating our ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”), Systemic Sclerosis (“SSc”), and Aspirin-Exacerbated Respiratory Disease ("AERD").

We have also completed Phase II clinical programs with ifetroban in patients with Hepatorenal Syndrome (“HRS”) and patients with Portal Hypertension (“PH”).

The Company has both product development and commercial capabilities and we believe we can leverage our existing infrastructure to support our expected growth.

In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”), a degenerative disease, Systemic Sclerosis (“SSc”), a deadly autoimmune condition, and Aspirin-Exacerbated Respiratory Disease ("AERD"), a severe form of asthma.

Cumberland has built core competencies in both product development and commercial capabilities.

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.

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

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

We currently feature seven FDA approved products for sale in the United States.

We currently feature seven FDA products approved for sale in the United States.

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

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

We also 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 largely to address unmet medical needs.

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

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 largely to address poorly met and unmet 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 progress promising, new product candidates, which Cumberland has the opportunity to further develop and commercialize.

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These filings are also available to the public at www.sec.gov.

COVID-19 Pandemic

In March 2020, the U.S.

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

The Company managed through the COVID-19 pandemic during 2020, continuing to operate our business - keeping facilities open and our organization intact.

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 faced the same headwinds affecting other companies that rely on hospital admissions and patient visits to drive revenue.

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

During 2020, we carefully monitored our supply chain during the pandemic including the flow of raw materials into the plants that manufacture our products as well as the batches of finished product emerging from those facilities.

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, with other brands delivering a strong performance.

Our key products include:

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Serious bacterial infections Marketed

RediTrex™ Arthritis and psoriasis Approved

Arthritis and psoriasis Approved

Acetadote is an intravenous formulation of N-acetylcysteine, indicated for the treatment of the liver toxicity associated with acetaminophen poisoning.

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Completion of our first Phase IV commitment resulted in the FDA's 2006 approval of expanded labeling for the product for use in pediatric patients.

Completion of our second Phase IV commitment resulted in further revised labeling for the product with FDA approval of

additional safety data in 2008.

Completion of our second Phase IV commitment resulted in further revised labeling for the product with FDA approval of additional safety data in 2008.

Completion of our third and final Phase IV commitment in 2010 culminated in the FDA’s approval of a new formulation for the product.

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On January 26, 2017, an Appeals Court affirmed the District Court ruling in the Company's favor upholding Cumberland's Acetadote patent and expressly rejected the validity challenge.

During 2020 we continued to distribute our Acetadote brand and, through Perrigo Company, our Authorized Generic product.

Caldolor, our intravenous formulation of ibuprofen, was the first injectable product approved in the U.S.

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The FDA approved Caldolor for marketing in the United States in 2009 following a priority review.

The product was indicated for use in adults as a sole treatment for the management of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics.

A non-steroidal anti-inflammatory drug ("NSAID"), the product was indicated for use in adults as a sole treatment for the management of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics.

It was also the first FDA approved intravenous therapy for treating fever.

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In 2015 we received FDA approval for the use of Caldolor in pediatric patients six months of age and older.

Caldolor is the first and only injectable non-steroidal anti-inflammatory drug (NSAID) approved for use in children.

Caldolor is the first and only injectable non-steroidal anti-inflammatory drug approved for use in children.

We then initiated a study to collect data on the use of Caldolor in children ranging in age from birth up to six months of age.

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In January 2019, the FDA approved the application for our next generation Caldolor product.

In April 2019, we began initial shipments of the product to select customers.

During the third and fourth quarters of 2019, there was a growing demand for the new product from these select accounts and we began planning for a full-scale launch in 2020 .

The new, premixed presentation provides healthcare professionals a formulation that is easy to administer, helping manage the treatment of patient pain and fever, while reducing opioid consumption.

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.

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

In April 2019, we began initial shipments of this next generation Caldolor product to select customers.

During the third and fourth quarters of 2019, there was a growing demand for the new product from these select accounts.

In January 2020, we initiated a full-scale launch of this ready-to-use product.

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

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

During 2020 we distributed both the vial and the ready-to-use premixed bag presentations of Caldolor.

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

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In late 2011, through a series of transactions, we entered into an agreement to acquire assets associated with the Kristalose brand including the Kristalose trademark and the FDA registration.

Using the preference data as a cornerstone of our marketing efforts, we repositioned the brand in early 2014.

The marketing strategy which continued in 2019 included an enhanced patient coupon program and expanded managed care coverage for the product.

Using preference data as a cornerstone of our marketing efforts, we repositioned the brand in early 2014.

The marketing strategy included an enhanced patient coupon program and expanded managed care coverage for the product.

We added a co-promotion partner to provide support for the brand in 2017.

Poly Pharmaceuticals is promoting Kristalose to physician targets not covered by our field sales forces.

In 2018 we added another co-promotion partner, 2R Pharmaceuticals who is repackaging Kristalose and featuring it with additional new physician targets.

In 2018, we added another partner, Foxland Pharmaceuticals, Inc., who is repackaging Kristalose and featuring it with additional new physician targets.

During 2020 we continued to support Kristalose through our field sales force as well as our partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals, Inc.

Omeclamox ® -Pak

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The closing of this transaction ended Cumberland’s payments of royalties and manufacturing fees to GEL, and we assumed responsibility for the maintenance of the product’s FDA approval and for the oversight of the product’s manufacturing and packaging.

Our field sales force promotes Omeclamox-Pak to the gastroenterology market segment, which accounts for the largest component of the prescriber base for this product.

We supplement this personal promotion through telemarketing campaigns to expand the support and use of the product.

Our field sales force has promoted Omeclamox-Pak to the gastroenterology market segment, which accounts for the largest component of the prescriber base for this product.

We supplemented this personal promotion through telemarketing campaigns to expand the support and use of the product.

We have also established a series of contracts to provide managed care coverage for Omeclamox-Pak.

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

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

We have notified the FDA that the product is currently not available.

In early 2014, we entered into an agreement with Astellas Pharma US, Inc.

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It is one of two branded prescription products indicated for the treatment of hyponatremia, and the only intravenously administered branded treatment.

During 2019 normal supply of the product resumed and we supported it through our hospital sales division.

Hyponatremia, an imbalance of serum sodium to body water, is the most common electrolyte disorder among hospitalized patients.

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Vaprisol raises serum sodium to appropriate levels and promotes free water secretion.

We re-launched active promotion of the brand during the middle of 2014 utilizing our hospital sales force supported by a series of marketing initiatives.

In late 2017, we encountered delays in manufacture and supply of the product which impacted its sales until the second quarter of 2018 when new inventory arrived.

We then restocked the distribution channels for Vaprisol and increased our inventory level of the brand.

In November 2018, the Company announced an agreement with Theravance Biopharma ("Theravance") to acquire the Vibativ assets from Theravance and assume global responsibility for Vibativ including the marketing, distribution, manufacturing and regulatory activities associated with the brand.

Vaprisol is supported by our hospital sales division.

Demand for the product increased during the 2020 pandemic, and we worked to ensure availability of the product to hospitals and clinics during the health care crisis.

In November 2018, the Company announced an agreement with Theravance Biopharma ("Theravance") to acquire the Vibativ assets from Theravance and assume global responsibility for the brand including the related marketing, distribution, manufacturing and regulatory activities.

Vibativ is a patented, FDA approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections.

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

Immediately after the closing, we initiated shipments of Vibativ and assumed responsibility for the supply chain and distribution of the product in the U.S.

Immediately after the closing, we initiated shipments of Vibativ, assumed responsibility for the supply chain and distribution of the product in the U.S.

and transitioned the brand's responsibilites from Theravance to Cumberland.

Vibativ is supported by our hospital sales division.

During 2019 we transitioned responsibilities for the brand from Theravance to Cumberland.

In late 2019, we announced a publication in Infectious Diseases and Therapy , with study results showing numerically superior cure rates of telavancin compared to vancomycin within a subset of patients who were enrolled in phase 3 ATTAIN trials and had hospital-acquired pneumonia caused by bacteria with low susceptibility to vancomycin.

Additionally, an online publication in Drugs - Real World Outcomes , detailed the positive clinical outcomes that resulted from treating multiple infection types with Vibativ, including complicated skin infections, bone and joint infections, bacteremia and endocarditis, and lower respiratory tract infections.

During 2020, demand for the product grew, and it was used to treat pneumonia resulting from secondary bacterial infections in hospitalized COVID-19 patients.

In November 2016, we announced an agreement with Nordic Group B.V.

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In December 2019, we received FDA approval for RediTrex and began planning for a launch of this product line.

In May 2016, the Company announced an agreement with Clinigen Group Plc ("Clinigen") in which Cumberland acquired the exclusive rights to commercialize and reintroduce Ethyol in the United States.

Ethyol is an FDA approved cytoprotective drug containing amifostine for injection.

It is indicated as an adjuvant therapy to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer.

It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

Under the terms of the agreement, Cumberland is responsible for all marketing, promotion, and distribution of the product in the United States.

In late 2016, we began distribution of Ethyol for injection to wholesalers within the United States and launched national promotional support for the brand by our hospital sales division.

In early 2019 we initiated a strategic review of our products, partners and organization.

As a result, we concluded our distribution and support for Ethyol and transitioned the product responsibilities back to Clinigen.

As a result, Cumberland will no longer be involved with the distribution, marketing and promotion of Ethyol or any competing products after 2019 .

In January 2017, we announced an exclusive agreement with Clinigen to distribute the oncology support drug, Totect in the United States.

It is an FDA approved hospital based emergency oncology intervention drug, indicated to treat the toxic effects of anthracycline chemotherapy.

It treats anthracycline extravasation that occurs when the injected medication escapes from the blood vessels and circulates into surrounding tissues in the body, causing severe damage and serious complications.

Totect can limit such damage without the need for additional surgeries or procedures and enables patients to continue their essential anti-cancer treatment.

In late July 2017, we initiated distribution and sale of Totect (dexrazoxane hydrochloride) in the United States.

This followed the FDA approval of the updated labeling and product manufacturer for the product.

In late September 2017, we announced the relaunch of Totect in the United States.We launched Totect during a national shortage of dexrazoxane in late 2017, resulting in strong initial demand for the product.

During 2018 a number of competitive products returned, reducing Totect’s share of the market.

Following our strategic review we concluded our distribution of Totect and transitioned the rights and responsibilities for the brand back to Clinigen.

In November 2020, we provided initial shipments of RediTrex to select accounts and began preparing for a national launch in the second half of 2021, once product supplies are assured and market conditions return to normal.

Our development pipeline includes a series of product candidates in Phase II development.

Our areas of focus include:

Hepatorenal Syndrome ("HRS")

In 2011, we entered into an agreement to acquire the rights to ifetroban, a new Phase II product candidate.

Our acquisition of the rights to the ifetroban program includes an extensive clinical database and non-clinical data package as well as manufacturing processes, know-how and intellectual property.

Ifetroban was initially developed by a large pharmaceutical company for significant cardiovascular indications.

That company conducted extensive studies for their target indications and eventually donated the entire program to Vanderbilt University.

Researchers at Vanderbilt identified ifetroban as a potentially valuable compound in treating patients for several niche indications.

Cumberland acquired the rights to the ifetroban program from Vanderbilt through CET with the intention to develop the product for several potential new indications.

We have commenced manufacturing of an intravenous formulation of ifetroban and the FDA has cleared our investigational new drug (“IND”) application for this product candidate.

We have initiated clinical development under the brand name Hepatoren and are evaluating this candidate for the treatment of critically ill hospitalized patients suffering from hepatorenal syndrome ("HRS").

HRS is a life threatening condition involving liver and kidney failure, with a high mortality rate and no approved pharmaceutical therapy in the U.S.

We completed a sixty-four patient Phase II study to evaluate the safety, efficacy and pharmacokinetics of escalating doses of Hepatoren in HRS patients.

Progression to higher dose levels was reviewed and approved by an independent safety committee.

The study was stratified into Type I or Type II patients with HRS based upon the progression of their disease.

Top line results from this study indicated that Hepatoren was overall well tolerated in the HRS patients with no safety concerns noted.

We have filed the results from this study with the FDA and began evaluating the design for a follow-on Phase II efficacy study.

During 2020, enrollment in our studies significantly slowed during the pandemic, due to trial suspensions and the decrease in eligible patient admissions to medical centers across the country.

We look forward to an improvement as the pandemic subsides and centers begin to reopen with a return of patients eligible for our trials.

Our clinical programs include the evaluation of ifetroban in the following areas:

Aspirin-Exacerbated Respiratory Disease ("AERD")

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Following this clearance, we initiated a follow-on multicenter Phase II efficacy study to evaluate the efficacy of Boxaban in seventy-six patients with symptomatic AERD.

Enrollment in this multi-center, placebo controlled study progressed in 2019 at a growing number of allergy and asthma centers across the United States.

Systemic Sclerosis ("SSc")

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As a result, we initiated a Phase II multicenter study in thirty-four SSc patients.

Enrollment in this randomized, placebo controlled trial progressed at several scleroderma centers of excellence in the United States during 2019.

Portal Hypertinsion ("PH")

In September 2016, we announced the addition of Portaban to our pipeline.

Cumberland has initiated the clinical development of Portaban for the treatment of portal hypertension ("PH") associated with chronic liver disease.

Preclinical studies have shown ifetroban can reduce portal pressure, inflammation, and fibrosis in multiple models of liver injury.

The FDA cleared our IND application for a clinical development program evaluating Portaban in thirty patients with PH.

Following that clearance, a multicenter Phase II study was initiated.

During 2018 enrollment in this randomized, placebo controlled study was completed.

This study was primarily designed to evaluate the safety of ifetroban treatment in this population and was not powered for any efficacy measurement.

An initial review of the data from the study shows ifetroban was safe and well tolerated with no unexpected safety findings.

We also measured hepatic venous pressure.

Patients enrolled had a greater degree of variability than expected in their hepatic venous pressure gradient, therefore no definitive conclusions could be made on the impact of ifetroban on modulating that gradient.

A full analysis of the data to include biomarkers and exploratory endpoints is ongoing.

Duchenne Muscular Dystrophy ("DMD")

On September 24, 2019, Cumberland announced U.S.

Food and Drug Administration ("FDA") Orphan Drug Grant funding for a new Phase II clinical program.

On September 24, 2019, Cumberland announced an FDA Orphan Drug Grant funding for a new Phase II clinical program.

The Company has initiated the clinical development of ifetroban for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”).

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It is the first DMD clinical study approved for FDA Orphan Product Development funding.

During 2020 the FDA awarded a supplemental grant in support of the Phase II study.

Other Clinical Programs

We have also completed Phase II clinical programs with ifetroban in patients with Hepatorenal Syndrome (“HRS”) and patients with Portal Hypertension (“PH”).

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

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During 2017, we completed a Phase I study which defined the pharmacokinetic properties and provided a favorable safety profile for this new product candidate.

The study results and a proposed clinical development plan were discussed with the FDA and, as a result, a Phase II study has been initiated and progressed during 2019.

The study results and a proposed clinical development plan were discussed with the FDA.

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

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

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

We currently market six FDA approved products for sale in the United States.

We currently market seven FDA approved products for sale in the United States.

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

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

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

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

Selectively add 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 represents our largest product acquisition.

Our acquisition of Vibativ represents the largest product acquisition we have completed.

Progress clinical pipeline and incubate future product opportunities at CET.

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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.

We expanded our network of university collaborations with the addition of Louisiana State University and the Medical University of South Carolina.

Leverage our infrastructure through co-promotion partnerships.

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Our co-promotion partnership with Poly Pharmaceuticals, Inc.

allows us to expand current promotional support for Kristalose across the United States.

and Foxland Pharmaceuticals, Inc.

allow us to expand the support for Kristalose across the United States.

Build an international contribution to our business.

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

We use excess cash flow for our ongoing share repurchase program.

SALES AND MARKETING

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Our strategy has been to increase the focus of our hospital sales team on targeted, high priority accounts.

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 both products.

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

By investing in our sales and marketing activities we believe that we can increase market share for both products.

Our field sales force features both Kristalose and Omeclamox-Pak during most of their physician calls, establishing our presence in the gastroenterology market.

Our marketing executives conduct ongoing analyses to evaluate marketing campaigns and promotional programs.

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.

By investing in our sales and marketing activities we believe that we can increase market share for these products.

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

The evaluations include development of product profiles, testing of the profiles against the needs of the market, determining what additional product information or development work is needed to effectively market the products and preparing financial forecasts.

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

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

National accounts maintain relationships with our wholesaler customers as well as with third-party payors such as group purchasing organizations, pharmacy benefit managers, hospital buying groups, state and federal government purchasers and health insurance companies.

MATERIAL CUSTOMERS

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Customer 3 21%

Customer 4 14%

INTERNATIONAL PARTNERSHIPS

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Caldolor South Korea Marketed

Vibativ Registration

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

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Caldolor India, Pakistan, Bangladesh and Nepal Marketed

GerminMED Caldolor Arabian Peninsula Marketed

GerminMED Caldolor Qutar Marketed

R-Pharm JSC Vibativ Russia Marketed

ETHICA Industri Farmasi Caldolor Indonesia Registration

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Caldolor Spain, Portugal and South America Registration

WinHealth Pharma Group Co.

Caldolor & Acetadote China and Hong Kong Development

R-Pharm JSC Vibativ Russia Marketed

Hikma Pharmaceuticals Vibativ Arabian Peninsula Registration

SciClone Pharmaceuticals, Inc.

Vibativ China and Hong Kong Registration

Reddy's Laboratories Vibativ India Registration

WinHealth Pharma Group Co.

Caldolor & Acetadote China and Hong Kong Development

Our international commercialization agreements include a license to one or more Cumberland products for a specific territory as noted in the table above.

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During 2020, we worked to support our existing international partners and to identify new companies to represent our products in select additional territories.

We also continued to transition the Vibativ license arrangements for several international markets from Theravance.

CLINICAL AND REGULATORY AFFAIRS

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CLINICAL DEVELOPMENT AND STUDY RESULTS

Vibativ Clinical Manuscript

In October 2019, a new study was published revealing the superiority of Vibativ (telavancin) over vancomycin in select patients with bacterial pneumonia.

Study results were published in Infectious Diseases and Therapy , and it showed numerically superior cure rates of telavancin compared to vancomycin within a subset of patients who were enrolled in phase 3 ATTAIN trials and had hospital-acquired pneumonia caused by bacteria with low susceptibility to vancomycin.

In November 2019, we announced another study, published online in Drugs - Real World Outcomes , detailing the positive clinical outcomes that resulted from treating multiple infection types with Vibativ, including complicated skin and skin structure infections, bone and joint infections, bacteremia and endocarditis, and lower respiratory tract infections.

Vibativ Clinical Manuscripts

Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections.

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In November 2018, Cumberland reached an agreement to acquire Vibativ from Theravance Biopharma and assume global responsibility for the product.

Caldolor Pediatric Study

In late 2019, we announced a publication in Infectious Diseases and Therapy , with study results showing numerically superior cure rates of telavancin compared to vancomycin within a subset of patients who were enrolled in Phase 3 ATTAIN trials and had hospital-acquired pneumonia caused by bacteria with low susceptibility to vancomycin.

In May 2020, Cumberland announced a new study published in Drugs - Real World Outcomes , detailing the positive clinical outcomes that resulted from treating patients with bacteremia or endocarditis with Vibativ.

This publication is a sub analysis of The Telavancin Observational Use Registry (TOUR™), a study conducted to record population characteristics, prescription information, and real-world clinical outcomes of patients with Gram-positive infections treated with Vibativ.

The analysis suggests Vibativ is a promising and viable option for patients with bacteremia or endocarditis, including those with MRSA or another S.

aureus pathogen.

Additionally, in May 2020, we announced the publication of two studies confirming the continued in vitro potency of telavancin.

Both publications were part of continued surveillance of telavancin activity since 2011.

The first publication tested a global collection of 24,408 Gram-positive clinical isolates, and the second publication tested a U.S.

collection of 15,882 S.

aureus isolates.

Both studies documented the sustained in vitro antimicrobial activity and spectrum of telavancin—many years after its clinical approval—against Gram-positive clinical isolates collected worldwide over 7 years, from 2011 through 2017.

Caldolor Clinical Manuscripts

In July 2020, Cumberland announced a study published in the Journal of Orthopedic Trauma , evaluating the efficacy of Caldolor administration in the management of acute pain in orthopedic trauma patients.

The study also measured Caldolor’s ability in minimizing opioid use.

This single-center, randomized, double-blind, placebo-controlled study found that Caldolor (ibuprofen) Injection reduced the quantity of opioids required to manage pain after a traumatic injury with fracture.

In addition, the time to first narcotic medication was longer in the Caldolor group than with hospital standard of care.

Pain was also managed better in the Caldolor group compared to standard of care narcotics.

Additionally, in August 2020, we announced the results of a review of nine clinical studies evaluating Caldolor.

The comprehensive review was published in the journal Clinical Therapeutics and involved 1,062 adult patients, with 757 receiving Caldolor and 305 receiving placebo or a comparator medication.

The data noted that the use of Caldolor improved post-surgery recovery, decreased surgical stress, and reduced the use of opioids and over-the-counter medication.

The study determined that patients given Caldolor experienced less postoperative pain and decreased opioid use.

Study authors also concluded that the rapid administration and preemptive use of Caldolor should be considered in Enhanced Recovery After Surgery protocols for the management of postoperative pain including that of traumatic origin.

Caldolor Newborn Study

We previously received FDA approval for the use of Caldolor in pediatric patients six months of age and older.

Caldolor is the first and only injectable non-steroidal anti-inflammatory drug (NSAID) approved for use in children.

Caldolor is the first and only injectable NSAID approved for use in children.

We then initiated a study to collect data on the use of Caldolor in children ranging in age from birth up to six months of age.

Enrollment in that multi-center study was completed in 2019.

Enrollment in that multi-center study was completed in 2019, and topline results were announced in 2020, indicating that Caldolor was well tolerated in this patient population, with no safety concerns noted.

Ifetroban Phase II Studies

In September 2019, Cumberland announced the receival of FDA Orphan Drug Grant funding for a new Phase II clinical program.

We initiated the clinical development of ifetroban for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD).

Based on preclinical findings, the FDA has cleared Cumberland's application to study ifetroban in DMD patients, seven years of age and older.

In addition, Cumberland was awarded just over $1 million in funding from the FDA through their Orphan Drug Grant program to support this Phase II DMD clinical study.

This study is the first DMD clinical study approved for FDA Orphan Product Development funding.

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) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles, 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 3) Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.

In addition, we have completed two pilot Phase II studies involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure and 2) patients with Portal Hypertension associated with chronic liver disease.

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

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

While enrollment of new patients is currently limited, we have worked to ensure that patients already entered into a trial continue to receive their study drug.

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.

New Hospital Product Candidate Study

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During 2017, we completed a Phase I study which defined the pharmacokinetic properties and provided a favorable safety profile for this new product candidate.

The study results and a proposed clinical development plan were discussed with the FDA and, as a result, in 2018 a Phase II study was initiated, with enrollment continuing in 2019.

The study results and a proposed clinical development plan were discussed with the FDA.

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.

BUSINESS DEVELOPMENT

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Because of that progress, we felt that it was prudent to take a fresh look at our product portfolio, partners, and organization to ensure proper focus and capabilities.

Expanded International Partners

As a result of our strategic review, we expanded our international arrangements through several new agreements.

International Partners

As a result of our strategic review, we altered our international arrangements through several new agreements as well as dissolution of prior agreements..

We executed a License and Distribution agreement with HongKong WinHealth Pharma Group Co.

Limited (“WinHealth”) for our Caldolor and Acetadote brands in China and Hong Kong.

We anticipate WinHealth will provide $2 million in milestone payments and up to an estimated $290 million in revenue contribution over a ten - year period for supplies of the products following their registration in China.

Under the terms of the agreement, WinHealth will provide development milestone payments and purchase supplies of the products following their registration in China.

We also entered into a Strategic Alliance agreement with WinHealth to explore future business opportunities that will further the mission and goals of each organization.

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WinHealth has established partnerships with international companies that include Boehringer-Ingelheim, Janssen, Novartis, Pfizer, and Roche, generating approximately $330 million in annual sales in 2018.

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.

Additionally, we completed the assignment and amendment of a Commercialization Agreement with R-Pharma JSC (“R Pharma”) associated with ongoing distribution of Vibativ in Russia and a number of adjacent countries in Eastern Europe.

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Headquartered in Moscow and focusing in a wide breadth of therapeutic areas in the specialty and hospital care markets, R-Pharma generated over $1.6 billion in revenues in 2018.

We completed the assignment and amendment of a Commercialization Agreement with Hikma Pharmaceuticals LLC (“Hikma”) to register and distribute Vibativ in a number of countries throughout the Middle East.

Hikma is a multinational pharmaceutical company currently headquartered in London, United Kingdom.

Originally founded in Amman, Jordan the company now has market representation throughout the world, with a particular focus in the Middle East and North African regions.

Hikma develops, manufactures, and markets a broad range of branded and non-branded generic medicines, generating over $2 billion in gross sales during 2018.

We also completed the assignment and amendment of a Commercialization Agreement with Dr.

Reddy’s Laboratories Limited (“Dr.

Reddy’s”) for the registration and distribution of Vibativ in India.

Reddy's is a multinational pharmaceutical company based in Hyderabad, India.

The company currently markets over 190 medications through their commercial operations in over 35 countries.

Combined with their extensive network of manufacturing capabilities, Dr.

Reddy’s generated over $2.2 billion in sales during their 2018 – 2019 fiscal year.

We are in the process of concluding our Commercialization Agreement with Hikma Pharmaceuticals LLC to register and distribute Vibativ in a number of countries throughout the Middle East, our agreement with Dr.

Reddy’s Laboratories Limited for the registration and distribution of Vibativ in India, and our License and Distribution Agreement with PT.

EHTICA Industri Farmasi for the registration and distribution of Caldolor in Indonesia.

Poly Co-Promotion Agreement

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

We originally entered into a co-promotion arrangement with Poly for our Kristalose product in 2017.

We entered into a co-promotion arrangement with Poly Pharmaceuticals, Inc.

(“Poly”) for our Kristalose product in 2017.

Poly is a privately held U.S.

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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.

Nordic License Agreement

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The product line is approved for patient use in various European countries and received FDA approval near the end of 2019.

Cumberland has registered and will commercialize the methotrexate products in the United States under the brand name RediTrex ™ .

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

2R and Foxland Agreements

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Cumberland continues to manage the regulatory activities associated with the product.

Piramal Co-promotion Agreement

In November 2019, we concluded our co-promotion agreement with Piramal Critical Care ("Piramal").

Cumberland previously entered into a co-promotion agreement with Piramal in 2015.

Through this agreement, Piramal co-promoted two of Cumberland’s branded hospital products, Caldolor and Vaprisol throughout the United States.

Clinigen Strategic Dissolution Agreement

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CET University Collaboration Agreements

In February 2019, CET and the technology transfer organization for the Medical University of South Carolina ("MUSC") entered into an agreement, adding to CET’s roster of academic collaborations which also includes Vanderbilt University, the University of Mississippi, Louisiana State University and the University of Tennessee Research Foundation.

Under the agreement, CET will evaluate MUSC discoveries, license intellectual property rights to promising technologies, and partner with MUSC research scientists to advance product development toward commercialization .

Through CET, we collaborate with a select group of academic research institutions located in the mid-south region of the U.S.

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

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 need.

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We manage these third-party relationships and are responsible for the quality review and release of each lot of our products.

For Acetadote we have agreements with two manufacturers, and one manufacturer provided commercial supplies of the product during 2019.

For Acetadote we had agreements with two manufacturers, and one manufacturer provided commercial supplies of the product during 2020.

We have agreements with multiple manufacturers for the supply of Caldolor and during 2020 we obtained commercial supplies from three of these manufacturers for our international and domestic Caldolor requirements.

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During 2019 we entered into a new packaging arrangement for this product.

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 effective October 14, 2020, and have not provided a date for the availability of new inventory.

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

In addition, as part of that transaction, we were assigned a commercial supply agreement with the historical Vaprisol manufacturer.

In 2018, the manufacturer informed us that they would no longer be able to provide the product following the manufacturing of one final batch which is expected to provide us with a multi-year supply.

Therefore, we are evaluating alternatives for a new manufacturer to provide us with long term supplies of the product.

In 2018, the manufacturer informed us that they would no longer be able to provide the product following the manufacturing of one final batch which is providing us with a multi-year supply.

We identified and reached an agreement during 2020 with a new manufacturer to provide us with long term supplies of the product.

We subsequently initiated the transfer of the product’s manufacturing to the new facility in 2020.

Through our acquisition of Vibativ, we acquired 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 in 2019.

Under our agreement with Nordic, they will be responsible for providing us the packaged and labeled commercial supply of the RediTrex product.

As part of the Ethyol agreement, during 2019 Clinigen was responsible for the supply of the product and has provided commercial inventory for Cumberland to package and distribute.

Under our Totect agreement, during 2019 Clinigen was also responsible for overseeing the manufacture of the product and has provided commercial supplies for us to package and distribute.

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 in 2020.

In 2016, we entered into an agreement with the Nordic Group B.V.

("Nordic") to acquire the exclusive U.S.

rights to Nordic’s injectable methotrexate product line.

In 2019, we received FDA approval for the product and authorization to market them under the RediTrex brand name.

Under our agreement with Nordic, they are responsible for providing us the packaged and labeled commercial supply of RediTrex.

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

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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 2019, we committed approximately $50,000 in cash contributions to be paid to the Foundation during 2020.

During 2020, we provided approximately $50,000 in cash contributions to the Foundation.

Cumberland Health and Wellness Political Action Committee

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The PAC received initial funding from us and future funding will include voluntary individual contributions from Cumberland Pharmaceuticals directors and employees.

SUBSEQUENT EVENTS

Next Generation Caldolor Product

In January 2020, we launched the next generation of our Caldolor (ibuprofen) Injection product.

This formulation of Caldolor comes in a ready-to-use bag that may be administered without dilution for pain relief.

This launch follows FDA approval in 2019 of the product's new delivery method.

A non-steroidal anti-inflammatory drug (NSAID), Caldolor may be used as the sole method of treatment for mild-moderate pain or as part of a multi-modal treatment for severe pain.

The new formulation of Caldolor comes 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.

Caldolor is still available as an 800 mg/8mL single–dose vial (100mg/mL) for dilution in addition to the ready-to-use bag (4 mg/mL).

The new, premixed presentation provides healthcare professionals a formulation that is easy to administer, helping manage the treatment of patient pain and fever, while reducing opioid consumption.

PATENTS, TRADEMARKS AND OTHER INTELLECTUAL PROPRIETARY RIGHTS

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The claims of the 356 Acetadote Patent encompass the new Acetadote formulation and include composition of matter claims.

Following its issuance, the 356 Acetadote Patent was listed in the FDA Orange Book.

Following its issuance, the 356 Acetadote Patent was listed in the FDA

The 356 Acetadote Patent is scheduled to expire in May 2026, which time period includes a 270-day patent term adjustment granted by the USPTO.

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On November 12, 2012, we entered into a Settlement Agreement (the “Settlement Agreement”) with Paddock and Perrigo to resolve the challenges and the pending litigation with those two companies.

On November 1, 2013, the United States District Court filed opinions granting Sagent’s and InnoPharma’s motions to dismiss our suits and we agreed not to file an appeal or motion to reconsider, thereby resolving the challenges and the pending litigation with those two companies.

On November 1, 2013, the United States District Courts filed opinions granting Sagent’s and InnoPharma’s motions to dismiss our suits and we agreed not to file an appeal or motion to reconsider, thereby resolving the challenges and the pending litigation with those two companies.

Under the Settlement Agreement, Paddock and Perrigo admit that the 356 Acetadote Patent is valid and enforceable and that any Paddock or Perrigo generic version of Acetadote (with or without EDTA) would infringe upon the 356 Acetadote Patent.

In addition, Paddock and Perrigo will not challenge the validity, enforceability, ownership or patentability of the 356 Acetadote Patent through its expiration currently scheduled for May 2026.

November 12, 2012, in connection with the execution of the Settlement Agreement, we entered into a License and Supply Agreement with Paddock and Perrigo (the “License and Supply Agreement”).

On November 12, 2012, in connection with the execution of the Settlement Agreement, we entered into a License and Supply Agreement with Paddock and Perrigo (the “License and Supply Agreement”).

Under the terms of the License and Supply Agreement, if a third party receives final approval from the FDA for an ANDA to sell a generic Acetadote product and such third party made such generic version available for purchase in commercial quantities in the United States, we are to supply Perrigo with an Authorized Generic version of our Acetadote product.

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Patent number 8,653,061 (the “061 Acetadote Patent”) which is assigned to us.

The claims of the 061 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation to treat patients with acetaminophen overdose.

The claims of the 061 Acetadote Patent encompass the use of the 200 mg/ml Acetadote formulation

to treat patients with acetaminophen overdose.

Following its issuance, the 061 Acetadote Patent was listed in the FDA Orange Book.

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The opinion upheld our 445 Acetadote Patent and expressly rejected Mylan's validity challenge.

The District Court

ruled that Mylan is liable to us for infringement of the 445 Acetadote patent in light of Mylan's Abbreviated New Drug Application in which Mylan sought to market a generic version of Acetadote.

The District Court ruled that Mylan is liable to us for infringement of the 445 Acetadote patent in light of Mylan's Abbreviated New Drug Application in which Mylan sought to market a generic version of Acetadote.

On November 17, 2015, the District Court entered an order enjoining Mylan and its affiliates from selling or using its generic version of Acetadote until August 2025, the date of expiration of the 445 Acetadote Patent.

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Patent number 9,138,404 (the “404 Caldolor Patent”) which is assigned to us.

The claims of the 404 Caldolor Patent include methods of treating pain in critically

ill patients with intravenous ibuprofen.

The claims of the 404 Caldolor Patent include methods of treating pain in critically ill patients with intravenous ibuprofen.

Following its issuance, the 404 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2029.

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

We have patent applications relating to our ifetroban products pending with the USPTO.

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

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

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• successful business development activities;

• extent of third-party reimbursements;

• extent of third-party reimbursements, insurance coverage;

• establishment of advantageous collaborations to conduct development, manufacturing or commercialization efforts.

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Our task is to position each brand to feature its competitive advantages, implement a well thought out marketing plan and provide focused sales and other tactical support.

Acetadote is our injectable formulation of NAC for the treatment of acetaminophen overdose.

Acetadote is our injectable formulation of N-acetylcysteine (" NAC") for the treatment of acetaminophen overdose.

NAC is accepted worldwide as the standard of care for acetaminophen overdose.

Our competitors in the acetaminophen overdose market are those companies selling orally administered NAC including, but not limited to, Geneva Pharmaceuticals, Inc., Bedford Laboratories division of Hikma Pharnaceuticals, Roxane Laboratories, Inc., InnoPharma Inc.

Our competitors in the acetaminophen overdose market are those companies selling orally administered NAC including, but not limited to, Geneva Pharmaceuticals, Inc., Bedford Laboratories division of Hikma Pharmaceuticals, Roxane Laboratories, Inc., InnoPharma Inc.

and Hospira Inc.

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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 included:

Akorn, AuroMedics Pharma, Fresenius Kabi and Sagent Pharmaceticals.

Caldolor is marketed for the treatment of pain and fever, primarily in a hospital setting.

Manufactures of the old Acetadote formulation include:

Akorn, AuroMedics Pharma, Fresenius Kabi and Sagent Pharmaceuticals.

Caldolor is marketed for the treatment of pain and fever, primarily in a hospital or surgery center setting.

A variety of other products address the acute pain market:

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• Ketorolac tromethamine (brand name Toradol ® ), an injectable NSAID, is also manufactured and distributed by several generic pharmaceutical companies;

• IV acetaminophen (brand name Ofirmev ®) , an injectable analgesic product is sold by Mallinckrodt plc;

• Bupivicaine injectable suspension (brand name Exparel ® ), pproduct sold by Pacira Pharmaceuticals, Inc.;

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

• 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.

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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constipation therapy market includes various prescription and over the counter, or OTC, products.

The prescription products which we believe are our primary competitors are:

The branded prescription products which we believe are our primary competitors are:

• Lubiproston (brand name Amitiza ® ), an oral product indicated for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation in adults, is manufactured and sold by Mallinckrodt Pharmaceuticals.

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MiraLax (polyethylene glycol 3350), previously a prescription product, was indicated for the treatment of constipation and manufactured and marketed by Bayer.

MiraLax was converted to an OTC product in February 2007 and recently, the FDA rescinded the approval of the generic prescription polyethylene glycol 3350 products.

MiraLax was converted to an OTC

product in February 2007 and recently, the FDA rescinded the approval of the generic prescription polyethylene glycol 3350 products.

Omeclamox ® -Pak

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pylori) infection and duodenal ulcer disease.

It combines three well-known and widely prescribed medications packaged in a daily dosepack for patient convenience:

It combines three well-known and widely prescribed medications packaged in a daily dose pack for patient convenience:

omeprazole, clarithromycin, and amoxicillin.

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• Ceftaroline fosamil (brand name Teflaro ® ) an injectable antibiotic manufactured and sold by Allergan

• Dalbavancine (brand name Dalvance ® ), an injectable antibiotic manufactured and sold by Allergan

• Dalbavancin (brand name Dalvance ® ), an injectable antibiotic manufactured and sold by Allergan

• Oritavancin (brand name Orbactiv ® ), an injectable antibiotic manufactured and sold by Melinta

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they are valuable in the treatment of patients that fail to respond to generics and it is considered good practice to conserve the use of these agents to reduce the risk of resistance.

RediTrex was introduced by Cumberland in the fourth quarter of 2020.

RediTrex is methotrexate for subcutaneous administration in a unique syringe designed for ease of use, improved accuracy, and enhanced safety.

It is indicated for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe, recalcitrant, or disabling psoriasis unresponsive to alternative treatments.

This market is highly competitive with drugs from several different therapeutic classes available for treatment.

Methotrexate is considered a standard of care especially when patients fail to respond adequately to low dose steroids or non-steroidal anti-inflammatory drugs (NSAIDs).

Methotrexate is available in multiple dose forms including oral, subcutaneous, and intra-venous.

Methotrexate may be used alone or in combination with drugs from other therapeutic classes to adequately control patient symptoms.

RediTrex competes with other dose forms and delivery systems for methotrexate including, oral tablets, conventional vial and syringe administration, and auto-injector pens.

Oral tablets and conventional vials are generic and available from many suppliers.

There are two auto-injector pen products available, Rasuvo and Otrexup.

RediTrex also competes with or may be used in combination with drugs from other therapeutic classes including, injectable biologics like Humira and Enbrel and oral JAK inhibitors like Xaljanz.

These newer agents are more expensive than the methotrexate products but benefit from significant promotion to patients and doctors.

GOVERNMENT REGULATION

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and other countries extensively regulate the research, development, testing, manufacturing, distribution, marketing and sale of pharmaceutical products.

In the U.S., the Food and Drug Administration ("FDA") under the Federal Food, Drug, and Cosmetic Act, ("FDCA"), the Public Health Service Act, and other federal statutes and regulations, subjects pharmaceutical products to rigorous review.

In the U.S., the FDA under the Federal Food, Drug, and Cosmetic Act, ("FDCA"), the Public Health Service Act, and other federal statutes and regulations, subjects pharmaceutical products to rigorous review.

Failure to comply with applicable U.S.

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First, scientists work in the laboratory to discover and develop a new compound.

Next, basic questions on safety are answered by nonclinical testing with animals and then, a drug or biotechnology company develops a prototype drug.

Next, basic questions on safety are answered by nonclinical testing with

animals and then, a drug or biotechnology company develops a prototype drug.

That company must seek clearance from the FDA by way of an Investigational New Drug ("IND") application to test the product with human subjects.

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Once the NDA is validated and accepted for filing, the FDA begins an in-depth review of the NDA.

Under policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA (currently PDUFA VI - effective October 1, 2017), the FDA has a target timeline of 10 months in which to complete its initial review of

a standard NDA and respond to the applicant.

The review process and the PDUFA goal date may be extended by two months to address deficiencies, or by three months if the FDA requests or the NDA sponsor otherwise provides additional information or clarification regarding information already provided in the submission at any time during the review clock period.

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

FDA reported that NDAs showed a steadier increase with the percentage of first-cycle approval letters for new molecular entities rising from 31% for FY 2000 applications to 91% for FY 2017 applications.

FDA reported that NDAs showed a steadier increase with the

percentage of first-cycle approval letters for new molecular entities rising from 56% for FY 2009 applications to 89% for FY 2018 applications.

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

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Further clinical trials may be necessary to gain approval for the use of the product for any additional indications or dosage forms.

The FDA also requires post market safety surveillance reporting to monitor the side effects of the drug, which may result in withdrawal of approval after marketing begins.

The FDA also requires post market safety surveillance reporting to monitor the side effects of the drug, which may result in withdrawal of approval after marketing begins if significant adverse safety findings are found.

Section 505(b)(1) or the 'full' NDA is used for new chemical entities ("NCEs") and requires full clinical and nonclinical development of a compound.

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Orphan drug designation

The Orphan Drug Act of 1983, ("Orphan Drug Act"), encourages manufacturers to seek approval of products intended to treat “rare diseases and conditions” with a prevalence of fewer than 200,000 patients in the U.S.

The Orphan Drug Act of 1983 (the "Orphan Drug Act") encourages manufacturers to seek approval of products intended to treat “rare diseases and conditions” with a prevalence of fewer than 200,000 patients in the U.S.

or for which there is no reasonable expectation of recovering the development costs for the product.

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Section 505(j)(2)(A)(vii)(IV), the so-called Paragraph IV, allows 180-day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.

Hatch-Waxman Amendments grant generic manufacturers the ability to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement.

These Hatch-Waxman amendments grant generic manufacturers the ability to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement.

Hatch-Waxman essentially redistributes the relative risk assessments and explains the flow of settlement funds and their magnitude.

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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.

Cures 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.

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.

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This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other.

Violations of the anti-kickback statute are punishable

by imprisonment, criminal fines, civil monetary penalties and exclusion from participation in federal health care programs.

Violations of the anti-kickback statute are punishable by imprisonment, criminal fines, civil monetary penalties and exclusion from participation in federal health care programs.

Federal False Claims Act

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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.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

We make statements in this Annual Report on Form 10-K that are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.

All statements other than statement of historical facts may be forward-looking statements.

In particular, forward-looking statements include, among other things, statements regarding our intent, belief or expectations, and can be identified by the use of terminology such as “may,” “will,” “expect,” “believe,” “intend,” “plan,” “estimate,” “should,” “seek,” “anticipate” and other comparable terms or the negative thereof.

In addition, we, through our senior management, from time to time make forward-looking oral and written public statements concerning our expected future operations and other developments.

While forward-looking statements reflect our good-faith beliefs and best judgment based upon current information, they are not guarantees of future performance and are subject to known and unknown risks and uncertainties, including those mentioned in Item 1A, “Risk Factors,” Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Form 10-K.

Accordingly, investors are cautioned not to place undue reliance on any forward-looking statements.

Actual results may differ materially from the expectations contained in the forward-looking statements as a result of various factors.

Such factors include, but are not limited to:

• The possible or assumed future results of operations, including the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;

• 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 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;

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

• The success, cost and timing of our product acquisition and development activities and clinical trials;

and our ability to successfully commercialize our product candidates;

• Product efficacy or safety concerns, whether or not based on scientific evidence, resulting in product withdrawals, recalls, regulatory action on the part of the FDA (or international counterparts) or declining sales;

• The performance of our third-party suppliers and manufacturers which impacts our supply chain and could create business shutdowns or product shortages;

and the retention of key scientific and management personnel;

• Challenges to our patents and the introduction of generic versions of our products and product candidates, which could negatively impact our ability to commercialize and sell our products and product candidates and decrease sales a result of market exclusivity;

• 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;

• 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.

The list above contains many, but not all, of the factors that could impact our ability to achieve results described in any forward-looking statements.

Investors should understand that it is not possible to predict or identify all such factors and should not consider this list to be a complete statement of all potential risks and uncertainties.

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