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What changed in CUMBERLAND PHARMACEUTICALS INC's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of CUMBERLAND PHARMACEUTICALS INC's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+405 added−392 removedSource: 10-K (2025-03-07) vs 10-K (2024-03-13)

Top changes in CUMBERLAND PHARMACEUTICALS INC's 2024 10-K

405 paragraphs added · 392 removed · 318 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

174 edited+63 added−55 removed130 unchanged
Biggest changeNewer branded agents are also available including: • Ceftaroline fosamil (brand name Teflaro ® ), an injectable antibiotic manufactured and sold by Allergan; • Dalbavancin (brand name Dalvance ® ), an injectable antibiotic manufactured and sold by Allergan; and • Oritavancin (brand name Orbactiv ® ), an injectable antibiotic manufactured and sold by Melinta We are also aware of a number of other novel antibiotics that are currently in development.
Biggest changeNewer branded agents are also available, including: • Ceftaroline fosamil (brand name Teflaro ® ), an injectable antibiotic manufactured and sold by Allergan; • Ceftolozane/Tazobactam (brand name Zerbaxa ® ), a combination cephalosporin and beta-lactamase inhibitor manufactured and sold by Merck; • Omadacycline (brand name Nuzyra ® ), a new tetracycline approved in October 2018 and sold by Paratek Pharmaceuticals Inc.; 25 • Dalbavancin (brand name Dalvance ® ), an injectable antibiotic manufactured and sold by Allergan; • Oritavancin (brand name Orbactiv ® ), an injectable antibiotic manufactured and sold by Melinta; and • Ceftobripole (brand name Zevetera), an injectable antibiotic registered in 2024 by Basilea.
Additional Testing Program Cumberland entered into a non-clinical evaluation agreement, to test one of our products against bacterial strains and subsequently, in vivo animal models utilizing the preclinical services program funded by the Division of Microbiology and Infectious Diseases (“DMID”), part of the National Institute of Allergy and Infectious Diseases (“NIAID”), an institute of the National Institutes of Health (“NIH”), which is part of the Department of Health and Human Services (“HHS”), an agency of the U.S. government.
Additional Testing Program Cumberland entered into a non-clinical evaluation agreement, to test one of our products against bacterial strains and subsequently, in vivo animal models utilizing the preclinical services program funded by the Division of Microbiology and Infectious Diseases (“DMID”), which is part of the National Institute of Allergy and Infectious Diseases (“NIAID”), an institute of the National Institutes of Health (“NIH”), which is part of the Department of Health and Human Services (“HHS”), an agency of the U.S. government.
The claims of the 452 Caldolor Patent encompass methods of treating pain using intravenous ibuprofen. Following its issuance, the 452 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2029. On October 28, 2014, the USPTO issued U.S. Patent number 8,871,810 (the “810 Caldolor Patent”) which is assigned to us.
Following its issuance, the 452 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2029. On October 28, 2014, the USPTO issued U.S. Patent number 8,871,810 (the “810 Caldolor Patent”) which is assigned to us. The claims of the 810 Caldolor Patent encompass methods of treating pain using intravenous ibuprofen.
A variety of other products address the acute pain market: • Morphine, the most commonly used product for the treatment of acute, post-operative pain, is manufactured and distributed by several generic pharmaceutical companies; • Other generic injectable opioids, including fentanyl, meperidine and hydromorphone, address this market; • 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, and there are also generic versions from different manufacturers available; • Bupivacaine and meloxicam extended release solution (brand name Zynrelef ® ), is a dual-acting anesthetic for postoperative pain sold by Heron Therapeutics; • Oliceridine injection (brand name Olinvyk ® ), is an opioid agonist, a new chemical entity in the acute surgical postoperative pain market, sold by Trevena, Inc.; • Bupivacaine injectable suspension (brand name Exparel ® ), product sold by Pacira Pharmaceuticals, Inc., along with two additional bupivacaine products, Xaracoll and Posimir,which were more recently approved; and • Acetaminophen and ibuprofen combination injection (brand name Combogesic ® ), is a combination of acetaminophen and ibuprofen approved by the U.S.
A variety of other products address the acute pain market: • Morphine, the most commonly used product for the treatment of acute, post-operative pain, is manufactured and distributed by several generic pharmaceutical companies; • Other generic injectable opioids, including fentanyl, meperidine and hydromorphone, address this market; • 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, and there are also generic versions from different manufacturers available; • Bupivacaine and meloxicam extended release solution (brand name Zynrelef ® ), is a dual-acting anesthetic for postoperative pain sold by Heron Therapeutics; • Oliceridine injection (brand name Olinvyk ® ), is an opioid agonist, a new chemical entity in the acute surgical postoperative pain market, sold by Trevena, Inc.; • Bupivacaine injectable suspension (brand name Exparel ® ), a product sold by Pacira Pharmaceuticals, Inc., along with two additional bupivacaine products, Xaracoll and Posimir, which were more recently approved; and • Acetaminophen and ibuprofen combination injection (brand name Combogesic ® ), is a combination of acetaminophen and ibuprofen approved by the U.S.
GOVERNMENT REGULATION The development of new pharmaceutical products can be a long, expensive and risky process. There is no assurance we will obtain successful study results or secure the needed market approvals for our pipeline product candidates. Governmental authorities in the U.S. and other countries extensively regulate the research, development, testing, manufacturing, distribution, marketing and sale of pharmaceutical products.
GOVERNMENT REGULATION The development of new pharmaceutical products can be a long, expensive and risky process. There is no assurance we will obtain successful study results or secure the market approvals needed for our pipeline product candidates. Governmental authorities in the U.S. and other countries extensively regulate the research, development, testing, manufacturing, distribution, marketing and sale of pharmaceutical products.
In addition, we also are required to participate in the Public Health Service’s 340B drug pricing program, which requires us to agree to 28 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.
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.
Upon this condition, in accordance with the License and Supply agreement with Perrigo, we began to supply Perrigo with our Authorized Generic. On January 7, 2013, Perrigo announced initial distribution of our Authorized Generic acetylcysteine injection product. On March 19, 2013, the USPTO issued U.S. Patent number 8,399,445 (the “445 Acetadote Patent”) which is assigned to us.
Upon this condition, in accordance with the License and Supply agreement with Perrigo, we began to supply Perrigo with our Authorized Generic. On January 7, 2013, Perrigo announced initial distribution of our Authorized Generic acetylcysteine injection product. 20 On March 19, 2013, the USPTO issued U.S. Patent number 8,399,445 (the “445 Acetadote Patent”) which is assigned to us.
The new, premixed presentation provides health care 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.
The new, premixed presentation provides health care professionals with 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.
We conducted a preference study which indicated that 77% of patients surveyed prefer the taste, consistency and portability of Kristalose over similar products in syrup forms. We acquired the assets and exclusive rights to Kristalose through a series of transactions, then assembled a dedicated field sales force which re-launched the product as a Cumberland brand.
We conducted a preference study which indicated that 77% of patients surveyed prefer the taste, consistency and portability of Kristalose over similar products in syrup forms. 4 We acquired the assets and exclusive rights to Kristalose through a series of transactions, then assembled a dedicated field sales force which re-launched the product as a Cumberland brand.
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 An NDA may be submitted under different methods, a 505(b)(1), 505(b)(2) or 505(j).
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. 27 Section 505(b) New Drug Applications An NDA may be submitted under different methods, a 505(b)(1), 505(b)(2) or 505(j).
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 26 whether the application will ultimately be approved. An approval letter authorizes commercial marketing of the drug for the proposed indication(s) under study.
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. An approval letter authorizes commercial marketing of the drug for the proposed indication(s) under study.
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. We seek partners who have the local infrastructure to support the registration and commercialization of our products in their territory.
Acetadote & Caldolor 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. We seek partners who have the local infrastructure to support the registration and commercialization of our products in their territory.
In June 2021, SciClone submitted an application to the 13 Chinese regulatory authority for the approval of Vibativ in that country. In October 2021, SciClone informed us that the filing was accepted by the regulatory agency for review. We have since been supporting SciClone and their requests associated with review of that submission.
In June 2021, SciClone submitted an application to the Chinese regulatory authority for the approval of Vibativ in that country. In October 2021, SciClone informed us that the filing was accepted by the regulatory agency for review. We have since been supporting SciClone and their requests associated with review of that submission.
Regulatory harmonization offers many direct benefits to both regulatory authorities and the pharmaceutical industry with beneficial impact for the protection of public health. 30 ENVIRONMENTAL MATTERS We are subject to federal, state and local environmental laws and regulations and we believe that our operations comply with such regulations.
Regulatory harmonization offers many direct benefits to both regulatory authorities and the pharmaceutical industry with beneficial impact for the protection of public health. ENVIRONMENTAL MATTERS We are subject to federal, state and local environmental laws and regulations and we believe that our operations comply with such regulations.
Our Vaprisol product has a proven day-one response rate to normalize serum sodium levels in hyponatremic patients and move them out of the Intensive Care Unit as efficiently as possible. Vaprisol is supported by our hospital sales division.
Our Vaprisol product has a proven day-one response rate to normalize serum sodium levels in hyponatremic patients and move them out of the Intensive Care Unit as efficiently as possible. 5 Vaprisol is supported by our hospital sales division.
The PAC received initial funding from us, and future funding will include voluntary individual contributions from Cumberland Pharmaceuticals directors and employees. 17 MANUFACTURING AND DISTRIBUTION Manufacturing We partner with third parties for certain non-core, capital-intensive capabilities, including the manufacturing and distribution of our products.
The PAC received initial funding from us, and future funding will include voluntary individual contributions from Cumberland Pharmaceuticals directors and employees. MANUFACTURING AND DISTRIBUTION Manufacturing We partner with third parties for certain non-core, capital-intensive capabilities, including the manufacturing and distribution of our products.
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. 29 They then use information gleaned from the surveillance data to determine a course of action.
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.
The other competing product is Samsca ® (an oral tolvaptan product sold by Otsuka Pharmaceutical Company). There are also several generic versions of tolvaptan sold by other companies. 24 Vibativ ® Vibativ is a potent, once-daily, injectable antibiotic for the treatment of certain gram-positive infections.
The other competing product is Samsca ® (an oral tolvaptan product sold by Otsuka Pharmaceutical Company). There are also several generic versions of tolvaptan sold by other companies. Vibativ ® Vibativ is a potent, once-daily, injectable antibiotic for the treatment of certain gram-positive infections.
Caldolor India Marketed R-Pharm JSC Vibativ Russia and CIS Marketed Tabuk Pharmaceuticals Vibativ Saudi Arabia and Jordan Registration PiSA Pharmaceutical Caldolor Mexico Registration SciClone Pharmaceuticals, Inc. Vibativ China and Hong Kong Registration D.B. Pharm Korea Co., Ltd. Vaprisol & Vibativ South Korea Registration WinHealth Pharma Group Co.
Caldolor South Korea Marketed R-Pharm JSC Vibativ Russia and CIS Marketed Tabuk Pharmaceuticals Vibativ Saudi Arabia and Jordan Registration PiSA Pharmaceutical Caldolor Mexico Registration SciClone Pharmaceuticals, Inc. Vibativ China and Hong Kong Registration D.B. Pharm Korea Co., Ltd. Vaprisol & Vibativ South Korea Registration WinHealth Pharma Group Co.
The NIAID contractors completed these studies and prepared a manuscript for submission to a scientific journal for publication. CORPORATE DEVELOPMENT Cumberland Pharma Foundation We have formed the Cumberland Pharma Foundation (the “Foundation”) to provide the ongoing philanthropic endeavors of Cumberland Pharmaceuticals Inc.
The NIAID contractors completed these studies and prepared a manuscript for submission to a scientific journal for publication. 17 CORPORATE DEVELOPMENT Cumberland Pharma Foundation We have formed the Cumberland Pharma Foundation (the “Foundation”) to provide the ongoing philanthropic endeavors of Cumberland Pharmaceuticals Inc.
It is sold by Allergan, Inc. and Ironwood Pharmaceuticals, Inc. • Plecanatide (brand name Trulance ® ), an oral product indicated for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.
It is sold by Allergan, Inc. and Ironwood Pharmaceuticals, Inc. 24 • Plecanatide (brand name Trulance ® ), an oral product indicated for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation.
Pharm”) has licensed our Caldolor product for the South Korean market, and they obtained regulatory approval for Caldolor in their country. During 2023, D.B. Pharm continued to purchase supplies of Caldolor and distributed the brand in South Korea. We have also entered into agreements with D.B. Pharm to register and commercialize our Vaprisol and Vibativ brands in their country.
Pharm”) has licensed our Caldolor product for the South Korean market, and they obtained regulatory approval for Caldolor in their country. During 2024, D.B. Pharm continued to purchase supplies of Caldolor and distributed the brand in South Korea. We have also entered into agreements with D.B. Pharm to register and commercialize our Vaprisol and Vibativ brands in their country.
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. R-Pharma JSC (“R Pharma”) has licensed our Vibativ product for a territory that includes Russia and a number of adjacent countries in Eastern Europe.
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. R-Pharma JSC (“R Pharm”) has licensed our Vibativ product for a territory that includes Russia and a number of adjacent countries in Eastern Europe.
Although we participate in governmental programs that subject us to this fee, our sales volume in such programs is less than $10 million, with the first $5 million of sales being exempt from the fee. This fee has not had a material impact and is not expected to have a material impact on our results of operations.
Although we participate in government programs that subject us to this fee, our sales volume in such programs is less than $10 million, with the first $5 million of sales being exempt from the fee. This fee has not had a material impact and is not expected to have a material impact on our results of operations.
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; • The impact of macroeconomic conditions, including inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in monetary policy, volatile market conditions, financial institution instability, as well as geopolitical instability and the ongoing conflicts outside the U.S., on our operations; • 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; • The impact on our business, financial condition and results of operations from the effects of a pandemic or the outbreak of an infectious disease in the United States and worldwide and resulting governmental and societal responses; • 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; and • Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the Securities and Exchange Commission. 32 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.
Such factors include, but are not limited to: 32 • 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; • The impact of macroeconomic conditions, including inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in monetary policy, volatile market conditions, financial institution instability, as well as geopolitical instability and the ongoing conflicts outside the U.S., on our operations; • 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; • The impact on our business, financial condition and results of operations from the effects of a pandemic or the outbreak of an infectious disease in the United States and worldwide and resulting governmental and societal responses; • 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; and • Issuance of new or revised accounting standards by the Financial Accounting Standards Board and the Securities and Exchange Commission.
Our sales and marketing executives direct our national marketing campaigns and maintain key national account relationships. They also manage our dedicated hospital, field and oncology sales forces, which are comprised of approximately 60 sales professionals. • Hospital market: We promote Caldolor, Vaprisol, Acetadote and Vibativ through our dedicated hospital sales division.
Our sales and marketing executives direct our national marketing campaigns and maintain key national account relationships. They also manage our dedicated hospital, field and oncology sales forces, which are comprised of approximately 60 sales professionals. • Hospital market: We promote Caldolor and Vibativ through our dedicated hospital sales division.
Acetaminophen overdose continues to be a leading cause of poisonings reported by hospital emergency departments in the U.S., and Acetadote has become a standard of care for treating this potentially life-threatening condition. Acetadote received U.S. FDA approval as an orphan drug, which provided seven years of marketing exclusivity from the date of approval. That exclusivity has since expired.
Acetaminophen overdose continues to be a leading cause of poisonings reported by hospital emergency departments in the U.S., and Acetadote became a standard of care for treating this potentially life-threatening condition. 2 Acetadote received U.S. FDA approval as an orphan drug, which provided seven years of marketing exclusivity from the date of approval. That exclusivity has since expired.
Kyowa Kirin retains 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.
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.
We manage these third-party relationships and are responsible for the quality review and release of each lot of our products. Acetadote ® We have an agreement with one manufacturer, who provided commercial supplies of Acetadote in 2023.
We manage these third-party relationships and are responsible for the quality review and release of each lot of our products. Acetadote ® We have an agreement with one manufacturer, who provided commercial supplies of Acetadote in 2024.
Caldolor Newborn Study and Clinical Manuscripts We previously received FDA approval for the use of Caldolor in pediatric patients 6 months of age and older. Caldolor is the first and only injectable NSAID approved for use in children.
Caldolor Newborn Study, Clinical Manuscripts and Other Studies We previously received FDA approval for the use of Caldolor in pediatric patients 6 months of age and older. Caldolor is the first and only injectable NSAID approved for use in children.
Caldolor ® We have agreements with multiple manufacturers for the supply of Caldolor and during 2023, we obtained commercial supplies from three of these manufacturers for our international and domestic Caldolor requirements. Kristalose ® We have an agreement for the purchase of Kristalose API with an international supplier.
Caldolor ® We have agreements with multiple manufacturers for the supply of Caldolor and during 2024, we obtained commercial supplies from three of these manufacturers for our international and domestic Caldolor requirements. Kristalose ® We have an agreement for the purchase of Kristalose API with an international supplier.
We believe the hospital market is under-served and highly concentrated, and that it can be penetrated effectively by a small, dedicated sales force without large-scale promotional activity. Our established position in the hospital market provided the rationale for adding Vibativ as our first infectious disease product that complements our hospital product line.
We believe the hospital market is underserved and highly concentrated, and that it can be penetrated effectively by a small, dedicated sales force without large-scale promotional activity. Our established position in the hospital market provided the rationale for adding Vibativ as our first infectious disease product that complements our hospital product line.
BACKLOG Due to the relatively short lead-time required to fill orders for our products, backlog of orders is not considered material to our business. EMPLOYEES As of December 31, 2023, we had 91 employees.
BACKLOG Due to the relatively short lead-time required to fill orders for our products, backlog of orders is not considered material to our business. EMPLOYEES As of December 31, 2024 we had 91 employees.
We utilize professional branding and packaging as well as promotional items to support our products, including direct mail, sales brochures, journal advertising, educational and reminder leave-behinds, patient educational pieces, coupons and product sampling. We also regularly attend select medical meetings and trade shows to expand the awareness of our products.
We utilize professional branding and packaging as well as promotional items to support our products, including direct mail, promotional aides, journal advertising, educational and reminder leave-behinds, patient educational pieces, coupons and product sampling. We also regularly attend select medical meetings and trade shows to expand the awareness of our products.
Additional Information We were incorporated in 1999 and have been headquartered in Nashville, Tennessee since inception. During 2009, we completed an initial public offering of our common shares and listing on the Nasdaq stock exchange. Our website address is www.cumberlandpharma.com .
Additional Information We were incorporated as a Tennessee corporation in 1999 and have been headquartered in Nashville, Tennessee since inception. During 2009, we completed an initial public offering of our common shares and listing on the Nasdaq stock exchange. Our website address is www.cumberlandpharma.com .
We have entered into a series of agreements to establish an international network, which is summarized in the table below and includes information on our primary partners: International Partner Product(s) Territory Status Phebra Pty Ltd Acetadote & Caldolor Australia Marketed D.B. Pharm Korea Co., Ltd. Caldolor South Korea Marketed Sandor Medicaids Pvt. Ltd.
We have entered into a series of agreements to establish an international network, which is summarized in the table below and includes information on our primary partners: International Partner Product(s) Territory Status Phebra Pty Ltd Acetadote & Caldolor Australia Marketed D.B. Pharm Korea Co., Ltd.
During 2023, we worked to support our existing international partners, conclude unproductive arrangements and identify new companies to represent our products in select additional territories. 12 BUSINESS DEVELOPMENT Since inception, we have had an active business development initiative focused on acquiring rights to marketed products and product candidates that fit our strategy and target markets.
During 2024, we worked to support our existing international partners, conclude unproductive arrangements and identify new companies to represent our products in select additional territories. 11 BUSINESS DEVELOPMENT Since inception, we have had an active business development initiative focused on acquiring rights to marketed products and product candidates that fit our strategy and target markets.
During 2022, we worked with them to prepare the submissions for the approval of each brand there. They are currently awaiting the approval of Vibativ in their country. We have 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.
During 2024, we worked with them to prepare the submissions for the approval of each brand there. They are currently pursuing the approval of Vibativ in their country. We have 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.
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 84% for FY 2023, we cannot be certain that timely first-cycle approvals will be maintained by the FDA.
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 74% for FY 2024, we cannot be certain that timely first-cycle approvals will be maintained by the FDA.
Other Ifetroban Programs We also completed a pilot Phase II study involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure 2) patients with Portal Hypertension associated with chronic liver disease and 3) patients with Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.
We have also completed a pilot Phase II study involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure, 2) patients with Portal Hypertension associated with chronic liver disease and 3) patients with Aspirin-Exacerbated Respiratory Disease, a severe form of asthma.
To get that approval, the manufacturer must demonstrate the drug's safety and effectiveness according to criteria specified in law and agency regulations, ensure that its manufacturing plant passes FDA inspection, and obtain FDA approval for the drug's labeling, a term that includes all written material about the drug, including, for example, packaging, prescribing information for physicians and patient brochures. 25 The progression to drug approval begins before FDA involvement.
To get that approval, the manufacturer must demonstrate the drug's safety and effectiveness according to criteria specified in law and agency regulations, ensure that its manufacturing plant passes FDA inspection, and obtain FDA approval for the drug's labeling, a term that includes all written material about the drug, including, for example, packaging, prescribing information for physicians and patient brochures.
Total revenue by customer for each customer representing 10% or more of consolidated gross revenues are summarized below for the year ended December 31, 2023: 2023 Customer 1 29% Customer 2 26% Customer 3 24% 11 INTERNATIONAL PARTNERSHIPS We have established our own capabilities to support the commercialization of our products in the U.S.
Total revenue by customer for each customer representing 10% or more of consolidated gross revenues are summarized below for the year ended December 31, 2024: 2024 Customer 1 29% Customer 2 26% Customer 3 21% 10 INTERNATIONAL PARTNERSHIPS We have established our own capabilities to support the commercialization of our products in the U.S.
We are not aware of any approved injectable products indicated for the treatment of fever in the U.S. other than Caldolor and Ofirmev. There are, however, numerous drugs available to physicians to reduce fevers in hospital settings via oral and rectal administration to the patient, including ibuprofen, acetaminophen and aspirin.
We are not aware of any approved injectable products indicated for the treatment of fever in the U.S. other than Caldolor and Ofirmev. There are, however, numerous drugs available to physicians to reduce fevers in hospital settings via oral and rectal administration to the patient, including ibuprofen, acetaminophen and aspirin. These drugs are manufactured by numerous pharmaceutical companies.
CET University Collaboration Agreements 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.
We renewed our agreement with Foxland in 2022. CET University Collaboration Agreements 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.
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.
We subsequently completed the transfer of the product’s manufacturing to the new facility in 2021. 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.
The institutional review board ("IRB"), or ethics committee (outside of the U.S.), of each clinical site generally must approve the clinical trial design and patient informed consent and may also impose other conditions or require the clinical trial at that site to be halted, either temporarily or permanently, for failure to comply with the IRB's requirements.
Each clinical site that conducts a trial must obtain institutional review board ("IRB"), or ethics committee (outside of the U.S.), approval of the clinical trial design and patient-informed consent , and may also impose other conditions or require the clinical trial at that site to be halted, either temporarily or permanently, for failure to comply with the IRB's requirements.
In 2023, we 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.
In 2024, we also highlighted our investment in our employees through our continuing education programs, employee development initiatives and employee recognition awards. We reported that women represented 49% of Cumberland’s workforce and 27% 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.
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 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.
During 2023, we continued to support Kristalose through our field sales force as well as our partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals, Inc. We have found that the brand performs best in states where we have Medicaid coverage.
During 2023, we continued to support Kristalose through our field sales force as well as our partnerships with Poly Pharmaceuticals and Foxland Pharmaceuticals, Inc. We have found that the brand performs best in states where we have Medicaid coverage, such as Texas, New York and Wisconsin.
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. On October 30, 2015, Mylan filed a notice of appeal to the U.S.
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. On October 30, 2015, Mylan filed a notice of appeal to the U.S. Court of Appeals for the Federal Circuit (the “Appeals Court”).
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 organization targets key oncologists and clinics across the U.S. and is comprised of both inside and field-based sales professionals.
We also believe that we can increase market share for Kristalose through our co-promotion and marketing initiatives. • Oncology market: In early 2022, we formed a new oncology sales force to promote our Sancuso brand. This organization targets key oncologists and clinics across the U.S. and is comprised of both inside and field-based sales professionals.
We continually work to manage our expenses in line with our revenues to deliver positive cash flow from operations. We remain in a strong financial position, with favorable gross margins and a strong balance sheet. 10 SALES AND MARKETING Cumberland’s sales and marketing team has broad industry experience in selling branded pharmaceuticals.
We continually work to manage our expenses in line with our revenues, to deliver positive cash flow from operations. We seek to maintain favorable gross margins and a strong balance sheet. SALES AND MARKETING Cumberland’s sales and marketing team has broad industry experience in selling branded pharmaceuticals.
Food and Drug Administration (“FDA”) includes: • Acetadote ® ( acetylcysteine ) injection, for the treatment of acetaminophen poisoning; • Caldolor ® ( ibuprofen ) injection, for the treatment of pain and fever; • Kristalose ® ( lactulose ) for oral solution, a prescription laxative, for the treatment of constipation; • Omeclamox ® -Pak , ( omeprazole, clarithromycin, amoxicillin ) oral, for the treatment of Helicobacter pylori ( H. pylori ) infection and related duodenal ulcer disease; • 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; and • 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.
Food and Drug Administration (“FDA”) includes: • Acetadote ® ( acetylcysteine ) injection, for the treatment of acetaminophen poisoning; • Caldolor ® ( ibuprofen ) injection, for the treatment of pain and fever; • Kristalose ® ( lactulose ) for oral solution, a prescription laxative, for the treatment of constipation; • 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; and • 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.
The FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, fast track and priority reviews and the newer designation, breakthrough therapy.
The FDA and associated regulations detail the requirements at each step. The FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, fast track and priority reviews, and the newer designation, breakthrough therapy.
We also completed a pilot Phase II study involving 1) patients suffering from Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure 2) patients with Portal Hypertension associated with chronic liver disease and 3) patients with Aspirin-Exacerbated Respiratory Disease, a severe form of asthma. There were no significant safety issues identified with the use of ifetroban in these patients.
We have also completed pilot Phase II studies in patients with 1) Hepatorenal Syndrome, a life-threatening condition involving liver and kidney failure, 2) Portal Hypertension associated with chronic liver disease and 3) Aspirin-Exacerbated Respiratory Disease, a severe form of asthma. No significant safety issues were identified with ifetroban use in these patient populations.
Our strategy has been to focus our hospital sales team on select, 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 the products.
Our strategy has been to focus our hospital sales team on select, high-priority accounts. 9 • Gastroenterology market: We promote Kristalose through a dedicated field sales team addressing a targeted group of physicians who are existing and potential large prescribers of the product.
The claims of the 810 Caldolor Patent encompass methods of treating pain using intravenous ibuprofen. Following its issuance, the 810 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2029. During the third quarter of 2015, we obtained four additional patents for Caldolor. On July 7, 2015, the USPTO issued U.S.
Following its issuance, the 810 Caldolor Patent was listed in the FDA Orange Book and is scheduled to expire in September 2029. During the third quarter of 2015, we obtained four additional patents for Caldolor. On July 7, 2015, the USPTO issued U.S.
Court of Appeals for the Federal Circuit (the “Appeals Court”). 20 On May 3, 2016, the USPTO issued U.S. Patent number 9,327,028 (the “028 Acetadote Patent”) which is assigned to us. The claims of the 028 Acetadote Patent encompass administration methods of acetylcysteine injection, without specification of the presence or lack of EDTA in the injection.
On May 3, 2016, the USPTO issued U.S. Patent number 9,327,028 (the “028 Acetadote Patent”) which is assigned to us. The claims of the 028 Acetadote Patent encompass administration methods of acetylcysteine injection, without specification of the presence or lack of EDTA in the injection.
It is sold by Synergy Pharmaceuticals. • Generic and branded liquid lactulose products are marketed by a number of pharmaceutical companies. • Lactitol for oral solution (brand name Pizensy ® ), an oral, osmotic laxative indicated for the treatment of chronic idiopathic constipation. It is distributed by Braintree Laboratories, Inc. and was recently approved by the FDA.
It is sold by Synergy Pharmaceuticals. • Generic and branded liquid lactulose products are marketed by a number of pharmaceutical companies. • Lactitol for oral solution (brand name Pizensy ® ), an oral, osmotic laxative indicated for the treatment of chronic idiopathic constipation.
FDA in October 2023, and is sold by Hikma Pharmaceuticals PLC. 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. We believe non-narcotic analgesics for the treatment of post-surgical pain are the primary potential competitors to Caldolor.
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. We believe non-narcotic analgesics for the treatment of post-surgical pain are the primary potential competitors to Caldolor.
Poly Co-Promotion Agreement 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. specialty pharmaceutical company that is featuring Kristalose to an expanded number of physicians. Poly’s sales organization is more than doubling the number of nationwide physicians that are reached with the Kristalose brand message.
(“Poly”) for our Kristalose product in 2017. Poly is a privately held U.S. specialty pharmaceutical company that is featuring Kristalose to an expanded number of physicians. Poly’s sales organization is more than doubling the number of nationwide physicians that are reached with the Kristalose brand message.
Pharmaceutical Industry Fee: Beginning in calendar-year 2011, an annual fee was imposed on pharmaceutical manufacturers and importers that sell branded prescription drugs to specified government programs (e.g., Medicare Part D, Medicare Part B, Medicaid, Department of Veterans Affairs programs, Department of Defense programs and TRICARE).
The following highlights certain provisions of the legislation that may affect us. Pharmaceutical Industry Fee: Beginning in calendar-year 2011, an annual fee was imposed on pharmaceutical manufacturers and importers that sell branded prescription drugs to specified government programs (e.g., Medicare Part D, Medicare Part B, Medicaid, Department of Veterans Affairs programs, Department of Defense programs and TRICARE).
We seek to protect our products from competition through a combination of patents, trademarks, trade secrets, FDA exclusivity and contractual restrictions on disclosure. Proprietary rights, including patents, are an important element of our business.
Over time, we intend to maintain registrations on trademarks that remain valuable to our business. We seek to protect our products from competition through a combination of patents, trademarks, trade secrets, FDA exclusivity and contractual restrictions on disclosure. Proprietary rights, including patents, are an important element of our business.
Our Annual Reports (on Form 10-K), Quarterly Reports (on Form 10-Q), Current Reports (on Form 8-K) and all material press releases are available on our website as soon as reasonably practicable after their filing with the U.S. Securities and Exchange Commission (“SEC”).
Our Annual Reports (on Form 10-K), Quarterly Reports (on Form 10-Q), Current Reports (on Form 8-K) and all material press releases are available on our website as soon as reasonably practicable after their filing with the U.S. Securities and Exchange Commission (“SEC”). These filings are also available to the public at www.sec.gov.
PiSA expects to provide the product in both 400- and 800-milligram vials. In 2023, the FDA approved expanded labeling for Caldolor to include use in infants 3 to 6 months old. The safety and efficacy of Caldolor has now been established for the treatment of pain and fever in pediatric patients aged 3 months and older.
In 2023, the FDA approved expanded labeling for Caldolor to include use in infants 3 to 6 months old. The safety and efficacy of Caldolor has now been established for the treatment of pain and fever in pediatric patients aged 3 months and older.
We seek to protect our proprietary information by requiring our employees, consultants, contractors and other advisors to execute agreements providing for protection of our confidential information upon commencement of their employment or engagement. We also require confidentiality agreements from entities to which we provide our confidential information or materials.
We seek to protect our proprietary information by requiring our employees, consultants, contractors and other advisors to execute agreements providing for protection of our confidential information upon commencement of their employment or engagement.
In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidate in 1) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, 2) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy (“DMD”), a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles and 3) patients with Idiopathic Pulmonary Fibrosis (“IPF”), the most common form of progressive fibrosing interstitial lung disease.
In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidate in patients with 1) Systemic Sclerosis (“SSc”) or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) Idiopathic Pulmonary Fibrosis (“IPF”), the most common form of progressive fibrosing interstitial lung disease.
It was also the first FDA-approved intravenous therapy for treating fever. We then launched Caldolor and continue to promote the product in the U.S. through our hospital sales force. We completed a series of Phase IV studies to gather additional data to support our Caldolor product. Those clinical trials involved another 1,000 adult and pediatric patients.
We then launched Caldolor and continue to promote the product in the U.S. through our hospital sales force. 3 We completed a series of Phase IV studies to gather additional data to support our Caldolor product. Those clinical trials involved another 1,000 adult and pediatric patients.
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.
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.
Specifically, we are seeking long-term, sustainable growth by: • Supporting and expanding the use of our marketed products. We continue to evaluate our products following their FDA approval to determine if additional clinical data could expand their market and use. For example, we have secured pediatric approval of Acetadote and Caldolor and expanded the labeling for both brands accordingly.
We continue to evaluate our products following their FDA approval to determine if additional clinical data could expand their market and use. For example, we have secured pediatric approval of Acetadote and Caldolor and expanded the labeling for both brands accordingly.
These drugs are manufactured by numerous pharmaceutical companies. 23 Kristalose ® Kristalose is a dry powder crystalline prescription formulation of lactulose indicated for the treatment of constipation. The U.S. constipation therapy market includes various prescription and over the counter, or OTC, products.
Kristalose ® Kristalose is a dry powder crystalline prescription formulation of lactulose indicated for the treatment of constipation. The U.S. constipation therapy market includes various prescription and over the counter, or OTC, products.
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.
Pharm, our partner in South Korea who also distributes Caldolor, is awaiting the approval of Vibativ in their country. 6 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.
Our 2023 sustainability metrics reveal that during that year we provided 3 million patient doses of our products, while safely disposing of nearly 6,000 pounds of expired and damaged products. We had no product recalls and no clinical trials terminated due to failure to practice good clinical standards.
Our 2024 sustainability metrics noted that during that year we provided 3.9 million patient doses of our brands, while safely disposing of nearly 12,480 pounds of expired and damaged goods. We had no product recalls and no clinical trials terminated due to failure to practice good clinical standards.
SciClone Pharmaceuticals (Holdings) Limited (“SciClone”) has licensed our Vibativ product for sale and distribution in China and several adjacent countries. In February 2021, SciClone completed an initial public offering and listing of their shares on the Hong Kong stock exchange.
R-Pharm has registered Vibativ in Russia and during 2024, continued to purchase supplies of the product for that market. 12 SciClone Pharmaceuticals (Holdings) Limited (“SciClone”) has licensed our Vibativ product for sale and distribution in China and several adjacent countries. In February 2021, SciClone completed an initial public offering and listing of their shares on the Hong Kong stock exchange.
Drug exposure to Vibativ was lower in children compared with the same body weight-based dosing in adults. The study suggests Vibativ is a safe and viable option for pediatric patients ages 2 to 17 who require systemic antibiotics for the treatment of a known or suspected bacterial infection, including those with MRSA or another S. aureus pathogen.
The study suggests Vibativ is a safe and viable option for pediatric patients ages 2 to 17 who require systemic antibiotics for the treatment of a known or suspected bacterial infection, including those with MRSA or another S. aureus pathogen.
Antibiotic drug selection is based both on an empiric and susceptibility proven basis. In the hospital setting, cost is an important factor which favors the use of generic agents if they are effective.
We are also aware of a number of other novel antibiotics that are currently in development. Antibiotic drug selection is based both on an empiric and susceptibility proven basis. In the hospital setting, cost is an important factor which favors the use of generic agents if they are effective.
We have three Phase II clinical programs underway evaluating our ifetroban product candidate in 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, 2) patients with cardiomyopathy associated with Duchenne Muscular Dystrophy , a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles and 3) patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.
We have two Phase II clinical programs underway evaluating our ifetroban product candidate in 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.
Vibativ ® 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 manufacturing of the product.
Vibativ ® 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 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.
The sponsor of the drug typically conducts human clinical trials in three sequential phases, but the phases may overlap. Phase I clinical trials are generally conducted in a small number of healthy volunteers, primarily to collect and assess pharmacokinetics and safety data at one or more dosages prior to proceeding into patients.
Phase I clinical trials are generally conducted in a small number of healthy volunteers, primarily to collect and assess pharmacokinetics and safety data at one or more dosages prior to proceeding into patients.
Additional pilot studies of ifetroban are underway, including several investigator-initiated trials. 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.
There were no significant safety issues identified with the use of ifetroban in these patients. Additional pilot studies of ifetroban are underway, including several investigator-initiated trials. We are 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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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf we are unable to maintain, train and build an effective sales and marketing infrastructure, we will not be able to commercialize and grow our products and product candidates successfully. As we grow, we may not be able to secure sales personnel or organizations that are adequate in number or expertise to successfully market and sell our products.
Biggest changeAs a result of the foregoing and other factors, we do not know the extent to which our product candidates will contribute to our future growth. 40 If we are unable to maintain, train and build an effective sales and marketing infrastructure, we will not be able to commercialize and grow our products and product candidates successfully.
In addition, changes impacting any of our products in areas such as competition, lack of market acceptance or demand, government regulation, intellectual property, reimbursement and manufacturing could have an adverse impact on our future revenues and profitability including: • Changes in intellectual property protection available for our products or competing treatments; • Any unfavorable publicity concerning us, our products, or the markets for these products such as information concerning product contamination or other safety issues in any of our product markets, whether or not directly involving our products; • Perception by physicians and other members of the healthcare community of the safety or efficacy of our products or competing products; • Regulatory developments related to our marketing and promotional practices or the manufacture or continued use of our products; • The prices of our products relative to other drugs or competing treatments; • The impact of current or additional generic competitors; • The availability and level of third-party reimbursement for sales of our products; 35 • The continued availability of adequate supplies of our products to meet demand: • Weakened demand for our products; and • Unforeseen or serious adverse effects outside of those specified in current product labeling being attributed to any of our approved products.
In addition, changes impacting any of our products in areas such as competition, lack of market acceptance or demand, government regulation, intellectual property, reimbursement and manufacturing could have an adverse impact on our future revenues and profitability including: • Changes in intellectual property protection available for our products or competing treatments; • Any unfavorable publicity concerning us, our products, or the markets for these products such as information concerning product contamination or other safety issues in any of our product markets, whether or not directly involving our products; • Perception by physicians and other members of the healthcare community of the safety or efficacy of our products or competing products; • Regulatory developments related to our marketing and promotional practices or the manufacture or continued use of our products; 35 • The prices of our products relative to other drugs or competing treatments; • The impact of current or additional generic competitors; • The availability and level of third-party reimbursement for sales of our products; • The continued availability of adequate supplies of our products to meet demand: • Weakened demand for our products; and • Unforeseen or serious adverse effects outside of those specified in current product labeling being attributed to any of our approved products.
These risk factors and uncertainties include, but are not limited to the following: 34 RISKS RELATED TO OUR BUSINESS Global and national economic conditions and events, including, but not limited to increased inflation, rising interest rates, supply chain disruptions, labor conditions, pandemics and public health crises and international conflicts, could affect our future access to liquidity and materially adversely affect our results of operations and financial condition.
These risk factors and uncertainties include, but are not limited to the following: 34 RISKS RELATED TO OUR BUSINESS Unfavorable global and national economic conditions and events, including, but not limited to increased inflation, rising interest rates, supply chain disruptions, labor conditions, pandemics and public health crises and international conflicts, could affect our future access to liquidity and materially adversely affect our results of operations and financial condition.
Many of our competitors have significantly greater financial and marketing resources than we do. Additional competitors may enter our markets. The pharmaceutical industry is characterized by constant and significant investment in new product development, which can result in rapid technological change. The introduction of new products could substantially reduce our market share or render our products obsolete.
Many of our competitors have significantly greater financial and marketing resources than we do. Additional competitors may enter our markets. 38 The pharmaceutical industry is characterized by constant and significant investment in new product development, which can result in rapid technological change. The introduction of new products could substantially reduce our market share or render our products obsolete.
Furthermore, any system failure, accident or security breach that causes interruptions in our operations could result in a material disruption of our drug development programs. While we continue to invest in data protection and information technology, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions.
Furthermore, any system failure, accident or security breach that causes interruptions in our operations could result in a material disruption of our drug development programs. 43 While we continue to invest in data protection and information technology, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or other disruptions.
Even if any of our drug candidates receives regulatory approval, it could be subject to matters such as post-regulatory surveillance, additional clinical trials or testing, reformulation, changes in labeling, warnings to the public, recall, competition from similar or superior products, and lack of sufficient payor reimbursement by 44 insurance companies or Medicare.
Even if any of our drug candidates receives regulatory approval, it could be subject to matters such as post-regulatory surveillance, additional clinical trials or testing, reformulation, changes in labeling, warnings to the public, recall, competition from similar or superior products, and lack of sufficient payor reimbursement by insurance companies or Medicare.
Like many companies in our industry, we have from time to time received inquiries and other types of information requests from government authorities. 45 While the ultimate outcomes of investigations and legal proceedings are difficult to predict, adverse resolutions or settlements of those matters could result in, among other things: • significant damage awards, fines, penalties or other payments, and administrative remedies, such as exclusion and/or debarment from government programs, or other rulings that preclude us from operating our business in a certain manner; • changes and additional costs to our business operations to avoid risks associated with such litigation or investigations; • product recalls; • reputational damage and decreased demand for our products; and • expenditure of significant time and resources that would otherwise be available for operating our business.
Like many companies in our industry, we have from time to time received inquiries and other types of information requests from government authorities. 46 While the ultimate outcomes of investigations and legal proceedings are difficult to predict, adverse resolutions or settlements of those matters could result in, among other things: • significant damage awards, fines, penalties or other payments, and administrative remedies, such as exclusion and/or debarment from government programs, or other rulings that preclude us from operating our business in a certain manner; • changes and additional costs to our business operations to avoid risks associated with such litigation or investigations; • product recalls; • reputational damage and decreased demand for our products; and • expenditure of significant time and resources that would otherwise be available for operating our business.
The occurrence of any information system failures could result in interruptions, delays, loss or corruption of data and cessations or interruptions in the availability of these systems. All of these events or 43 circumstances, among others, could have an adverse effect on our business, results of operations, financial position and cash flows, and they could harm our business reputation.
The occurrence of any information system failures could result in interruptions, delays, loss or corruption of data and cessations or interruptions in the availability of these systems. All of these events or circumstances, among others, could have an adverse effect on our business, results of operations, financial position and cash flows, and they could harm our business reputation.
Our inability to comply with the covenants in our debt instruments could lead to a default or an event of default under the terms thereof, for which we may need to seek relief from our lender in order to waive the associated default or event of default and avoid a potential acceleration of the related indebtedness or cross-default or cross- 55 acceleration to other debt.
Our inability to comply with the covenants in our debt instruments could lead to a default or an event of default under the terms thereof, for which we may need to seek relief from our lender in order to waive the associated default or event of default and avoid a potential acceleration of the related indebtedness or cross-default or cross-acceleration to other debt.
We and these third parties are required to comply with Good Clinical Practice (GCPs), which are regulations and guidelines enforced by 37 the FDA and comparable foreign regulatory authorities for therapeutic candidates in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites.
We and these third parties are required to comply with Good Clinical Practice (GCPs), which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for therapeutic candidates in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites.
If the manufacturers of Caldolor are unable to produce marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Caldolor. 36 Kristalose: The active pharmaceutical ingredient for Kristalose is manufactured at a single facility through a complex process.
If the manufacturers of Caldolor are unable to produce marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Caldolor. Kristalose: The active pharmaceutical ingredient for Kristalose is manufactured at a single facility through a complex process.
If our third-party manufacturers do not comply with these requirements, we could be subject to fines and civil penalties; suspension of production or distribution; suspension or delay in product approval; product seizure or recall; and withdrawal of product approval. We are dependent on a variety of other third parties.
If our third-party manufacturers do not comply with these requirements, we could be subject to fines and civil penalties; suspension of production or distribution; suspension or delay in product approval; product seizure or recall; and withdrawal of product approval. 37 We are dependent on a variety of other third parties.
With future acquisitions, we may face financial and operational risks and uncertainties. We may not be able to engage in future product acquisitions, and those we do complete may not be beneficial to us in the long term. 39 Furthermore, other products in development may encounter unforeseen issues during their clinical trials.
With future acquisitions, we may face financial and operational risks and uncertainties. We may not be able to engage in future product acquisitions, and those we do complete may not be beneficial to us in the long term. Furthermore, other products in development may encounter unforeseen issues during their clinical trials.
Further consolidation or financial difficulties could also cause our customers to reduce the amounts of our products that they purchase, adversely impacting our business, financial condition and results of operations. Our CET joint initiative may not result in our gaining access to commercially viable products.
Further consolidation or financial difficulties could also cause our customers to reduce the amounts of our products that they purchase, adversely impacting our business, financial condition and results of operations. 41 Our CET joint initiative may not result in our gaining access to commercially viable products.
If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or 46 frequency, or problems with a facility where the product is manufactured, a regulatory agency may impose restrictions on that product or the manufacturer, including withdrawal of the product from the market or suspension of manufacturing.
If we or a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with a facility where the product is manufactured, a regulatory agency may impose restrictions on that product or the manufacturer, including withdrawal of the product from the market or suspension of manufacturing.
We have a life insurance policy covering the life of Mr. Kazimi. We have entered into agreements with each of our employees that 41 contain restrictive covenants relating to non-competition and non-solicitation of our customers and suppliers for one year after termination of employment.
We have a life insurance policy covering the life of Mr. Kazimi. We have entered into agreements with each of our employees that contain restrictive covenants relating to non-competition and non-solicitation of our customers and suppliers for one year after termination of employment.
If a licensor does not perform and if we do not assume the 49 maintenance of the licensed patents in sufficient time to make required payments or filings with the appropriate governmental agencies, we risk losing the benefit of all or some of those patent rights.
If a licensor does not perform and if we do not assume the maintenance of the licensed patents in sufficient time to make required payments or filings with the appropriate governmental agencies, we risk losing the benefit of all or some of those patent rights.
A long-term inability to meet demand for our products could result in impairment of our brands overall future and the carrying value of the assets associated with our brands. Acetadote: We have an agreement with one manufacturer to provide commercial supply of Acetadote.
A long-term inability to meet demand for our products could result in impairment of our brands overall future and the carrying value of the assets associated with our brands. 36 Acetadote: We have an agreement with one manufacturer to provide commercial supply of Acetadote.
As a result, we may not commercialize or continue to commercialize a product that has obtained regulatory approval. Any approved drug product that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community.
As a result, we may not commercialize or continue to commercialize a product that has obtained regulatory approval. 45 Any approved drug product that we bring to the market may not gain market acceptance by physicians, patients, healthcare payors and others in the medical community.
If we are unable to obtain any needed additional funding, we may be required to reduce the scope of, delay, or eliminate some or all of, our planned research, development and commercialization activities or to license to third parties the rights to develop and/or commercialize products or technologies that we would otherwise seek to develop and/or commercialize ourselves or on terms that are less attractive than they might otherwise be, any of which could materially harm our business. 52 We might also seek to sell assets or rights in one or more commercial products or product development programs.
If we are unable to obtain any needed additional funding, we may be required to reduce the scope of, delay, or eliminate some or all of, our planned research, development and commercialization activities or to license to third parties the rights to develop and/or commercialize products or technologies that we would otherwise seek to develop and/or commercialize ourselves or on terms that are less attractive than they might otherwise be, any of which could materially harm our business. 53 We might also seek to sell assets or rights in one or more commercial products or product development programs.
A significant adverse ruling in any such lawsuit could put our trademarks at risk of being invalidated and could compromise the issuance of our existing trademark applications. 50 Competitors may infringe on our trademarks or the trademarks of our collaborators or licensors.
A significant adverse ruling in any such lawsuit could put our trademarks at risk of being invalidated and could compromise the issuance of our existing trademark applications. Competitors may infringe on our trademarks or the trademarks of our collaborators or licensors.
We cannot currently predict the specific outcome or impact on our business of such regulatory and legislative initiatives. We must comply with the Foreign Corrupt Practices Act.
We cannot currently predict the specific outcome or impact on our business of such regulatory and legislative initiatives. 48 We must comply with the Foreign Corrupt Practices Act.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. We are subject to stringent government regulation. All of our products face regulatory challenges. 51 RISKS RELATED TO OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our operating results are likely to fluctuate from period to period.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. We are subject to stringent government regulation. All of our products face regulatory challenges. 52 RISKS RELATED TO OUR FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our operating results are likely to fluctuate from period to period.
Our business could be adversely affected by an inability to retain personnel or upward pressure on wages as a result of the competitive labor market. The size of our organization and our potential growth may lead to difficulties in managing operations. As of December 31, 2023, we had 91 employees.
Our business could be adversely affected by an inability to retain personnel or upward pressure on wages as a result of the competitive labor market. The size of our organization and our potential growth may lead to difficulties in managing operations. As of December 31, 2024, we had 91 employees.
A lack of research coverage may adversely affect our stock’s market price. 53 RISKS RELATED TO OWNING OUR STOCK The market price of our common stock may fluctuate substantially. The price for the shares of our common stock sold in our initial public offering was determined by negotiation between the representatives of the underwriters and us.
A lack of research coverage may adversely affect our stock’s market price. 54 RISKS RELATED TO OWNING OUR STOCK The market price of our common stock may fluctuate substantially. The price for the shares of our common stock sold in our initial public offering was determined by negotiation between the representatives of the underwriters and us.
It would be particularly difficult to find a new manufacturer of the Kristalose active pharmaceutical ingredient on an expedited basis. We have manufacturing relationship with one packager who provided finished supplies of Kristalose for commercial and sampling purposes during 2022.
It would be particularly difficult to find a new manufacturer of the Kristalose active pharmaceutical ingredient on an expedited basis. We have a manufacturing relationship with one packager who has provided finished supplies of Kristalose for commercial and sampling purposes since 2022.
As cyber threats continue to evolve, we may be required to expend significant capital and other resources to protect against the threat of security breaches or to mitigate and alleviate problems caused by breaches, including unauthorized access to proprietary information and personally identifiable information stored in our information systems, and the introduction of computer viruses or other malicious software programs to our systems.
As cyber threats continue to evolve (including through the use of artificial intelligence), we may be required to expend significant capital and other resources to protect against the threat of security breaches or to mitigate and alleviate problems caused by breaches, including unauthorized access to proprietary information and personally identifiable information stored in our information systems, and the introduction of computer viruses or other malicious software programs to our systems.
These risks are discussed more fully in the section titled “Risk Factors.” These risks and uncertainties include, but are not limited to, the following: • Global and national conditions and events, including, but not limited to, rising interest rates, increased inflation, supply chain disruptions, labor conditions, pandemics and public health crises and international conflict, may adversely affect our business, revenues, results of operations and financial condition. • Failure to implement strategies to enhance our performance could have a material adverse effect on our business, results of operations and financial conditions. • Our ability to perform depends on keeping and hiring exceptionally talented management and employees, and our failure to do so could have a material adverse effect on our business, revenues, results of operations and financial condition. • Our success depends, in part, on our ability to successfully obtain or retain high-performing third-party performers on commercially acceptable terms, and the failure to do so can have a material adverse effect on our business, financial conditions and results of operations. • Our business is subject to stringent government regulations, it must adhere to numerous complex pieces of legislation, and all of our products face regulatory challenges. • Our business depends on the successful protection of our intellectual property rights and our product candidates becoming approved by regulatory agencies, commercially viable, and accepted by the market. • Our business faces a serious financial risk if generic products that compete with any of our branded pharmaceutical products are approved and sold because sales of our products will be adversely-affected and our business may not recover the capital costs of bringing that product to market. • Our business faces an inherent risk of product liability lawsuits related to the testing of our product candidates and the commercial sale of our products, and if we cannot successfully defend ourselves against the product liability claim, we may incur substantial liabilities. • We may attempt to develop internationally and license our products globally, as well as invest in other businesses or joint ventures, all of which may be unsuccessful, divert our management’s attention and harm our operating results and prospects.
These risks are discussed more fully in the section titled “Risk Factors.” These risks and uncertainties include, but are not limited to, the following: • Global and national conditions and events, including, but not limited to, rising interest rates, increased inflation, supply chain disruptions, labor conditions, significant natural disasters, pandemics and public health crises and international conflict, may adversely affect our business, revenues, results of operations and financial condition. • Failure to implement strategies to enhance our performance could have a material adverse effect on our business, results of operations and financial conditions. • Our ability to perform depends on keeping and hiring exceptionally talented management and employees, and our failure to do so could have a material adverse effect on our business, revenues, results of operations and financial condition. • Our success depends, in part, on our ability to successfully obtain or retain high-performing third-party performers on commercially acceptable terms, and the failure to do so can have a material adverse effect on our business, financial conditions and results of operations. • Our business is subject to stringent government regulations, it must adhere to numerous complex pieces of legislation, and all of our products face regulatory challenges. • Our business depends on the successful protection of our intellectual property rights and our product candidates becoming approved by regulatory agencies, commercially viable, and accepted by the market. • Our business is subject to cybersecurity and artificial-intelligence related risks, including risks related to system failures, security breaches, including any cybersecurity incidents, adverse events or other disruptions within our information technology infrastructure at our corporate headquarters; or intellectual property infringement. • Our business faces a serious financial risk if generic products that compete with any of our branded pharmaceutical products are approved and sold because sales of our products will be adversely affected and our business may not recover the capital costs of bringing that product to market. • Our business faces an inherent risk of product liability lawsuits related to the testing of our product candidates and the commercial sale of our products, and if we cannot successfully defend ourselves against the product liability claim, we may incur substantial liabilities. • We may attempt to develop internationally and license our products globally, as well as invest in other businesses or joint ventures, all of which may be unsuccessful, divert our management’s attention and harm our operating results and prospects.
Our focus on acquisitions as a growth strategy has created intangible assets whose amortization could negatively affect our results of operations. Our total assets include intangible assets related to our acquisitions. As of December 31, 2023, intangible assets relating to products, which are being amortized, represented approximately 28 percent of our total assets.
Our focus on acquisitions as a growth strategy has created intangible assets whose amortization could negatively affect our results of operations. Our total assets include intangible assets related to our acquisitions. As of December 31, 2024, intangible assets relating to products, which are being amortized, represented approximately 24 percent of our total assets.
An adverse development regarding our products could have a material and adverse impact on our future revenues and profitability. Our product portfolio currently includes seven brands: Acetadote, Caldolor, Kristalose, Vaprisol, Omeclamox-Pak, Vibativ and Sancuso.
An adverse development regarding our products could have a material and adverse impact on our future revenues and profitability. Our product portfolio currently includes six brands: Acetadote, Caldolor, Kristalose, Sancuso, Vaprisol and Vibativ.
If we achieve profitability, we may not be able to sustain or increase profitability. Our officers, directors, and principal shareholders, acting as a group, could significantly influence corporate actions. As of December 31, 2023, our officers and directors control approximately 43.3 percent of our common stock.
If we achieve profitability, we may not be able to sustain or increase profitability. Our officers, directors, and principal shareholders, acting as a group, could significantly influence corporate actions. As of December 31, 2024, our officers and directors control approximately 44.41 percent of our common stock.
We have added six products to our portfolio of brands through acquisitions. Our business strategy is to continue to acquire rights to FDA-approved products as well as pharmaceutical product candidates in the late stages of development. We do not plan to conduct basic research or preclinical product development, except to the extent of our investment in CET.
Our business strategy is to continue to acquire rights to FDA-approved products as well as pharmaceutical product candidates in the late stages of development. We do not plan to conduct basic research or preclinical product development, except to the extent of our investment in CET.
We are required to comply with the United States Physician Payment Sunshine Act, which requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals. Manufacturers are required to report this information annually to The Centers for Medicare & Medicaid Services ("CMS").
We must comply with the Physician Payment Sunshine Act. We are required to comply with the United States Physician Payment Sunshine Act, which requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal healthcare programs to report certain payments and items of value given to physicians and teaching hospitals.
Third parties may oppose registration of our federal trademark applications. Further, we could be involved in lawsuits for allegedly infringing the rights of others with respect to their prior-existing trademarks. These lawsuits or opposition proceedings can be costly and time-consuming.
Over time, we intend to obtain and maintain registrations on trademarks that remain valuable to our business. Third parties may oppose registration of our federal trademark applications. Further, we could be involved in lawsuits for allegedly infringing the rights of others with respect to their prior-existing trademarks. These lawsuits or opposition proceedings can be costly and time-consuming.
Liability claims may result in decreased demand for our products; injury to our reputation; withdrawal of clinical trial participants; significant litigation costs; substantial monetary awards to or costly settlement with patients; product recalls; loss of revenue; and the inability to commercialize our product candidates.
If we cannot successfully defend ourselves against the product liability claim, we may incur substantial liabilities. Liability claims may result in decreased demand for our products; injury to our reputation; withdrawal of clinical trial participants; significant litigation costs; substantial monetary awards to or costly settlement with patients; product recalls; loss of revenue; and the inability to commercialize our product candidates.
“Formulary” practices of third-party payors could adversely affect our competitive position. Many managed healthcare organizations control the pharmaceutical products included on their formulary lists. Having products listed on these formulary lists creates competition among pharmaceutical companies which, in turn, has created a trend of downward pricing pressure in our industry.
Many managed healthcare organizations control the pharmaceutical products included on their formulary lists. Having products listed on these formulary lists creates competition among pharmaceutical companies which, in turn, has created a trend of downward pricing pressure in our industry.
Similarly, there are a number of legislative proposals in the European Union, the United States, at both the federal and state level, as well as other jurisdictions that could impose new obligations or limitations in areas affecting our business.
Similarly, there are a number of legislative proposals in the European Union, the United States, at both the federal and state level, as well as other jurisdictions that could impose new obligations or limitations in areas affecting our business. These changes may lead to additional costs and increase our overall risk exposure.
We have established formal policies or procedures for prohibiting or monitoring this conduct, but we cannot assure you that our employees or other agents will not engage in such conduct for which we might be held responsible.
We have established formal policies or procedures for prohibiting or monitoring this conduct, but we cannot assure you that our employees or other agents will not engage in such conduct for which we might be held responsible. If our employees or other agents are found to have engaged in such practices, we could suffer severe penalties.
The delisting of our common stock from NASDAQ could negatively impact us by (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; (iii) impacting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing or limiting us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees. 54 Some provisions of our third amended and restated charter, bylaws and Tennessee law may inhibit potential acquisition bids that you may consider favorable.
The delisting of our common stock from NASDAQ could negatively impact us by (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; (iii) impacting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing or limiting us from accessing the public capital markets; and (iv) impairing our ability to provide equity incentives to our employees.
In addition, all manufacturers of our products and product candidates must comply with current good manufacturing practices, ("GMPs"), enforced by the FDA through its facilities inspection program. These requirements include quality control, quality assurance, and the maintenance of records and documentation.
The product’s FDA registration was subsequently transferred from Kyowa Kirin, Inc. to Cumberland in August 2023. In addition, all manufacturers of our products and product candidates must comply with current good manufacturing practices, ("GMPs"), enforced by the FDA through its facilities inspection program. These requirements include quality control, quality assurance, and the maintenance of records and documentation.
In addition, legislation enacted in most U.S. states allows or, in some instances mandates, that a pharmacist dispense an available generic equivalent when filling a prescription for a branded product, in the absence of specific instructions from the prescribing physician.
In addition, legislation enacted in most U.S. states allows or, in some instances mandates, that a pharmacist dispense an available generic equivalent when filling a prescription for a branded product, in the absence of specific instructions from the prescribing physician. Governmental and private healthcare payors also emphasize substitution of branded pharmaceuticals with less expensive generic equivalents.
Governmental and private healthcare payors also emphasize substitution of branded pharmaceuticals with less expensive generic equivalents. 38 Pursuant to the provisions of the Hatch-Waxman Act, manufacturers of branded products often bring lawsuits to enforce their patent rights against generic products released prior to the expiration of branded products’ patents, but it is possible for generic manufacturers to offer generic products while such litigation is pending.
Pursuant to the provisions of the Hatch-Waxman Act, manufacturers of branded products often bring lawsuits to enforce their patent rights against generic products released prior to the expiration of branded products’ patents, but it is possible for generic manufacturers to offer generic products while such litigation is pending.
In addition, we have largely obtained regulatory approval to market our products in the United States. Not all foreign jurisdictions may represent attractive opportunities for our products due to pricing, competitive, regulatory or other factors. In certain foreign jurisdictions, we have licensed the right to market some of our products to third parties.
Not all foreign jurisdictions may represent attractive opportunities for our products due to pricing, competitive, regulatory or other factors. In certain foreign jurisdictions, we have licensed the right to market some of our products to third parties. These third parties are responsible for seeking and maintaining regulatory approval for the products in their respective jurisdictions.
In addition, we may find it necessary to initiate litigation to protect our trade secrets, to enforce our intellectual property rights and to determine the scope and validity of any proprietary rights of others. Any such litigation, or the failure to obtain any necessary licenses or other rights, could materially and adversely affect our business.
In addition, we may find it necessary to initiate litigation to protect our trade secrets, to enforce our intellectual property rights and to determine the scope and validity of any proprietary rights of others.
In addition, some states require reporting information concerning payments to health care providers or other transfers of value by drug manufacturers beyond the requirements of the Federal Sunshine Act.
Manufacturers are required to report this information annually to The Centers for Medicare & Medicaid Services ("CMS"). In addition, some states require reporting information concerning payments to health care providers or other transfers of value by drug manufacturers beyond the requirements of the Federal Sunshine Act.
Our corporate documents contain provisions that may enable our board of directors to resist a change in control of our company even if a change in control were to be considered favorable by you and other shareholders.
Some provisions of our third amended and restated charter, bylaws and Tennessee law may inhibit potential acquisition bids that you may consider favorable. Our corporate documents contain provisions that may enable our board of directors to resist a change in control of our company even if a change in control were to be considered favorable by you and other shareholders.
Even after regulatory approval, certain developments may decrease demand for our products, including the following: • the re-review of products that are already marketed; • new scientific information and evolution of scientific theories; • the recall or loss of marketing approval of products that are already marketed; • changing government standards or public expectations regarding safety, efficacy or labeling changes; and • greater scrutiny in advertising and promotion.
Even after regulatory approval, certain developments may decrease demand for our products, including the following: • the re-review of products that are already marketed; • new scientific information and evolution of scientific theories; • the recall or loss of marketing approval of products that are already marketed; • changing government standards or public expectations regarding safety, efficacy or labeling changes; and • greater scrutiny in advertising and promotion. 47 Certain regulatory changes or decisions could make it more difficult for us to sell our products and could have a material adverse effect on our business, results of operations, financial condition and cash flows.
If our costs, in particular costs related to clinical trial expenses and/or employee-related expenses, were to become subject to significant inflationary pressures, it may adversely impact our business, operating results and financial condition. In response to inflationary pressures, the Federal Reserve raised interest rates in 2022 and 2023, and these increases may continue in 2024 and beyond.
If our costs, in particular costs related to clinical trial expenses and/or employee-related expenses, were to become subject to significant inflationary pressures, it may adversely impact our business, operating results and financial condition.
Our future growth depends on our ability to identify, acquire rights and successfully integrate new brands into our operations. If we do not successfully identify and acquire rights to products or if we do not successfully integrate acquired product brands into our operations, our growth opportunities may be limited.
If we do not successfully identify and acquire rights to products or if we do not successfully integrate acquired product brands into our operations, our growth opportunities may be limited. We have added six products to our portfolio of brands through acquisitions.
We may be subject to foreign, federal, and state data privacy and security laws, and failure to protect our information systems against security breaches, service interruptions, or misappropriation of data could disrupt operations, compromise sensitive data, and expose us to liability, possibly causing our business and reputation to suffer.
Our failure to comply with our reporting and payment obligations under the Medicaid Drug Rebate program and other governmental programs could negatively impact our financial results. 49 We may be subject to foreign, federal, and state data privacy and security laws, and failure to protect our information systems against security breaches, service interruptions, or misappropriation of data could disrupt operations, compromise sensitive data, and expose us to liability, possibly causing our business and reputation to suffer.
We have never paid cash dividends on our capital stock. We have never paid cash dividends on our capital stock. The availability of funds for distributions to shareholders will depend on our financial performance and assets. Any future decision to declare or pay dividends will be at the sole discretion of our Board of Directors.
We have never paid cash dividends on our capital stock. We have never paid cash dividends on our capital stock. The availability of funds for distributions to shareholders will depend on our financial performance and assets.
We may not be able to maintain our listing on the NASDAQ Global Select Market (“NASDAQ”), which could have a material adverse effect on us and our stockholders.
This could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements. 55 We may not be able to maintain our listing on the NASDAQ Global Select Market (“NASDAQ”), which could have a material adverse effect on us and our stockholders.
These conditions include, but are not limited to, increased inflation, high and rising interest rates, supply chain disruptions, labor conditions, the negative impacts from pandemics and public health crises (including any lingering or recurring adverse impacts from the COVID-19 pandemic) and the negative impacts resulting from the ongoing conflicts in Eastern Europe and the Middle East.
These conditions include, but are not limited to, increased inflation, high and rising interest rates, supply chain disruptions, labor conditions, significant natural disasters (including as a result of climate change), the negative impacts from pandemics and public health crises (such as the COVID-19 pandemic) and the negative impacts resulting from political and military conflict, trade and other international disputes, including the ongoing conflicts in Eastern Europe and the Middle East.
We have experienced, and may continue to experience, growth and increased expenses in the scope of our operations in connection with the continued marketing and development of our products. Our financial performance will depend, in part, on our ability to manage any such growth and expenses of the current organization effectively.
We have experienced, and may continue to experience, growth and increased expenses in the scope of our operations in connection with the continued marketing and development of our products.
DEBT-RELATED RISKS Our Revolving Credit Agreement impose restrictive and financial covenants on us. Our failure to comply with these covenants could trigger events that would have a material adverse effect on our business.
Any future decision to declare or pay dividends will be at the sole discretion of our Board of Directors. 56 DEBT-RELATED RISKS Our Revolving Credit Agreement impose restrictive and financial covenants on us. Our failure to comply with these covenants could trigger events that would have a material adverse effect on our business.
As of December 31, 2023, we did not have any outstanding interest rate swap contracts. Item 1B. Unresolved Staff Comments. None.
As of December 31, 2024, we did not have any outstanding interest rate swap contracts.
If the manufacturing or packaging facilities are unable to produce useable or marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Kristalose. Omeclamox-Pak: Our packager for Omeclamox-Pak encountered financial difficulties due to the impact of COVID-19, and their operations are currently suspended.
If the manufacturing or packaging facilities are unable to produce useable or marketable inventory in sufficient quantities, in the agreed upon time period, we could suffer an inability to meet demand for Kristalose.
Furthermore, our competitors may independently develop similar technologies or duplicate technology developed by us in a manner that does not infringe our patents or other intellectual property. As a result of these factors, our patent rights may not provide any commercially valuable protection from competing products.
Furthermore, our competitors may independently develop similar technologies or duplicate technology developed by us in a manner that does not infringe our patents or other intellectual property.
Our failure to follow FDA rules and guidelines relating to promotion and advertising may cause the FDA to suspend or withdraw an approved product from the market, require a recall or payment of fines, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our business. 42 Our business and operations would suffer in the event of system failures, security breaches, including any cybersecurity incidents, adverse events or other disruptions within our information technology infrastructure at our corporate headquarters; or in the event of intellectual property infringement.
Our failure to follow FDA rules and guidelines relating to promotion and advertising may cause the FDA to suspend or withdraw an approved product from the market, require a recall or payment of fines, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our business.
We seek to secure and extend marketing exclusivity for our products through a variety of means, including FDA exclusivity and patent rights. Additional barriers for competitors seeking to enter the market include the time and cost associated with the development, regulatory approval and manufacturing of a similar product formulation.
Additional barriers for competitors seeking to enter the market include the time and cost associated with the development, regulatory approval and manufacturing of a similar product formulation.
We may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States.
We may not be able, alone or with our collaborators and licensors, to prevent misappropriation of our proprietary rights, particularly in countries where the laws may not protect such rights as fully as in the United States. 51 Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, some of our confidential information could be disclosed during this type of litigation.
If we cannot obtain adequate reimbursement levels, our business, financial condition and results of operations would be materially and adversely affected. Our employees have been trained to submit accurate and correct pricing information to payors. If, despite the training, our employees provide incorrect or fraudulent information, then we will be subject to various administrative and judicial investigations and litigation.
Our employees have been trained to submit accurate and correct pricing information to payors. If, despite the training, our employees provide incorrect or fraudulent information, then we will be subject to various administrative and judicial investigations and litigation. “Formulary” practices of third-party payors could adversely affect our competitive position.
An individual may bring a liability claim against us if one of our product candidates or products causes, or appears to have caused, an injury. If we cannot successfully defend ourselves against the product liability claim, we may incur substantial liabilities.
We face an inherent risk of product liability lawsuits related to the testing of our product candidates and the commercial sale of our products. An individual may bring a liability claim against us if one of our product candidates or products causes, or appears to have caused, an injury.
At this time no assurances can be given that these measures, or subsequent legislative proposals, will not have an adverse effect on our revenues in the future.
At this time no assurances can be given that these measures, or subsequent legislative proposals, will not have an adverse effect on our revenues in the future. Future cost control initiatives, legislation, and regulations could decrease the price that we receive for our products, which would limit our revenue and profitability.
If for any reason we are unable to obtain or retain third-party manufacturers on commercially acceptable terms, we may not be able to sell our products as planned. Furthermore, if we encounter delays or difficulties with contract manufacturers in producing our products, the distribution, marketing and subsequent sales of these products could be adversely affected.
If for any reason we are unable to obtain or retain third-party manufacturers on commercially acceptable terms, we may not be able to sell our products as planned.
Our Revolving Credit Agreement contains specified quarterly financial maintenance covenants. As of December 31, 2023, we were in compliance with the Maximum Funded Debt Ratio financial covenant of the Revolving Credit Agreement. However, we can make no assurance that we will be able to comply with the restrictive and financial covenants contained in the Revolving Credit Agreement in the future.
However, we can make no assurance that we will be able to comply with the restrictive and financial covenants contained in the Revolving Credit Agreement in the future.
The extent to which these product candidates will be reimbursed by the U.S. government or third-party payors is also currently unknown. As a result of the foregoing and other factors, we do not know the extent to which our product candidates will contribute to our future growth.
The extent to which these product candidates will be reimbursed by the U.S. government or third-party payors is also currently unknown.
With uncertain future cash flows, the Board of Directors approved the write-down of the intangible assets related to the product. Vaprisol: In 2018, the manufacturer of Vaprisol 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.
Vaprisol: In 2018, the manufacturer of Vaprisol 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 are in the process of transitioning to a new manufacturing partner, who was issued a U.S.
We have applied for trademark registration for other various names and logos. We also may have common law trademark rights in unregistered names, phrases, and logos under which we market or offer certain products and services. Over time, we intend to obtain and maintain registrations on trademarks that remain valuable to our business.
We own certain trademark registrations for each of our branded pharmaceutical products as well as for our corporate name and logo. We have applied for trademark registration for other various names and logos. We also may have common law trademark rights in unregistered names, phrases, and logos under which we market or offer certain products and services.
If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected. In addition to patents, we rely upon trade secrets, unpatented proprietary know-how and continuing technological innovation where we do not believe patent protection is appropriate or attainable.
In addition to patents, we rely upon trade secrets, unpatented proprietary know-how and continuing technological innovation where we do not believe patent protection is appropriate or attainable. For example, the manufacturing process for Kristalose involves substantial trade secrets and proprietary know-how.
Future cost control initiatives, legislation, and regulations could decrease the price that we receive for our products, which would limit our revenue and profitability. 40 Also, reimbursement practices of third-party payors might preclude us from achieving market acceptance for our products or maintaining price levels sufficient to realize an appropriate return on our investment in product acquisition and development.
Also, reimbursement practices of third-party payors might preclude us from achieving market acceptance for our products or maintaining price levels sufficient to realize an appropriate return on our investment in product acquisition and development. If we cannot obtain adequate reimbursement levels, our business, financial condition and results of operations would be materially and adversely affected.
We may be involved in lawsuits to protect or enforce our trademarks or for allegedly infringing the trademark rights of others, which could be costly and time consuming. We own certain trademark registrations for each of our branded pharmaceutical products as well as for our corporate name and logo.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. We may be involved in lawsuits to protect or enforce our trademarks or for allegedly infringing the trademark rights of others, which could be costly and time consuming.
We license our products globally; therefore, we may have exposure to foreign regulatory requirements and fluctuations in foreign currency exchange rates.
Any such litigation, or the failure to obtain any necessary licenses or other rights, could materially and adversely affect our business. 44 We license our products globally; therefore, we may have exposure to foreign regulatory requirements and fluctuations in foreign currency exchange rates.
This risk would be accentuated if we acquire products in areas outside of our current focus areas since our sales forces specialize in our existing areas.
As we grow, we may not be able to secure sales personnel or organizations that are adequate in number or expertise to successfully market and sell our products. This risk would be accentuated if we acquire products in areas outside of our current focus areas since our sales forces specialize in our existing areas.
These changes may lead to additional costs and increase our overall risk exposure. 48 RISKS RELATING TO INTELLECTUAL PROPERTY Our strategy to secure and extend marketing exclusivity or patent rights may provide only limited or no protection from competition.
RISKS RELATING TO INTELLECTUAL PROPERTY Our strategy to secure and extend marketing exclusivity or patent rights may provide only limited or no protection from competition. We seek to secure and extend marketing exclusivity for our products through a variety of means, including FDA exclusivity and patent rights.
We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product or product candidate and may have to limit its commercialization. We face an inherent risk of product liability lawsuits related to the testing of our product candidates and the commercial sale of our products.
Our financial performance will depend, in part, on our ability to manage any such growth and expenses of the current organization effectively. 42 We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product or product candidate and may have to limit its commercialization.
We will be required to identify and enroll a sufficient number of subjects for each of our clinical trials. Delays that may result from difficulty enrolling patients could impact our ability to explore opportunities for label expansion and limit our ability to bring our products to new patient populations.
Delays that may result from difficulty enrolling patients could impact our ability to explore opportunities for label expansion and limit our ability to bring our products to new patient populations. 39 In addition, we have largely obtained regulatory approval to market our products in the United States.
These third parties are responsible for seeking and maintaining regulatory approval for the products in their respective jurisdictions. We have no control over these third parties and cannot be sure that marketing approval for our products will be obtained outside the United States.
We have no control over these third parties and cannot be sure that marketing approval for our products will be obtained outside the United States. Our future growth depends on our ability to identify, acquire rights and successfully integrate new brands into our operations.
We are currently working with a new manufacturer to provide us with long term supplies of the product. In February 2022, we notified the FDA of a shortage of Vaprisol. If we are unable to produce additional marketable inventory in sufficient quantities, in the required time frame, we could suffer an inability to meet demand for Vaprisol.
Meanwhile, we have been working with them to support a special, interim supply of compounded product for critically ill patients, which they introduced to the market in late 2023. If we are unable to produce additional marketable inventory in sufficient quantities, in the required time frame, we could suffer an inability to meet demand for Vaprisol.
Removed
Cumberland is awaiting resumption of those operations while also exploring other alternatives to restart the product’s packaging. In October 2020, we informed the FDA of a shortage of Omeclamox-Pak which continues. If we are unable to obtain marketable inventory in the future, we could continue to suffer an inability to meet demand for Omeclamox-Pak.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe also work with third parties from time to time to assist us in identification, assessment and management of cybersecurity risks. For additional informant and a description of the risks from cybersecurity threats that may materially affect us and how they may do so, refer to Part I, Item 1A. Risk Factors. 56 Governance.
Biggest changeWe also work with third parties from time to time to assist us in identification, assessment and management of cybersecurity risks. For additional informant and a description of the risks from cybersecurity threats that may materially affect us and how they may do so, refer to Part I, Item 1A. Risk Factors. Governance.
They participates in cybersecurity incident response efforts and directs the company’s response to cybersecurity incidents. Our Board of Directors addresses the company’s cybersecurity risk management as part of its general oversight function. The Board of Directors has access to various reports, summaries or presentations related to cybersecurity threats, risk, and mitigation.
They participates in cybersecurity incident response efforts and directs the company’s response to cybersecurity incidents. 58 Our Board of Directors addresses the company’s cybersecurity risk management as part of its general oversight function. The Board of Directors has access to various reports, summaries or presentations related to cybersecurity threats, risk, and mitigation.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeDuring 2023, Cumberland exercised the 2nd Extension option to extend the lease for five more years though April 2028. CET leases approximately 14,200 square feet of office and wet laboratory space in Nashville, Tennessee to operate the CET Life Sciences Center. Cumberland’s product formulation and testing laboratories are located at this facility, along with CET’s offices.
Biggest changeCET leases approximately 14,200 square feet of office and wet laboratory space in Nashville, Tennessee to operate the CET Life Sciences Center. Cumberland’s product formulation and testing laboratories are located at this facility, along with CET’s offices. The CET Life Sciences Center also provides laboratory and office space, equipment and infrastructure to early-stage life sciences companies and university spin-outs.
Item 2. Properties. As of December 31, 2023, we leased approximately 16,903 rentable square feet of space at the new Broadwest development in Nashville, Tennessee for our corporate headquarters. The lease commencement date occurred in October 2022 with a term of 157 months leased through November 2035.
Item 2. Properties. As of December 31, 2024, we leased approximately 16,903 rentable square feet of space at the Broadwest development in Nashville, Tennessee for our corporate headquarters. The lease commencement date occurred in October 2022 with a term of 157 months leased through November 2035. We believe these facilities are adequate to meet our current needs for office space.
We believe these facilities are adequate to meet our current needs for office space. Manufacturing, packaging or warehousing services are provided to us through contracts with third-party organizations. The laboratory space at CET, under an agreement amended in July 2012, is now leased through April 2028.
Manufacturing, packaging or warehousing services are provided to us through contracts with third-party organizations. The laboratory space at CET, under an agreement amended in July 2012, is now leased through April 2028. During 2023, Cumberland exercised the 2nd Extension option to extend the lease for five more years through April 2028.
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The CET Life Sciences Center also provides laboratory and office space, equipment and infrastructure to early-stage life sciences companies and university spin-outs.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe following table summarizes the activity, by month, during the fourth quarter of 2023: Period Total Number of Shares (or Units) Purchased Average Price Paid per Share (or Unit) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs October 28,114 $2.04 28,114 $3,135,727 November 50,220 (1) $1.81 50,220 $3,044,578 December 21,359 (2) $1.83 21,359 $3,005,385 Total 99,693 (1) Of this amount, 25,000 shares were repurchased directly in private purchases at the then-current fair market value of common stock.
Biggest changeThe following table summarizes the activity, by month, during the fourth quarter of 2024: Period Total Number of Shares (or Units) Purchased Average Price Paid per Share (or Unit) Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs October 29,404 $1.31 29,404 $2,491,306 November 17,908 $1.21 17,908 $2,469,705 December 16,800 $2.17 16,800 $2,433,312 Total 64,112 Item 6.
The graph assumes an initial investment of $100 on December 31, 2018, and that all dividends were reinvested. 58 Purchases of Equity Securities The Company currently has a share repurchase program to repurchase up to $10.0 million of our common stock pursuant to Rule 10b-18 of the Securities Exchange Act of 1934, as amended.
The graph assumes an initial investment of $100 on December 31, 2018, and that all dividends were reinvested. 60 Purchases of Equity Securities The Company currently has a share repurchase program to repurchase up to $10.0 million of our common stock pursuant to Rule 10b-18 of the Securities Exchange Act of 1934, as amended.
Performance Graph The stock performance graph below illustrates a comparison of the total cumulative stockholder return on our common stock since December 31, 2018 to the Nasdaq Composite and a composite of ten Nasdaq Pharmaceutical and Specialty Pharmaceutical Stocks which most closely compare to our Company - Avadel Pharmaceuticals plc, Harrow Health, Inc., Eagle Pharmaceuticals, Inc., Assertio Holdings, Inc., HLS Therapeutics Inc., EyePoint Pharmaceuticals, Inc., Eton Pharmaceuticals, Inc., Theratechnologies Inc., Acorda Therapeutics Inc. and Talphera, Inc.
Performance Graph The stock performance graph below illustrates a comparison of the total cumulative stockholder return on our common stock since December 31, 2019 to the Nasdaq Composite and a composite of ten Nasdaq Pharmaceutical and Specialty Pharmaceutical Stocks which most closely compare to our Company - Avadel Pharmaceuticals plc, Harrow Health, Inc., Eagle Pharmaceuticals, Inc., Assertio Holdings, Inc., HLS Therapeutics Inc., EyePoint Pharmaceuticals, Inc., Eton Pharmaceuticals, Inc., Theratechnologies Inc. and Talphera, Inc.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock, no par value, has been traded on the Nasdaq Global Select Market since August 11, 2009 under the symbol “CPIX.” As of March 8, 2024, we had 97 shareholders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock, no par value, has been traded on the Nasdaq Global Select Market since August 11, 2009 under the symbol “CPIX.” As of March 4, 2025, we had 93 shareholders of record of our common stock.
In January 2019, the Company’s Board of Directors established the current $10.0 million repurchase program to replace the prior authorizations. We repurchased 402,143 shares and 367,793 shares of common stock for approximately $0.7 and $1.0 million during the years ended December 31, 2023 and 2022, respectively.
In January 2019, the Company’s Board of Directors established the current $10.0 million repurchase program to replace the prior authorizations. We repurchased 339,200 and 402,143 shares of common stock for approximately $0.6 million and $0.7 million during the years ended December 31, 2024 and 2023, respectively.
This excludes shareholders whose shares are held by brokers and other institutions on behalf of shareholders. The closing price of our common stock on the Nasdaq Global Select Market on March 8, 2024 was $2.03 per share. 57 Dividend Policy We have not declared or paid any cash dividends on our common stock.
This excludes shareholders whose shares are held by brokers and other institutions on behalf of shareholders. The closing price of our common stock on the Nasdaq Global Select Market on March 4, 2025 was $6.05 per share. Dividend Policy We have not declared or paid any cash dividends on our common stock.
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(2) Of this amount, 971 shares were repurchased directly in private purchases at the then-current fair market value of common stock. Item 6. Reserved. None.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeWe also expanded our oncology sales division to further support the brand. • Helped advance the submissions for the approval of Vibativ in China, South Korea and Saudi Arabia. • Completed the transition of our former RediTrex ® product to Nordic Pharma. • Obtained FDA clearance of the Investigational New Drug application for a new ifetroban Phase II program in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. • Shared our fourth annual Sustainability Metrics, which detail the Company’s activities pertaining to our environmental, social and governance matters. • Entered into a new revolving credit loan agreement with Pinnacle Bank for a $20 million facility, expandable to $25 million over a three-year term. • Continued our corporate share repurchase initiative, with a group of our board members also purchasing shares through Rule 10b5-1 trading plans in order to add to their holdings in the Company. 61 CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES Accounting Estimates and Judgments The preparation of condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period.
Biggest changeBy simplifying the dosing regimen, health care providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes. • Introduced our newly Cumberland-packaged Sancuso ® , supported by our expanded oncology sales division, after successfully transferring its supply to a new facility that previously received FDA approval for manufacturing the product there. • Helped advance the submissions for the approval of Vibativ ® in China and Saudi Arabia. • Progressed our clinical trials evaluating ifetroban for patients with Systemic Sclerosis, Duchenne muscular dystrophy and Idiopathic Pulmonary Fibrosis. • Received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the use of ifetroban for the treatment of Duchenne muscular dystrophy heart disease, reflecting its potential significance in treating this devastating condition. • Continued our corporate share repurchase initiative, with a group of our board members also purchasing shares through trading plans in order to add to their holdings in the Company. 63 CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES Accounting Estimates and Judgments The preparation of condensed consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period.
Of these amounts, our estimated liability for fee for services represented $1.4 million and $1.5 million, respectively, while our accrual for product returns totaled $2.6 million and $2.7 million, respectively.
Of these amounts, our estimated liability for fee for services represented $1.5 million and $1.4 million, respectively, while our accrual for product returns totaled $2.7 million and $2.6 million, respectively.
We establish them using our best estimate at the time of sale based on: • Each product’s historical experience adjusted to reflect known changes in the factors that impact such allowances; • The contractual terms with direct and indirect customers; • Analyses of historical levels of chargebacks, discounts and returns of product; • Communications with customers; 62 • Purchased information about the rate of prescriptions being written and the level of inventory remaining in the distribution channel, if known; and • Expectations about the market for each product, including any anticipated introduction of competitive products.
We establish them using our best estimate at the time of sale based on: • Each product’s historical experience adjusted to reflect known changes in the factors that impact such allowances; • The contractual terms with direct and indirect customers; • Analyses of historical levels of chargebacks, discounts and returns of product; • Communications with customers; • Purchased information about the rate of prescriptions being written and the level of inventory remaining in the distribution channel, if known; and • Expectations about the market for each product, including any anticipated introduction of competitive products.
The Company’s accounting policy with respect to interest and penalties arising from income tax settlements is to recognize them as part of the provision for income taxes. 63 Share-Based Payments We recognize compensation expense for all share-based payments based on the fair value of the award on the date of grant.
The Company’s accounting policy with respect to interest and penalties arising from income tax settlements is to recognize them as part of the provision for income taxes. Share-Based Payments We recognize compensation expense for all share-based payments based on the fair value of the award on the date of grant.
In addition, in 2023 we recognized a gain of $0.5 million to settle a manufacturing dispute and a gain of $0.3 million for a payout earned on a company owned insurance policy. 67 LIQUIDITY AND CAPITAL RESOURCES Our primary sources of liquidity are cash flows provided by our operations, the amounts borrowed and available under our line of credit and the cash proceeds from our initial public offering of common stock that was completed in August 2009.
In addition, in 2023 we recognized a gain of $0.5 million to settle a manufacturing dispute and a gain of $0.3 million for a payout earned on a company owned insurance policy. 69 LIQUIDITY AND CAPITAL RESOURCES Our primary sources of liquidity are cash flows provided by our operations, the amounts borrowed and available under our line of credit and the cash proceeds from our initial public offering of common stock that was completed in August 2009.
You should review the “Risk Factors” section of this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis. 59 EXECUTIVE SUMMARY We are a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription pharmaceutical products.
You should review the “Risk Factors” section of this Form 10-K for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements described in the following discussion and analysis. 61 EXECUTIVE SUMMARY We are a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription pharmaceutical products.
The contingent consideration liability represents the fair value of the royalty payments of up to 20% of future net sales as part of the Vibativ acquisition. 69 4. The contingent consideration liability represents the fair value of the royalty payments of up to 10% of future net sales as part of the Sancuso acquisition. 5.
The contingent consideration liability represents the fair value of the royalty payments of up to 20% of future net sales as part of the Vibativ acquisition. 4. The contingent consideration liability represents the fair value of the royalty payments of up to 10% of future net sales as part of the Sancuso acquisition. 5.
The estimated inventory obsolescence amounts are calculated based upon specific review of the inventory expiration dates and the quantity on-hand at December 31, 2023, in comparison to our expected inventory usage. The amount of actual inventory obsolescence and unmarketable inventory could differ (either higher or lower) in the near term from the estimated amounts.
The estimated inventory obsolescence amounts are calculated based upon specific review of the inventory expiration dates and the quantity on-hand at December 31, 2024, in comparison to our expected inventory usage. The amount of actual inventory obsolescence and unmarketable inventory could differ (either higher or lower) in the near term from the estimated amounts.
A change in our rebate estimate of one percentage point would have impacted net sales by approximately $0.6 million for the years ended December 31, 2023 and 2022. A change in our product return estimate of one percentage point would have impacted net sales by $0.4 million for the years ended December 31, 2023 and 2022.
A change in our rebate estimate of one percentage point would have impacted net sales by approximately $0.6 million for the years ended December 31, 2024 and 2023. A change in our product return estimate of one percentage point would have impacted net sales by $0.4 million for the years ended December 31, 2024 and 2023.
Changes in our estimates would be recorded in our statement of operations in the period of the change. Non-current inventories consist of active pharmaceutical ingredients which typically has an extended life and selected finished good products with extended life longer than one year. Income Taxes We provide for deferred taxes using the asset and liability approach.
Changes in our estimates would be recorded in our statement of operations in the period of the change. Non-current inventories consist of active pharmaceutical ingredients which typically have an extended life and selected finished good products with an extended life longer than one year. 65 Income Taxes We provide for deferred taxes using the asset and liability approach.
We are dedicated to our mission of working together to provide unique products that improve the quality of patient care. Our commercial portfolio includes seven branded products approved for marketing by the FDA.
We are dedicated to our mission of working together to provide unique products that improve the quality of patient care. Our commercial portfolio includes six branded products approved for marketing by the FDA.
At December 31, 2023 and December 31, 2022, all our investments had original maturities of less than ninety days and as a result were classified as cash equivalents.
At December 31, 2024 and December 31, 2023, all our investments had original maturities of less than ninety days and as a result were classified as cash equivalents.
Of the accounts receivable allowances and our sales related accruals, our accrual for product returns and rebates represents the majority of the balance. Sales related accrued liabilities for rebates, product returns, service fees, and administrative fees totaled $7.6 million and $8.3 million as of December 31, 2023 and 2022 , respectively.
Of the accounts receivable allowances and our sales related accruals, our accrual for product returns and rebates represents the majority of the balance. Sales related accrued liabilities for rebates, product returns, service fees, and administrative fees totaled $7.8 million and $7.6 million as of December 31, 2024 and 2023, respectively.
Other revenue, which is a component of net revenues, includes non-refundable upfront payments and milestone payments under licensing agreements along with grant and rental income. Other revenue was approximately 5.2% percent of net revenues in 2023 and 3.2% in 2022.
Other revenue, which is a component of net revenues, includes non-refundable upfront payments and milestone payments under licensing agreements along with grant and rental income. Other revenue was approximately 3.5% of net revenues in 2024 and 5.2% in 2023.
Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability of our brands. 60 2023 Highlights Below is a list of our Company’s highlights from 2023.
Our marketing and sales organization is responsible for our commercial activities, and we work closely with our distribution partners to ensure the availability of our brands. 62 2024 Highlights Below is a list of our Company’s highlights from 2024.
These amounts are based on the $12.8 million line of credit assuming the current $12.8 million balance outstanding on December 31, 2023 is consistently outstanding through maturity of October 2026. Interest and unused line of credit payments are due and payable quarterly in arrears. 3.
These amounts are based on the $15.3 million line of credit assuming the current $15.3 million balance outstanding on December 31, 2024 is consistently outstanding through maturity of October 2026. Interest and unused line of credit payments are due and payable quarterly in arrears. 3.
Our financial statements reflect accounts receivable allowances of $0.6 million at December 31, 2023 and 2022, for chargebacks and early pay discounts for products.
Our financial statements reflect accounts receivable allowances of $1.1 million and $0.6 million at December 31, 2024 and 2023, respectively, for chargebacks and early pay discounts for products.
General and administrative expenses for the year ended December 31, 2023, were $10.7 million compared to $10.2 million in the prior year.
General and administrative expenses for the year ended December 31, 2024, were $11.1 million compared to $10.7 million in the prior year.
Our product development team creates proprietary formulations, manages our clinical studies, prepares our FDA submissions and staffs our medical call center. Our quality and manufacturing professionals oversee the manufacturing, release and shipment of our products.
Our business development team identifies, evaluates and negotiates product acquisition, licensing and co-promotion agreements. Our product development team creates proprietary formulations, manages our clinical studies, prepares our FDA submissions and staffs our medical call center. Our quality and manufacturing professionals oversee the manufacturing, release and shipment of our products.
Net revenues for the year ended December 31, 2023, were approximately $39.6 million compared to $42.0 million for the year ended December 31, 2022. As detailed in the table above, net revenue increased during 2023 for two of our marketed products: Kristalose and Vibativ.
Net revenues for the year ended December 31, 2024, were approximately $37.9 million compared to $39.6 million for the year ended December 31, 2023. As detailed in the table above, net revenue increased during 2024 for two of our marketed products: Sancuso and Caldolor.
This decrease in Caldolor revenue for the year ended December 31, 2023, w as the result of the timing of international shipments. There was no Vaprisol revenue for the year ended December 31, 2023, as Cumberland is currently out of commercial inventory of the product. Net revenue was positively impacted by various sales deduction adjustments.
This 14.4% increase in Caldolor revenue for the year ended December 31, 2024, w as impacted by an increase in international shipments. There was no Vaprisol revenue for the year ended December 31, 2024, as Cumberland is currently out of commercial inventory of the product. Net revenue was negatively impacted by various sales deduction adjustments.
The components of the statements of operations discussed above reflect the following impacts from Sancuso: Financial Impact of Sancuso Years ended December 31, 2023 2022 Net revenue $ 8,096,788 $ 13,555,603 Cost of products sold (1) 1,214,826 1,543,600 Royalty and operating expenses 3,375,823 4,202,026 Sancuso contribution $ 3,506,139 $ 7,809,977 (1) The Sancuso inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2022.
The components of the statements of operations discussed above reflect the following impacts from Sancuso: Financial Impact of Sancuso Years ended December 31, 2024 2023 Net revenue $ 9,005,132 $ 8,096,788 Cost of products sold (1) 856,608 1,214,826 Royalty and operating expenses 3,777,160 3,375,823 Sancuso contribution $ 4,371,364 $ 3,506,139 (1) The Sancuso inventory included in the costs of product sold during the period was acquired and paid for by Cumberland as part of the acquisition of the brand during 2022.
The following table reflects our sales-related accrual activity for the periods indicated below: 2023 2022 Balance, January 1 $ 8,347,214 $ 3,680,677 Current provision 22,184,661 24,426,431 Actual product returns and credits issued (22,952,092) (19,759,894) Balance, December 31 $ 7,579,783 $ 8,347,214 The allowances for chargebacks and discounts and sales related accruals for rebates, fee for service and product returns are determined on a product-by-product basis.
The following table reflects our sales-related accrual activity for the periods indicated below: 2024 2023 Balance, January 1 $ 7,579,783 $ 8,347,214 Current provision 20,235,610 22,184,661 Actual product returns and credits issued (19,981,182) (22,952,092) Balance, December 31 $ 7,834,211 $ 7,579,783 64 The allowances for chargebacks and discounts and sales related accruals for rebates, fee for service and product returns are determined on a product-by-product basis.
Acetadote revenue included net sales of our branded product and our share of net sales from our Authorized Generic. For the year ended December 31, 2023, the Acetadote net revenue was $0.5 million, similar to the prior year period.
Acetadote revenue included net sales of our branded product and our share of net sales from our Authorized Generic. For the year ended December 31, 2024, the Acetadote net revenue was $0.2 million, as compared to $0.5 million from the prior year period. This decrease results from lower sales for our Authorized Generic.
In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidate for patients with 1) cardiomyopathy associated with Duchenne Muscular Dystrophy, a fatal, genetic neuromuscular disease and 2) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by fibrosis of the skin and internal organs.
In addition to these commercial brands, we have Phase II clinical programs underway evaluating our ifetroban product candidate for patients with 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by fibrosis of the skin and internal organs and 2) Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease.
Income taxes totaled $45,769 for the year ended December 31, 2023, and $68,850 for the year ended December 31, 2022. Other income. In 2023, we recognized a $2.8 million refund of FDA fees for the periods of 2023 and 2022 to be used to further our product research efforts.
For the year ended December 31, 2023, we recognized a $2.8 million refund of FDA fees for the periods of 2023 and 2022 to further our product research efforts.
Amortization and impairment. Amortization and impairment expenses represent the ratable use of our capitalized intangible assets including product and license rights, patents, trademarks and patent defense costs. Amortization and impairment for 2023 totaled approximately $8.1 million which is an increase of $3.0 million due to a $3.3 million write down of our Omeclamox intangible assets. Income taxes .
Amortization. Amortization expense represent the ratable use of our capitalized intangible assets including product and license rights, patents, trademarks and patent defense costs. Amortization for 2024 totaled approximately $4.7 million which is a decrease of $3.4 million due to a $3.3 million write down of our Omeclamox intangible assets for the year ended December 31, 2023. Income taxes .
RECENT ACCOUNTING PRONOUNCEMENTS Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments-Credit Losses,” which changes the impairment model for most financial assets and certain other instruments.
OFF-BALANCE SHEET ARRANGEMENTS During 2024 and 2023 we did not engage in any off-balance sheet arrangements. 72 RECENT ACCOUNTING PRONOUNCEMENTS Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments-Credit Losses,” which changes the impairment model for most financial assets and certain other instruments.
The following table summarizes our liquidity and working capital as of the years ended December 31: 2023 2022 Cash and cash equivalents $ 18,321,624 $ 19,757,970 Total cash and cash equivalents $ 18,321,624 $ 19,757,970 Working capital (current assets less current liabilities) $ 7,732,161 $ 17,290,378 Current ratio (multiple of current assets to current liabilities) 1.3 1.6 Revolving line of credit availability $ 7,215,856 $ 3,800,000 The following table summarizes our net changes in cash and cash equivalents for the years ended December 31: 2023 2022 Cash provided by (used in): Operating activities $ 6,093,821 $ 8,453,396 Investing activities (105,695) (13,674,456) Financing activities (7,424,472) (2,061,786) Net decrease in cash and cash equivalents $ (1,436,346) $ (7,282,846) The net $1.4 million decrease in cash and cash equivalents for the year ended December 31, 2023, was attributable to cash provided by operating activities offset by cash used in investing and financing activities.
The following table summarizes our liquidity and working capital as of the years ended December 31: 2024 2023 Cash and cash equivalents $ 17,964,184 $ 18,321,624 Total cash and cash equivalents $ 17,964,184 $ 18,321,624 Working capital (current assets less current liabilities) $ 4,830,429 $ 7,732,161 Current ratio (multiple of current assets to current liabilities) 1.2 1.3 Revolving line of credit availability $ 4,723,830 $ 7,215,856 The following table summarizes our net changes in cash and cash equivalents for the years ended December 31: 2024 2023 Cash provided by (used in): Operating activities $ (612,186) $ 6,093,821 Investing activities 57,842 (105,695) Financing activities 196,904 (7,424,472) Net decrease in cash and cash equivalents $ (357,440) $ (1,436,346) The net $0.4 million decrease in cash and cash equivalents for the year ended December 31, 2024, was attributable to cash used in operating activities offset by cash provided by financing and investing activities.
Shelf Registration In December 2023, the Company filed a Shelf Registration on Form S-3 with the SEC associated with the sale of up to $100 million in corporate securities which also was declared effective in December 2023.
Shelf Registration On December 14, 2023, the Company filed a Shelf Registration on Form S-3 with the SEC associated with the sale of up to $100 million in corporate securities which also was declared effective on December 26, 2023. The Company entered into a Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“H.C.
Debt Agreement On September 5, 2023, the Company entered into a new Revolving Credit Loan Agreement with Pinnacle Bank. This facility provides for an aggregate principal funding amount of up to $25 million. The initial revolving line of credit is up to $20 million, with the ability for Cumberland to increase the amount to $25 million, under certain conditions.
Wainwright for to up to $10 million and filed a prospectus supplement under the Sales Agreement for that aggregate offering amount. Debt Agreement On September 5, 2023, the Company entered into a new Revolving Credit Loan Agreement with Pinnacle Bank. This facility provides for an aggregate principal funding amount of up to $25 million.
Omeclamox-Pak had no sales for the year ended December 31, 2023, as Cumberland is currently out of commercial inventory of this product. The packager for our Omeclamox-Pak product encountered financial difficulties and currently is under new management and is reorganizing. Reditrex revenue decreased $0.2 million in 2023 compared to 2022. We discontinued sale of the product in 2023. Other Revenue.
Omeclamox-Pak had no sales for the years ended December 31, 2024 and 2023 as Cumberland is currently out of commercial inventory of this product. The packager for our Omeclamox-Pak product encountered financial difficulties and currently is under new management and is reorganizing. We discontinued the product RediTrex in 2023. Net revenue was positively impacted by various sales deduction adjustments.
Research and development costs for the year ended December 31, 2023, were $5.8 million, compared to $6.7 million last year, representing a decrease of $0.9 million due to reduced FDA fees.
Research and development costs for the year ended December 31, 2024, were $4.8 million, compared to $5.8 million in the prior year, representing a decrease of $1.0 million due primarily to reduced FDA fees, salaries and consulting expenses.
These increases were mainly offset by decreased net product sales of Sancuso and Caldolor. 65 Kristalose revenue increased by $0.8 million, or 5.1%, compared to December 31, 2022, primarily as a result of increased shipments of the product.
These increases were mainly offset by decreases in net product sales of Kristalose and Vibativ. 67 Kristalose revenue decreased by $0.7 million, compared to December 31, 2023, primarily as a result of decreased shipments of the product.
The change resulted from an increase in hiring costs and deferred compensation expenses. 66 The components of the statements of operations discussed above reflect the following impacts from Vibativ: Financial Impact of Vibativ Years ended December 31, 2023 2022 Net revenue (1) $ 9,812,692 $ 7,637,462 Cost of products sold (2) 1,423,399 3,535,851 Royalty and operating expenses 2,379,939 83,145 Vibativ contribution $ 6,009,354 $ 4,018,466 (1) 2023 net revenue includes a $1,000,000 payment to Cumberland related to a settlement agreement of milestone payments.
The primary driver of the increase was higher salary costs. 68 The components of the statements of operations discussed above reflect the following impacts from Vibativ: Financial Impact of Vibativ Years ended December 31, 2024 2023 Net revenue (1) $ 7,161,413 $ 9,812,692 Cost of products sold (2) 1,829,824 1,423,399 Royalty and operating expenses 1,754,411 2,379,939 Vibativ contribution $ 3,577,178 $ 6,009,354 (1) 2023 net revenue includes a $1,000,000 payment to Cumberland related to a settlement agreement of milestone payments.
It has a three year term expiring on October 1, 2026. The interest rate is based on Benchmark (Term SOFR) plus a spread of 2.75%. Cumberland is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of our assets.
Cumberland is subject to one financial covenant, the maintenance of a Funded Debt Ratio, determined on a quarterly basis. Borrowings under the line of credit are collateralized by substantially all of our assets.
This increase was primarily a result of an increase in marketing expenses associated with the Sancuso acquisition including royalty costs, promotional spending and the cost associated with our expanded Oncology division. Research and development .
This decrease was primarily a result of a decrease in marketing expenses associated with royalty costs and promotional spending. Research and development .
The Broadwest contractual cash obligation began upon commencement in October 2022 and CET began May 2023. OFF-BALANCE SHEET ARRANGEMENTS During 2023 and 2022 we did not engage in any off-balance sheet arrangements.
The Broadwest contractual cash obligation began upon commencement in October 2022 and CET began May 2023.
Our financing activities included payments of $2.2 million of contingent consideration for Vibativ and Sancuso and $1.1 million in cash used to repurchase shares of our common stock.
Cash provided by financing activities of $0.2 million was primarily due to a $2.5 million net borrowing, partially offset by payments of $1.7 million of contingent consideration for Vibativ and Sancuso, and $0.6 million in cash used to repurchase shares of our common stock.
As noted above, we continue to repurchase shares of our common stock, as discussed in Part II, Item 5, "Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities", of this Form 10-K.
As noted above, we continue to repurchase shares of our common stock, as discussed in Part II, Item 5, "Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities", of this Form 10-K. 70 The net $1.4 million decrease in cash and cash equivalents for the year ended December 31, 2023, was attributable to cash provided by operating activities offset by cash used in investing and financing activities.
This decrease in net revenue was primarily a result of an inordinate amount of product returns and higher commercial rebates. Caldolor revenue was $4.3 million during the year ended December 31, 2023, compared to $4.8 million in the same period last year.
Vibativ revenue decreased to $7.2 million for the year ended December 31, 2024, compared to $8.8 million in the same prior year period. The decrease was the result of decreased shipments of the product and higher product returns. Caldolor revenue was $5.0 million during the year ended December 31, 2024, compared to $4.3 million in the same period last year.
We believe we can leverage this existing infrastructure to support new products and our expected growth. Our management team consists of pharmaceutical industry veterans with significant experience in their areas of responsibility. Our business development team identifies, evaluates and negotiates product acquisition, licensing and co-promotion agreements.
We have established the capabilities needed to acquire, develop and commercialize branded pharmaceuticals in the U.S. We believe we can leverage this existing infrastructure to support new products and our expected growth. Our management team consists of pharmaceutical industry veterans with significant experience in their areas of responsibility.
The Company intends to enter into an At the Market Sales Agreement in March 2024, in order to allow the Company to sell shares at market prices. The Company did not issue any shares under its ATM program during the year ended December 31, 2023.
Wainwright”) on March 20, 2024, in order to allow the Company to sell shares at market prices. The Company did not issue any shares under its ATM program during the year ended December 31, 2024. On February 5, 2025, the Company utilized the Sales Agreement with H. C. Wainwright and sold 1,000,000 shares of Cumberland’s common shares.
Other revenue increased due to the litigation settlement based on two $500,000 milestone payments due to us for the license associated with our Vibativ product. Cost of products sold . Cost of products sold for the year ended December 31, 2023, were $6.1 million compared to $9.1 million in the prior year, a decrease of $3.1 million.
Other Revenue. Other revenue decreased from 2023 when milestone payments of $1 million associated with our Vibativ product were recorded. Cost of products sold . Cost of products sold for the year ended December 31, 2024, were $6.6 million compared to $6.1 million in the prior year, an increase of $0.5 million.
Cash provided by operating activities of $8.5 million includes a decrease of inventory of $0.9 million, most of which was Vibativ and Sancuso related, an increase in accounts payable and other accrued liabilities of $14.5 million, partially offset by a $6.1 million increase in accounts receivable and a decrease in non-cash contingent consideration of $2.1 million.
Cash used in operating activities of $0.6 million is primarily due to an increase in accounts receivable of $1.9 million, a decrease in non-cash contingent consideration of $1.5 million, an increase in CSV of life insurance policies over premiums paid of $0.1 million, the gain on insurance proceeds of $0.2 million and a $1.0 million decrease in operating lease liabilities, partially offset by an increase in inventory of $2.4 million and an increase in accounts payable and other accrued liabilities.
We promote our approved products through our hospital, field and oncology sales divisions in the United States and are building a network of international partners to register and provide our medicines to patients in their countries. We have established the capabilities needed to acquire, develop and commercialize branded pharmaceuticals in the U.S.
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 building a network of international partners to register and provide our medicines to patients in their countries.
Fair value is determined through various valuation techniques including quoted market prices, third-party independent appraisals and discounted cash flow models, as considered necessary. 64 RESULTS OF OPERATIONS Year ended December 31, 2023 compared to year ended December 31, 2022 The following table presents the statements of operations for the years ended December 31, 2023 and 2022: Years ended December 31, 2023 2022 Change Net revenues $ 39,552,507 $ 42,010,949 $ (2,458,442) Costs and expenses: Cost of products sold 6,066,611 9,118,521 (3,051,910) Selling and marketing 18,451,765 16,660,945 1,790,820 Research and development 5,834,229 6,688,924 (854,695) General and administrative 10,651,915 10,180,120 471,795 Amortization and impairment 8,102,648 5,067,368 3,035,280 Total costs and expenses 49,107,168 47,715,878 1,391,290 Operating loss (9,554,661) (5,704,929) (3,849,732) Interest income 286,854 98,405 188,449 Other income 2,828,871 — 2,828,871 Other income - settlement 475,000 — 475,000 Other income - insurance proceeds 346,800 611,330 (264,530) Interest expense (667,861) (585,995) (81,866) Loss before income taxes (6,284,997) (5,581,189) (703,808) Income tax (expense) benefit (45,769) (68,850) 23,081 Net loss $ (6,330,766) $ (5,650,039) $ (680,727) The following table summarizes net revenues for the years presented: Years ended December 31, 2023 2022 Change Products: Kristalose $ 15,981,850 $ 15,205,155 $ 776,695 Vibativ 8,812,692 7,487,462 1,325,230 Sancuso 8,096,788 13,205,603 (5,108,815) Caldolor 4,333,923 4,827,200 (493,277) Acetadote 458,759 501,040 (42,281) Omeclamox-Pak 20,030 29,145 (9,115) Vaprisol 151,336 (447,697) 599,033 RediTrex (341,886) (126,726) (215,160) Other 2,039,015 1,329,767 709,248 Total net revenues $ 39,552,507 $ 42,010,949 $ (2,458,442) Net revenues.
Fair value is determined through various valuation techniques including quoted market prices, third-party independent appraisals and discounted cash flow models, as considered necessary. 66 RESULTS OF OPERATIONS Year ended December 31, 2024 compared to year ended December 31, 2023 The following table presents the statements of operations for the years ended December 31, 2024 and 2023: Years ended December 31, 2024 2023 Change Net revenues $ 37,867,945 $ 39,552,507 $ (1,684,562) Costs and expenses: Cost of products sold 6,585,972 6,066,611 519,361 Selling and marketing 17,023,023 18,451,765 (1,428,742) Research and development 4,816,206 5,834,229 (1,018,023) General and administrative 11,126,901 10,651,915 474,986 Amortization and impairment 4,748,252 8,102,648 (3,354,396) Total costs and expenses 44,300,354 49,107,168 (4,806,814) Operating loss (6,432,409) (9,554,661) 3,122,252 Interest income 334,444 286,854 47,590 Other income — 2,828,871 (2,828,871) Other income - settlement — 475,000 (475,000) Other income - gain on insurance proceeds 237,089 346,800 (109,711) Interest expense (605,508) (667,861) 62,353 Loss before income taxes (6,466,384) (6,284,997) (181,387) Income tax benefit (expense) 22,669 (45,769) 68,438 Net loss $ (6,443,715) $ (6,330,766) $ (112,949) The following table summarizes net revenues for the years presented: Years ended December 31, 2024 2023 Change Products: Kristalose $ 15,315,259 $ 15,981,850 $ (666,591) Sancuso 9,005,129 8,096,788 908,341 Vibativ 7,160,125 8,812,692 (1,652,567) Caldolor 4,959,385 4,333,923 625,462 Acetadote 185,182 458,759 (273,577) Omeclamox (3,075) 20,030 (23,105) Vaprisol (174,538) 151,336 (325,874) RediTrex 90,237 (341,886) 432,123 Other 1,330,241 2,039,015 (708,774) Total net revenues $ 37,867,945 $ 39,552,507 $ (1,684,562) Net revenues.
Vibativ revenue increased to $8.8 million for the year ended December 31, 2023, compared to $7.5 million in the same prior year period. The increase of $1.3 million, or 17.7%, reflected fewer product returns in the current year. Sancuso revenue was $8.1 million compared to $13.2 million in the prior year.
Sancuso revenue was $9.0 million compared to $8.1 million in the prior year, an increase of $0.9 million or 11.2% for the year ended December 31, 2024. This increase in net revenue was impacted by an improvement in product returns in 2024.
These cost savings were due to the availability of lower cost inventory and fewer inventory write downs. Selling and marketing . Selling and marketing expense for the year ended December 31, 2023, were $18.5 million compared to $16.7 million in the prior year, which was an increase of $1.8 million.
The gross margin for the years ended December 31, 2024 and 2023, were 82.6% and 84.7%, respectively. Selling and marketing . Selling and marketing expense for the year ended December 31, 2024, were $17.0 million compared to $18.5 million in the prior year, which was a decrease of $1.4 million.
Cash used in investing activities of $13.7 million was the result of the acquisition of Sancuso of $13.5 68 million, additions to intangibles of $2.0 million, additions to property and equipment of $0.1 million and the proceeds of officer life insurance proceeds of $0.9 million.
Cash provided by investing activities less than $0.1 million was the result of more life insurance proceeds received offset by additions of intangibles and property.
Removed
We are also developing an oral capsule to treat Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. Following FDA clearance of our Investigational New Drug application in May 2023, we are in the process of initiating our Phase II study in patients in centers of excellence across the U.S.
Added
Additionally, we recently completed a Phase II study in patients with cardiomyopathy associated with Duchenne muscular dystrophy, a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.
Removed
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.
Added
Next steps include further data analysis and completion of a full study report in preparation for an end-of-Phase-II meeting with the FDA to determine next steps associated with the product’s development and commercialization. Our primary target markets are hospital acute care, gastroenterology and oncology.
Removed
For more information, please see Part I, Item I, Business of this Form 10-K. • Announced our newly refined mission statement: Working together to provide unique products that improve the quality of patient care. • Obtained FDA approval for our Caldolor ® product, to include its use in infants.
Added
For more information, please see Part I, Item I, Business of this Form 10-K. • Announced the publication of new real-world outcomes research involving 150,000 patients, which compared our Caldolor ® (ibuprofen) injection to its key competitor – ketorolac.
Removed
The non-narcotic agent may now be administered for the treatment of pain and fever in patients 3 to 6 months of age.
Added
The results provided compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions and also improved healthcare utilization. • Shared a Caldolor ® Special Report, which was published in Anesthesiology News , General Surgery News and Pharmacy Practice News that presented the growing amount of data supporting the use of Caldolor as a standard of care for the treatment of pain and fever.
Removed
With this newly approved labeling, Caldolor is the only non-opioid product approved to treat pain in infants that is delivered through injection. • Shared the publication of positive results from a clinical study investigating the safety and pharmacokinetics of Caldolor in newborns.
Added
The results demonstrated that the product is a safe and effective treatment for pain and fever in adults, children and infants as young as 3 months of age. • Announced the FDA approval of a supplemental New Drug Application for Acetadote ® , our IV treatment for preventing or lessening liver injury after ingestion of potentially toxic quantities of acetaminophen.
Removed
Published in the journal Pediatric Drugs , the results of the study support the growing body of evidence that demonstrates Caldolor is a safe therapeutic option available to practitioners for the treatment of fever and pain in infants, children and adults. • Announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of our Vibativ ® product in children 2 to 17 years of age.
Added
The new, streamlined approach reduces the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions without compromising the effectiveness of Acetadote.
Removed
The results of the study suggest that a single dose of Vibativ is safe in children. • Completed the Sancuso ® transition from Kyowa Kirin to Cumberland, including the NDA transfer, and initiation of the product’s manufacture at a new facility.
Added
Income taxes totaled $22,669 as a benefit for the year ended December 31, 2024, and $45,769 tax expense for the year ended December 31, 2023. Other income. For the year ended December 31, 2024, we recognized a gain of $0.2 million for a payout earned on a company owned insurance policy.
Removed
The net $7.3 million decrease in cash and cash equivalents for the year ended December 31, 2022, was attributable to cash provided by operating activities offset by cash used in investing and financing activities.
Added
These shares sold at a volume weighted average price of $5.4688 per share for aggregate gross proceeds of $5,468,800. On February 14, 2025, the Company increased the maximum aggregate offering amount of the shares of the Company’s common stock issuable under the Sales Agreement with H.C.
Removed
Minimum Product Purchase Requirements Our manufacturing and supply agreements do not require minimum annual purchase obligations.
Added
The initial revolving line of credit is up to $20 million, with the ability for Cumberland to increase the amount to $25 million, under certain conditions. It has a three year term expiring on October 1, 2026. The interest rate is based on Benchmark (Term SOFR) plus a spread of 2.75%.
Removed
Contractual cash obligations The following table summarizes our contractual cash obligations as of December 31, 2023: Payments Due by Year Contractual obligations (1) Total 2024 2025 2026 2027 2026 and thereafter Line of credit (2) $ 12,784,144 $ — $ — $ 12,784,144 $ — $ — Estimated interest on debt (2) 2,856,458 1,038,712 1,038,712 779,034 — — Vibativ contingent consideration liability payments (3) 4,033,273 245,361 514,476 508,997 492,696 2,271,743 Sancuso contingent consideration liability payments (4) 2,306,000 124,565 387,316 365,174 344,064 1,084,881 Operating leases (5) 9,131,702 863,320 836,100 909,911 934,180 5,588,191 Total (1) $ 31,111,577 $ 2,271,958 $ 2,776,604 $ 15,347,260 $ 1,770,940 $ 8,944,815 1.
Added
On May 6, 2024, the Company entered into a First Amendment to the Loan Agreement which provides an alternative to the financial covenant by delivering to the lender a borrowing base certificate and complying with certain borrowing base requirements which set forth a maximum revolver amount equal to the lessor of (a) up to $20 million or (b) the sum of the Company's cash balances and eligible accounts receivable.
Added
Minimum Product Purchase Requirements Our manufacturing and supply agreements do not require minimum annual purchase obligations. 71 Contractual cash obligations The following table summarizes our contractual cash obligations as of December 31, 2024: Payments Due by Year Contractual obligations (1) Total 2025 2026 2027 2028 2029 and after Line of credit (2) $ 15,276,170 $ — $ 15,276,170 $ — $ — $ — Estimated interest on debt (2) 1,904,747 1,088,427 816,320 — — — Vibativ contingent consideration liability payments (3) 3,242,999 381,989 474,553 512,466 481,680 1,392,311 Sancuso contingent consideration liability payments (4) 1,516,000 332,594 336,884 325,578 204,427 316,517 Operating leases (5) 8,268,382 836,100 909,910 934,180 740,791 4,847,401 Total (1) $ 30,208,298 $ 2,639,110 $ 17,813,837 $ 1,772,224 $ 1,426,898 $ 6,556,229 1.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

4 edited+0 added−0 removed3 unchanged
Biggest changeThe Company did not have any investments in marketable securities at December 31, 2023. The interest rate risk related to borrowings under our line of credit is based on a benchmark (Term SOFR) plus a spread of 2.75%.
Biggest changeThe Company did not have any investments in marketable securities at December 31, 2024. The interest rate risk related to borrowings under our line of credit is based on a benchmark (Term SOFR) plus a spread of 2.75%. As of December 31, 2024, we had $15.3 million in borrowings outstanding under our revolving line of credit.
Neither a five percent increase nor decrease from current exchange rates would have had a material effect on our operating results or financial condition.
Neither a five percent increase nor decrease from current exchange rates would have had a material effect on our operating results or financial condition. 73
We believe our exposure to foreign currency fluctuation is minimal as our purchases in foreign currency have a maximum exposure of 90 days based on invoice terms with a portion of the exposure being limited to 30 days based on the due date of the invoice. Foreign currency exchange losses were immaterial for 2023 and 2022.
We believe our exposure to foreign currency fluctuation is minimal as our purchases in foreign currency have a maximum exposure of 90 days based on invoice terms with a portion of the exposure being limited to 30 days based on the due date of the invoice. Foreign currency exchange losses were immaterial for 2024 and 2023.
As of December 31, 2023, we had $12.8 million in borrowings outstanding under our revolving line of credit. 70 Exchange Rate Risk While we operate primarily in the U.S., we are exposed to foreign currency risk. A portion of our research and development is performed abroad. Currently, we do not utilize financial instruments to hedge exposure to foreign currency fluctuations.
Exchange Rate Risk While we operate primarily in the U.S., we are exposed to foreign currency risk. A portion of our research and development is performed abroad. Currently, we do not utilize financial instruments to hedge exposure to foreign currency fluctuations.

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