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CUMBERLAND PHARMACEUTICALS INC

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Business Summary

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription pharmaceuticals. Its primary target markets are hospital acute care, gastroenterology and oncology, which are characterized by relatively concentrated prescriber bases that can be served effectively by relatively small, targeted sales forces.

The company promotes its approved products through its hospital, field and oncology sales divisions in the United States. It has also established a network of international partners with the needed regulatory and commercial capabilities to register and provide its medicines to patients in their countries. Competitors named in the filing include, for Acetadote, Geneva Pharmaceuticals, Inc., Bedford Laboratories division of Hikma Pharmaceuticals, Roxane Laboratories, Inc., InnoPharma Inc. and Hospira Inc.; for Caldolor, competitors include morphine, ketorolac tromethamine, IV acetaminophen, and others; for Kristalose, competitors include Amitiza, Movantik, Linzess, Trulance, and others; for Sancuso, competitors include Akynzeo, Emend Oral, Varubi, Zuplenz, and Kytril; for Talicia, competitors include Voquezna Triple Pak and Voquezna Dual Pak; for Vaprisol, the competitor is Samsca; and for Vibativ, competitors include vancomycin, linezolid, daptomycin, Teflaro, Zerbaxa, Nuzyra, Dalvance, Orbactiv, and Zevetera.

The company generates revenue primarily from the product sales of its FDA approved pharmaceutical brands. Net product revenue reflects the reduction from gross product revenue for estimated allowances for chargebacks, and discounts and reflects sales related accruals for rebates, coupons, product returns, and certain administrative and service fees. Other revenue includes non-refundable upfront payments and milestone payments under licensing agreements, contract services, grant funding programs and rental income.

The company's portfolio of brands approved for marketing by the FDA includes Acetadote (acetylcysteine) injection for the treatment of acetaminophen poisoning; Caldolor (ibuprofen) injection for the treatment of pain and fever; Kristalose (lactulose) 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; 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; and Talicia (omeprazole, amoxicillin and rifabutin) oral capsule for the treatment of H. pylori infection. For the year ended December 31, 2025, net revenues by product were: Sancuso $11,907,141 , Kristalose $10,542,793 , Vibativ $9,484,874 , Caldolor $4,659,457 , Talicia $3,311,235 , Acetadote $508,169 , Vaprisol ($18,346) , RediTrex $11,391 , Omeclamox ($10,436) , and Other $4,125,153 .

The company also has a pipeline including ifetroban, a selective thromboxane-prostanoid receptor antagonist. In February 2025, positive top-line results were announced from the completed Phase II study (CPI-IFE-007, the FIGHT DMD trial) in patients with cardiomyopathy associated with Duchenne muscular dystrophy. The study enrolled 41 DMD patients who received either low-dose ifetroban (100 mg per day), high-dose ifetroban (300 mg per day), or placebo. High-dose ifetroban treatment resulted in a 3.3% improvement in left ventricular ejection fraction (LVEF) compared to placebo. When compared to propensity-matched natural history controls, high-dose treatment provided a statistically significant 5.4% overall improvement in LVEF (p=0.002) , as control patients experienced a 3.6% decline in LVEF. Ifetroban received Orphan Drug Designation and Rare Pediatric Drug Designation for DMD in November 2024. Fast Track Designation was granted in February 2026. An End-of-Phase 2 meeting was held with FDA in September 2025, and a subsequent Type C meeting was held in January 2026. The Systemic Sclerosis study (CPI-IFE-004) closed to enrollment in February 2025, with the diffuse cutaneous SSc cohort meeting its target enrollment goal of 20 patients. The Idiopathic Pulmonary Fibrosis study (CPI-IFE-008, the FIGHTING FIBROSIS trial) is actively enrolling, with over 70 subjects enrolled across 17 activated sites. A safety interim analysis was completed in November 2025 evaluating the first 25% of patients completing 12 weeks of treatment. In October 2025, the company announced strategic arrangements with RedHill Biopharma Ltd. to jointly commercialize Talicia, forming a new company named Talicia Holdings, Inc. (THI) which holds the worldwide rights and assets associated with the brand. Cumberland acquired a 30% equity interest in THI in return for a $4 million investment capital - $2 million at execution and $2 million payable on the one year anniversary. On February 5, 2025, the company sold 1,000,000 shares of common stock under its ATM program 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 under the ATM program to up to $10 million. The company repurchased 58,947 shares of common stock for approximately $0.3 million during the year ended December 31, 2025. During 2025, the company provided nearly 5 million patient doses of its brands, while safely disposing of over 5,500 pounds of expired and damaged goods. Women represented 50% of Cumberland's workforce and 30% of employees were minorities.

Net revenues for the year ended December 31, 2025 were approximately $44.5 million compared to $37.9 million for the year ended December 31, 2024. Net loss attributable to common shareholders was ($2,836,128) for 2025 compared to ($6,479,770) for 2024. Basic and diluted loss per share attributable to common shareholders was ($0.19) for 2025 compared to ($0.46) for 2024. The gross margin for the years ended December 31, 2025 and 2024 were 85.0% and 82.6% , respectively.

Business Outlook

A key growth vector is the ifetroban clinical pipeline. The company is pursuing ifetroban registration for DMD-associated cardiomyopathy as its lead indication, with the IPF and SSc programs providing additional potential indications. The DMD study enrolled 41 patients. The Systemic Sclerosis study closed to enrollment in February 2025 with 20 patients in the diffuse cutaneous cohort and 9 of 14 targeted subjects in the SSc-associated Pulmonary Arterial Hypertension cohort. The Idiopathic Pulmonary Fibrosis study has over 70 subjects enrolled across 17 activated sites. Another growth vector is the expansion of the commercial portfolio, exemplified by the addition of Talicia in the fourth quarter of 2025 through a co-commercialization agreement with RedHill Biopharma Ltd. Talicia generated $3,311,235 in net revenue for the year ended December 31, 2025. The company is also building international partnerships, with a network of partners for products in various territories. In 2025, Vibativ received regulatory approval in China through partner SciClone, and the product was launched in Saudi Arabia through partner Tabuk. Caldolor received regulatory approval in Mexico through partner PiSA. Other revenue, which includes milestone payments from international partners, was $4,125,153 for 2025, an increase of $2,794,912 compared to 2024, primarily due to $3.1 million in milestone payments from international partners.

The gross margin for the years ended December 31, 2025 and 2024 were 85.0% and 82.6% , respectively. Cost of products sold was $6,667,207 for 2025 and $6,585,972 for 2024. The company states it continually works to manage expenses in line with revenues to deliver positive cash flow from operations and seeks to maintain favorable gross margins.

The company partners with third parties for manufacturing and distribution. It has agreements with one manufacturer for Acetadote, multiple manufacturers for Caldolor, an international supplier for Kristalose API, and a manufacturer for Sancuso. For Vaprisol, the company is awaiting FDA approval for a new manufacturing facility. For Vibativ, a contract manufacturer continued to provide supplies in 2025. In 2025, Cardinal Health Specialty Solutions exclusively handled U.S. product logistics activities. As of December 31, 2025, the company had 93 employees. The company believes its future will depend in part on its continued ability to attract, hire, and retain qualified personnel, including hospital oncology and field sales personnel.

Research and development costs for the year ended December 31, 2025 were $5,566,498 , compared to $4,816,206 in the prior year. The company continues to fund ongoing clinical initiatives associated with its pipeline products. Capital expenditures for property and equipment were $97,903 in 2025 and $66,461 in 2024. The company has a share repurchase program to repurchase up to $10.0 million of its common stock. As of December 31, 2025, approximately $2.2 million remained available under the program. The company has not declared or paid any cash dividends on its common stock.

The company faces headwinds from generic competition. For Kristalose, substitution by pharmacists dispensing generic alternatives has historically impacted the brand, and during 2025, substitution rates increased with the entry of new generic competitors. A generic crystalline lactulose product was approved for PAI Pharma and became available during the second quarter of 2025. For Acetadote, the FDA has approved several ANDAs filed by various generics companies. The company also experienced a shortage of Acetadote in 2025 due to delays in the manufacture, serialization and delivery of orders from its supplier. For Vaprisol, the company is out of commercial inventory and awaiting FDA approval for a new manufacturing facility. The company's manufacturing partner is working with the FDA to address several Form 483 and warning letter issues.

Risk Factors

The company faces material risks from generic competition, as generic equivalents for branded products are typically sold at lower costs, and after their introduction, a significant percentage of prescriptions are often written for the generic version. For Kristalose, substitution rates increased in 2025 with the entry of new generic competitors, and a generic crystalline lactulose product became available during the second quarter of 2025. The company also faces risks related to its dependence on third-party manufacturers; for example, it experienced a shortage of Acetadote in 2025 due to delays from its supplier, and for Vaprisol, the company is out of commercial inventory and awaiting FDA approval for a new manufacturing facility whose partner is working to address several Form 483 and warning letter issues. The company's ifetroban product candidates have not been approved for sale and may never be successfully commercialized, as drug development is a long, expensive and inherently uncertain process with a high risk of failure at every stage. The company's officers and directors control approximately 42.1% of its common stock as of December 31, 2025, which could significantly influence corporate actions and may adversely affect the trading price of the common stock.

Management Priorities

Management's message emphasizes the company's mission of working together to provide unique products that improve the quality of patient care. Key themes include progressing the clinical development programs for ifetroban, expanding the commercial portfolio with the addition of Talicia, achieving an important reimbursement milestone for Caldolor with a CMS issued J-code, and expanding U.S. market access for Vibativ through new national group purchasing agreements. Management also highlights the company's sustainability metrics, noting that during 2025 the company provided nearly 5 million patient doses of its brands, safely disposed of over 5,500 pounds of expired and damaged goods, had no product recalls, and reported women represented 50% of the workforce and 30% of employees were minorities.

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 7, MD&A — Results of Operations
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  11. [11] Item 1, Business — Pipeline
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  20. [20] Item 8, Note 2 — Co-Commercialization, Stock Agreements and Collaborative Arrangement
  21. [21] Item 8, Note 2 — Co-Commercialization, Stock Agreements and Collaborative Arrangement
  22. [22] Item 8, Note 2 — Co-Commercialization, Stock Agreements and Collaborative Arrangement
  23. [23] Item 8, Note 2 — Co-Commercialization, Stock Agreements and Collaborative Arrangement
  24. [24] Item 7, MD&A — Liquidity and Capital Resources
  25. [25] Item 7, MD&A — Liquidity and Capital Resources
  26. [26] Item 7, MD&A — Liquidity and Capital Resources
  27. [27] Item 7, MD&A — Liquidity and Capital Resources
  28. [28] Item 5, Market for Registrant's Common Equity
  29. [29] Item 5, Market for Registrant's Common Equity
  30. [30] Item 1, Business — Sustainability Metrics
  31. [31] Item 1, Business — Sustainability Metrics
  32. [32] Item 1, Business — Sustainability Metrics
  33. [33] Item 1, Business — Sustainability Metrics
  34. [34] Item 7, MD&A — Results of Operations
  35. [35] Item 7, MD&A — Results of Operations
  36. [36] Item 8, Consolidated Statements of Operations
  37. [37] Item 8, Consolidated Statements of Operations
  38. [38] Item 8, Consolidated Statements of Operations
  39. [39] Item 8, Consolidated Statements of Operations
  40. [40] Item 7, MD&A — Results of Operations
  41. [41] Item 7, MD&A — Results of Operations
  42. [42] Item 1, Business — Pipeline
  43. [43] Item 1, Business — Pipeline
  44. [44] Item 1, Business — Pipeline
  45. [45] Item 1, Business — Pipeline
  46. [46] Item 1, Business — Pipeline
  47. [47] Item 7, MD&A — Results of Operations
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  50. [50] Item 8, Note 4 — Other Revenues
  51. [51] Item 7, MD&A — Results of Operations
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  55. [55] Item 1, Business — Employees
  56. [56] Item 7, MD&A — Results of Operations
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  58. [58] Item 8, Consolidated Statements of Cash Flows
  59. [59] Item 8, Consolidated Statements of Cash Flows
  60. [60] Item 5, Market for Registrant's Common Equity
  61. [61] Item 8, Note 10 — Share Repurchases
  62. [62] Item 1A, Risk Factors — Risks Related to Our Financial Condition
  63. [63] Item 1, Business — Sustainability Metrics
  64. [64] Item 1, Business — Sustainability Metrics
  65. [65] Item 1, Business — Sustainability Metrics
  66. [66] Item 1, Business — Sustainability Metrics
  67. [67] Item 8, Consolidated Statements of Operations
  68. [68] Item 8, Consolidated Statements of Operations
  69. [69] Item 8, Consolidated Statements of Operations
  70. [70] Item 8, Consolidated Statements of Operations
  71. [71] Item 8, Consolidated Statements of Operations
  72. [72] Item 8, Consolidated Statements of Operations
  73. [73] Item 8, Consolidated Statements of Operations
  74. [74] Item 8, Consolidated Statements of Operations
  75. [75] Item 7, MD&A — Results of Operations
  76. [76] Item 7, MD&A — Results of Operations
  77. [77] Item 8, Consolidated Balance Sheets
  78. [78] Item 8, Consolidated Balance Sheets
  79. [79] Item 8, Consolidated Balance Sheets
  80. [80] Item 8, Consolidated Statements of Operations
  81. [81] Item 8, Note 2 — Impairment of Long-Lived Assets
  82. [82] Item 7, MD&A — Results of Operations
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Analysis on 6/21/2026