Cumberland Pharmaceuticals Stock Price, News & Analysis

Cumberland Pharmaceuticals Inc. (CPIX) is a specialty pharmaceutical company that develops, acquires, and commercializes branded prescription products. According to the company’s public disclosures, Cumberland focuses on hospital acute care, gastroenterology, and oncology market segments and offers a portfolio of FDA-approved medicines aimed at improving the quality of patient care. Cumberland is incorporated in Tennessee and its common stock trades on Nasdaq under the ticker CPIX.

Business focus and operating model

Cumberland describes itself as a specialty pharmaceutical and biopharmaceutical company centered on branded prescription drugs. The company’s revenue is derived from sales of FDA-approved pharmaceutical brands, and it promotes these products through hospital, field, and oncology sales efforts in the United States, while also working with international partners to register and supply its medicines in other countries. Cumberland reports that it operates as a single segment focused on specialty pharmaceutical products.

The company repeatedly notes that it is the largest biopharmaceutical company founded and headquartered in Tennessee, emphasizing its regional roots while pursuing a national and international commercial footprint through partnerships and distribution agreements.

Key therapeutic areas and product portfolio

Cumberland’s portfolio of FDA-approved brands, as described in its press releases, includes several hospital and specialty therapies:

• Acetadote (acetylcysteine) injection – indicated for the treatment of acetaminophen poisoning and used in emergency department settings to prevent or lessen hepatic injury when administered within a defined time window after overdose.
• Caldolor (ibuprofen) injection – indicated in adults and pediatric patients for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and reduction of fever. It is described as the first FDA-approved intravenous therapy for fever.
• Kristalose (lactulose) oral – a prescription laxative indicated for the treatment of acute and chronic constipation, presented as a proprietary crystalline form of lactulose.
• Sancuso (granisetron) transdermal system – a skin patch indicated for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy. It is described as the only FDA-approved patch for chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy.
• Vaprisol (conivaptan) injection – an intravenous treatment used in the critical care setting to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia, acting as a vasopressin receptor antagonist.
• Vibativ (telavancin) injection – a patented, injectable lipoglycopeptide antibiotic indicated for certain serious Gram-positive bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated skin and skin structure infections (cSSSI), particularly where pathogens are difficult-to-treat or multidrug-resistant.
• Talicia (omeprazole magnesium, amoxicillin and rifabutin) oral capsule – an FDA-approved fixed-dose, all-in-one oral therapy indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection and leading risk factor for gastric cancer.

Across these brands, Cumberland’s products address conditions such as acetaminophen overdose, pain and fever management, constipation, chemotherapy-induced nausea and vomiting, hyponatremia in hospitalized patients, serious Gram-positive infections including MRSA-related pneumonia and skin infections, and H. pylori infection.

Market segments and geographic reach

The company states that its target markets include hospital acute care, gastroenterology, rheumatology, and oncology. In more recent disclosures, Cumberland highlights hospital acute care, gastroenterology, and oncology as its primary commercial focus. Within the United States, Cumberland promotes its approved products through hospital, field, and oncology sales divisions. Internationally, the company works with partners to register and commercialize its medicines in their local markets.

Examples from recent announcements include agreements that support the distribution of Vibativ in Saudi Arabia and other Middle Eastern countries through Tabuk Pharmaceutical Manufacturing Company, and regulatory approval of Cumberland’s ibuprofen injection product in Mexico through a partnership with PiSA Farmaceutica. These arrangements illustrate Cumberland’s use of regional partners for registration, supply, and commercialization outside the U.S.

Partnerships and commercialization arrangements

Cumberland’s business model incorporates collaborations with other pharmaceutical companies and healthcare organizations. For instance, the company has entered into strategic arrangements with RedHill Biopharma Ltd. to jointly commercialize Talicia in the United States and to participate in the value of Talicia’s broader business through a jointly owned entity. Under these arrangements, Cumberland assumes responsibility for U.S. distribution and sales of Talicia, records product sales, and shares net revenues, while RedHill contributes Talicia-related assets and retains a majority ownership position in the new company.

In the anti-infective space, Cumberland has supply and group purchasing agreements involving Vibativ, including contracts with Vizient and Premier, which are described as large healthcare performance improvement and group purchasing organizations serving thousands of U.S. hospitals and other providers. These agreements are intended to make Vibativ available to member institutions under pre-negotiated terms and configurations, such as a 12-vial carton and a 4-vial starter pack.

Research and development programs

Beyond its commercial portfolio, Cumberland reports a series of Phase II clinical programs evaluating its ifetroban product candidate. These studies focus on patients with:

• Cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD),
• Systemic Sclerosis, and
• Idiopathic Pulmonary Fibrosis (IPF) or Pulmonary Fibrosis.

Public updates from the company describe ongoing Phase II trials, including the FIGHT DMD study in DMD cardiomyopathy and the FIGHTING FIBROSIS trial in IPF. Cumberland has reported analyses of clinical data, preparation of study reports, and interactions with the U.S. Food and Drug Administration (FDA) related to these programs. These development efforts are presented as targeting unmet medical needs in orphan or serious disease populations.

Financial and corporate disclosures

Cumberland files periodic and current reports with the U.S. Securities and Exchange Commission (SEC). Recent Form 8-K filings reference:

• Quarterly updates on results of operations and financial condition, including net revenues from its portfolio of FDA-approved brands and information on assets, liabilities, and shareholders’ equity.
• A material definitive agreement with Pinnacle Bank amending an existing revolving credit facility, providing for borrowing capacity up to a specified principal amount, with the facility collateralized by substantially all of the company’s assets and subject to financial covenants and borrowing base requirements.
• Disclosure of the strategic arrangements with RedHill Biopharma to jointly commercialize Talicia.

These filings provide investors with information on Cumberland’s capital structure, access to credit, and the financial contribution of its commercial portfolio.

Position within the pharmaceutical industry

Cumberland is categorized in the pharmaceutical preparation manufacturing industry within the broader manufacturing sector. The company emphasizes its focus on branded prescription products for hospital and specialty settings rather than on generic commodities. Its portfolio spans emergency care (Acetadote), perioperative and inpatient pain and fever management (Caldolor and ibuprofen injection products), gastrointestinal conditions (Kristalose and Talicia), oncology supportive care (Sancuso), critical care electrolyte disorders (Vaprisol), and serious infectious diseases (Vibativ).

By combining marketed brands with late-stage clinical development programs such as ifetroban, Cumberland presents itself as both a commercial-stage and development-stage organization. Its strategy, as described in public communications, is to develop, acquire, and commercialize unique products that can enhance patient care in targeted hospital and specialty markets.

FAQs about Cumberland Pharmaceuticals Inc. (CPIX)

• What does Cumberland Pharmaceuticals Inc. do?
  Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company that develops, acquires, and commercializes branded prescription products. The company focuses on hospital acute care, gastroenterology, and oncology market segments and generates revenue from sales of its FDA-approved pharmaceutical brands.
• Which therapeutic areas are central to Cumberland’s business?
  According to the company’s disclosures, Cumberland targets hospital acute care, gastroenterology, rheumatology, and oncology. Its marketed portfolio includes products for acetaminophen poisoning, pain and fever, constipation, chemotherapy-induced nausea and vomiting, hyponatremia in hospitalized patients, serious Gram-positive infections, and H. pylori infection.
• What are Cumberland’s main FDA-approved brands?
  Cumberland’s portfolio of FDA-approved brands includes Acetadote (acetylcysteine) injection, Caldolor (ibuprofen) injection, Kristalose (lactulose) oral, Sancuso (granisetron) transdermal system, Vaprisol (conivaptan) injection, Vibativ (telavancin) injection, and Talicia (omeprazole magnesium, amoxicillin and rifabutin) oral capsule.
• How does Cumberland reach patients outside the United States?
  The company works with international partners to register and commercialize its products in other countries. Examples include an agreement with Tabuk Pharmaceutical Manufacturing Company to launch Vibativ in Saudi Arabia and other Middle Eastern markets, and a partnership with PiSA Farmaceutica for regulatory approval and commercialization of an ibuprofen injection product in Mexico.
• What is Cumberland’s relationship with RedHill Biopharma regarding Talicia?
  Cumberland has entered into strategic arrangements with RedHill Biopharma to jointly commercialize Talicia, an FDA-approved oral capsule for H. pylori infection in adults. The companies formed a jointly owned entity for Talicia-related assets, and Cumberland assumes responsibility for distribution and sale of Talicia in the U.S., recording product sales and sharing net revenues.
• Which clinical development programs is Cumberland pursuing?
  Cumberland reports a series of Phase II clinical programs evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis, and Idiopathic Pulmonary Fibrosis or Pulmonary Fibrosis. These programs are designed to assess ifetroban’s potential in serious and often orphan disease indications.
• How is Vibativ positioned within Cumberland’s portfolio?
  Vibativ (telavancin) injection is described as a patented, FDA-approved injectable antibiotic for serious Gram-positive infections, including HABP/VABP and complicated skin and skin structure infections. Cumberland has entered into agreements with organizations such as Vizient and Premier to make Vibativ available to member hospitals under pre-negotiated terms and configurations.
• What role does Caldolor play in Cumberland’s business?
  Caldolor (ibuprofen) injection is one of Cumberland’s key hospital acute care products. It is indicated for pain and fever management in adults and pediatric patients and is described as the first FDA-approved intravenous therapy for fever. Cumberland has also highlighted studies of Caldolor in older post-operative patients and regulatory milestones such as reimbursement-related coding for its use as a non-opioid pain management option.
• How does Cumberland finance its operations?
  Cumberland’s SEC filings reference a revolving credit facility with Pinnacle Bank, collateralized by substantially all of the company’s assets and subject to financial covenants. The company also reports on net revenues from its portfolio of FDA-approved brands and discloses assets, liabilities, and shareholders’ equity in its financial statements.
• Is Cumberland Pharmaceuticals still an active public company?
  Recent press releases and SEC filings, including Forms 8-K reporting financial results and credit facility amendments, indicate that Cumberland Pharmaceuticals Inc. continues to operate as a public company with its shares listed on Nasdaq under the symbol CPIX.