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About Cumberland Pharmaceuticals Inc.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) is a specialty pharmaceutical company dedicated to the acquisition, development, and commercialization of branded prescription pharmaceutical products. Headquartered in Nashville, Tennessee, Cumberland is the largest biopharmaceutical company founded in the state and focuses on delivering high-quality products that address unmet medical needs. The company operates primarily in the hospital acute care, gastroenterology, rheumatology, and oncology market segments, targeting underserved physician groups and patient populations.
Core Business Model and Operations
Cumberland's business model is built on three key pillars:
- Acquisition: The company strategically acquires FDA-approved products and late-stage development assets that align with its therapeutic focus.
- Development: Cumberland invests in clinical trials and regulatory processes to enhance its product portfolio, including expanding indications and improving formulations.
- Commercialization: The company markets its products through specialized hospital, field, and oncology sales teams in the United States, while leveraging a network of international partners to distribute its medicines globally.
The company derives its revenue primarily from the sales of FDA-approved pharmaceutical brands, including Acetadote®, Caldolor®, Kristalose®, Omeclamox®-Pak, Sancuso®, Vaprisol®, and Vibativ®. These products address critical medical needs such as pain management, gastrointestinal disorders, oncology support, and treatment of severe infections.
Product Portfolio
Cumberland's portfolio includes a range of innovative therapies:
- Acetadote®: An intravenous treatment for acetaminophen overdose to prevent liver damage.
- Caldolor®: The first FDA-approved intravenous ibuprofen for pain and fever management, now approved for use in infants as young as 3 months.
- Kristalose®: A prescription-strength laxative for acute and chronic constipation.
- Omeclamox®-Pak: A combination therapy for Helicobacter pylori infection and duodenal ulcer disease.
- Sancuso®: The only FDA-approved transdermal patch for chemotherapy-induced nausea and vomiting.
- Vaprisol®: An intravenous treatment for hyponatremia in critical care settings.
- Vibativ®: A potent antibiotic for multidrug-resistant Gram-positive infections, including hospital-acquired and ventilator-associated pneumonia.
Clinical Development Pipeline
Cumberland is actively advancing its clinical development pipeline, with a focus on rare and orphan diseases. Key programs include:
- Ifetroban: A selective thromboxane receptor antagonist being evaluated in Phase II trials for systemic sclerosis, cardiomyopathy associated with Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). The drug has received both Orphan Drug and Rare Pediatric Disease Designations from the FDA for its DMD indication.
These programs underscore the company's commitment to addressing critical unmet medical needs and expanding its therapeutic footprint.
Market Position and Competitive Landscape
Cumberland operates in a competitive yet specialized niche within the pharmaceutical industry. By focusing on underserved markets and leveraging its expertise in hospital acute care and specialty therapies, the company differentiates itself from larger pharmaceutical players. Its strategy of acquiring and enhancing existing products allows it to mitigate some of the risks associated with new drug development while maintaining a robust pipeline for future growth.
Global Reach
While Cumberland's primary market is the United States, the company has established partnerships with international distributors to expand the availability of its products globally. Recent developments include regulatory approvals and product launches in markets such as China, Saudi Arabia, and Mexico.
Commitment to Quality and Patient Care
Cumberland is committed to improving patient outcomes through innovative therapies and rigorous quality standards. The company's efforts to enhance its product labeling, expand clinical indications, and support patient access initiatives reflect its dedication to addressing unmet medical needs and improving the quality of care.
Conclusion
With a diversified portfolio of FDA-approved products, a strong clinical pipeline, and a strategic focus on underserved markets, Cumberland Pharmaceuticals Inc. is well-positioned as a key player in the specialty pharmaceutical sector. Its commitment to innovation, quality, and patient care underscores its role in addressing critical healthcare challenges and delivering value to patients and healthcare providers alike.
Cumberland Pharmaceuticals (NASDAQ: CPIX) has relocated its headquarters to the Broadwest campus in Nashville, Tennessee. This move accommodates recent growth, increasing staff to over 100 employees. The Broadwest complex features a 21-story office tower and various amenities that enhance the company's operational capabilities. CEO A.J. Kazimi highlighted Nashville's role as a healthcare hub, which supports the company's FDA-approved brands and pipeline for future medicines. The location near Vanderbilt University Medical Center will foster further collaborations.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported a 14% revenue increase to $10.3 million for Q2 2022, with year-to-date gross revenue rising 10% to $21.5 million compared to 2021. Cash flow from operations reached $2.2 million, and the company holds total assets of $93 million against liabilities of $53 million. Key highlights include the acquisition of Sancuso® and its national co-promotion with Verity Pharmaceuticals. Additionally, Cumberland is advancing multiple Phase II clinical studies for its product candidate ifetroban.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) has released its 2021 Sustainability Report, showcasing significant achievements in environmental, social, and governance initiatives. The company delivered 2.43 million patient doses and disposed of 6,200 pounds of expired goods without any product recalls or FDA-related issues. Cumberland invested $4,000 per employee in training, while maintaining a workforce composed of 44% women and 15% minorities. Additionally, the company supported patients by covering up to 60% of prescription costs for gastrointestinal products.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) will announce its second quarter 2022 financial results on August 9, 2022, after market close. A conference call is scheduled for the same day at 4:30 p.m. ET to discuss the results. The company focuses on developing and commercializing prescription brands for hospital acute care, gastroenterology, rheumatology, and oncology. Its FDA-approved products include Acetadote, Caldolor, and Kristalose. Cumberland is also advancing Phase II clinical programs for its ifetroban candidate, targeting conditions like cardiomyopathy and systemic sclerosis.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) announced the appointment of Martin Brown Jr. to its Board of Directors as of July 19, 2022. Brown, with nearly 30 years of legal experience, previously served on the Board of Brown-Forman Corporation and currently practices at Adams and Reese LLP. His background in health care and corporate law is expected to enhance Cumberland's mission to address unmet medical needs. Brown holds degrees from Yale University and Vanderbilt University.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported financial results for Q1 2022, with net revenues of $11.2 million, a 6% increase from the prior year. Adjusted earnings were $0.5 million or $0.03 per share. The company had total assets of $96.7 million and total liabilities of $55.9 million, resulting in shareholders' equity of $41.0 million. Cumberland acquired the oncology-supportive drug Sancuso and formed a new sales division. Additionally, partnerships were announced for Vibativ in the Middle East and Puerto Rico, expanding market reach.
Cumberland Pharmaceuticals Inc. (CPIX) announced a national co-promotion agreement with Verity Pharmaceuticals to promote Sancuso, the first FDA-approved patch for preventing chemotherapy-induced nausea and vomiting (CINV). Sancuso releases granisetron through the skin, effective for up to five days when applied before chemotherapy. Verity will leverage its oncology sales organization to enhance Sancuso's market reach following Cumberland's earlier acquisition of its U.S. rights. This partnership aims to expand patient access to Sancuso through shared marketing and sales efforts.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) will release its first quarter 2022 financial results and an update on May 10, 2022, after market close. A conference call is scheduled for 4:30 p.m. ET that day for discussion on the results. Interested parties can join via phone or through the company’s website. The company specializes in high-quality prescription products for hospital acute care, gastroenterology, and rheumatology, with a strong portfolio of FDA-approved brands and ongoing clinical programs for ifetroban in various conditions.
Cumberland Pharmaceuticals has launched Vibativ (telavancin) in the Middle East, partnering with Tabuk Pharmaceutical Manufacturing Co. This collaboration grants Tabuk exclusive rights to register and promote Vibativ in Saudi Arabia and Jordan. Vibativ is a once-daily antibiotic indicated for multidrug-resistant infections, particularly effective against MRSA and pneumonia. The partnership aims to enhance Tabuk's anti-infective portfolio and improve patient access to this critical treatment.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported its full-year 2021 financial results, with net revenues reaching $36 million and cash flow from operations of $6 million. The company acquired Sancuso®, a drug for preventing chemotherapy-induced nausea and vomiting, enhancing its product portfolio. Total assets stood at $84 million, with total liabilities of $42 million. Adjusted earnings for 2021 were $(1.2 million), or $(0.08) per share, indicating improved performance compared to a net loss of $(5.6 million) in the previous year.
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