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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 Inc. (NASDAQ: CPIX) will release its annual 2021 financial results and company update after the market closes on March 8, 2022. A conference call to discuss these results will take place that same day at 4:30 p.m. Eastern Time, accessible by phone and via a live webcast on the company's website. Cumberland focuses on delivering high-quality prescription brands for acute care, gastroenterology, and rheumatology, with a portfolio that includes several FDA-approved products such as Acetadote and Caldolor.
Cumberland Pharmaceuticals (NASDAQ: CPIX) has acquired SANCUSO® (granisetron transdermal patch) from Kyowa Kirin for $13.5 million, with additional milestone payments and royalties up to 10% on U.S. net sales. SANCUSO is the only FDA-approved patch for preventing chemotherapy-induced nausea and vomiting, with U.S. sales exceeding $14 million in 2020. This acquisition allows Cumberland to enhance its oncology portfolio, addressing the needs of the approximately 500,000 Americans undergoing chemotherapy each year.
Cumberland Pharmaceuticals has received FDA approval for expanded labeling of Caldolor, an intravenous ibuprofen formulation, allowing its use in pre-operative administration. This approval aims to reduce post-surgery pain significantly for patients waking up from procedures. The labeling includes details on indications, appropriate patient populations, and clinical study results. A recent study involving 185 patients showed significant pain reduction with Caldolor compared to a placebo over 24 hours post-surgery. This development aligns with the ongoing efforts to manage surgical pain and decrease opioid reliance.
Cumberland Pharmaceuticals (NASDAQ: CPIX) reported a net revenue of $8.1 million for Q3 2021, totaling $27.7 million for the first nine months, reflecting a 1.8% increase year-over-year. The company holds total assets of $87.6 million and $25.8 million in cash, with total liabilities of $41 million. The launch of RediTrex for rheumatoid arthritis and psoriasis was implemented during Q3 2021. Despite the pandemic challenges, Cumberland remains focused on improving patient care and has additional clinical programs for its ifetroban candidate.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) will announce its third quarter 2021 financial results and provide a company update on November 9, 2021, after market close. A conference call is scheduled for the same day at 4:30 p.m. Eastern Time. The company specializes in branded prescription products for acute care, gastroenterology, and rheumatoid arthritis. Key FDA-approved brands include Acetadote, Caldolor, and Vaprisol, among others. Additionally, Cumberland is developing therapies for conditions like Duchenne Muscular Dystrophy.
Cumberland Pharmaceuticals (NASDAQ: CPIX) has launched its RediTrex (methotrexate) line of pre-filled syringes, designed for treating active rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriatic arthritis. RediTrex is FDA-approved and offers advantages such as easy handling, accurate dosing, and reduced discomfort. It is more effective and less costly than oral methotrexate, potentially delaying the need for expensive biologics. This injectable option is particularly beneficial for patients with dexterity issues, addressing the challenges of existing administration methods.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported second quarter 2021 net revenues of $9.1 million, with total revenues for the first half reaching $19.6 million, a 9.3% increase from 2020. The company achieved a net income of $1.4 million year-to-date, rebounding from a loss of $2 million in the previous year. Despite a slight decline from Q2 2020, total operating expenses decreased to $10.5 million. Cumberland's financial health includes $89 million in total assets and $48 million in shareholders' equity. The company is committed to improving patient care through its diverse product portfolio.
Cumberland Pharmaceuticals (CPIX) will release its second quarter 2021 financial results on August 10, 2021, after market close. A conference call is scheduled for the same day at 4:30 p.m. ET to discuss these results. The company specializes in branded prescription products for hospital acute care, gastroenterology, and rheumatoid arthritis. Its FDA-approved portfolio includes Acetadote and Caldolor, among others. Cumberland is also advancing Phase II clinical programs in various therapeutic areas.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) released its 2020 Sustainability Report, highlighting significant achievements in environmental, social, and governance (ESG) matters. The company safely delivered 2.5 million patient doses, managed over 4,000 pounds of expired products, and reported no product recalls or FDA safety issues. The report emphasizes Cumberland's commitment to sustainability, with initiatives like drug serialization to combat counterfeiting. The workforce comprises 46% women and 18% minorities, showcasing its focus on diversity and employee development.
Cumberland Pharmaceuticals (NASDAQ: CPIX) released case reports detailing the effectiveness of Vibativ (telavancin) in treating secondary bacterial infections in COVID-19 patients, especially those with pre-existing health conditions such as obesity, diabetes, and heart disease. The reports include five instances where Vibativ effectively treated hospital-acquired and ventilator-associated bacterial pneumonia, resulting from serious staph infections. The timely use of Vibativ has shown to improve patient outcomes significantly, showcasing its potential in combating these severe infections.
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