Welcome to our dedicated page for Cumberland Pharmaceuticals news (Ticker: CPIX), a resource for investors and traders seeking the latest updates and insights on Cumberland Pharmaceuticals stock.
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 announced the promotion of John Hamm to Director of Finance & Accounting and Chief Financial Officer. With over 25 years of experience, including 20 in health care, Hamm will oversee finance, accounting, and corporate development activities. Previously the Director of Corporate Development, Hamm has been integral to the company since 2019. CEO A.J. Kazimi expressed confidence in Hamm's leadership to enhance patient care through quality medicines. Cumberland develops and commercializes approved pharmaceutical brands in acute care, gastroenterology, and rheumatology.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported a 26.5% increase in net revenues to $10.5 million for Q1 2021. The company also generated an additional $500,000 from divested product rights. Key products contributed significantly, with Vibativ® earning $5.1 million. Operating expenses rose to $10.9 million, influenced by higher costs from Vibativ sales. Net income was $0.2 million, representing a turnaround from a loss of $1.1 million the previous year. The financial position included $93 million in total assets and $47 million in shareholders' equity.
Cumberland Pharmaceuticals (NASDAQ: CPIX) will release its Q1 2021 financial results and company update on May 11, 2021, post-market. A conference call will follow at 4:30 p.m. ET. The company focuses on high-quality prescription brands for hospital acute care and gastroenterology. Its FDA-approved product portfolio includes Acetadote, Caldolor, Kristalose, Omeclamox-Pak, Vaprisol, Vibativ, and RediTrex. The firm is also advancing Phase II clinical programs for ifetroban targeting various diseases.
Cumberland Pharmaceuticals Inc. (CPIX) reported a strong performance for Q4 and full-year 2020, highlighting net revenues of $10.3 million in Q4, a 10% year-over-year increase, and totals of $37.4 million for the year, up 9% from 2019. The company also recognized $3.2 million in revenue from divested product rights. Total assets stood at $96.5 million, with cash and investments of $24.8 million. The firm launched new formulations for its Caldolor product, helped hospitals during the pandemic, and plans to expand its RediTrex line in 2021.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) will announce its fourth quarter and annual 2020 financial results after the market closes on March 9, 2021. A conference call will take place the same day at 4:30 p.m. Eastern Time to discuss these results. The company focuses on specialty pharmaceuticals, offering several FDA-approved products that target acute care, gastroenterology, and oncology markets. Additionally, Cumberland has ongoing Phase II clinical programs for its ifetroban product candidates aimed at treating conditions like Duchenne Muscular Dystrophy.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) announced the launch of RediTrex® (methotrexate) injection, a pre-filled syringe system aimed at improving the ease and accuracy of methotrexate administration for patients with arthritis and psoriasis. RediTrex is FDA approved for severe rheumatoid arthritis and psoriasis patients who struggle with oral methotrexate. It features a retractable needle and user-friendly design, reducing pain and confusion compared to existing options. The launch is slated for two phases, beginning with select centers and expanding nationally in Q1 2021.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported third quarter 2020 net revenues of $9.3 million, up from $6.9 million year-over-year. The firm also recorded $750,000 from divested product rights. Total assets stood at $96 million with $27 million in cash. The company has launched new initiatives including the FDA-approved RediTrex and expanded use of Vibativ for COVID-19 patients. However, net income for Q3 was a loss of $(0.5) million or $(0.03) per share, a slight improvement from $(2.0) million in the previous year.
Cumberland Pharmaceuticals (NASDAQ: CPIX) will announce its third quarter 2020 financial results on Nov. 10, 2020, after market close. A conference call, including a live webcast, is scheduled for the same day at 4:30 p.m. ET. The company develops and commercializes prescription brands for acute care, gastroenterology, and oncology. Its FDA-approved products include Acetadote and Kristalose, among others. Currently, Cumberland is conducting Phase II clinical trials for its ifetroban candidates targeting multiple diseases.
Cumberland Pharmaceuticals (NASDAQ: CPIX) announced results from a review of clinical studies on Caldolor® (ibuprofen) Injection published in Clinical Therapeutics. The review included 1,062 adult patients and found that Caldolor leads to a quicker plasma concentration, enhances postoperative recovery, and reduces opioid and over-the-counter medication use. The study supports the incorporation of Caldolor into Enhanced Recovery After Surgery protocols. CEO A.J. Kazimi emphasized its role in reducing opioid use amid ongoing efforts to address opioid consumption in healthcare.
Cumberland Pharmaceuticals (NASDAQ: CPIX) reported second quarter 2020 net revenues of $9.6 million from ongoing operations, up from $9.4 million year-over-year. Total revenues were $10.3 million, boosted by $750,000 from divested product rights. The Company's financial position showed $97.5 million in total assets, $49.1 million in liabilities, and $48.5 million in shareholders' equity. Net income for Q2 was a loss of $(0.9) million, equating to $(0.06) per share, while adjusted earnings improved to $1.2 million or $0.08 per diluted share. Cumberland continued to support healthcare during COVID-19 with product supply initiatives.
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