Cumberland Pharmaceuticals Sees 16% Revenue Growth in Q2 2024

Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company based in Nashville, Tennessee, reported significant financial improvements and overall positive company performance for the second quarter of 2024.

Key Highlights:
- The company achieved $9.9 million in net revenue for Q2 2024, which marks a 16% sequential increase from Q1 2024.
- Adjusted earnings for the period were $0.2 million, an $0.8 million improvement over the previous quarter.
- The company reported $78.5 million in assets, $52.5 million in liabilities, and $26.3 million in shareholders' equity.

CEO A.J. Kazimi expressed optimism about the company’s future, anticipating continued revenue growth and positive cash flow throughout the rest of the year.

Recent Developments:

Kristalose Medicaid Coverage & AGA Guidelines
The state of Wisconsin has added Kristalose, Cumberland's prescription-strength laxative, to its Medicaid formulary. This addition follows similar coverage in New York and Texas, which are significant markets for the product. The American Gastroenterological Association (AGA) has also recommended Kristalose as a first-line treatment for opioid-induced constipation, which is a widespread issue among patients using opioids.

Vibativ Study for Anthrax Infections
A study published in Antimicrobial Agents and Chemotherapy showcased Vibativ (telavancin) as an effective treatment for inhalational anthrax, the most dangerous form of the infection. The study demonstrated that telavancin was highly effective in eliminating anthrax strains in laboratory tests and significantly improved survival rates in preclinical trials involving rabbits. These findings suggest that telavancin could be a valuable treatment option, especially if current antibiotics lose efficacy due to resistance.

Product Pipeline
Cumberland continues to advance its ifetroban product candidate, a selective thromboxane-prostanoid receptor antagonist, through various clinical studies. So far, nearly 1,400 subjects have been dosed, demonstrating safety and tolerability. The company is currently running three Phase II clinical programs to evaluate ifetroban in treating systemic sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and idiopathic pulmonary fibrosis. Additionally, Cumberland has sought Orphan Drug and Rare Pediatric Disease designations from the FDA for its Duchenne Muscular Dystrophy treatment candidate, which could expedite its review process and offer other benefits.

Manufacturing and Supplies of Sancuso
Following the acquisition of U.S. rights to Sancuso, Cumberland completed the transition from Kyowa Kirin, including the New Drug Application (NDA) transfer. A new FDA-approved manufacturing facility has started producing Cumberland-branded Sancuso, with product shipments commencing this summer.

Federal NOPAIN Act
Cumberland expects its non-opioid pain relief product, Caldolor, to qualify for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act. This act mandates separate Medicare reimbursement for non-opioid pain management products used in surgeries. The reimbursement rule will be in effect from January 1, 2025, to January 1, 2028. In response to the CMS’s request, Cumberland submitted clinical evidence to support Caldolor’s inclusion under this act, and awaits reimbursement details in the 2025 Medicare OPPS Final Rule.

Financial Overview
For the second quarter of 2024, Cumberland's net revenues totaled $9.9 million, with Kristalose contributing $4.1 million, Vibativ $2.5 million, Sancuso $2.2 million, and Caldolor $0.8 million. Year-to-date revenues reached $18.3 million. The company's operating expenses for Q2 were $10.9 million, leading to a net loss of $1.1 million, or $0.08 per share, and a year-to-date net loss of $3.0 million, or $0.21 per share. Adjusted earnings for the quarter stood at $0.2 million, or $0.01 per share. As of June 30, 2024, Cumberland had $78.5 million in assets, $52.5 million in liabilities, and $26.3 million in shareholders' equity.

Company Profile
Cumberland Pharmaceuticals focuses on developing, acquiring, and commercializing unique treatments for hospital acute care, gastroenterology, and oncology markets. Its FDA-approved product lineup includes Acetadote for acetaminophen poisoning, Caldolor for pain and fever, Kristalose for constipation, Sancuso for chemotherapy-induced nausea and vomiting, Vaprisol for hyponatremia, and Vibativ for serious bacterial infections. The company also has ongoing Phase II clinical programs for ifetroban in treating several serious conditions.

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