On May 7, 2024 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined revenues of $8.5 million during the first quarter of 2024 (Press release, Cumberland Pharmaceuticals, MAY 7, 2024, View Source;company-update-302138742.html [SID1234642810]). The company ended the quarter with $82 million in total assets, $54 million in total liabilities and $27 million of shareholders’ equity.
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"It has been a steady start to 2024 – and despite some challenges the biopharmaceutical sector is facing in the financial markets amid stubborn inflation and stalled interest rate cuts, we remain optimistic about our industry’s fundamentals and future," said Cumberland’s CEO, A.J. Kazimi. "We continue to build our portfolio of innovative and differentiated products here at Cumberland, and our resulting, diversified product line has enabled us to weather external challenges while our team remains responsive to the evolving market. We look forward to sharing an update on our brands, pipeline and partnerships, including a number of growth opportunities."
Recent company developments include:
Caldolor Special Report
In March 2024, a Special Report was published in Anesthesiology News, General Surgery News and Pharmacy Practice News presenting the growing amount of clinical data supporting the use of Cumberland’s Caldolor (ibuprofen) injection as a standard of care for the treatment of pain and fever in adults, children and infants as young as 3 months of age.
Takeaways from the Special Report include:
Intravenous ibuprofen results in significant reduction in temperature compared with placebo in adults and with acetaminophen in pediatric patients.
Administration of the product prior to surgery leads to patients waking up in significantly less postsurgical pain, while also lessening or even eliminating the need for opioids.
The use of intravenous ibuprofen in the hospital emergency department for acute pain can minimize opioid requirements while achieving significant pain control.
Caldolor should be considered a foundation for any multimodal pain regimen.
Pain management has become one of the most common health care problems. As this Special Report states, comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control, while minimizing the need for opioids. A non-steroidal anti-inflammatory drug, such as Caldolor, can provide a cornerstone for many treatment paradigms.
Federal NOPAIN Act
Cumberland expects Caldolor will be eligible for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation Act (the "NOPAIN Act"), which was enacted as part of the Consolidated Appropriations Act of 2023.
The NOPAIN Act requires Medicare to provide separate and more favorable reimbursement for non-opioid products used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers. The NOPAIN Act applies, in part, to products that are indicated to provide analgesia without acting upon the body’s opioid receptors.
The Centers for Medicare & Medicaid Services ("CMS") requested that manufacturers with potentially applicable non-opioid products submit comments and supporting clinical evidence regarding products that should be eligible for separate payment. Cumberland submitted a comment letter along with the requisite clinical information to the CMS in September 2023 explaining why Caldolor should be included and separately reimbursed. The company now awaits information from CMS regarding the reimbursement status and price for the product.
The Act is scheduled to go into effect in early 2025 and will initially apply to products that are furnished between January 1, 2025 and January 1, 2028.
New Manufacturing & Supplies of Sancuso
After acquiring U.S. rights to Sancuso, Cumberland successfully completed the transition from Kyowa Kirin in 2023, including the NDA transfer. A new facility was approved by the FDA for Sancuso and, during the first quarter of 2024, Cumberland completed the manufacturing of Cumberland-packaged product there. The company will launch these new supplies this year. Meanwhile, it continues to support the product through its expanded oncology sales division to help cancer patients by addressing certain side effects associated with their chemotherapy treatments.
Vaprisol Supply Update
Cumberland’s new manufacturing and distribution partner for Vaprisol is providing a special supply of compounded product in support of critically ill patients. The companies await FDA approval for the facility in order to relaunch the brand.
Vaprisol is the first and only intravenously administered vasopressin receptor antagonist. It is used to raise serum sodium levels in hospitalized patients with hyponatremia, the most common electrolyte disorder among such patients.
Clinical Development Pipeline
Cumberland has been evaluating its ifetroban product candidate, a selective thromboxane-prostanoid receptor antagonist, in a series of clinical studies. It has now been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in healthy volunteers and various patient populations.
Cumberland has initiated its newest clinical program in medical centers across the country and enrollment has now begun in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. This FIGHTING FIBROSIS trial is designed to enroll 128 patients in over 20 medical centers of excellence across the United States. Recent studies have shown ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.
Patient enrollment is already well underway in its two other company-sponsored Phase II clinical programs evaluating ifetroban in patients with: 1) Systemic Sclerosis, or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs and 2) cardiomyopathy associated with Duchenne Muscular Dystrophy, a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles.
Cumberland’s plan going forward is to complete each of its company-sponsored studies, analyze their final data, announce top-line results and decide on the best development path for the registration of ifetroban, which the company continues to believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.
FINANCIAL RESULTS:
Net Revenue: For the three months ended March 31, 2024, net revenues were $8.5 million.
Net revenue by product for the first quarter of 2024 included $3.2 million for Kristalose, $1.8 million for Sancuso, $1.6 million for Vibativ and $1.5 million for Caldolor.
Operating Expenses: Total operating expenses for the first quarter were $10.4 million.
Net Income: The net loss for the first quarter of 2024 was $1.9 million, or $0.14 a share.
Adjusted Earnings: Adjusted earnings for the first quarter of 2024 were a loss of $0.6 million, or $0.05 per share. The adjusted earnings calculation does not include the benefit of the $0.5 million cost of goods for Vibativ and Sancuso during the quarter, which were received as part of each product’s acquisition.
Balance Sheet: At March 31, 2024, Cumberland had $82 million in total assets, including $19 million in cash and cash equivalents.
Total liabilities were $54 million, including $16 million outstanding on the company’s revolving line of credit. Total shareholders’ equity was $27 million at the end of the quarter.
EARNINGS REPORT CALL:
A conference call will be held on May 7, 2024, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. To participate in the call, please register at: https://register.vevent.com/register/BIbb2d35bc9570474dabf8b2e3d2e4ca72.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting View Source