On November 4, 2025 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined net revenues of $8.3 million during the third quarter of 2025. Year-to-date revenues for the first nine months of the year totaled $30.8 million, representing an increase of 12% over the first nine months of 2024.
Cumberland ended the quarter with approximately $66 million in total assets, $40 million in liabilities and $26 million of shareholders’ equity.
"We are very pleased to add an established, FDA approved brand to our commercial portfolio," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "We are also encouraged by the continued progress with our development programs designed to address a series of unmet medical needs in orphan patient populations. As we move into the final quarter of 2025, we remain focused on our mission of working together to provide unique products that improve the quality of patient care."

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RECENT COMPANY DEVELOPMENTS INCLUDE:
New Product Added to Commercial Product Portfolio
Cumberland recently announced arrangements with RedHill Biopharma Ltd. ("RedHill") to jointly commercialize Talicia, marking the latest addition to its commercial product portfolio. The FDA-approved oral capsule is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection and leading risk factor for gastric cancer.
Cumberland has formed a new company with RedHill, named Talicia Holdings, Inc. RedHill has assigned all its Talicia-related assets to the new company for a 70% ownership position. Cumberland will provide $4 million in investment capital over a two-year period and receive ownership of the 30% remaining shares. Cumberland and RedHill have equal board seats and voting rights in the new company, and these arrangements will enable Cumberland to participate in the value it helps create in the brand.
Through a co-commercialization agreement, Cumberland will assume responsibility for the distribution and sale of Talicia in the U.S. Cumberland will record Talicia product sales and equally share Talicia’s net revenues. Cumberland will also provide an annual investment to cover certain distribution, marketing and sales costs, and will lead the sales promotion for Talicia by leveraging its established field national sales division.

Talicia is the only all-in-one treatment containing omeprazole, amoxicillin and rifabutin, and is now recommended as a first-line therapy in the American College of Gastroenterology (ACG) clinical guidelines. Talicia is patent protected through 2042 and received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation.
International Agreements
During the third quarter, Cumberland announced the launch of Vibativ in Saudi Arabia. The product launch follows an agreement with Tabuk Pharmaceutical Manufacturing Company to introduce Vibativ into the Middle East. The arrangement provided Tabuk exclusive rights to distribute Vibativ in Saudi Arabia and Jordan, with the option to expand into other countries in the region. Tabuk has obtained the final approvals needed to commercialize Vibativ in Saudi Arabia.
In October 2025, Cumberland’s ibuprofen injection product received regulatory approval in Mexico. The Company previously announced its partnership with PiSA Farmaceutica, a well-established Mexican pharmaceutical firm. Under the agreement, PiSA is responsible for the registration and commercialization of the product for the Mexican market, while Cumberland provides regulatory support and the product supply.
Additionally, Cumberland previously announced that its Vibativ product received approval from the regulatory authorities in China, the world’s second-largest pharmaceutical market.
Vibativ 4-Vial Starter Pak Now Available for Vizient Providers
Cumberland recently announced the availability of the Vibativ (telavancin) 4-Vial Starter Pak through a new supply arrangement with Vizient Inc., making it accessible to their healthcare providers nationwide.
As the country’s largest provider-driven healthcare performance improvement company, Vizient serves more than 65% of the nation’s acute care providers, including 97% of academic medical centers and 35% of the non-acute market. Through this agreement, Vizient members now have access to Vibativ’s new 4-vial configuration, which supports flexible treatment initiation in both inpatient and outpatient settings for this potentially life-saving therapy.
Vibativ Added to Premier National Group Purchasing Agreement
In October 2025, Cumberland announced that Vibativ was added to a national group purchasing agreement with Premier, Inc. The product additional allows Premier members to purchase Vibativ, in the 12-vial carton and 4-vial Starter Pak. Premier is a leading healthcare improvement company, uniting an alliance of approximately 4,350 U.S. hospitals and 325,000 other providers and organizations. With expanded access, Premier member healthcare providers now have greater flexibility in ordering Vibativ for both inpatient and outpatient settings.

Ifetroban Clinical Studies
In June 2025, breakthrough findings from Cumberland’s Phase II FIGHT DMD trial, evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy ("DMD"), were presented at the Parent Project Muscular Dystrophy Annual Conference. The findings demonstrated that high-dose ifetroban delivered a 5.4% improvement in cardiac function in patients with DMD. The presentation also included additional biomarker data indicating reduced cardiac damage, which correlated with the clinical findings. These results position ifetroban as a potential treatment for DMD cardiomyopathy – the leading cause of death in these patients and a critical unmet medical need affecting 90% of DMD patients.
The top-line FIGHT DMD study findings were also selected for a late-breaking presentation at the Muscular Dystrophy Association’s Clinical & Scientific Conference in March 2025. In June 2025, Cumberland completed the comprehensive analysis of the study results, finalized its clinical study report and submitted it to the FDA, along with a request for an end-of-Phase 2 meeting. Cumberland then began interaction with the FDA to determine the remaining development requirements.
Meanwhile, Cumberland has been evaluating its ifetroban product candidate in a Phase II clinical program in patients with Systemic Sclerosis. Enrollment in the study was completed this year, and Cumberland is monitoring the clinical sites in preparation to lock the database and begin evaluating the results.
In addition, Cumberland has a Phase II clinical study, the FIGHTING FIBROSIS trial, underway in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. Patient enrollment is now well underway in medical centers across the U.S. The study design includes both an interim safety analysis, as well as an interim efficacy analysis.

FINANCIAL RESULTS:
Net Revenue: For the third quarter of 2025, net revenues were $8.3 million and included $1.2 million for Kristalose, $3.2 million for Sancuso, $2.6 million for Vibativ and $0.9 million for Caldolor.
Year-to-date 2025 net revenues were $30.8 million. Year-to-date net revenues by product were $7.4 million for Kristalose, $8.6 million for Sancuso, $6.7 million for Vibativ and $3.8 million for Caldolor.
Operating Expenses: Total operating expenses were $10.3 million for the third quarter of 2025 and $32.3 million for the first nine months of the year.
Net Income (Loss): Year-to-date net loss was approximately $1.4 million and the third quarter net loss was approximately $1.9 million.
Adjusted Earnings: The adjusted loss for the third quarter of 2025 was $0.8 million, or $0.06 per share. Adjusted earnings for the first nine months of 2025 was $1.9 million, or $0.13 per diluted share.
Balance Sheet: On September 30, 2025, Cumberland had approximately $66 million in total assets, including $15 million in cash and cash equivalents. Liabilities totaled $40 million, including $5 million on the Company’s credit facility. Total shareholders’ equity was $26 million on September 30, 2025.

EARNINGS REPORT CALL:
A conference call will be held today, November 4, 2025, at 4:30 p.m. Eastern Time to provide a Company update and discuss the financial results.
The link to register is View Source
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

(Press release, Cumberland Pharmaceuticals, NOV 4, 2025, View Source [SID1234659384])