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DATE
Tuesday, March 3, 2026 at 4:30 p.m. ET
CALL PARTICIPANTS
- Chief Executive Officer — A.J. Kazimi
- Vice President, Organizational Development — Todd Anthony
- Chief Financial Officer — John Hamm
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TAKEAWAYS
- Annual Revenue — $44.5 million, an increase of 18% driven by increased sales across the portfolio.
- Fourth-Quarter Revenue — $13.7 million, up by 31% largely due to Vibativ, Sancuso, and Talicia sales.
- Full-Year Adjusted Earnings — $1.7 million, a turnaround of more than $2 million as stated by management.
- Full-Year Cash Flow from Operations — $4.9 million, an improvement of $5.5 million from the previous year as described by management.
- Key Product Contributions — Vibativ, Sancuso, and new Talicia brand led revenue gains, with initial Talicia sales commencing in Q4.
- Balance Sheet Strengthened — Shareholder equity increased; line of credit balance reduced by over $10 million.
- Regulatory Approvals — Vibativ approved in China and launched in Saudi Arabia; ibuprofen injection approved in Mexico.
- Strategic Partnerships — Co-commercialization agreement for Talicia with RedHill Biopharma and formation of Talicia Holdings, Inc.
- Caldolor J-code — CMS issued a J-code, providing enhanced reimbursement and access for hospital billing.
- Ifetroban Clinical Progress — Phase II FIGHT DMD trial showed high-dose treatment improved LVEF by 3.3% versus placebo and 5.4% over propensity-matched controls, with Fast Track, Orphan Drug, and Rare Pediatric Disease designations confirmed.
- Vibativ Commercial Progress — New agreements with Vizient, Inc. and Premier, Inc. expanded market access through national group purchasing organizations.
- Operating Expenses — $47.3 million for the year, up from $44.3 million, related to higher royalties and cost of goods tied to sales growth.
- Net Loss — $2.9 million for the year and $1.4 million for Q4, both improved from 2024 figures.
- Total Assets and Liabilities — $76.8 million in assets and $52.3 million in liabilities at year-end; cash and cash equivalents totaled $11.4 million.
- Tax Assets — Over $54 million in net operating loss carryforwards remain.
SUMMARY
Cumberland Pharmaceuticals (CPIX 5.37%) prioritized expanding its commercial and development pipeline, reporting tangible regulatory and market access wins in key international markets. The company emphasized its expanded oncology and gastroenterology offerings following the Sancuso and Talicia additions, noting collaborative arrangements and product launches as revenue drivers. Management confirmed progress in advanced clinical candidates, particularly ifetroban, with top-line data submitted and multiple FDA designations secured to potentially expedite review. The company reported the completion of a manuscript publication highlighting ifetroban’s oncology potential and disclosed ongoing investigator-sponsored trials targeting additional indications. Shareholder equity and operational cash generation both improved, aided by asset additions and financial discipline, resulting in greater balance sheet flexibility.
- The company invested $2 million in the Talicia Holdings, Inc. joint venture and committed an additional $2 million, resulting in a 30% ownership stake accounted for under the equity method.
- Kristalose prescription activity faced increased substitution pressure after new generic entrants, leading management to implement new protection strategies.
- Vibativ’s comprehensive pharmacokinetic analysis in over 1,200 patients supported tailored dosing and informed marketing for severe infections as presented in a peer-reviewed journal.
- CMS reimbursement milestones for Caldolor facilitated wider access and use in pediatric hospital environments after new FDA labeling for infants.
- Board members implemented trading plans and made additional share purchases during the year to increase insider holdings.
INDUSTRY GLOSSARY
- LVEF (Left Ventricular Ejection Fraction): Percentage measure of how much blood the left ventricle pumps out with each contraction, used as a key indicator in cardiomyopathy studies.
- J-code: A reimbursement code assigned by CMS for medical billing in the United States, streamlining hospital claims processes.
- Propensity-matched controls: A comparison group in clinical studies statistically matched for baseline characteristics to minimize bias in efficacy results.
- Fast Track designation: FDA process designed to accelerate development and review of therapies for serious conditions with unmet need.
Full Conference Call Transcript
A.J. Kazimi, Cumberland Pharmaceuticals Inc.’s Chief Executive Officer; Todd Anthony, Vice President, Organizational Development; and John Hamm, Chief Financial Officer. Please keep in mind that their discussions may include some forward-looking statements as defined in the Private Securities Reform Act. Those statements reflect the company’s current views and expectations concerning future events and may involve risks, as well as uncertainties. There are many factors that could affect Cumberland Pharmaceuticals Inc.’s future results, including natural disasters, economic downturns, international conflicts, trade restrictions, public health epidemics, and others that are beyond the company’s control. Those issues are described under the caption Risk Factors in Cumberland Pharmaceuticals Inc.’s Annual Report on Form 10-K and any subsequent updates filed with the SEC.
Any forward-looking statements made during today’s call are qualified by those risk factors. Despite the company’s best efforts, actual results may differ materially from expectations, so information shared on this call should be considered current as of today only. Also, please remember that the company is not responsible for updating any forward-looking statements whether as a result of new information or due to future developments. During today’s call, there will be references to several of Cumberland Pharmaceuticals Inc.’s marketed brands. Full prescribing and safety information for each brand is included on the individual product website, and you can find links to those sites on the corporate site at www.cumberlandpharma.com.
The company will also be providing some non-GAAP financial measures with respect to its performance. An explanation and reconciliation to GAAP measures can be found in the tables of the earnings release that I noted was issued earlier this afternoon. If you have any questions, please hold them until the end of the call, at which point we will be happy to answer them. Management is also prepared to hold a follow-up conversation with shareholders after the call if you prefer. With that introduction, I will turn the call over to Cumberland Pharmaceuticals Inc.’s Chief Executive Officer, A.J. Kazimi.
A.J. Kazimi: Thank you, Emily. Good afternoon, everyone. We appreciate you joining us today. As Emily mentioned, we will provide a review of both our fourth quarter and our full year financial performance for 2025. We will also share an overall company update and discuss several recent developments that continue to underscore our optimism about the company’s future. I would like to start by stating that 2025 was an outstanding year for Cumberland Pharmaceuticals Inc. We announced breakthrough clinical study results, delivered strong financial performance, expanded our global reach, and added to our commercial portfolio, highlighting a year of consistent progress for our company.
Most importantly, we remain focused on our mission of delivering unique products that improve the quality of patient care. So let us begin with a review of our financial performance. Our portfolio of FDA-approved brands delivered combined revenues of $13,700,000 during 2025, representing a 31% increase over the prior-year period. For the full year, revenues totaled $44,500,000, up 18% over 2024, and we therefore achieved our goal of double-digit revenue growth for the year. This revenue growth resulted in a turnaround in adjusted earnings, which improved by over $2,000,000 to $1,700,000, or $0.11 a share. In addition, cash flow from operations improved by $5,500,000 and was just under $5,000,000 for the full year.
This financial performance reflects strong execution across our commercial organization with growing demand for our products. It was led by dramatic growth for Vibativ and Sancuso, along with the initial sales of our newest brand, Talicia, which we began shipping in the fourth quarter. We also strengthened our balance sheet during the year. We increased shareholder equity and reduced the balance on our line of credit by more than $10,000,000, further improving our financial position. Beyond our financial performance, we made significant progress expanding our global presence. In 2025, Vibativ received regulatory approval in China, the world’s second largest pharmaceutical market, creating a major new opportunity for the brand.
Also in 2025, Vibativ was successfully launched in Saudi Arabia, resulting in initial sales and the first patients receiving treatment with the product in that country. In addition, our ibuprofen injection product received regulatory approval in Mexico, which will enable our expansion into another important international market. Turning now to our business development efforts, we continue to execute on our strategy of acquiring rights to differentiated branded pharmaceuticals. We added Talicia, an FDA-approved treatment for Helicobacter pylori infections, expanding our presence in gastrointestinal care. Talicia complements our existing portfolio and represents an excellent strategic fit, leveraging our established commercial infrastructure. Meanwhile, the Centers for Medicare and Medicaid Services, or CMS, issued a J-code for Caldolor.
This important reimbursement milestone enhances product access, simplifies hospital billing, and further supports Caldolor’s continued growth and its role as a standard of care for the treatment of pain and fever. During 2025, we also continued to advance our clinical programs, reinforcing our commitment to developing new therapies for patients with serious and underserved medical needs. Significantly, we continued to advance our clinical pipeline in 2025, highlighted by breakthrough results from our FIGHT DMD clinical study. That trial evaluated our ifetroban product candidate in patients with cardiomyopathy associated with Duchenne muscular dystrophy, which is the leading cause of death in those patients.
The top-line findings from that study were selected for a late-breaking presentation at the Muscular Dystrophy Association’s Clinical and Scientific Conference and were also presented at the Parent Project Muscular Dystrophy Annual Conference. We then completed the comprehensive analysis of the study results, prepared our clinical study report, and submitted it to the FDA, and began interactions with them to determine their remaining development requirements. The FDA has approved our request for orphan drug, rare pediatric disease, and, more recently, Fast Track designations for our DMD program. Overall, 2025 was a defining year for Cumberland Pharmaceuticals Inc. We grew our commercial business, advanced our development pipeline, expanded our global footprint, and strengthened our financial foundation.
With that overview and developments, I would now like to turn to Todd Anthony, Cumberland Pharmaceuticals Inc.’s Vice President, Organizational Development, to further discuss both our brands and our organization. Todd?
Todd Anthony: Thank you, AJ. I will start by sharing an update on each of our major brands. Vibativ is our intravenous antibiotic designed for difficult-to-treat infections, such as hospital-acquired and ventilator-associated pneumonia, as well as complicated skin and skin structure infections caused by certain gram-positive bacteria, including those that are multidrug resistant. Unlike many antibiotics that are losing the ability to fight bacteria, Vibativ’s unique dual method of action was specifically designed to address drug-resistant bacteria. We therefore believe it has lifesaving potential to help many patients amid this growing antibiotic resistance crisis, which faces a fragile pipeline of new antibiotic development.
To reinforce this message, we are conducting a series of Infectious Insights, which are discussions with infectious disease experts that we are disseminating across the country. These video vignettes share the opportunity to use Vibativ as a solution for select patient types where other products have failed. We also shared that a comprehensive pharmacokinetic analysis of Vibativ was published in Antimicrobial Agents and Chemotherapy. The analysis utilized data from over 1,200 patients across varied demographics and comorbidity profiles. The findings support optimized dosing strategies for patients with different infection severities and renal function levels, reinforcing Vibativ’s critical role in treating life-threatening gram-positive infections.
In 2025, we also announced the availability of the Vibativ four-vial starter pack through a new supply arrangement with Vizient, making it accessible to their healthcare members 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 our country’s academic medical centers. Through this agreement, Vizient members have access to Vibativ’s four-vial configuration, which supports flexible treatment initiation in both an inpatient and outpatient setting for this potentially lifesaving therapy. Vibativ was also added to a national group purchasing agreement with Premier, Inc., an alliance of approximately 4,350 U.S. hospitals designed to drive transformation across the healthcare system.
The product’s addition provides Premier’s membership with a cost-effective solution to treat resistant gram-positive infections. Moving next to Kristalose, which is our prescription-strength product provided in a convenient premeasured powder dose that dissolves quickly in just four ounces of water, resulting in a clear, taste-free, and grit-free solution. While our field sales division has been able to generate prescriptions of Kristalose through their promotional efforts, we have always faced substitution by pharmacies in favor of generic alternatives. That substitution has increased this year with the arrival of additional generic competition. We have taken appropriate action and are implementing strategies to protect and grow this business. Let us shift now to Caldolor, our intravenous ibuprofen product.
With its newest pediatric labeling cleared with the FDA, Caldolor now is the only non-opioid product approved to treat pain in infants that is delivered by injection. As a reminder, we are featuring Caldolor through sales and marketing initiatives highlighting this new indication, resulting in a growing use of the product in our country’s children’s hospitals. In 2025, we announced the publication of our study investigating Caldolor in Clinical Therapeutics, demonstrating the product’s safety and efficacy for managing postoperative pain in patients 60 years of age and older. The analysis, encompassing over 1,000 patients from our comprehensive postsurgical study, represents the first such evaluation in this vulnerable population where traditional pain management options such as opioids carry increased risk.
Turning now to Sancuso, our transdermal patch FDA approved for the management of chemotherapy-induced nausea, we continue to see favorable sales results following expansion of our oncology division. We have also launched a new Sancuso website along with promotional marketing resources and digital marketing campaigns to further support awareness and access to this product. Lastly, let us review our newest product, Talicia, an FDA-approved and leading treatment for Helicobacter pylori infection, provided in a single capsule that contains omeprazole, amoxicillin, and rifabutin. Talicia is now recommended as a first-line therapy for H. pylori infections via the American College of Gastroenterology’s clinical guidelines.
Also note that the effective treatment of gastric ulcers is an important step in the prevention of gastric cancers. The product’s outstanding profile includes three key advantages: a high eradication rate exceeding 90%, the convenience of an all-in-one capsule, and minimal antibiotic resistance. In 2025, we entered arrangements with RedHill Biopharma to jointly commercialize Talicia and formed a new company with RedHill named Talicia Holdings, Inc. Through our co-commercialization agreement, we have assumed responsibility for the distribution and sale of Talicia in the U.S. and equally share Talicia’s net revenues. We launched the promotion of Talicia at the beginning of the year, and our newest brand is supported by our field sales division that also details Kristalose.
We now have a national sales and medical organization that includes 50 customer-facing individuals who feature our brands. That completes my updates for today, so I will turn it back to you, AJ.
A.J. Kazimi: Thank you, Todd. I would now like to provide an update on our ongoing clinical activities. We continue to progress our pipeline of innovative products designed to improve patient care and their quality of life. Our ifetroban product candidate, a potent and selective thromboxane receptor antagonist, is being evaluated in several clinical programs for patients with a series of unmet medical needs. It has now been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in those individuals, resulting in an outstanding safety database.
In February 2025, we announced positive top-line results from our completed Phase II study in patients with cardiomyopathy associated with Duchenne muscular dystrophy, which is a rare, fatal, genetic neuromuscular disease that results in deterioration of the skeletal, heart, and lung muscles. Our study enrolled 41 DMD patients who received either low-dose ifetroban, high-dose ifetroban, or placebo. High-dose ifetroban treatment resulted in a 3.3% improvement in the patients’ left ventricular ejection fraction compared to the placebo group. When compared to the propensity-matched natural history controls, the difference was even more pronounced, with high-dose treatment providing a statistically significant 5.4% overall improvement in cardiac function as measured by LVEF.
Both doses of ifetroban were well tolerated, with no serious drug-related adverse events seen in the study, and all subjects who completed the 12-month treatment period opted into an open-label extension. They continue to receive ifetroban with long-term follow-up. As I mentioned, ifetroban previously received orphan drug designation and rare pediatric disease designation for DMD. I am pleased to report the program was also recently granted by the FDA Fast Track designation, and that will enable us to have more frequent FDA interactions and also enable us to submit our application for approval on a rolling basis. We held an end-of-Phase II meeting with the FDA last fall and a follow-up meeting in January.
We have been discussing with them the findings from our study and the path forward and the requirements for approval of this product. Meanwhile, we have also been evaluating ifetroban in a clinical program in patients with systemic sclerosis, or scleroderma (SSc). Enrollment in this study was completed last year, and we look forward to announcing the top-line findings this year. In addition, we have a Phase II clinical study, the Fighting Fibrosis trial, in patients with idiopathic pulmonary fibrosis, the most common form of progressive fibrosing interstitial lung disease. Patient enrollment is well underway in medical centers across the U.S., and the study includes both an interim safety analysis and an interim efficacy analysis.
Today I am pleased to announce that the interim safety analysis was completed, where it evaluated the first cohort of patients completing 12 weeks of treatment. The independent committee concluded that there were no new safety signals identified and no changes in study conduct were necessary. Based on those findings, enrollment has continued, and we expect to announce next the interim efficacy results this year. We are also pleased with the publication of a manuscript which discussed the use of ifetroban to target platelet–tumor interactions to reduce metastases in triple-negative breast cancer. That publication came out last November. It was peer-reviewed, and it highlights the novel mechanism of ifetroban and its potential to address serious and difficult-to-treat conditions.
The manuscript was accepted and published in the Journal of Experimental Hematology & Oncology, and we believe this recognition helps strengthen the scientific foundation supporting ifetroban and contributes to broader awareness in the scientific and medical community as we continue to advance this development. There are additional pilot patient studies of ifetroban also underway through several investigator-initiated trials. Based on the results from the FIGHT DMD study that I mentioned, we have decided to now pursue ifetroban’s registration for the DMD-associated cardiomyopathy as our lead indication, as we plan to pursue the requirements and approval of the drug.
We also plan to continue our systemic sclerosis and pulmonary fibrosis programs that we believe can provide additional potential indications for this, our first new chemical entity. With that update on our clinical activities, I will now turn it over to our Chief Financial Officer, John Hamm, to review our financial results. John?
John Hamm: Thank you, AJ. For the three months ending December 31, 2025, net revenue from continuing operations was $13,700,000, which represented a $3,200,000, or 31%, increase over the prior-year period. Net revenue by product for 2025 included $3,100,000 for Kristalose, $3,300,000 for Sancuso, $2,800,000 for Vibativ, $900,000 for Caldolor, and $3,300,000 for Talicia. As a reminder, due to quarterly fluctuations in our customers’ purchases, we believe our performance should be assessed based on annual sales results. With that in mind, I am pleased to report that net revenues for the full year of 2025 were $44,500,000, a $6,700,000, or 18%, increase over the prior year.
Full-year product revenues totaled $10,500,000 for Kristalose, $11,900,000 for Sancuso, $9,400,000 for Vibativ, $4,700,000 for Caldolor, and $3,300,000 for Talicia. We also received a $3,000,000 milestone payment associated with the approval of Vibativ in the Chinese market. Turning to our expenditures, total operating expenses for the fourth quarter were $15,000,000, compared to $12,000,000 for the prior-year period. We did see an increase in operating expenses due to the higher royalties, cost of goods, and other items associated with the growth in product sales during the period. For the full year 2025, total operating expenses were $47,300,000 compared to $44,300,000 during the prior year.
The net loss was approximately $1,400,000 for the fourth quarter and $2,900,000 for the full year, both significantly improved over 2024. When noncash expenses are added back, the resulting adjusted earnings for the year were $1,700,000, or $0.11 a share. In addition, cash flow from operations was $4,900,000 in 2025. Also, please note that the adjusted earnings calculations do not include the additional benefit of the $200,000 of Vibativ cost of goods during the fourth quarter. Those goods were received as part of the product’s acquisition. We are pleased to see that the additions of Vibativ, Sancuso, and Talicia to our portfolio are providing a significant positive impact to our financial performance.
As a result of the Vibativ acquisition, a total of $34,000,000 in new assets were added, including approximately $21,000,000 in inventory, $12,000,000 of intangible assets, and $1,000,000 of goodwill. The estimated value of those assets was $10,000,000 at the end of 2025. The financial terms for the Vibativ transaction included a $20,000,000 payment upon closing and a subsequent $5,000,000 milestone payment. We also continue to provide royalties tied to product sales. Sancuso added a total of $19,000,000 in new assets, including approximately $4,000,000 in inventory and $14,000,000 of intangibles. The estimated value of those assets was $10,000,000 at the end of 2025.
We provided $13,500,000 at closing for the Sancuso acquisition, and we paid $1,500,000 in milestone payments, and there are ongoing royalties that we pay based on the brand’s sales. We have formed a new company with RedHill Biopharma named Talicia Holdings, Inc. RedHill has contributed the worldwide rights to Talicia and the product’s assets to the new company. Cumberland Pharmaceuticals Inc. invested $2,000,000 during 2025 and will provide another $2,000,000 later this year to participate in the new company’s joint ownership. As a result of this investment, Cumberland Pharmaceuticals Inc. owns 30% of the new THI and are accounting for this holding using the equity method.
Turning to our balance sheet, as of 12/31/2025, we had $76,800,000 in total assets, including $11,400,000 in cash and cash equivalents. Liabilities totaled $52,300,000, including $5,200,000 on our credit facility. Total shareholders’ equity was $24,900,000 at the end of 2025. We continue to hold a bank line of credit which provides up to $15,000,000 in capital. The interest rate is based on benchmark terms, and is subject to a financial covenant determined on a quarterly basis, and we were in compliance at the end of the fourth quarter. We also continued the process of implementing trading plans for our board members in 2025, who purchased Cumberland Pharmaceuticals Inc. shares throughout the year to increase their holdings in the company.
I would like to note that Cumberland Pharmaceuticals Inc. continues to hold over $54,000,000 in tax net operating loss carryforwards, primarily resulting from the prior exercise of stock options. That completes our financial report for the fourth quarter and full year 2025. Back to you, AJ.
A.J. Kazimi: Thank you, John. I am very pleased with Cumberland Pharmaceuticals Inc.’s performance in 2025. We delivered strong sales, strengthened our financial position, broadened our international presence, enhanced our commercial portfolio, and continued advancing our clinical programs. These achievements reflect the disciplined execution of our strategy and the growing impact of our products. We remain focused on delivering differentiated medicines that address meaningful patient needs. Meanwhile, we are advancing our development programs as we work towards bringing new treatment options to patients facing serious unmet conditions. These accomplishments would not be possible without the dedication and experience of our team, and we appreciate the continued support of our shareholders, our partners, and our other stakeholders.
As we look ahead, we are once again targeting double-digit revenue growth in 2026, driven by the continued performance of our in-line brands combined with the additional sales from the newest addition, Talicia, as well as our growing international business. We are also again targeting meaningful positive cash flow from operations. With that report, we will now open for questions. Operator, please proceed.
Operator: Thank you, sir. Ladies and gentlemen, that concludes the company’s presentation. We will now open the call for any questions. If you would like to ask a question, please press the star key on your phone followed by the digit one twice. That is star-one-one. Please stand by.
A.J. Kazimi: If there are no questions, I want to thank everybody for joining today’s call. We understand many of our shareholders prefer a private discussion with management. If so, please just reach out. We will be happy to get a call scheduled with you and hold such a discussion. As always, we appreciate your time and interest in our company, and we look forward to providing another update in the coming months.
