Cumberland Pharmaceuticals Inc.

Good afternoon and welcome to Cumberland Pharmaceutical 2025 Financial Report and Company Update. This call is being recorded at the company's request and will be archived on its website for one year from today's date. I'd like to turn it over to Emily Kent from Dalton Agency who handles Cumberland's communications. Emily, please proceed.

Thank you, everyone, and thank you for joining us today. This afternoon, Cumberland issued a press release announcing its annual and fourth quarter financial results. The release also provided an overall company update, including key developments during the year. The release, which includes the related financial tables, can be found on the company's website at www.cumberlandpharma.com. During today's call, management will share an overview of those financial results. and a company update, including a recent development and a discussion of Cumberland's brands, pipeline, and partners. Participating in today's call are A.J. Kazemi, Cumberland'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 Security 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'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'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 isn't 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'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'll turn the call over to Cumberland's Chief Executive Officer, A.J. Kazemi.

Thank you, Emily, and good afternoon, everyone. We do appreciate you joining us today. As Emily mentioned, we'll provide a review of both our fourth quarter and our full-year financial performance for 2025. We'll also share an overall company update and discuss several recent developments that continue to underscore our optimism about the company's future. Well, I'd like to start by stating that 2025 was an outstanding year for Cumberland. 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's begin with a review of our financial performance. Our portfolio of FDA-approved brands delivered combined revenues of $13.7 million during the fourth quarter of 2025, representing a 31% increase over the prior year period. For the full year, revenues totaled $44.5 million of 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 million to $1.7 million, or 11 cents a share. In addition, cash flow from operations improved by $5.5 million and we're just under $5 million 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 Vibative and Sancuso, along with the initial sales of our newest brand, Elysia, 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 million, further improving our financial position. And beyond our financial performance, we made significant progress expanding our global presence. In 2025, Vibative received regulatory approval in China, the world's second largest pharmaceutical market, creating a major new opportunity for the brand. Also in 2025, Vibative was successfully launched in Saudi Arabia, resulting in initial sales in 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. Tilesia 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 Caldilore. This important reimbursement milestone enhances product access, simplifies hospital billing, and further supports Caldilore'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 our Fitraban 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 then 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 DMT program. Overall, 2025 was a defining year for Cumberland. We grew our commercial business, advanced our development pipeline, expanded our global footprint, and strengthened our financial foundation. So with that overview and developments, I'd now like to turn to Todd Anthony, Cumberland's Vice President of Organizational Development, to further discuss both our brands and our organization. Todd?

Well, thank you, AJ. I'll start by sharing an update on each of our major brands. Vibative 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 multi-drug resistant. Unlike many antibiotics that are losing the ability to fight bacteria, Vibative'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. Recall that to reinforce this message, we are conducting a series of infectious insights. which are discussions with infectious disease experts that we're disseminating across the country. These video vignettes share the opportunity to use Vibative as a solution for select patient types where other products have failed. We also shared that a comprehensive pharmacokinetic analysis of Vibative 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 Vibative's critical role in treating life-threatening gram-positive infections. In 2025, we also announced the availability of the Vibative 4-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 Vibative's four vial configuration which supports flexible treatment initiation in both an inpatient and outpatient setting for this potentially life-saving therapy. Vibative was also added to a national group purchasing agreement with Premier Incorporated, an alliance of approximately 4,350 US 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 Crystallose, which is our prescription strength laxative provided in a convenient, pre-measured 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 Crystalose 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 in our implementing strategies to protect and grow this business. Let's 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's 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 post-operative pain in patients 60 years of age and older. The analysis, encompassing over 1,000 patients from our comprehensive post-surgical 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's review our newest product, Talicia, an FDA-approved and leading treatment for Helicobacter pylori infections. Provided in a single capsule that contains Omeprazole, Amoxicillin, and Rifabutin, Telicia 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 Incorporated. Through our co-commercialization agreement, we have assumed responsibility for the distribution and sale of Talicia in the U.S., and equally share Telicia's net revenues. We launched the promotion of Telicia at the beginning of the year, and our newest brand is supported by our field sales division that also details Crystalose. We now have a national sales and medical organization that includes 50 customer-facing individuals who feature our brands. Well, that completes my updates for today, so I'll turn it back to you, AJ.

Thank you, Todd. I'd 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 iFitraBand 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's 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 the 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 ifitroban, high-dose ifitroban, or placebo. High-dose ifitroban treatment resulted in a 3.3% improvement in the patient's 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 ifetriban were well tolerated with no serious drug related adverse offense seen in the study. And all subjects who completed the 12 month treatment period opted into an open label extension where they continue to receive ifitroban with long-term follow-up. As I mentioned, ifitroban previously received orphan drug designation and rare disease designation for DMD. I'm 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 two meeting with the FDA last fall and a follow-up meeting in January of this year. We've been discussing with them the findings from our study and the path forward and the requirements for approval of this product. Meanwhile, we've also been evaluating ifitroban 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'm 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 safety signals, 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're also pleased with the publication of a manuscript which discussed the use of ifitroban 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 ifitroban and its potential to address serious and difficult to treat conditions. The manuscript was accepted and published in the Journal of Experimental Hematology and Oncology And we believe this recognition helps strengthen the scientific foundation supporting ifitroban 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 ifitroban also underway through several investigator-initiated trials. And based on the results from the FITE-DMD study that I mentioned, We've decided to now pursue ifitriban'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. So with that update on our clinical activities, now I'd like to turn it over to our Chief Financial Officer, John Hamm, to review our financial results. John?

Thank you, AJ. For the three months ending December 31st, 2025 net revenue from continuing operations was $13.7 million, which represented a $3.2 million or 31% increase over the prior year period. Net revenue by product for the fourth quarter of 2025 included $3.1 million for Crystalos, $3.3 million for Sancuso, $2.8 million for Vibatav, $0.9 million for Caldolor, and $3.3 million for Tilesia. 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'm pleased to report that net revenues for the full year of 2025 were $44.5 million, a 6.7 million, or 18% increase over the prior year. Full year product revenues totaled $10.5 million for Crystalos, $11.9 million for San Cuso, $9.4 million for Vybatov, $4.7 million for Kaldalur, and $3.3 million for Tilesia. We also received a $3 million milestone payment associated with the approval of Vybatov to the Chinese market. Turning to our expenditures, total operating expenses for the fourth quarter were $15 million compared to $12 million 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 $47.3 million compared to $44.3 million during the prior year. The net loss was approximately $1.4 million for the fourth quarter and $2.9 million for the full year. both significantly improved over 2024. When non-cash expenses are added back, the resulting adjusted earnings for the year were $1.7 million or 11 cents a share. In addition, cash flow from operations was $4.9 million in 2025. Also, please note that the adjusted earnings calculations do not include the additional benefit of the $0.2 million of Vibative cost of goods during the fourth quarter. Those goods were received as part of the product's acquisition. We're pleased to see that the additions of Vibative, Sancuso, and Tilesia to our portfolio are providing a significant positive impact to our financial performance. As a result of the Vibative acquisition, a total of $34 million in new assets were added, including approximately $21 million in inventory, $12 million of intangible assets and $1 million of goodwill. The estimated value of those assets was $10 million at the end of 2025. The financial terms for the Vibato transaction included a $20 million payment upon closing and a subsequent $5 million milestone payment. We also continue to provide royalties tied to product sales. Sancuso added a total of $19 million in new assets including approximately $4 million in inventory and $14 million of intangibles. The estimated value of those assets was $10 million at the end of 2025. We provided $13.5 million at closing for the San Cuso acquisition, and we paid $1.5 million in milestone payments. And there are ongoing royalties that we pay based on the brand 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 invested $2 million during the fourth quarter of 2025 and will provide another $2 million later this year to participate in the new company's joint ownership. As a result of this investment, Cumberland owns 30% of the new THI and are accounting for this holding using the equity method. Turning to our balance sheet, as of December 31st, 2025, we had $76.8 million in total assets, including $11.4 million in cash and cash equivalents. Liabilities total, $52.3 million, including $5.2 million on our credit facility. Total shareholders' equity was $24.9 million at the end of 2025. We continue to hold a bank line of credit, which provides up to $15 million in capital. The interest rate is based on benchmark terms so far 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 continue the process of implementing trading plans for our board members in 2025 who purchased Cumberland shares throughout the year to increase their holdings in the company. I'd like to note that Cumberland continues to hold over $54 million in tax net operating loss carry-forwards, primarily resulting from the prior exercise of stock options. And that completes our financial report for the fourth quarter and full year 2025. Back to you, AJ.

Thank you, John. I'm very pleased with Cumberland'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're 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're 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, Talisia, as well as our growing international business. We're also again targeting meaningful positive cash flow from operations. So with that report, now let's open the call to any questions. Operator, please proceed.

Thank you, sir. Ladies and gentlemen, that concludes the company's presentation, and we will now open the call for any questions. If you'd like to ask a question, please press the star key on your phone, followed by the digit 1 twice. That's star 1 1. Please stand by.

Well, if there are no questions, I just want to thank everybody for joining today's call. We do understand many of our shareholders provide a private discussion with management, and if so, please just reach out, and we'll 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.

Thank you, sir. Ladies and gentlemen, that concludes today's call. If you would like to listen to a replay of the discussion, please visit the investor relations section on Competence website. I would like to thank you for your participation. You may now disconnect.