Cumberland Pharmaceuticals Inc. Aktie

Good afternoon, and welcome to Cumberland Pharmaceuticals' Second Quarter 2026 Company Update and Financial Report. The call is being recorded at the company's request and will be archived on its website for 1 year from today's date. I would now like to turn it over to Emily Kent, The Dalton Agency, who handles communications. Emily, please proceed.

Hello, everyone, and thank you for joining us today. This afternoon, Cumberland will issue a press release announcing its second quarter financial results. The release will provide an overall company update, including key developments during the quarter. The release, which includes the related financial tables, will 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 recent developments and a discussion of Cumberland's clinical pipeline. Participating in today's call are A.J. Kazimi, 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 Securities Litigation 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 Cumberland's new product candidates.

For more information, please visit the corporate website 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 financial tables of the earnings release that will be issued 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. Kazimi. A.J.?

Thank you, Emily, and good afternoon, everyone. We appreciate your joining us today as we review Cumberland's second quarter results and discuss one of the most significant milestones in our company's history. In June, our shareholders overwhelmingly approved the strategic transaction with Apotex, and on July 1st, we successfully closed the agreement to integrate our branded U.S. commercial businesses. This transformational transaction strengthened Cumberland's financial position, unlocked substantial value for our shareholders, and established a solid foundation for the company's next phase of growth.

I'd like to take this opportunity to thank our shareholders for their support throughout this process. Over 99% of the voting shareholders voted in favor of the transaction. Their approval affirmed our strategy and reflects confidence in Cumberland's future as an innovation-focused biopharmaceutical company. We're also delighted to recently announce and fund a special dividend to return capital to our shareholders. After the dividend, we've retained sufficient capital to fund operations for the long term while maintaining significant additional financial reserves for any special opportunities that may arise.

Our strong financial position will provide the foundation for executing our plans as we pivot to a focus on developing new medicines for the future. As a reminder, under the terms of the transaction with Apotex, they acquired our portfolio of FDA-approved commercial brands and related U.S. organization. Cumberland received $100 million in cash at closing, with an additional $11 million due for inventory and transition payments, along with a potential $10 million milestone payment.

Importantly, this transaction enables us to sharpen our strategic focus while maintaining the financial strength needed to advance our development programs. It also provides additional capital to invest in our clinical pipeline, pursue new opportunities, and continue to create overall value for our shareholders. Our commercial portfolio served as the foundation of Cumberland's business for many years and facilitated our developing innovative therapies for patients with serious unmet medical needs.

With the divestiture of our commercial brands, our strategy and focus now centers on advancing our ifetroban clinical programs, which target multiple diseases with significant medical needs and substantial commercial opportunities. We believe monetizing the value of our commercial portfolio was well-timed, as our clinical programs have made great strides, benefiting from years of scientific investment and clinical research. Several have now advanced to a point where they've generated very promising data, which has been highlighted in medical publications and in medical conferences.

Following our strategic transaction, we are now in a financial position to accelerate the funding for these clinical programs. And even if just 1 of our products in development goes on to receive FDA approval, that milestone has the potential to be a significant value creator for Cumberland. Now I'd like to turn it over to [ Todd Anthony ] for the clinical update. [ Todd ]?

Thank you, A.J. Well, as previously noted, our key development programs are based on our first new chemical entity, ifetroban. It's a potent and selective thromboxane receptor antagonist that has now been administered to approximately 1,400 subjects across multiple clinical studies, demonstrating a strong safety profile. We are evaluating ifetroban across several advanced clinical programs for patients with a series of unmet medical needs.

I'll begin with our Duchenne muscular dystrophy, or DMD, program. DMD is a rare fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart, and lung muscles. Our ifetroban product candidate is being developed specifically to preserve cardiac function and improve outcomes for patients living with DMD-associated cardiomyopathy. We previously announced positive top-line results from our completed Phase 2 FIGHT-DMD clinical trial, demonstrating encouraging safety and biomarker findings that support continued development of the program.

Earlier this year, the FDA granted Fast Track designation for ifetroban in DMD, recognizing both the seriousness of the disease and the significant unmet medical need that exists for these patients. This designation allows for more frequent FDA interaction, rolling data submissions, and earlier guidance throughout the approval process. The program has also previously received both Orphan Drug designation and Rare Pediatric Disease designation from the FDA, further reinforcing the importance of this development effort.

During the second quarter, new biomarker data from the FIGHT-DMD clinical study was presented at the Parent Project Muscular Dystrophy Annual Conference. Those findings provide additional evidence that the therapy can help preserve cardiac function in this patient population. You can review that presentation on our corporate website. We continue to hold discussions with the FDA regarding the regulatory pathway for this program with another meeting scheduled this fall as we remain focused on determining the most efficient path toward approval. We look forward to providing additional updates as those discussions progress.

Turning now to our systemic sclerosis, or SSc, program. We are also studying ifetroban in patients with systemic sclerosis, a rare autoimmune disease characterized by progressive fibrosis and vascular dysfunction that can affect multiple organs throughout the body. Patient enrollment in the study has been completed, and evaluation of the Phase 2 study data is underway with top-line results anticipated this year.

Our third advanced clinical program, FIGHT IPF, is evaluating ifetroban in patients with idiopathic pulmonary fibrosis, or IPF, the most common form of progressive fibrosing interstitial lung disease. The study's interim safety analysis was performed, evaluating the first cohort of patients completing 12 weeks of treatment. The independent committee concluded no new safety signals were identified and no changes in study conduct were needed. Based on those findings, patient enrollment in the study has continued and we will expect to announce interim efficacy results as the next milestone.

In addition to our company-sponsored clinical programs, we have collaborated with Vanderbilt Health to evaluate ifetroban for the prevention of cancer metastasis in patients with high-risk solid tumors. During the second quarter, we jointly announced positive results from their Phase 2 clinical trials. The study achieved its primary endpoint by demonstrating that ifetroban was safe and well tolerated in this patient population.

In addition, the trial generated encouraging efficacy signals, including fewer patients experiencing metastatic recurrence and fewer deaths related to metastasis in the ifetroban treatment arm when compared with placebos. We are pleased with the progress in this collaboration and look forward to working with our partners at Vanderbilt as we determine the next steps for this oncology program.

Next, I'd like to briefly discuss Cumberland Emerging Technologies, or CET. CET remains an important strategic asset for Cumberland and plays a valuable role in identifying, supporting, and advancing innovative biomedical technologies originating from leading research institutions. Through CET, we continue to collaborate with academic investigators, healthcare institutions, and emerging life sciences companies to help translate promising scientific discoveries into potential therapeutic products.

These activities complement our internal development efforts while expanding our access to innovative technologies that may strengthen Cumberland's pipeline and create additional opportunities for future growth. Overall, we believe our portfolio of clinical development programs combined with our financial strength positions Cumberland exceptionally well for the future. I'll turn it back over to you now, A.J.

Thanks, [ Todd ]. I'll next look to our Chief Financial Officer, John Hamm, for the financial update. John?

Thank you, A.J. I'll begin with a review of our financial results for the second quarter, followed by an update on the financial impact of our recently completed strategic transaction. During the second quarter, we reorganized our income statement to classify revenue and expenses associated with the Apotex transaction as discontinued operations. Our ongoing investment in research and development, supported by our remaining general administrative expenses, resulted in an operating loss of $3.1 million for the quarter.

With the addition of the discontinued operations, the net loss for the quarter was $4.1 million. As of June 30, 2026, Cumberland had total assets of $63 million, including approximately $4 million in cash and cash equivalents. Please note that we retired our bank line of credit through a payment of $5.2 million at the end of the second quarter. Therefore, total liabilities were reduced to $46 million, resulting in shareholders' equity of approximately $17 million at quarter end.

The successful completion of our strategic transaction with Apotex marks a significant change in the company's financial profile. The agreement closed on July 1st and therefore will further impact our financial statements in the third quarter. We received $100 million at closing and estimate the taxes associated with the transaction to be less than $1 million due to our tax loss carryforwards and R&D tax credits. The net proceeds along with the $11 million in additional funds due over the next 12 months will result in significant net proceeds from the transaction estimated at $111 million.

In July, our board met and evaluated alternatives for this new capital. They declared a special dividend of $1.50 per share, which totaled $22 million based on the approximately 15 million shares outstanding. We believe that our strengthened cash position provides Cumberland with the financial flexibility to advance our clinical development programs, evaluate additional strategic opportunities, and support the company's long-term growth initiatives. We project that the remaining cash will fund company operations for over 5 years as we continue to invest in our new product candidates.

We also currently estimate significant additional cash reserves of over $50 million should be available for unexpected expenses, or special opportunities that may arise. I'd also like to further discuss the accounting for the strategic transaction. Accordingly, our financial statements will differ meaningfully from prior periods as Cumberland transitions from a commercially oriented specialty pharmaceutical company to an innovation-focused biopharmaceutical company centered on product development.

We will no longer be recording the revenue from the commercial brands, nor the related expenses, which include cost of goods, sales, and marketing. As a reference, please note those expenses totaled nearly $32 million in 2025. It should be noted that future operating results will primarily reflect our investment in clinical development and regulatory activities supported by manufacturing and corporate administrative expenses and any future milestone or collaboration payments associated with our development programs. We expect the transaction to significantly strengthen our balance sheet, simplifying our ongoing operating structure.

Looking ahead, Cumberland enters this next phase from a position of considerable financial strength. The proceeds from the transaction provide the resources necessary to advance our clinical pipeline while we maintain disciplined financial management. Financial priorities remain clear. First, we're clearly funding the investment of our development program. Second, maintaining a strong balance sheet and preserving financial flexibility. And third, continuing to maintain significant financial reserves for opportunities that can enhance shareholder value.

Going forward, investors should increasingly evaluate Cumberland based on the advancement of our clinical pipeline, execution against key development milestones, and the management of the company's capital resources. Overall, we believe Cumberland is exceptionally well-positioned to execute on its strategy and create long-term value for shareholders. With that, I'll turn the call back over to you, A.J.

Thank you, John. Well, as you heard today, the successful completion of our strategic transaction marks a defining moment in Cumberland's evolution. With the completion of the transaction, we've sharpened our strategic focus, strengthened our financial position, and assembled an advanced clinical pipeline targeting serious diseases with significant unmet medical needs, with important multiple clinical milestones anticipated during the remainder of 2026.

We believe we're entering one of the most exciting periods in our company's history. For our Duchenne muscular dystrophy program, we'll continue our discussions with the FDA as we define the regulatory pathway forward. For our systemic sclerosis program, we're completing the final analysis of our study data and look forward to announcing top-line results this year. Patient enrollment in our idiopathic pulmonary fibrosis study is progressing very well, and we remain on track to report interim efficacy findings this year.

In addition, we'll continue evaluating opportunities to advance our oncology collaboration with Vanderbilt Health following the encouraging results from the recently completed metastases prevention study. These milestones represent opportunities to advance our development programs while continuing to build value for patients and shareholders alike. Importantly, we now have the financial resources, organizational focus, and experienced development team necessary to execute the strategy.

We're working to bring differentiated therapies to patients with rare diseases and other serious medical conditions where treatment options remain limited. Before concluding, I'd just like to once again thank our employees for their dedication throughout this transformational year. Their hard work has made a successful completion of our strategic transaction possible, while ensuring continued progress across each of our development programs.

I'd also like to thank our Board of Directors and shareholders for their continued confidence and support. We appreciate the trust you've placed in Cumberland as we begin our next chapter. We're excited about the opportunities that lie ahead and look forward to updating you on our continued progress. Thank you again for joining us today. And so with that, operator, let's now open the call for questions.

Ladies and gentlemen, that concludes the company's presentation, and we will now open the call for any questions. [Operator Instructions] Please stand by while we compile our Q&A roster.

Well, there are no questions. I just want to thank everybody for joining us for today's call. And we do understand many of our shareholders prefer a private discussion with management. If so, please just reach out and we'll be happy to get such a call scheduled and have 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, the investor relations section on Cumberland's website. I would like to thank you for your participation. You may now disconnect.

Good afternoon, and welcome to the Cumberland Pharmaceuticals First Quarter 2026 Financial Report and Company Update. This call is being recorded at the company's request and will be archived on its website for 1 year from today's date.

I would now like to turn it over to Emily Kent from the Dalton Agency, who handles Cumberland's Communications. Emily, please proceed.

Hello, everyone, and thank you for joining us today. This afternoon, Cumberland issued a press release announcing its first quarter financial results. The release also provided an overall company update, including key developments during the quarter. 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 recent developments and a discussion of Cumberland's brands, pipeline and partners.

Participating in today's call are A.J. Kazimi, 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 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'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 any -- 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 financial 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. Kazimi.

Well, thank you, Emily, and good afternoon, everyone. We appreciate you joining us today. As Emily mentioned, we'll provide a review of our financial results for the first quarter of 2026. We'll discuss key developments during the period, but we'll also share recent updates.

Recall that Cumberland enjoyed an outstanding year in 2025 with double-digit growth in sales, significant cash flow from operations, the addition of a new brand to our portfolio, new international product approvals and breakthrough clinical study results. I believe those were certainly terrific findings, and I'd like to congratulate our team that is responsible for delivering that performance.

We're pleased to report continued momentum in 2026 as we're off to an excellent start with FDA approval for expanded Caldolor labeling, initiation of our sales promotional efforts in support of Talicia, the first shipment of Vibativ to China and FDA clearance of the manufacturing facility, which will enable the relaunch of Vaprisol. We've also entered into a transformational agreement that positions Cumberland for the next phase of our company's evolution and growth. Today, I'm delighted to discuss that agreement, which we've entered into with Apotex, the largest Canadian-based pharmaceutical company, to integrate our branded U.S. commercial businesses.

Under the terms of the agreement, Apotex will acquire our portfolio of marketed products for cash consideration of $100 million, subject to our shareholders' approval. Cumberland will also receive $9 million in payments for inventory, fees for transitional support services and a milestone payment tied to future product sales. This transaction represents a significant event for Cumberland as it unlocks substantial near-term value for our shareholders. Moreover, our hope and our expectation is that even more patients will benefit from the array of our marketed products given Apotex' larger market presence.

It's important to note that with the tax basis associated with the assets involved, combined with the tax loss carryforwards, we are estimating the income taxes resulting from the transaction will be modest. As a result, the net consideration will significantly strengthen our balance sheet. Following the close of the transaction, we intend to focus on advancing our robust pipeline of product candidates to address unmet medical needs, which, if successful, can greatly benefit patients and shareholders alike. That strategic shift will position Cumberland as an innovation-driven organization, developing new medicines for the future.

Overall, we believe this transaction is very beneficial on several fronts. It unlocks the near-term value of our branded products. It considerably strengthens our balance sheet. It sharpens our strategic focus on developing new products that represent large market opportunities and it enhances our ability to create and deliver additional value for our shareholders. It also creates a branded business platform with more critical mass that Apotex can build upon to broaden the distribution of our brands and deliver them to more patients. In short, we're confident in the direction of the company and in our ability to execute on this new strategy.

So with that, I'll now turn the call over to Todd Anthony, Vice President, Organizational Development. Todd?

Well, thank you, A.J. In February, we hosted our spring National Sales meeting in Nashville and in attendance were the 50 individuals across the country who interact with our medical community in support of our FDA-approved products through our 3 national sales divisions, our hospital sales division, which calls on key institutional accounts across the country, our field sales division that covers select office-based physicians and our Cumberland Oncology division, which calls on cancer patients.

I'd now like to share our first quarter brand updates. Let's start with Caldolor, our intravenous ibuprofen product. In April, we announced approval from the FDA for an expanded indication for Caldolor. The indication now includes the management of postoperative pain. This approval enhances the clinical utility of Caldolor and supports its role in non-opioid and opioid-sparing pain management strategies. With this update, Caldolor is indicated for use in adult and pediatric patients ages 3 months and older for the treatment of pain and fever. This expanded labeling further broadens Caldolor's use across perioperative and acute care settings.

Additionally, we resubmitted our application to CMS for Caldolor's inclusion under the NOPAIN Act in the first quarter. This program is designed to support the use of non-opioid pain management therapies.

Now let's turn to Sancuso, our transdermal patch FDA approved for the management of chemotherapy-induced nausea and vomiting. During the first quarter, we announced the launch of the new Sancuso website, which is designed to provide health care professionals and patients with enhanced access to educational resources, clinical information and expert insights related to the prevention of chemotherapy-induced nausea and vomiting.

Next, I'd like to share an update for Talicia, an FDA-approved leading treatment for Helicobacter pylori infection. In February, we announced the launch of our national sales promotion for Talicia under our co-commercialization agreement with Talicia Holdings, Inc., which we jointly own. As a reminder, under that agreement, we assumed responsibility for the distribution and sales promotion of the brand in the United States. As part of the launch, we leveraged our existing field sales division with supporting marketing initiatives designed to increase awareness among gastroenterologists and other prescribers.

Finally, recall, we have been awaiting FDA clearance of the site where we have successfully transferred the manufacturing of Vaprisol. Today, I am pleased to announce that the FDA has just reinstated their approval status for that facility, which will enable us to submit for manufacture of Vaprisol there. With approval for our submission, we will then arrange for commercial supplies to support the relaunch of the brand, which is expected this year. That completes my updates for today.

I'll turn it over now to our Chief Financial Officer, John Hamm, to review our financial results. John?

Thanks, Todd. During the first quarter, our portfolio of FDA-approved brands delivered combined revenue of $9.1 million, which represented a 5% increase after removing the onetime $3 million milestone payment last year associated with the approval of Vibativ in China. Net revenue by product for the first quarter of 2026 included $1 million for Kristalose, $2.9 million for Sancuso, $2.1 million for Vibativ, $1 million for Caldolor and $1.9 million for Talicia.

Turning to our expenditures. Total operating expenses for the first quarter were $12.3 million, resulting in a net loss of approximately $3.3 million for the first quarter. When noncash expenses are added back, the resulting adjusted loss for the first quarter was $1.9 million or $0.13 a share. We're pleased to see that our most recent acquisitions resulting in additions of Vibativ, Sancuso and Talicia to our portfolio have provided a significant positive impact on our financial performance. Note that the shipments for individual brands fluctuate from quarter-to-quarter based on customer buying patterns, which include the timing of international orders.

There is also some seasonality to our business with orders being strongest in the fourth quarter and traditionally lightest in the first quarter. Therefore, we believe our sales performance is best evaluated on an annual basis. Meanwhile, we did continue to achieve our goal of generating positive cash flow from operations, which totaled $387,000 during the first quarter. As a reminder, we participated in the formation of a new company named Talicia Holdings, Inc., which holds the worldwide rights to the Talicia brand and its related product assets. Cumberland invested $4 million in exchange for a 30% ownership position in the new company. We are accounting for this holding using the equity method.

Turning to our balance sheet. As of March 31, 2026, we had $71 million in total assets, including $11 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5 million on our credit facility. Total shareholders' equity was $21.6 million at the end of the first quarter. As A.J. mentioned, we have signed an agreement to enter into a strategic transaction. In exchange for the assets associated with our portfolio of commercial products, we expect to receive $100 million cash at closing. We will also receive $9 million in payments for our commercial product inventory and a milestone payment.

Cumberland will support the transition of the products for a monthly fee associated with the transition services agreement. I'd like to note that Cumberland continues to hold over $53 million in tax net operating loss carryforwards, primarily resulting from the prior exercise of stock options. The assets involved in our pending strategic transaction have a tax basis of $30 million. We, therefore, believe that the income taxes resulting from the transaction will be modest.

Finally, given the announced strategic transaction, we are no longer targeting a goal of double-digit revenue growth for the year. However, our expenses will be significantly decreased after closing as Apotex will assume responsibility for the sales, marketing, medical, manufacturing and FDA fees associated with the brands. I would also point out at this time that we do not see any significant change to our current clinical spending levels for 2026 as we continue to advance our line of product candidates, which are in the advanced stages of development. And that completes our financial report for the first quarter of 2026.

Back to you, A.J.

Thank you, John. Following the close of the strategic transaction, Cumberland will be an innovation-driven development-focused company. We'll continue to progress our valuable pipeline of new product candidates designed to improve patient care and their quality of life. Our ifetroban new chemical entity, which is a potent and selective thromboxane receptor antagonist, is being evaluated in several advanced 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.

We previously announced positive top line results from our completed Phase II study in patients with Duchenne muscular dystrophy, a rare fatal genetic neuromuscular disease that results in deterioration of the skeletal, lung, and heart muscles. During the first quarter, the FDA granted Fast Track designation for our ifetroban candidate in these DMD patients. This designation is intended to accelerate the development and review of therapies addressing serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process.

The program also previously received both orphan drug and rare pediatric disease designations from the FDA. An end of Phase II meeting was held with the FDA last fall, and we had a follow-up meeting during the first quarter of 2026 to discuss both the DMD study results and to determine the regulatory pathway and requirements for approval. We're finalizing our plans for this important program now. And once completed, we'll announce additional results and expected time lines.

Meanwhile, we've also been evaluating our ifetroban product candidate in a clinical program in patients with systemic sclerosis or scleroderma. Enrollment in that study has been completed, and we look forward to announcing top line findings, which will be forthcoming. 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 in that study is well underway in centers across the United States.

An interim safety analysis was conducted evaluating the first cohort of patients who completed their 12 weeks of treatment. The independent committee concluded there were no new safety signals and therefore, no changes in the study conduct were needed. Based on those findings, enrollment in the study has continued, and we next expect to announce interim efficacy results later this year. Additional pilot patient studies of ifetroban are also underway through several investigator-initiated trials.

So in summary, our clinical programs are focused on select patient populations, helping to address unmet medical needs in markets that are very large from a commercial perspective for a company our size. And as we look ahead, we'll work to close our strategic transaction, support the transition of our commercial operations and sharpen our focus on advancing our exciting pipeline of new product candidates. And lastly, I'd just like to extend my sincere thanks and appreciation to all of those at Cumberland for their unwavering dedication towards the patients we aim to serve every day. We're confident in the direction of the company, our future prospects and in our ability to execute on our strategy.

Thank you again for your continued support and interest in Cumberland. And with that, we can open the call for any questions. Operator, please proceed.

[Operator Instructions] Our first question comes from [ Alyssa Nye ] from [ IQ Solutions ].

Operator, are there other questions?

Our next question is [ Brandon Bishop ].

Operator, there appears to be difficulties with the questions. There is also an echo.

Well, since we're having difficulty hearing the questions, it's very unfortunate. But I suppose what we can do is if you would like a follow-up conversation, please reach out to the company, and we're happy to schedule a call with you and to answer your questions. Meanwhile, I just want to thank everybody for joining us on today's call, and we look forward to providing another update in the coming months. Operator?

We have someone coming to fix the situation right now if we want to hold for just one second.

No, that's okay. We will hold any questions. You can reach out to the company, make sure that we can get those questions answered.

I apologize. I have jumped into the queue. If you'd like, I can go over the Q&A instructions again, and I will open the line for anyone that's got into the queue.

That's okay. We will take our questions privately, if you don't mind.

Okay. Absolutely. I apologize for the inconvenience. Thank you. And this does conclude today's conference. You may now disconnect.

Good afternoon, and welcome to Cumberland Pharmaceuticals 2025 Financial Report and Company Update. This call is being recorded at the company's request and will be archived on its website for 1 year from today's date.

I'd now like to turn it over to Emily Kent from Dalton Agency, who handles Cumberland 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 updates, including a recent development and a discussion of Cumberland's brands, pipeline and partners.

Participating in today's call are A.J. Kazimi, 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 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'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. Kazimi.

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 improved 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, 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 million to $1.7 million or $0.11 a share.

In addition, Cash flow from operations improved by $5.5 million and were just under $5 million for the full year. Its financial performance reflects strong execution across our commercial organization with growing demand for our products. It was led by dramatic growth for Vibativ and Sanucuso, along with the initial sales of our newest brand, [ Alecia ], 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, 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 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 [ helicobacterylori ] infections, expanding our presence in gastrointestinal care. Talicia complements our existing portfolio, it represents an excellent strategic fit, leveraging our established commercial infrastructure. Meanwhile, the Centers for Medicare and Medicaid Services were CMS issued a J-code for Caldolor. This important reimbursement milestone enhances product access, simplifies hospital billing and further supports Caldolor 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 continue to advance our clinical pipeline in 2025, highlighted by great results from our FIGHT DMD clinical study. That trial evaluated our IB -- our [indiscernible] 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 DMD program. Over all 2025 was a defining year for Cumberland. We grew our commercial business, advanced our development pipeline, expanded our global footprint and strengthen our financial foundation.

So with that overview and development, I'd now like to turn to Todd Anthony, Cumberland's Vice President Organizational Development to further discuss both our brands and our organization. Todd?

Well, thank you, A.J. I'll 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 specifically designed to address drug-resistant bacteria. We therefore believe it has lifesaving potential to help many patients of 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 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 in chemotherapy. The analysis utilized data from over 1,200 patients across very demographics and comorbidity profiles. The finding 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 4-vial starter pack for a new supply arrangement with [ Vizient ], making it accessible to their health care members nationwide. As the country's largest provider-driven health care 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 4 vial configuration, which supports flexible treatment initiation in both an inpatient and outpatient setting for this potentially life-saving 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 health care 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 laxative provided in a convenient, premeasured powdered dose that dissolves quickly in just 4 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'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 and 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 postoperative 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 Sanucuso. 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 Sanucuso 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 [indiscernible] Talicia is now recommended as a first-line therapy for a 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 3 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.

Well that completes my updates for today. So I'll turn it back to you A. J.

Well, 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 [ 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'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 had announced positive top line results from our completed Phase II study in patients with the cardiobyopathy 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 fitrobane 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 ifetroban were well tolerated with no serious drug-related adverse fens seen in the study. At all subjects who completed the 12-month treatment period opted into an open-label extension where they continue to receive ifetroban with long-term follow-up. As I mentioned, ifetroban 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 II 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 ifetroban in a clinical program in patients with systemic sclerosis or [ scleroderma ], SSC. We -- 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 were 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 where 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 ifetroban to target platelet tumor interactions to reduce metastasis 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 and Oncology, and we believe this recognition helps strengthen the scientific foundation supporting ifetroban and contributes to broader awareness in a scientific and medical community as we continue to advance this development. There are additional patient -- pilot patient studies of ifetroban also underway through several investigator-initiated trials.

And based on the results from the FIGHT DMD study that I mentioned, we've 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.

So with that update on our clinical activities, and I'd like to turn it over to our Chief Financial Officer, John Hamm, to review our financial results. John?

Thank you, A.J. For the 3 months ending December 31, 2025, net revenue from continuing operations was $13.7 million, which represented a $3.2 million or a 31% increase over the prior year period. Net revenue by product for the fourth quarter of 2025 included $3.1 million for Kristalose, $3.3 million for Sanucuso, $2.8 million for Vibativ, $0.9 million for Caldolor and $3.3 million 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'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 Kristalose, $11.9 million for Sanucuso, $9.4 million for Vibativ, 4.7 million for Caldolor and $3.3 million for Talicia. We also received a $3 million milestone payment associated with the approval of Vibativ for 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 noncash expenses are added back, the resulting adjusted earnings for the year were $1.7 million or $0.11 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 Vibativ cost of goods during the fourth quarter. Those goods were received as part of the products acquisition. We're pleased to see that the additions of Vibativ, Sanucuso and Talicia to our portfolio are providing a significant positive impact our financial performance as a result of the Vibativ 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 goodwill. The estimated value of those assets was $10 million at the end of 2025. The financial terms for the Vibativ 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. Sanucuso 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 Sanucuso 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 to worldwide rights to Talicia and the products 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 31, 2025, we had $76.8 million in total assets, including $11.4 million in cash and cash equivalents. Liabilities totaled $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 [ SOFR ] and is subject to a financial covenant determined on a quarterly basis. And we [indiscernible] 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 holding in the company. I'd like to note that Cumberland continues to hold over $54 million in tax net operating loss carryforwards, 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, A.J.

Thank you, John. I'm very pleased with Cumberland's performance in 2025. We delivered strong sales, strengthened our financial position, broaden 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, Talicia, 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.

[Operator Instructions].

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 Cumberland website. I would like to thank you for your participation. You may now disconnect.

Good afternoon, and welcome to Cumberland Pharmaceuticals Third Quarter 2025 Financial Report and Company Update. This call is being recorded at the company's request and will be archived on its website for 1 year from today's date.

I would now like to turn it over to Emily Kent from the Dalton Agency, who handles Cumberland's Communications. Emily, please proceed.

Hello, everyone, and thank you for joining us today. This afternoon, Cumberland issued a press release announcing its third quarter financial results. The release also provided an operational update, including key developments during the quarter. 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. They'll also provide an overall company update, including recent developments, along with the discussion of Cumberland's brands, pipeline and partners.

Participating in today's call are A.J. Kazimi, Cumberland's Chief Executive Officer; along with 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'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 any -- 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 the 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 financial tables of the earnings release noted earlier. If you have any questions, please hold them until the end of the call at which point, we'll 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. Kazimi.

Thank you, Emily. Good afternoon, everyone. We appreciate you joining us today. As Emily mentioned during the call, we'll provide a review of our financial results for the third quarter this year and we'll also cover key operational developments that occurred during that period.

In addition, we'll discuss several recent updates that continue to underscore our optimism about the company's future. So let's get started. Today, I'm very pleased to announce a new addition to our commercial product portfolio. We've entered into arrangements with RedHill Biopharma to jointly commercialize Talicia which is an FDA-approved and leading treatment for helicobacter pylori infections, provided in a single capsule that contains Omeprazil, amoxicillin and rifabutin, Talicia is now recommended as a first-line therapy for aged pylori infections in the American College of Gastroenterology clinical guidelines.

The product is patent protected through 2042 and also received 8 years of U.S. market exclusivity under its qualified infectious disease product designation. We believe Talicia is an excellent strategic fit for our company. It was FDA-approved based on two large successful clinical studies, and it features an outstanding safety -- excuse me, an outstanding profile of the three 3 key advantages: a high eradication rate exceeding 90%, the convenience of an all-in-one capsule containing three medicines and minimal antibiotic resistance.

We formed a new company with RedHill called Talicia Holdings, Inc., and RedHill has contributed to worldwide rights to Talicia, as well as the product assets to the new company. Cumberland will invest $2 million this year and $2 million next to participate in the new company's joint ownership. Through a joint commercialization agreement, we'll assume responsibility for the distribution and sale of Talicia in the U.S. and will equally share Talicia's net revenues.

In 2024, net sales of Talicia totaled $8 million. Cumberland will also assume responsibility for product promotion through our field sales division, which currently details Kristalose, another gastroetrology product. And we'll provide an annual investment of up to $2 million to cover certain distribution, marketing and sales costs associated with the brand.

Meanwhile, during the third quarter, we announced international developments, including the launch of our Vibativ product in Saudi Arabia. The launch follows an agreement with to book pharmaceutical manufacturing company, to introduce Vibativ into the Middle East. To book had obtained the final approvals needed to commercialize Vibativ in Saudi Arabia, and we're pleased the product is now available for patients in that market.

In October, we announced the regulatory approval of our ibuprofen injection product in Mexico. We worked to secure that approval through our partnership with PiSA Pharmaceutical a well-established Mexican pharma firm. Under the terms of the agreement, PiSA is responsible for both the registration and commercialization of the product in their country, while we provide regulatory support and the product supply.

Additionally, we previously shared that our antibiotic batter received approval from the regulatory authorities in China earlier this year. That milestone provides us with access to the world's second largest pharma market, and we're now preparing to support the launch of Vibativ there. Here in the U.S., we announced the availability of our Vibativ starter pack through a new supply arrangement with Vizient, making it accessible to their health care members nationwide. And we also announced that Vibativ was added to a national purchasing agreement with Premier Inc.

Meanwhile, we've continued to progress our Phase II clinical programs evaluating our ifetroban product candidate in patients with Duchenne muscular dystrophy, systemic sclerosis and an idiopathic pulmonary fibrosis.

Turning to the third quarter financial results. Our portfolio of FDA-approved brands delivered combined revenues of $8.3 million during the quarter. Year-to-date revenues for the first 9 months of the year totaled $30.9 million, while third quarter sales were impacted by a delay in some Kristalose and Caldolor shipments our year-to-date revenue has grown 12% over the same period last year.

Furthermore, as a reminder, the fourth quarter is often our strongest as customers tend to increase their product purchases towards the end of the year. And therefore, we continue to believe our financial performance is best evaluated on an annual basis. The adjusted loss for the third quarter was $0.8 million or $0.06 a share, and our year-to-date adjusted earnings were $1.9 million or $0.13 a share.

In addition, our business continued to generate positive cash flow from operations, which increased to nearly $5 million through this year through September. At the end of the third quarter, we held $66 million in total assets, including $15 million in cash. Liabilities totaled $40 million and shareholders' equity was $26 million at the end of the third quarter. And please note that our total debt has been reduced by $10 million since the end of 2024.

With those developments and overview, I'd now like to turn to Todd Anthony, Cumberland's Vice President Organizational Development to further discuss both our brands and our sales organization. Todd?

Well, thank you, A.J. I'll 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 battle to fight bacteria, Vibativ's unique dual method of action was specifically designed to address these drug-resistant bacteria. We, therefore, believe it has lifesaving potential to help many patients amid this growing antibiotic resistance crisis, which faces a very fragile pipeline of new antibiotic development.

Recall that to reinforce the message, we are conducting a series of infectious insights. These 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.

In June, a comprehensive new pharmacokinetic analysis of Vibativ was published in antimicrobial agents and chemotherapy. The analysis utilizes 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, which reinforces Vibativ's critical role in treating life-threatening gram-positive infections.

We recently announced the availability of the Vibativ 4-Vial Starter Pak through a new supply arrangement with Vizient, making it accessible to their health care members nationwide. As the country's largest provider-driven health care 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 now have access to Vibativ's new 4-vial configuration, which supports flexible treatment initiation in both inpatient and outpatient settings, again, for this life potentially life-saving 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 health care system. The product's addition provides Premier's members with a cost-effective solution to treat resistant gram-positive infections.

Moving next to Kristalose, which is our prescription strength laxative provided in a convenient premeasured powder dose that dissolves quickly in just 4 ounces of water, resulting in a clear taste-free and grid-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 implementing strategies to protect and grow our business.

Let's shift now to Caldolor, our intravenous ibuprofen product. With its new pediatric labeling cleared with the FDA, Caldolor is now 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 growing use of the product in our country's children's hospitals.

We previously 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. This analysis encompassing over 1,000 patients from our comprehensive post-surgical studies represents the first such evaluation in this vulnerable population where traditional pain management options such as opioids, carry increased risk.

Turning to Sancuso, our transdermal patch FDA approved for the management of chemotherapy-induced nausea and vomiting. We continue to see favorable sales results following the expansion of our oncology sales force. 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.

Recall, our Vaprisol product is the only intravenously administered vasopressin receptor antagonist. It's used to raise serum sodium levels in hospitalized patients with hyponatremia, which is the most common electrolyte disorder among these patients. Our new manufacturing and distribution partner for Vaprisol has successfully begun producing the product in their facility and are now awaiting FDA's GMP certification for this site. Once they receive regulatory clearance we will file for approval to manufacture branded Vaprisol there.

Well, that completes my updates for today. And so I'll turn it back to you, A.J.

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 ifetroban product candidate just a potent and selective thromboxane receptor antagonist is being evaluated in several clinical programs for patients with a series of unmet medical needs.

Ifetroban 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. Earlier this year, we announced positive top line results from our FIGHT DMD trial. The study evaluated ifetroban as a therapy for Duchenne muscular dystrophy and its heart disease, which is the leading cause of death in DMD patients.

The study and its results mark a breakthrough for these patients, as is the first successful study, specifically targeting the cardiac complications of their disease. The trial enrolled 41 DMD patients who received either a low dose of ifetroban, a high dose of ifetroban or a placebo.

The study's primary efficacy end point was an improvement in the heart left ventricular injection fraction or LVEF and key findings associated with the patient's LVEF included high-dose ifetroban treatment resulted in an overall 3.3% improvement and the high-dose ifetroban showed an increase of 1.8%, while the placebo group showed the expected decline of 1.5%. And when those are combined, you get the 3.3% overall improvement I mentioned.

Now when compared with propensity matched natural history controls, the difference was even more pronounced, with the high-dose treatment providing a significant 5.4% overall improvement as the control patients experienced a 3.6% decline. And both doses of ifetroban were well tolerated with no serious drug-related events.

These top line FIGHT DMD study findings were selected for a late-breaking presentation at the Muscular Dystrophy Association Clinical and Scientific Conference in March and were then presented at the Parent Project Muscular Dystrophy Annual Conference in June. We completed the comprehensive analysis of the study results.

We've prepared our clinical study report and then we submitted it to the FDA along with a request for an end of Phase II meeting. We held that meeting in September, and we began interaction with the FDA to determine their remaining development requirements. The FDA recommended a follow-on meeting, which we are now planning is the next step in that process.

Meanwhile, we've been evaluating our ifetroban product candidate, in a clinical program in patients with systemic sclerosis or scleroderma. Enrollment in the study was completed this year, and we've been monitoring the clinical study sites in preparation to lock the database and begin evaluating the study results and we look forward to announcing those findings from this study.

In addition, we have a Phase II clinical study, the finding fibrosis trial underway in patients with idiopathic pulmonary fibrosis, the most common form of progressive fibrosing interstitial lung disease. Patient enrollment in that study is moving rapidly. It's well underway and medical centers across the country. The study design includes both an interim safety analysis as well as an interim efficacy analysis, and we'll look forward to reporting on both of those findings.

Additional pilot studies of ifetroban are also underway through several investigator-initiated trials and following completion of our ongoing studies and with the FDA feedback will then determine the optimal regulatory pathway for development of ifetroban, our first new chemical entity.

So with that update on our clinical activities, I'd now like to turn it over to our Chief Financial Officer, John Hamm, to review our third quarter financial results. John?

Thank you, A.J. For the 3 months ending September 30, 2025, net revenue from continuing operations was $8.3 million. Revenue for the first 9 months of the year totaled $30.9 million. Net revenue by product for the third quarter of 2025 included a $1.2 million for Kristalose, $3.2 million for Sancuso, $2.6 million for Vibativ and $0.9 million for Caldolor. Year-to-date, product revenues totaled $7.4 million for Kristalose, $8.6 million for Sancuso, $6.7 million for Vibativ and $3.8 million for Caldolor.

Turning to our expenditures. Total operating expenses for the third quarter were $10.3 million. Year-to-date expenses totaled $32.3 million, the net loss for the quarter was $1.9 million. Year-to-date net income loss was $1.4 million, and when noncash expenses are added back, the resulted adjusting earnings for the first 9 months of 2025 or $1.9 million or $0.13 a share. Cash flow from operations during 2025 was $5 million.

Also, please note that the adjusted earnings calculations do not include the additional benefit of the $0.1 million of Vibativ cost of goods during the third quarter. Those goods were received as part of the Products acquisition. We're pleased to see that the additions of Vibativ and Sancuso to our portfolio continue to positively impact our financial performance.

As a result of the Vibativ 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 for those assets was $10 million at the end of the third quarter. The financial terms for the Vibativ 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, $12 million of intangibles. The estimated value of those assets was $9.5 million at the end of the third quarter. We provided $13.5 million at closing for the Sancuso acquisition, and we paid $1.5 million in milestone payments. There are ongoing royalties that we pay based on the brand sales.

Turning to our balance sheet as of September 30, 2025, we had $66 million in total assets, including $15.2 million in cash and cash equivalents. Liabilities totaled $40 million including $5 million on our credit facility. Total shareholders' equity was $26 million at the end of the quarter. We continue to hold a bank line of credit, which provides up to $20 million in capital.

The interest rate is based on benchmark term SOFR and is subject to a financial covenant determined on a quarterly basis, and we were in compliance at the end of the third quarter. We are also continuing the process of implementing new trading plans for our Board members who are purchasing Cumberland shares throughout the year to increase their holdings in the company.

Lastly, I'd like to note that Cumberland continues to hold over $53 million in tax net operating loss carryforwards, primarily resulting from the prior exercise of stock options.

And that completes our financial report for the third quarter of 2025. Back to you, A.J.

Thank you, John. Well, overall, it's been a successful year-to-date, and we're encouraged by our progress. The addition of a new product marks an exciting next phase of growth for our company. We remain dedicated to our mission of working together to provide unique products that improve the quality of patient care. And we pursued our mission by building a portfolio of FDA-approved brands with the outstanding safety and efficacy profiles that can make a difference in patients' lives.

We continue to support our product portfolio through our three dedicated sales divisions, each focused on strategic segments of the health care market. And we're encouraged by the progress of our ifetroban clinical programs as we continue to progress, as we continue to pursue therapeutic solutions unmet medical needs.

Looking ahead, we expect continued momentum across our approved brands, increased international contributions, further progress in our clinical pipeline and new opportunities to select product additions. We have a lean, highly productive organization and the achievements outlined today were made possible by the dedication and fine efforts of our outstanding team, and we look forward to providing updates on further developments as the year progresses.

Now let's open the call to any questions. Operator, please proceed.

[Operator Instructions]

Well, if there are no questions, I'd just like to thank everybody for joining us for today's call. We understand that many of our shareholders prefer 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 look forward to providing updates 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 Cumberland's website. I would now like to thank you for your participation. You may now disconnect.