Earnings Labs

Cumberland Pharmaceuticals Inc. (CPIX)

Q3 2025 Earnings Call· Tue, Nov 4, 2025

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Transcript

Operator

Operator

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.

Emily Kent

Management

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.

A. Kazimi

Management

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…

Todd Anthony

Management

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. Kazimi

Management

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…

John Hamm

Management

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…

A. Kazimi

Management

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

Operator

[Operator Instructions]

A. Kazimi

Management

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.

Operator

Operator

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.