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11/4/2025
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 one 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 a discussion of Cumberland's brands, pipeline, and partners. Participating in today's call are AJ Kazemi, 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 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. Kazemi.
Thank you, Emily. Good afternoon, everyone. We appreciate your 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 Telicia, which is an FDA-approved and leading treatment for Helicobacter pylori infections. Provided in a single capsule that contains Omeprazole, Amoxicillin, and Rifabutin, Telicia is now recommended as a first-line therapy for H. pylori infections in the American College of Gastroenterology's clinical guidelines. The product is patent protected through 2042 and also received eight years of U.S. market exclusivity under its qualified infectious disease product designation. We believe Telicia is an excellent strategic fit for our company. It was FDA approved based on two large successful clinical studies And it features an outstanding profile with three 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 Tilesia Holdings, Inc. and Redhill has contributed the worldwide rights to Tilesia 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 Tilesia in the U.S. and will equally share Tilesia's net revenues. In 2024, net sales of Tilesia totaled $8 million. Cumberland will also assume responsibility for product promotion through our field sales division, which currently details Crystalos, another gastroenterology product, and will 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 Vibative product in Saudi Arabia. The launch follows an agreement with Tabuk Pharmaceutical Manufacturing Company to introduce Vibative into the Middle East. Tabuk had obtained the final approvals needed to commercialize Vibative 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 Vybattiv 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 Vybattiv there. Here in the U.S., we announced the availability of our Vybattiv four-vial starter pack through a new supply arrangement with Vizient, making it accessible to their health care members nationwide. And we also announced that Vibatab was added to a national purchasing agreement with Premier, Inc. Meanwhile, we've continued to progress our Phase II clinical programs, evaluating our Ifitroban product candidate in patients with Duchenne muscular dystrophy, systemic sclerosis, and an idiopathic pulmonary fibrosis. Returning 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 nine months of the year totaled $30.9 million. While third quarter sales were impacted by a delay in some Crystalos 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 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 in 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.
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