Cumberland Pharmaceuticals Inc.

Good afternoon and welcome to the Cumberland Pharmaceuticals third quarter 2024 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 Mally Agus, Account Supervisor at the Dalton Agency who handles Cumberland's communications. Mally, please proceed.

Hello everyone and thank you for joining us today. Earlier this afternoon, Cumberland issued a press release announcing the company's financial results for the third quarter of 2024, as well as an operational update. The release, which includes the related financial tables, can be found on the company's website at www.cumberlandpharma.com. Management will share an overview of those financial results during today's call. They'll also provide an overall company update, including a discussion of Cumberland's brands, pipeline, and partners. Participating in today's call are A.J. Kazemi, Cumberland's Chief Executive Officer, Todd Anthony, Vice President, Organizational Development, and John Hamm, Chief Financial Officer. Please keep in mind that their discussions may include some forward-looking statements as defined in the Private 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, public health epidemics, international conflicts, and others that are beyond the company's control. Those issues are described under the caption Risk Factors in Cumberland's Form 10-K and any additional 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. 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 websites, and you can find links to those sites on 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 was issued earlier this afternoon. 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 after the call if you prefer. So with that introduction, I'll turn the call over to Cumberland's Chief Executive Officer, A.J. Kazemi.

Thank you, Molly, and good afternoon, everyone. We do appreciate you joining us today as we share how the year is going. As Molly mentioned, during this call, we'll provide both a company update as well as a review of our financial results for the third quarter, 2024. So let's get started. There are a number of positive developments here at Cumberland, which we'll discuss today, that bolster our optimistic view about the company's future outlook. During the quarter, our line of FDA-approved brands provided $9.1 million in net revenue, which included solid performance from Chrysalos, from Caldor, and Sancuso, but unfortunately, Vibative was impacted by an inordinate amount of product returns and by shipment delays at the end of the third quarter, all of which resulted from Hurricane Helene. Furthermore, two manufacturing facilities that supply much of our country's IV fluids were damaged by that storm. That created a fluid shortage and has impacted sales of Vibative which is provided in a lyophilized powder and needs to be reconstituted with an IV fluid before administration. Therefore, we continue to believe our brand performance is best measured on an annual basis. Our September ending balance sheet included $77 million in total assets, $17.5 million in cash and investments, total liabilities of $52 million, and shareholders' equity of $25 million. With that financial overview, I'd like to next share several updates regarding our products, including a number of growth opportunities. We continue to see that Crystallose, our prescription strength laxative, performs best in states where we have Medicaid coverage. Today, I'm pleased to report that several more states have now added Crystallose to their Medicaid plans and will work to increase awareness of that coverage. Regarding San Cuso, our oncology support medication, we introduced several new patient-oriented programs for the product during the summer, and we also continue to see the favorable impact of our recently expanded oncology sales solution. Turning next to Vibative, our potent antibiotic that features a unique dual mechanism of action specifically designed to address drug-resistant bacteria. We therefore believe that Vibatav has the potential to help many patients amid the growing global resistance crisis that was recently highlighted in a report from the World Health Organization. Vibatav should also benefit from the initiatives underway to register and launch the product in new international markets, and in fact the product is now approved in Saudi Arabia with launch plans well underway for that country. We also continue to pursue new clinical data to expand the use of our products and the patients who can benefit from them. For example, there are several such initiatives underway for Caldolor, our intravenous ibuprofen product approved for the treatment of pain and fever in adults, children, and recently newborns. We just announced the publication of a new real-world outcomes research study comparing Caldolor to its key competitor, Ketorolac. This extensive analysis evaluated 17 million patient records and selected over 150,000 adult and pediatric patients who received either Kaldalor or Ketorolac. The results provide compelling evidence that Kaldalor is associated with a significantly reduced incidence of adverse drug reactions and also improved healthcare utilization. We believe these important new findings underscore Caldolor's potential to improve patient care by reducing their treatment complications while also deliver potential savings for healthcare systems through decreased hospital readmissions and shortened treatment times. Caldolor is currently approved and being sold in Australia and South Korea and we believe there's an opportunity to increase the international contribution to our business. Today I'm pleased to announce that our newest partner in Mexico, Pisa Pharmaceutical, one of the largest established pharma companies in that country, has completed the submission of the approval dossier to Mexico's regulatory agency for the product's registration in that country. So with that financial update and operational overview, I'd now like to turn to Todd Anthony, Cumberland's Vice President, Organizational Development, to further discuss both our brands and our team.