Earnings Labs

Cumberland Pharmaceuticals Inc. (CPIX)

Q3 2024 Earnings Call· Sat, Nov 9, 2024

$4.30

+2.63%

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Transcript

Operator

Operator

Good afternoon. And welcome to 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 Molly Aggas, Account Supervisor at the Dalton Agency, who handles Cumberland's communications. Molly, please proceed.

Molly Aggas

Management

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. 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. d There are many factors that could affect Cumberlan'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 also 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. With that introduction, I'll turn the call over to Cumberland's Chief Executive Officer, A.J. Kazimi.

A.J. Kazimi

Management

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 the 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 Kristalose from Caldolor and Sancuso. But unfortunately, Vibativ 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 Vibativ which is provided in 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 Kristalose, 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 Kristalose to their Medicaid plans and we'll work to increase awareness of that coverage. Regarding Sancuso, our oncology support medication, we introduced several new patient-oriented programs for the product during the…

Todd Anthony

Management

Thank you, A.J. I'd like to start with an overview of our customer-facing organization. We now have a total of 50 individuals across the country interacting with the medical community in support of our FDA-approved medicines. Our sales professionals are organized into three national divisions with the hospital sales group calling on key institutional accounts in support of Caldolor and Vibativ, our field sales division focusing on select office-based physicians featuring Kristalose and our recently expanded Cumberland Oncology division, which cover cancer clinics promoting our Sancuso product. These 3 sales divisions are augmented by our national accounts and our field-based medical teams. We also have two co-promotional partnerships that help bring Kristalose to additional physicians and their patients. Next, I'd like to share some more insight regarding our brands Vibativ is our potent 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. A new report from the World Health Organization, which A.J. mentioned, found that antimicrobial resistance is becoming an urgent global health and socioeconomic crisis. Further, they noted that the worldwide rise in antibiotic resistance poses a significant threat, diminishing the effectiveness of many common antibiotics used widespread against bacterial infections. And according to a recent article in Lancet, the global number of deaths from antimicrobial resistance is expected to reach nearly 2 million by 2050. Unlike many antibiotics that are losing the battle to fight bacteria, Vibativ's unique dual method of action was specifically designed to address drug-resistant bacteria. We therefore believe it has life-saving potential to help many patients amid the growing antibiotic resistance crisis. To reinforce this message, we are conducting a series of infectious insights discussions with infectious disease experts and disseminating the results across the country. These…

A.J. Kazimi

Management

Thank you, Todd. I'd now like to take a few minutes, to provide an update on our new product development activities. Through our work at Cumberland Emerging Technologies or CET, we continue to build a long-term pipeline of innovative new biopharmaceutical products. And today, I'll share two recent developments among the programs CET is supporting. First, CET is developing a new treatment for delirium, a growing neurological condition, seen in hospitalized critical care patients. I'm pleased to share that enrollment has concluded and top line results are now available for the MENDING trial, a Phase 2 pilot study evaluating the safety and efficacy of a new treatment for delirium in critically ill patients. The study was conducted in partnership with Vanderbilt University Medical Center and it was funded by the National Institutes of Health. The primary endpoint was the safety of this new treatment, which was successfully met as it was well-tolerated in these patients. The study also demonstrated that the new treatment was associated with fewer days of delirium, reduced use of antipsychotics opioids and sedatives, and the decrease in patients experiencing comas. While these efficacy results were not statistically significant given the limited number of patients treated in this pilot study, the researchers concluded that the findings were indeed clinically meaningful and support continued product development. Delirium is the most common presentation of neurologic dysfunctions in critically ill patients and it affects a sizable percentage of patients admitted to our country's intensive care units. The progression of delirium is associated with several poor outcomes including increased length of hospital stays, long-term cognitive deficits, additional hospital costs, and impaired quality of life and even mortality. Despite the prevalence and impact of delirium, there are currently no FDA-approved products for the prevention or treatment of this problem, highlighting an unmet…

John Hamm

Management

Thank you, A.J. For the three months ended September 30, 2024 net revenue from continuing operations were $9.1 million. Net revenue by product for the third quarter included $3.6 million for Kristalose, $2.6 million for Sancuso, $1.3 million for Caldolor, and $1 million for Vibativ. As mentioned sales during the quarter were impacted by a halt in shipments due to the hurricane and there were also an inordinate amount of product returns recorded in Q3, which we do not expect to continue. Total year-to-date net revenues were $27 million. Year-to-date product revenues totaled $10.9 million for Kristalose, $6.6 million for Sancuso, $5.1 million for Vibativ and $3.6 million for Caldolor. Given the fulfillment of late September orders in October, we continue to believe it's important to evaluate our brand performance on an annual basis. Our gross margin improved during the quarter to 85%. Turning to our expenditures. Total operating expenses for the third quarter were $10.8 million, a $1 million improvement over the prior year period reflecting our efforts to reduce costs as we strive for sustained profitability. Year-to-date expenses totaled $32 million, a $1.5 million savings from the prior year period. Net loss for the quarter was $1.5 million and when the non-cash expenses are added back, the resulting adjusted loss was $0.26 million or $0.02 a share. 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 represent a non-cash item as they were received as part of the Products acquisition. We're pleased to see that the additions of Vibativ and Sancuso to our product portfolio continue to positively impact our financial performance. Cash contributions from each of these brands have now exceeded their acquisition costs, and therefore, going…

A.J. Kazimi

Management

Thank you, John. Well, overall, it's been a successful year-to-date, and we're encouraged by our progress. It's particularly good to see the steady performance of our Kristalose business and the number of states adding the product to their Medicaid formularies. And we continue to see the positive impact of our sales and marketing initiatives that are now supporting the growth of Sancuso. We have more work to do with Vibativ, but note that the brand will be favorably impacted by new international shipments. And we also believe the recent publication of our new Caldolor clinical data can have a meaningful impact on the brand's future growth. We're also encouraged with the progress of our clinical studies evaluating patients with ifetroban to address unmet medical needs and believe it has the potential to benefit many patients. And we're pleased to share the two new programs emerging from CET, including the positive top line study results for a new delirium treatment as well as the corporate partnership for the development of a new GI imaging product. Lastly, I'd like to note that we have an active acquisition initiative underway as we seek select FDA-approved brands to add to our portfolio and bolt-on to our infrastructure. As we move into the remainder of the year, our dedicated team will continue in their efforts working together to provide unique products that improve the quality of patient care. Please note that shipments of our brands are typically strongest in the fourth quarter and we look forward to our next report, which will provide our full year performance. With that report, let's now open the call to any questions. Operator, please proceed.

Operator

Operator

A.J. Kazimi

Management

Well, if there's no questions, I just want to thank everyone for joining today's call. We do understand that many of you prefer a private discussion with management. If so, just reach out, and we'll be happy to get calls scheduled with you and hold such a discussion. And as always, we appreciate your time and interest in our company and we then look forward to providing another update in the coming months.

Operator

Operator

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