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Cumberland Pharmaceuticals Inc. (CPIX)

Q4 2023 Earnings Call· Tue, Mar 5, 2024

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Transcript

Operator

Operator

Good afternoon, and welcome to Cumberland Pharmaceuticals 2023 Financial Report and Company Update. This call is being recorded at Cumberland's request and will be archived on the company's 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 go ahead.

Molly Aggas

Management

Hello, everyone. Good afternoon. Thanks for joining us today. This afternoon, Cumberland issued a press release announcing the company's annual financial results with an operational update for the year ending December 31, 2023. 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 brand, 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 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 and 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'll 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. You can find the links to those sites can be found on the corporate website at www.cumberlandpharma.com. The company will 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 today. 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 preference. So 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 appreciate you joining us as we recap our progress here at Cumberland. As Molly mentioned, during today's call, we'll provide both a company update as well as a review of our 2023 financial results. So, let's begin. In many ways, 2023 was a productive and important year for Cumberland, as we were able to take key steps in laying the foundation for future success. We continued to integrate our newest products while also delivering a number of significant achievements, which we'll recap on today's call. In 2023, Cumberland delivered net revenues of $40 million. Sancuso has become a valuable addition to our product line with continued significant shipments during 2023, but also an unusual amount of sales deductions during that year. Meanwhile, Kristalose, Caldolor, and Vibativ continued their steady contributions to our revenue mix. In fact, Vibativ sales rebounded in 2023, with the brand beginning to deliver an attractive return on the investment associated with its acquisition. Our gross margins remained attractive in 2023, resulting in $6 million in cash generated from operations for the year. Our balance sheet also remained strong as we ended the year with $82 million in total assets, including $20 million in cash, $53 million in liabilities, and $30 million of shareholders' equity. Now, I'm pleased to share a series of exciting developments which occurred in 2023, including several growth opportunities for our brands. Throughout the year, we continued to work with our partners in their efforts to register and launch Vibativ in several international markets, which can provide significant catalysts for the brands in the future. SciClone Pharmaceuticals, our partner for the Chinese market, has continued to respond to regulatory inquiries as they seek approval for Vibativ in their country. Tabuk Pharmaceuticals has updated Vibativ's approval…

Todd Anthony

Management

Thank you, A.J. There certainly was a lot of activity at Cumberland throughout 2023, so I'd like to offer a further update on each of our major brands. In October, we announced a new publication in Antimicrobial Agents and Chemotherapy, detailing the results of the first clinical study investigating the safety and pharmacokinetics of our Vibativ product in children two to 17 years of age. Vibativ is an intravenous antibiotic approved by the FDA for the treatment of hospital acquired and ventilator associated bacterial pneumonia, as well as complicated skin and skin structure infections caused by certain gram positive bacteria. The results of the study suggest that a single dose of Vibativ is safe in children and that they experienced reduced exposure to Vibativ compared with the same body weight based dosing in adults. Antimicrobial resistance continues to pose a significant challenge in the treatment of bacterial infections, necessitating the development of new antibiotic therapies. We're pleased to see that Vibativ sales continue to improve and were up 18% in 2023, reflecting the several new initiatives underway to improve the brand's performance. Touching next on Kristalose, which is our prescription strength laxative packaged in a convenient pre-measured powder dose that dissolves quickly in just four ounces of water for a clear, taste-free and grit-free solution. Kristalose continues to be our largest selling product and is benefiting nicely from the support of our two co-promotion partners, with 2023 sales up 5% over the prior year. Moreover, we found that the brand performs best in states where we have Medicaid coverage. New York State recently added Kristalose to its Medicaid formulary and we are implementing a special initiative to increase our presence and share a voice in that market. We believe that this new coverage is contributing to the growth of the…

A. J. Kazimi

Management

Thank you, Todd. Now I'd like to take a few minutes to provide an update on our clinical program. We continue to progress our pipeline of innovative products designed to improve patient care and patients' quality of life. Our ifetroban product candidate, a potent and selective thromboxane receptor antagonist, is being evaluated in three phase, two clinical studies 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. Patient enrollment is well underway in two of those company-sponsored Phase II clinical programs. The first involves patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis, the skin, and internal organs. The other is evaluating ifetroban in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy or DMD. It's a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal heart and lung muscles. We're sponsoring the FIGTH DMD trial, a multi-center randomized placebo-controlled Phase II study, which is enrolling patients across 10 centers across the United States and centers that specialize in DMD. We've completed enrollment in the younger age group of patients and are now working to finish enrollment in the older patient cohort with DMD. Recall the FDA has provided grant awards of over a million dollars to support the study. We're also developing an oral capsule of ifetroban to treat idiopathic pulmonary fibrosis or IPF, the most common form of progressive fibrosing interstitial lung disease. Following FDA clearance of our investigational new drug application in May of 2023, we're now in the process of initiating our Phase II FIGHTING FIBROSIS trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S. Recent studies have shown, ifetroban can both prevent and enhance resolution of lung fibrosis in multiple preclinical models. Well, in addition to these sponsored studies, there are several other preclinical and pilot patient studies of ifetroban underway, including several investigator initiated studies. We believe ifetroban has the potential to benefit many patients and we look forward to sharing the results from our company sponsored studies as they emerge. Our plan is to then decide on the best development path for the product, which represents our first new chemical entity. So with that update on our ongoing clinical trials, I'd now like to turn it over to our Chief Financial Officer, John Hamm, to review our 2023 financial results. John?

John Hamm

Management

Thank you, A.J. For the three months ended December 31, 2023, net revenue from continuing operations were $9.4 million, an increase over the $9.1 million in revenue recorded during the prior year period. Net revenue by product for the fourth quarter of 2023 included $2.4 million for Sancuso, $3.7 million for Kristalose, $2 million for Vibativ, and $1 million for Caldolor. As a reminder, due to quarterly fluctuation 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 revenue for the full year 2023 were $40 million. Full year product revenue totaled $16 million for Kristalose, $8.1 million for Sancuso, $8.8 million for Vibativ, and $4.3 million for Caldolor. Turning to our expenditures, total operating expenses for the fourth quarter were $15.5 million compared to $11.4 million for the prior year period. Total operating expenses for 2023 were $49.1 million up from $47.7 million during the prior year. The net loss for the quarter and the year was approximately $6.3 million, which includes a $3.3 million one-time write-down of Omeclamox in tangible assets. When non-cash expenses are added back, the resulting adjusted earnings for the year were $2.4 million, or $0.17 a share. Also, please note that the adjusted earnings calculations do not include the benefit of the $0.6 million of Vibativv and Sancuso cost of goods during the fourth quarter, which was a $2.3 million benefit for the full 2023 year. Those goods were received as part of each product's acquisition. As a result, when taking into account all these items, total cash flow from operations was $6 million in 2023. As a reminder, the additions of Vibativ and Sancuso to our product portfolio have continued to significantly impact our financial statements. As…

A. J. Kazimi

Management

Thank you, John. Well, as you may recall, in 2023, we took a fresh look at our mission statement, and we refined it to better capture the spirit of what we do each day here at Cumberland. Our mission is now working together to provide unique products that improve the quality of patient care. In designing this statement, we considered several factors. First, we wanted it to address the constituencies we serve, which includes patients in need of care, as well as the health care providers, our employees, shareholders, partners, and our community. We also sought to reflect Cumberland's culture, where teamwork is prized, emphasized, and expected in order to achieve our goals. Next, we needed to demonstrate our focus on developing, acquiring, and distributing differentiated brands. And finally, we wanted to emphasize that the patient is at the core of everything we do. Our collective efforts are directed at providing unique products that serve as better alternatives for poorly met medical needs. We remain committed to fulfilling this mission by building a portfolio of specialty pharmaceutical brands, which we do by maximizing the potential of our commercial brands, progressing our pipeline, and also pursuing select acquisitions. Overall, it was a good year, and we are encouraged by the developments that we've shared with you today. It's been particularly encouraging to see the recent growth in our Kristalose business, along with the rebound in Vibativ sales. We're excited about the expansion of our oncology sales division and the opportunity to further help cancer patients. And we believe the special reimbursement associated with the Federal No Pain Act can have a meaningful impact on Caldolor's future growth. We're pleased to share the recent pediatric studies involving favorable results for both Vibativ and Caldolor in children, as well as FDA's approval of the expanded labeling for Caldolor to now include infants. So, with that, let's open the call to any questions you may have. Operator, please proceed.

Operator

Operator

A. J. Kazimi

Management

Well, thank you, everyone, for joining today's call. We do understand many of you prefer a private discussion with management, and if so, please just reach out, and we'd 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.

Operator

Operator

Thank you. This concludes today's program. Thank you all for participating. You may now disconnect.