Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q3 2023 Earnings Call Transcript

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) Q3 2023 Earnings Call Transcript November 11, 2023

Operator: Good afternoon, and welcome to Cumberland Pharmaceuticals Third Quarter 2023 Company Update and Financial Report. 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: Hello, everyone. Good afternoon. Thanks for joining today’s call. Earlier today, Cumberland issued a press release announcing the company’s financial results with an operational update for the third quarter ending September 30, 2023. 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 a discussion of its 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.

A lab worker holding a vial of biopharmaceuticals for cellular therapies.

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 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 the links to those sites can be found on the corporate website at www.cumberlandpharma.com. The company will also provide 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 that’s your preference. So with that overview, I’ll turn the call over to Cumberland’s Chief Executive Officer, A. J. Kazimi.

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Q&A Session

A. J. Kazimi: Thank you, Molly, and good afternoon, everyone. I do have a slight cough today, so please bear with me. We appreciate you taking the time to join us today as we share how the year is going. As Molly mentioned, during today’s call, we’ll provide both the company update as well as a review of our financial results for the third quarter of 2023. I’d like to start by mentioning that we’ve recently refined our mission statement to better capture the spirit of what we endeavor to do here each day at Cumberland that now reads as follows: working together to provide unique products that improve the quality of patient care. In designing this statement, we took into account several factors. First, we wanted a mission that’s designed to address the constituents we serve, which include the patients in need of care, healthcare providers, our employees, our shareholders, our partners and our community.

We also wanted to reflect Cumberland’s culture, where teamwork is prized, emphasized and expected in order to achieve our goals. Next, it needed to demonstrate our focus on developing, acquiring and distributing differentiated brands. And finally, it emphasizes that the patient is at the core of everything we do. Our collective efforts are directed at providing better alternatives for poorly met medical needs. Our hope is that everyone across our organization will embrace our newly refined mission statement and use it not only as an inspiration, but also as a guide in supporting the achievement of our goals. Our strategy for fulfilling this mission is to build a portfolio of specialty pharmaceutical brands. Touching on a few. Our Sancuso patch is the only FDA-approved prescription patch for the prevention of certain side effects in oncology patients receiving chemotherapy treatment.

Caldolor is the only injectable therapy approved in the U.S. for the treatment of both pain and fever in a wide range of patients that includes children, adults and now newborns. And Kristalose is the only branded prescription laxative that combines the established safety and efficacy of lactulose with the convenience and portability of a premeasured dose. So now as we reflect on the progress we’ve made throughout 2023, we are pleased to share a number of exciting updates and growth opportunities for our product portfolio. For example, we continue to work with our partners in their efforts to register and launch Vibativ in several international markets, which would provide significant future catalysts for the brand. To book Pharmaceuticals has updated by Vibativ approval in Saudi Arabia with new manufacturing information as they plan to introduce the product into the Middle East.

DB Farm, our partner in South Korea, who also distributes Caldolor is awaiting the approval of Vibativ in their country and Sky Clone Pharmaceuticals, our Vibativ partner for the Chinese market has continued to respond to regulatory inquiries as they seek approval in their country. We now await the approval of these three initiatives and look forward to the launch of our product in those markets. We recently announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of our Caldolor product in newborns, which supported the brand’s FDA approval in infants of three to six months of age. And we’re thrilled to further expand Caldolor’s labeling the youngest patients. Additionally, we expect Caldolor will be eligible for special Medicare reimbursement under the new no pain legislation.

The Act is scheduled to go into effect in early 2025, and we expect CMS to next issue regulations for implementing the act and the amount of the separate reimbursement. Meanwhile, we’ve completed the expansion of our oncology sales division as we work to expand the use of our newest brand, Sancuso, to help cancer patients tolerate the chemotherapy treatments. Our largest selling brand Kristalose is now beginning to benefit from its listing on the New York State Medicaid formulary, and we’re glad to share today that we now have now successfully transferred the manufacturing of our Vaprisol product to a new facility. Following that successful production of the first batches, we’re now planning to provide supplies of a special compounded conivaptan product on an interim basis to the market starting at the end of this year.

We then expect to file for the approval of Vaprisol at the new plant in order to then relaunch the branded version of the product in the future. Turning next to some highlights on our financial performance. During the third quarter, our product portfolio of FDA-approved brands delivered combined revenues of $10.1 million and year-to-date revenues totaled $30.2 million. Adjusted earnings for the quarter were $260,000 or $0.02 a share, and the year-to-date adjusted earnings were totaled $4.2 million or $0.29 a share. Also, I’m pleased to report that cash flow from operations this year has totaled $5.1 million. We ended the third quarter with $88 million in total assets, $52 million in liabilities and $36 million in shareholders’ equity. Additionally, I’m very pleased to report that we entered into a new revolving credit loan agreement for a $20 million facility, expandable to $25 million with a three-year term.