speaker
Conference Call Operator
Operator

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 Julia Motis, Senior Account Manager at the Dalton Agency who handles Cumberland's communications. Julia, please go ahead.

speaker
Julia Motis
Senior Account Manager, Dalton Agency

Hello everyone and good afternoon. Thanks for joining today's call. Earlier today, Cumberland issued a press release announcing the company's financial results and operational update for the first quarter ending March 31, 2023. The release, which includes the related financial tables, can be found on Cumberland's website at www.cumberlandpharma.com. Company 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 its brands, pipeline, and partners. Participating in today's call are A.J. Cazzini, Cumberland's Chief Executive Officer, Todd Anthony, Vice President of 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 epidemic, 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 is 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 the links to those sites can be found on the corporate website at www.cumberland.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 that was issued earlier today. If you have any questions, please don't withhold them until the end of the call, at which point we will continue with that. I'll turn the call over to Cleveland's Chief Executive Officer, A.J. Kazemi.

speaker
A.J. Kazemi
Chief Executive Officer, Cumberland

Thank you, Julia. Good afternoon, everyone. We do appreciate you taking the time to join us as we share how the year has gone so far. As Julia mentioned, during today's call, We'll provide both a company update as well as a review of our financial results for the first quarter, 2023. So let's get started. During the first quarter, we continue to face challenges in our operating environment, ranging from workforce shortages at healthcare facilities, supply chain interruptions, rising interest rates, the overall economic downturn, and now the recent banking crisis. Despite these difficulties, our team has been working diligently through these headwinds, and they remain dedicated to delivering our FDA-approved products for the patients who need them, while also advancing the development of our new medicines for the future. There have been two important recent developments that I'd like to share with you. First, we expect that Caldwell will be eligible for special Medicare reimbursement under the new no pain legislation. No pain stands for non-opioids prevent addiction in the nation, and it was enacted as part of the Consolidated Appropriations Act of 2023. The No Pain Act requires Medicare to provide separate and more favorable reimbursement for non-opioid products that are used to manage pain during surgeries conducted in an outpatient hospital department, or in an ambulatory surgical center. This legislation applies to products that are indicated to provide analgesia without acting on the body's opioid receptors. As a result, we understand that the No Pain Act will affect Medicare reimbursement for Kaldalor, our non-opioid analgesic injection product. The Act is scheduled to go into effect in early 2025. and we expect CMS to issue the reimbursement guidelines for Caldolor in 2024. Second, we were very pleased to learn that the FDA decided to grant a barrier to innovation waiver for drug program fees that we had previously paid for our ReadyTracks product line. As a result of this waiver, the FDA will provide us with a refund of nearly $2 million. The FDA granted this barrier innovation waiver after concluding that we did meet the statutory criteria based on the innovation associated with our iFitraBand clinical development programs. The request for the waiver provided the rationale that the funds could be better used to advance our clinical programs, which are designed to address a series of unmet medical needs. Meanwhile, we've largely completed the transition of Sancuso, our newest brand, from the U.S. affiliate of Japan-based Kyuakuren, Inc. Sancuso is the first FDA-approved dissolvable prescription patch to help oncology patients tolerate their chemotherapy treatments, and it's been an important contributor to our business since it joined our product line last year. We're also pleased to announce that the FDA has approved the manufacture of Sancuso at a new facility, which will be our source of the product's future supplies. We continue with the transition of ReadyTrex to Nordic Pharma, and our distribution of the product line will conclude at the end of June. We've already transferred the marketing authorization to Nordic, and we'll cooperate with them as they assume commercial responsibilities for the brand. Recall these new arrangements resulted in a million dollar refund to us, a million dollar credit for us, and a return of the 180,000 shares that we had issued to Nordic. We're also now settled into our new headquarter offices on the broad west campus in the Vanderbilt West End corridor of Nashville. This new location allows us to remain close to the Vanderbilt Medical Center and continue our collaboration there while also maintaining our presence in the national healthcare community, which represents the nation's largest concentration of healthcare companies. Turning to some highlights on our financial performance during the first quarter, net revenues were $9.2 million, similar to the fourth quarter of 2022. These revenues were down from the same quarter last year, primarily due to a delay in international shipments, and an unusual number of product returns. However, our operating expenses were also down nearly 14% from the prior year period, and our gross margins improved to 86% for the first quarter. We posted net income of $0.2 million for the quarter, and adjusted earnings were $1.7 million, or 11 cents a share. Total assets at the end of March were $89 million, and total liabilities $53 million, and total shareholders' equity $36 million. So with that overview, I'd now like to turn to Todd Anthony, Cumberland's Vice President, Organizational Development, to further discuss our team and our brads. Todd?

Disclaimer

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