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Transcript
OP
Operator
Operator
Good afternoon, and welcome to Cumberland Pharmaceuticals' Third Quarter 2022 Financial Report and Company Update. This call is being recorded at Cumberland's request and will be archived on the company's website for 1 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.
MA
Molly Aggas
Management
Hello, everyone, and good afternoon. Thanks for joining today's call. Earlier this afternoon, Cumberland issued a press release containing financial results for the third quarter of 2022, along with the company update. 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. Kazimi, Cumberland's Chief Executive Officer; 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 of 1995. These statements reflect the company's current views and expectations concerning future events, it may involve risks and uncertainties. Additionally, 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 website. And a link 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 performance. An explanation and reconciliation to GAAP measures can be found in the financial tables in 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. With that overview, I'll turn the call over to Cumberland's Chief Executive Officer, A.J. Kazimi.
KA
A. J. Kazimi
Management
Thank you, Molly, and good afternoon, everyone. We appreciate you joining us. As you'll hear today, we had another active and productive quarter here at Cumberland. We'll provide an update on the latest developments and review our financial results for the third quarter of 2022. So let's get started. I'm pleased to report that Cumberland had a very successful third quarter, delivering on our goal of double-digit revenue growth for the period. Our line of FDA-approved brands generated $11.4 million in revenue and $1.4 million in adjusted earnings or $0.10 a share. Our sales organization continues to navigate the challenges in the marketplace, and we are starting to see a return to a more typical selling environment. However, we are still seeing staffing shortages at hospitals, clinics and physician offices, which are impacting the number of patient procedures and the facility visits. Still, we experienced strong year-over-year financial performance led by contributions from our newest brand, Sancuso, it's off to a great start. And we're supporting the product through our new sales division, Cumberland Oncology. During the third quarter, we largely completed the transition of Sancuso from Kyowa Kirin to here at Cumberland. We've now assumed full commercial responsibility for the product in the U.S., including its marketing, its promotion, distribution and medical support activities. Already, we've seen Sancuso quickly becoming one of our most important brands and a significant contributor to our business. To fund this acquisition, recall we extended our bank line of credit for a new 3-year term and expanded that facility to provide up to $20 million in capital. Sancuso is the first and only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment. By addressing these issues, we can help patients tolerate and continue to need…
JH
John Hamm
Management
Thank you, A.J. For the 3 months ended September 30, 2022, net revenues from continuing operations were $11.4 million, a 41% increase over the $8.1 million in revenue recorded during the prior year period. Net revenues by product for the third quarter of 2022 included $4 million for Sancuso, $3.9 million for Kristalose, $1.9 million for Vibativ and $0.9 million for Caldolor. It's important to note that given the quarterly fluctuations in buying patterns from our customers, we believe that our performance should be assessed based on annual sales results. Year-to-date, net revenues were $32.9 million, up 19% from the $27.7 million in revenue during the first 9 months of 2021. Year-to-date, product revenues totaled $11.4 million for Kristalose, $10.8 million for Sancuso, $6 million for Vibativ and $3.1 million for Caldolor. Total operating expenses for the third quarter were $11.7 million compared to $9.6 million for the prior year period. The primary driver of this increase was the addition of Sancuso expenses including those associated with the product's amortization, distribution, marketing and selling. Year-to-date, expenses totaled $36.3 million compared to $31 million for the first 9 months of 2021. Again, the new Sancuso expenses were the main contributor to this increase. The net loss for the quarter was $408,000, and year-to-date, we have a net loss of $3.1 million when noncash expenses are added back, the resulting adjusted earnings for the third quarter were $1.4 million, a significant improvement of the adjusted loss of $327,000 last year. The year-to-date adjusted earnings were $1.7 million, also a significant increase over the $723,000 during the same period last year. Also, please note that those adjusted earnings do not include the additional benefit of the $1.4 million of Vibativ and Sancuso cost-of-goods during the quarter. Year-to-date, the benefit is $3.3 million. Those…
KA
A. J. Kazimi
Management
Thank you, John. We're working to build an innovative pipeline of new product opportunities. And many of you who have been following us know, we're sponsoring 3 Phase II clinical programs featuring our ifetroban product candidate. These studies involve patients with aspirin-exacerbated respiratory disease, a severe form of asthma; Systemic Sclerosis, a debilitating autoimmune disorder; and Duchenne Muscular Dystrophy, a genetic neuromuscular disease. This program is being funded by a $1 million grant provided by the FDA's Office Drug Products. While patient enrollment in these studies slowed significantly last year during the height of the pandemic. This year, enrollment has improved as medical centers reopened to clinical research and patients began returning for their treatments. Today, I'm announcing the closure to enrollment in our Phase II AERD clinical study. This randomized placebo-controlled trial is designed to evaluate whether ifetroban can improve the symptoms in AERD patients without [indiscernible] desensitization. A total of 56 patients were enrolled in 19 medical centers across the U.S. Top line results will be announced upon completion of the study's data analysis. We're also working on an application to the FDA for a fourth Phase II clinical program which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases. In addition to our company-sponsored studies, there are also several investigators-initiated studies underway with ifetroban at various stages of completion. For these studies, Cumberland typically supplies ifetroban product as well as the placebo to the research groups involved. So our plan going forward is to complete each of our company-sponsored studies, analyze the final data, announce top line results and then decide on the best development path with the registration of ifetroban, which we continue to believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.…
OP
Operator
Operator
KA
A. J. Kazimi
Management
Thanks, everyone, for joining today's call. And we do understand that many of you prefer a private discussion with management. And if so, please just reach out with us, and we'll be happy to hold such a call and get on schedule with you. As always, we appreciate your time and interest in Cumberland, and we look forward to providing another update after the end of the year.
OP
Operator
Operator
Thank you, sir. Ladies and gentlemen, that concludes today's call. If you would 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.