Earnings Labs

Cumberland Pharmaceuticals Inc. (CPIX)

Q2 2022 Earnings Call· Sat, Aug 13, 2022

$4.30

+2.63%

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Transcript

Operator

Operator

Good afternoon, and welcome to Cumberland Pharmaceuticals Second Quarter 2022 Financial Report and Company Update. This call is being recorded at the company's request and will be archived on Cumberland's website for 1 year from today's date. I would now like to introduce Molly Aggas, Account Supervisor at the Dalton Agency, who handles Cumberland's Communications. Molly, please go ahead.

Molly Aggas

Management

Hello, everyone, and good afternoon. I hope you're doing well, and thank you for joining today's call. Earlier this afternoon, Cumberland issued a press release containing a company update and financial results for the second quarter of 2022. The release is 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. It will also provide an overall company update, including a discussion of its brands, pipeline and partners. With us today are A.J. Kazimi, Cumberland's Executive Officer; Todd Anthony, Vice President; and John Hamm, Chief Financial Officer, who will participate in today's report. 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 and may involve risks, uncertainties. Additionally, there are many factors that could affect Cumberland's future results, including natural disasters, economic downturn, 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. The 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 the links to those sites can be found on the corporate website at www.cumberlandpharma.com. Also, today, the company will provide some non-GAAP financial measures with respect to performance. An explanation and reconciliation to GAAP measures can be found on 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. And with that overview, I'll turn the call over to Cumberland's Chief Executive Officer, A.J. Kazimi, to begin the discussion.

A.J. Kazimi

Management

Thank you, Molly, and good afternoon, everyone. We do appreciate you joining us today. While I'm pleased to report that Cumberland had a successful second quarter, delivering on our goal of double-digit revenue growth for the period. And we've largely transitioned our newest brand, Sancuso from Kyowa Kirin and began supporting the product through our newest sales division, Cumberland Oncology. We're very pleased to have added another quality brand with good performance to our portfolio. And Sancuso has quickly become one of our most important products and is already a significant contributor to our business. It's an innovative oncology support care medicine that's delivered through a prescription patch and designed to prevent nausea and vomiting during certain chemotherapy treatments. By addressing those issues, we can help patients tolerate and continue their needed treatments for the cancers. In January, we acquired Sancuso from the Japanese-based Kyowa Kirin's U.S. affiliate. And under the terms of that agreement, we assumed full commercial responsibility for the product, including its marketing, promotion, distribution, manufacturing and medical support here in the United States. To fund the acquisition, we extended our bank line of credit for a new 3-year term, and we also expanded the facility to provide up to $20 million in capital. To support Sancuso, we appointed a new marketing executive and, as I mentioned, formed a new sales division, Cumberland Oncology. This new division has been staffed by a group of individuals who came over to Cumberland from Kyowa Kirin, bringing significant experience with the brand and helping us continue the key customer contacts needed to support prescriptions of the product. Also, during the second quarter, we entered into a significant co-promotion agreement with Verity Pharmaceuticals to feature Sancuso through their national oncology sales organization. Following their success in building their Trelstar oncology brand,…

Todd Anthony

Management

Thank you, A.J. I would first like to touch on Vibativ, our potent injectable antibiotic product designed to treat certain serious bacterial infections, including hospital-acquired or ventilator-associated pneumonias and complicated skin infections. There are 2 different settings where Vibativ can be used to help treat and cure these difficult infections. The first is in our country's medical centers, where our hospital sales division is supporting medical professionals in their use of the product. The second is in the outpatient marketplace, which is the focus of our national accounts team. During the first half of 2022, our marketing and sales leadership has taken a fresh look at how we can support Vibativ and launched a series of new initiatives to increase awareness and use of this important, potentially life-saving brand. Next, I'd like to turn to Kristalose, our prescription strength laxative product. It's packaged in a convenient premeasured powder dose, which dissolves quickly in just 4 ounces of water for a clear, taste-free and grid-free solution. As our largest selling brand, Kristalose's steady performance continues to benefit from the co-promotion partnerships we've established for the product. While our field sales division continues to feature Kristalose, our co-promotion partners expand our reach by taking the product to physicians and facilities that Cumberland doesn't cover. We've also continued to refresh the award-winning marketing campaign we have been using to support Kristalose. Turning now to Caldolor, our intravenously delivered formulation of ibuprofen, designed to significantly reduce fever and pain in patients unable to tolerate oral medications. You may recall that late last year, we announced the FDA's approval of Caldolor's use prior to surgery. When our nonnarcotic pain reliever is administered just prior to their surgeries, patients wake up from the procedure in significantly less pain and need significantly fewer opioids. As more patients…

A.J. Kazimi

Management

Okay. Thank you, Todd. As we work to build an innovative pipeline of new product opportunities, we are excited to be sponsoring the 3 Phase II clinical studies currently underway to evaluate our ifetroban candidate in patients with a series of unmet medical needs. Those studies involve patients with aspirin-exacerbated respiratory disease, which is a severe form of asthma, systemic sclerosis, a debilitating autoimmune disorder and Duchenne muscular dystrophy, a genetic neuromuscular disease. This third program is being funded by a $1 million FDA grants. We're also working on an application to the FDA for a fourth Phase II program which will evaluate the use of ifetroban to treat patients with progressive fibrosing interstitial lung diseases. In June, the American Journal of Respiratory and Critical Care Medicine published a series of preclinical studies that support the use of ifetroban, our selective thromboxane receptor antagonist as a promising therapeutic for patients with pulmonary fibrosis associated with our lung disease. Specifically, the research is reported that ifetroban was used to block thromboxane receptor signaling in 3 preclinical models of lung fibrosis. Ifetroban reduced pro fibrotic signaling in the lungs and preventive lung fibrosis due to multiple causes, bleomycin, genetic and radiation. In addition to these sponsored studies, our company is supporting select investigator-initiated studies. Harvard Clinical investigators have led a Phase II trial in patients with the severe form of asthma I mentioned, and their study is supported by a $5 million grant from NIH and designed to understand the mechanism of ifetroban in those patients and therefore, complements the work that we have underway. With patient enrollment now closed and their study analysis is underway, we look forward to sharing the results and data once we receive them. After our other Phase II studies are complete, we'll be sharing those results…

John Hamm

Management

Thank you, A.J. For the 3 months ended June 30, 2022, net revenue from continuing operations were $10.3 million, a 14% increase over the $9.1 million in revenue recorded during the prior year period. Net revenue by product for the second quarter of 2022 included $3.6 million for Kristalose, $3.4 million for Sancuso, 1.6 million for Vibativ and $1.2 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 $21.5 million, up 10% from the first 6 months of 2021. Year-to-date product revenues totaled $7.5 million for Kristalose, $6.8 million for Sancuso, $4.1 million for Vibativ and $2.2 million for Caldolor. Total operating expenses for the second quarter were $12.1 million compared to $10.5 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 and marketing. Year-to-date expenses totaled $25 million. The net loss for the quarter was $1.3 million or $0.09 per share. Year-to-date, we have a net loss of $2.7 million. When noncash expenses are added back, the resulting adjusted loss for the second quarter were $0.3 million or $0.01 per share and the year-to-date adjusted earnings were $0.3 million. Also, please note that those adjusted earnings do not include the additional benefit of the $0.7 million of Vibativ and Sancuso cost of goods during the quarter. Year-to-date, the benefit is $1.9 million. Those goods were received as part of each product's acquisition. So total cash flow from operations was $2.2 million. I'd like to remind you that our financial statements have been significantly impacted by the Vibativ and Sancuso acquisitions. The financial terms for the Vibativ transaction…

A.J. Kazimi

Management

Thank you, John. So overall, Cumberland has developed -- delivered a successful second quarter and first half of the year. We'll continue with our strategy of maximizing the potential of our commercial brands, progressing our pipeline and continuing to pursue select acquisitions. We're particularly encouraged by the arrival of Sancuso and the positive impact it's having on our business. We believe that the contributions from this newest product will provide a catalyst for growth and also better care for cancer patients. We're also pleased with the latest addition to our Board of Directors. Martin Brown Jr. is an attorney with over 30 years of corporate law experience. He also previously served 10 years on the Board of Brown-Forman Corporation, a large American spirits and wine company whose shares are listed on the New York Stock Exchange. Additionally, he has served since 2018, on the Board of Directors of the parent company at Aegis Sciences Corporation, a federally certified health care laboratory headquartered here in Nashville. Martin has also been an active board member for many community organizations and bring significant legal, public company, health care and civic experience to our Board. We believe these contributions will be valuable in our efforts as we work to acquire, develop and deliver innovative products to improve the quality of care for patients. Also, ahead of today's call, we released the results of our newest sustainability report, detailing Cumberland's impact on environmental, social and governance matters. A few highlights from the report include: that we provided 2.4 million doses of product up to patients. We also safely disposed of over 6,000 pounds of expired in damaged goods and no products were recalled with no studies terminated due to failure to practice good clinical standards. The sustainability report also highlights our investment in our community to the Cumberland Foundation and our investment in our employees through our continuing educational programs, career development initiatives and recognition awards. So with new products and presentations to promote and improving selling environment and a robust pipeline, we're very optimistic about our future prospects, and we continue to expect 2022 to be a year of double-digit revenue growth. With that review and update, let's open the call to any questions you may have. Operator, please proceed.

Operator

Operator

Ladies and gentlemen, that concludes the company's presentation. [Operator Instruction]

A.J. Kazimi

Management

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.