Earnings Labs

Cumberland Pharmaceuticals Inc. (CPIX)

Q1 2018 Earnings Call· Sat, May 12, 2018

$4.20

-1.64%

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Transcript

Operator

Operator

Thank you for joining the Cumberland Pharmaceuticals First Quarter 2018 Financial Report and Company Update Conference Call. Please be advised that this call is being recorded at company's request and will be archived on Cumberland's website for 1 week from today's date. Now, I would like to introduce Erin Smith, Senior Corporate Relations Associate at Cumberland. Erin, please go ahead.

Erin Smith

Management

Good afternoon, everyone. Before we begin today, I'd like to point out that earlier today, we issued a press release containing the company's financial results and a corporate update for the first quarter ended March 31, 2018. That release includes the first quarter financial tables, is available on our website at www.cumberlandpharma.com. I'd also like to review the following safe harbor language before we get started today. Today's call may contain forward-looking statements within the meaning of the Private Securities Reform Act of 1995. Because they reflect the company's current views and expectations concerning future events, such forward-looking statements may involve risks and uncertainties. Investors should note, that many factors could affect the company's future results as more fully described under the caption Risk Factors in our most recent Form 10-K and any updates filed with the SEC. Any forward-looking statements made during today's call are qualified by those risk factors. Because future results could differ materially from the views expressed in today's call, please note that we do not assume an obligation to publicly update such forward-looking statements, whether as a result of new information or future development. During today's call, we'll be referring to several of the company's marketed brands. For more information on each of those brands, including full prescribing and safety information, please see the link to the product website, which can be found at www.cumberlandpharma.com. Also, please note that today, we'll provide the adjusted earnings financial metrics with respect to our performance. An explanation and reconciliation to GAAP measures can be found in our earnings release and financial tables. I'll now turn the call over to our Chief Executive Officer, A.J. Kazimi, to begin the corporate update and discussion of the company's performance.

A. J. Kazimi

Management

Good afternoon, everyone. And thank you for joining us, as we review our first quarter 2018 results. Also here with me on today's call are Cumberland's Chief Commercial Officer; Marty Cearnal; and our Chief Financial Officer, Michael Bonner. I'll start with the discussion of recent developments and review the first quarter highlights. Marty will follow with an update on our commercial activities, and I'll then discuss our clinical programs, and Michael will review our first quarter financial results. We'll provide some closing remarks and then, before opening the to any questions you may have. Let me begin by saying, those familiar with Cumberland Pharmaceuticals know that our goal is to build a business that generates sustainable growth and profitability. Our strategy in recent years for accomplishing that goal has been multifaceted. We've added new brands, increased the number of sales representatives supporting our products, launched new marketing campaigns, expanded product labeling, protected our intellectual property and advanced our clinical pipeline. That strategy has been a success, and we were able to post double-digit revenue growth in 2017, while advancing our clinical pipeline. However, these activities did bring additional expenses, such as increased royalties, supply costs and clinical study expenditures. Moreover, the products in our portfolio have recently faced a variety of challenges, ranging from manufacturing delays, inconsistent ordering patterns and in some cases, increased competition, but none of those expenses or developments come as a surprise, because it is the nature of our business, and we often remind investors, given such quarter-to-quarter fluctuations, it's best to view our business on an annual basis. And it's important for us to point out that our confidence is strong, and the commitment to our strategy is unwavering, as we firmly believe that we're on the best path forward for taking Cumberland to the…

Marty Cearnal

Management

Thanks, A.J. The sales of our branded portfolio were particularly strong in the fourth quarter of 2017 and then weakened during the first quarter of this year. We previously noted that seasonality in our business based on wholesaler, hospital and retailer buying patterns combined with the impact of high deductible insurance plans, appears to result in more spending later in the year. Based on these dynamics, we continue to believe that our business should be evaluated on an annual basis. During the first quarter of this year, we held a successful National Sales Meeting to help support and equip our sales teams in their efforts to build our brands. As a reminder, we have 2 national sales divisions. One calling on key hospital accounts across the country, featuring our Caldolor, Vaprisol, Ethyol and Totect brands. And the other, calling on select office-based physicians in the promotion of our Kristalose and Omeclamox-Pak brands. We have 50 sales professionals working in these 2 divisions. We recently announced the appointment of Chris Bitterman to lead our hospital sales division. Chris brings over 25 years of industry experience and a successful track record in leading hospital sales teams and building hospital brands. Highlights include, his role in building the national hospital sales force, as National Sales Director for Daiichi Sankyo. There he held – there he led the organization that grew to 200 representatives and managers. Working with copromotion partner Eli Lilly helped build Effient to over $500 million in annual gross revenues. Prior to his tenure at Daiichi, he held a number of increasingly responsible hospital sales positions at Sanofi Aventis, including sales and national account management as well as sales training. We also promoted Kenneth Acevedo to lead our field sales force. Kenny brings over 30 years of industry experience with previous…

A. J. Kazimi

Management

Thank you, Marty. I'd next like to discuss the product development efforts here -- underway at Cumberland. We previously reported on our agreement with the Nordic Group to acquire the exclusive U.S. rights to their injectable methotrexate product line. Methotrexate is approved in United States as a treatment for several diseases, including arthritis. An injectable methotrexate has been shown to result in increased efficacy, greater continuation rates and less discomfort for patients. We're working to introduce a line of new injectable methotrexate products in the United States, intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and severe psoriatic arthritis. We've selected the name RediTrex for these products and have been busy preparing for the FDA submission. We have received a significant amount of information from Nordic, including their European dossier, and our goal is to finalize the U.S. approval submission as soon as possible. With approval, we believe that RediTrex has the potential to be a meaningful contributor to our revenue, and we'll keep you posted as this initiative progresses. Meanwhile, our other development programs continue to advance, as we are fortunate to have a pipeline of promising candidates in Phase II clinical development. All are derived from ifetroban, our first new first chemical entity. We're pursuing several patient conditions with this molecule that represent unmet medical needs and do include candidates for orphan drug designation. You see ifetroban's been studied in some 26 clinical studies, involving over 1300 subjects. As a result, we have an extensive database available, including a large safety database for this particular drug. Preclinical studies have been published, demonstrating ifetroban's impact on platelet aggregation and inflammation, and more recent findings have emerged, indicating an anti-fibrotic effect. We successfully manufactured, both oral and injectable formulations of the drug, and we've teamed with leading…

Michael Bonner

Chief Financial Officer

Thank you, A.J. For the 3 months ended March 31, 2018, net revenues were $8.6 million compared to $9.6 million for the prior year period. Kristalose delivered $3.3 million of revenue in the first quarter, followed by $2.3 million for Ethyol. Net revenues during the quarter were $1.3 million for Acetadote, $1 million for Caldolor, $0.4 million for Totect and approximately $0.1 million each for Omeclamox-Pak and Vaprisol. Turning to our expenditures, total operating expenses for the 3 months ended March 31, 2018 were $11 million compared to $10.3 million for the prior year period. Adjusted earnings for the first quarter was a loss of $1.4 million or $0.09 per share compared to earnings of $0.3 million or $0.02 per share for the prior year period. During the first quarter, our balance sheet remained strong with total assets of over $91 million, including over $50 million in cash and marketable securities. Liabilities at the end of the quarter totaled $30 million, including $12 million on our credit facility. As I previously reported, we filed a shelf registration through From S-3, which was cleared by the SEC during the first quarter. The shelf provided for the potential sale of up to $100 million in corporate securities. It included an at-the-market, or ATM, feature which enables us to make stock available to new institutions who would like to quickly take a position in our shares. That completes our financial report for the first quarter of 2018.

A. J. Kazimi

Management

Thanks, Michael. So as you heard this afternoon, we're working hard on multiple fronts to build the value of Cumberland. I'm very encouraged by the progress we're making and expect those activities to help us achieve our goals. Given the large insider ownership in the company, our interests are closely aligned with our shareholders. In March, we provided our full financial results for 2017, reporting net revenues up 25% from the prior year. Although we do not expect that same level of growth in 2018, we do anticipate another surge in revenue, following the launch of our next products. Fortunately, we have to growth catalysts pending in our next-generation Caldolor product and our new branded methotrexate product line. We're also working hard to deliver on our pipeline, which is directed towards multiple market opportunities that are much larger than those we operate in today. For the longer term, our colleagues at CET continue their work with several academic institutions to identify and deliver new medicines for the future. We'll also continue our business development efforts and our acquisitions initiative. Through those efforts, we'll continue to seek select additions that complement our commercial portfolio. We'll manage our operations with financial discipline to maintain a strong balance sheet and keep Cumberland on a solid financial footing. We've recently stepped up our investor outreach to raise our profile in the investment community. Our goals are to expand the number of institutional holders of our shares, improve our share liquidity and obtain a price that better reflects our value. And most importantly, we'll continue to remain focused on our mission of advancing patient care through the delivery of high-quality pharmaceutical products with our experienced team of industry professionals. So with that review and update, now let's open the call to any questions you may have. Operator, please proceed.

Operator

Operator

Thank you, sir. Ladies and gentlemen, that concludes the company's presentation. We will now open the call for questions. [Operator Instructions] And our first question comes from the line of Andrew D'Silva from B. Riley FBR. Your line is open.

A. J. Kazimi

Management

Hello.

Operator

Operator

Just one moment. It looks like they had gotten out of the queue.

A. J. Kazimi

Management

Okay. Well, we understand that many of you may prefer a private discussion with the management, and we're certainly available to have those conversations. If you would like to have a call, please reach out to Erin Smith here, and she'll organize such a meeting by phone with you. Meanwhile, thank you, everyone, for participating in today's call and for hearing our update, and we will look forward to sharing another one at the following the end of the second quarter.

Operator

Operator

Thank you, sir. Ladies and gentlemen, that concludes our conference for today. If you would like to listen to a replay of today's conference, please dial 855-859-2056 using the access code 4296607. Alternatively, a replay of the webcast will the available on the company's website. I would like to thank you for your participation. You may now disconnect.