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Cumberland Pharmaceuticals Inc. (CPIX)

Q3 2018 Earnings Call· Tue, Nov 13, 2018

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Transcript

Operator

Operator

Thank you for joining the Cumberland Pharmaceuticals Third Quarter 2018 Financial Report and Company Update. Please note that this conference call is being recorded at the company's request and will be archived on Cumberland's website for one week from today's date. Now I would like to introduce Erin Smith, who is responsible for Corporate Relations at Cumberland. Erin, please go ahead.

Erin Smith

Management

Hello, everyone. Before we begin today, I'd like to point out that earlier, we issued a press release containing Cumberland's financial results and corporate update for the third quarter ended September 30, 2018. You can find a copy of that release including the financial tables on our website at www.cumberlandpharma.com. I'd next like to review the following safe harbor language. Today's call may contain forward-looking statements within the meaning of the Private Securities Reform Act of 1995. Because such statements reflect the company's current views and expectations concerning future events, they may involve risks and uncertainties. Please 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, and future results could differ materially from the views expressed in today's call, and we don't assume any obligation to publicly update such forward-looking statements, whether as a result of new information or future developments. During today's call, we will be referring to some -- to several of the company's marketed brands. For more information on each of these brands, including full prescribing and safety information, you can find links to each of the individual product websites at www.cumberlandpharma.com. Also, please note that today, we'll provide adjusted earnings and financial metrics with respect to our performance, and explanation and reconciliation to GAAP measures can be found in our earnings release and in financial tables. I'll now turn the call over to our Chief Executive Officer, A.J. Kazimi, to begin our corporate update and discussion of the company's performance.

A. J. Kazimi

Management

Thanks, Erin. Good afternoon, everyone, and thank you for joining us. We appreciate your participation in today's call. As Erin noted, we'll provide an overall company update as well as a review of our third quarter financial results. Also with me on the call today are Marty Cearnal, Cumberland's Chief Commercial Officer; and Michael Bonner, our Chief Financial Officer. Today, we'll start with a report on several major developments. We'll then follow with an update on our commercial products and our development activities and then review our financial results, before finishing with our closing remarks, and then opening the call to any questions that you may have. So let's begin. As you will hear today, there has been an abundance of activity here at Cumberland, and I'm pleased to report we had another successful quarter as a result of that meaningful progress we've made in several key areas in building towards our long-term growth strategy. We believe this progress will translate into incremental revenues starting as soon as the end of this year. And even though our revenue performance for Q3 was a bit down when compared to the prior year and sequentially, once put into context, we believe the quarterly financial performance was actually better than it might appear. The key takeaway from these highlights I'm about to share is that 2019 is shaping up to be one of solid incremental revenue growth. We expect to have three new revenue drivers if all goes well. First, our newest acquisition should provide meaningful contributions during all of next year. Next, we're planning for our launch of the next-generation Caldolor product during the first half of 2019, and then during the second half of next year, we'll be planning to launch our new RediTrex product line pending favorable approval decisions by…

Martin Cearnal

Management

Thanks, A.J. This is both a busy and exciting time for our commercial endeavors. We continue to develop and implement programs for our seven marketed products while planning for the successful transition of Vibativ and the pending launches of the next-generation Caldolor and later next year for RediTrex. During the third quarter, we held a successful National Sales Meeting. At the gathering, our field and hospital sales representatives received the preparation needed to conclude 2018 and to start 2019 with a strong sales effort. The meeting included presentations from senior management, brand marketing and outside experts in our medical department. The district managers each conducted sessions with their teams devoted to ensuring competent implementation of all planned promotional activities. Later this month, we will convene an additional special meeting for our hospital sales force as a part of the transition activities for Vibativ. Turning to our in-line products. We recently announced two favorable Caldolor clinical study publications, adding to the growing library of literature supporting the brands. A study at the Ohio State Wexner Medical Center revealed more effective pain control and opioid-sparing activity with Caldolor when compared to ketorolac in patients undergoing arthroscopic knee surgery. Another clinical study conducted at Tufts University School of Dental Medicine concluded that preemptive treatment with Caldolor is more effective than treatment with IV acetaminophen in reducing both postsurgical pain and opioid use. In addition to the recent Caldolor publications, we also had favorable Ethyol clinical study results published during the third quarter. Ethyol is our patented, branded amifostine product indicated to reduce xerostomia, or dry mouth, which is often a side effect in patients undergoing postoperative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.…

A. J. Kazimi

Management

Thanks for sharing our progress, Marty. Well, during the third quarter, we welcomed our newest board member, Joe Galante at our September Board of Directors meeting. Joe is the former Chairman of Sony Music here in Nashville and a former President of RCA Records in New York. We are fortunate to be headquartered in Nashville, one of the country's most successful cities in the 21st century and our two largest industries here are health care and entertainment, and we now have leaders of both of those industries helping to build our company through participation on our board. We are delighted to welcome Joe to our Board of Directors and his successful business track record, entrepreneurial and public company experience make him a valuable new member. Meanwhile, we've continued to advance our robust clinical pipeline, which includes several potential orphan drug candidates. As an update, we've now completed study enrollment for Portaban, our portal hypertension clinical program. Portaban is a form of ifetroban and is in development for the treatment of the portal hypertension associated with liver disease. We enrolled 30 patients in a randomized, double-blind, placebo-controlled pilot study to assess ifetroban for the treatment of portal hypertension in cirrhotic patients. Cirrhosis is a life-threatening condition that can impair the flow of blood through the liver resulting in portal hypertension. The preclinical studies have shown ifetroban can reduce that portal pressure, necrosis, inflammation and fibrosis in multiple models of liver injury. An initial review of the data emerging from our study shows that ifetroban was safe and well tolerated with no unexpected side effects. Please note that the study was primarily designed to evaluate the safety of the ifetroban treatment in this population and it was not powered for an efficacy measurement. We did monitor hepatic venous pressure and patients enrolled…

Michael Bonner

Chief Financial Officer

Thank you, A.J. Total net revenues for the nine months ended September 30, 2018, were $27.2 million compared to $29.5 million for the prior year period. For the three months in September 30, 2018, net revenues were $8.5 million compared to $11.2 million for the prior year period. Our gross margin for the quarter was 83%. A major driver of this decrease was the significant sales of Totect last year resulting from a competitive drug shortage. Sales in the third quarter were also impacted by modest reorders of Vaprisol, following a surge in that product sales in the prior quarter. Net revenue by product for the three months ended September 30, 2018, included $3 million for Kristalose and $2.6 million for Ethyol. Net revenue for the quarter also included $1.3 million for Caldolor and $1.1 million for Acetadote. While net revenues were down sequentially in the third quarter, if you evaluate the results by product, 6 of our 7 marketed brands performed consistently with the prior quarter. One product, Vaprisol accounted for the majority of the sequential shortfall. In Q2, we reported $1.7 million in Vaprisol sales following increased product supply to the market after limited availability. Customers replenished their inventory of Vaprisol last quarter so sales this quarter were minimal. We do expect to see a return in Vaprisol shipments to more normalized trends in subsequent quarters. We believe that the best way to analyze our performance is on an annual basis as quarterly results do vary. Recall that our revenues grew 25% during the last full calendar year. We look forward to our next set of growth drivers associated with the shipments of our newest commercial brand, Vibativ, the launch of our next-generation Caldalor product and the launch of our new methotrexate product line. If all goes well, these three products should be contributing to our revenue, first with Vibativ in late 2018, followed by our next-generation Caldolor and RediTrex in 2019 pending their FDA approvals. We believe the combination of these three new products should have a meaningful impact on our revenue next year. Total operating expenses for the three months ended September 30, 2018, were $10.3 million compared to $12 million during the prior year period. That completes our financial report for the third quarter of 2018.

A. J. Kazimi

Operator

Thanks, Michael. We're working hard to build a specialty pharma company that delivers sustained growth, profitable operations and long-term value. As you've heard today, we've been extremely active in pursuing our goals and we expect the results of those efforts to be contributing as soon as this quarter. We're very excited about the potential of these developments that we reported today, including the Vibativ acquisition, the Caldolor and RediTrex FDA submissions and the new NIH grant award associated with CET. As we continue through the end of this year, the same initiatives remain our focus, and we're confident that our strategy of building a diversified product portfolio is on track and well suited to deliver sustained growth and profitability in the years to come. We'll continue to manage our operations with financial discipline, with the goal of delivering positive cash flow. And we remain in a strong financial position with high margins and a favorable balance sheet as we continue our work to advance our mission of improving patient care through the delivery of high-quality pharmaceutical products. So that's our review and update. And now let's open the call if there are any questions. Operator, please proceed.

Operator

Operator

[Operator Instructions]. And our first question comes from the line of Andrew DeSilva with B. Riley FBR.

Andrew D'Silva

Analyst · B. Riley FBR

If you could please just touch base on Vibativ, the acquisition, and what it does to your broader R&D activity as it relates to the ifetroban candidates primarily? Should we expect this to be viewed as a steady state from your internal development goals or should we expect a shift now that you'll obviously need to focus on the integration? And then what kind of increase should we model for hospital sales force from an additional team member standpoint or additional costs?

A. J. Kazimi

Operator

Sure. So the first -- to answer your first question, I would assume a steady state, full steam ahead in pursuing the development of ifetroban. The Vibativ acquisition does not impact that strategy, and as we've noted, getting any one of those ifetroban products to the market could be a game changer for our company and a key value driver. Regarding the expansion of the organization, we are fortunate that we have an existing infrastructure that we can layer Vibativ into. And a lot of costs to commercialize and support Vibativ are already being incurred. As you noted, there will be some expansion and we will be adding a few hospital sales territories and perhaps a few medical positions in the field as well as a position or two in the home office. But no major expansion but just a rounding out of our current team.

Andrew D'Silva

Analyst · B. Riley FBR

And you had some comarketing agreements in the past with other products. Is this a situation where we should expect that as well?

A. J. Kazimi

Operator

As you know, we do have copromotion agreements for Caldolor and Vaprisol with one company and then for Kristalose with another. We are -- right now, regarding Vibativ in your question, we are focusing on the smooth transition of the product from Theravance to Cumberland, and the training needed to get our people up to speed on how to best support the brand. That's our focus in the near term. But you're correct that over time, we do consider copromotion opportunities and that's certainly a possibility for this new brand.

Operator

Operator

[Operator Instructions]

A. J. Kazimi

Operator

Okay. Well, thank you, everyone, for joining our call today. As we've mentioned in the past, we do understand that many of you prefer a private discussion with management and if so, just reach out to Erin here and she can help us schedule such a call. We do appreciate your time and interest in Cumberland, and we look forward to then providing you with an update after the end of the fourth quarter. Goodbye, everyone.

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 4258737. Alternatively, a replay of the webcast will be available on the company's website. I would like to thank you for your participation. You may all disconnect.