Cumberland Pharmaceuticals (CPIX)
Q2 2013 Earnings Call
August 06, 2013 4:30 pm ET
A. J. Kazimi - Founder, Chairman, Chief Executive Officer and President
Martin E. Cearnal - Chief Commercial Officer, Senior Vice President and Director
Richard S. Greene - Chief Financial Officer, Principal Accounting Officer and Vice President
Abbott J. Keller - Kestrel Investment Management Corporation
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Good afternoon, everyone. And before we begin, we'd like to advise that this call will include forward-looking statements, which reflect our current views about future events. Such forward-looking statements are subject to the risks outlined in the Safe Harbor section of today's press release and are detailed in our 10-K and 10-Q reports on file with SEC. Despite our best efforts, actual results could differ materially from our expectations.
Information shared on the call today should be considered current as of today only, and please remember that the company assumes no duty to update it. Today, we issued a press release featuring our second quarter 2013 financial results and company update. If you have not seen our press release issued today, you can access it on our website at www.cumberlandpharma.com. We also post and maintain the current version of our corporate presentation as well as any other press releases and company updates on the investor portion of our website. Additionally, please note that this conference call is being webcast through our website and will be available there.
I'll now turn the call over to our Chief Executive Officer, A.J. Kazimi.
A. J. Kazimi
Thanks, Elizabeth. Good afternoon, everyone, and thank you for joining us as we review our second quarter results for 2013. With me on today's call are Cumberland's Chief Commercial Officer, Martin Cearnal; and, our Chief Financial Officer, Rick Greene. We'll start by reviewing highlights from the quarter, then we'll provide an update on our products, followed by a discussion of our financial performance. And lastly, we'll provide an overview of our strategy before opening the call to any questions. So let's begin.
During the second quarter, we announced that the FDA had approved updated labeling for Acetadote. The new labeling revises the product's indication and offers new dosing guidance for specific patient populations. The new indication states that Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. The product's previous indication included the qualifying phrase, "Administered intravenously within 8 to 10 hours," which was originally intended to repress the urgency for early treatment. However, this phrase has now been removed due to potential confusion concerning efficacy.
Furthermore, specific dosing guidance is now included for patients weighing over 100 kilograms. A new language has also been added to alert health care providers that, in certain clinical situations, therapy should be extended for some patients. The Acetadote labeling changes reflect our commitment to this patient population by providing clearer and more extensive dosing guidance to assist health care professionals when treating patients in a time-urgent and life-threatening situation.
Additionally, you may recall, we've been working to expand the labeling on our Caldolor brand. Today, we're pleased to announce that we've completed enrollment in our pediatric fever study. In that study, we evaluated the safety and efficacy of Caldolor, compared to acetaminophen, in treating fevers in hospitalized children. The top line results from this study indicate that we met our primary endpoint, demonstrating greater overall fever reduction with Caldolor versus the acetaminophen comparator.
Turning to other positive developments. On the international front, we entered into 2 new agreements for the registration and commercialization of Caldolor outside the United States during the second quarter of 2013.
The first agreement is with Laboratorios Grifols, a Spanish-based company, for a territory that features our first European countries, Spain and Portugal, along with much of South America, including Argentina, Chile, Brazil, Ecuador, Peru and Uruguay.
The second agreement is with our Indonesian partner, PT. SOHO Industri Pharmasi. And that new agreement with SOHO add several Pacific Rim countries, including Singapore, Thailand, Vietnam, Cambodia Laos, Brunei and the Philippines.
Also, during the second quarter, we amended our agreement with our Chinese partner, Harbin Gloria, by extending their territory to now include Hong Kong and Macau. This growing number of international partnerships represents the successful implementation of our international growth strategy.
As a reminder, we do own the worldwide rights to all our products, and we expect that our network of international partners will be an important contributor to Cumberland's long-term growth.
I'll now turn it over to Marty Cearnal, to provide an update on our marketed products. Marty?
Martin E. Cearnal
Thank you, A.J. Let's begin with Acetadote. Early in 2013, Acetadote encountered generic competition. Therefore, we approved the launch of our authorized generic product distributed by Perrigo. Both Acetadote and our authorized generic feature our new formulation, which is free of EDTA and any other chelating or preservative agents. Our goal has been to maintain a majority share of this market in 2013 through the combined sales of our Acetadote brand and the authorized generic. Through the second quarter of 2013, we have done just that. We've provided active sales support for key medical facilities and poison control centers across the country through our hospital sales division. We've also utilized additional non-personnel promotional tools to extend our communication efforts. These targeted promotional efforts support our new formulation and consistently contain the EDTA-free message, as well as describing its enhanced stability compared to the old formulation. We believe the differences between our EDTA-free product and the EDTA-containing generic version are meaningful, and we continue to feature that message to the medical community.