CPIX

Cumberland Pharmaceuticals Inc. (CPIX)

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Cumberland Pharmaceuticals Inc. (CPIX)

Q1 2013 Earnings Call

May 2, 2013 4:30 PM ET

Executives

Elizabeth Davis - Corporate Relations

A.J. Kazimi - Chief Executive Officer

Martin Cearnal - Senior Vice President and Chief Commercial Officer

Rick Greene - Chief Financial Officer and Vice President, Finance and Accounting

Analysts

David Gu - Wells Fargo Securities

Presentation

Operator

Good afternoon, ladies and gentlemen, and welcome to the Cumberland Pharmaceuticals first quarter 2013 earnings conference call. (Operator Instructions) At this time, I would like to turn the call over to Elizabeth Davis, who handles Corporate Relations for Cumberland Pharmaceuticals. Please go ahead.

Elizabeth Davis

Good afternoon, everyone. Before we begin, we'd like to advise that this call will include forward-looking statements, which reflect our current views about future events. These statements are subject to risks outlined in the Safe Harbor section of today's news release and detailed in our 10-K and 10-Q reports on file with the 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. If anyone has 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 other press releases and company updates on the Investors portion of our website. Additionally, this conference call is being webcast through our website and will be archived there for future reference.

I'll now turn the call over to our Chief Executive Officer, A.J. Kazimi.

A.J. Kazimi

Thanks, Elizabeth, and good afternoon, everyone. Thank you for joining us, as we review our first quarter results for 2013. With me on today's call are Marty Cearnal, Cumberland's Chief Commercial Officer; and Rick Greene, our Chief Financial Officer.

We'll start by reviewing highlights on the quarter, and then we'll provide updates on each of our products. We will finish by discussing our financial performance, before opening the call to your question. So let's begin.

We're pleased to start the year with favorable financial results in the first quarter. Net income was $0.9 million during the first quarter more than doubling from $0.4 million last year. Caldolor continue its growth curve and actually produced its best quarter since launch, with the net sales of $0.4 million.

Total net revenue for the first quarter of 2013 was $10.3 million similar to the prior-year period. Total assets as of March 31, 2013, were $98.3 million, including $70.2 million in cash and marketable securities.

Early in the quarter we announced topline results from three new Caldolor studies. Two were adult registry studies that support the safety of a shortened infusion time for the product. These two large studies evaluated Caldolor in 450 patients at 34 leading medical sites across the country.

The first registry study assess the safety and efficacy of Caldolor administered intravenously over five to 10 minutes to adult patients in hospital setting. These patients had either preexisting fever or preexisting pain. The intravenous ibuprofen reduced both fever and pain, and the shortened infusion time was well tolerated in this hospital study.

The second registry assess the safety of Caldolor administered intravenously again over five to 10 minutes in adult hospitalized patients, who are undergoing surgical procedures. The shortened infusion time was also well tolerated by the patients in the surgery study.

We also announced important data from a third Caldolor study during the quarter. Topline results from this 50 patient study provided our first direct and favorable comparison of Caldolor to ketorolac, which is the only other NSAID available for injection in this country.

51 adult patients were enrolled at the Ohio State University Medical Center, and compared to patients receiving ketorolac, the patients receiving Caldolor experienced less postoperative pain and received less rescue narcotic both prior to discharge and in the 24 hours following surgery. Patients in the Caldolor treatment group were also less likely to require any rescue narcotics prior to their discharge.

The topline results from each of these recently completed studies will be presented at appropriate medial meeting throughout the year. And then the final results will be published in appropriate medical journals. Meanwhile, our pediatric fever study is nearing completion. And we expect topline results from that study to be available here in 2013 as well.

All of this new Caldolor data will ultimately be incorporated into an FDA submission to seek updated and expanded labeling for the product. On to the international front, during the first quarter of 2013, we announced agreements for Caldolor with Sandor Medicaids in India and SOHO Group in Indonesia.

Expanding its international market is a key component of our growth strategy, and these partners represent an important milestone in our efforts to build an international presence for our brand. We're pleased to welcome both of these very capable partners, who now pursue regulatory approval and prepare for product launch in their respected countries.

I'll now turn it over to Marty Cearnal, to provide you with an update on our marketed products. Marty?

Martin Cearnal

Thank you, A.J. In the first quarter of 2013, Acetadote encountered generic competition. Therefore, we approve the launch of our authorized generic product distributed by Perrigo. The overall market for these products appears to have expanded during first quarter, as shortages of competitive oral products have reemerged.

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