CPIX

Cumberland Pharmaceuticals Inc. (CPIX)

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Cumberland Pharmaceuticals (CPIX)

Q4 2012 Earnings Call

February 28, 2013 4:30 pm ET

Executives

Elizabeth Davis

A. J. Kazimi - Founder, Chairman, Chief Executive Officer and President

Amy Dix Rock - Senior Director of Regulatory & Scientific Affairs

Martin E. Cearnal - Chief Commercial Officer, Senior Vice President and Director

Richard S. Greene - Chief Financial Officer, Principal Accounting Officer and Vice President

Analysts

David Gu - Wells Fargo Securities, LLC, Research Division

Presentation

Operator

Good afternoon, ladies and gentlemen, and welcome to the Cumberland Pharmaceuticals Fourth Quarter and Full Year 2012 Earnings Conference Call. [Operator Instructions] This call is being recorded and a replay will be available for 1 week shortly following its conclusion.

At this time, I'd like to turn the call over to Elizabeth Davis, 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 on the Investors portion of our website under Events and Presentations. 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. Good afternoon, everyone, and thank you for joining us as we review our 2012 results and discuss our strategy for 2013. With me on today's call are Marty Cearnal, our Chief Commercial Officer; Rick Greene, Cumberland's Chief Financial Officer; and Amy Rock, our Senior Director, Regulatory and Scientific Affairs.

I'd like to begin by reviewing some of our 2012 highlights and then move on to providing an in-depth update on our development and commercial activities, followed by a review of our financial performance. We'll then conclude with Cumberland's plans and outlook for 2013 before opening the call to questions.

So let's begin with some highlights from 2012. We continued to make progress on a number of key initiatives as we advanced our mission, delivering products to improve the quality of health care for patients. As we review the full year 2012 financial results, we're pleased to report a productive year, which included continued profitability and positive cash flow from our operations. We also ended the year with a very strong balance sheet, including over $70 million of cash reserves, nearly $100 million of total assets and minimal debt. We provided our products to a growing number of patients in 2012, and we realigned our sales force to efficiently provide continued support for all 3 of our marketed brands.

In 2012, our clinical development team completed patient enrollment in 4 new Caldolor studies. In September, we announced top line results of our first pediatric study, demonstrating that Caldolor resulted in a significant reduction in narcotics given to children undergoing tonsillectomy procedures. We recently announced top line results from 2 adult registry studies that support the safety of a shortened infusion time for Caldolor. These 2 large studies evaluated Caldolor in 450 patients in 34 leading medical sites around the country.

Now today, we're pleased to announce important data from the fourth new Caldolor study. Top line 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.

Regarding our intellectual property, last year, the U.S. Patent and Trademark Office allowed 2 patent applications associated with Acetadote. Following the issuance of the first patent, we did receive several challenges and have already settled with 2 of those challengers. We were disappointed to learn that the FDA approved a generic version of Acetadote in November, which was based on the old formulation of the product. Later in the year, we learned of initial shipments of that generic product. That prompted us to release initial shipments of our authorized generic version, enabling us to compete in that segment of the market. Throughout the year, we took appropriate measures to defend Acetadote, including suits to contest each challenger, as well as a suit to contest the FDA's decision to approve an old formulation generic.

Meanwhile, in 2012, our business development team finalized a series of new licensing agreements, expanding our network of international partners, which now includes Canada, Australia, China, Indonesia and India. In 2012, Caldolor was launched in Canada, and today, I am pleased to announce that Caldolor was also approved in Australia at the end of last year.

Turning to CET, or Cumberland Emerging Technologies, recall, we formed that subsidiary to deliver a long-term pipeline of innovative new products. CET was the source of Hepatoren, which progressed in Phase II testing in 2012 as a potential treatment for Hepatorenal Syndrome. Last year, we also completed an expansion of the CET Life Sciences Center, which houses our formulation laboratories.

Overall, we made progress on many fronts in 2012, and I appreciate all the dedicated efforts and contributions from our team.

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