Cumberland Pharmaceuticals Inc. (CPIX) Q1 2015 Earnings Report, Transcript and Summary

Thank you for joining the Cumberland Pharmaceuticals First Quarter 2015 Financial Results Conference Call. Please be advised that this call is being recorded at the company’s request and will be archived on the company’s website for one week from today’s date. At this time, I would like to introduce Erin Smith who handles Corporate Relations for Cumberland Pharmaceuticals. Erin. Please go ahead.

Hello, everyone. Before we begin I’d like to point out that earlier today the company issued a press release containing our financial results for the first quarter ended March 31, 2015. The release, including the financial tables, is available on the company's website at www.cumberlandpharma.com. I’d now like to share this following Safe Harbor language. This call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Because these statements reflect the Company's current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption Risk Factors in our Form 10-K, Form 10-Q, and Form 8-K filings with the SEC, could affect the company's future financial results. Those future results could differ materially from those expressed in these forward-looking statements which are qualified by these risk factors. The company does not assume any obligation to publicly update any forward-looking statements, whether as a result of new information, future development, or otherwise. We will also provide some non-GAAP financial measures with respect to our performance today. A reconciliation to GAAP measures can be found in our earnings release and its related financial table. Also, please note that this conference call is being webcast through our website and will be available there. I will now turn the call over to our Chief Executive Officer, A. J. Kazimi, to begin our discussion of the company's performance.

Good afternoon, everyone, and thank you for joining us, as we review our first quarter 2015 results. With me on today's call are Cumberland's Chief Commercial Officer, Marty Cearnal; our Chief Financial Officer, Rick Greene; and our Senior Director, Regulatory and Scientific Affairs, Dr. Amy Rock. We’ll plan to discuss our recent developments, provide a clinical update, and then present an overview of our financial results for the quarter. We’ll then conclude with a review of the company's strategy and plans before opening the call to any questions you may have. So let’s begin. In the first quarter of 2015 we continued the momentum established in a successful 2014. During the first quarter we generated robust year-over-year growth in adjusted earnings, continued to advance the goals of the company which we believe bodes well for our future growth. More specifically we advanced our clinical candidates and our marketed product profiles, we expanded our international activities, posted sequential growth in our newly acquired products, and continued to repurchase shares all while maintaining a strong balance sheet. We’ll now take you through our more detailed review of that progress made in each of the areas that I just highlighted. After completing the series of Phase IV studies for Caldolor in 2014, we filed a supplemental new drug application or SNDA with the FDA earlier this year. Today we are pleased to announce that the FDA has accepted our submission for review and will consider our request to changes to the package insert to include pediatric and other updated information. This is just one of several recent developments in a very productive start to 2015 for our clinical and regulatory department. In January we announced the publication of two large Phase IV registry studies supporting a Shortened Infusion Time for Caldolor. And in…

Thanks A.J. Our team has never been busier and I am delighted to share our progress on several key initiatives. As A.J. mentioned we had completed a number of Phase IV studies for Caldolor in a total of over 1,000 patients. These studies included the evaluation of Caldolor in both children and adults. The results from two Caldolor Phase IV studies were recently published and are currently available as manuscripts in the journal Clinical Therapeutics. These two studies evaluated the tolerability and efficacy of a Shortened Infusion Time for Caldolor in 450 patients at 30 leading medical centers across the country. Based on the findings from our Phase IV Caldolor program we completed and submitted a supplemental new drug application to the FDA for the product. We requested changes to the package insert to include pediatric and other updated information. We are pleased that the FDA has now accepted our submission for review and we look forward to working with them as they evaluate this application. Early in the first quarter we announced the addition of a new Phase II development program to our pipeline with Boxaban an oral formulation of ifetroban. We are evaluating this product candidate as a treatment for patients with aspirin-exacerbated respiratory disease or AERD. AERD affects approximately one in 20 individuals with asthma which translates to 1 million patients in the United States. It is characterized by sharp increases in inflammatory mediators and platelets activity within the respiratory system. We have completed manufacturing of the Boxaban oral capsules, received FDA clearance, and initiated a Phase II clinical study. This multicenter study led by investigators at the Scripps Clinic is designed to gather initial safety and tolerability data on ifetroban and AERD patients. The study is now well under way and we’ve made significant progress with patient enrollment. We look forward to announcing findings from this important trial later this year. Finally you may recall that we announced top line results for our other pipeline candidate Hepatoren. We are developing Hepatoren as a potential treatment for hepatorenal syndrome or HRS, a life threatening condition involving both liver and kidney failure. Patients with HRS suffer from a high mortality rates and there is no approved pharmaceutical therapy for the disease in this country. Top line results from these patients indicate that Hepatoren was overall well tolerated in this patient population with no safety concerns noted. Furthermore the patients receiving the higher dose levels of Hepatoren were more likely to experience increases in urine output, an important signal of improved kidney function compared to patients who receive placebo. Based on these encouraging results we are proceeding with clinical development of this product candidate. Next steps include enrollment of the remaining patients, a full review to data set, and design of a follow on study. That completes our clinical update and I’ll now turn the call back over to you A.J.

Thanks Amy, I must say we are very excited about these new developments and we do look forward to providing further updates as these clinical and regulatory initiatives progress. So I’ll now turn it over to our Chief Financial Officer, Rick Green for the financial review. Rick?

Thank you A.J. For the three months ended March 31, 2015 net revenues were 8.7 million compared to 8.1 million for the prior year period. Net revenues of our product for the first quarter were 4.1 million for Kristalose, 1.5 million for Acetadote, including 0.5 million for our authorized generic, 1.2 million for Caldolor, 1 million for Vaprisol, and 0.8 million for Omeclamox. I’d like to provide some color on these revenue results of our product. First of all please note that our authorized generic was on back order for much of the first quarter which significantly impacted Acetadote sales results. Shipments of Omeclamox pack started to rebound in Q1 following the temporary shortage of that product in late 2014. Both these back order situations are now resolved and normal shipments have resumed. Caldolor sales increase significantly during the first quarter while Kristalose sales continued their strong growth following the repositioning of that brand early last year. Overall I am pleased with our first quarter revenue results and the fact that they grew compared to the prior year in spite of the back order issues I mentioned. Total operating expenses for the three months ended March 31, 2015 were 8.7 million compared to 7.7 million for the prior year period. These expenses were impacted by 1.2 million and FDA filing associated with our supplemental new drug application for Caldolor. Adjusted earnings for the first quarter grew 72% to 1.6 million or $0.09 per share compared to 9.9 million or $0.05 per share for the prior year period. This significant growth in adjusted earnings was due to both increased revenues and our ongoing efforts to efficiently manage the company’s expenses. Meanwhile we continue to believe our share represent an attractive investment opportunity. During the first quarter we repurchased another 268,000 shares and have now repurchased over 4.7 million shares through this program since its inception. In January our Board of Directors authorized an additional $10 million available for repurchase of Cumberland shares using our excess cash generated from operations. As of March 31, 2015 we had 92 million in total assets including approximately 53 million in cash and cash equivalents and marketable securities. We had no debt and tax loss carry forwards of $44 million. That completes our financial review of the first quarter of 2015. And I’ll turn the call back over to you A.J.

Thanks Rick. We believe that 2015 is off to a promising start and you see our strategy is to build upon the positive momentum we generated last year and maximize the full potential of our commercial brands. We also pursue opportunities to further expand our product portfolio to our business development efforts and advancement of our internal pipeline. We are confident that we are well positioned to achieve our goals this year and most importantly we remain focused on our mission of advancing patient care through the delivery of high quality pharmaceutical products. So with that now let’s open the call to any questions you may have. Operator, please proceed.

I would just like to thank everyone for joining our call today. We do appreciate your time and interest in Cumberland and we’ll look forward to providing another update after the end of the second quarter. Goodbye.