Elizabeth Davis - Corporate Relations A. J. Kazimi - CEO Marty Cearnal - Chief Commercial Officer Rick Greene - Chief Financial Officer.
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Good day ladies and gentlemen and welcome to the Cumberland Pharmaceuticals First Quarter 2014 Earnings Conference Call. (Operator Instructions). I’d now like to introduce your host for today’s conference Elizabeth Davis, Corporate Relations. Please go ahead..
Hello, everyone. Before we begin I would like to point out that the company issued a press release containing financial results for the first quarter ended March 31, 2014. The release included the financial table is available on the Company’s website at www.cumberlandpharma.com. Before we begin, allow me to read the following Safe Harbor Statements.
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, expectation and beliefs concerning future events. These forward-looking statements involve risk and uncertainties.
Investors should note that many factors as more fully described under the caption, risk factors and our form 10-K, form 10-Q and form 8-K filings with the SEC could affect the company’s future financial results and could differ materially from those expressed in forward-looking statements contained in the company’s annual report on 10-K or other SEC filings or public statements.
The forward-looking statements are qualified by these risk factors. The company assumes no obligation to publically update any forward-looking statements whether as a result of new information, future developments or otherwise. Also 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 to begin our discussion of the company’s quarterly performance..
Good afternoon everyone. Thank you for joining us as we review our first quarter 2014 results. With me on today’s call are Cumberland’s Chief Commercial Officer, Marty Cearnal and our Chief Financial Officer, Rick Greene.
We’ll start by reviewing our recent developments and then provide an update on our products, followed by a discussion of our financial performance. We’ll then review our strategy and key objectives.
So let’s begin, our first quarter of 2014 was very successful as we effectively executed on many important goals which had positively impacted our future growth. Furthermore I’m very pleased to report that through the sales of our five FDA approved products we were able to return Cumberland to profitability this quarter.
You may recall in our last earnings report we announced both the Omeclamox-Pak launch and the Vaprisol acquisition. Today I’m pleased to report that the Omeclamox-Pak is off to a strong start as we are encouraged by the products performance since we began active promotion in January.
Omeclamox is been promoted in conjunction with our partner Pernix Therapeutics, who details the product to select primary care physicians. Our field sales force covers the gastroenterologists who are the most prolific prescribers in this product.
We worked closely with Pernix to coordinate transition of the commercial responsibilities for Omeclamox and that planning was time well spent resulting in a smooth transition and solid prescription growth in the Cumberland territories.
We’re also pleased to announce that we have now formerly launched our promotional efforts to support Vaprisol, our fifth commercial product. Vaprisol is an injectable hospital product used in a critical care setting which represents a very complimentary addition for our hospital sales force.
This patented product was developed and registered by Astellas who launched it in 2006. Vaprisol is one of two branded prescription products indicated for the treatment of hyponatremia. This condition can be associated with a variety of critical care issues including congestive heart, liver and kidney failure, cancer or pneumonia.
Meanwhile in another major development we announced last week a $1 million investment into CET by our Chinese Partner Gloria Pharmaceuticals. We established CET along with Vanderbilt University and the state of Tennessee to develop a long term pipeline of innovative new products.
We believe Gloria’s investment can help accelerate the development of CET’s programs. Gloria will have the first opportunity to negotiate a license to CET products for China while Cumberland will retain access to CETs products for the rest of the world. We’re delighted to welcome Gloria as a new partner in the CET initiative.
I would now like to ask Marty Cearnal to provide an update on our marketed products.
Marty?.
Thank you A.J. Let’s begin with our newest products, we excited about the addition of Vaprisol, our newest injectable hospital product. Vaprisol is the first and only intravenously administered vasopressin receptor antagonist.
Vaprisol is one of just two branded prescription products indicated for the treatment of hyponatremia, that reduces excess water to increase serum sodium concentration and regulates the water sodium balance in hospitalized patients.
Vaprisol does not require dilution and has a well-defined daily regimen of 10 milligrams, 20 milligrams or 40 milligrams providing convenient administration with the control of IV dosing. Vaprisol was approved by the U.S.
Food and Drug Administration in 2005 for euvolemic hyponatremia and in 2007 for hypervolemic hyponatremia launched commercially in 2006 the product was developed and registered by Astellas before being acquired late in February by Cumberland. As A.J. mentioned Vaprisol was especially launched by Cumberland last week at our National Sales Meeting.
The meeting was a big success in part because Vaprisol is an exciting new product for the hospital sales force to detail and in turn they are very enthusiastic about the potential of the product. Regarding a leading expert in the field to provide the latest information on the product for our hospital sales team.
We have made adjustments to their territories to ensure appropriate coverage for the product. We have also made a seamless transition with Astellas and are now selling the product through our distribution channels. Our second new product Omeclamox-Pak is off to a very strong start.
Prescriptions in Cumberland’s territories were up 28% in the first quarter and I would note that the field sales force is very energized about the positive acceptance of this product so far. As you may know many stomach ulcers are caused by an infection from the bacteria Helicobacter pylori or H. pylori which colonize in the stomach and duodenal.
When present this bacterial infection has been proven to be the cause of over 90% of duodenal ulcers. These ulcers commonly cause abdominal pain and may lead to serious bleeding. The U.S. prevalence of H. pylori is approximately 30% to 40% than adult and it's eradication has been shown to reduce the risk of duodenal ulcer recurrence.
Omeclamox-Pak is a branded prescription product that combines three key ingredients, omeprazole, amoxicillin, clarithromycin for the treatment of H. pylori infection and related ulcer disease. Omeclamox is prescribed over a shorten treatment period of 10 days and has the lowest pill burden of available combination products to treat H. pylori.
Now on to Caldolor, pediatric fever results on efficacy and safety of Caldolor were presented at the Pediatric Anesthesiology Conference, 2014 in Ft. Lauderdale in early March.
The pediatric study met it's primary end point demonstrating that Caldolor was associated with a statistically significant reduction in temperature within the first two hours of dosing when compared to acetaminophen. Equally important, no safety concerns were observed during the study.
During the study, febrile hospitalized children ranging in age from less than 1 year to 16 years, were administered Caldolor, ibuprofen injection or oral or rectal acetaminophen as a single or multiple dose therapy for up to five days.
The presentation was entitled a multi-center, open-label parallel active comparator multi-dose trials to determine the efficacy, safety and pharmacokinetics of intravenous ibuprofen in pediatric patients and the presentation was provided by Dr. Samia N. Khalil, from the Department of Anesthesiology, the University of Texas Medical School at Houston.
On to Acetadote, we continue to feature the EDTA free message at all levels of distribution and promotion. We’re maintaining sales promotion coverage at key medical facilities in all poison control centers. As a result we have continued to maintain majority share of the market between the sales of Acetadote and our authorized generic.
Lastly we have launched new marketing strategy for Kristalose and are already seeing it's positive impact. Our new strategy has allowed us to better support the product for patients and offers new opportunities to partner with managed care providers.
We’re also utilizing a new couponing programs with an ePrescribing feature to enhance patient access to Kristalose. That completes the update on our marketed brands and I will turn it over to Rick Greene for the financial review..
Thank you Marty. For the three months ended March 31, 2014 net revenues were 8.1 million. Net revenues by product was 3.4 million for Kristalose, 2.7 million for Acetadote including 1.3 million of authorized generic, 1.1 million for Omeclamox. 0.5 million for Caldolor and 0.3 million for Vaprisol.
Vaprisol was included in our financial results for only one month. Total operating expenses for the first three months of 2014 was 7.7 million down 14% compared to 8.9 million for the prior year period. We continue to focus on managing our expenses in-line with our revenues.
Net income for the three months ended March 31, 2014 was 0.3 million compared to 0.9 million in 2013 but this represents a significant sequential improvement from the net loss of 1.5 million for the fourth quarter of 2013.
Diluted earnings per share for the first quarter were $0.02 down from $0.05 in the first quarter of 2013 was up significantly from the loss per share of $0.08 in the fourth quarter of 2013. Cash flow from operations for the three months ended March 31, 2014 was $1 million compared to 1.7 million in the first quarter of 2013.
As of March 31, 2014 we had approximately 52.6 million in cash and securities. We were approximately 39 million in cash and cash equivalents and 13.5 million in marketable securities. Total assets were 91.1 million. Our financial position remained strong with over 50 million in cash and investments and no debt.
We continue to believe our shares represent a valuable investment and continued our buyback program each quarter. During the first quarter we repurchased approximately 193,000 shares and have now repurchased over 3.5 million shares through this program since it's inception. With that I will turn the call back over to you A.J..
Thanks Rick. We’re extremely pleased that we’re able to return the company to profitability in a relatively short period of time. Furthermore we’re very optimistic about the opportunities that Vaprisol and Omeclamox offer Cumberland. We feel that both product additions will allow us to continue momentum and growth to our commercialization efforts.
We’re building a diversified product portfolio while deploying our resources to sustain long term profitability. And we will selectively pursue additional new commercial and late stage development opportunities. Meanwhile we’re also focusing our development efforts on accelerating our pipeline candidate that’s associated in clinical programs.
We intend to conclude the analysis reports and publications for the completed Caldolor studies and we will then update the comprehensive safety and efficacy data set for the product and seek expanded labeling for Caldolor.
Our lead development candidate Hepatoren is progressing through it's Phase II study in patient suffering from life threatening liver and kidney failure and our goal is to complete enrollment in that key study this year.
Management remains committed to placing revenues back on the growth trajectory, returning the company to profitability and maintaining a strong balance sheet. We believe our stock represents an attractive investment opportunity and we will continue to repurchase shares with excess cash as Rick described.
The interest of this organization, management and our shareholders remain closely aligned. And we will continue to focus on our mission of improving patient care to the delivery of high quality pharmaceutical products. With that lets open the call to any questions. Operator, please proceed..
(Operator Instructions). And I’m not showing any questions at this time. I would now like to turn the call back to management for any closing remarks..
Okay. Well management remains available for any questions that may come up afterwards and I just want to thank everyone for joining us on the call today. We do appreciate your time and interest in Cumberland and we look forward to providing you with another update after the end of the second quarter. Good bye..
Ladies and gentlemen thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone have a great day..