NASHVILLE, Tenn., March 10 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. , a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced full year 2009 financial results.
Net Revenue: For the year ended December 31, 2009, net revenue was $43.5 million, an increase of 24% over the same period in 2008. This growth was due primarily to an increase in volume for Acetadote(R) (acetylcysteine) Injection, the Company’s treatment for acetaminophen overdose, as well as initial stocking from the launch of Caldolor(R) (ibuprofen) Injection, Cumberland’s recently approved IV treatment for pain and fever. Net revenue for the three months ended December 31, 2009 was $10.7 million, compared to $9.8 million for the same period in 2008.
Net Income: Net income for the year ended December 31, 2009 was $3.1 million, or $0.17 per diluted share, compared to $4.8 million, or $0.29 per diluted share, for the same period in 2008. This change in earnings per share is due in part to an increase in shares outstanding from Cumberland’s initial public offering in 2009. Excluding the aforementioned Caldolor milestone and payroll tax expenses, net income as adjusted for the year ended December 31, 2009, was $4.9 million, or $0.27 per diluted share.
EBITDA: Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) for the year ended December 31, 2009 was $6.6 million compared to $8.1 million for the same period in 2008. Excluding $0.7 million of non-cash stock compensation expense, $1.1 million in payroll taxes from non-qualified stock option exercises and $2.0 million in Caldolor milestone expenses in 2009, and $0.6 million in non-cash compensation expense in 2008, adjusted EBITDA would have been $10.4 million and $8.6 million in 2009 and 2008, respectively, representing growth of 20%.
2009 Highlights
In September 2009, Cumberland successfully launched Caldolor in the United States. The Company’s hospital and field sales forces, comprised of 113 experienced sales professionals, are now promoting the product and Caldolor is fully stocked at wholesalers serving hospitals nationwide. The Company is working to introduce Caldolor and secure formulary approval nationally, and the product is now stocked in a number of medical facilities across the country. In addition to personal sales promotion, Cumberland is supporting the product through a multi-faceted marketing campaign, including internet and media advertising, medical society and convention presence, journal publications, and its medical information call center.
In August 2009, Cumberland completed its initial public offering of 5,000,000 shares of common stock at a price of $17.00 per share, raising $85.0 million in gross proceeds. Net proceeds to the Company were $74.8 million after commissions and offering expenses. Cumberland’s common stock began trading on the NASDAQ Global Select Market on August 11, 2009, under the trading symbol “CPIX”. Proceeds from the offering helped to fund the launch of Caldolor, and Cumberland’s continued profitability and positive cash flow have allowed the Company to retain the majority of the proceeds for potential new acquisitions.
In 2009, the Company announced that it entered into exclusive agreements with Phebra Pty Ltd. for commercialization of Caldolor in Australia and New Zealand, and with DB Pharm Korea for registration and commercialization of the product in South Korea. Phebra and DB Pharm Korea will be responsible for obtaining regulatory approval for Caldolor in their respective territories, and for handling ongoing regulatory requirements, product marketing, distribution and sales. Cumberland will maintain responsibility for product formulation, development and manufacturing, and will provide finished product for sale. Cumberland will receive upfront and milestone payments as well as a transfer price from the partnering companies, and will also receive royalties on any sales of Caldolor in those territories.
In addition to Cumberland’s issued patent for Caldolor, the Company has filed the two new patent applications based on its clinical data for the product. Cumberland’s research in hospitalized patients uncovered new findings for which the Company previously filed several provisional patent applications. Cumberland has now converted two of these provisional applications to full applications, which address the effect of intravenous ibuprofen in critically-ill, hospitalized patients as well as its effect on patient blood pressure.
Cumberland intends to file a supplemental New Drug Application (sNDA) for Acetadote related to the product’s ability to treat acute liver failure. Cumberland originally received FDA approval for Acetadote in 2004 for the treatment of acetaminophen overdose in adults, and has since expanded the product’s label with a pediatric indication in 2006 and data further supporting the product’s safety in 2008. This new sNDA submission is primarily based on a recent multicenter clinical study led by investigators at the University of Texas Southwestern Medical Center. The study results demonstrate that Acetadote is both safe and effective in treating patients suffering from acute liver failure, significantly improving transplant-free survival rates and reducing the number of patients requiring liver transplant.
The following table provides a reconciliation of Cumberland’s reported (GAAP) statement of income to our adjusted (non-GAAP) statement of income for the period ended December 31, 2009. The adjusted statement includes certain items that management believes are infrequent or unusual in amount, and is provided to assist investors in evaluating Cumberland’s current and future performance. The adjusted statement should not be considered a substitute for Cumberland’s reported statement of income.
The following table presents a reconciliation of Cumberland’s net income to EBITDA and adjusted EBITDA. The Company defines EBITDA as net income plus interest, income tax, depreciation and amortization, and presents these measures to assist investors in evaluating Cumberland’s operating performance and comparing the Company’s results with those of other companies. EBITDA and adjusted EBITDA should not be considered in isolation from or as a substitute for net income.
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About Cumberland Pharmaceuticals
About Caldolor
About Acetadote
Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Initial dosing may produce flatulence and intestinal cramps, which are usually transient. Excessive dosage can lead to diarrhea with potential complications such as loss of fluids, hypokalemia and hypernatremia. Nausea and vomiting have been reported. Use with caution in diabetics. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing information, visit www.kristalose.com.
This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland’s current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland’s operations are subject to factors outside its control, and any one or combination of these factors could materially affect Cumberland’s results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland’s products on a timely basis or a failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure and other factors discussed in the Company’s Registration Statement declared effective by the SEC on August 10, 2009. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.
Cumberland Pharmaceuticals Inc.
