NASHVILLE, Tenn., Aug. 27 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. , a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced second quarter 2009 financial results.
Net Revenue: For the three months ended June 30, 2009, net revenue was $9.8 million, up 18% from the corresponding period in 2008. This growth was primarily attributable to an increase in volume for Acetadote, the Company’s injectable treatment for acetaminophen overdose. Net revenue for the six months ended June 30, 2009, was $19.2 million, compared with $16.7 million for the same period in 2008.
Net Income: Net income for the three months ended June 30, 2009, was $0.3 million, or $0.02 per diluted share, compared to $1.1 million, or $0.07 per diluted share, for the same period in 2008. Net income for the six months ended June 30, 2009, was $1.5 million, or $0.09 per diluted share, compared to $2.5 million, or $0.15 per diluted share, for the corresponding period in 2008. The decrease in both periods was due primarily to milestone obligations triggered by FDA approval of Caldolor in the second quarter of 2009, as well as the aforementioned sales force expansion.
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“We expect Caldolor to be used to treat pain either as a stand-alone agent or as a multi-modal treatment in conjunction with opioids. Caldolor is also approved to treat fever in the acute care setting, where existing alternatives to oral treatment often include the use of cold blankets and ice packs,” says Kazimi. “We believe Caldolor has an excellent safety profile, supported by a long history of ibuprofen use as well as our clinical trial database that shows no serious adverse events associated with the product and no significant safety difference compared to placebo.”
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Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults. It is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, visit www.caldolor.com.
Acetadote is used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. It is the only approved injectable product in the United States for the treatment of acetaminophen overdose, the leading cause of poisonings presenting in emergency departments in the country(1). Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. To avoid fluid overload, the volume of diluent should be reduced as needed. If volume is not adjusted, fluid overload can occur, potentially resulting in hyponatremia, seizure, and death. For full prescribing information, visit www.acetadote.net.
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” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act, including statements regarding estimated results of operations in future periods. These forward-looking statements are subject to the finalization of Cumberland’s quarterly financial and accounting procedures and reflect Cumberland’s current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given, however, that these events will occur. As with any business, all phases of Cumberland’s operations are subject to influences outside its control. Any one, or a combination, of these factors could materially affect the results of the Cumberland’s operations. These factors include among other things, market conditions, the commercialization of Caldolor, Cumberland’s dependence on Acetadote and Kristalose to generate almost all of its revenues, intense competition from existing and new products, which could diminish the commercial potential of Cumberland’s products, an inability of manufacturers to produce Cumberland’s products on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to pharmaceutical drug manufacturers, maintaining and building an effective sales and marketing infrastructure, Cumberland’s ability to identify and acquire rights to products, government regulation, the possibility that Cumberland’s marketing exclusivity and patent rights may provide only limited protection from competition, and other factors discussed in our Registration Statement declared effective by the SEC on August 10, 2009. There can be no assurance that the results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the Company or its business and operations. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE Cumberland Pharmaceuticals Inc.
CONTACT: Angela Novak, Corporate Relations of Cumberland Pharmaceuticals
Inc., +1-615-255-0068, anovak@cumberlandpharma.com; or Kathy Waller of
Financial Relations Board, +1-312-543-6708, for Cumberland Pharmaceuticals
Inc.
Web site: http://www.cumberlandpharma.com/
