Cumberland Pharmaceuticals Reports Second Quarter Financial Results

NASHVILLE, Tenn., Aug. 6, 2013 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, today announced second quarter 2013 financial results.

Net Revenue:  For the three months ended June 30, 2013, net revenue was $7.1 million compared to $12.4 million for the prior year period.

Net revenue was $4.1 million for Acetadote, $2.0 million for Kristalose and $0.6 million for Caldolor. Other revenue was $0.3 million and includes upfront payments recognized as a result of new international agreements.

For the six months ended June 30, 2013, net revenue was $17.3 million compared with $22.6 million for the six months ended June 30, 2012.

Operating Expenses:  Total operating expenses for the three months ended June 30, 2013, were $8.2 million compared to $10.4 million during the prior year period. 

For the six months ended June 30, 2013, operating expenses were $17.2 million compared to $20.0 million for the prior year period.

Net Income (Loss):  Net income (loss) attributable to common shareholders for the three months ended June 30, 2013, was $(0.6) million, or $(0.03) per diluted share.

For the six months ended June 30, 2013, net income attributable to common shareholders was $0.2 million, or $0.01 per diluted share.

Cash Flow: Operating cash flows for the six months ended June 30, 2013, were $1.8 million, compared to $3.2 million, for the prior year period. 

Balance Sheet:  As of June 30, 2013, Cumberland had $69.2 million in cash and marketable securities, with approximately $49.7 million in cash and equivalents and $19.5 million in marketable securities.  Total assets at June 30, 2013, were $95.5 million.

"We made considerable progress this quarter by completing our pediatric program for Caldolor, obtaining FDA approval for new Acetadote labeling and further expanding our network of international partners," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We are fortunate to have a strong balance sheet through this transition period as we manage Acetadote's life cycle and work to add new products to our portfolio."

Product Highlights

Caldolor^®

Caldolor Pediatric Fever Study

Today, Cumberland announced top-line results from a clinical pediatric fever study evaluating the safety and efficacy of Caldolor (ibuprofen) Injection compared to acetaminophen in treating fever (greater than or equal to 101.0 degrees F) in hospitalized patients ranging from birth to 16 years old. One hundred and three patients were enrolled in this multi-center, randomized, open-label active comparator study. The pediatric patients received either 10 mg/kg intravenous ibuprofen (not to exceed 400 mg per dose) or 10 mg/kg acetaminophen (not to exceed 650 mg per dose).

The primary endpoint of the study was to assess the area under the change in temperature versus time curve from baseline to 2 hours after the start of the initial dose of study drug. In the two hours following dosing, pediatric patients receiving intravenous ibuprofen experienced a greater temperature reduction compared to patients receiving acetaminophen, p= 0.012; therefore meeting the primary endpoint of the study. 

After a single dose, significantly more patients receiving intravenous ibuprofen (93%) were considered to no longer be febrile (temperature less than 100.4 degrees F) compared to patients receiving acetaminophen (78%), p=0.036.

Patients receiving intravenous ibuprofen experienced a greater temperature reduction compared to patients receiving acetaminophen upon all temperature assessments during the four hours after dosing with reductions reaching statistical significance by ninety minutes post-dose.

No safety concerns were identified in the study, as the incidence of adverse events was similar across the treatment groups.

Acetadote^®

Acetadote Updated Labeling

In June 2013, Cumberland announced that the U.S. Food and Drug Administration ("FDA") approved updated labeling for Acetadote (acetylcysteine) Injection. The new labeling revises the product's indication and offers new dosing guidance for specific patient populations.  The new indication states, "Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen." The product's previous indication included the qualifying phrase, "administered intravenously within 8 to 10 hours," which was originally intended to impress the urgency for early treatment. This phrase has been removed due to potential confusion concerning efficacy when administration within that time period is not possible.

In addition, specific dosing guidance is now included for patients weighing over 100 kg. New language has also been added to alert health care providers that in certain clinical situations, therapy should be extended for some patients.

Acetadote does not contain Ethylene diamine tetracetic acid (EDTA) or any other stabilization or chelating agents and is free of preservatives.  The product's formulation was developed as part of our Phase IV commitment in response to a request by the FDA to evaluate the reduction of EDTA. The new formulation's 30 month shelf life is longer than the shelf life of the previous formulation.

International Licensing Agreements

During the second quarter of 2013, Cumberland entered into two new agreements for the registration and commercialization of Caldolor outside the United States.  The first agreement is with the Spanish-based company, Laboratorios Grifols, S.A, for a territory that includes Spain, Portugal, Argentina, Chile, Brazil, Ecuador, Peru, and Uruguay. The second agreement is with PT. SOHO Industri Pharmasi an Indonesian-based company and includes a territory of Singapore, Thailand, Vietnam, Cambodia, Laos, Brunei and the Philippines.

Also during the second quarter, Cumberland amended the agreement with Harbin Gloria Pharmaceuticals for the registration and commercialization of Caldolor and Acetadote in China by extending the territory to include Hong Kong and Macau.

The agreements entered into during 2013 provide that each of the partners are responsible for seeking regulatory approvals for the products, and following approvals, will handle ongoing distribution and sales in the respective international territories. Cumberland maintains responsibility for the intellectual property, product formulations, development and manufacturing, and will provide finished product for sale. Under the licensing agreements, Cumberland is entitled to receive upfront and milestone payments upon the achievement of defined regulatory approvals and sales milestones. 

Conference Call and Webcast

A conference call and live Internet webcast will be held on Tuesday, August 6, 2013 at 4:30 p.m. Eastern Time to discuss the Company's second quarter 2013 financial results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 24879662. The live webcast and rebroadcast can be accessed via Cumberland's website at http://investor.shareholder.com/cpix/events.cfm.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company's primary target markets include hospital acute care and gastroenterology. Cumberland's marketed products include Acetadote^® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor^® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States, and Kristalose^® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products that improve quality of care for patients. For more information, please visit the Company's website at www.cumberlandpharma.com.

About Acetadote

Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. 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 weighing 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.com.

About Caldolor

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 was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticarial, 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, including boxed warning, visit www.caldolor.com.

About Kristalose

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.

Forward-Looking Statements

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 of 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 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 most recent Form 10-K and subsequent 10-Q's as filed with the SEC. 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.

SOURCE Cumberland Pharmaceuticals Inc.