NASHVILLE, Tenn., March 3, 2016 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, today announced fourth quarter 2015 financial results with Net Revenues of $8.0 million and Adjusted Earnings of $0.6 million or $0.03 per share. Net Revenues for the year ended December 31, 2015 were $33.5 million with Adjusted Earnings of $4.5 million or $0.26 per share.
As of December 31, 2015, the Company had approximately $91.9 million in total assets including approximately $52.8 million in cash and investments. Total Liabilities were $15.1 million and Total Shareholder’s Equity was $76.9 million. Cumberland also had approximately $43.0 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options.
2015 Highlights:
- Completed Boxaban® and Hepatoren® Phase II studies, with favorable top line results.
- Received FDA approval of Caldolor® for use in pediatric patients, six months of age and older.
- Launched Caldolor® in Australia, its second major international market.
- Entered into Strategic Alliance with Clinigen Group plc, and will work to deliver Clinigen’s medicines to hospitalized patients in the U.S.
- Assumed full commercial rights and responsibilities for Omeclamox®-Pak in the U.S.
- Obtained a favorable court ruling upholding the validity and enforceability of the key Acetadote® patent through August 2025.
- Entered into a co-promotion agreement with Piramal Critical Care to help expand sales coverage for Caldolor® and Vaprisol®.
“Cumberland had many key accomplishments in 2015 that have laid important groundwork for a successful 2016 and beyond,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. " We expect these positive developments will make an important contribution towards our goal of delivering long-term sustainable growth. We remain focused on our mission of advancing patient care through the delivery of high quality pharmaceutical products.”
FINANCIAL RESULTS:
Net Revenue: For the three months ended December 31, 2015, net revenues were $8.0 million, compared to $9.3 million for the prior year period. Net revenue by product for the three months ended December 31, 2015, included $3.6 million for Kristalose®, $2.1 million for Acetadote®, including $1.2 million for the Company’s Authorized Generic, $1.1 million for Caldolor®, $0.6 million for Omeclamox®-Pak, and $0.5 million for Vaprisol®.
For the year ended December 31, 2015, net revenues were $33.5 million compared to $36.9 million for the year ended December 31, 2014.
Operating Expenses: Total operating expenses for the three months ended December 31, 2015 were $7.9 million, compared to $8.4 million during the prior year period, as the Company continued to manage expenses in line with its revenues.
Total operating expenses for the year ended December 31, 2015 were $32.4 million, compared to $33.3 million for 2014. These expenses include a $1.2 million fee during the first quarter of 2015 associated with the submission of our Caldolor pediatric data and request to update that product’s label.
Adjusted Earnings: This performance measure represents net income attributable to common shareholders with adjustments for the impact of income taxes, depreciation, amortization, share based compensation expenses, and non-recurring expenses. A reconciliation to GAAP net income is provided in this release.
Adjusted Earnings for the fourth quarter of 2015 were $0.6 million or $0.03 per share, compared to $1.8 million or $0.10 per share for the prior year period.
Adjusted Earnings for the year ended December 31, 2015 were $4.5 million, or $0.26 per share compared to $6.3 million, or $0.35 per share in 2014. The definition and reconciliation of Adjusted Earnings is provided in this release.
Balance Sheet: At December 31, 2015, Cumberland had $52.8 million in cash and marketable securities, with approximately $38.2 million in cash and equivalents and $14.6 million in marketable securities. Total assets at December 31, 2015 were $91.9 million. Total Liabilities were $15.1 million, including $1.7 million outstanding on our revolving line of credit, resulting in Total Shareholder’s Equity of $76.9 million. Cumberland also had approximately $43.0 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options.
Conference Call and Webcast
A conference call and live Internet webcast will be held on Thursday, March 3, 2016 at 4:30 p.m. Eastern Time to discuss the Company’s fourth quarter and annual 2015 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 41386233. 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 five marketed products include Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, for treatment of pain and fever, Kristalose® (lactulose) for Oral Solution, a prescription laxative, Vaprisol® (conivaptan) Injection, for the treatment of hyponatremia and Omeclamox-Pak® for the treatment of H. pylori and duodenal ulcer disease. Cumberland is developing Hepatoren®(ifetroban) Injection for the treatment of Hepatorenal Syndrome and Boxaban® (ifetroban) Oral Capsule for treatment of aspirin-exacerbated respiratory disease. Cumberland is dedicated to providing innovative products that improve quality of care for patients. For more information on Cumberland’s approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company’s website www.cumberlandpharma.com.
About Acetadote® (acetylcysteine) Injection
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. 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® (ibuprofen) Injection
Caldolor is indicated in adults and pediatric patients 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. 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 a history of asthma or other 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® (lactulose) Oral Solution
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.
About Omeclamox®-Pak (omeprazole, clarithromycin, amoxicillin)
Omeprazole is an antisecretory drug, which works by decreasing the amount of acid the stomach produces. Clarithromycin and amoxicillin are antibacterial drugs, which inhibit the growth of bacteria allowing the stomach lining to heal.
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