Cumberland Pharmaceuticals Reports First Quarter 2016 Financial Results

NASHVILLE, Tenn., May 10, 2016 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, today announced first quarter 2016 financial results with Net Revenues of $7.7 million and Adjusted Earnings of $0.3 million or $0.02 per share.

As of March 31, 2016, the Company had just under $90 million in Total Assets including over $51 million in cash and marketable securities. Total Liabilities were approximately $14 million and Total Shareholder's Equity was just over $75 million. Cumberland also had approximately $43 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options.

"During the first quarter, we began to build upon the foundation we established in 2015," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "We have already had a series of positive developments this year that we expect to make important contributions toward our goal of delivering long-term sustainable growth."

QUARTER HIGHLIGHTS:

Caldolor® Pediatric Launch

Cumberland launched the promotion of Caldolor for the treatment of pain and fever in children at its National Sales Meeting in March. Caldolor has been approved for use in adults for the management of pain, as well as the reduction of fever, since 2009. The Company received pediatric approval and three year exclusivity from the FDA of Caldolor for use in children six months of age and older in November 2015. Cumberland seeks to maximize the potential of its FDA approved product line and expand the use of its products into new patient populations. The pediatric approval and launch of Caldolor for use in children is one more achievement toward supporting those objectives.

Hospital Co-Promotion

During the first quarter, Cumberland launched a co-promotion agreement with Piramal Critical Care to increase the support for our Caldolor® and Vaprisol® brands.

This collaboration provides coverage to an additional group of hospitals where Piramal's critical care sales force has existing relationships. The Company expects this new initiative to provide expanded promotional coverage and increased communication to medical professionals in support of these two brands.

RECENT DEVELOPMENTS:

Vasculan Program

Cumberland recently announced a new clinical program to develop Vasculan (ifetroban) oral capsule for the treatment of systemic sclerosis.  Systemic sclerosis (SSc), also called scleroderma, is a rare autoimmune disorder that affects the skin and internal organs. It is characterized by vasculopathy, inflammation, and fibrosis.  This disease has a high morbidity and the highest case-specific mortality of any rheumatic disorder with 50% of patients dying or developing major internal organ complications within 3 years of diagnosis.

Although several medications are used to treat the skin disease associated with SSc, there is no universally effective treatment to improve the function of affected internal organs such as the lungs, heart, and gastrointestinal tract, hence the treatment of SSc remains an unmet need. The U.S. Food and Drug Administration has cleared Cumberland's investigational new drug application for a Phase II clinical program for Vasculan in patients with systemic sclerosis.

Ethyol® Agreement

Earlier today, the Company announced an agreement for the commercialization of Ethyol® (amifostine) in the United States.  This is the first product to be licensed by Cumberland from Clinigen Group plc under the Strategic Alliance entered into last year and also Cumberland's first oncology product. Under the terms of the agreement, Cumberland will be responsible for all marketing, promotion, and distribution of the product in the U.S.

Ethyol is an FDA approved cytoprotective drug indicated as an adjuvant therapy to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

FINANCIAL RESULTS:

Net Revenue:  For the three months ended March 31, 2016, net revenues were $7.7 million, compared to $8.7 million for the prior year period.  Net revenue by product for the three months ended March 31, 2016, included $3.6 million for Kristalose®, $1.8 million for Acetadote®, including $1.2 million for the Company's Authorized Generic, $1.1 million for Caldolor®, $0.8 million for Omeclamox®-Pak, and $0.4 million for Vaprisol®.

Operating Expenses:  Total operating expenses for the three months ended March 31, 2016 were $8.2 million, compared to $8.7 million during the prior year period, as the Company continued its efforts to maintain expenses in line with its revenues.

Adjusted Earnings:  Adjusted Earnings for the first quarter were $0.3 million or $0.02 per share, compared to $1.6 million or $0.09 per share for the prior year period. The definition and reconciliation of Adjusted Earnings is provided in this release.

Balance Sheet:  At March 31, 2016, Cumberland had $51.3 million in cash and marketable securities, with approximately $36.4 million in cash and equivalents and $14.9 million in marketable securities.  Total Assets at March 31, 2016 were $89.2 million.  Total Liabilities were $13.9 million, including $1.7 million outstanding on our revolving line of credit, resulting in Total Shareholder's Equity of $75.4 millionCumberland also had approximately $43 million in off-balance sheet 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 Tuesday, May 10, 2016 at 4:30 p.m. Eastern Time to discuss the Company's first quarter 2016 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 87898815. 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 the 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 infection and duodenal ulcer disease. Cumberland is developing Hepatoren®(ifetroban) Injection for the treatment of Hepatorenal Syndrome, Boxaban® (ifetroban) Oral Capsule for the treatment of Aspirin- Exacerbated Respiratory Disease, and Vasculan (ifetroban) Oral Capsule for the treatment of systemic sclerosis. 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. Omeclamox-Pak is contraindicated in patients with a history of hypersensitivity to omeprazole, any macrolide antibiotic or penicillin. The safety and effectiveness of Omeclamox-Pak in the pediatric population has not yet been established. Omeclamox-Pak was approved by the U.S. Food and Drug Administration in 2011. For full prescribing information, visit www.omeclamox.com.

About Vaprisol® (conivaptan hydrochloride) Injection

Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. 

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