News Release
<< Back
Cumberland Pharmaceuticals Reports First Quarter 2014 Financial Results
Net Revenue: For the three months ended March 31, 2014, net revenues were
Net revenue was
Operating Expenses: Total operating expenses for the three months ended March 31, 2014, were
Net Income: Net income attributable to common shareholders for the three months ended March 31, 2014, was
Operating
Balance Sheet: As of March 31, 2014, Cumberland had
"We are very optimistic about the opportunities that Vaprisol and Omeclamox-Pak will offer Cumberland. We continue to build a diversified product portfolio while deploying our resources to sustain long-term growth," said
QUARTER HIGHLIGHTS
Vaprisol®
Acquisition and Launch of Vaprisol
In
Hyponatremia, an imbalance of serum sodium to body water, is the most common electrolyte disorder among hospitalized patients. These electrolyte disturbances occur when the sodium ion concentration in the plasma is lower than normal and are often associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. Vaprisol raises serum sodium to appropriate levels and promotes free water secretion.
Cumberland believes that Vaprisol, an injectable hospital product, used in the critical care setting, is an excellent strategic fit for the Company as it overlays well with the existing efforts of its sales organization. The Company began shipping Vaprisol in early
Omeclamox®-Pak
Launch of Omeclamox-Pak
Cumberland launched promotion and distribution efforts to support Omeclamox-Pak in January 2014. The Company's field sales force promotes Omeclamox-Pak to the gastroenterologist segment, which accounts for the largest component of the prescriber base for this product. Omeclamox-Pak is a branded prescription product used for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease. This innovative product combines three well-known and widely prescribed medications: omeprazole, clarithromycin, and amoxicillin. Omeclamox-Pak contains omeprazole as the proton pump inhibitor, which works to decrease the amount of acid the stomach produces. Clarithromycin and amoxicillin are both antibiotic agents which hinder the growth of H. pylori. Interaction of these agents allows the stomach lining to heal effectively. The medications are packaged together on convenient daily dosing cards, making it simple to follow the twice a day dosing before meals.
While there are competing products, Omeclamox-Pak is one of the few actively marketed products for this condition. In addition, compared to the competing branded products, Omeclamox-Pak has the lowest pill burden, fewest days of therapy and the lowest cost. Cumberland's involvement with Omeclamox-Pak was effective
Caldolor®
Caldolor Pediatric Presentation
Data from the Company's Caldolor pediatric fever study was presented at the
The pediatric study met its primary endpoint demonstrating that Caldolor was associated with a statistically significant reduction in temperature within the first 2 hours of dosing when compared to acetaminophen. Equally important, no safety concerns were observed during the study. During the study, febrile hospitalized children ranging in age from less than 1 year to 16 years, were administered Caldolor (ibuprofen) injection or oral or rectal acetaminophen as a single or multiple dose therapy for up to five days. 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).
International Agreement
As announced last week, Cumberland received approximately
Conference Call and Webcast
A conference call and live Internet webcast will be held on Tuesday, May 13, 2014 at
About
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
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
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.
About Omeclamox-Pak
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
About Vaprisol
Vaprisol 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. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol does not require dilution and has a well-defined daily dose of 10 mg, 20 mg, or 40 mg. Vaprisol was approved by the
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
| |||||||
Condensed Consolidated Balance Sheets | |||||||
(Unaudited) | |||||||
March 31, 2014 |
| ||||||
ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ |
39,047,959 |
$ |
40,869,457 |
|||
Marketable securities |
13,531,808 |
14,019,761 |
|||||
Accounts receivable, net of allowances |
5,417,093 |
4,530,424 |
|||||
Inventories |
7,422,145 |
5,722,882 |
|||||
Other current assets |
3,847,125 |
3,537,191 |
|||||
Total current assets |
69,266,130 |
68,679,715 |
|||||
Property and equipment, net |
809,227 |
880,647 |
|||||
Intangible assets, net |
18,473,434 |
15,498,819 |
|||||
Other assets |
2,557,341 |
2,554,557 |
|||||
Total assets |
$ |
91,106,132 |
$ |
87,613,738 |
|||
LIABILITIES AND EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ |
4,724,873 |
$ |
2,035,853 |
|||
Other current liabilities |
6,624,983 |
5,509,917 |
|||||
Total current liabilities |
11,349,856 |
7,545,770 |
|||||
Revolving line of credit |
— |
— |
|||||
Other long-term liabilities |
795,837 |
776,125 |
|||||
Total liabilities |
12,145,693 |
8,321,895 |
|||||
Commitments and contingencies |
|||||||
Equity: |
|||||||
Shareholders' equity: |
|||||||
Common stock—no par value; 100,000,000 shares authorized; 17,807,317 and 17,985,503 shares issued and outstanding as of |
62,467,355 |
63,073,941 |
|||||
Retained earnings |
16,680,860 |
16,394,540 |
|||||
Total shareholders' equity |
79,148,215 |
79,468,481 |
|||||
Noncontrolling interests |
(187,776) |
(176,638) |
|||||
Total equity |
78,960,439 |
79,291,843 |
|||||
Total liabilities and equity |
$ |
91,106,132 |
$ |
87,613,738 |
| ||||||||
Condensed Consolidated Statements of Operations and Comprehensive Income | ||||||||
(Unaudited) | ||||||||
Three months ended |
||||||||
2014 |
2013 |
|||||||
Net revenues |
$ |
8,093,244 |
$ |
10,258,132 |
||||
Costs and expenses: |
||||||||
Cost of products sold |
1,053,717 |
1,108,635 |
||||||
Selling and marketing |
3,613,931 |
3,673,939 |
||||||
Research and development |
826,373 |
1,448,718 |
||||||
General and administrative |
1,897,217 |
2,575,739 |
||||||
Amortization |
293,955 |
125,050 |
||||||
Total costs and expenses |
7,685,193 |
8,932,081 |
||||||
Operating income |
408,051 |
1,326,051 |
||||||
Interest income |
67,343 |
92,377 |
||||||
Interest expense |
(12,203) |
(17,735) |
||||||
Income before income taxes |
463,191 |
1,400,693 |
||||||
Income tax expense |
(188,009) |
(559,367) |
||||||
Net income |
275,182 |
841,326 |
||||||
Net loss at subsidiary attributable to noncontrolling interests |
11,138 |
13,383 |
||||||
Net income attributable to common shareholders |
$ |
286,320 |
$ |
854,709 |
||||
Earnings per share attributable to common shareholders |
||||||||
- basic |
$ |
0.02 |
$ |
0.05 |
||||
- diluted |
$ |
0.02 |
$ |
0.05 |
||||
Weighted-average shares outstanding |
||||||||
- basic |
17,907,848 |
18,758,383 |
||||||
- diluted |
18,161,680 |
18,925,165 |
||||||
Comprehensive income |
$ |
275,182 |
$ |
841,326 |
| |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(Unaudited) | |||||||
Three months ended | |||||||
2014 |
2013 | ||||||
Cash flows from operating activities: |
|||||||
Net income |
$ |
275,182 |
$ |
841,326 |
|||
Adjustments to reconcile net income to net cash provided by operating activities: |
|||||||
Depreciation and amortization expense |
395,135 |
290,508 |
|||||
Deferred tax expense |
— |
65,413 |
|||||
Share-based compensation |
125,758 |
128,625 |
|||||
Excess tax benefit derived from exercise of stock options |
(188,008) |
(478,698) |
|||||
Noncash interest expense |
6,019 |
6,019 |
|||||
Noncash investment losses |
141,920 |
10,571 |
|||||
Net changes in assets and liabilities affecting operating activities, net of effect of business combination: |
|||||||
Accounts receivable |
(886,669) |
49,570 |
|||||
Inventory |
(289,263) |
226,324 |
|||||
Other current assets and other assets |
(319,506) |
(8,298) |
|||||
Accounts payable and other current liabilities |
1,696,229 |
492,983 |
|||||
Other long-term liabilities |
25,775 |
46,308 |
|||||
Net cash provided by operating activities |
982,572 |
1,670,651 |
|||||
Cash flows from investing activities: |
|||||||
Additions to property and equipment |
(29,760) |
(60,911) |
|||||
Purchases of marketable securities |
(750,000) |
(2,970,000) |
|||||
Proceeds from sale of marketable securities |
1,096,033 |
686,755 |
|||||
Cash paid for acquisitions |
(2,000,000) |
— |
|||||
Additions to intangible assets |
(388,768) |
(961,013) |
|||||
Net cash used in investment activities |
(2,072,495) |
(3,305,169) |
|||||
Cash flows from financing activities: |
|||||||
Exercise of stock options |
— |
(41,292) |
|||||
Excess tax benefit derived from exercise of stock options |
188,008 |
478,698 |
|||||
Repurchase of common shares |
(919,583) |
(1,942,725) |
|||||
Net cash used in financing activities |
(731,575) |
(1,505,319) |
|||||
Net decrease in cash and cash equivalents |
(1,821,498) |
(3,139,837) |
|||||
Cash and cash equivalents at beginning of period |
40,869,457 |
54,349,381 |
|||||
Cash and cash equivalents at end of period |
$ |
39,047,959 |
$ |
51,209,544 |
Logo - http://photos.prnewswire.com/prnh/20140505/84325
SOURCE
News Provided by Acquire Media