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Cumberland Pharmaceuticals Reports Third Quarter Financial Results
Net Revenue: For the three months ended September 30, 2013, net revenue was
For the nine months ended September 30, 2013, net revenue was
Operating Expenses: Total operating expenses for the three months ended September 30, 2013, were
For the nine months ended September 30, 2013, operating expenses were
Net Income (Loss): Net income (loss) attributable to common shareholders for the three months ended September 30, 2013, was
For the nine months ended September 30, 2013, net income attributable to common shareholders was
Balance Sheet: As of September 30, 2013, Cumberland had
"The recent addition of Omeclamox-Pak reflects our commitment to the expansion of our product portfolio and to help improve patient care," said
Product Highlights
Caldolor®
Posters with data from three Caldolor studies were presented at the Annual Meeting of the
A poster entitled "Multicenter, Open-label Surveillance Trials to Evaluate the Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen" was presented. Two registry studies made up this presentation. In the first registry study eligible patients were enrolled to receive one of two dose strengths (400 mg for treatment of fever, 800 mg for treatment of pain) of intravenous ibuprofen for up to a 24- hour dosing period. One hundred fifty patients from 13 clinical sites were enrolled in this study. Intravenous ibuprofen reduced fever and pain and the shortened infusion time was well tolerated.
The second registry study was a phase IV multi-center, open-label surveillance clinical study to assess the safety of ibuprofen administered intravenously over five to ten minutes to adult hospitalized patients undergoing surgical procedures. Eligible patients were enrolled to receive 800 mg of intravenous ibuprofen administered at induction of anesthesia and could continue Caldolor therapy for up to 24 hours. Three hundred patients from 21 clinical sites were enrolled in this study. The shortened infusion time was well tolerated.
Another poster presentation was entitled "A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery." This study was conducted at the
Omeclamox-Pak®
Cumberland recently announced an agreement with
Under the terms of the agreement, Cumberland will promote the product to gastroenterologists across
Conference Call and Webcast
A conference call and live Internet webcast will be held on
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 Helicobacter pylori
H. pylori is a bacterium acquired largely by people living in developing countries. Researchers suspect the bacteria are passed through contact with human saliva and waste, or contaminated food and water. If H. pylori is left untreated, it can damage the stomach and small intestine wall causing peptic ulcer disease, specifically duodenal ulcers. Symptoms of H. pylori-induced duodenal ulcers generally surface in adults and may include burning pain in the abdomen, nausea, vomiting, bloating, and weight loss. Nearly two-thirds of the world population is infected with H. pylori, including 50 percent of adults older than age 60 and 20 percent of adults under 40 years old.
About Duodenal Ulcers
Despite common belief, healthcare providers do not attribute the cause of duodenal ulcers to stress, alcohol consumption or spicy foods, though all can further inflame the small intestine wall. Patients with duodenal ulcers caused by H. pylori can be diagnosed through a series of simple tests, including blood, urea breath and stool antigen sampling. Other more invasive procedures can include both an upper gastrointestinal (GI) series and endoscopy. Patients who suffer severe abdominal pains, or blood in stool or vomit, may have ulcers which perforated the duodenal wall.
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) | |||||||
September 30, |
| ||||||
ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ |
46,011,203 |
$ |
54,349,381 |
|||
Marketable securities |
19,163,442 |
16,686,136 |
|||||
Accounts receivable, net of allowances |
4,194,415 |
6,017,201 |
|||||
Inventories |
5,435,613 |
6,218,355 |
|||||
Other current assets |
3,465,791 |
3,961,169 |
|||||
Total current assets |
78,270,464 |
87,232,242 |
|||||
Property and equipment, net |
975,016 |
1,188,914 |
|||||
Intangible assets, net |
11,235,866 |
9,476,798 |
|||||
Other assets |
1,429,951 |
695,777 |
|||||
Total assets |
$ |
91,911,297 |
$ |
98,593,731 |
|||
LIABILITIES AND EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ |
2,272,018 |
$ |
2,790,554 |
|||
Other current liabilities |
3,139,884 |
5,264,806 |
|||||
Total current liabilities |
5,411,902 |
8,055,360 |
|||||
Revolving line of credit |
4,859,951 |
4,359,951 |
|||||
Other long-term liabilities |
707,062 |
611,933 |
|||||
Total liabilities |
10,978,915 |
13,027,244 |
|||||
Commitments and contingencies |
|||||||
Equity: |
|||||||
Shareholders' equity: |
|||||||
Common stock—no par value; 100,000,000 shares authorized; 18,157,957 and 18,937,107 shares issued and outstanding as of |
63,203,085 |
67,197,167 |
|||||
Retained earnings |
17,894,903 |
18,499,154 |
|||||
Total shareholders' equity |
81,097,988 |
85,696,321 |
|||||
Noncontrolling interests |
(165,606) |
(129,834) |
|||||
Total equity |
80,932,382 |
85,566,487 |
|||||
Total liabilities and equity |
$ |
91,911,297 |
$ |
98,593,731 |
| |||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three months ended |
Nine months ended | ||||||||||||||
2013 |
2012 |
2013 |
2012 | ||||||||||||
Net revenues |
$ |
6,528,575 |
$ |
12,531,719 |
$ |
23,867,795 |
$ |
35,154,871 | |||||||
Costs and expenses: |
|||||||||||||||
Cost of products sold |
1,030,943 |
921,862 |
3,294,411 |
2,873,417 | |||||||||||
Selling and marketing |
3,410,205 |
4,914,551 |
10,626,193 |
15,387,068 | |||||||||||
Research and development |
1,440,584 |
1,696,592 |
4,276,206 |
4,653,957 | |||||||||||
General and administrative |
1,958,629 |
1,890,849 |
6,389,569 |
6,303,392 | |||||||||||
Amortization |
202,982 |
128,702 |
610,677 |
371,928 | |||||||||||
Total costs and expenses |
8,043,343 |
9,552,556 |
25,197,056 |
29,589,762 | |||||||||||
Operating (loss) income |
(1,514,768) |
2,979,163 |
(1,329,261) |
5,565,109 | |||||||||||
Interest income |
20,350 |
107,719 |
161,709 |
256,074 | |||||||||||
Interest expense |
(24,286) |
(17,222) |
(62,721) |
(56,369) | |||||||||||
(Loss) income before income taxes |
(1,518,704) |
3,069,660 |
(1,230,273) |
5,764,814 | |||||||||||
Income tax benefit (expense) |
686,209 |
(1,207,504) |
590,250 |
(1,752,563) | |||||||||||
Net (loss) income |
(832,495) |
1,862,156 |
(640,023) |
4,012,251 | |||||||||||
Net loss at subsidiary attributable to noncontrolling interests |
12,553 |
7,338 |
35,772 |
24,741 | |||||||||||
Net (loss) income attributable to common shareholders |
$ |
(819,942) |
$ |
1,869,494 |
$ |
(604,251) |
$ |
4,036,992 | |||||||
Earnings (loss) per share attributable to common shareholders |
|||||||||||||||
- basic |
$ |
(0.04) |
$ |
0.10 |
$ |
(0.03) |
$ |
0.20 | |||||||
- diluted |
$ |
(0.04) |
$ |
0.10 |
$ |
(0.03) |
$ |
0.20 | |||||||
Weighted-average shares outstanding |
|||||||||||||||
- basic |
18,233,407 |
19,432,715 |
18,420,465 |
19,737,216 | |||||||||||
- diluted |
18,233,407 |
19,670,741 |
18,420,465 |
19,969,051 | |||||||||||
Comprehensive (loss) income |
$ |
(832,495) |
$ |
1,862,156 |
$ |
(640,023) |
$ |
4,012,251 |
| |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(Unaudited) | |||||||
Nine months ended | |||||||
2013 |
2012 | ||||||
Cash flows from operating activities: |
|||||||
Net (loss) income |
$ |
(640,023) |
$ |
4,012,251 | |||
Adjustments to reconcile net (loss) income to net cash provided by operating activities: |
|||||||
Depreciation and amortization expense |
917,012 |
664,369 | |||||
Deferred tax benefit |
(76,332) |
— | |||||
Share-based compensation |
480,806 |
556,704 | |||||
Excess tax expense (benefit) derived from exercise of stock options |
511,908 |
(2,176,222) | |||||
Noncash interest expense |
12,038 |
16,050 | |||||
Noncash investment losses (gains) |
135,296 |
(99,286) | |||||
Net changes in assets and liabilities affecting operating activities: |
|||||||
Accounts receivable |
1,822,786 |
1,615,435 | |||||
Inventory |
782,742 |
(1,736,947) | |||||
Other current assets and other assets |
(177,754) |
(1,228,382) | |||||
Accounts payable and other current liabilities |
(2,942,455) |
4,178,708 | |||||
Other long-term liabilities |
112,737 |
(655,201) | |||||
Net cash provided by operating activities |
938,761 |
5,147,479 | |||||
Cash flows from investing activities: |
|||||||
Additions to property and equipment |
(92,435) |
(293,693) | |||||
Purchases of marketable securities |
(4,371,508) |
(18,849,492) | |||||
Proceeds from sale of marketable securities |
1,758,906 |
389,302 | |||||
Additions to intangible assets |
(2,600,266) |
(1,621,100) | |||||
Net cash used in investment activities |
(5,305,303) |
(20,374,983) | |||||
Cash flows from financing activities: |
|||||||
Net borrowings (repayments) on line of credit |
500,000 |
(500,000) | |||||
Exercise of stock options |
(41,292) |
580,101 | |||||
Excess tax (expense) benefit derived from exercise of stock options |
(511,908) |
2,176,222 | |||||
Repurchase of common shares |
(3,918,436) |
(6,826,394) | |||||
Net cash used in financing activities |
(3,971,636) |
(4,570,071) | |||||
Net decrease in cash and cash equivalents |
(8,338,178) |
(19,797,575) | |||||
Cash and cash equivalents at beginning of period |
54,349,381 |
70,599,146 | |||||
Cash and cash equivalents at end of period |
$ |
46,011,203 |
$ |
50,801,571 | |||
Supplemental disclosure of cash flow information: |
|||||||
Non-cash investing and financing activities: |
|||||||
Net change in unpaid additions to intangibles, property and equipment |
$ |
230,522 |
$ |
95,272 |
SOURCE
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