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Cumberland Pharmaceuticals Reports Second Quarter 2014 Financial Results
SUMMARY FINANCIAL RESULTS: During the second quarter 2014, net revenues were
As of
SUMMARY QUARTER HIGHLIGHTS:
- In
May 2014 , Cumberland launched promotional efforts to support Vaprisol® following the brand's acquisition from Astellas in February. - The launch of Omeclamox®-Pak and a new marketing strategy for Kristalose® also contributed to the Company's second quarter growth.
- During the quarter, Cumberland announced a new research and development initiative with its Chinese partner,
Gloria Pharmaceuticals , with each company contributing$1.0 million to Cumberland Emerging Technologies. - Cumberland also entered into a new three year line of credit with
SunTrust Bank providing up to$20 million in debt financing availability to support the Company's growth and acquisition initiatives.
"The launch of our two new products, Vaprisol and Omeclamox-Pak, has diversified our business and has contributed to our return to profitability in 2014," said
FINANCIAL RESULTS:
Net Revenue: For the three months ended June 30, 2014, net revenue was
Net revenue was
For the six months ended June 30, 2014, net revenue was
Net revenue for the six months ended
Operating Expenses: Total operating expenses for the three months ended June 30, 2014, were
For the six months ended June 30, 2014, operating expenses were
Net Income: Net income attributable to common shareholders for the three months ended June 30, 2014, was
For the six months ended June 30, 2014, net income attributable to common shareholders was
Operating
Balance Sheet: As of June 30, 2014, Cumberland had
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 re-launched active promotion of the brand in early
Omeclamox®-Pak
Launch of Omeclamox-Pak
Cumberland launched our promotion and distribution efforts to support Omeclamox-Pak in early 2014. Our 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 is the first
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. Our involvement with Omeclamox-Pak was effective
International Agreement
In
Caldolor®
Caldolor Pediatric Pain Study Published
Data from the Company's Caldolor (ibuprofen) pediatric pain study was published in the
During the study a total of 161 pediatric patients undergoing tonsillectomy, ranging in age from 6 years to 17 years, were randomized to receive either a single dose of Caldolor or placebo prior to surgery. Postoperative pain was managed with intravenous narcotic on an as needed basis based on the visual analog scale (VAS) as well as deemed appropriate by the recovery room nurses and physicians. The primary endpoint was the number of doses and amount of narcotic administered following surgery.
The pediatric study indicated that there was a significant reduction in the number of postoperative doses and the amount of narcotic administered after surgery in the group that was administered Caldolor compared with the placebo group. There were no differences in the time to the first analgesia request or the number of patients who required analgesia after surgery. There were no significant differences in the incidence of serious adverse events. The study concluded that the administration of Caldolor significantly reduced narcotic use in pediatric tonsillectomy patients.
Caldolor Patents
On
On
Conference Call and Webcast
A conference call and live Internet webcast will be held on Tuesday, August 5, 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
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ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ |
39,050,841 |
$ |
40,869,457 |
|||
Marketable securities |
14,825,632 |
14,019,761 |
|||||
Accounts receivable, net of allowances |
6,014,477 |
4,530,424 |
|||||
Inventories |
6,996,843 |
5,722,882 |
|||||
Other current assets |
3,744,244 |
3,537,191 |
|||||
Total current assets |
70,632,037 |
68,679,715 |
|||||
Property and equipment, net |
726,868 |
880,647 |
|||||
Intangible assets, net |
19,073,458 |
15,498,819 |
|||||
Other assets |
3,036,301 |
2,554,557 |
|||||
Total assets |
$ |
93,468,664 |
$ |
87,613,738 |
|||
LIABILITIES AND EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ |
4,220,194 |
$ |
2,035,853 |
|||
Other current liabilities |
7,642,960 |
5,509,917 |
|||||
Total current liabilities |
11,863,154 |
7,545,770 |
|||||
Revolving line of credit |
— |
— |
|||||
Other long-term liabilities |
873,246 |
776,125 |
|||||
Total liabilities |
12,736,400 |
8,321,895 |
|||||
Commitments and contingencies |
|||||||
Equity: |
|||||||
Shareholders' equity: |
|||||||
Common stock—no par value; 100,000,000 shares authorized; |
63,529,644 |
63,073,941 |
|||||
Retained earnings |
17,403,430 |
16,394,540 |
|||||
Total shareholders' equity |
80,933,074 |
79,468,481 |
|||||
Noncontrolling interests |
(200,810) |
(176,638) |
|||||
Total equity |
80,732,264 |
79,291,843 |
|||||
Total liabilities and equity |
$ |
93,468,664 |
$ |
87,613,738 |
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Three months ended |
Six months ended | ||||||||||||||
2014 |
2013 |
2014 |
2013 |
||||||||||||
Net revenues |
$ |
9,750,168 |
$ |
7,081,088 |
$ |
17,843,412 |
$ |
17,339,220 |
|||||||
Costs and expenses: |
|||||||||||||||
Cost of products sold |
1,298,816 |
1,154,833 |
2,352,533 |
2,263,468 |
|||||||||||
Selling and marketing |
3,930,082 |
3,542,049 |
7,544,013 |
7,215,988 |
|||||||||||
Research and development |
861,154 |
1,386,904 |
1,687,527 |
2,835,622 |
|||||||||||
General and administrative |
2,140,249 |
1,855,201 |
4,037,466 |
4,430,940 |
|||||||||||
Amortization |
304,258 |
282,645 |
598,213 |
407,695 |
|||||||||||
Total costs and expenses |
8,534,559 |
8,221,632 |
16,219,752 |
17,153,713 |
|||||||||||
Operating income (loss) |
1,215,609 |
(1,140,544) |
1,623,660 |
185,507 |
|||||||||||
Interest income |
29,544 |
48,982 |
96,887 |
141,359 |
|||||||||||
Interest expense |
(12,278) |
(20,700) |
(24,481) |
(38,435) |
|||||||||||
Income (loss) before income taxes |
1,232,875 |
(1,112,262) |
1,696,066 |
288,431 |
|||||||||||
Income tax (expense) benefit |
(523,339) |
463,408 |
(711,348) |
(95,959) |
|||||||||||
Net income (loss) |
709,536 |
(648,854) |
984,718 |
192,472 |
|||||||||||
Net loss at subsidiary attributable to noncontrolling interests |
13,034 |
9,836 |
24,172 |
23,219 |
|||||||||||
Net income (loss) attributable to common shareholders |
$ |
722,570 |
$ |
(639,018) |
$ |
1,008,890 |
$ |
215,691 |
|||||||
Earnings (loss) per share attributable to common shareholders |
|||||||||||||||
- basic |
$ |
0.04 |
$ |
(0.03) |
$ |
0.06 |
$ |
0.01 |
|||||||
- diluted |
$ |
0.04 |
$ |
(0.03) |
$ |
0.06 |
$ |
0.01 |
|||||||
Weighted-average shares outstanding |
|||||||||||||||
- basic |
17,743,395 |
18,405,522 |
17,825,174 |
18,580,891 |
|||||||||||
- diluted |
18,025,913 |
18,405,522 |
18,093,391 |
18,756,691 |
|||||||||||
Comprehensive income (loss) |
$ |
709,536 |
$ |
(648,854) |
$ |
984,718 |
$ |
192,472 |
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Six months ended | |||||||
2014 |
2013 |
||||||
Cash flows from operating activities: |
|||||||
Net income |
$ |
984,718 |
$ |
192,472 |
|||
Adjustments to reconcile net income to net cash provided by operating activities: |
|||||||
Depreciation and amortization expense |
800,231 |
610,052 |
|||||
Deferred tax expense |
— |
65,413 |
|||||
Share-based compensation |
325,344 |
305,199 |
|||||
Excess tax benefit derived from exercise of stock options |
(711,348) |
(15,288) |
|||||
Noncash interest expense |
12,038 |
12,038 |
|||||
Noncash investment losses |
181,950 |
62,323 |
|||||
Net changes in assets and liabilities affecting operating activities, net of |
|||||||
Accounts receivable |
(1,484,052) |
2,046,259 |
|||||
Inventory |
136,039 |
124,061 |
|||||
Other current assets and other assets |
(701,604) |
59,877 |
|||||
Accounts payable and other current liabilities |
2,165,828 |
(1,707,560) |
|||||
Other long-term liabilities |
109,244 |
37,479 |
|||||
Net cash provided by operating activities |
1,818,388 |
1,792,325 |
|||||
Cash flows from investing activities: |
|||||||
Additions to property and equipment |
(48,239) |
(69,119) |
|||||
Purchases of marketable securities |
(3,254,903) |
(4,371,508) |
|||||
Proceeds from sale of marketable securities |
2,267,082 |
1,481,682 |
|||||
Cash paid for acquisitions |
(2,000,000) |
— |
|||||
Additions to intangible assets |
(732,072) |
(1,829,693) |
|||||
Net cash used in investment activities |
(3,768,132) |
(4,788,638) |
|||||
Cash flows from financing activities: |
|||||||
Net borrowings on line of credit |
— |
1,500,000 |
|||||
Exercise of stock options |
— |
(41,292) |
|||||
Excess tax benefit derived from exercise of stock options |
711,348 |
15,288 |
|||||
Sale of subsidiary shares to noncontrolling interest |
1,000,005 |
— |
|||||
Repurchase of common shares |
(1,580,225) |
(3,162,302) |
|||||
Net cash provided by (used in) financing activities |
131,128 |
(1,688,306) |
|||||
Net decrease in cash and cash equivalents |
(1,818,616) |
(4,684,619) |
|||||
Cash and cash equivalents at beginning of period |
40,869,457 |
54,349,381 |
|||||
Cash and cash equivalents at end of period |
$ |
39,050,841 |
$ |
49,664,762 |
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SOURCE
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