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Cumberland Pharmaceuticals Reports Second Quarter 2016 Financial Results
As of
QUARTER HIGHLIGHTS:
- Announced the acquisition of exclusive
U.S. rights to Ethyol®, through an agreement with the Clinigen Group plc. - Initiated a new clinical program to develop Vasculan™ (ifetroban) oral capsule for the treatment of systemic sclerosis.
- Announced the expansion our Board of Directors with the addition of
Caroline Young , former president of theNashville Health Care Council .
"These are exciting times at
RECENT DEVELOPMENTS:
Ethyol®
It is a cytoprotective drug indicated to support select patients undergoing radiation treatment as well as those undergoing chemotherapy for certain cancers.
This is the first product to be licensed by
Vasculan™
The
FINANCIAL RESULTS:
Net Revenue: For the three months ended
For the six months ended
Operating Expenses: Total operating expenses for the three months ended
Total operating expenses for the first six months of 2016 were
Earnings: Net income (loss) for the second quarter of 2016 was (
Net income (loss) for the six months ended
Adjusted Earnings for the six months ended
Balance Sheet: At
Conference Call and Webcast
A conference call and live
About
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
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
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
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. 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 was approved by the
About Ethyol® (amifostine)
Ethyol is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. It is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.
About Cumberland Emerging Technologies (CET)
Forward-Looking Statements
This announcement contains forward-looking statements, which are subject to certain risks and reflect
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2016 |
2015 | |
ASSETS |
||
Current assets: |
||
Cash and cash equivalents |
$ 35,837,240 |
$ 38,203,059 |
Marketable securities |
14,565,154 |
14,564,115 |
Accounts receivable, net of allowances |
4,550,945 |
6,077,120 |
Inventories |
4,921,681 |
4,270,143 |
Other current assets |
4,117,059 |
3,997,637 |
Total current assets |
63,992,079 |
67,112,074 |
Property and equipment, net |
505,667 |
536,450 |
Intangible assets, net |
20,881,286 |
21,168,596 |
Other assets |
2,509,898 |
3,101,839 |
Total assets |
$ 87,888,930 |
$ 91,918,959 |
LIABILITIES AND EQUITY |
||
Current liabilities: |
||
Accounts payable |
$ 3,667,440 |
$ 2,877,479 |
Other current liabilities |
5,227,831 |
9,534,268 |
Total current liabilities |
8,895,271 |
12,411,747 |
Revolving line of credit |
3,500,000 |
1,700,000 |
Other long-term liabilities |
1,119,201 |
987,429 |
Total liabilities |
13,514,472 |
15,099,176 |
Commitments and contingencies |
||
Equity: |
||
Shareholders' equity: |
||
Common stock—no par value; 100,000,000 shares authorized;16,236,348 and 16,379,501 shares issued and outstanding as of June 30, 2016 and |
55,222,464 |
57,338,294 |
Retained earnings |
19,248,459 |
19,549,614 |
Total shareholders' equity |
74,470,923 |
76,887,908 |
Noncontrolling interests |
(96,465) |
(68,125) |
Total equity |
74,374,458 |
76,819,783 |
Total liabilities and equity |
$ 87,888,930 |
$ 91,918,959 |
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Three months ended |
Six months ended | |||||||||
2016 |
2015 |
2016 |
2015 | |||||||
Net revenues |
$ 7,414,835 |
$ 8,909,741 |
$ 15,152,367 |
$ 17,596,515 | ||||||
Costs and expenses: |
||||||||||
Cost of products sold |
1,155,261 |
1,237,001 |
2,379,200 |
2,398,842 | ||||||
Selling and marketing |
3,272,279 |
3,505,486 |
6,971,241 |
7,036,401 | ||||||
Research and development |
678,780 |
828,070 |
1,385,252 |
2,687,082 | ||||||
General and administrative |
1,874,396 |
2,153,562 |
3,952,368 |
3,797,703 | ||||||
Amortization |
539,428 |
511,691 |
1,070,198 |
998,440 | ||||||
Total costs and expenses |
7,520,144 |
8,235,810 |
15,758,259 |
16,918,468 | ||||||
Operating income (loss) |
(105,309) |
673,931 |
(605,892) |
678,047 | ||||||
Interest income |
31,483 |
57,846 |
108,612 |
114,248 | ||||||
Interest expense |
(28,247) |
(18,489) |
(48,689) |
(34,039) | ||||||
Income (loss) before income taxes |
(102,073) |
713,288 |
(545,969) |
758,256 | ||||||
Income tax (expense) benefit |
41,135 |
(318,990) |
216,474 |
(337,446) | ||||||
Net income (loss) |
(60,938) |
394,298 |
(329,495) |
420,810 | ||||||
Net loss at subsidiary attributable to noncontrolling |
||||||||||
interests |
12,894 |
11,700 |
28,340 |
31,469 | ||||||
Net income (loss) attributable to common shareholders |
$ (48,044) |
$ 405,998 |
$ (301,155) |
$ 452,279 | ||||||
Earnings (loss) per share attributable to common shareholders |
||||||||||
- basic |
$ — |
$ 0.02 |
$ (0.02) |
$ 0.03 | ||||||
- diluted |
$ — |
$ 0.02 |
$ (0.02) |
$ 0.03 | ||||||
Weighted-average shares outstanding |
||||||||||
- basic |
16,247,028 |
16,820,725 |
16,293,744 |
16,916,193 | ||||||
- diluted |
16,247,028 |
17,184,345 |
16,293,744 |
17,294,087 | ||||||
Comprehensive income (loss) attributable to common |
||||||||||
shareholders |
(48,044) |
405,998 |
$ (301,155) |
$ 452,279 | ||||||
Net loss at subsidiary attributable to noncontrolling |
||||||||||
interests |
12,894 |
11,700 |
28,340 |
31,469 | ||||||
Total comprehensive income (loss) |
$ (60,938) |
$ 394,298 |
$ (329,495) |
$ 420,810 |
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Six months ended | ||
2016 |
2015 | |
Cash flows from operating activities: |
||
Net income (loss) |
$ (329,495) |
$ 420,810 |
Adjustments to reconcile net income (loss) to net cash provided by operating |
||
activities: |
||
Depreciation and amortization expense |
1,171,437 |
1,143,002 |
Deferred tax benefit |
533,067 |
23,593 |
Share-based compensation |
408,226 |
549,603 |
Excess tax expense (benefit) derived from exercise of stock options |
835,016 |
(313,955) |
Noncash interest expense |
37,323 |
19,782 |
Noncash investment gains |
(51,213) |
(44,870) |
Net changes in assets and liabilities affecting operating activities: |
||
Accounts receivable |
1,526,175 |
(303,286) |
Inventory |
(651,538) |
804,776 |
Other current assets and other assets |
(97,871) |
422,946 |
Accounts payable and other current liabilities |
(4,061,546) |
1,265,725 |
Other long-term liabilities |
136,483 |
79,742 |
Net cash (used in) provided by operating activities |
(543,936) |
4,067,868 |
Cash flows from investing activities: Additions to property and equipment |
(70,454) |
(62,291) |
Purchases of marketable securities |
(2,959,285) |
(4,046,142) |
Proceeds from sale of marketable securities |
3,009,459 |
4,795,505 |
Additions to intangible assets |
(1,077,547) |
(2,740,001) |
Net cash used in investing activities |
(1,097,827) |
(2,052,929) |
Cash flows from financing activities: |
||
Net borrowings on line of credit |
1,800,000 |
1,700,000 |
Exercise of stock options |
— |
21,366 |
Excess tax (expense) benefit derived from exercise of stock options |
(835,016) |
313,955 |
Cash settlement of contingent consideration |
— |
(1,618,983) |
Repurchase of common shares |
(1,689,040) |
(3,356,633) |
Net cash used in financing activities |
(724,056) |
(2,940,295) |
Net decrease in cash and cash equivalents |
(2,365,819) |
(925,356) |
Cash and cash equivalents at beginning of period |
38,203,059 |
39,866,037 |
Cash and cash equivalents at end of period |
$ 35,837,240 |
$ 38,940,681 |
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Three months ended |
Three months ended | |||||
Earnings |
Earnings per |
Earnings impact |
Earnings per | |||
Net income (loss) attributable to common |
$ (48,044) |
$ — |
$ 405,998 |
$ 0.02 | ||
Less: Net loss at subsidiary attributable to noncontrolling |
||||||
interests |
12,894 |
— |
11,700 |
— | ||
Net income (loss) |
(60,938) |
— |
394,298 |
0.02 | ||
Adjustments to net income (loss) |
||||||
Income tax expense (benefit) |
(41,135) |
— |
318,990 |
0.02 | ||
Depreciation and amortization expense |
589,344 |
0.04 |
581,754 |
0.03 | ||
Share-based compensation (a) |
233,448 |
0.01 |
303,128 |
0.02 | ||
Interest income |
(31,483) |
— |
(57,846) |
— | ||
Interest expense |
28,247 |
— |
18,489 |
— | ||
Adjusted Earnings and Adjusted Diluted Earnings |
||||||
Per Share |
$ 717,483 |
$ 0.04 |
$ 1,558,813 |
$ 0.09 | ||
Diluted weighted-average common shares outstanding: |
16,523,680 |
17,184,345 | ||||
Six months ended |
Six months ended | |||||
Earnings |
Earnings per |
Earnings |
Earnings per | |||
Net income (loss) attributable to common |
$ (301,155) |
$ (0.02) |
$ 452,279 |
$ 0.03 | ||
Less: Net loss at subsidiary attributable to noncontrolling |
||||||
interests |
28,340 |
— |
31,469 |
— | ||
Net income (loss) |
(329,495) |
(0.02) |
420,810 |
0.02 | ||
Adjustments to net income (loss) |
||||||
Income tax expense (benefit) |
(216,474) |
(0.01) |
337,446 |
0.02 | ||
Depreciation and amortization expense |
1,171,437 |
0.07 |
1,143,002 |
0.07 | ||
Share-based compensation (a) |
408,226 |
0.03 |
549,603 |
0.03 | ||
Product label expansion fees (b) |
1,167,600 |
0.07 |
1,167,600 |
0.07 | ||
Gain on contingent consideration (c) |
— |
— |
(381,037) |
(0.02) | ||
Interest income |
(108,612) |
(0.01) |
(114,248) |
(0.01) | ||
Interest expense |
48,689 |
— |
34,039 |
— | ||
Adjusted Earnings and Adjusted Diluted Earnings |
||||||
Per Share |
$ 2,141,371 |
$ 0.13 |
$ 3,157,215 |
$ 0.18 | ||
Diluted weighted-average common shares outstanding: |
16,622,448 |
17,294,087 |
The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable
Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release.
The Company defines these supplemental financial measures as follows:
- Adjusted Earnings: net income adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation expense and other income and interest expense.
(a) Represents the share-based compensation ofCumberland .
(b) Represents Cumberland's fee paid to theFDA in connection with a request for expanded pediatric labeling for Caldolor.
(c) Represents Cumberland's reduction in contingent liabilities as the result of a reduction in the cost of the Vaprisol acquisition. - Adjusted Diluted Earnings Per Share: Adjusted Earnings divided by diluted weighted-average common shares outstanding.
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