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Cumberland Pharmaceuticals Reports First Quarter 2015 Financial Results
As of
QUARTER HIGHLIGHTS:
- Received
FDA acceptance to review the Caldolor®supplemental New Drug Application (sNDA) requesting a label update with pediatric information. - Announced the addition of Boxaban™, in Phase II development, for the treatment of asthma patients with Aspirin Exacerbated Respiratory Disease (AERD).
- Provided encouraging top line results from the Phase II Hepatoren® study first patient cohort.
"Our first quarter was successful on many fronts," said
FINANCIAL RESULTS:
Net Revenue: For the three months ended
Operating Expenses: Total operating expenses for the three months ended
Adjusted Earnings: Adjusted Earnings for the first quarter were
Balance Sheet: At
RECENT DEVELOPMENTS
Caldolor®
Additionally, in
One study entitled, "A Multicenter, Open-Label, Surgical Surveillance Trial to Evaluate Safety and Efficacy" provided for eligible enrolled patients to receive one of two dose strengths of intravenous ibuprofen for up to a 24-hour dosing period. One hundred fifty patients from thirteen clinical sites were enrolled in this study. Intravenous ibuprofen reduced fever and pain and the shortened infusion time was well tolerated.
The other registry study entitled "A Multicenter, Open-Label, Surgical Surveillance Trial to Evaluate Safety" 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 twenty-one clinical sites were enrolled in this study. The shortened infusion time was well tolerated.
Hepatoren®
The Company has completed enrollment of the Type II patients. Top line results from these patients indicate that Hepatoren was overall well tolerated with no safety concerns noted. Furthermore, the patients receiving the higher dose levels of Hepatoren were more likely to experience increases in urine output, a signal of improved kidney function, compared to patients who received placebo.
Enrollment of the remaining patients in the Type I HRS cohort is underway. Next steps include further analysis of the data set received from the Type II patient study, completion of enrollment for the Type I patients, and design of a follow-up study based on these findings.
Boxaban™
Conference Call and Webcast
A conference call and live Internet webcast will be held on
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
About Caldolor® (ibuprofen) Injection
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® (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 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
Forward-Looking Statements
This press release contains forward-looking statements, which are subject to certain risks and reflect
| |||||||
Condensed Consolidated Balance Sheets | |||||||
(Unaudited) | |||||||
|
| ||||||
ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ |
39,044,749 |
$ |
39,866,037 |
|||
Marketable securities |
13,865,122 |
14,841,418 |
|||||
Accounts receivable, net of allowances |
5,174,866 |
5,504,728 |
|||||
Inventories |
4,634,065 |
5,600,319 |
|||||
Other current assets |
4,826,271 |
5,002,469 |
|||||
Total current assets |
67,545,073 |
70,814,971 |
|||||
Property and equipment, net |
685,188 |
651,030 |
|||||
Intangible assets, net |
21,551,175 |
21,568,541 |
|||||
Other assets |
2,408,399 |
2,370,572 |
|||||
Total assets |
$ |
92,189,835 |
$ |
95,405,114 |
|||
LIABILITIES AND EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ |
3,371,184 |
$ |
3,242,713 |
|||
Other current liabilities |
8,523,418 |
10,506,769 |
|||||
Total current liabilities |
11,894,602 |
13,749,482 |
|||||
Revolving line of credit |
— |
— |
|||||
Other long-term liabilities |
950,699 |
902,841 |
|||||
Total liabilities |
12,845,301 |
14,652,323 |
|||||
Commitments and contingencies |
|||||||
Equity: |
|||||||
Shareholders' equity: |
|||||||
Common stock—no par value; 100,000,000 shares authorized; |
60,507,641 |
61,942,410 |
|||||
Retained earnings |
18,864,544 |
18,818,263 |
|||||
Total shareholders' equity |
79,372,185 |
80,760,673 |
|||||
Noncontrolling interests |
(27,651) |
(7,882) |
|||||
Total equity |
79,344,534 |
80,752,791 |
|||||
Total liabilities and equity |
$ |
92,189,835 |
$ |
95,405,114 |
| ||||||||
Condensed Consolidated Statements of Income and Comprehensive Income | ||||||||
(Unaudited) | ||||||||
Three months ended |
||||||||
2015 |
2014 |
|||||||
Net revenues |
$ |
8,686,774 |
$ |
8,093,244 |
||||
Costs and expenses: |
||||||||
Cost of products sold |
1,161,841 |
1,053,717 |
||||||
Selling and marketing |
3,530,915 |
3,613,931 |
||||||
Research and development |
1,859,012 |
826,373 |
||||||
General and administrative |
1,644,141 |
1,897,217 |
||||||
Amortization |
486,749 |
293,955 |
||||||
Total costs and expenses |
8,682,658 |
7,685,193 |
||||||
Operating income |
4,116 |
408,051 |
||||||
Interest income |
56,402 |
67,343 |
||||||
Interest expense |
(15,550) |
(12,203) |
||||||
Income before income taxes |
44,968 |
463,191 |
||||||
Income tax expense |
(18,456) |
(188,009) |
||||||
Net income |
26,512 |
275,182 |
||||||
Net loss at subsidiary attributable to noncontrolling interests |
19,769 |
11,138 |
||||||
Net income attributable to common shareholders |
$ |
46,281 |
$ |
286,320 |
||||
Earnings per share attributable to common shareholders |
||||||||
- basic |
$ |
— |
$ |
0.02 |
||||
- diluted |
$ |
— |
$ |
0.02 |
||||
Weighted-average shares outstanding |
||||||||
- basic |
17,012,852 |
17,907,848 |
||||||
- diluted |
17,405,019 |
18,161,680 |
||||||
Comprehensive income attributable to common shareholders |
46,281 |
286,320 |
||||||
Net loss at subsidiary attributable to noncontrolling interests |
19,769 |
11,138 |
||||||
Total comprehensive income |
$ |
26,512 |
$ |
275,182 |
||||
| |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(Unaudited) | |||||||
Three months ended | |||||||
2015 |
2014 | ||||||
Cash flows from operating activities: |
|||||||
Net income |
$ |
26,512 |
$ |
275,182 |
|||
Adjustments to reconcile net income to net cash provided by operating activities: |
|||||||
Depreciation and amortization expense |
561,248 |
395,135 |
|||||
Share-based compensation |
246,475 |
125,758 |
|||||
Excess tax benefit derived from exercise of stock options |
(18,558) |
(188,008) |
|||||
Noncash interest expense |
8,051 |
6,019 |
|||||
Noncash investment (gains) losses |
(20,818) |
141,920 |
|||||
Net changes in assets and liabilities affecting operating activities, net of effect of business combination: |
|||||||
Accounts receivable |
329,862 |
(886,669) |
|||||
Inventory |
966,254 |
(289,263) |
|||||
Other current assets and other assets |
130,321 |
(319,506) |
|||||
Accounts payable and other current liabilities |
(251,261) |
1,696,229 |
|||||
Other long-term liabilities |
55,735 |
25,775 |
|||||
Net cash provided by operating activities |
2,033,821 |
982,572 |
|||||
Cash flows from investing activities: |
|||||||
Additions to property and equipment |
(108,658) |
(29,760) |
|||||
Purchases of marketable securities |
(1,500,000) |
(750,000) |
|||||
Proceeds from sale of marketable securities |
2,497,114 |
1,096,033 |
|||||
Cash paid for acquisitions |
— |
(2,000,000) |
|||||
Additions to intangible assets |
(2,062,321) |
(388,768) |
|||||
Net cash used in investing activities |
(1,173,865) |
(2,072,495) |
|||||
Cash flows from financing activities: |
|||||||
Exercise of stock options |
12,000 |
— |
|||||
Excess tax benefit derived from exercise of stock options |
18,558 |
188,008 |
|||||
Repurchase of common shares |
(1,711,802) |
(919,583) |
|||||
Net cash used in financing activities |
(1,681,244) |
(731,575) |
|||||
Net decrease in cash and cash equivalents |
(821,288) |
(1,821,498) |
|||||
Cash and cash equivalents at beginning of period |
39,866,037 |
40,869,457 |
|||||
Cash and cash equivalents at end of period |
$ |
39,044,749 |
$ |
39,047,959 |
| |||||||||||||||||
Reconciliation of Net Income Attributable to Common Shareholders to Adjusted Earnings and Adjusted Diluted Earnings Per Share | |||||||||||||||||
(Unaudited) | |||||||||||||||||
Three months ended March |
Three months ended March | ||||||||||||||||
Earnings |
Earnings per share impact |
Earnings |
Earnings per | ||||||||||||||
Net income attributable to common shareholders |
$ |
46,281 |
$ |
— |
$ |
286,320 |
$ |
0.02 |
|||||||||
Less: Net loss at subsidiary attributable to noncontrolling interests |
19,769 |
— |
11,138 |
— |
|||||||||||||
Net income |
26,512 |
— |
275,182 |
0.02 |
|||||||||||||
Adjustments to net income |
|||||||||||||||||
Income tax expense |
18,456 |
— |
188,009 |
0.01 |
|||||||||||||
Depreciation and amortization expense |
561,248 |
0.03 |
395,135 |
0.02 |
|||||||||||||
Share-based compensation expense (a) |
246,475 |
0.01 |
125,758 |
0.01 |
|||||||||||||
Product label expansion fees (b) |
1,167,600 |
0.07 |
— |
— |
|||||||||||||
Gain on contingent consideration (c) |
(381,037) |
(0.02) |
— |
— |
|||||||||||||
Interest income |
(56,402) |
— |
(67,343) |
— |
|||||||||||||
Interest expense |
15,550 |
— |
12,203 |
— |
|||||||||||||
Adjusted Earnings and Adjusted Diluted Earnings Per Share |
$ |
1,598,402 |
$ |
0.09 |
$ |
928,944 |
$ |
0.05 |
|||||||||
Diluted weighted-average common shares outstanding: |
17,405,019 |
18,161,680 |
|||||||||||||||
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 expense ofCumberland .
(b) Represents Cumberland's fee paid to theFDA in connection with a request for expanded pediatric labeling for Caldolor
(c) Represents Cumberland's gain on contingent consideration 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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