UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): | August 27, 2009 |
Cumberland Pharmaceuticals Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Tennessee | 001-33637 | 62-1765329 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
2525 West End Avenue, Suite 950, Nashville, Tennessee | 37203 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | (615) 255-0068 |
Not Applicable
______________________________________________
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On August 27, 2009, Cumberland Pharmaceuticals Inc. (the "Company") issued a press release announcing the operating results for the three and six months ended June 30, 2009. A copy of the press release is furnished as Exhibit 99.1.
This information is furnished pursuant to Item 2.02 of Form 8-K and shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, unless specifically incorporated by reference in a document filed under the Securities Act of 1933, as amended, or the Exchange Act. By filing this report on Form 8-K and furnishing this information, the Company makes no admission as to the materiality of any information in this report that is required to be disclosed solely by Item 2.02.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press release dated August 27, 2009
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Cumberland Pharmaceuticals Inc. | ||||
August 28, 2009 | By: |
/s/ A.J. Kazimi
|
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|
||||
Name: A.J. Kazimi | ||||
Title: Chief Executive Officer |
Exhibit Index
Exhibit No. | Description | |
|
|
|
99.1
|
Press release dated August 27, 2009 |
Exhibit 99.1
CUMBERLAND PHARMACEUTICALS REPORTS SECOND QUARTER 2009 FINANCIAL RESULTS
- Revenue up 18% to $9.8 million
Sales Force Expansion for CaldolorÒ Launch Complete
NASHVILLE, TN, August 27, 2009 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on the hospital acute care and gastroenterology markets, today announced second quarter 2009 financial results.
Our second quarter and the weeks since have encompassed two of the most significant events in the Companys historyreceipt of Food and Drug Administration (FDA) approval for CaldolorÒ and the completion of our initial public offering, said A.J. Kazimi, Chief Executive Officer at Cumberland. We have also completed the expansion of our hospital sales force to facilitate a successful product launch of Caldolor, our injectable ibuprofen product. We believe Caldolor will offer an important alternative for physicians in treating patients with fever or pain where oral treatment is not ideal or even a viable option.
Net Revenue: For the three months ended June 30, 2009, net revenue was $9.8 million, up 18% from the corresponding period in 2008. This growth was primarily attributable to an increase in volume for AcetadoteÒ, the Companys injectable treatment for acetaminophen overdose. Net revenue for the six months ended June 30, 2009, was $19.2 million, compared with $16.7 million for the same period in 2008.
Operating Expenses: Total operating expenses for the three months ended June 30, 2009, were $9.2 million, compared to $6.5 million for the same period in 2008. The increase in expenses was due primarily to milestone payments associated with FDA approval of Caldolor, as well as increased marketing expenses for that product. For the six-month period ended June 30, 2009, total operating expenses were approximately $16.5 million, compared with $13.0 million for the corresponding period in 2008. This increase was primarily a result of the Caldolor milestone obligations, costs incurred in connection with the expansion of the hospital sales force and increased marketing and advertising costs.
Net Income: Net income for the three months ended June 30, 2009, was $0.3 million, or $0.02 per diluted share, compared to $1.1 million, or $0.07 per diluted share, for the same period in 2008. Net income for the six months ended June 30, 2009, was $1.5 million, or $0.09 per diluted share, compared to $2.5 million, or $0.15 per diluted share, for the corresponding period in 2008. The decrease is due primarily to milestone obligations triggered by FDA approval of Caldolor in the second quarter of 2009, as well as the aforementioned sales force expansion.
Cash and Cash Equivalents: At June 30, 2009, Cumberland had $12.5 million in cash and cash equivalents, compared to $10.1 million at March 31, 2009, representing an increase of $2.4 million. At June 30, 2009, the Company had net accounts receivable and inventories of approximately $3.3 million and $1.1 million, respectively. Included in current assets is an income tax receivable of approximately $1.8 million that was a result of a tax benefit associated with the exercise of stock options during the first quarter of 2009. Total working capital was approximately $12.0 million and the current ratio was 2.5x.
Recent Events
Caldolor Approval and Launch Preparation: In June 2009 Cumberland received FDA approval for Caldolor, the first injectable product approved in the U.S. for the treatment of pain and fever. Cumberland recently completed an expansion that nearly tripled the size of its hospital sales force in preparation for the products launch, increasing the size of this group from 27 to 77 experienced hospital representatives and managers.
We expect Caldolor to be used to treat pain either as a stand-alone agent or as a multi-modal treatment in conjunction with opioids. Caldolor is also approved to treat fever in the acute care setting, where existing alternatives to oral treatment often include the use of cold blankets and ice packs, says Kazimi. We believe Caldolor has an excellent safety profile, supported by a long history of ibuprofen use as well as our clinical trial database that shows no serious adverse events associated with the product and no significant safety difference compared to placebo.
Initial Public Offering: In early August 2009, Cumberland completed an initial public offering of 5,000,000 shares of common stock, raising $85.0 million in gross proceeds. Net proceeds to the Company are estimated to be approximately $75.2 million after deducting underwriting discounts and commissions as well as offering expenses, and before exercise of any over-allotment option. Cumberland expects to use these proceeds primarily for potential acquisitions and the pending launch of Caldolor.
Conference Call and Webcast
A conference call and live webcast will be held on Thursday, August 27, 2009, at 10:00 a.m. Eastern Time to discuss the Companys second quarter 2009 financial results. To participate on the call, please dial 877-604-9672 (for U.S. callers) or 719-325-4909 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 888-203-1112 (for U.S. callers) or 719-457-0820 (for international callers). The passcode for the rebroadcast is 7834064. The live webcast and rebroadcast can be accessed via Cumberland Pharmaceuticals website at http://investor.shareholder.com/cpix/events.cfm.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Companys primary target markets include hospital acute care and gastroenterology. Cumberland markets Acetadote® for the treatment of acetaminophen poisoning and Kristalose®, a prescription laxative. The Company also recently received FDA approval for Caldolor®, the first injectable treatment for pain and fever available in the United States, and is preparing for the commercial launch of that product. Cumberland is dedicated to providing innovative products which improve quality of care for patients.
For more information on Cumberland Pharmaceuticals, please visit www.cumberlandpharma.com.
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 is the first FDA approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. Caldolor should be used with caution in patients with prior history of ulcer disease or GI bleeding, in patients with fluid retention or heart failure, in the elderly, those with renal impairment, heart failure, liver impairment, and those taking diuretics or ACE inhibitors. Blood pressure should be monitored during treatment with Caldolor. For full prescribing information, visit www.caldolor.com.
About Acetadote
Acetadote is used in the emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter painkillers. It is the only approved injectable product in the United States for the treatment of acetaminophen overdose, the leading cause of poisonings presenting in emergency departments in the country1. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. Serious anaphylactoid reactions, including death in a patient with asthma, have been reported in patients administered acetylcysteine intravenously. Acetadote should be used with caution in patients with asthma, or where there is a history of bronchospasm. The total volume administered should be adjusted for patients less than 40 kg and for those requiring fluid restriction. 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.net.
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.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act, including statements regarding estimated results of operations in future periods. These forward-looking statements are subject to the finalization of Cumberlands quarterly financial and accounting procedures and reflect Cumberlands current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given, however, that these events will occur. As with any business, all phases of Cumberlands operations are subject to influences outside its control. Any one, or a combination, of these factors could materially affect the results of the Cumberlands operations. These factors include among other things, market conditions, the commercialization of Caldolor, Cumberlands dependence on Acetadote and Kristalose to generate almost all of its revenues, intense competition from existing and new products, which could diminish the commercial potential of Cumberlands products, an inability of manufacturers to produce Cumberlands products on a timely basis or a failure of manufacturers to comply with stringent regulations applicable to pharmaceutical drug manufacturers, maintaining and building an effective sales and marketing infrastructure, Cumberlands ability to identify and acquire rights to products, government regulation, the possibility that Cumberlands marketing exclusivity and patent rights may provide only limited protection from competition, and other factors discussed in our Registration Statement declared effective by the SEC on August 10, 2009. There can be no assurance that the results or developments anticipated by the Company will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the Company or its business and operations. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE: Cumberland Pharmaceuticals Inc.
Contacts:
Angela Novak
Corporate Relations
(615) 255-0068
anovak@cumberlandpharma.com
Kathy Waller
Financial Relations Board
312-543-6708
CUMBERLAND PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
December 31, | June 30, | |||||||||||||||
2008 | 2009 | |||||||||||||||
ASSETS |
||||||||||||||||
Current assets: |
||||||||||||||||
Cash and cash equivalents |
$ | 11,829,551 | $ | 12,531,110 | ||||||||||||
Accounts receivable, net of allowances |
3,129,347 | 3,254,371 | ||||||||||||||
Inventories |
1,762,776 | 1,108,376 | ||||||||||||||
Prepaid and other current assets |
481,312 | 709,511 | ||||||||||||||
Income taxes receivable |
| 1,800,632 | ||||||||||||||
Deferred tax assets |
507,212 | 507,212 | ||||||||||||||
Total current assets |
17,710,198 | 19,911,212 | ||||||||||||||
Property and equipment, net |
432,413 | 505,174 | ||||||||||||||
Intangible assets, net |
8,528,732 | 8,226,047 | ||||||||||||||
Deferred tax assets |
1,000,031 | 1,000,031 | ||||||||||||||
Other assets |
3,447,813 | 3,705,275 | ||||||||||||||
Total assets |
$ | 31,119,187 | $ | 33,347,739 | ||||||||||||
LIABILITIES AND EQUITY |
||||||||||||||||
Current liabilities: |
||||||||||||||||
Current portion of long-term debt |
$ | 1,250,000 | $ | 1,666,667 | ||||||||||||
Current portion of other long-term obligations |
457,915 | 1,263,491 | ||||||||||||||
Accounts payable |
3,257,164 | 2,420,175 | ||||||||||||||
Other accrued liabilities |
2,640,855 | 2,586,396 | ||||||||||||||
Total current liabilities |
7,605,934 | 7,936,729 | ||||||||||||||
Revolving line of credit |
1,825,951 | 1,825,951 | ||||||||||||||
Long-term debt, excluding current portion |
3,750,000 | 2,916,666 | ||||||||||||||
Other long-term obligations, excluding current portion |
382,487 | 159,165 | ||||||||||||||
Total liabilities |
13,564,372 | 12,838,511 | ||||||||||||||
Commitments and contingencies |
||||||||||||||||
Redeemable common stock |
| 630,000 | ||||||||||||||
Shareholders equity: |
||||||||||||||||
Cumberland Pharmaceuticals Inc. shareholders equity: |
||||||||||||||||
Convertible preferred stock no par value; 3,000,000 shares |
||||||||||||||||
authorized; 812,749 shares issued and outstanding |
2,604,070 | 2,604,070 | ||||||||||||||
Common stock no par value; 100,000,000 shares authorized; |
||||||||||||||||
9,903,047 and 10,475,693(1) shares issued and outstanding |
||||||||||||||||
as of December 31, 2008 and June 30, 2009, respectively |
13,500,034 | 14,331,181 | ||||||||||||||
Retained earnings |
1,450,711 | 2,964,672 | ||||||||||||||
Total shareholders equity |
17,554,815 | 19,899,923 | ||||||||||||||
Noncontrolling interests |
| (20,695 | ) | |||||||||||||
Total equity |
17,554,815 | 19,879,228 | ||||||||||||||
Total liabilities and equity |
$ | 31,119,187 | $ | 33,347,739 | ||||||||||||
_________________ |
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(1) Number of shares issued and outstanding represents total shares of common stock regardless of classification on the |
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consolidated balance sheet. The number of shares of redeemable common stock at June 30, 2009 was 42,000. |
CUMBERLAND PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2008 | 2009 | 2008 | 2009 | |||||||||||||
Net revenues |
$ | 8,357,532 | $ | 9,820,613 | $ | 16,661,359 | $ | 19,225,212 | ||||||||
Costs and expenses: |
||||||||||||||||
Cost of products sold |
737,230 | 777,076 | 1,492,721 | 1,510,294 | ||||||||||||
Selling and marketing |
3,644,796 | 4,383,802 | 7,008,802 | 8,523,989 | ||||||||||||
Research and development |
918,460 | 2,630,725 | 2,028,402 | 3,400,842 | ||||||||||||
General and administrative |
1,021,639 | 1,236,435 | 2,104,733 | 2,681,298 | ||||||||||||
Amortization of product license right |
171,726 | 171,726 | 343,452 | 343,452 | ||||||||||||
Other |
25,193 | 26,733 | 51,222 | 54,196 | ||||||||||||
Total costs and expenses |
6,519,044 | 9,226,497 | 13,029,332 | 16,514,071 | ||||||||||||
Operating income |
1,838,488 | 594,116 | 3,632,027 | 2,711,141 | ||||||||||||
Interest income |
50,647 | 10,160 | 133,019 | 27,756 | ||||||||||||
Interest expense |
(10,377 | ) | (84,224 | ) | (123,981 | ) | (181,935 | ) | ||||||||
Net income before income taxes |
1,878,758 | 520,052 | 3,641,065 | 2,556,962 | ||||||||||||
Income tax expense |
(820,335 | ) | (232,637 | ) | (1,187,392 | ) | (1,063,696 | ) | ||||||||
Net income |
1,058,423 | 287,415 | 2,453,673 | 1,493,266 | ||||||||||||
Net loss at subsidiary attributable to |
||||||||||||||||
noncontrolling interests |
| 8,456 | | 20,695 | ||||||||||||
Net income attributable to common
shareholders |
$ | 1,058,423 | $ | 295,871 | $ | 2,453,673 | $ | 1,513,961 | ||||||||
Earnings per share attributable to |
||||||||||||||||
common shareholders basic |
$ | 0.10 | $ | 0.03 | $ | 0.24 | $ | 0.15 | ||||||||
Earnings per share attributable to |
||||||||||||||||
common shareholders diluted |
$ | 0.07 | $ | 0.02 | $ | 0.15 | $ | 0.09 |
1 | National Poison Data System, American Association of Poison Control Centers |
CUMBERLAND PHARMACEUTICALS INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Six Months Ended June 30, | ||||||||
2008 | 2009 | |||||||
Cash flows from operating activities: |
||||||||
Net income |
$ | 2,453,673 | $ | 1,493,266 | ||||
Adjustments to reconcile net income to net cash |
||||||||
flows from operating activities: |
||||||||
Gain on early extinguishment of other long-term obligations |
(38,577 | ) | | |||||
Depreciation and amortization expense |
392,896 | 398,341 | ||||||
Nonemployee stock granted for services received |
27,500 | 182,091 | ||||||
Nonemployee stock option grant expense |
| 826,290 | ||||||
Stock-based compensation employee stock options |
121,725 | 313,064 | ||||||
Excess tax benefit derived from exercise of stock options |
(156,758 | ) | (2,842,825 | ) | ||||
Noncash interest expense |
63,113 | 29,376 | ||||||
Net changes in assets and liabilities affecting operating activities: |
||||||||
Accounts receivable |
(627,785 | ) | (125,024 | ) | ||||
Inventory |
1,110 | 654,400 | ||||||
Prepaid, other current assets and other assets |
625,462 | 743,951 | ||||||
Accounts payable and other accrued liabilities |
(8,332 | ) | (986,592 | ) | ||||
Other long-term obligations |
47,856 | 582,254 | ||||||
Net cash provided by operating activities |
2,901,883 | 1,268,592 | ||||||
Cash flows from investing activities: |
||||||||
Additions to property and equipment |
(54,259 | ) | (85,863 | ) | ||||
Additions to patents |
(41,791 | ) | (34,551 | ) | ||||
Net cash used in investment activities |
(96,050 | ) | (120,414 | ) | ||||
Cash flows from financing activities: |
||||||||
Costs of initial public offering |
(322,664 | ) | (154,179 | ) | ||||
Principal payments on note payable |
(916,668 | ) | (416,667 | ) | ||||
Net borrowings on line of credit |
500,000 | | ||||||
Payment of other long-term obligations |
(2,760,000 | ) | | |||||
Costs of financing for long-term debt and credit facility |
| (15,475 | ) | |||||
Proceeds from exercise of stock options |
39,098 | 4,296 | ||||||
Excess tax benefit derived from exercise of stock options |
156,758 | 2,842,825 | ||||||
Payments made in connection with repurchase of common shares |
| (2,707,419 | ) | |||||
Net cash used in financing activities |
(3,303,476 | ) | (446,619 | ) | ||||
Net (decrease) increase in cash and cash equivalents |
(497,643 | ) | 701,559 | |||||
Cash and cash equivalents at beginning of period |
10,814,518 | 11,829,551 | ||||||
Cash and cash equivalents at end of period |
$ | 10,316,875 | $ | 12,531,110 | ||||