e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2009
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 001-33637
Cumberland Pharmaceuticals Inc.
(Exact name of registrant as specified in its charter)
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Tennessee
(State or other jurisdiction
of incorporation or organization)
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62-1765329
(I.R.S. Employer Identification No.) |
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2525 West End Avenue, Suite 950, Nashville, Tennessee
(Address of principal executive offices)
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37203
(Zip code) |
(615) 255-0068
(Registrants telephone number, including area code)
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. YES o NO þ
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). YES o NO þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer þ
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES o NO þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date.
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Class |
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Outstanding
at August 28, 2009 |
Common stock, no par value
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19,955,343 |
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
INDEX
PART I FINANCIAL INFORMATION
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ITEM 1: |
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FINANCIAL STATEMENTS |
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
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December 31, |
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June 30, |
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2008 |
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2009 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
11,829,551 |
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$ |
12,531,110 |
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Accounts receivable, net of allowances |
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3,129,347 |
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3,254,371 |
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Inventories |
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1,762,776 |
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1,108,376 |
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Prepaid and other current assets |
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481,312 |
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709,511 |
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Income taxes receivable |
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1,800,632 |
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Deferred tax assets |
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507,212 |
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507,212 |
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Total current assets |
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17,710,198 |
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19,911,212 |
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Property and equipment, net |
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432,413 |
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505,174 |
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Intangible assets, net |
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8,528,732 |
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8,226,047 |
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Deferred tax assets |
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1,000,031 |
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1,000,031 |
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Other assets |
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3,447,813 |
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3,705,275 |
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Total assets |
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$ |
31,119,187 |
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$ |
33,347,739 |
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LIABILITIES AND EQUITY |
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Current liabilities: |
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Current portion of long-term debt |
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$ |
1,250,000 |
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$ |
1,666,667 |
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Current portion of other long-term obligations |
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457,915 |
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1,263,491 |
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Accounts payable |
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3,257,164 |
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2,420,175 |
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Other accrued liabilities |
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2,640,855 |
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2,586,396 |
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Total current liabilities |
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7,605,934 |
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7,936,729 |
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Revolving line of credit |
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1,825,951 |
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1,825,951 |
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Long-term debt, excluding current portion |
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3,750,000 |
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2,916,666 |
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Other long-term obligations, excluding current portion |
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382,487 |
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159,165 |
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Total liabilities |
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13,564,372 |
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12,838,511 |
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Commitments and contingencies |
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Redeemable common stock |
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630,000 |
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Shareholders equity: |
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Cumberland Pharmaceuticals Inc. shareholders equity: |
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Convertible preferred stock no par value; 3,000,000 shares |
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authorized; 812,749 shares issued and outstanding |
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2,604,070 |
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2,604,070 |
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Common stock no par value; 100,000,000 shares authorized; |
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9,903,047 and 10,475,693(1) shares issued and outstanding |
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as of December 31, 2008 and June 30, 2009, respectively |
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13,500,034 |
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14,331,181 |
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Retained earnings |
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1,450,711 |
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2,964,672 |
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Total shareholders equity |
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17,554,815 |
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19,899,923 |
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Noncontrolling interests |
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(20,695 |
) |
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Total equity |
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17,554,815 |
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19,879,228 |
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Total liabilities and equity |
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$ |
31,119,187 |
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$ |
33,347,739 |
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(1) |
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Number of shares issued and outstanding represents total shares of common stock regardless of classification on the consolidated
balance sheet. The number of shares of redeemable common stock at June 30, 2009 was 42,000. |
See accompanying notes to unaudited condensed consolidated financial statements.
1
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(UNAUDITED)
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Three months ended June 30, |
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Six months ended June 30, |
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2008 |
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2009 |
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2008 |
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2009 |
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Net revenues |
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$ |
8,357,532 |
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$ |
9,820,613 |
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$ |
16,661,359 |
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$ |
19,225,212 |
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Costs and expenses: |
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Cost of products sold |
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737,230 |
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777,076 |
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1,492,721 |
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1,510,294 |
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Selling and marketing |
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3,644,796 |
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4,383,802 |
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7,008,802 |
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8,523,989 |
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Research and development |
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918,460 |
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2,630,725 |
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2,028,402 |
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3,400,842 |
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General and administrative |
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1,021,639 |
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1,236,435 |
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2,104,733 |
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2,681,298 |
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Amortization of product license right |
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171,726 |
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171,726 |
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343,452 |
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343,452 |
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Other |
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25,193 |
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26,733 |
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51,222 |
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54,196 |
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Total costs and expenses |
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6,519,044 |
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9,226,497 |
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13,029,332 |
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16,514,071 |
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Operating income |
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1,838,488 |
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594,116 |
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3,632,027 |
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2,711,141 |
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Interest income |
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50,647 |
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10,160 |
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133,019 |
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27,756 |
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Interest expense |
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(10,377 |
) |
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(84,224 |
) |
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(123,981 |
) |
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(181,935 |
) |
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Net income before income taxes |
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1,878,758 |
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520,052 |
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3,641,065 |
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2,556,962 |
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Income tax expense |
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(820,335 |
) |
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(232,637 |
) |
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(1,187,392 |
) |
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(1,063,696 |
) |
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Net income |
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1,058,423 |
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|
287,415 |
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2,453,673 |
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1,493,266 |
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Net loss at subsidiary attributable to |
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noncontrolling interests |
|
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8,456 |
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20,695 |
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Net income attributable to common shareholders |
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$ |
1,058,423 |
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$ |
295,871 |
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$ |
2,453,673 |
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$ |
1,513,961 |
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Earnings per share attributable to common |
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shareholders basic |
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$ |
0.10 |
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$ |
0.03 |
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$ |
0.24 |
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$ |
0.15 |
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Earnings per share attributable to common |
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shareholders diluted |
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$ |
0.07 |
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$ |
0.02 |
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$ |
0.15 |
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$ |
0.09 |
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Weighted-average shares outstanding basic |
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10,124,647 |
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10,467,781 |
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10,109,239 |
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10,394,883 |
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Weighted-average shares outstanding diluted |
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|
16,116,104 |
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|
16,046,844 |
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|
16,263,889 |
|
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|
16,087,448 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
2
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
AND COMPREHENSIVE INCOME
(UNAUDITED)
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Cumberland Pharmaceuticals Inc. Shareholders |
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Non- |
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Preferred stock |
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Common stock |
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Retained |
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controlling |
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Total |
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Shares |
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Amount |
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Shares |
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Amount |
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earnings |
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interests |
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equity |
|
Balance, December 31, 2008 |
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|
812,749 |
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$ |
2,604,070 |
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|
9,903,047 |
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$ |
13,500,034 |
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$ |
1,450,711 |
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$ |
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$ |
17,554,815 |
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Issuance of common stock |
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for services received |
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11,750 |
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|
182,091 |
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182,091 |
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Stock options granted |
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for services received |
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|
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|
826,290 |
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|
826,290 |
|
Exercise of options and |
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related tax benefit, net of |
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mature shares redeemed |
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for the exercise price and |
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|
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statutory tax withholdings |
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|
564,914 |
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|
191,936 |
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|
191,936 |
|
Stock-based compensation - |
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employee stock option grants |
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|
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|
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|
313,064 |
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|
313,064 |
|
Repurchase of common shares |
|
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|
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|
|
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|
(4,018 |
) |
|
|
(52,234 |
) |
|
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|
|
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|
|
|
(52,234 |
) |
Net and comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,513,961 |
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(20,695 |
) |
|
|
1,493,266 |
|
Reclass of redeemable |
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|
common stock |
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|
|
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|
(630,000 |
) |
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|
(630,000 |
) |
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|
Balance, June 30, 2009 |
|
|
812,749 |
|
|
$ |
2,604,070 |
|
|
|
10,475,693 |
|
|
$ |
14,331,181 |
|
|
$ |
2,964,672 |
|
|
$ |
(20,695 |
) |
|
$ |
19,879,228 |
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|
See accompanying notes to unaudited condensed consolidated financial statements.
3
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
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|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Cash paid during the year for: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
132,489 |
|
|
$ |
116,848 |
|
Income taxes |
|
|
598,239 |
|
|
|
93,969 |
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
Increase in incurred but unpaid costs of initial public offering |
|
|
56,185 |
|
|
|
119,646 |
|
See accompanying notes to unaudited condensed consolidated financial statements.
4
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(1) BASIS OF PRESENTATION
In the opinion of management, the accompanying unaudited condensed consolidated financial
statements (condensed consolidated financial statements) of Cumberland Pharmaceuticals Inc. and
its subsidiaries (collectively, the Company or Cumberland) have been prepared on a basis
consistent with the December 31, 2008 audited consolidated financial statements and include all
adjustments, consisting of only normal recurring adjustments, necessary to fairly present the
information set forth herein. All significant intercompany accounts and transactions have been
eliminated in consolidation. The condensed consolidated financial statements have been prepared in
accordance with the regulations of the Securities and Exchange Commission (SEC), and omit certain
information and footnote disclosures necessary to present the statements in accordance with U.S.
generally accepted accounting principles. These condensed consolidated financial statements should
be read in conjunction with the audited consolidated financial statements and notes thereto for the
year ended December 31, 2008 included on pages F-3 through F-27 in the Companys Prospectus filed
pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the Securities Act), filed
with the SEC on August 12, 2009. The results of operations for the three and six months ended June
30, 2009 are not necessarily indicative of the results to be expected for the entire fiscal year or
any future period.
Total comprehensive income was comprised solely of net income for the three and six months ended
June 30, 2008 and 2009.
Accounting Policies
In preparing the condensed consolidated financial statements in conformity with U.S. generally
accepted accounting principles, management must make decisions that impact the reported amounts and
the related disclosures. Such decisions include the selection of the appropriate accounting
principles to be applied and the assumptions on which to base accounting estimates. In reaching
such decisions, management applies judgments based on its understanding and analysis of the
relevant circumstances, historical experience, and other available information. Actual amounts
could differ from those estimated at the time the consolidated financial statements are prepared.
Note 2 in the Companys consolidated financial statements for the year ended December 31, 2008
provides a summary of significant accounting policies followed in the preparation of the condensed
consolidated financial statements. Other footnotes in the Companys 2008 consolidated financial
statements describe various elements of the condensed consolidated financial statements and the
assumptions made in determining specific amounts.
Initial public offering costs of approximately $3.6 million are included in non-current assets and
will be accounted for as a reduction of equity upon completion of the initial public offering. As
of June 30, 2009, approximately $0.7 million of unpaid costs related to our initial public offering
are included in accounts payable and other accrued liabilities.
Fair Value of Financial Instruments
The Companys financial instruments include cash and cash equivalents, accounts receivable,
accounts payable, accrued liabilities, revolving line of credit, long-term debt and other
long-term obligations. The carrying values for cash and cash equivalents, accounts receivable,
accounts payable and accrued liabilities approximate fair value due to their short-term nature. The
terms of the revolving line of credit and term debt include variable interest rates, which
approximate current market rates.
The
current portion of other long-term liabilities is primarily related
to the milestone payments due to a third party as a result of the FDA
approval of Caldolor in June 2009, and approximates fair value due to its
short-term nature. The long-term portion of other long-term
liabilities is primarily related to the difference between
straight-line rent
expense recognized during the course of our operating leases and the
amount paid to the lessor, and is not subject to changes in fair value.
(2) ADOPTION OF NEW ACCOUNTING PRONOUNCEMENTS
Effective January 1, 2009, the Company adopted the provisions of Statement of Financial Accounting
Standards (SFAS) No. 160, Noncontrolling Interests in Consolidated Financial Statements an
amendment of ARB No. 51 (SFAS 160). This statement requires that noncontrolling interests in a
subsidiary be classified as a component of equity in the consolidated balance sheet. In addition,
the
5
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
consolidated results of operations must include amounts attributable to both the parent and the
noncontrolling interests. As of the date of adoption of SFAS 160, the equity balance of the
noncontrolling interests in Cumberland Emerging Technologies, Inc. (CET), the Companys 85%-owned
subsidiary, had been reduced to zero. In accordance with SFAS 160, the operating loss at CET for
the three and six months ended June 30, 2009 was allocated between the Company and the
noncontrolling interests.
The Company adopted the provisions of SFAS 165, Subsequent Events, in the second quarter of 2009.
This statement establishes general standards of accounting for, and disclosure of, events that
occur after the balance sheet date but before financial statements are issued or are available to
be issued. Prior to SFAS 165, the guidance for evaluating subsequent events was provided in the
auditing literature. SFAS 165 was issued to include in the accounting hierarchy the requirement to
evaluate subsequent events. See footnote 9 for disclosure of events occurring subsequent to June
30, 2009.
(3) EARNINGS PER SHARE
The following tables reconcile the numerator and the denominator used to calculate diluted earnings
per share for the three and six months ended June 30, 2008 and 2009:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
2008 |
|
|
2009 |
|
|
Numerator: |
|
|
|
|
|
|
|
|
Net income attributable to common shareholders |
|
$ |
1,058,423 |
|
|
$ |
295,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding basic |
|
|
10,124,647 |
|
|
|
10,467,781 |
|
Convertible preferred stock shares |
|
|
1,710,990 |
|
|
|
1,625,498 |
|
Dilutive effect of other securities |
|
|
4,280,467 |
|
|
|
3,953,565 |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding diluted |
|
|
16,116,104 |
|
|
|
16,046,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2009 |
|
|
Numerator: |
|
|
|
|
|
|
|
|
Net income attributable to common shareholders |
|
$ |
2,453,673 |
|
|
$ |
1,513,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding basic |
|
|
10,109,239 |
|
|
|
10,394,883 |
|
Convertible preferred stock shares |
|
|
1,710,990 |
|
|
|
1,625,498 |
|
Dilutive effect of other securities |
|
|
4,443,660 |
|
|
|
4,067,067 |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding diluted |
|
|
16,263,889 |
|
|
|
16,087,448 |
|
|
|
|
|
|
|
|
As of June 30, 2008 and 2009, options to purchase 17,008 and 86,716 shares of common stock,
respectively, were outstanding but were not included in the computation of diluted earnings per share because the
effect would be antidilutive.
(4) SEGMENT REPORTING
We operate in one segment, specialty pharmaceutical products. Management has chosen to organize the
Company based on the type of products sold. All of the Companys assets are located in the United
States. The Company did not have sales to non-U.S. customers during the three month periods ended
June 30, 2008 and 2009, respectively. Sales of $0 and $0.7 million were to non-U.S. customers
during the six month periods ended June 30, 2008 and 2009, respectively.
6
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The Companys net revenues consisted of the following for the three and six months ended June 30,
2008 and 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
Products: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acetadote |
|
$ |
5,958,058 |
|
|
$ |
7,239,776 |
|
|
$ |
11,757,335 |
|
|
$ |
14,373,206 |
|
Kristalose |
|
|
2,352,884 |
|
|
|
2,518,728 |
|
|
|
4,831,270 |
|
|
|
4,747,344 |
|
Other |
|
|
46,590 |
|
|
|
62,109 |
|
|
|
72,754 |
|
|
|
104,662 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
8,357,532 |
|
|
$ |
9,820,613 |
|
|
$ |
16,661,359 |
|
|
$ |
19,225,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5) MILESTONE OBLIGATIONS
In June 2009, the Company received marketing approval for Caldolor, an injectable form of
ibuprofen, from the Food and Drug Administration (FDA). The approval triggered a milestone
obligation of approximately $1.0 million to a third party who assisted in a variety of development
efforts related to Caldolor and is payable as follows: approximately $0.8 million due upon
approval and the remaining $0.2 million due in equal monthly installments over the subsequent
twelve months. As of June 30, 2009, the milestone obligation of approximately $1.0 million is
included in the current portion of other long-term obligations in the condensed consolidated
balance sheet and the expense is included as a component of research and development expenses in
the condensed consolidated statement of income for the three and six months ended June 30, 2009.
In addition to the milestone obligation discussed above, the third party immediately vested in
60,000 performance-based options with an exercise price of $1.63 per share. The Company calculated
the fair value of this award to be $13.41 using the Black-Scholes methodology
and the following assumptions: expected term of 2.3 years, risk-free interest rate of 1.1%,
volatility of 51% and an expected dividend yield of 0%. During the second quarter of 2009, the
Company recognized approximately $0.8 million of research and development expense associated with
this award.
As a result of the FDAs approval of Caldolor, a third-party research institution from which the
Company obtained the license rights to Caldolor vested in 10,000 shares of common stock valued at
$150,000. The expense associated with the grant of stock is included in research and development
expense during the second quarter of 2009.
(6) STOCK OPTIONS
In January 2009, two executives exercised options to purchase 730,680 shares of common stock with a
weighted-average exercise price of $0.11 per share. Options were exercised using a net-share
settlement feature that provided for an option holder to use 204,245 shares acquired upon exercise
to settle the minimum statutory tax withholding requirements of approximately $2.7 million. In
connection with these exercises, the Company agreed to repurchase up to $0.6 million in common
stock, acquired upon exercise, during the first quarter of 2010 to provide for the settlement of
the remaining tax liabilities associated with the exercise. The estimated repurchase amount is
presented as redeemable common stock in the condensed consolidated balance sheet.
As a result of the exercise of the nonqualified options, the Company recognized a tax benefit of
$2.8 million. The tax benefit was used to offset the estimated tax liability resulting from the
results of operations for the six months ended June 30, 2009. The remaining tax benefit of
approximately $1.8 million at June 30, 2009 is expected to be used by the end of 2009. Accordingly,
the Company has recognized the income tax receivable as a current asset in the condensed
consolidated balance sheet.
7
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(7) COLLABORATIVE AGREEMENTS
The Company is a party to several collaborative arrangements with certain research institutions to
identify and pursue promising pre-clinical pharmaceutical product candidates. The Company has
determined these collaborative agreements do not meet the criteria for accounting under EITF 07-1,
Accounting for Collaborative Arrangements. The agreements do not specifically designate each
partys rights and obligations to each other under the collaborative arrangements. Except for
patent defense costs, expenses incurred by one party are not required to be reimbursed by the other
party. The funding for these programs is generally provided through private sector investments or
federal Small Business (SBIR/STTR) grant programs. Expenses incurred under these collaborative
agreements are included in research and development expenses in the consolidated statements of
income. Funding received from private sector investments and grants are recorded as net revenue in
the consolidated statements of income.
(8) CONTINGENCIES
During the
second quarter of 2006, our Chief Executive, a Vice President of
the Company, and the Company were named
as co-defendants in Parniani v. Cardinal Health, Inc. et al., Case No. 0:06-cv-02514-PJS-JJG in the
U.S. District Court in the District of Minnesota for unspecified damages based on workers
compensation and related claims. In July 2007, the federal district court dismissed the case
against the Company and its officers. The U.S. Court of Appeals for the Eighth Circuit (Eighth Circuit)
affirmed this ruling in December 2008. The plaintiff filed a petition for rehearing en banc with
the Eighth Circuit in February 2009. After this petition was denied in March 2009, the plaintiff
filed a motion for stay of mandate with the Eighth Circuit in April 2009. The Eighth Circuit denied
plaintiffs motion for stay of mandate as well as the plaintiffs subsequent motion appealing that
denial in April 2009. The plaintiff requested an extension of time to file a petition for writ of
certiorari with the U.S. Supreme Court in May 2009. The U.S. Supreme Court granted the plaintiffs
extension request until July 14, 2009. The plaintiff did not file a petition for writ of certiorari
with the U.S. Supreme Court by the Supreme Courts July 14, 2009 deadline. The plaintiff is a
former employee of a third-party service provider to the Company. The service provider, which was also named
as a co-defendant, agreed to assume control of the Companys defense at its cost pursuant to a contract
between the service provider and the Company. Based upon the
information available to the Company to date, management believes
that all asserted claims against the Company and the individual defendants are without merit. However, if
any of the plaintiffs claims are deemed to be meritorious upon
rehearing, the Company expects to be
indemnified by the service provider so that resolution of this matter is not expected to have a
material adverse effect on the Companys future financial results or financial condition.
(9) SUBSEQUENT EVENTS
The
Company performed an evaluation of subsequent events through
August 31, 2009, the date the
financial statements were issued. Based on this review, certain items were identified
that required disclosure in these condensed consolidated financial statements, as noted below.
On August 10, 2009, the Company completed its initial public offering of 5,000,000 shares of common
stock at $17.00 per share, raising gross proceeds of approximately $85.0 million. After deducting
underwriting discounts of approximately $6.0 million and estimated offering expenses incurred by us
of approximately $3.9 million, the net proceeds to the Company were approximately $75.2 million.
Contemporaneously with the offering, each outstanding share of preferred stock was automatically
converted into two shares of common stock.
In July 2009, the Company amended its debt agreement with Bank of America to provide for $18.0
million in term debt and a $4.0 million revolving credit facility, both with an interest rate of
LIBOR plus an applicable margin based on the Companys leverage ratio, as defined in the agreement.
The term debt is payable in quarterly installments of $1.5 million beginning on March 31, 2010 and
continuing until December 31, 2012. The revolving credit facility is due on December 31, 2012. The
Company may be required to make additional principal payments on the term debt if the leverage
ratio, as defined, exceeds 1.75 to 1.0 on an annual basis. The borrowings are collateralized by a
first lien against all of the Companys assets. The proceeds
from the term debt are restricted for the payment in part of the minimum
statutory tax withholding
8
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
requirements of approximately $24.6 million due from option
holders who exercised options to purchase shares of our common stock at the pricing of the
Companys initial public offering. The consideration for that payment was the transfer to the
Company of shares acquired upon exercise at the then-current fair market value of the Companys
common stock.
In August 2009, two executives exercised options to purchase 4,377,090 shares of common stock with
a weighted-average exercise price of $0.55 per share. The options were exercised using a net-share
settlement feature that provided for an option holder to use 1,445,074 shares acquired upon
exercise to settle the minimum statutory tax withholding requirements of approximately $24.6
million. The payment of the exercise price of approximately $2.4 million was settled by the
tendering of 140,788 shares of common stock by the optionees. As a result of the exercise, the
Company recognized a tax benefit of approximately $25.5 million. A portion of this benefit is
expected to be used in 2009, and the remainder will be used to offset future tax liabilities.
9
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
The following discussion contains certain forward-looking statements which reflect managements
current views of future events and operations. These statements involve certain risks and
uncertainties, and actual results may differ materially from them. Forward-looking statements are
made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of
1995. We caution you that our actual results may differ significantly from the results we discuss
in these forward looking statements. Some important factors which may cause results to differ from
expectations include: availability of additional debt and equity capital required to finance the
business model; market conditions at the time additional capital is required; significant leverage
and debt service requirements of the Company; our ability to continue to acquire branded products;
product sales; and management of our growth and integration of our acquisitions. Other important
factors that may cause actual results to differ materially from forward-looking statements are
discussed in Risk Factors on pages 7 through 22 and Special note regarding forward-looking
statements on page 23 of our Prospectus filed pursuant to Rule 424(b) under the Securities Act
filed with the SEC on August 12, 2009. The Company does not undertake to publicly update or revise
any of its forward-looking statements, even in the event that experience or future changes indicate
that the anticipated results will not be realized. The following presentation of managements
discussion and analysis of financial condition and results of operations should be read in
conjunction with the Companys unaudited consolidated financial statements and related notes
thereto.
OVERVIEW
We are a specialty pharmaceutical company focused on the acquisition, development and
commercialization of branded, prescription products. We are building our product portfolio
primarily by acquiring rights to FDA-approved and late-stage development products and marketing
them to specialty physician segments. Our primary target markets are hospital acute care and
gastroenterology. Our current portfolio consists of two products marketed in the United States and
one product recently approved by the FDA.
We pursued the development of Acetadote for the treatment of acetaminophen poisoning and acquired
rights to clinical data to support its approval. Approval of the product was obtained in January
2004 and we began to market Acetadote in the second quarter of 2004, launching the product with a
dedicated hospital sales force. In March 2006, we received approval from the FDA for the use of
Acetadote in pediatric patients.
In April 2006, we acquired exclusive commercial rights in the U.S. to Kristalose, a
gastroenterology product we had previously co-promoted under an arrangement with Bertek
Pharmaceuticals Inc., a subsidiary of Mylan Laboratories Inc. In September 2006, we re-launched
Kristalose under the Cumberland brand with a dedicated field sales force, targeting
gastroenterologists and other high prescribers of laxative products.
Our research and development expenses have continued to grow because of our program to develop
Caldolor. We completed the clinical program for Caldolor intended to support regulatory approval in
2008 and received that approval in June 2009. We expect research and development expenses to
continue to be significant as we continue clinical work related to Caldolor and other products.
We have funded our operations with private equity capital of approximately $14 million since our
inception in 1999. We have supplemented this equity funding by re-investing our profits and
utilizing our credit facilities in order to support our operations.
Prior to 2007, our sales forces were contracted to us by a third party. In January 2007, we brought
the hospital sales force in-house via our wholly-owned subsidiary,
Cumberland Pharma Sales Corp. We continue to outsource the dedicated gastroenterology sales force. All expenses associated with the
sales forces are included in selling and marketing expense. In 2000,
we formed CET with Vanderbilt University and
10
Tennessee Technology Development Corporation
to identify early-stage drug development activities. CET partners with universities and other
research organizations to advance promising, early-stage product candidates through the development
process and on to commercialization.
Our operating results have fluctuated in the past and are likely to fluctuate in the future. These
fluctuations can result from competitive factors, new product acquisitions or introductions, the
nature, scope and results of our research and development programs, pursuit of our growth strategy
and other factors. As a result of these fluctuations, our historical financial results are not
necessarily indicative of future results.
We were incorporated in 1999 and have been headquartered in Nashville, Tennessee since inception.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
Please see a discussion of our critical accounting policies and significant judgments and estimates
in Managements Discussion and Analysis for the year ended December 31, 2008 on pages 33 through 38
in the Prospectus filed pursuant to Rule 424(b) under the Securities Act filed with the SEC on
August 12, 2009. There have been no changes to these policies or estimates as of June 30, 2009,
except as noted below.
Accounting Estimates and Judgments
The preparation of consolidated financial statements in conformity with U.S. generally accepted
accounting principles requires management to make estimates, judgments and assumptions that affect
the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the period. We
base our estimates on past experience and on other factors we deem reasonable given the
circumstances. Past results help form the basis of our judgments about the carrying value of assets
and liabilities that are not determined from other sources. Actual results could differ from these
estimates. These estimates, judgments and assumptions are most critical with respect to our
accounting for revenue recognition, provision for income taxes, stock-based compensation, research
and development expenses and intangible assets.
Revenue Recognition
We recognize revenue in accordance with the SECs Staff Accounting Bulletin No. 101, Revenue
Recognition in Financial Statements, as amended by Staff Accounting Bulletin No. 104 (together, SAB
101), and Statement of Financial Accounting Standards No. 48, Revenue Recognition When Right of
Return Exists (SFAS 48).
Our revenue is derived primarily from the product sales of Acetadote and Kristalose. Revenue is
recognized when persuasive evidence of an arrangement exists, delivery has occurred, the fee is
fixed or determinable and collectability is probable. Delivery is considered to have occurred upon
either shipment of the product or arrival at its destination based on the shipping terms of the
transaction. When these conditions are satisfied, we recognize gross product revenue, which is the
price we charge generally to our wholesalers for a particular product.
Our net product revenue reflects the reduction of gross product revenue at the time of initial
sales recognition for estimated accounts receivable allowances for chargebacks, discounts and
damaged product, as well as provisions for sales related accruals for rebates, product returns and
administrative fees and fee-for-services.
11
The following table reflects our sales-related accrual activity:
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
Sales related accruals |
|
2008 |
|
|
2009 |
|
|
Balance at beginning of period |
|
$ |
738,362 |
|
|
$ |
1,040,203 |
|
Current provision |
|
|
657,001 |
|
|
|
1,439,754 |
|
Current provision for prior period sales |
|
|
(65,647 |
) |
|
|
58,000 |
|
Actual returns/credits |
|
|
(448,729 |
) |
|
|
(1,275,586 |
) |
|
|
|
|
|
|
|
Balance at end of period |
|
$ |
880,987 |
|
|
$ |
1,262,371 |
|
|
|
|
|
|
|
|
RESULTS OF OPERATIONS
Three months ended June 30, 2009 compared to the three months ended June 30, 2008
Net revenues. Net revenues for the three months ended June 30, 2009 totaled approximately $9.8
million, representing an increase of approximately $1.5 million, or 18%, over the same period in
2008 with approximately $1.3 million related to Acetadote and approximately $0.2 million related to
Kristalose. The increase in net revenues for Acetadote is primarily due to an increase in gross
sales of approximately $1.7 million offset by an increase of approximately $0.5 million in sales
discounts and allowances. Acetadote volume increased 16%, resulting in increased gross revenues of
approximately $1.1 million, as we continued to gain market share in our target market. The remainder
of the increase in gross sales of Acetadote was due to an increase in the selling price. The
increase in gross sales of Kristalose was primarily due to an increase in the selling price.
For the three months ended June 30, 2009, gross sales were reduced by approximately $1.2 million,
of which approximately $0.4 million related to damaged and expired product returns, approximately
$0.2 million related to cash discounts, approximately $0.5 million related to fee-for-services and
approximately $0.1 million related to rebates. For the three months ended June 30, 2008, gross
sales were reduced by approximately $0.6 million, of which approximately $0.2 million related to
damaged and expired product returns, approximately $0.2 million related to cash discounts,
approximately $0.1 million related to fee-for-services and approximately $0.1 million related to
rebates. We expect our fee-for-service expenses to increase in the future as we (1) enter into new
wholesaler agreements and (2) launch Caldolor.
Cost of products sold. Cost of products sold for the three months ended June 30, 2009 totaled
approximately $0.8 million, representing an increase of approximately $40,000, or 5%, over the same
period in 2008. As a percentage of net revenues, cost of products sold decreased from 8.8% of net
revenues for the three months ended June 30, 2008 to 7.9% of net revenues for the three months
ended June 30, 2009. The decrease in cost of products sold as a percentage of net revenues was
primarily due to a change in the sales mix between the periods. The launch of Caldolor is expected
to increase our cost of products sold as a percentage of net revenue. The impact on future results
of operations from the recognition of sales of Caldolor will depend on the relative proportion of
sales that Caldolor has to total sales.
Selling and marketing. Selling and marketing expense for the three months ended June 30, 2009
totaled approximately $4.4 million, representing an increase of approximately $0.7 million, or 20%,
over the same period in 2008. The increase was primarily due to marketing, advertising and market
research for Caldolor as we prepare for our launch in the fourth quarter of 2009. In addition, we
incurred additional royalty expense as a result of increased sales in the second quarter of 2009 as
compared to the same period in 2008.
12
Research and development. Research and development expense for the three months ended June 30, 2009
totaled approximately $2.6 million, representing an increase of approximately $1.7 million, or
186%, over the same period in 2008. The increase was primarily due to the recognition of
approximately $2.0 million of milestone obligations due upon FDA approval of Caldolor in June 2009.
The milestone payments include approximately $1.0 million of cash payments to a third-party who
assisted in early development efforts with approximately $0.8 million due upon approval and the
remaining $0.2 million due in equal monthly installments over the subsequent twelve months. In
addition to the cash payments, the third party immediately vested in 60,000 stock options with a
fair value of approximately $0.8 million at the time of approval, calculated using the
Black-Scholes methodology. A separate third-party research institution immediately vested in 10,000
shares of common stock valued at $150,000 upon FDA approval.
The increase in research and development expense resulting from the milestone obligations was
partially offset by a decrease in supplies expense in the second quarter of 2009 as compared to
2008. In the second quarter of 2008, we incurred setup and validation costs associated with
entering into a new, secondary supplier agreement for Acetadote and Caldolor that did not reoccur
in 2009.
General and administrative. General and administrative expense for the three months ended June 30,
2009 totaled approximately $1.2 million, representing an increase of approximately $0.2 million, or
21%, over the same period in 2008. The increase is primarily due to increased stock compensation
expense due to the timing of when stock options were issued in 2009 as compared to 2008.
Income tax expense. Income tax expense for the three months ended June 30, 2009 totaled
approximately $0.2 million, representing a decrease of approximately $0.6 million, or 72%, over the
same period in 2008. As a percentage of net income before income taxes, income tax expense
increased from 43.7% for the three months ended June 30, 2008 to 44.7% for the three months ended
June 30, 2009. The increase was primarily due to an increase in incentive stock options expense in
2009 for which we do not receive a tax benefit.
Six months ended June 30, 2009 compared to the six months ended June 30, 2008
Net revenues. Net revenues for the six months ended June 30, 2009 totaled approximately $19.2
million, representing an increase of approximately $2.6 million, or 15%, over the same period in
2008. The increase in net revenues is primarily due to increase in gross sales of Acetadote of
approximately $3.3 million offset by an increase of approximately $0.7 million of related sales
discounts and allowances. Acetadote volume increased 16%, resulting in an increase in gross sales
of approximately $2.2 million, as we continued to gain market share in our target market. The
remainder of the increase in gross sales of Acetadote was due to an increase in the selling price.
Net revenue for Kristalose during the six months ended June 30, 2009 remained consistent with the
same period in 2008.
For the six months ended June 30, 2009, gross sales were reduced by approximately $2.2 million, of
which approximately $0.7 million related to damaged and expired product returns, approximately $0.4
million related to cash discounts, approximately $0.8 million related to fee-for-services and
approximately $0.3 million related to rebates. For the six months ended June 30, 2008, gross sales
were reduced by approximately $1.2 million, of which approximately $0.5 million related to damaged
and expired product returns, approximately $0.4 million related to cash discounts and approximately
$0.2 million related to fee-for-services. We expect our fee-for-service expense to increase in the
future as we (1) enter into new wholesaler agreements and (2) launch Caldolor.
13
Cost of products sold. Cost of products sold for the six months ended June 30, 2009 and 2008
totaled approximately $1.5 million and $1.5 million, respectively. As a percentage of net revenues,
cost of products sold decreased from 9.0% for the six months ended June 30, 2008 to 7.9% for the
six months ended June 30, 2009. The decrease in cost of products sold as a percentage of net
revenues was primarily due to a change in the sales mix between the periods. The launch of Caldolor
is expected to increase our cost of products sold as a percentage of net revenue. The impact on
future results of operations from the recognition of sales of Caldolor will depend on the relative
proportion of sales that Caldolor has to total sales.
Selling and marketing. Selling and marketing expense for the six months ended June 30, 2009 totaled
approximately $8.5 million, representing an increase of approximately $1.5 million, or 22%, over
the same period in 2008. The increase was primarily due to (1) increased marketing, advertising and
market research for Caldolor and Acetadote, (2) increased payroll and related costs due to the
expansion of our sales force, (3) increased royalty expense as a result of our increase in sales
and (4) increased freight and distribution costs.
Research and development. Research and development expense for the six months ended June 30, 2009
totaled approximately $3.4 million, representing an increase of approximately $1.4 million, or 68%,
over the same period in 2008. The increase was primarily due to the recognition of approximately
$2.0 million of milestone obligations due upon the FDA approval of Caldolor in June 2009. The
milestone payments include approximately $1.0 million of cash payments to a third-party who
assisted in early development efforts, with approximately $0.8 million due upon approval and the
remaining $0.2 million due in equal monthly installments over the subsequent twelve months. In
addition to the cash payments, the third party immediately vested in 60,000 stock options with a
fair value of approximately $0.8 million at the time of approval, calculated using the
Black-Scholes methodology. A separate third-party research institution immediately vested in 10,000
shares of common stock valued at $150,000 upon FDA approval.
The increase in research and development expense resulting from the milestone obligations was
offset by a decrease in supplies expense in the second quarter of 2009 as compared to 2008. In
2008, we incurred setup and validation costs associated with entering into a new, secondary
supplier agreement for Acetadote and Caldolor that did not reoccur in 2009.
General and administrative. General and administrative expense for the six months ended June 30,
2009 totaled approximately $2.7 million, representing an increase of approximately $0.6 million, or
27%, over the same period in 2008. The increase is primarily due to (1) increased salary expense
due to pay raises and personnel additions, (2) increased payroll-related taxes associated with the
exercise of nonqualified options in January 2009 and (3) increased stock compensation expense due
to the timing of when stock options were issued in 2009 as compared to 2008.
Income tax expense. Income tax expense for the six months ended June 30, 2009 totaled approximately
$1.1 million, representing a decrease of approximately $0.1 million, or 10%, over the same period
in 2008. As a percentage of net income before income taxes, income tax expense increased from 32.6%
for the six months ended June 30, 2008 to 41.6% for the six months ended June 30, 2009. The
increase was primarily due to (1) the recognition in the first quarter of 2008 of approximately
$0.4 million of previously unrecognized tax benefits and (2) an increase in incentive stock options
expense in 2009 for which we do not receive a tax benefit.
During the first quarter of 2009, an executive exercised nonqualified stock options that resulted
in a tax benefit to us of approximately $2.8 million. The benefit did not impact our income tax
expense; however, the benefit will be applied to offset future tax liabilities. As a result, we do
not anticipate making significant income tax payments until the fourth quarter of 2009, the time at
which we anticipate fully utilizing this benefit.
14
LIQUIDITY AND CAPITAL RESOURCES
Working Capital
Our primary sources of liquidity are cash flows provided by our operations and our borrowings. We
believe that our internally generated cash flows and amounts available under our credit facilities
will be adequate to service existing debt, finance internal growth and fund capital expenditures.
As of December 31, 2008 and June 30, 2009, cash and cash equivalents was $11.8 million and $12.5
million, respectively, working capital (current assets minus current liabilities) was $10.1 million
and $12.0 million, respectively, and our current ratio (current assets to current liabilities) was
2.3x and 2.5x, respectively. As of June 30, 2009, we had an additional $5.7 million available to us
on our line of credit.
On August 10, 2009, the Company completed its initial public offering of 5,000,000 shares of common
stock at $17.00 per share, raising gross proceeds of approximately $85.0 million. After deducting
underwriting discounts of approximately $6.0 million and estimated offering expenses incurred by us
of approximately $3.9 million, the net proceeds to the Company were approximately $75.2 million.
In July 2009, we amended our debt agreement with Bank of America to provide for $18.0 million in
term debt and a $4.0 million revolving credit facility. We used $4.2 million of the proceeds from
our initial public offering to repay the outstanding balance from our previous term debt agreement.
Further, we used the proceeds from the new term debt to pay in part the minimum statutory tax
withholding requirements of approximately $24.6 million due from option holders who exercised
options to purchase shares of our common stock at the pricing of our initial public offering on
August 10, 2009. The remaining balance due of approximately $6.6 million related to the minimum
statutory tax withholding requirements was funded by our existing cash balances. As a result of the
exercise, the Company recognized a tax benefit of approximately $25.5 million. A portion of this
benefit is expected to be used in 2009, and the remainder will be used to offset future tax
liabilities.
The following table summarizes our net changes in cash and cash equivalents for the six months
ended June 30, 2008 and 2009:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2009 |
|
|
|
(in thousands) |
|
Net cash provided by (used in): |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
2,902 |
|
|
$ |
1,269 |
|
Investing activities |
|
|
(96 |
) |
|
|
(120 |
) |
Financing activities |
|
|
(3,303 |
) |
|
|
(447 |
) |
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents (1) |
|
$ |
(498 |
) |
|
$ |
702 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The sum of the individual amounts may not agree due to rounding. |
Cash provided by operating activities for the six months ended June 30, 2009 of approximately
$1.3 million was primarily due to net income of approximately $1.5 million offset by an increase in
our accounts receivable balance of approximately $0.1 million.
Cash used by investing activities for the six months ended June 30, 2009 of approximately $0.1
million was primarily due to the purchase of property and equipment.
Cash used by financing activities for the six months ended June 30, 2009 of approximately $0.4
million was primarily due to principal payments on our term debt of $0.4 million.
15
OFF-BALANCE SHEET ARRANGEMENTS
During the six months ended June 30, 2009, we did not engage in any off-balance sheet arrangements.
|
|
|
ITEM 3: |
|
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Interest Rate Risk
We are exposed to market risk related to changes in interest rates on our revolving credit facility
and our term note payable. We do not utilize derivative financial instruments or other market
risk-sensitive instruments to manage exposure to interest rate changes. The main objective of our
cash investment activities is to preserve principal while maximizing interest income through
low-risk investments.
The interest rate related to borrowings under our revolving credit facility and term debt is a
variable rate of LIBOR plus an applicable margin, as defined in the debt agreement (3.81% at June
30, 2009). As of June 30, 2009, we had outstanding borrowings of approximately $6.4 million under
our revolving credit facility and term debt combined. If interest rates increased by 1.0%, our
annual interest expense on our borrowings would increase by approximately $64,000.
Exchange Rate Risk
While we operate primarily in the U.S., we are exposed to foreign currency risk. Acetadote is
manufactured by a supplier that denominates supply prices in Canadian dollars. Additionally, some
of our research and development is performed abroad. As of June 30, 2009, our outstanding payables
denominated in a foreign currency totaled $0.2 million.
One of our supply agreements for Caldolor is denominated in Australian dollars. As of June 30,
2009, we have not incurred any costs for purchases of Caldolor from this supplier. The extent of
our exposure to foreign currency gains or losses will depend on the quantity of our purchases and
the exchange rate at the time the invoices are paid.
Currently, we do not utilize financial instruments to hedge exposure to foreign currency
fluctuations. We believe our exposure to foreign currency fluctuation is minimal as our purchases
in foreign currency have a maximum exposure of 90 days based on invoice terms, with much of the
exposure being limited to 30 days based on the due date of the invoice. Foreign currency exchange
gains and losses were not significant for the three and six months ended June 30, 2009. Neither a
10% increase nor decrease from current exchange rates would have a significant effect on our
operating results or financial condition.
|
|
|
ITEM 4T: |
|
CONTROLS AND PROCEDURES |
We have established disclosure controls and procedures designed to ensure that material information
required to be disclosed in our reports filed under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified by the Securities and Exchange Commission
and that any material information relating to us is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely
decisions regarding required disclosures. In designing and evaluating our disclosure controls and
procedures, our management recognizes that controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving desired control objectives. In
reaching a reasonable level of assurance, our management necessarily was required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and procedures.
As required by Exchange Act Rule 13a-15(b), we performed an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this
16
report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have
each concluded that as of June 30, 2009 our disclosure controls and procedures are effective to
ensure that information we are required to disclose in reports filed or submitted under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the Securities and Exchange Commissions rules and forms, and that our controls and procedures
designed to ensure that information required to be disclosed by us in such reports is accumulated
and communicated to our management, including our Chief Executive Officer and Chief Financial
Officer, as appropriate to allow timely decisions regarding required disclosure.
PART II OTHER INFORMATION
|
|
|
ITEM 1: |
|
LEGAL PROCEEDINGS |
Except as described below, we are not a party to litigation or other legal proceedings.
During the second quarter of 2006, our Chief Executive, a Vice President of ours, and we were named
as co-defendants in Parniani v. Cardinal Health, Inc. et al., Case No. 0:06-cv-02514-PJS-JJG in the
U.S. District Court in the District of Minnesota for unspecified damages based on workers
compensation and related claims. In July 2007, the federal district court dismissed the case
against us and our officers. The U.S. Court of Appeals for the Eighth Circuit (Eighth Circuit)
affirmed this ruling in December 2008. The plaintiff filed a petition for rehearing en banc with
the Eighth Circuit in February 2009. After this petition was denied in March 2009, the plaintiff
filed a motion for stay of mandate with the Eighth Circuit in April 2009. The Eighth Circuit denied
plaintiffs motion for stay of mandate as well as the plaintiffs subsequent motion appealing that
denial in April 2009. The plaintiff requested an extension of time to file a petition for writ of
certiorari with the U.S. Supreme Court in May 2009. The U.S. Supreme Court granted the plaintiffs
extension request until July 14, 2009. The plaintiff did not file a petition for writ of certiorari
with the U.S. Supreme Court by the Supreme Courts July 14, 2009 deadline. The plaintiff is a
former employee of a third-party service provider to us. The service provider, which was also named
as a co-defendant, agreed to assume control of our defense at its cost pursuant to a contract
between the service provider and us. Based upon the information available to us to date, we believe
that all asserted claims against us and the individual defendants are without merit. However, if
any of the plaintiffs claims are deemed to be meritorious upon rehearing, we expect to be
indemnified by the service provider so that resolution of this matter is not expected to have a
material adverse effect on our future financial results or financial condition.
Information regarding risk factors appears under Risk Factors on pages 7 through 22 and Special
note regarding forward-looking statements on page 23 of our
Prospectus filed pursuant to Rule 424(b) under the Securities act filed with
the SEC on August 12, 2009. There have been no material changes in these risk factors.
|
|
|
ITEM 2: |
|
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
On August 10, 2009, the Companys Registration Statement on Form S-1 (File No. 333-142535) was
declared effective for the Companys initial public offering. On August 10, 2009 and pursuant to
the Registration Statement, the Company sold 5,000,000 shares of Common Stock at a public offering
price of $17.00 per share. The managing underwriters were UBS Investment Bank, Jefferies & Company,
Wells Fargo Securities and Morgan Joseph.
As a result of the initial public offering, the Company received gross proceeds of $85.0 million.
After deducting underwriting discounts and commissions of approximately $6.0 million and estimated
offering expenses paid by the Company of approximately $3.9 million, the Company received net
proceeds of approximately $75.2 million. None of such payments were direct or indirect payments to
directors, officers, general partners of the Company or their associations, to persons owning 10 percent or
more of any class of equity securities of the Company or to affiliates of the Company.
17
The Company used approximately $4.2 million of the net proceeds to pay off the existing term debt
with Bank of America. The remaining proceeds have been invested in
money market accounts until the final allocation has been determined. There
have been no material changes in the planned expected use of the net proceeds from the offering.
|
|
|
ITEM 3: |
|
DEFAULTS UPON SENIOR SECURITIES |
None
|
|
|
ITEM 4: |
|
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS |
Our annual meeting of shareholders was held on April 21, 2009 in Nashville, Tennessee. At the
meeting, Dr. Lawrence W. Greer (8,338,681 votes for, 9,067 votes against and 110,000 votes
abstained) and Thomas R. Lawrence (8,237,276 votes for, 110,472 votes against and 110,000 votes
abstained) were elected to serve a three-year term as directors until 2012. Other directors whose
terms continued after the annual meeting included A. J. Kazimi, Martin E. Cearnal and Dr. Robert G.
Edwards.
|
|
|
ITEM 5: |
|
OTHER INFORMATION |
None
31.1 |
|
Certification of Chief Executive Officer Pursuant to Rule 13-14(a) of the Securities Exchange
Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 |
|
Certification of Chief Financial Officer Pursuant to Rule 13-14(a) of the Securities Exchange
Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 |
|
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
18
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused this
report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
Cumberland Pharmaceuticals Inc.
|
|
Dated: August 31, 2009 |
By: |
/s/ A. J. Kazimi |
|
|
|
A. J. Kazimi |
|
|
|
Chief Executive Officer |
|
|
|
|
|
|
|
|
|
|
Dated: August 31, 2009 |
By: |
/s/ David L. Lowrance |
|
|
|
David L. Lowrance |
|
|
|
Vice President and
Chief Financial Officer |
|
19
Index to Exhibits
31.1 |
|
Certification of Chief Executive Officer Pursuant to Rule 13-14(a) of the Securities Exchange
Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2 |
|
Certification of Chief Financial Officer Pursuant to Rule 13-14(a) of the Securities Exchange
Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1 |
|
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C.
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
20