Form 10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 September 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 |
For the transition period from to
Commission File Number: 001-33609
SUCAMPO PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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30-0520478 |
(State or other jurisdiction of
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(I.R.S. employer |
incorporation or organization)
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identification no.) |
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4520 East-West Highway, Suite 300 |
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Bethesda, MD 20814
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(301) 961-3400 |
(Address of principal executive offices,
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(Registrants telephone number, |
including zip code)
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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 þ No o
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 during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer or a smaller reporting company. Please see definition 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 þ
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Non accelerated filer o
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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 the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No þ
As of November 4, 2009, there were 15,654,258 shares of the registrants class A common
stock outstanding and 26,191,050 shares of the registrants class B common stock outstanding.
Sucampo Pharmaceuticals, Inc.
Form 10-Q Index
PART I FINANCIAL INFORMATION
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Item 1. |
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Condensed Consolidated Financial Statements (Unaudited) |
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share data)
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September 30, |
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December 31, |
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2009 |
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2008 |
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ASSETS: |
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Current assets: |
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Cash and cash equivalents |
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$ |
31,751 |
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$ |
11,536 |
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Investments, current |
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53,038 |
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93,776 |
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Product royalties receivable |
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9,368 |
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9,725 |
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Unbilled accounts receivable |
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828 |
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4,373 |
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Accounts receivable |
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1,350 |
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878 |
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Prepaid and income taxes receivable |
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133 |
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Deferred tax assets, net |
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190 |
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963 |
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Prepaid expenses and other current assets |
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3,447 |
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3,641 |
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Total current assets |
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99,972 |
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125,025 |
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Investments, non-current |
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38,853 |
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16,222 |
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Property and equipment, net |
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2,357 |
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2,275 |
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Deferred tax assets, non-current |
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4,216 |
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4,026 |
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Other assets |
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4,339 |
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3,246 |
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Total assets |
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$ |
149,737 |
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$ |
150,794 |
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LIABILITIES AND STOCKHOLDERS EQUITY: |
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Current liabilities: |
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Accounts payable |
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$ |
2,122 |
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$ |
1,433 |
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Accrued expenses |
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9,414 |
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9,764 |
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Deferred revenue, current |
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13,499 |
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15,599 |
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Income taxes payable, net |
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313 |
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Total current liabilities |
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25,348 |
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26,796 |
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Deferred revenue, non-current |
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10,217 |
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8,061 |
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Other liabilities |
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2,110 |
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2,147 |
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Total liabilities |
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37,675 |
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37,004 |
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Commitments (Note 6) |
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Stockholders equity: |
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Preferred stock, $0.01 par value; 5,000,000 shares authorized at September 30, 2009 and December
31, 2008; no shares issued and outstanding at September 30, 2009 and December 31, 2008 |
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Class A common stock, $0.01 par value; 270,000,000 shares authorized at September 30, 2009 and
December 31, 2008; 15,654,258 and 15,651,849 shares issued and outstanding at September 30,
2009 and December 31, 2008, respectively |
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156 |
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156 |
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Class B common stock, $0.01 par value; 75,000,000 shares authorized at September 30, 2009 and
December 31, 2008; 26,191,050 shares issued and outstanding at September 30, 2009 and
December 31, 2008 |
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262 |
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262 |
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Additional paid-in capital |
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98,516 |
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98,243 |
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Accumulated other comprehensive income |
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454 |
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354 |
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Retained earnings |
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12,674 |
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14,775 |
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Total stockholders equity |
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112,062 |
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113,790 |
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Total liabilities and stockholders equity |
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$ |
149,737 |
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$ |
150,794 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) (Unaudited)
(In thousands, except per share data)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Revenues: |
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Research and development revenue |
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$ |
7,045 |
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$ |
5,436 |
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$ |
19,966 |
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$ |
66,982 |
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Product royalty revenue |
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9,367 |
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7,718 |
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27,227 |
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24,699 |
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Co-promotion revenue |
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1,266 |
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1,185 |
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3,406 |
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3,643 |
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Contract and collaboration revenue |
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153 |
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142 |
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451 |
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425 |
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Total revenues |
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17,831 |
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14,481 |
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51,050 |
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95,749 |
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Operating expenses: |
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Research and development |
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7,383 |
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11,390 |
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26,969 |
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35,537 |
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General and administrative |
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4,317 |
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3,863 |
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10,696 |
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10,591 |
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Selling and marketing |
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3,047 |
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2,680 |
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7,747 |
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8,398 |
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Milestone royalties related parties |
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875 |
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3,531 |
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Product royalties related parties |
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1,664 |
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1,359 |
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4,837 |
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4,391 |
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Total operating expenses |
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16,411 |
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19,292 |
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51,124 |
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62,448 |
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Income (loss) from operations |
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1,420 |
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(4,811 |
) |
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(74 |
) |
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33,301 |
|
Non-operating income (expense): |
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Interest income |
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211 |
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655 |
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742 |
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1,862 |
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Other expense, net |
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(250 |
) |
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(15 |
) |
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(36 |
) |
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(16 |
) |
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Total non-operating income (expense), net |
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(39 |
) |
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640 |
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706 |
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1,846 |
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Income (loss) before income taxes |
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1,381 |
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(4,171 |
) |
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632 |
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35,147 |
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Income tax benefit (provision) |
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(1,469 |
) |
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1,745 |
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(2,733 |
) |
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(7,192 |
) |
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Net income (loss) |
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$ |
(88 |
) |
|
$ |
(2,426 |
) |
|
$ |
(2,101 |
) |
|
$ |
27,955 |
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Net income (loss) per share: |
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Basic net income (loss) per share |
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$ |
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$ |
(0.06 |
) |
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$ |
(0.05 |
) |
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$ |
0.67 |
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Diluted net income (loss) per share |
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$ |
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$ |
(0.06 |
) |
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$ |
(0.05 |
) |
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$ |
0.67 |
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Weighted average common shares outstanding basic |
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41,844 |
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41,813 |
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41,844 |
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41,768 |
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Weighted average common shares outstanding diluted |
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41,844 |
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41,813 |
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41,844 |
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42,022 |
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Comprehensive income (loss): |
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Net income (loss) |
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$ |
(88 |
) |
|
$ |
(2,426 |
) |
|
$ |
(2,101 |
) |
|
$ |
27,955 |
|
Other comprehensive income gain (loss): |
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|
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|
|
|
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|
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|
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Unrealized gain (loss) on investments, net of tax effect |
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20 |
|
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|
374 |
|
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|
(52 |
) |
|
|
(1,082 |
) |
Foreign currency translation |
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|
15 |
|
|
|
54 |
|
|
|
152 |
|
|
|
59 |
|
|
|
|
|
|
|
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Comprehensive income (loss) |
|
$ |
(53 |
) |
|
$ |
(1,998 |
) |
|
$ |
(2,001 |
) |
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$ |
26,932 |
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|
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statement of Changes in Stockholders Equity (Unaudited)
(In thousands, except share data)
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Accumulated |
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Class A |
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Class B |
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Additional |
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Other |
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Total |
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Common Stock |
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Common Stock |
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Paid-In |
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Comprehensive |
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Retained |
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Stockholders |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Income |
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Earnings |
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Equity |
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Balance at December 31, 2008 |
|
|
15,651,849 |
|
|
$ |
156 |
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|
|
26,191,050 |
|
|
$ |
262 |
|
|
$ |
98,243 |
|
|
$ |
354 |
|
|
$ |
14,775 |
|
|
$ |
113,790 |
|
Employee stock option expense |
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
259 |
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|
|
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|
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|
259 |
|
Stock issued under employee stock purchase plan |
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2,409 |
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14 |
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|
14 |
|
Foreign currency translation |
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
152 |
|
|
|
|
|
|
|
152 |
|
Unrealized loss on investments, net of tax effect |
|
|
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|
|
|
|
|
|
|
|
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|
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(52 |
) |
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|
(52 |
) |
Net loss |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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(2,101 |
) |
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|
(2,101 |
) |
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Balance at September 30, 2009 |
|
|
15,654,258 |
|
|
$ |
156 |
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|
|
26,191,050 |
|
|
$ |
262 |
|
|
$ |
98,516 |
|
|
$ |
454 |
|
|
$ |
12,674 |
|
|
$ |
112,062 |
|
|
|
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|
|
|
|
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In thousands)
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Nine Months Ended September 30, |
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2009 |
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2008 |
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|
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Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(2,101 |
) |
|
$ |
27,955 |
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities: |
|
|
|
|
|
|
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Depreciation and amortization |
|
|
532 |
|
|
|
326 |
|
Deferred tax provision (benefit) |
|
|
616 |
|
|
|
(4,312 |
) |
Stock-based compensation |
|
|
259 |
|
|
|
567 |
|
Amortization of premiums (accretion of discounts) on investments |
|
|
898 |
|
|
|
(95 |
) |
Unrealized gain on trading securities |
|
|
(2,601 |
) |
|
|
|
|
Unrealized loss on settlement rights on auction rate securities |
|
|
2,352 |
|
|
|
|
|
Changes in operating assets and liabilities: |
|
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|
|
|
|
|
|
Accounts receivable |
|
|
(472 |
) |
|
|
493 |
|
Unbilled accounts receivable |
|
|
3,545 |
|
|
|
1,219 |
|
Product royalties receivable |
|
|
357 |
|
|
|
1,055 |
|
Prepaid and income taxes receivable and payable, net |
|
|
441 |
|
|
|
3,224 |
|
Accounts payable |
|
|
643 |
|
|
|
(415 |
) |
Accrued expenses |
|
|
(520 |
) |
|
|
3,815 |
|
Deferred revenue |
|
|
(483 |
) |
|
|
4,893 |
|
Other assets and liabilities, net |
|
|
(501 |
) |
|
|
(114 |
) |
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
2,965 |
|
|
$ |
38,611 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of investments |
|
|
(205,726 |
) |
|
|
(135,584 |
) |
Proceeds from the sales of investments |
|
|
127,092 |
|
|
|
41,000 |
|
Maturities of investments |
|
|
98,359 |
|
|
|
43,125 |
|
Purchases of property and equipment |
|
|
(463 |
) |
|
|
(342 |
) |
Purchase of intangible assets |
|
|
(2,915 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
16,347 |
|
|
|
(51,801 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
|
|
|
|
870 |
|
Excess tax benefits from share-based payments |
|
|
|
|
|
|
155 |
|
Proceeds from employee stock purchase plan |
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
14 |
|
|
|
1,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
889 |
|
|
|
(30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
20,215 |
|
|
|
(12,195 |
) |
Cash and cash equivalents at beginning of period |
|
|
11,536 |
|
|
|
25,559 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
31,751 |
|
|
$ |
13,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
Purchase of intangible assets included in accrued expenses |
|
$ |
500 |
|
|
$ |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. Business Organization and Basis of Presentation
Description of the Business
Sucampo Pharmaceuticals, Inc., or the Company, is an international biopharmaceutical company
focused on the discovery, development and commercialization of proprietary drugs based on
prostones, a class of compounds derived from functional fatty acids that occur naturally in the
human body. The Company is focused on developing prostones for the treatment of gastrointestinal,
respiratory, vascular and central nervous system diseases and other disorders for which there are
unmet or underserved medical needs and significant commercial potential.
In January 2006, the Company received marketing approval from the U.S. Food and Drug
Administration, or FDA, for its first product, Amitiza® (lubiprostone), to treat chronic idiopathic
constipation, or CIC, in adults. In April 2008, the Company received a second marketing approval
from the FDA for Amitiza to treat irritable bowel syndrome with constipation in adult women.
Amitiza is being marketed and developed in the United States for gastrointestinal indications under
a collaboration and license agreement with Takeda Pharmaceutical Company Limited, or Takeda. The
Company is primarily responsible for development activities under the agreement. The Company and
Takeda initiated commercial sales of Amitiza in the United States for the treatment of CIC in April
2006 and for the treatment of irritable bowel syndrome with constipation in May 2008 and they are
currently developing Amitiza for the treatment of opioid-induced bowel dysfunction, or OBD.
In February 2009, the Company entered into a license, commercialization and supply agreement
with Abbott Japan Co. Ltd., or Abbott, for lubiprostone in Japan. Under the terms of the agreement,
Abbott received exclusive rights to commercialize lubiprostone in Japan for the treatment of CIC
and received the right of first refusal to any additional indications for which lubiprostone is
developed in Japan. The Company is primarily responsible for development activities under the
agreement. Abbott is responsible for all commercialization expenses and efforts. The Company has
retained the right to co-promote lubiprostone in Japan.
In April 2009, the Company entered into two agreements with R-Tech Ueno Ltd., or R-Tech, a
Japanese manufacturing and research and development company, to acquire all patents and other
intellectual property rights related to Rescula® (unoprostone isopropyl) in the United States and
Canada (Note 7). R-Tech is majority owned by the Companys founders and one of the founders serves
as the chair of R-Techs board of directors. Although Rescula eye drops were approved by the FDA
for the treatment of open-angle glaucoma and ocular hypertension in 2000, Rescula is not currently
marketed in the United States or Canada. The Company plans to re-launch Rescula in the United
States for the treatment of open-angle glaucoma and ocular hypertension and to initiate clinical
trials of Rescula for the treatment of dry age-related macular degeneration, or dry AMD, in 2010.
The Companys founders, Drs. Ueno and Kuno, directly or indirectly own the majority holdings
in the Company as well as in other companies that have significant contractual relationships with
the Company as described more fully in Note 7. Dr. Ueno, who is married to Dr. Kuno, serves as the
chairman of the board of directors, chief executive officer and chief scientific officer of the
Company and Dr. Kuno serves as a director of the Company and the executive advisor of international
business development.
The Companys operations are conducted through its subsidiaries based in Japan, the United
States, and the United Kingdom.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States, or GAAP, and the
rules and regulations of the Securities and Exchange Commission, or SEC, for interim financial
information. Accordingly, they do not include all of the information and footnotes required by GAAP
for complete financial statements and should be read in conjunction with the Companys consolidated
financial statements as of and for the year ended December 31, 2008 included in the Companys
Annual Report on Form 10-K. The financial information as of September 30, 2009 and for the three
and nine months ended September 30, 2009 and 2008 is unaudited. In the opinion of management, all
adjustments, consisting only of normal recurring adjustments or accruals, considered necessary for
a fair statement of the results of these interim periods have been included. The results of the
Companys operations for any interim period are not necessarily indicative of the results that may
be expected for any other interim period or for a full fiscal year.
The condensed consolidated financial statements include the accounts of the Company and its
wholly owned subsidiaries. All significant inter-company balances and transactions have been
eliminated in the consolidated accounts.
5
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
2. Summary of Significant Accounting Policies
Cash and Cash Equivalents
For the purpose of the condensed consolidated balance sheets and condensed consolidated
statements of cash flows, cash equivalents include all highly liquid investments with an original
maturity of 90 days or less at the time of purchase.
Current and Non-current Investments
Current and non-current investments consist primarily of U.S. Treasury bills and notes, U.S.
government agencies securities, municipal and corporate bonds and auction rate securities, or ARS.
The Company classifies its investments into current and non-current based on their maturities and
managements reasonable expectation to realize these investments in cash. The Company classifies
all of its investments, except ARS, as available for sale securities and reports unrealized gains
or losses, net of related tax effects, in other comprehensive income. Pursuant to the Companys
acceptance of settlement rights for its investments in ARS in October 2008, the Company classifies
its investments in ARS as trading securities and records gains or losses resulting from the changes
in fair values of its ARS and related settlement rights in other income (expense), net. The fair
value of the settlement rights related to ARS is recorded as non-current other assets. The fair
value of the settlement rights has been derived from the par value of the Companys investment in
ARS and the fair value of ARS as of the recognition date, since the settlement rights obligate the
broker to redeem the ARS at par value.
Fair Value
The carrying amounts of the Companys financial instruments, which include cash and cash
equivalents, restricted cash, current and non-current investments, receivables, accounts payable
and accrued expenses, approximate their fair values based on their short maturities, independent
valuations or internal assessments.
Revenue Recognition
The Companys revenues are derived primarily from collaboration and license agreements and
include up-front payments, development milestone payments, reimbursements of development and
co-promotion costs and product royalties.
The Company evaluated the multiple deliverables within the collaboration and license
agreements in accordance with the guidance of multiple deliverables to determine whether the
delivered elements that are the obligation of the Company have value to other parties to the
agreement on a stand-alone basis and whether objective reliable evidence of fair value of the
undelivered items exists. Deliverables that meet these criteria are considered a separate unit of
accounting. Deliverables that do not meet these criteria are combined and accounted for as a single
unit of accounting. The appropriate recognition of revenue is then applied to each separate unit of
accounting. The Companys deliverables under the Takeda and Abbott agreements are more fully
described in Note 8.
The Company applies a time-based model of revenue recognition for cash flows associated with
research and development deliverables under the Takeda collaboration and license agreement. Under
this model, cash flow streams related to each unit of accounting are recognized as revenue over the
estimated performance period. Upon receipt of cash payments, revenue is recognized to the extent
the accumulated service time, if any, has occurred. The remainder is deferred and recognized as
revenue ratably over the remaining estimated performance period. A change in the period of time
expected to complete the deliverable is accounted for as a change in estimate on a prospective
basis. Revenue is limited to amounts that are nonrefundable and that the other party to the
agreement is contractually obligated to pay to the Company.
The Company applies a proportional-performance model using the percentage-of-completion method
of revenue recognition for cash flows associated with research and development deliverables under
the Abbott license, commercialization and supply agreement. Since the Company has previous research
and development experience and the expected cost to complete the development can be reasonably
estimated, the Company believes a proportional-performance methodology of revenue recognition is
appropriate. Under this method, revenue in any period is recognized as a percentage of the total
actual cost expended relative to the total estimated costs required to satisfy the performance
obligations under the arrangement related to the development. Revenue recognized is limited to the
amounts that are non-refundable and that the other party to the agreement is contractually
obligated to pay to the Company.
6
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Company recognizes reimbursable research and development costs under the Takeda agreement
as research and development revenue using a time-based model over the estimated performance period.
The research and development revenue for these obligations is limited to the lesser of the actual
reimbursable costs incurred or the straight-line amount of revenue recognized over the estimated
performance period. Revenues are recognized for reimbursable costs only if those costs can be
reasonably determined. Research and development costs are not reimbursable under the Abbott
agreement.
Under the Takeda agreement, royalties are based on net sales of licensed products and are
recorded on the accrual basis when earned in accordance with contractual terms when third-party
results are reliably measurable, collectability is reasonably assured and all other revenue
recognition criteria are met. Under the Abbott agreement, should Amitiza be commercialized in
Japan, the Company will purchase and assume title to inventories of Amitiza and recognize revenues
from the sales of such product when earned.
Contract revenue related to development and consulting activities is also accounted for under
the time-based model.
The Company considers its participation in the joint committees under the collaboration
agreements as separate deliverables under the contracts and recognizes the fair value of such
participation as revenue over the period of the participation per the terms of the contracts.
The Company has determined that it is acting as a principal under both the Takeda and Abbott
agreements and, as such, records revenue on a gross basis in the condensed consolidated statements
of operations and comprehensive income (loss).
Certain Risks, Concentrations and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of
credit risk consist of cash and cash equivalents, restricted cash, investments and receivables. The
Company places its cash, cash equivalents and restricted cash with highly rated financial
institutions and invests its excess cash in highly rated investments. As of September 30, 2009 and
December 31, 2008, approximately $68.3 million, or 55.2%, and $62.2 million, or 51.1%,
respectively, of the Companys cash, cash equivalents, restricted cash and investments was issued
or insured by the federal government or government agencies. The Company has not experienced any
losses on these accounts related to amounts in excess of insured limits.
The settlement rights between the Company and UBS AG, or the ARS Broker, obligate the ARS
Broker to purchase the remaining ARS at a par value of $10.0 million during a two-year period
beginning June 30, 2010 if the Company exercises its related settlement rights. The Company does
not anticipate needing to sell the remaining ARS before June 30, 2010.
The Companys products and product candidates under development require approval from the FDA
or other international regulatory agencies prior to commercial sales. For those product candidates
or indications that have not yet been approved by the FDA or international regulatory agencies,
there can be no assurance the products will receive the necessary approval. If the Company is
denied approval or approval is delayed, it may have a material adverse impact on the Company.
The Companys products, Amitiza and Rescula, compete in a rapidly changing, highly competitive
market, which is characterized by advances in scientific discovery, changes in customer
requirements, evolving regulatory requirements and developing industry standards. Any failure by
the Company to anticipate or to respond adequately or timely to scientific developments in its
industry, changes in customer requirements or changes in regulatory requirements or industry
standards, or any significant delays in the development or introduction of products could have a
material adverse effect on the Companys business, operating results and future cash flows.
The Companys expected activities may necessitate significant uses of working capital. The
Companys working capital requirements will depend on many factors, including the successful sales
of Amitiza and Rescula, research and development efforts to develop new products or indications,
payments received under contractual agreements with other parties, the status of competitive
products and market acceptance of the Companys new products by physicians and patients. The
Company plans to continue financing operations with its existing cash and investments as well as
with product royalty revenue and cash received from milestones and other revenue related to its
joint collaboration, license and supply agreements.
7
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
Revenues from one unrelated party, Takeda, accounted for 80% and 99%, of the Companys total
revenues for the three months ended September 30, 2009 and 2008, respectively, and 85% and 100% for
the nine months ended September 30, 2009 and 2008, respectively. Accounts receivable, unbilled
accounts receivable and product royalties receivable from Takeda accounted for 96% and
97% of the Companys total accounts receivable, unbilled accounts receivable and product
royalties receivable at September 30, 2009 and December 31, 2008, respectively. Revenues from
another unrelated party, Abbott, accounted for 20% of the Companys total revenues for the three
months ended September 30, 2009 and 15% for the nine months ended September 30, 2009. There was no
corresponding revenue for 2008. The Company depends significantly upon the collaborations with
Takeda and Abbott and its activities may be impacted if these relationships are disrupted (Note 8).
The Company has an exclusive supply arrangement with R-Tech to provide it with commercial and
clinical supplies of its product and product candidates. R-Tech also provides certain preclinical
and other research and development services. Any difficulties or delays in performing the services
under these arrangements may cause the Company to lose revenues, delay research and development
activities or otherwise disrupt the Companys operations (Note 7).
The Company has previously entered into a restated license agreement with Sucampo AG, or SAG,
to grant the Company a royalty-bearing, exclusive, worldwide license to develop prostone compounds,
including Amitiza. SAG is a Swiss-patent holding company and an entity wholly-owned by the
Companys founders. The Companys success depends, in part, on SAGs ability to obtain and maintain
proprietary protection for the intellectual property rights relating to the prostone technology and
products (Note 7).
Recent Accounting Pronouncements
In December 2007, the FASB issued authoritative guidance for collaborative arrangements which
prohibits the equity method of accounting for collaboration agreements unless a legal entity
exists. According to this guidance, payments between the collaborative partners are evaluated and
reported in the income statement based on applicable GAAP. Absent specific GAAP, the participants
to the arrangement will apply other existing GAAP by analogy or apply a reasonable and rational
accounting policy consistently. The guidance is effective for periods that begin after December 15,
2008 and applies to arrangements in existence as of the effective date. The effect of the new
consensus shall be accounted for as a change in accounting principle through retrospective
application. The Company adopted the provisions of this guidance effective January 1, 2009 and such
adoption did not have a material impact on the condensed consolidated financial statements.
In February 2008, the FASB issued authoritative guidance which delayed the effective date of
the guidance for fair value measurements for one year for all nonfinancial assets and liabilities,
except those that are recognized or disclosed at fair value in the financial statements on a
recurring basis. This statement partially deferred the effective date to fiscal years beginning
after November 15, 2008. The Company adopted the provisions of this guidance effective January 1,
2009 and such adoption did not have a material impact on the condensed consolidated financial
statements.
In October 2008, the FASB issued authoritative guidance that clarifies the application for
fair value measurements in a market that is not active. This guidance addresses how management
should consider measuring fair value when relevant observable data does not exist. This guidance
also addresses how observable market information in a market that is not active should be
considered when measuring fair value, as well as how the use of market quotes should be considered
when assessing the relevance of observable and unobservable data available to measure fair value.
Revisions resulting from a change in the valuation technique or its application shall be accounted
for as a change in accounting estimate. The application of this guidance did not have a material
impact on the condensed consolidated financial statements.
In April 2009, the FASB issued authoritative guidance which affirms that the objective of fair
value when the market for an asset is not active is the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction between market participants at the
measurement date under current market conditions. This guidance addresses estimating fair value
when the volume and level of market activity for an asset or liability have significantly decreased
and determining whether a transaction was orderly. It became effective for interim and annual
periods ending after June 15, 2009, with early adoption permitted for periods ending after March
15, 2009. This guidance applies to all fair value measurements when appropriate. The Company
adopted the guidance effective April 1, 2009 and such adoption did not have a material impact on
the condensed consolidated financial statements.
In April 2009, the FASB issued authoritative guidance for subsequent events which establishes
general standards of accounting for and disclosure of events that occur after the balance sheet
date but before financial statements are issued. The subsequent events sets forth the period after
the balance sheet date during which management of a reporting entity should evaluate events or
transactions that may occur for potential recognition in the financial statements, identifies the
circumstances under which an entity should recognize events or transactions occurring after the
balance sheet date in its financial statements, and the disclosures that should be
made about events or transactions that occur after the balance sheet date. The Company adopted
the provisions of this guidance effective April 2009 and such adoption did not have a material
impact on the condensed consolidated financial statements.
8
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
In June 2009, the FASB issued an amendment to the accounting and disclosure requirements for
the consolidation of variable interest entities, or VIEs. The elimination of the concept of
qualifying special-purpose entities, or QSPEs, removes the exception from applying the
consolidation guidance within this amendment. This amendment requires an enterprise to perform a
qualitative analysis when determining whether or not it must consolidate a VIE. The amendment also
requires an enterprise to continuously reassess whether it must consolidate a VIE. Additionally,
the amendment requires enhanced disclosures about an enterprises involvement with VIEs and any
significant change in risk exposure due to that involvement, as well as how its involvement with
VIEs impacts the enterprises financial statements. Finally, an enterprise will be required to
disclose significant judgments and assumptions used to determine whether or not to consolidate a
VIE. This amendment is effective for financial statements issued for fiscal years beginning after
November 15, 2009. The Company is continuing to evaluate the impact that this amendment would have
on its financial condition and results of operation upon adoption.
In June 2009, the FASB also issued the FASB Accounting Standards Codification, or
Codification. The Codification has become the single source for all authoritative GAAP recognized
by the FASB to be applied for financial statements issued for periods ending after September 15,
2009. The Codification does not change GAAP and has no effect on these condensed consolidated
financial statements, other than to modify certain disclosures regarding the accounting policies
followed by the Company.
In
September 2009, the FASB issued an amendment to the authoritative
guidance which addresses how revenues should be allocated among
products and services in multiple-deliverable revenue arrangements. The guidance
establishes a hierarchy for determining the selling price of each
product or service, with vendor-specific objective evidence (VSOE) at
the highest level, third-party evidence of VSOE at the intermediate
level, and managements best estimate at the lowest level. It
replaces fair value with selling price in
revenue allocation guidance. It also significantly expands the
disclosure requirements for multiple-deliverable revenue
arrangements. This guidance will be effective prospectively for
agreements entered into or materially modified in fiscal years
beginning on or after June 15, 2010. The Company is continuing
to evaluate the impact that this amendment would have on its
financial condition and results of operation upon adoption.
3. Earnings per Share
Basic net income (loss) per share is computed by dividing net income (loss) by the sum of the
weighted average class A and B common shares outstanding. Diluted net income per share is computed
by dividing net income by the weighted average common shares and potential dilutive common shares
outstanding. Diluted net loss per share, when applicable, is computed by dividing net loss by the
weighted average common shares outstanding without the impact of potential dilutive common shares
outstanding because they would have an anti-dilutive impact on diluted net loss per share.
9
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The computation of net income (loss) per share for the three and nine months ended September
30, 2009 and 2008 is shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
(in thousands, except per share data) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Basic net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(88 |
) |
|
$ |
(2,426 |
) |
|
$ |
(2,101 |
) |
|
$ |
27,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B common shares
outstanding |
|
|
41,844 |
|
|
|
41,813 |
|
|
|
41,844 |
|
|
|
41,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share |
|
$ |
|
|
|
$ |
(0.06 |
) |
|
$ |
(0.05 |
) |
|
$ |
0.67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(88 |
) |
|
$ |
(2,426 |
) |
|
$ |
(2,101 |
) |
|
$ |
27,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B common shares
outstanding for diluted net income per share |
|
|
41,844 |
|
|
|
41,813 |
|
|
|
41,844 |
|
|
|
41,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assumed exercise of stock options under the treasury
stock method |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,844 |
|
|
|
41,813 |
|
|
|
41,844 |
|
|
|
42,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share |
|
$ |
|
|
|
$ |
(0.06 |
) |
|
$ |
(0.05 |
) |
|
$ |
0.67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the periods listed above, the potentially dilutive securities used in the
calculations of diluted historical net income (loss) per share as of September 30, 2009 and 2008
are as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Employee stock options |
|
|
|
|
|
|
381 |
|
Non-employee stock options |
|
|
|
|
|
|
450 |
|
For the periods listed above, the following securities were excluded from the computation
of diluted net income (loss) per share as their effect would be anti-dilutive as of September 30,
2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Employee stock options |
|
|
778 |
|
|
|
407 |
|
Non-employee stock options |
|
|
450 |
|
|
|
|
|
10
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
4. Current and Non-Current Investments
At September 30, 2009 and December 31, 2008, current and non-current available-for-sale
investments consisted of the following securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2009 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills and notes |
|
$ |
2,999 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,999 |
|
U.S. commercial paper |
|
|
750 |
|
|
|
|
|
|
|
|
|
|
|
750 |
|
U.S. government securities |
|
|
22,980 |
|
|
|
20 |
|
|
|
(1 |
) |
|
|
22,999 |
|
Municipal securities |
|
|
24,979 |
|
|
|
2 |
|
|
|
(8 |
) |
|
|
24,973 |
|
Certificates of deposits |
|
|
750 |
|
|
|
|
|
|
|
(1 |
) |
|
|
749 |
|
Money market funds |
|
|
568 |
|
|
|
|
|
|
|
|
|
|
|
568 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
53,026 |
|
|
$ |
22 |
|
|
$ |
(10 |
) |
|
$ |
53,038 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government securities |
|
$ |
9,721 |
|
|
$ |
13 |
|
|
$ |
(3 |
) |
|
$ |
9,731 |
|
Municipal securities |
|
|
1,817 |
|
|
|
1 |
|
|
|
(3 |
) |
|
|
1,815 |
|
Certificates of deposits |
|
|
1,000 |
|
|
|
|
|
|
|
(2 |
) |
|
|
998 |
|
Corporate bonds |
|
|
16,858 |
|
|
|
28 |
|
|
|
|
|
|
|
16,886 |
|
Auction rate securities |
|
|
10,000 |
|
|
|
|
|
|
|
(577 |
) |
|
|
9,423 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
39,396 |
|
|
$ |
42 |
|
|
$ |
(585 |
) |
|
$ |
38,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills and notes |
|
$ |
42,620 |
|
|
$ |
130 |
|
|
|
|
|
|
$ |
42,750 |
|
Money market funds |
|
|
51,026 |
|
|
|
|
|
|
|
|
|
|
|
51,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
93,646 |
|
|
$ |
130 |
|
|
$ |
|
|
|
$ |
93,776 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
$ |
19,400 |
|
|
$ |
|
|
|
$ |
(3,178 |
) |
|
$ |
16,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company records unrealized gains and losses resulting from changes in the fair value
of the auction rate securities and related settlement rights within other income (loss).
11
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Companys assets measured at fair value on a recurring basis, which are subject to the
fair value disclosure requirements, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
for identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
September 30, 2009 |
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
U.S. Treasury bills and notes |
|
$ |
2,999 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,999 |
|
U.S. government securities |
|
|
32,730 |
|
|
|
|
|
|
|
|
|
|
|
32,730 |
|
U.S. commercial paper |
|
|
|
|
|
|
750 |
|
|
|
|
|
|
|
750 |
|
Corporate bonds |
|
|
16,886 |
|
|
|
|
|
|
|
|
|
|
|
16,886 |
|
Municipal securities |
|
|
26,788 |
|
|
|
|
|
|
|
|
|
|
|
26,788 |
|
Auction rate securities |
|
|
|
|
|
|
|
|
|
|
9,423 |
|
|
|
9,423 |
|
Settlement rights for auction rate securities* |
|
|
|
|
|
|
|
|
|
|
466 |
|
|
|
466 |
|
Money market funds |
|
|
568 |
|
|
|
|
|
|
|
|
|
|
|
568 |
|
Certificates of deposits |
|
|
|
|
|
|
1,747 |
|
|
|
|
|
|
|
1,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
79,971 |
|
|
$ |
2,497 |
|
|
$ |
9,889 |
|
|
$ |
92,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
for Identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
December 31, 2008 |
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
U.S. Treasury bills and notes |
|
$ |
42,750 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
42,750 |
|
Auction rate securities |
|
|
|
|
|
|
|
|
|
|
16,222 |
|
|
|
16,222 |
|
Settlement rights for auction rate securities* |
|
|
|
|
|
|
|
|
|
|
2,818 |
|
|
|
2,818 |
|
Money market funds |
|
|
51,026 |
|
|
|
|
|
|
|
|
|
|
|
51,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
93,776 |
|
|
$ |
|
|
|
$ |
19,040 |
|
|
$ |
112,816 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
included in non-current other assets in the accompanying condensed consolidated balance sheets |
The following table presents the Companys assets measured at fair value on a recurring
basis using significant unobservable inputs (Level 3) as defined in the fair value measurement
statement during the nine months ended September 30, 2009:
|
|
|
|
|
|
|
Auction Rate |
|
|
|
Securities and |
|
|
|
Related |
|
|
|
Settlement |
|
(In thousands) |
|
Rights |
|
Balance at December 31, 2008 |
|
$ |
19,040 |
|
Total net unrealized gains included in earnings |
|
|
249 |
|
Redemptions |
|
|
(9,400 |
) |
|
|
|
|
Balance at September 30, 2009 |
|
$ |
9,889 |
|
|
|
|
|
12
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
5. Accrued Expenses
Accrued expenses consisted of the following as of:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Research and development costs |
|
$ |
4,617 |
|
|
$ |
7,086 |
|
Employee compensation |
|
|
897 |
|
|
|
1,748 |
|
Selling and marketing costs |
|
|
778 |
|
|
|
346 |
|
Product royalty liability-related
party |
|
|
1,663 |
|
|
|
|
|
Other accrued expenses |
|
|
1,459 |
|
|
|
584 |
|
|
|
|
|
|
|
|
Total |
|
$ |
9,414 |
|
|
$ |
9,764 |
|
|
|
|
|
|
|
|
The accrued selling and marketing expenses include $696,000 in costs incurred upon the
Companys withdrawal of certain European marketing applications in the third quarter of 2009. These
expenses were recorded during the three months ended September 30, 2009 and consist mainly of
adverse commitments to purchase initial stock of lubiprostone in respect to its previously
anticipated European commercial launch.
6. Commitments
Operating Leases
The Company leases office space in the United States, the United Kingdom and Japan under
operating leases ranging through 2017. Total future minimum, non-cancelable lease payments under
operating leases, which do not include future sub-lease receipts of approximately $97,000, were as
follows as of September 30, 2009:
|
|
|
|
|
(In thousands) |
|
|
|
|
2009 (October-December) |
|
$ |
370 |
|
2010 |
|
|
1,204 |
|
2011 |
|
|
1,006 |
|
2012 |
|
|
963 |
|
2013 |
|
|
992 |
|
2014 and thereafter |
|
|
3,297 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
7,832 |
|
|
|
|
|
Rent expense for all operating leases was $322,000 and $296,000 for the three months
ended September 30, 2009 and 2008, respectively, and $965,000 and $874,000 for the nine months
ended September 30, 2009 and 2008, respectively.
Research and Development Costs
The Company routinely enters into agreements with third-party clinical research organizations,
or CROs, to oversee clinical research and development studies provided on an outsourced basis. The
Company is not generally contractually obligated to pay the CRO if the service or reports are not
provided. Total future estimated costs through 2013 under these agreements as of September 30, 2009
were approximately $9.8 million.
7. Related Party Transactions
R-Tech Ueno, Ltd.
The Company is a party to multiple exclusive license and supply agreements with R-Tech
covering various compounds and territories. The Companys founders, directly or indirectly, own a
majority of the stock of R-Tech and one of the founders is the chairman of the board of directors
of R-Tech.
The following paragraphs describe the agreements entered into in 2009:
On February 23, 2009, the Company entered into an Exclusive Manufacturing and Supply
Agreement, under which it granted R-Tech the exclusive right to manufacture and supply lubiprostone
to meet its commercial and clinical requirements in Asia, Australia and New Zealand. In
consideration, R-Tech made an up-front payment of $250,000 to the Company and is obligated to make
milestone payments of $500,000 upon regulatory approval of lubiprostone in Japan and $250,000 upon
the commercial launch of lubiprostone in Japan.
13
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
On April 23, 2009, the Company entered into two agreements with R-Tech to acquire rights to
Rescula in the United States and Canada. Under the terms of the agreements, the Company holds the
exclusive rights to commercialize Rescula in the United States and Canada for the treatment of
glaucoma and ocular hypertension and any new indication developed by the Company, and has the right
of first refusal to commercialize in the United States and Canada any additional indications for
which unoprostone isopropyl is developed by R-Tech. The Company is solely responsible for the
development, as well as regulatory and commercialization activities and expenses, for Rescula in
the United States and Canada and R-Tech is exclusively responsible for the supply of Rescula to the
Company within the United States and Canada.
Under the terms of the April 2009 agreements, the Company made an upfront payment of $3.0
million and is required to make up to $5.5 million in additional milestone payments to R-Tech based
on the achievement of specified development and commercialization goals. The first milestone
payment of $500,000 is payable upon the re-launch of Rescula for the treatment of glaucoma and is
considered probable of occurring; therefore, this amount is included in accrued expenses and
recorded as part of the initial cost of the acquired assets. The Company allocated the acquisition
cost between an intangible asset of $3.4 million and a non-current prepaid inventory of $85,000 as
of September 30, 2009, both of which are reflected in other non-current assets in the accompanying
condensed consolidated balance sheet. The Company is amortizing the $3.4 million intangible asset
over the 10-year life of the license agreement, which the Company believes approximates the useful
life of the underlying rights and data. Amortization expense of $142,000 for the nine months ended
September 30, 2009 is recorded in research and development expenses in the accompanying condensed
consolidated statement of operations and comprehensive income (loss). The annual estimated
amortization expense of these intangible assets is approximately $342,000 through April 2019.
The Company recorded the following expenses under all of its agreements with R-Tech:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Clinical supplies |
|
$ |
720 |
|
|
$ |
38 |
|
|
$ |
2,341 |
|
|
$ |
553 |
|
Other research and development services |
|
|
7 |
|
|
|
62 |
|
|
|
3,046 |
|
|
|
111 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
727 |
|
|
$ |
100 |
|
|
$ |
5,387 |
|
|
$ |
664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the amounts included in deferred revenue resulting from
the deferral of upfront payments relating to the exclusive supply agreements with R-Tech:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Deferred revenue, current |
|
$ |
431 |
|
|
$ |
419 |
|
Deferred revenue, non-current |
|
|
6,354 |
|
|
|
6,444 |
|
|
|
|
|
|
|
|
|
|
$ |
6,785 |
|
|
$ |
6,863 |
|
|
|
|
|
|
|
|
The Company recognized approximately $105,000 of revenue relating to its agreements with
R-Tech for each of the three months ended September 30, 2009 and 2008 and approximately $314,000
for each of the nine months ended September 30, 2009 and 2008, which was recorded as contract and
collaboration revenue in the accompanying condensed consolidated statements of operations and
comprehensive income (loss).
14
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
Sucampo AG License Agreements
In February 2009, the Company entered into an addendum to the Amended and Restated Patent
Access Agreement originally entered between the Company and SAG on June 30, 2006. The Companys
founders directly or indirectly own all of the stock of SAG. Under the addendum, the patent and
know-how royalties Sucampo Japan is obligated to pay to SAG were reduced with respect to sales of
lubiprostone in Asia, Australia and New Zealand as follows:
|
|
|
the patent royalty on net sales, due until the expiration of the last patent covering
lubiprostone that existed at the time of the Companys initial public offering, was reduced
from 4.5% to 2.2%; |
|
|
|
|
the patent royalty on net sales, due thereafter until all other patents covering
lubiprostone have expired in the relevant country, was reduced from 2.25% to 1.1%; and |
|
|
|
|
the know-how royalty on net sales, due until the fifteenth anniversary of the first
commercial sale of lubiprostone, was reduced from 2.0% to 1.0%. |
The Company expensed approximately $1.7 million and $1.4 million in product royalties -
related parties under the license agreement with SAG for the three months ended September 30, 2009
and 2008, respectively, and approximately $4.8 million and $4.4 million for the nine months ended
September 30, 2009 and 2008, respectively, reflecting 3.2% of Amitiza net sales in the U.S. during
each of these periods.
The Company is also required to pay additional milestone payments to SAG, including 5% of
milestone payments received under any sublicensing agreements for the in-licensed compounds.
In February 2009, the Company entered into a Technology Assignment and License Agreement with
R-Tech and SAG, under which the parties agreed that R-Tech and SAG would share joint ownership of
eight U.S. patents and patent applications, and several related international patents and patent
applications, which had previously been filed by R-Tech. These patents relate to specific prostone
compounds and formulations and to methods for producing prostone compounds. The parties also agreed
that R-Tech and SAG would share joint ownership of know-how and other inventions previously created
by R-Tech relating to prostones. R-Tech and SAG cross-licensed to each other, on a worldwide,
royalty-free, perpetual, exclusive basis, their respective rights in these patents, patent
applications, know-how and other inventions. R-Techs right to utilize the licensed intellectual
property is limited to uses in connection with research, development and commercialization of
Rescula, and three other prostone compounds it is currently developing. SAGs right to utilize the
licensed intellectual property is limited to uses in connection with research, development and
commercialization of all other prostone compounds. SAGs rights under this agreement are in turn
licensed to the Company under the existing patent license arrangements. None of the parties made
any monetary payments to the other parties under this agreement.
8. Collaboration and License Agreements
Abbott license and commercialization and supply agreement
In February 2009, the Company entered into an exclusive 15-year license, commercialization and
supply agreement with Abbott to develop and commercialize lubiprostone for the treatment of CIC in
Japan. Additionally, the agreement grants Abbott the right of first refusal to any additional
indications for which lubiprostone is developed in Japan under all relevant patents, know-how and
trademarks.
The collaboration efforts under the agreement are governed by two committees consisting of an
equal number of representatives from both parties. The joint commercialization and steering
committee oversee commercialization-related activities and resolves any conflicts arising from a
joint development committee, which oversee the development-related activities in Japan.
The Company is required to fund and complete all the development work including additional
clinical studies required to obtain regulatory approval for the treatment of CIC in Japan. The
Company owns all the rights covered under the regulatory filings.
Abbott is required to fund and undertake all commercialization efforts including pre-launch
and post-launch marketing, promotion and distribution. Abbott is required to maintain the number of
sales staff and the estimated level of annual net sales based on the commercialization plan to be
developed and approved by the joint commercialization and steering committee described above. The
Company has retained the right to co-promote the product in Japan and is responsible for the cost
of co-promotion.
Under the terms of the agreement, payments to the Company include a non-refundable upfront
payment and non-refundable development and commercial milestone payments based on achieving
specified development, regulatory and sales goals. Following marketing authorization and pricing
approval, Abbott will purchase the finished product from the Company for distribution in Japan at
agreed upon prices. Based on the terms of the agreement, the Company received an upfront payment of
$10.0 million upon execution of the agreement in February 2009. In May 2009, the Company achieved
the first development milestone when it initiated the phase 3 clinical trial for lubiprostone for
the treatment of CIC in Japan and received a $7.5 million milestone payment from Abbott. The
Company is recognizing these payments as research and development revenue under a
proportional-performance model using the percentage-of-completion method of revenue recognition.
There can be no assurances that the Company will receive additional development or commercial
milestone payments under this agreement.
15
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The following table summarizes the cash streams and related revenue recognized or deferred
under the license, commercialization and supply agreement with Abbott for the nine months ended
September 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Revenue |
|
|
Foreign Currency |
|
|
|
|
|
|
Amount |
|
|
for the Nine |
|
|
Recognized for the |
|
|
Effects for the |
|
|
Amount |
|
|
|
Deferred at |
|
|
Months Ended |
|
|
Nine Months Ended |
|
|
Nine Months Ended |
|
|
Deferred at |
|
|
|
December 31, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2009 |
|
|
2009 |
|
|
2009 |
|
|
2009 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment associated with the Companys
obligation to participate in joint committees |
|
$ |
|
|
|
$ |
677 |
|
|
$ |
27 |
|
|
$ |
(19 |
) |
|
$ |
669 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment |
|
$ |
|
|
|
$ |
9,323 |
|
|
$ |
4,058 |
|
|
$ |
(40 |
) |
|
$ |
5,305 |
|
Development milestone payment |
|
|
|
|
|
|
7,500 |
|
|
|
3,369 |
|
|
|
(262 |
) |
|
$ |
4,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
16,823 |
|
|
$ |
7,427 |
|
|
$ |
(302 |
) |
|
$ |
9,698 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Takeda commercialization and license agreement
In October 2004, the Company entered into a 16-year collaboration and license agreement with
Takeda to exclusively co-develop, commercialize and sell products that contain lubiprostone for
gastroenterology indications in the United States and Canada. On February 1, 2006, the Company
entered into a supplemental agreement with Takeda, which amended the responsibilities of both the
Company and Takeda for the co-promotion of Amitiza and clarified the responsibilities and funding
arrangements for other marketing services to be performed by both parties. Payments to the Company
under these agreements include a non-refundable up-front
payment, non-refundable development and commercial milestone payments, reimbursement of
certain development and co-promotion costs and product royalties.
The Company has received a total of $150.0 million in up-front and development milestone
payments through September 30, 2009 under these agreements. Subject to future development and
commercial milestones, the Company is potentially entitled to receive additional development
milestone and commercial milestone payments under the collaboration and license agreements with
Takeda, although there can be no assurance that the Company will receive any such payments.
16
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The following table summarizes the cash streams and related revenue recognized or deferred
under the collaboration and license agreements with Takeda for the nine months ended September 30,
2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Revenue |
|
|
Change in Accounts |
|
|
|
|
|
|
Amount |
|
|
for the Nine |
|
|
Recognized for the |
|
|
Receivable for the |
|
|
Amount |
|
|
|
Deferred at |
|
|
Months Ended |
|
|
Nine Months Ended |
|
|
Nine Months Ended |
|
|
Deferred at |
|
|
|
December 31, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2009 |
|
|
2009 |
|
|
2009* |
|
|
2009 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment associated with the Companys
obligation to participate in joint committees |
|
$ |
1,764 |
|
|
$ |
|
|
|
$ |
111 |
|
|
$ |
|
|
|
$ |
1,653 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of research and development expenses |
|
$ |
14,755 |
|
|
$ |
6,272 |
|
|
$ |
12,539 |
|
|
$ |
(3,578 |
) |
|
$ |
4,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
|
|
|
$ |
27,584 |
|
|
$ |
27,227 |
|
|
$ |
(357 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promotion revenue |
|
$ |
|
|
|
$ |
2,972 |
|
|
$ |
3,406 |
|
|
$ |
434 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Includes billed and unbilled accounts receivable. |
In May 2009, the Company issued a press release expressing its disappointment with the level
of U.S. Amitiza sales being generated by Takeda and noted that it intended to exercise its rights
to pursue a performance audit under its contract with Takeda. The Company has subsequently
initiated certain audit procedures and continues to analyze Takedas performance.
9. Stock Option Plan
The following table summarizes the employee stock option activity for the nine months ended
September 30, 2009 under the Companys 2001 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Exercise Price Per |
|
|
Contractual Term |
|
|
Aggregate |
|
|
|
Shares |
|
|
Share |
|
|
(Years) |
|
|
Intrinsic Value |
|
Options outstanding, December 31, 2008 |
|
|
455,600 |
|
|
$ |
10.34 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(850 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(96,050 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, September 30, 2009 |
|
|
358,700 |
|
|
|
10.43 |
|
|
|
4.45 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, September 30, 2009 |
|
|
358,700 |
|
|
|
10.43 |
|
|
|
4.45 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The following table summarizes the employee stock option activity for the nine months
ended September 30, 2009 under the Companys 2006 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Exercise Price Per |
|
|
Contractual Term |
|
|
Aggregate |
|
|
|
Shares |
|
|
Share |
|
|
(Years) |
|
|
Intrinsic Value |
|
Options outstanding, December 31, 2008 |
|
|
275,000 |
|
|
$ |
13.86 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
167,000 |
|
|
|
5.37 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(38,950 |
) |
|
|
13.07 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(32,250 |
) |
|
|
14.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, September 30, 2009 |
|
|
370,800 |
|
|
|
10.19 |
|
|
|
7.95 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, September 30, 2009 |
|
|
88,000 |
|
|
|
14.42 |
|
|
|
6.50 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant date fair value of options granted during the nine months
ended September 30, 2009 and the year ended December 31, 2008 were $2.77 and $5.88, respectively.
As of September 30, 2009, approximately $978,000 of total unrecognized compensation costs, net of
estimated forfeitures, related to non-vested awards are expected to be recognized over a weighted
average period of 3.18 years.
The following table summarizes the non-employee stock option activity for the nine months
ended September 30, 2009 under the Companys 2001 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Exercise Price Per |
|
|
Contractual Term |
|
|
Aggregate |
|
|
|
Shares |
|
|
Share |
|
|
(Years) |
|
|
Intrinsic Value |
|
Options outstanding, December 31, 2008 |
|
|
450,000 |
|
|
$ |
5.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, September 30, 2009 |
|
|
450,000 |
|
|
|
5.85 |
|
|
|
5.58 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, September 30, 2009 |
|
|
450,000 |
|
|
|
5.85 |
|
|
|
5.58 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No non-employee stock options were exercised, forfeited or expired during the nine months
ended September 30, 2009.
Employee Stock Purchase Plan
Under the 2006 Employee Stock Purchase Plan, or ESPP, a total of 2,409 shares of class A
common stock were purchased during the nine months ended September 30, 2009. The ESPP is
non-compensatory and is intended to qualify as an Employee Stock Purchase Plan as defined in
Section 423 of the Internal Revenue Code of 1986 and in accordance with GAAP guidance that requires
estimates in the fair value of share-based payment awards on the date of the grant using an
option-pricing model and recognizing the expense over the required service periods in the
accompanying condensed consolidated statement of operations and comprehensive income (loss). The
Company received $13,801 upon purchase of shares under the ESPP for the nine months ended September
30, 2009.
10. Income Taxes
For the three months ended September 30, 2009, the Company recorded a tax provision of $1.5
million and a tax benefit of $1.7 million for the three months ended September 30, 2008. For the
nine months ended September 30, 2009 and 2008, the Company recorded a tax provision of $2.7 million
and $7.2 million, respectively. The tax provision for the three and nine months ended September 30,
2009 primarily pertained to taxable income generated by the Companys U.S. and Asian subsidiaries.
The Companys other subsidiary based in Europe incurred a pre-tax loss for the nine months ended
September 30, 2009, for which no tax benefit was recognized. The tax provision recorded for the
nine months ended September 30, 2008 was primarily due to a discrete release of U.S. deferred tax
asset valuation allowances and a reduction in the projected effective tax rate for 2008 based on an
increase in projected milestone and product royalty revenue.
18
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Company has estimated its annual effective tax rate for the full fiscal year 2009 and 2008
and applied that rate to its income before income taxes in determining its income tax provision for
the interim periods. There is no tax benefit recognized on the net operating losses incurred in the
foreign jurisdictions due to the lack of evidence supporting the Companys ability to use these
losses in the future.
Uncertain Tax Positions
The Company applies the FASBs guidance for uncertainty in income taxes that requires the
application of a more likely than not threshold to the recognition and derecognition of uncertain
tax positions.
The Company had an outstanding non-current income tax liability of $713,622 for uncertain tax
positions as of September 30, 2009. The amount represented the aggregate tax effect of differences
between tax return positions and the amounts otherwise recognized in the Companys condensed
consolidated financial statements, and is reflected in other liabilities in the accompanying
condensed consolidated balance sheets. The liability for uncertain tax positions as of September
30, 2009 mainly pertained to the Companys interpretation of nexus in certain states related to
revenue sourcing for state income tax purposes.
The Company recognizes accrued interest and penalties related to uncertain tax positions as a
component of the income tax provision. The Company has identified no uncertain tax position for
which it is reasonably possible that the total amount of liability for unrecognized tax benefits
will significantly increase or decrease within 12 months, except for recurring accruals on existing
uncertain tax positions.
19
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
11. Segment Reporting
The Company has determined that it has three reportable segments based on the Companys method
of internal reporting, which disaggregates business by geographic location. These segments are the
Americas, Europe and Asia. The Company evaluates the performance of these segments based on income
(loss) from operations, as well as other factors, including the progress of its research and
development activities. The reportable segments have historically derived their revenue from joint
collaboration and strategic alliance agreements. Transactions between the segments consist
primarily of loans and the provision of research and development services. Following is a summary
of financial information by reportable geographic segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
Americas |
|
|
Europe |
|
|
Asia |
|
|
Eliminations |
|
|
Consolidated |
|
Three Months Ended September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
3,562 |
|
|
$ |
|
|
|
$ |
3,483 |
|
|
$ |
|
|
|
$ |
7,045 |
|
Product royalty revenue |
|
|
9,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,367 |
|
Co-promotion revenue |
|
|
1,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,266 |
|
Contract and collaboration revenue |
|
|
141 |
|
|
|
|
|
|
|
282 |
|
|
|
(270 |
) |
|
|
153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
14,336 |
|
|
|
|
|
|
|
3,765 |
|
|
|
(270 |
) |
|
|
17,831 |
|
Research and development expenses |
|
|
3,040 |
|
|
|
459 |
|
|
|
3,884 |
|
|
|
|
|
|
|
7,383 |
|
Depreciation and amortization |
|
|
213 |
|
|
|
3 |
|
|
|
7 |
|
|
|
|
|
|
|
223 |
|
Other operating expenses |
|
|
7,790 |
|
|
|
1,029 |
|
|
|
256 |
|
|
|
(270 |
) |
|
|
8,805 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
3,293 |
|
|
|
(1,491 |
) |
|
|
(382 |
) |
|
|
|
|
|
|
1,420 |
|
Interest income |
|
|
277 |
|
|
|
|
|
|
|
2 |
|
|
|
(68 |
) |
|
|
211 |
|
Other non-operating expense, net |
|
|
(17 |
) |
|
|
(22 |
) |
|
|
(279 |
) |
|
|
68 |
|
|
|
(250 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
3,553 |
|
|
$ |
(1,513 |
) |
|
$ |
(659 |
) |
|
$ |
|
|
|
$ |
1,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
64 |
|
|
$ |
|
|
|
$ |
87 |
|
|
$ |
|
|
|
$ |
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
5,436 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,436 |
|
Product royalty revenue |
|
|
7,718 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,718 |
|
Co-promotion revenue |
|
|
1,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,185 |
|
Contract and collaboration revenue |
|
|
142 |
|
|
|
|
|
|
|
213 |
|
|
|
(213 |
) |
|
|
142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
14,481 |
|
|
|
|
|
|
|
213 |
|
|
|
(213 |
) |
|
|
14,481 |
|
Research and development expenses |
|
|
10,217 |
|
|
|
330 |
|
|
|
843 |
|
|
|
|
|
|
|
11,390 |
|
Depreciation and amortization |
|
|
110 |
|
|
|
1 |
|
|
|
3 |
|
|
|
|
|
|
|
114 |
|
Other operating expenses |
|
|
7,602 |
|
|
|
139 |
|
|
|
257 |
|
|
|
(210 |
) |
|
|
7,788 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
(3,448 |
) |
|
|
(470 |
) |
|
|
(890 |
) |
|
|
(3 |
) |
|
|
(4,811 |
) |
Interest income |
|
|
678 |
|
|
|
1 |
|
|
|
2 |
|
|
|
(26 |
) |
|
|
655 |
|
Other non-operating expense, net |
|
|
(6 |
) |
|
|
(17 |
) |
|
|
(21 |
) |
|
|
29 |
|
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
(2,776 |
) |
|
$ |
(486 |
) |
|
$ |
(909 |
) |
|
$ |
|
|
|
$ |
(4,171 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
5 |
|
|
$ |
35 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
Americas |
|
|
Europe |
|
|
Asia |
|
|
Eliminations |
|
|
Consolidated |
|
Nine Months Ended September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
12,539 |
|
|
$ |
|
|
|
$ |
7,427 |
|
|
$ |
|
|
|
$ |
19,966 |
|
Product royalty revenue |
|
|
27,227 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,227 |
|
Co-promotion revenue |
|
|
3,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,406 |
|
Contract and collaboration revenue |
|
|
424 |
|
|
|
|
|
|
|
717 |
|
|
|
(690 |
) |
|
|
451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
43,596 |
|
|
|
|
|
|
|
8,144 |
|
|
|
(690 |
) |
|
|
51,050 |
|
Research and development expenses |
|
|
16,398 |
|
|
|
788 |
|
|
|
9,783 |
|
|
|
|
|
|
|
26,969 |
|
Depreciation and amortization |
|
|
512 |
|
|
|
9 |
|
|
|
11 |
|
|
|
|
|
|
|
532 |
|
Other operating expenses |
|
|
20,851 |
|
|
|
1,659 |
|
|
|
1,803 |
|
|
|
(690 |
) |
|
|
23,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
5,835 |
|
|
|
(2,456 |
) |
|
|
(3,453 |
) |
|
|
|
|
|
|
(74 |
) |
Interest income |
|
|
928 |
|
|
|
|
|
|
|
4 |
|
|
|
(190 |
) |
|
|
742 |
|
Other non-operating expense, net |
|
|
191 |
|
|
|
(392 |
) |
|
|
(25 |
) |
|
|
190 |
|
|
|
(36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
6,954 |
|
|
$ |
(2,848 |
) |
|
$ |
(3,474 |
) |
|
$ |
|
|
|
$ |
632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
3,259 |
|
|
$ |
3 |
|
|
$ |
116 |
|
|
$ |
|
|
|
$ |
3,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
66,982 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
66,982 |
|
Product royalty revenue |
|
|
24,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,699 |
|
Co-promotion revenue |
|
|
3,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,643 |
|
Contract and collaboration revenue |
|
|
425 |
|
|
|
|
|
|
|
630 |
|
|
|
(630 |
) |
|
|
425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
95,749 |
|
|
|
|
|
|
|
630 |
|
|
|
(630 |
) |
|
|
95,749 |
|
Research and development expenses |
|
|
29,976 |
|
|
|
1,703 |
|
|
|
3,858 |
|
|
|
|
|
|
|
35,537 |
|
Depreciation and amortization |
|
|
318 |
|
|
|
1 |
|
|
|
7 |
|
|
|
|
|
|
|
326 |
|
Other operating expenses |
|
|
25,348 |
|
|
|
1,188 |
|
|
|
679 |
|
|
|
(630 |
) |
|
|
26,585 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
40,107 |
|
|
|
(2,892 |
) |
|
|
(3,914 |
) |
|
|
|
|
|
|
33,301 |
|
Interest income |
|
|
1,924 |
|
|
|
6 |
|
|
|
5 |
|
|
|
(73 |
) |
|
|
1,862 |
|
Other non-operating expense, net |
|
|
(39 |
) |
|
|
(30 |
) |
|
|
(20 |
) |
|
|
73 |
|
|
|
(16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
41,992 |
|
|
$ |
(2,916 |
) |
|
$ |
(3,929 |
) |
|
$ |
|
|
|
$ |
35,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
304 |
|
|
$ |
35 |
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
342 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
2,108 |
|
|
$ |
37 |
|
|
$ |
212 |
|
|
$ |
|
|
|
$ |
2,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets, net of intercompany loans
and investments |
|
$ |
134,692 |
|
|
$ |
1,281 |
|
|
$ |
14,836 |
|
|
$ |
(1,072 |
) |
|
$ |
149,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
2,134 |
|
|
$ |
39 |
|
|
$ |
102 |
|
|
$ |
|
|
|
$ |
2,275 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets, net of intercompany loans |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and investments |
|
$ |
146,074 |
|
|
$ |
568 |
|
|
$ |
4,469 |
|
|
$ |
(317 |
) |
|
$ |
150,794 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12. Subsequent Events
On October 7, 2009, the board of directors of the Company adopted a new compensation program
for its non-employee directors and approved a new form of stock option agreement to be used for
future stock option awards to non-employee directors.
Management of the Company has evaluated subsequent events for potential recognition and
disclosure through November 6, 2009, the date the financial statements were issued.
21
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
This Quarterly Report on Form 10-Q contains forward-looking statements regarding Sucampo
Pharmaceuticals, Inc. (the Company, we, us, or our) and our business, financial condition,
results of operations and prospects within the meaning of the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements include those that express plans, anticipation,
intent, contingency, goals, targets or future development and/or otherwise are not statements of
historical fact. These forward-looking statements are based on our current expectations and
projections about future events and they are subject to risks and uncertainties known and unknown
that could cause actual results and developments to differ materially from those expressed or
implied in such statements. You should read the following discussion and analysis of our financial
condition and results of operations in conjunction with our consolidated financial statements as of
and for the year ended December 31, 2008 included in our Annual Report on Form 10-K.
Overview
We are an international biopharmaceutical company focused on the discovery, development and
commercialization of proprietary drugs based on prostones, a class of compounds derived from
functional fatty acids that occur naturally in the human body. In January 2006, we received
marketing approval from the U.S. Food and Drug Administration, or FDA, for our first product,
Amitiza® (lubiprostone), for the treatment of chronic idiopathic constipation, or CIC,
in adults. In April 2008, the FDA approved Amitiza for its second indication for the treatment of
irritable bowel syndrome with constipation, or IBS-C, in adult women. We are currently developing
Amitiza for the treatment of opioid-induced bowel dysfunction, or OBD.
In the United States and Canada, Amitiza is being marketed and developed under a collaboration
and license agreement with Takeda Pharmaceutical Company Limited, or Takeda, for gastrointestinal
indications. Under the agreement with Takeda, we are primarily responsible for the research and
development of Amitiza, while Takeda is primarily responsible for the commercialization and
marketing activities. Additionally, Takeda funds the majority of our research and development
activities in the United States and part of the co-promotion activities of our own sales force, per
the terms of the agreement. Takeda records all product revenue and we receive a royalty on such
product sales.
In February 2009, we entered into a license, commercialization and supply agreement with
Abbott Japan Co. Ltd., or Abbott, for lubiprostone in Japan. Under the terms of the agreement,
Abbott received exclusive rights to commercialize lubiprostone in Japan for the treatment of CIC
and received the right of first refusal to any additional indications for which lubiprostone is
developed in Japan under all relevant patents, know-how and trademarks. Abbott is responsible for
all commercialization expenses and efforts. We are responsible for the research and development
activities under the agreement. We have retained the right to co-promote lubiprostone in Japan and
we are responsible for such costs of co-promotion. Based on the terms of the agreement, we received
an upfront payment of $10.0 million upon execution of the agreement in February 2009 and in May
2009 we received a development milestone payment of $7.5 million upon the initiation of phase 3
clinical trials of lubiprostone for CIC in Japan. We are recognizing revenue from the upfront and
development milestone payments over the term of the CIC development program in Japan on a
percentage of completion basis.
In April 2009, we entered into two agreements with R-Tech Ueno Ltd., or R-Tech, a Japanese
manufacturing and research and development company that is majority owned by our founders, to
acquire all patents and other intellectual property rights related to Rescula®
(unoprostone isopropyl) in the United States and Canada. Although Rescula eye drops have been
approved by the FDA for the treatment of open-angle glaucoma and ocular hypertension since 2000,
Rescula is not currently marketed in the United States or Canada. We plan to re-launch Rescula in
the United States for the treatment of open-angle glaucoma and ocular hypertension and to initiate
clinical trials of Rescula for the treatment of dry age-related macular degeneration, or dry AMD,
in 2010.
Under the terms of the agreements, we made an upfront payment of $3.0 million and may be
required to pay up to $5.5 million in additional milestone payments to R-Tech based on the
achievement of specified development and commercialization goals. The first milestone payment of
$500,000 is payable upon the re-launch of Rescula for the treatment of glaucoma and is considered
probable of occurring; therefore, this amount is recorded as part of the initial cost of the
acquired assets. We allocated the acquisition cost between an intangible asset of $3.4 million and
a non-current prepaid inventory of $85,000 as of September 30, 2009, both of which are reflected in
other non-current assets in the accompanying condensed consolidated balance sheet. We are
amortizing the $3.4 million over the 10-year life of the license agreement, which we believe
approximates the useful life of the underlying rights and data. The annual amortization expense is
estimated at approximately $342,000 through April 2019.
22
We generate revenue mainly from product royalties, development milestone payments, and
research and development activities. We expect to continue to incur significant expenses for the
next several years as we continue our research and development activities, seek regulatory
approvals for additional indications for Amitiza and for other compounds in the United States and
abroad and expand our international operations. Although we reported net income for our last three
fiscal years, whether we are able to sustain profitability will depend upon our ability to generate
sufficient revenues and receive payments under our contracts with Takeda, Abbott and similar future
arrangements. In the near term, our ability to generate product revenues will depend primarily on
the growth of Amitiza sales in the United States, continued development of additional indications
for Amitiza, successful development and approval of our pipeline of prostone product candidates and
additional future licensing agreements.
We hold an exclusive worldwide royalty-bearing license from Sucampo AG, or SAG, a Swiss
patent-holding company that is wholly owned by our founders, to develop and commercialize Amitiza
and all other prostone compounds covered by patents and patent applications held by SAG. We are
obligated to assign to SAG all patentable improvements that we make in the field of prostones,
which in turn SAG is obligated to license back to us on an exclusive basis.
Drs. Ryuji Ueno and Sachiko Kuno, our founders, are married to each other and directly or
indirectly own the majority of our common stock, a majority of the stock of R-Tech and all of the
stock of SAG. Dr. Ueno serves as the chairman of our board of directors and is our chief executive
officer and chief scientific officer. Dr. Kuno is a member of our board of directors and executive
advisor of international business development. Dr. Kuno also serves as the chair of the board of
directors of R-Tech.
We conduct our business through our subsidiaries based in the United States, the United
Kingdom and Japan. These subsidiaries represent our reportable geographic segments and we evaluate
the performance of these segments based primarily on income (loss) from operations, as well as
other factors that depend on the development status of these subsidiaries. Such measures include
the progress of research and development activities, collaboration and licensing efforts,
commercialization activities and other factors.
Our Clinical Development Programs
We are developing prostone compounds for the treatment of a broad range of diseases. The most
advanced of these programs are:
Amitiza (lubiprostone) in the United States and Canada. We currently are developing Amitiza to
treat OBD. We recently announced the top line results from the two identically designed phase 3
placebo-controlled pivotal clinical trials of Amitiza (24 mcg, twice daily) for the treatment of
OBD in patients with chronic, non-cancer pain. We also are conducting a follow-on open-label safety
extension trial that we plan to complete by the end of 2009.
Results of recently completed phase 3 clinical trials of Amitiza for the treatment of OBD are
as follows:
|
|
|
The first study met the primary endpoint of a statistically significant change from
baseline in the frequency of spontaneous bowel movements, or SBMs, at week 8 of treatment
when lubiprostone was compared to placebo. Additionally, statistical significance was
achieved for eight of the twelve secondary endpoints, including key symptoms associated
with OBD. The second study did not achieve statistical significance for the same primary
endpoint. Statistically significant improvements with lubiprostone were achieved for two of
the secondary endpoints and positive trends were observed in four of the other secondary
endpoints in the second trial. Subjects treated with lubiprostone in both trials showed a
statistically significant increase in the frequency of SBMs at week 8 from their baseline,
from 1.42 to 4.54 SBMs in the first trial and from 1.60 to 4.10 SBMs in the second trial.
The increase for placebo over their baseline was from 1.46 to 3.81 SBMs for the first trial
and 1.60 to 3.95 SBMs for the second trial. |
|
|
|
|
There was a high rate of response in the placebo arm of the second trial. Approximately
58% of subjects treated with placebo in the second trial experienced more than three SBMs
per week during each week of the trial. |
|
|
|
|
In both trials, a post-hoc sub-analysis showed that subjects on methadone treatment
regimens who were randomized to receive lubiprostone showed a lower SBM response when
compared to lubiprostone patients treated with other opioid medications. Additionally, in
both trials, methadone subjects treated with lubiprostone did not show improvement in OBD
symptomatic endpoints while lubiprostone subjects treated with other opioids showed
statistically significant improvement in both studies in abdominal discomfort and pain,
constipation severity, stool consistency and straining over the placebo. |
|
|
|
|
The overall adverse event rate for the combined trials was 54.9% for lubiprostone and
51.6% for placebo. The most common adverse events were nausea, 15% for lubiprostone
compared to 7.5% for placebo, and diarrhea, 8.5% for lubiprostone compared 3.7% for
placebo. |
23
We continue to analyze the results of these trials, and the outcome of this process and the
results of the follow-on open-label safety extension trial will determine the next steps in this
development program and we plan to submit the data from these trials to the FDA in 2010.
In connection with our marketing approval of Amitiza for the treatment of CIC in adults, we
committed to the FDA to conduct post-marketing studies to evaluate the safety of the product in
pediatric patients, in adult patients with renal impairment and in adult patients with hepatic
impairment, which were initiated in January 2007. We filed results from these three post-marketing
studies with the FDA in May 2009. In connection with our marketing approval for Amitiza for the
treatment of IBS-C in adult women, we committed to the FDA to conduct a post-marketing study to
evaluate the safety and efficacy for the treatment of irritable bowel syndrome in pediatric
patients ages 6 to 17. In addition, we committed to conduct a post-marketing study in male and
female patients with IBS-C utilizing a higher dose than currently recommended for this indication.
In accordance with the collaboration and co-promotion arrangement, Takeda funds the majority of
Amitizas development program in the United States.
Amitiza (lubiprostone) in other countries. In September 2009, we announced the withdrawal of
our European Marketing authorization applications, or MAAs, for lubiprostone, 24 mcg, for the
indication of CIC in adults filed in nine European countries using the decentralized procedure. Our
decision to withdraw the MAAs was strategic, based upon lubiprostones projected commercial
position in the global market. We continue to evaluate our opportunities to obtain an appropriate
label in the European Union based on the fact that lubiprostone is the only product registered for
chronic therapy for CIC and IBS-C in the U.S. We also continue to pursue our MAA in Switzerland for
the same indication.
In
August 2009, we completed enrollment into the open-label phase 3 safety trial and in October
2009, we completed enrollment of the pivotal phase 3 efficacy trial of lubiprostone for CIC in
Japan.
Rescula. In April 2009, we licensed from R-Tech the development and commercialization rights
to Rescula (unoprostone isopropyl) in the United States and Canada, including all associated
patents and other intellectual property. Although Rescula has been approved for marketing in the
United States for the treatment of open-angle glaucoma and ocular hypertension since 2000, it was
marketed only to a limited extent by a previous licensee shortly after the approval and is not
currently commercialized in the United States or Canada. We plan to relaunch Rescula in the United
States for the treatment of open-angle glaucoma and ocular hypertension in 2010. We also intend to
initiate a phase 2 clinical trial of unoprostone isopropyl to treat dry age-related macular
degeneration in 2010.
Cobiprostone. We are developing orally administered cobiprostone to treat various
gastrointestinal and liver disorders, including the prevention of non-steroidal anti-inflammatory
drug, or NSAID, induced ulcers. We also plan to develop an inhaled formulation of cobiprostone for
the treatment of chronic obstructive pulmonary disease and for the treatment of respiratory
symptoms of cystic fibrosis and a topical formulation for the treatment of ulcers and wounds.
Our near-term focus is on the development of cobiprostone for the prevention of NSAID-induced
ulcers. In July 2009, we announced top-line results of our phase 2 clinical trial of cobiprostone
for this indication. A total of 124 patients with osteoarthritis and/or rheumatoid arthritis were
enrolled at 12 sites in the U.S. in this 12-week, double-blinded, randomized, dose-ranging and
placebo-controlled phase 2 trial. All patients in the trial received 500 mg of naproxen twice a
day. There were four treatment cohorts. One cohort received placebo while the other three cohorts
received 18 mcg of cobiprostone either once, twice or three times a day (daily totals of 18, 36 or
54 mcg, respectively).
Efficacy endpoints that we evaluated included: the overall incidence of gastric ulcers during
the 12-week treatment period, overall incidence of duodenal ulcers, change in the number of ulcers
and erosions (gastric and duodenal) by patient, time-to-onset analysis of ulcer and erosion
development, and the severity of overall gastrointestinal injury measured on a standardized grading
scale.
A top-line analysis of data from the trial indicates that patients receiving cobiprostone
experienced a lower overall incidence of ulcers. At week 12, patients receiving the 54 mcg dose
experienced a 50.0% reduction in the overall incidence of gastric ulcers when compared to patients
taking placebo. Cobiprostone patients experienced an overall statistically significant reduction in
the number of gastric erosions through the treatment period of 12 weeks compared to placebo
patients. The reduction of gastric erosions through week 12 was dose dependent, with 36 mcg and 54
mcg demonstrating statistical significance. The time-to-onset of all ulcer or erosion
development was delayed in the cobiprostone cohorts with overall statistical significance
across the 12-week treatment period. Overall, the data showed cobiprostone was well tolerated in
patients receiving NSAID therapy.
24
SPI-017. We are currently developing SPI-017 to treat vascular disease and central nervous
system disorders. We are initially focused on developing an intravenous formulation of this product
candidate for the treatment of peripheral arterial disease, or PAD, and we commenced phase 1
clinical trials of the intravenous formulation of SPI-017 for this indication in December 2008 in
Japan.
Results of Operations
Comparison of three months ended September 30, 2009 and September 30, 2008
Revenues
The following table summarizes our revenues for the three months ended September 30, 2009 and
2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Research and development revenue |
|
$ |
7,045 |
|
|
$ |
5,436 |
|
Product royalty revenue |
|
|
9,367 |
|
|
|
7,718 |
|
Co-promotion revenue |
|
|
1,266 |
|
|
|
1,185 |
|
Contract and collaboration revenue |
|
|
153 |
|
|
|
142 |
|
|
|
|
|
|
|
|
Total |
|
$ |
17,831 |
|
|
$ |
14,481 |
|
|
|
|
|
|
|
|
Total revenues were $17.8 million for the three months ended September 30, 2009 compared
to $14.5 million for the three months ended September 30, 2008, an increase of $3.3 million or
23.1%.
Research and development revenue was $7.0 million for the three months ended September 30,
2009 compared to $5.4 million for the three months ended September 30, 2008, an increase of $1.6
million or 29.6%. The increase was primarily due to $3.5 million in revenue recognized from the
initial upfront payment and development milestone payment received under the agreement with Abbott.
We are recognizing the revenue from the upfront and development milestone payments from Abbott
using a percentage-of-completion model over the term of the CIC development program. The increase
was offset in part by reduced revenue recognized in respect to the pediatric, renal, hepatic and
OBD trials for Amitiza in the U. S. funded by Takeda. We are recognizing this revenue using a
time-based model over the estimated performance period and we reflect any changes in the estimated
costs or performance period prospectively.
Product royalty revenue represents royalty revenue earned on net sales of Amitiza in the
United States. For the three months ended September 30, 2009 and 2008, we recognized $9.4 million
and $7.7 million, respectively, of product royalty revenue, an increase of $1.7 million or 21.4%.
This increase is to a large extent attributable to the method of revenue recognition used for the
royalty revenue recorded from the initial stocking of inventory of Amitiza 8 mcg for IBS-C during
2008. Based on the terms of our agreement with Takeda, we recognized approximately $1.9 million of
product royalty immediately upon the initial stocking that was completed in May 2008, rather than
as those stocks were drawn down during the subsequent two quarters. The increase also reflects the
growth in net sales of Amitiza, which for the three months ended September 30, 2009 and 2008 were
approximately $52.0 million and $50.8 million, respectively.
Co-promotion revenue represents partial reimbursement by Takeda of Amitiza co-promotion costs
for our 38 member specialty sales force targeting long-term care facilities. For each of the three
months ended September 30, 2009 and 2008, we recognized $1.3 million and $1.2 million,
respectively, of co-promotion revenues for reimbursement of sales force costs.
25
Research and Development Expenses
The following summarizes our research and development expenses for the three months ended
September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Direct costs: |
|
|
|
|
|
|
|
|
Amitiza |
|
$ |
5,721 |
|
|
$ |
8,166 |
|
Cobiprostone |
|
|
568 |
|
|
|
1,180 |
|
SPI-017 |
|
|
309 |
|
|
|
616 |
|
Rescula |
|
|
90 |
|
|
|
|
|
Other |
|
|
184 |
|
|
|
749 |
|
|
|
|
|
|
|
|
Total |
|
$ |
6,872 |
|
|
$ |
10,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
511 |
|
|
|
679 |
|
|
|
|
|
|
|
|
Total |
|
$ |
7,383 |
|
|
$ |
11,390 |
|
|
|
|
|
|
|
|
Total research and development expenses for the three months ended September 30, 2009
were $7.4 million compared to $11.4 million for the three months ended September 30, 2008, a
decrease of $4.0 million or 35.2%. The decrease was primarily due to the completion in July 2009 of
the two phase 3 pivotal clinical trials for the treatment of OBD, the completion in 2008 of the
trial related to pediatric constipation for Amitiza, the completion in July 2009 of the phase 2
trial of cobiprostone for the prevention of NSAID-induced ulcers and overall preclinical and basic
development costs, offset in part by ongoing costs of the phase 3 efficacy and safety trials of
lubiprostone for CIC and the phase 1 program of SPI-017 for the PAD in Japan.
General and Administrative Expenses
The following summarizes our general and administrative expenses for the three months ended
September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Salaries, benefits and related costs |
|
$ |
963 |
|
|
$ |
1,156 |
|
Legal, consulting and other professional
expenses |
|
|
2,009 |
|
|
|
852 |
|
Other expenses |
|
|
1,345 |
|
|
|
1,855 |
|
|
|
|
|
|
|
|
Total |
|
$ |
4,317 |
|
|
$ |
3,863 |
|
|
|
|
|
|
|
|
General and administrative expenses were $4.3 million for the three months ended
September 30, 2009, compared to $3.9 million for the three months ended September 30, 2008, an
increase of $454,000 or 11.8%. The decrease in salaries, benefits and related costs was primarily
attributable to a reduction in force in January 2009 and an overall reduction in incentive
compensation for 2009. The increase in legal, consulting and other professional expenses is
primarily a result of $1.4 million in costs incurred in the preparation and the on-going conduct of
a performance audit under our contract with Takeda and a certain one-time business development
effort, that we elected not to pursue, offset in part by savings from cost reduction initiatives.
Selling and Marketing Expenses
Selling and marketing expenses represent costs we incur to co-promote Amitiza, including
salaries, benefits and related costs of our sales force and other sales and marketing personnel,
costs of market research and analysis and other selling and marketing expenses. Selling and
marketing expenses were $3.0 million for the three months ended September 30, 2009, compared to
$2.7 million for the three months ended September 30, 2008, an increase of $367,000 or 13.7%. The
increase was primarily due to approximately $696,000 of a one-time expense resulting from the
withdrawal of our European MAAs, for lubiprostone, 24 mcg, for the indication of CIC, offset in
part by streamlined commercial operations and a reduction in market research expenses.
26
Product Royalties Related Parties
Product royalties related parties expense, representing 3.2% of Amitiza net sales for the
respective periods payable to SAG, increased to $1.7 million for the three months ended September
30, 2009 from $1.4 million for the three months ended September 30, 2008, proportionally with the
increase of product royalty revenue.
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the three months ended
September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Interest income |
|
$ |
211 |
|
|
$ |
655 |
|
Other expense, net |
|
|
(250 |
) |
|
|
(15 |
) |
|
|
|
|
|
|
|
Total |
|
$ |
(39 |
) |
|
$ |
640 |
|
|
|
|
|
|
|
|
Interest income was $211,000 for the three months ended September 30, 2009, compared to
$655,000 for the three months ended September 30, 2008, a decrease of $444,000, or 67.8%. The
decrease was primarily due to lower prevailing interest rates earned by our investments and due to
the shift in the composition of our investments during the three months ended September 30, 2009 as
compared to three months ended September 30, 2008. The other expense, net was primarily
attributable to net foreign exchange gains and losses resulting from the weakening of the U.S.
dollar.
Income Taxes
We recorded a tax provision of $1.5 million for the three months ended September 30, 2009 and
a tax benefit of $1.7 million for the three months ended September 30, 2008. The tax provision for
the three months ended September 30, 2009 mainly pertained to taxable income generated by our U.S.
and Asian subsidiaries. Our other subsidiary, based in Europe, incurred a pre-tax loss for the
three months ended September 30, 2009, for which no tax benefit was recognized. As of September 30,
2009, we had an outstanding non-current income tax liability of $713,622 for uncertain tax
positions which represented the aggregate tax effect of differences between tax return positions
and the amounts otherwise recognized in our condensed consolidated financial statements. The
liability for uncertain tax positions as of September 30, 2009 was mainly a result of our
interpretation of nexus in certain states related to revenue sourcing for state income tax
purposes.
Comparison of nine months ended September 30, 2009 and September 30, 2008
Revenues
The following table summarizes our revenues for the nine months ended September 30, 2009 and
2008:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Research and development revenue |
|
$ |
19,966 |
|
|
$ |
66,982 |
|
Product royalty revenue |
|
|
27,227 |
|
|
|
24,699 |
|
Co-promotion revenue |
|
|
3,406 |
|
|
|
3,643 |
|
Contract and collaboration revenue |
|
|
451 |
|
|
|
425 |
|
|
|
|
|
|
|
|
Total |
|
$ |
51,050 |
|
|
$ |
95,749 |
|
|
|
|
|
|
|
|
Total revenues were $51.1 million for the nine months ended September 30, 2009, compared
to $95.7 million for the nine months ended September 30, 2008, a decrease of $44.6 million or
46.7%.
27
Research and development revenue was $20.0 million for the nine months ended September 30,
2009, compared to $67.0 million for the nine months ended September 30, 2008, a decrease of $47.0
million or 70.2%. This decrease was primarily due to the $50.0
million development milestone received from Takeda in May 2008 upon FDA approval of Amitiza
for the treatment of the IBS-C in adult women that was immediately recognized as research and
development revenue. The decrease also reflects reduced revenue recognized in respect to the
pediatric, renal, hepatic and OBD trials for Amitiza funded by Takeda. The research and development
revenue in 2009 also reflects the $7.4 million in revenue recognized from the initial $10.0 million
upfront payment and the $7.5 million development milestone payment received under the agreement
with Abbott.
For the nine months ended September 30, 2009 and 2008, we recognized $27.2 million and $24.7
million, respectively, of product royalty revenue, an increase of $2.5 million or 10.2%. The
increase reflects primarily the growth in net sales of Amitiza to approximately $151.2 million for
the nine months ended September 30, 2009 from $134.7 million in the same period in 2008.
For the nine months ended September 30, 2009 and 2008, we recognized $3.4 million and $3.6
million, respectively, of co-promotion revenues for reimbursement of sales force costs. The
co-promotion reimbursement is capped at $4.5 million annually for 12-month periods ending March 31.
The reduced revenue during the nine months ended September 30, 2009 reflects this annual limit.
Research and Development Expenses
The following summarizes our research and development expenses for the nine months ended
September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Direct costs: |
|
|
|
|
|
|
|
|
Amitiza |
|
$ |
20,071 |
|
|
$ |
27,192 |
|
Cobiprostone |
|
|
2,145 |
|
|
|
3,450 |
|
SPI-017 |
|
|
2,625 |
|
|
|
2,232 |
|
Rescula |
|
|
148 |
|
|
|
|
|
Other |
|
|
438 |
|
|
|
1,048 |
|
|
|
|
|
|
|
|
Total |
|
$ |
25,427 |
|
|
$ |
33,922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
1,542 |
|
|
|
1,615 |
|
|
|
|
|
|
|
|
Total |
|
$ |
26,969 |
|
|
$ |
35,537 |
|
|
|
|
|
|
|
|
Total research and development expenses for the nine months ended September 30, 2009 were
$27.0 million, compared to $35.5 million for the nine months ended September 30, 2008, a decrease
of $8.5 million or 24.1%. During the nine months ended September 30, 2008, we incurred filing and
data purchase costs of approximately $2.5 million, which were necessary to submit our European
regulatory filings. No such expenditure was recorded during the nine months ended September 30,
2009. The decrease was also due to the completion in July 2009 of the two phase 3 pivotal clinical
trials for the treatment of opioid-induced bowel dysfunction, the completion in 2008 of the
pediatric constipation trial for Amitiza, the completion in July 2009 of the phase 2 trial of
cobiprostone for the prevention of NSAID-induced ulcers and overall preclinical and basic
development costs, offset in part by on-going costs of the phase 3 efficacy and safety trials of
lubiprostone for CIC in Japan.
General and Administrative Expenses
The following summarizes our general and administrative expenses for the nine months ended
September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Salaries, benefits and related costs |
|
$ |
2,873 |
|
|
$ |
3,277 |
|
Legal, consulting and other professional
expenses |
|
|
3,998 |
|
|
|
2,101 |
|
Other expenses |
|
|
3,825 |
|
|
|
5,213 |
|
|
|
|
|
|
|
|
Total |
|
$ |
10,696 |
|
|
$ |
10,591 |
|
|
|
|
|
|
|
|
28
General and administrative expenses were $10.7 million for the nine months ended
September 30, 2009, compared to $10.6 million for the nine months ended September 30, 2008, an
increase of $105,000 or 1.0%. The decrease in salaries, benefits and related costs was primarily
attributable to a reduction in force in January 2009 and an overall reduction in incentive
compensation for 2009. The increase in legal, consulting and other professional expenses was
primarily a result of $1.8 million in costs incurred in the preparation and the on-going conduct of
a performance audit under our contract with Takeda and in a certain one-time business development
effort that we elected not to pursue.
Selling and Marketing Expenses
Selling and marketing expenses were $7.7 million for the nine months ended September 30, 2009,
compared to $8.4 million for the nine months ended September 30, 2008, a decrease of $651,000 or
7.8%. The decrease was primarily due to streamlined commercial operations and a reduction in market
research expenses offset in part by the $696,000 of one-time expenses resulting from the withdrawal
of our European MAAs for lubiprostone, 24 mcg, for the indication of CIC.
Milestone Royalties Related Parties
Milestone royalties related parties expense was $875,000 for the nine months ended September
30, 2009, compared to $3.5 million for the nine months ended September 30, 2008. The milestone
royalties of $875,000 reflect the 5% royalty payments to SAG as a result of the $10.0 million
upfront payment and the $7.5 million development milestone payment we received from Abbott in 2009.
The milestone royalties of $3.5 million for the nine months ended September 30, 2008 consist of
$1.0 million paid to SAG upon the filing of the European MAAs, and of $2.5 million paid to SAG,
reflecting 5% of the $50.0 million development milestone payment that we received from Takeda in
2008.
Product Royalties Related Parties
Product royalties related parties expense, representing 3.2% of Amitiza net sales for the
respective periods payable to SAG, increased to $4.8 million for the nine months ended September
30, 2009, from $4.4 million for the nine months ended September 30, 2008, proportionally with the
increase of product royalty revenue.
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the nine months ended
September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Interest income |
|
$ |
742 |
|
|
$ |
1,862 |
|
Other expense, net |
|
|
(36 |
) |
|
|
(16 |
) |
|
|
|
|
|
|
|
Total |
|
$ |
706 |
|
|
$ |
1,846 |
|
|
|
|
|
|
|
|
Interest income was $742,000 for the nine months ended September 30, 2009, compared to
$1.9 million for the nine months ended September 30, 2008, a decrease of $1.1 million or 60.2%. The
decrease was primarily due to lower prevailing interest rates earned by our investments and due to
the shift in the composition of our investments.
Income Taxes
We recorded a tax provision of $2.7 million and $7.2 million for the nine months ended
September 30, 2009 and 2008, respectively. The tax provision for the nine months ended September
30, 2009 mainly pertained to taxable income generated by our U.S. and Asian subsidiaries. Our other
subsidiary, based in Europe, incurred a pre-tax loss for the nine months ended September 30, 2009,
for which no tax benefit was recognized. The tax provision recorded for the nine months ended
September 30, 2008 was primarily due to a discrete release of U.S. deferred tax asset valuation
allowances and a reduction in the projected effective tax rate for 2008 based on an increase in
projected milestone and product royalty income. As of September 30, 2009, we had an outstanding
non-current income tax liability of $713,622 for uncertain tax positions which represented the
aggregate tax effect of differences between tax return positions and the amounts otherwise
recognized in the our condensed consolidated financial statements. The liability for
uncertain tax positions as of September 30, 2009 was mainly a result of our interpretation of
nexus in certain states related to revenue sourcing for state income tax purposes.
29
Cost Reduction Initiatives
To conserve cash and more closely align our spending towards our strategic objectives, we
implemented cost reduction initiatives in January 2009, which included a workforce reduction and
refocused research and development plans. We expect that these initiatives will result in reduced
costs of approximately $3.0 million during 2009. However, there is no assurance that we will be
successful in achieving these cost savings if actual spending varies from our estimates.
Additionally, during the second quarter of 2009, we decided to initiate most of our future
preclinical and early clinical research and development through our Japanese subsidiary.
Reportable Geographic Segments
We have determined that we have three reportable segments based on our method of internal
reporting, which disaggregates business by geographic location. These segments are the Americas,
Europe and Asia. We evaluate the performance of these segments based primarily on income (loss)
from operations, as well as other factors, including the progress of research and development
activities.
The financial results of our segments reflect their varying stages of development. Our
Americas segment recorded income before taxes of $7.0 million for the nine months ended September
30, 2009 compared to income before taxes of $42.0 million for the nine months ended September 30,
2008, reflecting the $50.0 million milestone payment from Takeda in the nine months ended September
30, 2008.
Our segment in Europe recorded a loss before taxes of $2.8 million for the nine months ended
September 30, 2009. This compared to a loss before taxes of $2.9 million for the nine months ended
September 30, 2008, reflecting the expenses incurred for the European regulatory approval and
pre-commercialization activities for lubiprostone in Europe.
Our segment in Asia recorded a loss before taxes of $3.5 million for the nine months ended
September 30, 2009 compared to a loss before taxes of $3.9 million during the nine months ended
September 30, 2008. These results reflect the ongoing investment in the clinical program for
lubiprostone and SPI-017 and the ongoing preclinical programs for other prostone-based compounds.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
Americas |
|
|
Europe |
|
|
Asia |
|
|
Eliminations |
|
|
Consolidated |
|
Three Months Ended September 30,
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
14,336 |
|
|
$ |
|
|
|
$ |
3,765 |
|
|
$ |
(270 |
) |
|
$ |
17,831 |
|
Income (loss) before taxes |
|
|
3,553 |
|
|
|
(1,513 |
) |
|
|
(659 |
) |
|
|
|
|
|
|
1,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
14,481 |
|
|
$ |
|
|
|
$ |
213 |
|
|
$ |
(213 |
) |
|
$ |
14,481 |
|
Income (loss) before taxes |
|
|
(2,775 |
) |
|
|
(487 |
) |
|
|
(909 |
) |
|
|
|
|
|
|
(4,171 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
43,596 |
|
|
$ |
|
|
|
$ |
8,144 |
|
|
$ |
(690 |
) |
|
$ |
51,050 |
|
Income (loss) before taxes |
|
|
6,954 |
|
|
|
(2,848 |
) |
|
|
(3,474 |
) |
|
|
|
|
|
|
632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
95,749 |
|
|
$ |
|
|
|
$ |
630 |
|
|
$ |
(630 |
) |
|
$ |
95,749 |
|
Income (loss) before taxes |
|
|
41,992 |
|
|
|
(2,916 |
) |
|
|
(3,929 |
) |
|
|
|
|
|
|
35,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2009 |
|
$ |
134,692 |
|
|
$ |
1,281 |
|
|
$ |
14,836 |
|
|
$ |
(1,072 |
) |
|
$ |
149,737 |
|
As of December 31, 2008 |
|
$ |
146,074 |
|
|
$ |
568 |
|
|
$ |
4,469 |
|
|
$ |
(317 |
) |
|
$ |
150,794 |
|
30
Liquidity and Capital Resources
Sources of Liquidity
We require cash principally to meet our operating expenses. Historically, we have financed our
operations with a combination of up-front payments, milestone and royalty payments, research and
development expense reimbursements, private placements of equity securities and our initial public
offering.
Our cash, cash equivalents and investments consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Cash and cash equivalents |
|
$ |
31,751 |
|
|
$ |
11,536 |
|
Investments, current |
|
|
53,038 |
|
|
|
93,776 |
|
Investments, non-current |
|
|
38,853 |
|
|
|
16,222 |
|
|
|
|
|
|
|
|
Total |
|
$ |
123,642 |
|
|
$ |
121,534 |
|
|
|
|
|
|
|
|
Our cash and cash equivalents are deposits in operating accounts and highly liquid
investments with an original maturity at time of purchase of 90 days or less.
As of September 30, 2009, our short-term investments consisted of municipal securities, U.S.
government securities, U.S. Treasury notes and bills, certificates of deposits and money market
funds which have short-term maturities. Our non-current investments consisted of corporate bonds,
U.S. government securities, investments in ARS, municipal securities and certificates of deposits.
Pursuant to a settlement rights agreement from our ARS broker, we can require the broker to
purchase our ARS at par value between June 30, 2010 and July 2, 2012. We do not anticipate having
to sell these securities in order to operate our business before June 30, 2010.
Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2009 and
2008:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
2,965 |
|
|
$ |
38,611 |
|
Investing activities |
|
|
16,347 |
|
|
|
(51,801 |
) |
Financing activities |
|
|
14 |
|
|
|
1,025 |
|
Effect of exchange rates |
|
|
889 |
|
|
|
(30 |
) |
|
|
|
|
|
|
|
Net increase (decrease) in cash
and cash equivalents |
|
$ |
20,215 |
|
|
$ |
(12,195 |
) |
|
|
|
|
|
|
|
Nine Months Ended September 30, 2009
Net cash provided by operating activities was $3.0 million for the nine months ended September
30, 2009. This reflected a net loss of $2.1 million, which included $2.3 million in non-cash items,
and a $3.5 million decrease in unbilled revenue, offset in part by changes in other operating
assets and liabilities.
Net cash provided by investing activities of $16.3 million for the nine months ended September
30, 2009 primarily reflected our proceeds from the sales and maturities of investments, offset in
part by purchases of investments.
Net cash provided by financing activities of $14,000 for the nine months ended September 30,
2009 resulted from the proceeds we received under our employee stock purchase plan.
31
Nine Months Ended September 30, 2008
Net cash provided by operating activities was $38.6 million for the nine months ended
September 30, 2008 and reflected net income of $28.0 million, a decrease of $3.2 million in net
prepaid and income taxes receivable and payable, an increase in accrued expenses of $3.8 million
and an increase of $4.9 million in deferred revenue, offset by a non-cash reversal of deferred tax
asset valuation allowances of $4.3 million and changes in other operating assets and liabilities.
Net cash used in investing activities of $51.8 million for the nine months ended September 30,
2008 primarily reflected our purchases of investments, offset in part by proceeds from the sales
and maturities of investments.
Net cash provided by financing activities of $1.0 million for the nine months ended September
30, 2008 primarily resulted from the net proceeds we received from the exercise of stock options.
Off-Balance Sheet Arrangements
As of September 30, 2009, we did not have any off-balance sheet arrangements, as such term is
defined in Item 303(a)(4) of Regulation S-K under the Securities Act of 1933, as amended.
Funding Requirements
We may need substantial amounts of capital to continue growing our business. We may require
this capital, among other things, to:
|
|
|
fund our share of the ongoing development program of Amitiza in the United States; |
|
|
|
|
fund development and regulatory efforts in Europe and Japan for lubiprostone; |
|
|
|
|
fund development and regulatory activities for Rescula in the United States and
Canada; |
|
|
|
|
fund research and development activities for other prostone compounds, including
cobiprostone and SPI-017; |
|
|
|
|
fund the expansion of our commercialization activities in the United States and the
initiation of commercialization efforts in non-U.S. markets; |
|
|
|
|
fund capital expenditures to support the growth of our business; and |
|
|
|
|
fund the purchase of shares of our class A common stock up to $10.0 million, if we
elect to do so, pursuant to our board-approved stock repurchase program. |
The timing of these funding requirements is difficult to predict due to many factors,
including the outcomes of our preclinical and clinical research and development programs and when
those outcomes are determined, the timing of obtaining regulatory approvals and the presence and
status of competing products. Our capital needs may exceed the capital available from our future
operations, collaborative and licensing arrangements and existing liquid assets. Our future capital
requirements and liquidity will depend on many factors, including, but not limited to:
|
|
|
the revenue from Amitiza and Rescula; |
|
|
|
|
the future expenditures we may incur to increase revenue from Amitiza; |
|
|
|
|
the cost and time involved to pursue our research and development programs; |
|
|
|
|
our ability to establish collaborative arrangements and to enter into licensing
agreements and contractual arrangements with others; and |
|
|
|
|
any future change in our business strategy. |
To the extent that our capital resources may be insufficient to meet our future capital
requirements, we may need to finance our future cash needs through public or private equity
offerings, debt financings or corporate collaboration and licensing arrangements.
Fair Value Estimates
We adopted the fair value measurement guidance, issued by the FASB, effective January 1, 2008
for our financial assets and liabilities and adopted the fair value measurement standard for
non-financial assets and liabilities effective January 1, 2009. The carrying amounts of our
financial instruments, which include cash and cash equivalents, restricted cash, current and
non-current investments, receivables, accounts payable and accrued liabilities, approximate their
fair values based on their short maturities, independent valuations or internal assessments. The
adoption of the fair value measurement guidance for non-financial assets and liabilities did not
have a material impact on the accompanying condensed consolidated financial statements.
32
For the nine months ended September 30, 2009, we recorded a net $249,000 gain within other
income, net in the accompanying condensed consolidated statements of operations and comprehensive
income (loss) as a change in the fair value of our investments in ARS and related settlement
rights.
Recent Accounting Pronouncements
Recent accounting pronouncements applicable to our financial statements are described in Note
2 to the accompanying condensed consolidated financial statements.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures about Market Risk |
Foreign Exchange Risk
We are subject to foreign exchange risk for revenues and expenses denominated in foreign
currencies. Foreign currency risk arises from the fluctuation of foreign exchange rates and the
degree of volatility of these rates relative to the United States dollar. We do not believe that we
have any material risk due to foreign currency exchange. We do not currently hedge our foreign
currency transactions.
Interest Rate Risk
Our exposure to market risks associated with changes in interest rates relates primarily to
the increase or decrease in the amount of interest income earned on our investment portfolio. We
ensure the safety and preservation of invested funds by attempting to limit default risk, market
risk and reinvestment risk. We attempt to mitigate default risk by investing in investment grade
securities. A hypothetical one percentage point decline in interest rates would not have materially
affected the fair value of our interest-sensitive financial instruments as of September 30, 2009.
We do not use derivative financial instruments for trading or speculative purposes. However,
we regularly invest excess cash in overnight repurchase agreements that are subject to changes in
short-term interest rates. We believe that the market risk arising from holding these financial
instruments is minimal.
Credit Risk
Our exposure to credit risk consists of cash and cash equivalents, restricted cash,
investments and receivables. We place our cash, cash equivalents and restricted cash with what we
believe to be highly rated financial institutions and invest the excess cash in highly rated
investments. As of September 30, 2009 and December 31, 2008, approximately 55.2% and 51.1%,
respectively, of our cash, cash equivalents, restricted cash and investments is issued or insured
by the federal government or government agencies. We have not experienced any losses on these
accounts related to amounts in excess of insured limits.
As of September 30, 2009, we had $9.4 million invested in one non-mortgage related ARS.
Pursuant to the $10.0 million settlement rights offered by our ARS broker, we have the right to
require the broker to purchase the remaining ARS at par value at any time during the two-year
period beginning June 30, 2010. We recorded the fair value of the ARS settlement right of
approximately $466,000 in other non-current assets in the accompanying condensed consolidated
balance sheet.
33
|
|
|
Item 4. |
|
Controls and Procedures |
a) Evaluation of Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Chief Executive
Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and
operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of
the Securities Exchange Act of 1934, as amended) as of September 30, 2009. In designing and
evaluating such controls, management recognizes that any controls and procedures, no matter how
well designed and operated, can provide only reasonable assurance of achieving their objectives and
management necessarily applies its judgment in evaluating the benefits of possible controls and
procedures relative to their costs. Based upon this evaluation, our Chief Executive Officer and
Chief Financial Officer have concluded that, as of September 30, 2009, our disclosure controls and
procedures were effective to provide reasonable assurance that the information required to be
disclosed is recorded, processed, summarized and reported within the time periods
specified under applicable rules of the Securities and Exchange Commission, and that such
information is accumulated and communicated to management, including our Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely decisions regarding required
disclosures.
b) Changes in Internal Controls
There were no changes in our internal control over financial reporting during the quarter
ended September 30, 2009 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
34
Part II OTHER INFORMATION
|
|
|
Item 1. |
|
Legal Proceedings |
We and our subsidiaries are not currently a party to any legal proceedings of which the
ultimate outcome, in our judgment, would have a material adverse effect on our business, financial
condition or results of operations.
Our business is subject to certain risks and events that, if they occur, could adversely
affect our financial condition and results of operations and the trading price of our common stock.
For a discussion of these risks, please refer to the Risk Factors section of our Annual Report on
Form 10-K for the fiscal year ended December 31, 2008, filed by us with the SEC on March 16, 2009,
and the Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, as filed with the SEC on
August 7, 2009. In connection with our preparation of this quarterly report, management has
reviewed and considered these risk factors and has determined that the following risk factor should
be read in conjunction with the existing risk factors disclosed in the Form 10-K and the Form 10-Q.
We have exercised our right to a performance audit of Takedas sales efforts with respect to
Amitiza; if our dispute with Takeda continues or escalates, we could be required to commit
significant financial resources and management time and could ultimately face termination of our
Takeda contract and market Amitiza through other means.
In May 2009, we announced our disappointment with the level of U.S. Amitiza sales being
generated by Takeda Pharmaceuticals North America and noted that we intend to exercise our rights
to pursue a performance audit under our contract with Takeda. We have spent significant financial
resources to date to prepare for, negotiate the scope of and conduct this on-going performance
audit. If the results of the audit are unfavorable and if we do not come to terms with Takeda on
means to improve overall sales performance, we may conclude we have no choice but to take the
matter to arbitration or to take other legal action. Arbitration or other legal action would likely
be expensive and also require the attention of our senior management team.
If our dispute with Takeda escalates, our relationship with Takeda could be compromised and
our contracts with Takeda could be jeopardized. Ultimately, our contractual relationship could be
terminated, either by us or Takeda, in which case we would be required to market the product by
ourselves or to find another commercial partner. In either case, there would likely be a transition
period during which Amitiza sales may decline, or our efforts to market Amitiza through other means
may not be successful and we may lose significant Amitiza revenues.
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
On December 11, 2008, we announced a stock repurchase program pursuant to which we are
authorized to purchase up to $10.0 million of our class A common stock from time to time in open
market transactions. During the quarter ended September 30, 2009, we did not purchase any shares
under this program.
|
|
|
Item 3. |
|
Defaults Upon Senior Securities. |
None.
|
|
|
Item 4. |
|
Submission of Matters to a Vote of Security Holders |
No matters were submitted to a vote of security holders during the quarter ended September 30,
2009.
35
(a) Exhibits
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Reference |
|
|
|
|
|
|
|
|
3.1 |
|
|
Certificate of Incorporation
|
|
Exhibit 3.1 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
|
|
|
|
|
|
|
|
3.2 |
|
|
Certificate of Amendment
|
|
Exhibit 3.2 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
|
|
|
|
|
|
|
|
3.3 |
|
|
Restated Bylaws
|
|
Exhibit 3.3 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
|
|
|
|
|
|
|
|
4.1 |
|
|
Specimen Stock Certificate
evidencing the shares of class
A common stock
|
|
Exhibit 4.1 to
Registration Statement
No. 333-135133,
Amendment No. 5 (filed
February 1, 2007) |
|
|
|
|
|
|
|
|
10.1 |
* |
|
Form of Nonstatutory Stock
Option Agreement for
Non-Employee Directors
|
|
Included herewith |
|
|
|
|
|
|
|
|
31.1 |
|
|
Certification of the Principal
Executive Officer, as required
by Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
|
|
|
|
|
|
|
|
31.2 |
|
|
Certification of the Principal
Financial Officer, as required
by Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
|
|
|
|
|
|
|
|
32.1 |
|
|
Certification of the Principal
Executive Officer pursuant to
18 U.S.C. Section 1350, as
adopted pursuant to Section 906
of the Sarbanes-Oxley Act of
2002
|
|
Included herewith |
|
|
|
|
|
|
|
|
32.2 |
|
|
Certification of the Principal
Financial Officer pursuant to
18 U.S.C. Section 1350, as
adopted pursuant to Section 906
of the Sarbanes-Oxley Act of
2002
|
|
Included herewith |
|
|
|
* |
|
Confidential treatment has been requested for portions of this exhibit. |
36
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
Sucampo Pharmaceuticals, Inc.
|
|
November 6, 2009 |
By: |
/s/ RYUJI UENO
|
|
|
|
Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
|
|
Chief Executive Officer, Chief Scientific
Officer and Chairman of the Board of Directors
(Principal Executive Officer) |
|
|
November 6, 2009 |
By: |
/s/ JAN SMILEK
|
|
|
|
Jan Smilek |
|
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
37
Sucampo Pharmaceuticals, Inc.
Exhibit Index
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Reference |
|
|
|
|
|
|
|
|
3.1 |
|
|
Certificate of Incorporation
|
|
Exhibit 3.1 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
|
|
|
|
|
|
|
|
3.2 |
|
|
Certificate of Amendment
|
|
Exhibit 3.2 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
|
|
|
|
|
|
|
|
3.3 |
|
|
Restated Bylaws
|
|
Exhibit 3.3 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
|
|
|
|
|
|
|
|
4.1 |
|
|
Specimen Stock Certificate
evidencing the shares of class
A common stock
|
|
Exhibit 4.1 to
Registration Statement
No. 333-135133,
Amendment No. 5 (filed
February 1, 2007) |
|
|
|
|
|
|
|
|
10.1 |
* |
|
Form of Nonstatutory Stock
Option Agreement for
Non-Employee Directors
|
|
Included herewith |
|
|
|
|
|
|
|
|
31.1 |
|
|
Certification of the Principal
Executive Officer, as required
by Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
|
|
|
|
|
|
|
|
31.2 |
|
|
Certification of the Principal
Financial Officer, as required
by Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
|
|
|
|
|
|
|
|
32.1 |
|
|
Certification of the Principal
Executive Officer pursuant to
18 U.S.C. Section 1350, as
adopted pursuant to Section 906
of the Sarbanes-Oxley Act of
2002
|
|
Included herewith |
|
|
|
|
|
|
|
|
32.2 |
|
|
Certification of the Principal
Financial Officer pursuant to
18 U.S.C. Section 1350, as
adopted pursuant to Section 906
of the Sarbanes-Oxley Act of
2002
|
|
Included herewith |
|
|
|
* |
|
Confidential treatment has been requested for portions of this exhibit. |
38
Exhibit 10.1
Exhibit 10.1
Nonstatutory Stock Option Agreement
for Non-Employee Directors
Granted Under 2006 Stock Incentive Plan
1. Grant of Option.
This agreement evidences the grant by Sucampo Pharmaceuticals, Inc., a Delaware corporation
(the Company), on
_____
, 200
_____
(the Grant Date) to
_____
, a director of the Company
(the Participant), of an option to purchase, in whole or in part, on the terms provided herein
and in the Companys 2006 Stock Incentive Plan (the Plan), a total of
_____
shares (the
Shares) of Class A common stock, $0.01 par value per share, of the Company (Common Stock) at
$ per Share. Unless earlier terminated, this option shall expire at 5:00 p.m., Eastern time,
on the tenth anniversary of the Grant Date (the Final Exercise Date).
It is intended that the option evidenced by this agreement shall not be an incentive stock
option as defined in Section 422 of the Internal Revenue Code of 1986, as amended, and any
regulations promulgated thereunder (the Code). Except as otherwise indicated by the context, the
term Participant, as used in this option, shall be deemed to include any person who acquires the
right to exercise this option validly under its terms.
2. Vesting Schedule.
This option will become exercisable (vest) [initial grants: as to one twelfth (1/12) of the
Shares (rounded up the nearest whole number of Shares) at the end of every three-month period
following the Grant Date, becoming fully vested on the third anniversary of the Grant Date] [annual
grants: as to one twelfth (1/12) of the Shares (rounded up the nearest whole number of Shares) at
the end of every one-month period following the Grant Date, becoming fully vested on the first
anniversary of the Grant Date]. Notwithstanding the foregoing, this option shall vest in full
immediately prior to the occurrence of a Change of Control Event (as defined in Section 8) with
respect to the Company.
The right of exercise shall be cumulative so that to the extent the option is not exercised in
any period to the maximum extent permissible it shall continue to be exercisable, in whole or in
part, with respect to all Shares for which it is vested until the earlier of the Final Exercise
Date or the termination of this option under Section 3 hereof or the Plan.
3. Exercise of Option.
(a) Form of Exercise. Each election to exercise this option shall be in writing,
signed by the Participant, and received by the Company at its principal office, accompanied by this
agreement, and payment in full in the manner provided in the Plan. The Participant may purchase
less than the number of shares covered hereby, provided that no partial exercise of this option may
be for any fractional share.
(b) Continuous Relationship with the Company Required. Except as otherwise provided
in this Section 3, this option may not be exercised unless the Participant, at the time he or she
exercises this option, is, and has been at all times since the Grant Date, a director of the
Company or any parent or subsidiary of the Company as defined in Section 424(e) or (f) of the Code
(an Eligible Participant).
(c) Termination of Relationship with the Company. If the Participant ceases to be an
Eligible Participant for any reason, then the right to exercise this option shall terminate one
year after such cessation (but in no event after the Final Exercise Date), provided
that this option shall be exercisable only to the extent that the Participant was entitled
to exercise this option on the date of such cessation.
4. Agreement in Connection with Public Offering.
The Participant agrees, in connection with any underwritten public offering of the Companys
securities pursuant to a registration statement under the Securities Act, (i) not to sell, make
short sale of, loan, grant any options for the purchase of, or otherwise dispose of any shares of
Common Stock held by the Participant (other than those shares included in the offering) without the
prior written consent of the Company or the underwriters managing such initial underwritten public
offering of the Companys securities for a period of 90 days from the effective date of such
registration statement, and (ii) to execute any agreement reflecting clause (i) above as may be
requested by the Company or the managing underwriters at the time of such offering.
5. Withholding.
No Shares will be issued pursuant to the exercise of this option unless and until the
Participant pays to the Company, or makes provision satisfactory to the Company for payment of, any
federal, state or local withholding taxes required by law to be withheld in respect of this option.
6. Nontransferability of Option.
This option may not be sold, assigned, transferred, pledged or otherwise encumbered by the
Participant, either voluntarily or by operation of law, except by will or the laws of descent and
distribution, and, during the lifetime of the Participant, this option shall be exercisable only by
the Participant.
7. Provisions of the Plan.
This option is subject to the provisions of the Plan, a copy of which is furnished to the
Participant with this option.
8. Change of Control Events.
A Change of Control Event shall mean:
-2-
(a) the acquisition by an individual, entity or group (within the meaning of Section 13(d)(3)
or 14(d)(2) of the Exchange Act) (a Person) of beneficial ownership of any capital stock of the Company if, after such acquisition, such Person beneficially owns (within the
meaning of Rule 13d-3 promulgated under the Exchange Act) 25% or more of either (x) the
then-outstanding shares of common stock of the Company (the Outstanding Company Common Stock) or
(y) the combined voting power of the then-outstanding securities of the Company entitled to vote
generally in the election of directors (the Outstanding Company Voting Securities);
provided, however, that for purposes of this subsection (a), the following
acquisitions shall not constitute a Change in Control Event: (1) any acquisition directly from the
Company (excluding an acquisition pursuant to the exercise, conversion or exchange of any security
exercisable for, convertible into or exchangeable for common stock or voting securities of the
Company, unless the Person exercising, converting or exchanging such security acquired such
security directly from the Company or an underwriter or agent of the Company), (2) any acquisition
by any employee benefit plan (or related trust) sponsored or maintained by the Company or any
corporation controlled by the Company, (3) any acquisition by any corporation pursuant to a
Business Combination (as defined below) which complies with clauses (x) and (y) of subsection (c)
of this definition, (4) any acquisition by Sachiko Kuno or Ryuji Ueno (Dr. Kuno and Dr. Ueno being
referred to as the Founders) or (5) any acquisition by a trust of which either or both Founders
are the sole trustees or otherwise control all decisions regarding the voting of any shares of
Company stock held by such trust, provided that such trust is established solely for the benefit of
(A) either or both Founders, (B) either Founders children, parents, uncles, aunts, siblings and
descendents of such siblings or grandchildren and descendents of such grandchildren, (C) the
estates of any of the foregoing individuals; or
(b) such time as the Continuing Directors (as defined below) do not constitute a majority of
the Board (or, if applicable, the Board of Directors of a successor corporation to the Company),
where the term Continuing Director means at any date a member of the Board (x) who was a member
of the Board on the date of the initial adoption of the Plan by the Board or (y) who was nominated
or elected subsequent to such date by at least a majority of the directors who were Continuing
Directors at the time of such nomination or election or whose election to the Board was recommended
or endorsed by at least a majority of the directors who were Continuing Directors at the time of
such nomination or election; provided, however, that there shall be excluded from
this clause (y) any individual whose initial assumption of office occurred as a result of an actual
or threatened election contest with respect to the election or removal of directors or other actual
or threatened solicitation of proxies or consents, by or on behalf of a person other than the
Board;
(c) the consummation of a merger, consolidation, reorganization, recapitalization or share
exchange involving the Company or a sale or other disposition of all or substantially all of the
assets of the Company (a Business Combination), unless, immediately following such Business
Combination, each of the following two conditions is satisfied: (x) all or substantially all of the
individuals and entities who were the beneficial owners of the Outstanding Company Common Stock and
Outstanding Company Voting Securities immediately prior to such Business Combination beneficially
own, directly or indirectly, more than 50% of the then-outstanding shares of common stock and the
combined voting power of the then-outstanding securities entitled to vote generally in the election
of directors, respectively, of the resulting or acquiring corporation in such Business Combination
(which shall include, without limitation, a corporation which as a result of such transaction owns
the Company or substantially all of the Companys assets either directly or through one or more
subsidiaries) (such resulting or acquiring corporation is referred to herein as the Acquiring
Corporation) in substantially the same proportions as their ownership of the Outstanding Company Common Stock and Outstanding Company
Voting Securities, respectively, immediately prior to such Business Combination and (y) no Person
(excluding the Acquiring Corporation or any employee benefit plan (or related trust) maintained or
sponsored by the Company or by the Acquiring Corporation) beneficially owns, directly or
indirectly, 25% or more of the then-outstanding shares of common stock of the Acquiring
Corporation, or of the combined voting power of the then-outstanding securities of such corporation
entitled to vote generally in the election of directors (except to the extent that such ownership
existed prior to the Business Combination); or
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(d) the consummation of any other transaction that is a Rule 13e-3 transaction as defined in
Rule 13e-3(a)(3) under the Exchange Act.
IN WITNESS WHEREOF, the Company has caused this option to be executed under its corporate seal
by its duly authorized officer. This option shall take effect as a sealed instrument.
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SUCAMPO PHARMACEUTICALS, INC. |
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Dated:
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By: |
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Name: |
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Title: |
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PARTICIPANTS ACCEPTANCE
The undersigned hereby accepts the foregoing option and agrees to the terms and conditions
thereof. The undersigned hereby acknowledges receipt of a copy of the Companys 2006 Stock
Incentive Plan.
-5-
Exhibit 31.1
EXHIBIT 31.1
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Ryuji Ueno, certify that:
1. |
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I have reviewed this Quarterly Report on Form 10-Q of Sucampo Pharmaceuticals, Inc.; |
2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a
material fact necessary to make the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this report; |
3. |
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly
present in all material respects the financial condition, results of operations and cash flows of the registrant
as of, and for, the periods presented in this report; |
4. |
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The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15(d)-15(e)) and internal control over
financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(F)) for the registrant and have: |
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designed such disclosure controls and procedures or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period
in which this report is being prepared; |
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designed such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles; |
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(c) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
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(d) |
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disclosed in this report any change in the registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case
of an annual report) that has materially affected, or is reasonably likely to materially affect the
registrants internal control over financial reporting; and |
5. |
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The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of
internal control over financial reporting, to the registrants auditors and the audit committee of registrants
board of directors (or persons performing the equivalent functions): |
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all significant deficiencies and material weaknesses in the design or operation of internal controls over
financial reporting which are reasonably likely to adversely affect the registrants ability to record,
process, summarize and report financial information; and |
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any fraud, whether or not material, that involves management or other employees who have a significant
role in the registrants internal control over financial reporting. |
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Date: November 6, 2009
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/s/ RYUJI UENO |
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Ryuji Ueno, M.D., Ph.D., Ph.D. |
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Chief Executive Officer |
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(Principal Executive Officer) |
Exhibit 31.2
EXHIBIT 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jan Smilek, certify that:
1. |
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I have reviewed this Quarterly Report on Form 10-Q of Sucampo Pharmaceuticals, Inc.; |
2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a
material fact necessary to make the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this report; |
3. |
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly
present in all material respects the financial condition, results of operations and cash flows of the registrant
as of, and for, the periods presented in this report; |
4. |
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The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15(d)-15(e)) and internal control over
financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(F)) for the registrant and have: |
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(a) |
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designed such disclosure controls and procedures or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period
in which this report is being prepared; |
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(b) |
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designed such internal control over financial reporting, or caused such internal control over financial
reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles; |
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(c) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this
report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
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(d) |
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disclosed in this report any change in the registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case
of an annual report) that has materially affected, or is reasonably likely to materially affect the
registrants internal control over financial reporting; and |
5. |
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The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of
internal control over financial reporting, to the registrants auditors and the audit committee of registrants
board of directors (or persons performing the equivalent functions): |
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(a) |
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all significant deficiencies and material weaknesses in the design or operation of internal controls over
financial reporting which are reasonably likely to adversely affect the registrants ability to record,
process, summarize and report financial information; and |
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(b) |
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any fraud, whether or not material, that involves management or other employees who have a significant
role in the registrants internal control over financial reporting. |
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Date: November 6, 2009
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/s/ JAN SMILEK |
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Jan Smilek |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
Exhibit 32.1
EXHIBIT 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title
18, United States Code), the undersigned officer of Sucampo Pharmaceuticals, Inc. (the Company) certifies to the best
of his knowledge that:
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The Quarterly Report on Form 10-Q for the period ended September 30, 2009 of the Company (the Report)
fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as
amended; and |
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(2) |
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The information contained in the Report fairly presents, in all material respects, the financial
condition and results of operations of the Company. |
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Date: November 6, 2009
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/s/ RYUJI UENO |
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Ryuji Ueno, M.D., Ph.D., Ph.D. |
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Chief Executive Officer |
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(Principal Executive Officer) |
Exhibit 32.2
EXHIBIT 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title
18, United States Code), the undersigned officer of Sucampo Pharmaceuticals, Inc. (the Company) certifies to the best
of her knowledge that:
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The Quarterly Report on Form 10-Q for the period ended September 30, 2009 of the Company (the Report)
fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as
amended; and |
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(2) |
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The information contained in the Report fairly presents, in all material respects, the financial
condition and results of operations of the Company. |
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Date: November 6, 2009
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/s/ JAN SMILEK |
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Jan Smilek |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |