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 June 30, 2009
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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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(301) 961-3400 |
Bethesda, MD 20814
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(Registrants telephone number, |
(Address of principal executive offices,
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including area code) |
including zip code) |
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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 August 6, 2009, there were 15,653,375 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
Item 1. Condensed Consolidated Financial Statements (Unaudited)
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share data)
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June 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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$ |
41,737 |
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$ |
11,536 |
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Investments, current |
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68,435 |
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93,776 |
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Product royalties receivable |
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8,913 |
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9,725 |
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Unbilled accounts receivable |
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3,623 |
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4,373 |
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Accounts receivable |
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889 |
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878 |
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Prepaid and income taxes receivable |
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1,069 |
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133 |
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Deferred tax assets, net |
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291 |
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963 |
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Prepaid expenses and other current assets |
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2,965 |
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3,641 |
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Total current assets |
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127,922 |
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125,025 |
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Investments, non-current |
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21,330 |
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16,222 |
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Property and equipment, net |
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2,330 |
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2,275 |
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Deferred tax assets, non-current |
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4,002 |
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4,026 |
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Other assets |
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4,354 |
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3,246 |
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Total assets |
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$ |
159,938 |
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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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$ |
2,029 |
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$ |
1,433 |
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Accrued expenses |
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10,770 |
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9,764 |
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Deferred revenue, current |
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21,305 |
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15,599 |
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Total current liabilities |
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34,104 |
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26,796 |
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Deferred revenue, non-current |
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11,771 |
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8,061 |
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Other liabilities |
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2,024 |
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2,147 |
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Total liabilities |
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47,899 |
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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 June 30,
2009 and December 31, 2008; no shares
issued and outstanding at June 30, 2009 and
December 31, 2008 |
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Class A common stock, $0.01 par value;
270,000,000 shares authorized at June 30,
2009 and December 31, 2008; 15,653,375 and
15,651,849 shares issued and outstanding at
June 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, $0.01 par value;
75,000,000 shares authorized at June 30,
2009 and December 31, 2008; 26,191,050
shares issued and outstanding at June 30,
2009 and
December 31, 2008 |
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262 |
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262 |
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Additional paid-in capital |
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98,440 |
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98,243 |
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Accumulated other comprehensive income |
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419 |
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354 |
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Retained earnings |
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12,762 |
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14,775 |
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Total stockholders equity |
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112,039 |
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113,790 |
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Total liabilities and stockholders equity |
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$ |
159,938 |
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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 June 30, |
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Six Months Ended June 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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$ |
7,395 |
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$ |
55,436 |
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$ |
12,921 |
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$ |
61,546 |
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Product royalty revenue |
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8,914 |
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10,901 |
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17,860 |
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16,981 |
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Co-promotion revenue |
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1,244 |
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1,236 |
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2,140 |
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2,458 |
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Contract and collaboration revenue |
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152 |
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141 |
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298 |
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283 |
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Total revenues |
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17,705 |
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67,714 |
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33,219 |
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81,268 |
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Operating expenses: |
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Research and development |
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9,621 |
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12,931 |
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19,586 |
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24,147 |
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General and administrative |
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2,924 |
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3,561 |
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6,379 |
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6,728 |
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Selling and marketing |
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2,188 |
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2,870 |
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4,700 |
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5,718 |
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Milestone royalties related parties |
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375 |
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2,500 |
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875 |
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3,531 |
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Product royalties related parties |
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1,583 |
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1,951 |
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3,173 |
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3,032 |
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Total operating expenses |
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16,691 |
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23,813 |
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34,713 |
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43,156 |
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Income (loss) from operations |
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1,014 |
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43,901 |
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(1,494 |
) |
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38,112 |
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Non-operating income (expense): |
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Interest income |
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219 |
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565 |
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531 |
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1,207 |
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Other income (expense), net |
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(608 |
) |
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(13 |
) |
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214 |
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(1 |
) |
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Total non-operating income (expense), net |
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(389 |
) |
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552 |
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745 |
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1,206 |
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Income (loss) before income taxes |
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625 |
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44,453 |
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(749 |
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39,318 |
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Income tax provision |
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(863 |
) |
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(14,577 |
) |
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(1,264 |
) |
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(8,937 |
) |
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Net income (loss) |
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$ |
(238 |
) |
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$ |
29,876 |
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$ |
(2,013 |
) |
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$ |
30,381 |
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Net income (loss) per share: |
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Basic net income (loss) per share |
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$ |
(0.01 |
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$ |
0.72 |
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$ |
(0.05 |
) |
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$ |
0.73 |
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Diluted net income (loss) per share |
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$ |
(0.01 |
) |
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$ |
0.71 |
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$ |
(0.05 |
) |
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$ |
0.72 |
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Weighted average common shares outstanding basic |
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41,844 |
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41,757 |
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41,844 |
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41,745 |
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Weighted average common shares outstanding diluted |
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41,844 |
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42,038 |
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41,844 |
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42,026 |
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Comprehensive income (loss): |
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Net income (loss) |
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$ |
(238 |
) |
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$ |
29,876 |
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$ |
(2,013 |
) |
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$ |
30,381 |
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Other comprehensive income (loss): |
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Unrealized loss on investments, net of tax effect |
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(7 |
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(616 |
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(72 |
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(1,456 |
) |
Foreign currency translation |
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340 |
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(325 |
) |
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137 |
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5 |
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Comprehensive income (loss) |
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$ |
95 |
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$ |
28,935 |
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$ |
(1,948 |
) |
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$ |
28,930 |
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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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Loss |
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Earnings |
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Equity |
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Balance at December 31, 2008 |
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15,651,849 |
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$ |
156 |
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26,191,050 |
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|
$ |
262 |
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$ |
98,243 |
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$ |
354 |
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$ |
14,775 |
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$ |
113,790 |
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Employee stock option expense |
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|
188 |
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188 |
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Stock issued under employee stock purchase plan |
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1,526 |
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9 |
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9 |
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Foreign currency translation |
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137 |
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|
137 |
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Unrealized loss on investments, net of tax effect |
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(72 |
) |
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(72 |
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Net loss |
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(2,013 |
) |
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(2,013 |
) |
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Balance at June 30, 2009 |
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15,653,375 |
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$ |
156 |
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26,191,050 |
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|
$ |
262 |
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|
$ |
98,440 |
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|
$ |
419 |
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$ |
12,762 |
|
|
$ |
112,039 |
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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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Six Months Ended June 30, |
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2009 |
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|
2008 |
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Cash flows from operating activities: |
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Net income (loss) |
|
$ |
(2,013 |
) |
|
$ |
30,381 |
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: |
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Depreciation and amortization |
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|
309 |
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|
212 |
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Deferred tax provision (benefit) |
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|
738 |
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(4,543 |
) |
Stock-based compensation |
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|
188 |
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|
440 |
|
Amortization of premiums (accretion of discounts) on investments |
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|
508 |
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|
(122 |
) |
Unrealized gain on trading securities |
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(2,611 |
) |
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Unrealized loss on settlement rights on auction rate securities |
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2,362 |
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|
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Changes in operating assets and liabilities: |
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Accounts receivable |
|
|
(26 |
) |
|
|
(1,336 |
) |
Unbilled accounts receivable |
|
|
750 |
|
|
|
204 |
|
Product royalties receivable |
|
|
812 |
|
|
|
(1,616 |
) |
Prepaid and income taxes receivable and payable, net |
|
|
(936 |
) |
|
|
15,213 |
|
Accounts payable |
|
|
601 |
|
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|
53 |
|
Accrued expenses |
|
|
1,009 |
|
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|
1,732 |
|
Deferred revenue |
|
|
9,445 |
|
|
|
9,521 |
|
Other assets and liabilities, net |
|
|
(123 |
) |
|
|
462 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
11,013 |
|
|
|
50,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of investments |
|
|
(139,824 |
) |
|
|
(111,304 |
) |
Proceeds from the sales of investments |
|
|
99,782 |
|
|
|
38,950 |
|
Maturities of investments |
|
|
62,264 |
|
|
|
22,500 |
|
Purchases of property and equipment |
|
|
(308 |
) |
|
|
(302 |
) |
Purchase of intangible assets |
|
|
(2,919 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
18,995 |
|
|
|
(50,156 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
|
|
|
|
404 |
|
Excess tax benefits from share-based payments |
|
|
|
|
|
|
71 |
|
Proceeds from employee stock purchase plan |
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
9 |
|
|
|
475 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
184 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
30,201 |
|
|
|
924 |
|
Cash and cash equivalents at beginning of period |
|
|
11,536 |
|
|
|
25,559 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
41,737 |
|
|
$ |
26,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
Purchase of intangible assets 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. (the Company) is a 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. The Company was established in December 1996.
In January 2006, the Company received marketing approval from the U.S. Food and Drug
Administration (FDA), for its first product, Amitiza® (lubiprostone), to treat chronic idiopathic
constipation 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 and Canada for gastrointestinal indications under
a collaboration and license agreement with Takeda Pharmaceutical Company Limited (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 chronic
idiopathic constipation (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 (OBD).
In February 2009, the Company entered into a license, commercialization and supply agreement
with Abbott Japan Co. Ltd. (Abbott) for Amitiza 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. (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 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. One of the Companys founders serves as the chairman of the board of
directors, chief executive officer and chief scientific officer of the Company and the second
founder 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 the United States,
the United Kingdom and Japan.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of the Company have
been prepared in accordance with accounting principles generally accepted in the United States
(GAAP) and the rules and regulations of the Securities and Exchange Commission (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 June 30, 2009 and for the three and six months ended June 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,
municipal bonds and auction rate securities (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. These investments are accounted for under the guidance of
Statements of Financial Accounting Standards (SFAS) No.115, Accounting for Certain Investments in
Debt and Equity Securities. Investments in U.S. Treasury bills, notes and municipal bonds are
classified as available for sale securities and unrealized gains or losses, net of related tax
effects, are reported 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, 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 liabilities, approximate their fair values based on their short maturities, independent
valuations or internal assessments. As of June 30, 2009 there was no material impact on the
condensed consolidated financial statements upon adoption of SFAS No.157, Fair Value Measurements
(SFAS 157), for non-financial assets and liabilities.
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 recognizes revenue from these sources in
accordance with Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition (SAB 104), Emerging
Issues Task Force (EITF) No. 99-19, Reporting Revenue Gross as a Principal Versus Net as an Agent
(EITF 99-19), and EITF No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables
(EITF 00-21).
The Company evaluated the multiple deliverables within the collaboration and license
agreements in accordance with the provisions of EITF 00-21 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
Abbott and Takeda 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 actual
cost expended in that period 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 are
supported by an invoice or final contract with a vendor. 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 with related parties 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 as per the terms of the contract.
Based on the guidance of EITF 99-19, 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 (loss) income.
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 and cash equivalents, restricted cash and investments with highly rated
financial institutions. As of June 30, 2009 and December 31, 2008, approximately $63.0 million, or
47.8%, 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 (the ARS broker) obligate the ARS broker
to purchase the remaining auction rate security 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 having to sell the remaining security in order to operate its business before
the expected redemption date.
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 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.
7
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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 entered into with Takeda, Abbott and R-Tech.
Revenues from one unrelated party, Takeda, accounted for 79% and 100%, of the Companys total
revenues for the three months ended June 30, 2009 and June 30, 2008, respectively, and 88% and 100%
for the six months ended June 30, 2009 and 2008, respectively. Accounts receivable, unbilled
accounts receivable and product royalties receivable from Takeda accounted for 97% of the Companys
total accounts receivable, unbilled accounts receivable and product royalties receivable at June
30, 2009 and December 31, 2008. Revenues from another unrelated party, Abbott, accounted for 20% of
the Companys total revenues for the three months ended June 30, 2009 and 12% for the six months
ended June 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 (SAG) to
grant the Company a royalty-bearing, exclusive, worldwide license to develop prostone compounds,
including Amitiza and cobiprostone. 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 ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements (EITF 07-1). The consensus prohibits the equity method of accounting for collaborative
arrangements under APB 18, The Equity Method of Accounting for Investments in Common Stock, unless
a legal entity exists. Payments between the collaborative partners will be 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 in EITF 07-1 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 EITF 07-1 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 Financial Staff Positions (FSP), SFAS No.157-2, Effective
Date of FASB Statement No. 157, (FSP 157-2), which delays the effective date of SFAS 157, for all
nonfinancial assets and nonfinancial liabilities, except those that are recognized or disclosed at
fair value in the financial statements on a recurring basis. FSP 157-2 partially defers the
effective date of SFAS 157 to fiscal years beginning after November 15, 2008. The Company adopted
the provisions of FSP 157-2 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 FSP FAS No. 157-3, Determining the Fair Value of a Financial
Asset in a Market That is Not Active (FSP FAS 157-3). FSP FAS 157-3 clarifies the application of
SFAS 157 in a market that is not active. FSP FAS 157-3 addresses how management should consider
measuring fair value when relevant observable data does not exist. FSP FAS 157-3 also provides
guidance on 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. FSP FAS 157-3 is
effective upon issuance, for companies that have adopted SFAS 157. Revisions resulting from a
change in the valuation technique or its application shall be accounted for as a change in
accounting estimate in accordance with SFAS 154, Accounting Changes and Error Corrections. The
application of the provisions of FSP FAS 157-3 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 April 2009, the FASB issued FSP FAS 157-4, Determining Fair Value when the Volume and Level
of Activity for the Asset or Liability have Significantly Decreased and Identifying Transactions
that are not Orderly (FSP FAS 157-4). FSP FAS 157-4 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. FSP FAS 157-4 provides guidance for 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. FSP FAS 157-4 will become effective for interim
and annual periods ending after June 15, 2009, with early adoption permitted for periods ending
after March 15, 2009. FSP FAS 157-4 applies to all fair value measurements when appropriate. The
Company adopted the provisions of FSP FAS 157-4 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 SFAS No. 165, Subsequent Events, (SFAS 165). SFAS 165
establishes general standards of accounting for and disclosure of events that occur after the
balance sheet date but before financial statements are issued. SFAS 165 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 SFAS 165 effective April 2009 and such adoption did not have a material impact on the condensed
consolidated financial statements.
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R), (SFAS
167), which amends the consolidation guidance applicable to variable interest entities (VIEs). The
amendments to the consolidation guidance affect all entities currently within the scope of FIN
46(R), as well as qualifying special-purpose entities (QSPEs) that are currently excluded from the
scope of FIN 46(R). SFAS 167 is effective for the Company as of January 1, 2010. The Company is
continuing to evaluate the impact that SFAS 167 would have on its financial condition and results
of operation upon adoption.
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards Codification and the
Hierarchy of Generally Accepted Accounting Principles a replacement of FASB Statement No.162,
(SFAS 168). The FASB Accounting Standards Codification, or Codification, will become the source of
authoritative U.S. GAAP recognized by the FASB applicable to non-governmental entities. Rules and
interpretive releases of the SEC under authority of federal securities laws are also sources of
authoritative GAAP for SEC registrants. On the effective date of this Statement, the Codification
will supersede all then-existing non-SEC accounting and reporting standards. All other
non-grandfathered non-SEC accounting literature not included in the Codification will no longer be
authoritative. SFAS 168 is effective for the Company in the third quarter of 2009 and is not
expected to have a material effect on the condensed consolidated financial statements.
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.
The computation of net income (loss) per share for the three and six months ended June 30,
2009 and 2008 is shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
(In thousands, except per share data) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Basic net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(238 |
) |
|
$ |
29,876 |
|
|
$ |
(2,013 |
) |
|
$ |
30,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares outstanding |
|
|
41,844 |
|
|
|
41,757 |
|
|
|
41,844 |
|
|
|
41,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share |
|
$ |
(0.01 |
) |
|
$ |
0.72 |
|
|
$ |
(0.05 |
) |
|
$ |
0.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(238 |
) |
|
$ |
29,876 |
|
|
$ |
(2,013 |
) |
|
$ |
30,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares outstanding for
diluted net income per share |
|
|
41,844 |
|
|
|
41,757 |
|
|
|
41,844 |
|
|
|
41,745 |
|
Assumed exercise of stock options
under the treasury stock method |
|
|
|
|
|
|
281 |
|
|
|
|
|
|
|
281 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,844 |
|
|
|
42,038 |
|
|
|
41,844 |
|
|
|
42,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share |
|
$ |
(0.01 |
) |
|
$ |
0.71 |
|
|
$ |
(0.05 |
) |
|
$ |
0.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
For the periods listed above, the potentially dilutive securities used in the calculations of
diluted historical net income per share as of June 30, 2009 and 2008 are as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Employee stock options |
|
|
|
|
|
|
583 |
|
Non-employee stock options |
|
|
|
|
|
|
470 |
|
For the periods listed above, the following securities were excluded from the computation of
diluted net income per share as their effect would be anti-dilutive as of June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Employee stock options |
|
|
670 |
|
|
|
260 |
|
Non-employee stock options |
|
|
450 |
|
|
|
|
|
4. Current and Non-Current Investments
At June 30, 2009 and December 31, 2008, current and non-current available-for-sale investments
consisted of the following securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2009 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills and notes |
|
$ |
23,991 |
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
23,994 |
|
Money market funds |
|
|
186 |
|
|
|
|
|
|
|
|
|
|
|
186 |
|
Municipal securities |
|
|
19,585 |
|
|
|
|
|
|
|
(1 |
) |
|
|
19,584 |
|
U.S. government agencies |
|
|
21,413 |
|
|
|
11 |
|
|
|
(2 |
) |
|
|
21,422 |
|
U.S. corporate commercial paper |
|
|
3,248 |
|
|
|
1 |
|
|
|
|
|
|
|
3,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
68,423 |
|
|
$ |
15 |
|
|
$ |
(3 |
) |
|
$ |
68,435 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Municipal securities |
|
$ |
10,821 |
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
10,824 |
|
U.S. government agencies |
|
|
1,071 |
|
|
|
2 |
|
|
|
|
|
|
|
1,073 |
|
Auction rate securities |
|
|
10,000 |
|
|
|
|
|
|
|
(567 |
) |
|
|
9,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
21,892 |
|
|
$ |
5 |
|
|
$ |
(567 |
) |
|
$ |
21,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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). On April 29,
2009, one ARS was redeemed by the issuer at par for $9.4 million.
10
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
disclosure requirements of SFAS 157, at June 30, 2009 and December 31, 2008, respectively, were as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Unobservable |
|
|
Total as of |
|
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
June 30, |
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2009 |
|
U.S. Treasury bills and notes |
|
$ |
23,994 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
23,994 |
|
U.S. government agencies |
|
|
22,495 |
|
|
|
|
|
|
|
|
|
|
|
22,495 |
|
U.S. corporate commercial paper |
|
|
|
|
|
|
3,249 |
|
|
|
|
|
|
|
3,249 |
|
Municipal securities |
|
|
30,408 |
|
|
|
|
|
|
|
|
|
|
|
30,408 |
|
Auction rate securities |
|
|
|
|
|
|
|
|
|
|
9,433 |
|
|
|
9,433 |
|
Settlement rights for auction rate securities* |
|
|
|
|
|
|
|
|
|
|
456 |
|
|
|
456 |
|
Money market funds |
|
|
186 |
|
|
|
|
|
|
|
|
|
|
|
186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
77,083 |
|
|
$ |
3,249 |
|
|
$ |
9,889 |
|
|
$ |
90,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Unobservable |
|
|
Total as of |
|
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
December 31, |
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2008 |
|
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 |
|
Other available-for-sale securities |
|
|
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 SFAS 157 during the six months
ended June 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 |
|
Settlements |
|
|
(9,400 |
) |
|
|
|
|
Balance at June 30, 2009 |
|
$ |
9,889 |
|
|
|
|
|
5. Accrued Expenses
Accrued expenses consisted of the following as of:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Research and development costs |
|
$ |
6,627 |
|
|
$ |
7,086 |
|
Employee compensation |
|
|
913 |
|
|
|
1,748 |
|
Selling and marketing costs |
|
|
90 |
|
|
|
346 |
|
Product royalty liability related party |
|
|
1,584 |
|
|
|
|
|
Other accrued expenses |
|
|
1,556 |
|
|
|
584 |
|
|
|
|
|
|
|
|
Total |
|
$ |
10,770 |
|
|
$ |
9,764 |
|
|
|
|
|
|
|
|
11
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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 $148,000, were as follows as of
June 30, 2009:
|
|
|
|
|
(In thousands) |
|
|
|
|
2009 (July-December) |
|
$ |
753 |
|
2010 |
|
|
1,143 |
|
2011 |
|
|
1,002 |
|
2012 |
|
|
963 |
|
2013 |
|
|
992 |
|
2014 and thereafter |
|
|
3,297 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
8,150 |
|
|
|
|
|
Rent expense for all operating leases was $341,000 and $292,000 for the three months ended
June 30, 2009 and 2008, respectively, and $642,000 and $577,000 for the six months ended June 30,
2009 and 2008, respectively.
Research and Development Costs
The Company routinely enters into agreements with third-party clinical research organizations
(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 2011 under these agreements as of June 30, 2009 were
approximately $13.5 million.
7. Related Party Transactions
R-Tech Ueno, Ltd.
The Company is a party to multiple exclusive license and supply agreements with R-Tech. 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.
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.
The Company recorded the following expenses under its agreements with R-Tech:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Clinical supplies |
|
$ |
577 |
|
|
$ |
127 |
|
|
$ |
1,620 |
|
|
$ |
515 |
|
Other research and development services |
|
|
3,034 |
|
|
|
39 |
|
|
|
3,039 |
|
|
|
49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,611 |
|
|
$ |
166 |
|
|
$ |
4,659 |
|
|
$ |
564 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Deferred revenue, current |
|
$ |
430 |
|
|
$ |
419 |
|
Deferred revenue, non current |
|
|
6,449 |
|
|
|
6,444 |
|
|
|
|
|
|
|
|
|
|
$ |
6,879 |
|
|
$ |
6,863 |
|
|
|
|
|
|
|
|
The Company recognized approximately $105,000 of deferred revenue relating to its agreements
with R-Tech for each of the three months ended June 30, 2009 and 2008 and approximately $209,000
for the six months ended June 30, 2009 and 2008, which was recorded as contract and collaboration
revenue in the accompanying condensed consolidated statements of operations and comprehensive
(loss) income.
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 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 $81,500 as of June 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 $57,000 for the six months ended June 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.
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 Sucampo AG (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 $1.6 million and $1.9 million in product royalties
related parties under the license agreement with SAG for the three months ended June 30, 2009 and
2008, respectively, and approximately $3.2 million and $3.0 million for the six months ended June
30, 2009 and 2008, respectively, reflecting 3.2% of Amitiza net sales during each of these periods.
13
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Company is also required to pay additional milestone payments to SAG, including 5% of
milestone payments received under any sublicensing agreements for Amitiza.
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 a 15-year license, commercialization and supply
agreement with Abbott to develop and commercialize lubiprostone for the treatment of chronic
idiopathic constipation (CIC) in Japan. The agreement grants Abbott exclusive rights to
commercialize lubiprostone in Japan for the treatment of CIC and also 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 responsible 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. Abbott shall procure finished product ready for commercial sale from the Company
at agreed-upon prices.
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.
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. The Company is potentially
entitled to receive additional development milestone payments and commercial milestone payments
under this agreement although there can be no assurances that the Company will receive any such
payments.
14
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The following table summarizes the cash streams and related revenue recognized under the
license, commercialization and supply agreement with Abbott for the six months ended June 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
Foreign |
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
Currency Effects |
|
|
|
|
|
|
Amount |
|
|
Six Months |
|
|
Six Months |
|
|
for the Six |
|
|
Amount |
|
|
|
Deferred at |
|
|
Ended |
|
|
Ended |
|
|
Months Ended |
|
|
Deferred at |
|
|
|
December 31, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2009 |
|
|
2009 |
|
|
2009 |
|
|
2009 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment associated with
the Companys obligation to
participate in joint
commercialization and steering
committee with Abbott |
|
$ |
|
|
|
$ |
677 |
|
|
$ |
16 |
|
|
$ |
23 |
|
|
$ |
638 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment |
|
$ |
|
|
|
$ |
9,323 |
|
|
$ |
2,136 |
|
|
$ |
349 |
|
|
$ |
6,838 |
|
Development milestone payment |
|
|
|
|
|
|
7,500 |
|
|
|
1,808 |
|
|
|
(72 |
) |
|
|
5,764 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
16,823 |
|
|
$ |
3,944 |
|
|
$ |
277 |
|
|
$ |
12,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 June 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.
The following table summarizes the cash streams and related revenue recognized under the
collaboration and license agreements with Takeda for the six months ended June 30, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
Change in |
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
Accounts |
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
Receivable |
|
|
|
|
|
|
Amount |
|
|
Six Months |
|
|
Six Months |
|
|
for the Six |
|
|
Amount |
|
|
|
Deferred at |
|
|
Ended |
|
|
Ended |
|
|
Months Ended |
|
|
Deferred at |
|
|
|
December 31, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2009 |
|
|
2009 |
|
|
2009* |
|
|
2009 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment associated with
the Companys obligation to
participate in joint committees
with Takeda |
|
$ |
1,764 |
|
|
$ |
|
|
|
$ |
74 |
|
|
$ |
|
|
|
$ |
1,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of research and
development expenses |
|
$ |
14,755 |
|
|
$ |
6,243 |
|
|
$ |
8,977 |
|
|
$ |
(754 |
) |
|
$ |
11,267 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
|
|
|
$ |
18,672 |
|
|
$ |
17,860 |
|
|
$ |
(812 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promotion revenue |
|
$ |
|
|
|
$ |
2,086 |
|
|
$ |
2,140 |
|
|
$ |
54 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Includes billed and unbilled accounts receivable. |
15
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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 scope and the timing of the audit
have not yet been agreed.
9. Stock Option Plan
The following table summarizes the employee stock option activity for the six months ended
June 30, 2009 under the Companys 2001 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise Price |
|
|
Contractual |
|
|
Intrinsic |
|
(In thousands, except share and per share data) |
|
Shares |
|
|
Per Share |
|
|
Term (Years) |
|
|
Value |
|
Options outstanding, December 31, 2008 |
|
|
455,600 |
|
|
$ |
10.34 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(850 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(7,650 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, June 30, 2009 |
|
|
447,100 |
|
|
|
10.34 |
|
|
|
3.74 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, June 30, 2009 |
|
|
447,100 |
|
|
|
10.34 |
|
|
|
3.74 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the employee stock option activity for the six months ended
June 30, 2009 under the Companys 2006 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise Price |
|
|
Contractual |
|
|
Intrinsic |
|
(In thousands, except share and per share data) |
|
Shares |
|
|
Per Share |
|
|
Term (Years) |
|
|
Value |
|
Options outstanding, December 31, 2008 |
|
|
275,000 |
|
|
$ |
13.86 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
30,000 |
|
|
|
6.45 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(46,750 |
) |
|
|
13.38 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(2,000 |
) |
|
|
14.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, June 30, 2009 |
|
|
256,250 |
|
|
|
13.08 |
|
|
|
6.48 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, June 30, 2009 |
|
|
118,250 |
|
|
|
14.34 |
|
|
|
4.98 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant date fair value of options granted during the six months ended June
30, 2009 and the year ended December 31, 2008 were $3.52 and $5.88, respectively. As of June 30,
2009, approximately $688,000 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 2.03 years.
The following table summarizes the non-employee stock option activity for the six months ended
June 30, 2009 under the Companys 2001 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise Price |
|
|
Contractual |
|
|
Intrinsic |
|
(In thousands, except share and per share data) |
|
Shares |
|
|
Per Share |
|
|
Term (Years) |
|
|
Value |
|
Options outstanding, December 31, 2008 |
|
|
450,000 |
|
|
$ |
5.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, June 30, 2009 |
|
|
450,000 |
|
|
|
5.85 |
|
|
|
5.84 |
|
|
$ |
216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, June 30, 2009 |
|
|
450,000 |
|
|
|
5.85 |
|
|
|
5.84 |
|
|
$ |
216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No non-employee stock options were exercised, forfeited or expired during the six months ended
June 30, 2009.
Employee Stock Purchase Plan
Under the 2006 Employee Stock Purchase Plan (ESPP), a total of 1,526 shares of class A common
stock were purchased during the six months ended June 30, 2009. The ESPP 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 SFAS No. 123(R) and this plan is non-compensatory. The Company received $8,910
upon purchase of shares under the ESPP for the six months ended June 30, 2009.
16
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
10. Income Taxes
For the three months ended June 30, 2009 and 2008, the Company recorded a tax provision of
$863,000 and $14.6 million, respectively. For the six months ended June 30, 2009 and 2008, the
Company recorded a tax provision of $1.3 million and $8.9 million, respectively. The tax provision
for the three and six months ended June 30, 2009 primarily pertained to taxable income generated by
the Companys U.S. subsidiary. The Companys other subsidiaries based in Japan and Europe incurred
pre-tax losses for the six months ended June 30, 2009, for which no tax benefit was recognized. The
tax provision recorded for the six months ended June 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.
As required under Accounting Principles Board Opinion (APB) No. 28, Interim Financial
Reporting, 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 provisions of FASB Interpretation (FIN) No. 48, Accounting for
Uncertainty in Income Taxes (FIN 48). FIN 48 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 $570,780 for uncertain tax
positions as of June 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 June 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.
17
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
11. Segment Reporting
The Company has determined that it has three reportable geographic 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 June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
3,825 |
|
|
$ |
|
|
|
$ |
3,570 |
|
|
$ |
|
|
|
$ |
7,395 |
|
Product royalty revenue |
|
|
8,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,914 |
|
Co-promotion revenue |
|
|
1,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,244 |
|
Contract and collaboration revenue |
|
|
142 |
|
|
|
|
|
|
|
220 |
|
|
|
(210 |
) |
|
|
152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
14,125 |
|
|
|
|
|
|
|
3,790 |
|
|
|
(210 |
) |
|
|
17,705 |
|
Depreciation and amortization |
|
|
182 |
|
|
|
3 |
|
|
|
2 |
|
|
|
|
|
|
|
187 |
|
Other operating expenses |
|
|
12,018 |
|
|
|
479 |
|
|
|
4,274 |
|
|
|
(210 |
) |
|
|
16,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
1,982 |
|
|
|
(482 |
) |
|
|
(486 |
) |
|
|
|
|
|
|
1,014 |
|
Interest income |
|
|
292 |
|
|
|
|
|
|
|
(1 |
) |
|
|
(72 |
) |
|
|
219 |
|
Other non-operating expense, net |
|
|
(36 |
) |
|
|
(334 |
) |
|
|
(310 |
) |
|
|
72 |
|
|
|
(608 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
2,238 |
|
|
$ |
(816 |
) |
|
$ |
(797 |
) |
|
$ |
|
|
|
$ |
625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
3,068 |
|
|
$ |
3 |
|
|
$ |
29 |
|
|
$ |
|
|
|
$ |
3,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
55,436 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
55,436 |
|
Product royalty revenue |
|
|
10,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,901 |
|
Co-promotion revenue |
|
|
1,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,236 |
|
Contract and collaboration revenue |
|
|
141 |
|
|
|
|
|
|
|
210 |
|
|
|
(210 |
) |
|
|
141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
67,714 |
|
|
|
|
|
|
|
210 |
|
|
|
(210 |
) |
|
|
67,714 |
|
Depreciation and amortization |
|
|
108 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
110 |
|
Other operating expenses |
|
|
20,561 |
|
|
|
584 |
|
|
|
2,768 |
|
|
|
(210 |
) |
|
|
23,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
47,045 |
|
|
|
(584 |
) |
|
|
(2,560 |
) |
|
|
|
|
|
|
43,901 |
|
Interest income |
|
|
590 |
|
|
|
1 |
|
|
|
|
|
|
|
(26 |
) |
|
|
565 |
|
Other non-operating expense, net |
|
|
(6 |
) |
|
|
(32 |
) |
|
|
(1 |
) |
|
|
26 |
|
|
|
(13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
47,629 |
|
|
$ |
(615 |
) |
|
$ |
(2,561 |
) |
|
$ |
|
|
|
$ |
44,453 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
128 |
|
|
$ |
|
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
Americas |
|
|
Europe |
|
|
Asia |
|
|
Eliminations |
|
|
Consolidated |
|
Six Months Ended June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
8,977 |
|
|
$ |
|
|
|
$ |
3,944 |
|
|
$ |
|
|
|
$ |
12,921 |
|
Product royalty revenue |
|
|
17,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,860 |
|
Co-promotion revenue |
|
|
2,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,140 |
|
Contract and collaboration revenue |
|
|
283 |
|
|
|
|
|
|
|
435 |
|
|
|
(420 |
) |
|
|
298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
29,260 |
|
|
|
|
|
|
|
4,379 |
|
|
|
(420 |
) |
|
|
33,219 |
|
Depreciation and amortization |
|
|
299 |
|
|
|
6 |
|
|
|
4 |
|
|
|
|
|
|
|
309 |
|
Other operating expenses |
|
|
26,476 |
|
|
|
959 |
|
|
|
7,446 |
|
|
|
(420 |
) |
|
|
34,461 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
2,542 |
|
|
|
(965 |
) |
|
|
(3,071 |
) |
|
|
|
|
|
|
(1,494 |
) |
Interest income |
|
|
651 |
|
|
|
|
|
|
|
2 |
|
|
|
(122 |
) |
|
|
531 |
|
Other non-operating income (expense), net |
|
|
208 |
|
|
|
(370 |
) |
|
|
254 |
|
|
|
122 |
|
|
|
214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
3,401 |
|
|
$ |
(1,335 |
) |
|
$ |
(2,815 |
) |
|
$ |
|
|
|
$ |
(749 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
3,195 |
|
|
$ |
3 |
|
|
$ |
29 |
|
|
$ |
|
|
|
$ |
3,227 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
61,546 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
61,546 |
|
Product royalty revenue |
|
|
16,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,981 |
|
Co-promotion revenue |
|
|
2,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,458 |
|
Contract and collaboration revenue |
|
|
283 |
|
|
|
|
|
|
|
417 |
|
|
|
(417 |
) |
|
|
283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
81,268 |
|
|
|
|
|
|
|
417 |
|
|
|
(417 |
) |
|
|
81,268 |
|
Depreciation and amortization |
|
|
208 |
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
212 |
|
Other operating expenses |
|
|
37,505 |
|
|
|
2,422 |
|
|
|
3,437 |
|
|
|
(420 |
) |
|
|
42,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
43,555 |
|
|
|
(2,422 |
) |
|
|
(3,024 |
) |
|
|
3 |
|
|
|
38,112 |
|
Interest income |
|
|
1,246 |
|
|
|
5 |
|
|
|
3 |
|
|
|
(47 |
) |
|
|
1,207 |
|
Other non-operating income (expense), net |
|
|
(33 |
) |
|
|
(13 |
) |
|
|
1 |
|
|
|
44 |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
44,768 |
|
|
$ |
(2,430 |
) |
|
$ |
(3,020 |
) |
|
$ |
|
|
|
$ |
39,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
299 |
|
|
$ |
|
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
302 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
2,168 |
|
|
$ |
41 |
|
|
$ |
121 |
|
|
$ |
|
|
|
$ |
2,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets |
|
$ |
141,350 |
|
|
$ |
1,857 |
|
|
$ |
17,350 |
|
|
$ |
(619 |
) |
|
$ |
159,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
In accordance with SFAS No. 165, Subsequent Events, management of the Company evaluated
subsequent events through August 7, 2009, the date the financial statements were issued.
19
|
|
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 Amitiza 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 maybe
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 $81,500 as of June 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.
20
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 and an entity 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, 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 measures.
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. Based on the results of these three
trials, we plan to file a supplemental new drug application for Amitiza in OBD with the FDA in
2010.
Results of recently completed phase 3 clinical trials of Amitiza for the treatment of OBD are
as follows:
|
|
|
In study OBD0631, which we refer to as the 631 trial, the primary endpoint of a
statistically significant change from baseline in the frequency of spontaneous bowel
movements, or SBMs, at week 8 of treatment was met when lubiprostone was compared to
placebo. Additionally, statistical significance was achieved for eight of the twelve
secondary endpoints, including key symptoms associated with OBD. Study OBD0632, or the 632
trial, 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 632 trial. Without comparing the results to placebo, 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 631 trial and from 1.60
to 4.10 SBMs in the 632 trial. The increase for placebo over their baseline was from 1.46
to 3.81 SBMs for the 631 trial and 1.60 to 3.95 SBMs for the 632 trial. |
|
|
|
There was a high rate of response in the placebo arm of the 632 trial. Approximately 58%
of subjects treated with placebo in the 632 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
the 631 and 632 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. |
21
In connection with our marketing approval of Amitiza for the treatment of chronic idiopathic
constipation 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
post-marketing studies with the FDA in May 2009. In connection with our marketing approval for
Amitiza for the treatment of irritable bowel syndrome with constipation 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 irritable bowel syndrome with
constipation 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. We currently are awaiting responses to our
marketing authorization applications for lubiprostone, 24 mcg, for the treatment of chronic
idiopathic constipation in adults filed in ten European countries in early 2008.
In September 2008, we announced positive results from our multi-center phase 2b dose-ranging
study in Japan to evaluate the safety and efficacy of lubiprostone for treating chronic idiopathic
constipation in adults. The results enabled us to enter into the license agreement with Abbott in
Japan.
In May 2009, we initiated enrollment and completed the randomization of the first patients
into the pivotal phase 3 efficacy trial and an open-label phase 3 safety trial of lubiprostone for
chronic idiopathic constipation 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-induced ulcers, or NSAID, and the treatment of non-alcoholic fatty liver disease. 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 non-steroidal
anti-inflammatory drug-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 at 12 sites in the U.S. were enrolled 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.
22
Overall, the data showed cobiprostone was well tolerated in patients receiving NSAID therapy.
SPI-017. We are conducting pre-clinical development of 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. We commenced phase 1
clinical trials of the intravenous formulation of SPI-017 in December 2008 in Japan.
Results of Operations
Comparison of three months ended June 30, 2009 and June 30, 2008
Revenues
The following table summarizes our revenues for the three months ended June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Research and development revenue |
|
$ |
7,395 |
|
|
$ |
55,436 |
|
Product royalty revenue |
|
|
8,914 |
|
|
|
10,901 |
|
Co-promotion revenue |
|
|
1,244 |
|
|
|
1,236 |
|
Contract and collaboration revenue |
|
|
152 |
|
|
|
141 |
|
|
|
|
|
|
|
|
Total |
|
$ |
17,705 |
|
|
$ |
67,714 |
|
|
|
|
|
|
|
|
Total revenues were $17.7 million for the three months ended June 30, 2009 compared to $67.7
million for the three months ended June 30, 2008, a decrease of $50.0 million or 73.9%.
Research and development revenue was $7.4 million for the three months ended June 30, 2009
compared to $55.4 million for the three months ended June 30, 2008, a decrease of $48.0 million or
86.7%. 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 irritable bowel syndrome
with constipation in adult women and due to reduced revenue recognized in respect to the pediatric,
renal, hepatic and OBD trials for Amitiza in the U. S. funded by Takeda. The decrease was offset in
part by $3.9 million in revenue recognized from the initial upfront payment and development
milestone payment received under the agreement with Abbott in Japan. We are recognizing the revenue
from the upfront and development milestone payments from Abbott in Japan using a
percentage-of-completion model over the term of the CIC development program.
Product royalty revenue represents royalty revenue earned on net sales of Amitiza in the
United States. For the three months ended June 30, 2009 and 2008, we recognized $8.9 million and
$10.9 million, respectively, of product royalty revenue, a decrease of $2.0 million or 18.2%. The
decrease was primarily due to the product royalty revenue of approximately $1.9 million recognized
from initial stockings of Amitiza 8 mcg for irritable bowel syndrome with constipation in April
2008.
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 June 30, 2009 and 2008, we recognized $1.2 million of co-promotion revenues for
reimbursement of sales force costs.
23
Research and Development Expenses
The following summarizes our research and development expenses for the three months ended June
30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Direct costs: |
|
|
|
|
|
|
|
|
Amitiza |
|
$ |
7,579 |
|
|
$ |
10,040 |
|
Cobiprostone |
|
|
687 |
|
|
|
1,276 |
|
SPI - 017 |
|
|
679 |
|
|
|
937 |
|
Rescula |
|
|
58 |
|
|
|
|
|
Other |
|
|
110 |
|
|
|
164 |
|
|
|
|
|
|
|
|
Total |
|
|
9,113 |
|
|
|
12,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
508 |
|
|
|
514 |
|
|
|
|
|
|
|
|
Total |
|
$ |
9,621 |
|
|
$ |
12,931 |
|
|
|
|
|
|
|
|
Total research and development expenses for the three months ended June 30, 2009 were $9.6
million compared to $12.9 million for the three months ended June 30, 2008, a decrease of $3.3
million or 25.6%. The decrease was primarily due to the completion 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 and the completion of the phase 2 trial of cobiprostone for the prevention
of non-steroidal anti-inflammatory drug-induced ulcers, partially offset 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 three months ended
June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Salaries, benefits and related costs |
|
$ |
751 |
|
|
$ |
1,206 |
|
Legal and consulting expenses |
|
|
911 |
|
|
|
595 |
|
Other operating expenses |
|
|
1,262 |
|
|
|
1,760 |
|
|
|
|
|
|
|
|
Total |
|
$ |
2,924 |
|
|
$ |
3,561 |
|
|
|
|
|
|
|
|
General and administrative expenses were $2.9 million for the three months ended June 30,
2009, compared to $3.6 million for the three months ended June 30, 2008, a decrease of $637,000 or
17.9%. 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 associated primarily with
preparation of a performance audit under our contract with Takeda.
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 $2.2 million for the three months ended June 30, 2009, compared to $2.9
million for the three months ended June 30, 2008, a decrease of $682,000 or 23.8%. The decrease was
primarily due to streamlined commercial operations and a reduction in market research expenses.
Milestone Royalties Related Parties
Milestone royalties related parties expense was $375,000 for the three months ended June 30,
2009, reflecting the 5% royalty payment we owed to SAG as a result of the $7.5 million development
milestone payment we received from Abbott for the initiation of the first phase 3 study in Japan.
We expensed $2.5 million for the three months ended June 30, 2008, reflecting the 5% royalty
payment to SAG as a result of the $50.0 million development milestone payment we received from
Takeda.
24
Product Royalties Related Parties
Product royalties related parties expense, representing 3.2% of Amitiza net sales for the
respective periods payable to SAG, decreased to $1.6 million for the three months ended June 30,
2009 from $2.0 million for the three months ended June 30, 2008, proportionally with the decrease
of product royalty revenue.
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the three months ended
June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Interest income |
|
$ |
219 |
|
|
$ |
565 |
|
Other expense, net |
|
|
(608 |
) |
|
|
(13 |
) |
|
|
|
|
|
|
|
Total non-operating income (expense), net |
|
$ |
(389 |
) |
|
$ |
552 |
|
|
|
|
|
|
|
|
Interest income was $219,000 for the three months ended June 30, 2009, compared to $565,000
for the three months ended June 30, 2008, a decrease of $346,000, or 61.2%. The decrease was
primarily due to lower prevailing interest rates earned by our investments in U.S. Treasury funds,
notes and money market securities during the three months ended June 30, 2009 as compared to three
months ended June 30, 2008. The other expense, net was primarily attributable to foreign exchange
gains and losses.
Income Taxes
We recorded a tax provision of $863,000 and $14.6 million for the three months ended June 30,
2009 and 2008, respectively. The tax provision for the three months ended June 30, 2009 mainly
pertained to taxable income generated by our U.S. subsidiary. Our other subsidiaries based in Japan
and Europe incurred pre-tax losses for the three months ended June 30, 2009, for which no tax
benefit was recognized. The tax provision recorded for the three months ended June 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 revenues. As of June 30, 2009, we had an outstanding non-current income tax
liability of $570,780 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 June 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 six months ended June 30, 2009 and June 30, 2008
Revenues
The following table summarizes our revenues for the six months ended June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Research and development revenue |
|
$ |
12,921 |
|
|
$ |
61,546 |
|
Product royalty revenue |
|
|
17,860 |
|
|
|
16,981 |
|
Co-promotion revenue |
|
|
2,140 |
|
|
|
2,458 |
|
Contract and collaboration revenue |
|
|
298 |
|
|
|
283 |
|
|
|
|
|
|
|
|
Total |
|
$ |
33,219 |
|
|
$ |
81,268 |
|
|
|
|
|
|
|
|
Total revenues were $33.2 million for the six months ended June 30, 2009, compared to $81.3
million for the six months ended June 30, 2008, a decrease of $48.1 million or 59.1%.
Research and development revenue was $12.9 million for the six months ended June 30, 2009,
compared to $61.5 million for the six months ended June 30, 2008, a decrease of $48.6 million or
79.0%. 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 irritable bowel syndrome
with constipation in adult women and to reduced revenue recognized in respect to the pediatric,
renal, hepatic and OBD trials for Amitiza funded by Takeda, offset in part by $3.9 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 in Japan.
25
For the six months ended June 30, 2009 and 2008, we recognized $17.9 million and $17.0
million, respectively, of product royalty revenue, an increase of $900,000 or 5.2%. The increase
reflects primarily the sales of Amitiza, 8 mcg, for the treatment of irritable bowel syndrome with
constipation in adult women, following its approval by the FDA in April 2008.
For the six months ended June 30, 2009 and 2008, we recognized $2.1 million and $2.5 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 six months ended June 30, 2009 reflects this annual limit.
Research and Development Expenses
The following summarizes our research and development expenses for the six months ended June
30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Direct costs: |
|
|
|
|
|
|
|
|
AMITIZA |
|
$ |
14,350 |
|
|
$ |
19,026 |
|
Cobiprostone |
|
|
1,577 |
|
|
|
2,270 |
|
SPI - 017 |
|
|
2,316 |
|
|
|
1,616 |
|
Rescula |
|
|
58 |
|
|
|
|
|
Other |
|
|
254 |
|
|
|
299 |
|
|
|
|
|
|
|
|
Total |
|
|
18,555 |
|
|
|
23,211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
1,031 |
|
|
|
936 |
|
|
|
|
|
|
|
|
Total |
|
$ |
19,586 |
|
|
$ |
24,147 |
|
|
|
|
|
|
|
|
Total research and development expenses for the six months ended June 30, 2009 were $19.6
million, compared to $24.1 million for the six months ended June 30, 2008, a decrease of $4.5
million or 18.9%. During the six months ended June 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 six months ended June 30, 2009. The decrease
was also primarily due to the completion of the two phase 3 pivotal clinical trials for the
treatment of opioid-induced bowel dysfunction, the completion in 2008 of the trial related to
pediatric constipation for Amitiza and the completion of the phase 2 trial of cobiprostone for the
prevention of non-steroidal anti-inflammatory drug-induced ulcers, partially offset 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 six months ended June
30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Salaries, benefits and related costs |
|
$ |
1,909 |
|
|
$ |
2,121 |
|
Legal and consulting expenses |
|
|
1,989 |
|
|
|
1,249 |
|
Other operating expenses |
|
|
2,481 |
|
|
|
3,358 |
|
|
|
|
|
|
|
|
Total |
|
$ |
6,379 |
|
|
$ |
6,728 |
|
|
|
|
|
|
|
|
General and administrative expenses were $6.4 million for the six months ended June 30, 2009,
compared to $6.7 million for the six months ended June 30, 2008, a decrease of $300,000 or 5.2%.
The decrease in salaries, benefits and related costs was primarily attributable to a reduction in
force in January 2009. The increase in legal, consulting and other professional expenses was
primarily associated with the negotiation of our license agreement with Abbott and with preparation
for a performance audit under our contract with Takeda.
Selling and Marketing Expenses
Selling and marketing expenses were $4.7 million for the six months ended June 30, 2009,
compared to $5.7 million for the six months ended June 30, 2008, a decrease of $1.0 million or
17.8%. The decrease was primarily due to streamlined commercial operations and a reduction in
market research expenses.
26
Milestone Royalties Related Parties
Milestone royalties related parties expense was $875,000 for the six months ended June 30,
2009, compared to $3.5 million for the six months ending June 30, 2008. The milestone royalties of
$875,000 reflect the 5% royalty payment we owed 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 six months ended June 30, 2008 consist of $1.0 million
paid to SAG upon the filing of the European marketing authorization application, 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 $3.2 million for the six months ended June 30,
2009, from $3.0 million for the six months ended June 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 six months ended
June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Interest income |
|
$ |
531 |
|
|
$ |
1,207 |
|
Other income (expense), net |
|
|
214 |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
Total non-operating income, net |
|
$ |
745 |
|
|
$ |
1,206 |
|
|
|
|
|
|
|
|
Interest income was $531,000 for the six months ended June 30, 2009, compared to $1.2 million
for the six months ended June 30, 2008, a decrease of $676,000 or 56.0%. The decrease was primarily
due to lower prevailing interest rates earned by our investments in U.S. Treasury funds, notes and
money market securities during the six months ended June 30, 2009 as compared to the six months
ended June 30, 2008. The increase in other income was primarily attributable to foreign exchange
gains and fair value changes in auction rate securities, or ARS, and related settlement rights.
Income Taxes
We recorded a tax provision of $1.3 million and $8.9 million for the six months ended June 30,
2009 and 2008, respectively. The tax provision for the six months ended June 30, 2009 mainly
pertained to taxable income generated by our U.S. subsidiary. Our other subsidiaries based in Japan
and Europe incurred pre-tax losses for the six months ended June 30, 2009, for which no tax benefit
was recognized. The tax provision recorded for the six months ended June 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 June 30, 2009, we had an outstanding non-current income tax liability of
$570,780 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 June 30, 2009 was mainly a
result of our interpretation of nexus in certain states related to revenue sourcing for state
income tax purposes.
Cost Reduction Initiatives
To conserve cash and more closely align our spending towards our strategic objectives, we
implemented cost reduction initiatives in January 2009, including a workforce reduction and a
refocusing of our 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.
During the second quarter of 2009, we have 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.
27
The financial results of our segments reflect their varying stages of development. Our
Americas segment recorded income before taxes of $3.4 million for the six months ended June 30,
2009 compared to income before taxes of $44.8 million for the six months ended June 30, 2008,
reflecting the $50.0 million milestone payment from Takeda in the six months ended June 30, 2008.
Our segment in Europe recorded a loss before taxes of $1.3 for the six months ended June 30,
2009 compared to a loss before taxes of $2.4 million for the six months ended June 30, 2008,
reflecting the expenses incurred for the European regulatory approval and pre-commercialization
activities for Amitiza in Europe.
Our segment in Asia recorded a loss before taxes of $2.8 million for the six months ended June
30, 2009 as compared to a loss before taxes of $3.0 million during the six months ended June 30,
2008. These losses reflect the ongoing investment to plan and implement a phase 3 clinical program
for Amitiza and the ongoing preclinical programs for other prostone-based compounds.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
Americas |
|
|
Europe |
|
|
Asia |
|
|
Eliminations |
|
|
Consolidated |
|
Three Months Ended June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
14,125 |
|
|
$ |
|
|
|
$ |
3,790 |
|
|
$ |
(210 |
) |
|
$ |
17,705 |
|
Income (loss) before taxes |
|
|
2,238 |
|
|
|
(816 |
) |
|
|
(797 |
) |
|
|
|
|
|
|
625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
67,714 |
|
|
$ |
|
|
|
$ |
210 |
|
|
$ |
(210 |
) |
|
$ |
67,714 |
|
Income (loss) before taxes |
|
|
47,629 |
|
|
|
(616 |
) |
|
|
(2,560 |
) |
|
|
|
|
|
|
44,453 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
29,260 |
|
|
$ |
|
|
|
$ |
4,379 |
|
|
$ |
(420 |
) |
|
$ |
33,219 |
|
Income (loss) before taxes |
|
|
3,401 |
|
|
|
(1,335 |
) |
|
|
(2,815 |
) |
|
|
|
|
|
|
(749 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
81,268 |
|
|
$ |
|
|
|
$ |
417 |
|
|
$ |
(417 |
) |
|
$ |
81,268 |
|
Income (loss) before taxes |
|
|
44,767 |
|
|
|
(2,430 |
) |
|
|
(3,019 |
) |
|
|
|
|
|
|
39,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At June 30, 2009 |
|
$ |
141,350 |
|
|
$ |
1,857 |
|
|
$ |
17,350 |
|
|
$ |
(619 |
) |
|
$ |
159,938 |
|
At December 31, 2008 |
|
|
146,074 |
|
|
|
568 |
|
|
|
4,469 |
|
|
|
(317 |
) |
|
|
150,794 |
|
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:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Cash and cash equivalents |
|
$ |
41,737 |
|
|
$ |
11,536 |
|
Investments, current |
|
|
68,435 |
|
|
|
93,776 |
|
Investments, non-current |
|
|
21,330 |
|
|
|
16,222 |
|
|
|
|
|
|
|
|
|
|
$ |
131,502 |
|
|
$ |
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.
28
As of June 30, 2009, our short-term investments consisted of U.S. Treasury notes and bills,
money market funds, U.S. government agencies, U.S. corporate commercial paper and municipal
securities which have short-term maturities. Our non-current investments primarily consist of
municipal securities, U.S. government agencies and investments in ARS. 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 the expected redemption dates.
Cash Flows
The following table summarizes our cash flows for the six months ended June 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
11,013 |
|
|
$ |
50,601 |
|
Investing activities |
|
|
18,995 |
|
|
|
(50,156 |
) |
Financing activities |
|
|
9 |
|
|
|
475 |
|
Effect of exchange rates |
|
|
184 |
|
|
|
4 |
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
$ |
30,201 |
|
|
$ |
924 |
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2009
Net cash provided
by operating activities was $11.0 million for the six months ended June 30,
2009. This reflected a net loss of $2.0 million, which included a non-cash unrealized loss on
settlement rights of $2.4 million, offset in part by a $2.6 million unrealized gain on trading
securities, an increase in deferred revenue of $9.4 million, an increase in accrued expenses of
$1.0 million and a $936,000 increase in prepaid and income taxes receivable and payable, net. The
increase in deferred revenue primarily related to a $10.0 million upfront payment from Abbott upon
execution of the license and commercialization agreement by Sucampo Japan in February 2009 and a
$7.5 million development milestone payment from Abbott for the initiation of a phase 3 study in
Japan, offset by amortization of revenues in the period.
Net cash provided by investing activities of $19.0 million for the six months ended June 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 $9,000 for the six months ended June 30, 2009
resulted from the net proceeds we received under our employee stock purchase plan.
Six Months Ended June 30, 2008
Net cash provided by operating activities was $50.6 million for the six months ended June 30,
2008 and reflected net income of $30.4 million, an increase of $15.2 million in prepaid and income
taxes receivable and payable, net, and an increase of $9.5 million in deferred revenue, partially
offset by a non-cash reversal of deferred tax asset valuation allowances of $4.5 million.
Net cash used in investing activities of $50.1 million for the six months ended June 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 $475,000 for the six months ended June 30, 2008
primarily resulted from the net proceeds we received from the exercise of stock options.
Off-Balance Sheet Arrangements
We do 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.
29
Funding Requirements
We will need substantial amounts of capital to continue growing our business. We will 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 Amitiza; |
|
|
|
|
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 costs for 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 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; |
|
|
|
|
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 provisions of Statement of Financial Accounting Standards, or SFAS 157, Fair
Value Measurements, effective January 1, 2008 for our financial assets and liabilities and adopted
SFAS 157 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 SFAS 157 for non-financial assets and liabilities did not have a material impact on the
accompanying condensed consolidated financial statements.
For the six months ended June 30, 2009, we recorded a net $249,000 gain within other income,
net in the accompanying condensed consolidated statements of operations and comprehensive (loss)
income 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.
30
|
|
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 June 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 and cash equivalents, restricted cash and
investments with what we believe to be highly rated financial institutions. As of June 30, 2009 and
December 31, 2008, approximately 47.8% 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 June 30, 2009, we had $9.4 million invested in one non-mortgage related ARS. On April
29, 2009, one ARS was redeemed by the issuer at par for $9.4 million. Pursuant to the 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. In addition, given
the complexity of ARS and their valuations, our estimates of their fair value may differ from the
actual amount we would be able to collect at the time of redemption under the settlement rights
offer or ultimate sale.
|
|
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 June 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 June 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 June 30, 2009 that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
31
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.
Item 1A. Risk Factors
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 March 31, 2009, as filed with the SEC
on May 11, 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 and negotiate the scope of this performance audit. If we do not
come to terms with Takeda not only on the scope of this audit but 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 June 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 |
Our annual meeting of stockholders was held on May 28, 2009. Of the total number of common
shares outstanding on April 1, 2009, a total of 10,795,614 shares of class A common stock and a
total of 26,191,050 shares of class B common stock were represented in person or by proxy at the
meeting. Results of votes with respect to proposals submitted at the meeting are set forth below.
|
(a) |
|
To elect seven nominees to serve as directors and hold officer for a term of one year.
Our stockholders voted to elect all seven nominees to serve as directors. Votes recorded,
by nominee, were as follows: |
|
|
|
|
|
|
Nominee |
|
For |
|
Against/Withheld |
|
Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
272,698,755 |
|
7,359 |
|
Anthony C. Celeste |
|
272,705,378 |
|
736 |
|
Gayle R. Dolecek |
|
272,634,460 |
|
71,654 |
|
Andrew J. Ferrara |
|
272,705,452 |
|
662 |
|
Sachiko Kuno |
|
272,634,534 |
|
71,580 |
|
Timothy I. Maudlin |
|
272,705,452 |
|
662 |
|
John C. Wright |
|
272,705,378 |
|
736 |
|
|
(b) |
|
To consider and vote upon a proposal to ratify the selection of PricewaterhouseCoopers
LLP as our independent registered public accounting firm for the fiscal year ending
December 31, 2009. Votes recorded were as follows: |
|
|
|
|
|
For |
|
Against |
|
Abstain |
272,700,251 |
|
5,801 |
|
62 |
32
Item 6. Exhibits
(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*
|
|
Unoprostone Exclusive
Manufacturing and Supply
Agreement between R-Tech Ueno,
Ltd. and Sucampo Pharma Americas,
Inc.
|
|
Exhibit 10.1 to the
Companys Quarterly
Report on Form 10-Q for
the quarter ended March
31, 2009 (filed May 11,
2009) |
|
|
|
|
|
10.2*
|
|
Unoprostone NDA Transfer, Patent
and Know-how Licensing, and Data
Sharing Agreement between R-Tech
Ueno, Ltd. and Sucampo Pharma
Americas, Inc.
|
|
Exhibit 10.2 to the
Companys Quarterly
Report on Form 10-Q for
the quarter ended March
31, 2009 (filed May 11,
2009) |
|
|
|
|
|
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. |
33
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.
|
|
August 7, 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) |
|
|
|
|
August 7, 2009 |
By: |
/s/ JAN SMILEK
|
|
|
|
Jan Smilek |
|
|
|
Chief Financial Officer
(Principal Financial and Accounting
Officer) |
|
34
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*
|
|
Unoprostone Exclusive
Manufacturing and Supply
Agreement between R-Tech Ueno,
Ltd. and Sucampo Pharma Americas,
Inc.
|
|
Exhibit 10.1 to the
Companys Quarterly
Report on Form 10-Q for
the quarter ended March
31, 2009 (filed May 11,
2009) |
|
|
|
|
|
10.2*
|
|
Unoprostone NDA Transfer, Patent
and Know-how Licensing, and Data
Sharing Agreement between R-Tech
Ueno, Ltd. and Sucampo Pharma
Americas, Inc.
|
|
Exhibit 10.2 to the
Companys Quarterly
Report on Form 10-Q for
the quarter ended March
31, 2009 (filed May 11,
2009) |
|
|
|
|
|
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. |
35
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. |
|
I have reviewed this Quarterly Report on Form 10-Q of Sucampo Pharmaceuticals, Inc.; |
|
2. |
|
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. |
|
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. |
|
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: |
|
(a) |
|
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; |
|
|
(b) |
|
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; |
|
|
(c) |
|
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 |
|
|
(d) |
|
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. |
|
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): |
|
(a) |
|
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 |
|
|
(b) |
|
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. |
|
|
|
|
|
|
|
|
Date: August 7, 2009 |
/s/ RYUJI UENO
|
|
|
Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
|
Chief Executive Officer
(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. |
|
I have reviewed this Quarterly Report on Form 10-Q of Sucampo Pharmaceuticals, Inc.; |
|
2. |
|
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. |
|
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. |
|
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: |
|
(a) |
|
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; |
|
|
(b) |
|
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; |
|
|
(c) |
|
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 |
|
|
(d) |
|
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. |
|
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): |
|
(a) |
|
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 |
|
|
(b) |
|
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: August 7, 2009 |
/s/ JAN SMILEK
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Jan Smilek |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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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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(1) |
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The Quarterly Report on Form 10-Q for the period ended June 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: August 7, 2009 |
/s/ RYUJI UENO
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Ryuji Ueno, M.D., Ph.D., Ph.D. |
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Chief Executive Officer
(Principal Executive Officer) |
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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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(1) |
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The Quarterly Report on Form 10-Q for the period ended June 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: August 7, 2009 |
/s/ JAN SMILEK
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Jan Smilek |
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Chief Financial Officer
(Principal Financial and Accounting Officer) |
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