Form 10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2010
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-33609
SUCAMPO PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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30-0520478 |
(State or other jurisdiction of
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(I.R.S. employer |
incorporation or organization)
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identification no.) |
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4520 East-West Highway, Suite 300 |
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Bethesda, MD 20814
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(301) 961-3400 |
(Address of principal executive offices,
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(Registrants telephone number, |
including zip code)
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including area code) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes
þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No þ
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company. 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 May 4, 2010, there were 15,657,059 shares of the registrants class A common stock
outstanding and 26,191,050 shares of the registrants class B common stock outstanding.
Sucampo Pharmaceuticals, Inc.
Form 10-Q Index
PART I FINANCIAL INFORMATION
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Item 1. |
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Condensed Consolidated Financial Statements (Unaudited) |
SUCAMPO PHARMACEUTICALS, INC. Condensed Consolidated
Balance Sheets
(Unaudited)
(In thousands, except share data)
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March 31, |
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December 31, |
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2010 |
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2009 |
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ASSETS: |
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Current assets: |
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Cash and cash equivalents |
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$ |
31,185 |
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$ |
26,714 |
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Investments, current |
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60,631 |
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72,434 |
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Product royalties receivable |
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9,773 |
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11,023 |
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Unbilled accounts receivable |
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427 |
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644 |
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Accounts receivable, net |
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117 |
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512 |
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Prepaid and income tax receivable |
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86 |
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Deferred tax assets, net |
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105 |
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315 |
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Prepaid expenses and other current assets |
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2,513 |
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3,137 |
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Total current assets |
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104,837 |
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114,779 |
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Investments, non-current |
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25,093 |
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19,167 |
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Property and equipment, net |
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2,191 |
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2,242 |
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Deferred tax assets, non-current |
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4,078 |
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3,995 |
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Other assets |
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4,702 |
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4,788 |
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Total assets |
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$ |
140,901 |
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$ |
144,971 |
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LIABILITIES AND STOCKHOLDERS EQUITY: |
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Current liabilities: |
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Accounts payable |
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$ |
2,017 |
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$ |
3,195 |
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Accrued expenses |
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7,617 |
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6,545 |
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Deferred revenue, current |
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7,325 |
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10,565 |
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Income taxes payable |
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349 |
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Total current liabilities |
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16,959 |
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20,654 |
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Deferred revenue, non-current |
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8,427 |
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8,643 |
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Other liabilities |
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2,109 |
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2,121 |
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Total liabilities |
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27,495 |
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31,418 |
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Commitments (Note 7) |
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Stockholders equity: |
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Preferred stock, $0.01 par value; 5,000,000 shares authorized
at March 31, 2010 and December 31,
2009; no shares issued and outstanding
at March 31, 2010 and December 31, 2009 |
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Class A common stock, $0.01 par value; 270,000,000 shares
authorized at March 31, 2010 and
December 31, 2009; 15,657,059 and 15,655,730 shares issued
and outstanding at March 31, 2010 and
December 31, 2009 , respectively |
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156 |
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156 |
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Class B common stock, $0.01 par value; 75,000,000 shares
authorized at March 31, 2010 and
December 31, 2009; 26,191,050 shares
issued and outstanding at March 31, 2010
and December 31, 2009 |
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262 |
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262 |
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Additional paid-in capital |
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98,785 |
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98,636 |
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Accumulated other comprehensive income |
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487 |
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484 |
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Retained earnings |
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13,716 |
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14,015 |
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Total stockholders equity |
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113,406 |
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113,553 |
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Total liabilities and stockholders equity |
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$ |
140,901 |
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$ |
144,971 |
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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 |
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March 31, |
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2010 |
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2009 |
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Revenues: |
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Research and development revenue |
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$ |
4,057 |
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$ |
5,526 |
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Product royalty revenue |
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9,773 |
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8,946 |
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Co-promotion revenue |
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855 |
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896 |
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Contract and collaboration revenue |
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151 |
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146 |
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Total revenues |
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14,836 |
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15,514 |
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Operating expenses: |
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Research and development |
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5,366 |
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9,965 |
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General and administrative |
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5,759 |
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3,455 |
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Selling and marketing |
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2,187 |
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2,512 |
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Milestone royalties related parties |
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500 |
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Product royalties related parties |
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1,737 |
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1,590 |
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Total operating expenses |
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15,049 |
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18,022 |
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Loss from operations |
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(213 |
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(2,508 |
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Non-operating income (expense): |
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Interest income |
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211 |
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312 |
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Other income (expense), net |
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(92 |
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822 |
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Total non-operating income, net |
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119 |
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1,134 |
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Loss before income taxes |
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(94 |
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(1,374 |
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Income tax provision |
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(205 |
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(401 |
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Net loss |
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$ |
(299 |
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$ |
(1,775 |
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Net loss per share: |
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Basic net loss per share |
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$ |
(0.01 |
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$ |
(0.04 |
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Diluted net loss per share |
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$ |
(0.01 |
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$ |
(0.04 |
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Weighted average common shares outstanding basic |
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41,845 |
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41,844 |
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Weighted average common shares outstanding diluted |
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41,845 |
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41,844 |
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Comprehensive loss: |
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Net loss |
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$ |
(299 |
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$ |
(1,775 |
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Other comprehensive income loss: |
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Unrealized loss on investments, net of tax effect |
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(17 |
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(65 |
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Foreign currency translation |
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20 |
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(203 |
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Comprehensive loss |
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$ |
(296 |
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$ |
(2,043 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statement of Changes in Stockholders Equity
(Unaudited)
(In thousands, except share data)
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Accumulated |
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Class A |
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Class B |
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Additional |
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Other |
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Total |
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Common Stock |
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Common Stock |
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Paid-In |
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Comprehensive |
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Retained |
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Stockholders |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Income |
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Earnings |
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Equity |
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Balance at December 31, 2009 |
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15,655,730 |
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$ |
156 |
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26,191,050 |
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$ |
262 |
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$ |
98,636 |
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$ |
484 |
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$ |
14,015 |
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$ |
113,553 |
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Employee stock option expense |
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145 |
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145 |
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Stock issued under employee
stock purchase plan |
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1,329 |
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4 |
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4 |
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Foreign currency translation |
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20 |
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20 |
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Unrealized loss on
investments, net of tax
effect |
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(17 |
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(17 |
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Net loss |
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(299 |
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(299 |
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Balance at March 31, 2010 |
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15,657,059 |
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$ |
156 |
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26,191,050 |
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$ |
262 |
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$ |
98,785 |
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$ |
487 |
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$ |
13,716 |
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$ |
113,406 |
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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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Three Months Ended |
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March 31, |
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2010 |
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2009 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(299 |
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$ |
(1,775 |
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Adjustments to reconcile net loss to net cash provided by
(used in) operating activities: |
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Depreciation and amortization |
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228 |
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122 |
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Deferred tax provision |
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138 |
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394 |
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Stock-based compensation |
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145 |
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111 |
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Amortization of premiums on investments |
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461 |
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Unrealized gain on trading securities |
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(2,672 |
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Unrealized
loss on settlement rights on auction rate securities |
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2,423 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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395 |
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617 |
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Unbilled accounts receivable |
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217 |
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547 |
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Product royalties receivable |
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1,250 |
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780 |
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Prepaid and income taxes receivable and payable, net |
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(436 |
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(1,406 |
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Accounts payable |
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(1,178 |
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1,382 |
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Accrued expenses |
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1,078 |
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(811 |
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Deferred revenue |
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(3,461 |
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7,245 |
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Other assets and liabilities, net |
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607 |
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348 |
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Net cash provided by (used in) operating activities |
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(855 |
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7,305 |
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Cash flows from investing activities: |
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Purchases of investments |
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(21,028 |
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(47,202 |
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Proceeds from sales of investments |
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1,500 |
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Maturities of investments |
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24,917 |
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29,504 |
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Purchases of property and equipment |
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(94 |
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(127 |
) |
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Net cash
provided by (used in) investing activities |
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5,295 |
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(17,825 |
) |
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Cash flows from financing activities: |
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Proceeds from employee stock purchase plan |
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4 |
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5 |
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Net cash provided by financing activities |
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4 |
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5 |
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Effect of exchange rates on cash and cash equivalents |
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27 |
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(589 |
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Net increase in cash and cash equivalents |
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4,471 |
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(11,104 |
) |
Cash and cash equivalents at beginning of period |
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26,714 |
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62,562 |
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Cash and cash equivalents at end of period |
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$ |
31,185 |
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$ |
51,458 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. Business Organization and Basis of Presentation
Description of the Business
Sucampo Pharmaceuticals, Inc., or the Company, is an international biopharmaceutical company
focused on the discovery, development and commercialization of proprietary drugs based on
prostones. Prostones are a class of compounds occurring naturally in the human body by enzymatic,
15-PGDH, transformation of certain fatty acids. The Company is focused on developing prostones for
the treatment of gastrointestinal, ocular, respiratory, vascular and central nervous system
diseases and other disorders for which there are unmet or underserved medical needs and significant
commercial potential.
The therapeutic potential of prostones was first identified by one of the Companys founders,
Dr. Ryuji Ueno. To date, two prostone products have received marketing approval.
Amitiza® (lubiprostone) is a FDA-approved treatment for chronic idiopathic constipation,
or CIC, in adults of both genders and all ages and irritable bowel syndrome with constipation, or
IBS-C, in adult women. Rescula® (unoprostone isopropyl) is FDA-approved for the
treatment of open-angle glaucoma and ocular hypertension.
Amitiza is being marketed and developed in the U.S. for gastrointestinal indications under a
collaboration and license agreement with Takeda Pharmaceutical Company Limited, or Takeda. The
Company is primarily responsible for development activities under the agreement. The Company and
Takeda initiated commercial sales of Amitiza in the U.S. for the treatment of CIC in April 2006 and
for the treatment of IBS-C in May 2008 and Amitiza is currently being developed for the treatment
of opioid-induced bowel dysfunction, or OBD.
In Japan, lubiprostone is being developed under a license, commercialization and supply
agreement with Abbott Japan Co. Ltd., or Abbott. In April 2009, the Company acquired the rights to
Rescula that allow the Company to commercialize Rescula in the U.S. and Canada for the treatment of
glaucoma and ocular hypertension and any new indication developed by the Company.
The Company continues to evaluate the opportunities to obtain an appropriate label in the
European Union consistent with the fact that lubiprostone is the only product approved by the FDA
in the U.S. for chronic therapy for either CIC or IBS-C and received marketing authorization from
Swissmedic, the Swiss Agency for Therapeutic Products, in November 2009 for CIC.
Other prostone compounds in the Companys development plan include cobiprostone for the
prevention of gastric ulcers and other gastrointestinal injuries in patients treated with
non-steroidal anti-inflammatory drugs, or NSAIDs, for use as a treatment for chronic obstructive
pulmonary disease, or COPD, and as a potential treatment for wound healing. Additionally, the
Company is developing SPI-017 for peripheral arterial disease, or PAD, and SPI-3608 as a potential
treatment for spinal stenosis.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States, or GAAP, and the
rules and regulations of the Securities and Exchange Commission, or SEC, for interim financial
information. Accordingly, they do not include all of the information and footnotes required by GAAP
for complete financial statements and should be read in conjunction with the Companys consolidated
financial statements as of and for the year ended December 31, 2009 included in the Companys
Annual Report on Form 10-K. The financial information as of March 31, 2010 and for the three months
ended March 31, 2010 and 2009 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: Sucampo Pharma Ltd., based in Tokyo and Osaka, Japan, in which the
Company conducts its Asian operations; Sucampo Pharma Americas, Inc., based in Bethesda, Maryland,
in which the Company conducts operations in North and South America; and Sucampo Pharma Europe
Ltd., based in Oxford, U.K., in which the Company conducts operations in Europe and the rest of the
world. All inter-company balances and transactions have been eliminated. In April 2010, the Company
incorporated a wholly owned subsidiary, Sucampo Manufacturing & Research AG, in Wollerau,
Switzerland, whose operations will focus on managing specific manufacturing, research and
intellectual property activities.
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 statements of cash flows,
cash equivalents include all highly liquid investments with an original maturity of 90 days or less
at the time of purchase.
Current and Non-current Investments
Current and non-current investments consist primarily of U.S. Treasury bills and notes, U.S.
government agencies securities, municipal and corporate bonds, mutual funds and auction rate
securities, or ARS. The Company classifies its investments into current and non-current based on
their maturities and managements reasonable expectation to realize these investments in cash. The
Company classifies all of its investments, except ARS, as available for sale securities and reports
unrealized gains or losses, net of related tax effects, in other comprehensive income. Pursuant to
the Companys acceptance of settlement rights for its investments in ARS in October 2008, the
Company classifies its investments in ARS as trading securities and records gains or losses
resulting from the changes in fair values of its ARS and related settlement rights in other income
(expense), net. The fair value of the settlement rights related to ARS is recorded in non-current
other assets. The fair value of the settlement rights has been derived from the par value of the
Companys investment in ARS and the fair value of ARS as of the recognition date, since the
settlement rights obligate the broker to redeem the ARS at par value.
Fair Value
The carrying amounts of the Companys financial instruments, which include cash and cash
equivalents, restricted cash, current and non-current investments, receivables, accounts payable
and accrued expenses, approximate their fair values based on their short maturities, independent
valuations or internal assessments.
Revenue Recognition
The Companys revenues are derived primarily from collaboration and license agreements and
include up-front payments, development milestone payments, reimbursements of development and
co-promotion costs and product royalties.
The Company evaluated the multiple deliverables within the collaboration and license
agreements in accordance with the guidance of multiple deliverables to determine whether the
delivered elements that are the obligation of the Company have value to other parties to the
agreement on a stand-alone basis and whether objective reliable evidence of fair value of the
undelivered items exists. Deliverables that meet these criteria are considered a separate unit of
accounting. Deliverables that do not meet these criteria are combined and accounted for as a single
unit of accounting. The appropriate recognition of revenue is then applied to each separate unit of
accounting. The Companys deliverables under the Takeda and Abbott agreements, including the
related rights and obligations, contractual cash flows and performance periods, are more fully
described in Note 9.
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, such as development milestones,
revenue is recognized to the extent the accumulated service time 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. In cases where milestone payments are received after the completion of the
associated development period, the Company recognizes revenue upon completion of the performance
obligation. 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 recognizes reimbursable
research and development costs under the Takeda agreement as research and development revenue using
a time-based model over the estimated performance period. The research and development revenue for
these obligations is limited to the lesser of the actual reimbursable costs incurred or the
straight-line amount of revenue recognized over the estimated performance period. Revenues are
recognized for reimbursable costs only if those costs can be reasonably determined.
6
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Company applies a proportional-performance model using the percentage-of-completion method
of revenue recognition for cash flows associated with research and development deliverables under
the Abbott license, commercialization and supply agreement.
Since the Company has previous research and development experience and the expected cost to
complete the development can be reasonably estimated, the Company believes a
proportional-performance methodology of revenue recognition is appropriate. Under this method,
revenue in any period is recognized as a percentage of the total actual cost expended relative to
the total estimated costs required to satisfy the performance obligations under the arrangement
related to the development. Revenue recognized is limited to the amounts that are non-refundable
and that the other party to the agreement is contractually obligated to pay to the Company. A
change in the period of time expected to complete the deliverable is accounted for as a change in
estimate on a prospective basis. Research and development costs are not reimbursable under the
Abbott agreement.
The Company recognizes reimbursable research and development costs under the Takeda agreement
as research and development revenue using a time-based model over the estimated performance period.
The research and development revenue for these obligations is limited to the lesser of the actual
reimbursable costs incurred or the straight-line amount of revenue recognized over the estimated
performance period. Revenues are recognized for reimbursable costs only if those costs can be
reasonably determined. Research and development costs are not reimbursable under the Abbott
agreement.
Under the Takeda agreement, royalties are based on net sales of licensed products and are
recorded on the accrual basis when earned in accordance with contractual terms when third party
results are reliably measurable, collectability is reasonably assured and all other revenue
recognition criteria are met. Under the Abbott agreement, should Amitiza be commercialized in
Japan, the Company will purchase and assume title to inventories of Amitiza and recognize revenues
from the sales of such product when earned.
The Takeda supplemental agreement consists of the following key funding streams:
reimbursements of co-promotion costs based upon a per-day rate and reimbursements of the costs of
miscellaneous marketing activities, which the Company recognizes as revenue as the related costs
are incurred and Takeda becomes contractually obligated to pay the amounts.
The Company considers its participation in the joint committees under the collaboration and
license agreements as separate deliverables under the contracts and recognizes the fair value of
such participation as collaboration revenue over the period of the participation per the terms of
the contracts.
The Company has determined that it is acting as a principal under both the Takeda and Abbott
agreements and, as such, records revenue on a gross basis in the condensed consolidated statements
of operations and comprehensive income (loss).
Contract Revenue
Contract revenue relates to development and consulting activities with R-Tech and is accounted
for under the time-based model.
Certain Risks, Concentrations and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of
credit risk consist of cash and cash equivalents, restricted cash, investments and receivables. The
Company places its cash, cash equivalents and restricted cash with highly rated financial
institutions and invests its excess cash
in highly rated investments. As of March 31, 2010 and December 31, 2009, approximately $52.1
million, or 44.5%, and $60.7 million, or 51.2%, respectively, of the Companys cash, cash
equivalents, restricted cash and investments was issued or insured by the federal government or
government agencies. The Company has not experienced any losses on these accounts related to
amounts in excess of insured limits.
The settlement rights between the Company and UBS AG, or the ARS Broker, obligate the ARS
Broker to purchase the remaining ARS at a par value of $10.0 million during a two-year period
beginning June 30, 2010 if the Company exercises its related settlement rights. The Company does
not anticipate needing to sell the remaining ARS before June 30, 2010.
The Companys products and product candidates under development require approval from the FDA
or other international regulatory agencies prior to commercial sales. For those product candidates
or indications that have not yet been approved by the FDA or international regulatory agencies,
there can be no assurance the products will receive the necessary approval. If the Company is
denied approval or approval is delayed, it may have a material adverse impact on the Company.
The Companys products, Amitiza and Rescula® (unoprostone isopropyl), compete in a rapidly
changing, highly competitive market, which is characterized by advances in scientific discovery,
changes in customer requirements, evolving regulatory requirements and developing industry
standards. Any failure by the Company to anticipate or to respond adequately or timely to
scientific developments in its industry, changes in customer requirements or changes in regulatory
requirements or industry standards, or any significant delays in the development or introduction of
products could have a material adverse effect on the Companys business, operating results and
future cash flows.
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.
Revenues from one unrelated party, Takeda, accounted for 81% and 97%, of the Companys total
revenues for the three months ended March 31, 2010 and 2009, respectively. Accounts receivable,
unbilled accounts receivable and product royalties receivable from Takeda accounted for 100% and
96% of the Companys total accounts receivable, unbilled accounts receivable and product royalties
receivable at March 31, 2010 and December 31, 2009, respectively. Revenues from another unrelated
party, Abbott, accounted for 19% and 2% of the Companys total revenues for the three months ended
March 31, 2010 and 2009, respectively. The Company depends significantly upon the collaborations
with Takeda and Abbott and its activities may be impacted if these relationships are disrupted
(Note 9).
The Company has an exclusive supply arrangement with R-Tech to provide it with commercial and
clinical supplies of its product and product candidates. Additionally, in April 2009, the Company
acquired from R-Tech all patents and other intellectual property rights related to Rescula in the
U.S. and Canada. 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 8).
The Company has previously entered into a restated license agreement with Sucampo AG, or SAG,
to grant the Company a royalty-bearing, exclusive, worldwide license to develop prostone compounds,
other than Rescula. 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 8).
Reclassifications
Certain amounts in the prior year financial statements have been reclassified to conform to
the current year presentation. The Company reclassified money market funds of $33.7 million from
current
investments to cash and cash equivalents as of March 31, 2009. The Company has adjusted the
cash flow statement for the quarter ended March 31, 2009 accordingly.
Recent Accounting Pronouncements
In June 2009, the FASB issued an amendment to the accounting and disclosure requirements for
the consolidation of variable interest entities, or VIEs. The elimination of the concept of
qualifying special-purpose entities, or QSPEs, removes the exception from applying the
consolidation guidance within this amendment. This amendment requires an enterprise to perform a
qualitative analysis when determining whether or not it must consolidate a VIE. The amendment also
requires an enterprise to continuously reassess whether it must consolidate a VIE. Additionally,
the amendment requires enhanced disclosures about an enterprises involvement with VIEs and any
significant change in risk exposure due to that involvement, as well as how its involvement with
VIEs impacts the enterprises financial statements. Finally, an enterprise will be required to
disclose significant judgments and assumptions used to determine whether or not to consolidate a
VIE. This amendment is effective for financial statements issued for fiscal years beginning after
November 15, 2009. The Company adopted the guidance effective January 1, 2010 and such adoption did
not have an impact on the condensed consolidated financial statements.
In September 2009, the FASB issued an amendment to the authoritative guidance which addresses
how revenues should be allocated among products and services in a singular sales arrangement. The
guidance establishes a hierarchy for determining the selling price of each product or service, with
vendor-specific objective evidence, or VSOE, at the highest level, third-party evidence of VSOE at
the intermediate level, and managements best estimate at the lowest level. It replaces fair
value with selling price in revenue allocation guidance. It also significantly expands the
disclosure requirements for multiple-deliverable revenue arrangements.
This guidance will be effective prospectively for agreements entered into or materially modified in
fiscal years beginning on or after June 15, 2010. The Company is continuing to evaluate the impact
that this amendment would have on its financial condition and results of operation upon adoption.
8
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
In January 2010, the FASB issued authoritative guidance on improving the disclosures about
fair value measurements. This statement requires additional disclosures about fair value
measurements including transfers in and out of Levels 1 and 2 and a higher level of disaggregation
for the different types of financial instruments. For the reconciliation of Level 3 fair value
measurements, information about purchases, sales, issuances and settlements should be presented
separately. This statement is effective for annual and interim reporting periods beginning after
December 15, 2009 for most of the new disclosures and for periods beginning after December 15, 2010
for the new Level 3 disclosures. The Company adopted the guidance effective January 1, 2010 and
such adoption did not have a material impact on the condensed consolidated financial statements.
In March 2010, the FASB issued authoritative guidance on applying the milestone method to
milestone payments for achieving specified performance measures when those payments are related to
uncertain future events. Under this statement, an accounting policy election can be made to
recognize arrangement consideration received for achieving specified performance measures during
the period in which the milestones are achieved, provided certain criteria are met. This statement
is limited to transactions involving research or development. This statement is effective for
annual and interim reporting periods beginning on or after June 15, 2010 and may be early adopted.
The Company is continuing to evaluate the impact that this amendment may have on its financial
condition and results of operation if the Company chooses to adopt this standard.
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 months ended March 31, 2010 and
2009 is shown below:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(in thousands, except per share data) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Basic net loss per share: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(299 |
) |
|
$ |
(1,775 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares
outstanding |
|
|
41,845 |
|
|
|
41,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per share |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per share: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(299 |
) |
|
$ |
(1,775 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares
outstanding for diluted net
income per share |
|
|
41,845 |
|
|
|
41,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per share |
|
$ |
(0.01 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
For the periods listed above, there were no potentially dilutive securities to be used in
the calculations of diluted historical net loss per share as of March 31, 2010 and 2009.
9
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
For the periods listed above, the following securities were excluded from the computation of
diluted net loss per share as their effect would be anti-dilutive as of March 31, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
Employee stock options |
|
|
1,144 |
|
|
|
694 |
|
Non-employee stock options |
|
|
450 |
|
|
|
450 |
|
4. Current and Non-Current Investments
At March 31, 2010 and December 31, 2009, current and non-current available-for-sale investments
consisted of the following securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury
bills and notes |
|
$ |
2,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,000 |
|
U.S. commercial
paper |
|
|
2,934 |
|
|
|
3 |
|
|
|
|
|
|
|
2,937 |
|
U.S. government
securities |
|
|
19,592 |
|
|
|
5 |
|
|
|
(8 |
) |
|
|
19,589 |
|
Municipal
securities |
|
|
16,967 |
|
|
|
1 |
|
|
|
(11 |
) |
|
|
16,957 |
|
Certificates of
deposits |
|
|
1,500 |
|
|
|
|
|
|
|
(1 |
) |
|
|
1,499 |
|
Corporate bonds |
|
|
17,610 |
|
|
|
40 |
|
|
|
(1 |
) |
|
|
17,649 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
60,603 |
|
|
$ |
49 |
|
|
$ |
(21 |
) |
|
$ |
60,631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government
securities |
|
$ |
8,597 |
|
|
$ |
8 |
|
|
$ |
(20 |
) |
|
$ |
8,585 |
|
Municipal
securities |
|
|
3,270 |
|
|
|
5 |
|
|
|
(1 |
) |
|
|
3,274 |
|
Certificates of
deposits |
|
|
250 |
|
|
|
|
|
|
|
(1 |
) |
|
|
249 |
|
Corporate bonds |
|
|
4,079 |
|
|
|
|
|
|
|
(8 |
) |
|
|
4,071 |
|
Auction rate
securities |
|
|
10,000 |
|
|
|
|
|
|
|
(1,086 |
) |
|
|
8,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
26,196 |
|
|
$ |
13 |
|
|
$ |
(1,116 |
) |
|
$ |
25,093 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2009 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury
bills and notes |
|
$ |
2,999 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,999 |
|
U.S. commercial
paper |
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
1,000 |
|
U.S. government
securities |
|
|
26,020 |
|
|
|
16 |
|
|
|
(6 |
) |
|
|
26,030 |
|
Municipal
securities |
|
|
25,339 |
|
|
|
4 |
|
|
|
(7 |
) |
|
|
25,336 |
|
Certificates of
deposits |
|
|
1,250 |
|
|
|
|
|
|
|
(1 |
) |
|
|
1,249 |
|
Corporate bonds |
|
|
15,782 |
|
|
|
38 |
|
|
|
|
|
|
|
15,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
72,390 |
|
|
$ |
58 |
|
|
$ |
(14 |
) |
|
$ |
72,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government
securities |
|
$ |
6,065 |
|
|
$ |
7 |
|
|
$ |
(12 |
) |
|
$ |
6,060 |
|
Municipal
securities |
|
|
1,802 |
|
|
|
4 |
|
|
|
|
|
|
|
1,806 |
|
Certificates of
deposits |
|
|
500 |
|
|
|
|
|
|
|
(2 |
) |
|
|
498 |
|
Corporate bonds |
|
|
1,891 |
|
|
|
1 |
|
|
|
(3 |
) |
|
|
1,889 |
|
Auction rate
securities |
|
|
10,000 |
|
|
|
|
|
|
|
(1,086 |
) |
|
|
8,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
20,258 |
|
|
$ |
12 |
|
|
$ |
(1,103 |
) |
|
$ |
19,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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).
The Company performs fair value measurements in accordance with the guidance for fair value
measurements and disclosures, which defines fair value as the exchange price that would be received
for selling an asset or paid to transfer a liability in the principal or most advantageous market
for the asset or liability in an orderly transaction between market participants on the measurement
date. A fair value hierarchy is established which requires an entity to maximize the use of
observable inputs and minimize the use of unobservable inputs when measuring fair value. The
Company classifies its investments into the following categories based on the three levels of
inputs used to measure fair value:
Level 1: quoted prices in active markets for identical assets or liabilities;
Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as
quoted prices in active markets for similar assets or liabilities, quoted prices for identical or
similar assets or liabilities in markets that are not active, or other inputs that are observable
or can be corroborated by observable market data for substantially the full term of the assets or
liabilities; or
Level 3: unobservable inputs that are supported by little or no market activity and
that are significant to the fair value of the assets or liabilities.
The Companys assets measured at fair value on a recurring basis, which are subject to the fair
value disclosure requirements, are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
for identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
March 31, 2010 |
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills and
notes |
|
$ |
2,000 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,000 |
|
U.S. government
securities |
|
|
28,174 |
|
|
|
|
|
|
|
|
|
|
|
28,174 |
|
U.S. commercial paper |
|
|
|
|
|
|
2,937 |
|
|
|
|
|
|
|
2,937 |
|
Corporate bonds |
|
|
21,720 |
|
|
|
|
|
|
|
|
|
|
|
21,720 |
|
Municipal securities |
|
|
20,231 |
|
|
|
|
|
|
|
|
|
|
|
20,231 |
|
Auction rate securities |
|
|
|
|
|
|
|
|
|
|
8,914 |
|
|
|
8,914 |
|
Settlement rights for
auction rate
securities* |
|
|
|
|
|
|
|
|
|
|
1,086 |
|
|
|
1,086 |
|
Certificates of deposits |
|
|
|
|
|
|
1,748 |
|
|
|
|
|
|
|
1,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured
at fair value |
|
$ |
72,125 |
|
|
$ |
4,685 |
|
|
$ |
10,000 |
|
|
$ |
86,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
Significant |
|
|
|
|
|
|
|
|
|
Active Markets |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
for identical |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
December 31, 2009 |
|
Assets |
|
|
Inputs |
|
|
Inputs |
|
|
|
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills and
notes |
|
$ |
2,999 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,999 |
|
U.S. government
securities |
|
|
32,090 |
|
|
|
|
|
|
|
|
|
|
|
32,090 |
|
U.S. commercial paper |
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
1,000 |
|
Corporate bonds |
|
|
17,709 |
|
|
|
|
|
|
|
|
|
|
|
17,709 |
|
Municipal securities |
|
|
27,142 |
|
|
|
|
|
|
|
|
|
|
|
27,142 |
|
Auction rate securities |
|
|
|
|
|
|
|
|
|
|
8,914 |
|
|
|
8,914 |
|
Settlement rights for
auction rate
securities* |
|
|
|
|
|
|
|
|
|
|
1,086 |
|
|
|
1,086 |
|
Certificates of deposits |
|
|
|
|
|
|
1,747 |
|
|
|
|
|
|
|
1,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured
at fair value |
|
$ |
79,940 |
|
|
$ |
2,747 |
|
|
$ |
10,000 |
|
|
$ |
92,687 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
included in non-current other assets in the accompanying condensed consolidated balance sheets. |
If quoted prices in active markets for identical assets and liabilities are not available
to determine fair value, then the Company uses quoted prices for similar assets and liabilities or
inputs other than the quoted prices that are observable, either directly or indirectly. This
pricing methodology applies to the Companys Level 2 investments.
The fair value of Companys auction rate security holdings and settlement rights are estimated
based on an internal pricing model and categorized in Level 3 of the fair value hierarchy. The
pricing model takes into consideration the characteristics of the underlying securities as well as
multiple inputs, including counterparty credit quality, expected timing of redemptions and the
yield premium that a market participant would require over otherwise comparable securities. These
inputs require significant management judgment.
5. Intangible Assets
In April 2009, the Company entered into two agreements with R-Tech, a Japanese manufacturing
and research and development company that is majority owned by the Companys founders, to acquire
all patents and other intellectual property rights related to Rescula in the U.S. 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 U.S. or Canada. The
Company plans to re-launch Rescula in the U.S. for the treatment of open-angle glaucoma and ocular
hypertension. Additionally, the Company plans 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 R-Tech agreements, the Company made an upfront payment of $3.0 million
and may be required to pay up to $5.5 million in additional milestone payments to R-Tech based on
the achievement of specified development and commercialization goals. The first milestone payment
of $500,000 is payable upon the re-launch of Rescula for the treatment of glaucoma which is
considered as being probable; therefore, this amount is recorded as part of the initial cost of the
acquired assets. The Company allocated the acquisition cost between an intangible asset of $3.4
million and a non-current prepaid inventory of $85,000 as of March 31, 2010, both of which are
reflected in other non-current assets in the accompanying consolidated balance sheet. The Company
is amortizing the $3.4 million over the 10-year life of the license agreement, which management
believes approximates the useful life of the underlying rights and data. Amortization expense was
$85,000 for the three months ended March 31, 2010. There was no corresponding expense for the three
months ended March 31, 2009. The annual amortization expense will be approximately $342,000 through
April 2019.
12
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
6. Accrued Expenses
Accrued expenses consisted of the following as of:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Research and development costs |
|
$ |
2,602 |
|
|
$ |
3,624 |
|
Employee compensation |
|
|
1,001 |
|
|
|
879 |
|
Selling and marketing costs |
|
|
102 |
|
|
|
731 |
|
Other accrued expenses |
|
|
3,912 |
|
|
|
1,311 |
|
|
|
|
|
|
|
|
Total |
|
$ |
7,617 |
|
|
$ |
6,545 |
|
|
|
|
|
|
|
|
7. Commitments
Operating Leases
The Company leases office space in the U.S., the United Kingdom and Japan under operating
leases ranging through 2017. Total future minimum, non-cancelable lease payments under operating
leases, which do not include future sub-lease receipts of approximately $45,000, were as follows as
of March 31, 2010:
|
|
|
|
|
(In thousands) |
|
|
|
|
2010 (April December) |
|
$ |
1,035 |
|
2011 |
|
|
1,067 |
|
2012 |
|
|
966 |
|
2013 |
|
|
994 |
|
2014 |
|
|
1,024 |
|
2015 and thereafter |
|
|
2,275 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
7,361 |
|
|
|
|
|
Rent expense for all operating leases was approximately $333,000 and $301,000 for the
three months ended March 31, 2010 and 2009, respectively.
Research and Development Costs
The Company routinely enters into agreements with third-party clinical research organizations,
or CROs, to oversee clinical research and development studies provided on an outsourced basis. The
Company is not generally contractually obligated to pay the CRO if the service or reports are not
provided. Total future estimated costs through 2013 under these agreements as of March 31, 2010
were approximately $6.8 million.
8. Related Party Transactions
R-Tech Ueno, Ltd.
In addition to the Rescula agreements described in Note 5 above, the Company is a party to
other development and exclusive supply agreements with R-Tech covering various compounds and
territories. The Companys founders, Drs. Ueno and Kuno, directly or indirectly, own a majority of
the stock of R-Tech. Dr. Kuno is the chairman of the board of directors of R-Tech.
13
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Company recorded the following expenses under its agreements with R-Tech:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Clinical supplies |
|
$ |
112 |
|
|
$ |
1,044 |
|
Other research and development services |
|
|
63 |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
$ |
175 |
|
|
$ |
1,049 |
|
|
|
|
|
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Deferred revenue, current |
|
$ |
431 |
|
|
$ |
431 |
|
Deferred revenue, non-current |
|
|
6,133 |
|
|
|
6,256 |
|
|
|
|
|
|
|
|
|
|
$ |
6,564 |
|
|
$ |
6,687 |
|
|
|
|
|
|
|
|
The Company recognized approximately $105,000 of revenue relating to its agreements with
R-Tech for each of the three months ended March 31, 2010 and 2009, which was recorded as contract
and collaboration revenue in the accompanying condensed consolidated statements of operations and
comprehensive income (loss).
Sucampo AG License Agreements
The Company expensed approximately $500,000 in milestone royalties related parties expense
under our sublicense agreement with SAG for the three months ended March 31, 2009, reflecting 5% of
the $10.0 million upfront payment received from Abbott. There was no corresponding expense in 2010.
The Company expensed approximately $1.7 million and $1.6 million in product royalties -
related parties under the license agreement with SAG for the three months ended March 31, 2010 and
2009, respectively, reflecting 3.2% of Amitiza net sales in the U.S. during each of these periods.
9. Collaboration and License Agreements
Abbott license and commercialization and supply agreement
In February 2009, the Company entered into an exclusive 15-year license, commercialization and
supply agreement with Abbott to develop and commercialize lubiprostone for the treatment of CIC in
Japan. Additionally, the agreement grants Abbott the right of first refusal to any additional
indications for which lubiprostone is developed in Japan under all relevant patents, know-how and
trademarks. Payments to the Company under the terms of the agreement include a non-refundable
upfront payment and non-refundable development and commercial milestone payments based on achieving
specified development, regulatory and sales goals.
The Company has received a total of $17.5 million in up-front and development milestone
payments through March 31, 2010 under this agreement. Subject to future development and commercial
milestones, the Company will receive additional development milestone and commercial milestone
payments under this agreement with Abbott, although there can be no assurance 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 or deferred
under the license, commercialization and supply agreement with Abbott for the three months ended
March 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized for |
|
|
Foreign Currency |
|
|
|
|
|
|
Amount |
|
|
for the Three |
|
|
the Three |
|
|
Effects for the |
|
|
Amount |
|
|
|
Deferred at |
|
|
Months Ended |
|
|
Months Ended |
|
|
Three Months |
|
|
Deferred at |
|
|
|
December 31, |
|
|
March 31, |
|
|
March 31, |
|
|
Ended March 31, |
|
|
March 31, |
|
(In thousands) |
|
2009 |
|
|
2010 |
|
|
2010 |
|
|
2010 |
|
|
2010 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment
associated with the
Companys
obligation to
participate in
joint committees |
|
$ |
812 |
|
|
$ |
|
|
|
$ |
10 |
|
|
$ |
(4 |
) |
|
$ |
798 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment |
|
$ |
3,991 |
|
|
$ |
|
|
|
$ |
1,497 |
|
|
$ |
19 |
|
|
$ |
2,513 |
|
Development milestone
payment |
|
$ |
3,366 |
|
|
|
|
|
|
|
1,256 |
|
|
|
10 |
|
|
$ |
2,120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
7,357 |
|
|
$ |
|
|
|
$ |
2,753 |
|
|
$ |
29 |
|
|
$ |
4,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 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 March 31, 2010 under these agreements. Subject to future development and
commercial milestones, the Company will 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.
On March 12, 2010, the Company submitted for filing with the International Court of
Arbitration, International Chamber of Commerce a demand for arbitration under the applicable
provisions of the Collaboration and License Agreement between the Company and Takeda dated October
29, 2004. The Company is disappointed with the level of U.S. sales of Amitiza being generated by
Takeda and what the Company believes to be other failures of performance by Takeda under the
agreements. The Company believes that Takeda materially breached its agreement, without limitation,
by its continuing failure to exercise its best efforts to commercialize Amitiza and maximize net
sales revenue, and its ongoing refusal to collaborate and provide the Company with information to
which the Company is entitled under the agreement. The Company also claimed that Takedas conduct,
including, without limitation, its dealings with pharmacy benefit managers/managed care
organizations, has injured not only the Company and the Amitiza brand, but also consumers. The
Company is seeking all appropriate relief, including production by Takeda of all information to
which we are entitled, a declaration of termination of applicable agreements, and all available
monetary relief, equitable relief, attorneys fees and costs. Both the Company and Takeda have
selected their respective arbitrators and if confirmed will select a third arbitrator to comprise
the panel that will conduct the arbitration proceedings. The Company spent and expects to spend
significant resources in the dispute with Takeda and these legal proceedings may require the
continuing attention of the Companys senior management.
15
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The following table summarizes the cash
streams and related revenue recognized or deferred under the collaboration and license
agreements with Takeda for the three months ended March 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized for |
|
|
Change in Accounts |
|
|
|
|
|
|
Amount |
|
|
for the Three |
|
|
the Three |
|
|
Receivable for the |
|
|
Amount |
|
|
|
Deferred at |
|
|
Months Ended |
|
|
Months Ended |
|
|
Three Months |
|
|
Deferred at |
|
|
|
December 31, |
|
|
March 31, |
|
|
March 31, |
|
|
Ended March 31, |
|
|
March 31, |
|
(In thousands) |
|
2009 |
|
|
2010 |
|
|
2010 |
|
|
2010* |
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment
associated with the
Companys
obligation to
participate in
joint committees |
|
$ |
1,617 |
|
|
$ |
|
|
|
$ |
37 |
|
|
$ |
|
|
|
$ |
1,580 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of
research and
development expenses |
|
$ |
2,734 |
|
|
$ |
965 |
|
|
$ |
1,304 |
|
|
$ |
(216 |
) |
|
$ |
2,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
|
|
|
$ |
11,023 |
|
|
$ |
9,773 |
|
|
$ |
(1,250 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promotion revenue |
|
$ |
|
|
|
$ |
1,157 |
|
|
$ |
855 |
|
|
$ |
(302 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Includes billed and unbilled accounts receivable. |
10. Stock Option Plans
The following table summarizes the employee stock option activity for the three months ended
March 31, 2010 under the Companys 2001 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Exercise Price Per |
|
|
Contractual Term |
|
|
Aggregate |
|
|
|
Shares |
|
|
Share |
|
|
(Years) |
|
|
Intrinsic Value |
|
Options
outstanding,
December 31, 2009 |
|
|
358,700 |
|
|
$ |
10.43 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(13,600 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding, March
31, 2010 |
|
|
345,100 |
|
|
|
10.44 |
|
|
|
3.87 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable, March
31, 2010 |
|
|
345,100 |
|
|
|
10.44 |
|
|
|
3.87 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the employee stock option activity for the three months
ended March 31, 2010 under the Companys 2006 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Exercise Price Per |
|
|
Contractual Term |
|
|
Aggregate |
|
|
|
Shares |
|
|
Share |
|
|
(Years) |
|
|
Intrinsic Value |
|
Options
outstanding,
December 31, 2009 |
|
|
509,800 |
|
|
$ |
8.58 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
289,000 |
|
|
|
3.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
outstanding, March
31, 2010 |
|
|
798,800 |
|
|
|
6.84 |
|
|
|
8.33 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options
exercisable, March
31, 2010 |
|
|
132,375 |
|
|
|
14.35 |
|
|
|
3.88 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant date fair value of options granted during the three months
ended March 31, 2010 and the year ended December 31, 2009 were $1.95 and $2.73, respectively. As of
March 31, 2010, approximately $1.6 million 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 2.88 years.
16
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Company granted 510,000 stock options with an exercise price of $5.85 per share to
non-employees in August 2005 under the 2001 Incentive Plan. As of March 31, 2010 and December 31,
2009, 450,000 options were outstanding and exercisable. These non-employee stock options vested
immediately. These options have a weighted average exercise price of $5.85 as of March 31, 2010 and
December 31,
2009 and a remaining contractual life of 5.09 and 5.33 years, respectively, as of March 31,
2010 and December 31, 2009.
Employee Stock Purchase Plan
Under the 2006 Employee Stock Purchase Plan, or ESPP, a total of 1,329 and 910 shares of class
A common stock were purchased during the three months ended March 31, 2010 and 2009, respectively.
The ESPP is non-compensatory and is intended to qualify as an Employee Stock Purchase Plan as
defined in Section 423 of the Internal Revenue Code of 1986 and in accordance with GAAP guidance
that requires estimates in the fair value of share-based payment awards on the date of the grant
using an option-pricing model and recognizing the expense over the required service periods in the
accompanying condensed consolidated statement of operations and comprehensive income (loss). The
Company received $4,507 and $5,299 upon purchase of shares under the ESPP for the three months
ended March 31, 2010 and 2009, respectively.
11. Income Taxes
For the three months ended March 31, 2010 and 2009, the Company recorded a tax provision of
$205,000 and $401,000, respectively. The tax provision for the three months ended March 31, 2010
and 2009 primarily pertained to taxable income generated by the Companys U.S. subsidiary. The
Companys other subsidiaries based in Europe and Japan incurred pre-tax losses for the three months
ended March 31, 2010, for which no tax benefit was recognized.
The Company has estimated its annual effective tax rate for the full fiscal year 2010 and 2009
and applied that rate to its income before income taxes in determining its income tax provision for
the interim periods. There is no tax benefit recognized on the net operating losses incurred in the
foreign jurisdictions due to the lack of evidence supporting the Companys ability to use these
losses in the future.
Uncertain Tax Positions
The Company applies the FASBs guidance for uncertainty in income taxes that requires the
application of a more likely than not threshold to the recognition and derecognition of uncertain
tax positions.
The Company had an outstanding non-current income tax liability of approximately $776,000 for
uncertain tax positions as of March 31, 2010. 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
March 31, 2010 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.
12. Segment Reporting
The Company has determined that it has three reportable segments based on the Companys method
of internal reporting, which disaggregates business by geographic location. These segments are the
Americas, Europe and Asia. The Company evaluates the performance of these segments based on income
(loss) from operations, as well as other factors, including the progress of its research and
development activities. The reportable segments have historically derived their revenue from joint
collaboration and strategic alliance agreements. Transactions between the segments consist
primarily of loans and the provision of research and development services. Following is a summary
of financial information by reportable geographic segment.
17
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
Americas |
|
|
Europe |
|
|
Asia |
|
|
Eliminations |
|
|
Consolidated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development revenue |
|
$ |
1,304 |
|
|
$ |
|
|
|
$ |
2,753 |
|
|
$ |
|
|
|
$ |
4,057 |
|
Product royalty
revenue |
|
|
9,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,773 |
|
Co-promotion revenue |
|
|
855 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
855 |
|
Contract and
collaboration
revenue |
|
|
141 |
|
|
|
|
|
|
|
285 |
|
|
|
(275 |
) |
|
|
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
12,073 |
|
|
|
|
|
|
|
3,038 |
|
|
|
(275 |
) |
|
|
14,836 |
|
Research and
development
expenses |
|
|
2,373 |
|
|
|
219 |
|
|
|
3,049 |
|
|
|
(275 |
) |
|
|
5,366 |
|
Depreciation and
amortization |
|
|
218 |
|
|
|
3 |
|
|
|
7 |
|
|
|
|
|
|
|
228 |
|
Other operating
expenses |
|
|
9,005 |
|
|
|
252 |
|
|
|
198 |
|
|
|
|
|
|
|
9,455 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss)
from operations |
|
|
477 |
|
|
|
(474 |
) |
|
|
(216 |
) |
|
|
|
|
|
|
(213 |
) |
Interest income |
|
|
273 |
|
|
|
|
|
|
|
1 |
|
|
|
(63 |
) |
|
|
211 |
|
Other non-operating
income (expense),
net |
|
|
(36 |
) |
|
|
(99 |
) |
|
|
(20 |
) |
|
|
63 |
|
|
|
(92 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss)
before income
taxes |
|
$ |
714 |
|
|
$ |
(573 |
) |
|
$ |
(235 |
) |
|
$ |
|
|
|
$ |
(94 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
91 |
|
|
$ |
|
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development revenue |
|
$ |
5,152 |
|
|
$ |
|
|
|
$ |
374 |
|
|
$ |
|
|
|
$ |
5,526 |
|
Product royalty
revenue |
|
|
8,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,946 |
|
Co-promotion revenue |
|
|
896 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
896 |
|
Contract and
collaboration
revenue |
|
|
141 |
|
|
|
|
|
|
|
215 |
|
|
|
(210 |
) |
|
|
146 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
15,135 |
|
|
|
|
|
|
|
589 |
|
|
|
(210 |
) |
|
|
15,514 |
|
Research and
development
expenses |
|
|
7,971 |
|
|
|
152 |
|
|
|
2,052 |
|
|
|
(210 |
) |
|
|
9,965 |
|
Depreciation and
amortization |
|
|
117 |
|
|
|
3 |
|
|
|
2 |
|
|
|
|
|
|
|
122 |
|
Other operating
expenses |
|
|
6,487 |
|
|
|
328 |
|
|
|
1,120 |
|
|
|
|
|
|
|
7,935 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss)
from operations |
|
|
560 |
|
|
|
(483 |
) |
|
|
(2,585 |
) |
|
|
|
|
|
|
(2,508 |
) |
Interest income |
|
|
359 |
|
|
|
|
|
|
|
3 |
|
|
|
(50 |
) |
|
|
312 |
|
Other non-operating
income (expense),
net |
|
|
244 |
|
|
|
(36 |
) |
|
|
564 |
|
|
|
50 |
|
|
|
822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss)
before income
taxes |
|
$ |
1,163 |
|
|
$ |
(519 |
) |
|
$ |
(2,018 |
) |
|
$ |
|
|
|
$ |
(1,374 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
127 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31,
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net |
|
$ |
1,967 |
|
|
$ |
29 |
|
|
$ |
195 |
|
|
$ |
|
|
|
$ |
2,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable
assets, net of
intercompany loans
and investments |
|
$ |
134,669 |
|
|
$ |
2,167 |
|
|
$ |
6,489 |
|
|
$ |
(2,424 |
) |
|
$ |
140,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net |
|
$ |
2,008 |
|
|
$ |
34 |
|
|
$ |
200 |
|
|
$ |
|
|
|
$ |
2,242 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable
assets, net of
intercompany loans
and investments |
|
$ |
134,714 |
|
|
$ |
864 |
|
|
$ |
11,294 |
|
|
$ |
(1,901 |
) |
|
$ |
144,971 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
|
|
|
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, 2009 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. Prostones are a class of compounds
occurring naturally in the human body by enzymatic, 15-PGDH, transformation of certain fatty acids.
We believe that most prostones function as activators of cellular ion channels. As a result,
prostones promote fluid secretion and enhance cell protection, including the recovery of cellular
barrier function. This activity gives prostones wide-ranging therapeutic potential, particularly
for age-related diseases. We are focused on developing prostones for the treatment of
gastrointestinal, ocular, respiratory, vascular and central nervous system diseases and other
disorders for which there are unmet or underserved medical needs and significant commercial
potential.
The therapeutic potential of prostones was first identified by one of our founders, Dr. Ryuji
Ueno. To date, two prostone products have received marketing approval. Amitiza®
(lubiprostone) is a FDA-approved treatment for chronic idiopathic constipation, or CIC, in adults
of both genders and all ages and irritable bowel syndrome with constipation, or IBS-C, in adult
women. Rescula®(unoprostone isopropyl) is FDA-approved for the treatment of open-angle
glaucoma and ocular hypertension.
We generate revenue mainly from product royalties, development milestone payments, and
clinical 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, Rescula and other compounds both in the U.S. and other
countries and expand our international operations. We hold an exclusive worldwide royalty-bearing
license from Sucampo AG, or SAG, a Swiss patent-holding company, 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.
In the United States, Amitiza is being marketed and developed under a collaboration and
license agreement with Takeda Pharmaceutical Company Limited, or Takeda, for gastrointestinal
indications. In Japan, lubiprostone is developed under a license, commercialization and supply
agreement with Abbott Japan Co. Ltd., or Abbott. In April 2009, we acquired the rights to Rescula
that allow us to commercialize Rescula in the U.S. and Canada for the treatment of glaucoma and
ocular hypertension and any new indication developed by us.
Under the Takeda agreement, Takeda is primarily responsible for the sales and marketing of
Amitiza in the U.S. and Canada. Takeda currently sells Amitiza mainly to U.S. office-based
specialty and primary care physicians and reimburses us a part of our co-promotion expenses. We
currently co-promote Amitiza in the U.S. through a specialty sales force focused on the
institutional marketplace, including specialist physicians based in academic medical centers and
long-term care and veterans affairs facilities. Takeda records all sales of Amitiza and we receive
a tiered royalty based on net sales. We are primarily responsible for Amitiza research and
development efforts and hold the new drug application, or NDA. Takeda reimburses us for a
significant portion of our research and development activities.
Our operations are conducted through subsidiaries based in Japan, the United States,
Switzerland and the United Kingdom. Our reportable geographic segments are Asia, the United States
and Europe and we
evaluate the performance of these segments based primarily on income (loss) from operations,
as well as other factors that depend on the development status of these subsidiaries. Such measures
include the progress of research and development activities, collaboration and licensing efforts,
commercialization activities and other factors.
19
Drs. Ryuji Ueno and Sachiko Kuno, together, directly or indirectly, own all of the stock of
SAG, and a majority of the stock of R-Tech Ueno, or R-Tech, as described more fully in Note 8 to
the condensed consolidated financial statements. Drs. Ueno and Kuno also are our controlling
stockholders and are married to each other. Dr. Ueno is our chief executive officer and chairman of
the Board of Directors. Dr. Kuno is a member of our Board of Directors, our advisor on
international business development and is Chair of the Board of Directors of R-Tech.
On March 12, 2010, we submitted for filing with the International Court of Arbitration,
International Chamber of Commerce a demand for arbitration under the applicable provisions of the
Collaboration and License Agreement between us and Takeda Pharmaceuticals Company Limited dated
October 29, 2004. We are disappointed with the level of U.S. sales of Amitiza being generated by
Takeda and other failures of performance by Takeda under the agreements. We believe that Takeda
materially breached its agreement, without limitation, by its continuing failure to exercise its
best efforts to commercialize Amitiza and maximize net sales revenue, and its ongoing refusal to
collaborate and provide us with information to which we are entitled under the agreement. We also
claimed that Takedas conduct, including, without limitation, its dealings with pharmacy benefit
managers/managed care organizations, has injured not only us and the Amitiza brand, but also
consumers. We are seeking all appropriate relief, including production by Takeda of all information
to which we are entitled, a declaration of termination of applicable agreements, and all available
monetary relief, equitable relief, attorneys fees and costs. Both the Company and Takeda have
selected their respective arbitrators and if confirmed will select a third arbitrator to comprise
the panel that will conduct the arbitration proceedings. We spent and expect to spend significant
resources in the dispute with Takeda and these legal proceedings may require the continuing
attention of our senior management.
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 pursing development
of a third gastrointestinal indication of Amitiza for the treatment of opioid-induced bowel
dysfunction, or OBD, in patients with non-malignant pain, a constipation-related gastrointestinal
indication. In July 2009, we reported top-line results for the two identically-designed efficacy
studies, one of which met the primary endpoint by demonstrating a statistically significant change
from baseline in the frequency of spontaneous bowel movements at week 8 of treatment when compared
to placebo. Based on a recent meeting with FDA, we will be required to conduct one additional
efficacy study to submit a supplemental new drug application for the OBD indication.
Amitiza (lubiprostone) in Japan. To date, we have received a total of $17.5 million in upfront
and development milestone payments from Abbott and we could receive additional milestone payments
based on achieving other pre-specified development and commercialization goals. We completed
enrollments into the phase 3 safety trial and the phase 3 efficacy trial in 2009. We anticipate
announcing data from these trials in 2010. If these trials are successful, we anticipate filing a
registration application with the Japanese regulatory authorities.
Amitiza (lubiprostone) in other countries. We have retained full rights to develop and
commercialize Amitiza for the rest of the worlds markets outside of the U.S., Canada and Japan. In
November 2009, we obtained a marketing authorization for lubiprostone in Switzerland for the
long-term treatment of adult patients with CIC. This is the first European regulatory approval for
us. Amitiza is the first prescription medicine to be approved in Switzerland for the long-term
treatment of CIC.
Rescula. Under our agreement with R-Tech, we hold the exclusive rights to commercialize
Rescula in the U.S. and Canada for the treatment of glaucoma and ocular hypertension and any new
indication developed by us. We also have the right of first refusal to commercialize Rescula in the
U.S. and Canada for any additional indications for which unoprostone is developed by R-Tech.
Currently, we may develop Rescula for treating an array of ophthalmic diseases including retinitis
pigmentosa, an orphan indication,
dry age-related macular degeneration, or dry AMD, and diabetic retinopathy. We anticipate
initiating a phase 2 trial for an ophthalmic indication in late 2010.
Cobiprostone. In July 2009, we reported top-line results from our phase 2a clinical trial of
orally administered cobiprostone for the prevention of gastric ulcers and other gastrointentinal
injuries in patients treated with non-steroidal anti-inflammatory drugs, or NSAIDs. Cobiprostone
patients experienced an overall statistically significant reduction in the number of gastric
erosions through the treatment period of 12 weeks as compared to placebo patients. In addition, the
high dose cobiprostone group experienced a 50.0% reduction in the overall incidence of gastric
ulcers when compared to patients taking placebo. We are designing a phase 2b study to complement
the findings of earlier studies. We also are designing a preclinical study of cobiprostone for use
as a treatment for chronic obstructive pulmonary disease, or COPD, and as a potential treatment for
wound healing.
20
SPI-017 is currently in preclinical and clinical testing in peripheral arterial and vascular
diseases as well as central nervous system disorders. In December 2008, we commenced a phase 1
clinical trial of the intravenous formulation of SPI-017 for peripheral arterial disease, or PAD,
in Japan. This phase 1 program has advanced to the administration of multiple doses at different
dose levels to patients, and we anticipate having these results in 2010.
SPI-3608: A novel prostone, SPI-3608 will continue to undergo preclinical testing. Based on
preclinical results seen to date, this compound may have potential as a treatment for spinal stenosis.
Results of Operations
Comparison of three months ended March 31, 2010 and March 31, 2009
Revenues
The following table summarizes our revenues for the three months ended March 31, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
4,057 |
|
|
$ |
5,526 |
|
Product royalty revenue |
|
|
9,773 |
|
|
|
8,946 |
|
Co-promotion revenue |
|
|
855 |
|
|
|
896 |
|
Contract and collaboration revenue |
|
|
151 |
|
|
|
146 |
|
|
|
|
|
|
|
|
Total |
|
$ |
14,836 |
|
|
$ |
15,514 |
|
|
|
|
|
|
|
|
Total revenues were $14.8 million for the three months ended March 31, 2010 compared to
$15.5 million for the three months ended March 31, 2009, a decrease of $678,000 million or 4.4%.
Research and development revenue was $4.1 million for the three months ended March 31, 2010
compared to $5.5 million for the three months ended March 31, 2009, a decrease of $1.5 million or
26.6%. The decrease was primarily due to reduced revenue recognized in respect to the OBD trials
for Amitiza in the U. S. funded by Takeda, partially offset by $2.8 million in revenue recognized
under the agreement with Abbott. The revenue recognized under the agreement with Takeda decreased
to $1.3 million for the three months ended March 31, 2010 from $5.2 million for the three months
ended March 31, 2009, generally reflecting a completion of the phase 3 efficacy trials. The revenue
recognized under the agreement with Abbott increased to $2.8 million for the three months ended
March 31, 2010 from $0.4 million for the three months ended March 31, 2009, reflecting the progress
of the Japanese development program for lubiprostone. We are recognizing the revenue from the
payments from Abbott using a percentage-of-completion model over the estimated 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 March 31, 2010 and 2009, we recognized $9.8 million and
$8.9 million, respectively, of product royalty revenue, an increase of $827,000 or 9.2%, reflecting
mainly a higher price per pill and a slight increase in volume.
Co-promotion revenues represent reimbursement by Takeda of co-promotion costs for our
specialty sales force. For each of the three months ended March 31, 2010 and 2009, we recognized
$855,000 and $896,000, respectively, of co-promotion revenues for reimbursement of sales force
costs.
21
Research and Development Expenses
The following summarizes our research and development expenses for the three months ended March 31,
2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Direct costs: |
|
|
|
|
|
|
|
|
Amitiza |
|
$ |
3,774 |
|
|
$ |
6,771 |
|
Cobiprostone |
|
|
145 |
|
|
|
890 |
|
SPI-017 |
|
|
810 |
|
|
|
1,637 |
|
Rescula |
|
|
117 |
|
|
|
|
|
Other |
|
|
61 |
|
|
|
144 |
|
|
|
|
|
|
|
|
Total |
|
|
4,907 |
|
|
|
9,442 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
459 |
|
|
|
523 |
|
|
|
|
|
|
|
|
Total |
|
$ |
5,366 |
|
|
$ |
9,965 |
|
|
|
|
|
|
|
|
Total research and development expenses for the three months ended March 31, 2010 were
$5.4 million compared to $10.0 million for the three months ended March 31, 2009, a decrease of $4.6
million or 46.2%. The decrease was primarily due to the completion in July 2009 of the two phase 3
pivotal clinical trials for the treatment of OBD, the completion in July 2009 of the phase 2 trial of
cobiprostone for the prevention of NSAID-induced ulcers and a reduction in overall preclinical and
basic development costs related to SPI-017.
General and Administrative Expenses
The following summarizes our general and administrative expenses for the three months ended
March 31, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Salaries, benefits and related costs |
|
$ |
1,245 |
|
|
$ |
1,159 |
|
Legal, consulting and other professional expenses |
|
|
3,234 |
|
|
|
1,077 |
|
Other expenses |
|
|
1,280 |
|
|
|
1,219 |
|
|
|
|
|
|
|
|
Total |
|
$ |
5,759 |
|
|
$ |
3,455 |
|
|
|
|
|
|
|
|
General and administrative expenses were $5.8 million for the three months ended March
31, 2010, compared to $3.5 million for the three months ended March 31, 2009, an increase of $2.3
million or 66.7%. The increase in legal, consulting and other professional expenses relates
primarily to costs incurred in connection with the on-going legal matters.
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 March 31, 2010, compared to $2.5
million for the three months ended March 31, 2009, a decrease of $325,000 or 12.9%. The decrease
was primarily due to streamlined commercial operations and a reduction in market research expenses.
Product Royalties - Related Parties
Product royalties related parties expense, representing 3.2% of Amitiza net sales for the
respective periods payable to SAG, increased to $1.7 million for the three months ended March 31,
2010 from $1.6
million for the three months ended March 31, 2009, which was consistent with the increase of
product royalty revenue.
22
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the three months ended
March 31, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Interest income |
|
$ |
211 |
|
|
$ |
312 |
|
Other income (expense), net |
|
|
(92 |
) |
|
|
822 |
|
|
|
|
|
|
|
|
Total |
|
$ |
119 |
|
|
$ |
1,134 |
|
|
|
|
|
|
|
|
Interest income was $211,000 for the three months ended March 31, 2010, compared to
$312,000 for the three months ended March 31, 2009, a decrease of $101,000, or 32.4%. The decrease
was primarily due to lower prevailing interest rates earned by our investments and a shift in the
composition of our portfolio from ARS, which bear higher interest rates, to other types of
investments. The decrease in other income was primarily attributable to foreign exchange gains and
losses and fair value changes in auction rate securities and the related settlement rights.
Income Taxes
We
recorded a tax provision of $205,000 and $401,000 for the three months ended March 31, 2010
and 2009, respectively. The tax provision for the three months ended March 31, 2010 mainly
pertained to taxable income generated by our U.S. subsidiary. Our other subsidiaries, based in
Europe and Japan, incurred a pre-tax loss for the three months ended March 31, 2010, for which no
tax benefit was recognized. As of March 31, 2010, we had an outstanding non-current income tax
liability of approximately $776,000 for uncertain tax positions which represented the aggregate tax
effect of differences between tax return positions and the amounts otherwise recognized in our
condensed consolidated financial statements. The liability for uncertain tax positions as of March
31, 2010 was mainly a result of our interpretation of nexus in certain states related to revenue
sourcing for state income tax purposes.
Reportable Geographic Segments
We have determined that we have three reportable segments based on our method of internal
reporting, which disaggregates business by geographic location. These segments are the Americas,
Europe and Asia. We evaluate the performance of these segments based primarily on income (loss)
from operations, as well as other factors, including the progress of research and development
activities.
The financial results of our segments reflect their varying stages of development. Our
Americas segment recorded income before taxes of $714,000 for the three months ended March 31, 2010
compared to income before taxes of $1.2 million for the three months ended March 31, 2009. These
results primarily reflect the completion of clinical trials for the treatment of OBD and
cobiprostone for the prevention of NSAIDs in 2009.
Our segment in Europe recorded a loss before taxes of $573,000 for the three months ended
March 31, 2010 compared to a loss before taxes of $519,000 for the three months ended March 31,
2009.
Our segment in Asia recorded a loss before taxes of $235,000 for the three months ended March
31, 2010 compared to a loss before taxes of $2.0 million during the three months ended March 31,
2009. These results primarily reflect the $2.8 million in revenue recognized during the three months ended March 31, 2010 from the payments
received from Abbott in 2009.
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
Americas |
|
|
Europe |
|
|
Asia |
|
|
Eliminations |
|
|
Consolidated |
|
Three Months Ended
March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
12,073 |
|
|
$ |
|
|
|
$ |
3,038 |
|
|
$ |
(275 |
) |
|
$ |
14,836 |
|
Income (loss)
before taxes |
|
|
714 |
|
|
|
(573 |
) |
|
|
(235 |
) |
|
|
|
|
|
|
(94 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
15,135 |
|
|
$ |
|
|
|
$ |
589 |
|
|
$ |
(210 |
) |
|
$ |
15,514 |
|
Income (loss)
before taxes |
|
|
1,163 |
|
|
|
(519 |
) |
|
|
(2,018 |
) |
|
|
|
|
|
|
(1,374 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2010 |
|
$ |
134,669 |
|
|
$ |
2,167 |
|
|
$ |
6,489 |
|
|
$ |
(2,424 |
) |
|
$ |
140,901 |
|
As of December 31,
2009 |
|
|
134,714 |
|
|
|
864 |
|
|
|
11,294 |
|
|
|
(1,901 |
) |
|
|
144,971 |
|
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 upfront payments, milestone and royalty payments and research and
development expense reimbursements received from Takeda, Abbott and other parties, private
placements of equity securities and our initial public offering.
Our cash, cash equivalents and investments consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
31,185 |
|
|
$ |
26,714 |
|
Investments, current |
|
|
60,631 |
|
|
|
72,434 |
|
Investments, non-current |
|
|
25,093 |
|
|
|
19,167 |
|
|
|
|
|
|
|
|
Total |
|
$ |
116,909 |
|
|
$ |
118,315 |
|
|
|
|
|
|
|
|
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.
Our total cash, cash equivalents, short and long-term investments decreased by $1.4 million to
$116.9 million at March 31, 2010 from $118.3 million at December 31, 2009 mainly due to the use of
cash in our operating activities.
As of March 31, 2010, our short-term investments consisted of corporate bonds, U.S. government
securities, U.S. Treasury notes and bills, U.S. corporate commercial paper, municipal securities,
certificates of deposits and money market funds which have short-term maturities of one year or
less. Our non-current investments consisted of corporate bonds, U.S. government securities,
investments in ARS, municipal securities and certificates of deposits. Pursuant to a settlement
rights agreement from our ARS broker, we can require the broker to purchase our ARS at par value
between June 30, 2010 and July 2, 2012. We do not anticipate having to sell these securities in
order to operate our business before June 30, 2010.
24
Cash Flows
The following table summarizes our cash flows for the three months ended March 31, 2010 and
2009:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(855 |
) |
|
$ |
7,305 |
|
Investing activities |
|
|
5,295 |
|
|
|
(17,825 |
) |
Financing activities |
|
|
4 |
|
|
|
5 |
|
Effect of exchange rates |
|
|
27 |
|
|
|
(589 |
) |
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
$ |
4,471 |
|
|
$ |
(11,104 |
) |
|
|
|
|
|
|
|
Three Months Ended March 31, 2010
Net cash used in operating activities was $855,000 for the three months ended March 31, 2010.
This reflected a net loss of $299,000 as well as changes in other operating assets and liabilities.
Net cash provided by investing activities of $5.3 million for the three months ended March 31,
2010 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 $4,000 for the three months ended May 31, 2010
resulted from the proceeds we received under our employee stock purchase plan.
Three Months Ended March 31, 2009
Net cash provided by operating activities was $7.3 million for the three months ended March
31, 2009. This reflected a net loss of $1.8 million, which included a non-cash unrealized loss on
settlement rights of $2.4 million, offset in part by a $2.7 million unrealized gain on trading
securities, an increase in deferred revenue of $7.2 million, and an increase in accounts payable of
$1.4 million and a $1.4 million 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.
Net cash used in investing activities of $17.8 million for the three months ended March 31,
2009 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 $5,000 for the three months ended March 31, 2009
resulted from proceeds we received under our employee stock purchase plan.
Off-Balance Sheet Arrangements
As of March 31, 2010, we did not have any off-balance sheet arrangements, as such term is
defined in Item 303(a)(4) of Regulation S-K under the Securities Act of 1933, as amended.
Funding Requirements
We may need substantial amounts of capital to continue growing our business. We may require
this capital, among other things, to:
|
|
|
fund our share of the ongoing development program of Amitiza in the U.S.; |
|
|
|
|
fund development and regulatory efforts in Europe and Asia for lubiprostone; |
|
|
|
|
fund development and regulatory activities for Rescula in the U.S. 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 U.S. and the
initiation of commercialization efforts in non-
U.S. markets; |
|
|
|
|
fund capital expenditures to support the growth of our business; and |
|
|
|
|
fund the purchase of shares of our class A common stock up to $10.0 million, if
we elect to do so, pursuant to our board-
approved stock repurchase program. |
25
The timing of these funding requirements is difficult to predict due to many factors,
including the outcomes of our preclinical and clinical research and development programs and when
those outcomes are determined, the timing of obtaining regulatory approvals and the presence and
status of competing products. Our capital needs may exceed the capital available from our future
operations, collaborative and licensing arrangements and existing liquid assets. Our future capital
requirements and liquidity will depend on many factors, including, but not limited to:
|
|
|
the revenue from Amitiza and Rescula; |
|
|
|
|
the future expenditures we may incur to increase revenue from Amitiza or in our disputes with Takeda; |
|
|
|
|
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. At March 31,
2010, we have sufficient liquidity for the next 12 months.
Additional equity or debt financing, grants or corporate collaboration and licensing
arrangements may not be available on acceptable terms, if at all. If adequate funds are not
available, we may be required to delay, reduce the scope of or eliminate our research and
development programs, reduce our planned commercialization efforts or obtain funds through
arrangements with collaborators or others that may require us to relinquish rights to certain
product candidates that we might otherwise seek to develop or commercialize independently. In
addition, any future equity funding would dilute the ownership of our stockholders.
Effects of Foreign Currency
We currently incur a portion of our operating expenses in the United Kingdom and Japan. The
reporting currency for our consolidated financial statements is U.S. dollars. As such, the results
of our operations could be adversely affected by changes in exchange rates either due to
transaction losses, which are recognized in the statement of operations, or translation losses,
which are recognized in comprehensive income. We currently do not hedge foreign exchange rate
exposure.
Recent Accounting Pronouncements
Recent accounting pronouncements applicable to our financial statements are described in Note
2 to the accompanying condensed consolidated financial statements.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures about Market Risk |
Foreign Exchange Risk
We are subject to foreign exchange risk for revenues and expenses denominated in foreign
currencies. Foreign currency risk arises from the fluctuation of foreign exchange rates and the
degree of volatility of
these rates relative to the United States dollar. We do not believe that we have any material
risk due to foreign currency exchange. We do not currently hedge our foreign currency transactions.
Interest Rate Risk
Our exposure to market risks associated with changes in interest rates relates primarily to
the increase or decrease in the amount of interest income earned on our investment portfolio. We
ensure the safety and preservation of invested funds by attempting to limit default risk, market
risk and reinvestment risk. We attempt to mitigate default risk by investing in investment grade
securities. A hypothetical one percentage point decline in interest rates would not have materially
affected the fair value of our interest-sensitive financial instruments as of March 31, 2010.
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.
26
Credit Risk
Our exposure to credit risk consists of cash and cash equivalents, restricted cash,
investments and receivables. We place our cash, cash equivalents and restricted cash with what we
believe to be highly rated financial institutions and invest the excess cash in highly rated
investments. As of March 31, 2010 and December 31, 2009, approximately 44.5% and 51.2%,
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 March 31, 2010, we had $8.9 million at fair value invested in one non-mortgage related
ARS. Pursuant to the $10.0 million settlement rights offered by our ARS broker, we have the right
to require the broker to purchase this ARS at par value of $10.0 million at any time during the
two-year period beginning June 30, 2010. We recorded the fair value of the ARS settlement right of
approximately $1.1 million in other non-current assets in the accompanying condensed consolidated
balance sheet.
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Item 4. |
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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 March 31, 2010. 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 March 31, 2010, 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 March 31, 2010 that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
27
Part II OTHER INFORMATION
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Item 1. |
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Legal Proceedings |
On March 12, 2010, we submitted for filing with the International Court of Arbitration,
International Chamber of Commerce a demand for arbitration under the applicable provisions of the
Collaboration and License Agreement between us and Takeda Pharmaceuticals Company Limited dated
October 29, 2004. We are disappointed with the level of U.S. sales of Amitiza being generated by
Takeda and what we
believe to be other failures of performance by Takeda under the agreements. We believe that
Takeda materially breached its agreement, without limitation, by its continuing failure to exercise
its best efforts to commercialize Amitiza and maximize net sales revenue, and its ongoing refusal
to collaborate and provide us with information to which we are entitled under the agreement. We
also claimed that Takedas conduct, including, without limitation, its dealings with pharmacy
benefit managers/managed care organizations, has injured not only us and the Amitiza brand, but
also consumers. We are seeking all appropriate relief, including production by Takeda of all
information to which we are entitled, a declaration of termination of applicable agreements, and
all available monetary relief, equitable relief, attorneys fees and costs. Both the Company and
Takeda have selected their respective arbitrators and if confirmed will select a third arbitrator
to comprise the panel that will conduct the arbitration proceedings. We spent and expect to spend
significant resources in the dispute with Takeda and these legal proceedings may require the
continuing attention of our senior management.
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, 2009, filed by us with the SEC on March 15, 2010.
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Item 2. |
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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 March 31, 2010, we did not purchase any shares under
this program.
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Item 3. |
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Defaults Upon Senior Securities. |
None.
28
(a) Exhibits
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Exhibit |
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Number |
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Description |
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Reference |
|
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|
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3.1
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Certificate of Incorporation
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Exhibit 3.1 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
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3.2
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Certificate of Amendment
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Exhibit 3.2 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
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3.3
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Restated Bylaws
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Exhibit 3.3 to the
Companys Current
Report on Form 8-K
(filed December 29,
2008) |
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4.1
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Specimen Stock Certificate
evidencing the shares of class
A common stock
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Exhibit 4.1 to
Registration Statement
No. 333-135133,
Amendment No. 5 (filed
February 1, 2007) |
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31.1
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Certification of the Principal
Executive Officer, as required
by Section 302 of the
Sarbanes-Oxley Act of 2002
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Included herewith |
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31.2
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Certification of the Principal
Financial Officer, as required
by Section 302 of the
Sarbanes-Oxley Act of 2002
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Included herewith |
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32.1
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|
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
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Included herewith |
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32.2
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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
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|
Included herewith |
29
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.
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Sucampo Pharmaceuticals, Inc.
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May 10, 2010 |
By: |
/s/ RYUJI UENO
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Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
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|
Chief Executive Officer, Chief Scientific Officer
and
Chairman of the Board of Directors
(Principal Executive Officer) |
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May 10, 2010 |
By: |
/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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30
Sucampo Pharmaceuticals, Inc.
Exhibit Index
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|
|
|
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) |
|
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|
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3.3
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|
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) |
|
|
|
|
|
31.1
|
|
Certification of the Principal
Executive Officer, as required
by Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
|
|
|
|
|
31.2
|
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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 |
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. |
|
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|
|
Date: May 10, 2010 |
/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. |
|
|
|
|
|
Date: May 10, 2010 |
/s/ JAN SMILEK
|
|
|
Jan Smilek |
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
Exhibit 32.1
EXHIBIT 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350,
chapter 63 of title 18, United States Code), the undersigned officer of Sucampo Pharmaceuticals,
Inc. (the Company) certifies to the best of his knowledge that:
(1) |
|
The Quarterly Report on Form 10-Q for the year ended March 31, 2010 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 |
(2) |
|
The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company. |
|
|
|
|
|
Date: May 10, 2010 |
/s/ RYUJI UENO
|
|
|
Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
Exhibit 32.2
EXHIBIT 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350,
chapter 63 of title 18, United States Code), the undersigned officer of Sucampo Pharmaceuticals,
Inc. (the Company) certifies to the best of her knowledge that:
(1) |
|
The Quarterly Report on Form 10-Q for the year ended March 31, 2010 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 |
(2) |
|
The information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company. |
|
|
|
|
|
Date: May 10, 2010 |
/s/ JAN SMILEK
|
|
|
Jan Smilek |
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
|