e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2008
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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13-3929237 |
(State or other jurisdiction of
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(I.R.S. employer |
incorporation or organization)
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identification no.) |
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4520 East-West Highway, Suite 300
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(301) 961-3400 |
Bethesda, MD 20814
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(Registrants telephone number, |
(Address of principal executive offices,
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including area code) |
including zip code) |
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions
of large accelerated filer, accelerated filer and smaller reporting
company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o | |
Accelerated filer
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Non-accelerated filer
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As
of November 13, 2008, there were 15,650,398 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
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Page |
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Part I. FINANCIAL INFORMATION |
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Item 1. |
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Condensed Consolidated Financial Statements (unaudited) |
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1 |
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Condensed Consolidated Balance Sheets as of September 30, 2008 and December 31, 2007 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income for the Three and Nine Months Ended September 30, 2008 and 2007 |
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2 |
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Condensed Consolidated Statement of Changes in Stockholders Equity for the Nine Months Ended September 30, 2008 |
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3 |
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Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2008 and 2007 |
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4 |
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Notes to Condensed Consolidated Financial Statements |
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5 |
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Item 2. |
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Managements Discussion and Analysis of Financial Condition and Results of Operations |
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17 |
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
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27 |
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Item 4. |
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Controls and Procedures |
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27 |
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Part II. OTHER INFORMATION |
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Item 1. |
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Legal Proceedings |
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27 |
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Item 1A. |
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Risk Factors |
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27 |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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29 |
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Item 4. |
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Submission of Matters to a Vote of Security Holders |
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29 |
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Item 6. |
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Exhibits |
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30 |
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SIGNATURES |
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31 |
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INDEX TO EXHIBITS |
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32 |
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PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (Unaudited)
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share data)
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September 30, |
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December 31, |
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2008 |
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2007 |
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ASSETS: |
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Current assets: |
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Cash and cash equivalents |
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$ |
13,364 |
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$ |
25,559 |
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Investments, current |
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93,117 |
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51,552 |
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Product royalties receivable |
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7,611 |
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8,667 |
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Unbilled accounts receivable |
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4,664 |
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5,883 |
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Accounts receivable |
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1,076 |
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1,525 |
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Prepaid and income taxes receivable |
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119 |
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1,922 |
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Deferred tax assets, net |
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1,066 |
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88 |
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Prepaid expenses and other current assets |
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2,226 |
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2,222 |
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Total current assets |
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123,243 |
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97,418 |
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Investments, non-current |
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17,626 |
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9,400 |
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Property and equipment, net |
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2,283 |
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2,265 |
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Deferred tax assets noncurrent, net |
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4,566 |
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551 |
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Other assets |
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401 |
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393 |
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Total assets |
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$ |
148,119 |
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$ |
110,027 |
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LIABILITIES AND STOCKHOLDERS EQUITY: |
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Current liabilities: |
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Accounts payable |
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$ |
2,959 |
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$ |
3,313 |
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Accrued expenses |
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12,491 |
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8,730 |
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Deferred revenue current |
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6,379 |
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1,062 |
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Income taxes payable |
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1,420 |
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Total current liabilities |
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23,249 |
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13,105 |
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Deferred revenue, net of current portion |
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8,202 |
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8,626 |
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Other liabilities |
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1,615 |
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1,768 |
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Total liabilities |
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33,066 |
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23,499 |
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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 September 30, 2008 and
December 31, 2007; no shares issued and
outstanding at September 30, 2008 and
December 31, 2007 |
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Class A common stock, $0.01 par value;
270,000,000 shares authorized at September
30, 2008 and December 31, 2007; 15,650,398
and 15,538,518 shares issued and
outstanding at September 30, 2008 and
December 31, 2007, respectively |
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156 |
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155 |
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Class B common stock, $0.01 par value;
75,000,000 shares authorized at September
30, 2008 and December 31, 2007; 26,191,050
shares issued and outstanding at September
30, 2008 and
December 31, 2007 |
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262 |
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262 |
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Additional paid-in capital |
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98,272 |
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96,680 |
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Accumulated other comprehensive loss |
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(1,416 |
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(393 |
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Retained earnings (accumulated deficit) |
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17,779 |
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(10,176 |
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Total stockholders equity |
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115,053 |
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86,528 |
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Total liabilities and stockholders equity |
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$ |
148,119 |
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$ |
110,027 |
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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 (Loss) Income (Unaudited)
(In thousands, except per share data)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Revenues: |
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Research and development revenue |
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$ |
5,436 |
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$ |
4,652 |
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$ |
66,982 |
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$ |
52,105 |
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Product royalty revenue |
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7,718 |
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6,998 |
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24,699 |
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18,869 |
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Co-promotion revenue |
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1,185 |
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1,051 |
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3,643 |
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3,318 |
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Contract and collaboration revenue |
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142 |
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151 |
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425 |
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454 |
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Total revenues |
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14,481 |
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12,852 |
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95,749 |
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74,746 |
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Operating expenses: |
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Research and development |
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11,390 |
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7,588 |
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35,537 |
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22,278 |
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General and administrative |
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3,863 |
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2,116 |
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10,591 |
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17,286 |
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Selling and marketing |
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2,680 |
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2,779 |
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8,398 |
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9,806 |
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Milestone royalties related parties |
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3,531 |
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1,500 |
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Product royalties related parties |
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1,359 |
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1,244 |
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4,391 |
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3,354 |
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Total operating expenses |
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19,292 |
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13,727 |
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62,448 |
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54,224 |
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(Loss) income from operations |
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(4,811 |
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(875 |
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33,301 |
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20,522 |
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Non-operating income (expense): |
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Interest income |
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655 |
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780 |
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1,862 |
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1,575 |
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Other expense, net |
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(15 |
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(228 |
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(16 |
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(192 |
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Total non-operating income, net |
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640 |
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552 |
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1,846 |
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1,383 |
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(Loss) income before income taxes |
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(4,171 |
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(323 |
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35,147 |
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21,905 |
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Income tax benefit (provision) |
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1,745 |
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(151 |
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(7,192 |
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(7,980 |
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Net (loss) income |
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$ |
(2,426 |
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$ |
(474 |
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$ |
27,955 |
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$ |
13,925 |
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Net (loss) income per share: |
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Basic net (loss) income per share |
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$ |
(0.06 |
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$ |
(0.01 |
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$ |
0.67 |
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$ |
0.38 |
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Diluted net (loss) income per share |
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$ |
(0.06 |
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$ |
(0.01 |
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$ |
0.67 |
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$ |
0.38 |
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Weighted average common shares outstanding basic |
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41,813 |
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39,312 |
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41,768 |
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36,447 |
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Weighted average common shares outstanding diluted |
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41,813 |
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39,312 |
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42,022 |
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36,835 |
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Comprehensive income: |
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Net (loss) income |
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$ |
(2,426 |
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$ |
(474 |
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$ |
27,955 |
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$ |
13,925 |
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Other comprehensive (loss) income: |
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Unrealized gain (loss) on investments, net of tax effect |
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374 |
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(1,082 |
) |
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Foreign currency translation |
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54 |
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281 |
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59 |
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205 |
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Comprehensive (loss) income |
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$ |
(1,998 |
) |
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$ |
(193 |
) |
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$ |
26,932 |
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$ |
14,130 |
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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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Retained |
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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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Earnings |
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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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(Accumulated |
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Stockholders |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Loss |
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Deficit) |
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Equity |
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Balance at December 31, 2007 |
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15,538,518 |
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$ |
155 |
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26,191,050 |
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$ |
262 |
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$ |
96,680 |
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$ |
(393 |
) |
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$ |
(10,176 |
) |
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$ |
86,528 |
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Stock issued upon exercise of stock options |
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111,880 |
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1 |
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|
869 |
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870 |
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Employee stock option expense, net of tax benefit |
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|
723 |
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|
723 |
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Foreign currency translation |
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59 |
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59 |
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Unrealized loss on investments, net of tax effect |
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(1,082 |
) |
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(1,082 |
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Net income |
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27,955 |
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27,955 |
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Balance at September 30, 2008 |
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15,650,398 |
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|
$ |
156 |
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26,191,050 |
|
|
$ |
262 |
|
|
$ |
98,272 |
|
|
$ |
(1,416 |
) |
|
$ |
17,779 |
|
|
$ |
115,053 |
|
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In thousands)
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Nine Months Ended September 30, |
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|
2008 |
|
|
2007 |
|
Cash flows from operating activities: |
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Net income |
|
$ |
27,955 |
|
|
$ |
13,925 |
|
Adjustments to reconcile net income to net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
326 |
|
|
|
153 |
|
Loss on disposal of property and equipment |
|
|
|
|
|
|
63 |
|
Deferred tax (benefit) provision |
|
|
(4,312 |
) |
|
|
4,413 |
|
Stock-based compensation |
|
|
567 |
|
|
|
6,144 |
|
Accretion of discounts on investments |
|
|
(95 |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
493 |
|
|
|
(2,831 |
) |
Unbilled accounts receivable |
|
|
1,219 |
|
|
|
|
|
Product royalties receivable |
|
|
1,055 |
|
|
|
(4,969 |
) |
Prepaid and income taxes receivable and payable, net |
|
|
3,224 |
|
|
|
(759 |
) |
Accounts payable |
|
|
(415 |
) |
|
|
1,951 |
|
Accrued expenses |
|
|
3,815 |
|
|
|
1,145 |
|
Deferred revenue |
|
|
4,893 |
|
|
|
(11,376 |
) |
Other assets and liabilities, net |
|
|
(114 |
) |
|
|
549 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
38,611 |
|
|
|
8,408 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of investments |
|
|
(135,584 |
) |
|
|
(86,847 |
) |
Proceeds from sales of investments |
|
|
41,000 |
|
|
|
55,795 |
|
Maturities of investments |
|
|
43,125 |
|
|
|
|
|
Purchases of property and equipment |
|
|
(342 |
) |
|
|
(2,128 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(51,801 |
) |
|
|
(33,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
870 |
|
|
|
|
|
Excess tax benefits from share-based payments |
|
|
155 |
|
|
|
|
|
Issuance of common stock, net of offering costs |
|
|
|
|
|
|
31,341 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,025 |
|
|
|
31,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
(30 |
) |
|
|
186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(12,195 |
) |
|
|
6,755 |
|
Cash and cash equivalents at beginning of period |
|
|
25,559 |
|
|
|
22,481 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
13,364 |
|
|
$ |
29,236 |
|
|
|
|
|
|
|
|
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. (Sucampo or the Company) is a biopharmaceutical company focused
on the discovery, development and commercialization of proprietary drugs based on prostones, a
class of compounds derived from functional fatty acids that occur naturally in the human body.
Sucampo is focused on developing prostones for the treatment of gastrointestinal, respiratory,
vascular and central nervous system diseases and disorders.
The Company is party to a collaboration and license agreement with Takeda Pharmaceutical
Company Limited (Takeda) to jointly develop and commercialize AMITIZA® (lubiprostone)
for chronic idiopathic constipation, irritable bowel syndrome with constipation, opioid-induced
bowel dysfunction and other gastrointestinal indications in the United States and Canada. In
January 2006, the Company received marketing approval from the U.S. Food and Drug Administration
(FDA) for AMITIZAs first indication to treat chronic idiopathic constipation in adults.
Commercialization of AMITIZA began in April 2006 throughout the United States. On April 29, 2008,
the Company received marketing approval from the FDA for AMITIZA to treat irritable bowel syndrome
with constipation in women 18 years of age or older. Commercialization for this indication began in
May 2008 throughout the United States. The Company is currently conducting Phase III pivotal
clinical trials of AMITIZA for the treatment of opioid-induced bowel dysfunction.
The Companys founders own directly or indirectly the majority holdings in Sucampo as well as
in other companies that have contractual relationships with Sucampo. One of the Companys founders
serves as the Chairman of the Board of Directors, Chief Executive Officer and Chief Scientific
Officer of the Company.
The Companys international operations are conducted through its subsidiaries in the United
Kingdom and Japan.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of the Company have
been prepared in accordance with accounting principles generally accepted in the United States of
America (GAAP) and the rules and regulations of the Securities and Exchange Commission (SEC) for
interim financial information. Accordingly, they do not include all of the information and
footnotes required by GAAP for complete financial statements and should be read in conjunction with
the Companys consolidated financial statements as of and for the year ended December 31, 2007,
included in the Companys Annual Report on Form 10-K. The financial information as of September 30,
2008 and for the three and nine months ended September 30, 2008 and 2007 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 Sucampo and its
wholly-owned subsidiaries. All significant inter-company balances and transactions have been
eliminated in the consolidated accounts.
2. Summary of Significant Accounting Policies
Current and Non-Current Investments
Current and non-current investments consist primarily of U.S. Treasury bills and notes and
auction rate securities. The Companys investments in these securities are classified as
available-for-sale securities under Statement of Financial Accounting Standards (SFAS) No. 115,
Accounting for Certain Investments in Debt and Equity Securities (SFAS 115).
The
available-for-sale securities are accounted for at fair market value and unrealized gains and
losses on these securities, if any, are included in accumulated other comprehensive loss in
stockholders equity. The fair value of the securities is measured in accordance with SFAS No. 157,
Fair Value Measurements (SFAS 157), which was adopted by the Company on January 1, 2008.
SFAS 157 addresses how companies should measure fair value when they are required to use a fair
value measure for recognition and disclosure purposes under generally accepted accounting
principles. The Company assesses the recoverability of its available-for-sale securities and, if
impairment is indicated, the Company measures the amount of such impairment by comparing the fair
value to the carrying value. Other-than-temporary impairments are included in the condensed
consolidated statement of operations and comprehensive (loss) income. Any future fluctuation in
fair value related to these instruments that the Company deems to be temporary, including any
recoveries of previous write-downs, will be recorded to other comprehensive income.
5
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The adoption of SFAS 157 did not materially affect the Companys financial condition, its
results of operations, or its cash flows. SFAS 157 establishes a three-tier fair value hierarchy,
which prioritizes the inputs used in measuring fair value. These tiers include: Level 1, defined as
observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than
quoted prices in active markets that are either directly or indirectly observable; and Level 3,
defined as unobservable inputs in which little or no market data exists, therefore requiring an
entity to develop its own assumptions. See additional disclosures related to the determination of
the fair value of the Companys investments (see Note 4).
The Company also adopted SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, Including an Amendment of FASB Statement No. 115 (SFAS 159), which permits
entities to measure many financial instruments and certain other assets and liabilities at fair
value on an instrument-by-instrument basis, on January 1, 2008. The adoption of SFAS 159 did not
materially affect the Companys financial condition, results of operations, or cash flows as the
Company has not elected to account for any assets or liabilities at fair value on an
instrument-by-instrument basis.
Certain Risks, Concentrations and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of
credit risk consist of cash and cash equivalents, restricted cash, investments and receivables. The
Company places its cash and cash equivalents, restricted cash and investments with highly rated
financial institutions. At September 30, 2008 and December 31, 2007, the Company had approximately
$98.1 million and $85.9 million, respectively, of cash and cash equivalents, restricted cash and
investments in excess of government insured limits. The Companys uninsured cash, cash equivalents
and investments as of September 30, 2008 consist primarily of $70.8 million of T-bills and notes
and $18.9 million of money market funds guaranteed under the U.S. Treasurys Temporary Guarantee
Program. The Company has not experienced any losses on these accounts related to amounts in excess
of insured limits.
At September 30, 2008, the Company holds $21.0 million of investments in auction rate
securities at fair value and has recorded a cumulative unrealized loss of $1.9 million, or $1.2
million net of tax effect, as of September 30, 2008 related to these investments. This unrealized
loss was recorded as other comprehensive loss during the nine months ended September 30, 2008.
On October 16, 2008, the Company accepted the settlement rights offered by the Companys
broker under a settlement agreement between the broker and the SEC and various state regulatory
authorities. The settlement rights allow the Company to redeem auction rate securities at par
within a specified period. Based on this settlement, the Company received $3.4 million on November
3, 2008, representing the par value of its tax-exempt auction rate securities and has the right to
request the redemption of the remaining auction rate securities at par value of an additional $19.4
million within, the two-year period starting June 30, 2010. As the settlement was accepted
subsequent to September 30, 2008, the Companys consolidated financial statements as of September
30, 2008 do not reflect any contingent gains, valuation adjustments or any other amounts relating
to the settlement rights. The Company has, however, classified auction rate securities as current
and non-current investments as of September 30, 2008 based on the expected redemption dates. The
Company does not anticipate having to sell these securities in order to operate its business before
the expected redemption dates.
The Companys product, AMITIZA, and other candidates under development require approval from
the FDA or other international regulatory agencies prior to commercial sales. For those product
candidates 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 product, AMITIZA, competes in a rapidly changing, highly competitive market,
which is characterized by advances in scientific discovery, changes in customer requirements,
evolving regulatory requirements and developing industry standards. Any failure by the Company to
anticipate or to respond adequately to scientific developments in its industry, changes in customer
requirements or changes in regulatory requirements or industry standards, or any significant delays
in the development or introduction of products or services could have a material adverse effect on
the Companys business, operating results and future cash flows.
6
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, research and development efforts to develop new products, 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 product royalty revenue as well as with cash received from milestones and other
revenue related to its joint collaboration and license agreement and the supplemental agreement
entered into with Takeda (see Note 9).
The Company depends significantly upon the collaboration with Takeda and the Companys
activities may be affected if this relationship is disrupted. Revenues from Takeda accounted for
more than 99% of the Companys total revenues for the three months ended September 30, 2008 and
2007 and the nine months ended September 30, 2008 and 2007. Accounts receivable, unbilled accounts
receivable and product royalties receivable from Takeda accounted for 98% and 99% of the Companys
accounts receivable, unbilled accounts receivable and product royalties receivable at September 30,
2008 and December 31, 2007, respectively (see Note 9).
The Company has an exclusive supply arrangement with R-Tech Ueno, Ltd (R-Tech), an affiliate,
to provide it with commercial and clinical supplies of its product and product candidates. R-Tech
also provides certain preclinical and other research and development services. Any difficulties or
delays in performing the services under these arrangements may cause the Company to lose revenues,
delay research and development activities or otherwise disrupt the Companys operations (see Note
8).
The Company has previously entered into a restated license agreement with Sucampo AG (SAG) to
grant the Company a royalty-bearing, exclusive, worldwide license to develop prostone compounds,
including AMITIZA and cobiprostone. SAG is a Swiss-patent holding company and an affiliate. 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 (see Note 8).
Deferred Revenue
Deferred revenue represents payments received or receivables for licensing fees, option fees,
consulting, research and development contracts and related cost sharing and supply agreements that
are deferred until revenue can be recognized under the Companys revenue recognition policy.
Deferred revenue is classified as current if management believes the Company will be able to
recognize the deferred amount as revenue within 12 months of the balance sheet date. During the
second quarter of 2008, the Company agreed to receive quarterly prepayments from Takeda for its
research and development expenses under the agreements with Takeda. As of September 30, 2008,
approximately $1.9 million of deferred revenue relates to these prepayments (see Note 6).
Reclassifications
Certain amounts in the previously issued financial statements have been reclassified to
conform with the current presentation. The Company reclassified expenses that have been previously
included within general and administrative expenses to research and development expenses. Such
expenses primarily include salaries and other employee benefits of personnel who oversee the
research and development process, and allocated depreciation and rent expenses and insurance costs.
The Company also reclassified allocated depreciation and rent expenses and insurance costs from
general and administrative expenses to selling and marketing expenses.
During the three months ended September 30, 2007, the Company reclassified $828,000 and
$84,000 of general and administrative expenses to research and development expenses and selling and
marketing expenses, respectively. During the nine months ended September 30, 2007, the Company
reclassified approximately $2.2 million and $154,000 of general and administrative expenses to
research and development expenses and selling and marketing expenses, respectively.
Cumulative Out-of-Period Adjustment
The Company recorded a cumulative adjustment of approximately $148,000 during the nine months
ended September 30, 2008 to recognize additional research and development expenses that have not
been recorded in prior periods. The error resulted from incorrect accounting for investigator
services for the Phase IIb study of lubiprostone for adult chronic idiopathic constipation
initiated in Japan in the fourth quarter of 2007. The effect of this adjustment on the consolidated
financial statements was not material for the year ended December 31, 2007 or for the period in
which it was recorded, as the adjustment consisted of insignificant amounts related to each of
these periods.
7
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
Changes in Estimate
In June 2006, a joint committee comprised of representatives of the Company and Takeda (the
Joint Commercialization Committee) granted approval for the Company and Takeda to begin three
studies related to funding arrangements discussed in the collaboration and license agreement and
its supplement. The Company accounts for these three required deliverables as a single unit of
accounting for revenue recognition purposes. Effective April 1, 2008, as a result of
lower-than-expected patient enrollment in one of the studies, the Joint Commercialization Committee
approved an increase in funding for patient recruitment. Additionally, the Company concluded that
the estimated completion of these trials would be extended from June 2009 to December 2009. As
such, the Company determined that the recognition period for associated research and development
revenue should be extended. The related research and development revenue is limited to the lesser
of the actual cumulative reimbursable costs incurred or the cumulative straight-line amount of
revenue recognized over the estimated performance period. As a result of the extended completion
date and an increase of total expected reimbursable costs, the Company deferred approximately $1.9
million and $3.6 million in research and development revenue for the three and nine months ended
September 30, 2008, respectively. The Company expects to recognize the deferred revenue of $3.6
million in 2009. Under the provision of SFAS No. 154, Accounting Changes and Error Corrections, a
replacement of APB Opinion No. 20 and FASB Statement No. 3 (SFAS 154), the Company will recognize
this as a change in estimate on a prospective basis from April 1, 2008.
During the three months ended September 30, 2008, as additional historic information became
available, the Company refined its estimated rebates, discounts and other expenses deducted from
Takedas gross sales in order to calculate Takedas net sales and product royalties due from Takeda
to the Company. As a result of this, the Company recorded a reduction to its product royalty
revenues of $644,000 during the three months ended September 30, 2008.
The above changes in estimate have the following impact on net income and basic and diluted
net income per share for the three and nine months ended September 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
(In thousands, except per share data) |
|
September 30, 2008 |
|
September 30, 2008 |
Decrease in revenue and income before income taxes |
|
$ |
(2,570 |
) |
|
$ |
(4,263 |
) |
Impact on basic net (loss) income per share |
|
|
(0.03 |
) |
|
|
(0.02 |
) |
Impact on diluted net (loss) income per share |
|
|
(0.03 |
) |
|
|
(0.02 |
) |
Recent Accounting Pronouncements
In June 2007, the Emerging Issues Task Force (EITF) issued EITF Issue No. 07-3, Accounting
for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities (EITF 07-3), which provides guidance to
research and development companies on how to account for the nonrefundable portion of an
advance payment made for research and development activities. The Company adopted EITF 07-3 as of
January 1, 2008 and there was no material impact upon its adoption.
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 141 (revised 2007), Business Combinations (SFAS 141R)
and SFAS No. 160, Noncontrolling Interests in Consolidated Financial Statements, an amendment of Accounting Research Bulletin No. 51 (SFAS 160).
SFAS 141R will change how business acquisitions are accounted for and will impact financial
statements both on the acquisition date and in subsequent periods. SFAS 160 will change the
accounting and reporting for minority interests, which will be recharacterized as noncontrolling
interests and classified as a component of equity. SFAS 141R and SFAS 160 will be applied to
acquisitions that close in years beginning after December 15, 2008. Early adoption is not
permitted. SFAS 141R and SFAS 160 will not have any impact on the Companys future consolidated
financial statements unless it undertakes an acquisition in the future.
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements (EITF 07-1). The consensus prohibits the equity method of accounting for
collaborative arrangements under Accounting Principles Board No. 18, The Equity Method of
Accounting for Investments in Common Stock", unless a legal entity exists. Payments between the
collaborative partners will be evaluated and reported in the income statement based on applicable
GAAP. Absent specific GAAP, the participants to the arrangement will apply other existing GAAP by
analogy or apply a reasonable and rational accounting policy consistently. The guidance in EITF
07-1 is effective for periods that begin after December 15, 2008 and will apply to arrangements in
existence as of the effective date. The effect of the new consensus will be accounted for as a
change in accounting principle through retrospective application. EITF 07-1 will not have any
impact on the consolidated financial statements upon adoption.
8
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
In February 2008, the FASB agreed to delay the effective date of SFAS 157 for all nonfinancial
assets and nonfinancial liabilities, except those that are recognized or disclosed at fair value in
the financial statements on a recurring basis, to fiscal years beginning after November 15, 2008.
The Company adopted SFAS 157 with respect to its financial assets and liabilities as of January 1,
2008 and does not expect that the adoption of SFAS 157 for its nonfinancial assets and liabilities
will have a significant impact on its financial position or results from operations.
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, except when their inclusion would be anti-dilutive.
The computation of net income per share for the three and nine months ended September 30, 2008
and 2007 is shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
(In thousands, except per share data) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Basic net (loss) income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(2,426 |
) |
|
$ |
(474 |
) |
|
$ |
27,955 |
|
|
$ |
13,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares outstanding |
|
|
41,813 |
|
|
|
37,252 |
|
|
|
41,768 |
|
|
|
35,753 |
|
Conversion of series A preferred
stock to class A common shares
outstanding |
|
|
|
|
|
|
2,060 |
|
|
|
|
|
|
|
694 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,813 |
|
|
|
39,312 |
|
|
|
41,768 |
|
|
|
36,447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net (loss) income per share |
|
$ |
(0.06 |
) |
|
$ |
(0.01 |
) |
|
$ |
0.67 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net (loss) income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(2,426 |
) |
|
$ |
(474 |
) |
|
$ |
27,955 |
|
|
$ |
13,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares outstanding for
diluted net income per share |
|
|
41,813 |
|
|
|
39,312 |
|
|
|
41,768 |
|
|
|
36,447 |
|
Assumed exercise of stock options
under the treasury stock method |
|
|
|
|
|
|
|
|
|
|
254 |
|
|
|
388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41,813 |
|
|
|
39,312 |
|
|
|
42,022 |
|
|
|
36,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net (loss) income per share |
|
$ |
(0.06 |
) |
|
$ |
(0.01 |
) |
|
$ |
0.67 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The potentially dilutive securities used in the calculations of diluted historical net income
per share as of the nine months ended September 30, 2008 and 2007 are as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
(In thousands) |
|
2008 |
|
2007 |
Employee stock options |
|
|
381 |
|
|
|
641 |
|
Non-employee stock options |
|
|
450 |
|
|
|
510 |
|
Potentially dilutive securities representing approximately 407,000 and nil shares of common
stock for the three months ended September 30, 2008 and 2007, respectively, were excluded from the
computation of diluted earnings per share for the periods because their effect would have been
anti-dilutive.
4. Current and Non-Current Investments
At September 30, 2008 and December 31, 2007, current and non-current available-for-sale
investments consisted of the following securities:
9
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2008 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills and notes |
|
$ |
70,716 |
|
|
$ |
115 |
|
|
$ |
|
|
|
$ |
70,831 |
|
Auction rate securities |
|
|
3,475 |
|
|
|
|
|
|
|
(104 |
) |
|
|
3,371 |
|
Money market funds |
|
|
18,915 |
|
|
|
|
|
|
|
|
|
|
|
18,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
93,106 |
|
|
$ |
115 |
|
|
$ |
(104 |
) |
|
$ |
93,117 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
$ |
19,400 |
|
|
$ |
|
|
|
$ |
(1,774 |
) |
|
$ |
17,626 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
$ |
51,500 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
51,500 |
|
Money market funds |
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
51,552 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
51,552 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
$ |
9,400 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
9,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys assets measured at fair value on a recurring basis, which are subject to the
disclosure requirements of SFAS 157, at September 30, 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Unobservable |
|
|
Total as of |
|
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
September 30, |
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
2008 |
|
U.S. Treasury bills and notes |
|
$ |
70,831 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
70,831 |
|
Auction rate securities |
|
|
|
|
|
|
|
|
|
|
20,997 |
|
|
|
20,997 |
|
Other available-for-sale securities |
|
|
18,915 |
|
|
|
|
|
|
|
|
|
|
|
18,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
89,746 |
|
|
$ |
|
|
|
$ |
20,997 |
|
|
$ |
110,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Based on market conditions, the Company changed its valuation methodology for auction rate
securities to a valuation method that includes market and income approaches during the first
quarter of 2008. Accordingly, these securities changed from Level 1 to Level 3 within SFAS 157s
valuation hierarchy at the time of the Companys initial adoption of SFAS 157 at January 1, 2008.
The Level 2 securities consist of the auction rate securities that were redeemed at par during
2008. The following table presents the Companys assets measured at fair value on a recurring basis
using significant observable inputs (Level 2) and significant unobservable inputs (Level 3) as
defined in SFAS 157 during the nine months ended September 30, 2008:
|
|
|
|
|
|
|
Auction Rate |
|
(In thousands) |
|
Securities |
|
Balance at January 1, 2008 |
|
$ |
9,400 |
|
Transfers to Level 2 |
|
|
(3,900 |
) |
Transfers to Level 3 |
|
|
51,500 |
|
Total gains (losses) (realized or unrealized): |
|
|
|
|
Included in earnings |
|
|
|
|
Included in other comprehensive loss |
|
|
(1,878 |
) |
Purchases |
|
|
5,100 |
|
Settlements |
|
|
(39,225 |
) |
|
|
|
|
Balance at September 30, 2008 |
|
$ |
20,997 |
|
|
|
|
|
10
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
5. Accrued Expenses
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Research and development costs |
|
$ |
7,717 |
|
|
$ |
4,422 |
|
Selling and marketing costs |
|
|
352 |
|
|
|
384 |
|
Employee compensation |
|
|
1,589 |
|
|
|
1,867 |
|
Legal service fees |
|
|
268 |
|
|
|
226 |
|
Product royalty liability related party |
|
|
1,706 |
|
|
|
1,536 |
|
Other accrued expenses |
|
|
859 |
|
|
|
295 |
|
|
|
|
|
|
|
|
|
|
$ |
12,491 |
|
|
$ |
8,730 |
|
|
|
|
|
|
|
|
6. Deferred Revenue
Total deferred revenue consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Deferred revenue current |
|
$ |
6,379 |
|
|
$ |
1,062 |
|
Deferred revenue, net of current portion |
|
|
8,202 |
|
|
|
8,626 |
|
|
|
|
|
|
|
|
|
|
$ |
14,581 |
|
|
$ |
9,688 |
|
|
|
|
|
|
|
|
During the second quarter of 2008, the Company agreed to receive quarterly prepayments from
Takeda for its research and development expenses under the agreements with Takeda. As of September
30, 2008, approximately $1.9 million of deferred revenue relates to these prepayments. As a result
of the change in estimate (see Note 2) resulting from an extended completion date and an increase
of total expected reimbursable costs of certain clinical studies, the Company deferred
approximately $3.6 million in research and development revenue as of September 30, 2008.
7. Commitments
Operating Leases
The Company leases office space in the United States, United Kingdom and Japan under operating
leases through 2017. Total future minimum, non-cancelable lease payments under operating leases,
which do not include future sublease receipts of $299,000, are as follows as of September 30, 2008:
|
|
|
|
|
(In thousands) |
|
|
|
|
2008 |
|
$ |
402 |
|
2009 |
|
|
1,520 |
|
2010 |
|
|
1,049 |
|
2011 |
|
|
938 |
|
2012 |
|
|
963 |
|
2013 and thereafter |
|
|
4,243 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
9,115 |
|
|
|
|
|
Rent expense for all operating leases was $296,000 and $288,000 for the three months ended
September 30, 2008 and 2007, respectively, and $874,000 and $751,000 for the nine months ended
September 30, 2008 and 2007, respectively.
Research and Development Costs
The Company routinely enters into agreements with clinical research organizations (CROs), to
oversee clinical research and development studies provided on an outsourced basis and assist in
other research and development activities. The Company generally is not contractually obligated to
pay the third party if the service or reports are not provided. Total future estimated costs under
these agreements as of September 30, 2008 were approximately $14.3 million.
11
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
8. Related Party Transactions
R-Tech Ueno, Ltd.
The Company is a party to multiple exclusive clinical and commercial supply agreements with
R-Tech, whereby R-Tech manufactures and supplies AMITIZA and other prostone compounds for Sucampo.
Also, R-Tech sells commercial supplies of AMITIZA directly to Takeda, which are not recorded in the
books of Sucampo.
The following table summarizes the Companys transactions with R-Tech towards these services:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical supplies |
|
$ |
38 |
|
|
$ |
1,357 |
|
|
$ |
553 |
|
|
$ |
2,899 |
|
Other research and development services |
|
|
62 |
|
|
|
67 |
|
|
|
111 |
|
|
|
85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
100 |
|
|
$ |
1,424 |
|
|
$ |
664 |
|
|
$ |
2,984 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the amounts included in deferred revenue resulting from the
deferral of upfront payments relating to the exclusive supply agreements with R-Tech:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
(In thousands) |
|
|
|
|
|
|
|
|
Deferred revenue current |
|
$ |
419 |
|
|
$ |
419 |
|
Deferred revenue, net of current portion |
|
|
6,549 |
|
|
|
6,862 |
|
|
|
|
|
|
|
|
|
|
$ |
6,968 |
|
|
$ |
7,281 |
|
|
|
|
|
|
|
|
The Company recognized approximately $105,000 of previously deferred revenue relating to its
agreements with R-Tech for the three months ended September 30, 2008 and 2007 and approximately
$314,000 for the nine months ended September 30, 2008 and 2007, which was recorded as contract and
collaboration revenue in the condensed consolidated statements of operations and comprehensive
(loss) income.
Sucampo AG License Agreements
During the three months ended March 31, 2008, the Company submitted a Marketing Authorization
Application (MAA) for lubiprostone, 24 micrograms, for the indication of chronic idiopathic
constipation in adults in nine European countries using the decentralized procedure. The submission
of the MAA triggered the obligation on the part of the Company under the license agreement with SAG
to make a $1.0 million payment to SAG. The Company recorded the expense as milestone royalties
related parties in the first quarter of 2008 and paid the milestone in the fourth quarter of 2008.
The Company expensed approximately $1.4 million and $1.2 million in product royalties
related parties under the license agreement with SAG for the three months ended September 30, 2008
and 2007, respectively, and approximately $4.4 million and $3.4 million for the nine months ended
September 30, 2008 and 2007, respectively, based on current AMITIZA sales.
9. Collaboration and License Agreements with Takeda
On October 29, 2004, the Company entered into a 16-year collaboration and license agreement
with Takeda to exclusively co-develop, commercialize and sell products that contain lubiprostone
for gastroenterology indications in the United States and Canada. On February 1, 2006, the Company
entered into a supplemental agreement with Takeda, which amended the responsibilities of both the
Company and Takeda for the co-promotion of AMITIZA and clarified the responsibilities and funding
arrangements for other marketing services to be performed by both parties. Payments to the Company
under these agreements include a non-refundable up-front payment, non-refundable development and
commercial milestone payments, reimbursement of certain development and co-promotion costs and
product royalties.
12
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The Company has received a total of $150.0 million in up-front and development milestone
payments through September 30, 2008 under these agreements. In June 2007, the Company submitted the
supplemental new drug application (sNDA) to the FDA for
irritable bowel syndrome with constipation and received a $30.0 million milestone from Takeda
that was recognized as revenue in the second quarter of 2007. The Company received a $50.0 million
milestone from Takeda as a result of the FDAs approval on April 29, 2008 of the sNDA for irritable
bowel syndrome with constipation in women 18 years of age and older and recognized the payment as
research and development revenue in the second quarter of 2008. Subject to future development and
commercial milestones, the Company is potentially entitled to receive up to $10.0 million in
additional development milestone payments and up to $50.0 million
in commercial milestone payments, under the collaboration and license agreements with Takeda,
although there can be no assurance that the Company will receive any such payments.
The following table summarizes the cash streams and related collaboration and research and
development revenue recognized under the collaboration and license agreements with Takeda for the
nine months ended September 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
Change in |
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
Accounts |
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
Receivable |
|
|
|
|
|
|
Amount |
|
|
Nine Months |
|
|
Nine Months |
|
|
for the Nine |
|
|
Amount |
|
|
|
Deferred at |
|
|
Ended |
|
|
Ended |
|
|
Months Ended |
|
|
Deferred at |
|
|
|
December 31, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2007 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment associated with the Companys
obligation to participate in joint committees
with Takeda |
|
$ |
1,911 |
|
|
$ |
|
|
|
$ |
110 |
|
|
$ |
|
|
|
$ |
1,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development milestones |
|
$ |
|
|
|
$ |
50,000 |
|
|
$ |
50,000 |
|
|
$ |
|
|
|
$ |
|
|
Reimbursement of research and development expenses |
|
|
|
|
|
|
24,653 |
|
|
|
16,982 |
|
|
|
(2,191 |
) |
|
|
5,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
74,653 |
|
|
$ |
66,982 |
|
|
$ |
(2,191 |
) |
|
$ |
5,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
|
|
|
$ |
25,755 |
|
|
$ |
24,699 |
|
|
$ |
(1,056 |
) |
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
|
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
|
|
|
|
|
|
|
Accounts |
|
|
Nine Months |
|
|
Nine Months |
|
|
Accounts |
|
|
Amount |
|
|
|
Receivable at |
|
|
Ended |
|
|
Ended |
|
|
Receivable at |
|
|
Deferred at |
|
|
|
December 31, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2007* |
|
|
2008 |
|
|
2008 |
|
|
2008* |
|
|
2008 |
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development milestones |
|
$ |
|
|
|
$ |
50,000 |
|
|
$ |
50,000 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of research and
development expenses |
|
$ |
6,887 |
|
|
$ |
24,653 |
|
|
$ |
16,982 |
|
|
$ |
4,696 |
|
|
$ |
5,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
8,667 |
|
|
$ |
25,755 |
|
|
$ |
24,699 |
|
|
$ |
7,611 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promotion revenue |
|
$ |
360 |
|
|
$ |
3,212 |
|
|
$ |
3,643 |
|
|
$ |
791 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Includes billed and unbilled accounts receivable. |
In connection with the Companys MAA filing for lubiprostone in Europe, the Company agreed
with Takeda to make a one-time payment of approximately $1.8 million, which will permit the Company
to use in Europe, the Middle East and Africa certain data and information developed under the
Takeda Agreement relating to the use of lubiprostone to treat chronic idiopathic constipation. The
Company recognized this payment as a research and development expense in the first quarter of 2008.
10. Stock Option Plan
13
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The following table summarizes the employee stock option activity for the nine months ended
September 30, 2008 under the Companys 2001 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise Price |
|
|
Contractual |
|
|
Intrinsic |
|
(In thousands, except share and per share data) |
|
Shares |
|
|
Per Share |
|
|
Term (Years) |
|
|
Value |
|
Options outstanding, December 31, 2007 |
|
|
640,900 |
|
|
$ |
10.24 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(51,880 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(34,850 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(48,750 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, September 30, 2008 |
|
|
505,420 |
|
|
|
10.30 |
|
|
|
6.07 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, September 30, 2008 |
|
|
490,545 |
|
|
|
10.31 |
|
|
|
6.02 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the employee stock option activity for the nine months ended
September 30, 2008 under the Companys 2006 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise Price |
|
|
Contractual |
|
|
Intrinsic |
|
(In thousands, except share and per share data) |
|
Shares |
|
|
Per Share |
|
|
Term (Years) |
|
|
Value |
|
Options outstanding, December 31, 2007 |
|
|
267,500 |
|
|
$ |
14.44 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
44,000 |
|
|
|
9.66 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(17,250 |
) |
|
|
14.12 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(11,750 |
) |
|
|
14.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, September 30, 2008 |
|
|
282,500 |
|
|
|
13.87 |
|
|
|
8.27 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, September 30, 2008 |
|
|
60,750 |
|
|
|
14.47 |
|
|
|
7.96 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant date fair value of options granted during the nine months ended
September 30, 2008 and the year ended December 31, 2007 were $5.25 and $7.19, respectively. As of
September 30, 2008, approximately $1.2 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 2.35 years.
The following table summarizes the non-employee stock option activity for the nine months
ended September 30, 2008 under the Companys 2001 Incentive Plan:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise Price |
|
|
Contractual |
|
|
Intrinsic |
|
(In thousands, except share and per share data) |
|
Shares |
|
|
Per Share |
|
|
Term (Years) |
|
|
Value |
|
Options outstanding, December 31, 2007 |
|
|
510,000 |
|
|
$ |
5.85 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(60,000 |
) |
|
|
5.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, September 30, 2008 |
|
|
450,000 |
|
|
|
5.85 |
|
|
|
6.58 |
|
|
$ |
1,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, September 30, 2008 |
|
|
450,000 |
|
|
|
5.85 |
|
|
|
6.58 |
|
|
$ |
1,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11. Income Taxes
For the three months ended September 30, 2008 and 2007, the Companys consolidated effective
tax rate was 41.8% and 46.6%, respectively. For the nine months ended September 30, 2008 and 2007,
the Companys consolidated annualized effective tax rate was 20.5% and 36.4%, respectively. As a
result of the FDA approval of the sNDA in April 2008 for irritable bowel syndrome with constipation
and the related impact on projected income in 2008 and future years based on the $50.0 million
milestone payment and expected product royalties, the Company believes that its U.S. deferred tax
assets will likely be realized. Accordingly, the tax provision recorded during the nine months
ended September 30, 2008 reflects a discrete release of U.S. deferred tax asset valuation
allowances of $4.8 million and a reduction in the projected 2008 effective tax rate applied to the
2008 pre-tax income for the nine months ended September 30, 2008.
14
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
12. Uncommitted Line of Credit
On March 5, 2008, the Company entered into a line of credit providing for uncommitted
borrowings of up to $30.0 million. The lender has no obligation to make advances under this line of
credit but may do so in its sole discretion. The line of credit is collateralized by our current
and non-current investments. Advances made under this line of credit will bear an interest rate
based on
LIBOR plus a predetermined percentage based on the amount of the advance and other conditions.
Borrowings under this line of credit are due upon the demand of the lender and the lender can make
a repayment demand at its sole option at any time for any or no reason. As of September 30, 2008,
the Company had not drawn down any funds under this line of credit.
13. Segment Reporting
The Company has determined that it has three reportable geographic segments based on the
Companys method of internal reporting, which disaggregates business by geographic location. These
segments are the United States, Europe and Japan. 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 intercompany loans and the provision of research and development
services. Following is a summary of financial information by reportable geographic segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
United States |
|
|
Europe |
|
|
Japan |
|
|
Eliminations |
|
|
Consolidated |
|
Three Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
5,436 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5,436 |
|
Product royalty revenue |
|
|
7,718 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,718 |
|
Co-promotion revenue |
|
|
1,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,185 |
|
Contract and collaboration revenue |
|
|
142 |
|
|
|
|
|
|
|
213 |
|
|
|
(213 |
) |
|
|
142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
14,481 |
|
|
|
|
|
|
|
213 |
|
|
|
(213 |
) |
|
|
14,481 |
|
Depreciation and amortization |
|
|
110 |
|
|
|
1 |
|
|
|
3 |
|
|
|
|
|
|
|
114 |
|
Other operating expenses |
|
|
17,819 |
|
|
|
469 |
|
|
|
1,100 |
|
|
|
(210 |
) |
|
|
19,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(3,448 |
) |
|
|
(470 |
) |
|
|
(890 |
) |
|
|
(3 |
) |
|
|
(4,811 |
) |
Interest income |
|
|
678 |
|
|
|
1 |
|
|
|
2 |
|
|
|
(26 |
) |
|
|
655 |
|
Other non-operating expense, net |
|
|
(6 |
) |
|
|
(17 |
) |
|
|
(21 |
) |
|
|
29 |
|
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
$ |
(2,776 |
) |
|
$ |
(486 |
) |
|
$ |
(909 |
) |
|
$ |
|
|
|
$ |
(4,171 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
5 |
|
|
$ |
35 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
4,652 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,652 |
|
Product royalty revenue |
|
|
6,998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,998 |
|
Co-promotion revenue |
|
|
1,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,051 |
|
Contract and collaboration revenue |
|
|
142 |
|
|
|
|
|
|
|
219 |
|
|
|
(210 |
) |
|
|
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
12,843 |
|
|
|
|
|
|
|
219 |
|
|
|
(210 |
) |
|
|
12,852 |
|
Depreciation and amortization |
|
|
85 |
|
|
|
1 |
|
|
|
7 |
|
|
|
|
|
|
|
93 |
|
Other operating expenses |
|
|
12,587 |
|
|
|
520 |
|
|
|
737 |
|
|
|
(210 |
) |
|
|
13,634 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
171 |
|
|
|
(521 |
) |
|
|
(525 |
) |
|
|
|
|
|
|
(875 |
) |
Interest income |
|
|
782 |
|
|
|
|
|
|
|
3 |
|
|
|
(5 |
) |
|
|
780 |
|
Other non-operating income (expense), net |
|
|
(69 |
) |
|
|
(16 |
) |
|
|
(148 |
) |
|
|
5 |
|
|
|
(228 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
884 |
|
|
$ |
(537 |
) |
|
$ |
(670 |
) |
|
$ |
|
|
|
$ |
(323 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
788 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
788 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
United States |
|
|
Europe |
|
|
Japan |
|
|
Eliminations |
|
|
Consolidated |
|
Nine Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
66,982 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
66,982 |
|
Product royalty revenue |
|
|
24,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24,699 |
|
Co-promotion revenue |
|
|
3,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,643 |
|
Contract and collaboration revenue |
|
|
425 |
|
|
|
|
|
|
|
630 |
|
|
|
(630 |
) |
|
|
425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
95,749 |
|
|
|
|
|
|
|
630 |
|
|
|
(630 |
) |
|
|
95,749 |
|
Depreciation and amortization |
|
|
318 |
|
|
|
1 |
|
|
|
7 |
|
|
|
|
|
|
|
326 |
|
Other operating expenses |
|
|
55,324 |
|
|
|
2,891 |
|
|
|
4,537 |
|
|
|
(630 |
) |
|
|
62,122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
40,107 |
|
|
|
(2,892 |
) |
|
|
(3,914 |
) |
|
|
|
|
|
|
33,301 |
|
Interest income |
|
|
1,924 |
|
|
|
6 |
|
|
|
5 |
|
|
|
(73 |
) |
|
|
1,862 |
|
Other non-operating (expense) income, net |
|
|
(39 |
) |
|
|
(30 |
) |
|
|
(20 |
) |
|
|
73 |
|
|
|
(16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
41,992 |
|
|
$ |
(2,916 |
) |
|
$ |
(3,929 |
) |
|
$ |
|
|
|
$ |
35,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
304 |
|
|
$ |
35 |
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
342 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
52,105 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
52,105 |
|
Product royalty revenue |
|
|
18,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,869 |
|
Co-promotion revenue |
|
|
3,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,318 |
|
Contract and collaboration revenue |
|
|
424 |
|
|
|
|
|
|
|
660 |
|
|
|
(630 |
) |
|
|
454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
74,716 |
|
|
|
|
|
|
|
660 |
|
|
|
(630 |
) |
|
|
74,746 |
|
Depreciation and amortization |
|
|
143 |
|
|
|
1 |
|
|
|
9 |
|
|
|
|
|
|
|
153 |
|
Other operating expenses |
|
|
52,201 |
|
|
|
829 |
|
|
|
1,671 |
|
|
|
(630 |
) |
|
|
54,071 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
22,372 |
|
|
|
(830 |
) |
|
|
(1,020 |
) |
|
|
|
|
|
|
20,522 |
|
Interest income |
|
|
1,573 |
|
|
|
|
|
|
|
7 |
|
|
|
(5 |
) |
|
|
1,575 |
|
Other non-operating income (expense), net |
|
|
(64 |
) |
|
|
(25 |
) |
|
|
(108 |
) |
|
|
5 |
|
|
|
(192 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
23,881 |
|
|
$ |
(855 |
) |
|
$ |
(1,121 |
) |
|
$ |
|
|
|
$ |
21,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
2,128 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,128 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
2,167 |
|
|
$ |
32 |
|
|
$ |
84 |
|
|
$ |
|
|
|
$ |
2,283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets |
|
$ |
158,420 |
|
|
$ |
2,160 |
|
|
$ |
5,364 |
|
|
$ |
(17,825 |
) |
|
$ |
148,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
2,182 |
|
|
$ |
|
|
|
$ |
83 |
|
|
$ |
|
|
|
$ |
2,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets |
|
$ |
114,490 |
|
|
$ |
2,381 |
|
|
$ |
1,987 |
|
|
$ |
(8,831 |
) |
|
$ |
110,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
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. (Sucampo, 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, 2007 included in our Annual Report on Form
10-K.
Overview
We are a biopharmaceutical company focused on the discovery, development and commercialization
of proprietary drugs based on prostones, a class of compounds derived from functional fatty acids
that occur naturally in the human body. In January 2006, we received marketing approval from the
U.S. Food and Drug Administration, or FDA, for our first product, AMITIZA, for the treatment of
chronic idiopathic constipation in adults. On April 29, 2008, the FDA approved AMITIZA for its
second indication, the treatment of irritable bowel syndrome with constipation in women 18 years of
age or older.
We and Takeda Pharmaceutical Company Limited, or Takeda, are party to a collaboration and
license agreement and a related supplemental agreement, or, collectively, the Takeda Agreements, to
jointly develop and commercialize AMITIZA for chronic idiopathic constipation, irritable bowel
syndrome with constipation, opioid-induced bowel dysfunction and other gastrointestinal indications
in the United States and Canada. We have the right to co-promote AMITIZA along with Takeda in these
markets. We and Takeda initiated commercial sales of AMITIZA in the United States for the treatment
of chronic idiopathic constipation in adults in April 2006. Under the Takeda Agreements, Takeda
records all product revenue and we receive a royalty on net product revenues for such sales.
Drs. Ryuji Ueno and Sachiko Kuno, our founders, own directly or indirectly the majority
holdings in Sucampo as well as in other companies that have contractual relationships with Sucampo.
One of the founders serves as the Chairman of the Board of Directors, Chief Executive Officer
and Chief Scientific Officer of Sucampo.
We hold an exclusive worldwide royalty-bearing license from Sucampo AG, or SAG, a Swiss
patent-holding company and an entity wholly owned by our founders, to develop and commercialize
AMITIZA and all other prostone compounds covered by patents and patent applications held by SAG. We
are obligated to assign to SAG all patentable improvements that we make in the field of prostones,
which SAG is obligated in turn to license back to us on an exclusive basis. AMITIZA, cobiprostone
and SPI-017 are covered by perpetual licenses that cannot be terminated unless we default in our
payment obligations to SAG. If we have not committed specified development efforts to any prostone
compound other than AMITIZA, cobiprostone and SPI-017 by the end of a specified period, which ends
on the later of June 30, 2011 or the date upon which Drs. Ryuji Ueno and Sachiko Kuno, our
founders, no longer control our company, then the commercial rights to that compound will revert to
SAG, subject to a 15-month extension in the case of any compound that we designate in good faith as
planned for development within that extension period.
We first generated product royalty revenue for commercial sales of AMITIZA in the second
quarter of 2006. Although we reported net income for the years ended December 31, 2007 and 2006, we
have historically incurred operating losses, resulting principally from costs incurred in our
research and development programs and from our general and administrative expenses. We expect to
continue to incur significant and increasing expenses for the next several years as we continue to
expand our research and development activities, seek regulatory approvals for additional
indications for AMITIZA and for other compounds in the United States and abroad, expand our
international operations and augment our sales and marketing capabilities. While we expect future
profitability, whether we are able to sustain profitability will depend upon our ability to
generate revenues and receive payments under our contracts with Takeda or similar future
arrangements. In the near term, our ability to generate product revenues will depend primarily on
the successful commercialization and continued development of additional indications for AMITIZA.
17
As a result of the FDA approval of AMITIZA for the treatment of the irritable bowel syndrome
with constipation in women 18 years and older, we received a development milestone payment of $50.0
million from Takeda in the second quarter of 2008 and we recognized the payment as research and
development revenue. Consequently, in accordance with the restated license agreement with
SAG, we paid and recorded as research and development expense a $2.5 million milestone royalty
to SAG during the nine months ended September 30, 2008, reflecting 5% of the $50.0 million
development milestone payment that we received from Takeda.
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 connection with our marketing approval for AMITIZA for the
treatment of chronic idiopathic constipation in adults, we committed to the FDA to conduct
post-marketing studies to evaluate the safety of the product in pediatric patients, in
patients with renal impairment and in patients with hepatic impairment, which were
initiated in January 2007. In connection with our marketing approval for AMITIZA for the
treatment of irritable bowel syndrome with constipation in adult women, we committed to the
FDA to conduct a post-marketing study to evaluate the safety and efficacy for the treatment
of irritable bowel syndrome in pediatric patients ages 6 to 17. In addition, we committed
to conduct a post-marketing study in male and female patients with irritable bowel syndrome
with constipation utilizing a higher dose than currently recommended for this indication.
We are also developing AMITIZA to treat opioid-induced bowel dysfunction. We commenced
Phase III pivotal clinical trials of AMITIZA for the treatment of opioid-induced bowel
dysfunction in September 2007 and we expect to complete these trials by the end of 2009 and
file the supplemental new drug application (sNDA) with the FDA in 2010. Our collaboration
and co-promotion arrangement with Takeda also covers these additional indications for
AMITIZA and Takeda funds a majority of AMITIZAs development program in the United States. |
|
|
|
|
In February 2008, we submitted a Marketing Approval Application, or MAA, for lubiprostone, 24
micrograms, or mcg, for the indication of chronic idiopathic constipation in adults in the
United Kingdom. The MAA was submitted using the decentralized procedure with the United
Kingdom, through its Medicines and Healthcare Products Regulatory Agency, serving as the
reference member state, with additional applications subsequently submitted to the member
states of Belgium, Denmark, France, Germany, Ireland, the Netherlands, Spain and Sweden. In
May 2008, we received notification that all of the MAAs have been received and validated by
the individual regulatory agencies. In June 2008, we submitted a MAA for lubiprostone, 24
micrograms, for the indication of chronic idiopathic constipation in adults in Switzerland. |
|
|
|
|
In September 2008, we announced positive results from our multi-center Phase 2b dose-ranging
study in Japan to evaluate the safety and efficacy of lubiprostone for treating chronic
idiopathic constipation in adults. We plan to initiate Phase III clinical trials in Japan in
mid-2009. |
|
|
|
|
Cobiprostone. We are developing orally administered cobiprostone to treat various
gastrointestinal and liver disorders, including non-steroidal anti-inflammatory
drug-induced ulcers, portal hypertension, non-alcoholic fatty liver disease and
gastrointestinal disorders associated with cystic fibrosis. We also are planning to develop
an inhaled formulation of cobiprostone for the treatment of respiratory symptoms of cystic
fibrosis and chronic obstructive pulmonary disease. Our near term focus is on the
development of cobiprostone as a treatment for non-steroidal anti-inflammatory drug-induced
ulcers. We commenced a Phase II clinical trial of cobiprostone for the treatment of
non-steroidal anti-inflammatory drug-induced ulcers in the third quarter of 2007. We expect
to enroll approximately 120 patients in this clinical trial, which we plan to complete in
mid-2009. We also initiated a Phase II proof-of-concept study of cobiprostone for the
treatment of portal hypertension in patients with liver cirrhosis in July 2008 and we
expect to complete the trials by the end of 2009. |
|
|
|
|
SPI-017. We are developing SPI-017 to treat vascular disease and central nervous system
disorders. We are initially focused on developing an intravenous formulation of this
product candidate for the treatment of peripheral arterial disease. We also are developing
an oral formulation of SPI-017 for the treatment of Alzheimers disease and a topical
formulation for wound healing. We plan to initiate Phase I clinical trials of the
intravenous and oral formulation of SPI-017 by the end of 2008. |
18
Results of Operations
Reclassifications
We have reclassified certain amounts in the previously issued financial statements to conform
with the current presentation. We reclassified expenses that have been previously included within
general and administrative expenses to research and development expenses. Such expenses primarily
include salaries and other employee benefits of personnel who oversee research and development
projects, and allocated depreciation and rent expenses and insurance costs. We also reclassified
allocated depreciation and rent expenses and insurance costs from general and administrative
expenses to selling and marketing expenses. During the three months
ended September 30, 2007, we reclassified $828,000 and $84,000 of general and administrative
expenses to research and development expenses and selling and marketing expenses, respectively.
During the nine months ended September 30, 2007, we reclassified approximately $2.2 million and
$154,000 of general and administrative expenses to research and development expenses and selling
and marketing expenses, respectively.
Comparison of three months ended September 30, 2008 and September 30, 2007
Revenues
The following table summarizes our revenues for the three months ended September 30, 2008 and
2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Research and development revenue |
|
$ |
5,436 |
|
|
$ |
4,652 |
|
Product royalty revenue |
|
|
7,718 |
|
|
|
6,998 |
|
Co-promotion revenue |
|
|
1,185 |
|
|
|
1,051 |
|
Contract and collaboration revenue |
|
|
142 |
|
|
|
151 |
|
|
|
|
|
|
|
|
Total |
|
$ |
14,481 |
|
|
$ |
12,852 |
|
|
|
|
|
|
|
|
Total revenues were $14.5 million for the three months ended September 30, 2008 compared to
$12.9 million for the three months ended September 30, 2007, an increase of $1.6 million or 12.4%.
Research and development revenue was $5.4 million for the three months ended September 30,
2008 compared to $4.7 million for the three months ended September 30, 2007, an increase of $0.7
million or 14.9%. This increase was primarily due to revenue recognized related to the on-going
opioid-induced bowel dysfunction Phase III pivotal trials funded by Takeda. During the three months
ended September 30, 2008, we deferred an additional $1.9 million of research and development
revenue as a result of a change, in the second quarter of 2008, in the estimated completion date
and an increase in total expected reimbursable costs associated with these trials.
Product royalty revenue represents royalty revenue earned on net sales of AMITIZA in
accordance with the Takeda Agreements. For the three months ended September 30, 2008 and 2007, we
recognized $7.7 million and $7.0 million, respectively, of product royalty revenue, an increase of
$0.7 million or 10%. The increase reflects the continuing acceptance by patients and physicians of
AMITIZA® 24 mcg for the treatment of chronic idiopathic constipation in adults and sales
of AMITIZA 8 mcg for irritable bowel syndrome with constipation in adult women. The product royalty
revenue for the three months ended September 30, 2008 was also burdened somewhat by lower
restocking orders for AMITIZA 8 mcg reflecting the draw-down of the inventory from the initial
stocking of AMITIZA 8 mcg completed during the second quarter of 2008. We recognized royalty of
approximately $1.9 million in the second quarter of 2008 for the portion of the 8 mcg product with
no right of return. Additionally, during the three months ended September 30, 2008, we recorded a
reduction of product royalty revenues of $644,000 resulting from a change in estimate relating to
rebates, discounts and other expenses.
Co-promotion revenues represent reimbursement by Takeda of certain co-promotion costs for our
specialty sales force and costs associated with miscellaneous marketing activities in connection
with the commercialization of AMITIZA. For the three months ended September 30, 2008 and 2007, we
recognized $1.2 million and $1.1 million, respectively, of co-promotion revenues for reimbursement
of sales force costs.
Research and Development Expenses
19
The following summarizes our research and development expenses for the three months ended
September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Direct costs: |
|
|
|
|
|
|
|
|
AMITIZA |
|
$ |
8,166 |
|
|
$ |
5,563 |
|
Cobiprostone |
|
|
1,180 |
|
|
|
875 |
|
SPI - 017 |
|
|
616 |
|
|
|
278 |
|
Other |
|
|
749 |
|
|
|
458 |
|
|
|
|
|
|
|
|
Total |
|
|
10,711 |
|
|
|
7,174 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
679 |
|
|
|
414 |
|
|
|
|
|
|
|
|
Total |
|
$ |
11,390 |
|
|
$ |
7,588 |
|
|
|
|
|
|
|
|
Total research and development expenses for the three months ended September 30, 2008 were
$11.4 million compared to $7.6 million for the three months ended September 30, 2007, an increase
of $3.8 million or 50%. This increase was due to our on-going clinical development programs of
AMITIZA for the treatment of opioid-induced bowel dysfunction, chronic idiopathic constipation in
Japan and cobiprostone for the treatment of non-steroidal anti-inflammatory drug-induced ulcers and
portal hypertension in patients with liver cirrhosis, and preclinical and basic development costs
associated with SPI-017.
General and Administrative Expenses
The following summarizes our general and administrative expenses for the three months ended
September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Salaries, benefits and related costs |
|
$ |
1,156 |
|
|
$ |
882 |
|
Legal and consulting expenses |
|
|
852 |
|
|
|
638 |
|
Stock-based compensation |
|
|
51 |
|
|
|
9 |
|
Founders stock-based award |
|
|
|
|
|
|
(1,000) |
|
Other operating expenses |
|
|
1,804 |
|
|
|
1,587 |
|
|
|
|
|
|
|
|
Total |
|
$ |
3,863 |
|
|
$ |
2,116 |
|
|
|
|
|
|
|
|
General and administrative expenses were $3.9 million for the three months ended September 30,
2008 compared to $2.1 million for the three months ended September 30, 2007, an increase of $1.8
million or 85.7%. This increase was primarily due to an adjustment to the founders stock-based
award during the three months ended September 30, 2007 and due to an increase in operational
headcount, an increase in expenses associated with our new office space and an increase in overall
costs associated with the compliance and regulatory requirements of being a publicly traded company
with international operations for the three months ended September 30, 2008.
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 $2.7 million for the three months ended September 30, 2008 compared to $2.8
million for the three months ended September 30, 2007, a decrease of $0.1 million or 3.6%. The
decrease was primarily due to reduced marketing expenses in the long-term care market, which we
support with our internal sales force.
Product Royalties Related Parties
Product royalties related parties expense represent 3.2% of AMITIZA net sales for the
respective periods payable to SAG and increased to $1.4 million for the three months ended
September 30, 2008 from $1.2 million for the three months ended September 30 2007 in line with the
increase of product royalty revenue.
20
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the three months ended
September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Interest income |
|
$ |
655 |
|
|
$ |
780 |
|
Other expense, net |
|
|
(15 |
) |
|
|
(228 |
) |
|
|
|
|
|
|
|
Total non-operating income, net |
|
$ |
640 |
|
|
$ |
552 |
|
|
|
|
|
|
|
|
Interest income was $655,000 for the three months ended September 30, 2008 compared to
$780,000 for the three months ended September 30, 2007, a decrease of $125,000 or 16.0%. The
decrease was primarily due to a decrease in yield earned by our investments as we moved our
investment portfolio mix from auction rate securities to U.S. Government securities.
Income Taxes
For the three months ended September 30, 2008 and 2007, our consolidated effective tax rate
was 41.8% and 46.6%, respectively. For the three months ended September 30, 2008, we recorded a tax
benefit of $1.7 million. For the three months ended September 30, 2007, we recorded a tax provision
of $151,000.
Comparison of nine months ended September 30, 2008 and September 30, 2007
Revenues
The following table summarizes our revenues for the nine months ended September 30, 2008 and
2007:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Research and development revenue |
|
$ |
66,982 |
|
|
$ |
52,105 |
|
Product royalty revenue |
|
|
24,699 |
|
|
|
18,869 |
|
Co-promotion revenue |
|
|
3,643 |
|
|
|
3,318 |
|
Contract and collaboration revenue |
|
|
425 |
|
|
|
454 |
|
|
|
|
|
|
|
|
Total |
|
$ |
95,749 |
|
|
$ |
74,746 |
|
|
|
|
|
|
|
|
Total revenues were $95.7 million for the nine months ended 2008 compared to $74.7 million for
the nine months ended September 30, 2007, an increase of $21.0 million or 28.1%.
Research and development revenue was $67.0 million for the nine months ended September 30,
2008 compared to $52.1 million for the nine months ended September 30, 2007, an increase of $14.9
million or 28.6%. The increase was primarily due to the $50.0 million development milestone earned
and received from Takeda in May 2008 upon FDA approval of AMITIZA for the treatment of the
irritable bowel syndrome with constipation in adult women compared to the $30.0 million development
milestone earned from Takeda upon filing of the sNDA for AMITIZA to treat irritable bowel syndrome
with constipation in June 2007. The increase was partially offset by a deferral of approximately
$3.6 million in research and development revenue as a result of a change in the second quarter of
2008 of the estimated completion date and an increase in total expected reimbursable costs
associated with the ongoing clinical trials for opioid-induced bowel dysfunction. The increase in
research and development revenue was partly offset by the recognition of $11.0 million of
AMITIZA-related deferred revenue during the first six months of 2007 resulting from payments
previously received from Takeda for development of AMITIZA to treat chronic idiopathic constipation
and irritable bowel syndrome with constipation. We recognized revenue for this development work
ratably over the estimated performance period, which was completed in June 2007 when we filed the
sNDA for the irritable bowel syndrome with constipation indication, and there is no corresponding
amount in 2008.
Product royalty revenue represents royalty revenue earned on net sales of AMITIZA in
accordance with the Takeda Agreements. For the nine months ended September 30, 2008 and 2007, we
recognized $24.7 million and $18.9 million, respectively, of product royalty revenue, an increase
of $5.8 million or 30.7%. The increase reflects the continuing acceptance by patients and
physicians of AMITIZA® 24 mcg for the treatment of chronic idiopathic constipation in
adults and sales of AMITIZA 8 mcg for irritable bowel syndrome with constipation in adult women,
including the royalty revenue of approximately $1.9 million recognized during the three months
ended June 30, 2008 from the initial stocking of AMITIZA 8 mcg in May 2008. Additionally, during
the nine months ended
September 30, 2008, we recorded a reduction of product royalty revenues of $644,000 resulting
from a change in estimate relating to rebates, discounts and other expenses.
21
Co-promotion revenues represent reimbursement by Takeda of co-promotion costs for our
specialty sales force and costs associated with miscellaneous marketing activities in connection
with the commercialization of AMITIZA. For the nine months ended September 30, 2008 and 2007, we
recognized $3.6 million and $3.3 million, respectively, of co-promotion revenues for reimbursement
of sales force costs.
Research and Development Expenses
The following summarizes our research and development expenses for the nine months ended
September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Direct costs: |
|
|
|
|
|
|
|
|
AMITIZA |
|
$ |
27,192 |
|
|
$ |
16,272 |
|
Cobiprostone |
|
|
3,450 |
|
|
|
3,101 |
|
SPI - 017 |
|
|
2,232 |
|
|
|
1,033 |
|
Other |
|
|
1,048 |
|
|
|
863 |
|
|
|
|
|
|
|
|
Total |
|
|
33,922 |
|
|
|
21,269 |
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
1,615 |
|
|
|
1,009 |
|
|
|
|
|
|
|
|
Total |
|
$ |
35,537 |
|
|
$ |
22,278 |
|
|
|
|
|
|
|
|
Total research and development expenses for the nine months ended September 30, 2008 were
$35.5 million compared to $22.3 million for the nine months ended September 30, 2007, an increase
of $13.2 million or 59.2%. This increase was due to our ongoing clinical development programs of
AMITIZA for the treatment of opioid-induced bowel dysfunction, chronic idiopathic constipation in
Japan and cobiprostone for the treatment of non-steroidal anti-inflammatory drug-induced ulcers and
portal hypertension in patients with liver cirrhosis, and preclinical and basic development costs
associated with SPI-017. We also incurred filing and data purchase costs of approximately $2.5
million, which were necessary to submit our European MAAs during the nine months ended September
30, 2008.
General and Administrative Expenses
The following summarizes our general and administrative expenses for the nine months ended
September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Salaries |
|
$ |
3,277 |
|
|
$ |
2,772 |
|
Legal and consulting expenses |
|
|
2,101 |
|
|
|
2,005 |
|
Stock-based compensation |
|
|
153 |
|
|
|
(194 |
) |
Founders stock-based award |
|
|
|
|
|
|
9,187 |
|
Other |
|
|
5,060 |
|
|
|
3,516 |
|
|
|
|
|
|
|
|
Total |
|
$ |
10,591 |
|
|
$ |
17,286 |
|
|
|
|
|
|
|
|
General and administrative expenses were $10.6 million for the nine months ended September 30,
2008 compared to $17.3 million for the nine months ended September 30, 2007, a decrease of $6.7
million or 38.7%. This decrease was primarily due to a one-time expense of $9.2 million related to
a stock-based award granted to the founders recorded in 2007, partially offset by an increase in
operational headcount, an increase in expenses associated with our new office space and an increase
in overall costs associated with the compliance and regulatory requirements of being a publicly
traded company with international operations.
22
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 $8.4 million for the nine months ended September
30, 2008 compared to $9.8 million for the nine months ended September 30, 2007, a decrease of $1.4
million or 14.3%. This decrease was primarily due to cost savings related to completing our initial
build-out of our own internal dedicated sales force to provide AMITIZA to patients in long-term
care facilities, as well as in medical schools and university hospitals, which was completed during
the second quarter of 2007 and reduced marketing expenses in the long-term care market.
Milestone Royalties Related Parties
Milestone royalties related parties expense was $3.5 million for the nine months ended
September 30, 2008. We are obligated to pay SAG a $1.0 million milestone in connection with our
first NDA filing, or comparable foreign regulatory filing, such as an MAA, in each of the three
following territories covered by the license agreement with SAG: North, Central and South America
(including the Caribbean); Asia; and the rest of the world. Our MAA filed in February 2008
represented the first such filing for the rest-of-the-world territory. As a result of our sNDA
approval for AMITIZA to treat irritable bowel syndrome with constipation, we paid SAG $2.5 million,
reflecting 5% of the $50.0 million development milestone payment that we received from Takeda in
May 2008. We recorded $1.5 million in milestone royalties related parties expense for the nine
months ended September 30, 2007, reflecting the 5% we owed SAG in respect of the $30.0 million
development milestone earned from Takeda during that period upon the filing of our sNDA.
Product Royalties Related Parties
Product royalties related parties expense was $4.4 million for the nine months ended
September 30, 2008 compared to $3.4 million for the nine months ended September 30, 2007, an
increase of $1.0 million or 29.4%, in line with the increase of product royalty revenue.
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the nine months ended
September 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Interest income |
|
$ |
1,862 |
|
|
$ |
1,575 |
|
Other expense, net |
|
|
(16 |
) |
|
|
(192 |
) |
|
|
|
|
|
|
|
Total non-operating income, net |
|
$ |
1,846 |
|
|
$ |
1,383 |
|
|
|
|
|
|
|
|
Interest income was $1.9 million for the nine months ended September 30, 2008 compared to $1.6
million for the nine months ended September 30, 2007, an increase of $0.3 million or 18.8%. The
increase was primarily due to an increase in the funds available for investment in 2008 compared to
2007, partially offset by a decrease in yield earned by our investments as our investment portfolio
mix moved from auction rate securities to U.S. Government securities.
Income Taxes
For the nine months ended September 30, 2008 and 2007, our consolidated effective tax rate was
20.5% and 36.4%, respectively. For the nine months ended September 30, 2008 and 2007, we recorded a
tax provision of $7.2 million and $7.9 million, respectively. As a result of the FDA approval of
the sNDA for irritable bowel syndrome with constipation in adult women and the related impact on
projected income in 2008 and future years from the $50.0 million milestone payment received in May
2008 and expected product royalties, we believe that our U.S. deferred tax assets will likely be
realized. Accordingly, the tax provision recorded for the nine months ended September 30, 2008
reflects a discrete release of U.S. deferred tax asset valuation allowances of $4.8 million and a
reduction in the projected 2008 effective tax rate applied to our pre-tax income.
Reportable Geographic Segments
We have determined that we have three reportable geographic segments based on our method of
internal reporting, which disaggregates business by geographic location. These segments are the
United States, Europe and Japan. We evaluate the performance of these segments based on income
(loss) from operations, as well as other factors, including the progress of research and
development activities. The following is a summary of financial information by reportable segment.
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
(In thousands) |
|
United States |
|
Europe |
|
Japan |
|
Eliminations |
|
Consolidated |
Three Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
14,481 |
|
|
$ |
|
|
|
$ |
213 |
|
|
$ |
(213 |
) |
|
$ |
14,481 |
|
Loss from operations |
|
|
(3,448 |
) |
|
|
(470 |
) |
|
|
(890 |
) |
|
|
(3 |
) |
|
|
(4,811 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
12,843 |
|
|
$ |
|
|
|
$ |
219 |
|
|
$ |
(210 |
) |
|
$ |
12,852 |
|
Income (loss) from operations |
|
|
171 |
|
|
|
(521 |
) |
|
|
(525 |
) |
|
|
|
|
|
|
(875 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
95,749 |
|
|
$ |
|
|
|
$ |
630 |
|
|
$ |
(630 |
) |
|
$ |
95,749 |
|
Income (loss) from operations |
|
|
40,107 |
|
|
|
(2,892 |
) |
|
|
(3,914 |
) |
|
|
|
|
|
|
33,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
74,716 |
|
|
$ |
|
|
|
$ |
660 |
|
|
$ |
(630 |
) |
|
$ |
74,746 |
|
Income (loss) from operations |
|
|
22,372 |
|
|
|
(830 |
) |
|
|
(1,020 |
) |
|
|
|
|
|
|
20,522 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2008 |
|
$ |
158,420 |
|
|
$ |
2,160 |
|
|
$ |
5,364 |
|
|
$ |
(17,825 |
) |
|
$ |
148,119 |
|
At December 31, 2007 |
|
|
114,490 |
|
|
|
2,381 |
|
|
|
1,987 |
|
|
|
(8,831 |
) |
|
|
110,027 |
|
Liquidity and Capital Resources
Sources of Liquidity
We require cash principally to meet our operating expenses. We have financed our operations
with a combination of private placements of equity securities, our initial public offering,
up-front payment, milestone and royalty payments and research and development expense
reimbursements received from Takeda and R-Tech Ueno, Ltd., a Japanese pharmaceutical manufacturer
and affiliate. We have raised net proceeds of $55.3 million from private equity financings and net
proceeds of $28.2 million from our initial public offering. We have also received an aggregate of
$215.3 million in up-front, milestone and expense reimbursement payments from Takeda.
Our cash, cash equivalents and investments consist of the following assets at fair value:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Cash and cash equivalents |
|
$ |
13,364 |
|
|
$ |
25,559 |
|
Investments, current |
|
|
93,117 |
|
|
|
51,552 |
|
Investments, non-current |
|
|
17,626 |
|
|
|
9,400 |
|
|
|
|
|
|
|
|
|
|
$ |
124,107 |
|
|
$ |
86,511 |
|
|
|
|
|
|
|
|
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.
At September 30, 2008, we continue to hold $21.0 million of investments in auction rate
securities at fair value and recorded an unrealized loss of $1.9 million, or $1.2 million net of
tax effect, as of September 30, 2008, related to these investments. This unrealized loss was
recorded as other comprehensive loss during the nine months ended September 30, 2008.
On October 16, 2008, we accepted the settlement rights offered by our broker under a
settlement agreement between the broker and the SEC and various state regulatory authorities. The
settlement rights allow us to redeem auction rate securities at par within a specified period.
Based on this settlement, we received $3.4 million on November 3, 2008, representing the par value
of our tax-exempt auction rate securities, and we have the right to request the redemption of the
remaining auction rate securities at par value of an additional $19.4 million within the two-year
period starting June 30, 2010. As the settlement was accepted subsequent to September 30, 2008, our
consolidated financial statements as of September 30, 2008 do not reflect any contingent gains,
valuation adjustments or any other amounts relating to the settlement rights. We have, however,
classified auction rate securities as current and
non-current investments as of September 30, 2008 based on the expected redemption dates. We do
not anticipate having to sell these securities in order to operate its business before the expected
redemption dates.
24
On March 5, 2008, we entered into a line of credit providing for uncommitted borrowings of up
to $30.0 million. The lender has no obligation to make advances under this line of credit but may
do so in its sole discretion. The line of credit is collateralized by our current and non-current
investments. Advances made under this line of credit will bear an interest rate based on LIBOR plus
a predetermined percentage based on the amount of the advance and other conditions. Borrowings
under this line of credit are due upon the demand of the lender and the lender can make a repayment
demand at its sole option at any time for any or no reason. As of September 30, 2008, we had not
drawn down any funds under this line of credit.
Cash Flows
The following table summarizes our cash flows for the nine months ended September 30, 2008 and
2007:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Cash (used in) provided by: |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
38,611 |
|
|
$ |
8,408 |
|
Investing activities |
|
|
(51,801 |
) |
|
|
(33,180 |
) |
Financing activities |
|
|
1,025 |
|
|
|
31,341 |
|
Effect of exchange rates |
|
|
(30 |
) |
|
|
186 |
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
$ |
(12,195 |
) |
|
$ |
6,755 |
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008
Net cash provided by operating activities was $38.6 million for the nine months ended
September 30, 2008 and reflected net income of $28.0 million, a change of $3.2 million in net
prepaid and income taxes receivable and payable, an increase in accrued expenses of $3.8 million
and an increase of $4.9 million in deferred revenue, offset by a non-cash reversal of deferred tax
asset valuation allowances of $4.3 million and changes in other operating assets and liabilities.
Net cash used in investing activities of $51.8 million for the nine months ended September 30,
2008 primarily reflected our net purchases of investments as a result of our investment of the
$50.0 million milestone payment received from Takeda in the second quarter of 2008.
Net cash provided by financing activities of $1.0 million for the nine months ended September
30, 2008 resulted from the exercise of stock options.
Nine Months Ended September 30, 2007
Net cash provided by operating activities was $8.4 million for the nine months ended September
30, 2007. This reflected net income of $13.9 million, which was offset by an increase in product
royalties receivable of $5.0 million, an increase in accounts receivable of $2.8 million and a
decrease in deferred revenue of $11.4 million. The decrease in deferred revenue primarily related
to the amortization of deferred research and development revenue over the performance period of the
development of AMITIZA.
Net cash used in investing activities of $33.2 million for the nine months ended September 30,
2007 primarily reflected our net purchases of investments as a result of our investment of the
$30.0 million milestone payment received from Takeda in the second quarter of 2007 and
approximately $2.1 million of purchases of property and equipment associated with the move of our
offices in the United States in July 2007.
Net cash provided by financing activities was $31.3 million for the nine months ended
September 30, 2007 and reflected primarily proceeds from our initial public offering, net of
certain offering costs.
Off-Balance Sheet Arrangements
25
We do not have any off-balance sheet arrangements, as such term is defined in Item 303(a)(4)
of Regulation S-K promulgated under the Securities Act of 1933, as amended.
Funding Requirements
We will need substantial amounts of capital to continue growing our business. We will require
this capital to:
|
|
|
fund our 30% share of the two post-marketing studies of AMITIZA to evaluate its safety
in patients with renal impairment and patients with hepatic impairment; |
|
|
|
|
fund regulatory efforts in Europe and Japan for AMITIZA; |
|
|
|
|
fund development and regulatory activities for cobiprostone and SPI-017; |
|
|
|
|
fund research and development activities for prostone compounds other than AMITIZA,
cobiprostone and SPI-017; |
|
|
|
|
fund the expansion of our commercialization activities in the United States and the
initiation of commercialization efforts in non-U.S. markets; and |
|
|
|
|
fund costs for capital expenditures to support the growth of our business. |
The timing of these funding requirements is difficult to predict due to many factors,
including the outcomes of our research and development programs and when those outcomes are
determined, the timing of obtaining regulatory approvals and the presence and status of competing
products. Our capital needs may exceed the capital available from our future operations,
collaborative and licensing arrangements and existing liquid assets. Our future capital
requirements and liquidity will depend on many factors, including, but not limited to:
|
|
|
the revenue from AMITIZA; |
|
|
|
|
the future expenditures we may incur to increase revenue from AMITIZA; |
|
|
|
|
the cost and time involved to pursue our research and development programs; |
|
|
|
|
our ability to establish collaborative arrangements and to enter into licensing
agreements and contractual arrangements with others; and |
|
|
|
|
any future change in our business strategy. |
To the extent that our capital resources may be insufficient to meet our future capital
requirements, we may need to finance our future cash needs through public or private equity
offerings, debt financings or corporate collaboration and licensing arrangements.
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 may dilute the ownership of our equity investors.
Recent Accounting Pronouncements
Recent accounting pronouncements applicable to our financial statements are described in Note
2 to our condensed consolidated financial statements.
26
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We do not use derivative financial instruments for trading or speculative purposes. However,
we regularly invest excess cash in overnight deposits that are subject to changes in short-term
interest rates.
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
mitigate default risk by investing in investment grade securities. A hypothetical one percentage
point adverse move in interest rates along the entire interest rate yield curve would not have
materially affected the fair value of our interest sensitive financial instruments as of September
30, 2008.
Our exposure to credit risk consists of cash and cash equivalents, restricted cash investments
and receivables. We place our cash and cash equivalents, restricted cash and investments with
highly rated financial institutions. Our uninsured cash, cash equivalents and investments as of
September 30, 2008 consist primarily of $70.8 million of U.S. Treasury and notes and $18.9 million
of money market funds guaranteed under the U.S. Treasurys Temporary Guarantee Program.
|
|
|
|
|
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
Cash and cash equivalents |
|
$ |
13,364 |
|
Investments |
|
|
110,743 |
|
Restricted cash |
|
|
213 |
|
Less: amounts subject to federally insured limits |
|
|
(26,239 |
) |
|
|
|
|
Total amounts in excess of federally insured limits |
|
$ |
98,081 |
|
|
|
|
|
Our investments in the auction rate securities and related risks are further described in Part
I, Item 2 Managements Discussion and Analysis of Financial Condition and Results of Operations
Liquidity and Capital Resources.
Item 4. Controls and Procedures
a) Evaluation of Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Principal Executive
Officer and Principal Financial Officer, performed an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and
15d-15(e) of the Securities Exchange Act of 1934, as amended) as of September 30, 2008. Based upon
this evaluation, our Principal Executive Officer and Principal Financial Officer have concluded
that, as of September 30, 2008, 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 Principal Executive Officer and Principal Financial Officer, as appropriate, to allow
timely decisions regarding required disclosures.
b) Changes in Internal Controls
There were no changes in our internal control over financial reporting during the quarter
ended September 30, 2008 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
Part II OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any legal proceedings of which the ultimate outcome, in our
judgment, would have a material adverse effect on our business, financial condition or results of
operations.
Item 1A. Risk Factors
Except for the risk factors listed below, we do not believe there have been material changes
to the risk factors affecting our business that we included in our Annual Report on Form 10-K for
the year ended December 31, 2007.
27
The recent downturn in the global economy and the recent pressure on capital markets increase the
possibility of and may exacerbate the impact of any adverse effects on our financial position and
business prospects.
The recent downturn in the U.S. economy and economics around the world and the extraordinary
pressure being placed on both debt and equity markets have led to significant retraction in the
U.S. businesses, sudden and severe decreases in the prices of U.S. equities generally and a severe
shortage in available credit. These factors have made it more difficult, in general, for companies
to expand or maintain their current operations and have increased the likelihood that certain
companies will fail. Although we cannot say with certainty the impact the current economic crises
has had on us to date or may have on us in the future, continued pressure on the U.S. economy and
its capital markets may have the effect of, among other things, reducing demand for our products
generally, increasing the cost to manufacture our products, or making it more difficult for us to
raise capital or enter into strategic relationships, each of which could have a materially negative
impact on our business or business prospects. The economic downturn may also lead to, or
accelerate, a decrease in the trading price of our class A common stock.
We depend significantly upon Takedas sales force to market AMITIZA. In addition to its own sales
force, Takeda has been utilizing a sales force within an affiliated joint venture for this purpose,
and the joint venture was recently terminated. Any disruptions in the marketing of AMITIZA by the
Takeda sales force as a result of this development could cause a decline in our revenues.
Under our collaboration and license agreement with Takeda Pharmaceutical Company Limited, or
Takeda, Takeda markets AMITIZA broadly to office-based specialty physicians and primary care
physicians. For this purpose, Takeda has been utilizing its own sales force and a sales force
within an affiliated joint venture, TAP Pharmaceutical Products, Inc., or TAP, which Takeda jointly
owned with Abbot Pharmaceuticals, or Abbott. Takeda and Abbott recently announced that they have
terminated the TAP joint venture. Takeda has informed us that the TAP sales force marketing AMITIZA
will become a Takeda sales force following the termination of the joint venture. These developments
could cause some short-term distraction and dislocation in the Takeda sales force promoting
AMITIZA, which could cause some disruption in the marketing of AMITIZA and in turn lead to
declining or deferred sales of AMITIZA. While we expect any such disruptions would be temporary and
short-term, we cannot assure you that will be the case. Any longer-term disruptions could cause a
material decline in our revenues.
The resignations of our chief financial officer, our vice president of business development and
company operations and our executive vice president of commercial operations could be disruptive to
our business, and our inability to replace them on a timely basis could compromise our ability to
manage our company.
Mariam E. Morris, our former chief financial officer, resigned her position with us effective
July 31, 2008. Kei S. Tolliver, our former vice president of business development and company
operations, resigned her position effective as of May 31, 2008. In addition, Brad Fackler, our
executive vice president, commercial operations, resigned his position effective as of October 10,
2008 and agreed to remain as an employee at Sucampo for a period of time to assist in the
transition of responsibilities. Our failure to successfully transition the responsibilities of
these employees to other employees could make it difficult for us to pursue our business strategy.
28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Use of Proceeds from Initial Public Offering of Class A Common Stock
In August 2007, we completed an initial public offering of class A common stock pursuant to a
registration statement on Form S-1 (Registration No. 333-135133) which the Securities and Exchange
Commission, or SEC, declared effective on August 2, 2007. Pursuant to the registration statement,
we registered the offering and sale of an aggregate of 4,312,500 shares of our class A common
stock, of which 3,125,000 shares were sold by us and 625,000 shares were sold by a selling
stockholder, at a price of $11.50 per share. S&R Technology Holdings, LLC, or S&R, which is wholly
owned by our founders, Drs. Kuno and Ueno, granted to the underwriters an option to purchase an
additional 562,500 shares of our class A common stock at the initial public offering price of
$11.50 per share to cover over-allotments, if any. The initial closing of the offering occurred on
August 2, 2007. The underwriters exercised their over-allotment option and purchased an additional
562,500 shares of class A common stock from S&R on August 29, 2007. We did not receive any proceeds
from the sale of these shares by S&R. The managing underwriters for the offering were Cowen and
Company, LLC, CIBC World Markets Corp. and Leerink Swann & Co., Inc.
We raised a total of $28.2 million in net proceeds from our initial public offering. We have
not used any of the net proceeds from the offering to make payments, directly or indirectly, to any
director or officer of ours, or any of their associates, to any person owning 10% or more of our
common stock or to any affiliate of ours, and none of the expenses we incurred in connection with
the offering or the underwriting discounts and commissions were paid, directly or indirectly, to
any such persons. We did, however, contemporaneously with the closing of our initial public
offering, make payments of approximately $3.1 million in the aggregate to Ryuji Ueno, a director,
officer and 10% stockholder, and Sachiko Kuno, a 10% stockholder, in settlement of special stock
and cash awards that had been made to them in June 2007.
We have used all proceeds from our initial public offering in line with the use of proceeds as
described in our final prospectus filed with the SEC pursuant to Rule 424(b) under the Securities
Act.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of security holders during the quarter ended September 30,
2008.
Item 5. Other Information.
None.
29
Item 6. Exhibits
(a) Exhibits
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|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Reference |
|
3.1
|
|
Restated Certificate of Incorporation
|
|
Exhibit 3.1 to the
Companys Current
Report on Form 8-K
(filed August 8,
2007) |
|
|
|
|
|
3.2
|
|
Form of Restated Bylaws
|
|
Exhibit 3.4 to
Registration
Statement No.
333-135133, Amendment
No. 2 (filed October
20, 2006) |
|
|
|
|
|
4.1
|
|
Specimen Stock Certificate evidencing
the shares of class A common stock
|
|
Exhibit 4.1 to
Registration
Statement No.
333-135133, Amendment
No. 5 (filed February
1, 2007) |
|
|
|
|
|
10.1
|
|
Indemnification Agreement by and
between the Company and Andrew J.
Ferrara
|
|
Exhibit 10.1 to the
Companys Current
Report on Form 8-K
(filed July 22, 2008) |
|
|
|
|
|
10.2
|
|
Separation Agreement and General
Release by and between the Company and
Mariam E. Morris
|
|
Exhibit 10.1 to the
Companys Current
Report on Form 8-K
(filed July 28, 2008) |
|
|
|
|
|
10.3
|
|
Consulting Agreement by and between
the Company and Mariam E. Morris
|
|
Exhibit 10.2 to the
Companys Current
Report on Form 8-K
(filed July 28, 2008) |
|
|
|
|
|
31.1
|
|
Certification of the Principal
Executive Officer, as required by
Section 302 of the Sarbanes-Oxley Act
of 2002
|
|
Included herewith |
|
|
|
|
|
31.2
|
|
Certification of the Principal
Financial Officer, as required by
Section 302 of the Sarbanes-Oxley Act
of 2002
|
|
Included herewith |
|
|
|
|
|
32.1
|
|
Certification of the Principal
Executive Officer pursuant to 18
U.S.C. Section 1350, as adopted
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
|
|
|
|
|
32.2
|
|
Certification of the Principal
Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
30
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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|
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Sucampo Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
November 14, 2008
|
|
By:
|
|
/s/ RYUJI UENO
Ryuji Ueno, M.D., Ph.D., Ph.D.
|
|
|
|
|
|
|
Chief Executive Officer, Chief Scientific Officer |
|
|
|
|
|
|
and Chairman of the Board of Directors |
|
|
|
|
|
|
(Principal Executive Officer) |
|
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|
|
|
|
|
|
November 14, 2008
|
|
By:
|
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/s/ JAN SMILEK
Jan Smilek
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|
Vice President, Finance and Acting Chief |
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Financial Officer |
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|
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|
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(Principal Financial Officer) |
|
|
31
Sucampo Pharmaceuticals, Inc.
Exhibit Index
|
|
|
|
|
Exhibit |
|
|
|
|
Number |
|
Description |
|
Reference |
|
3.1
|
|
Restated Certificate of Incorporation
|
|
Exhibit 3.1 to the
Companys Current
Report on Form 8-K
(filed August 8,
2007) |
|
|
|
|
|
3.2
|
|
Form of Restated Bylaws
|
|
Exhibit 3.4 to
Registration
Statement No.
333-135133, Amendment
No. 2 (filed October
20, 2006) |
|
|
|
|
|
4.1
|
|
Specimen Stock Certificate evidencing
the shares of class A common stock
|
|
Exhibit 4.1 to
Registration
Statement No.
333-135133, Amendment
No. 5 (filed February
1, 2007) |
|
|
|
|
|
10.1
|
|
Indemnification Agreement by and
between the Company and Andrew J.
Ferrara
|
|
Exhibit 10.1 to the
Companys Current
Report on Form 8-K
(filed July 22, 2008) |
|
|
|
|
|
10.2
|
|
Separation Agreement and General
Release by and between the Company and
Mariam E. Morris
|
|
Exhibit 10.1 to the
Companys Current
Report on Form 8-K
(filed July 28, 2008) |
|
|
|
|
|
10.3
|
|
Consulting Agreement by and between
the Company and Mariam E. Morris
|
|
Exhibit 10.2 to the
Companys Current
Report on Form 8-K
(filed July 28, 2008) |
|
|
|
|
|
31.1
|
|
Certification of the Principal
Executive Officer, as required by
Section 302 of the Sarbanes-Oxley Act
of 2002
|
|
Included herewith |
|
|
|
|
|
31.2
|
|
Certification of the Principal
Financial Officer, as required by
Section 302 of the Sarbanes-Oxley Act
of 2002
|
|
Included herewith |
|
|
|
|
|
32.1
|
|
Certification of the Principal
Executive Officer pursuant to 18
U.S.C. Section 1350, as adopted
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
|
|
|
|
|
32.2
|
|
Certification of the Principal
Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted
pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
|
Included herewith |
exv31w1
EXHIBIT 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE 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)) 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) |
|
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 |
|
|
(c) |
|
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: November 14, 2008 |
/s/ RYUJI UENO
|
|
|
Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
exv31w2
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)) 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) |
|
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 |
|
|
(c) |
|
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: November 14, 2008 |
/s/ JAN SMILEK
|
|
|
Jan Smilek |
|
|
Vice President, Finance
Acting Chief Financial Officer
(Principal Financial Officer) |
|
|
exv32w1
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 quarter ended September 30, 2008 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: November 14, 2008 |
/s/ RYUJI UENO
|
|
|
Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
exv32w2
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 quarter ended September 30, 2008 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: November 14, 2008 |
/s/ JAN SMILEK
|
|
|
Jan Smilek |
|
|
Vice President, Finance
Acting Chief Financial Officer
(Principal Financial Officer) |
|
|