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 June 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
(State or other jurisdiction of
incorporation or organization)
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13-3929237
(I.R.S. employer
identification no.) |
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4520 East-West Highway, Suite 300
Bethesda, MD 20814
(Address of principal executive offices,
including zip code)
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(301) 961-3400
(Registrants telephone number,
including area code) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes 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):
Large accelerated filer o |
Accelerated filer o |
Non-accelerated filer þ (Do not check if a smaller reporting company) |
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
As of August 6, 2008, there were 15,607,989 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 June 30, 2008 and December 31, 2007 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive Income for the Three and Six Months Ended June 30, 2008 and 2007 |
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2 |
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Condensed Consolidated Statement of Changes in Stockholders Equity for the Six Months Ended June 30, 2008 |
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3 |
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Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 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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18 |
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Item 3. |
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Quantitative and Qualitative Disclosures About Market Risk |
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29 |
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Item 4. |
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Controls and Procedures |
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29 |
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Part II. OTHER INFORMATION |
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Item 1. |
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Legal Proceedings |
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29 |
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Item 1A. |
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Risk Factors |
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29 |
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Item 2. |
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Unregistered Sales of Equity Securities and Use of Proceeds |
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30 |
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Item 4. |
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Submission of Matters to a Vote of Security Holders |
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31 |
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Item 6. |
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Exhibits |
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32 |
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SIGNATURES |
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33 |
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INDEX TO EXHIBITS |
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34 |
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PART I FINANCIAL INFORMATION
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Item 1. Condensed Consolidated Financial Statements (Unaudited) |
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SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets (Unaudited)
(In thousands, except share data)
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June 30, |
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December 31, |
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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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$ |
26,483 |
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$ |
25,559 |
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Investments, current |
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87,615 |
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51,552 |
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Product royalties receivable |
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10,283 |
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8,667 |
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Unbilled accounts receivable |
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5,679 |
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5,883 |
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Accounts receivable |
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2,910 |
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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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1,394 |
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88 |
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Prepaid expenses and other current assets |
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1,811 |
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2,222 |
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Total current assets |
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136,294 |
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97,418 |
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Investments, non-current |
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20,932 |
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9,400 |
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Property and equipment, net |
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2,355 |
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2,265 |
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Deferred tax assets noncurrent, net |
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4,713 |
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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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$ |
164,695 |
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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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$ |
3,524 |
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$ |
3,313 |
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Accrued expenses |
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10,404 |
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8,730 |
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Deferred revenue current |
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10,867 |
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1,062 |
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Income taxes payable |
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13,409 |
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Total current liabilities |
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38,204 |
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13,105 |
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Deferred revenue, net of current portion |
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8,344 |
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8,626 |
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Other liabilities |
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1,774 |
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1,768 |
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Total liabilities |
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48,322 |
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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 June 30, 2008 and
December 31, 2007; no shares issued and
outstanding at June 30, 2008 and December
31, 2007 |
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Class A common stock, $0.01 par value;
270,000,000 shares authorized at June 30,
2008 and December 31, 2007; 15,595,518 and
15,538,518 shares issued and outstanding at
June 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, $0.01 par value;
75,000,000 shares authorized at June 30,
2008 and December 31, 2007; 26,191,050
shares issued and outstanding at June 30,
2008 and
December 31, 2007 |
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262 |
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262 |
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Additional paid-in capital |
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97,594 |
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96,680 |
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Accumulated other comprehensive loss |
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(1,844 |
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(393 |
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Retained earnings (accumulated deficit) |
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20,205 |
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(10,176 |
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Total stockholders equity |
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116,373 |
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86,528 |
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Total liabilities and stockholders equity |
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$ |
164,695 |
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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 Income (Unaudited)
(In thousands, except per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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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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$ |
55,436 |
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$ |
38,087 |
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$ |
61,546 |
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$ |
47,453 |
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Product royalty revenue |
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10,901 |
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9,562 |
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16,981 |
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11,871 |
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Co-promotion revenue |
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1,236 |
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1,134 |
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2,458 |
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2,267 |
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Contract and collaboration revenue |
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141 |
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151 |
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283 |
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304 |
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Total revenues |
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67,714 |
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48,934 |
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81,268 |
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61,895 |
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Operating expenses: |
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Research and development |
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12,931 |
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8,082 |
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24,147 |
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14,690 |
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General and administrative |
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3,561 |
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13,017 |
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6,728 |
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15,170 |
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Selling and marketing |
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2,870 |
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3,776 |
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5,718 |
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7,026 |
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Milestone royalties related parties |
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2,500 |
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1,500 |
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3,531 |
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1,500 |
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Product royalties related parties |
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1,951 |
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1,700 |
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3,032 |
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2,111 |
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Total operating expenses |
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23,813 |
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28,075 |
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43,156 |
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40,497 |
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Income from operations |
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43,901 |
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20,859 |
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38,112 |
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21,398 |
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Non-operating income (expense): |
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Interest income |
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565 |
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471 |
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1,207 |
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795 |
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Other (expense) income, net |
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(13 |
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42 |
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(1 |
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36 |
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Total non-operating income, net |
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552 |
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513 |
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1,206 |
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831 |
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Income before income taxes |
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44,453 |
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21,372 |
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39,318 |
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22,229 |
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Income tax provision |
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(14,577 |
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(7,489 |
) |
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(8,937 |
) |
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(7,829 |
) |
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Net income |
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$ |
29,876 |
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$ |
13,883 |
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$ |
30,381 |
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$ |
14,400 |
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Net income per share: |
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Basic net income per share |
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$ |
0.72 |
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$ |
0.40 |
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$ |
0.73 |
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$ |
0.41 |
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Diluted net income per share |
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$ |
0.71 |
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$ |
0.39 |
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$ |
0.72 |
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$ |
0.41 |
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Weighted average common shares outstanding basic |
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41,757 |
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34,990 |
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41,745 |
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34,990 |
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Weighted average common shares outstanding diluted |
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42,038 |
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35,505 |
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42,026 |
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35,505 |
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Comprehensive income: |
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Net income |
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$ |
29,876 |
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$ |
13,883 |
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$ |
30,381 |
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$ |
14,400 |
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Other comprehensive (loss) income: |
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Unrealized loss on investments, net of tax effect |
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(616 |
) |
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(1,456 |
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Foreign currency translation |
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(325 |
) |
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(101 |
) |
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5 |
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(81 |
) |
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Comprehensive income |
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$ |
28,935 |
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$ |
13,782 |
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$ |
28,930 |
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$ |
14,319 |
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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 |
|
|
$ |
96,680 |
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$ |
(393 |
) |
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$ |
(10,176 |
) |
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$ |
86,528 |
|
Stock issued upon exercise of stock options |
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|
57,000 |
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1 |
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|
403 |
|
|
|
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|
404 |
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Employee stock option expense, net of tax benefit |
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|
|
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|
|
|
|
|
|
|
|
|
511 |
|
|
|
|
|
|
|
|
|
|
|
511 |
|
Foreign currency translation |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
5 |
|
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|
5 |
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Unrealized loss on investments, net of tax effect |
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|
|
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|
|
|
|
|
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|
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|
|
|
|
|
|
|
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|
(1,456 |
) |
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|
|
|
|
|
(1,456 |
) |
Net income |
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|
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|
|
|
|
|
|
|
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|
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|
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|
30,381 |
|
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|
30,381 |
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|
Balance at June 30, 2008 |
|
|
15,595,518 |
|
|
$ |
156 |
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|
|
26,191,050 |
|
|
$ |
262 |
|
|
$ |
97,594 |
|
|
$ |
(1,844 |
) |
|
$ |
20,205 |
|
|
$ |
116,373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
SUCAMPO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(In thousands)
|
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|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
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|
2008 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
30,381 |
|
|
$ |
14,400 |
|
Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
212 |
|
|
|
60 |
|
Deferred tax (benefit) provision |
|
|
(4,543 |
) |
|
|
4,367 |
|
Stock-based compensation |
|
|
440 |
|
|
|
6,071 |
|
Accretion of discounts on investments |
|
|
(122 |
) |
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(1,336 |
) |
|
|
(31,379 |
) |
Unbilled accounts receivable |
|
|
204 |
|
|
|
|
|
Product royalties receivable |
|
|
(1,616 |
) |
|
|
(7,532 |
) |
Prepaid and income taxes receivable and payable, net |
|
|
15,213 |
|
|
|
3,454 |
|
Accounts payable |
|
|
53 |
|
|
|
659 |
|
Accrued expenses |
|
|
1,732 |
|
|
|
4,321 |
|
Deferred revenue |
|
|
9,521 |
|
|
|
(11,234 |
) |
Other assets and liabilities, net |
|
|
462 |
|
|
|
3,989 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
50,601 |
|
|
|
(12,824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of investments |
|
|
(111,304 |
) |
|
|
|
|
Proceeds from the sales of investments |
|
|
38,950 |
|
|
|
24 |
|
Maturities of investments |
|
|
22,500 |
|
|
|
|
|
Purchases of property and equipment |
|
|
(302 |
) |
|
|
(1,340 |
) |
Excess tax benefits from share-based payments |
|
|
71 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(50,085 |
) |
|
|
(1,316 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
404 |
|
|
|
|
|
Payments of initial public offering costs |
|
|
|
|
|
|
(632 |
) |
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
404 |
|
|
|
(632 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
4 |
|
|
|
(69 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
924 |
|
|
|
(14,841 |
) |
Cash and cash equivalents at beginning of period |
|
|
25,559 |
|
|
|
22,481 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
26,483 |
|
|
$ |
7,640 |
|
|
|
|
|
|
|
|
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 specialty 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 multiple companies.
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 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 June 30, 2008 and for
the three and six months ended June 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). Although the auction
rate securities have variable interest rates which typically reset every seven to 49 days through a
competitive bidding process known as a Dutch auction, they have long-term contractual maturities
usually exceeding ten years, and therefore are not classified as cash equivalents. These
investments have historically been classified within current assets because the holder of the
auction rate security has had the ability to liquidate these securities if needed within a short
time frame, usually at the next auction. However, as a result of liquidity issues related to the
auction rate security market during 2008, the Company has classified $20.9 million of its auction
rate
securities as non-current as of June 30, 2008. The Company classified $3.9 million of its
auction rate securities as current investments as of June 30, 2008 due to its redemption at par
value on July 2, 2008.
5
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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 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, would be recorded to other comprehensive income.
Interest and dividend income is recorded when earned and included in interest income. Premiums
and discounts on investments, if any, are amortized or accreted to maturity and included in
interest income. The Company uses the specific identification method in computing realized gains
and losses on sale of its securities. During the three and six months ended June 30, 2008 and 2007,
there were no gains or losses realized on the sale of investments.
The adoption of SFAS 157 did not materially affect the Companys financial condition, results
of operations, or cash flow. The Company is now required to provide additional disclosures as part
of its financial statements. 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 in 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.
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 June 30, 2008 and December 31, 2007, the Company had approximately
$133.0 million and $85.9 million, respectively, of cash and cash equivalents, restricted cash and
investments in excess of government insured limits. The Company has not experienced any losses on
these accounts related to amounts in excess of insured limits.
As of June 30, 2008, all of the Companys auction rate securities consisted of AAA rated
non-mortgage related auction rate securities which are insured against loss of principal and
interest by bond insurers. During the three and six months ended June 30, 2008, the Company reduced
its investment in auction rate securities by either redeeming or selling $625,000 and $33.9
million, respectively, of investments at par value, net of purchases. At June 30, 2008, the Company
continues to hold $24.8 million of investments in auction rate securities at fair value. As a
result of the disruptions and failures in the auction rate securities market, the Company recorded
an unrealized loss of $844,000, or $453,000 net of tax effect, for the three months ended June 30,
2008, and $2.2 million, or $1.3 million net of tax effect, for the six months ended June 30, 2008,
related to its investment in auction rate securities. This unrealized loss was recorded as other
comprehensive loss during the three and six months ended June 30, 2008. Although recent actions
initiated primarily by the issuers of the auction rate securities led to redemptions and successful
auctions of certain securities, it remains uncertain as to when the liquidity issues relating to
these investments will be fully resolved. Therefore, the Company classified all of its investments
in auction rate securities as non-current investments as of June 30, 2008, with the exception of
the $3.9 million investment that was redeemed at par value in July 2008. The Company does not
anticipate having to sell the remaining
securities in order to operate its business. If this changes, however, the Company may be
unable to liquidate some holdings of the auction rate securities and, as a result, may suffer
losses from these investments. Although a very limited secondary market exists for these
securities, the Company does not currently intend to use the secondary market to dispose of the
auction rate securities. In addition, given the complexity of auction rate securities and their
valuations, the Companys estimates of their fair value may differ from the actual amount that the
Company would be able to collect in an ultimate sale.
6
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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.
The Companys expected activities will necessitate significant uses of working capital
throughout 2008 and beyond. 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 in part with cash received from its
initial public offering, from milestones and other revenue related to its joint collaboration and
license agreement and the supplemental agreement entered into with Takeda (see Note 9), as well as
continued product royalties.
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 June 30, 2008 and 2007 and
the six months ended June 30, 2008 and 2007. Accounts receivable, unbilled accounts receivable and
product royalties receivable from Takeda accounted for 91% and 99% of the Companys accounts
receivable, unbilled accounts receivable and product royalties receivable at June 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. Any
difficulties or delays in performing the services under this exclusive supply arrangement 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
Consistent with the Companys policy on revenue recognition, 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 reflected as deferred
revenue 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 three months
ended June 30, 2008, the Company agreed to receive quarterly prepayments from Takeda for its
research and development expenses under the agreements with Takeda. As of June 30, 2008,
approximately $8.1 million of deferred revenue relates to these prepayments (see Note 6).
Cumulative Out-of-Period Adjustment
The Company recorded a cumulative adjustment of approximately $871,000 and $148,000 during the
three and six months ended June 30, 2008, respectively, to recognize additional research and
development expenses that had not been recorded in prior periods. The error resulted from
incorrect accounting for investigator services for the Phase 2b 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, for the three months ended March 31, 2008 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)
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 June 30, 2007, the Company reclassified $734,000 and $51,000 of general and administrative
expenses to research and development expenses and selling and marketing expenses, respectively.
During the six months ended June 30, 2007, the Company reclassified approximately $1.4 million and
$69,000 of general and administrative expenses to research and development expenses and selling and
marketing expenses, respectively.
Change 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 $1.7
million in research and development revenue as of June 30, 2008. 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. This change in estimate has the following impact on net
income and basic and diluted net income per share for the three and six months ended June 30, 2008:
|
|
|
|
|
(In thousands, except per share data) |
|
|
|
|
Decrease in revenue and income before income taxes |
|
$ |
(1,693 |
) |
Impact on basic net income per share |
|
|
(0.04 |
) |
Impact on diluted net income per share |
|
|
(0.04 |
) |
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
8
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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. The Company is assessing EITF 07-1 and its impact on the consolidated
financial statements upon adoption.
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.
In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting
Principles (SFAS 162). SFAS 162 identifies the sources of accounting principles and the framework
for selecting the principles used in the preparation of financial statements of nongovernmental
entities that are presented in conformity with GAAP. The GAAP hierarchy previously resided in the
American Institute of Certified Public Accountants statements on auditing standards, which are
directed to the auditor rather than the reporting entity. SFAS 162 moves the GAAP hierarchy to the
accounting literature, thereby directing it to reporting entities since it is the entity (not its
auditor) that is responsible for selecting accounting principles for financial statements that are
presented in conformity with GAAP. SFAS 162 is effective 60 days following the Securities and Exchange Commissions (SEC) approval of
the Public Company Accounting Oversight Board amendments to AU Section 411, The Meaning of Present
Fairly in Conformity With Generally Accepted Accounting Principles. SFAS 162 will not have any
impact on the Companys consolidated financial statements.
3. Earnings per Share
Basic net income (loss) per share is computed by dividing net income (loss) by the sum of the
weighted average class A and B common shares outstanding. Diluted net income per share is computed
by dividing net income by the weighted average common shares and potential dilutive common shares
outstanding. Diluted net loss per share, when applicable, is computed by dividing net loss by the
weighted average common shares outstanding without the impact of potential dilutive common shares
outstanding because they would have an anti-dilutive impact on diluted net loss per share.
The computation of net income per share for the three and six months ended June 30, 2008 and
2007 is shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
(In thousands, except per share data) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Basic net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
29,876 |
|
|
$ |
13,883 |
|
|
$ |
30,381 |
|
|
$ |
14,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares outstanding |
|
|
41,757 |
|
|
|
34,990 |
|
|
|
41,745 |
|
|
|
34,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
0.72 |
|
|
$ |
0.40 |
|
|
$ |
0.73 |
|
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
29,876 |
|
|
$ |
13,883 |
|
|
$ |
30,381 |
|
|
$ |
14,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average class A and B
common shares outstanding for
diluted net income per share |
|
|
41,757 |
|
|
|
34,990 |
|
|
|
41,745 |
|
|
|
34,990 |
|
Assumed exercise of stock options
under the treasury stock method |
|
|
281 |
|
|
|
515 |
|
|
|
281 |
|
|
|
515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,038 |
|
|
|
35,505 |
|
|
|
42,026 |
|
|
|
35,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
0.71 |
|
|
$ |
0.39 |
|
|
$ |
0.72 |
|
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the periods listed above, the potentially dilutive securities used in the calculations of
diluted historical net income per share as of June 30, 2008 and 2007 are as follows:
9
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
June 30, |
(In thousands) |
|
2008 |
|
2007 |
Employee stock options |
|
|
583 |
|
|
|
641 |
|
Non-employee stock options |
|
|
470 |
|
|
|
510 |
|
For the periods listed above, the following securities were excluded from the computation of
diluted net income per share as their effect would be anti-dilutive as of June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
(In thousands) |
|
2008 |
|
2007 |
Employee stock options |
|
|
260 |
|
|
|
|
|
4. Current and Non-Current Investments
At June 30, 2008 and December 31, 2007, current and non-current available-for-sale investments
consisted of the following securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
|
|
(In thousands) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury bills and notes |
|
$ |
83,826 |
|
|
$ |
3 |
|
|
$ |
(166 |
) |
|
$ |
83,663 |
|
Auction rate securities |
|
|
3,900 |
|
|
|
|
|
|
|
|
|
|
|
3,900 |
|
Money market funds |
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
87,778 |
|
|
$ |
3 |
|
|
$ |
(166 |
) |
|
$ |
87,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
$ |
23,150 |
|
|
$ |
|
|
|
$ |
(2,218 |
) |
|
$ |
20,932 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 June 30, 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
Quoted Prices in |
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
Active Markets for |
|
|
Significant Other |
|
|
Unobservable |
|
|
|
|
|
|
Identical Assets |
|
|
Observable Inputs |
|
|
Inputs |
|
|
Total as of |
|
(In thousands) |
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
June 30, 2008 |
|
U.S. Treasury bills and notes |
|
$ |
83,663 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
83,663 |
|
Auction rate securities |
|
|
|
|
|
|
3,900 |
|
|
|
20,932 |
|
|
|
24,832 |
|
Other available-for-sale securities |
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
83,715 |
|
|
$ |
3,900 |
|
|
$ |
20,932 |
|
|
$ |
108,547 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
SUCAMPO PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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 since the Companys initial adoption of SFAS 157 at January 1, 2008. The Level
2 securities consist of the auction rate security that was redeemed at par subsequent to June 30,
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 six months ended June 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 |
|
|
(2,218 |
) |
Purchases |
|
|
5,100 |
|
Settlements |
|
|
(38,950 |
) |
|
|
|
|
Balance at June 30, 2008 |
|
$ |
24,832 |
|
|
|
|
|
5. Accrued Expenses
Accrued expenses consist of the following as of:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Research and development costs |
|
$ |
5,266 |
|
|
$ |
4,422 |
|
Selling and marketing costs |
|
|
245 |
|
|
|
384 |
|
Employee compensation |
|
|
1,556 |
|
|
|
1,867 |
|
Legal service fees |
|
|
179 |
|
|
|
226 |
|
Product royalty liability related party |
|
|
1,952 |
|
|
|
1,536 |
|
Other accrued expenses |
|
|
1,206 |
|
|
|
295 |
|
|
|
|
|
|
|
|
|
|
$ |
10,404 |
|
|
$ |
8,730 |
|
|
|
|
|
|
|
|
6. Deferred Revenue
At June 30, 2008 and December 31, 2007, total deferred revenue was approximately $19.2 million
and $9.7 million, respectively.
Total deferred revenue consists of the following as of:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Deferred revenue current |
|
$ |
10,867 |
|
|
$ |
1,062 |
|
Deferred revenue, net of current portion |
|
|
8,344 |
|
|
|
8,626 |
|
|
|
|
|
|
|
|
|
|
$ |
19,211 |
|
|
$ |
9,688 |
|
|
|
|
|
|
|
|
During the three months ended June 30, 2008, the Company began receiving quarterly prepayments
for its research and development expenses under the agreement with Takeda. As of June 30, 2008,
approximately $8.1 million of deferred revenue relates to these prepayments.
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 are
as follows as of June 30, 2008:
11
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
(In thousands) |
|
|
|
|
2008 |
|
$ |
759 |
|
2009 |
|
|
1,421 |
|
2010 |
|
|
969 |
|
2011 |
|
|
938 |
|
2012 |
|
|
963 |
|
2013 and thereafter |
|
|
4,243 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
9,293 |
|
|
|
|
|
Rent expense for all operating leases was $292,000 and $297,000 for the three months ended
June 30, 2008 and 2007, respectively, and $577,000 and $464,000 for the six months ended June 30,
2008 and 2007, respectively.
Research and Development Costs
The Company routinely enters into agreements with third-party clinical research organizations
(CROs) to oversee clinical research and development studies provided on an outsourced basis. The
Company is not generally contractually obligated to pay the CRO if the service or reports are not
provided. Total future estimated costs under these agreements as of June 30, 2008 were
approximately $18.4 million.
8. Related Party Transactions
R-Tech Ueno, Ltd.
The Company is a party to multiple exclusive supply agreements with R-Tech, whereby R-Tech
manufactures and supplies AMITIZA and other prostone compounds for Sucampo. During the three months
ended June 30, 2008 and 2007, the Company purchased from R-Tech $127,000 and $402,000,
respectively, and $525,000 and $1.6 million for the six months ended June 30, 2008 and 2007,
respectively, of clinical supplies under the terms of these agreements.
The following table summarizes the amounts included in deferred revenue resulting from the
deferral of upfront payments relating to the exclusive supply agreements with R-Tech:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Deferred revenue current |
|
$ |
419 |
|
|
$ |
419 |
|
Deferred revenue, net of current portion |
|
|
6,653 |
|
|
|
6,862 |
|
|
|
|
|
|
|
|
|
|
$ |
7,072 |
|
|
$ |
7,281 |
|
|
|
|
|
|
|
|
The Company recognized approximately $105,000 of deferred revenue relating to its agreements
with R-Tech for the three months ended June 30, 2008 and 2007 and approximately $209,000 for the
six months ended June 30, 2008 and 2007, which was recorded as contract and collaboration revenue
in the condensed consolidated statements of operations and comprehensive income.
Sucampo AG License Agreements
During the first quarter of 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 second quarter of 2008.
The Company expensed approximately $1.9 million and $1.7 million in product royalties
related parties under the license agreement with SAG for the three months ended June 30, 2008 and
2007, respectively, and approximately $3.0 million and $2.1 million for the six months ended June
30, 2008 and 2007, respectively.
12
SUCAMPO PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements (Unaudited) (Continued)
9. Collaboration and License Agreements with Takeda
On October 29, 2004, the Company entered into a 16-year collaboration and license agreement
with Takeda (Takeda Agreement) to exclusively co-develop, commercialize and sell products that
contain lubiprostone for gastroenterology indications in the United States and Canada. Payments to
the Company under the Takeda Agreement 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.
On February 1, 2006, the Company entered into the 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.
Takeda made an up-front payment of $20.0 million in 2004 and, upon its receipt, the Company
deferred approximately $2.4 million because the amount was associated with the Companys obligation
to participate in joint committees with Takeda. Approximately $1.8 million of the initial up-front
payment remains deferred as of June 30, 2008, and is being recognized on a straight-line basis over
the remaining life of the Takeda Agreement through 2020.
The Company has also received a total of $80.0 million in development milestone payments
through June 30, 2008 for this development work. 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
six months ended June 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
Change in |
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
Accounts |
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
Receivable |
|
|
|
|
|
|
Amount |
|
|
Six Months |
|
|
Six Months |
|
|
for the Six |
|
|
Amount |
|
|
|
Deferred at |
|
|
Ended |
|
|
Ended |
|
|
Months Ended |
|
|
Deferred at |
|
|
|
December 31, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
(In thousands) |
|
2007 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment associated with the Companys
obligation to participate in joint committees
with Takeda |
|
$ |
1,911 |
|
|
$ |
|
|
|
$ |
74 |
|
|
$ |
|
|
|
$ |
1,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development milestones |
|
$ |
|
|
|
$ |
50,000 |
|
|
$ |
50,000 |
|
|
$ |
|
|
|
$ |
|
|
Reimbursement of research and development expenses |
|
|
|
|
|
|
20,545 |
|
|
|
11,546 |
|
|
|
(881 |
) |
|
|
8,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
70,545 |
|
|
$ |
61,546 |
|
|
$ |
(881 |
) |
|
$ |
8,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
|
|
|
$ |
15,471 |
|
|
$ |
16,981 |
|
|
$ |
1,616 |
|
|
$ |
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
SUCAMPO PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
|
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
|
|
|
|
|
|
|
Accounts |
|
|
Six Months |
|
|
Six Months |
|
|
Accounts |
|
|
Amount |
|
|
|
Receivable at |
|
|
Ended |
|
|
Ended |
|
|
Receivable at |
|
|
Deferred at |
|
|
|
December 31, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 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 |
|
|
$ |
20,545 |
|
|
$ |
11,546 |
|
|
$ |
6,006 |
|
|
$ |
8,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
8,667 |
|
|
$ |
15,471 |
|
|
$ |
16,981 |
|
|
$ |
10,283 |
|
|
$ |
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promotion revenue |
|
$ |
360 |
|
|
$ |
2,442 |
|
|
$ |
2,458 |
|
|
$ |
376 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
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
The following table summarizes the employee stock option activity for the six months ended
June 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 |
|
|
(17,000 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(34,850 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(21,250 |
) |
|
|
10.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, June 30, 2008 |
|
|
567,800 |
|
|
|
10.27 |
|
|
|
6.49 |
|
|
$ |
261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, June 30, 2008 |
|
|
552,925 |
|
|
|
10.28 |
|
|
|
6.45 |
|
|
$ |
251 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table summarizes the employee stock option activity for the six months ended
June 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 |
|
|
30,000 |
|
|
|
12.25 |
|
|
|
|
|
|
|
|
|
Options forfeited |
|
|
(12,750 |
) |
|
|
14.12 |
|
|
|
|
|
|
|
|
|
Options expired |
|
|
(10,000 |
) |
|
|
14.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, June 30, 2008 |
|
|
274,750 |
|
|
|
14.09 |
|
|
|
8.47 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, June 30, 2008 |
|
|
62,500 |
|
|
|
14.46 |
|
|
|
8.25 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant date fair value of options granted during the six months ended June
30, 2008 and the year ended December 31, 2007 were $6.15 and $7.19, respectively. As of June 30,
2008, approximately $1.4 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 2.47 years.
14
SUCAMPO PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements (Unaudited) (Continued)
The following table summarizes the non-employee stock option activity for the six months ended
June 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 |
|
|
(40,000 |
) |
|
|
5.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding, June 30, 2008 |
|
|
470,000 |
|
|
|
5.85 |
|
|
|
6.83 |
|
|
$ |
2,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable, June 30, 2008 |
|
|
470,000 |
|
|
|
5.85 |
|
|
|
6.83 |
|
|
$ |
2,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11. Income Taxes
On January 1, 2007, the Company adopted FASB Interpretation (FIN) No. 48, Accounting for
Uncertainty in Income Taxes (FIN 48). FIN 48 prescribes a recognition threshold that a tax
position is required to meet before being recognized in the financial statements and provides
guidance on derecognition, measurement, classification, interest and penalties, accounting in
interim periods, disclosure and transition issues. The adoption of FIN 48 as of January 1, 2007 did
not impact the Companys consolidated financial statements.
For the three months ended June 30, 2008 and 2007, the Companys consolidated effective tax
rate was 32.8% and 35.0%, respectively. For the six months ended June 30, 2008 and 2007, the
Companys consolidated annualized effective tax rate was 22.7% and 35.2%, respectively. For the
three months ended June 30, 2008 and 2007, the Company recorded a tax provision of $14.6 million
and $7.5 million, respectively. For the six months ended June 30, 2008 and 2007, the Company
recorded a tax provision of $8.9 million and $7.8 million, respectively. As a result of the FDA
approval of the sNDA 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 six months ended June 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 first and second quarter 2008 pre-tax income.
As required under Accounting Principles Board Opinion No. 28, Interim Financial Reporting,
the Company has estimated its annual effective tax rate for the full fiscal year 2008 and 2007 and
applied that rate to its income before income taxes in determining its income tax provision for the
interim periods.
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 June
30, 2008, the Company had not drawn down any funds under this line of credit.
15
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
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 loans and the provision of research and development services by the
European and Japanese entities to the United States entity. Following is a summary of financial
information by reportable geographic segment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
United States |
|
|
Europe |
|
|
Japan |
|
|
Eliminations |
|
|
Consolidated |
|
Three Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
55,436 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
55,436 |
|
Product royalty revenue |
|
|
10,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,901 |
|
Co-promotion revenue |
|
|
1,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,236 |
|
Contract and collaboration revenue |
|
|
141 |
|
|
|
|
|
|
|
210 |
|
|
|
(210 |
) |
|
|
141 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
67,714 |
|
|
|
|
|
|
|
210 |
|
|
|
(210 |
) |
|
|
67,714 |
|
Depreciation and amortization |
|
|
108 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
110 |
|
Other operating expenses |
|
|
20,561 |
|
|
|
584 |
|
|
|
2,768 |
|
|
|
(210 |
) |
|
|
23,703 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
47,045 |
|
|
|
(584 |
) |
|
|
(2,560 |
) |
|
|
|
|
|
|
43,901 |
|
Interest income |
|
|
590 |
|
|
|
1 |
|
|
|
|
|
|
|
(26 |
) |
|
|
565 |
|
Other non-operating expense, net |
|
|
(6 |
) |
|
|
(32 |
) |
|
|
(1 |
) |
|
|
26 |
|
|
|
(13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
47,629 |
|
|
$ |
(615 |
) |
|
$ |
(2,561 |
) |
|
$ |
|
|
|
$ |
44,453 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
128 |
|
|
$ |
|
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
38,087 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
38,087 |
|
Product royalty revenue |
|
|
9,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,562 |
|
Co-promotion revenue |
|
|
1,134 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,134 |
|
Contract and collaboration revenue |
|
|
141 |
|
|
|
|
|
|
|
220 |
|
|
|
(210 |
) |
|
|
151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
48,924 |
|
|
|
|
|
|
|
220 |
|
|
|
(210 |
) |
|
|
48,934 |
|
Depreciation and amortization |
|
|
37 |
|
|
|
|
|
|
|
(1 |
) |
|
|
|
|
|
|
36 |
|
Other operating expenses |
|
|
27,409 |
|
|
|
144 |
|
|
|
696 |
|
|
|
(210 |
) |
|
|
28,039 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
21,478 |
|
|
|
(144 |
) |
|
|
(475 |
) |
|
|
|
|
|
|
20,859 |
|
Interest income |
|
|
471 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
471 |
|
Other non-operating income (expense), net |
|
|
8 |
|
|
|
(5 |
) |
|
|
39 |
|
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
21,957 |
|
|
$ |
(149 |
) |
|
$ |
(436 |
) |
|
$ |
|
|
|
$ |
21,372 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
1,244 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
SUCAMPO PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements (Unaudited) (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
|
|
(In thousands) |
|
United States |
|
|
Europe |
|
|
Japan |
|
|
Eliminations |
|
|
Consolidated |
|
Six Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
61,546 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
61,546 |
|
Product royalty revenue |
|
|
16,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,981 |
|
Co-promotion revenue |
|
|
2,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,458 |
|
Contract and collaboration revenue |
|
|
283 |
|
|
|
|
|
|
|
417 |
|
|
|
(417 |
) |
|
|
283 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
81,268 |
|
|
|
|
|
|
|
417 |
|
|
|
(417 |
) |
|
|
81,268 |
|
Depreciation and amortization |
|
|
208 |
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
212 |
|
Other operating expenses |
|
|
37,505 |
|
|
|
2,422 |
|
|
|
3,437 |
|
|
|
(420 |
) |
|
|
42,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
43,555 |
|
|
|
(2,422 |
) |
|
|
(3,024 |
) |
|
|
3 |
|
|
|
38,112 |
|
Interest income |
|
|
1,246 |
|
|
|
5 |
|
|
|
3 |
|
|
|
(47 |
) |
|
|
1,207 |
|
Other non-operating (expense) income, net |
|
|
(33 |
) |
|
|
(13 |
) |
|
|
1 |
|
|
|
44 |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
44,768 |
|
|
$ |
(2,430 |
) |
|
$ |
(3,020 |
) |
|
$ |
|
|
|
$ |
39,318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
299 |
|
|
$ |
|
|
|
$ |
3 |
|
|
$ |
|
|
|
$ |
302 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
47,453 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
47,453 |
|
Product royalty revenue |
|
|
11,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,871 |
|
Co-promotion revenue |
|
|
2,267 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,267 |
|
Contract and collaboration revenue |
|
|
283 |
|
|
|
|
|
|
|
441 |
|
|
|
(420 |
) |
|
|
304 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
61,874 |
|
|
|
|
|
|
|
441 |
|
|
|
(420 |
) |
|
|
61,895 |
|
Depreciation and amortization |
|
|
58 |
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
60 |
|
Other operating expenses |
|
|
39,614 |
|
|
|
309 |
|
|
|
934 |
|
|
|
(420 |
) |
|
|
40,437 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
22,202 |
|
|
|
(309 |
) |
|
|
(495 |
) |
|
|
|
|
|
|
21,398 |
|
Interest income |
|
|
791 |
|
|
|
|
|
|
|
4 |
|
|
|
|
|
|
|
795 |
|
Other non-operating income (expense), net |
|
|
5 |
|
|
|
(8 |
) |
|
|
39 |
|
|
|
|
|
|
|
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
22,998 |
|
|
$ |
(317 |
) |
|
$ |
(452 |
) |
|
$ |
|
|
|
$ |
22,229 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures |
|
$ |
1,340 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
2,268 |
|
|
$ |
|
|
|
$ |
87 |
|
|
$ |
|
|
|
$ |
2,355 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable assets |
|
$ |
173,195 |
|
|
$ |
471 |
|
|
$ |
3,070 |
|
|
$ |
(12,041 |
) |
|
$ |
164,695 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14. Subsequent Events
On July 28, 2008, the Company announced that it had enrolled its first patient in a
single-center Phase II trial evaluating its clinical stage compound, cobiprostone, for the treatment
of portal hypertension in patients with liver cirrhosis. Cirrhosis, a chronic degenerative liver
disease characterized by fibrous scar tissue on the lobes, inhibits liver function and restricts
normal blood flow. The obstruction in blood flow from cirrhosis is a common cause of portal
hypertension.
On August 8, 2008, the Companys broker agreed to a settlement in principle with the SEC and various state regulatory authorities, which includes
a program to redeem auction rate securities held by customers who purchased the securities through the broker. The broker has informed the Company
that the program will provide the Company an opportunity during a two-year period beginning June 30, 2010 to have all auction rate securities
it purchased through the broker redeemed at par value, if such securities have not already been redeemed.
17
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 specialty 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 product revenue for such sales.
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
and controlling stockholders, 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.
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 three months ended June 30, 2008, reflecting 5% of the $50.0 million development
milestone payment that we received from Takeda.
18
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 and we plan to initiate this
study in the first quarter of 2009. 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 and we plan to initiate this
study in the second quarter of 2009. 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. Our collaboration and co-promotion arrangement with Takeda
also covers these additional indications for AMITIZA. |
|
|
|
|
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 November 2007, we initiated a multi-center Phase 2b dose-ranging study in Japan to
evaluate the safety and efficacy of lubiprostone for treating chronic idiopathic constipation
in adults and we expect to complete this trial by the end of the fourth quarter of 2008. |
|
|
|
|
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 mid-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. We plan to
initiate Phase I clinical trials of the intravenous and oral formulation of SPI-017 by the
end of 2008. |
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 June 30, 2007, we
reclassified $734,000 and $51,000 of general and administrative expenses to research and
development expenses and selling and marketing expenses, respectively. During the six months ended
June 30, 2007, we reclassified approximately
19
$1.4 million and $69,000 of general and administrative expenses to research and development
expenses and selling and marketing expenses, respectively.
Comparison of three months ended June 30, 2008 and June 30, 2007
Revenues
The following table summarizes our revenues for the three months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Research and development revenue |
|
$ |
55,436 |
|
|
$ |
38,087 |
|
Product royalty revenue |
|
|
10,901 |
|
|
|
9,562 |
|
Co-promotion revenue |
|
|
1,236 |
|
|
|
1,134 |
|
Contract and collaboration revenue |
|
|
141 |
|
|
|
151 |
|
|
|
|
|
|
|
|
Total |
|
$ |
67,714 |
|
|
$ |
48,934 |
|
|
|
|
|
|
|
|
Total revenues were $67.7 million for the three months ended June 30, 2008 compared to $48.9
million for the three months ended June 30, 2007, an increase of $18.8 million or 38.4%.
Research and development revenue was $55.4 million for the three months ended June 30, 2008
compared to $38.1 million for the three months ended June 30, 2007, an increase of $17.3 million or
45.6%. The increase was primarily due to the $50.0 million development milestone received from
Takeda in May 2008 upon FDA approval of AMITIZA for the treatment of the irritable bowel syndrome
with constipation in adult women compared to the $30.0 million development milestone earned from
Takeda upon filing of the supplemental new drug application, or sNDA, for AMITIZA to treat
irritable bowel syndrome with constipation in June 2007. The increase in research and development
revenue was partly offset by the recognition of AMITIZA-related deferred revenue during the second
quarter of 2007 resulting from payments previously received from Takeda for the 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 revenue in 2008.
The following table summarizes the cash streams and related revenue recognition under the
Takeda Agreements:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
Change in |
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
Accounts |
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
Receivable |
|
|
|
|
|
|
Amount |
|
|
Six Months |
|
|
Six Months |
|
|
for the Six |
|
|
Amount |
|
|
|
Deferred at |
|
|
Ended |
|
|
Ended |
|
|
Months Ended |
|
|
Deferred at |
|
|
|
December 31, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
(In thousands) |
|
2007 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
|
2008 |
|
Collaboration revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Up-front payment associated with our
obligation to participate in joint
committees with Takeda |
|
$ |
1,911 |
|
|
$ |
|
|
|
$ |
74 |
|
|
$ |
|
|
|
$ |
1,837 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development milestones |
|
$ |
|
|
|
$ |
50,000 |
|
|
$ |
50,000 |
|
|
$ |
|
|
|
$ |
|
|
Reimbursement of research and development |
|
|
|
|
|
|
20,545 |
|
|
|
11,546 |
|
|
|
(881 |
) |
|
|
8,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
|
|
|
$ |
70,545 |
|
|
$ |
61,546 |
|
|
$ |
(881 |
) |
|
$ |
8,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
|
|
|
$ |
15,471 |
|
|
$ |
16,981 |
|
|
$ |
1,616 |
|
|
$ |
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Received |
|
|
Recognized |
|
|
|
|
|
|
|
|
|
|
|
|
|
for the |
|
|
for the |
|
|
|
|
|
|
|
|
|
Accounts |
|
|
Six Months |
|
|
Six Months |
|
|
Accounts |
|
|
Amount |
|
|
|
Receivable at |
|
|
Ended |
|
|
Ended |
|
|
Receivable at |
|
|
Deferred at |
|
|
|
December 31, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 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 |
|
|
$ |
20,545 |
|
|
$ |
11,546 |
|
|
$ |
6,006 |
|
|
$ |
8,118 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty revenue |
|
$ |
8,667 |
|
|
$ |
15,471 |
|
|
$ |
16,981 |
|
|
$ |
10,283 |
|
|
$ |
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promotion revenue |
|
$ |
360 |
|
|
$ |
2,442 |
|
|
$ |
2,458 |
|
|
$ |
376 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Includes billed and unbilled accounts receivable. |
Product royalty revenue represents royalty revenue earned on net sales of AMITIZA in
accordance with the Takeda Agreements. For the three months ended June 30, 2008 and 2007, we
recognized $10.9 million and $9.6 million, respectively, of product royalty revenue. The increase
reflects the continuing acceptance by patients and physicians of AMITIZA® 24 mcg for the
treatment of chronic idiopathic constipation in adults and also sales from initial stockings of
AMITIZA 8 mcg for irritable bowel syndrome with constipation as a result of the recent FDA approval. Product royalty revenue for the
corresponding periods in 2007 reflected the impact of the withdrawal of Novartis
Zelnorm® in April 2007. As a result of the withdrawal, our partner Takeda, significantly
increased inventory levels in the second quarter of 2007. Based on stipulations of our agreement
with Takeda, we were able to recognize a majority of the royalty revenue resulting from the
increase in the inventory levels at that time. We launched AMITIZA for irritable bowel syndrome
with constipation in mid-May 2008. As in the second quarter of 2007, we were able to recognize in the second quarter of 2008 the
guaranteed portion of the royalty revenue in the amount of approximately $1.9 million, which
represents a majority of the royalty revenue, resulting from the initial stockings of
AMITIZA® 8 mcg for the treatment of irritable bowel syndrome with constipation at that
time. Accordingly, we do not expect product royalty revenue necessarily will grow as significantly
in future periods as it did in the second quarter of 2008.
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 June 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
The following summarizes our research and development expenses for the three months ended June
30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Direct costs: |
|
|
|
|
|
|
|
|
AMITIZA |
|
$ |
10,040 |
|
|
$ |
5,759 |
|
Cobiprostone |
|
|
1,276 |
|
|
|
1,442 |
|
SPI 017 |
|
|
937 |
|
|
|
204 |
|
Other |
|
|
164 |
|
|
|
332 |
|
|
|
|
|
|
|
|
Total |
|
|
12,417 |
|
|
|
7,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
514 |
|
|
|
345 |
|
|
|
|
|
|
|
|
Total |
|
$ |
12,931 |
|
|
$ |
8,082 |
|
|
|
|
|
|
|
|
Total research and development expenses for the three months ended June 30, 2008 were $12.9
million compared to $8.1 million for the three months ended June 30, 2007, an increase of $4.8
million or 60.0%. Approximately $2.2 million of this increase was due to our on-going clinical
development programs of AMITIZA for the treatment of opioid-induced bowel dysfunction and
cobiprostone for the treatment of non-steroidal anti-inflammatory drug-induced ulcers, and
preclinical and basic development costs associated with
21
SPI-017. We also incurred filing and data purchase costs of approximately $2.5 million in the second quarter of 2008, which were necessary to
submit our European MAAs.
We recorded a cumulative adjustment of approximately $871,000 during the three months ended
June 30, 2008, to recognize additional research and development expenses that had not been
recorded in prior periods. The error resulted from incorrect accounting for investigator services
for the Phase 2b 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 three months ended June 30, 2008, as the adjustment consisted
of insignificant amounts related to this period.
General and Administrative Expenses
The following summarizes our general and administrative expenses for the three months ended
June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Salaries, benefits and related costs |
|
$ |
1,206 |
|
|
$ |
862 |
|
Legal and consulting expenses |
|
|
595 |
|
|
|
647 |
|
Stock-based compensation |
|
|
58 |
|
|
|
43 |
|
Founders stock-based award |
|
|
|
|
|
|
10,187 |
|
Other operating expenses |
|
|
1,702 |
|
|
|
1,278 |
|
|
|
|
|
|
|
|
Total |
|
$ |
3,561 |
|
|
$ |
13,017 |
|
|
|
|
|
|
|
|
General and administrative expenses were $3.6 million for the three months ended June 30, 2008
compared to $13.0 million for the three months ended June 30, 2007, an decrease of $9.4 million or
72.6%. This decrease was primarily due to a one-time expense of $10.2 million recorded in the
second quarter of 2007 related to a stock-based award granted to the founders, partially offset by
an increase in operational headcount, an increase in expenses associated with our new office space
and an increase in over-all costs associated with the compliance and regulatory requirements of
being a publicly traded company with international operations.
Selling and Marketing Expenses
Selling and marketing expenses were $2.9 million for the three months ended June 30, 2008
compared to $3.8 million for the three months ended June 30, 2007, a decrease of $0.9 million or
24.0%. 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.
Product Royalties Related Parties
Product royalties related parties represent 3.2% of AMITIZA net sales for the respective
periods payable to SAG and increased to $2.0 million for the three months ended June 30, 2008 from
$1.7 million for the three months ended June 30 2007 in line with the increase of product royalty
revenue.
Milestone Royalties Related Parties
Milestone royalties related parties expense was $2.5 million for the three months ended June
30, 2008. 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. We recorded $1.5 million in milestone royalties related
parties expense for the three months ended June 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.
22
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the three months ended
June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Interest income |
|
$ |
565 |
|
|
$ |
471 |
|
Other (expense) income, net |
|
|
(13 |
) |
|
|
42 |
|
|
|
|
|
|
|
|
Total non-operating income, net |
|
$ |
552 |
|
|
$ |
513 |
|
|
|
|
|
|
|
|
Interest income was $565,000 for the three months ended June 30, 2008 compared to $471,000 for
the three months ended June 30, 2007, an increase of $94,000 or 20.0%. The increase was primarily
due to an increase in the funds available for investment as a result of our receipt of the $30.0
million development milestone payment from Takeda in June 2007, net proceeds of $28.2 million from
our initial public offering in August 2007 and our receipt of the $50.0 million development
milestone payment from Takeda in May 2008, partially offset by cash used in operations.
Income Taxes
For the three months ended June 30, 2008 and 2007, our consolidated effective tax rate was
32.8% and 35.0%, respectively. For the three months ended June 30, 2008 and 2007, we recorded a tax
provision of $14.6 million and $7.5 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 and expected
product royalties, we believe that our U.S. deferred tax assets will likely be realized.
Accordingly, the tax provision recorded for the three months ended June 30, 2008 is affected by a
reduction in the projected 2008 effective tax rate applied to our pre-tax income.
Comparison of six months ended June 30, 2008 and June 30, 2007
Revenues
The following table summarizes our revenues for the six months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Research and development revenue |
|
$ |
61,546 |
|
|
$ |
47,453 |
|
Product royalty revenue |
|
|
16,981 |
|
|
|
11,871 |
|
Co-promotion revenue |
|
|
2,458 |
|
|
|
2,267 |
|
Contract and collaboration revenue |
|
|
283 |
|
|
|
304 |
|
|
|
|
|
|
|
|
Total |
|
$ |
81,268 |
|
|
$ |
61,895 |
|
|
|
|
|
|
|
|
Total revenues were $81.3 million for the six months ended 2008 compared to $61.9 million for
the six months ended June 30, 2007, an increase of $19.4 million or 31.3%.
Research and development revenue was $61.5 million for the six months ended June 30, 2008
compared to $47.5 million for the three months ended June 30, 2007, an increase of $14.0 million or
29.7%. The increase was primarily due to the $50.0 million development milestone received from
Takeda in May 2008 upon FDA approval of AMITIZA for the treatment of the irritable bowel syndrome
with constipation in adult women 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 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 six months ended June 30, 2008 and 2007, we
recognized $17.0 million and $11.9 million, respectively, of product royalty revenue, an increase of $5.1 million or 43.0%. The increase
reflects the continuing acceptance by patients and physicians of AMITIZA® 24 mcg for the
treatment of chronic idiopathic constipation in adults and also sales from initial stockings of
AMITIZA 8 mcg for irritable bowel syndrome with constipation as a result of the recent FDA
23
approval. Product royalty revenue for the corresponding periods in 2007 reflects the impact of
the withdrawal of Novartis Zelnorm® in April 2007. As a result of the withdrawal, our
partner Takeda, significantly increased inventory levels in the second quarter of 2007. Based on
stipulations of our agreement with Takeda, we were able to recognize a majority of the royalty
revenue resulting from the increase in the inventory levels at that time. We launched AMITIZA for
irritable bowel syndrome with constipation in mid-May 2008. As in the second quarter of 2007,
we were able to recognize in the second quarter of 2008 the guaranteed portion of the royalty revenue in the amount of
approximately $1.9 million, which represents a majority of the royalty revenue resulting from the
initial stockings of AMITIZA® 8 mcg for the treatment of irritable bowel syndrome with
constipation at that time. Accordingly, we do not expect product royalty revenue necessarily will
grow as significantly in future periods as it did in the second quarter of 2008.
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 six months ended June 30, 2008 and 2007, we
recognized $2.5 million and $2.3 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 six months ended June
30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Direct costs: |
|
|
|
|
|
|
|
|
AMITIZA |
|
$ |
19,026 |
|
|
$ |
10,709 |
|
Cobiprostone |
|
|
2,270 |
|
|
|
2,226 |
|
SPI 017 |
|
|
1,616 |
|
|
|
755 |
|
Other |
|
|
299 |
|
|
|
405 |
|
|
|
|
|
|
|
|
Total |
|
|
23,211 |
|
|
|
14,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indirect costs |
|
|
936 |
|
|
|
595 |
|
|
|
|
|
|
|
|
Total |
|
$ |
24,147 |
|
|
$ |
14,690 |
|
|
|
|
|
|
|
|
Total research and development expenses for the six months ended June 30, 2008 were $24.1
million compared to $14.7 million for the six months ended June 30, 2007, an increase of $9.4
million or 64.4%. This increase was primarily due to our on-going clinical development programs of
AMITIZA for the treatment of opioid-induced bowel dysfunction and cobiprostone for the treatment of
non-steroidal anti-inflammatory drug-induced ulcers, and preclinical and basic development costs
associated with SPI-017. We incurred filing and data purchase costs of approximately $2.5 million,
which were necessary to submit our European MAAs.
General and Administrative Expenses
The following summarizes our general and administrative expenses for the six months ended June
30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Salaries, benefits and related costs |
|
$ |
2,124 |
|
|
$ |
1,891 |
|
Legal and consulting expenses |
|
|
1,249 |
|
|
|
1,367 |
|
Stock-based compensation |
|
|
102 |
|
|
|
(203 |
) |
Founders stock-based award |
|
|
|
|
|
|
10,187 |
|
Other |
|
|
3,253 |
|
|
|
1,928 |
|
|
|
|
|
|
|
|
Total |
|
$ |
6,728 |
|
|
$ |
15,170 |
|
|
|
|
|
|
|
|
General and administrative expenses were $6.7 million for the six months ended June 30, 2008
compared to $15.2 million for the six months ended June 30, 2007, a decrease of $8.5 million or
55.6%. This decrease was primarily due to a one-time expense of $10.2 million recorded in the
second quarter of 2007 related to a stock-based award granted to the founders, partially offset by
an increase in operational headcount, an increase in expenses associated with our new office space
and an increase in over-all costs associated with the compliance and regulatory requirements of
being a publicly traded company with international operations.
We recorded a cumulative out-of-period adjustment of approximately $358,000 during the six
months ended June 30, 2007 to reduce an overstatement of additional paid-in capital and general
administrative expenses that had been recorded as of and for the year
24
ended December 31, 2006 in connection with employee stock options awarded in 2006. The error
resulted from applying the incorrect contractual term to the employee stock options.
Selling and Marketing Expenses
Selling and marketing expenses were $5.7 million for the six months ended June 30, 2008
compared to $7.0 million for the six months ended June 30, 2007, a decrease of $1.3 million or
18.6%. 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.
Product Royalties Related Parties
Product royalties related parties was $3.0 million for the six months ended June 30, 2008
compared to $2.1 million for the six months ended June 30, 2007, an increase of $0.9 million or
43.7%, in line with the increase of product royalty revenue.
Milestone Royalties Related Parties
Milestone royalties related parties expense was $3.5 million for the six months ended June
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 represents 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. We recorded $1.5 million in milestone
royalties related parties expense for the six months ended June 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.
Non-Operating Income and Expense
The following table summarizes our non-operating income and expense for the six months ended
June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Interest income |
|
$ |
1,207 |
|
|
$ |
795 |
|
Other (expense) income, net |
|
|
(1 |
) |
|
|
36 |
|
|
|
|
|
|
|
|
Total non-operating income, net |
|
$ |
1,206 |
|
|
$ |
831 |
|
|
|
|
|
|
|
|
Interest income was $1.2 million for the six months ended June 30, 2008 compared to $795,000
for the six months ended June 30, 2007, an increase of $412,000 or 51.8%. The increase was
primarily due to an increase in the funds available for investment as a result of our receipt of
the $30.0 million development milestone payment from Takeda in June 2007, net proceeds of $28.2
million from our initial public offering in August 2007 and our receipt of the $50.0 million
development milestone payment from Takeda in May 2008, partially offset by cash used in our
operations.
Income Taxes
For the six months ended June 30, 2008 and 2007, our consolidated effective tax rate was 22.7%
and 35.2%, respectively. For the six months ended June 30, 2008 and 2007, we recorded a tax
provision of $8.9 million and $7.8 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 and expected
product royalties, we believe that our U.S. deferred tax assets will likely be realized.
Accordingly, the tax provision recorded for the six months ended June 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
25
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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intercompany |
|
|
(In thousands) |
|
United States |
|
Europe |
|
Japan |
|
Eliminations |
|
Consolidated |
Three Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
67,714 |
|
|
$ |
|
|
|
$ |
210 |
|
|
$ |
(210 |
) |
|
$ |
67,714 |
|
Income (loss) from operations |
|
|
47,045 |
|
|
|
(584 |
) |
|
|
(2,560 |
) |
|
|
|
|
|
|
43,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
48,924 |
|
|
$ |
|
|
|
$ |
220 |
|
|
$ |
(210 |
) |
|
$ |
48,934 |
|
Income (loss) from operations |
|
|
21,478 |
|
|
|
(144 |
) |
|
|
(475 |
) |
|
|
|
|
|
|
20,859 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
81,268 |
|
|
$ |
|
|
|
$ |
417 |
|
|
$ |
(417 |
) |
|
$ |
81,268 |
|
Income (loss) from operations |
|
|
43,555 |
|
|
|
(2,422 |
) |
|
|
(3,024 |
) |
|
|
3 |
|
|
|
38,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
61,874 |
|
|
$ |
|
|
|
$ |
441 |
|
|
$ |
(420 |
) |
|
$ |
61,895 |
|
Income (loss) from operations |
|
|
22,202 |
|
|
|
(309 |
) |
|
|
(495 |
) |
|
|
|
|
|
|
21,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At June 30, 2008 |
|
$ |
173,195 |
|
|
$ |
471 |
|
|
$ |
3,070 |
|
|
$ |
(12,041 |
) |
|
$ |
164,695 |
|
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 received from Takeda and R-Tech Ueno, Ltd., a
Japanese pharmaceutical manufacturer and affiliate, and research and development expense
reimbursements from Takeda. 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 $190.5 million in up-front, milestone, option and expense reimbursement
payments from third parties.
As of June 30, 2008, we had cash and cash equivalents of $26.5 million, current investments of
$87.6 million and non-current investments of $20.9 million compared to cash and cash equivalents of
$25.6 million, current investments of $51.6 million and non-current investments of $9.4 million at
December 31, 2007. Our cash and cash equivalents are deposits in operating accounts and highly
liquid investments with the original maturity at time of purchase of 90 days or less.
As of June 30, 2008, our non-current investments include $20.9 million in auction rate
securities, net of an unrealized loss of $2.2 million, or $1.3 million net of tax effect. As a
result of the liquidity issues related to the auction rate security market during 2008, our
assessment of the market conditions and our belief that the market for these investments may take
more than twelve months to recover, we classified $20.9 million of our auction rate securities as
non-current investments as of June 30, 2008. We classified $3.9 million of our auction rate
securities as current investments as of June 30, 2008 due to their redemption at par value on July 2,
2008.
Our investments in auction rate securities consist
of AAA-rated non-mortgage related securities and are
insured against loss of principal and interest by bond insurers. At June 30, 2008, the fair market
values of these securities were determined through an independent valuation using two valuation
methods: the market approach and income approach. The valuation included an assessment of all key
underlying data and assumptions. Considerable judgment was involved in reaching these
determinations. As a result of the disruptions and failures in the auction rate securities market,
we recorded an unrealized loss of $844,000, or $453,000 net of tax effect, for the three months
ended June 30, 2008,and $2.2 million, or $1.3 million net of tax effect, for the six months ended
June 30, 2008, related to its investment in auction rate securities. This unrealized loss was
recorded to other comprehensive loss during the three and six months ended June 30, 2008. We
attribute the declines in the values of our auction rate securities to liquidity issues rather than credit issues. If the credit ratings of the
issuer, the bond insurer or the collateral deteriorate or the carrying value of the investments
decline for any other reason, we may need to adjust the
26
carrying value of these investments. Although recent actions initiated primarily by the
issuers of securities led to redemptions and successful auctions of certain securities, it remains
uncertain as to when the liquidity issues relating to these investments will be fully resolved.
Therefore, we classified all of our investments in auction rate securities as non-current
investments as of June 30, 2008, with the exception of the $3.9 million investment that was
redeemed at par value in July 2008. No active secondary market currently exists for these
securities and we do not intend, at this time, to use the secondary market to dispose of the
auction rate securities.
It is uncertain as to when the liquidity issues relating to these investments will improve.
Although we do not currently anticipate having to sell these securities in order to operate our
business, if that were to change, or if the liquidity issues continue over a prolonged period, we
might be unable to liquidate some holdings of our auction rate securities and as a result, might
suffer losses from these investments. In addition, given the complexity of auction rate securities
and their valuations, our estimates of their fair value may differ from the actual amount we would
be able to collect in an ultimate sale.
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 June 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 six months ended June 30, 2008 and 2007:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
50,601 |
|
|
$ |
(12,824 |
) |
Investing activities |
|
|
(50,085 |
) |
|
|
(1,316 |
) |
Financing activities |
|
|
404 |
|
|
|
(632 |
) |
Effect of exchange rates |
|
|
4 |
|
|
|
(69 |
) |
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
924 |
|
|
$ |
(14,841 |
) |
|
|
|
|
|
|
|
Six Months Ended June 30, 2008
Net cash provided by operating activities was $50.6 million for the six months ended June 30,
2008 and reflected net income of $30.4 million, an increase of $15.2 million in prepaid and income
taxes receivable and payable, net, and an increase of $9.5 million in deferred revenue, partially
offset by a non-cash reversal of deferred tax asset valuation allowances of $4.5 million.
Net cash used in investing activities of $50.1 million for the six months ended June 30, 2008
primarily reflected our purchases of $111.3 million of investments, offset by proceeds from the
sales and maturities of investments of $61.5 million.
Net cash provided by financing activities of $404,000 for the six months ended June 30, 2008
resulted from the net proceeds from the exercise of stock options.
Six Months Ended June 30, 2007
Net cash used in operating activities was $12.8 million for the six months ended June 30,
2007. The net income of $14.4 million was offset by an increase in accounts receivable and product
royalties receivables of $38.9 million and a decrease in deferred revenue of $11.2 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 $1.3 million for the six months ended June 30, 2007
reflected our purchases of property and equipment.
Net cash used in financing activities of $632,000 for the six months ended June 30, 2007
reflected payments incurred for our initial public offering expenses.
27
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. Except for
research and development funding and potential future development milestone payments of up to $10.0
million, and potential future commercial milestone payments of up to $50.0 million, none of which
we can assure you that we will receive, we do not currently have any commitments for future
external funding.
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.
28
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. We believe that the market risk arising from holding these financial instruments is
minimal.
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 June 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. As of June 30, 2008, we had $133.0 million of
cash and cash equivalents, restricted cash and investments in excess of federally insured limits.
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 Chief Executive
Officer and Chief Financial Officer, performed an evaluation of the effectiveness of the design and
operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e)
of the Securities Exchange Act of 1934, as amended) as of June 30, 2008. Based upon this
evaluation, management has concluded that, as of June 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 Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosures.
b) Changes in Internal Controls
There were no changes in our internal control over financial reporting during the quarter
ended June 30, 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.
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
29
owned with Abbot Pharmaceuticals, or Abbott. Takeda and Abbott recently announced that they
have concluded 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 and our vice president of business development and
company 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 chief financial officer, resigned her position with us effective July
31, 2008. Our board of directors has appointed Jan Smilek, our chief accounting officer, as acting
chief financial officer and initiated a search for a permanent replacement. However, we face
significant competition for such an executive. We may not be able to find a suitable successor in a
timely manner and we cannot be sure that a new chief financial officer, once in place, would meet
the expectations of the board of directors. Any failure to hire on a timely basis and implement a
smooth transition to a new chief financial officer could hurt our ability to manage our finance and
accounting functions.
In addition, Kei S. Tolliver, our vice president of business development and
company operations, resigned her position effective as of May 31, 2008. Our failure to successfully
transition her responsibilities to other employees could make it difficult for us to pursue our
business strategy.
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.
As of June 30, 2008, we have used approximately $16.5 million of the net proceeds from the
offering as follows:
|
|
|
approximately $1.2 million to fund our share of two post-marketing studies of AMITIZA to
evaluate its safety in patients with renal impairment and patients with hepatic impairment; |
|
|
|
|
approximately $5.9 million to fund development and regulatory activities for SPI-8811
and SPI-017; |
|
|
|
|
approximately $8.4 million to fund regulatory efforts by Sucampo Europe and Sucampo
Japan for AMITIZA; |
|
|
|
|
approximately $600,000 for research and development activities for prostone
compounds other than AMITIZA, cobiprostone and SPI-017; and |
|
|
|
|
approximately $400,000 to fund costs in connections with computers, software and
information technology to support growth in our business. |
30
We have invested the remaining net proceeds from the offering in short-term, investment grade,
interest-bearing instruments. There has been no material change in our planned use of the balance
of the net proceeds from the offering as described in our final prospectus filed with the SEC
pursuant to Rule 424(b) under the Securities Act.
Item 4. Submission of Matters to a Vote of Security Holders
Our annual meeting of stockholders was held on June 5, 2008. Of the total
number of common shares outstanding on April 16, 2008, a total of 9,413,537 shares of class A
common stock and a total of 26,191,050 shares of class B common stock were represented in person or
by proxy at the annual meeting. Results of votes with respect to proposals submitted at the annual
meeting are set forth below.
|
(a) |
|
To elect five nominees to serve as directors and hold officer for a term of one year.
Our stockholders voted to elect all five nominees to serve as directors. Votes recorded, by
nominee, were as follows: |
|
|
|
|
|
|
|
|
|
Nominee |
|
For |
|
Against/Withheld |
Ryuji Ueno, M.D., Ph.D., Ph.D. |
|
|
271,318,829 |
|
|
|
5,208 |
|
Anthony C. Celeste |
|
|
271,318,834 |
|
|
|
5,203 |
|
Timothy I. Maudlin |
|
|
271,318,834 |
|
|
|
5,203 |
|
V. Sue Molina |
|
|
271,318,834 |
|
|
|
5,203 |
|
John C. Wright |
|
|
271,318,834 |
|
|
|
5,203 |
|
|
(b) |
|
To consider and vote upon a proposal to ratify the selection of PricewaterhouseCoopers
LLP as our independent registered public accounting firm for the fiscal year ending
December 31, 2008. Votes recorded were as follows: |
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
271,315,634 |
|
|
4,400 |
|
|
|
4,002 |
|
31
Item 6. Exhibits
(a) Exhibits
|
|
|
|
|
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) |
|
|
|
|
|
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 |
32
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
Sucampo Pharmaceuticals, Inc.
|
|
August 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) |
|
|
|
|
|
August 14, 2008 |
By: |
/s/ JAN SMILEK
|
|
|
|
Jan Smilek |
|
|
|
Vice President, Finance and Acting
Chief Financial Officer
(Principal Financial Officer) |
|
|
33
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) |
|
|
|
|
|
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: August 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: August 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 June 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: August 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 June 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: August 14, 2008 |
/s/ JAN SMILEK
|
|
|
Jan Smilek |
|
|
Vice President, Finance
Acting Chief Financial Officer
(Principal Financial Officer) |
|
|