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
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FOR QUARTERLY PERIOD ENDED MARCH 31, 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
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Commission File Number: 0-20117
ENCYSIVE PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
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Delaware
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13-3532643
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(State or other jurisdiction of
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(I.R.S. Employer Identification No.)
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incorporation or organization)
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4848 Loop Central Drive, Suite 700, Houston, Texas
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77081
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(Address of principal executive office)
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(Zip code)
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(713) 796-8822
(Registrants telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
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 definition of large accelerated
filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check One):
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Large accelerated filer
o
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Accelerated filer
þ
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Non-accelerated filer
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Smaller reporting company
o
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(do not check if a smaller reporting company)
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes
o
No
þ
Indicate the number of shares outstanding of each of the issuers classes of Common Stock,
exclusive of treasury shares, as of the latest practicable date.
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Class
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Outstanding at April 30, 2008
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Common stock, $0.005 par value
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80,955,060
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ENCYSIVE PHARMACEUTICALS INC.
TABLE OF CONTENTS
ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
($ in thousands, except per share data)
(Unaudited)
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March 31,
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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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$
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12,696
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$
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33,153
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Restricted cash
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254
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244
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Accounts receivable
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11,518
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9,647
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Other current receivables
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1,912
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1,612
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Inventory, net of reserve of $1,470 and $1,046
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2,989
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3,503
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Prepaids
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1,423
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704
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Total current assets
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30,792
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48,863
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Equipment and leasehold improvements, net of
accumulated depreciation of $12,770 and $12,719
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4,966
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5,166
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Deferred debt origination costs, net of
accumulated amortization of $5,577 and $5,350
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4,266
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4,493
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Intangible assets, net of accumulated
amortization of $817 and $790
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149
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176
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Total assets
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$
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40,173
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$
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58,698
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LIABILITIES AND STOCKHOLDERS DEFICIT
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Current liabilities:
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Accounts payable
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$
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2,587
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$
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2,872
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Accrued expenses
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11,977
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16,668
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Total current liabilities
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14,564
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19,540
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Long-term debt
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186,191
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189,696
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Commitments and contingencies
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Stockholders deficit:
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Preferred
stock, par value $.005 per share. 5,000,000 Shares authorized; none issued or outstanding
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Common stock, par value $.005 per share.
150,000,000 shares authorized. At March 31, 2008,
81,168,060 shares issued, 80,955,060 outstanding;
at December 31, 2007, 81,130,866 shares issued,
80,917,866 shares outstanding
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406
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406
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Additional paid-in capital
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374,460
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373,452
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Treasury stock, 213,000 shares at March 31, 2008
and December 31, 2007
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(1,602
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)
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(1,602
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Accumulated other comprehensive income
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542
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161
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Accumulated deficit
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(534,388
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)
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(522,955
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Total stockholders deficit
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(160,582
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(150,538
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Total liabilities and stockholders deficit
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$
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40,173
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$
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58,698
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See accompanying notes to condensed consolidated financial statements
1
ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
($ in thousands, except per share data)
(Unaudited)
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Three Months Ended
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March 31,
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2008
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2007
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Revenues:
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Sales
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$
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9,272
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$
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941
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Royalty income
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5,439
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4,145
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License fee and milestones
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322
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Total Revenues
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14,711
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5,408
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Expenses:
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Cost of goods sold
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1,035
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66
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Research and development
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6,865
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17,499
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Sales and marketing
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7,258
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10,886
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General and administrative
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7,392
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5,616
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Total expenses
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22,550
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34,067
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Operating loss
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(7,839
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(28,659
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Investment income
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236
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795
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Interest expense
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(3,830
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(2,044
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Net loss
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$
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(11,433
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$
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(29,908
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Other comprehensive income:
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Unrealized gain
on foreign currency translation
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381
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7
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Comprehensive loss
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$
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(11,052
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$
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(29,901
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Loss per share:
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Continuing operations, basic
and diluted
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$
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(0.15
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$
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(0.49
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Weighted average common shares used
to compute net loss per share basic
and diluted
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78,573,504
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61,643,847
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See accompanying notes to condensed consolidated financial statements
2
ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
($ in thousands)
(Unaudited)
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Three Months Ended March 31,
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2008
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2007
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Cash flows from operating activities:
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Net loss
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$
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(11,433
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$
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(29,908
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Adjustments to reconcile net loss to cash used
in operating activities:
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Depreciation and amortization
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244
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265
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Expenses paid with stock
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80
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43
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Share-based compensation expense
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926
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1,553
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Amortization of debt issue costs
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228
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218
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Interest earned on restricted cash
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(72
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Loss on disposition of fixed assets
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4
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Reserve for obsolescence
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424
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129
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Changes in operating assets and liabilities:
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Restricted cash
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(10
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Accounts receivable
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(1,746
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62
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Inventory
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90
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(501
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Prepaids
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(714
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(754
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Other current receivables
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(224
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(435
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Accounts payable and accrued expenses
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(5,152
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(4,273
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Deferred revenue
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(322
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Net cash used in operating activities
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(17,287
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(33,991
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Cash flows from investing activities:
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Purchases of equipment and leasehold improvements
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(11
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(119
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Net cash used in investing activities
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(11
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(119
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Cash flows from financing activities:
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Borrowing of long-term debt
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60,000
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Proceeds restricted
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(10,000
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Debt issue costs
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(3,422
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)
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Repayment of long-term debt
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(3,505
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)
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(3,468
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Proceeds from option exercises
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2
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4
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Net cash (used in) provided by financing
activities
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(3,503
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)
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43,114
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Effect of exchange rate changes on cash
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344
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5
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Net increase (decrease) in cash and cash
equivalents
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(20,457
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)
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9,009
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Cash and cash equivalents at beginning of period
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33,153
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43,798
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Cash and cash equivalents at end of period
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$
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12,696
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$
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52,807
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Supplemental schedule of cash flow information:
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Interest paid
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4,386
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2,597
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See accompanying notes to condensed consolidated financial statements
3
ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2008 (unaudited)
(1) Merger
On February 20, 2008, Encysive Pharmaceuticals Inc., a Delaware corporation (Encysive or the
Company), entered into an Agreement and Plan of Merger (the Merger Agreement) with Pfizer Inc.,
a Delaware Corporation (Pfizer), and Explorer Acquisition Corp. (Explorer), a Delaware
corporation and a wholly-owned subsidiary of Pfizer, which provides for the merger (the Merger)
of Explorer with and into the Company, with the Company continuing as the surviving corporation,
wholly-owned by Pfizer. Pursuant to the Merger Agreement, on March 4, 2008, Explorer and Pfizer
commenced a tender offer (the Tender Offer) to purchase all of the outstanding shares of common
stock, par value $0.005 per share (including the associated preferred stock purchase rights, the
Shares), of the Company at a purchase price of $2.35 per Share in cash, without interest and less
any required withholding taxes (the Offer Consideration). The initial offering period of the
Tender Offer expired at 12:00 midnight, New York City time, on Monday, March 31, 2008, at which
time approximately 61,765,295 Shares (representing approximately 76.30% of the outstanding Shares)
were validly tendered and not withdrawn pursuant to the Tender Offer. On April 1, 2008, Explorer
accepted all validly tendered and not withdrawn Shares for payment in accordance with the terms of
the Tender Offer and promptly paid for and purchased such Shares
Pursuant to the Merger Agreement, on April 1, 2008, Explorer also commenced a subsequent
offering period in respect of the Tender Offer to acquire all of the remaining untendered Shares
for the Offer Consideration. The subsequent offering period expired at 5:00 p.m., New York City
time, on Monday, April 14, 2008. During the subsequent offering period, approximately 7,311,171
additional Shares were purchased by Explorer. The total number of Shares purchased by Explorer in
the Tender Offer through the expiration of the subsequent offering period was 69,076,466 Shares
(representing approximately 85.33% of the outstanding Shares).
The Merger will be effected in accordance with the General Corporation Law of the State
of Delaware (the DGCL) and the Merger Agreement. Since the affirmative vote of the holders of a
majority of the outstanding Shares is required to adopt the Merger Agreement, Explorer will be able
to adopt the Merger Agreement, and has an obligation to do so under the Merger Agreement, without
the vote or consent of any other Encysive stockholder. Upon completion of the Merger, each Share
issued and outstanding immediately prior to the effective time of the Merger (other than shares
owned by Pfizer, the Company and their wholly-owned subsidiaries and by stockholders who properly
exercise appraisal rights under the DGCL) will be converted into the right to receive $2.35 per
Share in cash, without interest and less any required withholding taxes (the Merger
Consideration). Prior to the effective time of the Merger, the Company will mail an information
statement to its stockholders of record on May 15, 2008 containing information about the Merger.
Under federal securities laws, the Merger may not be completed until 20 days after the Company
mails the information statement to such stockholders. Pfizer, Explorer and the Company are
obligated to complete the Merger pursuant to the terms and subject to the conditions of the Merger
Agreement. Management expects all of such conditions to be satisfied at the end of the 20 day
period. The Merger is expected to become effective in early June 2008.
The Merger Agreement includes customary representations, warranties and covenants of Encysive,
Pfizer and Explorer. Encysive has agreed to operate its business in the ordinary course until the
Merger is consummated.
After the consummation of the Merger, the Shares will be deregistered under applicable
rules of the Securities and Exchange Commission (SEC) and the Shares also will be delisted from
the NASDAQ Global Market.
The completion of the Tender Offer on April 1, 2008, resulted in a fundamental change, as
defined in the indenture governing the Companys 2.5% Convertible Notes due 2012 (the Convertible
Notes), pursuant to which the holders of the Convertible Notes can demand repayment of the
Convertible Notes in full, with accrued interest thereon. A notice of fundamental change was
distributed to the holders of the Convertible Notes, and the Company expects that the notes will be
repaid in the second quarter of 2008. Pursuant to the terms of the
Merger Agreement
4
Pfizer is
obligated to provide funds necessary to repay the Convertible Notes. For more
information about the Convertible Notes, see Note 10.
The completion of the Tender Offer on April 1, 2008, also represented a fundamental
transaction as defined in a Securities Purchase Agreement (Purchase Agreement), dated August 20,
2007, pursuant to which the Company sold units comprised of one share of the Companys common stock
and a warrant to purchase one share of the Companys common stock (each a Warrant and
collectively, the Warrants). As a result, in April 2008, the holders of the Warrants received
an amount of cash equal to the value of the Warrants, as determined
in accordance with the terms of the Warrants. As the holders of the Warrants have been paid in full, the Warrants
were cancelled in April 2008. For additional information about the Warrants, see Note 5.
Pursuant to the terms of the Merger Agreement, and the Companys various stock option plans,
all unvested outstanding awards, including stock options, phantom units and shares of restricted
stock vested upon the completion of the Tender Offer, and all remaining share-based compensation
will be recognized in the second quarter of 2008. Under the terms of the Merger Agreement, holders
of phantom units received the Offer Consideration in April 2008. Holders of stock options with an
exercise price below the Offer Consideration are entitled to a cash payment of the intrinsic value
of their options upon the effective time of the Merger. For additional information, see Note 11.
Upon
the completion of the Tender Offer on April 1, 2008, the Company
became obligated to pay other expenses related to the Merger of
approximately $5.8 million.
(2) Liquidity and Managements Plans
The accompanying condensed consolidated financial statements have been prepared assuming that
the Company will continue to operate as a going concern. The Company has sustained losses since
its formation, and at March 31, 2008 had a stockholders
deficit of $160.6 million, and had cash
and cash equivalents of $12.7 million. These matters raise substantial doubt about the Companys
ability to continue as a going concern. These condensed consolidated financial statements do not
include the adjustments that would be necessary should the Company be unable to continue as a going
concern.
As a result of the consummation of the Tender Offer, the Company is a majority-owned
subsidiary of Pfizer. Management expects Pfizer to provide sufficient liquidity as needed in order
for the Company to continue to operate as a majority owned subsidiary of Pfizer through the
effective time of the Merger.
(3) Organization and Significant Accounting Policies
(a) Organization
Encysive is a global biopharmaceutical company focused on the discovery, development and
commercialization of novel synthetic small molecule compounds to address unmet medical needs.
The Companys research and development programs are predominantly focused on the treatment and
prevention of interrelated diseases of the vascular endothelium and exploit its expertise in
the area of the intravascular inflammatory process, referred to as the inflammatory cascade,
and vascular diseases. Since its formation in 1989, the Company has been engaged principally
in research and drug discovery programs and clinical development of certain drug compounds.
The Company is presently working on a number of long-term development projects that
involve experimental and unproven technology, which may require many years and substantial
expenditures to complete, and which may or may not be successful. Sales of the Companys first
product approved by the United States Food and Drug Administration (FDA), Argatroban, for
which it receives royalty income, began during November 2000. Thelin (sitaxsentan sodium),
has been approved by the European Medicines Agency (EMEA), the Therapeutic Products
Directorate (TPD) in Canada, and the Australian Therapeutic Goods Administration (TGA).
(b) Basis of Consolidation
The Companys condensed consolidated financial statements include the accounts of the
Company, its wholly owned subsidiaries, ImmunoPharmaceutics, Inc. (IPI), a California
corporation; Encysive, L.P. (ELP), a Delaware limited partnership; EP-ET, LLC, a Delaware
limited liability company; Encysive (UK) Limited, a private company located in the United
Kingdom (UK); Encysive GmbH, a private company located in Germany; Encysive France S.A.S., a
private company located in France; Encysive Italy S.r.l., a private company located in Italy;
5
Encysive Canada Inc., a private company located in Canada; Encysive Switzerland GmbH, a
private company located in Switzerland; and Argatroban Royalty Sub LLC, a Delaware limited
liability company (Royalty Sub).
(c) Revenue Recognition
Revenue from sales of Thelin is recognized when product is shipped and ownership
transfers to the customer. Sales revenue includes value added taxes billed to customers, and
is reported net of discounts, allowances and returns. Sales revenue and cost of goods sold
included VAT of approximately $826,000 and $63,000 in the three months ended March 31, 2008 and
2007, respectively. Revenue from service contracts is recognized as services are performed.
Royalty revenue is recognized as products are sold by a licensee and the Company has received
sufficient information to record a receivable. The Company defers the recognition of milestone
payments related to contractual agreements that are still in the development stage. Such
deferred revenues are amortized into income over the estimated remaining development period.
Milestone payments received under contractual agreements which have completed the development
stage are evaluated, and either recognized into income when earned, or amortized over a future
period, depending upon whether the Company continues to have obligations under the terms of the
arrangement. License fees received under the terms of licensing agreements for the Companys
intellectual property are similarly deferred and amortized into income over the estimated
development period of the licensed item or items. The Company periodically evaluates its
estimates of remaining development periods and adjusts the recognition of remaining deferred
revenues over the adjusted development period remaining. Revenue from grants is recognized as
earned under the terms of the related grant agreements, typically as expenses are incurred.
Amounts received in advance of services being performed under contracts are recorded as
deferred revenue and recognized as services are performed.
(d) Debt issue costs
Debt issue costs are deferred, and recognized from the issuance through the final maturity
date of such debt.
(e) Use of Estimates
Management of the Company has made a number of estimates and assumptions relating to the
reporting of assets and liabilities, revenues and expenses, and the disclosure of contingent
assets and liabilities to prepare these condensed consolidated financial statements in
conformity with accounting principles generally accepted in the United States of America.
Actual results could differ from these estimates.
(
f) New Accounting Pronouncements
In September 2006, the FASB issued Statement of Financial Standards No. 157, Fair Value
Measurements (FAS 157). FAS 157 defines fair value, establishes a framework for measuring
fair value, and requires enhanced disclosures about fair value measurements. FAS 157 does not
require any new fair value measurements. The Company adopted FAS 157 on January 1, 2008. The
guidance in FAS 157 will be applied prospectively with the exception of (i) block discounts of
financial instruments; and (ii) certain financial and hybrid instruments measured at initial
recognition under FAS 133, which are to be applied retrospectively as of the beginning of
initial adoption (a limited form of retrospective adoption). The adoption of FAS 157 did not
have a material impact on the Companys condensed consolidated financial statements.
In February 2007, the FASB issued Statement of Financial Standards No. 159, The Fair
Value Option for Financial Assets and Financial Liabilities (FAS 159). FAS 159 permits
entities to choose to measure many financial instruments and certain other items at fair value.
The Company adopted FAS 159 during the first quarter of 2008. The Company did not elect to
adopt the fair value option provided under FAS 159 and the adoption of FAS 159 did not have a
material impact on the Companys condensed consolidated financial statements.
6
(g
) Reclassifications
Certain
prior period amounts have been reclassified to conform to current-year
presentation with no effect on net loss or stockholders equity previously reported.
(4) Inventory
Inventory balances are determined using the first-in first-out method. Inventory at March 31,
2008 and December 31, 2007 was as follows ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
Work-in-process
|
|
$
|
3,005
|
|
|
$
|
3,504
|
|
Finished goods
|
|
|
1,454
|
|
|
|
1,045
|
|
|
|
|
|
|
|
|
|
|
|
4,459
|
|
|
|
4,549
|
|
Less reserve
|
|
|
(1,470
|
)
|
|
|
(1,046
|
)
|
|
|
|
|
|
|
|
Net
|
|
$
|
2,989
|
|
|
$
|
3,503
|
|
|
|
|
|
|
|
|
(5) Capital Stock
In March 2005, the Company issued the Convertible Notes in the principal amount of $130
million. As the Convertible Notes are convertible into the Companys common stock, the Company has
reserved 9,322,001 shares for issuance upon conversion, including 213,000 treasury shares. For
additional information about the Convertible Notes, see Note 10.
On August 20, 2007, the Company entered into the Purchase Agreement with certain institutional
accredited investors and qualified institutional buyers relating to the offering of 7,692,305 units
at a price of $1.95 per unit, with each unit consisting of one share of the Companys common stock
and a Warrant. The offering closed on August 21, 2007 and, without giving effect to the potential
exercise of the Warrants, resulted in gross proceeds of approximately $15 million and net proceeds
of approximately $14 million, after placement agent fees and other expenses of the offering.
The Company has reserved common stock for issuance at March 31, 2008, as follows:
|
|
|
|
|
Stock option plans
|
|
|
7,715,956
|
|
Warrants
|
|
|
7,692,305
|
|
2.50% Convertible Senior Notes due 2012
|
|
|
9,322,001
|
|
|
|
|
|
|
Total shares reserved
|
|
|
24,730,262
|
|
Under the terms of the Purchase Agreement, the change in control of the Company on April 1,
2008 resulting from the Tender Offer represented a fundamental transaction as defined in the
Purchase Agreement. As a result, on April 24, 2008, the holders of the Warrants received an amount
of cash equal to the value of the Warrants as determined in accordance with in the terms of the
Warrants. As the holders of the warrants have been paid in full, and have executed releases in
exchange for payment, the Warrants were cancelled in April 2008. Pfizer provided the funds to pay
the holders of the Warrants pursuant to its obligation under the Merger Agreement.
(6) Cash, Cash Equivalents, and Restricted Cash
Cash equivalents are considered to be those securities or instruments with original
maturities, when purchased, of three months or less and are recorded at cost. Short-term
investments consist of debt securities with remaining maturities of less than one year and original
maturities greater than three months at the purchase date. The Company classifies all short-term
investments as held-to-maturity. Held-to-maturity securities are those securities in which the
Company has the ability and intent to hold the security until maturity. Short-term investments are
stated at amortized cost plus accrued interest. Interest income is accrued as earned. The Company
evaluates the carrying value of its securities by comparing the carrying value of the securities to
their market value. In the event that the fair value of a security were to decline below its
carrying cost, and in the opinion of management such decline was other than temporary, the Company
would record a loss and reduce the carrying value of such security to its fair value. All of the
Companys funds were invested in cash or cash equivalents at March 31, 2008 and December 31, 2007.
7
Restricted cash is comprised of cash and cash equivalents at Royalty Sub, and approximately
$0.1 million deposited by the Company into an account with a bank to secure a letter of credit.
(7) Net Loss per Common Share
Basic net loss per common share is calculated by dividing the net loss by the weighted average
number of common and common equivalent shares outstanding during the period. For the three-month
periods ended March 31, 2008 and 2007, the weighted average common shares used to compute basic and
diluted net loss per common share totaled 78,573,504 and 61,643,847, respectively. Securities
convertible into common stock comprised of stock options, shares of common stock reserved for
issuance upon exercise of the Warrants, shares of common stock reserved for issuance upon
conversion of the Convertible Notes and unvested shares of restricted common stock totaling
24,730,262 and 18,252,559 shares at March 31, 2008 and 2007, respectively, were not used in the
calculation of diluted net loss per common share because the effect would have been antidilutive.
(8) Income Taxes
The Company did not incur tax expense (benefit) during the three month periods ended March 31,
2008 and 2007, due to operating losses and the related increase in the valuation allowance.
(9) Entity-Wide Geographic Data
The Company operates in a single business segment that includes sales, research and
development of pharmaceutical products. The Companys revenues are primarily derived from sales of
Thelin in Europe, Canada and Australia, and royalties earned on sales of Argatroban by
GlaxoSmithKline plc (GSK) in the U.S. and Canada. The following table summarizes the Companys
sources of revenues from its principal customers (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Entities:
|
|
|
|
|
|
|
|
|
GSK
|
|
$
|
5,439
|
|
|
$
|
4,145
|
|
Others
|
|
|
9,272
|
|
|
|
1,263
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
14,711
|
|
|
$
|
5,408
|
|
|
|
|
|
|
|
|
The following table summarizes the Companys sources of revenues by geographical area (dollars
in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Geographical Area:
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
5,439
|
|
|
$
|
4,467
|
|
Europe
|
|
|
8,139
|
|
|
|
941
|
|
Other
|
|
|
1,133
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
14,711
|
|
|
$
|
5,408
|
|
|
|
|
|
|
|
|
The following table summarizes the Companys long-lived assets by geographical area (dollars
in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
Geographical Area:
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
9,145
|
|
|
$
|
9,592
|
|
Europe
|
|
|
236
|
|
|
|
246
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
9,381
|
|
|
$
|
9,838
|
|
|
|
|
|
|
|
|
8
(10) Long-Term Debt
On February 6, 2007, the Company, pursuant to the terms of a purchase and sale agreement,
sold, assigned and contributed to Royalty Sub, the rights of the Company to receive royalties and
certain payments (the Royalty Payments) from sales of Argatroban in the U.S. and Canada, in
exchange for approximately $56.6 million in cash and a capital contribution by the Company to
Royalty Sub in an amount equal to the excess of the agreed fair market value of the Royalty
Payments over the amount of the cash portion of the purchase price. Also on February 6, 2007,
Royalty Sub issued an aggregate principal amount of $60.0 million of Argatroban
PhaRMA
(sm)
Secured 12% Notes due 2014 (the Original Argatroban Notes) to certain
institutional investors in a private placement pursuant to Section 4(2) of the Securities Act.
The Royalty Payments to Royalty Sub were the sole source of payment of principal of, and
interest on, the Original Argatroban Notes. The payment dates for the Original Argatroban Notes
were March 30, June 30, September 30 and December 30 of each year.
On September 21, 2007, Royalty Sub issued the Argatroban PhaRMA
(sm)
Secured 18.5%
Notes due 2014 (the Argatroban Notes) to the holders of the Original Argatroban Notes in
consideration for the delivery of the Original Argatroban Notes for contemporaneous redemption and
cancellation, as well as cash consideration from the holders of the Original Argatroban Notes in an
amount of approximately $14.4 million. Of the $14.4 million, approximately $1.4 million was paid to
the holders of the Original Argatroban Notes for accrued and unpaid interest thereon and
approximately $1.8 million was paid in transaction expenses, resulting in net proceeds to the
Company of approximately $11.2 million.
The Argatroban Notes were issued pursuant to an Indenture, dated as of February 6, 2007
(the Original Indenture), between Royalty Sub and U.S. Bank National Association, as Trustee (the
Trustee), as supplemented by a First Supplemental Indenture, dated as of September 21, 2007 (the
Supplemental Indenture and collectively with the Original Indenture, the Indenture), between
Royalty Sub and the Trustee. The Indenture provides for $68.0 million in aggregate principal amount
of the Argatroban Notes. Except as described below, the Royalty Payments are the sole source of
payment for the Argatroban Notes, and the Company is not an obligor or guarantor of the Argatroban
Notes. Principal on the Argatroban Notes must be paid in full by the final legal maturity date of
September 30, 2014, unless redeemed earlier. The interest rate applicable to the Argatroban Notes
is 18.5% per annum (calculated on the basis of a 360-day year consisting of twelve 30-day months)
and is payable quarterly in arrears on March 30, June 30, September 30 and December 30 each year,
beginning on September 30, 2007 (each, a Payment Date). The calculation date for each such
Payment Date will be the fifth business day immediately preceding such Payment Date (the
Calculation Date). Non-payment of principal will not be an event of default prior to
September 30, 2014.
In March 2005, the Company issued $130,000,000 in Convertible Notes. The Company will pay
2.50% interest per annum on the Convertible Notes on March 15 and September 15 of each year.
Holders of the Convertible Notes may convert the Convertible Notes into shares of common stock
at any time prior to the maturity date of the Convertible Notes at a conversion rate of 71.7077
shares of common stock per $1,000 principal amount of Convertible Notes, which is equal to an
initial conversion price of approximately $13.95 per share, subject to adjustment as set forth in
the indenture governing the Convertible Notes. In the event of certain types of fundamental
changes, the Company will increase the number of shares issuable upon conversion or, in lieu
thereof, the Company may in certain circumstances elect to adjust the conversion rate and related
conversion obligation so that the Convertible Notes are convertible into shares of the acquiring or
surviving company, or at the option of the Company, the Company may elect to pay the additional
value represented by an increase in the conversion rate in cash to holders electing to convert
their Convertible Notes. On or after March 20, 2010, the Company may redeem some or all of the
Convertible Notes for cash at 100% of the principal amount plus accrued interest, if the trading
price of the Companys common stock exceeds 140% of the conversion price of the Convertible Notes
then in effect for at least 20 trading days within a period of 30 consecutive trading days ending
on the trading day prior to the date on which the redemption notice is mailed. Upon the occurrence
of a fundamental change meeting certain conditions, holders of the Convertible Notes may require
the Company to repurchase for cash all or part of their Convertible Notes.
The Convertible Notes are senior unsecured obligations and rank equally in right of payment
with any senior unsecured indebtedness that the Company may incur in the future. The Convertible
Notes will be effectively subordinated to all future secured indebtedness and all existing and
future liabilities of
9
the Companys subsidiaries, including trade payables and senior in right of payment to any
future subordinated indebtedness that the Company may incur.
The completion of the Tender Offer on April 1, 2008, qualified as a fundamental change under
the indenture governing the Convertible Notes, and in April 2008 the Company notified the holders
of the Convertible Notes of the fundamental change and the right to require the Company to
repurchase the Convertible Notes.
(11) Share-Based Payment
The Company has share-based awards outstanding under six different plans as follows:
The Amended and Restated 1990 Incentive Stock Option Plan (1990 Plan) allows for the
issuance of incentive and non-qualified options to employees, directors, officers, non-employee
independent contractors and non-employee directors, pursuant to which 22,500 shares of Common Stock
are reserved for issuance out of authorized but unissued shares of the Company. No new issuances
are being made under the 1990 Plan.
The Amended and Restated 1992 Incentive Stock Option Plan (1992 Plan) allows for the
issuance of incentive and non-qualified options to employees, directors, officers, non-employee
independent contractors and non-employee directors, pursuant to which 84,050 shares of Common Stock
are reserved for issuance out of authorized but unissued shares of the Company. No new issuances
are being made under the 1992 Plan.
The Amended and Restated 1995 Stock Option Plan (1995 Plan) allows for the issuance of
incentive and non-qualified options, shares of restricted stock and stock bonuses to employees,
officers, and non-employee independent contractors, pursuant to which 125,629 shares of Common
Stock are reserved for issuance out of authorized but unissued shares of the Company. No new
issuances are being made under the 1995 Plan.
The Amended and Restated 1995 Non-Employee Director Stock Option Plan (1995 Director Plan)
allows for the issuance of non-qualified options to non-employee directors, pursuant to which
337,500 shares of Common Stock are reserved for issuance out of authorized but unissued shares of
the Company. No new issuances are being made under the 1995 Director Plan.
The Amended and Restated 1999 Stock Incentive Plan (1999 Plan) allows for the issuance of
incentive and non-qualified options, shares of restricted stock and stock-based bonuses to
directors, employees, officers and non-employee independent contractors, pursuant to which
5,076,070 shares of Common Stock are reserved for issuance out of authorized but unissued shares of
the Company.
The 2007 Incentive Plan, as amended (2007 Plan), allows for the issuance of incentive and
non-qualified options, shares of restricted stock, and stock-based bonuses to directors, employees,
officers and non-employee independent contractors, pursuant to which 2,070,207 shares of Common
Stock are reserved for issuance out of authorized but unissued shares of the Company.
Pursuant to
the terms of the Merger Agreement and the Companys stock option plans, all
unvested outstanding awards, including stock options, phantom units, and shares of restricted stock
vested upon the completion of the Tender Offer on April 1, 2008, and all previously unrecognized
share-based compensation expense will be recognized in the second quarter of 2008.
Compensation expense related to all share-based awards during the three months ended March 31,
2008 and 2007 was as follows ($ in Thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
|
|
2008
|
|
|
2007
|
|
Options
|
|
$
|
79
|
|
|
$
|
848
|
|
Nonvested shares
of common stock
|
|
|
847
|
|
|
|
802
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
926
|
|
|
$
|
1,650
|
|
|
|
|
|
|
|
|
Cash received from stock options exercised during the three months ended March 31, 2008 and
2007 was $2,000 and $4,000, respectively.
10
The fair value of the Companys stock option awards is estimated on the date of grant using a
Black-Scholes option-pricing model that uses the assumptions in the table below. The fair value of
the Companys stock option awards, which are subject to graded vesting, is expensed over the
vesting period of the stock options using the straight-line method. Expected volatility is based
on an average of (i) historical volatility of the Companys stock, (ii) implied volatility from the
Companys convertible debt and (iii) implied volatility from traded options on the Companys stock.
The risk-free rate for periods within the contractual life of the stock option award is based on
the yield curve of a zero-coupon U.S. Treasury bond for the month during which the stock option
award is granted with a maturity equal to the expected term of the stock option award granted. The
Company uses historical data to estimate stock option exercises and forfeitures within its
valuation model. The expected term of stock option awards granted is derived from historical
exercise experience under the Companys share-based payment plans and represents the period of time
that stock option awards granted are expected to be outstanding.
No stock options were granted in the three months ended March 31, 2008. The significant
weighted average assumptions relating to the valuation of the Companys stock options for the three
months ended March 31, 2007 was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 31,
|
|
|
2008
|
|
2007
|
Expected dividend yield
|
|
|
|
|
|
|
0.0
|
|
Risk-free interest rate
|
|
|
|
|
|
|
4.7
|
%
|
Expected volatility
|
|
|
|
|
|
|
77.9
|
%
|
Expected life in years
|
|
|
|
|
|
|
5.0
|
|
A summary of the Companys stock option activity for the three months ended March 31, 2008 was
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Weighted Average
|
|
|
Aggregate
|
|
|
|
Stock
|
|
|
Average
|
|
|
Remaining
|
|
|
Intrinsic Value
|
|
|
|
Options
|
|
|
Exercise Price
|
|
|
Contractual Term
|
|
|
(in Thousands)
|
|
Outstanding
at January 1, 2008
|
|
|
5,081,422
|
|
|
$
|
7.01
|
|
|
|
4.94
|
|
|
$
|
|
|
Grants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited or expired
|
|
|
(219,818
|
)
|
|
$
|
7.77
|
|
|
|
|
|
|
|
|
|
Exercises
|
|
|
(2,500
|
)
|
|
$
|
0.93
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at March 31, 2008
|
|
|
4,859,104
|
|
|
$
|
6.98
|
|
|
|
4.83
|
|
|
$
|
554
|
|
As
discussed in Note 1, following the completion of the Tender Offer on April 1, 2008, holders
of stock options with an exercise price below the Offer Consideration are entitled to a
cash payment of the intrinsic value of their options upon the effective time of the Merger, which
is expected to occur in early June 2008.
The weighted average grant date fair value of options granted and total intrinsic value of
options exercised during the three months ended March 31, 2008 and 2007, was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
March 31,
|
|
|
2008
|
|
2007
|
Weighted average:
|
|
|
|
|
|
|
|
|
Grant date fair value
per option
|
|
$
|
|
|
|
$
|
1.98
|
|
Total intrinsic value of
options exercised
|
|
$
|
3,000
|
|
|
$
|
12,000
|
|
11
The fair value of nonvested shares of common stock is determined based on the closing trading
price of the Companys common stock on the day before the grant date. The weighted average grant
date fair value of nonvested shares granted during the three months ended March 31, 2008 and 2007
was $0.76 and $3.03, respectively. A summary of the Companys nonvested shares activity for the
three months ended March 31, 2008 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
|
|
|
|
|
|
|
|
Grant Date
|
|
|
|
Shares
|
|
|
Fair Value
|
|
Nonvested at January 1, 2008
|
|
|
2,450,275
|
|
|
$
|
1.85
|
|
Activity during quarter ended March 31, 2008
|
|
|
|
|
|
|
|
|
Grants
|
|
|
105,101
|
|
|
$
|
0.76
|
|
Vested
|
|
|
(112,476
|
)
|
|
$
|
1.43
|
|
Forfeited
|
|
|
(70,407
|
)
|
|
$
|
2.44
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2008
|
|
|
2,372,493
|
|
|
$
|
1.80
|
|
The Company began granting phantom units in 2006 to certain of its non-U.S. employees. The
fair value of unvested phantom units is determined based on the closing trading price of the common
stock on the day before the grant date. A summary of the Companys unvested phantom unit activity
for the three months ended March 31, 2008, was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Average
|
|
|
|
Phantom
|
|
|
Grant Date
|
|
|
|
Units
|
|
|
Fair Value
|
|
Unvested at January 1, 2008
|
|
|
1,949,387
|
|
|
$
|
1.42
|
|
Grants
|
|
|
34,636
|
|
|
$
|
2.31
|
|
Vested
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(112,496
|
)
|
|
$
|
1.56
|
|
|
|
|
|
|
|
|
Unvested at March 31, 2008
|
|
|
1,871,527
|
|
|
|
1.43
|
|
At March 31, 2008, there was $5.4 million of unrecognized compensation expense related to
unvested share-based awards granted under the Companys share-based payment plans of which $1.4
million relates to stock options and $4.0 million relates to nonvested shares. As a result of the
completion of the Tender Offer, all outstanding share-based awards vested on April 1, 2008 and
remaining share-based compensation expense will be recognized in the second quarter of 2008.
(12) Accrued expenses
Accrued expenses consisted of the following items (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2008
|
|
|
December 31, 2007
|
|
Accrued compensation and benefits
|
|
$
|
1,351
|
|
|
$
|
4,680
|
|
Accrued research and development
costs
|
|
|
4,451
|
|
|
|
5,961
|
|
Accrued interest on long-term debt
|
|
|
169
|
|
|
|
953
|
|
Accrued sales and marketing expenses
|
|
|
802
|
|
|
|
1,874
|
|
Reserve for future Argatroban returns
|
|
|
1,562
|
|
|
|
1,448
|
|
Legal and Professional Fees
|
|
|
2,925
|
|
|
|
901
|
|
Other accrued expenses
|
|
|
717
|
|
|
|
851
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
11,977
|
|
|
$
|
16,668
|
|
|
|
|
|
|
|
|
(13) Commitments and Contingencies
(a) Foreign Currency Exchange Risk
The Company is exposed to market risk primarily from changes in foreign currency exchange
rates. We have contracts with entities outside the U.S. that are denominated in a foreign
currency. Most of the Companys assets are located within the U.S. and are not subject to
changes in foreign currency exchange rates. Royalty revenues are denominated in U.S. dollars,
however all sales
12
revenue and a substantial portion of operating expense is denominated in foreign
currencies, primarily pounds sterling, euros or Canadian dollars. While the effect of changes
in foreign currency exchange rates has not had a material effect on the Companys financial
results or financial condition to date, management believes that fluctuations in foreign
currency exchange rates could have a material effect on the Companys future results.
(b) Employment agreements
The Company has entered into employment agreements with certain U.S. officers and key
employees and with all of its non-U.S. employees. Additionally, the Company has signed
agreements with 11 of its officers and key employees to provide certain benefits in the event
of a change of control as defined in these agreements and the occurrence of certain other
events. The agreements provide for a lump-sum payment in cash equal to 12 months to three
years of annual base salary and annual cash bonus, if any. The annual base salary and annual
cash bonus portion of the agreements would aggregate approximately $8.7 million at the rate
of compensation in effect at March 31, 2008. In addition, the agreements provide for
gross-up for certain taxes on the lump-sum payment, continuation of certain insurance and
other benefits for periods of 12 months to three years and reimbursement of certain legal
expenses in conjunction with the agreements. The employment agreements with non-U.S.
employees do not contain change of control provisions, but in addition to any applicable
statutory benefits, provide for payments upon termination without cause of annual base salary
of three to twelve months depending upon employee ranking.
(c) Other contingencies
Like other biopharmaceutical companies, the Company is subject to other contingencies,
including legal proceedings and claims arising out of its business that cover a wide range of
matters, including, among others, environmental matters, securities matters and shareholder
claims, contract and employment claims, intellectual property infringement claims and product
liability. The Company may be involved in legal actions from time to time. The Company has used
various substances in its research and development that have been or may be deemed to be
hazardous or dangerous, and the extent of its potential liability, if any, under environmental,
product liability and workers compensation statutes, rules, regulations and case law is
unclear.
13
Item 2.
ENCYSIVE PHARMACEUTICALS INC. AND SUBSIDIARIES
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Three Months Ended March 31, 2008, and March 31, 2007
FORWARD LOOKING STATEMENTS
The following discussion of our financial condition and results of operations should be read
in conjunction with our consolidated financial statements and the related notes to the financial
statements included in our Annual Report on Form 10-K, as amended, for the year ended December 31,
2007, and with the condensed consolidated financial statements and related notes to the financial
statements included elsewhere in this Form 10-Q. This Form 10-Q contains forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements represent our managements judgment
regarding future events. In many cases, you can identify forward-looking statements by terminology
such as may, will, should, target, seek, project, could, plan,
expect, anticipate, estimate, believe, predict, intend, potential, or
continue or the negative of these terms or other words of similar import, although some
forward-looking statements are expressed differently. All statements, other than statements of
historical fact, included in and incorporated by reference into this Form 10-Q regarding our
financial position, business strategy and plans or objectives for future operations are
forward-looking statements. Among the factors that could cause actual results to differ materially
from those indicated by such forward-looking statements are: statements regarding the expected
completion of the acquisition of us by Pfizer, including the Merger and the Merger Agreement; our
ability to earn a profit from sales or licenses of Thelin
TM
or other drug candidates;
unexpected delays in commencing and completing an additional Phase III clinical trial for
Thelin
TM
(sitaxsentan sodium) in pulmonary arterial hypertension (PAH) to address
concerns regarding efficacy raised in the third approvable letter, dated June 15, 2007, received
from the FDA; regulatory approval of Thelin
TM
and our other products under development
by the FDA; the unpredictability of the duration and results of regulatory review of our New Drug
Application(s) and Investigational New Drug Application(s) by the FDA and national regulatory
authorities in Australia, Canada, the EU and other countries; the high cost and uncertainty of the
research, clinical trials and other development activities involving our products and compounds;
possible delays in the timelines for initiating clinical trials and obtaining results of clinical
trials with respect to our products under development, including Thelin
TM
and TBC3711;
market acceptance of Thelin
TM
in the EU, Australia and Canada and the actual rate of
acceptance; the speed with which reimbursement and pricing approvals, and product launches for
Thelin
TM
may be achieved in the EU, Australia, Canada and in other countries where
Thelin
TM
may be approved; difficulties or delays in importing, manufacturing, packaging
or distributing Thelin
TM
in the EU, Australia and Canada and in other countries where
Thelin
TM
may be approved; the impact of competitive products on Thelin
TM
and
Argatroban sales; the availability of sufficient funds to continue to commercialize
Thelin
TM
in the EU and Canada; reduced estimates of patient populations and diagnosis
rates of patients with PAH; the impact of national, provincial and local reimbursement policies and
governmental regulation of prices for Thelin
TM
in the EU, Australia and Canada; our
ability to predict revenues from Thelin
TM
and expense levels in 2008 and beyond; the
impact of existing and future EU regulatory provisions on product exclusivity, including orphan
drug exclusivity for Thelin
TM
; the impact of legislation or regulations in the U.S., and
countries within the EU, Australia and in Canada affecting Thelins
TM
pricing,
reimbursement or access; the scope of our patents and challenges by others of the scope of our
patents; our ability to attract and retain qualified personnel; the ability of our subsidiary to
repay the notes secured by royalties on the sales of Argatroban; our ability to prevail in the
Argatroban abbreviated new drug application patent litigation and the costs of such litigation; the
breadth of approved labeling for our approved products and our competitors products; our ability
to establish future collaborative arrangements or licenses; and the availability of materials
necessary for the manufacture of our products; as well as more specific risks and uncertainties
facing us such as those set forth in Item 1A Risk Factors in our Annual Report on Form 10-K, as
amended for the year ended December 31, 2007 and below.
You should read these forward-looking statements carefully because they discuss our
expectations about our future performance, contain projections of our future operating results or
our future financial
14
condition, or state other forward-looking information. You should be aware that the
occurrence of any of the events described in Risk Factors, Managements Discussion and Analysis
of Financial Condition and Results of Operations and elsewhere in this Form 10-Q could
substantially harm our business, results of operations and financial condition and that upon the
occurrence of any of these events, the trading price of our common stock could decline, and you
could lose all or part of your investment.
All subsequent written and oral forward-looking statements attributable to us or to persons
acting on our behalf are expressly qualified in their entirety by the applicable cautionary
statements. We cannot guarantee any future results, levels of activity, performance or
achievements. Except as required by law, we undertake no obligation to update any of the
forward-looking statements in this Form 10-Q after the date of this Form 10-Q.
As used in this Form 10-Q, the words we, our, us, Encysive, and the Company refer to
Encysive Pharmaceuticals Inc., its predecessors and subsidiaries, except as otherwise specified.
This Form 10-Q may contain trademarks and service marks of other companies.
EXECUTIVE SUMMARY
On February 20, 2008, we entered into the Merger Agreement with Pfizer and Explorer, which
provides for the merger of Explorer with and into Encysive with Encysive continuing as the
surviving corporation, wholly-owned by Pfizer. Pursuant to the Merger Agreement, on March 4, 2008,
Explorer and Pfizer commenced the Tender Offer to purchase all of the outstanding Shares at a
purchase price equal to the Offer Consideration. The initial offering period of the Tender Offer
expired at 12:00 midnight, New York City time, on Monday, March 31, 2008, at which time
approximately 61,765,295 Shares (representing approximately 76.30% of the outstanding Shares) were
validly tendered and not withdrawn pursuant to the Tender Offer. On April 1, 2008, Explorer
accepted all validly tendered and not withdrawn Shares for payment in accordance with the terms of
the Tender Offer and promptly paid for and purchased such Shares.
Pursuant to the Merger Agreement, on April 1, 2008, Explorer also commenced a subsequent
offering period in respect of the Tender Offer to acquire all of the remaining untendered Shares
for the Offer Consideration. The subsequent offering period expired at 5:00 p.m., New York City
time, on Monday, April 14, 2008. During the subsequent offering period, approximately 7,311,171
additional Shares were purchased by Explorer. The total number of Shares purchased by Explorer in
the Tender Offer through the expiration of the subsequent offering period was 69,076,466 Shares
(representing approximately 85.33% of the outstanding Shares).
The Merger will be effected in accordance with the DGCL and the Merger Agreement. Since
the affirmative vote of the holders of a majority of the outstanding Shares is required to adopt
the Merger Agreement, Explorer will be able to adopt the Merger Agreement, and has an obligation to
do so under the Merger Agreement, without the vote or consent of any other Encysive stockholder.
Upon completion of the Merger, each Share issued and outstanding immediately prior to the effective
time of the Merger (other than shares owned by Pfizer, the Company and their wholly-owned
subsidiaries and by stockholders who properly exercise appraisal rights under the DGCL), will be
converted into the Merger Consideration. Prior to the effective time of the Merger, the Company
will mail an information statement to its stockholders of record on May 15, 2008 containing
information about the Merger. Under federal securities laws, the Merger may not be completed until
20 days after the Company mails the information statement to such stockholders. Pfizer, Explorer
and the Company are obligated to complete the Merger pursuant to the terms and subject to the
conditions set forth in the Merger Agreement. Management expects all such conditions to be
satisfied at the end of the 20 day period. The Merger is expected to become effective in early
June 2008; however, we cannot assure you that the Merger will become effective at that time, if at
all.
After the consummation of the Merger, the Shares will be deregistered under applicable
rules of the SEC and the Shares also will be delisted from the NASDAQ Global Market.
We are now a majority-owned subsidiary of Pfizer. Pfizer has informed us that it expects that
immediately following the Merger, the business and operations of Encysive will be continued
substantially as they are currently being conducted. Pfizer will continue to evaluate the business
and operations of Encysive and will take such actions as it deems appropriate under the
circumstances then
15
existing. Thereafter, Pfizer intends to review such information as part of a comprehensive
review of Encysives business, operations, capitalization and management with a view to optimizing
development of Encysives potential in conjunction with Pfizers existing business.
Thelin for the treatment of Pulmonary Arterial Hypertension
Thelin (sitaxsentan sodium) is a selective oral ETA receptor antagonist dosed once a day for
the treatment of PAH. In August 2006, Thelin was approved by the European Commission, or EC, for
use in patients with pulmonary arterial hypertension classified as World Health Organization, or
WHO, functional class III, to improve exercise capacity, as well as in primary pulmonary
hypertension and in pulmonary hypertension associated with connective tissue disease. After the EC
approved Thelin for marketing and sale in the EU, we started to build the necessary commercial
infrastructure, including the establishment of country sales organizations and the negotiation of
third party distributor relationships, to promote and sell Thelin in various countries of the EU.
The centralized licensing procedure of the European Agency for the Evaluation of Medicinal
Products, or EMEA, permits us to market Thelin in all 27 member states of the EU, however in most
of the EU countries we must negotiate pricing and reimbursement prior to commercial launch. In the
fourth quarter of 2006, we made Thelin commercially available in the UK and Germany, and
subsequently in 2007 in Austria, Belgium, Denmark, France, Ireland, Italy, Luxembourg, the
Netherlands and Sweden. In addition, Thelin is commercially available through third parties in
Greece and Spain. We anticipate subsequent product launches of Thelin in other EU countries as
their respective national governments approve pricing and reimbursement.
On March 7, 2007, we announced that the Australian Therapeutic Goods Administration, or TGA,
had granted marketing approval for Thelin
100 mg tablets as a once daily oral treatment
for patients with PAH. We have subsequently received reimbursement approval in Australia and have
begun to commercialize Thelin through a third party in Australia.
On May 30, 2007, the Therapeutic Products Directorate, or TPD, of Health Canada approved
Thelin for the treatment of primary pulmonary arterial hypertension and pulmonary hypertension
secondary to connective tissue disease, in patients with WHO functional class III who have not
responded to conventional therapy. Thelin is also indicated in patients with WHO functional class
II who did not respond to conventional therapy and for whom no appropriate alternative treatment
can be identified. Thelin is commercially available in Canada and is being reimbursed by private
insurance and the province of Quebec and we are applying for reimbursement with the remaining
provincial governments in Canada. We currently have a limited commercial presence in Canada.
We have established central EU commercial operations near London, England, with regional sales
offices established in Munich, Germany, Paris, France and Milan, Italy. We will evaluate the need
to add additional infrastructure and commercial support as reimbursement is obtained in countries
within the EU where Thelin is approved. We will also evaluate the need for commercial
infrastructure and support worldwide if Thelin receives regulatory approval and reimbursement in
other countries outside of the EU. In some markets, we may choose to use third parties to
distribute Thelin, or to provide other services such as reimbursement and/or sales support. In
Canada, we have invested in a limited commercial infrastructure.
Argatroban
Argatroban, licensed from Mitsubishi Pharma Corporation, or Mitsubishi, and developed in North
America by us, is a synthetic direct thrombin inhibitor that was approved by the FDA in 2000. It
is indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with HIT,
and as an anticoagulant in patients with or at risk for HIT undergoing percutaneous coronary
intervention, or PCI. Argatroban was approved in Canada in 2001 for use as an anticoagulant
therapy in patients with HIT syndrome. We have licenses to a formulation patent, which expires in
2014, and a manufacturing process patent that expires in 2017. The composition of matter patent
has expired. We are not aware of any regulatory submissions by other parties for generic compounds
that could compete with Argatroban. Argatroban is marketed and sold by GSK in the U.S. and Canada
under a license agreement whereby our subsidiary described below receives royalties on sales.
On February 6, 2007, our wholly owned subsidiary, Argatroban Royalty Sub LLC, or Royalty Sub,
closed a private placement of $60 million in aggregate principal amount of the Original Argatroban
Notes to institutional investors. The Original Argatroban Notes were redeemed and cancelled on
16
September 21, 2007 when Royalty Sub issued the Argatroban Notes in exchange for the Original
Argatroban Notes, as well as cash consideration from the holders of the Original Argatroban Notes
in an amount of approximately $14.4 million. Of the $14.4 million, approximately $1.4 million was
paid to the holders of the Original Argatroban Notes for accrued and unpaid interest thereon and
approximately $1.8 million was paid in transaction expenses, resulting in net proceeds to the
Company of approximately $11.2 million. The Argatroban Notes are secured by royalties to be paid
from sales of Argatroban and by a pledge by us of the stock of Royalty Sub. All interest and
principal payments on the Argatroban Notes will be made solely from royalties and other payments
payable under the license agreement with GSK, all of which have been transferred to Royalty Sub.
The Argatroban Notes are non-recourse and non-convertible and have not been guaranteed by us.
Royalty Sub will receive all royalties on the sales of Argatroban until the Argatroban Notes have
been repaid in full; therefore, future royalties will not be available to fund our operations. For
additional information about the Argatroban Notes, refer to Note 10 to the condensed consolidated
financial statements included herein.
Clinical Trials
To date, we have conducted clinical studies with Thelin in three diseases congestive heart
failure, essential hypertension and PAH. Our current clinical development programs for Thelin
include plans to develop oral Thelin more broadly in PAH and to explore other indications for both
intravenous and oral Thelin. We continue to study oral Thelin in PAH in the STRIDE-3
continuation safety trial in countries other than the U.S. and Latin America, where we have
discontinued STRIDE-3.
In March 2006, we initiated a Phase II clinical trial to study oral Thelin as a treatment for
diastolic heart failure (DHF), a type of congestive heart failure. Thelin is being tested in
approximately 150 DHF patients at approximately 40 study centers. On September 4, 2007, we
completed patient enrollment in this Phase II trial and the results of the trial are expected in
the middle of 2008.
We will also be conducting additional clinical trials with oral Thelin as part of our post
approval commitments to the EMEA. These trials will include a study of PAH combination therapy
involving Thelin and sildenafil, and a pediatric clinical trial for Thelin in PAH. In November
2006, we presented data for an intravenous formulation of Thelin being studied in patients
undergoing cardiac bypass procedures (CABG). The trial demonstrated that intravenous Thelin
prevented the post-operative increase in pulmonary arterial pressure that is believed to be
associated with increased morbidity and mortality in patients shortly after cardiac bypass surgery.
We are conducting a second clinical trial to optimize the dosing regimen. We are also conducting a
Phase II clinical trial with Thelin in patients with chronic renal disease (CRD).
We are currently working with the FDA to finalize a study protocol for a Phase III clinical
trial to seek regulatory approval for Thelin in the U.S. We believe the additional Phase III
study (STRIDE-5) trial design will include a 2-arm randomized, double-blinded, 12 week study of
100 mg once daily Thelin versus placebo, a primary efficacy endpoint of change in 6MWD from
baseline, and an estimated sample size of approximately 180 patients. Enrollment is expected to
begin in the third quarter of 2008 after the STRIDE-5 protocol is finalized.
TBC3711 is our second-generation endothelin antagonist and next clinical candidate. We
believe TBC3711 is more selective and more potent than Thelin, with the potential to treat PAH and
other diseases. TBC3711 has completed two Phase I clinical studies and we have an ongoing Phase II
study with TBC3711 in resistant hypertension
Research Programs
Our research efforts are concentrated on targets within the vasculature, and the potential
indications of our drug candidates include cardiovascular diseases and a potentially wide variety
of inflammatory diseases involving two complementary sets of targets. The first set of targets
relate to G protein-coupled receptors, or GPCRs. Historically, GPCRs have been some of the most
amenable targets for developing commercially successful pharmaceuticals, such as beta-blockers,
antihistamines, and most anti-psychotics and anti-depressants. Endothelin receptors, targeted by
Thelin and TBC3711, are examples of GPCRs.
17
We have also developed expertise in pharmacologically intervening in the intravascular
inflammatory cascade, representing a second set of intravascular targets. Bimosiamose, licensed to
Revotar Biopharmaceutics A.G., and TBC4746, licensed to Schering-Plough, are examples of drug
candidates that we designed to target two distinct steps in this cascade, the selectins and VLA-4,
respectively. Some of the targets in this cascade are GPCRs. Thus, we believe that our focus on
endothelial cell and related vascular biology has opened up a broad range of disease targets with
high unmet medical need.
Our CCR-9
antagonist, ENC8856, is progressing through preclinical development and we expect to
file an investigational new drug application with the FDA in 2008.
Critical Accounting Policies
Revenue Recognition
|
|
|
We recognize revenue from sales of Thelin when product is shipped and ownership
transfers to the customer. Sales revenue includes value added taxes billed to customers,
and is reported net of applicable discounts, allowances and returns.
|
|
|
|
|
We recognize royalty revenue as a licensee sells products and we have received
sufficient information to record a receivable. Our royalty revenue is based on net sales
of product, that is, sales net of discounts, returns and allowances. Argatroban is
licensed to GSK, which distributes and sells the product, and from which we receive a
quarterly royalty payment. At the time of each payment, GSK provides us with limited
quarterly data related to the products gross sales, sales returns, discounts and
allowances. While we are informed of the amount of product returns recorded each quarter,
we do not have information necessary to identify the period or periods to which such
returns correspond. We believe that substantially all discounts and allowances pertain to
current period sales. We also believe that a portion of sales recorded in each period
will ultimately be returned, and therefore estimate future returns and their impact on
royalty revenues. In the pharmaceutical industry, product returns are primarily
influenced by remaining or expired shelf life, product withdrawals or recalls, significant
price changes from competitors or the introduction of generic products or other new
competition. We are not aware of any pending product recalls or withdrawals, significant
price fluctuations or generic competition. Accordingly, we have estimated only the impact
of product dating on returns.
|
|
|
|
|
Since we do not manufacture, sell or distribute Argatroban, we do not have information
related to levels of inventory in the distribution channels. However, due to the cost of
the drug and pressures on hospitals to minimize operating expenditures, we believe
inventory levels are maintained at a minimally acceptable level. Inventory level is
therefore not a part of the Companys estimate process.
|
|
|
|
|
We have estimated remaining shelf life, which is an important reason for product returns,
based upon the fact that Argatroban has an expiration date of two years from manufacture.
Common industry practice is that prescription drugs can be returned to the manufacturer at
any time; however, product is normally returned when the remaining shelf life is reduced to
six months or less. Our reserve is therefore based upon an estimate of the percentage of
sales made in the preceding 18-month period that may be returned in future periods.
Initially, lacking any historical sales data for Argatroban and based upon managements
experience with other pharmaceutical products in the industry, management estimated that
four percent of gross sales of Argatroban would be returned during future periods. Based
upon subsequent analysis of historical sales data, we believe that differences between
estimated and actual future returns will not have a material effect on our results of
operations or financial condition.
|
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|
Revenue from collaborative research and development activities is recognized as
services are performed.
|
|
|
|
|
We defer the recognition of milestone payments related to contractual agreements that
are still in the development stage. Such deferred revenues are amortized into income over
the estimated remaining development period. Milestone payments received under contractual
agreements which have completed the development stage are evaluated, and either recognized
into income
|
18
|
|
|
when earned, or amortized over a future period, depending upon whether we continue to have
obligations under the terms of the arrangement.
|
|
|
|
License fees received under the terms of licensing agreements for our intellectual
property are deferred and amortized into income over the estimated development period of
the licensed item or items.
|
|
|
|
|
Revenue from grants is recognized as earned under the terms of the related grant
agreements, typically as expenses are incurred.
|
Amounts received in advance of services being performed under contracts are recorded as
deferred revenue, and recognized as services are performed. We periodically evaluate our estimates
of remaining development periods, and adjust the recognition of remaining deferred revenues over
the adjusted development period remaining.
Cost of goods sold
Cost of goods sold is comprised of the direct cost of inventory consumed, using the first-in,
first-out method. Value added taxes billed to customers along with the fees associated with third
party distributors are also included in cost of goods sold.
Stock Options
The Company adopted the provisions of FAS 123R on January 1, 2006 using the modified
prospective transition method. See Note 11 to the condensed consolidated financial statements for
further detail on the impact of FAS 123R on the Companys condensed consolidated financial
statements.
Drug Manufacturing and Packaging
Costs arising from the manufacturing and packaging of drug product, which is intended for use
in clinical trials, are recognized as incurred and included in research and development expenses.
Inventory balances are determined using the first-in first-out method. We periodically evaluate
inventory balances based upon inventory production plans, expiration dates of product on hand and
projected future sales. At March 31, 2008 and December 31, 2007 we recorded a reserve for
inventory obsolescence of approximately $1.5 and $1.0 million, respectively.
Costs Related to Issue of Long-Term Debt
Costs incurred in the issuance of the Argatroban Notes and the Convertible Notes, primarily
comprised of initial purchasers discounts, legal and other professional fees have been deferred,
and will be amortized and reported as a component of interest expense during the periods beginning
with the issuance date to the date that we have the ability to call the debt.
Results of Operations
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires us to make estimates and assumptions that affect
the reported amounts of assets, liabilities, disclosures of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and expenses during the
reporting period. Our operating results have fluctuated significantly during each quarter and
year, and we anticipate that such fluctuations, which are largely attributable to increasing
commercialization expenditures, will continue for the next several years. We have been
unprofitable to date and expect to make substantial expenditures during the next several years as
we invest in launching Thelin in Europe, obtaining regulatory approval of Thelin in the U.S., and
if approval is received, the commercializing of Thelin in the U.S.
We have sustained net losses of approximately $534.4 million from the date of our inception to
March 31, 2008. We have primarily financed our operations to date through a series of private
placements, and public offerings of our common stock and convertible debt, debt issued by our
subsidiary that is secured by royalties on Argatroban and from funds received through our
collaborations,
19
research agreements and partnerships. We are now a majority-owned subsidiary of Pfizer, and
we believe Pfizer will provide sufficient liquidity in order for us to continue to operate. See
discussion of Liquidity and Capital Resources below.
Three month periods ended March 31, 2008 and 2007
Sales
Sales of Thelin were $9.3 million in the three months ended March 31, 2008, compared with
$0.9 million in the three months ended March 31, 2007. Thelin first became commercially available
in the UK and Germany in the fourth quarter of 2006. Subsequently we have made Thelin
commercially available in Austria, Belgium, Denmark, France, Ireland, Italy, Luxembourg, the
Netherlands and Sweden. In addition, Thelin is commercially available through third parties in
Greece and Spain. We anticipate subsequent product launches of Thelin in other EU countries as
their respective national governments approve pricing and reimbursement. Thelin is also
commercially available in Canada and is sold in Australia through an exclusive distributor. We
continue to expect to record sales of Thelin in the range of approximately $40 to $50
million in 2008.
Royalties
Royalties increased approximately $1.3 million in the three months ended March 31, 2008
compared with the three months ended March 31, 2007. The increase in royalties is due to higher
sales of Argatroban during the current year period. Since February 2007, all royalty revenues from
sales of Argatroban are used to pay interest and to repay the Argatroban Notes and interest
thereon, and are no longer available to fund our operations until the Argatroban Notes are repaid
in full.
Total Revenues
Revenues in the three months ended March 31, 2008 increased approximately $9.3 million, to
approximately $14.7 million from approximately $5.4 million in the three months ended March 31,
2007, primarily due to increased sales of Thelin in Europe, Canada and Australia.
Cost of Goods Sold
Cost of goods sold in the three months ended March 31, 2008 of approximately $1.0 million was
primarily comprised of the cost to manufacture, finish and package quantities of Thelin sold in
Europe, Canada and Australia. There was no significant cost of goods sold in the three months
ended March 31, 2007 as Thelin had only recently been commercially launched.
Research and Development Expense
Research and development expense in the three months ended March 31, 2008 decreased $10.6
million compared to the three months ended March 31, 2007. The decreases primarily resulted from
the phasing out of the STRIDE-3 safety extension trial in the U.S. and Latin America, a reduction
in the number of on-going regulatory submissions and reductions in research staff due to our
restructuring of operations in June 2007.
Sales and Marketing Expense
Sales and marketing expenses declined $3.6 million in the three months ended March 31, 2008
compared with the three months ended March 31, 2007. As our sales and marketing expense in the
U.S. declined significantly as a result of our restructuring of operations in June 2007, current
year sales and marketing expenses are primarily related to our commercial operations in Europe and
Canada.
General and Administrative Expense
General and administrative expense increased $1.8 million in the three months ended March 31,
2008 compared to the three months ended March 31, 2007. General
and administrative expense in the three months ended March 31,
2008 included approximately $2.6 million related to the
Companys evaluation of its strategic alternatives and the
acquisition by Pfizer. While we have reduced our general and
administrative expenses in the U.S., general and administrative expenses have increased in Europe
as we have continued to build the infrastructure necessary to commercially support Thelin in
Europe and Canada. We believe the commercial infrastructure in Europe is substantially complete
20
Total Operating Expenses
Total operating expenses in the three months ended March 31, 2008 decreased $11.5 million,
compared to the three months ended March 31, 2007, primarily due to our restructuring of operations
in June 2007.
Operating Loss
Operating loss in the three months ended March 31, 2008, decreased $20.8 million compared with
the three months ended March 31, 2007, primarily as a result of higher revenues and lower expenses
in the 2008 period.
Interest Expense
Interest expense increased $1.8 in the three months ended March 31, 2008, compared with the
three months ended March 31, 2007. The increase is primarily due to interest on the Original
Argatroban Notes, which were issued on February 6, 2007, and the Argatroban Notes which were issued
in September 2007.
Investment Income
Investment income in the three month period ended March 31, 2008, decreased approximately $0.6
million, compared to the three month period ended March 31, 2007, primarily due to reduced funds
available for investment during 2008.
Net Loss
Net loss decreased $18.5 million in the three months ended March 31, 2008, compared with the
three months ended March 31, 2007, due to higher revenues and reduced expenses in the 2008 period.
21
Liquidity and Capital Resources
While the condensed consolidated financial statements included herein have been prepared
assuming that we will continue as a going concern, because of our losses and need for additional
financing to execute our business strategy, our independent auditors report on our consolidated
financial statements for the year ended December 31, 2007 contained a statement relating to their
substantial doubt about our ability to continue as a going concern. At March 31, 2008, we had cash
and cash equivalents of $12.7 million. To date, we have financed our research and development
activities and other operations primarily through public and private offerings of common stock,
proceeds from the issuance and sale of our Convertible Notes, the Original Argatroban Notes and the
Argatroban Notes; funds received through collaborations, research agreements, licenses and
partnerships; and royalty revenue from sales of Argatroban. In order to reduce our ongoing
expenses, on June 25, 2007 we announced that we were implementing a strategic restructuring, to
focus our resources on our most promising assets. In July 2007, we retained the investment banking
firm of Morgan Stanley to assist in evaluating strategic alternatives to maximize stockholder value
and on February 20, 2008, we entered into the Merger Agreement with Pfizer and Explorer. As we are
now a majority-owned subsidiary of Pfizer, we expect our future activities to be financed by
Pfizer.
For additional information about the Merger Agreement, see Note 1 to the Condensed
Consolidated Financial Statements.
Outlook for 2008
Pfizer has informed us that it expects that immediately following the Merger,
the business and operations of Encysive will be continued substantially as they are currently being
conducted. Pfizer will continue to evaluate the business and operations of Encysive and will take
such actions as it deems appropriate under the circumstances then existing. Thereafter, Pfizer
intends to review such information as part of a comprehensive review of Encysives business,
operations, capitalization and management with a view to optimizing development of Encysives
potential in conjunction with Pfizers existing business.
Cash Used in Operating Activities:
Cash and cash equivalents, including accrued interest thereon, was $12.7 million at March 31,
2008, compared with $33.2 million at December 31, 2007. The decrease in cash and cash equivalents
during the three months ended March 31, 2008 was primarily due to operating losses during the
period, and to amounts used to repay principal and interest on the Argatroban Notes. We used
$17.3 million in cash in continuing operations during the three months ended March 31, 2008,
compared to $34.0 million during the three months ended March 31, 2007. The primary operating uses
of cash in the 2008 and 2007 periods were to fund our general operating expenses and the ongoing
research and development programs, as well as preparations for the commercialization of Thelin,
partially offset by cash received from revenues and investment income.
Cash used in Investing Activities:
Investing activities are primarily comprised of purchases of equipment and leasehold
improvements, and of our investments in debt securities. Purchases of equipment and leasehold
improvements were $0.1 million in the three months ended March 31, 2007.
Cash provided by Financing Activities:
Cash used in financing activities of $3.5 million during the three months ended March 31, 2008
was primarily comprised of repayment of Argatroban Notes. Cash provided by financing activities of
$43.1 million in the three months ended March 31, 2007 was primarily comprised of proceeds of the
Original Argatroban Notes, reduced by the costs associated with their issuance. See Note 10.
22
Material Commitments:
Our material contractual obligations are comprised of (i) amounts borrowed through the
issuance of the Convertible Notes, (ii) amounts borrowed through the issuance of the Argatroban
Notes and (iii) obligations under our operating lease agreements. In addition, we have signed a
long-term purchase agreement for the manufacturing and supply of Thelin; however, our obligations
under the agreement are contingent upon receiving regulatory approval for the marketing of Thelin
in the U.S.
As of March 31, 2008, the Company had contractual obligations as follows (dollars in
thousands):
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|
|
|
|
|
|
|
|
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|
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|
Less
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|
|
|
|
|
|
|
|
|
|
Contractual
|
|
|
|
|
|
than 1
|
|
|
1-3
|
|
|
3-5
|
|
|
After 5
|
|
Obligations
|
|
Total
|
|
|
year
|
|
|
Years
|
|
|
Years
|
|
|
years
|
|
Convertible Notes
|
|
$
|
130,000
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
130,000
|
|
Argatroban Notes
|
|
|
56,191
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56,191
|
|
Operating leases
|
|
|
2,412
|
|
|
|
1,770
|
|
|
|
642
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
188,603
|
|
|
$
|
1,770
|
|
|
$
|
642
|
|
|
$
|
|
|
|
$
|
186,191
|
|
The completion of the Tender Offer on April 1, 2008, resulted in a fundamental change, as
defined in the indenture governing the Convertible Notes, pursuant to which the holders of the
Convertible Notes can demand repayment of the Convertible Notes in full, with accrued interest
thereon. A notice of fundamental change was distributed to the holders of the Convertible Notes,
and we expect the notes to be repaid in the second quarter of 2008.
Pursuant to the terms of the Merger Agreement, Pfizer is obligated to provide
funds necessary to repay the Convertible Notes. For more information about the Convertible Notes,
see Note 10.
Encysive has entered into employment agreements with certain U.S. officers and key employees
and with all of its non-U.S. employees. Additionally, we have signed agreements with 11 of our
officers and key employees to provide certain benefits in the event of a change of control as
defined in these agreements and the occurrence of certain other events. The agreements provide for
a lump-sum payment in cash equal to 12 months to three years of annual base salary and annual cash
bonus, if any. The annual base salary and annual cash bonus portion of the agreements would
aggregate approximately $8.7 million at the rate of compensation in effect at March 31, 2008. In
addition, the agreements provide for gross-up for certain taxes on the lump-sum payment,
continuation of certain insurance and other benefits for periods of 12 months to three years and
reimbursement of certain legal expenses in conjunction with the agreements. The employment
agreements with non-U.S. employees do not contain change of control provisions, but provide for
payments upon termination without cause of annual base salary of three to twelve months depending
upon employee ranking.
Off-Balance Sheet Arrangements:
We have not engaged in off-balance sheet financing arrangements.
Impact of Inflation and Changing Prices
The pharmaceutical research industry is labor intensive and wages and related expenses
increase in inflationary periods. The leases of space and related building services for our Houston
office and laboratory facilities each contain clauses that escalate rent and related services each
year based on the increase in building operating costs and the increase in the Houston Consumer
Price Index, respectively. To date, inflation has not had a significant impact on our operations.
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
Foreign Currency Exchange Risk
The Company is exposed to market risk primarily from changes in foreign currency exchange
rates. We have contracts with entities outside the U.S. that are denominated in a foreign
currency. Most of the Companys assets are located within the U.S., and are not subject to changes
in foreign currency
23
exchange rates. Royalty revenues are denominated in U.S. dollars, however all sales revenue
and a substantial portion of operating expense is denominated in foreign currencies, primarily
pounds sterling, euros or Canadian dollars. While the effect of changes in foreign currency
exchange rates has not had a material effect on the Companys financial results or financial
condition to date, management believes that fluctuations in foreign currency exchange rates could
have a material effect on the Companys future results.
Item 4.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this report, our management carried out an evaluation,
with the participation of our principal executive officer (the CEO) and our principal financial
officer (the PFO), of the effectiveness of our disclosure controls and procedures pursuant to
Rule 13a-15 of the Securities Exchange Act of 1934. Based on those evaluations, the CEO and PFO
concluded:
(i) that our disclosure controls and procedures are designed to ensure that information
required to be disclosed by us in the reports that we file or submit under the Securities Exchange
Act of 1934 is recorded, processed, summarized and reported within the time periods specified in
the SECs rules and forms, and that such information is accumulated and communicated to our
management, including the CEO and PFO, as appropriate to allow timely decisions regarding required
disclosure; and
(ii) that our disclosure controls and procedures are effective.
Changes in Internal Controls Over Financial Reporting
There have been no changes in our internal controls over financial reporting during the period
covered by this report that have materially affected, or that are reasonably likely to materially
affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
On November 19, 2007, we received a Paragraph IV Certification Notice from Barr Laboratories
Inc. (Barr) advising us of the filing of an abbreviated new drug application (ANDA) with the
FDA for a generic version of 100 mg/mL Argatroban injections. We received the notification as the
holder of the NDA for Argatroban. Barrs ANDA seeks approval to market a generic version of
Argatroban injections prior to the expiration of the patent covering the drug, U.S. patent no.
5,214,052, which is listed in the Orange Book with an expiration date of June 30, 2014. Barr
contends that U.S. Patent No. 5,214,052, is invalid, unenforceable, and/or will not be infringed by
Barrs manufacture, importation, use, or sale of the product for which the ANDA was submitted. Barr
has lodged a contention with respect to obviousness, but provided no grounds for alleged
unenforceability or noninfringement. On December 28, 2007, we announced that we, together with
Mitsubishi Chemical Corporation, the patent holder for Argatroban injections, Mitsubishi Tanabe
Pharma Corporation, and GSK filed a patent infringement lawsuit in the U.S. District Court for the
Southern District of New York against Barr related to Argatroban injections. The commencement of
this lawsuit against Barr will automatically stay, or bar, the FDA from approving Barrs ANDA for
30 months (unless modified by the Court), or until a final district court decision finding the
patent invalid, unenforceable, or not infringed, whichever is earlier. We are responsible for
sharing equally with Mitsubishi Chemical Corporation and Mitsubishi Tanabe Pharma Corporation in
the costs of this patent infringement lawsuit.
24
Item 1A.
Risk Factors
The following risks should be read in conjunction with other risk factors disclosed under Item 1A.
Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, 2007.
We have a history of losses and we may never become profitable.
Until recently, the majority of our financial resources have been dedicated to the research
and development of Argatroban, Thelin and other drug compounds. Beginning in 2005, we have spent
an increasing percentage of our financial resources on preparations for the anticipated commercial
launch of Thelin in the U.S., and more recently, in building the commercial infrastructure
necessary to launch Thelin in Europe and Canada. As described below, we expect to continue to
invest in our commercial organization in Europe and Canadian launch preparations for Thelin,
however as a result of the restructuring of our operations in June 2007, we have terminated our
U.S. sales force and significantly reduced our commercial infrastructure in the U.S. While we
continue to invest in developing several new drug compounds, we currently do not have any drug
candidates that may be commercialized in the near future other than Thelin. We also intend to
maintain a smaller headquarters in the U.S.
We believe that the commercial activity related to Thelin in Europe and Canada will require
additional funding due to higher levels of sales and marketing expenditures, particularly in
Europe, than in recent periods. Even though we have received regulatory approval to market Thelin
in Europe, Canada and Australia, significant uncertainties make it difficult to forecast or predict
future sales. Uncertainties that could materially affect any revenue projections include the
market acceptance of Thelin in each country, approved pricing and reimbursement policies of
third-party payers, the speed with which government or other third-party payers grant pricing and
reimbursement approvals, competitive activity, the timing of competitive product approvals and the
breadth of competitive product labeling, market acceptance and other factors impacting the timing,
effectiveness and speed of our product launches.
We believe Pfizer intends to provide funds necessary to focus on continued sales and
marketing activities of Thelin in Europe and Canada; advancing regulatory approval for Thelin for
PAH in the U.S.; continuing the clinical development of TBC3711; continuing the Phase II proof of
concept study of oral Thelin as a treatment for diastolic heart failure; and completing activities
to maintain the value of our Chemokine C-motif Receptor 9 and its two late stage pre-clinical
programs against an undisclosed target.
We cannot assure you that we will be able to develop, produce at reasonable cost, obtain
regulatory approvals, or market successfully, any of our product candidates, including Thelin.
All of our products will require regulatory approval before they may be commercialized. Products,
if any, resulting from our research and development programs other than Argatroban and Thelin, or
the use of our products in new indications, may not be commercially available for a number of
years, if at all, and we cannot assure you that any successfully developed products will generate
substantial revenues or that we will ever be profitable.
We make business decisions based on forecasts of future sales of Thelin in markets where we have
approval that may be inaccurate.
Our forecasts of future sales of Thelin in the EU, Canada and Australia are based on many
assumptions, including, but not limited to, reliance on external primary and secondary market
research, our own internal research, population estimates, estimates of disease diagnostic rates,
treatment trends, and sales of similar and competitive products, and market estimates by third
parties. Any of these assumptions can materially impact our forecasts and we cannot assure you
that the assumptions are accurate. In addition, our sales forecasts include the transition of our
current clinical trial patients to Thelin commercial supply. We cannot assure you that patients
currently receiving Thelin in our clinical trials will be prescribed Thelin when the clinical
trials are terminated.
Legislative changes or regulatory decisions in Europe may adversely impact our orphan drug status
which may result reduced revenues in the European Union.
The EC has designated Thelin as an orphan drug. Orphan drug status precludes European
regulators from approving marketing applications in the EU for medicinal products that are
chemically
25
similar to Thelin for a period of ten years. We have been requested to provide information
to support the designation of Thelin as an orphan drug in the EU and have responded to this
request. In May 2007, we met with officials of the EC to discuss the EMEAs reassessment of the
orphan drug status of Thelin in the EU, and following that meeting, we submitted documents
supporting our position that Thelins orphan drug status
should be maintained in the EU. Following the meeting, the EC
confirmed it had completed its reassessment and the orphan drug status
of Thelin was not changed. If the
EC amends its decision designating Thelin as an orphan drug, or if the EC decides not to renew the
orphan drug designation of Thelin after the first five years following marketing approval, Thelin
will lose its orphan drug status and European regulators may approve medicinal products that are
chemically similar to Thelin. In such case, we would need to rely on our existing patent
protection to prevent the commercialization of competing products in the EU. This protection
presently extends to 2016, subject to any available extensions, and may be broader or narrower than
that offered by orphan drug status, depending on the scope of patent claims applicable to Thelin.
If Thelin loses its orphan drug status in the EU, and existing patent claims applicable to Thelin
cannot prevent commercialization of competing products, Thelin will face increased competition,
which may decrease the amount of revenue we receive from Thelin.
We depend on third parties in the manufacture of our products and in the conduct of our clinical
trials for our product candidates and any failure of those parties to fulfill their obligations
could adversely affect our development plans.
We depend on independent clinical investigators, contract research organizations, hospitals
and other third party service providers and our collaborators in the conduct of our clinical trials
for our product candidates. We rely on these parties for successful execution of our clinical
trials but do not control many aspects of their activities. For example, the investigators are not
our employees. However, as the sponsor of these trials we are responsible for ensuring that each
of our clinical trials is conducted in accordance with the clinical investigational plan, protocols
for each clinical trial, good clinical practices and other regulatory requirements. Third parties
may not complete activities on schedule or may not conduct our clinical trials in accordance with
regulatory requirements or our stated protocols. The failure of these third parties to carry out
their obligations could delay or prevent the development, approval and commercialization of our
product candidates.
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
None
Item 3.
Defaults Upon Senior Securities
None
Item 4.
Submission of Matters to a Vote of Security Holders
None
Item 5. Other Information
Amendments to Amended and Restated By-Laws of the Company.
On and effective as of May 7, 2008, the Board of Directors approved amendments to the Amended
and Restated By-Laws of the Company to:
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delete the following sentence from Article II, Section 2.13 thereof: Whenever it is
intended that action is to be taken by stockholders without a meeting, a form for
expressing consent in writing to such action shall be sent to all holders of Stock
entitled to vote on such action., and
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delete the following sentence from Article V, Section 5.1 thereof: The Chairman of the
Board, the Chairman of the Executive Committee, the President, and the Executive Vice
President shall be selected from the directors.
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26
Officer Changes
On May 7, 2008, the Board of Directors approved the removal of George W. Cole, the Companys
President and Chief Executive Officer, and Derek J. Maetzold, the Companys Vice President,
Marketing and Sales, from their respective offices with the Company, effective May 13, 2008. In
addition, on such date, the Board of Directors elected Paul S. Manierre, the Companys Vice
President, General Counsel and Secretary, to the office of President,
effective May 13, 2008. Mr. Manierres biographical
information disclosed in the Companys Amendment No. 1 to its
Annual Report on Form 10-K/A for the fiscal year ended
December 31, 2007 under Item 10 is incorporated herein by
reference.
Item 6.
Exhibits
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Exhibit No.
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|
Description
|
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2.1
|
|
Agreement and Plan of Merger, dated February 20, 2008, among Pfizer Inc.,
Explorer Acquisition Corp. and Encysive Pharmaceuticals Inc. (incorporated by reference
to Exhibit 2.1 to the Companys Current Report on Form 8-K (Commission File No.
000-20117) filed with the Commission on February 25, 2008).
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3.1
|
|
Amended and Restated By-Laws of Encysive Pharmaceuticals Inc. adopted September
6, 1996, as amended on June 29, 2000 and May 7, 2008.
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10.1
|
|
Ninth Amendment dated February 15, 2008 to Consulting Agreement with John M.
Pietruski dated January 1, 1992 (incorporated by reference to Exhibit 10.1 to the
Companys Current Report on Form 8-K (Commission File No. 000-20117) filed with the
Commission on February 19, 2008).
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31.1
|
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Certification of Chief Executive Officer pursuant to Rule 13a-14(a) / Rule
15d-14(a), promulgated under the Securities Exchange Act of 1934, as amended.
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31.2
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) / Rule
15d-14(a), promulgated under the Securities Exchange Act of 1934, as amended.
|
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32.1
|
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Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
|
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32.2
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
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27
ENCYSIVE PHARMACEUTICALS INC.
May 12, 2008
SIGNATURES
Pursuant to the requirements 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, on the 12th
day of May 2008.
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ENCYSIVE PHARMACEUTICALS INC.
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By:
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/s/ George Cole
|
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George Cole
|
|
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|
President and Chief Executive Officer
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By:
|
/s/ Richard A. Goeggel
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Richard A. Goeggel
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Vice President, Finance and Treasurer
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28
INDEX TO EXHIBITS
|
|
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Exhibit No.
|
|
Description
|
|
|
|
2.1
|
|
Agreement and Plan of Merger, dated February 20, 2008, among Pfizer Inc.,
Explorer Acquisition Corp. and Encysive Pharmaceuticals Inc. (incorporated by reference
to Exhibit 2.1 to the Companys Current Report on Form 8-K (Commission File No.
000-20117) filed with the Commission on February 25, 2008).
|
|
|
|
3.1
|
|
Amended and Restated By-Laws of Encysive Pharmaceuticals Inc. adopted September
6, 1996 as amended on June 29, 2000 and May 7, 2008.
|
|
|
|
10.1
|
|
Ninth Amendment dated February 15, 2008 to Consulting Agreement with John M.
Pietruski dated January 1, 1992 (incorporated by reference to Exhibit 10.1 to the
Companys Current Report on Form 8-K (Commission File No. 000-20117) filed with the
Commission on February 19, 2008).
|
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|
31.1
|
|
Certification pursuant to Rule 13a-14(a) / Rule 15d-14(a), promulgated under the
Securities Exchange Act of 1934, as amended.
|
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31.2
|
|
Certification pursuant to Rule 13a-14(a) / Rule 15d-14(a), promulgated under the
Securities Exchange Act of 1934, as amended.
|
|
|
|
32.1
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
|
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|
|
32.2
|
|
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
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