e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 000-50447
Pharmion Corporation
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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84-1521333
(I.R.S. Employer
Identification No.) |
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2525 28th Street, Suite 200,
Boulder, Colorado
(Address of principal executive offices)
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80301
(Zip Code) |
720-564-9100
(Registrants telephone number, including area code)
None
(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,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No
þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as
of the latest practicable date.
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Class
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Outstanding at August 7, 2006 |
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Common Stock, $.001 par value per share
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32,051,664 shares |
PART I
FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
PHARMION CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands, except for share amounts)
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June 30, |
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December 31, |
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2006 |
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2005 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
93,270 |
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$ |
90,443 |
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Short-term investments |
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95,189 |
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152,963 |
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Accounts receivable, net of allowances of $3,840 and $3,573, respectively |
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34,625 |
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32,213 |
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Inventories |
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13,178 |
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11,472 |
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Prepaid research and development costs |
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10,734 |
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16,020 |
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Other current assets |
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4,900 |
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5,779 |
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Total current assets |
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251,896 |
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308,890 |
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Product rights, net |
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99,874 |
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104,045 |
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Goodwill |
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13,691 |
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12,920 |
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Property and equipment, net |
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6,312 |
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6,606 |
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Other assets |
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5,036 |
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169 |
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Total assets |
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$ |
376,809 |
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$ |
432,630 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
7,703 |
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$ |
8,456 |
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Accrued liabilities |
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35,401 |
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73,813 |
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Total current liabilities |
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43,104 |
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82,269 |
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Deferred tax liability |
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2,965 |
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2,797 |
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Other long-term liabilities |
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24 |
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940 |
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Total liabilities |
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46,093 |
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86,006 |
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Stockholders equity: |
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Common stock, $0.001 par value; 100,000,000 shares authorized and
32,051,240 and 31,912,751 shares issued and outstanding at June 30, 2006
and December 31, 2005, respectively |
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32 |
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32 |
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Preferred stock, $0.001, 10,000,000 shares authorized, no shares
issued and outstanding at June 30, 2006 and December 31, 2005 |
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Additional paid-in capital |
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484,742 |
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482,893 |
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Deferred compensation |
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(227 |
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Other comprehensive income (loss) |
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5,019 |
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(247 |
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Accumulated deficit |
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(159,077 |
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(135,827 |
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Total stockholders equity |
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330,716 |
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346,624 |
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Total liabilities and stockholders equity |
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$ |
376,809 |
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$ |
432,630 |
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The accompanying notes are an integral part of these consolidated financial statements
3
PHARMION CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except for per share amounts)
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2006 |
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2005 |
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2006 |
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2005 |
Net sales |
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$ |
60,366 |
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$ |
56,257 |
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$ |
116,960 |
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$ |
107,994 |
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Operating expenses: |
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Cost of sales, inclusive of
royalties, exclusive of product
rights amortization shown
separately below |
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16,672 |
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15,120 |
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31,885 |
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29,067 |
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Research and development |
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18,386 |
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9,800 |
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33,519 |
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19,263 |
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Acquired in-process research |
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20,480 |
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Selling, general and administrative |
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25,986 |
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22,618 |
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48,498 |
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43,298 |
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Product rights amortization |
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2,451 |
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2,227 |
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4,890 |
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4,466 |
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Total operating expenses |
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63,495 |
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49,765 |
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139,272 |
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96,094 |
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Operating income (loss) |
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(3,129 |
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6,492 |
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(22,312 |
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11,900 |
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Interest and other income, net |
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1,755 |
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1,215 |
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3,416 |
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2,994 |
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Income (loss) before taxes |
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(1,374 |
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7,707 |
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(18,896 |
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14,894 |
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Income tax expense |
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2,140 |
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2,153 |
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4,354 |
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5,071 |
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Net income (loss) |
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$ |
(3,514 |
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$ |
5,554 |
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$ |
(23,250 |
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$ |
9,823 |
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Net income (loss) per common share: |
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Basic |
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$ |
(0.11 |
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$ |
0.17 |
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$ |
(0.73 |
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$ |
0.31 |
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Diluted |
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$ |
(0.11 |
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$ |
0.17 |
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$ |
(0.73 |
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$ |
0.30 |
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Weighted average number of common and
common equivalent shares used to
calculate net income (loss) per common
share: |
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Basic |
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32,007 |
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31,822 |
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31,963 |
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31,814 |
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Diluted |
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32,007 |
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32,856 |
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31,963 |
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32,946 |
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The accompanying notes are an integral part of these consolidated financial statements
4
PHARMION CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Six Months Ended |
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June 30, |
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2006 |
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2005 |
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Operating activities |
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Net income (loss) |
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$ |
(23,250 |
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$ |
9,823 |
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Adjustments to reconcile net income (loss) to net cash
provided by (used in) operating activities: |
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Depreciation and amortization |
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6,079 |
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5,678 |
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Share-based compensation expense |
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1,562 |
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108 |
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Other |
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(171 |
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82 |
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Changes in operating assets and liabilities: |
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Accounts receivable, net |
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(1,102 |
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1 |
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Inventories |
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(1,241 |
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(2,738 |
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Other current assets |
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7,160 |
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(335 |
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Other long-term assets |
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4 |
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21 |
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Accounts payable |
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(985 |
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(2,306 |
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Accrued liabilities |
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(39,226 |
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(3,494 |
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Net cash provided by (used in) operating activities |
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(51,170 |
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6,840 |
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Investing activities |
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Purchases of property and equipment |
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(660 |
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(4,148 |
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Addition to product rights |
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(5,000 |
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Acquisition of business, net of cash acquired |
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(10,072 |
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Purchase of available-for-sale investments |
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(52,141 |
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(111,996 |
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Sale and maturity of available-for-sale investments |
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105,682 |
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64,732 |
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Net cash provided by (used in) investing activities |
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52,881 |
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(66,484 |
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Financing activities |
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Proceeds from exercise of common stock options |
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514 |
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243 |
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Payment of debt obligations |
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(1,073 |
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(2,108 |
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Net cash used in financing activities |
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(559 |
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(1,865 |
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Effect of exchange rate changes on cash and cash equivalents |
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1,675 |
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(3,980 |
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Net increase (decrease) in cash and cash equivalents |
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2,827 |
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(65,489 |
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Cash and cash equivalents at beginning of period |
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90,443 |
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119,658 |
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Cash and cash equivalents at end of period |
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$ |
93,270 |
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$ |
54,169 |
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Non cash items |
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Financed addition to product rights |
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1,870 |
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The accompanying notes are an integral part of these consolidated financial statements
5
PHARMION CORPORATION
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1. BUSINESS OPERATIONS
Pharmion Corporation (the Company) is engaged in the acquisition, development and
commercialization of pharmaceutical products for the treatment of oncology and hematology patients.
The Companys product acquisition and licensing efforts are focused on both development stage
products as well as those approved for marketing. In exchange for distribution and marketing
rights, the Company generally grants the licensor royalties on future sales and, in some cases, up
front cash payments. The Company has acquired the rights to six products, including four that are
currently marketed or sold on a compassionate use or named patient basis, and two products that are
in varying stages of clinical development. The Company has established operations in the United
States, Europe and Australia. Through a distributor network, the Company can reach the hematology
and oncology community in additional countries in the Middle East and Asia.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying unaudited consolidated financial statements of the Company and its
subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles
for interim financial information and pursuant to the rules and regulations of the SEC pertaining
to Form 10-Q. All significant intercompany accounts and transactions have been eliminated in
consolidation. Certain disclosures required for complete financial statements are not included
herein. These statements should be read in conjunction with the consolidated financial statements
and notes thereto included in the Companys 2005 Annual Report on Form 10-K, which has been filed
with the SEC.
In the opinion of management, the unaudited interim financial statements reflect all
adjustments, which include all normal, recurring adjustments necessary to present fairly the
Companys financial position at June 30, 2006, results of operations for the three and six months
ended June 30, 2006 and 2005 and cash flows for the six months ended June 30, 2006 and 2005. The
results of operations for the interim periods are not necessarily indicative of the results to be
expected for the year ending December 31, 2006 or for any other interim period or for any other
future year.
Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the date of the
financial statements, and the reported amounts of net sales and expenses during the reporting
period. Actual results could differ from those estimates or assumptions.
Cash and Cash Equivalents
Cash and cash equivalents consist of money market accounts and overnight deposits. The Company
also considers all highly liquid investments purchased with a maturity of three months or less to
be cash equivalents. Interest income was $3.6 million and $3.0 million for the six months ended
June 30, 2006 and 2005, respectively.
The Company has entered into domestic and international standby letters of credit to guarantee
both current and future commitments of office lease agreements. The aggregate amount outstanding
under the letters of credit was approximately $1.7 million at June 30, 2006 and is secured by an
equivalent amount of restricted cash held in U.S. cash accounts.
Short-term Investments
Short-term investments consist of investment grade government agency auction rate and
corporate debt securities due within one year. Investments with maturities beyond one year are
classified as short-term based on their highly liquid nature and because such investments represent
the investment of cash that is available for current operations. All investments are classified as
available-for-sale and are recorded at market value. Unrealized gains and losses are reflected in
other comprehensive income (loss).
6
Inventories
Inventories consist of raw materials and finished goods and are stated at the lower of cost or
market, cost being determined under the first-in, first-out method. The Company periodically
reviews inventories and any items considered outdated or obsolete are reduced to their estimated
net realizable value. The Company estimates reserves for excess and obsolete inventories based on
inventory levels on hand, future purchase commitments, product expiration dates and current and
forecasted product demand. If an estimate of future product demand suggests that inventory levels
are excessive, then inventories are reduced to their estimated net realizable value.
Inventories at June 30, 2006 and December 31, 2005 consisted of the following (in thousands):
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June 30, |
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December 31, |
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2006 |
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2005 |
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Raw materials |
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$ |
4,529 |
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$ |
3,444 |
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Finished goods |
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8,649 |
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8,028 |
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Total inventories |
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$ |
13,178 |
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$ |
11,472 |
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Long-Lived Assets
Our long-lived assets consist primarily of product rights and property and equipment. In
accordance with Statement of Financial Accounting Standards (SFAS) No. 144 , Accounting for the
Impairment or Disposal of Long-Lived Assets, we evaluate our ability to recover the carrying value
of long-lived assets used in our business, considering changes in the business environment or other
facts and circumstances that suggest their value may be impaired. If this evaluation indicates the
carrying value will not be recoverable, based on the undiscounted expected future cash flows
estimated to be generated by these assets, we reduce the carrying amount to the estimated fair
value.
Goodwill
In association with a business acquisition in 2003 and related contingent payments that were
made in 2004 and 2005, goodwill was created. In accordance with SFAS No. 142, Goodwill and Other
Intangible Assets, the Company does not amortize goodwill. SFAS No. 142 requires the Company to
perform an impairment review of goodwill at least annually. If it is determined that the value of
goodwill is impaired, the Company will record the impairment charge in the statement of operations
in the period it is discovered.
Property and Equipment
Property and equipment are stated at cost. Repairs and maintenance are charged to operations
as incurred, and significant expenditures for additions and improvements are capitalized. Leasehold
improvements are amortized over the economic life of the asset or the lease term, whichever is
shorter. Depreciation and amortization of property and equipment are computed using the
straight-line method based on the following estimated useful lives:
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Estimated Useful Life |
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Computer hardware and software |
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3 years |
Leasehold improvements |
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3-5 years |
Equipment |
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7 years |
Furniture and fixtures |
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10 years |
Revenue Recognition
The Company sells its products to wholesale distributors and, for certain products, directly
to hospitals and clinics. Revenue from product sales is recognized when ownership of the product is
transferred to the customer, the sales price is fixed and determinable, and collectibility is
reasonably assured. Within the U.S. and certain foreign countries, revenue is recognized upon
shipment (freight on board shipping point) since title to the product passes and the customers have
assumed the risks and rewards of ownership. In certain other foreign countries, it is common
practice that ownership transfers upon receipt of product and, accordingly, in these circumstances
revenue is recognized upon delivery (freight on board destination) when title to the product
effectively transfers.
7
The Company records allowances for product returns, chargebacks, rebates and prompt pay
discounts at the time of sale, and reports revenue net of such amounts. In determining allowances
for product returns, chargebacks and rebates, the Company must make significant judgments and
estimates. For example, in determining these amounts, the Company estimates end-customer demand,
buying patterns by end-customers and group purchasing organizations from wholesalers and the levels
of inventory held by wholesalers. Making these determinations involves estimating whether trends in
past buying patterns will predict future product sales.
A description of the Companys allowances requiring accounting estimates, and the specific
considerations the Company uses in estimating these amounts, is as follows:
Product returns. The Companys customers have the right to return any unopened product during
the 18-month period beginning 6 months prior to the labeled expiration date and ending 12 months
past the labeled expiration date. As a result, in calculating the allowance for product returns,
the Company must estimate the likelihood that product sold to wholesalers might remain in its
inventory or in end-customers inventories to within 6 months of expiration and analyze the
likelihood that such product will be returned within 12 months after expiration.
To estimate the likelihood of product remaining in wholesalers inventory to within six months
of its expiration, the Company relies on information from its wholesalers regarding their inventory
levels, measured end-customer demand as reported by third party sources, and on internal sales
data. The Company believes the information from its wholesalers and third party sources is a
reliable indicator of trends, but the Company is unable to verify the accuracy of such data
independently. The Company also considers its wholesalers past buying patterns, estimated
remaining shelf life of product previously shipped and the expiration dates of product currently
being shipped.
Since the Company does not have the ability to track a specific returned product back to its
period of sale, the product returns allowance is primarily based on estimates of future product
returns over the period during which customers have a right of return, which is in turn based in
part on estimates of the remaining shelf life of products when sold to customers. Future product
returns are estimated primarily based on historical sales and return rates.
At June 30, 2006 and December 31, 2005, the allowance for returns was $0.7 million and $0.6
million, respectively.
Chargebacks and rebates. Although the Company sells its products in the U.S. primarily to
wholesale distributors, the Company typically enters into agreements with certain governmental
health insurance providers, hospitals, clinics, and physicians, either directly or through group
purchasing organizations acting on behalf of their members, to allow purchase of Company products
at a discounted price and/or to receive a volume-based rebate. The Company provides a credit, or
chargeback, to the wholesaler representing the difference between the wholesalers acquisition list
price and the discounted price paid to the wholesaler by the end-customer. Rebates are paid
directly to the end-customer, group purchasing organization or government insurer.
As a result of these contracts, at the time of product shipment the Company must estimate the
likelihood that product sold to wholesalers might be ultimately sold by the wholesaler to a
contracting entity or group purchasing organization. For certain end-customers, the Company must
also estimate the contracting entitys or group purchasing organizations volume of purchases.
The Company estimates its chargeback allowance based on its estimate of the inventory levels
of its products in the wholesaler distribution channel that remain subject to chargebacks, and
specific contractual and historical chargeback rates. The Company estimates its Medicaid rebate and
commercial contractual rebate accruals based on estimates of usage by rebate-eligible customers,
estimates of the level of inventory of its products in the distribution channel that remain
potentially subject to those rebates, and terms of its contractual and regulatory obligations.
At June 30, 2006 and December 31, 2005, the allowance/accrual for chargebacks and rebates was
$2.9 million and $2.6 million, respectively.
Prompt pay discounts. As incentive to expedite cash flow, the Company offers some customers a
prompt pay discount whereby if they pay their accounts within 30 days of product shipment, they may
take a 2% discount. As a result, the Company must estimate the likelihood that its customers will
take the discount at the time of product shipment. In estimating the allowance for prompt pay
discounts, the Company relies on past history of its customers payment patterns to determine the
likelihood that future prompt pay discounts will be taken and for those customers that historically
take advantage of the prompt pay discount, the Company increases the allowance accordingly.
At June 30, 2006 and December 31, 2005, the allowance for prompt pay discounts was $0.4
million and $0.5 million, respectively.
8
The Company has adjusted the allowances for product returns, chargebacks and rebates and
prompt pay discounts in the past based on differences between its estimates and its actual
experience, and the Company will likely be required to make adjustments to these allowances in the
future. The Company continually monitors the allowances and makes adjustments when the Company
believes actual experience may differ from estimates.
Cost of Sales
Cost of sales includes the cost of product sold, royalties due on the sales of the products
and the distribution and logistics costs related to selling the products. Cost of sales does not
include product rights amortization expense as it is disclosed separately.
Risks and Uncertainties
The Company is subject to risks common to companies in the pharmaceutical industry including,
but not limited to, uncertainties related to regulatory approvals, dependence on key products,
dependence on key customers and suppliers, and protection of proprietary rights.
Translation of Foreign Currencies
The functional currencies of the Companys foreign subsidiaries are the local currencies,
primarily the British pound sterling, euro and Swiss franc. In accordance with SFAS No. 52,
Foreign Currency Translation, assets and liabilities are translated using the current exchange
rate as of the balance sheet date. Income and expenses are translated using a weighted average
exchange rate over the period ending on the balance sheet date. Adjustments resulting from the
translation of the financial statements of the Companys foreign subsidiaries into U.S. dollars are
excluded from the determination of net income (loss) and are accumulated in a separate component of
stockholders equity. Foreign exchange transaction gains and losses, which to date have not been
significant, are included in the results of operations.
Research and Development
Research and development costs include salaries, benefits and other personnel related expenses
as well as fees paid to third parties for clinical development and regulatory services. Such costs
are expensed as incurred.
Acquired In-Process Research
In January 2006, the Company entered into a license and collaboration agreement for the
research, development and commercialization of MethylGene Inc.s HDAC inhibitors, including its
lead compound MGCD0103, in North America, Europe, the Middle East and certain other markets. Under
the terms of the agreement, the Company made up front payments to MethylGene totaling $25.0
million, including $20.5 million for a license fee and the remainder as an equity investment in
MethylGene common shares. The $20.5 million license fee was immediately expensed as acquired
in-process research as MGCD0103 has not yet achieved regulatory approval for marketing and, absent
obtaining such approval, has no alternative future use.
Concentration of Credit Risk
Financial instruments which potentially subject the Company to concentrations of credit risk
are primarily cash and cash equivalents, short-term investments and accounts receivable. The
Company maintains its cash and investment balances in the form of money market accounts, debt and
equity securities and overnight deposits with financial institutions that management believes are
creditworthy. The Company has no financial instruments with off-balance-sheet risk of accounting
loss.
The Companys products are sold both to wholesale distributors and directly to hospitals and
clinics. Ongoing credit evaluations of customers are performed and collateral is generally not
required. The Company maintains a reserve for potential credit losses, and such losses have been
within managements expectations. Net revenues generated as a percent of total consolidated net
revenues, for three largest customers in the U.S. were as follows for the six months ended June 30,
2006 and 2005:
9
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, |
|
|
2006 |
|
2005 |
Oncology Supply |
|
|
19 |
% |
|
|
16 |
% |
Cardinal Health |
|
|
12 |
% |
|
|
15 |
% |
McKesson Corporation |
|
|
11 |
% |
|
|
15 |
% |
Net sales generated from international customers were individually less than 5% of
consolidated net sales.
Share-Based Compensation
On January 1, 2006, the Company adopted SFAS No. 123R, Share-Based Payment which establishes
accounting for share-based awards exchanged for employee services and requires companies to expense
the estimated fair value of these awards over the requisite employee service period. Under SFAS No.
123R, share-based compensation cost is determined at the grant date using an option pricing model.
The value of the award that is ultimately expected to vest is recognized as expense on a straight
line basis over the employees requisite service period. The Company adopted SFAS No. 123R using
the modified prospective method. Under this method, prior periods are not restated for comparative
purposes. Rather, compensation for awards outstanding, but not vested, at the date of adoption
using the grant date value determined under SFAS No. 123, Accounting for Share-Based
Compensation, as well as new awards granted after the date of adoption using the grant date value
under SFAS No. 123R will be recognized as expense in the statement of operations over the remaining
service period of the award.
The Company has estimated the fair value of each award using the Black-Scholes option pricing
model, which was developed for use in estimating the value of traded options that have no vesting
restrictions and that are freely transferable. The Black-Scholes model considers, among other
factors, the expected life of the award and the expected volatility of the Companys stock price.
On November 10, 2005 the Financial Accounting Standards Board issued Staff Position No. FAS
123R-3, Transition Election Related to Accounting for Tax Effects of Share-Based Payment Awards
(FAS 123R-3). The Company has elected to adopt the alternative transition method provided in FAS
123R-3 for calculating the tax effects of stock-based compensation pursuant to SFAS No. 123R. The
alternative transition method includes a simplified method to establish the beginning balance of
the additional paid-in capital pool related to the tax effects of employee stock-based compensation
expense, which is available to absorb tax deficiencies recognized subsequent to the adoption of
SFAS No. 123R.
Prior to the adoption of SFAS No. 123R, the Company accounted for share-based payment awards
to employees and directors in accordance with APB 25 as allowed under SFAS No. 123. In accordance
with APB 25, the Company recorded deferred compensation in connection with stock options granted in
2003 under the intrinsic value method. The amount of deferred compensation was equal to the
difference between the exercise price of the stock options granted to employees and the higher fair
market value of the underlying stock at the date of grant. The deferred compensation was recognized
ratably over the vesting period of these options as stock-based compensation expense up to the
adoption of SFAS No. 123R. Upon adoption, the unamortized deferred compensation balance was
eliminated with a corresponding reduction to additional paid in capital.
Adoption of SFAS No. 123R
Employee share-based compensation expense recognized in 2006 was calculated based on awards
ultimately expected to vest and has been reduced for estimated forfeitures at an expected rate of
15 percent. SFAS No. 123R requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those estimates. The
post-vesting forfeiture rate was based on the Companys historical option cancellations. There was
no impact to cash flows or financial position upon adoption.
10
Share-based compensation expense recognized under SFAS No. 123R was (in thousands, except
for per share data):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2006 |
|
|
2006 |
|
Research and development |
|
$ |
215 |
|
|
$ |
440 |
|
Selling, general and administrative |
|
|
572 |
|
|
|
1,122 |
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
787 |
|
|
$ |
1,562 |
|
|
|
|
|
|
|
|
Share-based compensation expense, per common share: |
|
|
|
|
|
|
|
|
Basic and Diluted |
|
$ |
0.02 |
|
|
$ |
0.05 |
|
|
|
|
|
|
|
|
Pro Forma Information for Periods Prior to Adoption of SFAS No. 123R
The following pro forma net income and earnings per share were determined as if we had
accounted for employee share-based compensation for our employee stock plans under the fair value
method prescribed by SFAS No. 123. (in thousands, except for per share data):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Six Months |
|
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
|
2005 |
|
|
2005 |
|
Net income as reported |
|
$ |
5,554 |
|
|
$ |
9,823 |
|
Plus: share-based compensation recognized under the intrinsic value method |
|
|
52 |
|
|
|
108 |
|
Less: share-based compensation under fair value method |
|
|
(1,891 |
) |
|
|
(3,872 |
) |
|
|
|
|
|
|
|
Pro forma net income |
|
$ |
3,715 |
|
|
$ |
6,059 |
|
|
|
|
|
|
|
|
Net income per common share: |
|
|
|
|
|
|
|
|
Basic, as reported |
|
$ |
0.17 |
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
Basic, pro forma |
|
$ |
0.12 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
Diluted, as reported |
|
$ |
0.17 |
|
|
$ |
0.30 |
|
|
|
|
|
|
|
|
Diluted, pro forma |
|
$ |
0.11 |
|
|
$ |
0.18 |
|
|
|
|
|
|
|
|
Valuation assumptions used to determine fair value of share based compensation
The employee share-based compensation expense recognized under SFAS No. 123R and presented in
the pro forma disclosure required under SFAS No. 123 was determined using the Black-Scholes option
valuation model. Option valuation models require the input of subjective assumptions and these
assumptions can vary over time. The weighted-average assumptions used include:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Six Months |
|
|
Ended June 30, |
|
Ended June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.8 |
% |
|
|
3.9 |
% |
|
|
4.7 |
% |
|
|
3.8 |
% |
Expected stock price volatility |
|
|
41 |
% |
|
|
50 |
% |
|
|
41 |
% |
|
|
58 |
% |
Expected option term until exercise |
|
4.1 years |
|
|
4.0 years |
|
|
4.1 years |
|
|
4.0 years |
|
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
|
|
0 |
% |
The risk free interest rate was derived from the US Treasury yield in effect at the time of
grant with terms similar to the contractual life of the option. The expected life of the options
was estimated using peer data of companies in the life science industry with similar equity plans.
The weighted-average fair value per share was $6.90 and $9.70 for stock options granted in the
three months ended June 30, 2006 and 2005, respectively. The weighted-average fair value per share
was $6.72 and $15.92 for stock options granted in the six months ended June 30, 2006 and 2005,
respectively.
As of June 30, 2006, there was approximately $6.7 million of total unrecognized compensation
cost related to nonvested stock options granted under the Companys plans. This cost is expected
to be recognized over a weighted average period of 2.9 years.
11
A summary of the option activity for the six months ended June 30, 2006 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Aggregate Intrinsic |
|
|
|
|
|
|
|
Weighted Average |
|
|
Contractual Term |
|
|
Value |
|
|
|
Number of Shares |
|
|
Exercise Price |
|
|
(years) |
|
|
(in thousands) |
|
Outstanding at December 31, 2005 |
|
|
3,386,858 |
|
|
$ |
20.60 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
167,325 |
|
|
$ |
19.02 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(138,576 |
) |
|
$ |
3.71 |
|
|
|
|
|
|
|
|
|
Terminated |
|
|
(496,417 |
) |
|
$ |
32.51 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, June 30, 2006 |
|
|
2,919,190 |
|
|
$ |
19.29 |
|
|
|
5.22 |
|
|
$ |
11,607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, June 30, 2006 |
|
|
2,378,848 |
|
|
$ |
19.38 |
|
|
|
5.03 |
|
|
$ |
10,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, June 30, 2006 |
|
|
1,714,975 |
|
|
$ |
19.49 |
|
|
|
4.60 |
|
|
$ |
10,227 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
On May 24, 2006, the Company completed its previously announced Offer to Exchange Outstanding
Options to Purchase Common Stock (the Offer) under which the Company accepted for exchange
certain outstanding options to purchase the Companys common stock for cancellation and issued new
options to purchase a lesser number of shares of common stock at an exercise price per share equal
to the fair market value on the closing date of the Offer. The Companys executive officers and
directors were not eligible to participate in the Offer. As a result of the Offer, the Company
accepted for cancellation, options to purchase an aggregate of 282,940 shares of common stock,
versus 286,950 shares as reported on May 24, 2006. The Company issued new options to purchase an
aggregate of 99,825 shares of common stock, versus 101,425 shares previously reported on May 24,
2006.
The intrinsic value of options exercised during the six months ended June 30, 2006 and 2005
was $2.1 million and $1.6 million, respectively.
The following table summarizes the options that are outstanding and exercisable at June 30,
2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Range of Exercise |
|
Number of Shares |
|
Contractual Term |
|
Weighted Average |
|
Number of Shares |
|
Contractual Term |
|
Weighted Average |
Prices |
|
Outstanding |
|
(years) |
|
Exercise Price |
|
Outstanding |
|
(years) |
|
Exercise Price |
$0.40 to 2.40 |
|
|
705,339 |
|
|
|
3.42 |
|
|
$ |
1.94 |
|
|
|
638,742 |
|
|
|
3.41 |
|
|
$ |
1.91 |
|
$2.41 to 18.20 |
|
|
412,936 |
|
|
|
4.94 |
|
|
$ |
14.80 |
|
|
|
189,486 |
|
|
|
4.44 |
|
|
$ |
14.04 |
|
$18.21 to 18.49 |
|
|
485,000 |
|
|
|
6.44 |
|
|
$ |
18.49 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
$18.50 to 21.54 |
|
|
424,270 |
|
|
|
5.91 |
|
|
$ |
20.98 |
|
|
|
290,453 |
|
|
|
5.35 |
|
|
$ |
21.36 |
|
$21.55 to 35.15 |
|
|
461,927 |
|
|
|
5.87 |
|
|
$ |
27.57 |
|
|
|
179,076 |
|
|
|
5.43 |
|
|
$ |
31.91 |
|
$35.16 to 52.27 |
|
|
429,718 |
|
|
|
5.68 |
|
|
$ |
42.43 |
|
|
|
417,218 |
|
|
|
5.60 |
|
|
$ |
42.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
2,919,190 |
|
|
|
5.22 |
|
|
$ |
19.29 |
|
|
|
1,714,975 |
|
|
|
4.60 |
|
|
$ |
19.49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents a summary of the Companys non-vested shares of
restricted stock granted as of June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
Number of Shares |
|
|
Fair Value at Grant Date |
|
Non-vested at December 31, 2005 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
50,850 |
|
|
$ |
17.90 |
|
Vested |
|
|
|
|
|
$ |
|
|
Terminated |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Non-vested, June 30, 2006 |
|
|
50,850 |
|
|
$ |
17.90 |
|
|
|
|
|
|
|
|
The restricted stock grants vest over a four year period, with 25% of the award vesting on the
first year anniversary date. Thereafter, the award vests in equal installments of 6.25% on a
quarterly basis. Expense of approximately $55,000 was recognized in the six months ended June 30,
2006 with the remaining expense of approximately $0.9 million to be recognized over a weighted
average period of 3.8 years.
12
NOTE 3. NET INCOME (LOSS) PER COMMON SHARE
The Company applies SFAS No. 128, Earnings per Share, which establishes standards for
computing and presenting earnings per share. Basic net income (loss) per common share is calculated
by dividing net income (loss) applicable to common stockholders by the weighted average number of
unrestricted common shares outstanding for the period. Diluted net loss per common share is the
same as basic net loss per common share for the three and six months ended June 30, 2006, since the
effects of potentially dilutive securities were antidilutive for that period. Diluted net income
per common share is calculated by dividing net income applicable to common stockholders by the
weighted average number of common shares outstanding for the period increased to include all
additional common shares that would have been outstanding assuming the issuance of potentially
dilutive common shares. Potential incremental common shares include shares of common stock issuable
upon exercise of stock options outstanding during the periods presented.
A reconciliation of the weighted average number of shares used to calculate basic and diluted
net income (loss) per common share is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Basic |
|
|
32,007 |
|
|
|
31,822 |
|
|
|
31,963 |
|
|
|
31,814 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
1,034 |
|
|
|
|
|
|
|
1,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
32,007 |
|
|
|
32,856 |
|
|
|
31,963 |
|
|
|
32,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total number of potential common shares excluded from diluted earnings per share
computation because they were anti-dilutive was 1,740,136 and 1,048,356 for the three months ended
June 30, 2006 and 2005, respectively, and 1,967,549 and 921,929 for the six months ended June 30,
2006 and 2005, respectively.
NOTE 4. LICENSE AGREEMENTS AND PRODUCT RIGHTS
The cost value and accumulated amortization associated with the Companys product rights was
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2006 |
|
|
As of December 31, 2005 |
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
Amount |
|
|
Amortization |
|
|
Amount |
|
|
Amortization |
|
Amortized product rights: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thalidomide |
|
$ |
102,731 |
|
|
$ |
(13,831 |
) |
|
$ |
101,837 |
|
|
$ |
(9,690 |
) |
Refludan |
|
|
12,208 |
|
|
|
(4,234 |
) |
|
|
12,208 |
|
|
|
(3,560 |
) |
Innohep |
|
|
5,000 |
|
|
|
(2,000 |
) |
|
|
5,000 |
|
|
|
(1,750 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product rights |
|
$ |
119,939 |
|
|
$ |
(20,065 |
) |
|
$ |
119,045 |
|
|
$ |
(15,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Thalidomide
In 2001, the Company licensed rights relating to the development and commercial use of
thalidomide from Celgene Corporation and separately entered into an exclusive supply agreement for
thalidomide with Celgene U.K. Manufacturing II Limited (formerly known as Penn T Limited), or
CUK, which was acquired by Celgene in 2004. Under the agreements, as amended in December 2004, the
territory licensed from Celgene is for all countries other than the United States, Canada, Mexico,
Japan and all provinces of China (except Hong Kong). The Company pays (i) Celgene a royalty/license
fee of 8% on the Companys net sales of thalidomide under the terms of the license agreements, and
(ii) CUK product supply payments equal to 15.5% of the Companys net sales of thalidomide under the
terms of the product supply agreement. The agreements with Celgene and CUK each have a ten-year
term commencing on the date of receipt of the Companys first regulatory approval for thalidomide
in the United Kingdom.
13
In December 2004, the Company amended its thalidomide agreements with Celgene and CUK to
reduce the thalidomide product supply payment, expand the Companys licensed territory, and
eliminate certain license termination rights held by Celgene. The Company paid Celgene a one-time
payment of $80 million in exchange for (i) the reduction in the cost of product supply from 28.0%
of net sales to 15.5% of net sales, (ii) the addition of Korea, Hong Kong, and Taiwan to the
Companys licensed territory and, (iii) elimination of Celgenes right to terminate the license
agreement in the event the Company has not obtained a marketing authorization approval for
thalidomide in the United Kingdom by November 2006. The $80 million payment was capitalized as part
of the thalidomide product rights and is being amortized over the remaining period the Company
expects to generate significant thalidomide sales, approximately 12 years from December 31, 2005.
The Company has also committed to provide funding to support further clinical development
studies of thalidomide sponsored by Celgene. Under these agreements, the Company has paid Celgene
$12.0 million through June 30, 2006 and will provide payments of $1.3 million over the last six
months of 2006 and $2.7 million in 2007.
In connection with a third party patent dispute associated with thalidomide, the Company
agreed to make a $5.0 million payment in 2005, with two $1.0 million payments due in 2006 and 2007.
Accordingly, these amounts increased the thalidomide product rights.
In connection with the 2003 acquisition of Laphal, the Company acquired rights to Laphals
formulation of thalidomide. The portion of the purchase price allocated to thalidomide has been
included in product rights, net on the accompanying balance sheet.
Vidaza
In 2001, the Company licensed worldwide rights to Vidaza (azacitidine) from Pharmacia & Upjohn
Company, now part of Pfizer, Inc. Under terms of the license agreement, the Company is responsible
for all costs to develop and market Vidaza and the Company pays Pfizer a royalty of 8% to 20% of
Vidaza net sales. No up-front or milestone payments have been or will be made to Pfizer. The
license has a term extending for the longer of the last to expire of valid patent claims in any
given country or ten years from the first commercial sale of the product in a particular country.
Satraplatin
In December 2005, the Company entered into a co-development and license agreement with GPC
Biotech for satraplatin, an oral platinum-based compound in advanced clinical development. Under
the terms of the agreement, the Company obtained exclusive commercialization rights for Europe,
Turkey, the Middle East, Australia and New Zealand, while GPC Biotech retained rights to the North
American market and all other territories. In January 2006, the Company made an up front payment of
$37.1 million to GPC Biotech, including a $21.2 million reimbursement for satraplatin clinical
development costs incurred prior to the agreement and $15.9 million for funding of ongoing and
certain future clinical development to be conducted jointly by the Company and GPC Biotech. The
Company and GPC Biotech will pursue a joint development plan to evaluate development activities for
satraplatin in a variety of tumor types and will share global development costs, for which the
Company has made an additional commitment of $22.2 million, in addition to the $37.1 million in
initial payments. The Company could also pay GPC Biotech $30.5 million based on the achievement of
certain regulatory filing and approval milestones, and up to an additional $75 million for up to
five subsequent European approvals for additional indications. GPC Biotech will also receive
royalties on sales of satraplatin in the Companys territories at rates of 26% to 30% on annual
sales up to $500 million, and 34% on annual sales over $500 million. Finally, the Company could pay
GPC Biotech sales milestones totaling up to $105 million, based on the achievement of significant
annual sales levels in its territories.
MethylGene
In January 2006, the Company entered into a license and collaboration agreement for the
research, development and commercialization of MethylGene Inc.s HDAC inhibitors, including its
lead compound MGCD0103, in North America, Europe, the Middle East and certain other markets. Under
the terms of the agreement, the Company made up front payments to MethylGene totaling $25 million,
including a $20.5 million license fee and the remainder as an equity investment in MethylGene
common shares. The common shares were purchased at a subscription price of CDN $3.125 which
represented a 25% premium over the market closing price on January 27, 2006. Subsequent to the
transaction, the Company had a 7.8% ownership in MethylGene. The ownership interest was initially
recorded at fair value and is now accounted for as a long-term available-for-sale security, which
is classified in other assets.
MGCD0103 is currently in Phase I/II development and has a number of clinical studies underway.
Under the terms of the license agreement, MethylGene will initially fund 40% of the preclinical and
clinical development for MGCD0103 (and any additional second
14
generation compounds) required, to obtain marketing approval in North America, while the
Company will fund 60% of such costs. MethylGene will receive royalties on net sales in North
America ranging from 13% to 21%. The royalty rate paid to MethylGene will be determined based upon
the level of annual net sales achieved in North America and the length of time development costs
are funded by MethylGene. MethylGene will have an option, at its sole discretion, as long as it
continues to fund development, to co-promote approved products and, in lieu of receiving royalties,
to share the resulting net profits equally with the Company. If MethylGene exercises its right, at
its sole discretion, to discontinue development funding, the Company will be responsible for 100%
of development costs incurred thereafter.
In all other licensed territories, which include Europe, the Middle East, Turkey, Australia,
New Zealand, South Africa and certain countries in Southeast Asia, the Company is responsible for
development and commercialization costs and MethylGene will receive a royalty on net sales in those
markets at a rate of 10% to 13% based on annual net sales.
Refludan
In May 2002, the Company entered into agreements to acquire the exclusive right to market and
distribute Refludan in all countries outside the U.S. and Canada. These agreements, as amended in
August 2003, transferred all marketing authorizations and product registrations for Refludan in the
individual countries within the Companys territories. The Company has paid Schering an aggregate
of $13 million to date and has capitalized to product rights $12.2 million, which is being
amortized over a 10 year period during which the Company expects to generate revenue. Additional
payments of up to $7.5 million will be due Schering upon achievement of certain milestones. Because
such payments are contingent upon future events, they are not reflected in the accompanying
financial statements. In addition, the Company pays Schering a royalty of 14% of net sales of
Refludan until the aggregate royalty payments total $12.0 million measured from January 2004. At
that time, the royalty rate will be reduced to 6%.
Innohep
In June 2002, the Company entered into a ten-year agreement with LEO Pharma A/S for the
license of the low molecular weight heparin, Innohep. Under the terms of the agreement, the Company
acquired an exclusive right and license to market and distribute Innohep in the United States. On
the closing date the Company paid $5 million for the license, which was capitalized as product
rights and is being amortized over a 10 year period in which the Company expects to generate
significant sales. In addition, the Company is obligated to pay LEO Pharma royalties at the rate of
30% of net sales on annual net sales of up to $20 million and at the rate of 35% of net sales on
annual net sales exceeding $20 million, less in each case the Companys purchase price from LEO
Pharma of the units of product sold. Furthermore, the agreement contains a minimum net sales clause
that is effective for two consecutive two-year periods. If the Company does not achieve these
minimum sales levels for two consecutive years, it has the right to pay LEO Pharma additional
royalties up to the amount LEO Pharma would have received had the Company achieved these net sales
levels. If the Company opts not to make the additional royalty payment, LEO Pharma has the right to
terminate the license agreement. The second of the two-year terms will conclude on December 31,
2006.
NOTE 5. OTHER COMPREHENSIVE INCOME (LOSS)
The Company reports comprehensive income (loss) in accordance with the provisions of SFAS No.
130, Reporting Comprehensive Income. Comprehensive income (loss) includes all changes in equity
for cumulative translation adjustments resulting from the consolidation of foreign subsidiaries and
unrealized gains and losses on available-for-sale securities.
Total comprehensive income (loss) for the three and six months ended June 30, 2006 and 2005
was (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Net income (loss) |
|
$ |
(3,514 |
) |
|
$ |
5,554 |
|
|
$ |
(23,250 |
) |
|
$ |
9,823 |
|
Other comprehensive income (loss), net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation gain (loss) |
|
|
2,962 |
|
|
|
(4,863 |
) |
|
|
4,790 |
|
|
|
(7,291 |
) |
Unrealized gain (loss) on available-for-sale securities |
|
|
(1,070 |
) |
|
|
103 |
|
|
|
476 |
|
|
|
55 |
|
|
|
|
Comprehensive income (loss) |
|
$ |
(1,622 |
) |
|
$ |
794 |
|
|
$ |
(17,984 |
) |
|
$ |
2,587 |
|
|
|
|
15
The foreign currency translation amounts relate to the operating results of our foreign
subsidiaries.
NOTE 6. INCOME TAXES
Income taxes have been provided for using the liability method in accordance with SFAS No.
109, Accounting for Income Taxes. The provision for income taxes reflects managements estimate
of the effective tax rate expected to be applicable for the full fiscal year for each country in
which we do business. This estimate is re-evaluated by management each quarter based on the
Companys estimated tax expense for the year. Income tax expense for the three and six months ended
June 30, 2006 and 2005 resulted primarily from taxable income generated in certain foreign
jurisdictions.
NOTE 7. GEOGRAPHIC INFORMATION
Domestic and foreign financial information for the three and six months ended June 30, 2006
and 2005 was (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
United States net sales |
|
$ |
36,796 |
|
|
$ |
32,066 |
|
|
$ |
70,583 |
|
|
$ |
60,981 |
|
Foreign entities net sales |
|
|
23,570 |
|
|
|
24,191 |
|
|
|
46,377 |
|
|
|
47,013 |
|
|
|
|
Total net sales |
|
$ |
60,366 |
|
|
$ |
56,257 |
|
|
$ |
116,960 |
|
|
$ |
107,994 |
|
|
|
|
United States operating income (loss) |
|
$ |
315 |
|
|
$ |
4,294 |
|
|
$ |
(7,578 |
) |
|
$ |
8,981 |
|
Foreign entities operating income (loss) |
|
|
(3,444 |
) |
|
|
2,198 |
|
|
|
(14,734 |
) |
|
|
2,919 |
|
|
|
|
Total operating income (loss) |
|
$ |
(3,129 |
) |
|
$ |
6,492 |
|
|
$ |
(22,312 |
) |
|
$ |
11,900 |
|
|
|
|
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Managements Discussion and Analysis of Financial Condition and Results of Operations should
be read in conjunction with the condensed financial statements and the related notes that appear
elsewhere in this document. This Quarterly Report on Form 10-Q should also be read in conjunction with the
Companys Annual Report on Form 10-K for the fiscal year ended December 31, 2005.
FORWARD-LOOKING STATEMENTS
All statements, trend analysis and other information contained in this Form 10-Q that are not
historical in nature are forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements include, without limitation,
discussion relative to markets for our products and trends in sales, gross margins and anticipated
expense levels, as well as other statements including words such as anticipate, believe,
plan, estimate, expect and intend and other similar expressions. All statements regarding
our expected financial position and operating results, business strategy, financing plans, forecast
trends relating to our industry are forward-looking statements. These forward-looking statements
are subject to business and economic risks and uncertainties, and our actual results of operations
may differ materially from those contained in the forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those mentioned in the
discussion below and the factors set forth under Risk
Factors below and in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2005.
As a result, you should not place undue reliance on these forward-looking statements. We undertake
no obligation to revise these forward-looking statements to reflect future events or developments.
Overview
We are a global pharmaceutical company focused on acquiring, developing and commercializing
innovative products for the treatment of hematology and oncology patients. We have established our
own regulatory, development and sales and marketing organizations covering the U.S., Europe and
Australia. We have also developed a distributor network to cover the hematology and oncology
markets in numerous additional countries throughout Europe, the Middle East and Asia. To date, we
have acquired the rights to six products, including four that are currently marketed or sold on a
compassionate use or named patient basis, and two products that are in varying stages of
development.
16
In May 2004, Vidaza® was approved for marketing in the U.S. and we commenced sales of the
product in July 2004. Pending positive data from an ongoing Phase III/IV study, we plan to file for
marketing approval in the European Union (E.U.) in 2007. Until Vidaza is approved, we intend to
sell Vidaza on a compassionate use and named patient basis throughout the major markets in the E.U.
We have filed for approval to market Vidaza in certain other international markets and these
submissions are under review by the respective regulatory authorities.
Thalidomide Pharmion 50mg(tm) is being sold by us on a compassionate use or named patient
basis in Europe and other international markets while we pursue marketing authorization in those
markets. In addition, we sell Innohep® in the U.S. and Refludan® in Europe and other international
markets.
In December 2005, we entered into a co-development and license agreement with GPC Biotech for
satraplatin, an oral platinum-based compound in advanced clinical trials. Under the terms of the
agreement, we obtained exclusive commercialization rights for Europe, Turkey, the Middle East,
Australia and New Zealand. Enrollment in a Phase III study examining satraplatin as a second line
treatment for hormone refractory prostate cancer was completed in the fourth quarter of 2005 and
data from this study is expected to be available in late 2006.
In January 2006, we entered into a license and collaboration agreement with MethylGene for the
research, development and commercialization of the oncology applications of MethylGenes histone
deacetylase (HDAC) inhibitors in North America, Europe, the Middle East and certain other
international markets, including MGCD0103, MethylGenes lead HDAC inhibitor, which is currently in
several Phase I and Phase II clinical trials.
With our combination of regulatory, development and commercial capabilities, we intend to
continue to build a balanced portfolio of approved and pipeline products targeting the hematology
and oncology markets.
Critical Accounting Policies
Revenue Recognition
We sell our products to wholesale distributors and, for certain products, directly to
hospitals and clinics. Revenue from product sales is recognized when ownership of the product is
transferred to the customer, the sales price is fixed and determinable, and collectibility is
reasonably assured. Within the U.S. and certain foreign countries, revenue is recognized upon
shipment (freight on board shipping point) since title to the product passes and the customers have assumed the risks
and rewards of ownership. In certain other foreign countries, it is common practice that ownership
transfers upon receipt of product and, accordingly, in these circumstances revenue is recognized
upon delivery (freight on board destination) when title to the product effectively transfers.
We record allowances for product returns, chargebacks, rebates and prompt pay discounts at the
time of sale, and report revenue net of such amounts. In determining allowances for product
returns, chargebacks and rebates, we must make significant judgments and estimates. For example, in
determining these amounts, we estimate end-customer demand, buying patterns by end-customers and
group purchasing organizations from wholesalers and the levels of inventory held by wholesalers.
Making these determinations involves estimating whether trends in past buying patterns will predict
future product sales.
A description of our allowances requiring accounting estimates, and the specific
considerations we use in estimating these amounts, are as follows:
Product returns. Our customers have the right to return any unopened product during the
18-month period beginning 6 months prior to the labeled expiration date and ending 12 months past
the labeled expiration date. As a result, in calculating the allowance for product returns, we must
estimate the likelihood that product sold to wholesalers might remain in its inventory or in
end-customers inventories to within 6 months of expiration and analyze the likelihood that such
product will be returned within 12 months after expiration.
To estimate the likelihood of product remaining in wholesalers inventory to within six months
of its expiration, we rely on information from our wholesalers regarding their inventory levels,
measured end-customer demand as reported by third party sources, and on internal sales data. We
believe the information from our wholesalers and third party sources is a reliable indicator of
trends, but we are unable to verify the accuracy of such data independently. We also consider our
wholesalers past buying patterns, estimated remaining shelf life of product previously shipped and
the expiration dates of product currently being shipped.
17
Since we do not have the ability to track a specific returned product back to its period of
sale, the product returns allowance is primarily based on estimates of future product returns over
the period during which customers have a right of return, which is in turn based in part on
estimates of the remaining shelf life of products when sold to customers. Future product returns
are estimated primarily based on historical sales and return rates.
The allowance for returns was $0.7 million at June 30, 2006 and $0.6 million at December 31,
2005.
Chargebacks and rebates. Although we sell our products in the U.S. primarily to wholesale
distributors, we typically enter into agreements with certain governmental health insurance
providers, hospitals, clinics, and physicians, either directly or through group purchasing
organizations acting on behalf of their members, to allow purchase of our products at a discounted
price and/or to receive a volume-based rebate. We provide a credit to the wholesaler, or a
chargeback, representing the difference between the wholesalers acquisition list price and the
discounted price paid to the wholesaler by the end-customer. Rebates are paid directly to the
end-customer, group purchasing organization or government insurer.
As a result of these contracts, at the time of product shipment we must estimate the
likelihood that product sold to wholesalers might be ultimately sold by the wholesaler to a
contracting entity or group purchasing organization. For certain end-customers, we must also
estimate the contracting entitys or group purchasing organizations volume of purchases.
We estimate our chargeback allowance based on our estimate of the inventory levels of our
products in the wholesaler distribution channel that remain subject to chargebacks, and specific
contractual and historical chargeback rates. We estimate our Medicaid rebate and commercial
contractual rebate accruals based on estimates of usage by rebate-eligible customers, estimates of
the level of inventory of our products in the distribution channel that remain potentially subject
to those rebates, and terms of our contractual and regulatory obligations.
The allowance/accrual for chargebacks and rebates was $2.9 million at June 30, 2006 and $2.6
million at December 31, 2005.
Prompt pay discounts. As incentive to expedite cash flow, we offer some customers a prompt pay
discount whereby if they pay their accounts within 30 days of product shipment, they may take a 2%
discount. As a result, we must estimate the likelihood that our customers will take the discount at
the time of product shipment. In estimating the allowance for prompt pay discounts, we rely on past
history of our customers payment patterns to determine the likelihood that future prompt pay
discounts will be taken and for those customers that historically take advantage of the prompt pay
discount, we increase the allowance accordingly.
The allowance for prompt pay discounts was $0.4 million at June 30, 2006 and $0.5 million at
December 31, 2005.
We have adjusted the allowances for product returns, chargebacks and rebates and prompt pay
discounts in the past based on differences between our estimates and our actual experience, and we
will likely be required to make adjustments to these allowances in the future. We continually
monitor the allowances and make adjustments when we believe actual experience may differ from
estimates.
Cost of sales
Cost of sales includes the cost of product sold, royalties due on the sales of the products
and the distribution and logistics costs related to selling the products. Cost of sales does not
include product rights amortization expense as it is disclosed separately.
Inventories
Inventories are stated at the lower of cost or market, cost being determined under the
first-in, first-out method. We periodically review inventories and items considered outdated or
obsolete are reduced to their estimated net realizable value. We estimate reserves for excess and
obsolete inventories based on inventory levels on hand, future purchase commitments, product
expiration dates and current and forecasted product demand. If an estimate of future product demand
suggests that inventory levels are excessive, then inventories are reduced to their estimated net
realizable value.
18
Long-Lived Assets
Our long-lived assets consist primarily of product rights and property and equipment. In
accordance with Statement of Financial Accounting Standards (SFAS) No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, we evaluate our ability to recover the carrying value
of long-lived assets used in our business, considering changes in the business environment or other
facts and circumstances that suggest their value may be impaired. If this evaluation indicates the
carrying value will not be recoverable, based on the undiscounted expected future cash flows
estimated to be generated by these assets, we reduce the carrying amount to the estimated fair
value.
Goodwill
In association with a business acquisition in 2003 and related milestone payments that were
made in 2004 and 2005, goodwill was created. In accordance with SFAS No. 142, Goodwill and Other
Intangible Assets, we do not amortize goodwill. SFAS No. 142 requires us to perform an impairment
review of goodwill at least annually. We perform an evaluation in the fourth quarter of each year.
If it is determined that the value of goodwill is impaired, we will record the impairment charge in
the statement of operations in the period it is discovered. The process of reviewing for impairment
of goodwill is similar to that of long-lived assets in that expected future cash flows are
calculated using estimated future events and trends such as sales, cost of sales, operating
expenses and income taxes. The actual results of any of these factors could be materially different
than what we estimate.
Acquired in-process research
In January 2006, we entered into a license and collaboration agreement for the research,
development and commercialization of MethylGene Inc.s HDAC inhibitors, including its lead compound
MGCD0103, in North America, Europe, the Middle East and certain other markets. Under the terms of
the agreement, we made up front payments to MethylGene totaling $25.0 million, including $20.5
million for a license fee and the remainder as an equity investment in MethylGene common shares.
The $20.5 million license fee was immediately expensed as acquired in-process research as MGCD0103
has not yet achieved regulatory approval for marketing and, absent obtaining such approval, has no
alternative future use.
Accounting for Share-Based Compensation
On January 1, 2006, we adopted SFAS No. 123R, Share-Based Payment which establishes
accounting for share-based awards exchanged for employee services and requires companies to expense
the estimated fair value of these awards over the requisite employee service period. Under SFAS No.
123R, share-based compensation cost is determined at the grant date using an option pricing model.
The value of the award that is ultimately expected to vest is recognized as expense on a straight
line basis over the employees requisite service period. We adopted SFAS No. 123R using the
modified prospective method. Under this method, prior periods are not restated for comparative
purposes. Rather, compensation for awards outstanding, but not vested, at the date of adoption
using the grant date value determined under SFAS No. 123, Accounting for Share-Based
Compensation, as well as new awards granted after the date of adoption using the grant date value under SFAS No. 123R will be
recognized as expense in the statement of operations over the remaining service period of the
award.
We have estimated the fair value of each award using the Black-Scholes option pricing model,
which was developed for use in estimating the value of traded options that have no vesting
restrictions and that are freely transferable. The Black-Scholes model considers, among other
factors, the expected life of the award and the expected volatility of our stock price. Option
valuation models require the input of subjective assumptions and these assumptions can vary over
time.
Prior to the adoption of SFAS No. 123R, we accounted for share-based payment awards to
employees and directors in accordance with APB 25 as allowed under SFAS No. 123. In accordance with
APB 25, we recorded deferred compensation in connection with stock options granted in 2003 under
the intrinsic value method. The amount of deferred compensation was equal to the difference between
the exercise price of the stock options granted to employees and the higher fair market value of
the underlying stock at the date of grant. The deferred compensation was recognized ratably over
the vesting period of these options as share-based compensation expense up to the adoption of SFAS
No. 123R. Upon adoption, the unamortized deferred compensation balance was eliminated with a
corresponding reduction to additional paid in capital.
Employee share-based compensation expense recognized in 2006 was calculated based on awards
ultimately expected to vest and has been reduced for estimated forfeitures. SFAS No. 123R requires
forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods
if actual forfeitures differ from those estimates.
19
The overall impact of adopting SFAS No. 123R was an increase of $0.8 million and $1.6 million
in operating expenses for the three and six months ended June 30, 2006. As of June 30, 2006, total
compensation cost related to nonvested stock options not yet recognized in the statement of
operations was $6.7 million, which is estimated to be expensed over a weighted average period of
2.9 years.
NET INCOME (LOSS) PER COMMON SHARE
The total number of potential common shares excluded from diluted earnings per share
computation because they were anti-dilutive was 1,740,136 and 1,048,356 for the three months ended
June 30, 2006 and 2005, respectively, and 1,967,549 and 921,929 for the six months ended June 30,
2006 and 2005, respectively.
Results of Operations
Comparison of the Companys Results for the Three Months Ended June 30, 2006 and 2005
Net sales. Net sales totaled $60.4 million for the three months ended June 30, 2006 as
compared to $56.3 million for the three months ended June 30, 2005. Net sales included $36.8
million and $32.1 million in the U.S. for the three months ended June 30, 2006 and 2005,
respectively and $23.6 million and $24.2 million in Europe and other countries for the three months
ended June 30, 2006 and 2005, respectively. The primary reason for the net sales increase is due to
the growth of Vidaza sales in the U.S. as well as increases in compassionate use sales of Vidaza in
Europe and other countries. Vidaza net sales increased to $36.1 million for the three months ended
June 30, 2006 as compared to $31.5 million for the three months ended June 30, 2005. The increase
was the result of Vidaza being a more established drug having been on the U.S. market for nearly
two years, as well as having greater visibility to physicians due to increased marketing and
educational efforts. In addition, we began selling Vidaza on a compassionate use basis in Europe
in 2006. Such sales totaled approximately $2 million for the three month ended June 30, 2006. The
increase in Vidaza net sales was partially offset by a decrease in thalidomide sales, which totaled
$19.1 million for the three months ended June 30, 2006, as compared to $21.4 million for the
quarter ended June 30, 2005. The decrease in thalidomide sales was due primarily to the
introduction of new competition, the increased availability of thalidomide from other suppliers,
and reimbursement resistance in certain markets.
Reductions from gross to net sales, which include product returns, chargebacks, rebates and
prompt pay discounts totaled $4.5 million and $4.7 million for the three months ended June 30, 2006
and 2005, respectively. As a percentage of gross sales, the reductions were 7.0% for the second
quarter of 2006 versus 7.7% for the second quarter in 2005.
Cost of sales. Cost of sales for the three months ended June 30, 2006 totaled $16.7 million
compared to $15.1 million for the three months ended June 30, 2005. Cost of sales reflects the cost
of product sold plus royalties due on the sales of our products as well as the distribution costs
related to selling our products. However, product rights amortization is excluded from cost of
sales and included separately with operating expenses. The increase was the direct result of the
increase in net sales. Our gross margin was 72% for the three months ended June 30, 2006 compared
to 73% for the same period in 2005. We expect the gross margin for our products will remain in the
low 70% range for the foreseeable future.
Research and development expenses. Research and development expenses totaled $18.4 million for
the three months ended June 30, 2006 as compared to $9.8 million for the three months ended June
30, 2005. These expenses generally consist of regulatory, clinical and manufacturing development,
and medical and safety monitoring costs for our products. Increased development expenses resulting
from the licensing of satraplatin and the MethylGene HDAC inhibitor program resulted in $4.2
million of the increase. Growth in clinical study costs for Vidaza and thalidomide, as well as
alternative formulation and back-up manufacturer development costs for Vidaza amounted to $3.0
million of the increase. We expect research and development expenses to continue to grow for the
remainder of 2006 as the development programs for our products mature.
Selling, general and administrative expenses. Selling, general and administrative expenses
totaled $26.0 million for the three months ended June 30, 2006 as compared to $22.6 million for the
three months ended June 30, 2005. Sales and marketing expenses increased to $19.4 million for the
three months ended June 30, 2006 from $15.2 million for the comparable period of 2005. The
expansion of our field-based headcount in the U.S. and increased Vidaza marketing activities in
response to new competitive products that were launched in 2006 increased sales and marketing
expenses by $2.7 million. Additionally, we continued to increase pre-approval marketing costs for
thalidomide, Vidaza and satraplatin in Europe and other international markets which accounted for
the remaining $1.5 million increase.
20
General and administrative expenses totaled $6.6 million for the three months ended June 30,
2006 as compared to $7.4 million for the three months ended June 30, 2005. The decrease is the
result of $1.7 million of relocation expenses associated with the move of our European headquarters
incurred in 2005. This decrease was partially offset in the current quarter by a $0.9 million
increase in personnel costs for general and administrative functions such as finance, human
resources and information technology. These personnel costs were incurred to support the
significant growth we have experienced as a company.
Product rights amortization. Product rights amortization totaled $2.4 million for the three
months ended June 30, 2006 as compared to $2.2 million for the three months ended June 30, 2005.
The increase is due to an addition to thalidomide product rights in June 2005 such that the prior
year quarter only had one month of the additional amortization versus three months in the current
year quarter.
Interest and other income, net. Interest and other income, net, totaled $1.7 million for the
three months ended June 30, 2006, compared with $1.2 million for the second quarter of 2005.
Although we experienced a decrease in cash, cash equivalents, and short-term investments as a
result of the up front payments made to GPC Biotech and MethylGene in the first quarter of 2006,
this has been offset by the improved investment returns due to higher interest rates for
investments in the current quarter versus the comparable period in 2005.
Income tax expense. Income tax expense totaled $2.1 million for the three months ended June
30, 2006 as compared to $2.2 million for the three months ended June 30, 2005. The provision for
income taxes reflects managements estimate of the effective tax rate expected to be applicable for
the full fiscal year in each of our taxing jurisdictions. Although our income before taxes
decreased significantly in the second quarter of 2006 as compared to 2005, this had minimal impact
on our tax expense as much of the decline in pre tax income was incurred in jurisdictions where we
incurred minimal tax expense in 2005.
Comparison of the Companys Results for the Six Months Ended June 30, 2006 and 2005
Net sales. Net sales totaled $117.0 million for the six months ended June 30, 2006 as compared
to $108.0 million for the six months ended June 30, 2005. Net sales included $70.6 million and
$61.0 million in the U.S. and $46.4 million and $47.0 million in Europe and other countries for the
six months ended June 30, 2006 and 2005, respectively. The primary reason for the net sales
increase is due to the growth of Vidaza sales in the U.S. as well as increases in compassionate use
sales of Vidaza in Europe and other countries. Vidaza net sales increased to $69.0 million for the
six months ended June 30, 2006 as compared to $59.0 million for the six months ended June 30, 2005.
The increase was the result of Vidaza being a more established drug, having been on the market for
more than one year, and having greater visibility to physicians due to increased marketing and
educational efforts. In addition, we began selling Vidaza on a compassionate use basis in Europe
in 2006. Such sales totaled approximately $3 million for the six months ended June 30, 2006. The
increase in Vidaza net sales was partially offset by a decrease in thalidomide sales, which totaled
$38.6 million for the six months ended June 30, 2006, as
compared to $41.7 million for the six months ended June 30, 2005. The decrease in thalidomide sales was due primarily to the introduction of new
competition, increased availability of thalidomide from other suppliers, and reimbursement
resistance in certain markets.
Reductions from gross to net sales, which include product returns, chargebacks, rebates and
prompt pay discounts totaled $9.3 million and $8.7 million for the six months ended June 30, 2006
and 2005, respectively. As a percentage of gross sales, the reductions were 7.4% for the six
months ended June 30, 2006 versus 7.5% for the six months ended June 30, 2005.
Cost of sales. Cost of sales for the six months ended June 30, 2006 totaled $31.9 million
compared to $29.1 million for the six months ended June 30, 2005. Cost of sales reflects the cost
of product sold plus royalties due on the sales of our products as well as the distribution costs
related to selling our products. However, product rights amortization is excluded from cost of
sales and included separately with operating expenses. The increase was the direct result of the
increase in net sales. Our gross margins for the six months ended June 30, 2006 and 2005 remained
constant at 73%. We expect the gross margin for our products will remain in the low 70% range for
the foreseeable future.
Research and development expenses. Research and development expenses totaled $33.5 million for
the six months ended June 30, 2006 as compared to $19.3 million for the six months ended June 30,
2005. These expenses generally consist of regulatory, clinical and manufacturing development, and
medical and safety monitoring costs for our products. Development expenses related to our
licensing of satraplatin and the MethylGene HDAC inhibitor program resulted in $7.5 million of the
increase. Additional growth in clinical study costs for Vidaza and thalidomide, as well as
alternative formulation and back-up manufacturer development costs for
21
Vidaza amounted to $5.9 million of the increase. We expect research and development expenses
to continue to grow for the remainder of 2006 as the development programs for our products mature.
Acquired in-process research. In January 2006, we entered into a licensing and collaboration
agreement with MethylGene for the research, development and commercialization of MethylGenes HDAC
inhibitor in North America, Europe, the Middle East and certain other markets. Under terms of this
agreement, we made up front payments to MethylGene of $25.0 million, including $20.5 million for a
license fee and the remainder as an equity investment in MethylGene common shares The $20.5 million
license fee was immediately expensed as acquired in-process research as MethylGenes HDAC inhibitor
has not yet achieved regulatory approval for marketing and, absent obtaining such approval, has no
alternative future use. No such expense was incurred in the first half of 2005.
Selling, general and administrative expenses. Selling, general and administrative expenses
totaled $48.5 million for the six months ended June 30, 2006 as compared to $43.3 million for the
six months ended June 30, 2005. Sales and marketing expenses totaled $35.3 million for the six
months ended June 30, 2006, an increase of $5.3 million over the comparable period of 2005. The
expansion of our field-based headcount in the U.S. and increased Vidaza marketing activities in
response to new competitive products being launched in 2006 increased sales and marketing expenses
by $3.5 million. Increases in pre-approval marketing costs for thalidomide, Vidaza and satraplatin
in Europe and other international markets accounted for the remaining $1.8 million increase.
General and administrative expenses totaled $13.2 million for the six months ended June 30,
2006 as compared to $13.3 million for the six months ended June 30, 2005. The $0.1 million
decrease is the result of $2.4 million of relocation expenses associated with the move of our
European headquarters being incurred in the prior year, offset by an increase in the current year
of $2.3 million related to personnel costs for general and administrative functions such as
finance, human resources and information technology. These personnel cost increases were incurred
to support the significant growth we have experienced as a company.
Product rights amortization. Product rights amortization totaled $4.9 million for the six
months ended June 30, 2006 as compared to $4.5 million for the six months ended June 30, 2005. The
increase is due to an addition to thalidomide product rights in June 2005 such that the prior year
period only had one month of the additional amortization versus six months in the current year
period.
Interest and other income, net. Interest and other income, net, totaled $3.4 million for the
six months ended June 30, 2006, an increase of $0.4 million over the same period in 2005. Although
we have experienced a decrease in cash, cash equivalents, and short-term investments as a result of
the up front payments made to GPC Biotech and MethylGene in the first quarter of 2006, this has
been offset by the improved investment returns due to higher interest rates for investments in the
current year versus the comparable period in 2005.
Income tax expense. Income tax expense totaled $4.4 million for the six months ended June 30,
2006 as compared to $5.1 million for the six months ended June 30, 2005. The provision for income
taxes reflects managements estimate of the effective tax rate expected to be applicable for the
full fiscal year in each of our taxing jurisdictions. Although our income before taxes decreased
significantly in the second quarter of 2006 as compared to 2005, this had minimal impact on our tax
expense as much of the decline in pre tax income was incurred in jurisdictions where we incurred
minimal tax expense in 2005.
Liquidity and Capital Resources
We achieved profitability on a full year basis for the first time in 2005. As of June 30,
2006, we had an accumulated deficit of $159.1 million. Although we achieved profitability during
2005, our recent product licensing transactions have and will continue to significantly increase
our research and development expenses. As a result, we incurred a loss in the six months ended June
30, 2006 and expect to incur a net loss for all of 2006. To date, our operations have been funded
primarily with proceeds from the sale of preferred and common stock and net sales of our products.
Net proceeds from the sale of our preferred stock was $125.0 million and our public offerings of
common stock completed in November 2003 and July 2004 resulted in combined net proceeds of $314.2
million. We began generating revenue from product sales in July 2002.
Cash, cash equivalents and short-term investments decreased from $243.4 million at December
31, 2005 to $188.5 million at June 30, 2006. This $54.9 million decrease is primarily due to the
$62.1 million up front payments made to GPC Biotech and MethylGene in connection with the licensing
of satraplatin and the MethylGene HDAC products, partially offset by cash generated from operating
activities less cash used for capital expenditures and repayment of debt obligations.
We expect that our cash on hand at June 30, 2006, along with cash generated from expected
product sales, will be adequate to fund our operations for at least the next twelve months.
However, we re-examine our cash requirements periodically in light of changes in
22
our business. For example, in the event that we make additional product acquisitions, we may
need to raise additional funds. Adequate funds, either from the financial markets or other sources
may not be available when needed or on terms acceptable to us. Insufficient funds may cause us to
delay, reduce the scope of, or eliminate one or more of our planned development, commercialization
or expansion activities. Our future capital needs and the adequacy of our available funds will
depend on many factors, including the effectiveness of our sales and marketing activities, the cost
of clinical studies and other actions needed to obtain regulatory approval of our products in
development, and the timing and cost of any product acquisitions.
Contractual Obligations
Our contractual obligations as of June 30, 2006 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual Obligations |
|
Total |
|
|
2006 |
|
|
2007 |
|
|
2008 |
|
|
2009 |
|
|
2010 |
|
|
Thereafter |
|
Research and development |
|
$ |
26,200 |
|
|
$ |
1,333 |
|
|
$ |
10,067 |
|
|
$ |
7,400 |
|
|
$ |
7,400 |
|
|
$ |
|
|
|
$ |
|
|
Operating leases |
|
|
13,244 |
|
|
|
1,944 |
|
|
|
3,669 |
|
|
|
2,648 |
|
|
|
2,367 |
|
|
|
843 |
|
|
|
1,773 |
|
Inventory purchase commitments |
|
|
7,577 |
|
|
|
7,577 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty payments |
|
|
2,012 |
|
|
|
2,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product acquisition payments |
|
|
1,000 |
|
|
|
|
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt obligations |
|
|
70 |
|
|
|
36 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total fixed contractual
obligations |
|
$ |
50,103 |
|
|
$ |
12,902 |
|
|
$ |
14,770 |
|
|
$ |
10,048 |
|
|
$ |
9,767 |
|
|
$ |
843 |
|
|
$ |
1,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development funding. In December 2005, we entered into a co-development and
licensing agreement for satraplatin with GPC Biotech. Pursuant to that agreement, we made an up
front payment of $37.1 million to GPC Biotech in January 2006. Of that amount, $21.2 million was
allocated to acquired in-process research and charged to expenses in 2005. The remaining amount of
$15.9 million represents a prepayment of future clinical development costs. The licensing agreement
also stipulates we provide an additional $22.2 million for similar future development costs. This
amount is reflected in the schedule above in equal annual amounts for 2007-2009.
We previously entered into two agreements with Celgene to provide funding to support clinical
development studies sponsored by Celgene studying thalidomide as a treatment for various types of
cancers. Under these agreements, we will pay $2.7 million in each of 2006 and 2007.
Operating leases. Our commitment for operating leases relates primarily to our corporate and
sales offices located in the U.S., Europe, Thailand and Australia. These lease commitments expire
on various dates through 2013.
Inventory purchase commitments. The contractual summary above includes contractual obligations
related to our product supply contracts. Under these contracts, we provide our suppliers with
rolling 12-24 month supply forecasts, with the initial 3-6 month periods representing binding
purchase commitments.
Product royalty payments. Pursuant to our thalidomide product license agreements with Celgene,
we are required to make additional quarterly payments to the extent that the royalty and license
payments due under those agreements do not meet certain minimums. These minimum royalty and license
payment obligations expire the earlier of 2006 or the date we obtain regulatory approval to market
thalidomide in the E.U. The amounts reflected in the summary above represent the minimum amounts
due under these agreements. In addition, our Innohep license agreement with LEO Pharma requires
annual minimum royalty payments through 2006.
Product acquisition payments. We have future payment obligations associated with the June 2005
addition to thalidomide product rights. We paid $5.0 million in June 2005, with additional $1.0
million payments due in each of 2006 and 2007.
Contingent product acquisition payments. The contractual summary above reflects only payment
obligations for product and company acquisitions that are fixed and determinable. We also have
contractual payment obligations, the amount and timing of which are contingent upon future events.
In accordance with U.S. generally accepted accounting principles, contingent payment obligations
are not recorded on our balance sheet until the amount due can be reasonably determined. Under the
terms of the agreement with GPC Biotech, we will pay them up to an additional $30.5 million based
on the achievement of certain regulatory filing and approval milestones, up to an additional $75
million for up to five subsequent E.U. approvals for additional indications and we will pay them
sales milestones totaling up to $105 million, based on the achievement of significant annual sales
levels in our territories. Similarly, under the agreement with MethylGene, our milestone payments
for MGCD0103 could reach $145 million, based on the achievement
23
of significant development, regulatory and sales goals, with the nearest milestone of $4
million to be paid upon enrollment of the first patient in a Phase II trial. Furthermore, up to
$100 million for each additional HDAC inhibitor may be paid, also based on the achievement of
significant development, regulatory and sales milestones. Also, under the agreements with Schering
AG, payments totaling up to $7.5 million are due if milestones relating to sales and gross margin
targets for Refludan are achieved.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We have no material changes to the disclosure on this Item made in our Companys Annual Report
on Form 10-K for the fiscal year ended December 31, 2005.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We carried out an evaluation under the supervision and with the participation of our
management, including our Chief Executive Officer (CEO) and Chief Financial Officer (CFO), of
the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and
15(d)-15(e) of the Securities Exchange Act of 1934, as amended (Exchange Act), as of the end of
the period covered by this report. Based on that evaluation, the CEO and CFO have concluded that
our disclosure controls and procedures are effective to provide reasonable assurance that
information required to be disclosed by us in our periodic reports under the Exchange Act is
recorded, processed, summarized and reported within the time periods specified in Securities and
Exchange Commission rules and forms, and that such information is accumulated and communicated to
our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding
required disclosure. It should be noted that the design of any system of controls is based in part
upon certain assumptions about the likelihood of future events, and can therefore only provide
reasonable, not absolute, assurance that the design will succeed in achieving its stated goals.
Changes in Internal Controls
There were no changes in our internal control over financial reporting that occurred during
the period covered by this report that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
PART II
OTHER INFORMATION
Item 1. Legal Proceedings
For a description of the Companys outstanding legal proceedings, please see our Annual Report
on Form 10-K for the fiscal year ended December 31, 2005, filed with the SEC on March 16, 2006. No
material changes have occurred during the period covered by this report.
Item 1A. Risk Factors
The Risk Factors included in the Companys Annual Report on Form 10-K for the fiscal year
ended December 31, 2005 have not materially changed other than as set forth below.
Our existing commercial business is largely dependent on the success of Vidaza.
Sales of Vidaza account for a significant portion of our total product sales. For the three
months ended June 30, 2006 and for the year ended December 31, 2005, Vidaza net sales represented
60% and 57%, respectively, of our total net sales. Vidaza now faces competition from two approved
therapies in the United States: Revlimid®, manufactured by Celgene Corporation, which
was approved for marketing by the FDA in late 2005 as a treatment for a subset of low-risk MDS
patients, and Dacogen®, manufactured by MGI Pharma, Inc., which was approved by the FDA
in May 2006 for the treatment of all sub-types of MDS. Although
Vidaza sales increased during the period covered by this report as
compared with the same period a year ago and over the prior quarter,
we are unable to fully assess the impact these relatively recent
competitive product launches will have on future Vidaza sales. We may also face competition from any other
new therapeutics for treating MDS that may be under development by our competitors. The commercial
success of Vidaza and future growth in Vidaza sales will depend, among other things, upon:
24
|
|
|
continued acceptance by regulators, physicians, patients and other key decision-makers as a
safe, superior therapeutic as compared to currently existing or future treatments for MDS; |
|
|
|
|
the success of our current survival clinical trial for Vidaza in MDS; |
|
|
|
|
our ability to achieve a marketing authorization for Vidaza in Europe and in other countries; and |
|
|
|
|
our ability to expand the indications for which we can market Vidaza. |
As a consequence, we cannot make assurances that Vidaza will gain increased market acceptance
from members of the medical community or that the acceptance of Vidaza we have observed thus far
will be maintained. Even if Vidaza does gain increased market acceptance, we may not be able to
maintain that market acceptance over time if the competitive products recently introduced to the
marketplace are more favorably received than Vidaza or render Vidaza obsolete.
Regulatory authorities in our markets subject approved products and manufacturers of approved
products to continual regulatory review. Previously unknown problems, such as unacceptable
toxicities or side effects, may only be discovered after a product has been approved and used in an
increasing number of patients. If this occurs, regulatory authorities may impose labeling
restrictions on the product that could affect its commercial viability or could require withdrawal
of the product from the market. Accordingly, there is a risk that we will discover such previously
unknown problems associated with the use of Vidaza in patients, which could limit sales growth or
cause sales of Vidaza to decline.
We face substantial competition, which may result in others commercializing competing products
before or more successfully than we do.
Our industry is highly competitive. Our success will depend on our ability to acquire, develop
and commercialize products and our ability to establish and maintain markets for our products.
Potential competitors in North America, Europe and elsewhere include major pharmaceutical
companies, specialized pharmaceutical companies and biotechnology firms, universities and other
research institutions. Many of our competitors have substantially greater research and development
capabilities and experience, and greater manufacturing, marketing and financial resources, than we
do. Accordingly, our competitors may develop or license products or other novel technologies that
are more effective, safer or less costly than our existing products or products that are being
developed by us, or may obtain regulatory approval for products before we do. Clinical development
by others may render our products or product candidates noncompetitive.
Other pharmaceutical companies may develop generic versions of our products that are not
subject to patent protection or otherwise subject to orphan drug exclusivity or other proprietary
rights. In particular, because we have only limited patent protection for thalidomide, we face
substantial competition from generic versions of thalidomide throughout Europe and other
territories in which we sell thalidomide without orphan drug exclusivity. Governmental and other
pressures to reduce pharmaceutical costs may result in physicians writing prescriptions for these
generic products. Increased competition from the sale of competing generic pharmaceutical products
could cause a material decrease in sales of our products.
Vidaza faces competition from two products that have been approved by the FDA and launched in
2006: Dacogen, approved by the FDA for the treatment of all MDS sub-types and launched in May 2006,
and Revlimid, approved by the FDA as a treatment for certain low risk MDS patients and launched
early in the first quarter of 2006. Vidaza also competes with traditional therapies for the
treatment of MDS, including the use of blood transfusions and growth factors, such as
erythropoietin and granulocyte colony stimulating factor. Thalidomide faces competition from sales
of other versions of thalidomide sold in generic or unlicensed forms in Europe, including
compounding of thalidomide by pharmacists, and Velcade® from Millenium Pharmaceuticals Inc. and
Johnson & Johnson Pharmaceutical Research & Development LLC, approved as a second-line treatment
for multiple myeloma in Europe. Thalidomide also faces potential competition from Revlimid from
Celgene Corporation, which is currently under review for regulatory approval by the EMEA as a
second-line treatment of multiple myeloma.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
25
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
At
our 2006 Annual Meeting of Shareholders held on June 8, 2006 (the Annual Meeting), our
shareholders: (i) elected two Class III Directors, each to serve for a term to expire in 2009 (Item
No. 1); (ii) ratified the appointment of Ernst & Young LLP as independent registered public
accounting firm for the fiscal year ending December 31, 2003 (Item No. 2); and (iii) approved the
adoption of the Pharmion Corporation 2006 Employee Stock Purchase Plan (Item No. 3). The
tabulation of votes for each of the Items is set forth below:
Item No. 1
Election of two Class III Directors for a three-year term:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Votes |
DirectorsClass II |
|
Votes For |
|
Withheld |
Dr. Thorlef Spickschen |
|
|
25,128,930 |
|
|
|
1,572,844 |
|
Dr. John C. Reed |
|
|
26,676,620 |
|
|
|
25,154 |
|
The terms of office for the Class I Directors and Class II Directors of the Company, Brian
G. Atwood; M. James Barrett, Ph.D; James Blair, Ph.D; Cam L. Garner; Patrick J. Mahaffy and Edward
McKinley, continued after the Annual Meeting.
Item No. 2
Ratification of the appointment of Ernst & Young LLP as independent auditors of the Company
for the 2005 fiscal year:
|
|
|
|
|
FOR |
|
AGAINST |
|
ABSTAIN |
26,455,048
|
|
4,907
|
|
7,092 |
Item No. 3
Approval of the adoption of the Pharmion Corporation 2006 Employee Stock Purchase Plan:
|
|
|
|
|
|
|
FOR |
|
AGAINST |
|
ABSTAIN |
|
Broker Non-Vote |
21,101,948
|
|
138,406
|
|
6,205
|
|
5,502,715 |
Item 5. Other Information
None.
26
Item 6. Exhibits
The following documents are being filed as part of this report:
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
31.1
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for President and Chief Executive Officer. |
|
|
|
31.2
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for Chief Financial Officer. |
|
|
|
32.1
|
|
Sarbanes-Oxley Act of 2002, Section 906 Certifications for President and Chief Executive
Officer and Chief Financial Officer. |
27
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.
|
|
|
|
|
|
|
PHARMION CORPORATION |
|
|
|
|
|
|
|
By:
|
|
/s/ Patrick J. Mahaffy |
|
|
|
|
|
|
|
|
|
President and Chief Executive Officer |
|
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
Date: August 9, 2006 |
|
|
|
|
|
|
|
|
|
|
|
PHARMION CORPORATION |
|
|
|
|
|
|
|
By:
|
|
/s/ Erle T. Mast |
|
|
|
|
|
|
|
|
|
Chief Financial Officer |
|
|
|
|
(Principal Financial and Accounting Officer) |
Date: August 9, 2006 |
|
|
|
|
28
Exhibit Index
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
31.1
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for President and Chief Executive Officer. |
|
|
|
31.2
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification for Chief Financial Officer. |
|
|
|
32.1
|
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Sarbanes-Oxley Act of 2002, Section 906 Certifications for President and Chief Executive
Officer and Chief Financial Officer. |