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 September 30, 2007
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 000-50447
Pharmion Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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84-1521333 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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2525 28th Street, Suite 200,
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Boulder, Colorado
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80301 |
(Address of principal executive offices)
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(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 November 6, 2007 |
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Common Stock, $.001 par value per share
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37,250,223 shares |
PART I
FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements
PHARMION CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands, except for share amounts)
(Unaudited)
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September 30, |
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December 31, |
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2007 |
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2006 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
135,047 |
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$ |
59,903 |
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Short-term investments |
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122,585 |
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76,310 |
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Accounts receivable, net of allowances of $3,799 and $4,711, respectively |
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45,407 |
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40,299 |
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Inventories |
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12,986 |
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12,411 |
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Other current assets |
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13,968 |
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14,045 |
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Total current assets |
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329,993 |
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202,968 |
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Product rights, net |
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89,145 |
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95,591 |
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Goodwill |
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15,568 |
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14,402 |
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Property and equipment, net |
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10,979 |
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7,121 |
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Other assets |
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5,825 |
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6,650 |
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Total assets |
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$ |
451,510 |
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$ |
326,732 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
10,075 |
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$ |
11,612 |
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Accrued and other current liabilities |
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57,463 |
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38,359 |
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Total current liabilities |
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67,538 |
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49,971 |
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Deferred tax liability |
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2,955 |
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2,734 |
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Other long-term liabilities |
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984 |
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945 |
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Total liabilities |
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71,477 |
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53,650 |
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Stockholders equity: |
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Common stock, $0.001 par value; 100,000,000 shares authorized and
37,172,286 and 32,102,520 shares issued and outstanding at September 30,
2007 and December 31, 2006, respectively |
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37 |
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32 |
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Preferred stock, $0.001, 10,000,000 shares authorized, no shares issued
and outstanding at September 30, 2007 and December 31, 2006 |
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Additional paid-in capital |
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627,492 |
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488,553 |
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Other comprehensive income |
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15,727 |
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11,336 |
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Accumulated deficit |
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(263,223 |
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(226,839 |
) |
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Total stockholders equity |
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380,033 |
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273,082 |
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Total liabilities and stockholders equity |
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$ |
451,510 |
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$ |
326,732 |
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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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Nine Months Ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Net sales |
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$ |
67,315 |
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$ |
61,636 |
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$ |
195,834 |
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$ |
178,596 |
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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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18,236 |
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16,629 |
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53,341 |
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48,514 |
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Research and development |
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29,118 |
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16,675 |
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71,992 |
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50,194 |
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Acquired in-process research |
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8,000 |
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4,000 |
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8,000 |
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24,480 |
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Selling, general and administrative |
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32,522 |
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24,465 |
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93,174 |
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72,963 |
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Product rights amortization |
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2,475 |
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2,454 |
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7,407 |
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7,344 |
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Total operating expenses |
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90,351 |
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64,223 |
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233,914 |
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203,495 |
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Operating loss |
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(23,036 |
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(2,587 |
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(38,080 |
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(24,899 |
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Interest and other income, net |
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2,991 |
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1,870 |
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6,448 |
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5,286 |
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Loss before taxes |
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(20,045 |
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(717 |
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(31,632 |
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(19,613 |
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Income tax expense |
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1,395 |
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2,834 |
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4,752 |
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7,188 |
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Net loss |
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$ |
(21,440 |
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$ |
(3,551 |
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$ |
(36,384 |
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$ |
(26,801 |
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Net loss per common share: |
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Basic and Diluted |
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$ |
(0.58 |
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$ |
(0.11 |
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$ |
(1.05 |
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$ |
(0.84 |
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Weighted average number of common and
common equivalent shares used to
calculate net loss per common share: |
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Basic and Diluted |
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36,996 |
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32,053 |
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34,506 |
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31,993 |
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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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Nine Months Ended |
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September 30, |
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2007 |
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2006 |
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Operating activities |
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Net loss |
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$ |
(36,384 |
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$ |
(26,801 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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9,307 |
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9,140 |
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Share-based compensation expense |
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4,130 |
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2,410 |
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Amortization of discounts and premiums on short-term investments, net |
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(1,279 |
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(337 |
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Other |
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38 |
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64 |
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Changes in operating assets and liabilities: |
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Accounts receivable, net |
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(2,993 |
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(5,629 |
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Inventories |
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413 |
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(950 |
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Other current assets |
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640 |
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10,601 |
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Other long-term assets |
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(80 |
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(6 |
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Accounts payable |
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(1,842 |
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(3,481 |
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Accrued liabilities |
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17,157 |
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(36,912 |
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Net cash used in operating activities |
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(10,893 |
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(51,901 |
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Investing activities |
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Purchases of property and equipment |
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(5,411 |
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(1,197 |
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Purchase of available-for-sale investments |
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(168,077 |
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(80,129 |
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Sale and maturity of available-for-sale investments |
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123,126 |
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140,255 |
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Net cash provided by (used in) investing activities |
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(50,362 |
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58,929 |
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Financing activities |
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Proceeds from sale of common stock, net of issuance costs |
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129,566 |
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Proceeds from exercise of common stock options and employee stock purchase plan |
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5,418 |
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547 |
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Payment of debt obligations |
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(920 |
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(1,092 |
) |
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Net cash provided by (used in) financing activities |
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134,064 |
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(545 |
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Effect of exchange rate changes on cash and cash equivalents |
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2,335 |
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1,899 |
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Net increase in cash and cash equivalents |
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75,144 |
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8,382 |
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Cash and cash equivalents at beginning of period |
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59,903 |
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90,443 |
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Cash and cash equivalents at end of period |
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$ |
135,047 |
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$ |
98,825 |
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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) was incorporated in Delaware on August 26, 1999 and
commenced operations in January 2000. 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 some combination of royalties on future sales, up
front and/or milestone cash payments, and development funding. The Company has acquired the rights
to or developed eight products, including four that are currently marketed or sold on a
compassionate use or named patient basis, and four products that are in varying stages of clinical
development. The Company has established drug development, regulatory, and commercial capabilities
in the United States, Europe and Australia. Through its distributor network, the Company can reach
the hematology and oncology markets in additional countries in Asia, Latin America, and the Middle
East.
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 2006 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 fairly present the
Companys financial position at September 30, 2007, results of operations for the three and nine
months ended September 30, 2007 and 2006 and cash flows for the nine months ended September 30,
2007 and 2006. The results of operations for the interim periods are not necessarily indicative of
the results to be expected for the year ending December 31, 2007 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 $6.6 million and $5.7 million for the nine months ended
September 30, 2007 and 2006, respectively.
The Company has entered into several standby letters of credit to guarantee both current and
future commitments with office and equipment lease agreements and customer supply public tender
commitments. The aggregate amount outstanding under the letters of credit was approximately $2.4
million and $2.2 million at September 30, 2007 and December 31, 2006, respectively. The letters of
credit are secured by an equivalent amount of restricted cash held in U.S. and foreign cash
accounts.
6
Short-term Investments
Short-term investments consist of investment grade government agency and corporate debt
securities due within one year. Investments with maturities beyond one year are also 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. The estimated fair value of the available-for-sale securities is
determined based on quoted market prices or rates for similar instruments.
Inventories
Inventories consist of Vidaza, Innohep, Refludan and thalidomide. Vidaza is sold commercially
in the U.S. and, to a lesser extent, on a compassionate use basis within Europe and other
international markets. Innohep is sold exclusively in the U.S. market, and Refludan and thalidomide
are both sold within Europe and the other international markets. All of the products are
manufactured by third-party manufacturers and delivered to the Company as finished goods. The
Company purchases the active ingredient for Vidaza which is supplied to the third-party manufacturer.
Inventories 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 items considered outdated or
obsolete are reduced to their estimated net realizable value.
Inventories at September 30, 2007 and December 31, 2006 consisted of the following (in
thousands):
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September 30, |
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December 31, |
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2007 |
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2006 |
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Raw materials |
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$ |
2,948 |
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$ |
3,709 |
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Finished goods |
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10,038 |
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8,702 |
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Total inventories |
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$ |
12,986 |
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$ |
12,411 |
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Product Rights
The cost of acquiring the distribution and marketing rights of the Companys products that are
approved for commercial use were capitalized and are being amortized on a straight-line basis over
the estimated benefit period of 10-15 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.
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 include:
Product returns. The Companys customers have the right to return any unopened product during
the 18-month period beginning six months prior to the labeled expiration date and ending twelve
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 six months of expiration and analyze the
likelihood that such product will be returned within twelve months after expiration.
7
To estimate the likelihood of product remaining in wholesalers inventory to within six months
of its expiration, the Company relies on its internal estimate of wholesalers inventory levels, measured
end-customer demand as reported by third party sources, and on internal sales data. The Company
believes the information from 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 September 30, 2007 and December 31, 2006, the allowance for returns was $0.8 million and
$1.0 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 September 30, 2007 and December 31, 2006, the allowance/accrual for chargebacks and rebates
was $3.1 million and $4.0 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 September 30, 2007 and December 31, 2006, the allowance for prompt pay discounts was $0.3
million and $0.4 million, respectively.
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.
8
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
The Company has acquired and will continue to acquire the rights to develop and commercialize
new drug opportunities. The upfront payment to acquire the new drug candidate as well as future
milestone payments will be immediately expensed as acquired in-process research provided that the
new drug has not 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, investments and accounts receivable. The Company maintains
its cash, cash equivalent 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 an allowance for potential credit losses, and such losses have been
within managements expectations. Net revenues generated as a percent of total consolidated net
revenues, for our three largest customers in the U.S. were as follows for the nine months ended
September 30, 2007 and 2006:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
September 30, |
|
|
2007 |
|
2006 |
Oncology Supply |
|
|
18 |
% |
|
|
19 |
% |
Cardinal Health |
|
|
10 |
% |
|
|
11 |
% |
Oncology Therapeutics Network |
|
|
7 |
% |
|
|
6 |
% |
Net sales generated from international customers were individually less than 5% of
consolidated net sales.
Share-Based Compensation
The Company recognizes compensation for share based awards to employees and non-employee
directors under Statement of Financial Accounting Standard (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. 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.
Employee share-based compensation expense recognized in the three and nine months ended
September 30, 2007 and 2006 was calculated based on awards ultimately expected to vest and has been
reduced for estimated forfeitures at a rate of 15 percent, based on the Companys historical option
cancellations. 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.
Share-based compensation expense recognized under SFAS No. 123R for the three and nine months
ended September 30, 2007 and 2006 was (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Nine Months |
|
|
|
Ended September 30, |
|
|
Ended September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Research and development |
|
$ |
411 |
|
|
$ |
230 |
|
|
$ |
1,071 |
|
|
$ |
670 |
|
Selling, general and administrative |
|
|
1,078 |
|
|
|
617 |
|
|
|
3,059 |
|
|
|
1,740 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
1,489 |
|
|
$ |
847 |
|
|
$ |
4,130 |
|
|
$ |
2,410 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
Valuation assumptions used to determine fair value of share based compensation
The employee share-based compensation expense recognized under SFAS No. 123R 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 |
|
Nine Months |
|
|
Ended September 30, |
|
Ended September 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Risk-free interest rate |
|
|
4.5 |
% |
|
|
4.9 |
% |
|
|
4.6 |
% |
|
|
4.9 |
% |
Expected stock price volatility |
|
|
48 |
% |
|
|
42 |
% |
|
|
43 |
% |
|
|
42 |
% |
Expected option term until exercise |
|
4.5 years |
|
|
4.3 years |
|
|
4.4 years |
|
|
4.2 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 option was $11.79 and $7.34 for stock options granted in
the three months ended September 30, 2007 and 2006, respectively. The weighted-average fair value
per option was $11.95 and $7.17 for stock options granted in the nine months ended September 30,
2007 and 2006, respectively.
As of September 30, 2007, there was approximately $8.0 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 2.5 years.
A summary of the option activity for the nine months ended September 30, 2007 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Aggregate Intrinsic |
|
|
|
|
|
|
|
Weighted Average |
|
|
Contractual Term |
|
|
Value |
|
|
|
Number of Shares |
|
|
Exercise Price |
|
|
(years) |
|
|
(in thousands) |
|
Outstanding at January 1, 2007 |
|
|
3,287,559 |
|
|
$ |
19.26 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
179,832 |
|
|
$ |
28.97 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(421,821 |
) |
|
$ |
11.38 |
|
|
|
|
|
|
|
|
|
Terminated |
|
|
(63,173 |
) |
|
$ |
24.77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, September 30, 2007 |
|
|
2,982,397 |
|
|
$ |
20.85 |
|
|
|
4.79 |
|
|
$ |
75,594 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, September 30, 2007 |
|
|
2,691,771 |
|
|
$ |
20.62 |
|
|
|
4.65 |
|
|
$ |
68,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, September 30, 2007 |
|
|
1,777,408 |
|
|
$ |
19.55 |
|
|
|
3.94 |
|
|
$ |
47,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents a summary of the Companys non-vested shares of restricted stock
unit awards as of September 30, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
Fair Value at Grant |
|
|
|
Number of Shares |
|
|
Date |
|
Non-vested at December 31, 2006 |
|
|
229,878 |
|
|
$ |
23.38 |
|
Granted |
|
|
130,800 |
|
|
$ |
29.32 |
|
Vested |
|
|
(20,983 |
) |
|
$ |
17.82 |
|
Terminated |
|
|
(22,540 |
) |
|
$ |
21.07 |
|
|
|
|
|
|
|
|
Non-vested, September 30, 2007 |
|
|
317,155 |
|
|
$ |
24.67 |
|
|
|
|
|
|
|
|
The restricted stock units 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.
10
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 nine months ended September 30, 2007 and
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.
The total number of potential common shares excluded from diluted earnings per share
computation because they were anti-dilutive was 3.4 million and 1.6 million for the three months
ended September 30, 2007 and 2006, respectively, and 3.5 million and 1.9 million for the nine
months ended September 30, 2007 and 2006, respectively.
NOTE 4. LICENSE AGREEMENTS AND PRODUCT RIGHTS
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. The Company currently
owns approximately 5.0% of the outstanding common shares of MethylGene Inc. The investment in
MethylGene common stock is classified in other assets and is accounted for as a long-term
available-for-sale security with changes in fair value recorded to other comprehensive income
(loss).
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 nine months ended September 30, 2007 and 2006 was (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(21,440 |
) |
|
$ |
(3,551 |
) |
|
$ |
(36,384 |
) |
|
$ |
(26,801 |
) |
Other comprehensive loss, net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation gain |
|
|
4,674 |
|
|
|
949 |
|
|
|
5,265 |
|
|
|
5,739 |
|
Unrealized gain (loss) on available-for-sale securities |
|
|
(1,187 |
) |
|
|
1,657 |
|
|
|
(874 |
) |
|
|
2,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(17,953 |
) |
|
$ |
(945 |
) |
|
$ |
(31,993 |
) |
|
$ |
(18,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 nine months
ended September 30, 2007 and 2006 resulted primarily from taxable income generated in certain
foreign jurisdictions. The Company has generated net operating loss carryforwards in certain
jurisdictions, most notably in the U.S. and Switzerland. The Company has fully reserved the
potential tax benefit in its balance sheet, due to the uncertainty of realizing the asset in future
periods. The Internal Revenue Code contains provisions that limit the annual utilization of U.S.
net operating loss and tax credit carryforwards if there has been a change of ownership as
described in Section 382 of the Code. Such an ownership change occurred for the Company in 2006.
11
The Company adopted the provisions of FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income Taxes an Interpretation of FASB Statement No. 109, on January 1, 2007. The
Company has analyzed tax positions in all jurisdictions where we are required to file an income tax
return and we have concluded that we do not have any material unrecognized tax benefits. As a
result, there was no material effect on our financial position or results of operations due to the
implementation of FIN 48. We file a U.S. federal income tax return as well as returns for various
state and foreign jurisdictions. Most of the income tax returns filed in the U.S. and foreign
jurisdictions are subject to potential examination from the date of start-up through the current
year, due to net operating losses that have been generated since the commencement of operations.
Income tax returns in the U.K. and Switzerland have been reviewed by
local authorities through 2004 and 2005, respectively. We are not
aware of any circumstances that we believe will result in any material changes in our unrecognized tax positions over
the next 12 months.
The Companys policy is to recognize interest and penalties accrued on any unrecognized tax
benefits as a component of income tax expense. As of the date of adoption of FIN 48, we did not
have interest or penalties accrued for any unrecognized tax benefits and there was no significant
interest expense recognized during the current year.
NOTE 7. GEOGRAPHIC INFORMATION
Domestic and foreign financial information for the three and nine months ended September 30,
2007 and 2006 was (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
United States net sales |
|
$ |
36,058 |
|
|
$ |
36,009 |
|
|
$ |
105,646 |
|
|
$ |
106,591 |
|
Foreign entities net sales |
|
|
31,257 |
|
|
|
25,627 |
|
|
|
90,188 |
|
|
|
72,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net sales |
|
$ |
67,315 |
|
|
$ |
61,636 |
|
|
$ |
195,834 |
|
|
$ |
178,596 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operating loss |
|
$ |
(9,250 |
) |
|
$ |
(653 |
) |
|
$ |
(16,349 |
) |
|
$ |
(8,231 |
) |
Foreign entities operating loss |
|
|
(13,786 |
) |
|
|
(1,934 |
) |
|
|
(21,731 |
) |
|
|
(16,668 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating loss |
|
$ |
(23,036 |
) |
|
$ |
(2,587 |
) |
|
$ |
(38,080 |
) |
|
$ |
(24,899 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
United States total assets |
|
$ |
249,350 |
|
|
$ |
129,528 |
|
Foreign entities total assets |
|
|
202,160 |
|
|
|
197,204 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
451,510 |
|
|
$ |
326,732 |
|
|
|
|
|
|
|
|
NOTE 8. ACCRUED AND OTHER CURRENT LIABILITIES
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(in thousands) |
|
Accrued and other current liabilities: |
|
|
|
|
|
|
|
|
Accrued product development expenses |
|
$ |
19,490 |
|
|
$ |
6,632 |
|
Royalties payable |
|
|
13,204 |
|
|
|
10,893 |
|
Accrued salaries and benefits |
|
|
9,066 |
|
|
|
9,191 |
|
Income taxes payable |
|
|
2,140 |
|
|
|
262 |
|
Other accrued operating expenses |
|
|
13,563 |
|
|
|
11,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total accrued and other operating liabilities |
|
$ |
57,463 |
|
|
$ |
38,359 |
|
|
|
|
|
|
|
|
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, 2006.
12
FORWARD-LOOKING STATEMENTS
All statements, trend analysis and other information contained in this Quarterly Report on
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, 2006. 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, Middle East, Asia, and Latin America.
To date, we have acquired the rights to or internally developed eight products, including four that
are currently marketed or sold on a compassionate use or named patient basis, and four products
that are in varying stages of development.
In May 2004, Vidaza® was approved for marketing in the U.S. and we commenced sales of the
product in July 2004. We plan to file for marketing approval in the European Union (E.U.) by the
end of 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.
Thalidomide (including Thalidomide Pharmion and the Laphal thalidomide formulation) 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 territories. We also sell thalidomide on an approved
basis in Australia and certain other international markets. In February 2007, the European
Medicines Agency (EMEA) accepted for review our Marketing Authorization Application (MAA) for
Thalidomide Pharmion for the treatment of untreated multiple myeloma. We expect the results of the
EMEAs review to be available in late 2007 or early 2008. 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. Progression free survival data from the Phase 3 study examining satraplatin as a treatment
for hormone refractory prostate cancer was presented in February 2007 and we submitted an MAA to
the EMEA based on this data in July 2007. In October 2007, the overall survival results
from this Phase 3 trial were released.
The trial did not achieve the endpoint of overall survival.
We planned on submitting the overall survival results to the EMEA
during the review process. Over the next few months we intend to
review these results with the EMEA to determine the next steps for our
marketing application.
In January 2006, we entered into a license and collaboration agreement with MethylGene for the
research, development and commercialization 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 1 and Phase 2
clinical trials in both solid tumors and hematological disorders.
In November 2006, we acquired 100% of the outstanding common stock of Cabrellis
Pharmaceuticals Corporation and gained the rights to amrubicin, a third-generation synthetic
anthracycline currently in development for small cell lung cancer (SCLC) in North America and the
E.U. In October, 2007, we initiated an international Phase 3 pivotal study evaluating amrubicin in
the treatment of second-line SCLC.
With our combination of regulatory, development and commercial capabilities, we intend to
continue to build a portfolio of approved products and product candidates targeting the hematology
and oncology markets.
13
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 include:
Product returns. Our customers have the right to return any unopened product during the
18-month period beginning six months prior to the labeled expiration date and ending twelve 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 six months of expiration and analyze the likelihood that such
product will be returned within twelve months after expiration.
To estimate the likelihood of product remaining in wholesalers inventory to within six months
of its expiration, we rely on our internal estimate of the wholesalers inventory levels, measured
end-customer demand as reported by third party sources, and on internal sales data. We believe the
information from our 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.
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 $0.8 million and $1.0 million at September 30, 2007 and December
31, 2006, respectively.
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.
14
The allowance/accrual for chargebacks and rebates was $3.1 million and $4.0 million at
September 30, 2007 and December 31, 2006, respectively.
Prompt
pay discounts. As an incentive to expedite cash flow, we offer some customers a prompt pay
discount of 2% when the customer pays their balance within 30 days of product shipment. 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 $0.3 million and $0.4 million at September 30, 2007
and at December 31, 2006, respectively.
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.
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.
Acquired In-Process Research
The Company has acquired and will continue to acquire the rights to develop and commercialize
new drug opportunities. The upfront payment to acquire the new drug candidate as well as future
milestone payments will be immediately expensed as acquired in-process research provided that the
new drug has not achieved regulatory approval for marketing and, absent obtaining such approval,
has no alternative future use.
Accounting for Share-Based Compensation
We account for share-based awards exchanged for services using SFAS No. 123R, Share-Based
Payment which 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 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.
Employee share-based compensation expense 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.
As of September 30, 2007, total compensation cost related to nonvested stock options not yet
recognized in the statement of operations was approximately $8.0 million, which is estimated to be
expensed over a weighted average period of 2.5 years.
Recently Issued Accounting Standards
The Company adopted the provisions of FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income Taxes an Interpretation of FASB Statement No. 109, on January 1, 2007.
We have analyzed tax positions in all jurisdictions where
15
we are required to file an income tax return and have concluded that we do not have any
material unrecognized tax benefits. As a result, there was no material effect on our financial
position or results of operations due to the implementation of FIN 48. We file a U.S. federal
income tax return as well as returns for various state and foreign jurisdictions. Most of the
income tax returns filed in the U.S. and foreign jurisdictions are subject to potential examination
from the date of start-up through the current year, due to net operating losses that have been
generated since the commencement of operations. Certain income tax returns in the U.K. and France
for years prior to 2001 and 2003, respectively, are no longer subject to examination. We do not
believe there will be any material changes in our unrecognized tax positions over the next 12
months.
The Companys policy is to recognize interest and penalties accrued on any unrecognized tax
benefits as a component of income tax expense. As of the date of adoption of FIN 48, we did not
have interest or penalties accrued for any unrecognized tax benefits and there was no significant
interest expense recognized during the current year.
Results of Operations
Comparison of the Companys Results for the Three Months Ended September 30, 2007 and 2006
Net
Sales: Net sales and related changes for the three months ended September 30, 2007
and 2006 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
September 30, |
|
Increase |
|
Percent |
|
|
2007 |
|
2006 |
|
(Decrease) |
|
Change |
|
|
|
Vidaza |
|
$ |
42,349 |
|
|
$ |
36,601 |
|
|
$ |
5,748 |
|
|
|
16 |
% |
Thalidomide |
|
|
20,192 |
|
|
|
20,199 |
|
|
|
(7 |
) |
|
|
0 |
% |
Other |
|
|
4,774 |
|
|
|
4,836 |
|
|
|
(62 |
) |
|
|
(1 |
%) |
|
|
|
|
|
|
|
|
|
$ |
67,315 |
|
|
$ |
61,636 |
|
|
$ |
5,679 |
|
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
September 30, |
|
Increase |
|
Percent |
|
|
2007 |
|
2006 |
|
(Decrease) |
|
Change |
|
|
|
United States |
|
$ |
36,058 |
|
|
$ |
36,009 |
|
|
$ |
49 |
|
|
|
0 |
% |
Foreign Entities |
|
|
31,257 |
|
|
|
25,627 |
|
|
|
5,630 |
|
|
|
22 |
% |
|
|
|
|
|
|
|
|
|
$ |
67,315 |
|
|
$ |
61,636 |
|
|
$ |
5,679 |
|
|
|
9 |
% |
|
|
|
Net sales for the three months ended September 30, 2007 increased compared to the three months
ended September 30, 2006. The primary reason for the net sales
increase is due to Vidaza net sales in Europe and other international
markets. Although not approved for marketing in the E.U., we sell
Vidaza on a named patient or compassionate use basis within these
markets. Vidaza sales in Europe and other international markets increased by $5.7 million to $9.0
million for the three months ended September 30, 2007 as compared to the three months ended
September 30, 2006. While total net sales of Vidaza in the third quarter of 2007 have increased by
$5.7 million to $42.3 million as compared to the same
period in 2006, U.S. Vidaza sales levels remained
constant at $33.3 million for the three months ended
September 30, 2007 and 2006, respectively. Sales of
thalidomide in Europe and other international markets remained constant at $20.2 million for the
three months ended September 30, 2007 and 2006.
Reductions from gross to net sales, which include allowances for product returns, chargebacks,
rebates and prompt pay discounts totaled $4.6 million and $4.5 million for the three months ended
September 30, 2007 and 2006, respectively. As a percentage of gross sales, the reductions were 6.4%
for the third quarter of 2007 versus 6.8% for the third quarter in 2006.
16
Operating
Expenses: Operating expenses and related changes for the three months ended
September 30, 2007 and 2006 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
September 30, |
|
Increase |
|
Percent |
|
|
2007 |
|
2006 |
|
(Decrease) |
|
Change |
|
|
|
Cost of sales |
|
$ |
18,236 |
|
|
$ |
16,629 |
|
|
$ |
1,607 |
|
|
|
9.7 |
% |
Percent of net sales |
|
|
27.1 |
% |
|
|
27.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
29,118 |
|
|
$ |
16,675 |
|
|
$ |
12,443 |
|
|
|
74.6 |
% |
Percent of net sales |
|
|
43.3 |
% |
|
|
27.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research |
|
$ |
8,000 |
|
|
$ |
4,000 |
|
|
$ |
4,000 |
|
|
|
100.0 |
% |
Percent of net sales |
|
|
11.9 |
% |
|
|
6.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative |
|
$ |
32,522 |
|
|
$ |
24,465 |
|
|
$ |
8,057 |
|
|
|
32.9 |
% |
Percent of net sales |
|
|
48.3 |
% |
|
|
39.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights amortization |
|
$ |
2,475 |
|
|
$ |
2,454 |
|
|
$ |
21 |
|
|
|
0.9 |
% |
Percent of net sales |
|
|
3.7 |
% |
|
|
4.0 |
% |
|
|
|
|
|
|
|
|
Cost of sales. Cost of sales for the three months ended September 30, 2007 increased compared
to the three months ended September 30, 2006. Cost of sales includes the cost of product sold,
royalties due on the sales of our products and the distribution costs related to selling our
products. However, product rights amortization is excluded from cost of sales and is presented
separately within operating expenses. The increase in cost of sales was a direct result of the
increase in net sales. Our gross margin was 73% for the three months ended September 30, 2007 and
2006. 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 for the three months
ended September 30, 2007 increased compared to the three months ended September 30, 2006. These
expenses generally consist of regulatory, clinical and manufacturing development, and medical and
safety monitoring costs for our products. Development expenses
relating to amrubicin and the MethylGene HDAC inhibitor products,
which were licensed in 2006, resulted in $5.4 million of the increase. An
additional $4.7 million of the increase is due to Phase 3 clinical studies and EMEA regulatory
activities for thalidomide and expenses for oral azacitidine
development and Vidaza alternative dosing studies. Additionally, personnel related costs increased $1.5 million due to the hiring of new
employees to manage the research and development programs for our products acquired during 2006. We
expect research and development expenses for the remainder of 2007 to be consistent with the third
quarter results.
Acquired in-process research. In September 2006, the Company paid a development milestone of
$4.0 million to MethylGene Inc. upon the initiation of Phase 2 clinical trials for MGCD0103. In
July 2007, the European Medicines Agency (EMEA) accepted our marketing authorization application
for satraplatin in combination with prednisone for hormone-refractory prostate cancer. This
acceptance triggered an $8.0 million milestone payment to GPC Biotech AG. Both milestone payments were immediately expensed as
acquired in-process research, as the products have not achieved regulatory approval for marketing
and, absent obtaining such approval, have no alternative future use.
Selling, general and administrative expenses. Selling, general and administrative expenses for
the three months ended September 30, 2007 increased compared to the three months ended September
30, 2006. Sales and marketing expenses totaled $23.3 million for the three months ended September
30, 2007, an increase of $5.7 million over the comparable period in 2006. The expansion of our
field-based headcount in the U.S. and increased Vidaza marketing activities increased sales and marketing expenses by $2.2
million. The remaining increase to sales and marketing expense was attributable to pre-approval
market research and other activities undertaken to prepare for the potential approval and launch of
thalidomide and Vidaza in Europe and product branding and market development for MGCD0103 and
amrubicin in the U.S.
17
General and administrative expenses totaled $9.2 million for the three months ended September
30, 2007 as compared to $6.8 million for the three months ended September 30, 2006. The increase
was due to higher personnel costs for our general and administrative functions, such as legal,
finance, human resources and information technology, supporting the expansion of commercial and
research and development activities. In addition, employee
recruitment and relocation costs, information
technology expense and communications costs were higher in 2007 due to the continued growth of the
Company. We expect selling, general and administrative expenses will
continue to increase for the remainder of 2007 and in 2008, as we increase our staffing and
launch preparation activities for the potential European approvals
of thalidomide and Vidaza.
Product rights amortization. Product rights amortization totaled $2.5 million for the three
months ended September 30, 2007 and 2006. There were no additions to product rights since the
second quarter of 2006 and, therefore, amortization expense is expected to be consistent with the
comparable quarter in the prior year.
Interest and other income, net. Interest and other income, net totaled $3.0 million for the
three months ended September 30, 2007, compared with $1.9 million for the third quarter of 2006.
During the second quarter of 2007, we sold 4.6 million shares of common stock in an underwritten
public offering which raised $129.6 million in net proceeds. This increase to cash and short-term
investments, as well as the improved investment returns in the third quarter of 2007 in comparison
to the third quarter of 2006, resulted in an increase to interest and other income, net.
Income tax expense. Income tax expense totaled $1.4 million for the three months ended
September 30, 2007 as compared to $2.8 million for the three months ended September 30, 2006. 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. The decrease in income tax
expense was primarily due to a reduction in the current year effective tax rate in France resulting
from the utilization of net operating losses. The losses became available in the third quarter of
2007 upon completion of an organizational restructuring of two entities operating in this
jurisdiction which reduced income tax expense by $0.7 million in comparison to the third quarter of
2006. The remaining decrease in income tax expense was primarily due to a reduction in alternative
minimum taxes related to operating activities in the U.S..
Comparison of the Companys Results for the Nine Months Ended September 30, 2007 and 2006
Net
Sales: Net sales and related changes for the nine months ended September 30, 2007 and
2006 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
September 30, |
|
Increase |
|
Percent |
|
|
2007 |
|
2006 |
|
(Decrease) |
|
Change |
|
|
|
Vidaza |
|
$ |
120,511 |
|
|
$ |
105,614 |
|
|
$ |
14,897 |
|
|
|
14 |
% |
Thalidomide |
|
|
60,691 |
|
|
|
58,754 |
|
|
|
1,937 |
|
|
|
3 |
% |
Other |
|
|
14,632 |
|
|
|
14,228 |
|
|
|
404 |
|
|
|
3 |
% |
|
|
|
|
|
|
|
|
|
$ |
195,834 |
|
|
$ |
178,596 |
|
|
$ |
17,238 |
|
|
|
10 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
Increase |
|
|
Percent |
|
|
|
2007 |
|
|
2006 |
|
|
(Decrease) |
|
|
Change |
|
|
|
|
United States |
|
$ |
105,646 |
|
|
$ |
106,591 |
|
|
$ |
(945 |
) |
|
|
(1 |
)% |
Foreign Entities |
|
|
90,188 |
|
|
|
72,005 |
|
|
|
18,183 |
|
|
|
25 |
% |
|
|
|
|
|
|
|
|
|
$ |
195,834 |
|
|
$ |
178,596 |
|
|
$ |
17,238 |
|
|
|
10 |
% |
|
|
|
18
Net sales for the nine months ended September 30, 2007 increased compared to the nine months
ended September 30, 2006. The primary reason for the net sales increase is due to the growth of
Vidaza sales. Named patient and compassionate use sales of Vidaza in Europe and other
international markets continued to grow, increasing to $23.3 million for the nine months ended
September 30, 2007 as compared to $6.9 million for the nine months ended September 30, 2006. U.S.
sales of Vidaza totaled $97.2 million for the nine months ended September 30, 2007 as compared to
$98.7 million in the comparable period of 2006. Additionally, thalidomide net sales totaled
$60.7 million for the nine months ended September 30, 2007 as compared to $58.8 million for the
nine months ended September 30, 2006.
Reductions from gross to net sales, which include allowances for product returns, chargebacks,
rebates and prompt pay discounts totaled $15.1 million and $13.8 million for the nine months ended
September 30, 2007 and 2006, respectively. As a percentage of gross sales, the reductions were 7.2%
for the nine months ended September 30, 2007 and 2006, respectively.
Operating
Expenses: Operating expenses and changes for the nine months ended
September 30, 2007 and 2006 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
September 30, |
|
Increase |
|
Percent |
|
|
2007 |
|
2006 |
|
(Decrease) |
|
Change |
|
|
|
Cost of sales |
|
$ |
53,341 |
|
|
$ |
48,514 |
|
|
$ |
4,827 |
|
|
|
9.9 |
% |
Percent of net sales |
|
|
27.2 |
% |
|
|
27.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
71,992 |
|
|
$ |
50,194 |
|
|
$ |
21,798 |
|
|
|
43.4 |
% |
Percent of net sales |
|
|
36.8 |
% |
|
|
28.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research |
|
$ |
8,000 |
|
|
$ |
24,480 |
|
|
$ |
(16,480 |
) |
|
|
(67.3 |
)% |
Percent of net sales |
|
|
4.1 |
% |
|
|
13.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative |
|
$ |
93,174 |
|
|
$ |
72,963 |
|
|
$ |
20,211 |
|
|
|
27.7 |
% |
Percent of net sales |
|
|
47.6 |
% |
|
|
40.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights amortization |
|
$ |
7,407 |
|
|
$ |
7,344 |
|
|
$ |
63 |
|
|
|
0.9 |
% |
Percent of net sales |
|
|
3.8 |
% |
|
|
4.1 |
% |
|
|
|
|
|
|
|
|
Cost of sales. Cost of sales for the nine months ended September 30, 2007 increased compared
to the nine months ended September 30, 2006. 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 is presented
separately within operating expenses. The increase in cost of sales of $4.8 million was the direct result of the
increase in net sales. Our gross margins for the nine months ended September 30, 2007 and 2006
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 for the nine months ended
September 30, 2007 increased compared to the nine months ended September 30, 2006. These expenses
generally consist of regulatory, clinical and manufacturing development, and medical and safety
monitoring costs for our products. Development expenses relating to amrubicin
and the MethylGene HDAC inhibitor program, which were licensed in 2006, resulted in $9.7 million of the increase. An additional
$7.3 million of the increase was due to Phase 3 clinical studies and EMEA regulatory activities
associated with thalidomide and expenses for oral azacitidine development and alternative dosing
studies for Vidaza. Personnel related costs increased by $5.5 million due to the hiring of additional
employees to manage the development programs for our products, including those acquired in 2006.
These increases were partially offset by a reduction in severance costs of $0.9 million, due
primarily to the retirement of an executive officer of the Company in 2006. No such severance costs
have been incurred to date in 2007. We expect research and development expenses for the remainder
of 2007 to be consistent with the level of development costs incurred in the third quarter of 2007.
19
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
inhibitors, including MGCD0103, 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. In September 2006, the Company paid a development
milestone of $4.0 million to MethylGene for the initiation of Phase 2 clinical trials for
MGCD0103. The total of the license fee and the milestone payment of $24.5 million was 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.
In July 2007, the EMEA accepted our marketing authorization
application for satraplatin in combination with prednisone for hormone-refractory prostate cancer.
This acceptance triggered an $8.0 million milestone payment to GPC Biotech, which was recognized
as an acquired in-process research expense in the third quarter of 2007 as satraplatin has not
achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative
future use.
Selling, general and administrative expenses. Selling, general and administrative expenses for
the nine months ended September 30, 2007 increased compared to the nine months ended September 30,
2006. Sales and marketing expenses totaled $67.8 million for the nine months ended September 30,
2007, an increase of $14.8 million over the comparable period of 2006. With the continued expansion
of the sales organization to support the commercial sales growth in the U.S., Europe and other
international markets, personnel related costs have increased $8.6 million. In addition, activities
undertaken to prepare for the potential approval and launch of thalidomide, Vidaza and satraplatin
in Europe have increased sales and marketing expenses by $5.0 million for the nine months ended
September 30, 2007 over the comparable period of 2006. U.S. sales and marketing expenses also
increased by $1.1 million primarily due to product branding and market development for MGCD0103 and
amrubicin in 2007.
General and administrative expenses totaled $25.4 million for the nine months ended September
30, 2007 as compared to $20.0 million for the nine months ended September 30, 2006. Personnel costs
for our general and administrative functions, such as legal, finance, human resources and
information technology, have increased $3.0 million for the nine months ended September 30, 2007
over the comparable period of 2006 to support the overall expansion of our commercial and research
and development activities. In addition, employee recruitment costs, information technology systems
support and communications costs have increased $2.5 million in the current year due to the growth
of the Company. We expect selling, general and administrative
expenses will continue to increase in 2008 as we increase our
staffing and launch preparation activities for the potential
European approvals of thalidomide and Vidaza.
Product rights amortization. Product rights amortization totaled $7.4 million and $7.3 million
for the nine months ended September 30, 2007 and 2006, respectively. No additions to product rights
have occurred since the first half of 2006.
Interest
and other income, net. Interest and other income, net, totaled $6.4 million for the
nine months ended September 30, 2007 as compared to $5.3 million for the nine months ended
September 30, 2006. The increase was due to the increase in cash and short-term investments in the
second quarter of 2007 as a result of the receipt of $129.6 million in net proceeds from the sale of
common stock in an underwritten public offering completed in June 2007, as well as the improved investment returns in 2007.
Income tax expense. Income tax expense totaled $4.8 million for the nine months ended
September 30, 2007 as compared to $7.2 million for the nine months ended September 30, 2006. 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. The decrease in income
tax expense was partially due to a reduction in the current year effective tax rate in France
resulting from the utilization of net operating losses. The losses became available in the third
quarter of 2007 upon completion of an organizational restructuring of two entities operating in
this jurisdiction which reduced income tax expense by $0.7 million in comparison to the income tax
expense recorded for the nine months ended September 30, 2006. The remaining decrease in income
tax expense was primarily due to a reduction to U.S. taxes associated
with alternative minimum tax and a reduction in taxable income in
certain foreign jurisdictions.
Liquidity and Capital Resources
As of September 30, 2007, we had an accumulated deficit of $263.2 million. Although we
achieved profitability during 2005, our recent product acquisitions and development have
significantly increased our operating expenses, resulting in net losses during 2006
20
and for the nine months ended September 30, 2007. We expect to continue to incur significant
net losses for 2007. To date, our operations have been funded primarily with proceeds from the sale
of equity and net sales of our products.
Cash, cash equivalents and short-term investments increased from $136.2 million at December
31, 2006 to $257.6 million at September 30, 2007. This $121.4 million increase is primarily related
to the receipt of $129.6 million of net proceeds from the sale of common stock through our public
offering completed in June 2007, offset by a milestone payment made to GPC Biotech in the third
quarter of 2007 and by cash used to purchase property and equipment and to fund operations.
We expect that our cash on hand at September 30, 2007, along with cash generated from expected
product sales, will be adequate to fund our operations for at least the next twelve months.
However, we reexamine our cash requirements periodically in light of changes in 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 September 30, 2007 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Remainder of 2007 |
|
|
2008 |
|
|
2009 |
|
|
2010 |
|
|
2011 |
|
|
Thereafter |
|
|
|
(In thousands) |
|
Contractual Obligations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases |
|
$ |
24,996 |
|
|
$ |
1,328 |
|
|
$ |
4,921 |
|
|
$ |
4,560 |
|
|
$ |
3,780 |
|
|
$ |
3,400 |
|
|
$ |
7,007 |
|
Research and development |
|
|
15,007 |
|
|
|
2,517 |
|
|
|
7,400 |
|
|
|
5,090 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory purchase commitments |
|
|
12,767 |
|
|
|
8,559 |
|
|
|
4,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product royalty payments |
|
|
300 |
|
|
|
300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total fixed contractual obligations |
|
$ |
53,070 |
|
|
$ |
12,704 |
|
|
$ |
16,529 |
|
|
$ |
9,650 |
|
|
$ |
3,780 |
|
|
$ |
3,400 |
|
|
$ |
7,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases. Our commitment for operating leases relates primarily to our corporate,
clinical, and sales offices located in the U.S., Europe, Thailand and Australia. These lease
commitments expire on various dates through 2015.
Research and development. 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 early 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 was a prepayment of clinical development costs. The licensing agreement also stipulates we
provide an additional funding commitment of $22.2 million for
similar future development costs, of which $14.3 million of this
funding commitment remains at September 30, 2007. 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 for clinical
development studies sponsored by Celgene studying thalidomide as a treatment for various types of
cancers. Under these agreements, we paid Celgene $4.7 million in 2005, $2.7 million in 2006, and
$2.7 million will be paid in 2007.
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 on 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 and assumes that thalidomide is approved in the E.U. in the first quarter of
2008.
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 for
21
satraplatin, we will pay GPC Biotech 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 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
$141 million, based on the achievement of significant development, regulatory and sales goals.
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. Under the terms of the
Cabrellis Pharmaceuticals Corporation acquisition agreement, we will pay $12.5 million for the
initial approval of amrubicin by regulatory authorities in each of the U.S. and the E.U.
Additionally, upon amrubicins approval for a second indication in the U.S. or E.U., we will pay an
additional payment of $10 million for each market. Under the terms of our license agreement for
amrubicin, we are also required to make milestone payments of $7.0 million and $1.0 million to
Dainippon Sumitomo Pharma Co. Ltd. upon regulatory approval of amrubicin in the U.S. and the E.U.,
respectively, and up to $17.5 million upon achieving certain annual sales levels in the U.S.
Finally, under the agreements with Schering AG, payments totaling up to $7.5 million are due if
milestones relating to revenue 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, 2006.
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.
22
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, 2006, filed with the SEC on March 15, 2007. 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, 2006 have not materially changed other than as set forth below.
We may not receive regulatory approvals for our product candidates, or approvals may be delayed.
Our growth
prospects depend to a large extent upon our ability to obtain regulatory approval of our near-term
product candidates in Europe: Thalidomide Pharmion, satraplatin and Vidaza. The regulatory review
and approval process to obtain marketing approval, even for a drug that is approved in other
jurisdictions, takes many years and requires the expenditure of substantial resources. This
process can vary substantially based on the type, complexity, novelty and indication of the
product candidate involved. Changes in the regulatory approval policy during the development
period, changes in or the enactment of additional statutes or regulations, or changes in
regulatory review for each submitted product application may cause delays in the approval
or rejection of an application. The regulatory authorities have substantial discretion in
the approval process and may refuse to accept any application or may decide that data is
insufficient for approval and require additional pre-clinical, clinical or other studies,
even if the clinical trials supporting the application for approval achieve their endpoints.
In addition, varying interpretations of the data obtained from pre-clinical and clinical
testing by regulatory authorities could delay, limit or prevent regulatory approval of a
product candidate.
Thalidomide
Pharmion. In January 2007, we submitted an MAA to the EMEA seeking a marketing
authorization for Thalidomide Pharmion in the E.U. We believe that the clinical data
supporting this submission provides compelling evidence of Thalidomide Pharmions efficacy
in treating multiple myeloma patients. However, our MAA is still currently under review by
the EMEA and we cannot make any assurances that this review will result in a positive
recommendation for approval. Thalidomides well-known potential for causing severe birth
defects and its negative historical reputation may delay or prevent an approval of our MAA,
despite its proven efficacy. In addition, thalidomide continues to be widely available and,
in most cases, without a comprehensive safety program. Any report of a birth defect attributed
to the current use of thalidomide could compel the regulatory authorities to delay approval
or elect not to grant us marketing authorization for Thalidomide Pharmion.
Satraplatin. In June 2007, we submitted an MAA to the EMEA seeking marketing approval
for satraplatin based upon the results achieved in the SPARC Phase 3 clinical trial evaluating
satraplatin in second line hormone refractory prostate cancer (HRPC). The trial met its
co-primary endpoint by demonstrating a statistically significant improvement in
progression-free survival, or PFS, in the satraplatin treatment arm.
PFS is a composite endpoint that assesses when a patients disease has progressed
based upon a number of clinical criteria relevant to the disease state. Although both the
EMEA and the FDA have accepted PFS as a suitable endpoint for some product approvals, in
other cases regulatory authorities have indicated that only overall survival endpoints will
be sufficient for approvals of some cancer therapy candidates. In July 2007, our partner GPC
Biotech withdrew its NDA seeking approval for satraplatin in the U.S., following the
unanimous recommendation of the Oncologic Drugs Advisory Committee that the FDA wait
for the final overall survival data analysis before deciding whether the NDA should be
approved. Previously, the EMEA had advised us and GPC Biotech, that it would accept the
final analysis of PFS as a basis for an MAA submission for satraplatin, but that the
submission must also include available overall survival data from the SPARC trial.
In October 2007, in a joint press release with GPC Biotech, we announced that the SPARC
trial failed to achieve the overall survival co-primary endpoint, with a median overall
survival of 61.3 weeks in the satraplatin arm compared to 61.4 weeks for the control group.
We believe this failure will have a significantly negative impact on the review of our MAA
by the EMEA. We are currently performing further analysis of the results of the SPARC trial, including
pre-specified subset analyses that could provide important information relevant to our MAA
submission. However, given the failure of the SPARC trial to demonstrate any survival
advantage in favor of satraplatin, we cannot assure you that the EMEA will accept the
final data from SPARC as a basis for marketing approval of satraplatin.
Vidaza. In early August 2007, we announced that our on-going clinical study of
Vidaza in 358 high-risk MDS patients demonstrated a statistically-significant survival
advantage for patients in the Vidaza treatment arm versus conventional care regimens.
We intend to file an MAA with the EMEA seeking a marketing authorization for Vidaza in
the E.U. by the end of 2007 and a supplemental NDA with the FDA seeking to include these
new data in the prescribing information for Vidaza in the U.S. These results were based
upon a preliminary, or top line, analysis of data from the trial and further analyses
of the results from the trial are on-going. We cannot assure you that the top line results
from this clinical trial will be confirmed upon full analysis of the results of the study
or that negative information relating to the safety, efficacy or tolerability of Vidaza
may be discovered upon further analysis of data from this study. Furthermore, even if these
top line results are confirmed upon full analysis of the study, we cannot guarantee that
these results or the trial design will be deemed sufficient for approval by regulatory
authorities in the E.U. or that information from the study will ultimately be included
in the approved prescribing information in the U.S.
The
timing of our submissions, the outcome of reviews by the applicable regulatory authorities
in each relevant market, and the initiation and completion of clinical trials are subject
to uncertainty, change and unforeseen delays. Moreover, favorable results in later stage
clinical trials do not ensure regulatory approval to commercialize a product. We will be
unable to market Thalidomide Pharmion, Vidaza or satraplatin in Europe if we do not receive
marketing authorization from the European Commission. Without such authorization, we will
only be able to sell those products, if at all, on a compassionate use or named patient
basis in Europe, which will significantly limit our revenues.
23
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
Not applicable.
Item 5. Other Information
None.
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 of the President and Chief Executive Officer. |
|
|
|
31.2
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification of the Chief Financial Officer. |
|
|
|
32.1
|
|
Sarbanes-Oxley Act of 2002, Section 906 Certifications of the President and Chief Executive
Officer and Chief Financial Officer. |
24
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: November 9, 2007
|
|
|
|
|
|
PHARMION CORPORATION
|
|
|
By: |
/s/ Erle T. Mast
|
|
|
|
Chief Financial Officer |
|
|
|
(Principal Financial and Accounting Officer) |
|
|
Date: November 9, 2007
25
Exhibit Index
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
31.1
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification of the President and Chief Executive Officer. |
|
|
|
31.2
|
|
Sarbanes-Oxley Act of 2002, Section 302 Certification of the Chief Financial Officer. |
|
|
|
32.1
|
|
Sarbanes-Oxley Act of 2002, Section 906 Certifications of the President and Chief Executive
Officer and Chief Financial Officer. |
26