e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
Or
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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 0-21863
EPIX Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in its Charter)
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Delaware
(State of incorporation)
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04-3030815
(I.R.S. Employer Identification No.) |
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161 First Street, Cambridge, Massachusetts
(Address of principal executive offices)
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02142
(Zip Code) |
Registrants telephone number, including area code: (617) 250-6000
Securities registered pursuant to Section 12(b) of the Act:
Common Stock, $.01 par value per share
(Title of Class)
Securities
registered pursuant to Section 12(g) of the Act: None
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. (Check one):
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
As of July 28, 2006, 23,296,136 shares of the registrants Common Stock, $.01 par value per share,
were issued and outstanding.
EPIX Pharmaceuticals, Inc.
INDEX
2
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS
EPIX PHARMACEUTICALS, INC.
BALANCE SHEETS
(unaudited)
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June 30, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
66,740,536 |
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$ |
72,502,906 |
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Available-for-sale marketable securities |
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47,277,256 |
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52,225,590 |
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Accounts receivable |
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149,287 |
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Prepaid expenses and other current assets |
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537,297 |
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346,919 |
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Total current assets |
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114,555,089 |
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125,224,702 |
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Property and equipment, net |
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1,919,158 |
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2,517,859 |
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Other assets |
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4,336,863 |
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2,973,155 |
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Total assets |
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$ |
120,811,110 |
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$ |
130,715,716 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
326,432 |
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$ |
1,268,325 |
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Accrued expenses |
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3,263,484 |
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4,310,003 |
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Contract advances |
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4,754,808 |
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6,112,549 |
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Deferred revenue |
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225,335 |
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435,861 |
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Total current liabilities |
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8,570,059 |
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12,126,738 |
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Deferred revenue |
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642,980 |
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755,647 |
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Convertible debt |
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100,000,000 |
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100,000,000 |
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Commitments and contingencies |
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Stockholders equity: |
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Preferred Stock, $0.01 par value, 1,000,000 shares authorized;
no shares issued |
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Common Stock, $0.01 par value, 40,000,000 shares authorized;
23,296,136 and 23,284,810 shares issued and outstanding
at June 30, 2006 and December 31, 2005 |
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232,961 |
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232,848 |
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Additional paid-in-capital |
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198,728,253 |
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197,311,313 |
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Accumulated deficit |
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(187,328,017 |
) |
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(179,644,632 |
) |
Accumulated other comprehensive loss |
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(35,126 |
) |
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(66,198 |
) |
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Total stockholders equity |
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11,598,071 |
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17,833,331 |
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Total liabilities and stockholders equity |
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$ |
120,811,110 |
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$ |
130,715,716 |
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See accompanying notes.
3
EPIX PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
(unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Product development revenue |
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$ |
731,191 |
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$ |
314,026 |
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$ |
1,814,058 |
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$ |
1,789,845 |
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Royalty revenue |
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462,718 |
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578,321 |
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920,496 |
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1,022,610 |
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License fee revenue |
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161,597 |
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165,896 |
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323,194 |
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331,792 |
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Total revenues |
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1,355,506 |
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1,058,243 |
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3,057,748 |
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3,144,247 |
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Operating expenses: |
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Research and development |
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3,239,700 |
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5,637,426 |
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7,232,661 |
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11,170,577 |
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General and administrative |
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1,701,877 |
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2,570,535 |
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4,040,240 |
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5,314,240 |
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Restructuring costs |
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61,472 |
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351,105 |
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Total operating expenses |
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5,003,049 |
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8,207,961 |
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11,624,006 |
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16,484,817 |
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Operating loss |
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(3,647,543 |
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(7,149,718 |
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(8,566,258 |
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(13,340,570 |
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Interest income |
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1,410,928 |
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950,610 |
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2,715,501 |
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1,796,511 |
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Interest expense |
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(875,631 |
) |
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(896,976 |
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(1,744,994 |
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(1,807,580 |
) |
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Loss before provision for income taxes |
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(3,112,246 |
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(7,096,084 |
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(7,595,751 |
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(13,351,639 |
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Provision for income taxes |
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43,818 |
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87,634 |
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Net loss |
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$ |
(3,156,064 |
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$ |
(7,096,084 |
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$ |
(7,683,385 |
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$ |
(13,351,639 |
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Weighted average shares: |
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Basic and diluted |
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23,284,810 |
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23,257,197 |
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23,284,810 |
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23,242,022 |
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Net loss per share, basic and diluted |
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$ |
(0.14 |
) |
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$ |
(0.31 |
) |
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$ |
(0.33 |
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$ |
(0.57 |
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See accompanying notes.
4
EPIX PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
(unaudited)
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Six Months Ended June 30, |
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2006 |
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2005 |
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Operating activities: |
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Net loss |
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$ |
(7,683,385 |
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$ |
(13,351,639 |
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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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640,422 |
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538,642 |
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Stock compensation expense |
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1,376,523 |
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3,419 |
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Amortization of deferred financing costs |
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243,977 |
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235,443 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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149,287 |
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(39,063 |
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Prepaid expenses and other current assets |
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(190,377 |
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(179,236 |
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Accounts payable |
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(941,893 |
) |
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139,728 |
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Accrued expenses |
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(1,046,519 |
) |
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209,292 |
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Contract advances |
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(1,357,741 |
) |
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771,598 |
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Deferred revenue |
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(323,193 |
) |
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(1,295,075 |
) |
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Net cash used in operating activities |
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(9,132,899 |
) |
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(12,966,891 |
) |
Investing activities: |
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Purchases of marketable securities |
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(45,014,631 |
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(42,678,695 |
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Sale or redemption of marketable securities |
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49,994,037 |
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56,765,831 |
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Increase in other assets |
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(1,607,686 |
) |
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Purchases of fixed assets |
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(41,721 |
) |
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(678,721 |
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Net cash provided by investing activities |
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3,329,999 |
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13,408,415 |
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Financing activities: |
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Proceeds from loan payable from strategic partner |
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30,000,000 |
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Repayment of loan payable to strategic partner |
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(30,000,000 |
) |
Proceeds from stock options |
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441,751 |
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Proceeds from Employee Stock Purchase Plan |
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40,530 |
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70,299 |
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Net cash provided by financing activities |
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40,530 |
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512,050 |
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Net increase (decrease) in cash and cash equivalents |
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(5,762,370 |
) |
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953,574 |
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Cash and cash equivalents at beginning of period |
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72,502,906 |
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73,364,538 |
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Cash and cash equivalents at end of period |
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$ |
66,740,536 |
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$ |
74,318,112 |
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Supplemental cash flow information: |
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Cash paid for interest |
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$ |
1,500,000 |
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$ |
1,581,889 |
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Cash paid for taxes |
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$ |
87,634 |
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$ |
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See accompanying notes.
5
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
1. Nature of Business
EPIX Pharmaceuticals, Inc. (EPIX or the Company) discovers and develops innovative
pharmaceuticals for imaging that are designed to transform the diagnosis, treatment and monitoring
of disease. The Company uses its proprietary Target Visualization Technology TM
to create imaging agents targeted at the molecular level. These agents are designed to enable
physicians to use magnetic resonance imaging (MRI) to obtain detailed information about specific
disease processes. MRI has been established as the imaging technology of choice for a broad range
of applications, including the identification and diagnosis of a variety of medical disorders. MRI
is safe, relatively cost-effective and provides three-dimensional images that enable physicians to
diagnose and manage disease in a minimally invasive manner.
The Company is currently developing two products for use in MRI to improve the diagnosis of
multiple diseases affecting the bodys arteries and veins, collectively known as the vascular
system: Vasovist TM , the Companys novel blood-pool contrast agent for use in
magnetic resonance angiography (MRA), which was approved for marketing in all 25 member states of
the European Union (E.U.) in October 2005; and EP-2104R for detecting human thrombi, or blood
clots, using MRI. The Company has entered into various partnership agreements with Schering AG with
respect to both Vasovist and other of its product candidates. Schering AG began marketing Vasovist
in Europe in the second quarter of 2006. The Company currently owns all development rights to
EP-2104R and intends to pursue a collaboration for the continued development of EP-2104R, following
Schering AGs decision not to exercise its option for the product candidate. The Company has active
research programs with respect to products for diagnostic imaging and therapeutic uses.
On April 3, 2006, the Company announced the signing of a definitive merger agreement to
acquire Predix Pharmaceuticals Holdings, Inc. (Predix). Predix is a privately-held pharmaceutical
company focused on the discovery and development of novel, highly-selective, small molecule drugs
that target G-Protein Coupled Receptors (GPCR) and ion channels. The merger with Predix is a
stock transaction valued at approximately $90 million, including the assumption of net debt at
closing. In addition, Predix shareholders will be paid a milestone payment of $35 million in cash,
stock or a combination of both based on Predix having achieved a certain strategic milestone.
Specifically, on July 31, 2006, Predix entered into an exclusive worldwide license agreement with
Amgen Inc. to develop and commercialize products based on Predixs preclinical compounds which
target the GPCR sphingosine-1-phosphate receptor-1 (S1P1) and compounds and products that may be
identified by or acquired by Amgen and that are active against the S1P1 receptor. Under the
license agreement, Predix will receive a $20 million upfront payment and royalties on future net
sales of products developed in the collaboration, if any. In addition, if and when specified
milestones relating to the development, regulatory approval and sales of products from the
collaboration are achieved, Predix could receive up to an aggregate of $287.5 million in milestone
payments from Amgen. The EPIX board of directors has determined that Predixs entry into the
agreement with Amgen resulted in the achievement of a milestone pursuant to the terms of the merger
agreement by and between EPIX and Predix and described in the Joint Proxy Statement/Prospectus.
Accordingly, in addition to the initial merger consideration, Predix stockholders, option holders
and warrant holders will be entitled to the milestone payment under the merger agreement in the
aggregate amount of $35.0 million. The merger with Predix is anticipated to close around August
15, 2006, pending stockholder approval.
2. Basis of Presentation
The unaudited condensed financial statements of EPIX have been prepared in accordance with
accounting principles generally accepted in the United States (U.S.) for interim financial
information and the instructions to Form 10-Q and the rules of the Securities and Exchange
Commission (the SEC or the Commission). Accordingly, they do not include all of the information
and footnotes required to be presented for complete financial statements. The accompanying
unaudited condensed financial statements reflect all adjustments (consisting only of normal
recurring adjustments) which are, in the opinion of management, necessary for a fair presentation
of the results for the interim periods presented. The results of the interim period ended June 30,
2006 are not necessarily indicative of the results expected for the full fiscal year.
The unaudited condensed financial statements and related disclosures have been prepared with
the assumption that users of the unaudited condensed financial statements have read or have access
to the audited financial statements for the preceding fiscal year. Accordingly, these unaudited
condensed financial statements should be read in conjunction with the audited financial statements
and the related notes thereto included in the Companys Annual Report on Form 10-K, as amended, for
the year ended December 31, 2005.
6
3. Significant Accounting Policies
Revenue Recognition
Product development revenue
In June 2000, the Company entered into a strategic collaboration agreement with Schering AG,
whereby each party to the agreement shares equally in Vasovist development costs and U.S. operating
profits and the Company will receive royalties related to non-U.S. sales. The Company recognizes
as revenue the cash consideration received from Schering AG for amounts expended by the Company in
excess of the Companys obligation under the agreement to expend 50% of the costs to develop
Vasovist. This revenue is recognized in the same period in which the costs are incurred. With
respect to payments due to Schering AG, if any, in connection with the Vasovist development
program, the Company would recognize such amounts as a reduction to revenue at the time Schering AG
performs the research and development activities for which the Company is obligated to pay Schering
AG.
On a monthly basis, the Company calculates the revenue or reduction to revenue, as the case
may be, with respect to the partnership with Schering AG for Vasovist as follows:
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The Company calculates its development costs directly related to Vasovist. |
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The Company obtains cost reports, or an estimate of costs, from Schering AG for costs
incurred by Schering AG related to the development of Vasovist during the same period.
Where estimates are used, the Company reviews the estimates and records, as necessary,
adjustments in the subsequent quarter when the Company receives actual results from
Schering AG. To date, there have been no material adjustments. |
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The Company multiplies its and Schering AGs development costs by approximately 50%
based on the contractual allocation of work contemplated under the agreement. |
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The Company then records the net difference as development revenue if the balance
results in a payment to the Company and negative revenue if the balance results in a
payment to Schering AG. |
The result of this calculation is that the Company records revenue only for amounts it is owed
by Schering AG in excess of 50% of development expenses of the project in the particular period.
The Company would record a reduction to revenue for any amounts owed to Schering AG in the
particular period. To date, the Company has not been required to make any payments to Schering AG.
The additional payments made by Schering AG to the Company represent revenue to the Company
because the Company is providing additional services to Schering AG which Schering AG was
contractually obligated to perform itself. For example, the Company performed substantial amounts
of the work on behalf of Schering AG required to prepare the regulatory submission to the European
regulatory authorities for Vasovist which would otherwise have been Schering AGs responsibility
under the agreement. Had the Company not performed these and other additional services, Schering AG
would have had to contract with a third party to perform the work or Schering AG would have had to
perform the work itself.
In May 2003, the Company entered into a development agreement with Schering AG for EP-2104R
and a collaboration agreement with Schering AG for MRI research. Under the EP-2104R development
agreement, Schering AG agreed to make fixed payments totaling approximately $9.0 million to the
Company over a two year period, which began in the second quarter of 2003 and ended in the fourth
quarter of 2004, to cover a portion of the Companys expenditures for the EP-2104R feasibility
program. The Company recognizes revenue from Schering AG for the feasibility program in proportion
to actual cost incurred relative to the estimated total program costs. As estimated total cost to
complete a program increases, revenue in the period is adjusted downwards, and conversely, as
estimated cost to complete decreases, revenue in the period is adjusted upwards. Total estimated
costs of the feasibility program are based on managements assessment of costs to complete the
program based upon an evaluation of the portion of the program completed, costs incurred to date,
planned program activities, anticipated program timelines and expected future costs of the program.
To the extent that estimated costs to complete the feasibility program change materially from the
previous periods, adjustments to revenue are recorded in the period. As of June 30, 2006, the
estimated cost to complete the EP-2104R feasibility program is $15.2 million, unchanged from the
estimate to complete at March 31, 2006 and December 31, 2005. During the first quarter of 2006, the
Company completed enrollment in the feasibility program. Revenue under the MRI research
collaboration is recognized at the time services are provided for which Schering AG is obligated to
reimburse the Company.
Payments received by the Company from Schering AG in advance of EPIX performing research and
development activities are recorded as contract advances.
7
Royalty revenue
The Company earns royalty revenue pursuant to its sub-license on certain of its patents to
Bracco Imaging S.p.A. (Bracco). Royalty revenue is recognized based on actual revenues as
reported by Bracco to the Company in the period in which royalty reports are received. With the
expiration in 2006 of certain patents related to the sublicense with Bracco, the Company expects to
receive lower royalty payments from Bracco beginning in the second half of 2006, and it expect such
payments to end in the first quarter of 2007.
Massachusetts General Hospital (MGH) owns the patents that are subject to the Companys
agreement with Bracco and has
exclusively licensed those patents to the Company, which has in turn sub-licensed the patents
to Bracco. The Company owes MGH a percentage of all royalties received from its sub-licenses. The
Company paid royalties of $66,073 to MGH during the six months ended June 30, 2006. No amounts were
paid during the six month period ended June 30, 2005.
The Company is also entitled to receive a royalty on sales of Vasovist by Schering AG
following the commercial launch of the product in the E.U., which began on a country-by-country
basis in the second quarter of 2006. The Company will recognize royalty revenue from sales of
Vasovist in the E.U. in the quarter when Schering AG reports those sales to the Company.
License fee revenue
The Company records license fee revenue in accordance with SEC Staff Accounting Bulletin No.
104, Revenue Recognition (SAB 104). Pursuant to SAB 104, the Company recognizes revenue from
non-refundable license fees and milestone payments, not specifically tied to a separate earnings
process, ratably over the period during which the Company has a substantial continuing obligation
to perform services under the contract. When milestone payments are specifically tied to a separate
earnings process, revenue is recognized when the specific performance obligations associated with
the payment are completed.
In September 2001, the Company sub-licensed certain patents to Bracco and received a $2.0
million license fee from Bracco. This license fee is included in deferred revenue and is being
recorded as revenue ratably from the time of the payment until the expiration of MGHs patents,
which occurred in the E.U. in May 2006 and will occur in the U.S. in November 2006.
As part of the strategic collaboration agreement the Company entered into with Schering AG in
2000, the Company granted Schering AG an exclusive license to co-develop and market Vasovist
worldwide, exclusive of Japan. Later in 2000, the Company amended this strategic collaboration
agreement to grant Schering AG exclusive rights to develop and market Vasovist in Japan. In return,
the Company received a $3.0 million license fee from Schering AG in connection with that amendment.
This license fee was included in deferred revenue and is being recorded as revenue ratably from the
time of the payment until anticipated approval in Japan. The Company will continue to review this
estimate and make appropriate adjustments as information becomes available.
Pursuant to an earlier collaboration agreement with Mallinckrodt, Inc., a subsidiary of
Tyco/Mallinckrodt, the Company recorded $4.4 million of deferred revenue that is being recorded as
revenue ratably from the time of payment until anticipated approval of Vasovist in the U.S. The
Company will continue to review this estimate and make appropriate adjustments as information
becomes available.
Research and Development Expenses
Research and development costs, including those associated with technology, licenses and
patents, are expensed as incurred. Research and development costs primarily include employee
salaries and related costs, third party service costs, the cost of preclinical and clinical trial
supplies and consulting expenses.
In order to conduct research and development activities and compile regulatory submissions,
the Company enters into contracts with vendors who render services over an extended period of time,
generally one to three years. Typically, the Company enters into three types of vendor contracts:
time-based, patient-based or a combination thereof. Under a time-based contract, using critical
factors contained within the contract, usually the stated duration of the contract and the timing
of services provided, the Company records the contractual expense for each service provided under
the contract ratably over the period during which it estimates the service will be performed. Under
a patient-based contract, the Company first determines an appropriate per patient cost using
critical factors contained within the contract, which include the estimated number of patients and
the total dollar value of the contract. The Company then records expense based upon the total
number of patients enrolled during the period. On a quarterly basis, the Company reviews both the
timetable of services to be rendered and the timing of services actually received. Based upon this
review, revisions may be made to the forecasted timetable or the extent of services performed, or
both, in order to reflect the Companys most current estimate of the contract.
8
Loss per Share
The Company computes loss per share in accordance with the provisions of Statement of
Financial Accounting Standards No. 128, Earnings per Share. Basic net loss per share is based
upon the weighted-average number of common shares outstanding and excludes the effect of dilutive
common stock issuable upon exercise of stock options and convertible debt. Diluted net loss per
share includes the effect of dilutive common stock issuable upon exercise of stock options and
convertible debt using the treasury stock method. In computing diluted loss per share, only
potential common shares that are dilutive, or those that reduce earnings per share, are included.
The exercise of options or convertible debt is not assumed if the result is anti-dilutive, such as
when a loss is reported.
In June 2004, the Company completed a sale, pursuant to Rule 144A under the Securities Act of
1933, of $100.0 million of 3.0% convertible senior notes due 2024 for net proceeds of approximately
$96.4 million. Each $1,000 of senior notes is convertible into 33.5909
shares of the Companys common stock representing a conversion price of approximately $29.77
per share if (1) the price of the Companys common stock trades above 120% of the conversion price
for a specified time period, (2) the trading price of the senior notes is below a certain
threshold, (3) the senior notes have been called for redemption, or (4) specified corporate
transactions have occurred. None of these conversion triggers has occurred as of June 30, 2006.
Common stock potentially issuable, but excluded from the calculation of dilutive net loss per
share for the three months and six months ended June 30, 2006 and 2005 because their inclusion
would have been antidilutive, consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
Stock options and awards |
|
|
2,041,895 |
|
|
|
3,846,979 |
|
Shares
issuable on conversion of 3.0% Convertible Senior
Notes |
|
|
3,359,090 |
|
|
|
3,359,090 |
|
|
|
|
|
|
|
|
Total |
|
|
5,400,985 |
|
|
|
7,206,069 |
|
|
|
|
|
|
|
|
Comprehensive Loss
Comprehensive loss is comprised of net loss and unrealized gains or losses on the Companys
available-for-sale marketable securities. The Companys comprehensive loss for the three months
ended June 30, 2006 and 2005 amounted to $3.2 million and $7.0 million, respectively, and for the
six months ended June 30, 2006 and 2005 amounted to $7.7 million and $13.2 million, respectively.
Employee Stock Compensation
The Company adopted the provisions of Statement of Financial Accounting Standards No. 123(R),
Share-Based Payment An Amendment of FASB Statements No. 123 and 95 (SFAS 123(R)), beginning
January 1, 2006, using the modified prospective transition method. Under the modified prospective
transition method, financial statements for periods prior to the adoption date are not adjusted for
the change in accounting. Compensation expense is now recognized, based on the requirements of SFAS
123(R), for (a) all share-based payments granted after the effective date and (b) all awards
granted to employees prior to the effective date that remain unvested on the effective date.
Prior to adopting SFAS 123(R), the Company used the intrinsic value method to account for
stock-based compensation under Accounting Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees. As a result of the adoption of SFAS 123(R), the Company is amortizing the
unamortized stock-based compensation expense related to unvested option grants issued prior to the
adoption of SFAS 123(R). The Company has elected to continue to use the Black-Scholes Option
Pricing Model to determine the fair value of options. SFAS 123(R) also requires companies to
utilize an estimated forfeiture rate when calculating the expense for the period, whereas SFAS 123
permitted companies to record forfeitures based on actual forfeitures, which was the Companys
historical policy under disclosure requirements of SFAS 123. As a result, the Company has applied
an estimated forfeiture rate to remaining unvested awards based on historical experience in
determining the expense recorded in the Companys consolidated statement of operations. This
estimate will be evaluated quarterly and the forfeiture rate will be adjusted as necessary. The
actual expense recognized over the vesting period will only be for those shares that vest during
that period. The Company has also elected to recognize compensation cost for awards with pro-rata
vesting using the straight-line method.
As a result of adopting the new standard, the Company has recorded $583,768 and $1.4 million
of stock-based compensation expense, which includes a charge for the shares issued under the
Companys Employee Stock Purchase Plan (the ESPP), for the
9
three and six months ended June 30,
2006, respectively. The stock-based compensation expense included $417,390 in research and
development and $166,378 in general and administrative expense for the three months ended June 30,
2006, and $936,390 in research and development and $439,934 in general and administrative expense
for the six months ended June 30, 2006. The compensation expense increased both basic and diluted
net loss per share for the three and six months ended June 30, 2006 by $0.03 and $0.06,
respectively. In accordance with the modified-prospective transition method of SFAS 123(R), results
for prior periods have not been restated. As of June 30, 2006, there was $6.2 million of
unrecognized compensation expense related to non-vested market-based share awards that is expected
to be recognized over a weighted-average period of 1.8 years.
The following table illustrates the effect on net loss and net loss per share for the three
and six months ended June 30, 2005 if the Company had applied the fair value provisions of SFAS
123(R) to options granted under the Companys stock option plans.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2005 |
|
|
June 30, 2005 |
|
Net loss as reported |
|
$ |
(7,096,084 |
) |
|
$ |
(13,351,639 |
) |
Add: employee stock-based compensation included in net loss as
reported |
|
|
|
|
|
|
|
|
Deduct: pro forma adjustment for stock-based compensation |
|
|
(1,448,039 |
) |
|
|
(2,535,848 |
) |
|
|
|
|
|
|
|
Net loss pro forma |
|
$ |
(8,544,123 |
) |
|
$ |
(15,887,487 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
|
|
|
|
|
|
|
As reported |
|
$ |
(0.31 |
) |
|
$ |
(0.57 |
) |
Pro forma |
|
|
(0.37 |
) |
|
|
(0.68 |
) |
|
|
|
|
|
|
|
Effect of pro forma adjustment |
|
$ |
(0.06 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
The fair value of each stock option is estimated on the date of grant using the Black-Scholes
Option Pricing Model using the assumptions noted in the following table. The risk-free interest
rate is based on a treasury instrument whose term is consistent with the expected life of the stock
options. Expected volatility is based on historical volatility data of the Companys stock and
comparable companies to the expected option term. The Company estimated the stock option
forfeitures based on historical experience. The Company used the simplified method, as prescribed
by the SECs Staff Accounting Bulletin No. 107, to calculate the expected term, or life, of these
options.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options |
|
ESPP |
|
|
Three Months Ended June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Expected stock price volatility |
|
|
70 |
% |
|
|
83 |
% |
|
|
70 |
% |
|
|
83 |
% |
Weighted average risk-free interest rate |
|
|
4.95 |
% |
|
|
3.89 |
% |
|
|
4.85 |
% |
|
|
3.12 |
% |
Expected forfeiture rate |
|
|
9.00 |
% |
|
|
0.00 |
% |
|
|
N/A |
|
|
|
N/A |
|
Expected life of option (years) |
|
|
6.3 |
|
|
|
6.7 |
|
|
|
0.5 |
|
|
|
0.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Expected stock price volatility |
|
|
70 |
% |
|
|
84 |
% |
|
|
70 |
% |
|
|
83 |
% |
Weighted average risk-free interest rate |
|
|
4.65 |
% |
|
|
3.72 |
% |
|
|
4.85 |
% |
|
|
3.12 |
% |
Expected forfeiture rate |
|
|
9.00 |
% |
|
|
0.00 |
% |
|
|
N/A |
|
|
|
N/A |
|
Expected life of option (years) |
|
|
6.3 |
|
|
|
6.9 |
|
|
|
0.5 |
|
|
|
0.5 |
|
The weighted average grant-date fair value of options granted during the three and six months
ended June 30, 2006 was $2.65 and $3.05 per share, respectively.
10
The following is a summary of the status of the Companys stock option plans as of June 30,
2006 and the stock option activity for all stock option plans during the six months ended June 30,
2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Average |
|
|
|
|
|
|
Number |
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
of Stock |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Options |
|
|
Price |
|
|
Term |
|
|
Value |
|
Outstanding at December 31, 2005 |
|
|
3,271,909 |
|
|
$ |
11.39 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
327,062 |
|
|
|
4.54 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(1,557,076 |
) |
|
|
11.39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2006 |
|
|
2,041,895 |
|
|
$ |
10.29 |
|
|
|
6.80 |
|
|
$ |
12,025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2006 |
|
|
1,103,208 |
|
|
$ |
10.78 |
|
|
|
5.30 |
|
|
$ |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4. Restructuring Charges
During the three months ended June 30, 2006, the Company incurred an additional restructuring
charge of $61,472 related to actions previously announced by management to control costs and
improve the focus of the Companys operations in order to reduce losses and conserve cash. The
restructuring charge recorded during the three months ended June 30, 2006 was for additional
severance related costs. The Company is accounting for the restructuring costs in accordance with
Statement of Financial Accounting Standards No. 146, Accounting for Costs Associated with Exit or
Disposal Activities.
The following table displays the restructuring activity and liability balances:
|
|
|
|
|
Balance at December 31, 2005 |
|
$ |
971,828 |
|
Restructuring charges for the six months ended June 30, 2006 |
|
|
351,105 |
|
Employee related payments |
|
|
(964,434 |
) |
Impairment charges related vacated space and fixed asset write-offs |
|
|
(169,910 |
) |
|
|
|
|
Balance at June 30, 2006 |
|
$ |
188,589 |
|
|
|
|
|
5. Deferred Merger Costs
The Company has recorded $1.6 million of deferred merger costs relating to the pending
acquisition of Predix (see note 1). These costs, including other additional acquisition costs that
are dependent upon the approval of the merger by the stockholders of EPIX and Predix, will be
included in total acquisition costs upon consummation of the merger.
6. Convertible Debt
In June 2004, the Company completed a sale, pursuant to Rule 144A under the Securities Act of
1933, of $100.0 million of 3.0% convertible senior notes due 2024 for net proceeds of approximately
$96.4 million. Each $1,000 of senior notes is convertible into 33.5909 shares of the Companys
common stock representing a conversion price of approximately $29.77 per share if (1) the price of
the Companys common stock trades above 120% of the conversion price for a specified time period,
(2) the trading price of the senior notes is below a certain threshold, (3) the senior notes have
been called for redemption, or (4) specified corporate transactions have occurred. None of these
conversion triggers has occurred as of June 30, 2006. Each of the senior notes is also convertible
into the Companys common stock in certain other circumstances. The senior notes bear an interest
rate of 3.0%, payable semiannually on June 15 and December 15 of each year. Interest payments of
$1.5 million were made during the six months ended June 30, 2006 and 2005. The senior notes are
unsecured and are subordinated to secured debt.
The Company has the right to redeem the notes on or after June 15, 2009 at an initial
redemption price of 100.85%, plus accrued and unpaid interest. Noteholders may require the Company
to repurchase the notes at par, plus accrued and unpaid interest, on June 15, 2011, 2014 and 2019
and upon certain other events, including a change of control and termination of trading, each as
defined in the indenture governing the senior notes.
In connection with the issuance of the senior notes, the Company incurred $3.65 million of
issuance costs, which primarily consisted of investment banker fees and legal and other
professional fees. The costs are being amortized as interest expense using the effective interest
method over the term from issuance through the first date that the holders are entitled to require
repurchase of the senior notes (June 2011). Amortization of the issuance costs for the three
months ended June 30, 2006 and 2005 was $124,868 and
11
$120,582, respectively, and for the six months
ended June 30, 2006 and 2005 was $243,977 and $235,443, respectively.
7. Subsequent Events
On July 13, 2006, the Company announced that Schering AG, which is undergoing a merger with
Bayer AG, will not exercise its option for the development of EPIXs fibrin-binding imaging agent
EP-2104R. Under the terms of the agreement, EPIX will retain full rights to the EP-2104R program.
8. Recent Accounting Pronouncements
In May 2005, the FASB issued Statement of Financial Accounting Standards No. 154, Accounting
Changes and Error Corrections, (SFAS 154), a replacement of APB No. 20, Accounting Changes,
and Statement of Financial Accounting Standards No. 3, Reporting Accounting Changes in Interim
Financial Statements, (SFAS 3). SFAS 154 replaces the provisions of SFAS 3 with respect to
reporting accounting changes in interim financial statements. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December 15, 2005. The
Company does not believe the adoption of SFAS 154 will have a material impact on its overall
financial position or results of operations.
In June 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes An Interpretation of FASB Statement No. 109, (FIN 48), which prescribes a
recognition threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. FIN 48 will be
effective for fiscal years beginning after December 15, 2006. The Company does not believe the
adoption of FIN 48 will have a material impact on its overall financial position or results of
operations.
12
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
At EPIX Pharmaceuticals, Inc., we discover and develop innovative pharmaceuticals for imaging
that are designed to transform the diagnosis, treatment and monitoring of disease. We use our
proprietary Target Visualization TechnologyTM to create imaging agents targeted
at the molecular level. These agents are designed to enable physicians to use magnetic resonance
imaging, or MRI, to obtain detailed information about specific disease processes. MRI has been
established as the imaging technology of choice for a broad range of applications, including the
identification and diagnosis of a variety of medical disorders. MRI is safe, relatively
cost-effective and provides three-dimensional images that enable physicians to diagnose and manage
disease in a minimally invasive manner.
We are currently developing two products for use in MRI to improve the diagnosis of multiple
diseases involving the bodys arteries and veins, collectively known as the vascular system:
VasovistTM, our novel blood-pool contrast agent for use in magnetic resonance
angiography, which was approved for marketing in all 25 member states of the European Union, or
E.U., in October 2005; and EP-2104R for detecting human thrombi, or blood clots, using MRI. We have
entered into various partnership agreements with Schering AG with respect to both Vasovist and
other product candidates. In addition, we have active research programs with respect to products
for diagnostic imaging and therapeutic uses.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The discussion and analysis of our financial condition and results of operations is based on
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States. The preparation of these financial statements requires us
to make estimates and judgments that affect our reported assets and liabilities, revenues and
expenses, and other financial information. Actual results may differ significantly from the
estimates under different assumptions and conditions.
Our significant accounting policies are more fully described in Note 2 of the Companys
Financial Statements for the year ended December 31, 2005. Not all significant accounting policies
require management to make difficult, subjective or complex judgments or estimates. We believe
that our accounting policies related to revenue recognition, research and development and employee
stock compensation, as described below, require critical accounting estimates and judgments.
Revenue Recognition
We recognize revenue from non-refundable license fees and milestone payments not specifically
tied to a separate earnings process ratably over the period during which we have substantial
continuing obligations to perform services under the contract. When milestone payments are
specifically tied to a separate earnings process, revenue is recognized when the specific
performance obligations associated with the payment are completed. When the period of deferral
cannot be specifically identified from the contract, we estimate the period of deferral based upon
our obligations under the contract. We continually review these estimates and, if any of these
estimates change, adjustments are recorded in the period in which they become reasonably estimable.
These adjustments could have a material effect on our results of operations.
We recognize as revenue the cash consideration received from Schering AG for efforts provided
by us in excess of our obligation under the agreement to expend 50% of the costs to developing
Vasovist. This revenue is recognized in the same period in which the costs are incurred. With
respect to payments due to Schering AG, if any, in connection with the Vasovist development
program, we would recognize such amounts as a reduction to revenue at the time Schering AG performs
the research and development activities for which we are obligated to pay Schering AG.
On a monthly basis, we calculate the revenue or reduction to revenue, as the case may be, with
respect to the partnership with Schering AG for Vasovist as follows:
|
|
|
We calculate our development costs directly related to Vasovist. |
|
|
|
|
We obtain cost reports, or an estimate of costs, from Schering AG for costs incurred by
them related to the development of Vasovist during the same period. Where estimates are
used, we review the estimates and record, as necessary, adjustments in the subsequent
quarter when we receive actual results from Schering AG. To date, there have been no
material adjustments. |
|
|
|
|
We multiply our and Schering AGs development costs by approximately 50% based on the
contractual allocation of work contemplated under the agreement. |
13
|
|
|
|
We then record the net difference as development revenue if the balance results in a
payment to us and negative revenue if the balance results in a payment to Schering AG. |
The result of this calculation is that we record revenue only for amounts we are owed by
Schering AG in excess of 50% of
development expenses of the project in the particular period. We would record a reduction to
revenue for any amounts owed to Schering AG in the particular period. To date, we have not been
required to make any payments to Schering AG.
We recognize product development revenue from Schering AG for the EP-2104R feasibility program
in proportion to our actual cost incurred relative to our estimate of the total cost of the
feasibility program. As estimated total cost to complete the program increases, revenue is adjusted
downwards, and conversely, as estimated total cost to complete decreases, revenue is adjusted
upwards. Total estimated costs of the feasibility program are based on managements assessment of
costs to complete the program based on an evaluation of the portion of the program completed, costs
incurred to date, planned program activities, anticipated program timelines and the expected future
costs of the program. Adjustments to revenue are recorded if estimated costs to complete change
materially from previous periods. To the extent that our estimated costs change materially, our
revenues recorded under this activity could be materially affected and such change could have a
material adverse effect on our operations in future periods.
Revenue under our research collaboration with Schering AG is recognized as services are
provided, for which Schering AG is obligated to reimburse us.
Royalty revenue is recognized based on actual revenues reported to us by Bracco Imaging
S.p.A., or Bracco, and Schering AG in the period in which royalty reports are received. We will be
entitled to receive a royalty on sales of Vasovist by Schering AG following the commercial launch
of the product in the E.U., which commenced in the second quarter of 2006. We will recognize
royalty revenue from sales of Vasovist in the E.U. in the quarter when Schering AG actually reports
those sales to us.
Research and Development
Research and development costs, including those associated with technology, licenses and
patents, are expensed as incurred. Research and development costs primarily include employee
salaries and related costs, third party service costs, the costs of preclinical and clinical trial
supplies and consulting expenses.
In order to conduct research and development activities and compile regulatory submissions, we
enter into contracts with vendors who render services over extended periods of time, generally one
to three years. Typically, we enter into three types of vendor contracts: time-based, patient-based
or a combination thereof. Under a time-based contract, using critical factors contained within the
contract, usually the stated duration of the contract and the timing of services provided, we
record the contractual expense for each service provided under the contract ratably over the period
during which we estimate the service will be performed. Under a patient-based contract, we first
determine an appropriate per patient cost using critical factors contained within the contract,
which include the estimated number of patients and the total dollar value of the contract. We then
record expense based upon the total number of patients enrolled during the period. On a quarterly
basis, we review both the timetable of services to be rendered and the timing of services actually
rendered. Based upon this review, revisions may be made to the forecasted timetable or to the
extent of services performed, or both, in order to reflect our most current estimate of the
contract. Adjustments are recorded in the period in which the revisions are estimable. These
adjustments could have a material effect on our results of operations.
Employee Stock Compensation
We have adopted the provisions of Statement of Financial Accounting Standards No. 123(R),
Share-Based Payment An Amendment of FASB Statements No. 123 and 95, or SFAS 123(R), beginning
January 1, 2006, using the modified prospective transition method. Under the modified prospective
transition method, financial statements for periods prior to the adoption date are not adjusted for
the change in accounting. However, compensation expense is recognized, based on the requirements of
SFAS 123(R), for (a) all share-based payments granted after the effective date and (b) all awards
granted to employees prior to the effective date that remain unvested on the effective date.
Determining the appropriate fair value model and calculating the fair value of share-based
awards requires us to make various judgments, including estimating the expected life of the
share-based award, the expected stock price volatility over the expected life of the share-based
award and forfeiture rates. In order to determine the fair value of share-based awards on the date
of grant, we use the Black-Scholes option-pricing model. Inherent in this model are assumptions
related to stock price volatility, option life, risk-free interest rate and dividend yield. The
risk-free interest rate is a less subjective assumption as it is based on treasury instruments
whose
14
term is consistent with the expected life of options. We use a dividend yield of zero as we
have never paid cash dividends and have no intention to pay cash dividends in the immediate future.
The stock price volatility and option life assumptions require a greater level of judgment which
makes them critical accounting estimates. Estimating forfeitures also requires significant
judgment. Our stock-price volatility assumption is based on trends in both our current and
historical volatilities of our stock and those of comparable companies. We use the simplified
method, as prescribed by the Securities and Exchange
Commissions, or SEC, Staff Accounting Bulletin No. 107, to
calculate the expected term
of options. We estimate forfeitures based on our historical experience of cancellations of
share-based compensation prior to vesting. We believe that our estimates are based on outcomes that
are reasonably likely to occur. To the extent actual forfeitures differ from our estimates, we will
record an adjustment in the period the estimates are revised. See Note 3 to the Notes to
Condensed Financial Statements (unaudited).
RESULTS OF OPERATIONS
Comparison of Three Months Ended June 30, 2006 versus 2005
Revenues
Our current revenues have arisen principally from our collaboration agreements with Schering
AG for Vasovist, EP-2104R and MRI discovery research; from license fee revenues relating to our
agreements with Schering AG, Tyco/Mallinckrodt and Bracco; and from royalties related to our
agreements with Bracco and Schering AG. Our MRI discovery research collaboration with Schering AG
concluded in May 2006. Revenues for the three months ended June 30, 2006 and 2005 were $1.4
million and $1.1 million, respectively. Revenues for 2006 consisted of $731,000 of product
development revenue from Schering AG, $463,000 of royalty revenue related to the Bracco and
Schering AG agreements and $162,000 of license fee revenue related to the Schering AG,
Tyco/Mallinckrodt strategic collaboration and Bracco agreements. The increase in total revenues of
$297,000 for the three months ended June 30, 2006 compared to the same period last year was
primarily attributed to higher product development revenue, which was partly offset by lower
royalty revenue. The product development revenue increase of $417,000 during the three month
period ended June 30, 2006 resulted from higher EP-2104R revenue recorded during the period, partly
offset by lower overall Vasovist development costs. The increase in EP-2104R revenue was due
primarily to last years downward revenue adjustment resulting from managements higher estimated
cost to complete the development of EP-2104R that we recognized in the second quarter of 2005. As
noted elsewhere in this Quarterly Report, Schering AG has decided not to exercise its option with
respect to EP-2104R, and accordingly we will not receive additional revenues from Schering AG
relating to this product. The decrease in royalty revenue compared to the same period last year
resulted from a reduction in the royalty rate on sales of MultiHance® by Bracco once total
qualified sales of MultiHance exceeded a level established in the agreement. With the expiration
in 2006 of certain patents related to the sublicense with Bracco, we expect to receive lower
royalty payments from Bracco beginning in the second half of 2006, and we expect such payments to
end in the first quarter of 2007.
Research and Development Expenses
Our research and development expenses have arisen from our development activities for Vasovist
and EP-2104R and from our discovery research programs. Research and development expenses for the
three months ended June 30, 2006 were $3.2 million compared to $5.6 million for the same period in
2005. The decrease of approximately $2.4 million was attributed to lower levels of spending on our
Vasovist and EP-2104R development programs and from lower expenditures on our MRI and therapeutics
research programs, partly offset by the non-cash expense of approximately $417,000 resulting from
our recognition of stock compensation related to the implementation of SFAS 123(R). Spending
during the second quarter of 2006 for Vasovist primarily involved reviewing our path forward with
the U.S. Food and Drug Administration, or FDA, and considering all options, including formally
appealing the FDAs decision to require an additional clinical trial and/or conducting one or more
additional clinical trials. With the completion of enrollment on our Phase II clinical trial for
EP-2104R in early 2006, the rate of spending during the current quarter for this development
program also decreased. Lastly, the reduction-in-force, which was announced in the fourth quarter
of 2005 and implemented in the first quarter of 2006, significantly reduced our spending activities
for both our MRI and therapeutics projects, all in an effort to control costs and improve the focus
of our operations in order to reduce losses and conserve cash.
15
The following table summarizes the primary components of our research and development expenses
for our principal research and development programs for the three months ended June 30, 2006 and
2005.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Research and Development |
|
2006 |
|
|
2005 |
|
Vasovist |
|
$ |
975,404 |
|
|
$ |
1,578,697 |
|
EP-2104R |
|
|
392,429 |
|
|
|
1,293,306 |
|
Other research |
|
|
1,871,867 |
|
|
|
2,765,423 |
|
|
|
|
|
|
|
|
Total research and development expenses |
|
$ |
3,239,700 |
|
|
$ |
5,637,426 |
|
|
|
|
|
|
|
|
The decrease in both Vasovist and EP-2104R development expenses for the three months ended
June 30, 2006 compared to the three months ended June 30, 2005 was primarily due to a decrease in
personnel associated with the reduction-in-force that took place in January 2006 and lower outside
expenses related to contract services and consultants required to support both efforts. The
decrease in other research expenses for the three months ended June 30, 2006 compared to the three
months ended June 30, 2005 was primarily due to a decrease in personnel costs for both the MRI
imaging and therapeutic research programs.
The timeframe and costs involved in developing our products, including Vasovist and EP-2104R,
and gaining regulatory approval for and commercializing our products may vary greatly from current
estimates for several reasons, including the following:
|
|
|
We conduct our clinical trials in accordance with specific protocols, which we have
filed with the FDA or other relevant authorities. If the FDA requires us to perform
additional studies, to perform additional procedures in our studies or to increase
patient numbers in those studies, we could incur significant additional costs and additional
time to complete our clinical trials, assuming we are able to reach agreement with the FDA on
protocols for any additional studies or procedures. |
|
|
|
|
We rely on third party clinical trial centers to find suitable patients for our
clinical trial program. If these clinical trial centers do not find suitable patients in
the timeframe for which we have planned, we will not be able to complete our clinical
trials according to our expected schedule. |
|
|
|
|
We rely on third party contract research organizations for a variety of activities in
our development program, including conducting blinded reading activities, lab testing and
analysis of clinical samples, data collection, cleanup and analysis and drafting study
reports and regulatory submissions. |
|
|
|
|
The length of time that the FDA or other regulatory authorities take to review our
regulatory submissions and the length of time it takes us to respond to the FDA or other
regulatory authorities questions can also vary widely. In January 2005, we received an
approvable letter from the FDA for Vasovist in which the FDA requested additional clinical
studies to demonstrate efficacy prior to approval. In May 2005, we submitted our response
to the approvable letter received from the FDA in January 2005 and it was accepted by the
FDA as a complete response in June 2005. In November 2005, we received a second approvable
letter from the FDA for Vasovist in which the FDA again requested an additional clinical
trial and a re-read, or reanalysis, of images in certain of the previously completed Phase
III trials by a new group of radiologists. We have filed a formal appeal with the FDA to
approve Vasovist and to utilize an advisory committee as part of the appeal process. The
FDA has advised us that it expects to respond to the appeal in September 2006. The process
of obtaining agreement with the FDA for conducting necessary clinical trial studies is
subject to significant uncertainties in terms of timing, costs and outcome. |
|
|
|
|
Our partner, Schering AG, is responsible for the commercial launch and marketing of
Vasovist in Europe, where Vasovist has been approved for commercial sale and is currently
being marketed by Schering AG, and in the U.S., where Vasovist is not approved for
commercial sale. |
We could incur increased clinical development costs if we experience delays in clinical trial
enrollment, delays in the evaluation of clinical trial results or delays in regulatory approvals.
In addition, we face significant uncertainty with respect to our ability to enter into strategic
collaborations with respect to our product candidates. As a result of these factors, it is
difficult to estimate the cost and length of a clinical trial. We are unable to accurately and
meaningfully estimate the cost to bring a product to market due to the variability in length of
time to develop and obtain regulatory approval for a product candidate.
Under our EP-2104R agreement, Schering AG made fixed payments to us totaling approximately
$9.0 million over a two year period, which was initially intended to cover most of our costs of the
feasibility program for EP-2104R. The amount of expenditures necessary to execute the feasibility
program is subject to numerous uncertainties, which may adversely affect our cash outlay. At year
end 2005, we lowered our estimate of costs to complete the feasibility program from $16.1 million
to $15.2 million because we were able to add new clinical trial sites and take other steps to
improve enrollment. We have completed this clinical trial. Schering AG had an option to
exclusively license EP-2104R, which it declined to exercise. As a result of Schering AG deciding
not to exercise this option, we intend to pursue a collaboration for the continued development of
EP-2104R with other potential partners. The future
16
clinical development plan of EP-2104R, and the
costs relating to that plan, are uncertain and we cannot estimate what portions of the future
development we will undertake and what portions of the future development a potential partner, if
any, will undertake.
General and Administrative Expenses
General and administrative expenses, which consist primarily of salaries, benefits, outside
professional services and related costs associated with our executive, finance and accounting,
business development, marketing, human resources, legal and corporate communications activities,
were $1.7 million for the three months ended June 30, 2006 as compared to $2.6 million for the
three months ended June 30, 2005. The decrease of $869,000 was primarily attributed to lower
marketing, non-merger related legal and consulting costs and to lower staff levels resulting from
the reduction in force that took place in January 2006, partly offset by the non-cash expense of
approximately $166,000 resulting from our recognition of stock compensation. General and
administrative expenses also include royalties payable to Massachusetts General Hospital, or MGH,
based on sales by Bracco of MultiHance. Royalty expenses totaled $28,000 and $26,000 for the three
months ended June 30, 2006 and 2005, respectively.
Restructuring Costs
The current quarters restructuring costs of $61,000 represent a continuation of planned
actions taken by management to control costs and improve the focus of operations in order to reduce
losses and conserve cash. In the fourth quarter of 2005, we announced a planned reduction in our
workforce by 48 employees, or approximately 50%, in response to the FDAs second approvable letter
regarding Vasovist. The reductions, which were completed in January 2006, affected both our
research and development and the general and administrative areas. During the most recent quarter,
we recorded restructuring costs primarily related to additional severance related costs.
Interest Income and Interest Expense
Interest income for the three months ended June 30, 2006 was $1.4 million as compared to
$951,000 for the three months ended June 30, 2005. The increase of $460,000 was primarily due to
higher interest rates on our invested cash, cash equivalents and marketable securities during the
period. Interest expense for the three months ended June 30, 2006 and 2005 was $876,000 and
$897,000, respectively. The decrease in interest expense of $21,000 for the three months ended
June 30, 2006 resulted primarily from the draw down of the Schering AG loan facility during the
second quarter of 2005 that was no longer available because the loan facility was terminated by
both parties in January 2006.
Provision for Income Taxes
The provision for income taxes, which represents Italian income taxes related to the Bracco
agreement, was $44,000 for the three months ended June 30, 2006 as compared to $0 for the three
months ended June 30, 2005. Because the remaining balance of prepaid royalties from Bracco has
been fully offset and we are receiving cash remittances from Bracco, Italian income taxes are being
withheld on Bracco royalties on sales of MultiHance. We expect to have Italian income taxes
withheld on all Bracco royalties for the remainder of the term of the agreement, which is expected
to end when the final royalty payment is made to us by Bracco in early 2007.
Comparison of Six Months Ended June 30, 2006 versus 2005
Revenues
Revenues for the six months ended June 30, 2006 and 2005 were $3.1 million. Revenues for 2006
consisted of $1.8 million of product development revenue from Schering AG, $920,000 of royalty
revenue related to the Bracco and Schering AG agreements and $323,000 of license fee revenue
related to the Schering AG, Tyco/Mallinckrodt strategic collaboration and Bracco agreements. The
decrease in total revenues of $86,000 for the six months ended June 30, 2006 compared to the same
period last year was primarily attributed to lower royalties from Bracco on sales of MultiHance.
The decrease in royalty revenue compared to the same period last year resulted from a reduction in
the royalty rate on sales of MultiHance by Bracco once total qualified sales of MultiHance exceeded
a level established in the agreement. With the expiration in 2006 of certain patents related to the
sublicense with Bracco, we expect to receive lower royalty payments from Bracco beginning in the
second half of 2006, and we expect such payments to end in the first quarter of 2007.
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2006 were $7.2 million
compared to $11.2 million for the
17
same period in 2005. The decrease of approximately $3.9 million
was attributed to lower levels of spending on our Vasovist and EP-2104R development programs and
from lower expenditures on our MRI and therapeutics research programs, partly offset by the
non-cash expense of approximately $936,000 resulting from our recognition of stock compensation
related to the implementation of SFAS 123(R). Spending during the second quarter of 2006 for
Vasovist primarily involved reviewing our path forward with the FDA, and included formally
appealing the FDAs decision to require an additional clinical trial and/or conducting one or more
additional clinical trials. With the completion of enrollment on our Phase II clinical trial for
EP-2104R in early 2006, the rate of spending during the current quarter for this development
program also decreased. Lastly, the reduction-in-force, which was announced in the fourth quarter
of 2005 and implemented in the first quarter of 2006, significantly reduced our spending activities
for both our MRI and therapeutics projects, all in an effort to control costs and improve the focus
of our operations in order to reduce losses and conserve cash.
The following table summarizes the primary components of our research and development expenses
for our principal research and development programs for the six months ended June 30, 2005 and
2006.
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Research and Development |
|
2006 |
|
|
2005 |
|
Vasovist |
|
$ |
2,199,386 |
|
|
$ |
3,189,857 |
|
EP-2104R |
|
|
1,145,157 |
|
|
|
2,704,222 |
|
Other research |
|
|
3,888,118 |
|
|
|
5,276,498 |
|
|
|
|
|
|
|
|
Total research and development expenses |
|
$ |
7,232,661 |
|
|
$ |
11,170,577 |
|
|
|
|
|
|
|
|
The decrease in both Vasovist and EP-2104R development expenses for the six months ended June
30, 2006 compared to the six months ended June 30, 2005 was primarily due to a decrease in
personnel associated with the reduction-in-force that took place in January 2006 and lower outside
expenses related to contract services and consultants required to support both efforts. The
decrease in other research expenses for the six months ended June 30, 2006 compared to the six
months ended June 30, 2005 was primarily due to a decrease in personnel costs for both the MRI
imaging and therapeutic research programs.
General and Administrative Expenses
General and administrative expenses were $4.0 million for the six months ended June 30, 2006
as compared to $5.3 million for the six months ended June 30, 2005. The decrease of $1.3 million
was primarily attributed to lower marketing, non-merger related legal and consulting costs and to
lower staff levels resulting from the reduction in force that took place in January 2006, partly
offset by the non-cash expense of approximately $440,000 resulting from our recognition of stock
compensation. General and administrative expenses also include royalties payable to Massachusetts
General Hospital, or MGH, based on sales by Bracco of MultiHance. Royalty expenses totaled $72,000
and $46,000 for the six months ended June 30, 2006 and 2005, respectively.
Restructuring Costs
The current year to date restructuring costs of $351,000 represent a continuation of planned
actions taken by management to control costs and improve the focus of operations in order to reduce
losses and conserve cash. During the six month period ended June 30, 2006, we recognized additional
restructuring costs related to vacating space in some of our facilities while subsequently
sub-leasing that space. We also recorded an impairment charge related to leasehold improvements
located in that same space as well as excess lab and office equipment in our facilities, and
additional severance related costs.
Interest Income and Interest Expense
Interest income for the six months ended June 30, 2006 was $2.7 million as compared to $1.8
million for the six months ended June 30, 2005. The increase of $919,000 was primarily due to
higher interest rates on our invested cash, cash equivalents and marketable securities during the
period. Interest expense for the six months ended June 30, 2006 and 2005 was $1.7 and $1.8
million, respectively. The decrease in interest expense of $63,000 for the six months ended June
30, 2006 resulted primarily from the draw down of the Schering AG loan facility during the six
month period ended June 30, 2005 that was no longer available because the loan facility was
terminated by both parties in January 2006.
Provision for Income Taxes
The provision for income taxes, which represents Italian income taxes related to the Bracco
agreement, was $88,000 for the six months ended June 30, 2006 as compared to $0 for the six months
ended June 30, 2005. Because the remaining balance of prepaid royalties from Bracco has now been
fully offset and we are receiving cash remittances from Bracco, Italian income taxes are being
withheld on Bracco royalties on sales of MultiHance. We expect to have Italian income taxes
withheld on all Bracco royalties for the
18
remainder of the term of the agreement, which is expected
to end when the final royalty payment is made to us by Bracco in early 2007.
LIQUIDITY AND CAPITAL RESOURCES
Our principal sources of liquidity consist of cash, cash equivalents and available-for-sale
marketable securities of $114.0 million at June 30, 2006 as compared to $124.7 million at December
31, 2005. The decrease in cash, cash equivalents and available-for-sale marketable securities was
primarily attributed to funding of ongoing operations.
We used approximately $9.1 million of net cash to fund operations for the six months ended
June 30, 2006, which compares to $13.0 million for the same period in 2005. The net use of cash to
fund operations during the six months ended June 30, 2006 resulted from the net loss of $7.7
million, which included non-cash expenses for amortization and depreciation of $640,000 and the
recognition of stock compensation expense of $1.4 million as a result of the adoption of SFAS
123(R) in January 2006. Other significant increases in uses of working capital included the
combined reductions in contract advances of $1.4 million and accounts payable/accrued expenses of
$2.0 million. The reduction in contract advances resulted from the offset of funds previously
received from Schering AG for the Vasovist and EP-2104R programs and from the MRI research
collaboration. Lower accounts payable and accrued expenses were primarily attributed to the
general reduction in development costs, including clinical trial activities.
Our investing activities resulted in net cash provided of $3.3 million during the six months
ended June 30, 2006 as compared to net cash provided of $13.4 million for the same period last
year. The net contribution of $5.0 million of proceeds from the sale and redemption of maturing
marketable securities, partly offset by the reinvestment into marketable securities of available
cash, and the increase in other assets resulting from the capitalization of transaction costs
related to the merger of $1.6 million, accounted for the entire increase in other investing
activities during the six months ended June 30, 2006. During the same six-month period last year,
we sold or redeemed available-for-sale marketable securities of $56.8 million, partly offset by the
cash used to purchase $42.7 million of available-for-sale marketable securities that was primarily
funded from the rollover of securities within our portfolio. We had $42,000 of capital
expenditures during the six months ended June 30, 2006, compared to $679,000 in capital
expenditures for the same period last year. The higher capital expenditures in 2005 were primarily
attributed to leasehold improvements.
We had $41,000 of cash provided from financing activities during the six months ended June 30,
2006, which was attributed to proceeds from our Employee Stock Purchase Plan. During the six
months ended June 30, 2005, the primary source of net financing came from the proceeds of stock
option exercises of $512,000. During the six month period ended June 30, 2005, we borrowed $30.0
million on the loan facility with Schering AG, of which $15.0 million was outstanding at June 30,
2005. Also during that same six month period, we repaid $30.0 million on our loan facility with
Schering AG, of which $15.0 million was outstanding at December 31, 2004. The loan facility with
Schering AG was terminated in January 2006.
We receive quarterly cash payments from Schering AG for its share of development costs of
Vasovist and for its share of research costs on our joint MRI research collaboration, which expired
in May 2006. We also receive monthly interest income on our cash, cash equivalents and
available-for-sale marketable securities. We are also scheduled to receive quarterly royalty
payments from Bracco for a portion of the royalty revenue actually earned from the sales of
MultiHance. With the expiration in 2006 of certain patents related to the sublicense with Bracco,
we expect to receive lower royalty payments from Bracco beginning in the second half of 2006, and
we expect such payments to end in the first quarter of 2007. We will also be entitled to receive a
royalty payment from sales of Vasovist by Schering AG following the commercial launch of the
product in the E.U., which began on a country-by-country basis in the second quarter of 2006. Other
potential cash inflows include: a milestone payment of $1.3 million from Schering AG, which is
dependent on the FDAs approval of Vasovist, and up to $22.0 million in additional milestone
payments from Schering AG as well as our share of the profits earned on sales of Vasovist
worldwide. As a result of Schering AG deciding not to exercise its option for the development of
EP-2104R, we no longer expect to receive funds from Schering AG for this program. In addition, our
MRI research collaboration with Schering AG expired in May 2006, so we do not expect any cash flows
from this collaboration. We expect to discuss the disposition of current research programs with
Schering AG and to continue to advance at least some of these programs either unilaterally or with
another partner. Pursuant to the license agreement between us and Schering AG, we are entitled to a
worldwide royalty on sales of certain Schering AG products covered by the agreement.
Known outflows, in addition to our ongoing research and development and general and
administrative expenses, include the semi-annual royalties that we owe to MGH on sales by Bracco of
MultiHance; a milestone payment of $2.5 million owed to Tyco/Mallinckrodt, which is dependent on
the FDAs approval of Vasovist; a share of profits due Tyco/Mallinckrodt on sales of Vasovist
worldwide; a royalty to Daiichi on sales of Vasovist in Japan and a royalty due MGH on our share of
the profits of Vasovist worldwide. In addition, as a result of Schering AG deciding not to exercise
its option for the development of EP-2104R, we may be required to incur significant additional
expenses to continue the development of EP-2104R, even if we successfully enter into a new
19
collaboration arrangement for EP-2104R. With the expiration in 2006 of certain patents related to
the license with MGH, we expect to reduce our royalty payments to MGH beginning in the second half
of 2006. As of December 31, 2005, all remaining unearned prepaid royalties that would be due to
Bracco upon termination of our license agreement have been offset against earned royalties.
We expect that our cash, cash equivalents and marketable securities on hand as of June 30,
2006 will be sufficient to fund our operations for at least the next several years. However, we
premise this expectation on our current operating plan, which may change as a result of many
factors, including our acquisition of Predix. Taking into consideration our acquisition of Predix
and incorporating its research and development programs into our operations, we estimate that cash,
cash equivalents and marketable securities on hand as of June 30, 2006, together with expected
revenue from the sale of Vasovist and reimbursement of clinical trial costs by Schering AG, and the
cash, cash equivalents and marketable securities acquired from Predix, will fund the combined
companys operations through 2007. If, however, we consider other opportunities, change our planned
activities or are required to pay all or a substantial portion of the milestone payment under the
merger agreement in cash, we may require additional funding before currently expected. On July 31,
2006, Predix entered into an exclusive worldwide license agreement with Amgen Inc. to develop and
commercialize products based on Predixs preclinical compounds which target the GPCR
sphingosine-1-phosphate receptor-1, or S1P1, and compounds and products that may be identified by or
acquired by Amgen and that are active against the S1P1 receptor. Our board of directors has
determined that Predixs entry into the agreement with Amgen resulted in the achievement of a
milestone pursuant to the terms of the merger agreement by and between us and Predix and described
in the Joint Proxy Statement/Prospectus. Accordingly, in addition to the initial merger
consideration, Predix stockholders, option holders and warrant holders will be entitled to the
milestone payment under the merger agreement in the aggregate amount of $35.0 million. If holders
of our convertible senior notes require redemption of the notes, we may be required to repay $100.0
million upon any redemption. Our future liquidity and capital requirements will depend on numerous
factors, including the following: the progress and scope of clinical and pre-clinical trials; the
timing and costs of filing future regulatory submissions; the timing and costs required to receive
both U.S. and foreign governmental approvals; the cost of filing, prosecuting, defending and
enforcing patent claims and other intellectual property rights; the extent to which our products,
if any, gain market acceptance; the timing and costs of product introductions; the extent of our
ongoing and new research and development programs; the costs of training physicians to become
proficient with the use of our potential products; and, if necessary, once regulatory approvals are
received, the costs of developing marketing and distribution capabilities. If we complete the
merger, Predix does not have significant revenues and has significant product development expenses
which will accelerate our use of funds and our need for additional funding.
Because of anticipated spending for the continued development of Vasovist and EP-2104R and to
support selective research programs, we do not expect positive cash flow from operating activities
for any future quarterly or annual period prior to commercialization of Vasovist in the United
States.
The following table, which has been adjusted to reflect changes since the filing of our
Contractual Obligations table as set forth in
our Annual Report on Form 10-K for the year ended December 31, 2005, represents payments due
under contractual obligations and commercial commitments as of June 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments
Due by Period |
|
|
|
|
|
|
|
Less than |
|
|
1-3 |
|
|
3-5 |
|
|
More than |
|
Contractual Obligations |
|
Total |
|
|
1 year |
|
|
years |
|
|
years |
|
|
5 years |
|
Long-term debt obligations, including
interest payments |
|
$ |
114,875,000 |
|
|
$ |
3,000,000 |
|
|
$ |
6,000,000 |
|
|
$ |
105,875,000 |
|
|
$ |
|
|
Operating lease obligations |
|
|
1,708,303 |
|
|
|
1,144,679 |
|
|
|
562,972 |
|
|
|
652 |
|
|
|
|
|
Purchase obligations |
|
|
3,049,928 |
|
|
|
3,013,178 |
|
|
|
30,750 |
|
|
|
6,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
119,633,230 |
|
|
$ |
7,157,856 |
|
|
$ |
6,593,722 |
|
|
$ |
105,881,652 |
|
|
$ |
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We have incurred tax losses to date and therefore have not paid significant federal or state
income taxes since inception. As of December 31, 2005, we had federal net operating loss
carryforwards of approximately $180.5 million available to offset future taxable income. These
amounts expire at various times through 2025. As a result of ownership changes resulting from
sales of equity securities, our ability to use the net operating loss carryforwards is subject to
limitations as defined in Sections 382 and 383 of the Internal Revenue Code of 1986, or the Code,
as amended. We currently estimate that the annual limitation on our use of net operating losses
generated through May 31, 1996 to be approximately $900,000. Pursuant to Sections 382 and 383 of
the Code, the change in ownership resulting from public equity offerings in 1997 and any other
future ownership changes may further limit utilization of losses and credits in any one year. We
also are eligible for research and development tax credits that can be carried forward to offset
federal taxable income. The annual limitation and the timing of attaining profitability may result
in the expiration of net operating loss and tax credit carryforwards before utilization.
20
Certain Factors That May Affect Future Results of Operations
This report contains certain forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. Such statements are based on managements current
expectations and are subject to a number of factors and uncertainties, which could cause actual
results to differ materially from those described in the forward-looking statements. We caution
investors that there can be no assurance that actual results or business conditions will not differ
materially from those projected or suggested in such forward-looking statements as a result of
various factors, including, but not limited to, the following: the uncertainties and costs
associated with pre-clinical studies and clinical trials; our lack of product revenues; the need to
devote resources to the development of Predix products following the completion of the merger; our
history of operating losses and accumulated deficit; our lack of commercial manufacturing
experience and commercial sales, distribution and marketing capabilities; reliance on suppliers of
key materials necessary for production of our products and technologies; the potential development
by competitors of competing products and technologies; our dependence on existing and potential
collaborative partners, and the lack of assurance that we will receive any funding under such
relationships to develop and maintain strategic alliances; the lack of assurance regarding patent
and other protection for our proprietary technology; governmental regulation of our activities,
facilities, products and personnel; the dependence on key personnel; uncertainties as to the extent
of reimbursement for the costs of our potential products and related treatments by government and
private health insurers and other organizations; the potential adverse impact of
government-directed health care reform; the risk of product liability claims; and economic
conditions, both generally and those specifically related to the biotechnology industry. As a
result, our future development efforts involve a high degree of risk. For further information,
refer to the more specific risks and uncertainties discussed in our Annual Report on Form 10-K, as
amended, for the year ended December 31, 2005, and to those discussed under Part II Item 1A
Risk Factors, of this Quarterly Report on Form 10-Q.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The objective of our investment activities is to preserve principal, while at the same time
maximizing yields without significantly increasing risk. To achieve this objective, in accordance
with our investment policy, we invest our cash in a variety of financial instruments, principally
restricted to U.S. government issues, high-grade bank obligations, high-grade corporate bonds and
certain money market funds. These investments are denominated in U.S. dollars.
Investments in both fixed rate and floating rate interest earning instruments carry a degree
of interest rate risk. Fixed rate securities may have their fair market value adversely impacted
due to a rise in interest rates, while floating rate securities may produce less income than
expected if interest rates fall. Due in part to these factors, our future investment income may
fall short of expectations due to changes in interest rates or we may suffer losses in principal if
forced to sell securities that have seen a decline in market value due to changes in interest
rates. A hypothetical 10% increase or decrease in interest rates would result in a decrease in the
fair market value of our total portfolio of approximately $89,000, and an increase of approximately
$89,000, respectively, at June 30, 2006.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures. Our principal executive officer and
principal financial officer, after evaluating the effectiveness of our disclosure controls
and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of
the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such
evaluation, our disclosure controls and procedures were adequate and effective to ensure that
material information relating to us was made known to them by others within those entities,
particularly during the period in which this Quarterly Report on Form 10-Q was being
prepared.
(b) Changes in Internal Controls. There were no significant changes in our internal control
over financial reporting identified in connection with the evaluation of such internal
control that occurred during our last fiscal quarter that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
On January 27, 2005, a securities class action was filed in U.S. District Court for the
District of Massachusetts against us and certain of our officers on behalf of persons who purchased
the Companys common stock between July 10, 2003 and January 14, 2005. The complaint alleges that
our Company and certain of our officers violated the Securities Exchange Act of 1934 by issuing a
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series of materially false and misleading statements to the market throughout the class period,
which statements had the effect of artificially inflating the market price of the Companys
securities. After this initial complaint was filed, other similar actions were filed against the
Company and the same officers in the U.S. District Court for the District of Massachusetts. One of
these later-filed
complaints purports to be brought on behalf of persons who purchased the Companys common
stock between March 18, 2002 and January 14, 2005. Since these actions were filed, various
plaintiffs have filed motions to consolidate the related actions, and to appoint a lead plaintiff
and lead counsel. On September 27, 2005, these motions were consolidated by the U.S. District
Court. On January 31, 2006, the U.S. District Court for the District of Massachusetts granted our
Motion to Dismiss for Failure to Prosecute the previously disclosed shareholder class action
lawsuit against the Company. The dismissal was issued without prejudice after a hearing, which
dismissal does not prevent another suit to be brought based on the same claims.
We are not a party to any other material pending legal proceedings.
ITEM 1A. RISK FACTORS
An investment in our common stock involves a high degree of risk. You should carefully
consider the following risk factors and other information in our periodic reports filed with the
SEC. If any of the following risks actually occur, our
business, financial condition or results of operations could be materially and adversely affected.
RISKS RELATING TO THE PROPOSED MERGER WITH PREDIX
If we are not successful in integrating our organizations, we may not be able to operate
efficiently after the merger.
Achieving the benefits of the merger with Predix will depend in part on the successful
integration of our operations and personnel in a timely and efficient manner. The integration
process requires coordination of different development, regulatory, manufacturing and commercial
teams, and involves the integration of systems, applications, policies, procedures, business
processes and operations. This may be difficult and unpredictable because of possible cultural
conflicts and different opinions on scientific and regulatory matters. The combination of our and
Predixs organizations may result in greater competition for resources and the elimination of
research and development programs that might otherwise be successfully completed. If we cannot
successfully integrate our operations and personnel, we may not realize the expected benefits of
the merger.
Integrating our companies may divert managements attention away from our operations.
Successful integration of our operations, product candidates and personnel may place a
significant burden on our management and our internal resources. The integration will require
efforts from each company, including the coordination of their general and administrative
functions. For example, integration of administrative functions includes coordinating employee
benefits, payroll, financial reporting, purchasing and disclosure functions. Delays in successfully
integrating and managing employee benefits could lead to dissatisfaction and employee turnover.
Problems in integrating purchasing and financial reporting could result in control issues,
including unplanned costs. In addition, the combination of our and Predixs organizations may
result in greater competition for resources and elimination of research and development programs
that might otherwise be successfully completed, especially in light of the difference in our
current imaging focus and Predixs current therapeutic focus. The diversion of managements
attention and any difficulties encountered in the transition and integration process could result
in delays in the companies clinical trial programs and could otherwise harm our business,
financial condition and operating results.
We expect to incur significant costs in connection with the merger and in integrating the
companies into a single business.
We estimate that we and Predix will incur aggregate direct transaction costs of approximately
$5.8 million associated with the merger. In addition, we expect to incur significant costs
integrating our operations, product candidates and personnel, which cannot be estimated accurately
at this time. These costs may include costs for:
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conversion of information systems; |
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combining development, regulatory, manufacturing and commercial teams and processes; |
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reorganization of facilities; and |
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relocation or disposition of excess equipment. |
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If the total costs of the merger exceed our estimates, or benefits of the merger do not exceed
the total costs of the merger, the financial results of the combined company could be adversely
affected.
We may be unable to repay, repurchase or redeem our 3.0% Convertible Senior Notes due 2024 if,
and when, required.
The entire $100.0 million outstanding principal amount of our 3.0% Convertible Senior Notes
will become due and payable at maturity in 2024. In addition, noteholders may require us to
repurchase these notes at par, plus accrued and unpaid interest, on June 15, 2011, 2014 and 2019
and upon certain other designated events under the notes, which include a change of control of us
or termination of trading of our common stock on The NASDAQ Global Market. The definition of change
in control set forth in the indenture governing the notes does not include certain mergers and
similar transactions that are not deemed a change in control. While we believe that the merger does
not constitute a change of control of us under the indenture, we cannot assure you that we will not
become obligated to repurchase these notes, in whole or in part, as a result of this merger. Based
on the current trading price of our common stock, we anticipate that in such event most, if not
all, of the noteholders would tender their notes for repurchase. We may not have enough funds or be
able to arrange for additional financing to repurchase the notes tendered by the holders upon a
designated event or otherwise. Any failure to repurchase tendered notes would constitute an event
of default under the indenture, which might also constitute a default under the terms of our other
debt. If we are required to repurchase or redeem these notes prior to their maturity, whether as a
result of this merger or otherwise, the financial position of the combined company would be
materially adversely affected and the anticipated benefits of the merger would be significantly
diminished.
Our failure to comply with the initial listing standards of The NASDAQ Global Market will
subject our stock to delisting from The NASDAQ Global Market, which listing is a condition to
the consummation of the merger.
Our common stock is currently listed for trading on The NASDAQ Global Market. Immediately
prior to the consummation of the merger, we will be required to meet the initial listing
requirements to maintain the listing and continued trading of our shares on The NASDAQ Global
Market. These initial listing requirements are more difficult to achieve than the continued listing
requirements under which we are now trading. Based on information currently available to us, we
anticipate that we will be unable to meet the $5.00 minimum bid price initial listing requirement
at the closing of the merger unless we effect a reverse stock split as discussed in our Proposal
No. 3 contained in our Joint Proxy Statement/Prospectus relating to the merger. If we are unable to
satisfy these requirements, NASDAQ will notify us that our stock will be subject to delisting from
The NASDAQ Global Market. It is a condition to Predixs obligation to consummate the merger that we
maintain the listing of our common stock on The NASDAQ Global Market. In addition, oftentimes a
reverse stock split will not result in a trading price for the affected common stock that is
proportional to the ratio of the split. We believe that a reverse stock split is in the best
interest of the combined company and its stockholders. However, we cannot assure you that the
implementation of the reverse stock split will have a positive impact on the price of our common
stock.
If we fail to retain key employees, the benefits of the merger could be diminished.
The successful combination of EPIX and Predix will depend in part on the retention of key
personnel, including Michael G. Kauffman, M.D., Ph.D., Andrew C.G. Uprichard, M.D. and Kimberlee C.
Drapkin, the expected Chief Executive Officer, President and Chief Financial Officer of the
combined company, respectively. There can be no assurance that we will be able to retain our key
management and scientific personnel. Although Dr. Kauffman and Ms. Drapkin are subject to
employment agreements with Predix, the employment agreements may be terminated by either party for
any reason and there is no guarantee that Dr. Kauffman, Dr. Uprichard or Ms. Drapkin will remain
with the combined company. If we fail to retain such key employees, particularly those identified
in the Joint Proxy Statement/Prospectus relating to the merger as the expected management of the
combined company, we may not realize the anticipated benefits of the merger. The business of each
of EPIX and Predix is also subject to risks associated with the retention of key employees which
are discussed in greater detail below.
If one or more of the product candidates in the combined company cannot be shown to be safe and
effective in clinical trials, is not approvable or not commercially successful, then the
benefits of the merger may not be realized.
The combined company will have five product candidates in the clinic and several additional
product candidates planned to enter clinical testing in the next several years. All of these
product candidates must be rigorously tested in clinical trials, and shown to be safe and effective
before the FDA or its foreign counterparts, will consider them for approval. Failure to demonstrate
that one or more of the product candidates is safe and effective, or significant delays in
demonstrating safety and efficacy, could diminish the benefits of the merger. All of these product
candidates must be approved by a government authority such as the FDA before they can be
commercialized. Failure of one or more of the product candidates to obtain such approval, or
significant delays in obtaining such approval, could diminish the benefits of the merger. Even if
approved for sale, these product candidates must be successfully commercialized. Failure to
commercialize successfully one or more of these product candidates could diminish the benefits of
the merger.
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Because Predix stockholders will receive a fixed number of shares of our common stock in the
merger, rather than a fixed value, if the market price of our common stock declines, Predix
stockholders will receive consideration in the merger of lesser value and if the market price of
our common stock increases, we will pay consideration in the merger of greater value.
The aggregate number of shares of our common stock to be issued to Predix stockholders is
fixed. Accordingly, the aggregate number of shares that Predix stockholders will receive in the
merger will not change, even if the market price of our common stock changes. In recent years, the
stock market in general, and the securities of biotechnology companies in particular, including our
securities, have experienced extreme price and volume fluctuations. These market fluctuations may
adversely affect the market price of our common stock. The market price of our common stock upon
and after the consummation of the merger could be lower than the market price on the date of the
merger agreement or the current market price, which would decrease the value of the consideration
to be received by Predix stockholders in the merger. Predix stockholders should obtain recent
market quotations of our common stock before they vote on the merger.
In addition, the market price of our common stock upon and after the consummation of the
merger could be higher than the market price on the date of the merger agreement or the current
market price. As a result of the fixed number of shares of our common stock issuable in the merger,
increases in the market price of our common stock would increase the value of the consideration
payable by us in the merger. Our stockholders should obtain recent market quotations of our common
stock before they vote on the matters set forth in the Joint Proxy Statement/Prospectus.
The merger may fail to qualify as a reorganization for U.S. federal income tax purposes,
resulting in recognition of taxable gain or loss by Predix stockholders in respect of their
Predix stock.
We and Predix intend for the merger to qualify as a reorganization within the meaning of
Section 368(a) of the Internal Revenue Code of 1986, as amended. Although the Internal Revenue
Service, or IRS, will not provide a ruling on the matter, both we and Predix will, as a condition
to closing, obtain a legal opinion from our respective tax counsel that the merger will constitute
a reorganization for U.S. federal income tax purposes. These opinions do not bind the IRS, nor do
they prevent the IRS from adopting a contrary position. If the merger fails to qualify as a
reorganization, each Predix stockholder generally will be treated as exchanging their Predix stock
in a fully taxable transaction for our common stock and the milestone payment obligation. In
addition, the merger would be treated as a sale of all of the assets of Predix to us, with a
corporate level tax liability owed by us for the period in which the merger occurs. Such a tax
liability may be significant and could have a material adverse effect on the financial position of
the combined company.
Failure to complete the merger could adversely affect our stock price and our and Predixs
future business and operations.
The merger is subject to the satisfaction of various closing conditions, including the
approval by both our and Predix stockholders, and neither we nor Predix can guarantee that the
merger will be successfully completed. In the event that the merger is not consummated, we and
Predix will be subject to many risks, including the costs related to the merger, such as legal,
accounting and advisory fees, which must be paid even if the merger is not completed, or the
payment of a termination fee under certain circumstances. If the merger is not consummated, the
market price of our common stock could decline.
Certain of our directors and management and certain directors and management of Predix may have
interests that are different from, or in addition to our stockholders and the stockholders of
Predix.
The directors and management of us and Predix may have interests in the merger that are
different from, or are in addition to, those of the respective our stockholders and Predix
stockholders generally, including the following:
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Upon the closing of the merger, Christopher F.O. Gabrieli, Michael Gilman, Ph.D., Mark
Leuchtenberger and Gregory D. Phelps, each of whom is a current member of our board of
directors, is expected to be a member of the combined companys board of directors. |
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It is anticipated that certain of our current officers and key employees, including
Andrew C.G. Uprichard, M.D., Philip Graham, Ph.D., and Brenda Sousa, will be executive
officers or key employees of the combined company. |
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Upon completion of the merger, Brenda Sousa, our Vice President of Human Resources, is
entitled to a bonus of $47,500. In addition, Philip Chase, our Vice President and General
Counsel, is entitled to a bonus of $72,000 upon completion of the merger. |
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Upon the closing of the merger, the executive officers of Predix, including Michael G.
Kauffman, M.D., Ph.D., Silvia
Noiman, Ph.D., Oren Becker, Ph.D., Chen Schor and Kimberlee C. Drapkin will become executive
officers of the combined company. |
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We will maintain all rights to indemnification existing in favor of Predix directors
and officers for their acts and omissions occurring prior to the completion of the merger
and will maintain the directors and officers liability insurance to cover any such
liabilities for six years following the completion of the merger. |
In addition, you should be aware that Frederick Frank, Michael G. Kauffman, M.D., Ph.D.,
Patrick J. Fortune, Ph.D. and Ian F. Smith, CPA, ACA will have a relationship with both us and
Predix due to their positions as current directors of Predix and future members of our board of
directors. Moreover, Mr. Frank, the Chairman of the Predix board of directors, is also the Vice
Chairman and a director of Lehman Brothers Inc., Predixs financial advisor in connection with the
merger. Lehman Brothers is entitled to a fee of $2.0 million from Predix, all of which is
contingent upon consummation of the merger, as well as reimbursement of up to $50,000 of its
expenses. Please see the sections of the Joint Proxy Statement/Prospectus entitled The Merger
Interests of Predixs Directors and Management in the Merger and Current Management of Predix and
Related Information Certain Transactions with Management and Affiliates.
In addition, options, with exercise prices ranging from $0.81 to $2.99, held by each of
Michael G. Kauffman, M.D., Ph.D., Silvia Noiman, Ph.D., Oren Becker, Ph.D., Chen Schor and
Kimberlee C. Drapkin to purchase 594,679, 308,096, 261,376, 251,213, and 144,996 shares,
respectively, will become immediately exercisable in full if, within 12 months after the merger,
the officer is terminated without cause or terminates his or her employment due to a material
change in duties, authority or responsibilities.
These interests may influence these directors in making their recommendation that you vote in
favor of the approval and adoption of the merger agreement, the approval of the merger and/or the
approval of the amendment to our restated certificate of incorporation. You should be aware of
these interests when you consider the respective Predix and EPIX boards of directors
recommendations that you vote in favor of the approval and adoption of the merger agreement, the
approval of the merger and/or the approval of the amendment to our restated certificate of
incorporation.
Our stockholders will have a reduced ownership and voting interest after the merger and will
exercise less influence over management of the combined company following the merger.
After the merger, the stockholders of each of EPIX and Predix will own a significantly smaller
percentage of the combined company than their respective ownership of Predix and us. At the
effective time of the merger, our stockholders will collectively own approximately 53% of the
outstanding shares of the combined company and Predix stockholders will collectively own
approximately 47% of the outstanding shares of the combined company, based on the number of shares
of our common stock and Predix common stock and preferred stock outstanding as of the date of the
merger agreement. Consequently, our stockholders and Predix stockholders will be able to exercise
less influence over the management and policies of the combined company than they currently
exercise over the management and policies of their respective companies.
Future sales of common stock by our existing stockholders and existing stockholders of Predix
may cause the stock price of the combined company to fall.
The market price of our common stock could decline as a result of sales by our existing
stockholders and former Predix stockholders in the market after the completion of the merger, or
the perception that these sales could occur. These sales might also make it more difficult for the
combined company to sell equity securities at an appropriate time and price.
RISKS RELATING TO EPIX
Research and Development Risks
We may never receive marketing approval for any of our product candidates in the United States,
including Vasovist and EP-2104R.
We are not able to market any of our product candidates in the United States, Europe or in any
other jurisdiction without marketing approval from the FDA, the European Commission, or any
equivalent foreign regulatory agency. The regulatory process to obtain marketing approval for a new
drug or biologic 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.
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Although the European Medicines Agency, or the EMEA, granted approval of Vasovist for all 25
member states of the E.U. in
October 2005, Vasovist has not been approved in the United States. In December 2003, we
submitted a new drug application, or NDA, for Vasovist to the FDA, and in June 2004, our
development partner Schering AG submitted a Marketing Authorization Application, to the EMEA. In
January 2005, we received an approvable letter from the FDA for Vasovist in which the FDA requested
additional clinical trials prior to approval. In May 2005, we submitted a response to the FDA
approvable letter, which was accepted by the FDA as a complete response in June 2005. In November
2005, the FDA provided us with a second approvable letter. Although no safety or manufacturing
issues were raised in the second approvable letter, the second approvable letter indicated that at
least one additional clinical trial and a re-read of images obtained in certain previously
completed Phase III trials will be necessary before the FDA could approve Vasovist. We believe that
these trials would require a substantial period of time to complete. We have had two meetings with
the FDA since receiving the second approvable letter to discuss the path forward for Vasovist in
the United States. After considering the parameters of the additional clinical trials requested by
the FDA, we filed a formal appeal with the FDA asking the FDA to approve Vasovist and to utilize an
advisory committee as part of the appeal process. The approval, timeliness of approval or labeling
of Vasovist are subject to significant uncertainties related to a number of factors, including the
outcome of the appeal, the process of reaching agreement with the FDA on the clinical data and on
any clinical trial protocol required for regulatory approval of Vasovist, a re-read, or reanalysis,
of images obtained from completed Phase III trials by a new group of radiologists, the timing and
process of conducting any clinical trials that may be ultimately required if the appeal is denied,
obtaining the desired outcomes of any required clinical trials and the FDAs review process and
conclusions regarding any additional Vasovist regulatory submissions. We cannot assure you that our
appeal will be successful or that we will be able to reach agreement with the FDA on the design or
clinical endpoints required for additional clinical trials or re-read of images from the completed
Phase III trials that may be required if the appeal is denied. Further, we cannot assure you that
any such agreed upon clinical trials will be feasible for us to conduct or whether such trials will
be completed in a commercially reasonable timeframe, if at all. Any further clinical trials that
are required could take several years to complete.
If the FDA does not approve Vasovist, then we will not receive revenues based on sales of
Vasovist in the United States. Even if ultimately approved, we do not expect revenues from the
commercial sales of any of our product candidates, other than Vasovist, for at least several years.
We completed a Phase IIa clinical trial of EP-2104R. Schering AG had an option to exclusively
license EP-2104R, which it declined to exercise. As a result of Schering AG deciding not to
exercise this option, we intend to pursue a collaboration for the continued development of EP-2104R
with other potential partners. The future clinical development plan of EP-2104R, and the costs
relating to that plan, are uncertain at this time, and the timing and number of future clinical
trials depends upon many factors, including our ability to enter into a collaboration to continue
the development of EP-2104R. If we are unable to find a new collaborative partner, we may bear the
expenses of further clinical development ourselves, which expenses would be significant.
Regardless, the FDA, the EMEA and other regulatory agencies to which we or our partners submit
applications for marketing authorization may not agree that our product candidate is safe and
effective and may not approve our product candidate, in which case our ability to receive any
revenues, milestone payments or royalty payments related to EP-2104R will be significantly reduced.
The relevant regulatory authorities may not approve any of our applications for marketing
authorization relating to any of our product candidates, including Vasovist and EP-2104R, or
additional applications for or variations to marketing authorizations that we may make in the
future as to these or other product candidates. Among other things, we have had only limited
experience in preparing applications and obtaining regulatory approvals. If approval is granted, it
may be subject to limitations on the indicated uses for which the product candidate may be marketed
or contain requirements for costly post-marketing testing and surveillance to monitor safety or
efficacy of the product candidate. If approval of an application to market product candidates is
not granted on a timely basis or at all, or if we are unable to maintain our approval, our business
may be materially harmed.
We are currently focusing our development efforts on only two product candidates and one
research program and will have limited prospects for successful operations if our two lead
product candidates do not prove successful in clinical trials or if our only research program
does not produce another product candidate suitable for clinical trials.
As a result of the FDAs second approvable letter regarding Vasovist, we eliminated
approximately 50% of our workforce in January 2006. As part of this reorganization, we are focusing
our resources primarily on the development of our lead product candidates, Vasovist and EP-2104R.
Accordingly, we have decided to cease work on the majority of our research projects related to
imaging. We continue to allocate resources to one high-priority research project. Our efforts may
not lead to commercially successful products for a number of reasons, including the inability to be
proven safe and effective in clinical trials, the lack of regulatory approvals or obtaining
regulatory approvals that are narrower than we seek, inadequate financial resources to complete the
development and commercialization of our product candidates or their lack of acceptance in the
marketplace. Given our limited focus on two lead product candidates and only one research program,
if Vasovist and EP-2104R do not prove successful in clinical trials or are not commercialized for
any reason, we will have only one operational research program from which to seek additional
product
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candidates. If we are not able to identify additional product candidates from this single
research program, we may be required to suspend or discontinue our operations and you could lose
your entire investment in us.
If our clinical trials are not successful, we may not be able to develop and commercialize
our product candidates.
To obtain regulatory approvals for the commercial sale of our potential products, we and our
partners will be required to complete extensive clinical trials in humans to demonstrate the safety
and efficacy of our product candidates. Vasovist and EP-2104R are currently our only product
candidates that have undergone human clinical trials and we cannot be certain that any of our other
research projects will yield a product candidate suitable for substantial human clinical testing.
With respect to both our current product candidates in human clinical trials and our research
product candidates which may be suitable for testing in human clinical trials at some point in the
future, we may not be able to commence or complete the required clinical trials in any specified
time period, or at all, either because the FDA or other regulatory agencies object, because we are
unable to attract or retain clinical trial participants, or for other reasons.
Even if we complete a clinical trial of one of our potential products, the data collected from
the clinical trial may not demonstrate that our product candidate is safe or effective to the
extent required by the FDA, the EMEA, or other regulatory agencies to approve the potential product
candidate, or at all. For example, in January and November 2005, the FDA informed us that the
clinical efficacy data for Vasovist that we submitted in connection with our NDA was not adequate
for approval.
The results from pre-clinical testing of a product candidate that is under development may not
be predictive of results that will be obtained in human clinical trials. In addition, the results
of early human clinical trials may not be predictive of results that will be obtained in larger
scale, advanced-stage clinical trials. Furthermore, we, one of our collaborators, or a regulatory
agency with jurisdiction over the trials may suspend clinical trials at any time if the patients
participating in such trials are being exposed to unacceptable health risks, or for other reasons.
The timing of completion of clinical trials is dependent in part upon the rate of enrollment
of patients. Patient accrual is a function of many factors, including the size of the patient
population, the proximity of patients to clinical sites, the eligibility criteria for the trial,
the existence of competitive clinical trials, and the availability of alternative treatments.
Delays in planned patient enrollment may result in increased costs and prolonged clinical
development. In addition, patients may withdraw from a clinical trial for a variety of reasons. If
we fail to accrue and maintain the number of patients into one of our clinical trials for which the
clinical trial was designed, the statistical power of that clinical trial may be reduced which
would make it harder to demonstrate that the product candidates being tested in such clinical trial
are safe and effective.
Regulatory authorities, clinical investigators, institutional review boards, data safety
monitoring boards and the hospitals at which our clinical trials are conducted all have the power
to stop our clinical trials prior to completion. If our trials are not completed, we would be
unable to show the safety and efficacy required to obtain marketing authorization for our product
candidates.
We must receive government regulatory approval for our product candidates before they can be
marketed and sold in the United States or in other countries and this approval process is
uncertain, time-consuming and expensive.
Vasovist and EP-2104R are regulated by the FDA as drugs. Under the Food, Drug and Cosmetic Act
and the FDAs implementing regulations, the FDA regulates the research, development, manufacture
and marketing, among other things, of pharmaceutical products. The process required by the FDA
before Vasovist and our other product candidates may be marketed in the United States typically
involves the performance of pre-clinical laboratory and animal tests; submission of an
investigational new drug application, or IND; completion of human clinical trials; submission of an
NDA to the FDA; and FDA approval of an NDA.
This regulatory approval process is lengthy and expensive. Although some of our employees have
experience in obtaining regulatory approvals, we have only limited experience in filing or pursuing
applications necessary to gain regulatory approvals. Pre-clinical testing of our product
development candidates is subject to good laboratory practices, as prescribed by the FDA, and the
manufacture of any products developed by us will be subject to current good manufacturing
practices, as prescribed by the FDA, or cGMP. We may not obtain the necessary FDA approvals and
subsequent approvals in a timely manner, if at all. We cannot be sure as to the length of the
clinical trial period or the number of patients that will be required to be tested in the clinical
trials in order to establish the safety and efficacy of Vasovist for regulatory approval in the
United States or any of our future product candidates. For example, we have received two approvable
letters from the FDA and have had two meetings with the FDA to discuss the path forward for
Vasovist in the United States and we have filed a formal appeal of the FDAs decision not to
approve Vasovist without data from additional clinical trials. We cannot predict whether the appeal
or additional trials would be completed timely or successfully. Our clinical trials may not be
successful and we may not complete them in a timely manner. We could report serious side effects as
the
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clinical trials proceed. Our results from early clinical trials may not predict results that we
obtain in later clinical trials, even after promising results in earlier trials. The rate of
completion of our clinical trials depends upon, among other things,
the rate of patient enrollment and subsequent blinded reading of images and data analysis.
Furthermore, we, or the FDA or other regulatory authorities may suspend or terminate clinical
trials at any time, including terminating clinical trials for safety reasons. In addition, the FDA
may suggest or require alterations to clinical trials at any time. For example, in September 2001,
after discussions with the FDA, we expanded our initial target indication for Vasovist from one
specific body region, the aortoiliac region, to a broader indication that included the entire
bodys vascular system, except for the heart. This expansion required us to add two new clinical
trials to our then existing Phase III clinical trial program; one to determine the efficacy of
Vasovist-enhanced magnetic resonance angiography for the detection of vascular disease in the renal
arteries, and another to determine the efficacy of Vasovist-enhanced magnetic resonance angiography
for the detection of vascular disease in the pedal arteries. Although providing us with greater
market potential for the sale of Vasovist upon approval, this change to the Phase III clinical
trial program and the associated delay in the startup of new clinical centers resulted in an
approximate 15-month delay in our NDA submission and an increase in costs associated with the
program. If we do not successfully complete clinical trials for our product candidates, we will not
be able to market these product candidates.
In addition, we may encounter unanticipated delays or significant costs in our efforts to
secure necessary approvals. Our analysis of data obtained from pre-clinical and clinical activities
is subject to confirmation and interpretation by regulatory authorities which could delay, limit or
prevent FDA regulatory approval. In addition, the FDA may require us to modify our future clinical
trial plans or to conduct additional clinical trials in ways that we cannot currently anticipate,
resulting in delays in our obtaining regulatory approval. Delays in obtaining government regulatory
approval could adversely affect our, or our partners, marketing as well as the ability to generate
significant revenues from commercial sales.
Future U.S. legislative or administrative actions also could prevent or delay regulatory
approval of our product candidates. Even if we obtain regulatory approvals, they may include
significant limitations on the indicated uses for which we may market a product. A marketed product
also is subject to continual FDA and other regulatory agency review and regulation. Later discovery
of previously unknown problems or failure to comply with the applicable regulatory requirements may
result in restrictions on the marketing of a product or withdrawal of the product from the market
as well as possible civil or criminal sanctions. Further, many academic institutions and companies
conducting research and clinical trials in the MRI contrast agent field are using a variety of
approaches and technologies. If researchers obtain any adverse results in pre-clinical studies or
clinical trials, it could adversely affect the regulatory environment for MRI contrast agents in
general. In addition, if we obtain marketing approval, the FDA may require post-marketing testing
and surveillance programs to monitor the products efficacy and side effects. Results of these
post-marketing programs may prevent or limit the further marketing of the monitored product. If we,
or our partners, such as Schering AG, cannot successfully market our product candidates, we will
not generate sufficient revenues to achieve or maintain profitability.
We and our strategic partners are also subject to numerous and varying foreign regulatory
requirements governing the design and conduct of clinical trials and the manufacturing and
marketing of our product candidates. The foreign regulatory approval process may include all of the
risks associated with obtaining FDA approval set forth above and we may not obtain foreign
regulatory approvals on a timely basis, if at all, thereby compromising our ability to market our
product candidates abroad.
Gadolinium-based imaging agents, such as Vasovist and EP-2104R, may cause adverse side
effects which could limit our ability to receive approval for these product candidates and
our ability to effectively market these product candidates, if approved.
Vasovist and EP-2104R, both MRI contrast drugs, contain gadolinium. In May 2006, the Danish
Medicines Agency announced that it was investigating a possible link between the use of Omniscan,
an imaging agent containing gadolinium, and the development of a very rare skin disease in 25
patients with severely impaired renal function who had been administered the imaging agent.
Although the Danish Medicines Agency stated that a causal relationship between Omniscan and the
skin changes had not been documented, they are conducting further investigations with respect to
all MRI contrast media containing gadolinium. Although we have reviewed our safety databases for
Vasovist and EP-2104R and have found no instances of this rare skin disease, our databases may be
too small to show such an effect, if it exists. In the event gadolinium-based imaging agents such
as Vasovist and EP-2104R are linked to this very rare skin disease or other unanticipated side
effects, such safety concerns could have a material adverse effect on our ability to obtain
marketing approval for Vasovist and/or EP-2104R or any such approval for use may be revoked. Any
safety concerns could also materially harm our and our partners ability to successfully market
Vasovist and/or EP-2104R.
If we fail to comply with the extensive regulatory requirements to which we and our
product candidates are subject, our product candidates could be subject to restrictions or
withdrawal from the market and we could be subject to penalties.
We are subject to extensive U.S. and foreign governmental regulatory requirements and lengthy
approval processes for our
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product candidates. The development and commercial use of our product
candidates will be regulated by numerous federal, state, local and foreign governmental authorities
in the United States, including the FDA and foreign regulatory agencies. The nature of
our research and development and manufacturing processes requires the use of hazardous
substances and testing on certain laboratory animals. Accordingly, we are subject to extensive
federal, state and local laws, rules, regulations and policies governing the use, generation,
manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials
and wastes as well as the use of and care for laboratory animals. If we fail to comply or if an
accident occurs, we may be exposed to legal risks and be required to pay significant penalties or
be held liable for any damages that result. Such liability could exceed our financial resources.
Furthermore, current laws could change and new laws could be passed that may force us to change our
policies and procedures, an event which could impose significant costs on us.
We are required to maintain pharmacovigilance systems for collecting and reporting information
concerning suspected adverse reactions to our product candidates. In response to pharmacovigilance
reports, regulatory authorities may initiate proceedings to revise the prescribing information for
our product candidates or to suspend or revoke our marketing authorizations. Procedural safeguards
are often limited, and marketing authorizations can be suspended with little or no advance notice.
Both before and after approval of a product, quality control and manufacturing procedures must
conform to cGMP. Regulatory authorities, including the EMEA and the FDA, periodically inspect
manufacturing facilities to assess compliance with cGMP. Accordingly, we and our contract
manufacturers will need to continue to expend time, funds, and effort in the area of production and
quality control to maintain cGMP compliance.
In addition to regulations adopted by the EMEA, the FDA, and other foreign regulatory
authorities, we are also subject to regulation under the Occupational Safety and Health Act, the
Toxic Substances Control Act, the Resource Conservation and Recovery Act, and other federal, state,
and local regulations.
In addition, the testing, manufacturing, labeling, advertising, promotion, export and
marketing, among other things, of our product candidates, both before and after approval, are
subject to extensive regulation by governmental authorities in the United States, Europe and
elsewhere throughout the world. Failure to comply with the laws administered by the FDA, the EMEA,
or other governmental authorities could result in any of the following:
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delay in approval or refusal to approve a product candidate; |
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product candidate recall or seizure; |
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interruption of production; |
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operating restrictions; |
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warning letters; |
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injunctions; |
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criminal prosecutions; and |
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unanticipated expenditures. |
Our research and development efforts may not result in product candidates appropriate for
testing in human clinical trials.
We have historically spent significant resources on research and development and pre-clinical
studies of product candidates. However, these efforts may not result in the development of product
candidates appropriate for testing in human clinical trials. For example, our research may result
in product candidates that are not expected to be effective in treating diseases or may reveal
safety concerns with respect to product candidates. In connection with our recent restructuring, we
postponed or terminated several research and development programs, and we may postpone or terminate
research and development of a product candidate or a program at any time for any reason such as the
safety or effectiveness of the potential product, allocation of resources or unavailability of
qualified research and development personnel. The failure to generate high-quality research and
development candidates would negatively impact our ability to advance product candidates into human
clinical testing and ultimately, negatively impact our ability to market and sell products.
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We have a limited manufacturing capability and we intend to outsource manufacturing of
Vasovist to third parties, who may not perform as we expect.
We do not have, nor do we currently have plans to develop, full-scale manufacturing capability
for Vasovist. While we have
manufactured small amounts of Vasovist for research and development efforts, we rely on, and
we intend to continue to rely on, Tyco/Mallinckrodt as the primary manufacturer of Vasovist for any
future human clinical trials and commercial use. Together with Schering AG, we are considering
alternative manufacturing arrangements for Vasovist for commercial use, including the transfer of
manufacturing to Schering AG. In the event that Tyco/Mallinckrodt fails to fulfill its
manufacturing responsibilities satisfactorily, Schering AG has the right to purchase Vasovist from
a third party or to manufacture the compound itself. However, either course of action could
materially delay the manufacture and development of Vasovist. Schering AG may not be able to find
an alternative manufacturer. In addition, Schering AG may not be able to manufacture Vasovist
itself in a timely manner or in sufficient quantities. If we experience a delay in manufacturing,
it could result in a delay in the approval or commercialization of Vasovist and have a material
adverse effect on our business, financial condition and results of operations.
Technology Risks
If MRI manufacturers are not able to enhance their hardware and software sufficiently, we
will not be able to complete development of our contrast agent for the evaluation of cardiac
indications.
Although MRI hardware and software is sufficient for the evaluation of non-coronary vascular
disease, which is our initial target indication, we believe that the technology is not as advanced
for cardiac applications. Our initial NDA filing for Vasovist is related to non-coronary vascular
disease. Based on feasibility studies we completed in 2001, however, the imaging technology
available for cardiac applications, including coronary angiography and cardiac perfusion imaging,
was not developed to the point where there was clear visualization of the cardiac region due to the
effects of motion from breathing and from the beating of the heart. In 2004, we initiated Phase II
feasibility trials of Vasovist for cardiac indications using available software and hardware that
can be adapted for coronary and cardiac perfusion data acquisition, and preliminary review of the
data indicates that we have not resolved the technical issues related to this use of Vasovist. We
have collaborated with a number of leading academic institutions and with GE Healthcare, Siemens
Medical Systems and Philips Medical Systems to help optimize cardiac imaging with Vasovist. We do
not know when, or if, these techniques will enable Vasovist to provide clinically relevant images
in cardiac indications. If MRI device manufacturers are not able to enhance their scanners to
perform clinically useful cardiac imaging, we will not be able to complete our development
activities of Vasovist for that application, thereby reducing the potential market for a product in
this area.
We depend on exclusively licensed technology from the Massachusetts General Hospital and if we
lose this license, it is unlikely we could obtain this technology elsewhere, which would have a
material adverse effect on our business.
Under
the terms of a license agreement that we have with MGH, we are the exclusive licensee
to certain technology, which relates to royalties we receive and to Vasovist. The license agreement
imposes various commercialization, sublicensing, royalty and other obligations on us. The license
agreement expires on a country-by-country basis when the patents covered by the license agreement
expire. For example, the patents covered by this license agreement are currently expected to expire
in November 2006, although the life of these patents may be extended. One of these patents has been
extended through Supplementary Protection Certificates for Primovist through May 2011 in certain
European countries. The license agreement does not contain a renewal provision. If we fail to
comply with these and other requirements, our license could convert from exclusive to nonexclusive,
or terminate entirely. It is unlikely that we would be able to obtain this technology elsewhere.
Any such event would mean that we would not receive royalties from Bracco for MultiHance or
Schering AG for Primovist, and that we or Schering AG could not sell Vasovist, either of which
would have a material adverse effect on our business, financial condition and results of
operations. Currently, we believe that we are in compliance with the terms of the license agreement
and we do not have any reason to believe that this license may be terminated.
We depend on patents and other proprietary rights, and if they fail to protect our business, we
may not be able to compete effectively.
The protection of our proprietary technologies is material to our business prospects. We
pursue patents for our product candidates in the United States and in other countries where we
believe that significant market opportunities exist. We own or have an exclusive license to patents
and patent applications on aspects of our core technology as well as many specific applications of
this technology. These patents relate to MRI signal generation technology, Vasovist, EP-2104R and
our other research projects and include method of use patents. Some of our patents related to
Vasovist will expire in 2006. Other patents related to Vasovist will not expire until 2015.
Protection for Vasovist manufacturing processes in the United States will not expire until 2017.
Patents related to certain methods of using Vasovist will not expire until 2021. A patent related
to EP-2104R will not expire until 2022. If all of our pending patent applications issue with claims
substantially similar to those currently set forth in such applications, further patent protection
for EP-2104R may not expire until 2022. Even though we hold numerous patents and have made numerous
patent applications, because the
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patent positions of pharmaceutical and biopharmaceutical firms,
including our patent positions, generally include complex legal and factual questions, our patent
positions remain uncertain. For example, because most patent applications
are maintained in secrecy for a period after filing, we cannot be certain that the named
applicants or inventors of the subject matter covered by our patent applications or patents,
whether directly owned or licensed to us, were the first to invent or the first to file patent
applications for such inventions. Third parties may oppose, challenge, infringe upon, circumvent or
seek to invalidate existing or future patents owned by or licensed to us. A court or other agency
with jurisdiction may find our patents invalid, not infringed or unenforceable and we cannot be
sure that patents will be granted with respect to any of our pending patent applications or with
respect to any patent applications filed by us in the future. Even if we have valid patents, these
patents still may not provide sufficient protection against competing products or processes. If we
are unable to successfully protect our proprietary methods and technologies, or if our patent
applications do not result in issued patents, we may not be able to prevent other companies from
practicing our technology and, as a result, our competitive position may be harmed.
We may need to initiate lawsuits to protect or enforce our patents and other intellectual
property rights, which could result in our incurrence of substantial costs and which could
result in the forfeiture of these rights.
We may need to bring costly and time-consuming litigation against third parties in order to
enforce our issued patents, protect our trade secrets and know how, or to determine the
enforceability, scope and validity of proprietary rights of others. In addition to being costly and
time-consuming, such lawsuits could divert managements attention from other business concerns.
These lawsuits could also result in the invalidation or a limitation in the scope of our patents or
forfeiture of the rights associated with our patents or pending patent applications. We may not
prevail and a court may find damages or award other remedies in favor of an opposing party in any
such lawsuits. During the course of these suits, there may be public announcements of the results
of hearings, motions and other interim proceedings or developments in the litigation. Securities
analysts or investors may perceive these announcements to be negative, which could cause the market
price of our stock to decline. In addition, the cost of such litigation could have a material
adverse effect on our business and financial condition.
Other rights and measures that we rely upon to protect our intellectual property may not be
adequate to protect our products and services and could reduce our ability to compete in the
market.
In addition to patents, we rely on a combination of trade secrets, copyright and trademark
laws, non-disclosure agreements and other contractual provisions and technical measures to protect
our intellectual property rights. While we require employees, collaborators, consultants and other
third parties to enter into confidentiality and/or non-disclosure agreements, where appropriate,
any of the following could still occur:
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the agreements may be breached; |
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we may have inadequate remedies for any breach; |
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proprietary information could be disclosed to our competitors; or |
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others may independently develop substantially equivalent proprietary information and
techniques or otherwise gain access to our trade secrets or disclose such technologies. |
If, as a result of the foregoing or otherwise, our intellectual property is disclosed or
misappropriated, it would harm our ability to protect our rights and our competitive position.
Moreover, several of our management and scientific personnel were formerly associated with other
pharmaceutical and biotechnology companies and academic institutions. In some cases, these
individuals are conducting research in similar areas with which they were involved prior to joining
us. As a result, we, as well as these individuals, could be subject to claims of violation of trade
secrets and similar claims.
Our success will depend partly on our ability to operate without infringing the intellectual
property rights of others, and if we are unable to do so, we may not be able to sell our
products.
Our commercial success will depend, to a significant degree, on our ability to operate without
infringing upon the patents of others in the United States and abroad. There may be pending or
issued patents held by parties not affiliated with us relating to technologies we use in the
development or use of certain of our contrast agents. If any judicial or administrative proceeding
upholds these or any third-party patents as valid and enforceable, we could be prevented from
practicing the subject matter claimed in such patents, or would be required to obtain licenses from
the owners of each such patent, or to redesign our product candidates or processes to avoid
infringement. For example, in November 2003, we entered into an intellectual property agreement
with Dr. Martin R. Prince, an early innovator in the field of magnetic resonance angiography,
relating to dynamic magnetic resonance angiography,
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which involves capturing magnetic resonance
angiography images during the limited time, typically 30 to 60 seconds, available for imaging with
extracellular agents. Under the terms of the intellectual property agreement, Dr. Prince granted us
certain
discharges, licenses and releases in connection with the historic and future use of Vasovist
by us and agreed not to sue us for intellectual property infringement related to the use of
Vasovist. In consideration of Dr. Prince entering into the agreement, we agreed to pay him an
upfront fee of $850,000 and royalties on sales of Vasovist consistent with a non-exclusive early
stage academic license and agreed to deliver to him 132,000 shares of our common stock, with a
value of approximately $2.3 million based on the closing price of our common stock on the date of
the agreement. In addition, we agreed to supply Dr. Prince with approximately $140,000 worth of
Vasovist. If we are unable to obtain a required license on acceptable terms, or are unable to
design around these or any third-party patents, we may be unable to sell our products, which would
have a material adverse effect on our business.
If we fail to get adequate levels of reimbursement from third-party payors for our product
candidates after they are approved in the United States and abroad, we may have difficulty
commercializing our product candidates.
We believe that reimbursement in the future will be subject to increased restrictions, both in
the United States and in foreign markets. We believe that the overall escalating cost of medical
products and services has led to, and will continue to lead to, increased pressures on the health
care industry, both foreign and domestic, to reduce the cost of products and services, including
products offered by us. There can be no assurance, in either the United States or foreign markets,
that third-party reimbursement will be available or adequate, that current reimbursement amounts
will not be decreased in the future or that future legislation, regulation, or reimbursement
policies of third-party payors will not otherwise adversely affect the demand for our product
candidates or our ability to sell our product candidates on a profitable basis, particularly if MRI
exams enhanced with our contrast agents are more expensive than competing vascular imaging
techniques that are equally effective. The unavailability or inadequacy of third-party payor
coverage or reimbursement could have a material adverse effect on our business, financial condition
and results of operations.
We could be adversely affected by changes in reimbursement policies of governmental or private
healthcare payors, particularly to the extent any such changes affect reimbursement for procedures
in which our product candidates would be used. Failure by physicians, hospitals and other users of
our product candidate to obtain sufficient reimbursement from third-party payors for the procedures
in which our product candidate would be used or adverse changes in governmental and private
third-party payors policies toward reimbursement for such procedures may have a material adverse
effect on our ability to market our product candidate and, consequently, it could have an adverse
effect on our business, financial condition and results of operations. If we obtain the necessary
foreign regulatory approvals, market acceptance of our product candidates in international markets
would be dependent, in part, upon the availability of reimbursement within prevailing healthcare
payment systems. Reimbursement and healthcare payment systems in international markets vary
significantly by country, and include both government sponsored health care and private insurance.
We and our strategic partners intend to seek international reimbursement approvals, although we
cannot assure you that any such approvals will be obtained in a timely manner, if at all, and
failure to receive international reimbursement approvals could have an adverse effect on market
acceptance of our product candidate in the international markets in which such approvals are
sought.
If we are unable to attract and retain key management and other personnel, it would hurt our
ability to compete.
Our future business and operating results depend in significant part upon our ability to
attract and retain qualified directors, senior management and key technical personnel. In September
2005, our board of directors appointed Michael J. Astrue as Interim Chief Executive Officer. Mr.
Astrue replaced Michael Webb, who resigned his position as our Chief Executive Officer and from our board of
directors in September 2005. Mr. Astrue resigned as Interim Chief Executive Officer on May 5, 2006.
In addition, our Chief Financial Officer resigned in July 2005. Andrew C.G. Uprichard, M.D., our
President and Chief Operating Officer, is currently acting as our principal executive officer and
we currently have no Chief Financial Officer. Mr. Robert Pelletier, our Executive Director of
Finance, is currently serving as our principal financial and accounting officer. Mr. Pelletier has
resigned as our Executive Director of Finance effective August 10, 2006. Christopher F.O. Gabrieli,
the Chairman of our board of directors, is a candidate for the Governor of the Commonwealth of
Massachusetts, the general election for which is scheduled in November 2006. If elected, Mr.
Gabrieli will step down from our board of directors. Our inability to attract and retain qualified
individuals to these positions and others, the loss of any of our key management and other
personnel, or their failure to perform their current positions could have a material adverse effect
on our business, financial condition and results of operations, and our ability to achieve our
business objectives or to operate or compete in our industry may be seriously impaired. Competition
for personnel is intense and we may not be successful in attracting or retaining such personnel. If
we were to lose these employees to our competition, we could spend a significant amount of time and
resources to replace them, which would impair our research and development or commercialization
efforts. If the merger is not consummated, we must compete with companies that have greater
resources and/or superior product candidates or products to rebuild our senior management team and
attract other personnel.
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Business Risks
We currently depend on our strategic collaborators for support in product development and the
regulatory approval process and, in the future, will depend on them for product marketing
support as well. These efforts could be materially harmed if we experience problems with our
collaborators.
We depend on strategic collaborators for support in product development and the regulatory
approval process as well as a variety of other activities including manufacturing, marketing and
distribution of our product candidates in the United States and abroad, when, and if, the FDA and
corresponding foreign agencies approve our product candidates for marketing. To date, we have
entered into strategic alliances and collaborations with Schering AG, Tyco/Mallinckrodt, GE
Healthcare, Philips Medical Systems and Siemens Medical Systems. Three of our key agreements
include two collaboration agreements with Schering AG to perform joint research and to develop and
commercialize Vasovist and other MRI vascular agents worldwide, and an agreement with
Tyco/Mallinckrodt granting Tyco/Mallinckrodt rights to enter into an agreement with Schering AG to
manufacture Vasovist for clinical development and commercial use. We may not receive milestone
payments from these alliances should Vasovist fail to meet certain performance targets in
development and commercialization. On July 12, 2006, Schering AG notified us that it decided not to
exercise its option to exclusively license EP-2104R. As a result, we intend to pursue a
collaboration for the continued development of EP-2104R with new potential partners. Further, our
receipt of revenues from strategic alliances is affected by the level of efforts of our
collaborators. Our collaborators may not devote the resources necessary to complete development and
commence marketing of Vasovist, EP-2104R or other product candidates in their respective
territories, or they may not successfully market Vasovist, EP-2104R or other product candidates. In
addition, Schering AG and Tyco/Mallinckrodt currently manufacture imaging agents for other
technologies that will compete against Vasovist, and Schering AG will be responsible for setting
the price of the product candidate worldwide. Accordingly, Schering AG may not set prices in a
manner that maximizes revenues for us. Our failure to receive future milestone payments, or a
reduction or discontinuance of efforts by our partners would have a material adverse effect on our
business, financial condition and results of operations.
Furthermore, our collaboration agreement with Schering AG may be terminated early under
certain circumstances, including if there is a material breach of the agreement by either party. In
October 2005, we announced that we had entered into an amendment to our research collaboration
agreement with Schering AG. This amendment narrowed the definition of the field of collaboration to
exclude from the research collaboration certain specific types of imaging technology, including
certain nanotechnology-based imaging agents. This research collaboration concluded in May 2006. We
are in discussions, and expect to continue discussions, with Schering AG regarding the disposition
of the research products under this research collaboration. While the research agreement is
separate from our agreement with Schering AG relating to Vasovist, we cannot predict how the
disposition or winding down of the individual research programs will occur, or whether we will be
able to take forward any of these research programs ourselves or find alternative partners for
these programs.
In addition, we intend to seek additional collaborations with third parties, particularly for
the continued development of EP-2104R, who may negotiate provisions that allow them to terminate
their agreements with us prior to the expiration of the negotiated term under certain
circumstances. We are substantially dependent upon Schering AG to commercialize Vasovist, our lead
product candidate, in the United States and Europe. If Schering AG or any other third-party
collaborator were to terminate its agreements with us, if we are unable to negotiate an acceptable
agreement with Schering AG relating to a new research agreement or if Schering AG or any other
third-party collaborator otherwise fail to perform its obligations under our collaboration or to
complete them in a timely manner, we could lose significant revenue. If we are unable to enter into
future strategic alliances with capable partners on commercially reasonable terms, it may delay the
development and commercialization of future product candidates and could possibly postpone them
indefinitely.
In addition, Bayer AG recently extended an offer to acquire all of the outstanding shares of
Schering AG. Although we have not yet determined the impact this acquisition may have on our
relationship with Schering AG or the marketing of Vasovist, if the strategy of Bayer AG and
Schering AG after the acquisition differs from that of Schering AGs current strategy with respect
to the marketing of Vasovist, our expectations regarding the marketing of Vasovist could be
negatively impacted which could have a material adverse effect on our business.
In addition, we rely on certain of our collaborators, such as GE Healthcare, Siemens Medical
Systems and Philips Medical Systems, to develop software that can be used to enhance or suppress
veins or arteries from Vasovist-enhanced magnetic resonance angiography images. Although not
required for clinical use of Vasovist, the ability to separate veins from arteries using
Vasovist-enhanced magnetic resonance angiography may be useful to clinicians in reading
Vasovist-enhanced images for the evaluation of vascular disease. Therefore, if our collaborators do
not develop or implement the required software successfully, some clinicians may not be able to
easily interpret the information provided from Vasovist-enhanced images and may not be inclined to
use the product candidate. Our inability to market Vasovist successfully to clinicians would have a
material adverse effect on our business.
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Our stock price is volatile. It is possible that you may lose all or part of your investment.
The market prices of the capital stock of medical technology companies have historically been
very volatile and the market price of the shares of our common stock fluctuates. The market price
of our common stock is affected by numerous factors, including:
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developments with respect to proprietary rights, including patent and litigation matters; |
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results of pre-clinical studies and clinical trials; |
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the timing of our achievement of regulatory milestones; |
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conditions and trends in the pharmaceutical and other technology industries; |
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adoption of new accounting standards affecting such industries; |
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changes in financial estimates by securities analysts; |
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perceptions of the value of corporate transactions; and |
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degree of trading liquidity in our common stock and general market conditions. |
During the period from January 1, 2006 through June 30, 2006, the closing price of our common
stock ranged from $5.02 to $2.77. The last reported closing price for our common stock on June 30,
2006 was $4.35. Significant declines in the price of our common stock could impede our ability to
obtain additional capital, attract and retain qualified employees and reduce the liquidity of our
common stock.
In addition, the stock market has from time to time experienced significant price and volume
fluctuations that have particularly affected the market prices for the common stock of similarly
staged companies. These broad market fluctuations may adversely affect the market price of our
common stock. In the past, following periods of volatility in the market price of a particular
companys securities, shareholders have often brought class action securities litigation against
that company. Such litigation could result in substantial costs and a diversion of managements
attention and resources. For example, in January 2005, a securities class action was filed in U.S.
District Court for the District of Massachusetts against us and certain of our officers on behalf
of persons who purchased our common stock between July 10, 2003 and January 14, 2005. The complaint
alleged that we and the other defendants violated the Securities Exchange Act of 1934, as amended,
by issuing a series of materially false and misleading statements to the market throughout the
class period, which statements had the effect of artificially inflating the market price of our
securities. In January 2006, the U.S. District Court for the District of Massachusetts granted our
Motion to Dismiss for Failure to Prosecute the shareholder class action lawsuit against us. The
dismissal was issued without prejudice after a hearing, which dismissal does not prevent another
suit to be brought based on the same claims.
We have never generated revenues from commercial sales of our product candidates.
We currently have one product for sale in Europe and we cannot guarantee that we will ever
have additional marketable product candidates. Vasovist was approved for commercial sale in Europe
in October 2005 and is currently being marketed in Europe by our partner, Schering AG. If Schering
AG fails to launch Vasovist in all European countries or fails to achieve significant sales, our
revenues could be materially harmed and we may receive even less royalty income than we currently
expect to receive. We expect to receive a typical pharmaceutical royalty based on the sale of
Vasovist by Schering AG in Europe. Even if Schering AG continues its launch of Vasovist and it is
able to successfully market and sell Vasovist throughout Europe, we do not expect any significant
royalties for 2006 sales.
We have never generated positive cash flow, and if we fail to generate revenue, it will have a
material adverse effect on our business.
To date, we have received revenues from payments made under licensing, royalty arrangements
and product development and
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marketing agreements with strategic collaborators. In particular, our revenue for the six
months ended June 30, 2006 was $3.1 million and consisted of $1.8 million of product development
revenue from Schering AG, $920,000 of royalty revenue related to the Bracco and Schering AG
agreements, and $323,000 of license fee revenue related to the Schering AG, Tyco/Mallinckrodt
strategic collaborations and Bracco agreements. In addition to these sources of revenue, we have
financed our operations to date through public stock and debt offerings, private sales of equity
securities and equipment lease financings.
Although we believe that we are currently in compliance with the terms of our collaboration
and licensing agreements, the revenues derived from them are subject to fluctuation in timing and
amount. We may not receive anticipated revenue under our existing collaboration or licensing
agreements, these agreements may be subject to disputes and, additionally, these agreements may be
terminated upon certain circumstances. Therefore, to achieve profitable and sustainable operations,
we, alone or with others, must successfully develop, obtain regulatory approval for, introduce,
market and sell products. We may not receive revenue from the sale of any of our product candidates
for the next several years because we, and our partners, may not:
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successfully complete our product development efforts; |
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obtain required regulatory approvals in a timely manner, if at all; |
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manufacture our product candidates at an acceptable cost and with acceptable quality; or |
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successfully market any approved products. |
As a result, we may never generate revenues from sales of our product candidates and our
failure to generate positive cash flow could cause our business to fail.
We anticipate future losses and may never become profitable.
Our future financial results are uncertain. We have experienced significant losses since we
commenced operations in 1992. Our accumulated net losses as of June 30, 2006 were approximately
$187.3 million. These losses have primarily resulted from expenses associated with our research and
development activities, including pre-clinical studies and clinical trials, and general and
administrative expenses. We anticipate that our research and development expenses will remain
significant in the future and we expect to incur losses over at least the next several years as we
continue our research and development efforts, pre-clinical testing and clinical trials and as we
implement manufacturing, marketing and sales programs. In particular, we may be required to conduct
additional clinical trials in order to achieve FDA approval of Vasovist, which trials would be
expensive and which could contribute to our continuing to incur losses. As a result, we cannot
predict when we will become profitable, if at all, and if we do, we may not remain profitable for
any substantial period of time. Our expenses after the merger may increase significantly as a
result of the addition of Predixs research and development and commercialization efforts. In
addition, Predixs independent accountants raised substantial doubts about Predixs ability to
continue as a going concern and we will assume approximately $9.5 million in debt in connection
with our acquisition of Predix. Therefore, the merger may also result in losses to be sustained
over a longer period of time than we would experience on our own without the acquisition of Predix
and require us to raise additional funds sooner than if we did not acquire Predix. If we fail to
achieve profitability within the timeframe expected by investors or if the acquisition of Predix
and its research and development programs negatively impacts our results of operations, the market
price of our common stock may decline and consequently our business may not be sustainable.
If the market does not accept our technology and product candidates, we may not generate
sufficient revenues to achieve or maintain profitability.
The commercial success of Vasovist and our other product candidates, even if approved for
marketing by the FDA and corresponding foreign agencies, depends on their acceptance by the medical
community and third-party payors as clinically useful, cost-effective and safe. While contrast
agents are currently used in an estimated 25% to 35% of all MRI exams, there are no MRI agents
approved by the FDA for vascular imaging. Furthermore, clinical use of magnetic resonance
angiography has been limited and use of magnetic resonance angiography for some vascular disease
imaging has occurred mainly in research and academic centers. Market acceptance, and thus sales of
our products, will depend on several factors, including:
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safety; |
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cost-effectiveness relative to alternative vascular imaging methods; |
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availability of third-party reimbursement; |
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ease of administration; |
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clinical efficacy; and |
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availability of competitive products. |
Market acceptance will also depend on our ability and that of our strategic partners to
educate the medical community and third-party payors about the benefits of diagnostic imaging with
Vasovist-enhanced magnetic resonance angiography compared to imaging with other technologies.
Vasovist represents a new approach to imaging the non-coronary vascular system, and market
acceptance both of magnetic resonance angiography as an appropriate imaging technique for the
non-coronary vascular system, and of Vasovist, is critical to our success. If Vasovist or any of
our other product candidates, when and if commercialized, do not achieve market acceptance, we may
not generate sufficient revenues to achieve or maintain profitability.
We may need to raise additional funds necessary to fund our operations, and if we do not do so,
we may not be able to implement our business plan.
Since inception, we have funded our operations primarily through our public offerings of
common stock, private sales of equity securities, debt financing, equipment lease financings,
product development revenue, and royalty and license payments from our strategic partners. Although
we believe that we have adequate funding for the foreseeable future, we may need to raise
substantial additional funds for research, development and other expenses through equity or debt
financings, strategic alliances or otherwise. Our future liquidity and capital requirements will
depend upon numerous factors, including the following:
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the progress and scope of clinical trials; |
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the timing and costs of filing future regulatory submissions; |
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the timing and costs required to receive both U.S. and foreign governmental approvals; |
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the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; |
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the extent to which our product candidates gain market acceptance; |
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the timing and costs of product introductions; |
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the extent of our ongoing and any new research and development programs; |
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the costs of training physicians to become proficient with the use of our product candidates; and |
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the costs of developing marketing and distribution capabilities. |
Based on our current plans, expense rates, targeted timelines and our view regarding
acceptance of Vasovist in the marketplace, we estimate that cash, cash equivalents and marketable
securities on hand as of June 30, 2006 will be sufficient to fund our operations for at least the
next several years. However, we premise this expectation on our current operating plan, which may
change as a result of many factors, including the acquisition of Predix. Taking into consideration
the acquisition of Predix and incorporating its research and development programs into our
operations, we estimate that cash, cash equivalents and marketable securities on hand as of June
30, 2006, together with expected revenue from the sale of Vasovist and reimbursement of clinical
trial costs by Schering AG, and the cash, cash equivalents and marketable securities acquired from
Predix, will fund the combined companys operations through 2007. If, however, we consider other
opportunities, change our planned activities or are required to pay all or a substantial portion of
the milestone payment in cash under the merger agreement, we may require additional funding before
currently expected. On July 31, 2006, Predix entered into an exclusive worldwide license agreement with Amgen
Inc. to develop and commercialize products based on Predixs preclinical compounds which target the
GPCR S1P1 and compounds and products that may be identified
by or acquired by Amgen and that are active against the S1P1 receptor. Our board of directors has
determined that Predixs entry into the agreement with Amgen resulted in the achievement of a
milestone pursuant to the terms of the merger
agreement by and between us and Predix and described
36
in the Joint Proxy Statement/Prospectus.
Accordingly, in addition to the initial merger consideration, Predix stockholders, option holders
and warrant holders will be entitled to the milestone payment under the merger agreement in the
aggregate amount of $35.0 million.
Our competitors may have greater financial resources, superior products or product candidates,
manufacturing capabilities and/or marketing expertise, and we may not be able to compete with
them successfully.
The healthcare industry is characterized by extensive research efforts and rapid technological
change and there are several companies that are working to develop products similar to our product
candidates. However, there are a number of general use MRI agents approved for marketing in the
United States, and in certain foreign markets that, if used or developed for magnetic resonance
angiography, are likely to compete with Vasovist. Such products include Magnevist and Gadovist by
Schering AG, Dotarem by Guerbet, S.A., Omniscan by GE Healthcare, ProHance and MultiHance by Bracco
and OptiMARK by Tyco/Mallinckrodt. We are aware of five agents under clinical development that have
been or are being evaluated for use in magnetic resonance angiography: Schering AGs Gadomer and
SHU555C, Guerbets Vistarem, Braccos B-22956/1, Ferropharms Code VSOP-C184, and Advanced
Magnetics Ferumoxytol. We cannot assure you that our competitors will not succeed in the future in
developing products that are more effective than any that we are developing. We believe that our
ability to compete in developing MRI contrast agents depends on a number of factors, including the
success and timeliness with which we complete FDA trials, the breadth of applications, if any, for
which our product candidates receive approval, and the effectiveness, cost, safety and ease of use
of our product candidates in comparison to the products of our competitors. Public information on
the status of clinical development and performance characteristics for these agents is limited.
However, many of these competitors have substantially greater capital and other resources than we
do and may represent significant competition for us. These companies may succeed in developing
technologies and products that are more effective or less costly than any of those that we may
develop. In addition, these companies may be more successful than we are in developing,
manufacturing and marketing their products.
Moreover, there are several well-established medical imaging methods that currently compete
and will continue to compete with MRI, including digital subtraction angiography, which is an
improved form of X-ray angiography, computed tomography angiography, nuclear medicine and
ultrasound, and there are companies that are actively developing the capabilities of these
competing methods to enhance their effectiveness in vascular system imaging.
We cannot guarantee that we will be able to compete successfully in the future, or that
developments by others will not render Vasovist or our future product candidates obsolete or
non-competitive, or that our collaborators or customers will not choose to use competing
technologies or products. Any inability to compete successfully on our part will have a materially
adverse impact on our operating results.
Product liability claims could increase our costs and adversely affect our results of
operations.
The clinical testing of our products and the manufacturing and marketing of any approved
products may expose us to product liability claims and we may experience material product liability
losses in the future. We currently have limited product liability insurance for the use of our
approved products and product candidates in clinical research, which is capped at $10.0 million,
but our coverage may not continue to be available on terms acceptable to us or adequate for
liabilities we actually incur. We do not have product liability insurance coverage for the
commercial sale of our product candidates, but intend to obtain such coverage when and if we
commercialize our product candidates. However, we may not be able to obtain adequate additional
product liability insurance coverage on acceptable terms, if at all. A successful claim brought
against us in excess of available insurance coverage, or any claim or product recall that results
in significant adverse publicity against us, may have a material adverse effect on our business and
results of operations.
We significantly increased our leverage as a result of the sale of 3.0% Convertible Senior
Notes due 2024.
In connection with the sale of 3.0% Convertible Senior Notes due 2024, we have incurred
indebtedness of $100.0 million. In addition, holders of our 3.0% Convertible Senior Notes due 2024
may require us to repurchase these notes at par, plus accrued and unpaid interest, on June 15,
2011, 2014 and 2019. The amount of our indebtedness could, among other things:
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make it difficult for us to make payments on the notes; |
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make it difficult for us to obtain financing for working capital, acquisitions or other purposes on favorable terms, if at all; |
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make us more vulnerable to industry downturns and competitive pressures; and |
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limit our flexibility in planning for, or reacting to changes in, our business. |
Our ability to meet our debt service obligations will depend upon our future performance,
which will be subject to regulatory approvals and sales of our products, as well as other financial
and business factors affecting our operations, many of which are beyond our control.
Certain anti-takeover clauses in our charter and by-laws and in Delaware law may make an
acquisition of us more difficult.
Our restated certificate of incorporation authorizes our board of directors to issue, without
stockholder approval, up to 1,000,000 shares of preferred stock with voting, conversion and other
rights and preferences that could adversely affect the voting power or other rights of the holders
of our common stock. The issuance of preferred stock or of rights to purchase preferred stock could
be used to discourage an unsolicited acquisition proposal. In addition, the possible issuance of
preferred stock could discourage a proxy contest, make more difficult the acquisition of a
substantial block of our common stock or limit the price that investors might be willing to pay for
shares of our common stock. Our restated certificate of incorporation provides for staggered terms
for the members of our board of directors. A staggered board of directors and certain provisions of
our by-laws and of the state of Delaware law applicable to us could delay or make more difficult a
merger, tender offer or proxy contest involving us. We are subject to Section 203 of the General
Corporation Law of the State of Delaware, which, subject to certain exceptions, restricts certain
transactions and business combinations between a corporation and a stockholder owning 15% or more
of the corporations outstanding voting stock for a period of three years from the date the
stockholder becomes an interested stockholder. These provisions may have the effect of delaying or
preventing a change in control of us without action by the stockholders and, therefore, could
adversely affect the price of our stock.
ITEM 6. EXHIBITS
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Exhibit Number |
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Description |
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2.1
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Agreement and Plan of Merger, dated as of April 3, 2006, among the Company, EPIX
Delaware, Inc. and Predix Pharmaceuticals Holdings, Inc. Filed as Exhibit 2.1 to the
Companys Current Report on Form 8-K filed April 3, 2006 (File No. 000-21863) and
incorporated herein by reference. |
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2.1.1
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Amendment No. 1 to Agreement and Plan of Merger, dated July 10, 2006, among the
Company, EPIX Delaware, Inc. and Predix Pharmaceuticals Holding, Inc. Filed as Exhibit
99.1 to the Companys Current Report on Form 8-K filed July 12, 2006 (File No.
000-21863) and incorporated herein by reference. |
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3.1
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Restated Certificate of Incorporation of the Company. Filed as Exhibit 4.1 to the
Companys Registration Statement on Form S-8 (File No. 333-30531) and incorporated
herein by reference. |
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3.2
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Certificate of Amendment of Restated Certificate of Incorporation of the Company.
Filed as Exhibit 3.2 to the Companys Annual Report on Form 10-K for the year ended
December 31, 2001 (File No. 000-21863) and incorporated herein by reference. |
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3.3
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Certificate of Amendment of Restated Certificate of Incorporation of the Company.
Filed as Exhibit 3.2 to the Companys Quarterly Report on Form 10-Q for the period ended
September 30, 2004 (File No. 000-21863) and incorporated herein by reference. |
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3.4
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Form of Amended and Restated By-Laws of the Company. Filed as Exhibit 4.2 to the
Companys Registration Statement on Form S-8 (File No. 333-30531) and incorporated
herein by reference. |
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4.1
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Specimen certificate for shares of Common Stock of the Company. Filed as Exhibit
4.1 to the Companys Registration Statement on Form S-1 (File No. 333-17581) and
incorporated herein by reference. |
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4.2
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Indenture, dated as of June 7, 2004, between the Company and U.S. Bank National
Association as Trustee, relating to 3.0% Convertible Senior Notes due June 15, 2024.
Filed as Exhibit 4.1 to the Companys Current Report on Form 8-K filed June 7, 2004
(File No. 000-21863) and incorporated herein by reference. |
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10.1
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Voting Agreement, dated as of April 3, 2006, entered into between the Company and
certain stockholders of Predix Pharmaceuticals Holdings, Inc. Filed as Exhibit 10.1 to
the Companys Current Report on Form 8-K filed April 3, 2006 (File No. 000-21863) and
incorporated herein by reference. |
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10.2
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Consulting Agreement by and between the Company and Michael J. Astrue, dated May
5, 2006. Filed as Exhibit 99.2 to the Companys Current Report on Form 8-K filed May 5,
2006 (File No. 000-21863) and incorporated herein by reference. |
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10.3#
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Amendment to Severance and Incentive Agreement by and between the Company and Andrew Uprichard, M.D., dated May 19, 2006. Filed as Exhibit
99.1 to the Companys Current Report on Form 8-K filed May 24, 2006 (File
No. 000-21863) and incorporated herein by reference. |
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10.4#
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Retention Agreement by and between the Company and Robert B. Pelletier, dated
July 25, 2006. Filed as |
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Exhibit Number |
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Description |
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Exhibit 99.1 to the Companys Current Report on Form 8-K filed July 26, 2006 (File
No. 000-21863) and incorporated herein by reference. |
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10.5#
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Consulting Agreement by and between the Company and Robert B. Pelletier, dated
July 25, 2006. Filed as Exhibit 99.2 to the Companys Current Report on Form 8-K filed
July 26, 2006 (File No. 000-21863) and incorporated herein by reference. |
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31.1*
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Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for Andrew C.G. Uprichard. |
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31.2*
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Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for Robert B. Pelletier. |
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32*
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Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code). |
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* |
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Filed herewith. |
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Identifies a management contract or compensatory plan or
agreement in which an executive officer or director of the Company
participates. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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EPIX Pharmaceuticals, Inc.
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Date: August 4, 2006 |
By: |
/s/ ANDREW C.G. UPRICHARD, M.D.
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Andrew C.G. Uprichard, M.D. |
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President, Chief Operating Officer and Principal Executive Officer |
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EPIX Pharmaceuticals, Inc.
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Date: August 4, 2006 |
By: |
/s/
ROBERT B. PELLETIER
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Robert B. Pelletier |
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Executive Director of Finance
and Principal Accounting Officer |
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