e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
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(Mark One) |
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the quarterly period ended March 31, 2006 |
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or |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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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 |
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04-3030815 |
(State of incorporation) |
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(I.R.S. Employer
Identification No.) |
161 First Street, Cambridge, Massachusetts |
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02142 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code:
(617) 250-6000
Securities registered pursuant to Section 12(b) of the
Act:
NONE
Securities registered pursuant to Section 12(g) of the
Act:
Common Stock, $.01 Par Value Per Share
(Title of class)
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 April 28, 2006, 23,284,810 shares of the
registrants Common Stock, $.01 par value per share,
were issued and outstanding.
EPIX Pharmaceuticals, Inc.
INDEX
2
PART I. FINANCIAL
INFORMATION
ITEM 1. CONDENSED FINANCIAL
STATEMENTS
EPIX PHARMACEUTICALS, INC.
BALANCE SHEETS
(unaudited)
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March 31, | |
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December 31, | |
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2006 | |
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2005 | |
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ASSETS |
Current assets:
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Cash and cash equivalents
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$ |
75,963,558 |
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$ |
72,502,906 |
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Available-for-sale marketable securities
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42,882,538 |
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52,225,590 |
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Accounts receivable
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94,699 |
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149,287 |
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Prepaid expenses and other assets
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479,906 |
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346,919 |
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Total current assets
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119,420,701 |
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125,224,702 |
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Property and equipment, net
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2,107,960 |
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2,517,859 |
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Other assets
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3,492,867 |
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2,973,155 |
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Total assets
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$ |
125,021,528 |
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$ |
130,715,716 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
Current liabilities:
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Accounts payable
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$ |
541,148 |
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$ |
1,268,325 |
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Accrued expenses
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3,894,527 |
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4,310,003 |
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Contract advances
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5,425,318 |
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6,112,549 |
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Deferred revenue
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330,598 |
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435,861 |
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Total current liabilities
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10,191,591 |
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12,126,738 |
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Deferred revenue
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699,314 |
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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 Contigencies
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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, $0.01 par value, 40,000,000 shares
authorized; 23,284,810 shares issued and outstanding at
March 31, 2006 and December 31, 2005
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232,848 |
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232,848 |
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Additional paid-in-capital
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198,104,068 |
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197,311,313 |
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Accumulated deficit
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(184,171,953 |
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(179,644,632 |
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Accumulated other comprehensive loss
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(34,340 |
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(66,198 |
) |
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Total stockholders equity
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14,130,623 |
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17,833,331 |
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Total liabilities and stockholders equity
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$ |
125,021,528 |
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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 March 31, | |
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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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$ |
1,082,867 |
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$ |
1,475,819 |
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Royalty revenue
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457,778 |
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444,289 |
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License fee revenue
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161,597 |
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165,896 |
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Total revenues
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1,702,242 |
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2,086,004 |
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Operating expenses:
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Research and development
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3,992,961 |
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5,533,151 |
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General and administrative
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2,338,363 |
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2,743,705 |
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Restructuring costs
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289,633 |
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Total operating expenses
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6,620,957 |
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8,276,856 |
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Operating loss
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(4,918,715 |
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(6,190,852 |
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Interest income
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1,304,573 |
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845,901 |
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Interest expense
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(869,363 |
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(910,604 |
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Loss before provision for income taxes
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(4,483,505 |
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(6,255,555 |
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Provision for income taxes
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43,816 |
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Net loss
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$ |
(4,527,321 |
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$ |
(6,255,555 |
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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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23,226,677 |
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Net loss per share, basic and diluted
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$ |
(0.19 |
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$ |
(0.27 |
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See accompanying notes.
4
EPIX PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
(unaudited)
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Three Months Ended March 31, | |
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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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$ |
(4,527,321 |
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$ |
(6,255,555 |
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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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409,899 |
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264,033 |
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Stock compensation expense
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792,755 |
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3,419 |
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Amortization of deferred financing costs
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119,109 |
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114,861 |
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Changes in operating assets and liabilities:
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Accounts receivable
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54,588 |
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(341,637 |
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Prepaid expenses and other current assets
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(132,987 |
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(131,053 |
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Accounts payable
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(727,177 |
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83,261 |
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Accrued expenses
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(415,476 |
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891,834 |
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Contract advances
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(687,231 |
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(150,341 |
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Deferred revenue
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(161,596 |
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(602,474 |
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Net cash used in operating activities
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(5,275,437 |
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(6,123,652 |
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Investing activities:
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Purchases of marketable securities
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(22,788,633 |
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(17,466,958 |
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Sale or redemption of marketable securities
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32,163,543 |
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19,393,321 |
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Increase in other assets
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(638,821 |
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Purchases of fixed assets
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(157,888 |
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Net cash provided by investing activities
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8,736,089 |
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1,768,475 |
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Financing activities:
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Proceeds from loan payable from strategic partner
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15,000,000 |
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Repayment of loan payable to strategic partner
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(15,000,000 |
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Proceeds from exercises of stock options
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437,392 |
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Net cash provided by financing activities
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437,392 |
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Net increase (decrease) in cash and cash equivalents
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3,460,652 |
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(3,917,785 |
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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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$ |
75,963,558 |
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$ |
69,446,753 |
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Supplemental cash flow information:
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Cash paid for interest
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$ |
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$ |
45,326 |
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Cash paid for taxes
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$ |
43,816 |
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$ |
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See accompanying notes.
5
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
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
Technologytm
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:
Vasovisttm,
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
EP-2104R. 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) in a stock transaction
valued at approximately $90 million, including the
assumption of net debt at closing. In addition, Predix
shareholders will be paid a possible milestone payment of
$35 million in cash, stock or a combination of both based
on the achievement of certain clinical or strategic milestones
within a specified period of time. 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 and ion channels.
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
March 31, 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
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL
STATEMENTS (Continued)
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3. |
Significant Accounting Policies |
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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 product development revenue at the time
it performs research and development activities for which
Schering AG and other collaborators are obligated to
reimburse the Company. Product development revenues from
Schering AG are recorded net of the Companys portion
of Schering AGs actual or most recent estimate of its
Vasovist research and development costs.
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
March 31, 2006, the estimated cost to complete the
EP-2104R feasibility
program is $15.2 million, unchanged from the estimate to
complete at 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.
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.
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. Royalties paid to MGH totaled $66,073 and $0
for the three months ended March 31, 2006 and 2005,
respectively.
The Company 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 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.
7
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL
STATEMENTS (Continued)
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 will occur in the
E.U. in May 2006 and 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, and 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 a 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.
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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.
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
8
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL
STATEMENTS (Continued)
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% 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 March 31, 2006.
Common stock potentially issuable, but excluded from the
calculation of dilutive net loss per share for the three months
ended March 31, 2006 and 2005 because their inclusion would
have been antidilutive, consisted of the following:
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|
|
|
|
|
|
|
|
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
Stock options and awards
|
|
|
2,486,616 |
|
|
|
3,774,473 |
|
Shares issuable on conversion of 3% Convertible Senior Notes
|
|
|
3,359,090 |
|
|
|
3,359,090 |
|
|
|
|
|
|
|
|
|
Total
|
|
|
5,845,706 |
|
|
|
7,133,563 |
|
|
|
|
|
|
|
|
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 March 31, 2006 and 2005 amounted to
$4.5 million and $6.2 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
9
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL
STATEMENTS (Continued)
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 $792,755 of stock-based compensation expense for the
three months ended March 31, 2006. The stock-based
compensation expense included $519,000 in research and
development and $273,755 in general and administrative expense
for the three months ended March 31, 2006. The compensation
expense increased both basic and diluted net loss per share by
$0.03. In accordance with the modified-prospective transition
method of SFAS 123(R), results for prior periods have not
been restated. As of March 31, 2006, there was
$8.4 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 1.9 years.
The following table illustrates the effect on net loss and net
loss per share for the three months ended March 31, 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 | |
|
|
March 31, 2005 | |
|
|
| |
Net loss as reported
|
|
$ |
(6,255,555 |
) |
|
Add: employee stock-based compensation included in net loss as
reported
|
|
|
|
|
|
Deduct: pro forma adjustment for stock-based compensation
|
|
|
(1,087,809 |
) |
|
|
|
|
Net loss pro forma
|
|
$ |
(7,343,364 |
) |
|
|
|
|
Net loss per share, basic and diluted
|
|
|
|
|
|
As reported
|
|
$ |
(0.27 |
) |
|
Pro forma
|
|
|
(0.32 |
) |
|
|
|
|
|
Effect of pro forma adjustment
|
|
$ |
(0.05 |
) |
|
|
|
|
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
expected forfeiture rate is based on historical experience. The
Company estimated the stock option forfeitures based on
historical experience. The Company used the
simplified method, as prescribed by the Securities
and Exchange Commissions Staff Accounting
Bulletin No. 107, to calculate the expected term, or
life, of options.
|
|
|
|
|
|
|
|
|
|
|
Options | |
|
|
| |
|
|
Three Months | |
|
|
Ended | |
|
|
March 31, | |
|
|
| |
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
Expected stock price volatility
|
|
|
70 |
% |
|
|
84 |
% |
Weighted average risk-free interest rate
|
|
|
4.62 |
% |
|
|
3.62 |
% |
Expected forfeiture rate
|
|
|
9.00 |
% |
|
|
0.00 |
% |
Expected life of option (years)
|
|
|
6.3 |
|
|
|
7.0 |
|
The weighted average grant-date fair value of options granted
during the three months ended March 31, 2006 was
$3.08 per share.
10
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL
STATEMENTS (Continued)
The following is a summary of the status of the Companys
stock option plans as March 31, 2006 and the stock option
activity for all stock option plans during the three months
ended March 31, 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
|
|
|
300,562 |
|
|
|
4.59 |
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancelled
|
|
|
(1,085,855 |
) |
|
|
11.55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2006
|
|
|
2,486,616 |
|
|
$ |
10.50 |
|
|
|
6.86 |
|
|
$ |
16,745 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2006
|
|
|
1,299,973 |
|
|
$ |
10.81 |
|
|
|
5.24 |
|
|
$ |
400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three months ended March 31, 2006, the Company
incurred an additional restructuring charge of $290,000 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 additional restructuring
charge included costs to vacate leased office space, which were
partly offset by a sublease for a portion of that space, an
impairment charge for the remaining net book value for leasehold
improvements located within the vacated space as well as excess
lab and office equipment in our facilities, and 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 December 31, 2005
|
|
$ |
971,828 |
|
|
Restructuring charges for the three months ended March 31,
2006
|
|
|
289,633 |
|
|
Write-offs
|
|
|
(154,502 |
) |
|
Employee related payments
|
|
|
(835,028 |
) |
|
|
|
|
Balance March 31, 2006
|
|
$ |
271,931 |
|
|
|
|
|
The Company has recorded $638,821 of deferred merger costs
relating to the acquisition of Predix (See notes 1 and 7). These
costs will be included in acquisitions costs upon consummation
of the merger.
In June 2004, the Company completed a sale, pursuant to
Rule 144A under the Securities Act of 1933, of
$100 million of 3% 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 March 31,
2006. Each of the senior notes is also convertible into the
Companys common stock in certain
11
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL
STATEMENTS (Continued)
other circumstances. The senior notes bear an interest rate of
3%, payable semiannually on June 15 and December 15 of each
year, beginning on December 15, 2004. There were no
interest payments made during the three months ended
March 31, 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). For the
three months ended March 31, 2006 and 2005, amortization of
the issuance costs was $119,109 and $114,861, respectively.
On April 3, 2006, the Company announced the signing of a
definitive merger agreement to acquire Predix Pharmaceuticals
Holdings, Inc. (Predix) in a stock transaction
valued at approximately $90 million, including the
assumption of net debt at closing. In addition, Predix
shareholders will be paid a possible milestone payment of
$35 million in cash, stock or a combination of both based
on the achievement of certain clinical or strategic milestones
within a specified period of time. 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 and ion channels.
On April 25, 2006, the Company submitted a
Form S-4
Registration Statement to register shares that would be issuable
upon the completion of the merger to acquire Predix.
Effective May 5, 2006, Michael J. Astrue resigned as
Interim Chief Executive Officer of the Company. Mr. Astrue
was appointed to the position in September 2005 after Michael
Webb, the former Chief Executive Officer, resigned.
Dr. Andrew Uprichard, President of EPIX, will be the
Companys principal executive officer pending the closing
of the merger with Predix, which is expected to occur in June or
July of 2006.
Following the consummation of the merger, Dr. Michael
Kauffman, Predixs President and Chief Executive Officer,
will become the Chief Executive Officer of the combined company.
Dr. Uprichard is expected to remain with the combined
company in the role of President.
|
|
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.
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, or MRA, 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
EP-2104R. In addition,
we have active research programs with respect to products for
diagnostic imaging and therapeutic uses.
On April 3, 2006, we announced the signing of a definitive
merger agreement to acquire Predix Pharmaceuticals Holdings,
Inc., or Predix, in a stock transaction valued at approximately
$90 million, including the assumption of net debt at
closing. In addition, Predix shareholders will be paid a
possible milestone payment of $35 million in cash, stock or
a combination of both based on the achievement of certain
clinical or strategic milestones within a specified period of
time. 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 and ion channels.
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 and in Note 3 to the
financial statements set forth in Item 1 above. 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.
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
13
which they become reasonably estimable. These adjustments could
have a material effect on our results of operations.
With respect to payments received from Schering AG in
connection with the Vasovist development program, we recognize
product development revenue at the time we perform research and
development activities, for which Schering AG is obligated
to reimburse us. Product development revenues from
Schering AG are recorded net of our portion of
Schering AGs actual or most recent estimate of its
Vasovist research and development costs.
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., expected to start 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 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
14
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.
Our financial results could be materially adversely affected
with the required adoption of SFAS 123(R) to the extent of
the additional compensation expense that we are required to
recognize, which could change significantly from period to
period based on several factors, including the number of stock
options granted and fluctuations in our stock price and/or
interest rates. See Note 3 to the Notes to Condensed
Financial Statements (unaudited).
Results Of Operations
|
|
|
Comparison of Three Months Ended March 31, 2006
versus 2005 |
Our current revenues arise 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. Revenues for the three months ended
March 31, 2006 and 2005 were $1.7 million and
$2.1 million, respectively. Revenues for 2006 consisted of
$1.1 million of product development revenue from
Schering AG, $458,000 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 decrease in
total revenues of $384,000 for the three months ended
March 31, 2006 compared to the same period last year was
primarily attributed to lower product development revenue. The
product development revenue decrease of $393,000 resulted from
the lower reimbursable costs incurred by us related to Vasovist,
lower costs for the
EP-2104R
proof-of-concept
program, for which enrollment for our Phase II trial was
completed during the first quarter of 2006, and reduced spending
for our research projects because of the reduction in force that
occurred in January 2006.
|
|
|
Research and Development Expenses |
Our research and development expenses arise from our development
activities for Vasovist and
EP-2104R and from our
discovery research programs. Research and development expenses
for the three months ended March 31, 2006 were
$4.0 million compared to $5.5 million for the same
period in 2005. The decrease of approximately $1.5 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 $519,000 resulting from the initial recognition of
stock compensation related to the implementation of
SFAS 123(R). Spending during the first quarter of 2006 for
Vasovist primarily involved reviewing our path forward with the
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, 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 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 |
15
|
|
|
|
|
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
of images in certain of the previously completed Phase III
trials. 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 in the U.S., where
Vasovist is not approved for commercial sale. |
Current plans for developing and commercializing Vasovist and
EP-2104R reflect our
best estimate of the time involved in the development programs
based on factors currently known to us. The third parties
described above have the ability to greatly impact this
timetable and we may not have control over changes they cause to
our current estimates.
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
expenditure necessary to execute the feasibility program is
subject to numerous uncertainties, which may adversely affect
our cash outlay, net of Schering AGs reimbursement to
us. 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. In March
2006, we announced that we had completed enrollment for this
clinical trial. Our partner, Schering AG, has an option to
exclusively license
EP-2104R. The
exercisability of this option will continue for a specified
period of time after the submission of a report summarizing the
results of this clinical trial. If Schering AG exercises
its option for the program, it will be required to pay us a
milestone payment of $5.0 million and take over the
development of
EP-2104R. We will
receive a royalty on sales of
EP-2104R, the rate of
which will depend upon the amount that we contribute to further
product development, if the product is ultimately approved by
regulators.
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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 $2.3 million for
the three months ended March 31, 2006 as compared to
$2.7 million for the three months ended March 31,
2005. The decrease of $405,000 was primarily attributed to lower
spending by us and Schering AG for Vasovist marketing,
lower consulting fees 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 $274,000
resulting from the
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initial 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 $44,000 and $20,000 for
the three months ended March 31, 2006 and 2005,
respectively.
Restructuring costs for the three months ended March 31,
2006 were $290,000 as compared to $0 for the three months ended
March 31, 2005. The current quarters restructuring
costs 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
recognized additional restructuring costs related to vacating
space in some of our facilities and 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.
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Interest Income and Interest Expense |
Interest income for the three months ended March 31, 2006
was $1.3 million as compared to $846,000 for the three
months ended March 31, 2005. The increase of $459,000 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 March 31, 2006
and 2005 was $869,000 and $911,000, respectively. The decrease
in interest expense of $41,000 for the three months ended
March 31, 2006 resulted primarily from the decision not to
draw down the Schering AG loan facility at the end of 2005.
We subsequently terminated the loan facility with
Schering AG in January 2006.
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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 March 31, 2006 as compared to $0 for the three
months ended March 31, 2005. Because the remaining balance
of prepaid royalties from Bracco was fully offset at the end of
the third quarter of 2005, Italian income taxes must now be
withheld on Bracco royalties on sales of MultiHance that are
paid to us. We expect to have Italian income taxes withheld on
all Bracco royalties for the remainder of the agreement, which
is expected to end in the E.U. midway through 2006 and in early
2007 for the U.S.
Liquidity and Capital Resources
Our principal sources of liquidity consist of cash, cash
equivalents and available-for-sale marketable securities of
$118.8 million at March 31, 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 $5.3 million of net cash to fund
operations for the three months ended March 31, 2006, which
compares to $6.1 million for the same period in 2005. The
net use of cash to fund operations during the three months ended
March 31, 2006 resulted from the net loss of
$4.5 million, which included non-cash expenses for
amortization and depreciation of $410,000 and the recognition of
stock compensation expense of $793,000 as a result of the
adoption of SFAS 123(R) in January 2006. Other significant
increases in net working capital resulted from the combined
reductions in contract advances of $688,000 and accounts
payable/accrued expenses of $1.1 million. The reduction in
contract advances resulted from lower Vasovist development and
marketing costs incurred by Schering AG and to the offset
of funds previously received from Schering AG for the
EP-2104R program. Lower
accounts payable and
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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
$8.7 million during the three months ended March 31,
2006 as compared to net cash provided of $1.8 million for
the same period last year. The contribution of
$32.2 million of net proceeds from the sale and redemption
of maturing marketable securities, partly offset by the
reinvestment into marketable securities of available cash, and
other assets resulted from the capitalization of transaction
cost related to merger, accounted for the entire increase in
other investing activities during the three months ended
March 31, 2006. During the same three-month period last
year, we sold or redeemed available-for-sale marketable
securities of $19.4 million, partly offset by the cash used
to purchase $17.5 million of available-for-sale marketable
securities that was primarily funded from the rollover of
securities within our portfolio. We had no capital expenditures
during the three months ended March 31, 2006, compared to
$158,000 in capital expenditures for the same period last year.
The higher capital expenditures in 2005 were primarily
attributed to leasehold improvements.
We had no cash provided or used from financing activities during
the three months ended March 31, 2006 because of our
decision to terminate the loan facility with Schering AG in
January 2006. During the three months ended March 31, 2005,
the primary sources of financing came from the draw down of the
loan facility of $15.0 million with Schering AG, which
was outstanding at March 31, 2005 and the proceeds from
stock option exercises of $437,000. Also during that same
period, we repaid $15.0 million on our loan facility with
Schering AG, which was outstanding at December 31,
2004.
We currently 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. We also receive monthly interest income on our
cash, cash equivalents and available-for-sale marketable
securities. We also receive quarterly royalty payments from
Bracco for sales of MultiHance and Schering AG for sales of
Primovist in the E.U. 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. We also will 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. Additional future cash flows from
our EP-2104R
collaboration with Schering AG of up to $15.0 million
depend on Schering AGs decision to exercise its
development option and on the success of further development,
regulatory and commercialization work by Schering AG, none
of which is assured at this time. Additional future cash flows
from our MRI research collaboration with Schering AG depend
on the success of the research program and the success of
further development, regulatory and commercialization activities
with respect to any products generated. In October 2005, we
announced that an amendment to the research collaboration
agreement had been entered into with Schering AG. This
amendment narrowed the definition of the field of our
collaboration with Schering AG. This research collaboration
expires in May 2006, and we believe that it is unlikely that the
parties will extend the term of the collaboration. We expect to
discuss the disposition of current research programs with
Schering AG prior to expiration of the collaboration 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. With the expiration in 2006 of
certain patents related to the license with MGH, we expect to
reduce our
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royalty payments to MGH beginning in the second half of 2006.
All remaining unearned prepaid royalties that would be due to
Bracco upon termination of our license agreement had been offset
against earned royalties by the end of 2005.
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 December 31, 2005 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 April 24, 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 into 2008. 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 preclinical trials; the timing and costs
of filing future regulatory submissions; the time 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. We may need to devote resources to
the development of Predix products following the completion of
the merger which could 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 U.S.
We have not entered into any material contractual obligations
since the presentation of our table of Contractual Obligations
as set forth in our Annual Report on
Form 10-K, as
amended, for the fiscal year ended December 31, 2005.
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 $180.4 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.
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
associated with pre-clinical studies and clinical trials; our
lack of
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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.
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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
$92,000, and an increase of approximately $92,000, respectively,
at March 31, 2006.
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ITEM 4. |
CONTROLS AND PROCEDURES |
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(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. |
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(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
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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
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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 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.
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.
MERGER-RELATED RISKS
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Completion of the proposed merger with Predix is subject
to various closing conditions, involves significant costs and
will require considerable attention from our management. Failure
to complete the merger could adversely affect our stock price
and our future business and operations. |
The completion of the proposed merger with Predix is subject to
the satisfaction of various closing conditions, including the
approval by both our and Predixs stockholders, and we
cannot assure you that such conditions will be satisfied and
that the merger will be successfully completed. In the event
that the merger is not consummated we will have spent
considerable time and resources, and incurred substantial costs,
without result, including costs related to the merger, such as
legal, accounting and advisory fees, many of which must be paid
even if the merger is not completed, or the payment of a
termination fee to Predix under certain circumstances. If the
merger is not consummated, our reputation in our industry and in
the investment community could be damaged and, as a result, the
market price of our common stock could decline. In addition,
successful completion of the merger will require the attention
of our management and may divert their attention away from our
operations. Our Interim Chief Executive Officer has resigned as
of May 5, 2006, which may result in a more significant
burden on the remaining members of our management team and their
efforts to complete the merger.
RESEARCH AND DEVELOPMENT RISKS
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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.
Although the European Medicines Agency, or 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
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2004, our development partner Schering AG submitted a
Marketing Authorization Application, or MAA, 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 and considering the parameters of
the additional clinical trials requested by the FDA, we have
decided to pursue an appeal of the second approvable letter and
ask 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 our 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, the
timing and process of conducting any clinical trials that may be
ultimately required if our 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 Phase III trials that may be required if our
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 feasibility clinical trial of
EP-2104R. Our partner,
Schering AG, has an option to exclusively license
EP-2104R. The
exercisability of this option will continue for a specified
period of time after the submission of a report summarizing the
results of this clinical trial. If Schering AG exercises
its option to exclusively license the product candidate, then we
will be eligible for milestone payments for certain clinical and
regulatory achievements and a royalty after the product
candidate is commercialized. However, if Schering AG
declines to exercise its option, in which case we may bear the
expenses of further clinical development ourselves. Regardless
of whether Schering AG exercises its option to license
EP-2104R, the FDA, the
EMEA and other regulatory agencies to which we or
Schering AG 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 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, we 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.
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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 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.
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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
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 risk and be required to pay
significant
23
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.
Specifically, 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 determine to appeal
the FDAs decision not to approve Vasovist without data
from additional clinical trials. We cannot predict whether our
appeal will 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
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 MRA for the detection of vascular disease in
the renal arteries, and another to determine the efficacy of
Vasovist-enhanced MRA 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
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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.
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 law 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. |
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.
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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 had 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
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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.
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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 relate
to royalties we receive and to Vasovist. The license agreement
imposes various commercialization, sublicensing, royalty and
other obligations on us. 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 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.
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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. Even though we hold numerous
patents and have made numerous patent applications, because the
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.
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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.
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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.
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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 MRA, relating to dynamic
MRA, which involves capturing MRA 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 made certain covenants and
agreements and granted us certain discharges, licenses and
releases in connection with the use of Vasovist. In
consideration of Dr. Prince entering into the agreement, we
agreed to pay him an upfront fee 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 and certain quantities
of Vasovist. If we are unable to obtain another such 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.
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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
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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.
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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 from our Company and our board of
directors in September 2005. Mr. Astrue resigned as our
Interim Chief Executive Officer on May 5, 2006. In
addition, our Chief Financial Officer resigned in July 2005. We
currently have no Chief Financial Officer and our Executive
Director, Finance, is serving as our principal financial and
accounting officer. 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.
BUSINESS RISKS
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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
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Siemens Medical Systems. Four of our key agreements include
three collaboration agreements with Schering AG to perform
joint research and to develop and commercialize Vasovist,
EP-2104R 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 or
EP-2104R fail to meet
certain performance targets in development and
commercialization. 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. This research collaboration expires in
May 2006, and we believe that it is unlikely that the parties
will extend the term of the collaboration. We expect to discuss
the disposition of current research programs with
Schering AG prior to expiration of the collaboration and to
continue to advance at least some of these programs either
unilaterally or with another partner. While the research
agreement is separate from our agreement with Schering AG
relating to Vasovist and
EP-2104R, 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 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 MRA images.
Although not required for clinical use of Vasovist, the ability
to separate veins from arteries using Vasovist-enhanced MRA 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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actual or anticipated fluctuations in our operating results; |
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announcements of technological innovation or new commercial
products by us or our competitors; |
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new collaborations entered into by us or our competitors; |
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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 three months ended March 31, 2006, the closing
price of our common stock ranged from $5.02 to $3.42. The last
reported closing price for our common stock on March 31,
2006, the last trading day before the public announcement of the
merger, was $3.50. 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.
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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 the
Netherlands by our partner, Schering AG. If
Schering AG fails to launch Vasovist in other countries in
the timeframes we anticipate or fails to achieve the sales we
anticipate, 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
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to successfully market and sell Vasovist throughout Europe, we
do not expect any significant royalties for 2006 sales.
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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
marketing agreements with strategic collaborators. In
particular, our revenues for the three months ended
March 31, 2006 were $1.7 million and consisted of
$1.1 million of product development revenue from
Schering AG, $458,000 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. 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.
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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 March 31, 2006 were
approximately $184.2 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. 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. 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.
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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 MRA has been limited and
use of MRA 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 MRA compared to imaging with other
technologies. Vasovist represents a new approach to imaging the
non-coronary vascular system, and market acceptance both of MRA
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.
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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
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of March 31, 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 April 24, 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
into 2008. 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.
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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 MRA, 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 MRA: 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, or DSA, which is
an improved form of
X-ray angiography,
computed tomography angiography, or CTA, 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.
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Product liability claims could increase our costs and
adversely affect our results of operations. |
The clinical testing of our approved 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 product
candidates in clinical research, 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
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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.
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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 million. In addition, holders of our
3% 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.
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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
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.
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Exhibit |
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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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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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Exhibit |
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Number |
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Description |
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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% 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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Amendment Number One to Employment Agreement, dated as of
September 14, 2005, between the Company and Michael J.
Astrue, dated March 7, 2006. Filed as Exhibit 99.1 to
the Companys Current Report on Form 8-K filed
March 9, 2006 (File No. 000-21863) and incorporated
herein by reference. |
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10 |
.2 |
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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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31 |
.1* |
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Certification pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 for Michael J. Astrue. |
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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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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: May 5, 2006
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By: |
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/s/ MICHAEL J. ASTRUE
Michael
J. Astrue
Interim Chief Executive Officer |
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EPIX Pharmaceuticals, Inc. |
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Date: May 5, 2006
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By: |
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/s/ ROBERT B. PELLETIER
Robert
B. Pelletier
Executive Director of Finance and Principal Accounting Officer |
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