e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
Or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number 0-21863
EPIX Pharmaceuticals, Inc.
(Exact name of Registrant as Specified in its Charter)
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Delaware
(State of incorporation)
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04-3030815
(I.R.S. Employer Identification No.) |
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4 Maguire Road, Lexington, Massachusetts
(Address of principal executive offices)
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02421
(Zip Code) |
Registrants telephone number, including area code: (781) 761-7600
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 30, 2007, 32,600,099 shares of the registrants Common Stock, $0.01 par value per
share, were issued and outstanding.
EPIX Pharmaceuticals, Inc.
Quarterly Report on Form 10-Q
INDEX
2
PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements.
EPIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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March 31, |
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December 31, |
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2007 |
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2006 |
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ASSETS
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Current assets: |
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Cash and cash equivalents |
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$ |
17,008,949 |
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$ |
30,332,468 |
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Available-for-sale marketable securities |
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77,948,017 |
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79,210,430 |
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Accounts receivable |
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46,367 |
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Prepaid expenses and other assets |
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2,905,567 |
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2,575,265 |
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Total current assets |
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97,862,533 |
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112,164,530 |
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Property and equipment, net |
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5,128,433 |
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3,592,570 |
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Other assets |
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4,311,191 |
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4,330,578 |
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Goodwill |
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4,939,814 |
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4,939,814 |
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Total assets |
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$ |
112,241,971 |
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$ |
125,027,492 |
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LIABILITIES AND STOCKHOLDERS DEFICIT
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Current liabilities: |
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Accounts payable |
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$ |
3,845,534 |
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$ |
1,982,032 |
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Accrued expenses |
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10,868,696 |
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7,695,548 |
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Contract advances |
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4,754,556 |
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4,605,079 |
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Merger consideration payable |
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18,786,704 |
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18,504,084 |
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Current portion of capital lease obligation |
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116,184 |
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84,633 |
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Deferred revenue |
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2,958,985 |
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3,665,120 |
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Other current liabilities |
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485,753 |
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446,137 |
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Total current liabilities |
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41,816,412 |
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36,982,633 |
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Deferred revenue |
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16,771,764 |
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17,101,165 |
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Capital lease obligation |
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105,487 |
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102,077 |
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Other liabilities |
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4,314,646 |
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2,862,898 |
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Convertible debt |
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100,000,000 |
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100,000,000 |
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Total liabilities |
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163,008,309 |
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157,048,773 |
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Commitments and contigencies |
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Stockholders deficit: |
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Preferred Stock, $0.01 par value, 1,000,000 shares authorized;
no shares issued |
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Common Stock, $0.01 par value, 100,000,000 shares authorized;
32,597,971 and 32,524,726 shares issued and outstanding
at March 31, 2007 and December 31, 2006, respectively |
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325,979 |
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325,247 |
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Additional paid-in-capital |
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313,755,169 |
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312,984,862 |
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Accumulated deficit |
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(364,878,213 |
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(345,368,698 |
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Accumulated other comprehensive income |
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30,727 |
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37,308 |
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Total stockholders deficit |
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(50,766,338 |
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(32,021,281 |
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Total liabilities and stockholders deficit |
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$ |
112,241,971 |
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$ |
125,027,492 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
EPIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three Months Ended March 31, |
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2007 |
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2006 |
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Revenues: |
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Product development revenue |
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$ |
434,392 |
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$ |
1,082,867 |
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Royalty revenue |
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487,658 |
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457,778 |
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License fee revenue |
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1,032,850 |
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161,597 |
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Total revenues |
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1,954,900 |
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1,702,242 |
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Operating expenses: |
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Royalties |
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53,668 |
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43,795 |
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Research and development |
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13,491,119 |
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3,865,001 |
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General and administrative |
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8,613,758 |
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2,422,528 |
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Restructuring |
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289,633 |
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Total operating expenses |
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22,158,545 |
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6,620,957 |
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Operating loss |
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(20,203,645 |
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(4,918,715 |
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Interest and other income |
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1,962,953 |
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1,304,573 |
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Interest expense |
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(1,230,734 |
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(869,363 |
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Loss before provision for income taxes |
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(19,471,426 |
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(4,483,505 |
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Provision for income taxes |
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38,089 |
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43,816 |
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Net loss |
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$ |
(19,509,515 |
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$ |
(4,527,321 |
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Weighted average shares: |
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Basic and diluted |
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32,586,377 |
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15,523,207 |
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Net loss per share, basic and diluted |
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$ |
(0.60 |
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$ |
(0.29 |
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The accompanying notes are an integral part of these condensed consolidated financial
statements.
4
EPIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Three Months Ended March 31, |
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2007 |
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2006 |
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Operating activities: |
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Net loss |
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$ |
(19,509,515 |
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$ |
(4,527,321 |
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Adjustments to reconcile net loss to net cash used in operating
activities: |
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Depreciation, amortization and asset write offs |
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516,278 |
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409,899 |
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Stock compensation expense |
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696,677 |
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792,755 |
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Noncash interest expense from embedded derivative |
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(27,725 |
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Amortization of deferred financing costs |
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123,511 |
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119,109 |
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Accretion of premium (discount) on available-for-sale securities |
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(777,315 |
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8,985 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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46,367 |
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54,588 |
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Prepaid expenses and other current assets |
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(330,302 |
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(132,987 |
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Other assets and liabilities |
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1,517,178 |
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Accounts payable |
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1,863,502 |
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(727,177 |
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Accrued expenses |
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3,173,149 |
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(415,476 |
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Contract advances |
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149,477 |
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(687,231 |
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Merger consideration payable |
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310,345 |
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Deferred revenue |
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(1,035,536 |
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(161,596 |
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Net cash used in operating activities |
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(13,283,909 |
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(5,266,452 |
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Investing activities: |
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Purchases of marketable securities |
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(21,859,213 |
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(22,788,633 |
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Sales or redemptions of marketable securities |
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23,500,000 |
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32,154,558 |
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Restricted cash |
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262,422 |
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Purchases of fixed assets |
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(1,995,181 |
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(638,821 |
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Net cash provided by (used in) investing activities |
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(91,972 |
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8,727,104 |
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Financing activities: |
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Principal payments on capital leases |
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(22,000 |
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Proceeds from stock option exercises |
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74,362 |
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Net cash provided by financing activities |
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52,362 |
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Net increase (decrease) in cash and cash equivalents |
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(13,323,519 |
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3,460,652 |
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Cash and cash equivalents at beginning of period |
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30,332,468 |
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72,502,906 |
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Cash and cash equivalents at end of period |
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$ |
17,008,949 |
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$ |
75,963,558 |
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Supplemental disclosure of noncash financing and investing activities: |
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Purchases of fixed asset with capital lease |
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$ |
56,960 |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial
statements.
5
EPIX PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Nature of Business
EPIX Pharmaceuticals, Inc. (EPIX or the Company) is a biopharmaceutical company focused on
discovering, developing and commercializing novel pharmaceutical products through the use of
proprietary technologies to better diagnose, treat and manage patients. The Company has four
internally discovered therapeutic candidates in clinical trials. These drug candidates are
targeting conditions such as depression, Alzheimers disease, cardiovascular disease and obesity.
In addition, the Company has two imaging agents, one of which is
approved for marketing in 32
countries outside of the United States and one that has completed a
Phase 2a clinical trial. The Company also has
collaborations with leading organizations, including SmithKline Beecham Corporation
(GlaxoSmithKline), Amgen Inc., Cystic Fibrosis Foundation Therapeutics Incorporated, and Bayer
Schering Pharma AG, Germany.
2. Basis of Presentation
The unaudited condensed consolidated 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 consolidated 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, 2007 are not necessarily indicative of the results expected for
the full fiscal year.
The unaudited condensed consolidated financial statements and related disclosures have been
prepared with the assumption that users of the unaudited condensed consolidated financial
statements have read or have access to the audited financial statements for the preceding fiscal
year. Accordingly, these unaudited condensed consolidated 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, 2006.
6
3. Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the financial statements of the Company
and those of its wholly-owned subsidiary in Israel. All material intercompany balances and
transactions have been eliminated.
Income Taxes
In June 2006, the Financial Accounting Standards Board (FASB) issued Interpretation No.
48, Accounting for Uncertainty in Income Taxes (FIN 48). FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in an enterprises financial statements in accordance with
Statement of Financial Accounting Standards (SFAS) No. 109, Accounting for Income Taxes. This
interpretation prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax
return. FIN 48 also provides guidance on derecognition of tax benefits, classification on the
balance sheet, interest and penalties, accounting in interim periods, disclosure, and transition.
The Companys adoption of FIN 48 effective January 1, 2007 did not have a material effect on the
Companys financial position or results of operations.
Segment Information
SFAS No. 131, Disclosure about Segments of an Enterprise and Related Information,
establishes standards for reporting information regarding operating segments and for related
disclosures about products and services and geographical areas. The Company operates in one
business segment, which is the discovery and development of pharmaceutical products.
Revenue
The Company recognizes revenue relating to collaborations in accordance with the SECs
Staff Accounting Bulletin No. 104, Revenue Recognition in Financial Statements.
Revenue under collaborations may include the receipt of non-refundable license fees, milestone
payments, reimbursement of research and development costs and royalties.
The Company recognizes nonrefundable upfront license fees and guaranteed, time-based
payments that require continuing involvement in the form of research and development as revenue:
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ratably over the development period; or |
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based upon the level of research services performed during the period of the research contract. |
When the period of deferral cannot be specifically identified from the contract, the Company
estimates the period based upon other critical factors contained within the contract. EPIX
continually reviews such estimates which could result in a change in the deferral period and might
impact the timing and amount of revenue recognized.
Milestone payments are recognized as revenue when the performance obligations, as
defined in the contract, are achieved. Performance obligations typically consist of significant
milestones in the development life cycle of the related technology, such as initiation of clinical
trials, filing for approval with regulatory agencies and approvals by regulatory agencies.
Royalties are recognized as revenue when earned and are reasonably estimable, which is
typically upon receipt of royalty reports from the licensee or cash.
Reimbursements of research and development costs are recognized as revenue as the
related costs are incurred.
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 trials,
supplies, consulting expenses, facility costs and certain overhead costs.
7
To conduct research and development activities and compile regulatory submissions, the
Company enters into contracts with vendors who render services over extended periods of time.
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 the Company 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 the assumptions for each
contract in order to reflect its most current estimate of the costs incurred under each contract.
Adjustments are recorded in the period in which the revisions are estimable. These adjustments
could have a material effect on the Companys results of operations.
Loss Per Share
The Company computes loss per share in accordance with the provisions of SFAS No. 128,
Earnings per Share. Basic net loss per share is based upon the weighted-average number of common
shares outstanding and excludes the effect of dilutive common stock issuable upon exercise of stock
options, convertible debt and merger consideration. In computing diluted loss per share, only
potential common shares that are dilutive, or those that reduce earnings per share, are included.
The issuance of common stock from the exercise of options, convertible debt and merger
consideration is not assumed if the result is anti-dilutive, such as when a loss is reported.
Common stock potentially issuable but excluded from the calculation of dilutive net loss
per share for the three months ended March 31, 2007 and 2006 because their inclusion would have
been antidilutive consisted of the following:
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Three Months Ended March 31, |
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2007 |
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2006 |
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Stock options and awards |
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3,863,241 |
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1,657,744 |
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Shares issuable on conversion of 3% Convertible Senior Notes (1) |
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2,239,393 |
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2,239,393 |
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Shares issuable in satisfaction of merger consideration payable (2) |
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2,647,760 |
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8,750,394 |
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3,897,137 |
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(1) |
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Each $1,000 of senior notes is convertible into 22.39 shares of the Companys common
stock (representing a conversion price of approximately $44.66 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, 2007. |
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(2) |
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Share amount calculated as if the merger consideration was payable to the former
Predix security holders as of March 31, 2007. Actual settlement date for the merger
consideration is October 29, 2007. The remaining merger consideration is payable in EPIX
common stock to the extent that such payment in shares would not cause the former Predix
shareholders, warrant holders and option holders aggregate interest in EPIX to exceed
49.99%. |
Comprehensive Income (Loss)
In accordance with SFAS No. 130, Reporting Comprehensive Income components of
comprehensive income (loss) include net loss and certain transactions that have generally been
reported in the statements of stockholders equity (deficit). The Companys comprehensive loss is
comprised of net loss and unrealized gains/losses on the Companys available-for-sale marketable
securities. The comprehensive loss for the three months ended March 31, 2007 and 2006 was $19.5
million and $4.5 million, respectively.
8
Reclassifications
Certain items in the prior years consolidated financial statements have been
reclassified to conform to the current presentation of the financial statements.
4. Acquisition of Predix
On August 16, 2006, EPIX completed its acquisition of Predix Pharmaceuticals Holdings, Inc.
(Predix) pursuant to the terms of the merger agreement. Pursuant to the merger agreement, Predix
merged with and into EPIX Delaware, Inc. and became a wholly-owned subsidiary of EPIX. The merger
with Predix was primarily a stock transaction valued at approximately $125.0 million, including the
assumption of net debt at closing. The results of Predix have been included in the statement of
operations from August 16, 2006.
The following pro forma financial information presents the results of operations as if the
merger had occurred at the beginning of 2006 (in thousands, except per share amount). The pro forma
financial information excludes the write-off of in-process research and development of $123,500,000
as it has no continuing impact after the merger. The pro forma information does not purport to
indicate the results that would have actually been obtained had the merger been completed on the
assumed date or which may be realized in the future.
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Three Months Ended |
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March 31, 2006 |
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Revenues |
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$ |
2,487 |
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Net loss |
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$ |
(12,620 |
) |
Net loss per share, basic and diluted |
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$ |
(0.43 |
) |
5. Restructuring Charges
At December 31, 2006, the Company had a $229,976 restructuring liability for on-going lease
obligations related to restructuring charges recorded in 2006. During the three-months ended March
31, 2007, the Company paid $53,749 resulting in a liability balance of $176,227 at March 31, 2007.
6. Recent Accounting Pronouncements
On September 15, 2006,
the FASB issued SFAS No. 157 Fair Value Measurements .
SFAS 157 defines fair value, establishes a framework for measuring
fair value and expands
disclosures about fair value measurements. SFAS 157 is effective for the Company as of January 1,
2008. The Company is currently evaluating the potential impact of adopting SFAS 157.
9
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations
should be read in conjunction with our unaudited condensed consolidated financial statements and
related notes thereto that appear elsewhere in this Quarterly Report on Form 10-Q and the audited
financial statements and related notes thereto and Managements Discussion and Analysis of
Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the
year ended December 31, 2006, which has been filed with the Securities and Exchange Commission. In
addition to historical consolidated financial information, the following discussion contains
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, and are intended
to be covered by the safe harbor created by those sections. Forward-looking statements, which are
based on certain assumptions and reflect our plans, estimates and beliefs, can generally be
identified by the use of forward-looking terms such as believes, expects, may, will,
should, could, seek, intends, plans, estimates, anticipates or other comparable
terms. Our actual results could differ materially from those discussed in the forward-looking
statements. We urge you to consider the risks and uncertainties described in Part I, Item 1A. Risk
Factors in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2006, in
evaluating our forward-looking statements. We caution readers not to place undue reliance upon any
such forward-looking statements, which speak only as of the date made. Except as otherwise required
by the federal securities laws, we disclaim any obligation or undertaking to publicly release any
updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect
any change in our expectations with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
Overview
We are a biopharmaceutical company focused on discovering, developing and
commercializing novel pharmaceutical products through the use of proprietary technologies to better
diagnose, treat and manage patients. We have four internally discovered therapeutic candidates in
clinical trials. These drug candidates are targeting conditions such as depression, Alzheimers
disease, cardiovascular disease and obesity. In addition we have two imaging agents, one of which
is approved for marketing in 32 countries outside of the United
States and one that has completed a Phase 2a clinical trial. We
also have collaborations with leading organizations, including SmithKline Beecham Corporation
(GlaxoSmithKline), Amgen Inc., Cystic Fibrosis Foundation Therapeutics Incorporated, and Bayer
Schering Pharma AG, Germany.
The focus of our therapeutic drug discovery and development efforts is on the two
classes of drug targets known as G-protein Coupled Receptors or GPCRs and ion channels. GPCRs and
ion channels are classes of proteins embedded in the surface membrane of all cells and are
responsible for mediating much of the biological signaling at the cellular level. We believe that
our proprietary drug discovery technology and approach addresses many of the inefficiencies
associated with traditional GPCR and ion channel-targeted drug discovery. By integrating
computer-based, or in silico, technology with in-house medicinal chemistry, we believe that we can
rapidly identify and optimize highly selective drug candidates. We focus on GPCR and ion channel
drug targets whose role in disease has already been demonstrated in clinical trials or in
preclinical studies. In each of our four clinical-stage therapeutic programs, we have used our drug
discovery technology and approach to optimize a lead compound into a clinical drug candidate in
less than ten months, synthesizing fewer than 80 compounds per program. We have moved each of these
drug candidates into clinical trials in less than 18 months from lead identification. We believe
our drug discovery technology and approach enables us to efficiently and cost-effectively discover
and develop GPCR and ion channel-targeted drugs.
RESULTS OF OPERATIONS
Research and Development Overview
Research and development expense consists primarily of:
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salaries, benefits and related expenses for personnel engaged in research and development activities; |
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fees paid to contract research organizations to manage and monitor clinical trials; |
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fees paid to research organizations in conjunction with preclinical studies; |
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fees paid to access chemical and intellectual property databases; |
10
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costs of materials used in research and development and clinical studies; |
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academic testing and consulting, license and sponsored research fees paid to third parties; and |
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costs of facilities and equipment, including depreciation, used in research and development activities. |
We expense both internal and external research and development costs as incurred. We expect
that a large percentage of our research and development expenses in the future will be incurred in
support of our current and future preclinical and clinical therapeutic development programs. These
expenditures are subject to numerous uncertainties in timing and cost to completion. We test drug
candidates in preclinical studies for safety, toxicology and efficacy. We then conduct early-stage
clinical trials for each drug candidate. As we obtain results from trials, we may elect to
discontinue or delay clinical trials for certain drug candidates in order to focus our resources on
more promising drug candidates.
We currently have one imaging product, Vasovist, which is approved for marketing in 32
countries outside of the United States. We are appealing the U.S. Food and Drug Administrations
(FDA) decision to require additional clinical trials for approval of Vasovist in the United States.
We also have one imaging agent, EP-2104R, in clinical development. We completed a Phase 2a clinical
trial of EP-2104R in the second quarter of 2006. We do not intend to continue development of
EP-2104R and are actively pursuing a partner to continue further development. Future costs expected
to be incurred for Vasovist are currently limited to legal and consulting costs related to the
on-going FDA appeal. Future costs expected to be incurred for EP-2104 are limited to our partnering
efforts.
In connection with our acquisition of Predix, we incurred a charge of $123.5 million for
in-process research and development. The in-process research and development charge represents the
fair value of purchased in-process technology of Predix for research projects that, as of the
closing date of the merger, had not reached technological feasibility and have no alternative
future use. The in-process research and development primarily represented the fair value of the
following drug candidates: PRX-00023 ($70.9 million) that, as of the date of the merger, was in
Phase 3 clinical trials for the treatment of generalized anxiety disorder; PRX-03140 ($23.5
million) that, as of the date of the merger had completed Phase 1 clinical trials for the treatment
of Alzheimers disease; PRX-08066 ($20.2 million) that, as of the date of the merger, had entered
Phase 2 clinical trials for the treatment of pulmonary hypertension in association with chronic obstructive pulmonary disease (COPD); and
PRX-07034 ($8.9 million) that, as of the date of the merger, had entered Phase 1 clinical trials
for the treatment of obesity.
In September 2006, we completed a pivotal Phase 3 clinical trial for the treatment of
generalized anxiety disorder with PRX-00023. Results from this trial demonstrated that PRX-00023
did not achieve a statistically significant improvement over placebo for the primary endpoint of
efficacy with respect to generalized anxiety disorder at the dose tested (80mg once daily). The
trial was statistically powered to evaluate the efficacy of PRX-00023 compared to placebo as
measured by the change from baseline in the Hamilton Rating Scale for Anxiety or HAM-A. The HAM-A
scale is the accepted standard for the evaluation of anti-anxiety drug activity for the FDA.
Effects of PRX-00023 on symptoms of depression, which was a secondary endpoint of the Phase 3
clinical trial, were assessed using the Montgomery-Asberg Depression Rating Scale or MADRS, an
FDA-recommended assessment for depression. The data from this trial showed a statistically
significant improvement from baseline with PRX-00023 treatment compared to placebo in the MADRS
score, indicating that PRX-00023 reduced symptoms of depression present in the patients in this
trial. In this Phase 3 trial, PRX-00023 was well tolerated, and the rate of discontinuation due to
adverse events was very low (1.4% with PRX-00023 vs. 2.9% with placebo). To date, there have been
no serious adverse events associated with treatment in more than 250 subjects who have received
PRX-00023.
Based on the Phase 3 trial results, we have discontinued clinical development of
PRX-00023 at a dose of 80mg once daily in generalized anxiety disorder. We are currently focusing
our development efforts for this drug candidate on depression. We initiated a randomized, blinded
Phase 2b clinical trial of PRX-00023 in major depression in March 2007.
The following summarizes the applicable disease indication and the clinical status of
our four therapeutic drug candidates:
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Drug |
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Candidate |
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Disease Indication |
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Clinical Trial Status |
PRX-08066 |
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Pulmonary Hypertension/COPD |
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Phase 2a |
PRX-00023 |
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Depression |
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Phase 2b |
PRX-03140 |
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Alzheimers disease |
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Phase 2a |
PRX-07034 |
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Obesity/cognitive impairment |
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Phase 1b |
Completion of clinical trials may take several years or more, but the length of time can
vary substantially according to a number of factors, including the type, complexity, novelty and
intended use of a drug candidate. The cost of clinical trials, and therefore the amount and timing
of our capital requirements, may vary significantly over the life of a project as a result of
differences arising during clinical development, including, among others:
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the number of sites included in the trials; |
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the length of time required to enroll suitable patient subjects; |
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the number of patients that participate in the trials; |
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the duration of patient follow-up that seems appropriate in view of results; and |
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the efficacy and safety profile of the drug candidate. |
We could incur increased clinical development costs if we experience delays in clinical
trial enrollment, delays in the evaluation of clinical trial results or delays in regulatory
approvals. In addition, we face significant uncertainty with respect to our ability to enter into
strategic collaborations with respect to our drug candidates. As a result of these factors, it is
difficult to estimate the cost and length of a clinical trial. We are unable to accurately and
meaningfully estimate the cost to bring a product to market due to the variability in length of
time to develop and obtain regulatory approval for a drug candidate.
We estimate that clinical trials in our areas of focus are typically completed over the
following timelines, but delays can occur for many reasons including those set forth above:
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Clinical |
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Estimated |
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Phase |
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Objective |
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Completion Period |
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Phase 1 |
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Establish safety in healthy volunteers and occasionally in
patients; study how the drug works, is metabolized and interacts with other drugs |
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1-2 years |
Phase 2 |
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Evaluate efficacy, optimal dosages and expanded evidence of safety |
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2-3 years |
Phase 3 |
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Further evaluate efficacy and safety of the drug candidate in a
larger patient population |
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2-3 years |
If we successfully complete Phase 3 clinical trials of a drug candidate, we intend to submit the
results of all of the clinical trials for such drug candidate to the FDA to support regulatory
approval. Even if any of our drug candidates receive regulatory approval, we may still be required
to perform lengthy and costly post-marketing studies.
A major risk associated with the timely completion and commercialization of our drug
candidates is the ability to confirm safety and efficacy based on the data of long-term clinical
trials. We cannot be certain that any of our drug candidates will prove to be safe or effective,
will receive regulatory approvals or will be successfully commercialized. In order to achieve
marketing approval, the FDA or foreign regulatory agencies must conclude that our clinical data
establishes the safety and efficacy of our drug candidates. If our clinical-stage drug candidates
are not successfully developed, future results of operations may be adversely affected.
We do not budget or manage our research and development costs by project on a fully
allocated basis. Consequently, fully loaded research and development costs by project are not
available. We use our employee and infrastructure resources across several projects and many of our
costs are not attributable to an individually-named project but are directed to broadly applicable
research projects. As a result, we cannot state precisely the costs incurred for each of our
clinical and preclinical projects on a project-by-project basis. We estimate that, from the
12
date we acquired Predix, August 16, 2006, through March 31, 2007, total third party costs
incurred for preclinical study support, clinical supplies and clinical trials associated with our
four therapeutic clinical programs are as follows:
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PRX-08066 |
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$3.3 million |
PRX-00023 |
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$5.3 million |
PRX-03140 |
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$2.5 million |
PRX-07034 |
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$4.3 million |
As a result of the uncertainties discussed above, we are unable to determine the duration and
completion costs of our research and development projects or when and to what extent we will
receive cash inflows from the commercialization and sale of a product.
Financial Results
Revenues
The following table presents revenue and revenue growth (decline) for the three months
ended March 31, 2007 and 2006:
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Three Months Ended March 31, |
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2007 |
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2006 |
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Growth |
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Revenue |
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(Decline) |
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Revenue |
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Product
development revenue |
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$ |
434,392 |
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(60 |
)% |
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$ |
1,082,867 |
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Royalty revenue |
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487,658 |
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7 |
% |
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457,778 |
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License fee revenue |
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1,032,850 |
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539 |
% |
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161,597 |
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Total |
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$ |
1,954,900 |
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15 |
% |
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$ |
1,702,242 |
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Our revenues to date have arisen principally from our collaboration agreements with Bayer
Schering Pharma AG, Germany (for Vasovist, EP-2104R and MRI discovery research) and Cystic Fibrosis
Foundation Therapeutics (CFFT); from license fee revenues relating to our agreements with Amgen,
GlaxoSmithKline, Bayer Schering Pharma AG, Germany, CFFT, Tyco and Bracco; and from royalties
related to our agreements with Bracco and Bayer Schering Pharma AG, Germany. Our MRI discovery
research collaboration and our development agreement for EP-2104R with Bayer Schering Pharma AG,
Germany concluded in May 2006 and August 2006, respectively.
Product development revenue decreased 60% in the three months ended March 31, 2007
compared to the prior year period primarily as a result of the completion of the MRI discovery
research program in May 2006 and the EP-2104R program in August 2006. In addition, Vasovist
development revenue was significantly lower in the current quarter
due to lower development costs in 2007 as we
continue to appeal the FDAs decision to require additional clinical trials.
The increase in royalty revenue of 7% in the three months ended March 31, 2007 compared
to the prior year period resulted from royalties of $0.1 million from sales of Vasovist in Europe,
which was first marketed in the second quarter of 2006, partially offset by a reduction in the
royalties on sales of MultiHance by Bracco. We do not expect royalty income on
the European sales of Vasovist to be significant in 2007. In addition, we expect royalty revenue
from Bracco to end in the second quarter of 2007 due to the expiration of patents.
License fee revenue increased 539% in the three months ended March 31, 2007 compared to
the prior year period primarily as a result of the recognition of deferred revenue from the Amgen
and GlaxoSmithKline agreements. Partially offsetting this increase was a decrease in revenue from
the recognition of the Bracco license fee as this fee was fully recognized by June 2006.
13
Research and Development Expenses
Research and development expenses of $13.5 million for the three months ended March 31,
2007 reflects an increase of 249% from the prior year. The increase in research and development
expenses was primarily due to third party expenses of $7.6 million associated with our
clinical development programs as well as costs for the preclinical programs and internal costs
which began after the Predix acquisition was completed on August 16, 2006. Clinical program costs
incurred in the current quarter include initiation costs for Phase 2b clinical trial for depression
with PRX-00023; costs incurred for the ongoing Phase 2a clinical trial of PRX-03140 for the
treatment of Alzheimers disease, costs incurred for the ongoing Phase 2a clinical trial of
PRX-08066 for the treatment of pulmonary hypertension in association with COPD, and costs incurred for the completion of the Phase 1b multiple
ascending dose clinical trial of PRX-07034 for the treatment of obesity and cognitive impairment.
The increased costs in the three months ended March 31, 2007 as described above were partially offset by the discontinuation of
spending on imaging programs subsequent to the merger with Predix, notably the EP-2104R development
program and the MRI research programs. Spending during 2007 and 2006 for Vasovist primarily
involved costs related to our appeal to the FDA and was not significant.
General and Administrative Expenses
General and administrative expenses of $8.6 million for the three months ended March 31,
2007 reflects an increase of 256% from the prior year. The increase in general and administrative
expenses was primarily due to nonrecurring legal and accounting costs of approximately
$5.0 million associated with the stock option investigation that was recently completed as well as
increased costs associated with the increase in personnel and infrastructure relating to the Predix
business that was acquired on August 16, 2006. In addition, legal expenses for patent-related
matters and general corporate items increased due to the increasing complexity of the post merger
entity.
Restructuring Costs
Restructuring costs of $0.3 million in the three months ended March 31, 2006 represent
additional costs related to the December 2005 restructuring whereby we reduced 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 the research and
development and the general and administrative areas of the company. The 2006 costs included severance costs as well as costs related to vacating certain leased space and the
write-off of leasehold improvements.
We expect to incur restructuring costs of approximately $0.5 in the second quarter of 2007 for
the consolidation of our leased laboratory facility in Cambridge to our Lexington location. The
timing and amount of the additional restructuring costs will depend upon the completion of
laboratory construction at our Lexington facility, which is currently anticipated to be June 2007.
Interest and Other Income
Interest and other income of $2.0 million for the three months ended March 31, 2007 reflects
an increase of $0.7 million or 50% from the prior year. The increase was primarily due to $0.6
million of other income received from the settlement of a contractual dispute.
Interest Expense
Interest expense of $1.2 million for the three months ended March 31, 2007 reflects an
increase of $0.4 million or 42% from the prior year. The increase in interest expense was primarily
the result of $0.3 million of interest related to the $15.0 million milestone payment due to the
former Predix security holders on October 29, 2007. We record interest expense on the milestone at the
greater of the stated rate of 10% or the value of the embedded derivative included in the
milestone, which provides for the milestone payment to be paid in shares of our common stock based
on 75% of the 30-day average closing price of our common stock ending on the trading day that is
ten
days prior to the payment date. This embedded derivative is recorded at its fair value and
changes in the fair value are recorded as interest expense. Under the terms of the merger
agreement, if the milestone cannot be paid in shares of our common stock due to terms of the
agreement, the payment plus 10% interest will be made in cash. The change in the value of the
derivative was not significant in the first quarter of 2007.
14
Provision for Income Taxes
The provision for income taxes represents Italian income taxes required to be withheld
on Bracco royalties for MultiHance sales.
LIQUIDITY AND CAPITAL RESOURCES
Our principal sources of liquidity consist of cash, cash equivalents and available-for-sale
marketable securities of $95.0 million at March 31, 2007 as compared to $109.5 million at December
31, 2006. The decrease in cash, cash equivalents and available-for-sale marketable securities of
$14.5 million was primarily attributable to funding of ongoing operations during the current quarter.
We used approximately $13.3 million of cash to fund operating activities for the three
months ended March 31, 2007, as compared to $5.3 million used to fund operations for the same
period in 2006. The use of cash for the current quarter primarily resulted from the net loss of
$19.5 million, which was partially offset by an increase of $5.0 million in accounts payable and
accrued expenses largely resulting from costs incurred for the recently completed stock option
investigation. These costs will be paid in the second quarter of 2007. We also received
approximately $1.2 million during the current quarter of landlord allowances related to the
laboratory construction at our Lexington facility. The net cash used to fund operations during the
three months ended March 31, 2006 of $5.3 million was primarily due to the net loss of $4.5 million
for the quarter and the reduction of approximately $1.1 million of accounts payable and accrued
expenses due to a decrease in development activity in the quarter.
Our investing activities used $0.1 million of cash during the three months ended March
31, 2007 as compared to $8.7 million of cash provided during the same period last year. The primary
uses of cash from investing activities in 2007 was $2.0 million
of capital expenditures primarily related to
the build out of laboratory space at our Lexington facility, which was partially offset by net
redemptions of marketable securities of $1.6 million during the quarter. The primary source of
cash from investing activities in the 2006 period was the net redemption of marketable securities
of $9.3 million which was partially offset by $0.6 million of capital spending.
Our primary sources of cash include quarterly payments from CFFT for research services
and monthly interest income on our cash, cash equivalents and available-for-sale marketable
securities. In addition, in the second half of 2006, we began receiving royalty payments
(approximately $75,000 for 2006) from sales of Vasovist by Bayer Schering Pharma AG, Germany
following the commercial launch of the product in Europe, which began on a country-by-country basis
in the second quarter of 2006. We expect royalty payments from sales of Vasovist to slowly increase
as the product is introduced in other countries where it has been approved. Despite this, we do not
expect the royalties received on non-United States sales of Vasovist to be significant in the near
term. Other potential cash inflows include milestone payments from our current strategic
collaborators, GlaxoSmithKline, Amgen, CFFT and Bayer Schering Pharma AG, Germany.
Known outflows, in addition to our ongoing research and development and general and
administrative expenses, include the following: $15.0 million milestone payment to the former
Predix security holders due on October 29, 2007 primarily payable in shares of our stock if certain
conditions are met or otherwise payable in cash plus interest accrued at a rate of 10%; and
interest on our $100.0 million convertible notes at a rate of 3% payable semi-annually on June 15
and December 15.
We estimate that cash, cash equivalents and marketable securities on hand as of March
31, 2007 and anticipated revenue we will earn in 2007 and 2008, exclusive of any significant
milestone payments or opt-in fees, will fund our operations through 2008. Our past stock option
practices and the restatement of our prior financial statements expose us to greater risks
associated with litigation and regulatory proceedings. In the event of any litigation or regulatory
proceeding involving a negative finding or assertion by the SEC, U.S. Attorney, court of law or any
third party claim related to our stock option practices, we may be liable for damages, fines or
other civil or
criminal remedies or remedial actions, or be required to further restate prior period
financial statements or adjust current period financial statements. In addition, considerable legal
and accounting expenses related to these matters have been incurred to date and significant
expenditures may continue to be incurred in the future.
If holders of our convertible senior notes require redemption of the notes, we would be
required to repay $100.0 million, plus accrued and unpaid interest, on June 15, 2011, 2014 and 2019
and upon certain other designated events under the notes, which include a change of control of us
or termination of trading of our common stock on
15
the NASDAQ Global Market. 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 timing and costs required to receive both U.S. and foreign governmental approvals;
the cost of filing, prosecuting, defending and enforcing patent claims and other intellectual
property rights; the extent to which our products, if any, gain market acceptance; the timing and
costs of product introductions; the extent of our ongoing and new research and development
programs; the costs of training physicians to become proficient with the use of our potential
products; and, if necessary, once regulatory approvals are received, the costs of developing
marketing and distribution capabilities.
Because of anticipated spending for the continued development of our preclinical and
clinical compounds, we do not expect positive cash flow from operating activities for at least the
next several years.
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 government-sponsored enterprises, 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 change
in the fair market value of our total portfolio of approximately $0.1 million at March 31, 2007.
ITEM 4. Controls and Procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule
13a-15(e) of the Exchange Act) as of the end of the period covered by this report. Based on that
evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures as of the end of the period covered by this report were effective in
ensuring that information required to be disclosed by us in reports that we file or submit under
the Exchange Act is recorded, processed, summarized and reported within the time periods specified
in the Securities and Exchange Commissions rules and forms. We believe that a control system, no
matter how well designed and operated, cannot provide absolute assurance that the objectives of the
control system are met, and no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within a company have been detected.
There was no significant change in our internal control over financial reporting (as defined
in Rule 13a-15(f) of the Exchange Act) that occurred during the period covered by this report that
has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting. In the period covered by this report, in connection with our investigation of
our historical stock option practices, we adopted an equity award grant policy that formalizes how
we grant equity awards by setting a regular schedule for grants, outlining grant approval
requirements and specifying how awards are priced.
PART II. OTHER INFORMATION
ITEM 1. Legal Proceedings.
From time to time we are a party to various legal proceedings arising in the ordinary course
of our business. The outcome of litigation cannot be predicted with certainty and some lawsuits,
claims or proceedings may be disposed of unfavorably to us. Intellectual property disputes often
have a risk of injunctive relief which, if imposed against us, could materially and adversely
affect our financial condition, or results of operations. From time to time, third parties have
asserted and may in the future assert intellectual property rights to technologies that are
important to our business and have demanded and may in the future demand that we license their
technology.
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