e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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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 June 30, 2007
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o |
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Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of
1934 |
For the Transition Period from to
Commission File Number 001-33043
ImaRx Therapeutics, Inc.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
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86-0974730
(I.R.S. Employer
Identification No.) |
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1635 East 18th Street, Tucson, AZ
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85719-6803 |
(Address of Principal Executive Offices)
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(Zip Code) |
(520) 770-1259
(Registrants Telephone Number, Including Area Code)
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 at least the past 90 days. YES o NO þ
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of accelerated filer and large
accelerated filer in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer o Accelerated Filer o Non-accelerated filer þ
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
The number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date is as follows:
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Class |
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Outstanding at August 27, 2007 |
Common Stock $0.0001 par value
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10,008,183 |
PART 1. FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements.
ImaRx Therapeutics, Inc.
Consolidated Balance Sheets
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June 30 |
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December 31 |
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2007 |
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2006 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
6,598,074 |
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$ |
4,256,399 |
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Restricted cash |
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4,420,831 |
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Accounts receivable, less allowances of $2,731 in 2007 and $20,819 in 2006 |
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194,147 |
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575,610 |
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Inventory |
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11,680,168 |
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16,059,730 |
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Inventory subject to return |
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4,209,149 |
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445,245 |
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Prepaid expenses and other |
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356,579 |
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539,048 |
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Deferred financing costs |
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1,003,913 |
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Total current assets |
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28,462,861 |
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21,876,032 |
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Long-term assets: |
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Property and equipment, net |
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1,108,826 |
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916,966 |
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Intangible assets, net |
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1,983,333 |
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2,500,000 |
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Total assets |
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$ |
31,555,020 |
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$ |
25,292,998 |
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LIABILITIES AND STOCKHOLDERS DEFICIT |
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Current liabilities: |
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Accounts payable |
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$ |
1,428,350 |
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$ |
1,413,032 |
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Accrued expenses |
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1,174,893 |
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1,235,510 |
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Accrued chargebacks and administrative fees |
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2,579,367 |
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Deferred revenue |
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8,189,605 |
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955,263 |
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Notes payable |
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16,065,000 |
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15,615,000 |
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Total current liabilities |
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29,437,215 |
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19,218,805 |
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Other long-term liability |
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218,856 |
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Total liabilities |
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29,437,215 |
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19,437,661 |
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Redeemable convertible preferred stock: |
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Series A 8% Redeemable Convertible Preferred Shares,
$.0001 par, at carrying value including accrued dividends (liquidation
value of $9,658,830 and $9,406,804 at June 30, 2007 (unaudited) and
December 31, 2006, respectively): |
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Authorized shares 2,302,053 at June 30, 2007 (unaudited) and
December 31, 2006 |
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Issued and outstanding shares 2,291,144 at June 30, 2007
(unaudited) and December 31, 2006 |
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9,580,773 |
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9,328,747 |
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Series B 7% Mandatorily Redeemable Convertible Preferred Shares,
$.0001 par, at carrying value (liquidation value of $9,491,622 at June
30, 2007 (unaudited) and December 31, 2006, respectively): |
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Authorized shares 593,226 at June 30, 2007 (unaudited) and December
31, 2006 |
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Issued and outstanding shares 593,226 at June 30, 2007 (unaudited)
and December 31, 2006 |
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9,491,622 |
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9,491,622 |
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Series C Mandatorily Redeemable Convertible Preferred Shares,
$.0001 par, at carrying value (liquidation value of $1,999,998 at June
30, 2007 (unaudited) and December 31, 2006 , respectively): |
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Authorized shares 285,714 at June 30, 2007 (unaudited) and December
31, 2006 |
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Issued and outstanding shares 285,714 at June 30, 2007 (unaudited)
and December 31, 2006 |
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1,945,563 |
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1,945,563 |
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3
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June 30 |
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December 31 |
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2007 |
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2006 |
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(Unaudited) |
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Series D 8% Redeemable Convertible Preferred Shares,
$.0001 par, at carrying value including accrued dividends (liquidation
value of $1,631,949 and $1,583,743 at June 30, 2007 (unaudited) and
December 31, 2006, respectively): |
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Authorized shares 438,232 at June 30, 2007 (unaudited) and December
31, 2006 |
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Issued and outstanding shares 438,232 at June 30, 2007 (unaudited)
and December 31, 2006 |
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1,610,212 |
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1,562,007 |
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Series F 8% Redeemable Convertible Preferred Shares,
$.0001 par, at carrying value including accrued dividends (liquidation
value of $15,309,000 and $14,742,000 at June 30, 2007(unaudited) and
December 31, 2006, respectively): |
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Authorized shares 4,000,000 at June 30, 2007 (unaudited) and
December 31, 2006 |
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Issued and outstanding shares 2,835,000 at June 30, 2007
(unaudited) and December 31, 2006 |
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14,102,559 |
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13,535,559 |
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Total redeemable convertible preferred stock |
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36,730,729 |
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35,863,498 |
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Stockholders deficit: |
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Series E Redeemable Convertible Preferred Shares, $.0001 par: |
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Authorized shares 1,000,000 at June 30, 2007 (unaudited) and
December 31, 2006 |
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Issued and outstanding shares 1,000,000 at June 30, 2007
(unaudited) and December 31, 2006 |
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4,000,000 |
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4,000,000 |
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Common stock, $.0001 par: |
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Authorized shares 70,000,000 at June 30, 2007 (unaudited) and
December 31, 2006 |
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Issued and outstanding shares 2,607,054 at June 30, 2007
(unaudited) and 2,606,739 at December 31, 2006 |
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260 |
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260 |
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Additional paid-in capital |
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28,766,958 |
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28,619,883 |
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Accumulated deficit |
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(67,380,142 |
) |
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(62,628,304 |
) |
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Total stockholders deficit |
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(34,612,924 |
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(30,008,161 |
) |
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Total liabilities and stockholders deficit |
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$ |
31,555,020 |
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$ |
25,292,998 |
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See accompanying notes.
4
ImaRx Therapeutics, Inc.
Consolidated Statements of Operations
(Unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30 |
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June 30 |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenues: |
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Product sales, net |
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$ |
1,991,913 |
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$ |
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$ |
3,077,612 |
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$ |
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Research and development |
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160,646 |
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251,423 |
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282,650 |
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428,761 |
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Total revenue |
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2,152,559 |
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251,423 |
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3,360,262 |
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428,761 |
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Costs and expenses: |
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Cost of product sales |
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958,848 |
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1,419,912 |
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Research and development |
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1,606,221 |
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2,313,307 |
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3,142,541 |
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4,075,046 |
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General and administrative |
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1,157,524 |
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1,734,232 |
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2,581,919 |
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3,374,136 |
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Total cost and expenses |
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3,722,593 |
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4,047,539 |
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7,144,372 |
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7,449,182 |
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Operating loss |
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(1,570,034 |
) |
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(3,796,116 |
) |
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(3,784,110 |
) |
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(7,020,421 |
) |
Interest and other income, net |
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89,271 |
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111,210 |
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130,648 |
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215,796 |
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Interest expense |
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(225,000 |
) |
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(390,000 |
) |
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(450,000 |
) |
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(615,000 |
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Gain on extinguishment of debt |
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218,856 |
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218,856 |
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Net loss |
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(1,486,907 |
) |
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(4,074,906 |
) |
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(3,884,606 |
) |
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(7,419,625 |
) |
Accretion of dividends on preferred stock |
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(433,616 |
) |
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(150,116 |
) |
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(867,232 |
) |
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(300,230 |
) |
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Net loss attributed to common stockholders |
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$ |
(1,920,523 |
) |
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$ |
(4,225,022 |
) |
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$ |
(4,751,838 |
) |
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$ |
(7,719,855 |
) |
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Net loss per share: |
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Basic and diluted |
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$ |
(0.74 |
) |
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$ |
(1.62 |
) |
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$ |
(1.82 |
) |
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$ |
(2.98 |
) |
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Shares used in computing net loss per share: |
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Basic and diluted |
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2,606,019 |
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2,600,275 |
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2,605,968 |
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2,592,836 |
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See accompanying notes.
5
ImaRx Therapeutics, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
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Six Months Ended June 30 |
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2007 |
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2006 |
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Operating activities |
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Net loss |
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$ |
(3,884,606 |
) |
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$ |
(7,419,625 |
) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
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Depreciation and amortization |
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648,873 |
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331,872 |
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Stock-based compensation |
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147,072 |
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505,293 |
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Warrant amortization expense |
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173,909 |
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Gain on extinguishments of debt |
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(218,856 |
) |
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Loss on sale of property and equipment |
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2,983 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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381,463 |
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Inventory |
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4,379,562 |
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(4,175,000 |
) |
Inventory subject to return |
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(3,763,904 |
) |
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Prepaid expenses and other |
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182,469 |
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(209,612 |
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Accounts payable |
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15,320 |
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183,167 |
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Accrued expenses and other liabilities |
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2,968,750 |
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1,127,579 |
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Deferred revenue |
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7,234,342 |
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Net cash provided by (used in) operating activities |
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8,090,485 |
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(9,479,434 |
) |
Investing activities |
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Purchase of property and equipment |
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(324,066 |
) |
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(300,722 |
) |
Purchase of intangibles |
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(825,000 |
) |
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Net cash used in investing activities |
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(324,066 |
) |
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(1,125,722 |
) |
Financing activities |
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Deferred financing costs |
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(1,003,913 |
) |
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(1,098,281 |
) |
Change in restricted cash |
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(4,420,831 |
) |
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Proceeds from issuance of common stock |
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|
55,100 |
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Net proceeds from issuance of preferred stock |
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12,968,559 |
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Net cash (used in) provided by financing activities |
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(5,424,744 |
) |
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|
11,925,378 |
|
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|
Net increase in cash and cash equivalents |
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|
2,341,675 |
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|
|
1,320,222 |
|
Cash and cash equivalents at the beginning of the period |
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|
4,256,399 |
|
|
|
8,513,387 |
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Cash and cash equivalents at the end of the period |
|
$ |
6,598,074 |
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|
$ |
9,833,609 |
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Supplemental Schedule of Noncash Investing and Financing Activities: |
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Accretion of undeclared dividends on Series A/D Redeemable Convertible Preferred Stock |
|
$ |
867,232 |
|
|
$ |
300,230 |
|
Fair value of stock warrants issued for consulting services and placement agreement amendment |
|
|
|
|
|
|
173,909 |
|
Note issued for acquisition of technology and related inventory and intangibles |
|
|
|
|
|
|
15,000,000 |
|
See accompanying notes.
6
ImaRx Therapeutics, Inc.
Notes to Consolidated Financial Statements
June 30, 2007
(Unaudited)
1. Nature of Business
ImaRx Therapeutics, Inc. (the Company or ImaRx) is a biopharmaceutical company focused on
developing and commercializing therapies for vascular disorders. The Company has devoted
substantially all of its efforts towards the research and development of its product candidates and
the commercialization of its currently marketed product, Abbokinase®.
2. Basis of Presentation
The Company has prepared the accompanying unaudited financial statements in accordance with
accounting principles generally accepted in the United States for interim financial
information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X.
Accordingly, they do not include all of the information and disclosures required by generally
accepted accounting principles for complete financial statements. In the opinion of management, the
accompanying unaudited financial statements reflect all adjustments, which include only normal
recurring adjustments, necessary to present fairly the Companys interim financial information. The
results of operation for the three and six months ended June 30, 2007 are not necessarily
indicative of the results that may be reported for the year ended December 31, 2007 or any other
future interim period. The accompanying unaudited financial statements and notes thereto should be
read in conjunction with the audited financial statements for the year ended December 31, 2006
included in the Companys Registration Statement on Form S-1 (as amended), which was declared
effective by the Securities and Exchange Commission (the SEC) on July 25, 2007.
The condensed consolidated financial statements include the accounts of the Company and its
consolidated subsidiaries, ImaRx Oncology, Ltd. (IOL) and ImaRx Europe Limited (IEL). Since October
2, 2002, IOL has been a wholly owned subsidiary of ImaRx. The dissolution of IOL was completed on
March 9, 2007. IEL is a wholly owned subsidiary created in 2005 by the Company to facilitate
clinical trials in Europe. It was later determined that the European subsidiary was not required
and IEL was dissolved in December 2006 with no activity reported for the period. All significant
inter-company accounts and transactions have been eliminated.
3. Recently Issued Accounting Pronouncements
In June 2006, the Financial Accounting Standards Board (FASB) issued FASB Interpretation No.
48, Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement No. 109 (FIN
48) which became effective January 1, 2007. FIN 48 clarifies the accounting for uncertainty in
income taxes recognized in financial statements and requires the impact of a tax position to be
recognized in the financial statements if that position is more likely than not of being sustained
by the taxing authority. The adoption of FIN 48 had no effect on the Companys consolidated
financial position or results of operations.
In September 2006, the FASB issued SAFS 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 applies under other accounting pronouncements that require or permit
fair value measurements, the FASB having previously concluded in those accounting pronouncements
that fair value is the relevant measurement attribute. Accordingly, SFAS 157 does not require any
new fair value measurements, but may change current practice for some entities. SFAS 157 is
effective for fiscal years beginning after December 15, 2006. The adoption of SFAS No. 157
had no material effect on the Companys financial position or results of operations.
In September 2006, the SEC issued Staff Accounting Bulletin No. 108, Considering the Effects
of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,
which provides interpretive guidance on the consideration of the effects of prior year
misstatements in quantifying current year misstatements for the purpose of a materiality
assessment. SAB No. 108 requires registrants to quantify misstatements using both the balance sheet
and income statement approaches and to evaluate whether either approach results in quantifying an
error that is material based on relevant quantitative and qualitative factors. The guidance is
effective for the first fiscal period ending after November 15, 2006. The adoption of SAB No. 108
did not have any impact on these financial statements.
7
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159 The
Fair Value Option for Financial Assets and Financial Liabilities (SFAS 159). SFAS 159 permits
entities to choose to measure many financial instruments and certain other items at fair value. The
standard requires that unrealized gains and losses on items for which the fair value option has
been elected be reported in earnings. SFAS 159 is effective for the fiscal years beginning after
November 15, 2007. The adoption of SFAS No. 159 had no material effect on the
Companys financial position or results of operations.
4. Restricted Cash
Restricted cash consists of cash pledged as repayment of debt to secure the guarantees
described in Note 10.
5. Inventory and Inventory Subject to Return
Inventory is comprised of finished goods and is stated at the lower of cost or market value.
Inventory subject to return is comprised of finished goods, stated at the lower of cost or market
value, and represents the amount of inventory that has been sold to wholesale distributors. When
product is sold by the wholesale distributor to a hospital or other health care provider, a
reduction in this account occurs and cost of sales is recorded.
The Company has one commercially available product, marketed as a clot-dissolving, or
thrombolytic, urokinase drug called Abbokinase. Abbokinase is FDA approved and marketed for the
treatment of acute massive pulmonary embolism. Of the vials of Abbokinase held in inventory either
by the Company or by its wholesalers as of June 30, 2007, approximately 66% of the vials the
Company expects hospitals to purchase, or approximately $10.5 million in inventory value, are
unlabeled and will expire by October 2007 based on current stability data. The remaining
approximately 34% of the vials the Company expects hospitals to purchase, or approximately $5.4
million in inventory value, are labeled and will expire at various times up to August 2009. The
Company has an ongoing stability program to allow for expiration date extensions. The next testing
point of the ongoing stability program, at which the Company may obtain data sufficient to extend
the expiration dates of its unlabeled inventory, will be completed in the fall of 2007. If the
parameters tested are within the specifications previously approved by the FDA, the Company may
then label vials with extended expiration dating at that time to between June and August 2009. The
Company must obtain FDA approval for each lot release of inventory. Inventory is labeled with an
expiration date upon approval of a lot release by the FDA. Once labeled, the Company cannot extend
the expiration date of the vials labeled. If the Company is successful in extending the expiration
dates of its unlabeled inventory, the Company intends to continue the stability program after the
fall of 2007 to potentially enable further expiration extensions for future product labeling. The
Company periodically reviews the composition of inventory in order to identify obsolete,
slow-moving or otherwise un-saleable inventory. The Company will
write down inventory for
estimated obsolete or un-saleable inventory in an amount equal to the difference between the cost
of the inventory and the estimated market value based upon assumptions about future demand and
market conditions. The Company believes the expiration dates will be extended.
6. Revenue Recognition
Revenue from product sales is recognized pursuant to Staff Bulletin No. 104 (SAB 104), Revenue
Recognition in Financial Statements. Accordingly, revenue is recognized when all four of the
following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of
the products has occurred; (iii) the selling price is both fixed and determinable; and (iv)
collectibility is reasonably assured. The Company applies SFAS No. 48, Revenue Recognition When the
Right of Return Exists, which amongst other criteria requires that future returns can be reasonably
estimated in order to recognize revenue. The amount of future returns is uncertain due to the lack
of returns history data. Due to the uncertainty of returns, the Company is accounting for these
product shipments to wholesale distributors using a deferred revenue recognition model. Under the
deferred revenue model, the Company does not recognize revenue upon product shipment to wholesale
distributors; therefore, recognition of revenue is deferred until the product is sold by the
wholesale distributor to a hospital or other health care providers expected to be the end user. The
Companys returns policy allows end users to return product within 12 months after expiration, but
current practice by wholesalers and end users is a just in time purchasing methodology, meaning
that the product is purchased on an as-needed basis, typically on a daily or weekly basis. Although
the product was previously marketed by Abbott Laboratories, the Company was unable to obtain
historical returns data for the product from Abbott Laboratories at the time of its acquisition of
Abbokinase. Based on input from its wholesalers, current purchasing practices and the estimated
amount of product in the channel, the Company anticipates immaterial product returns from
hospitals.
The Companys customers consist primarily of large pharmaceutical wholesalers who sell
directly to hospitals and other healthcare providers. Provisions for product returns and exchanges,
sales discounts, chargebacks, managed care and Medicaid
8
rebates and other adjustments are established as a reduction of product sales revenues at the
time such revenues are recognized. These deductions from gross revenue are established by the
Company as its best estimate at the time of sale adjusted to reflect known changes in the factors
that impact such reserves.
7. Stock-Based Compensation
The Company maintains performance incentive plans under which incentive and non-qualified
stock options are granted primarily to employees and non-employee directors. Prior to January 1,
2006, the Company accounted for stock-based compensation in accordance with Accounting Principles
Board Opinion No. 25 (APB No. 25), Accounting for Stock Issued to Employees, SFAS No. 123,
Accounting for Stock Based Compensation, and related interpretations. Effective January 1, 2006,
the Company adopted SFAS 123(R), requiring measurement of the cost of employee services received in
exchange for all equity awards granted, based on the fair market value of the award as of the grant
date. Under this standard, the fair value of each employee stock option is estimated on the date of
grant using the Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
Six Months Ended |
|
|
June 30, 2007 |
|
June 30, 2006 |
Expected dividend yield |
|
|
0.00 |
% |
|
|
0.00 |
% |
Expected stock price volatility |
|
|
75.0 |
% |
|
|
75.0 |
% |
Risk free interest rate |
|
|
5.05 |
% |
|
|
5.03 |
% |
Expected life of option |
|
7 years |
|
|
7 years |
|
The dividend yield assumption is based on the Companys history and expectation of dividend
payouts. The Company uses guideline companies to determine volatility. The expected life of the
stock options is based on historical data and future expectations. The risk-free interest rate
assumption is based on observed interest rates appropriate for the terms of the Companys stock
options.
Stock Options
A summary of activity under the Companys 2000 Stock Plan is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise Price |
|
Weighted-Average |
|
|
Options |
|
Per Share |
|
Exercise Price |
Balance at December 31, 2006 |
|
|
630,351 |
|
|
$ |
2.50-30.00 |
|
|
$ |
18.15 |
|
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(315 |
) |
|
|
2.50 |
|
|
|
2.50 |
|
Canceled |
|
|
(84,792 |
) |
|
|
2.50-27.50 |
|
|
|
16.45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
|
545,244 |
|
|
$ |
2.50-30.00 |
|
|
$ |
15.42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available for grant at June 30, 2007 |
|
|
341,485 |
|
|
|
|
|
|
|
|
|
The Company issued no options during the three months ended and the six months ended June 30, 2007.
All outstanding options are currently exercisable.
8. Net Loss per Share
Basic and diluted net loss attributable to common stockholders per share is calculated by
dividing the net loss applicable to common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted net loss per common share is the same as basic net
loss per common share for all periods presented. The effects of potentially dilutive securities are
antidilutive in the loss periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six months Ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net loss attributed to common stockholders |
|
$ |
(1,920,523 |
) |
|
$ |
(4,225,022 |
) |
|
$ |
(4,751,838 |
) |
|
$ |
(7,719,855 |
) |
Basic and diluted weighted average shares outstanding |
|
|
2,606,019 |
|
|
|
2,600,275 |
|
|
|
2,605,968 |
|
|
|
2,592,836 |
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
$ |
(0.74 |
) |
|
$ |
(1.62 |
) |
|
$ |
(1.82 |
) |
|
$ |
(2.98 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
9
The following potential common shares have been excluded from the computation of diluted net
loss per share since their effect would be antidilutive in each of the loss periods presented:
|
|
|
|
|
|
|
|
|
|
|
At June 30, |
|
|
2007 |
|
2006 |
Convertible preferred stock |
|
|
4,401,129 |
|
|
|
4,401,129 |
|
Stock options |
|
|
545,244 |
|
|
|
579,404 |
|
Warrants |
|
|
352,324 |
|
|
|
352,324 |
|
9. Reverse Stock Split
The Companys Board of Directors and stockholders approved in September 2006 a reverse stock
split. On September 12, 2006, a six-for-ten reverse stock split of the Companys common stock
became effective. The Companys Board of Directors and stockholders approved in May 2007 a reverse
stock split. On May 4, 2007, a one-for-three reverse stock split of the Companys common stock
became effective. All common shares, per share and stock option data information in the
accompanying financial statements and notes thereto has been retroactively restated for all periods
to reflect the reverse stock splits.
10. Asset Acquisition
In April 2006, the Company acquired from Abbott Laboratories the assets related to Abbokinase,
including the remaining inventory of finished product, all regulatory and clinical documentation,
validated cell lines, and intellectual property rights, including trade secrets and know-how
relating the manufacture of urokinase using the tissue culture method, for a total purchase price
of $20,000,000. The purchase price is comprised of $5,000,000 in cash and a $15,000,000 secured
promissory note. The note is due December 31, 2007, accrues interest at 6% annually and is secured
by the Companys right, title and interest in the purchased assets. The purchase of these assets
did not constitute the purchase of a business as defined in EITF No. 98-3, Determining Whether a
Nonmonetary Transaction Involves Receipt of Productive Assets or of a Business, since no employees,
equipment, manufacturing facilities or arrangements, or sales and marketing organization were
included in the transaction. Since the purchase was not a business, the purchase price has been
allocated based upon fair value assessments as follows: inventory $16,700,000, Abbokinase trade
name $500,000 and other identifiable intangibles $2,800,000. The Company commenced selling
Abbokinase in October 2006. Of the total number of vials of Abbokinase inventory that the Company
acquired from Abbott, it is estimated that 28% of such vials will not be sold and, consequently,
these vials are carried with no book value assigned. Under the purchase agreement, after the
Company has received cash proceeds of $5,000,000 from the sale of Abbokinase, the Company is
required to deposit 50% of the cash received from sales of Abbokinase into an escrow account
securing the repayment of the $15,000,000 promissory note (See Note 4). If the promissory note is
not repaid by its maturity date, Abbott has the right to the amount held in the escrow account and
to reclaim any remaining inventory of Abbokinase and related rights.
11. Segment Information
The Company is engaged in the discovery, developing and commercializing therapies for vascular
disorders. The Company has only one reportable segment and, therefore, all segment-related
financial information required by Statement of Financial Accounting Standards No. 131, Disclosures
About Segments of an Enterprise and Related Information, is included in the condensed consolidated
financial statement. The reportable segment reflects the Companys structure, reporting
responsibilities to the chief executive officer and the nature of the products under development.
12. Subsequent Events
Initial Public Offering
On July 25, 2007, 3,000,000 shares of common stock were sold on the Companys behalf at an
initial public offering price of $5.00 per share, resulting in aggregate proceeds of approximately
$12.3 million, net of underwriting discounts and commissions and offering expenses. Upon the
completion of the Companys initial public offering in July 2007, all of the Companys previously
outstanding preferred shares converted into an aggregate of 4,401,129 shares of the Companys
common stock and all accrued dividends have been extinguished. These
shares combined with 2,607,054
shares of common stock outstanding immediately before the initial public offering result in the
Company having 10,008,183 shares of common stock outstanding upon completion of the initial public
offering in July 2007.
10
The per share conversion rate of Series F preferred stock (Series F) is variable and is
determined by dividing $5.00 by the lesser of (a) $25.00 (as adjusted for any stock dividends,
combinations, splits, recapitalizations and the like with respect to such shares) or (b) 85% of the
price per share paid in an initial public offering. The price per share of the initial public
offering was $5.00, therefore, the holders of the Series F have converted to shares of common stock
at a rate of 1.176 per share of Series F. The beneficial conversion is contemplated by EITF Issue
No. 00-27, Application of Issue No. 98-5 to Certain Convertible Instruments. In the third quarter
of 2007, a deemed dividend will be recorded at approximately $13.8 million, payable in the form of
2,768,294 shares of common stock.
11
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Cautionary Statement Regarding Forward-Looking Statements
The following discussion should be read in conjunction with the accompanying unaudited
Consolidated Financial Statements and related notes appearing elsewhere in this report. This
Quarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. We cannot guarantee the
accuracy of the forward-looking statements, and you should be aware that results and events could
differ materially and adversely from those contained in the forward-looking statements. You should
also consider carefully the statements set forth in Item 1A of Part II of this Quarterly Report
entitled Risk Factors which address these and additional factors that could cause results or
events to differ materially from those set forth in the forward-looking statements.
Our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and amendments to all such
reports are available, free of charge, on our Internet website under InvestorsFinancial
Information, as soon as reasonably practicable after we file electronically such reports with, or
furnish such reports to, the SEC. Our Internet website address is http://www.imarx.com. Information
on our website does not constitute a part of this Quarterly Report on Form 10-Q. As used in this
quarterly report on Form 10-Q, unless the context otherwise requires, the terms we, us, our,
the Company, and ImaRx refer to ImaRx Therapeutics, Inc., a Delaware corporation, and its
subsidiaries.
Overview
We are a biopharmaceutical company developing and commercializing therapies for vascular
disorders. Our development efforts are focused on therapies for stroke and other vascular
disorders, using our proprietary microbubble technology to treat vascular occlusions, or blood
vessel blockages, as well as the resulting ischemia, which is tissue damage caused by a reduced
supply of oxygen. Our commercialization efforts are currently focused on our product approved to
treat acute massive pulmonary embolism, or blood clots in the lungs.
We were organized as an Arizona limited liability company on October 7, 1999, which was our
date of inception for accounting purposes. We were subsequently converted to an Arizona corporation
on January 12, 2000, and then reincorporated as a Delaware corporation on June 23, 2000. As of June
30, 2007, we had received aggregate net proceeds of approximately $13.8 million from sales of our
commercial product Abbokinase to our wholesalers and customers, and we had deposited approximately
$4.2 million in escrow as security for the payment of our $15.0 million non-recourse promissory
note due in December 2007. From our inception through June 30, 2007, we accumulated a deficit from
operations of approximately $67.4 million. We have funded our operations to date primarily through
private placements of our preferred and common stock as well as the sale of convertible notes,
sales of Abbokinase and the receipt of government grants. Through June 30, 2007, we had received
net proceeds of approximately $46.8 million from the issuance of shares of our preferred and common
stock and convertible notes.
Since our inception, we have devoted substantially all of our efforts toward planning,
conducting and funding the various stages of development for our product candidates, researching
potential new product opportunities based upon our proprietary technologies, acquiring technology
and potential products, and commercializing our marketed product. We expect our operating losses to
increase for at least the next several years due to increasing expenses associated with proposed
clinical trials, product development, selling, general and administrative costs and regulatory
activities.
In September 2005, we acquired the technology and development assets of Abbott Laboratories
relating to two recombinant thrombolytic drug candidates. Since
they had not yet received FDA approval and presented no alternative
future use, we determined these technologies
did not meet established guidelines for technological feasibility sufficiently to be recorded as
assets. As a result, the full purchase price consideration of $24.0 million was recorded as
acquired in-process research and development expense for the year ended December 31, 2005. In
December 2006, we chose not to pursue further development and commercialization of these
technologies because we were unable to obtain adequate financing to repay the $15.0 million
non-recourse note due December 31, 2006, that we had issued to Abbott Laboratories as partial
consideration for the acquisition of these technologies or to pay the costs of such further
development and commercialization. Following that decision, Abbott Laboratories indicated its
intent to repossess the assets in accordance with its security
interest and forgive the debt. As a result, we realized a
gain of $16.1 million in December 2006 relating to extinguishment of the non-recourse note and
accrued interest. We incurred approximately $0.5 million in research and development costs on these
products before deciding not to pursue them further.
In April 2006, we acquired from Abbott Laboratories the assets related to Abbokinase,
including the remaining inventory of finished product, all regulatory and clinical documentation,
validated cell lines, and intellectual property rights,
12
including trade secrets and know-how
relating to the manufacture of urokinase using the tissue culture method. We commenced selling
Abbokinase in October 2006.
Subsequent
to June 30, 2007, we completed an initial public offering. On July
25, 2007, 3,000,000 shares of common stock were sold on our behalf at
a price of $5.00 per share, resulting in aggregate proceeds of
approximately $12.3 million, net of underwriting discounts and
commissions and offering expenses.
Product
Sales, Research and Development Revenue
We have generated only a limited amount of revenue to date, primarily by providing research
services for projects funded under various government grants and from Abbokinase sales. We
commenced sales of Abbokinase in October 2006 and anticipate that we will generate additional
revenue from sales of Abbokinase. However, any such revenue is difficult to predict as to both
timing and amount, may not be achieved in any consistent or predictable pattern, and in any case
will not be sufficient to prevent us from incurring continued and increasing losses from our
development and other activities. Additionally, wholesalers and hospitals may return outdated,
short dated or damaged Abbokinase product that is in its original, unopened cartons and received by
us prior to 12 months past the expiration date. We have a limited product returns history,
therefore we recognize revenue only after inventory has shipped from a wholesaler to a hospital. In
April 2007, we sold a total of approximately $9.0 million of Abbokinase, net of discounts and fees,
to two of our primary wholesalers. As of June 30, 2007, we had received aggregate net proceeds of
approximately $13.8 million from sales of Abbokinase to our wholesalers and customers, and we had
deposited approximately $4.2 million into an escrow account as security for repayment of our $15.0
million promissory note due in December 2007. If the escrowed amount were to be applied to the
outstanding balance of principal and interest on that note, the remaining amount due under the note
would be approximately $11.9 million as of June 30, 2007. The vials of Abbokinase that we sold have
expiration dates ranging from December 2008 to August 2009. We did not request a lot release for or
sell any vials of Abbokinase that expire between August and October 2007 because we do not believe
the vials would have been sold by the wholesalers and used by hospitals prior to such expiration
dates.
All product sales recorded relate to sales of Abbokinase in the United States, which we
commenced in October 2006. Due to the lack of returns history, we currently account for these
product shipments using a deferred revenue recognition model. We do not recognize revenue upon
product shipment to a wholesaler but rather, we defer the recognition of revenue until the right of
return no longer exists or when the product is sold to the end user hospital as is stipulated by
SFAS No. 48, Revenue Recognition When the Right of Return Exists. We record product sales net of
chargebacks, distributor fees, discounts paid to wholesalers, and administrative fees paid to Group
Purchasing Organizations (GPOs). The allowances are based on historical information and other
pertinent data. As of June 30, 2007, we had deferred revenue of approximately $8.2 million.
Cost of product sales is determined using a weighted-average method and includes the
acquisition cost of the inventory as well as additional labeling costs we incur to bring the
product to market. Our product pricing is fixed, but could include a variable sales or cash
discount depending on the nature of the sale. Our gross margins will be affected by chargebacks,
discounts and administrative fees paid to the wholesalers and GPOs.
Research and Development Expenses
We classify our research and development expenses into four categories of activity, namely,
research, development, clinical and regulatory. To date, our research and development efforts have
been focused primarily on product candidates from our microbubble technology program. We expect our
research and development expenses to increase with the planned continuation of clinical trials for
our SonoLysis product candidates. Clinical development timelines, likelihood of commercialization
and associated costs are uncertain and therefore vary widely. We anticipate determining which
research and development projects to pursue as well as the level of funding available for each
project based on the scientific and clinical results of each product candidate. We currently
estimate we will complete the current or imminent stage of development for each primary product
candidate as follows:
For our SonoLysis program, we intend to conduct the ongoing Phase I/II clinical trial
for ischemic stroke evaluating SonoLysis+tPA therapy, and to conduct additional
preclinical studies and prepare to initiate Phase II clinical trials for both
SonoLysis+tPA therapy and SonoLysis therapy. We estimate that these efforts will cost
approximately $10.0 million through September 2008.
We intend to maintain the regulatory status of Abbokinase as an FDA-approved product,
to continue our ongoing product stability studies and related regulatory matters, product
storage and labeling to enable us to
seek the extension of the expiration dates of the inventory, to continue our ongoing
200-patient immunogenicity
13
study and to explore the feasibility of manufacturing
Abbokinase. We estimate that these efforts may cost approximately $2.0 million through
September 2008.
We intend to further pursue research of our microbubble technologies and estimate that
this effort may cost approximately $1.0 million through September 2008. Any new
government grants or research collaborations could significantly alter our total research
expense depending on the timing and amount of any such awards or agreements.
At this time, due to the risks inherent in the clinical trial process and the related
regulatory process, our development completion dates and costs vary significantly for each product
candidate and are very difficult to estimate. The lengthy process of seeking regulatory approvals
and the subsequent compliance with applicable regulations require the expenditure of substantial
additional resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals
for our product candidates could cause our research and development expenditures to increase and,
in turn, have a material adverse effect on our results of operations. We cannot be certain when, if
ever, any cash flows from our current product candidates will commence.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related expenses and other
costs and fees associated with our general corporate activities, such as sales and marketing,
administrative support, business development, intellectual property protection, corporate
compliance and preparing to become a public reporting company, as well as a portion of our overhead
expenses. Our selling expenses have increased and may continue to increase as we expand our
infrastructure to support increased commercialization efforts relating to Abbokinase. We also
anticipate incurring additional expenses of approximately $1.5 million to $2.0 million per year as
a public company as a result of additional legal, accounting and corporate governance expenses as a
public reporting company, including costs associated with tax return preparations, accounting
support services, Sarbanes-Oxley compliance expenses, filing annual and quarterly reports with the
SEC, directors fees, directors and officers insurance, listing and transfer agent fees, and
investor relations expenses.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations
are based on our consolidated financial statements, which have been prepared in accordance with
accounting principles generally accepted in the U.S. The preparation of these consolidated
financial statements requires us to make estimates and assumptions that affect the reported amounts
of assets and liabilities, the disclosed amounts of contingent assets and liabilities and our
reported revenue and expenses. Significant management judgment is required to make estimates in
relation to clinical trial costs and costs related to public reporting company preparation. We
evaluate our estimates, and judgments related to these estimates, on an ongoing basis. We base our
estimates of the carrying values of assets and liabilities that are not readily apparent from other
sources on historical experience and on various other factors that we believe are reasonable under
the circumstances. Actual results may differ from these estimates under different assumptions or
conditions. There has been no significant change in our critical accounting policies or estimates
from those policies or estimates disclosed under the heading Critical Accounting Policies and
Significant Judgments and Estimates in our Registration Statement on Form S-1, as amended, filed
with the Securities and Exchange Commission on July 25, 2007.
Deferred Financing Costs
As of June 30, 2007, we had deferred financing costs consisting of $1.0 million which
consisted of legal, accounting, printing and other costs associated with our initial public
offering, or IPO. These costs will be netted against paid in capital
received from our initial public offering in July 2007.
Inventory
Inventory is comprised of finished goods and is stated at the lower of cost or market value.
We have one commercially available product, marketed as a clot-dissolving, or thrombolytic,
urokinase drug called Abbokinase. Abbokinase is FDA approved and marketed for the treatment of
acute massive pulmonary embolism. Cost was determined as a result of the purchase price allocation
from the acquisition of Abbokinase from Abbott Laboratories in 2006. We periodically review the
composition of inventory in order to identify obsolete, slow-moving or otherwise un-saleable
inventory. We will provide a valuation reserve for estimated obsolete or un-saleable inventory in
an amount equal to the difference between the cost of the inventory and the estimated market value
based upon assumptions about future demand
and market conditions. Approximately 66% of our vials of Abbokinase that we expect hospitals to
purchase and that are held
14
in inventory either by us or by our wholesalers are not salable after
October 2007 based upon their current expiration dates unless the results of an ongoing stability
program allows for expiration date extensions. We believe that the expiration dates will be
extended.
Clinical Trial Accrued Expenses
We record accruals for clinical trial costs associated with clinical research organizations,
investigators and other vendors based upon the estimated amount of work completed on each clinical
trial. All such costs are charged to research and development expenses based on these estimates.
These estimates may or may not match the actual services performed by the organizations as
determined by patient enrollment levels and related activities. We monitor patient enrollment
levels and related activities to the extent possible through internal reviews, correspondence and
discussions with our contract research organization and review of contractual terms. However, if we
have incomplete or inaccurate information, we may underestimate or overestimate activity levels
associated with various clinical trials at a given point in time. In this event, we could record
significant research and development expenses in future periods when the actual level of activities
becomes known. To date, we have not experienced material changes in these estimates.
Deferred Tax Asset Valuation Allowance
Our estimate of the valuation allowance for deferred tax assets requires us to make
significant estimates and judgments about our future operating results. Our ability to realize the
deferred tax assets depends on our future taxable income as well as limitations on utilization. A
deferred tax asset must be reduced by a valuation allowance if it is more likely than not that some
portion or all of the deferred tax asset will not be realized prior to its expiration. The
projections of our operating results on which the establishment of a valuation allowance are based
involve significant estimates regarding future demand for our products, competitive conditions,
product development efforts, approvals of regulatory agencies and product cost. We have recorded a
full valuation allowance on our net deferred tax assets due to uncertainties related to our ability
to utilize our deferred tax assets in the foreseeable future. These deferred tax assets primarily
consist of net operating loss carry forwards and research and development tax credits. Under
Section 382 of the Internal Revenue Code of 1986, as amended, or the Internal Revenue Code,
substantial changes in our ownership may limit the amount of net operating loss carryforwards that
could be utilized annually in the future to offset taxable income.
We adopted the Financial Accounting Standards Boards interpretation No. 48, Accounting for
Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109 (FIN 48), effective
January 1, 2007. FIN 48 clarifies the accounting for uncertainty in income taxes recognized in
financial statements and requires the impact of a tax position to be recognized in the financial
statements if that position is more likely than not to be sustained by the taxing authority. The
adoption of FIN 48 had no effect on our consolidated financial position or results of operations.
Revenue Recognition
We provide research services under certain contract and grant agreements, including federal
grants from the National Institutes of Health. We recognize revenue for these research services as
the services are performed. Revenue from grants is recognized over the contractual period of the
related award.
Revenue from product sales is recognized pursuant to Staff Bulletin No. 104 (SAB 104), Revenue
Recognition in Financial Statements. Accordingly, revenue is recognized when all four of the
following criteria are met: (i) persuasive evidence that an arrangement exists; (ii) delivery of
the products has occurred; (iii) the selling price is both fixed and determinable; and (iv)
collectibility is reasonably assured. We apply SFAS No. 48, Revenue Recognition When the Right of
Return Exists, which among other criteria requires that future returns can be reasonably estimated
in order to recognize revenue. The amount of future returns is uncertain due to the lack of returns
history data. Due to the uncertainty of returns, we are accounting for these product shipments to
wholesale distributors using a deferred revenue recognition model. Under the deferred revenue
model, we do not recognize revenue upon product shipment to wholesale distributors; therefore,
recognition of revenue is deferred until the product is sold by the wholesale distributor to a
hospital or other healthcare provider expected to be the end user.
Our customers consist primarily of large pharmaceutical wholesalers who sell directly to
hospitals and other healthcare providers. Provisions for product returns and exchanges, sales
discounts, chargebacks, managed care and Medicaid rebates and other adjustments are established as
a reduction of product sales revenues at the time such revenues are recognized. These deductions
from gross revenue are established by us as our best estimate at the time of sale adjusted to
reflect known changes in the factors that impact such reserves.
15
Stock-Based Compensation
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards, or SFAS,
No. 123R, Share-Based Payment or SFAS 123R, which revises SFAS 123, Accounting for Stock-Based
Compensation, and supersedes Accounting Principles Board Opinion, or APB, No. 25, Accounting for
Stock Issued to Employees. SFAS 123R requires that share-based payment transactions with employees
be recognized in the financial statements based on their value and recognized as compensation
expense over the requisite service period. Prior to SFAS 123R, we disclosed the pro forma effects
of SFAS 123 under the minimum value method. We adopted SFAS 123R effective January 1, 2006,
prospectively for new equity awards issued subsequent to December 31, 2005.
Pursuant to SFAS 123(R), our estimate of share-based compensation expense requires a number of
complex and subjective assumptions including our stock price volatility, employee exercise
patterns, and future forfeitures. The most significant assumptions are our estimates of the
expected volatility and the expected term of the award. Because we completed our IPO on July 31,
2007, there is no historical information available to support our estimate of certain assumptions
required to value our stock options. The value of a stock option is derived from its potential for
appreciation. The more volatile the stock, the more valuable the option becomes because of the
greater possibility of significant changes in stock price. We have limited historical information
on our stock price volatility. In accordance with the implementation guidance in SFAS 123(R), we
have therefore calculated expected volatility based on the average volatilities of similar
companies that are transitioning from newly public to more mature companies with more stock price
history. For purposes of identifying similar entities, we have considered factors such as industry,
company age, stage of life cycle, and size. The expected term of options granted represents the
periods of time that options granted are expected to be outstanding. The expected option term also
has a significant effect on the value of the option. The longer the term, the more time the option
holder has to allow the stock price to increase without a cash investment and thus, the more
valuable the option. Further, lengthier option terms provide more opportunity to exploit market
highs. However, historical data demonstrates that employees, for a variety of reasons, typically do
not wait until the end of the contractual term of a nontransferable option to exercise. When
establishing an estimate of the expected term of an award, we have elected to use the simplified
method of determining expected term as permitted by SEC Staff Accounting Bulletin 107. As a result
of using estimates, when factors change and we use different assumptions, our share-based
compensation expense could be materially different in the future. As required under the accounting
rules, we review our valuation assumptions at each grant date and, as a result, from time to time
we will likely change the valuation assumptions we use to estimate the value of share-based awards
granted in future periods.
Results of Operations
Three Months Ended June 30, 2006 Compared to 2007
Product
Sales, Research and Development Revenue. Our revenue-producing activities during the second
quarter of 2006 consisted of providing services under research grants and contracts, whereas sales
of Abbokinase, which commenced in October 2006, were our primary revenue-producing activities
during the second quarter of 2007. Our total revenues increased from approximately $0.3 million in
the second quarter of 2006 to $2.2 million in the second quarter of 2007, primarily as a result of
our commencement of sales of Abbokinase product which accounted for $2.0 million of our revenue in
the second quarter of 2007.
Cost of Product Sales. Cost of product sales was approximately $1.0 million in the second
quarter of 2007. There was no cost of product sales for the second quarter of 2006 as we acquired
the commercial product in April 2006 and commenced sales in October 2006. The cost of product sales
includes the price paid to acquire the asset as well as labeling costs that are directly incurred
in bringing the product to market.
Research and Development Expenses. Research and development expenses decreased from
approximately $2.3 million to approximately $1.6 million in the second quarter of 2006 and 2007,
respectively. This decrease was principally a result of a decrease in staff and consulting
expenses, of which, approximately $161,000 was associated with the recombinant thrombolytic drug
assets that we decided to relinquish to Abbott Laboratories in December 2006 as well as decreased
outside contract work performed on grants and pre-clinical studies, partially offset by an increase
in clinical trial expenses.
General and Administrative Expenses. General and administrative expenses decreased from
approximately $1.7 million to approximately $1.2 million in the second quarter of 2006 and 2007,
respectively. This decrease was principally a result of decreased consulting and staff expenses.
16
Interest and Other Income. Interest and other income was approximately $0.1 million in the
second quarter 2006 and 2007.
Interest Expense. Interest expense decreased from $0.4 million to $0.2 million in the second
quarter of 2006 and 2007, respectively. This decrease was due to the interest accrued in 2006 on
both a note payable issued in September 2005 and a second note payable issued in April 2006. The
note payable issued in 2005, plus interest, was extinguished in December 2006, so no interest on
this note accrued in 2007.
Six Months Ended June 30, 2006 Compared to 2007
Product Sales, Research and Development Revenue. Our revenue-producing activities during the six month
period ended June 30, 2006 consisted of providing services under research grants and contracts,
whereas sales of Abbokinase, which commenced in October 2006, were our primary revenue-producing
activities during the same period in 2007. Our total revenues increased from approximately $0.4
million for the six month period ended June 30, 2006 to $3.4 million for the same period in 2007,
primarily as a result of our commencement of sales of Abbokinase product which accounted for $3.1
million of our revenue in 2007. Our grant and other revenue decreased from approximately $0.4
million for the six month period ended June 30, 2006 to approximately $0.3 million for the same
period in 2007, primarily due to the completion of work under a grant in 2007.
Cost of Product Sales. Cost of product sales was approximately $1.4 million for the six month
period ended June 30, 2007. There was no cost of product sales for the same period in 2006 as we
did not acquire our commercialized product until April 2006 and did not commence product sales
until October 2006. The cost of product sales includes the price paid to acquire the asset as well
as labeling costs that are directly incurred in bringing the product to market.
Research and Development Expenses. Research and development expenses decreased from
approximately $4.1 million for the six month period ended June 30, 2006 to approximately $3.1
million for the same period in 2007. This decrease was principally a result of reduced staff
expenses and third party service costs and other expenses related to our refined focus on
development of our SonoLysis programs and the removal of expenses associated with the recombinant
thrombolytic drug assets that we decided to relinquish to Abbott Laboratories in December 2006
totaling approximately $243,000, partially offset by an increase in clinical trial expenses.
General and Administrative Expenses. General and administrative expenses decreased from
approximately $3.4 million for the six month period ended June 30, 2006 to approximately $2.6
million for the same period in 2007. This decrease was principally a result of our reduced
consulting, 123R compensation and other staff expenses. 123R compensation expense for the six month
period ended June 30, 2006 was approximately $497,000 and a credit of $57,000 in the same period in
2007.
Interest and Other Income. Interest and other income decreased from approximately $0.2
million for the six month period ended June 30, 2006 to approximately $0.1 million for the same
period in 2007, as a result of a lower cash balance throughout the year.
Interest Expense. Interest expense decreased from approximately $0.6 million for the six
month period ended June 30, 2006 to approximately $0.5 million for the same period in 2007. This
decrease was due to the interest accrued in 2006 on both a note payable issued in September 2005
and a second note payable issued in April 2006. The note payable issued in 2005, plus interest, was
extinguished in December 2006, so no interest on this note accrued in 2007.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred losses since our inception. At June 30, 2007 we had an accumulated deficit of
approximately
$67.4 million. We have historically financed our operations principally through the private
placement of shares of our common and preferred stock and convertible notes, government grants,
and, more recently, product sales, which commenced in October 2006. During the years ended December
31, 2004, 2005 and 2006, we received net proceeds of approximately $5.0 million, $17.9 million,
and $13.0 million, respectively, from the issuance of shares of our common and preferred stock and
convertible notes. These amounts do not include the $15.0 million secured non-recourse note and
$4.0 million of Series E preferred stock that we issued as partial consideration for an acquisition
of recombinant thrombolytic drug technologies in
17
September 2005, or the $15.0 million secured non-recourse note that we issued to acquire Abbokinase
and related assets in April 2006. At June 30, 2007, we had approximately $6.6 million in cash and
cash equivalents.
On July 25, 2007, 3,000,000 shares of common stock were sold on the Companys behalf at an
initial public offering price of $5.00 per share, resulting in aggregate proceeds of approximately
$12.3 million, net of underwriting discounts and commissions and offering expenses. Upon the
completion of the Companys initial public offering in July 2007, all of the Companys previously
outstanding preferred shares converted into an aggregate of 4,401,129 shares of the Companys
common stock.
In April 2006, we acquired from Abbott Laboratories the assets related to Abbokinase,
including the remaining inventory of finished product, all regulatory and clinical documentation,
validated cell lines, and intellectual property rights, including trade secrets and know-how
relating to the manufacture of urokinase using the tissue culture method.
We commenced selling Abbokinase in October 2006. In April 2007, we sold a total of
approximately $9.0 million of Abbokinase, net of discounts and fees, to two of our primary
wholesalers. These vials have expiration dates ranging from December 2008 to August 2009. We expect
that these orders will reduce Abbokinase sales to these wholesalers in the near term. As of June
30, 2007, we had received aggregate net proceeds of approximately $13.8 million from sales of
Abbokinase to our wholesalers and customers, of which approximately $4.2 million has been placed
into an escrow account as security for repayment of our $15.0 million non-recourse promissory note
payable to Abbott Laboratories, which will mature on December 31, 2007. In addition, we are
required to place 50% of the proceeds from all future sales of Abbokinase into the escrow account
as required by our escrow agreement with Abbott Laboratories until the $15.0 million note is
repaid. If the escrowed amount were to be applied to the outstanding balance of principal and
interest on that note, the remaining amount due under the note would be approximately $11.9 million
as of June 30, 2007.
The exact timing and amount of future sales of Abbokinase will depend on a number of external
factors, such as our ability to obtain an extension of the expiration dates for the bulk of our
Abbokinase inventory beyond October 2007, our ability to establish additional sales relationships
with current customers for that product, inventory levels of the wholesalers that are currently
stocking the product, and other competitive and regulatory factors. Based on stability data as of
June 30, 2007, approximately 66% of our vials of Abbokinase that we expect hospitals to purchase
will expire between August and October 2007. All of these vials are currently unlabeled and
therefore eligible for expiration date extension. The remaining vials of Abbokinase that we expect
hospitals to purchase are labeled with expiration dates between December 2008 and August 2009. We
are not permitted to sell these vials after expiration. We are continuing the current stability
testing program started by Abbott Laboratories, which has been ongoing for over four years. Based
on the testing to date, which has shown that the product changes very little from year to year, we
believe it is probable that the stability data will support extension of the inventory expiration
dates, that we will be able to sell this inventory and that we will recover the cost of this
inventory. The next testing point of our ongoing stability program, at which we may obtain data
sufficient to extend the expiration dates of our unlabeled inventory, will be completed in the fall
of 2007. We will be required to submit this data to the FDA. If the parameters tested are within
the specifications previously approved by the FDA, we may then submit a lot release request to the
FDA, and upon the FDAs approval, we may at that time label vials with extended expiration dating
to between June and August 2009. Once labeled, we cannot extend the expiration date of the vials
labeled. If we are successful in extending the expiration dates of our unlabeled vials, we intend
to continue the stability program after the fall of 2007 to potentially enable further expiration
extensions for future product labeling. If the expiration dates of this inventory are extended we
will need to re-brand the remaining inventory because our license to use the Abbokinase trademark
does not extend beyond the current inventory expiration dates.
We accounted for the Abbokinase transaction as an acquisition of assets with a purchase price
of $20.0 million rather than as an acquisition of a business. We arrived at this conclusion
because no employees, equipment, manufacturing facilities or arrangements or sales and marketing
organization were included in this transaction. The purchase price has been allocated to the assets
acquired based upon the fair value assessments. We allocated the $20.0 million purchase price for
Abbokinase as follows:
|
|
|
|
|
Asset |
|
Estimated Value |
Inventory |
|
$16.7 million |
Abbokinase trade name |
|
$ 0.5 million |
Other identifiable intangibles |
|
$ 2.8 million |
The anticipated carrying value of the inventory does not include a reserve for excess
inventory. We anticipate that hospitals will not purchase approximately 28% of the total number of
vials of Abbokinase inventory that we acquired from Abbott Laboratories, and, consequently, these
vials are carried with zero book value assigned, in effect creating a valuation
18
allowance. We anticipate that these vials will not be sold for a variety of reasons, including
expiration of vials that are labeled with a fixed expiration date prior to sale, potential future
competition from new products entering the market, and use of some of the vials for our own
research purposes. Of the remaining vials of Abbokinase that we expect hospitals to purchase and
that are held in inventory either by us or by our wholesalers at a value of $15.9 million as of
June 30, 2007, we estimate that approximately 34% of these vials, or approximately $5.4 million in
inventory value, is available for sale without risk of being written off and approximately 66% of
these vials, or approximately $10.5 million in inventory value, is available for sale but may be at
risk of being written off. We estimate that the remaining vials with zero inventory value will not
be sold. The estimated useful life of the Abbokinase trade name is one year, and the estimated
useful life of the other identifiable intangibles is four years from May 2006. While we intend to
investigate the requirements for us to manufacture Abbokinase, we currently have no plans to
manufacture Abbokinase in the near term. Not manufacturing Abbokinase reduces the period of benefit
for the intangible assets to the Company to four years from May 2006, which is directly related to
the years of inventory supply.
Cash Flows
Net Cash Provided by or Used in Operating Activities. Net cash used in operating activities
was approximately $9.5 million for the six months ended June 30, 2006, whereas operating activities
provided net cash of approximately $8.1 million for the equivalent period in 2007. The net cash
used in the six months ended June 30, 2006 primarily reflects the net loss as well as the purchase
of Abbokinase inventory, offset in part by depreciation, amortization of warrant expense,
stock-based compensation and changes in working capital. The net cash provided in the six months
ended June 30, 2007 primarily reflects the increase from sales of Abbokinase, changes in working
capital, depreciation, amortization, and stock-based compensation offset in part by the net loss.
Net Cash Used in Investing Activities. Net cash used in investing activities was
approximately $1.1 million, and $0.3 million for the six months ended June 30, 2006 and 2007,
respectively. Net cash used in investing activities primarily reflects purchases of property and
equipment, including manufacturing, information technology, laboratory and office equipment, and
with respect to the six months ended June 30, 2006 also includes the purchase of intangibles as
part of the Abbokinase acquisition.
Net Cash Provided by or Used in Financing Activities. Net cash provided by financing
activities was approximately $11.9 million for the six months ended June 30, 2006, whereas net cash
used in financing activities was approximately $5.4 million for the same period in 2007. Net cash
provided by financing activities for the six months ended June 30, 2006 was primarily attributable
to the issuance of Series F preferred stock totaling approximately $13.0 million net of issuance
costs, partially offset by deferred financing costs of $1.1 million. Net cash used in financing
activities for the six months ended June 30, 2007 was primarily attributable to the approximately
$4.2 million in cash deposited in the escrow account as required by our escrow agreement with
Abbott Laboratories until the $15.0 million note is repaid as well as deferred financing costs of
$1.0 million.
Operating Capital and Capital Expenditure Requirements
Based on our existing liquid assets, including the proceeds of our sales of Abbokinase and
proceeds of the IPO, we believe we have sufficient capital to fund anticipated levels of
operations, and pay our debt obligations as they come due, at least until the third quarter of
2008, assuming sales of Abbokinase are sufficient to repay the $15.0 million non-recourse note due
December 31, 2007, or we are able to refinance this note. In April 2007, we sold approximately $9.0
million of our Abbokinase inventory, net of discounts and fees, to two of our primary wholesalers.
This inventory consisted of vials having expiration dates ranging from December 2008 to August
2009. As of June 30, 2007, we had received aggregate net proceeds of approximately $13.8 million
from sales of Abbokinase to our wholesalers and customers, of which approximately $4.2 million has
been placed into an escrow account as security for repayment of our $15.0 million non-recourse
promissory note due in December 2007. If the escrowed amount were to be applied to the outstanding
balance of principal and interest on that note, the remaining amount due under the note would be
approximately $11.9 million as of June 30, 2007.
Our ability to refinance, or repay our $15.0 million secured non-recourse note due to Abbott
Laboratories on December 31, 2007, utilizing the escrowed funds in restricted cash and sales of
Abbokinase, is our most significant near term financing requirement. Our ability to fund the
repayment of the note as well as fund our other business activities will depend on numerous
factors, including:
the timing, scope and results of our preclinical studies and clinical trials;
the timing and amount of revenue from sales of Abbokinase;
19
the timing and amount of revenue from grants and other sources;
the timing of initiation of manufacturing for our product candidates;
the timing of, and the costs involved in, obtaining regulatory approvals;
our ability to establish and maintain collaborative relationships;
personnel, facilities and equipment requirements; and
the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent
claims and other patent-related costs, including litigation costs, if any, and the result
of any such litigation.
Until we can consistently generate significant cash from our sales of Abbokinase and other
operations, we expect to continue to fund our operations primarily from the proceeds of offerings
of our equity securities, from revenue or payments received under collaborations, grants, and
possibly from debt financing. We may not be successful in obtaining such additional proceeds or
revenue. We cannot be sure that our existing cash and cash equivalents will be adequate, or that
additional financing will be available when needed, or that, if available, such financing will be
obtained on terms favorable to us or our stockholders. Having insufficient funds may require us to
delay, scale back or eliminate some or all of our research or development programs or to relinquish
greater or all rights to product candidates at an earlier stage of development or on less favorable
terms than we would otherwise choose. Failure to obtain adequate financing may also adversely
affect our ability to operate as a going concern. If we raise additional funds by issuing equity
securities, substantial dilution to existing stockholders will likely result. If we raise
additional funds by incurring debt obligations, the terms of the debt will likely involve
significant cash payment obligations as well as covenants and specific financial ratios that may
restrict our ability to operate our business.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Interest Rate Risk. Our exposure to market risk is confined to our cash and cash
equivalents. We invest in high-quality financial instruments, primarily money market funds, which
we believe are subject to limited credit risk. We currently do not hedge interest rate exposure.
The effective duration of our portfolio is less than three months and no security has an effective
duration in excess of three months. Due to the short-term nature of our investments, we do not
believe that we have any material exposure to interest rate risk arising from our investments.
Foreign Currency Risk. Most of our transactions are conducted in U.S. dollars, although we
do have some development and clinical trial agreements with vendors located outside the U.S.
Transactions under certain of these agreements are conducted in U.S. dollars while others occur in
the local currency. If the exchange rate were to change by ten percent, we do not believe that it
would have a material impact on our results of operations or cash flows.
Item 4. Controls and Procedures.
Under the supervision and with the participation of our management, including our principal
executive officer and principal financial officer, we conducted an evaluation the effectiveness of
our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated
under the Securities Exchange Act of 1934, as amended. Based on that evaluation, our principal
executive officer and principal financial officer concluded that our disclosure controls and
procedures were effective as of the end of the period covered by this quarterly report.
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act) occurred during the three-month period ended June 30, 2007 that
has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
20
PART II
OTHER INFORMATION
Item 1. Legal Proceedings.
As of the date of this Quarterly Report on Form 10-Q, we were not involved in any material
legal proceedings.
Item 1A. Risk Factors.
The following important factors, among others, could cause our actual operating results to
differ materially from those indicated or suggested by forward-looking statements made in this
Quarterly Report on Form 10-Q or presented elsewhere by management from time to time. If any of
the following risks actually occur, our business, operating results, prospects or financial
condition could be harmed. Additional risks not presently known to us, or that we currently deem
immaterial, may also affect our business operations.
Risks Relating to Our Business
Unless we are able to generate sufficient product or other revenue, we will continue to incur
losses from operations and may never achieve or maintain profitability.
We have a history of net losses and negative cash flow from operations since inception. As of
June 30, 2007, we had received aggregate net proceeds of approximately $13.8 million from sales of
our commercial product Abbokinase to our wholesalers and customers and have funded our operations
primarily from private and public sales of our securities. Net losses attributable to common
stockholders for the fiscal years ended December 31, 2004, 2005, and 2006 were approximately $6.0
million, $28.5 million, and $1.9 million, respectively, and for the six months ended June 30, 2006
and 2007 we had net losses attributable to common stockholders of approximately $7.7 million and
$4.8 million, respectively. At June 30, 2007, we had an accumulated deficit of approximately $67.4
million. Except for Abbokinase, which is approved and marketed for the treatment of acute massive
pulmonary embolism and which we acquired from Abbott Laboratories in April 2006, we do not have
regulatory approval for any of our product candidates. Even if we receive regulatory approval for
any product candidates, sales of such products may not generate sufficient revenue for us to
achieve or maintain profitability.
Our ability to generate revenue depends on a number of factors, including our ability to:
market and sell our sole commercial product, Abbokinase, or any of our product
candidates if we ever obtain regulatory approval for their sale;
obtain regulatory approval for SonoLysis+tPA therapy, SonoLysis therapy,
NanO2 and other product candidates;
obtain commercial quantities of our products after approval at acceptable cost levels; and
enter into strategic partnerships for some of our product candidates.
We anticipate that our expenses will increase substantially in the next several years as a result of:
research and development programs, including significant requirements for clinical
trials, preclinical testing, contract manufacturing, and potential regulatory
submissions;
developing additional infrastructure and hiring additional management and other
employees to support the anticipated growth of our development and regulatory
activities;
regulatory submissions and commercialization activities;
additional costs for intellectual property protection and enforcement; and
expenses as a result of being a public company.
21
Because of the numerous risks and uncertainties associated with developing and commercializing
our potential products, we may experience larger than expected future losses and may never become
profitable.
Our independent registered public accounting firm has expressed substantial doubt about our ability
to continue as a going concern.
We have received an audit report from our independent registered accounting firm containing an
explanatory paragraph stating that our historical recurring losses from operations and net capital
deficiency raise substantial doubt about our ability to continue as a going concern. We believe
that the proceeds we received from the IPO will eliminate this doubt and allow us to continue as a
going concern at least in the near term. We estimate that the net proceeds from the IPO and our
existing cash and cash equivalents will be sufficient to meet our anticipated cash requirements
until September 2008, assuming continuing sales of Abbokinase (including the extension of product
expiration date) to wholesalers will be adequate to repay the $15.0 million note due to Abbott
Laboratories on December 31, 2007. We believe that, based on conversations with our wholesale
distributors about the current market demand for Abbokinase, we will sell a sufficient amount of
Abbokinase prior to December 31, 2007 to repay the note to Abbott Laboratories. It is possible that
the sales of Abbokinase that we expect to occur prior to December 31, 2007 may instead occur in the
first quarter of 2008 or later. In such event we would use a portion of the net proceeds of the IPO
to repay the note on December 31, 2007 and we would replenish our cash resources from subsequent
sales of Abbokinase. Alternatively, we may refinance the note using our Abbokinase inventory as
collateral.
We incurred significant indebtedness in connection with our acquisition of Abbokinase assets from
Abbott Laboratories. If we are unable to satisfy this obligation in December 2007, Abbott
Laboratories will have a right to reclaim our remaining inventory of Abbokinase, along with a
portion of the cash we have received from our sales of Abbokinase.
In connection with our April 2006 acquisition of the remaining inventory of and certain rights
related to Abbokinase, we issued to Abbott Laboratories a $15.0 million non-recourse note that is
secured by the inventory and rights acquired and matures in December 2007. Although we have
commenced selling Abbokinase to obtain near-term revenue that will help fund our cash needs, the
asset purchase agreement provides that after we have received initial net revenue of $5.0 million
from the sale of Abbokinase, we are then required to deposit 50% of the cash receipts we receive
from further sales of Abbokinase into an escrow account to secure the repayment of the note. As of
June 30, 2007, our net cash received from sales of Abbokinase to wholesalers and customers totaled
approximately $13.8 million and we had deposited approximately $4.2 million in escrow as security
for the note. If the escrow amount is not adequate to repay the note and we are otherwise unable to
repay the note by its maturity date, Abbott Laboratories has the right to reclaim our remaining
inventory of Abbokinase, along with the portion of the cash we have received from our sales of
Abbokinase that is in the escrow account.
We will need substantial additional capital to fund our operations. If we are unable to raise
capital when needed, we may be forced to delay, reduce or eliminate our research and development
programs or commercialization efforts, and we may be unable to timely pay our debts or may be
forced to sell or license assets or otherwise terminate further development of one or more of our
programs.
Since our inception, we have financed our operations principally through the private placement
and public sale of shares of our common stock, and the private placement of shares of our preferred
stock and convertible notes, sales of Abbokinase and the receipt of government grants. We believe
we have working capital sufficient to meet our anticipated cash needs through September 2008,
assuming our projected sales of Abbokinase to wholesalers occur within a timeframe adequate to
repay the $15.0 million note due to Abbott Laboratories on December 31, 2007. We expect our
expenses to increase substantially over the next several years, and we will require substantial
additional financing at various times in the future as we expand our operations and as our debt
obligations mature.
Our funding requirements will, however, depend on numerous factors, including:
the timing, scope and results of our preclinical studies and clinical trials;
the timing and amount of revenue from sales of Abbokinase;
our ability to refinance our $15.0 million secured non-recourse note due to Abbott
Laboratories on December 31, 2007, if sales of Abbokinase are insufficient to repay the
note;
the timing and amount of revenue from grants and other sources;
22
the timing of initiation of manufacturing for our product candidates;
the timing of, and the costs involved in, obtaining regulatory approvals;
our ability to establish and maintain collaborative relationships;
personnel, facilities and equipment requirements; and
the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent
claims and other patent-related costs, including litigation costs, if any, and the
result of any such litigation.
We intend to seek additional funding from a variety of sources, which may include
collaborations involving our technology, technology licensing, grants and public or private equity
and debt financings. We cannot be certain that any additional funding will be available on terms
acceptable to us, or at all. Accordingly, we may not be able to secure the substantial funding that
is required to maintain and continue our commercialization and development programs at levels that
may be required in the future. We may be forced to accept funds on terms or pricing that are highly
dilutive or otherwise disadvantageous to our existing stockholders. We are restricted from granting
any additional security interest in our Abbokinase assets that we acquired in 2006. Raising
additional funds through debt financing, if available, may involve covenants that restrict our
business activities. To the extent that we raise additional funds through collaborations and
licensing arrangements, we may have to relinquish valuable rights and control over our
technologies, research programs or product candidates, or grant licenses on terms that may not be
favorable to us. If we are unable to secure adequate financing, we could be required to sell or
license assets, delay, scale back or eliminate one or more of our development programs or enter
into licenses or other arrangements with third parties to commercialize products or technologies
that we would otherwise seek to develop and commercialize ourselves.
We have expanded our business strategy to include the sale of Abbokinase and this exposes us to
additional risks which we may not be able to overcome.
Until September 2005, our business strategy focused on the development of microbubbles for the
treatment of blood clots and various vascular disorders. In October 2006 we began selling
Abbokinase, a thrombolytic drug that we acquired in April 2006. Abbokinase is approved by the FDA
for marketing in the U.S. for acute massive pulmonary embolism. We have limited experience in
marketing or selling Abbokinase, and we may not be successful in these undertakings. Use of
Abbokinase in general involves significant risks, such as bleeding. In addition, adding Abbokinase
to our business places additional burdens on our management and technical staff to undertake
commercialization activities and may distract them from development activities. Furthermore, our
customers may return outdated, short dated or damaged product that is in its original, unopened
cartons and received by us prior to 12 months past the expiration date. Finally, the FDA must
formally approve the release of each lot of Abbokinase we wish to sell. We must submit a request
for each lot we intend to ship to our product wholesalers prior to shipment. If the FDA does not
release these lots for shipment in a timely manner or at all, our sales of Abbokinase may be
adversely affected.
We may be unable to sell our existing inventory of Abbokinase before product expiration, and even
if we are able to sell the existing inventory, the product may be returned prior to use by
hospitals and clinics. Additionally, even if we are successful in extending the product expiration
dates, we will need to re-brand the product.
In our acquisition of Abbokinase, we received approximately 153,000 vials of Abbokinase
manufactured between 2003 and 2005. At the time of our acquisition of Abbokinase, we estimated that
hospitals would purchase, and we would thereby recognize revenue for, approximately 111,000 vials,
or approximately 72% of the total vials we acquired. We also estimated that, due to expiration of
the vials or for other reasons, hospitals would not purchase approximately 42,000 vials, or
approximately 28% of the vials we acquired. Approximately $16.7 million of the $20.0 million
purchase price for Abbokinase was allocated to the vials we expect hospitals to purchase. Of our
vials of Abbokinase held in inventory either by us or by our wholesalers as of June 30, 2007,
approximately 66% of the vials we expect hospitals to purchase, or approximately $10.5 million in
inventory value, are unlabeled and will expire by October 2007 based on current stability data. The
remaining approximately 34% of the vials we expect to sell to hospitals, or approximately $5.4
million in inventory value, are labeled and will expire at various times between December 2008 and
August 2009. We commenced sales of Abbokinase in October 2006. We may or may not be able to sell
the entire inventory we acquired before the product expires, and we are not permitted to sell this
inventory after its expiration dates. We will continue our ongoing stability program to potentially
extend the expiration dates for this inventory. Our license to use the Abbokinase trademark does
not cover any inventory with extended expiration dates. Accordingly, if we are successful in
demonstrating extended stability and shelf life,
23
we would need to re-brand the inventory to
commercialize it. We cannot be certain that we will be successful in establishing
an alternate brand name for Abbokinase and obtaining market acceptance. Even if we are able to sell
the Abbokinase inventory to wholesalers prior to expiration, the product may be returned to us if
outdated or short dated, and our sales could be significantly reduced.
The thrombolytic drug market is highly competitive and dominated by products from Genentech. We
have limited sales and marketing capabilities and depend on drug wholesalers to distribute our
Abbokinase product.
The market for thrombolytic drugs is currently dominated by thrombolytic drugs offered by
Genentech, Inc., in particular alteplase, or tPA, which is approved for treatment of ischemic
stroke and pulmonary emboli, among other indications. We cannot be certain that we have sufficient
resources to effectively market or sell Abbokinase. We have a limited sales and marketing staff and
depend on the efforts of third parties for the sale and distribution of Abbokinase to hospitals and
clinics. If we are unable to maintain effective third party distribution on commercially reasonable
terms, we may be unable to market and sell Abbokinase in commercial quantities. Drug wholesale
companies may be unwilling to continue selling Abbokinase, or we may be forced to accept lower
prices or other unfavorable terms or to expend significant additional resources to sell our
Abbokinase inventory. Additionally, even if we are able to market and sell Abbokinase in commercial
quantities, we do not expect sales of Abbokinase to generate enough revenue for us to achieve
profitability.
Our competitors generally are larger than we are, have greater financial resources available to
them than we do and may have a superior ability to develop and commercialize competitive products.
In addition, if our competitors have products that are approved in advance of ours, marketed more
effectively or demonstrated to be safer or more effective than ours, our commercial opportunity
will be reduced or eliminated and our business will be harmed.
Our industry sector is intensely competitive, and we expect competition to continue to
increase. Many of our actual or potential competitors have substantially longer operating histories
and greater financial, research and development and marketing capabilities than we do. Many of them
also have substantially greater experience than we have in undertaking preclinical studies and
clinical trials, obtaining regulatory approvals and manufacturing and distributing products.
Smaller companies may also prove to be significant competitors, particularly through collaborative
arrangements with large pharmaceutical companies. In addition, academic institutions, government
agencies and other public and private research organizations also conduct research, seek patent
protection and establish collaborative arrangements for product development and marketing. We may
not be able to develop products that are more effective or achieve greater market acceptance than
our competitors products. Any company that brings competitive products to market before us may
achieve a significant competitive advantage.
We believe that the primary competitive factors in the market for treatments of vascular
disorders include safety and efficacy, access to and acceptance by leading physicians,
cost-effectiveness, physician relationships and sales and marketing capabilities. We may be unable
to compete successfully on the basis of any one or more of these factors, which could have a
material adverse effect on our business, financial condition and results of operations.
If we are unable to develop, manufacture and commercialize our product candidates, we may not
generate sufficient revenue to continue our business.
We currently have only one product, urokinase, currently marketed as Abbokinase, that has
received regulatory approval, and we have limited experience commercializing Abbokinase. The
process to develop, obtain regulatory approval for and commercialize potential drug candidates is
long, complex and costly. Our proprietary SonoLysis microbubble technology has not been used in
clinical trials other than our ongoing Phase I/II clinical trial of our SonoLysis+tPA therapy. We
do not expect to have the results of any clinical trials using our proprietary MRX-801 microbubbles
until at least 2008. As a result, our business in the near term is substantially dependent upon our
ability to sell Abbokinase and to complete development, obtain regulatory approval for and
commercialize our SonoLysis product candidates in a timely manner. If we are unable to further
develop, commercialize or license our SonoLysis product candidates, we may not be able to earn
sufficient revenue to continue our business.
If we want to sell urokinase beyond our existing inventory of Abbokinase, we would need to
undertake manufacturing and secure regulatory approval for a new manufacturing process and
facility.
As part of our acquisition of Abbokinase, we acquired cell lines that could be used to
manufacture urokinase. If we want to sell urokinase beyond our existing inventory of acquired
Abbokinase, we would need to undertake manufacturing and to demonstrate that our manufactured
material is comparable to the urokinase we purchased from Abbott Laboratories. To demonstrate this,
we would need to have our manufacturing process validated by the FDA and may be required to conduct
24
additional preclinical studies, and possibly additional clinical trials, to demonstrate its safety
and efficacy. In addition, the
manufacturing process for Abbokinase involves a roller bottle production method that is used
infrequently today and is available only from a limited number of manufacturers worldwide. We do
not currently intend to undertake any efforts required for manufacturing and regulatory approval of
additional urokinase in the near term, and even if we were to undertake these efforts in the
future, we cannot be certain that we would be able to manufacture and receive regulatory approval
for additional sales of urokinase beyond our existing inventory.
We do not plan to manufacture any of our product candidates and will depend on commercial contract
manufacturers to manufacture our products.
We do not have our own manufacturing facilities, have no experience in large-scale product
manufacturing, and do not intend to develop such facilities or capabilities. Our ability to conduct
clinical trials and commercialize our product candidates will depend, in part, on our ability to
manufacture our products through contract manufacturers. For all of our product candidates, we or
our contract manufacturers will need to have sufficient production and processing capacity to
support human clinical trials, and if those clinical trials are successful and regulatory approvals
are obtained, to produce products in commercial quantities. Delays in providing or increasing
production or processing capacity could result in additional expense or delays in our clinical
trials, regulatory submissions and commercialization of our products. In addition, we will be
dependent on such contract manufacturers to adhere to the FDAs current Good Manufacturing
Practices, or cGMP, and other regulatory requirements.
Establishing contract manufacturing is costly and time-consuming and we cannot be certain that
we will be able to engage contract manufacturers who can meet our quantity and quality requirements
in a timely manner and at competitive costs. The manufacturing processes for our product candidates
have not yet been tested at commercial levels, and it may not be possible to manufacture such
materials in a cost-effective manner. Further, there is no guarantee that the components of our
proposed drug product candidates will be available to our manufacturers when needed on terms
acceptable to us. If we are unable to obtain contract manufacturing on commercially reasonable
terms, we may not be able to conduct or complete planned or necessary clinical trials or
commercialize our product candidates.
If our clinical trials are not successful, or if we are unable to obtain regulatory approvals, we
will not be able to commercialize our products and we will continue to incur significant operating
losses.
Abbokinase is our only product approved for commercial sale. The sale of all of our product
candidates in the U.S. requires approval from the FDA and from foreign regulatory agencies for
sales outside the U.S. To gain regulatory approval for the commercial sale of our product
candidates, we must demonstrate the safety and efficacy of each product candidate in human clinical
trials. This process is expensive and can take many years, and failure can occur at any stage of
the testing process. There are many risks associated with our clinical trials. For example:
the only completed clinical trials related to our development of SonoLysis therapy or
SonoLysis+tPA therapy have not utilized our proprietary MRX-801 microbubbles and may not
be indicative of the safety and effectiveness of our product candidates;
if the clinical trial is not conducted in accordance with current Good Clinical
Practices, or cGCP, it may not be possible to complete the trial and the FDA may not
accept the results of the clinical trial;
clinicians, physicians and regulators may not favorably interpret the results of our
preclinical studies and clinical trials;
some patients in our clinical trials may experience unforeseen adverse medical events
related or unrelated to the use of our product candidates;
we may be unable to secure a sufficient number of clinical trial sites or patients to
enroll in our clinical trials;
we may experience delays in securing the services of, or difficulty scheduling,
clinical investigators for our clinical trials;
third parties who conduct our clinical trials may not fulfill their obligations;
25
we may in the future experience, and have in the past experienced, deviations from the
approved clinical trial protocol by our clinical trial investigators;
the FDA or the local institutional review board, or IRB, at one or more of our
clinical trial sites may interrupt, suspend or terminate a clinical trial or the
participation of a particular site in a clinical trial; and
the FDA or other regulatory bodies may change the policies and procedures we are
required to follow in connection with our clinical trials.
Any of these or other unexpected events could cause us to delay or terminate our ongoing
clinical trials, increase the costs associated with our clinical trials or affect the statistical
analysis of the safety and efficacy of our product candidates. If we fail to adequately demonstrate
the safety and efficacy of our product candidates, we will not obtain regulatory approval to
commercialize our products. Significant delays in clinical development could materially increase
our product development costs or impair our competitive position. In addition, any approvals we may
obtain may not cover all of the clinical indications for which we seek approval, or an approval may
contain significant limitations in the form of narrow labeling and warnings, precautions or
contraindications with respect to limitations on use. Accordingly, we may not be able to obtain our
desired product registration or marketing approval for any of our product candidates.
We rely on third parties to conduct our clinical trials who may not carry out their contractual
duties, with resulting negative impacts on our clinical trials.
We depend on contract research organizations, or CROs, for managing some of our preclinical
testing and clinical trials. If we are not able to retain CROs in a timely manner and on
commercially reasonable terms, we may not be able to conduct or complete clinical trials or
commercialize our product candidates and we do not know whether we will be able to develop or
attract partners with such capabilities. We have established relationships with multiple CROs for
our existing clinical trials, although there is no guarantee that the CROs will be available for
future clinical trials on terms acceptable to us. We may not be able to control the amount and
timing of resources that CROs devote to our clinical trials. In the event that we are unable to
maintain our relationship with any of our CROs or elect to terminate the participation of any of
these CROs, we may lose the ability to obtain follow-up information for patients enrolled in
ongoing clinical trials unless we are able to transfer the care of those patients to another
qualified CRO.
Our product candidates may never achieve market acceptance.
We cannot be certain that our products will achieve any degree of market acceptance among
physicians and other health care providers and payors, even if necessary regulatory approvals are
obtained. We believe that recommendations by physicians and other health care providers and payors
will be essential for market acceptance of our products, and we cannot be certain we will ever
receive any positive recommendations or reimbursement. Physicians will not recommend our products
unless they conclude, based upon clinical data and other factors, that our products are safe and
effective. We are unable to predict whether any of our product candidates will ever achieve market
acceptance, either in the U.S. or internationally. A number of factors may limit the market
acceptance of our products, including:
the timing and scope of regulatory approvals of our products and market entry compared
to competitive products;
the safety and efficacy of our products, including any inconveniences in
administration, as compared to alternative treatments;
the rate of adoption of our products by hospitals, doctors and nurses and acceptance
by the health care community;
the product labeling and marketing claims permitted or required by regulatory agencies
for each of our products;
the competitive features of our products, including price, as compared to other similar products;
the availability of sufficient third party coverage or reimbursement for our products;
the extent and success of our sales and marketing efforts; and
26
possible unfavorable publicity concerning our products or any similar products.
If our products are not commercialized, our business will be materially harmed.
Technological change and innovation in our market sector may cause our products to become obsolete
shortly after or even before such products reach the market.
New products and technological development in the pharmaceutical and medical device industries
may adversely affect our ability to complete required regulatory requirements and introduce our
product candidates into the market or may render our products obsolete. The markets into which we
plan to introduce our products are characterized by constant and sometimes rapid technological
change, new and improved product introductions, changes in regulatory requirements, and evolving
industry standards. Our ability to execute our business plan will depend to a substantial extent on
our ability to identify new market trends and develop, introduce and support our candidate products
on a timely basis. If we fail to develop and commercialize our product candidates on a timely
basis, we may be unable to compete effectively. For example, we are aware of other thrombolytic
drugs in development such as ancrod and desmoteplase, which are currently in Phase III clinical
trials as treatments for acute ischemic stroke. Since none of our product candidates for treatment
of ischemic stroke will be able to achieve regulatory approval for commercial sale in the U.S. any
earlier than 2011, if ever, we could by that time find that competitive developments have
diminished our product opportunities, which would have an adverse impact on our business prospects
and financial condition.
If we are unable to obtain acceptable prices or adequate reimbursement from third-party payors for
any product candidates that we seek to commercialize, our revenue and prospects for profitability
will suffer.
The commercialization of our product candidates is substantially dependent on whether
third-party coverage and reimbursement is available from governmental payors such as Medicare and
Medicaid, private health insurers, including managed care organizations and other third-party
payors. The U.S. Centers for Medicare and Medicaid Services, health maintenance organizations and
other third-party payors in the U.S. and in other jurisdictions are increasingly attempting to
contain health care costs by limiting both coverage and the level of reimbursement for new drugs
and medical devices and, as a result, they may not cover or provide adequate payment for our
products. Our products may not be considered cost-effective and reimbursement may not be available
to consumers or may not be sufficient to allow our products to be marketed on a competitive basis.
Large private payors, managed care organizations, group purchasing organizations and similar
organizations are exerting increasing influence on decisions regarding the use of, and
reimbursement levels for, particular treatments. Such third-party payors, including Medicare, are
challenging the prices charged for medical products and services, and many third-party payors limit
or delay reimbursement for newly approved medical products and indications. Cost-control
initiatives could lower the price we may establish for our products which could result in product
revenue lower than anticipated. If the prices for our product candidates decrease or if
governmental and other third-party payors do not provide adequate coverage and reimbursement
levels, our prospects for profitability could suffer.
We intend to rely heavily on third parties to implement critical aspects of our business strategy,
and our failure to enter into and maintain these relationships on acceptable business terms, or at
all, would materially adversely affect our business.
We intend to rely on third parties for certain critical aspects of our business, including:
manufacturing of our MRX-801 and other proprietary microbubbles;
conducting clinical trials;
conducting preclinical studies;
performing stability and product release testing with respect to Abbokinase;
preparing, submitting and maintaining regulatory records sufficient to meet the
requirements of the FDA; and
customer logistics and distribution of our products.
We do not currently have many of these relationships in place. Although we use a third party
manufacturer to produce MRX-801 microbubbles for our clinical trials on a purchase order basis,
that third party does not have the capacity to
27
produce the volume of MRX-801 microbubbles necessary
for large-scale clinical trials or commercial sales. We currently have agreements with contract
research organizations to manage our clinical trials; audit our clinical trials; help us write
protocols and study reports for our clinical trials; store, label, package and distribute our
commercial product; and conduct stability and product release testing for our commercialized
product. We also have agreements with wholesalers to market and distribute our product, as well as
agreements in place with many Group Purchasing Organizations that negotiate prices on behalf of
hospitals and clinics. To the extent that we are unable to maintain these relationships or to enter
into any one or more of the additional relationships necessary to our business on commercially
reasonable terms, or at all, or to eliminate the need for any such relationship by establishing our
own capabilities in a particular functional area in a timely manner, we could experience
significant delays or cost increases that could have a material adverse effect on our ability to
develop and commercialize our product candidates.
We rely on third party products, technology and intellectual property, which could negatively
affect our ability to sell our MRX-801 microbubbles or other products commercially or could
adversely affect our ability to derive revenue from such products.
Our SonoLysis program may require the use of multiple proprietary technologies, including
commercially available ultrasound devices and patented technologies. Manufacturing our products or
customizing related ultrasound devices may also require licensing technologies and intellectual
property from third parties. Obtaining and maintaining licenses for these technologies may require
us to make royalty payments or other payments to several third parties, potentially reducing our
revenue or making the cost of our products commercially prohibitive. We cannot be certain that we
will be able to establish any or all of the partnering relationships and technology licenses that
may be necessary for the pursuit of our business strategy, or, even if such relationships can be
established, that they will be on terms favorable to us or that they can be managed in a way that
will assist us in executing our business plan.
As a highly specialized scientific business enterprise, our ability to execute our business plan is
substantially dependent on certain key members of our scientific and management staff, the loss of
any of whom could have a material adverse effect on our business.
A small number of key officers and members of our professional staff are responsible for
certain critical areas of our business, such as product research and development, clinical trials,
regulatory affairs, manufacturing, intellectual property protection and licensing. The services
provided by our key personnel, including: Bradford A. Zakes, our President and Chief Executive
Officer; Rajan Ramaswami, our Vice President, Product Development; Walter Singleton, our Chief
Medical Officer; Lynne Weissberger, our Vice President, Regulatory Affairs, Quality Assurance and
Regulatory Compliance; and Reena Zutshi, our Vice President, Operations, would be difficult to
replace. Dr. Singleton has left the employ of the Company to pursue personal interests. He has
entered into a one-year consulting agreement with us. We believe that we will be able to continue
our product development activities as planned. All of our employees are employed at will. Our
business and future operating results also depend significantly on our ability to attract and
retain qualified management, manufacturing, technical, marketing, regulatory, sales and support
personnel for our operations, and competition for such personnel is intense. We cannot be certain
that our key executive officers and scientific staff members will remain with us or that we will be
able to attract or retain such personnel. If we are unable to retain and continue to attract
qualified management and technical staff, this could significantly delay and may prevent the
achievement of our research, development and business objectives. We do not maintain key-person
life insurance on the lives of any of our executive officers or scientific staff and we do not
intend to secure any key-person life insurance.
We will need to increase the size of our organization, and we may experience difficulties in
managing our growth.
As of August 1, 2007, we had 30 full-time employees. In the future, we will need to expand our
managerial, operational, financial, clinical, regulatory and other personnel to manage and expand
our operations, undertake clinical trials, manufacture our product candidates, continue our
research and development and collaborative activities and commercialize our product candidates. In
the next 12 months we anticipate hiring between five and eight new employees at an approximate
aggregate cost of between $450,000 and $700,000 annually. Our management and scientific personnel,
systems and facilities currently in place will not be adequate to support our planned future
growth. Our need to effectively manage our operations, growth and various projects requires that
we:
utilize a small sales and marketing organization;
identify and manage third party manufacturers for our products;
manage our clinical trials effectively;
28
manage our internal research and development efforts effectively while carrying out
our contractual obligations to collaborators and other third parties;
continue to improve our operational, financial and management controls, reporting
systems and procedures under increasing regulatory requirements; and
attract and retain sufficient numbers of talented employees.
We may be unable to implement and manage many of these tasks on a larger scale or in a timely
manner and, accordingly, may not achieve our research, development and commercialization goals.
We depend on patents and other proprietary rights, some of which are uncertain and unproven.
Further, our patent portfolio and other intellectual property rights are expensive to maintain,
protect against infringement claims by third parties, and enforce against third party
infringements, and are subject to potential adverse claims.
Because we are developing product candidates that rely on advanced and innovative
technologies, our ability to execute our business plan will depend in large part on our ability to
obtain and effectively use patents and licensed patent rights, preserve trade secrets and operate
without infringing upon the proprietary rights of others. Our Abbokinase product has no patent
protection and we have a one-half interest in a patent related to the manufacturing process for
Abbokinase. Some of our intellectual property rights are based on licenses that we have entered
into with owners of patents.
Although we have rights to 143 issued U.S. patents, plus some foreign equivalents and numerous
pending patent applications, the patent position of pharmaceutical, medical device and
biotechnology companies in general is highly uncertain and involves complex legal and factual
questions. Effective intellectual property protection may also be unavailable or limited in some
foreign countries. We have not pursued foreign patent protection in all jurisdictions or for all of
our patentable intellectual property. As a result, our patent protection for our intellectual
property will likely be less comprehensive if and when we commence international sales.
There are also companies that are currently commercializing FDA approved microbubbles-based
products for diagnostic uses. These companies may promote these products for off-label uses which
may directly compete with our products when and if approved. Additionally, physicians may prescribe
the use of such products for off-label indications which could have the impact of reducing our
revenues for our product candidates when and if approved.
In the U.S. and internationally, enforcing intellectual property rights against infringing
parties is often costly. Pending patent applications may not issue as patents and may not issue in
all countries in which we develop, manufacture or sell our products or in countries where others
develop, manufacture and sell products using our technologies. Patents issued to us may be
challenged and subsequently narrowed, invalidated or circumvented. We have been notified that, in
February 2005, a third party filed an opposition claim to one of our patents in Europe that relates
to targeted bubbles for therapeutic and diagnostic use. The third party has agreed to voluntarily
dismiss and terminate this claim, but other such conflicts could occur and could limit the scope of
the patents that we may be able to obtain or may result in the denial of our patent applications.
If a third party were to obtain intellectual property protection for any of the technologies upon
which our business strategy is based, we could be required to challenge such protections, terminate
or modify our programs that rely on such technologies or obtain licenses for use of these
technologies. For example, in July 2003 we received a notice from a third party who owns a patent
relating to the administration of ultrasound to break up blood clots indicating that we may need a
license to its patent if we intend to administer our therapies according to its patented method.
Although we do not intend to administer our therapies according to the third partys patented
method, other similar third party patents, if valid, could require us to seek a license that may
not be available on terms acceptable to us or at all, could impose limitations on how we administer
our therapies, and may require us to adopt restrictions or requirements as to the manner of
administration of our products that we might not otherwise adopt to avoid infringing patents of
others. Moreover, we may not have the financial resources to protect our patent and other
intellectual property rights and, in that event, our patents may not afford meaningful protection
for our technologies or product candidates, which would materially adversely affect our ability to
develop and market our product candidates and to generate licensing revenue from our patent
portfolio.
Additional risks related to our patent rights and other proprietary rights include:
challenge, invalidation, circumvention or expiration of issued patents already owned
by or licensed to us;
29
claims by our consultants, key employees or other third parties that our products or
technologies are the result of technological advances independently developed by them
and, therefore, not owned by us;
our failure to pay product development costs, license fees, royalties, milestone
payments or other compensation required under our technology license and technology
transfer agreements, and the subsequent termination of those agreements;
failure by our licensors or licensees to comply with the terms of our license
agreements;
misrepresentation by technology owners of the extent to which they have rights to the
technologies that we purport to acquire or license from them;
a potentially shorter patent term as a result of legislation which sets the patent
termination date at 20 years from the earliest effective filing date of the patent
application instead of 17 years from the date of the grant; and
loss of rights that we have licensed due to our failure or decision not to fund
further research or failure to achieve required development or commercialization
milestones or otherwise comply with our obligations under the license and technology
transfer agreements.
If any of these events occurs, our business may be harmed.
We have limited patent protection for Abbokinase, and third parties likely could develop urokinase
without a license from us, which could decrease the market opportunity for Abbokinase.
We own a one-half interest in a patent related to the manufacturing process for Abbokinase. We
also have a license to use the Abbokinase trademark that expires when our inventory is sold,
expires or its expiration date is extended, and trade secrets relating to the manufacturing process
for Abbokinase. A third party could acquire or develop a cell line capable of producing urokinase
and could devise a manufacturing process that could yield a product consistent with or superior to
our Abbokinase product in quality, safety and activity, in each case without a license from us,
which could decrease the market opportunity for Abbokinase.
Other companies may claim that we infringe their patents or trade secrets, which could subject us
to substantial damages.
A number of third parties, including certain of our competitors, have developed technologies,
filed patent applications or obtained patents on technologies and compositions that are related to
aspects of our business, including thrombolytic drug therapy, microbubbles and ultrasound. Such
third parties may sue us for infringing their patents. If we face an infringement action, defending
against such an action could require substantial resources that may not be available to us. In the
event of a successful claim of infringement against us, we may be required to:
pay substantial damages;
stop using infringing technologies and methods;
stop certain research and development efforts;
develop non-infringing products or methods; and
obtain one or more licenses from third parties.
Any claims of infringement could cause us to incur substantial costs and could divert
managements attention away from our business in defending against the claim, even if the claim is
invalid. A party making a claim could secure a judgment that requires us to pay substantial
damages. A claim of infringement could also be used by our competitors to delay market introduction
or acceptance of our products. If we are sued for infringement, we could encounter substantial
delays in development, manufacture and commercialization of our product candidates. Any litigation,
whether to enforce our patent rights or to defend against allegations that we infringe third party
rights, will be costly and time consuming and will likely distract management from other important
tasks.
30
Our rights to develop and commercialize certain of our product candidates are subject to the terms
and conditions of licenses or sublicenses granted to us by third parties, including other
pharmaceutical companies, that contain restrictions that may limit our ability to capitalize on
these products.
Our SonoLysis therapy and SonoLysis+tPA therapy product candidates are based in part on
patents and other intellectual property that we license or sublicense from third parties. Our
rights to develop and commercialize these product candidates using intellectual property licensed
from UNEMED Corporation may terminate, in whole or in part, if we fail to pay royalties to third
party licensors, or if we fail to comply with certain restrictions regarding our development
activities. In the event of an early termination of any such license or sublicense agreement,
rights licensed and developed by us under such agreements may be extinguished, and our rights to
the licensed technology may revert back to the licensor. Any termination or reversion of our rights
to develop or commercialize any such product candidate may have a material adverse effect on our
business.
We are party to an agreement with Bristol-Myers Squibb that restricts us from using our bubble
technology for non-targeted diagnostic imaging applications. Bristol-Myers Squibb also has a right
of first negotiation should we wish to license to a third party any of our future products or
technology related to the use of bubbles for targeted imaging of blood clots, or breaking up blood
clots with ultrasound and bubbles. Bristol-Myers Squibb has waived its rights under this agreement
with respect to our current generation of MRX-801 microbubbles that we are developing for breaking
up blood clots, as well as a new generation of MRX-802 microbubbles that we are developing for
breaking up blood clots that include targeting mechanisms to cause the bubbles to attach to blood
clots. This right of first negotiation for future technology we may develop in these applications
could adversely impact our ability to attract a partner or acquirer for SonoLysis therapy.
In addition, we have been awarded various government funding grants and contracts from The
National Institutes of Health and other government agencies. These grants include provisions that
provide the U.S. government with the right to use the technologies developed under such grants for
certain uses, under certain circumstances. If the government were to exercise its rights, our
ability to commercialize such technology would likely be impaired.
We could be exposed to significant product liability claims, which could be time consuming and
costly to defend, divert management attention and adversely impact our ability to obtain and
maintain insurance coverage. The expense and potential unavailability of insurance coverage for our
company or our customers could adversely affect our ability to sell our products, which would
negatively impact our business.
We face a risk of product liability exposure related to the testing of our product candidates
in clinical trials and will face even greater risks upon any commercialization by us of our product
candidates. Thrombolytic drugs are known to involve certain medical hazards, such as risks of
bleeding or immune reactions. Our product candidates may also involve presently unknown medical
risks of equal or even greater severity. Product liability claims or other claims related to our
products, or their off-label use, regardless of their merits or outcomes, could harm our reputation
in the industry, and reduce our product sales. Additionally, any lawsuits or product liability
claims against us may divert our management from pursuing our business strategy and may be costly
to defend. Further, if we are held liable in any of these lawsuits, we may incur substantial
liabilities and may be forced to limit or forego further commercialization of one or more of our
products. A product liability related claim or recall could be materially detrimental to our
business. Our current product liability insurance, which provides us with $10 million of coverage
in the aggregate, may be insufficient. We may not be able to obtain or maintain such insurance in
adequate amounts, or on acceptable terms, to provide coverage against potential liabilities. The
product liability coverage we currently have for our clinical trials may be insufficient to cover
fully the costs of any claim or any ultimate damages we may be required to pay. Our inability to
obtain or maintain sufficient insurance coverage at an acceptable cost or otherwise to protect
against potential product liability claims could prevent or limit the commercialization of any
products we develop, and could leave us exposed to significant financial losses relating to any
products that we do develop and commercialize.
Moreover, Abbokinase is made from human neonatal kidney cells. Products made from human source
material may contain infectious agents, such as viruses, that can cause disease. We believe the
risk that Abbokinase will transmit an infectious agent has been reduced by changes made by Abbott
Laboratories to its tissue acquisition and related manufacturing process that included screening
donors for prior exposure to certain viruses, testing donors for the presence of certain current
virus infections, testing for certain viruses during manufacturing and inactivating and/or removing
certain viruses. All of our inventory was produced after these changes were made. Despite these
measures, Abbokinase may still present a risk of transmitting infectious agents, which could expose
us to product liability lawsuits.
If we use hazardous or biological materials in a manner that causes injury or violates applicable
law, we may be liable for damages.
31
Our research and development activities involve the controlled use of potentially hazardous
substances, including toxic chemical and biological materials. Our recent expansion of our business
strategy to include the sale of Abbokinase has increased our involvement in the handling and
distribution of biological materials. In addition, our operations produce
hazardous waste products. Federal, state and local laws and regulations govern the use,
manufacture, storage, handling and disposal of these hazardous and biological materials. While we
believe that we are currently in compliance with these laws and regulations, continued compliance
may be expensive, and current and future environmental regulations may impair our research,
development and manufacturing efforts. In addition, if we fail to comply with these laws and
regulations at any point in the future, we may be subject to criminal sanctions and substantial
civil liabilities and could be required to suspend or modify our operations. Even if we continue to
comply with all applicable laws and regulations regarding hazardous materials, we cannot eliminate
the risk of accidental contamination or discharge and our resultant liability for any injuries or
other damages caused by these accidents. Although we maintain general liability insurance, this
insurance may not fully cover potential liabilities for these damages, and the amount of uninsured
liabilities may exceed our financial resources and materially harm our business.
The FDA approval process for drugs involves substantial time, effort and financial resources, and
we may not receive any new approvals for our product candidates on a timely basis, or at all.
The process required by the FDA before product candidates may be marketed in the U.S.
generally involves the following:
preclinical laboratory and animal testing;
submission of an IND application which must become effective before clinical trials may begin;
adequate and well-controlled human clinical trials to establish the safety and
efficacy of proposed drugs or biologics for their intended use;
pre-approval inspection of manufacturing facilities, company regulatory files and
selected clinical investigators; and
FDA approval of a new drug application, or NDA, or FDA approval of an NDA supplement
in the case of a new indication if the product is already approved for another
indication.
The testing and approval process requires substantial time, effort and financial resources,
and we cannot be certain that any new approvals for our product candidates will be granted on a
timely basis, if at all. We have failed in the past, and may in the future fail, to make timely
submissions of required reports or modifications to clinical trial documents, and such delays as
well as possible errors or omissions in such submissions could endanger regulatory acceptance of
clinical trial results or even our ability to continue with our clinical trials.
The results of product development, preclinical tests and clinical trials are submitted to the
FDA as part of an NDA, or as part of an NDA supplement. The FDA may deny approval of an NDA or NDA
supplement if the applicable regulatory criteria are not satisfied, or it may require additional
clinical data or an additional pivotal Phase III clinical trial. Even if such data are submitted,
the FDA may ultimately decide that the NDA or NDA supplement does not satisfy the criteria for
approval. The FDA may move to withdraw product approval, once issued, if ongoing regulatory
standards are not met or if safety problems occur after the product reaches the market. In
addition, the FDA may require testing and surveillance programs to monitor the effect of approved
products which have been commercialized, and the FDA may move to prevent or limit further marketing
of a product based on the results of these post-marketing programs.
Satisfaction of FDA requirements or similar requirements of state, local and foreign
regulatory agencies typically takes several years and the actual time required may vary
substantially based upon the type, complexity and novelty of the product or disease. Government
regulation may delay or prevent marketing of product candidates for new indications for a
considerable period of time and impose costly procedures upon our activities. The FDA or any other
regulatory agency may not grant approvals for new indications for our product candidates on a
timely basis, if at all. Success in early stage clinical trials does not ensure success in later
stage clinical trials. Data obtained from clinical trials is not always conclusive and may be
susceptible to varying interpretations, which could delay, limit or prevent regulatory approval.
Even if a product candidate receives regulatory approval, the approval may be significantly limited
to specific disease states, patient populations and dosages. Further, even after regulatory
approval is obtained, later discovery of previously unknown problems with a product may result in
restrictions on the product or even complete withdrawal of the product from the market. Delays in
obtaining, or
32
failures to obtain, additional regulatory approvals for our products would harm our
business. In addition, we cannot predict what adverse governmental regulations may arise from
future U.S. or foreign governmental action.
The FDAs policies may change and additional government regulations may be enacted, which
could prevent or delay regulatory approval of our product candidates or approval of new indications
for our product candidates. We cannot predict the likelihood, nature or extent of adverse
governmental regulation that might arise from future legislative or administrative action, either
in the U.S. or internationally.
If we or our contract manufacturers fail to comply with applicable regulations, sales of our
products could be delayed and our revenue could be harmed.
Every medical product manufacturer is required to demonstrate and maintain compliance with
cGMP. We and any third party manufacturers or suppliers with whom we enter into agreements will be
required to meet these requirements. Our contract manufacturers will be subject to unannounced
inspections by the FDA and corresponding foreign and state agencies to ensure strict compliance
with cGMP and other applicable government quality control and record-keeping regulations. In
addition, transfer of ownership of products triggers a mandatory manufacturing inspection
requirement from the FDA. We cannot be certain that we or our contract manufacturers will pass any
of these inspections. If we or our contract manufacturers fail one of these inspections in the
future, our operations could be disrupted and our manufacturing and sales delayed significantly
until we can demonstrate adequate compliance. If we or our contract manufacturers fail to take
adequate corrective action in a timely fashion in response to a quality system regulations
inspection, the FDA could shut down our or our contract manufacturers manufacturing operations and
require us, among other things, to recall our products, either of which would harm our business.
Failure to comply with cGMP or other applicable legal requirements can lead to federal seizure
of violative products, injunctive actions brought by the federal government, and potential criminal
and civil liability on the part of a company and its officers and employees. Because of these and
other factors, we may not be able to replace our manufacturing capacity quickly or efficiently in
the event that our contract manufacturers are unable to manufacture our products at one or more of
their facilities. As a result, the sale and marketing of our products could be delayed or we could
be forced to develop our own manufacturing capacity, which would require substantial additional
funds and personnel and compliance with extensive regulations.
Our products will remain subject to ongoing regulatory review even if they receive marketing
approval. If we fail to comply with applicable regulations, we could lose these approvals, and the
sale of our products could be suspended.
Even if we receive regulatory approval to market a particular product candidate, the FDA or
foreign regulatory authority could condition approval on conducting additional and costly
post-approval clinical trials or could limit the scope of approved labeling. For example, to sell
Abbokinase, we are required to continue an ongoing immunogenicity clinical trial that Abbott
Laboratories commenced in 2003. Moreover, the product may later cause adverse effects that limit or
prevent its widespread use, force us to withdraw it from the market or impede or delay our ability
to obtain regulatory approvals in additional countries. In addition, the manufacturer of the
product and its facilities will continue to be subject to FDA review and periodic inspections to
ensure adherence to applicable regulations. After receiving marketing approval, the FDA imposes
extensive regulatory requirements on the manufacturing, labeling, packaging, adverse event
reporting, storage, advertising, promotion and record keeping related to the product. We may not
promote or advertise any future FDA-cleared or approved products for use outside the scope of our
products label or make unsupported promotional claims about the benefits of our products. If the
FDA determines that our claims are outside the scope of our label or are unsupported, it could
require us to revise our promotional claims, correct any prior statements or bring an enforcement
action against us. Moreover, the FDA or other regulatory authorities may bring charges against us
or convict us of violating these laws, and we could become subject to third party litigation
relating to our promotional practices and there could be a material adverse effect on our business.
If we fail to comply with the regulatory requirements of the FDA and other applicable U.S. and
foreign regulatory authorities or discover previously unknown problems with our products,
manufacturers or manufacturing processes, we could be subject to administrative or judicially
imposed sanctions, including:
restrictions on the products, manufacturers or manufacturing processes;
warning letters;
civil or criminal penalties or fines;
33
injunctions;
product seizures, detentions or import bans;
voluntary or mandatory product recalls and publicity requirements;
suspension or withdrawal of regulatory approvals;
total or partial suspension of production; and
refusal to approve pending applications of marketing approval of new drugs or
supplements to approved applications.
If we were subject to any of the foregoing actions by the FDA, our sales could be delayed, our
revenue could decline and our reputation among clinicians, doctors, inventors and research and
academic institutions could be harmed.
Marketing and reimbursement practices and claims processing in the pharmaceutical and medical
device industries are subject to significant regulation in the U.S.
In addition to FDA restrictions on marketing of pharmaceutical products, several other state
and federal laws such as anti-kickback statutes and false claims statutes have been applied to
regulate certain marketing practices in the pharmaceutical and medical device industries in recent
years.
The federal health care program anti-kickback statute prohibits, among other things, knowingly
and willfully offering, paying, soliciting or receiving remuneration to induce or in return for
purchasing, leasing, ordering or arranging for the purchase, lease or order of any health care item
or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs.
This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on
one hand and prescribers, purchasers and formulary managers on the other. Although there are a
number of statutory exemptions and regulatory safe harbors protecting certain common activities
from potential liability, the exemptions and safe harbors are drawn narrowly. Practices that
involve remuneration intended to induce prescribing, purchases or recommendations may be subject to
scrutiny if they do not qualify for an exemption or safe harbor. Our future practices may not in
all cases meet the criteria for safe harbor protection from anti-kickback liability.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be
presented, a false claim for payment to the federal government, or knowingly making, or causing to
be made, a false statement to have a false claim paid. For example, several pharmaceutical and
other health care companies have been prosecuted under these laws for allegedly providing free
product to customers with the expectation that the customers would bill federal programs for the
product. Other companies have been prosecuted for causing false claims to be submitted because of
the companys marketing of the product for unapproved, and thus non-reimbursable, uses. The
majority of states also have statutes or regulations similar to the federal anti-kickback and false
claims laws, which apply to items and services reimbursed under Medicaid and other state programs,
or, in several states, apply regardless of the payor. Sanctions under these federal and state laws
may include civil monetary penalties, exclusion of a manufacturers products from reimbursement
under government programs, criminal fines and imprisonment.
Because of the breadth of these laws and the limited safe harbors, it is possible that some of
our commercial activities in the future could be subject to challenge under one or more of such
laws. Such a challenge could have a material adverse effect on our business.
If we seek regulatory approvals for our products in foreign jurisdictions, we may not obtain any
such approvals.
We may market our products outside the U.S., either with a commercial partner or alone. To
market our products in foreign jurisdictions, we will be required to obtain separate regulatory
approvals and comply with numerous and varying regulatory requirements. The approval procedure
varies among countries and jurisdictions and can involve additional testing, and the time required
to obtain foreign approvals may differ from that required to obtain FDA approval. We have no
experience with obtaining any such foreign approvals. Additionally, the foreign regulatory approval
process may include all of the risks associated with obtaining FDA approval. For all of these
reasons, we may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by
the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and
approval by one foreign regulatory authority does not ensure approval by regulatory authorities in
other foreign countries or jurisdictions or by the FDA. We may not be able to submit applications
for regulatory approvals and may
34
not receive necessary approvals to commercialize our products in
any market. The failure to obtain these approvals could materially adversely affect our business,
financial condition and results of operations.
Risks Related to our Common Stock
We may invest or spend the proceeds from our initial public offering in ways which may not enhance
our operating results or enhance the value of our common stock.
Our management and directors will have broad discretion in the use of the net
proceeds from our initial public offering and could spend the proceeds in ways that do not
necessarily improve our operating results or enhance the value of our common stock. We may also use
a portion of the net proceeds to acquire or invest in complementary businesses, technologies,
services or products. We have no present understandings, commitments or agreements with respect to
any such acquisitions or investments and no portion of the net proceeds from our initial public
offering has been allocated for any specific transaction. Until the net proceeds are used, they
will be placed in investments that do not produce significant income or that may lose value.
Our principal stockholders and management own a significant percentage of our stock and will be
able to exercise significant influence over our affairs.
Our executive officers, current directors and holders of five percent or more of our common
stock hold approximately 40.1% of our outstanding common stock. Consequently, these stockholders
will likely continue to have significant influence over our operations. The interests of these
stockholders may be different than the interests of other stockholders. This concentration of
ownership could also have the effect of delaying or preventing a change in control of our company
or otherwise discouraging a potential acquirer from attempting to obtain control of us, which in
turn could reduce the price of our common stock.
We will incur increased costs as a public company which may make it more difficult to achieve
profitability.
We are subject to the reporting obligations set forth in the Securities Exchange Act of 1934,
as amended. As a public company, we will incur significant legal, accounting, insurance, investor
relations and other expenses that we did not incur as a private company. The disclosures that we
will be required to make will generally involve a substantial expenditure of financial resources.
In addition, the Sarbanes-Oxley Act of 2002, as well as new rules subsequently implemented by the
Securities and Exchange Commission, or SEC, and the NASDAQ Capital Market have required changes in
corporate governance practices of public companies. We expect that full compliance with these new
rules and regulations will significantly increase our legal and financial compliance costs and make
some activities more time-consuming and costly. For example, in connection with becoming a
reporting company, we have created additional board committees and will be required to adopt and
maintain policies regarding internal controls and disclosure controls and procedures. We plan to
retain a consultant to assist us in developing our internal controls to comply with regulatory
requirements and may have to retain additional consultants and employees to assist us with other
aspects of complying with regulatory requirements applicable to public companies. Such additional
reporting and compliance costs may negatively impact our financial results and may make it more
difficult to achieve profitability. The rules and regulations imposed by the SEC and as implemented
under the Sarbanes-Oxley Act may also make it more difficult and expensive for us to obtain
director and officer liability insurance, and we may be required to accept reduced policy limits
and coverage or incur substantially higher costs to obtain the same or similar coverage. To the
extent our earnings suffer as a result of the financial impact of our SEC reporting or compliance
costs, our business could be harmed.
We expect the price of our common stock to be volatile, and purchasers of our common stock could
incur substantial losses.
Our stock price is likely to be volatile. The stock markets in general and the market for
small health care companies in particular have experienced extreme volatility that has often been
unrelated to the operating performance of particular companies. As a result of this volatility,
investors may not be able to sell their common stock at or above the initial public offering price.
The price for our common stock may be influenced by many factors, including:
announcements of technological innovations or new products by us or our competitors;
announcements of the status of FDA review of our products;
the success rate of our discovery efforts, animal studies and clinical trials;
35
developments or disputes concerning patents or proprietary rights, including
announcements of infringement, interference or other litigation regarding these rights;
the willingness of collaborators to commercialize our products and the timing of
commercialization;
changes in our strategic relationships which adversely affect our ability to acquire
or commercialize products;
announcements concerning our competitors or the health care industry in general;
public concerns over the safety of our products or our competitors products;
changes in governmental regulation of the health care industry;
changes in the reimbursement policies of third-party insurance companies or government agencies;
actual or anticipated fluctuations in our operating results from period to period;
variations in our quarterly results;
changes in financial estimates or recommendations by securities analysts;
changes in accounting principles; and
the loss of any of our key scientific or management personnel.
A decline in the market price of our common stock could cause investors to lose some or all of
their investment and may adversely impact our ability to attract and retain employees and raise
capital. In addition, shareholders may initiate securities class action lawsuits if the market
price of our stock drops significantly, which may cause us to incur substantial costs and could
divert the time and attention of our management.
A significant portion of our outstanding common stock may be sold into the market in the near
future. Substantial sales of common stock, or the perception that such sales are likely to occur,
could cause the price of our common stock to decline.
If our existing stockholders sell a large number of shares of common stock or the public
market perceives that existing stockholders might sell shares of common stock, the market price of
our common stock could decline significantly. All of the shares sold in the IPO are freely tradable
without restriction or further registration under the federal securities laws, unless purchased by
our affiliates, as that term is defined in Rule 144 under the Securities Act of 1933. An
aggregate of approximately 7.0 million shares of our common stock outstanding may also be sold
pursuant to Rules 144, 144(k) and 701, subject to the expiration of lock-up agreements. Lock-up
agreements covering approximately 6.0 million of these shares expire in January 2008, and lock-up
agreements covering the remaining approximately 1.0 million shares expire in July 2008.
In addition, holders of an aggregate of approximately 6.1 million shares of common stock and
warrants to purchase an aggregate of approximately 1.0 million shares of common stock have rights
with respect to the registration of their shares of common stock with the SEC. If we register their
shares of common stock following the expiration of the lock-up agreements, they can immediately
sell those shares in the public market.
If we fail to develop and maintain an effective system of internal controls, we may not be able to
accurately report our financial results or prevent fraud; as a result, current and potential
stockholders could lose confidence in our financial reporting, which could harm our business and
the trading price of our common stock.
Effective internal controls are necessary for us to provide reliable financial reports and
effectively prevent fraud. We have not undertaken any efforts to develop a sophisticated financial
reporting system. Section 404 of the Sarbanes-Oxley Act of 2002 will require us, beginning with our
fiscal year 2008, to evaluate and report on our internal controls over financial reporting and will
require our independent registered public accounting firm annually issue their own opinion on our
internal control over financial reporting. Because we operated as a private company until July
2007, we have limited experience attempting to comply with public company obligations, including
Section 404 of the Sarbanes-Oxley Act. The process of strengthening our internal controls and
complying with Section 404 is expensive and time consuming, and requires
36
significant management
attention, especially given that we have not previously undertaken any efforts to comply with the
requirements of Section 404. We plan to retain a consultant to assist us in developing our internal
controls to comply with regulatory requirements and may be required to retain additional
consultants or employees to assist us with other aspects of
complying with regulatory requirements applicable to public companies in the future. The
implementation of compliance efforts with Section 404 will be challenging in the face of our
planned rapid growth to support our operations as well as the establishment of infrastructure to
support our commercial operations. We cannot be certain that the measures we will undertake will
ensure that we will maintain adequate controls over our financial processes and reporting in the
future. Furthermore, if we are able to rapidly grow our business, the internal controls that we
will need will become more complex, and significantly more resources will be required to ensure our
internal controls remain effective. Failure to implement required controls, or difficulties
encountered in their implementation, could harm our operating results or cause us to fail to meet
our reporting obligations. If we or our auditors discover a material weakness, the disclosure of
that fact, even if quickly remedied, could diminish investors confidence in our financial
statements and harm our stock price. In addition, non-compliance with Section 404 could subject us
to a variety of administrative sanctions, including ineligibility for listing on the NASDAQ Capital
Market and the inability of registered broker-dealers to make a market in our common stock.
Anti-takeover defenses that we have in place could prevent or frustrate attempts to change our
direction or management.
Provisions of our amended and restated certificate of incorporation and bylaws and applicable
provisions of Delaware law may make it more difficult or impossible for a third party to acquire
control of us without the approval of our board of directors. These provisions:
limit who may call a special meeting of stockholders;
establish advance notice requirements for nominations for election to our board of
directors or for proposing matters that can be acted on at stockholder meetings;
prohibit cumulative voting in the election of our directors, which would otherwise
permit holders of less than a majority of our outstanding shares to elect directors;
prohibit stockholder action by written consent, thereby requiring all stockholder
actions to be taken at a meeting of our stockholders; and
provide our board of directors the ability to designate the terms of and issue new
series of preferred stock without stockholder approval.
In addition, Section 203 of the Delaware General Corporation Law generally prohibits us from
engaging in any business combination with certain persons who own 15% or more of our outstanding
voting stock or any of our associates or affiliates who at any time in the past three years have
owned 15% or more of our outstanding voting stock. These provisions may have the effect of
entrenching our management team and may deprive investors of the opportunity to sell their shares
to potential acquirers at a premium over prevailing prices. This potential inability to obtain a
control premium could reduce the price of our common stock.
We may become involved in securities class action litigation that could divert managements
attention and harm our business.
The stock market in general, and the NASDAQ Capital Market and the market for
biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations
that have often been unrelated or disproportionate to the operating performance of those companies.
These broad market and health care industry factors may materially harm the market price of our
common stock, regardless of our operating performance. In the past, following periods of volatility
in the market price of a particular companys securities, securities class action litigation has
often been brought against that company. We may become involved in this type of litigation in the
future, regardless of the merits. Litigation often is expensive and diverts managements attention
and resources, which could materially harm our financial condition and results of operations.
We do not intend to pay cash dividends on our common stock in the foreseeable future.
We have never declared or paid any cash dividends on our common stock or other securities, and
we currently do not anticipate paying any cash dividends in the foreseeable future. Instruments
governing any future indebtedness may also contain various covenants that would limit our ability
to pay dividends. Accordingly, our stockholders will not realize a
37
return on their investment
unless the trading price of our common stock appreciates. Our common stock may not appreciate in
value and may not even maintain the price at which investors purchased shares.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Use of Proceeds
Our initial public offering of common stock was effected through a Registration Statement on
Form S-1 (File No. 333-142646) that was declared effective by the Securities and Exchange
Commission on July 25, 2007, which registered an aggregate of 3,450,000 shares of our common stock.
On July 31, 2007, 3,000,000 shares of common stock were sold on our behalf at an initial public
offering price of $5.00 per share, for aggregate gross offering proceeds of $15.0 million, managed
by Maxim Group LLC as sole bookrunner and I-Bankers Securities, Inc. as co-manager. The
underwriters have until September 8, 2007 to exercise an over-allotment option to purchase the
additional 450,000 shares of our common stock. As of the date of this report the underwriters have
not exercised the over-allotment option.
We paid to the underwriters underwriting discounts totaling approximately $1.05 million in
connection with the offering. In addition, we incurred additional costs of approximately $1.6
million in connection with the offering, which when added to the underwriting discounts paid by us,
amounts to total expenses of approximately $2.65 million. Thus, the net offering proceeds to us,
after deducting underwriting discounts and offering expenses, were approximately $12.3 million. No
offering expenses were paid directly or indirectly to any of our directors or officers (or their
associates) or persons owning ten percent or more of any class of our equity securities or to any
other affiliates.
As of August 29, 2007, we had invested the $12.3 million in net proceeds from the offering in
short-term, interest-bearing, investment-grade securities. Through August 29, 2007, we have not
used the net proceeds from the offering. We plan to utilize the net proceeds from the offering in
the following manner:
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|
|
to fund development activities in our SonoLysis programs in ischemic stroke ,
including a Phase I/II clinical trial for SonoLysis+tPA therapy, preclinical safety
studies for our SonoLysis therapy, and manufacturing, additional personnel and material
costs related to these development programs; |
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to fund Abbokinase commercialization, including sales and marketing costs, medical
affairs activities, continuation of our ongoing product stability studies and related
regulatory matters, product storage and labeling, continuation of our ongoing
200-patient immunogenicity study, rebranding, additional personnel and exploring the
regulatory and commercial feasibility of manufacturing additional Abbokinase inventory; |
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|
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to fund research and preclinical development activities of our SonoLysis programs
for additional indications, as well as our NanO2 and other
microbubble technologies; and |
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for working capital and general corporate purposes. |
The amounts we actually expend in these areas may vary significantly from our expectations and will
depend on a number of factors, including developments relating to scientific, regulatory,
competitive and partnering matters. A portion of the net proceeds may be used to partially repay
our $15.0 million secured non-recourse promissory note maturing in December 2007, which would be
reduced to approximately $11.9 million as of June 30, 2007, including accrued interest at the rate
of 6% per annum, after applying the escrowed funds associated with our Abbokinase sales through
June 30, 2007, if we are unable to secure additional significant sales of Abbokinase to our third
party distributors or to refinance the promissory note with Abbott Laboratories. We will use a
portion of the net proceeds from the IPO to repay the promissory note only if, at the time of such
repayment, we anticipate sales of Abbokinase sufficient to replenish our cash resources so as not
to affect our planned expenditures under our then-current operating plan. Additionally, a portion
of the net proceeds may be used to acquire or invest in complementary businesses, technologies,
services or products. We nave no current plans, agreements or commitments with respect to any such
material acquisition or investment, and we are not currently engaged in any negotiations with
respect to any such transaction.
Item 4. Submission of Matters to a Vote of Security Holders.
On April 30, 2007 the company held its Annual Meeting of Stockholders. The following proposal
was the only matter submitted for approval at the meeting:
38
Proposal 1: To elect the following slate of individuals to serve as the directors of the company
until the next annual meeting of stockholders or until each persons successor is duly qualified
and elected:
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Nominees |
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For |
|
Withheld |
Richard Otto |
|
|
3,447,058 |
|
|
|
1,562,071 |
|
Richard Love |
|
|
4,924,243 |
|
|
|
84,886 |
|
Thomas W. Pew |
|
|
4,868,236 |
|
|
|
140,018 |
|
Philip Ranker |
|
|
4,872,622 |
|
|
|
136,517 |
|
James M. Strickland |
|
|
4,872,622 |
|
|
|
136,517 |
|
Evan C. Unger* |
|
|
4,911,117 |
|
|
|
97,137 |
|
Bradford Zakes |
|
|
4,872,611 |
|
|
|
136,517 |
|
|
|
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* |
|
Dr. Unger subsequently resigned from the Companys Board of Directors in May 2007. |
In May 2007, the following groups of our stockholders acted by less-than-unanimous written
consent to approve the following actions in connection with our IPO:
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The holders of at least (i) a majority of the outstanding shares of the companys
voting capital stock (voting together as a single class on an as-if-converted to common
stock basis), (ii) a majority of the outstanding shares of Series B preferred stock,
(iii) a majority of the outstanding shares of Series C preferred stock, (iv)
seventy-five percent (75%) of the outstanding shares of Series A preferred stock,
Series D preferred stock and Series F preferred stock (voting together as a single
class on an as-if-converted to common stock basis), and (v) sixty-six and two-thirds
percent (66-2/3%) of the outstanding shares of Series E preferred stock approved: |
|
§ |
|
The adoption of a Certificate of Amendment to the companys Certificate of
Incorporation to implement a one-for-three reverse stock split of our
outstanding common stock; |
|
|
§ |
|
The adoption of our Fifth Amended and Restated Certificate of Incorporation,
which, among other things, authorized 100,000,000 shares of common stock and
eliminated certain series of existing preferred stock and implemented certain
stockholder protection measures, including the authorization of up to 5,000,000
shares of undesignated preferred stock, to become effective upon the closing of
our IPO; and |
|
|
§ |
|
The adoption of our 2007 Performance Incentive Award Plan to become effective
upon the signing of the underwriting agreement in connection with our IPO. |
|
|
|
The holders of at least 75% of the companys common stock issuable upon conversion
of the outstanding shares of the companys Series A preferred stock, Series D preferred
stock and Series F preferred stock (voting together as a single class on an
as-if-converted to common stock basis) approved: |
|
§ |
|
The filing of a registration statement on Form S-1 with the Securities and
Exchange Commission (the SEC) registering the companys initial public
offering of shares of its common stock; and |
|
|
§ |
|
The appointment of Bradford A. Zakes as a director of the company and the
waiver of protective provisions and notice requirements applicable in connection
with such appointment. |
|
|
|
The holders of at least 75% of the companys common stock issuable upon conversion
of the outstanding shares of the companys Series A preferred stock, Series B preferred
stock, Series C preferred stock, Series D preferred stock and Series F preferred stock
(voting together as a single class on an as-if-converted to common stock basis)
approved: |
|
§ |
|
The waiver of the thirty (30) day prior notice requirement of the companys
intention to file a registration statement with the SEC; |
|
|
§ |
|
The waiver of any notice requirements, rights of first offer and preemptive
rights triggered in connection with the issuance of certain warrants to
purchase shares of the companys common stock. |
|
|
|
The holders of (i) at least seventy-five percent (75%) of the companys outstanding
Series A Preferred Stock and Series D Preferred Stock (voting together as a single
class on an as-if-converted to Common Stock basis); |
39
|
|
|
(ii) at least a majority of the
outstanding shares of Series F Preferred Stock; and (iii) at least fifty percent (50%)
of the outstanding Series E Preferred Stock approved: |
|
§ |
|
The waiver of anti-dilution adjustments triggered by the issuance of the
shares of common stock in the companys IPO and the issuance of certain warrants
to purchase common stock of the company from the holders of the companys Series
A, Series C, Series D, Series E and Series F preferred stock. |
Item 6. Exhibits.
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer |
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer |
|
|
|
32
|
|
Section 1350 Certification of Periodic Financial Report by the Chief
Executive Officer and Chief Financial Officer |
40
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
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|
|
|
IMARX THERAPEUTICS, INC.
|
|
Date: August 29, 2007 |
By: |
/s/ Bradford A. Zakes
|
|
|
|
Bradford A. Zakes, |
|
|
|
President and Chief Executive Officer (Principal Executive Officer) |
|
|
|
|
|
Date: August 29, 2007 |
By: |
/s/ Greg Cobb
|
|
|
|
Greg Cobb, |
|
|
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
|
|
41
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Description of Document |
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer |
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer |
|
|
|
32
|
|
Section 1350 Certification of Periodic Financial Report by the
Chief Executive Officer and Chief Financial Officer |