Filed by Bowne Pure Compliance
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 September 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
(Address of Principal Executive Offices)
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85719-6803
(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 þ NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer o Accelerated Filer 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 November 5, 2007 |
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Common Stock $0.0001 par value
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10,046,683 |
PART 1. FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements.
ImaRx Therapeutics, Inc.
Consolidated Balance Sheets
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September 30 |
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December 31 |
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2007 |
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2006 |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
16,039,567 |
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$ |
4,256,399 |
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Restricted cash |
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4,764,264 |
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Accounts receivable, net |
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491,645 |
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575,610 |
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Inventory |
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11,308,937 |
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16,059,730 |
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Inventory subject to return |
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3,471,775 |
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445,245 |
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Prepaid expenses and other |
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595,773 |
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539,048 |
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Total current assets |
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36,671,961 |
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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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1,176,278 |
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916,966 |
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Intangible assets, net |
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1,808,333 |
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2,500,000 |
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Total assets |
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$ |
39,656,572 |
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$ |
25,292,998 |
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LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable |
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$ |
1,086,042 |
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$ |
1,413,032 |
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Accrued expenses |
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916,166 |
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850,846 |
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Accrued chargebacks and administrative fees |
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2,377,716 |
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384,664 |
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Deferred revenue |
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6,698,647 |
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955,263 |
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Notes payable |
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16,290,000 |
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15,615,000 |
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Total current liabilities |
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27,368,571 |
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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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27,368,571 |
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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, no shares authorized, issued, or outstanding at
September 30, 2007 and 2,302,053 shares authorized and
2,291,144 shares issued and outstanding at December 31, 2006
at carrying value including accrued dividends |
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9,328,747 |
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Series B 7% Mandatorily Redeemable Convertible Preferred Shares,
$.0001 par, no shares authorized, issued, or outstanding at
September 30, 2007 and 593,266 shares authorized, issued and
outstanding at December 31, 2006 |
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9,491,622 |
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Series C Mandatorily Redeemable Convertible Preferred Shares,
$.0001 par, no shares authorized, issued, or outstanding at
September 30, 2007 and 285,714 shares authorized, issued and
outstanding at December 31, 2006 |
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1,945,563 |
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Series D 8% Redeemable Convertible Preferred Shares,
$.0001 par, no shares authorized, issued, or outstanding at
September 30, 2007 and 438,232 shares authorized, issued and
outstanding at December 31, 2006 at carrying value including
accrued dividends |
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1,562,007 |
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Series F 8% Redeemable Convertible Preferred Shares,
$.0001 par, no shares authorized, issued, or outstanding at
September 30, 2007 and 4,000,000 shares authorized and
2,835,000 shares issued and outstanding at December 31, 2006
at carrying value including accrued dividends |
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13,535,559 |
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Total redeemable convertible preferred stock |
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35,863,498 |
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Stockholders equity (deficit): |
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Series E Redeemable Convertible Preferred Shares, $.0001 par: |
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No shares authorized, issued, or outstanding at September 30,
2007 and 1,000,000 shares authorized, issued and outstanding
at December 31, 2006 |
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4,000,000 |
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Common stock, $.0001 par: |
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100,000,000 shares authorized, 10,046,683 shares issued and
outstanding at September 30, 2007 (unaudited) and 70,000,000
shares authorized, 2,606,739 shares issued and outstanding at
December 31, 2006 |
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1,003 |
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260 |
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Additional paid-in capital |
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91,255,885 |
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28,619,883 |
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Accumulated deficit |
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(78,968,887 |
) |
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(62,628,304 |
) |
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Total stockholders equity (deficit) |
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12,288,001 |
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(30,008,161 |
) |
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Total liabilities and stockholders equity (deficit) |
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$ |
39,656,572 |
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$ |
25,292,998 |
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See accompanying notes.
3
ImaRx Therapeutics, Inc.
Consolidated Statements of Operations
(Unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30 |
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September 30 |
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2007 |
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2006 |
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2007 |
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2006 |
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(Unaudited) |
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(Unaudited) |
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Revenues: |
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Product sales, net |
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$ |
2,291,225 |
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$ |
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$ |
5,368,837 |
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$ |
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Research and development |
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58,160 |
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192,840 |
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340,810 |
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621,601 |
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Total operating revenue |
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2,349,385 |
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192,840 |
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5,709,647 |
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621,601 |
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Costs and expenses: |
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Cost of product sales |
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1,108,606 |
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2,528,518 |
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Research and development |
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2,140,353 |
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2,418,415 |
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5,282,894 |
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6,493,461 |
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General and administrative |
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1,800,528 |
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1,408,409 |
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4,382,447 |
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4,782,545 |
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Total cost and expenses |
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5,049,487 |
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3,826,824 |
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12,193,859 |
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11,276,006 |
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Operating loss |
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(2,700,102 |
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(3,633,984 |
) |
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(6,484,212 |
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(10,654,405 |
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Interest and other income, net |
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258,834 |
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101,842 |
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389,482 |
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317,638 |
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Interest expense |
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(225,000 |
) |
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(450,000 |
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(675,000 |
) |
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(1,065,000 |
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Gain on extinguishment of debt |
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218,856 |
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Net loss |
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(2,666,268 |
) |
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(3,982,142 |
) |
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(6,550,874 |
) |
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(11,401,767 |
) |
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Deemed dividend from beneficial conversion
feature for Series F redeemable convertible
preferred stock |
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(13,841,471 |
) |
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(13,841,471 |
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Accretion of dividends on preferred stock |
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(425,617 |
) |
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(867,232 |
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(725,847 |
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Reversal of accretion of dividends on
preferred stock not paid |
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4,918,994 |
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4,918,994 |
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Net loss attributed to common stockholders |
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$ |
(11,588,745 |
) |
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$ |
(4,407,759 |
) |
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$ |
(16,340,583 |
) |
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$ |
(12,127,614 |
) |
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Net loss per share: |
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Basic and diluted |
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$ |
(1.43 |
) |
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$ |
(1.69 |
) |
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$ |
(3.66 |
) |
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$ |
(4.67 |
) |
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Shares used in computing net loss per share: |
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Basic and diluted |
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8,105,910 |
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2,605,897 |
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4,460,148 |
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2,597,238 |
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See accompanying notes.
4
ImaRx Therapeutics, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
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Nine Months Ended September 30 |
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2007 |
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2006 |
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Operating activities |
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Net loss |
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$ |
(6,550,874 |
) |
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$ |
(11,401,767 |
) |
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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899,609 |
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692,350 |
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Stock-based compensation |
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378,600 |
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668,050 |
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Restricted stock compensation |
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192,501 |
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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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3,215 |
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Changes in operating assets and liabilities: |
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Inventory |
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4,750,793 |
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(4,184,110 |
) |
Inventory subject to return |
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(3,026,530 |
) |
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Accounts receivable |
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83,965 |
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Prepaid expenses and other |
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(56,725 |
) |
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(208,997 |
) |
Accounts payable |
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(326,990 |
) |
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|
294,517 |
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Accrued expenses and other liabilities |
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2,733,372 |
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1,326,324 |
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Deferred revenue |
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5,743,384 |
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Net cash provided by (used in) operating activities |
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4,602,249 |
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(12,636,509 |
) |
Investing activities |
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Purchase of property and equipment |
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(467,254 |
) |
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(322,115 |
) |
Purchase of intangibles |
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(825,000 |
) |
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Net cash used in investing activities |
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(467,254 |
) |
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(1,147,115 |
) |
Financing activities |
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Deferred financing costs |
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(1,539,120 |
) |
Increase in restricted cash for note payable |
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(4,764,264 |
) |
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Proceeds from issuance of common stock |
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12,412,437 |
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|
56,101 |
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Net proceeds from issuance of preferred stock |
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12,968,559 |
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Net cash provided by financing activities |
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7,648,173 |
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11,485,540 |
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Net increase in cash and cash equivalents |
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11,783,168 |
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(2,298,084 |
) |
Cash and cash equivalents at the beginning of the period |
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4,256,399 |
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|
8,513,387 |
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Cash and cash equivalents at the end of the period |
|
$ |
16,039,567 |
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$ |
6,215,303 |
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Supplemental Schedule of Noncash Investing and Financing Activities: |
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Accretion of undeclared dividends on Series A/D/F redeemable
convertible preferred stock |
|
$ |
867,232 |
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$ |
725,847 |
|
Reversal of accretion of undeclared dividends on Series A/D/F redeemable convertible
preferred stock not paid |
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(4,918,994 |
) |
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|
Deemed dividend from beneficial conversion feature for Series F redeemable convertible
preferred stock |
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|
13,841,471 |
|
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Conversion of convertible preferred stock to common stock upon initial public offering |
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|
40,730,730 |
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Fair value of stock warrants issued in connection with Companys initial public offering |
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|
1,179,616 |
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Fair value of stock warrants issued for consulting services and placement agreement
amendment |
|
|
|
|
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|
173,909 |
|
Note issued for acquisition of technology and related inventory and intangibles |
|
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|
15,000,000 |
|
See accompanying notes.
5
ImaRx Therapeutics, Inc.
Notes to Consolidated Financial Statements
September 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 of America 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 nine months ended September 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. Reclassifications
Certain prior period amounts have been reclassified to the extent deemed necessary in order to
conform to the current period presentation.
4. 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 SFAS No. 157, Fair Value Measurements. SFAS 157 defines
fair value, establishes a framework for measuring fair value, and expands disclosures about fair
value measurements. SFAS 157 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.
6
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.
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 is not expected to have a material effect on the Companys
financial position or results of operations.
5. Restricted Cash
Restricted cash consists of cash pledged as repayment of debt to secure the guarantees
described in Note 11.
6. 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.
Abbokinase® (urokinase) is the Companys only commercially available FDA approved product.
Abbokinase is a thrombolytic or clot-dissolving agent approved for the treatment of acute massive
pulmonary embolism. As of September 30, 2007, approximately 29% of the vials in inventory or
approximately $4.2 million in inventory value, are labeled and will expire at various times up to
August 2009. The remaining approximately 71% of the vials held by the Company in inventory or
approximately $10.6 million in inventory value, are unlabeled and based on current stability data
are not saleable after October 2007.
The Company has an ongoing stability program to support expiration date extensions for the
unlabeled vials. The Company believes that recent results from its ongoing stability program
support extending the expiration dates of its unlabeled inventory to between July and September
2009. The Company expects to submit a lot release request for inventory to be labeled with the new
expiration dates in the fourth quarter 2007 and receive lot release approval from the FDA by the
first quarter of 2008. If the Company is successful in extending the expiration dates of its
unlabeled inventory, the Company intends to continue the stability program after the first quarter
of 2008 to potentially enable further expiration extensions for unlabeled vials of inventory.
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.
7
7. 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 the Companys 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 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.
8. 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 123R, 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:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, 2007 |
|
|
September 30, 2006 |
|
|
Expected dividend yield |
|
|
0.00% |
|
|
|
0.00% |
|
Expected stock price volatility |
|
|
75.0% |
|
|
|
75.0% |
|
Risk free interest rate |
|
|
4.77% |
|
|
|
4.92% |
|
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.
8
Stock Options
The Company has two equity incentive plans; the 2000 Stock Plan (2000 Plan) and the 2007
Performance Incentive Plan (2007 Plan). The 2000 Stock Plan was terminated immediately following
the closing of the Companys initial public offering on July 31, 2007. No additional grants will
be issued from the 2000 Stock Plan. The 2007 Plan became effective July 25, 2007, the effective
date of the Companys initial public offering.
A summary of activity under the Companys stock plans is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted-Average |
|
|
|
|
|
|
|
|
|
|
Exercise Price |
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Options |
|
|
Per Share |
|
|
Exercise Price |
|
|
Contractual Term |
|
|
Intrinsic Value |
|
Balance at December 31, 2006 |
|
|
630,351 |
|
|
$ |
2.50-30.00 |
|
|
$ |
18.15 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
317,155 |
|
|
|
3.81-5.00 |
|
|
|
4.73 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(315 |
) |
|
|
2.50 |
|
|
|
2.50 |
|
|
|
|
|
|
|
|
|
Canceled |
|
|
(157,991 |
) |
|
|
2.50-27.50 |
|
|
|
15.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2007 |
|
|
789,200 |
|
|
$ |
2.50-30.00 |
|
|
$ |
13.39 |
|
|
|
8.23 |
|
|
$ |
266,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at September 30, 2007 |
|
|
535,378 |
|
|
$ |
2.50-30.00 |
|
|
$ |
17.47 |
|
|
|
7.42 |
|
|
$ |
266,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock Awards
On July 31, 2007, the board of directors was issued a total of 38,500 shares of restricted
stock at a grant date fair value of $5.00 per share for services previously rendered for the board.
The expense was recorded in the consolidated statement of operations under general and
administrative expense.
9. Stockholders Equity (Deficit)
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.
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 cash proceeds of
approximately $12.4 million, net of underwriting discounts and commissions and offering expenses
or $11.2 million including the noncash fair value of warrants issued in connection with the Companys
IPO. 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 and the 3,000,000 shares sold in the initial public offering resulted in the Company
having 10,008,183 shares of common stock outstanding upon completion of the initial public offering
in July 2007.
The per share conversion rate of Series F preferred stock (Series F) was variable and was
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 three months
ended September 30, 2007, a deemed dividend on the conversion of preferred stock of $13.8 million
was recorded on the Companys consolidated statement of operations. The exchange of common shares
of stock for shares of Series F preferred stock resulted in the issuance of 2,768,294 shares of the
Companys common stock on July 25, 2007.
9
10. 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 September 30, |
|
|
Nine months Ended September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net loss attributed to common stockholders |
|
$ |
(11,588,745 |
) |
|
$ |
(4,407,759 |
) |
|
$ |
(16,340,583 |
) |
|
$ |
(12,127,614 |
) |
Basic and diluted weighted average shares outstanding |
|
|
8,105,910 |
|
|
|
2,605,897 |
|
|
|
4,460,148 |
|
|
|
2,597,238 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
($ |
1.43 |
) |
|
($ |
1.69 |
) |
|
($ |
3.66 |
) |
|
($ |
4.67 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
Three and Nine Months Ended |
|
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
Convertible preferred stock |
|
|
|
|
|
|
4,401,129 |
|
Stock options |
|
|
789,200 |
|
|
|
1,804,103 |
|
Warrants |
|
|
1,023,913 |
|
|
|
352,324 |
|
11. 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 to 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 original due date of the note was December 31, 2007 and is now March 31, 2008 (See Note 13).
The Note 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.
12. 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 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.
10
13. Subsequent Events
On October 25, 2007, the Company signed a Note Extension and Amendment Agreement with Abbott
Laboratories and the escrow agent. In this Agreement, Abbott Laboratories agreed to extend the due
date of the note described in Note 11 to March 31, 2008, and the Company instructed the escrow
agent to transfer the funds held in escrow of approximately $4.8 million to Abbott Laboratories in payment of
accrued interest through the transaction date of approximately
$1.4 million and principal of approximately $3.4 million. The
principal amount outstanding on the note upon completion of this
transaction is approximately $11.6 million.
The Company has an ongoing stability program to support expiration date extensions for its
unlabeled vials of Abbokinase inventory. The Company believes that recent results from its ongoing
stability program support extending the expiration dates of its unlabeled inventory to between July
and September 2009. The Company expects to submit to the FDA a lot release request for inventory to be labeled
with the new expiration dates in the fourth quarter 2007 and receive lot release approval from the
FDA by the first quarter of 2008. If the Company is successful in extending the expiration dates
of its unlabeled inventory, the Company intends to continue the stability program after the first
quarter of 2008 to potentially enable further expiration extensions for unlabeled vials of
inventory.
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
September 30, 2007, we had received aggregate net proceeds of approximately $14.4 million from
sales of our commercial product Abbokinase to our wholesalers and customers, and we had deposited
approximately $4.8 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 September 30, 2007, we accumulated
a deficit from operations of approximately $79.0 million. We have funded our operations to date
primarily through our initial registered public offering of shares of our common stock, 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 September 30,
2007, we had received net proceeds of approximately $58.0 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 repossessed the assets in accordance with
its security interest and forgave 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.
12
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.
We completed an initial public offering in July 2007. 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 $12.4 million, net of underwriting discounts and commissions and offering expenses
or $11.2 million as adjusted by the noncash fair value of warrants issued in connection with the
Companys IPO.
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. As
of September 30, 2007, we had received aggregate net proceeds of approximately $14.4 million from
sales of Abbokinase to our wholesalers and customers, and we had deposited approximately
$4.8 million into an escrow account as security for repayment of our $15.0 million promissory note
due in December 2007. On October 25, 2007, we signed a Note Extension and Amendment Agreement with
Abbott Laboratories and the escrow agent. In this Agreement, Abbott Laboratories agreed to extend
the due date of the note to March 31, 2008, and we instructed the escrow agent to transfer the
funds held in escrow of approximately $4.8 million to Abbott Laboratories in payment of accrued interest through
the transaction date of approximately $1.4 million and principal
of approximately $3.4 million. The principal amount
outstanding on the note upon completion of this transaction is
approximately $11.6 million.
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. We have received the results
from our ongoing Abbokinase stability program that we believe demonstrate that our inventory is
within the specifications previously approved by the FDA and that these results will be sufficient
to extend the expiration dates of our unlabeled inventory to between July and September 2009. We
expect to submit a lot release request for inventory to be labeled with the new expiration dates in
the fourth quarter 2007 and receive lot release approval from the FDA by the first quarter of 2008.
If we are successful in extending the expiration dates of our unlabeled inventory, we intend to
continue the stability program after the first quarter of 2008 to potentially enable further
expiration extensions for unlabeled vials of inventory.
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 September 30, 2007, we had deferred revenue of approximately $6.7 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.
13
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 SonoLysisTM 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.
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. We do not expect any of
our product candidates to be commercially available in major markets before 2011.
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, public reporting
and corporate compliance, 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 have incurred
and will continue to incur additional expenses in the areas of
legal, accounting and corporate governance as a public reporting company. These include 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 on-going clinical trial costs and previous costs associated with transitioning to a
public reporting company. 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 May 4,
2007.
Inventory
Inventory is comprised of finished goods and is stated at the lower of cost or market value.
Abbokinase is the Companys only commercially available FDA approved product.
Abbokinase is a thrombolytic or clot-dissolving agent approved 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. As of September 30, 2007, approximately 29%
of the vials in inventory or approximately $4.2 million in inventory value, are labeled and will
expire at various times up to August 2009. The remaining approximately 71% of the vials held by us
in inventory or approximately $10.6 million in inventory value, are unlabeled and based on current
stability data are not saleable after October 2007.
14
We have an ongoing stability program to support expiration date extensions for the unlabeled
vials. We believe that recent results from our ongoing stability program support extending the
expiration dates of our unlabeled inventory to between July and September 2009. We expect to submit
a lot release request for inventory to be labeled with the new expiration dates in the fourth
quarter 2007 and receive lot release approval from the FDA by the first quarter of 2008. If we
are successful in extending the expiration dates of its unlabeled inventory, we intend to continue
the stability program after the first quarter of 2008 to potentially enable further expiration
extensions for unlabeled vials of inventory.
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, 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 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.
15
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.
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 123R, 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 123R, 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 September 30, 2006 Compared to 2007
Product Sales, Research and Development Revenue. Our revenue-producing activities during the
third quarter of 2006 and 2007 consisted of sales of Abbokinase which commenced in October 2006,
and services provided under research grants and contracts. Our total revenues increased from
approximately $0.2 million in the third quarter of 2006 to
approximately $2.3 million in the third quarter of
2007, primarily as a result of our commencement of sales of
Abbokinase which accounted for approximately $2.3 million of our revenue in the third quarter of 2007.
Cost of Product Sales. Cost of product sales was approximately $1.1 million in the third
quarter of 2007. There was no cost of product sales for the third 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 $2.4 million to approximately $2.1 million in the third quarter of 2006 and 2007,
respectively. This decrease was principally a result of decreased outside contract work performed
on grants and pre-clinical studies as well as a decrease in staff and consulting expenses,
partially offset by increased clinical trial expenses.
16
General and Administrative Expenses. General and administrative expenses increased from
approximately $1.4 million to approximately $1.8 million in the third quarter of 2006 and 2007,
respectively. This increase was principally a result of an increase in SFAS 123R related expense,
increased fees to the board of directors and restricted stock issued to the board of directors upon
the IPO and increased administrative staff expenses.
Interest and Other Income. Interest and other income was approximately $0.1 million in the
third quarter 2006 and approximately $0.3 million in the third quarter 2007. The increase is due to the increase
in the cash balance from the proceeds of our IPO.
Interest
Expense. Interest expense decreased from approximately
$0.5 million to approximately $0.2 million in the third
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.
Nine Months Ended September 30, 2006 Compared to 2007
Product Sales, Research and Development Revenue. Our revenue-producing activities during the
nine month periods ending September 30, 2006 and 2007 consisted of sales of Abbokinase which
commenced in October 2006, and services provided under research grants and contracts. Our total
revenues increased from approximately $0.6 million for the nine month period ended September 30,
2006 to approximately $5.7 million for the same period in 2007, primarily as a result of our commencement of
sales of Abbokinase which accounted for approximately $5.4 million of our revenue in 2007. Our grant and other
revenue decreased from approximately $0.6 million for the nine month period ended September 30,
2006 to approximately $0.3 million for the same period in 2007, primarily due to the completion of
work under a grant in the second quarter of 2007.
Cost of Product Sales. Cost of product sales was approximately $2.5 million for the nine
month period ended September 30, 2007. There was no cost of product sales for the same period in
2006 as we acquired our commercialized product in 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 $6.5 million for the nine month period ended September 30, 2006 to approximately
$5.3 million for the same period in 2007. This decrease was principally a result of reduced
headcount 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,
partially offset by increased clinical trial expenses.
General and Administrative Expenses. General and administrative expenses decreased from
approximately $4.8 million for the nine month period ended September 30, 2006 to approximately
$4.4 million for the same period in 2007. This decrease was principally a result of our legal and consulting expenses
that were capitalized upon the completion of the IPO in 2007 but were expensed after the unsuccessful IPO attempt in 2006, as well as performing more services
in-house, partially offset by increase in SFAS 123R related expense, increased fees to the board of
directors and restricted stock issued to the board of directors upon the IPO and increased
administrative staff expenses.
Interest and Other Income. Interest and other income increased from approximately
$0.3 million for the nine month period ended September 30, 2006 to approximately $0.4 million for
the same period in 2007, as a result of a higher cash balance primarily from the proceeds of our
IPO.
Interest Expense. Interest expense decreased from approximately $1.1 million for the nine
month period ended September 30, 2006 to approximately $0.7 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.
17
Liquidity and Capital Resources
Sources of Liquidity
We have incurred losses since our inception. At September 30, 2007 we had an accumulated
deficit of approximately $79.0 million. We have historically financed our operations principally
through the public offering and 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, $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 September 2005,
or the $15.0 million secured non-recourse note that we issued to acquire Abbokinase and related
assets in April 2006. At September 30, 2007, we had approximately $16.0 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
$12.4 million, net of underwriting discounts commissions and offering expenses or $11.2 million as
adjusted by the noncash fair value of warrants issued by the Company upon the IPO. 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
September 30, 2007, we had received aggregate net proceeds of approximately $14.4 million from
sales of Abbokinase to our wholesalers and customers, of which approximately $4.8 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. On October
25, 2007, we signed a Note Extension and Amendment Agreement with Abbott Laboratories and the
escrow agent. In this Agreement, Abbott Laboratories agreed to extend the due date of the note to
March 31, 2008, and we instructed the escrow agent to transfer the funds held in escrow of approximately $4.8
million to Abbott Laboratories in payment of accrued interest through the transaction date of approximately $1.4
million and principal of approximately $3.4 million. The principal amount outstanding on the note upon
completion of this transaction is approximately $11.6 million. 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 $11.6 million note is repaid.
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 current stability
data as of September 30, 2007, approximately 71% of our inventory of 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 have an ongoing
stability program to support expiration date extensions for the unlabeled vials. We believe the recent
results from our ongoing stability program support extending the
expiration dates of our unlabeled inventory to between July and September 2009. Once labeled, we cannot extend the expiration date of the vials labeled.
If the FDA objects to the methods or results of the stability testing program, we estimate
that approximately 71% of our vials of Abbokinase that we expect hospitals to purchase, or
approximately $10.6 million in inventory value out of the total of approximately $14.8 million carried at
September 30, 2007, is at risk of being written off. 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. We expect to submit a lot
release request for inventory to be labeled with the new expiration dates in the fourth quarter
2007 and receive lot release approval from the FDA by the first quarter of 2008.
18
If we are successful in extending the expiration dates of our unlabeled inventory, we intend to
continue the stability program after the first quarter of 2008 to potentially enable further
expiration extensions for unlabeled vials of inventory. 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 $20.0 million purchase price for
Abbokinase as follows:
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Asset |
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Estimated Value |
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Inventory |
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$ |
16.7 million |
Abbokinase trade name |
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$ |
0.5 million |
Other identifiable intangibles |
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$ |
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 29% 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 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, a value of approximately $14.8 million as of September 30, 2007,
approximately 29% of these vials, or approximately $4.2 million in inventory value, is available
for sale without risk of being written off and approximately 71% of these vials, or approximately
$10.6 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 Used in or Provided by Operating Activities. Net cash used in operating activities was
approximately $12.6 million for the nine months ended September 30, 2006, whereas the net cash
provided by operating activities was approximately $4.6 million for the equivalent period in 2007.
The net cash used in the nine months ended September 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 by
operating activities in the nine months ended September 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 approximately $0.5 million for the nine months ended September 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 nine months ended September 30, 2006 also includes the purchase of intangibles
as part of the Abbokinase acquisition.
Net Cash Provided by Financing Activities. Net cash provided by financing
activities was approximately $11.5 million for the nine months ended September 30, 2006 and
approximately $7.6 million for the same period in 2007. Net cash provided by financing activities for the nine
months ended September 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 approximately $1.5 million. Net cash provided by financing activities for the nine months
ended September 30, 2007 was primarily attributable to the initial public offering in July offset
by approximately $4.8 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.
19
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 meet our anticipated cash requirements at least until the third quarter of
2008, assuming sales of Abbokinase are sufficient to repay the $11.6 million nonrecourse note due
March 31, 2008 or we are able to refinance this note. As of September 30, 2007, we had received
aggregate net proceeds of approximately $14.4 million from sales of Abbokinase to our wholesalers
and customers, of which approximately $4.8 million has been paid to Abbott Laboratories. These
vials have expiration dates ranging from December 2008 to August 2009.
Our ability to refinance, or repay our $11.6 million secured non-recourse note due to Abbott
Laboratories on March 31, 2008, utilizing 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, however, depend on numerous factors, including:
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the timing, scope and results of our preclinical studies and clinical trials; |
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the timing and amount of revenue from sales of Abbokinase; |
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the timing and amount of revenue from grants and other sources; |
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the timing of initiation of manufacturing for our product candidates; |
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the timing of, and the costs involved in, obtaining regulatory approvals; |
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our ability to establish and maintain collaborative relationships; |
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personnel, facilities and equipment requirements; and |
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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, including proceeds from the IPO, 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.
20
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 of 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 September 30, 2007
that has materially affected, or is reasonably likely to materially affect, our internal control
over financial reporting.
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 information sets forth material changes from the risk factors we previously
disclosed in our Quarterly Report on Form 10-Q for the second quarter 2007. These risks, 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
including those previously disclosed in our filings with the SEC as well as those not presently
known to us or those 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
September 30, 2007, we had received aggregate net proceeds of approximately $14.4 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 nine months ended
September 30, 2006 and 2007 we had net losses attributable to common stockholders of approximately
$12.1 million and $16.3 million, respectively. At September 30, 2007, we had an accumulated deficit
of approximately $79.0 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:
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market and sell our sole commercial product, Abbokinase, or any of our
product candidates if we ever obtain regulatory approval for their sale; |
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obtain regulatory approval for SonoLysis+tPA therapy, SonoLysis
therapy and other product candidates; |
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obtain commercial quantities of our products after approval at
acceptable cost levels; and |
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enter into strategic partnerships for some of our product candidates. |
21
We anticipate that our expenses will increase substantially in the next several years as a
result of:
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research and development programs, including significant requirements
for clinical trials, preclinical testing, contract manufacturing, and potential
regulatory submissions; |
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developing additional infrastructure and hiring additional management
and other employees to support the anticipated growth of our development and
regulatory activities; |
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regulatory submissions and commercialization activities; |
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additional costs for intellectual property protection and
enforcement; and |
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expenses as a result of being a public company. |
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 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. Recently, the labels of certain microbubbles
currently being commercialized as a contrast agent for use in echocardiography were revised by the
FDA to include a black-box warning with respect to certain serious cardiopulmonary reactions,
including fatalities observed when the bubbles were administered during echocardiography. One of
the microbubbles marketed under the brand name Definity® is similar in composition to the MRX-801
microbubble we are currently testing in our Phase I/II Tucson clinical trial. As a result, our
MRX-801 microbubble, if approved, may receive a black-box label as well which could negatively
impact use of our product by physicians and may require us to conduct additional clinical tests
which would increase our development costs and may delay commercialization of our product.
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:
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the timing and scope of regulatory approvals of our products and market entry compared
to competitive products; |
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the safety and efficacy of our products, including any inconveniences in
administration, as compared to alternative treatments; |
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the rate of adoption of our products by hospitals, doctors and nurses and acceptance
by the health care community; |
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the product labeling and marketing claims permitted or required by regulatory agencies
for each of our products; |
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the competitive features of our products, including price, as compared to other
similar products; |
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the availability of sufficient third party coverage or reimbursement for our products; |
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the extent and success of our sales and marketing efforts; and |
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possible unfavorable publicity concerning our products or any similar products. |
If our products are not commercialized, our business will be materially harmed.
22
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; Garen Manvelian, our Vice
President Clinical and 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. 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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Recent Sales of Unregistered Securities
During the period beginning July 1, 2007 and ending September 30, 2007, we sold the following
securities that were not registered under the Securities Act:
1. |
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On July 31, 2007, we granted stock options to certain employees under our 2000 Stock Plan
covering an aggregate of 233,321 shares of common stock, at an exercise price of $5.00 per
share. |
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2. |
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On July 31, 2007, we granted 38,500 shares of restricted stock to certain current and former
directors under our 2000 Stock Plan for services previously rendered on our board. |
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On July 31, 2007, in connection with the underwriting agreement for our initial public
offering completed on July 31, 2007, we issued Maxim Group LLC a warrant to purchase 175,000
shares of common stock, at an exercise price of $5.75 per share. |
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4. |
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On July 31, 2007, in connection with an agreement with a placement agent related to prior
exempt offers and sales of our securities, we issued warrants to purchase 496,589 shares of
common stock to certain stockholders, at an exercise price of $5.75 per share. |
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On September 7, 2007, we granted stock options to our chief executive officer, chief
financial officer, and certain other employees under our 2007 Performance Incentive Plan
covering an aggregate of 53,834 shares of common stock, at an exercise price of $4.05 per
share. |
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On September 10, 2007, we granted stock options to our chief medical officer under our 2007
Performance Incentive Plan covering an aggregate of 30,000 shares of common stock, at an
exercise price of $3.81 per share. |
The issuances of securities described in items (1) through (6) above were exempt from
registration under Section 4(2) of the Securities Act as transactions by an issuer not involving a
public offering. The recipients of the securities in each of these transactions represented their
intention to acquire the securities for investment only and not with view to or for sale in
connection with any distribution thereof and appropriate legends were affixed to the securities
issued in such transactions. We intend to file a registration statement on Form S-8 covering all
of the shares of common stock issuable upon exercise of options granted pursuant to our 2000 Stock
Plan and our 2007 Performance Incentive Plan.
No underwriters were used in connection with the foregoing issuances of securities.
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Use of Proceeds
Our initial public offering of common stock was effected through a Registration Statement on
Form S-1 (File No. 333-142646), which was declared effective by the Securities and Exchange
Commission on July 25, 2007.
We received net proceeds of $12.4 million from the offering. As of September 30, 2007, we had
invested $12.4 million of the net proceeds from the offering in short-term, interest-bearing,
investment-grade securities and have not used any of the net proceeds to date. We expect to use
the offering proceeds in the following manner:
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to fund development activities in our SonoLysis programs in ischemic stroke; |
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to fund Abbokinase commercialization activities; |
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to fund research and preclinical development activities; and |
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working capital and other 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 actual results of our clinical trials, operating
costs, capital expenditures.
Item 5. Other Information.
In October 2007 we entered into a research collaboration with Royal Philips Electronics to
evaluate Philips ultrasound technology as part of our SonoLysis drug development program. Under the
agreement, Philips Medical Systems division will provide ultrasound devices and technical
assistance to us during laboratory and preclinical studies. The objective of the collaboration is
to determine the optimal ultrasound parameters to use with our proprietary MRX-801 microbubble
technology. The agreement includes a mutual exclusivity clause during the term of the
collaboration. Following completion of the research program, there is an exclusive negotiation
period to discuss future development and commercialization of the technology developed under the
collaboration.
Item 6. Exhibits.
(a) Exhibits:
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Exhibit |
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Number |
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Description of Document |
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31.1
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Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer |
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31.2
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Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer |
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32
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Section 1350 Certification of Periodic Financial Report by the Chief
Executive Officer and Chief Financial Officer |
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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.
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Date: November 8, 2007 |
By: |
/s/ Bradford A. Zakes
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Bradford A. Zakes, |
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President and Chief Executive Officer (Principal Executive Officer) |
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Date: November 8, 2007 |
By: |
/s/ Greg Cobb
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Greg Cobb, |
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Chief Financial Officer (Principal Financial and Accounting Officer) |
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25
EXHIBIT INDEX
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Exhibit |
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Number |
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Description of Document |
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31.1
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Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer |
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31.2
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Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer |
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32 |
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Section 1350 Certification of Periodic Financial Report by the
Chief Executive Officer and Chief Financial Officer |
26