Neoprobe Corporation 10QSB
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
------------------------------------------------------
FORM 10-QSB
(Mark One)
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x |
QUARTERLY REPORT UNDER 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 |
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT |
For
the transition period from to to
Commission
file number 0-26520
(Exact name of small business issuer as specified in its charter)
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Delaware
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31-1080091 |
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.) |
425 Metro Place North, Suite 300, Dublin, OH 43017-1367
(Address of principal executive offices)
(Issuers telephone number)
(Former name, former address and former fiscal year, if changed since last report)
Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the
Exchange Act during the past 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes
x No o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
o
No x
State the number of shares outstanding of each of the issuers classes of common equity, as of the
latest practicable date: 66,884,202 shares of common stock, par value $.001 per share (as of the
close of business on November 9, 2007).
Transitional Small Business Disclosure Format (Check one):
Yes
o
No x
NEOPROBE CORPORATION and SUBSIDIARIES
INDEX
2
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
Neoprobe Corporation and Subsidiaries
Consolidated Balance Sheets
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ASSETS |
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September 30, |
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December 31, |
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2007 |
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2006 |
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(unaudited) |
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Current assets: |
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|
|
|
|
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Cash |
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$ |
1,219,101 |
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$ |
2,502,655 |
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Accounts receivable, net |
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1,387,453 |
|
|
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1,246,089 |
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Inventory |
|
|
1,024,966 |
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1,154,376 |
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Prepaid expenses and other |
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233,468 |
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|
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430,623 |
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|
|
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Total current assets |
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3,864,988 |
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5,333,743 |
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Property and equipment |
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2,342,856 |
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2,238,050 |
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Less accumulated depreciation and amortization |
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2,008,655 |
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1,882,371 |
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334,201 |
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355,679 |
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Patents and trademarks |
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3,121,636 |
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3,131,391 |
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Acquired technology |
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|
237,271 |
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237,271 |
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|
|
|
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|
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3,358,907 |
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|
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3,368,662 |
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Less accumulated amortization |
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1,701,400 |
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1,540,145 |
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|
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1,657,507 |
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1,828,517 |
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Other assets |
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195,596 |
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515,593 |
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Total assets |
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$ |
6,052,292 |
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$ |
8,033,532 |
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Continued
3
Neoprobe Corporation and Subsidiaries
Consolidated Balance Sheets, continued
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LIABILITIES AND STOCKHOLDERS DEFICIT |
|
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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Current liabilities: |
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Accounts payable |
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$ |
780,950 |
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$ |
668,288 |
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Accrued liabilities and other |
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844,107 |
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544,215 |
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Capital lease obligations, current portion |
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14,872 |
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14,841 |
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Deferred revenue, current portion |
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263,850 |
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348,568 |
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Notes payable to finance companies |
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- |
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136,925 |
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Note payable to CEO, net of discount of $130,567 |
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869,433 |
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- |
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Notes payable to investors, current portion, net of discounts
of $270,818 and $53,585, respectively |
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3,154,182 |
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1,696,415 |
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Total current liabilities |
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5,927,394 |
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3,409,252 |
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Capital lease obligations, net of current portion |
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5,683 |
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17,014 |
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Deferred revenue, net of current portion |
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70,388 |
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40,495 |
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Note payable to CEO, net of discount of $12,398
and $19,030, respectively |
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87,602 |
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80,970 |
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Notes payable to investors, net of current portion and
discounts of $481,298 and $1,468,845, respectively |
|
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2,018,702 |
|
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4,781,155 |
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Other liabilities |
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29,879 |
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2,673 |
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Total liabilities |
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8,139,648 |
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8,331,559 |
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Commitments and contingencies |
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Stockholders deficit: |
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Preferred stock; $.001 par value; 5,000,000 shares
authorized at September 30, 2007 and December 31, 2006;
none issued and outstanding |
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- |
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- |
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Common stock; $.001 par value; 150,000,000 shares
authorized, 65,084,134 and 59,624,379 shares issued and
outstanding at September 30, 2007 and December 31, 2006,
respectively |
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65,084 |
|
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59,624 |
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Additional paid-in capital |
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136,723,196 |
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135,330,668 |
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Accumulated deficit |
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|
(138,875,636) |
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|
(135,688,319) |
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Total stockholders deficit |
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(2,087,356) |
|
|
|
(298,027) |
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Total liabilities and stockholders deficit |
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$ |
6,052,292 |
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$ |
8,033,532 |
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See accompanying notes to the consolidated financial statements.
4
Neoprobe Corporation and Subsidiaries
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 |
|
2007 |
|
2006 |
|
Net sales |
|
$ |
1,985,049 |
|
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$ |
957,952 |
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$ |
5,245,799 |
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|
$ |
4,179,861 |
|
Cost of goods sold |
|
|
836,436 |
|
|
|
403,190 |
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|
|
2,325,772 |
|
|
|
1,741,172 |
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Gross profit |
|
|
1,148,613 |
|
|
|
554,762 |
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|
|
2,920,027 |
|
|
|
2,438,689 |
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Operating expenses: |
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|
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|
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Research and development |
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|
548,455 |
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|
1,241,899 |
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|
|
2,287,600 |
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|
2,718,655 |
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Selling, general and administrative |
|
|
690,206 |
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|
651,419 |
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|
2,123,075 |
|
|
|
2,257,714 |
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Total operating expenses |
|
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1,238,661 |
|
|
|
1,893,318 |
|
|
|
4,410,675 |
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4,976,369 |
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Loss from operations |
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|
(90,048) |
|
|
|
(1,338,556) |
|
|
|
(1,490,648) |
|
|
|
(2,537,680) |
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Other income (expenses): |
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Interest income |
|
|
12,601 |
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|
56,520 |
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|
56,858 |
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|
184,511 |
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Interest expense |
|
|
(862,762) |
|
|
|
(371,013) |
|
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(1,749,609) |
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(1,090,973) |
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Other |
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(1,569) |
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(3,318) |
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|
(3,918) |
|
|
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(1,296) |
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Total other expenses |
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|
(851,730) |
|
|
|
(317,811) |
|
|
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(1,696,669) |
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(907,758) |
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Net loss |
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$ |
(941,778) |
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|
$ |
(1,656,367) |
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$ |
(3,187,317) |
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$ |
(3,445,438) |
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Net loss per common share: |
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Basic |
|
$ |
(0.01) |
|
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$ |
(0.03) |
|
|
$ |
(0.05) |
|
|
$ |
(0.06) |
|
Diluted |
|
$ |
(0.01) |
|
|
$ |
(0.03) |
|
|
$ |
(0.05) |
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|
$ |
(0.06) |
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Weighted average shares outstanding: |
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|
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Basic |
|
|
63,756,043 |
|
|
|
58,560,046 |
|
|
|
61,687,077 |
|
|
|
58,543,859 |
|
Diluted |
|
|
63,756,043 |
|
|
|
58,560,046 |
|
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|
61,687,077 |
|
|
|
58,543,859 |
|
See accompanying notes to the consolidated financial statements.
5
Neoprobe Corporation and Subsidiaries
Consolidated Statements of Cash Flows
(unaudited)
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Nine Months Ended |
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September 30, |
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2007 |
|
2006 |
Cash flows from operating activities: |
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|
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|
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|
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|
Net loss |
|
$ |
(3,187,317) |
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|
$ |
(3,445,438) |
|
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
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|
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Depreciation and amortization |
|
|
306,143 |
|
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|
301,877 |
|
Amortization of debt discount and debt offering costs |
|
|
1,077,365 |
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|
595,500 |
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Stock compensation expense |
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|
77,608 |
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|
178,844 |
|
Other |
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|
34,020 |
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|
30,146 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(141,364) |
|
|
|
10,215 |
|
Inventory |
|
|
53,896 |
|
|
|
(319,433) |
|
Prepaid expenses and other assets |
|
|
154,489 |
|
|
|
424,560 |
|
Accounts payable |
|
|
112,662 |
|
|
|
235,740 |
|
Accrued liabilities and other liabilities |
|
|
339,099 |
|
|
|
(564,501) |
|
Deferred revenue |
|
|
(54,825) |
|
|
|
59,342 |
|
|
|
|
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|
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|
|
|
|
|
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|
Net cash used in operating activities |
|
|
(1,228,224) |
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|
(2,493,148) |
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Cash flows from investing activities: |
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|
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Maturities of available-for-sale securities |
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|
- |
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|
|
1,531,000 |
|
Purchases of property and equipment |
|
|
(36,872) |
|
|
|
(71,282) |
|
Proceeds from sales of property and equipment |
|
|
- |
|
|
|
4,097 |
|
Patent and trademark costs |
|
|
(5,889) |
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|
|
(26,898) |
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|
|
|
|
|
|
|
|
|
|
|
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|
Net cash (used in) provided by investing activities |
|
|
(42,761) |
|
|
|
1,436,917 |
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|
|
|
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Cash flows from financing activities: |
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|
|
|
|
|
|
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Proceeds from issuance of common stock |
|
|
1,300,000 |
|
|
|
- |
|
Payment of stock offering costs |
|
|
(21,510) |
|
|
|
- |
|
Proceeds from note payable |
|
|
1,000,000 |
|
|
|
- |
|
Payment of debt issuance costs |
|
|
(67,833) |
|
|
|
(30,000) |
|
Payment of notes payable |
|
|
(2,211,926) |
|
|
|
(197,054) |
|
Payments under capital leases |
|
|
(11,300) |
|
|
|
(14,444) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in financing activities |
|
|
(12,569) |
|
|
|
(241,498) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash |
|
|
(1,283,554) |
|
|
|
(1,297,729) |
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period |
|
|
2,502,655 |
|
|
|
4,940,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period |
|
$ |
1,219,101 |
|
|
$ |
3,643,217 |
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
6
Notes to the Consolidated Financial Statements
(unaudited)
1. |
|
Basis of Presentation |
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|
The information presented as of September 30, 2007 and for the three-month and nine-month
periods ended September 30, 2007 and September 30, 2006 is unaudited, but includes all
adjustments (which consist only of normal recurring adjustments) that the management of Neoprobe
Corporation (Neoprobe, the Company, or we) believes to be necessary for the fair presentation of
results for the periods presented. Certain information and footnote disclosures normally
included in financial statements prepared in accordance with U.S. generally accepted accounting
principles have been condensed or omitted pursuant to the rules and regulations of the U.S.
Securities and Exchange Commission. The results for the interim periods are not necessarily
indicative of results to be expected for the year. The consolidated financial statements should
be read in conjunction with Neoprobes audited consolidated financial statements for the year
ended December 31, 2006, which were included as part of our Annual Report on Form 10-KSB. |
|
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|
Our consolidated financial statements include the accounts of Neoprobe, our wholly-owned
subsidiary, Cardiosonix Ltd. (Cardiosonix), and our 90%-owned subsidiary, Cira Biosciences, Inc.
(Cira Bio). All significant inter-company accounts were eliminated in consolidation. |
|
2. |
|
Stock-Based Compensation |
|
|
|
At September 30, 2007, we have three stock-based compensation plans. Under the Amended and
Restated Stock Option and Restricted Stock Purchase Plan (the Amended Plan), the 1996 Stock
Incentive Plan (the 1996 Plan), and the 2002 Stock Incentive Plan (the 2002 Plan), we may grant
incentive stock options, nonqualified stock options, and restricted stock awards to full-time
employees, and nonqualified stock options and restricted awards may be granted to our
consultants and agents. Total shares authorized under each plan are 2 million shares, 1.5
million shares and 5 million shares, respectively. Although options are still outstanding under
the Amended Plan and the 1996 Plan, these plans are considered expired and no new grants may be
made from them. Under all three plans, the exercise price of each option is greater than or
equal to the closing market price of our common stock on the day prior to the date of the grant. |
|
|
|
Options granted under the Amended Plan, the 1996 Plan and the 2002 Plan generally vest on an
annual basis over one to three years. Outstanding options under the plans, if not exercised,
generally expire ten years from their date of grant or 90 days from the date of an optionees
separation from employment with us. |
|
|
|
Compensation cost arising from stock-based awards is recognized as expense using the
straight-line method over the vesting period. As of September 30, 2007, there was approximately
$63,000 of total unrecognized compensation cost related to unvested stock-based awards, which we
expect to recognize over remaining weighted average vesting terms of 0.7 years. For the
three-month periods ended September 30, 2007 and 2006, our total stock-based compensation
expense was approximately $10,000 and $40,000, respectively. For the nine-month periods ended
September 30, 2007 and 2006, our total stock-based compensation expense was approximately
$78,000 and $179,000, respectively. We have not recorded any income tax benefit related to
stock-based compensation in any of the three-month and nine-month periods ended September 30,
2007 and 2006. |
|
|
|
The fair value of each option award is estimated on the date of grant using the Black-Scholes
option pricing model to value share-based payments. Expected volatilities are based on the
Companys historical volatility, which management believes represents the most accurate basis
for estimating expected volatility under the current circumstances. Neoprobe uses historical
data to estimate forfeiture rates. The expected term of options granted is based on the vesting
period and the contractual life of the options. The risk-free rate is based on the U.S. Treasury
yield in effect at the time of the grant. |
7
|
|
A summary of stock option activity under our stock option plans as of September 30, 2007, and
changes during the nine-month period then ended is presented below: |
|
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|
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|
|
|
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|
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|
|
Nine Months Ended September 30, 2007 |
|
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Weighted |
|
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|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Options |
|
Price |
|
Life |
|
Value |
Outstanding at beginning
of period |
|
|
5,975,473 |
|
|
$ |
0.42 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
40,000 |
|
|
$ |
0.35 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(116,667) |
|
|
$ |
0.32 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(403,333) |
|
|
$ |
0.42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of period |
|
|
5,495,473 |
|
|
$ |
0.42 |
|
|
5.1 years |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at end of period |
|
|
4,586,473 |
|
|
$ |
0.45 |
|
|
4.6 years |
|
|
- |
|
|
|
|
|
|
|
|
|
|
3. |
|
Comprehensive Income (Loss) |
|
|
|
We had no accumulated other comprehensive income (loss) activity during the three-month and
nine-month periods ended September 30, 2007, thus our total comprehensive loss was equal to our
net loss for those periods. Due to our net operating loss position, there are no income tax
effects on comprehensive income (loss) components for the three-month and nine-month periods
ended September 30, 2006. |
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Nine Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
2006 |
|
Net loss |
|
$ |
(1,656,367) |
|
|
$ |
(3,445,438) |
|
Unrealized losses on securities |
|
|
- |
|
|
|
(2,018) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
$ |
(1,656,367) |
|
|
$ |
(3,447,456) |
|
|
|
|
|
|
8
4. |
|
Earnings Per Share |
|
|
|
Basic earnings (loss) per share is calculated using the weighted average number of common shares
outstanding during the periods. Diluted earnings (loss) per share is calculated using the
weighted average number of common shares outstanding during the periods, adjusted for the
effects of convertible securities, options and warrants, if dilutive. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
September 30, 2007 |
|
September 30, 2006 |
|
|
Basic |
|
|
Diluted |
|
|
Basic |
|
|
Diluted |
|
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
|
Per Share |
|
Per Share |
|
Per Share |
|
Per Share |
|
Outstanding shares |
|
|
65,084,134 |
|
|
|
65,084,134 |
|
|
|
58,690,046 |
|
|
|
58,690,046 |
|
Effect of weighting changes
in outstanding shares |
|
|
(1,328,091) |
|
|
|
(1,328,091) |
|
|
|
- |
|
|
|
- |
|
Contingently issuable shares |
|
|
- |
|
|
|
- |
|
|
|
(130,000) |
|
|
|
(130,000) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted shares |
|
|
63,756,043 |
|
|
|
63,756,043 |
|
|
|
58,560,046 |
|
|
|
58,560,046 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of anti-dilutive
common shares excluded |
|
|
40,354,155 |
|
|
|
40,354,155 |
|
|
|
41,365,016 |
|
|
|
41,365,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, 2007 |
|
September 30, 2006 |
|
|
Basic |
|
|
Diluted |
|
|
Basic |
|
|
Diluted |
|
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
Earnings |
|
|
|
Per Share |
|
Per Share |
|
Per Share |
|
Per Share |
|
Outstanding shares |
|
|
65,084,134 |
|
|
|
65,084,134 |
|
|
|
58,690,046 |
|
|
|
58,690,046 |
|
Effect of weighting changes
in outstanding shares |
|
|
(3,397,057) |
|
|
|
(3,397,057) |
|
|
|
(16,187) |
|
|
|
(16,187) |
|
Contingently issuable shares |
|
|
- |
|
|
|
- |
|
|
|
(130,000) |
|
|
|
(130,000) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted shares |
|
|
61,687,077 |
|
|
|
61,687,077 |
|
|
|
58,543,859 |
|
|
|
58,543,859 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of anti-dilutive
common shares excluded |
|
|
40,354,155 |
|
|
|
40,354,155 |
|
|
|
41,365,016 |
|
|
|
41,365,016 |
|
|
|
|
|
|
|
|
|
|
|
|
There is no difference in basic and diluted loss per share related to the three-month and
nine-month periods ended September 30, 2007 and 2006. The net loss per common share for these
periods excludes the effects of common shares issuable upon exercise of outstanding stock
options and warrants into our common stock or upon the conversion of convertible debt since such
inclusion would be anti-dilutive. |
|
5. |
|
Inventory |
|
|
|
We capitalize certain inventory costs associated with our Lymphoseek® product prior
to regulatory approval and product launch, based on managements judgment of probable future
commercial use and net realizable value. We could be required to permanently write down
previously capitalized costs related to pre-approval or pre-launch inventory upon a change in
such judgment, due to a denial or delay of approval by regulatory bodies, a delay in
commercialization, or other potential factors. Conversely, our gross margins may be favorably
impacted if some or all of the inventory previously written down becomes available and is used
for commercial sale. During the nine-month |
9
|
|
periods ended September 30, 2007 and 2006, we capitalized $150,000 and $48,000, respectively, in
inventory costs associated with our Lymphoseek product. |
|
|
|
The components of inventory are as follows: |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(unaudited) |
|
|
|
Materials and component parts |
|
$ |
352,995 |
|
|
$ |
522,225 |
|
Work-in-process |
|
|
151,741 |
|
|
|
167,188 |
|
Finished goods |
|
|
520,230 |
|
|
|
464,963 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,024,966 |
|
|
$ |
1,154,376 |
|
|
|
|
|
|
6. |
|
Intangible Assets |
|
|
|
The major classes of intangible assets are as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2007 |
|
December 31, 2006 |
|
|
Wtd |
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Avg |
|
|
Carrying |
|
|
Accumulated |
|
|
Carrying |
|
|
Accumulated |
|
|
|
Life |
|
Amount |
|
Amortization |
|
Amount |
|
Amortization |
|
Patents and trademarks |
|
9.0 yrs |
|
$ |
3,121,636 |
|
|
$ |
1,506,265 |
|
|
$ |
3,131,391 |
|
|
$ |
1,370,291 |
|
Acquired technology |
|
1.3 yrs |
|
|
237,271 |
|
|
|
195,135 |
|
|
|
237,271 |
|
|
|
169,854 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
3,358,907 |
|
|
$ |
1,701,400 |
|
|
$ |
3,368,662 |
|
|
$ |
1,540,145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The estimated amortization expenses for the next five fiscal years are as follows: |
|
|
|
|
|
|
|
Estimated |
|
|
|
Amortization |
|
|
|
Expense |
|
For the year ended 12/31/2007 |
|
$ |
222,709 |
|
For the year ended 12/31/2008 |
|
|
216,116 |
|
For the year ended 12/31/2009 |
|
|
170,852 |
|
For the year ended 12/31/2010 |
|
|
170,033 |
|
For the year ended 12/31/2011 |
|
|
168,581 |
|
7. |
|
Product Warranty |
|
|
|
We warrant our products against defects in design, materials, and workmanship generally for a
period of one year from the date of sale to the end customer, except in cases where the product
has a limited use as designed. Our accrual for warranty expenses is adjusted periodically to
reflect actual experience. Our primary marketing partner, Ethicon Endo-Surgery, Inc. (EES), a
Johnson & Johnson company, also reimburses us for a portion of warranty expense incurred based
on end customer sales they make during a given fiscal year. Payments charged against the
reserve are disclosed net of EES estimated reimbursement. |
10
|
The activity in the warranty reserve account for the three-month and nine-month periods ended
September 30, 2007 and 2006 is as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Warranty reserve at
beginning of period |
|
$ |
90,176 |
|
|
$ |
42,665 |
|
|
$ |
44,858 |
|
|
$ |
41,185 |
|
Provision for warranty claims and
changes in reserve for warranties |
|
|
39,911 |
|
|
|
4,812 |
|
|
|
111,817 |
|
|
|
28,086 |
|
Payments charged against the
reserve |
|
|
(12,791) |
|
|
|
(10,304) |
|
|
|
(39,379) |
|
|
|
(32,098) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warranty reserve at end of period |
|
$ |
117,296 |
|
|
$ |
37,173 |
|
|
$ |
117,296 |
|
|
$ |
37,173 |
|
|
|
|
|
|
|
|
|
|
8. |
|
Notes Payable |
|
|
|
In December 2004, we completed a private placement of four-year convertible promissory notes in
an aggregate principal amount of $8.1 million under a Securities Purchase Agreement with
Biomedical Value Fund, L.P., Biomedical Offshore Value Fund, Ltd. and David C. Bupp (our
President and CEO). Biomedical Value Fund, L.P. and Biomedical Offshore Value Fund, Ltd. are
funds managed by Great Point Partners, LLC (collectively, the Great Point Funds). The notes
originally bore interest at 8% per annum and were due on December 13, 2008. |
|
|
|
All of our material assets, except the intellectual property associated with our Lymphoseek and
RIGS® products under development, have been pledged as collateral for these notes.
In addition to the security interest in our assets, the notes carry substantial covenants that
impose significant requirements on us, including, among others, that: we pay all
principal, interest and other charges on the notes when due; we use the proceeds from the sale
of the notes only for permitted purposes such as Lymphoseek development and general corporate
purposes; we nominate and recommend for election as a director a person designated by the
holders of the notes (as of September 30, 2007, the holders of the notes have not designated a
potential board member); we keep reserved out of our authorized shares of common stock
sufficient shares to satisfy our obligation to issue shares on conversion of the notes and the
exercise of the warrants issued in connection with the sale of the notes; and we indemnify the
purchasers of the notes against certain liabilities. Additionally, with certain exceptions, the
notes prohibit us from: amending our organizational or governing agreements and documents;
entering into any merger or consolidation; dissolving the Company or liquidating its assets; or
acquiring all or any substantial part of the business or assets of any other person; engaging in
transactions with any affiliate; entering into any agreement inconsistent with our obligations
under the notes and related agreements; incurring any indebtedness, capital leases, or
contingent obligations outside the ordinary course of business; granting or permitting liens
against or security interests in our assets; making any material dispositions of our assets
outside the ordinary course of business; declaring or paying any dividends or making any other
restricted payments; or making any loans to or investments in other persons outside of the
ordinary course of business. |
|
|
|
As part of the original transaction, we issued the investors 10,125,000 Series T warrants to
purchase our common stock at an exercise price of $0.46 per share, expiring in December 2009.
The fair value of the warrants issued to the investors was $1,315,000 on the date of issuance
and was determined using the Black-Scholes option pricing model with the following assumptions:
an average risk-free interest rate of 3.4%, volatility of 50% and no expected dividend rate. In
connection with this financing, we also issued 1,600,000 Series U warrants to purchase our
common stock to the placement agents, containing substantially the same terms as the warrants
issued to the investors. The fair value of the warrants issued to the placement agents was
$208,014 using the Black-Scholes option pricing model with the same assumptions used to
determine the fair value of the warrants issued to the investors. The value of the beneficial
conversion feature of the notes was estimated at |
11
|
|
$1,315,000 based on the effective conversion price at the date of issuance. The fair value of
the warrants issued to the investors and the value of the beneficial conversion feature were
recorded as discounts on the note and were being amortized over the term of the notes using the
effective interest method. The fair value of the warrants issued to the placement agents was
recorded as a deferred debt issuance cost and was being amortized over the term of the notes. |
|
|
|
In November 2006, we amended the Agreement and modified several of the key terms in the related
notes. We treated the amendment to the Agreement as a modification for accounting purposes.
The modified notes bear interest at 12% per annum, payable on March 31, June 30, September 30
and December 31 of each year. The maturity of the notes was modified as follows: $500,000 due
January 8, 2007; $1,250,000 due July 9, 2007; $1,750,000 due January 7, 2008; $2,000,000 due
July 7, 2008 and the remaining $2,600,000 due January 7, 2009. Neoprobe is also required to
make mandatory repayments of principal to the Great Point Funds under certain circumstances such
as asset dispositions, partnering transactions and sales of equity. Such mandatory repayments
are applied against future scheduled principal payments. In exchange for the increased interest
rate and accelerated principal repayment schedule, the noteholders eliminated the financial
covenants under the original notes and eliminated certain conversion price adjustments from the
original notes related to sales of equity securities by Neoprobe. In addition, Neoprobe may
make optional prepayments to the Great Point Funds by giving them ten (10) business days notice
during which time the noteholders may decide to convert the notes into common stock of the
Company. The new notes remain freely convertible into shares of our common stock at a price of
$0.40 per share. Neoprobe may force conversion of the notes prior to their stated maturity
under certain circumstances. During the nine-month period ended September 30, 2007, we made a
total of $2,075,000 in principal repayments to the Great Point Funds. |
|
|
|
As a result of the November 2006 modification of the payment terms of the notes, the
amortization of debt discount and issuance costs using the effective interest method was
revised. During the third quarter of 2007, management determined that the Company had, from the
date of the modification of the notes payable on November 30, 2006, through June 30, 2007,
incorrectly applied the effective interest method in calculating the amortization of the debt
discount and issuance costs related to the notes. As a result of the error in calculation, we
recorded a total adjustment of $286,000 in non-cash interest expense related to the seven months
ended June 30, 2007 in our results of operations for the third quarter of 2007. The Company has
determined that the net effect of this adjustment was not material, either quantitatively or
qualitatively, to its results of operations and would not have resulted in changes to net loss
per share, as reported, for the year ended December 31, 2006 or for the quarters ended March 31,
2007 and June 30, 2007. Recording the adjustment does not require amendment of the previously
filed reports for the periods affected. |
|
|
|
In July 2007, David C. Bupp (our President and CEO) and certain members of his family purchased
a $1.0 million convertible note and warrants. The note bears interest at 10% per annum during
its one-year term and is repayable in whole or in part with no penalty. The note is convertible
into shares of our common stock at a price of $0.31 per share, a 25% premium to the average
closing market price of our common stock for the 5 days preceding the closing of the
transaction. As part of this transaction, we issued the investors 500,000 Series V warrants to
purchase our common stock at an exercise price of $0.31 per share, expiring in July 2012. The
fair value of the warrants issued to the investors was approximately $80,000 on the date of
issuance and was determined using the Black-Scholes option pricing model with the following
assumptions: an average risk-free interest rate of 4.95%, volatility of 105% and no expected
dividend rate. The value of the beneficial conversion feature of the note was estimated at
$86,000 based on the effective conversion price at the date of issuance. The fair value of the
warrants issued to the investors and the value of the beneficial conversion feature were
recorded as discounts on the note and are being amortized over the term of the note using the
effective interest method. |
12
9. |
|
Stock Warrants |
|
|
|
At September 30, 2007 there are 17.5 million warrants outstanding to purchase our common stock.
The warrants are exercisable at prices ranging from $0.13 to $0.50 per share with a weighted
average exercise price $0.39 per share. |
|
10. |
|
Income Taxes |
|
|
|
Effective January 1, 2007, we adopted Financial Interpretation (FIN) No. 48, Accounting for
Uncertainty in Income Taxes an Interpretation of FASB Statement No. 109 (FIN 48). FIN 48
clarifies the accounting for uncertainty in income taxes recognized in an enterprises financial
statements in accordance with SFAS No. 109, Accounting for Income Taxes. FIN 48 outlines a
recognition threshold and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also
provides guidance on derecognition, classification, interest and penalties, accounting in
interim periods, disclosure, and transition. The adoption of FIN 48 had no effect on our
results of operations and financial condition. |
|
11. |
|
Segment and Subsidiary Information |
|
|
|
We report information about our operating segments using the management approach in accordance
with SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information. This
information is based on the way management organizes and reports the segments within the
enterprise for making operating decisions and assessing performance. Our reportable segments
are identified based on differences in products, services and markets served. There were no
inter-segment sales. We own or have rights to intellectual property involving two primary types
of medical device products, including oncology instruments currently used primarily in the
application of sentinel lymph node biopsy (SLNB), and blood flow measurement devices. We also
own or have rights to intellectual property related to several drug and therapy products. |
13
The information in the following table is derived directly from each reportable segments
financial reporting. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ amounts in thousands) |
|
|
|
|
|
Blood |
|
|
Drug and |
|
|
|
|
|
|
|
Three Months Ended |
|
Oncology |
|
|
Flow |
|
|
Therapy |
|
|
|
|
|
|
|
September 30, 2007 |
|
Devices |
|
|
Devices |
|
|
Products |
|
|
Corporate |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
1,935 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,935 |
|
International |
|
|
12 |
|
|
|
38 |
|
|
|
- |
|
|
|
- |
|
|
|
50 |
|
Research and development expenses |
|
|
152 |
|
|
|
86 |
|
|
|
310 |
|
|
|
- |
|
|
|
548 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
592 |
|
|
|
592 |
|
Depreciation and amortization |
|
|
23 |
|
|
|
65 |
|
|
|
- |
|
|
|
10 |
|
|
|
98 |
|
Income (loss) from operations3 |
|
|
955 |
|
|
|
(133) |
|
|
|
(310) |
|
|
|
(602) |
|
|
|
(90) |
|
Other income (expenses)4 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(852) |
|
|
|
(852) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,916 |
|
|
|
667 |
|
|
|
187 |
|
|
|
1,662 |
|
|
|
4,432 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
- |
|
|
|
1,620 |
|
|
|
- |
|
|
|
- |
|
|
|
1,620 |
|
Capital expenditures |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1 |
|
|
|
1 |
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
877 |
|
|
$ |
16 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
893 |
|
International |
|
|
51 |
|
|
|
14 |
|
|
|
- |
|
|
|
- |
|
|
|
65 |
|
Research and development expenses |
|
|
279 |
|
|
|
131 |
|
|
|
832 |
|
|
|
- |
|
|
|
1,242 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
547 |
|
|
|
547 |
|
Depreciation and amortization |
|
|
24 |
|
|
|
66 |
|
|
|
- |
|
|
|
15 |
|
|
|
105 |
|
Income (loss) from operations3 |
|
|
294 |
|
|
|
(239) |
|
|
|
(832) |
|
|
|
(562) |
|
|
|
(1,339) |
|
Other income (expenses)4 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(318) |
|
|
|
(318) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,272 |
|
|
|
538 |
|
|
|
109 |
|
|
|
4,356 |
|
|
|
6,275 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
- |
|
|
|
1,999 |
|
|
|
- |
|
|
|
- |
|
|
|
1,999 |
|
Capital expenditures |
|
|
33 |
|
|
|
5 |
|
|
|
- |
|
|
|
10 |
|
|
|
48 |
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ amounts in thousands) |
|
|
|
|
|
Blood |
|
|
Drug and |
|
|
|
|
|
|
|
Nine Months Ended |
|
Oncology |
|
|
Flow |
|
|
Therapy |
|
|
|
|
|
|
|
September 30, 2007 |
|
Devices |
|
|
Devices |
|
|
Products |
|
|
Corporate |
|
|
Total |
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
4,825 |
|
|
$ |
160 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
4,985 |
|
International |
|
|
136 |
|
|
|
125 |
|
|
|
- |
|
|
|
- |
|
|
|
261 |
|
Research and development expenses |
|
|
532 |
|
|
|
291 |
|
|
|
1,465 |
|
|
|
- |
|
|
|
2,288 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,817 |
|
|
|
1,817 |
|
Depreciation and amortization |
|
|
74 |
|
|
|
197 |
|
|
|
- |
|
|
|
35 |
|
|
|
306 |
|
Income (loss) from operations3 |
|
|
2,206 |
|
|
|
(380) |
|
|
|
(1,465) |
|
|
|
(1,852) |
|
|
|
(1,491) |
|
Other income (expenses) 4 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,697) |
|
|
|
(1,697) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,916 |
|
|
|
667 |
|
|
|
187 |
|
|
|
1,662 |
|
|
|
4,432 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
- |
|
|
|
1,620 |
|
|
|
- |
|
|
|
- |
|
|
|
1,620 |
|
Capital expenditures |
|
|
16 |
|
|
|
9 |
|
|
|
- |
|
|
|
12 |
|
|
|
37 |
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States1 |
|
$ |
3,608 |
|
|
$ |
68 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
3,676 |
|
International |
|
|
179 |
|
|
|
325 |
|
|
|
- |
|
|
|
- |
|
|
|
504 |
|
Research and development expenses |
|
|
626 |
|
|
|
589 |
|
|
|
1,504 |
|
|
|
- |
|
|
|
2,719 |
|
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,956 |
|
|
|
1,956 |
|
Depreciation and amortization |
|
|
74 |
|
|
|
184 |
|
|
|
- |
|
|
|
44 |
|
|
|
302 |
|
Income (loss) from operations3 |
|
|
1,600 |
|
|
|
(634) |
|
|
|
(1,504) |
|
|
|
(2,000) |
|
|
|
(2,538) |
|
Other income (expenses) 4 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(908) |
|
|
|
(908) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets, net of depreciation
and amortization: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States operations |
|
|
1,272 |
|
|
|
538 |
|
|
|
109 |
|
|
|
4,356 |
|
|
|
6,275 |
|
Israeli operations (Cardiosonix Ltd.) |
|
|
- |
|
|
|
1,999 |
|
|
|
- |
|
|
|
- |
|
|
|
1,999 |
|
Capital expenditures |
|
|
33 |
|
|
|
7 |
|
|
|
- |
|
|
|
31 |
|
|
|
71 |
|
|
1 |
|
All sales to EES are made in the United States. EES distributes the product
globally through its international affiliates. |
|
|
2 |
|
Selling, general and administrative expenses, excluding depreciation and
amortization, represent expenses that relate to the general administration of the Company
and as such are not currently allocated to our individual reportable segments. |
|
|
3 |
|
Income (loss) from operations does not reflect the allocation of selling, general
and administrative expenses to the operating segments. |
|
|
4 |
|
Amounts consist primarily of interest income and interest expense which are not
currently allocated to our individual reportable segments. |
12. |
|
Agreements |
|
|
|
During January 2005, we executed a license agreement with The Ohio State University (OSU), Cira
Ltd., and Cira Bio for certain technology relating to activated cellular therapy. The license
agreement is effective until the expiration date of the longest-lived underlying patent. Under
the terms of the license agreement, OSU has granted the licensees the exclusive rights to make,
have made, use, lease, sell and import licensed products as defined in the agreement and to
utilize the defined licensed practices. We may also sublicense the patent rights. Also during
January 2005, we completed a business venture agreement with Cira Ltd. that defines each partys
responsibilities and |
15
|
|
commitments with respect to Cira Bio and the license agreement with OSU. During the third
quarter of 2007, we executed an option agreement with Cira Ltd., the sole minority shareholder
in Cira Bio, whereby Neoprobe may acquire Cira Ltd.s 10% interest in Cira Bio for $250,000,
subject to the closing of a financing transaction prior to June 30, 2008. In connection with
the execution of the option, Cira Ltd. also agreed to assign all interests in the ACT technology
in the event of the closing of such a financing transaction. |
|
13. |
|
Supplemental Disclosure for Statements of Cash Flows |
|
|
|
During the nine-month periods ended September 30, 2007 and 2006, we paid interest aggregating
$457,000 and $495,000, respectively. During the nine-month periods ended September 30, 2007 and
2006, we transferred $76,000 and $91,000, respectively, in inventory to fixed assets related to
the creation and maintenance of a pool of service loaner equipment. |
16
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The Company
Neoprobe Corporation is a biomedical technology company that provides innovative surgical and
diagnostic products that enhance patient care. We currently market two lines of medical devices;
our neo2000® gamma detection systems and the Quantix® line of blood flow
measurement devices of our wholly-owned subsidiary, Cardiosonix Ltd. (Cardiosonix). In addition to
our medical device products, we have two radiopharmaceutical products, Lymphoseek® and
RIGScan® CR, in the advanced phases of clinical development. We are also exploring the
development of our activated cellular therapy (ACT) technology for patient-specific disease
treatment through our majority-owned subsidiary, Cira Biosciences, Inc. (Cira Bio).
Overview
This Overview section contains a number of forward-looking statements, all of which are based on
current expectations. Actual results may differ materially from the anticipated results discussed
herein. Our financial performance is highly dependent on our ability to continue to generate
income and cash flow from our gamma detection device product line and on our ability to
successfully commercialize the blood flow measurement products of Cardiosonix. We cannot assure
you that we will achieve the volume of sales anticipated, or if achieved, that the margin on such
sales will be adequate to produce positive operating cash flow. We continue to be optimistic about
the longer-term potential for our other proprietary, procedural-based technologies such as
Lymphoseek, RIGS® (radioimmunoguided surgery) and ACT; however, these technologies are
not anticipated to generate any significant revenue for us during the remainder of 2007 or in 2008.
In addition, we cannot assure you that these products will ever obtain marketing clearance from
the appropriate regulatory bodies.
Our revenue for the first nine months of 2007 was higher overall than our original expectations.
We expect our overall revenue for 2007 to approach $7.0 million. Gamma detection device revenue was buoyed by sales of our Bluetooth® probes to our
primary gamma detection device marketing partner, Ethicon Endo-Surgery, Inc. (EES), a Johnson &
Johnson company. Higher than expected unit sales and unit prices of our Bluetooth probes and
higher unit prices of our base neo2000 system were offset by lower unit sales of our base neo2000
system and accessories. Due primarily to Bluetooth probe sales, we expect that revenue from our gamma detection systems for 2007 will be
higher than 2006; however, price declines for these base systems may adversely affect our gamma
detection device revenue for the remainder of 2007 as compared to 2006. Sales of our blood flow
measurement devices also continue to be below our expectations. We currently expect that blood
flow-related revenue for 2007 will fall below 2006 levels. Future sales of Quantix devices are
highly dependent upon our ability to maintain our blood flow measurement device marketing and
distribution partners, the success of our distribution partners in generating sales leads, our
distribution partners ability to negotiate within the constraints of current hospital purchasing
practices, and ultimately on physician response to these products and procedures themselves. The
clinical successes of our Lymphoseek product, however, are causing us to re-evaluate our blood flow
strategy and consider potential strategic options for this business over the coming months. However, we continue to believe our gamma device business is central
to our strategy and as a result are evaluating an extension of our current distribution agreement with EES.
Our operating expenses during the first nine months of 2007 were focused primarily on support of
Lymphoseek product development. In addition, we continued to modestly invest in our neo2000 gamma
detection device line and have significantly decreased the level of our ongoing investment in our
blood flow measurement line. We expect our drug-related development expenses to decrease over the
next few months until we initiate the multi-center Phase 3 clinical evaluations of Lymphoseek in
the first quarter of 2008. We expect to continue to incur development expenses to support our
gamma detection device product line as well as we move our other product initiatives forward. We
also expect to continue to make only minor investments in marketing and clinical development
support for our blood flow measurement products during the remainder of 2007 as we work with our
distribution partners to expand market penetration of our Quantix product lines and identify other
potential markets for application and commercialization of this technology platform.
17
Our efforts thus far in 2007 have resulted in the following research and development and business
milestone achievements:
|
|
|
Granted authorization by the U.S. Food and Drug Administration (FDA) to commence patient
enrollment in two Phase 1 clinical studies to evaluate the safety and efficacy of
Lymphoseek in prostate and colon cancers. |
|
|
|
Achieved and reported positive preliminary results from the Phase 2 Lymphoseek trial in
breast cancer and melanoma. Based on final pathology confirmed results, Lymphoseek
identified lymphatic tissue in over 95% of the surgically treated patients, which exceeded
the trials objective of 90% efficacy. |
|
|
|
Extended the Companys option agreement with the University of California, San Diego
covering the potential use of Lymphoseek as an optical or ultrasound agent. |
|
|
|
Filed an updated chemistry, manufacturing and control (CMC) amendment on Lymphoseek and
an expanded non-clinical study package with FDA in preparation for the next phase of
Lymphoseek clinical development program. |
|
|
|
Commenced development activities for the Phase 3 clinical studies of Lymphoseek,
including a submission of end of Phase 2 and pre-Phase 3 meeting materials to FDA. |
|
|
|
Completed the second of three current Good Manufacturing Practices (cGMP) production
runs of Lymphoseek, including the first product that will be used for the commercial launch
of the drug. |
|
|
|
Closed on a $1.0 million investment in the Company led by our President and CEO, David
Bupp. |
|
|
|
Executed a definitive term sheet for the marketing and distribution of Lymphoseek in the
United States with the nuclear pharmacy division of Cardinal Health, Inc. and completed
drafts of definitive distribution contracts. |
As noted above, an 80-patient Phase 2 trial for Lymphoseek was completed during the third quarter
of 2007. Localization of Lymphoseek to lymphoid tissue was observed in over 95% of the sentinel
lymph node biopsy (SLNB) procedures performed during the Phase 2 trial. The Phase 2 study was
conducted at five of the leading cancer centers in the U.S.: John Wayne Cancer Center; University
of California, San Francisco; MD Anderson Cancer Center; University Hospital Cleveland (Case
Western Reserve); and the University of Louisville.
In late October 2007, we held an end of Phase 2 meeting with FDA in which we discussed the Phase 2
results and the design of two pivotal Phase 3 protocols. Based on these discussions with FDA, we
are moving forward with the finalization of trial design for two separate Phase 3 studies, each of
which would involve approximately 200 evaluable patients with either melanoma or breast cancer. We
expect the study protocol to provide for patients in these trials to receive both Lymphoseek and a
non-radiopharmaceutical blue dye agent that is currently used as a visual marker in lymphatic
mapping procedures. Our discussions with FDA also suggest that the Phase 3 trials will be
structured to support the intended use of Lymphoseek as a lymphatic channel targeting agent in SLNB
procedures.
We plan to have approximately 35 participating institutions in each Phase 3 trial, which should
enable us to enroll patients at a more rapid rate than we experienced with the Phase 2 study. Our
goal is to file the new drug application for Lymphoseek during the second half of 2008, which will
be dependent upon our ability to commence and conclude the Phase 3 clinical studies in a timely
fashion. Depending on the timing and outcome of the FDA regulatory review cycle, we believe that
Lymphoseek can be commercialized in 2009.
As a result of the modifications made to the development and regulatory pathway over Lymphoseeks
development cycle, we estimate total out-of-pocket development costs to bring Lymphoseek to market
have increased to approximately $10 million, of which we estimate approximately $5 million has yet
to be incurred. In addition, Neoprobe has discussed the drug approval and registration process
through the centralized European drug evaluation procedures with the European Medicinal Evaluation
Agency (EMEA) in London. We plan to use the results from the Phase 3 clinical evaluation of
Lymphoseek, which we currently intend to include sites in the EU, to support the drug registration
application process with the
18
EMEA. We cannot assure you, however, that this product will achieve regulatory approval, or if
approved, that it will achieve market acceptance.
Over the past few years, we have made progress in advancing our RIGScan CR development program
while incurring little in the way of research expenses. Our RIGS technology, which had been
essentially inactive since failing to gain approval following our original license application in
1997, has been the subject of renewed interest due primarily to the analysis of survival data
related to patients who participated in the original Phase 3 clinical studies that were completed
in 1996. We believe there are development milestones that can be achieved prior to the need for
significant capital investment in RIGScan CR such as preparing the request for a protocol
assessment and completing a final protocol review. At present, we plan to submit a clinical
development plan for RIGScan CR to FDA and to request a meeting to review the development plan and
clinical protocol as part of the development plan in the first quarter of 2008. The clinical
protocol envisioned would involve evaluating the bio-staging of approximately 300 patients in a
randomized trial of patients with primary colorectal cancer. The participants in the trial would
be randomized to either a control or RIGS treatment arm. Patients randomized to the RIGS arm would
have their disease status evaluated at the end of their cancer surgery to determine the presence or
absence of RIGS-positive tissue. Patients in both randomized arms would be followed to determine
if patients with RIGS-positive status have a lower overall survival rate and/or a higher occurrence
of disease recurrence. The hypothesis for the trial is based upon the data from the earlier
NEO2-13 and NEO2-14 trial results. However, we continue to believe it will be necessary for us to
identify a development partner or an alternative funding source in order to prepare for and fund
the pivotal clinical testing that will be necessary to gain marketing clearance for RIGScan CR. We
have engaged in discussions with various parties regarding such alternatives. At the present time,
while we have parties who have indicated an interest in entering into a development relationship,
we do not believe these efforts will result in an agreement until further clarity can be added to
the RIGScan regulatory approval pathway, such as obtaining a positive protocol determination from
FDA. However, even if we are able to make such arrangements on satisfactory terms, we believe that
the time required for continued development, regulatory approval and commercialization of a RIGS
product would likely be a minimum of five years before we receive any significant product-related
royalties or revenues. We cannot assure you that we will be able to complete definitive agreements
with a development partner for the RIGS technology and do not know if a partner will be obtained on
a timely basis on terms acceptable to us, or at all. We also cannot assure you that FDA or the
EMEA will clear our RIGS products for marketing or that any such products will be successfully
introduced or achieve market acceptance.
Cira Bio was formed to raise the necessary capital to move the ACT technology platform forward.
During the third quarter of 2007, Neoprobe executed an option agreement with Cira Ltd., the sole
minority shareholder in Cira Bio, whereby Neoprobe may acquire Cira Ltd.s 10% interest in Cira Bio
for $250,000, subject to the closing of a financing transaction prior to June 30, 2008. In
connection with the execution of the option, Cira Ltd. also agreed to assign all interests in the
ACT technology in the event of the closing of such a financing transaction. However, it should be
noted that Cira Bio has not yet identified a potential source of capital. Obtaining this funding
would likely significantly dilute Neoprobes ownership interest in Cira Bio. While we believe that
moving forward such a promising technology will only yield positive results for the Neoprobe
stockholders and the patients who could benefit from these treatments, we do not know if we will be
successful in obtaining funding on terms acceptable to us, or at all.
We anticipate generating a net profit from the sale of our gamma detection devices in 2007,
excluding the allocation of any corporate general and administrative costs; however, we expect to
show a loss for our blood flow measurement device product line for 2007 as a whole. We are
currently devoting minimal incremental resources and funding to support our blood flow measurement
business beyond that needed to support our gamma detection device line and believe we are not far
from a breakeven point for the blood flow measurement line based on the incremental investment
anticipated in our current expectations. We will continue to monitor the state of market
development and success for our blood flow measurement business, as well as other potential
applications and strategic options for the product line. We will adjust our business plans
accordingly. Our overall operating results for 2007 will also be greatly affected by the amount of
development of our radiopharmaceutical products.
19
Primarily as a result of the significant development costs we expect to incur related to the
continued clinical development of Lymphoseek, we do not expect to achieve operating profit during
2007 or 2008. In addition, our net loss and loss per share will likely be significantly impacted
by the non-cash interest expense we expect to record related to the accounting treatment for the
beneficial conversion feature of the convertible debt and for the warrants issued in connection
with the private placement we completed in December 2004 and modified in November 2006, as well as
the private placement we completed in July 2007. We cannot assure you that our current or
potential new products will be successfully commercialized, that we will achieve significant
product revenues, or that we will achieve or be able to sustain profitability in the future.
Results of Operations
Revenue for the first nine months of 2007 increased to $5.2 million from $4.2 million during the
same period in 2006. Research and development expenses, as a percentage of net sales, decreased to
44% during the first nine months of 2007 from 65% during the same period in 2006. Selling, general
and administrative expenses, as a percentage of net sales, decreased to 40% during the first nine
months of 2007 from 54% during the same period in 2006. Research and development expenses as a
percentage of sales are expected to be lower in 2007 than they were in 2006 primarily because costs
related to conducting the Phase 2 Lymphoseek clinical activities in 2007 were lower than the
non-clinical expenses and trial preparation costs incurred in 2006. In addition, should we
continue to be successful in achieving increased sales of our Bluetooth probes, selling, general
and administrative expenses as a percentage of sales are expected to continue to decrease in 2007
compared to 2006.
Three Months Ended September 30, 2007 and 2006
Net Sales and Margins. Net sales, comprised primarily of sales of our gamma detection systems,
increased $1.0 million, or 107%, to $2.0 million during the third quarter of 2007 from $958,000
during the same period in 2006. Gross margins on net sales remained constant at 58% of net sales
for the third quarters of 2007 and 2006.
The increase in net sales was primarily the result of increased gamma detection device sales of
$996,000 and increased gamma detection device extended service contract revenue of $21,000. On a
quarterly basis, revenue from our new Bluetooth wireless probes coupled with unit sales and price
increases on our base gamma detection systems more than offset declines in unit sales of our 14mm
detector probes. The price at which we sell our gamma detection products to EES is based on a
percentage of the global average selling price received by EES on sales of Neoprobe products to end
customers, subject to a minimum floor price. The base system price at which we sold neo2000
systems to EES decreased approximately 2% during the third quarter of 2007 compared to the same
period in 2006.
Gross margins on net product sales remained steady during the third quarter of 2007. Gross margins
on our gamma detection devices reflected the combination of lower margins on sales of Bluetooth
probe demonstration units, higher than expected production costs on our initial production runs of
Bluetooth probes, increased estimated warranty costs related to the commercial launch of our new
Bluetooth probe products, and a price decline on base gamma detection systems sold by EES as
compared to the third quarter of 2006. The decline in gamma detection device gross margins was
offset by increased gross margins on our blood flow measurement devices, which were adversely
affected by inventory impairments of $54,000 in the third quarter of 2006.
Research and Development Expenses. Research and development expenses decreased $693,000 or 56% to
$548,000 during the third quarter of 2007 from $1.2 million during the same period in 2006.
Research and development expenses in the third quarter of 2007 included approximately $310,000 in
drug and therapy product development costs, $152,000 in gamma detection device development costs,
and $86,000 in product design activities for the Quantix products. This compares to expenses of
$832,000, $279,000 and $131,000 in these relative segment categories during the same period in
2006. The changes in each category were primarily due to (i) lower costs related to the conduct
the Phase 2 Lymphoseek clinical activities in 2007 than the non-clinical expenses and trial
preparation costs incurred
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in 2006, (ii) decreased product development activities related to our Bluetooth wireless gamma
detection probes, and (iii) decreased product refinement activities related to the
Quantix/ORTM, respectively.
Selling, General and Administrative Expenses. Selling, general and administrative expenses
increased $39,000 or 6% to $690,000 during the third quarter of 2007 from $651,000 during the same
period in 2006. The net difference was due primarily to increases in professional services and
personnel-related costs, partially offset by decreases in facilities expenses and insurance.
Other Income (Expenses). Other expenses increased $534,000 to $852,000 during the third quarter of
2007 from $318,000 during the same period in 2006. Interest expense related to the convertible
debt agreements we completed in December 2004 and July 2007 increased $492,000 to $863,000 during
the third quarter of 2007 from $371,000 for the same period in 2006. Of this interest expense,
$646,000 and $207,000 in the third quarters of 2007 and 2006, respectively, was non-cash in nature
related to the amortization of debt issuance costs and discounts resulting from the warrants and
beneficial conversion features of the convertible debt, including a $286,000 adjustment in non-cash
interest expense recorded during the third quarter of 2007 as discussed in Note 8. In addition,
we recorded a decrease of $44,000 in interest income related to lower balances of cash and
investments during the third quarter of 2007 compared to the same period in 2006.
Nine Months Ended September 30, 2007 and 2006
Net Sales and Margins. Net sales, comprised primarily of sales of our gamma detection systems,
increased $1.0 million, or 26%, to $5.2 million during the first nine months of 2007 from $4.2
million during the same period in 2006. Gross margins on net sales decreased to 56% of net sales
for the first nine months of 2007 compared to 58% of net sales for the same period in 2006.
The increase in net sales was the result of increased gamma detection device sales of $1.1 million
and increased gamma detection device extended service contract revenue of $65,000, offset by
decreases of $108,000 in blood flow measurement device sales and $17,000 in gamma detection device
service-related revenue. Revenue from our new Bluetooth wireless probes more than offset declines
in unit sales and pricing on our base gamma detection systems on a year-to-date basis. The price
at which we sell our gamma detection products to EES is based on a percentage of the global average
selling price received by EES on sales of Neoprobe products to end customers, subject to a minimum
floor price. The base system price at which we sold neo2000 systems to EES decreased approximately
2% during the first nine months of 2007 compared to the same period in 2006.
The decrease in gross margins on net product sales was primarily due to a combination of factors
including lower margins on sales of Bluetooth probe demonstration units during the first nine
months of 2007, higher than expected production costs on our initial production runs of Bluetooth
probes, increased estimated warranty costs following the commercial launch of our new Bluetooth
probe products, and a price decline on base gamma detection systems sold by EES. Gross margins in
the first nine months of 2007 and 2006 were also adversely affected by inventory impairments of
$48,000 and $54,000, respectively, related to our Quantix products.
Research and Development Expenses. Research and development expenses decreased $431,000 or 16% to
$2.3 million during the first nine months of 2007 from $2.7 million during the same period in 2006.
Research and development expenses in the first nine months of 2007 included approximately $1.5
million in drug and therapy product development costs, $532,000 in gamma detection device
development costs and $291,000 in product design activities for the Quantix products. This
compares to expenses of $1.5 million, $626,000 and $589,000 in these relative segment categories
during the same period in 2006. The changes in each category were primarily due to (i) lower costs
related to the conduct the Phase 2 Lymphoseek clinical activities in 2007 than the non-clinical
expenses and trial preparation costs incurred in 2006, (ii) decreased product development
activities related to our Bluetooth wireless gamma detection probes, and (iii) decreased product
refinement activities related to the Quantix/OR, respectively.
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Selling, General and Administrative Expenses. Selling, general and administrative expenses
decreased $135,000 or 6% to $2.1 million during the first nine months of 2007 from $2.3 million
during the same period in 2006. The net difference was due primarily to decreases in marketing,
facilities expenses, insurance, and other personnel-related expenses that were partially offset by
increases in professional services.
Other Income (Expenses). Other expenses increased $789,000 to $1.7 million during the first nine
months of 2007 from $908,000 during the same period in 2006. Interest expense related to the
convertible debt agreements we completed in December 2004 and July 2007 increased $659,000 to $1.7
million during the first nine months of 2007 from $1.1 million for the same period in 2006. Of
this interest expense, $1.1 million and $596,000 in the first nine months of 2007 and 2006,
respectively, was non-cash in nature related to the amortization of debt issuance costs and
discounts resulting from the warrants and beneficial conversion features of the convertible debt.
The increase in non-cash interest was primarily due to the impact of the acceleration of principal
repayments on the effective interest method of calculating the discount amortization which the
company adjusted during the third quarter of 2007. In addition, we recorded a decrease of $128,000
in interest income related to lower balances of cash and investments during the first nine months
of 2007 compared to the same period in 2006.
Liquidity and Capital Resources
Cash balances decreased to $1.2 million at September 30, 2007 from $2.5 million at December 31,
2006. The decrease was primarily a result of cash used in operations, mainly for research and
development activities, and to service our debt, partially offset by proceeds from issuance of
common stock and a new convertible note agreement during the first nine months of 2007. The
current ratio decreased to 0.7:1 at September 30, 2007 from 1.6:1 at December 31, 2006. The
significant decrease in the current ratio was primarily due to the reclassification of $3.75
million in principal amount of long term debt as a current liability, due to scheduled payment
dates that are now within one year of September 30, 2007.
Operating Activities. Cash used in operations decreased $1.3 million to $1.2 million during the
first nine months of 2007 compared to $2.5 million during the same period in 2006.
Accounts receivable increased to $1.4 million at September 30, 2007 from $1.2 million at December
31, 2006. The increase was primarily a result of normal fluctuations in timing of purchases and
payments by EES, including a pronounced increase in sales experienced during the third quarter of
2007 and better than expected pricing related to our Bluetooth probe as compared to the provisional
price. We expect overall receivable levels will continue to fluctuate during 2007 depending on the
timing of purchases and payments by EES.
Inventory levels decreased to $1.0 million at September 30, 2007 as compared to $1.2 million at
December 31, 2006. Gamma detection device materials and work-in-process inventories decreased as
we completed and sold the initial production runs of Bluetooth wireless probes, while finished
device inventories increased due to normal fluctuations in timing of production runs and sales to
EES. Blood flow measurement device materials and finished device inventories decreased, primarily
due to recording inventory impairment charges totaling $48,000 during the first nine months of
2007. These decreases were partially offset by increases in drug work-in-process inventories as we
completed the second commercial production run of Lymphoseek. We expect inventory levels to
increase somewhat over the remainder of 2007.
Investing Activities. Investing activities used $43,000 during the first nine months of 2007
versus $1.4 million provided during the same period in 2006. We received $1.5 million from
maturities of available-for-sale securities during the first nine months of 2006. Capital
expenditures during the first nine months of 2007 and 2006 were primarily for production tools and
equipment and software. We expect our overall capital expenditures for 2007 will be lower than for
2006.
Financing Activities. Cash used in financing activities decreased $229,000 to $13,000 during the
first nine months of 2007 from $241,000 during the same period in 2006. Proceeds from the issuance
of
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common stock were $1.3 million during the first nine months of 2007. Proceeds from the issuance of
new notes payable were $1.0 million during the same period. Payments of debt issuance costs were
$68,000 and $30,000 during the first nine months of 2007 and 2006, respectively. Payments of notes
payable were $2.2 million and $197,000 during the first nine months of 2007 and 2006, respectively.
In December 2004, we completed a private placement of four-year convertible promissory notes in an
aggregate principal amount of $8.1 million with Biomedical Value Fund, L.P., Biomedical Offshore
Value Fund, Ltd. and David C. Bupp (our President and CEO). Biomedical Value Fund, L.P. and
Biomedical Offshore Value Fund, Ltd. are funds managed by Great Point Partners, LLC (the Great
Point Funds). We modified the convertible notes in November 2006 to eliminate the revenue and cash
covenants, modify the repayment schedule of the notes, eliminate certain anti-dilution rights, and
avoid potential future violations of the debt covenants. The notes originally bore interest at 8%
per annum and were originally due on December 13, 2008. The modified notes bear interest at 12%
per annum. Also, instead of the principal being due on December 13, 2008, the principal is now due
as follows: $500,000 due January 8, 2007; $1,250,000 due July 9, 2007; $1,750,000 due January 7,
2008; $2,000,000 due July 7, 2008; and the remaining $2,600,000 due January 7, 2009. Additionally,
as part of the amendment we agreed to use our best efforts to offer and sell equity securities with
gross proceeds of up to $10 million and apply not less than 50% of the net proceeds of any such
sales to the repayment of the principal on the notes, and to apply at least 50% of the proceeds of
any permitted asset disposition or any permitted licensing, distribution or similar strategic
alliance agreement to the repayment of principal on the notes. The notes are freely convertible
into shares of our common stock at a price of $0.40 per share. Neoprobe may force conversion of
the notes prior to their stated maturity under certain circumstances. As part of the original
transaction, we issued the investors 10,125,000 Series T warrants to purchase our common stock at
an exercise price of $0.46 per share, expiring in December 2009. In connection with the original
placement of this financing, we issued 1,600,000 Series U warrants to purchase our common stock to
the placement agents, containing substantially identical terms to the warrants issued to the
investors. During the first nine months of 2007, we made a total of $2,075,000 in principal
repayments to the Great Point Funds. The payments made to the Great Point Funds through September
30, 2007 have reduced the January 7, 2008 payment to $1.4 million. The convertible promissory note
issued to Mr. Bupp in connection with this transaction had an outstanding principal amount of
$100,000 on September 30, 2007, and an outstanding principal amount of $100,000 as of November 9,
2007. During the first nine months of 2007 and 2006, we made interest payments due under the note
to Mr. Bupp totaling $6,000 in both periods.
In December 2006, we entered into a common stock purchase agreement with Fusion Capital Fund II,
LLC (Fusion). We have authorized up to 12,000,000 shares of our common stock for sale to Fusion
under the agreement. Under the terms of the agreement, in December 2006, we issued 720,000 shares
of our common stock as an initial commitment fee. We are also required to issue to Fusion up to an
additional 720,000 shares of our common stock as an additional commitment fee in connection with
future purchases made by Fusion. The additional 720,000 shares will be issued pro rata as we sell
our common stock to Fusion under the agreement, resulting in a total commitment fee of 1,440,000
shares of our common stock if the entire $6.0 million in value of stock is sold. The price of
shares sold to Fusion will generally be based on market prices for purchases that are not subject
to the floor price of $0.20 per share. We filed a registration statement covering sales to Fusion
and shares issued as additional commitment fees under the agreement, which became effective on
December 28, 2006. During the first nine months of 2007, we sold a total of 5,276,442 shares of
our common stock under the agreement, realized gross proceeds of $1.3 million from such sales, and
issued 156,000 shares of our common stock to Fusion as additional commitment fees related to such
sales. All of such sales and issuances were made pursuant to the registration statement.
In July 2007, David C. Bupp (our President and CEO) and certain members of his family purchased a
$1.0 million convertible note and warrants. The note bears interest at 10% per annum during its
one-year term and is repayable in whole or in part with no penalty. The note is convertible into
shares of our common stock at a price of $0.31 per share, a 25% premium to the average closing
market price of our common stock for the 5 days preceding the closing of the transaction. As part
of this transaction, we issued the purchasers 500,000 Series V warrants to purchase our common
stock at an exercise price of $0.31 per share, expiring in July 2012. The convertible promissory
note issued to Mr. Bupp in connection
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with this transaction had an outstanding principal amount of $1.0 million on September 30, 2007,
and an outstanding principal amount of $1.0 million as of November 9, 2007.
Our future liquidity and capital requirements will depend on a number of factors, including our
ability to raise additional capital in a timely manner through additional investment, expanded
market acceptance of our current products, our ability to complete the commercialization of new
products, our ability to monetize our investment in non-core technologies, our ability to obtain
milestone or development funds from potential development and distribution partners, regulatory
actions by FDA and international regulatory bodies, and intellectual property protection. Our most
significant near-term development priority is to commence Phase 3 clinical trials for Lymphoseek.
However, we also have to service a significant amount of debt that comes due over the next twelve
to eighteen months. We have timely paid all principal amounts due in 2007 under our amended 2004
convertible note agreement with the Great Point Funds; however, we have significant additional
principal repayments due under this agreement starting with a January 7, 2008 payment of $1.4
million and continuing at increasing amounts approximately every six months thereafter through
early 2009 that, based on our current operating plan, will require us to raise additional capital.
Through September 30, 2007, we have been successful in raising some capital through our common
stock purchase agreement with Fusion, allowing us to decrease the principal amount due on January
7, 2008 from $1.75 million to $1.4 million; however, we believe it is unlikely we will be able to
fund the remaining Phase 3 clinical study and development costs for Lymphoseek and meet our debt
obligations beyond January 2008 using the Fusion facility alone. We are actively soliciting and
evaluating other potential sources of equity and debt funding. However, if we are unsuccessful in
obtaining financing, we may be forced to seek relief from our current debt obligations and/or
significantly modify or curtail our strategic plans and operations in order to meet our obligations
as currently anticipated. If we are unable to meet our obligations, and we are unsuccessful in
obtaining modification of our existing debt terms, there is a risk that we may default on these
obligations, entitling these creditors to resort to legal remedies, including the sale of
collateral securing the loans. We cannot assure you that we will be successful in raising
additional capital through Fusion or any other sources at terms acceptable to the Company, or at
all. In addition, we cannot assure you that we will be able to achieve significant product
revenues from our current or potential new products. We also cannot assure you that we will
achieve profitability again.
Recent Accounting Developments
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards (SFAS) No. 157, Fair Value Measurements (SFAS No. 157). SFAS No. 157 defines
fair value, establishes a framework for measuring fair value in generally accepted accounting
principles, and expands disclosures about fair value measurements. SFAS No. 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 No. 157 does not require any new fair value measurements. SFAS No.
157 is effective for fiscal years beginning after November 15, 2007, and is required to be adopted
by Neoprobe beginning January 1, 2008. We do not expect the adoption of SFAS No. 157 to have a
material impact on our consolidated results of operations or financial condition.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS No.
159 permits entities to choose to measure many financial instruments and certain other items at
fair value at specified election dates. Most of the provisions of SFAS No. 159 apply only to
entities that elect the fair value option. However, the amendment to FASB Statement No. 115,
Accounting for Certain Investments in Debt and Equity Securities, applies to all entities with
available-for-sale and trading securities. The fair value option established by SFAS No. 159
permits all entities to choose to measure eligible items at fair value at specified election dates.
A business entity shall report unrealized gains and losses on items for which the fair value
option has been elected in earnings at each subsequent reporting date. The fair value option may
be applied instrument by instrument, with a few exceptions, such as investments otherwise accounted
for by the equity method, is irrevocable (unless a new election date occurs), and is applied only
to entire instruments and not to portions of instruments. SFAS No. 159 is
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effective for fiscal years beginning after November 15, 2007. Early adoption is permitted as of
the beginning of a fiscal year that begins on or before November 15, 2007, provided the entity also
elects to apply the provisions of SFAS No. 157, Fair Value Measurements. We plan to adopt SFAS No. 159 as required on January 1, 2008; however,
we do not plan to elect to measure any of our currently outstanding financial instruments using the fair value option outlined in SFAS No. 159.
As such, we do not expect the adoption of SFAS No. 159 to have a material impact on our consolidated results of operations or
financial condition.
In June 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force (EITF) on
Issue 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to be Used in
Future Research and Development Activities (EITF 07-3). The scope of EITF 07-3 is focused on the
accounting for non-refundable advance payments for goods that will be used or services that will be
performed in future research and development activities. The FASB concluded that these types of
payments should be deferred and capitalized until the goods have been delivered or the related
services have been rendered. EITF 07-3 is effective for financial statements issued for fiscal
years beginning after December 15, 2007, and interim periods within those fiscal years. We do not
expect EITF 07-3 to have a material effect on our consolidated results of operations or financial
condition.
Critical Accounting Policies
The following accounting policies are considered by us to be critical to our results of operations
and financial condition.
Revenue Recognition Related to Net Sales. We currently generate revenue primarily from sales of
our gamma detection products. Our standard shipping terms are FOB shipping point, and title and
risk of loss passes to the customer upon delivery to a common carrier. We generally recognize
sales revenue related to sales of our products when the products are shipped and the earnings
process has been completed. However, in cases where product is shipped but the earnings process is
not yet completed, revenue is deferred until it has been determined that the earnings process has
been completed. Our customers have no right to return products purchased in the ordinary course of
business.
The prices we charge our primary customer, EES, related to sales of products are subject to
retroactive annual adjustment based on a fixed percentage of the actual sales prices achieved by
EES on sales to end customers made during each fiscal year. To the extent that we can reasonably
estimate the end-customer prices received by EES, we record sales to EES based upon these
estimates. If we are unable to reasonably estimate end customer sales prices related to certain
products sold to EES, we record revenue related to these product sales at the minimum (i.e., floor)
price provided for under our distribution agreement with EES.
We also generate revenue from the service and repair of out-of-warranty products. Fees charged for
service and repair on products not covered by an extended service agreement are recognized on
completion of the service process when the serviced or repaired product has been returned to the
customer. Fees charged for service or repair of products covered by an extended warranty agreement
are deferred and recognized as revenue ratably over the life of the extended service agreement.
Use of Estimates. The preparation of financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities
at the date of the financial statements and the reported amounts of revenues and expenses during
the reporting period. We base these estimates and assumptions upon historical experience and
existing, known circumstances. Actual results could differ from those estimates. Specifically,
management may make significant estimates in the following areas:
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Stock-Based Compensation. Effective January 1, 2006, we adopted SFAS No. 123(R),
Share-Based Payment, which is a revision of SFAS No. 123, Accounting for Stock-Based
Compensation. SFAS No. 123(R) supersedes APB Opinion No. 25, Accounting for Stock Issued
to Employees, and amends SFAS No. 95, Statement of Cash Flows. SFAS No. 123(R) requires
all share-based payments to employees, including grants of employee stock options, to be
recognized in the income statement based on their estimated fair values. Compensation cost |
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arising from stock-based awards is recognized as expense using the straight-line method over
the vesting period. We used the modified prospective application method in adopting SFAS
No. 123 (R). We use the Black-Scholes option pricing model to value share-based payments.
The valuation assumptions used have not changed from those used under SFAS No. 123. Prior
to the adoption of SFAS No. 123(R), we followed the guidance in APB No. 25 which resulted in
disclosure only of the financial impact of stock options. Financial statements of the
Company for periods prior to January 1, 2006 do not reflect any recorded stock-based
compensation expense. In adopting SFAS No. 123(R), we made no modifications to outstanding
stock options, nor do we have any other outstanding share-based payment instruments subject
to SFAS No. 123(R). Based in part on the anticipated adoption of SFAS No. 123(R), the
Company generally reduced the number of stock options issued by individual in 2005 and
shortened the vesting periods, with a portion of the options vesting immediately and the
remainder vesting over a two-year period as compared to our previous practice of issuing
stock options that vested over a three-year period. We will continue to evaluate
compensation trends and may further revise our option granting practices in future years. |
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Inventory Valuation. We value our inventory at the lower of cost (first-in, first-out
method) or market. Our valuation reflects our estimates of excess, slow moving and
obsolete inventory as well as inventory with a carrying value in excess of its net
realizable value. Write-offs are recorded when product is removed from saleable inventory.
We review inventory on hand at least quarterly and record provisions for excess and
obsolete inventory based on several factors, including current assessment of future product
demand, anticipated release of new products into the market, historical experience and
product expiration. Our industry is characterized by rapid product development and
frequent new product introductions. Uncertain timing of product approvals, variability in
product launch strategies, product recalls and variation in product utilization all impact
the estimates related to excess and obsolete inventory. |
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Impairment or Disposal of Long-Lived Assets. We account for long-lived assets in
accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal
of Long-Lived Assets. This Statement requires that long-lived assets and certain
identifiable intangibles be reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be recoverable. The
recoverability of assets to be held and used is measured by a comparison of the carrying
amount of an asset to future net undiscounted cash flows expected to be generated by the
asset. If such assets are considered to be impaired, the impairment to be recognized is
measured by the amount by which the carrying amount of the assets exceeds the fair value of
the assets. Assets to be disposed of are reported at the lower of the carrying amount or
fair value less costs to sell. As of September 30, 2007, the most significant long-lived
assets on our balance sheet relate to assets recorded in connection with the acquisition of
Cardiosonix and gamma detection device patents related to ILM. The recoverability of these
assets is based on the financial projections and models related to the future sales success
of Cardiosonix products and the continuing success of our gamma detection product line.
As such, these assets could be subject to significant adjustment should the Cardiosonix
technology not be successfully commercialized or the sales amounts in our current
projections not be realized. |
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Product Warranty. We warrant our products against defects in design, materials, and
workmanship generally for a period of one year from the date of sale to the end customer.
Our accrual for warranty expenses is adjusted periodically to reflect actual experience.
EES also reimburses us for a portion of warranty expense incurred based on end customer
sales they make during a given fiscal year. |
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Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for
forward-looking statements made by or on behalf of the Company. From time to time, our
representatives and we may make written or verbal forward-looking statements, including statements
contained in this report and other Company filings with the SEC and in our reports to stockholders.
Statements that relate to other than strictly historical facts, such as statements about our plans
and strategies, expectations for future financial performance, new and existing products and
technologies, anticipated clinical and regulatory pathways, and markets for our products are
forward-looking statements within the meaning of the Act. Generally, the words believe,
expect, intend, estimate, anticipate, will and other similar expressions identify
forward-looking statements. The forward-looking statements are and will be based on our
then-current views and assumptions regarding future events and operating performance, and speak
only as of their dates. Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially from historical or anticipated
results due to many factors including, but not limited to, our continuing operating losses,
uncertainty of market acceptance of our products, reliance on third party manufacturers,
accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited marketing and manufacturing
experience, risks of development of new products, regulatory risks, and other risks detailed in our
most recent Annual Report on Form 10-KSB and other SEC filings. We undertake no obligation to
publicly update or revise any forward-looking statements.
Item 3. Controls and Procedures
Under the supervision and with the participation of our management, including our Chief Executive
Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of
our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange
Act of 1934 (the Exchange Act)). Based on that evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that, as of the end of the period covered by this report, our
disclosure controls and procedures are adequately designed and effective to provide reasonable
assurance that the information required to be disclosed by us in the reports we file or submit
under the Exchange Act is recorded, possessed, summarized and reported, within the time periods
specified in the applicable rules and forms. During the last fiscal quarter covered by this
Quarterly Report on Form 10-QSB, there was no change in our internal control over financial
reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified in connection with the
evaluation required by paragraph (d) of Rule 13a-15 that materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
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PART II
OTHER INFORMATION
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
(a) |
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On July 10, 2007, we issued 50,000 shares of our common stock to an investment banking firm
in exchange for investment advisory services. The issuance of these shares was exempt from
registration under Sections 4(2) and 4(6) of the Securities Act and Regulation D. |
Item 4. Submission of Matters to a Vote of Security Holders
(a) |
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Neoprobe Corporation held its Annual Meeting of Stockholders on July 26, 2007, for the
purpose of electing two directors. |
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(b) |
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At the Annual Meeting of Stockholders, Reuven Avital and David C. Bupp were elected. The
terms of office as director continued after the meeting for Carl J. Aschinger, Jr., Kirby I.
Bland, M.D., Fred B. Miller, and J. Frank Whitley, Jr. |
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(c) |
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The following table shows the voting tabulation for the election of directors. |
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ACTION |
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FOR |
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WITHHELD |
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Election of Directors: |
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Reuven Avital |
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45,025,946 |
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4,042,689 |
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David C. Bupp |
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44,719,888 |
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4,348,747 |
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Item 6. Exhibits
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31.1 |
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Certification of Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification of Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certification of Chief Executive Officer of Periodic Financial Reports pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350. |
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32.2 |
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Certification of Chief Financial Officer of Periodic Financial Reports pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350. |
Items 1, 3 and 5 are not applicable and have been omitted.
28
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized.
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NEOPROBE CORPORATION
(the Company)
Dated: November 14, 2007 |
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By:
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/s/ DAVID C. BUPP |
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David C. Bupp
President and Chief Executive Officer
(duly authorized officer; principal executive officer) |
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By:
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/s/ BRENT L. LARSON |
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Brent L. Larson
Vice President, Finance and Chief Financial Officer
(principal financial and accounting officer) |
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29