e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2009
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000 51481
ELECTRO-OPTICAL SCIENCES, INC.
(Exact name of Registrant as specified in its charter)
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Delaware
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13-3986004 |
(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.) |
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3 West Main Street, Suite 201 |
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Irvington, New York
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10533 |
(Address of Principal Executive offices)
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(Zip Code) |
Registrants Telephone Number, including area code:
(914) 591-3783
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definition of accelerated filer large
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes
o 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 þ
As of November 5, 2009, 22,247,829 shares of the Registrants common stock were outstanding.
Electro-Optical Sciences, Inc.
Table of Contents
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PART I. FINANCIAL INFORMATION |
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ITEM 1. Financial Statements |
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17 |
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25 |
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26 |
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26 |
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26 |
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29 |
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29 |
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29 |
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29 |
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30 |
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31 |
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32 |
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EX-31.1 |
EX-31.2 |
EX-32.1 |
1
ELECTRO-OPTICAL SCIENCES, INC.
CONDENSED BALANCE SHEETS
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September 30, |
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December 31, |
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2009 |
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2008 |
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(unaudited) |
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* |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
24,779,013 |
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$ |
15,069,939 |
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Marketable securities |
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390,512 |
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Prepaid expenses and other current assets |
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410,517 |
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375,612 |
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Total Current Assets |
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25,189,530 |
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15,836,063 |
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Property and equipment, net |
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663,763 |
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643,383 |
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Patents and trademarks, net |
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85,983 |
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94,908 |
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Deferred offering costs |
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140,407 |
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Other assets |
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48,000 |
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45,276 |
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Total Assets |
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$ |
26,127,683 |
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$ |
16,619,630 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current Liabilities: |
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Accounts payable (includes related parties of $13,906
as of September 30, 2009 and $17,500 as of December
31, 2008) |
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$ |
838,669 |
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$ |
634,394 |
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Accrued expenses |
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658,007 |
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832,228 |
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Deferred income |
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36,085 |
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Other current liabilities |
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28,835 |
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27,466 |
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Total Current Liabilities |
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1,525,511 |
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1,530,173 |
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COMMITMENTS AND CONTINGENCIES (Note 9) |
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Stockholders Equity |
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Preferred stock $.10 par value; authorized
10,000,000 shares; issued and outstanding: none |
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Common stock $.001 par value; authorized 30,000,000
shares; issued and outstanding 21,002,269 shares at
September 30, 2009 and 17,634,498 at December 31,
2008 |
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21,002 |
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17,634 |
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Additional paid-in capital |
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98,220,977 |
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75,845,953 |
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Accumulated other comprehensive loss |
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(6,868 |
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Accumulated deficit |
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(73,639,807 |
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(60,767,262 |
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Stockholders Equity |
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24,602,172 |
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15,089,457 |
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Total Liabilities and Stockholders Equity |
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$ |
26,127,683 |
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$ |
16,619,630 |
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Derived from the audited balance sheet as of December 31, 2008 |
See accompanying notes to the financial statements
2
ELECTRO-OPTICAL SCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
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Three months ended September 30, |
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Nine months ended September 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Operating expenses: |
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Research and development |
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$ |
2,801,208 |
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$ |
3,325,122 |
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$ |
7,636,224 |
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$ |
9,994,205 |
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General and administrative |
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2,262,571 |
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1,043,111 |
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5,361,123 |
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3,957,585 |
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Operating loss |
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(5,063,779 |
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(4,368,233 |
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(12,997,347 |
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(13,951,790 |
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Interest income |
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7,589 |
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105,569 |
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42,357 |
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380,167 |
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Other income |
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8,329 |
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62,752 |
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82,445 |
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143,610 |
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Net loss: |
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$ |
(5,047,861 |
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$ |
(4,199,912 |
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$ |
(12,872,545 |
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$ |
(13,428,013 |
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Basic and diluted net
loss per common share |
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$ |
(0.26 |
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$ |
(0.25 |
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$ |
(0.70 |
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$ |
(0.85 |
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Basic and diluted weighted
average number of common
shares outstanding |
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19,760,367 |
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16,678,852 |
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18,358,579 |
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15,832,391 |
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See accompanying notes to the financial statements
3
ELECTRO-OPTICAL SCIENCES, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
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Nine Months Ended September 30, |
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2009 |
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2008 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(12,872,545 |
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$ |
(13,428,013 |
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Adjustments to reconcile net loss to net cash used in operating
activities: |
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Depreciation and amortization |
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233,599 |
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225,825 |
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Non-cash compensation |
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410,621 |
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248,140 |
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Amortization of discount on marketable securities |
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519 |
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Changes in operating assets and liabilities: |
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Increase in other assets |
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(2,724 |
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(Increase) decrease in prepaid expenses and other current assets |
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(34,904 |
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263,072 |
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Increase in accounts payable and accrued expenses |
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30,054 |
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685,286 |
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Decrease in deferred income |
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(36,085 |
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(72,861 |
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Increase in other current liabilities |
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1,369 |
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8,642 |
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Net cash used in operating activities |
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(12,270,615 |
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(12,069,390 |
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Cash flows from investing activities: |
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Purchases of property and equipment |
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(245,054 |
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(298,733 |
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Proceeds from sale of marketable securities |
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397,380 |
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934,347 |
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Net cash provided by investing activities |
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152,326 |
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635,614 |
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Cash flows from financing activities: |
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Proceeds from exercise of stock options |
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167,807 |
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34,770 |
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Proceeds from exercise of stock warrants |
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121,672 |
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10,586 |
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Proceeds from registered direct offering-financing |
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15,000,000 |
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11,909,057 |
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Expenses relating to registered direct offering-financing |
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(1,249,593 |
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(941,438 |
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Proceeds from Committed Equity Financing Facility |
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7,977,000 |
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Expenses relating to Committed Equity Financing Facility |
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(189,523 |
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Net cash provided by financing activities |
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21,827,363 |
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11,012,975 |
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Net increase (decrease) in cash and cash equivalents |
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9,709,074 |
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(420,801 |
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Cash and cash equivalents at beginning of period |
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15,069,939 |
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19,196,589 |
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Cash and cash equivalents at end of period |
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$ |
24,779,013 |
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$ |
18,775,788 |
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Supplemental Schedule of Non-cash Investing and Financing Activities |
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Unrealized gain on marketable securities |
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$ |
6,868 |
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$ |
10,237 |
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See accompanying notes to the financial statements
4
ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(In thousands, except for share and per share data)
(unaudited)
1. ORGANIZATION AND BASIS OF PRESENTATION
Electro-Optical Sciences, Inc., a Delaware corporation (EOS or the Company) is a medical device
company focused on the design, development and commercialization of a non-invasive, point-of-care
instrument to assist in the early diagnosis of melanoma. Our flagship product,
MelaFind®, features a hand-held imaging device that emits light of multiple
wavelengths to capture images of suspicious pigmented skin lesions and extract data. The data are
then analyzed utilizing image processing classification algorithms, trained on our proprietary
database of melanomas and benign lesions, to provide information to assist in the management of the
patient, including information useful in the decision of whether to biopsy the lesion.
The components of the MelaFind® system include:
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a hand-held imaging device, which employs high precision optics and multi-spectral illumination
(multiple colors of light including near infra-red); |
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a proprietary database of pigmented skin lesions, which we believe to be the largest in the U.S.; and |
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lesion classifiers, which are sophisticated mathematical algorithms that extract lesion feature
information and classify lesions. |
On June 3, 2009, the Company submitted the MelaFind® Pre-market Approval
Application (PMA) to the U.S. Food and Drug Administration (FDA), which the FDA has previously
indicated will receive expedited review. Expedited review means that upon filing the PMA
application, the FDA will conduct a team review, prioritize the application, and allocate
sufficient resources toward a 180 day review period. While the expedited review could shorten the
MelaFind® FDA approval process, the Company can provide no assurances that this will be
the case.
The Company was notified by the FDA, pursuant to the submission of the MelaFind®
Pre-Market Approval Application on June 3, 2009, that the application was suitable for filing, and
the official filing date is June 9, 2009. The MelaFind® PMA is under review at the FDA,
and the Company is actively working with the FDA during this process. The date for an anticipated
FDA Advisory Panel to review the MelaFind® PMA has not been established, therefore, we
expect the review of the MelaFind® PMA to continue into 2010.
To date the Company has not generated any revenues from MelaFind®.
The Company anticipates that it will continue to incur net losses for the foreseeable future in the
development and commercialization of the Melafind® device. From inception,
the Company financed operations primarily through the sale of convertible preferred stock and
subsequently sold common stock as part of an initial public offering (IPO) on October 28, 2005,
two private placements: (one that closed in November 2006 and a second that closed in August 2007)
and two registered direct offerings (one that closed in August 2008 and a second that closed July
2009).
On May 7, 2009, the Company entered into a committed equity financing facility (CEFF) with
Kingsbridge Capital Limited, pursuant to which Kingsbridge committed to purchase, subject to
certain conditions, up to the lesser of $45 million or 3,327,000 shares of the Companys common
stock, subject to various other contractual and regulatory requirements. There is no assurance
that the Company will satisfy all the various conditions allowing it to use all of the CEFF.
5
In connection with this CEFF, the Company issued a 5 year warrant, exercisable as of November 7,
2009, to Kingsbridge to purchase up to 200,000 shares of the Companys common stock at an exercise
price of $11.35 per share, with a Black Scholes Fair Value of $678 (refer to Note 10 for further
details). A registration statement on Form S-3 was declared effective on May 22, 2009, on which
3,527,000 shares of common stock were registered for resale if and when acquired by Kingsbridge
under the CEFF and its warrant.
On July 16, 2009, the Company completed, pursuant to the Companys shelf registration statement on
Form S-3, a registered direct offering of 2,400,000 shares of the Companys common stock with a
select group of institutional investors. The aggregate gross proceeds from the offering were $15
million (with net proceeds of approximately $13.75 million). The offering closed on July 22, 2009
for a purchase price of $6.25 per share of the Companys common stock. Approximately $13.1 million
remains available under the Companys shelf registration statement as of September 30, 2009.
Under the May 7, 2009 CEFF, during August and September of 2009, the Company sold 862,201 shares of
common stock to Kingsbridge Capital Limited, at an average per share price of approximately $9.25,
for gross proceeds of $7.977 million. A proportionate share of the CEFF originating expenses was
allocated to this sale from deferred financing expense. Net of expenses, proceeds from this sale
were approximately $7.928 million.
Subsequent to September 30, 2009 and through November 5, 2009, also under the CEFF, the Company
sold 962,740 shares of common stock to Kingsbridge Capital Limited, at an average per share price
of approximately $9.23, for gross proceeds of $8.886 million. A proportionate share of the CEFF
originating expenses was allocated to this sale from deferred offering costs. Net of expenses,
proceeds from this sale were approximately $8.831 million (see also Note 14).
The Company faces certain risks and uncertainties which are present in many emerging medical device
companies regarding future profitability, ability to obtain future capital, protection of patents
and intellectual property rights, competition, rapid technological change, government regulations,
changing health care marketplace, recruiting and retaining key personnel, and reliance on third
party manufacturing organizations.
As of September 30, 2009, the Companys total of cash, cash equivalents and marketable securities
was $24.8 million. The Company will require additional funds to fully commercialize
Melafind®. There can be no assurances that the Company will be able to raise
funds as needed from time to time, whether under the Kingsbridge Capital Limited CEFF or by other
types of financing. Funds that become available may not be on acceptable terms, and there can be no
assurance that any additional funding the Company does obtain will be sufficient to meet the
Companys needs in the long term.
The unaudited condensed financial statements included herein have been prepared from the books and
records of the Company pursuant to the rules and regulations of the SEC for reporting on Form 10-Q.
The information and note disclosures normally included in complete financial statements prepared in
accordance with generally accepted accounting principles (GAAP) in the United States have been
condensed or omitted pursuant to such rules and regulations. The interim financial statements
should be read in conjunction with the audited financial statements and notes thereto included in
the Companys Annual Report on Form 10-K for the year ended December 31, 2008.
The Companys management is responsible for the financial statements included in this document. The
Companys interim financial statements are unaudited. Interim results may not be indicative of the
results that may be expected for the year. However, the Company believes all adjustments considered
necessary for a fair presentation of these interim financial statements have been included and are
of a normal and recurring nature.
6
2. MARKETABLE SECURITIES
At
December 31, 2008, the Companys marketable securities generally
consisted of corporate debt securities with a weighted
average maturity not in excess of twelve months. The Company classifies its marketable securities
as available-for-sale, as defined by Financial Accounting Standards Board (FASB) Accounting
Standards Codification (ASC) 320, Accounting for Certain Investments in Debt and Equity
Securities. Available-for-sale securities are carried at fair value, with unrealized gains and
losses reported as a component of stockholders equity in accumulated other comprehensive loss.
Interest income, realized gains and losses, and declines in value of securities judged to be
other-than-temporary are included in the Companys statement of operations. As of September 30,
2009, the Company did not hold any marketable securities.
The Company evaluates declines in the fair value of its investments in available-for-sale
marketable securities to determine if these declines are other-than-temporary. When a decline in
value is determined to be other-than-temporary, an impairment charge would be recorded and a new
cost basis in the investment would be established.
3. COMPREHENSIVE LOSS
Comprehensive loss includes net loss and unrealized gains and losses on available-for-sale
marketable securities. Cumulative unrealized gains and losses on available-for-sale marketable
securities are reflected as accumulated other comprehensive loss in stockholders equity on the
Companys balance sheet. As of September 30, 2009, the Company did not hold any marketable
securities.
For the three months ended September 30, 2009, comprehensive loss and net loss were $5,048 as there
was no unrealized gain or loss on available-for-sale marketable securities. For the three months
ended September 30, 2008, comprehensive loss was $4,199, which includes a net loss of $4,200 and an
unrealized gain on available-for-sale marketable securities of $1.
For the nine months ended September 30, 2009, comprehensive loss was $12,866 which includes a net
loss of $12,873, and an unrealized gain on available-for-sale marketable securities of $7. For the
nine months ended September 30, 2008, comprehensive loss was $13,418, which includes a net loss of
$13,428 and an unrealized gain on available-for-sale marketable securities of $10.
4. USE OF ESTIMATES
The preparation of financial statements in conformity with GAAP requires the use of estimates and
assumptions by management that affect 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. The most significant estimates relate to
stock based compensation arrangements and accrued expenses. Actual results could differ from these
estimates.
5. RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS
In June 2009, the Financial Accounting Standards Board (FASB) issued guidance which is included in
the Codification in FASB Accounting Standards Codification (ASC) 105, Generally Accepted
Accounting Principles. This guidance modifies the Generally Accepted Accounting Principles (GAAP)
hierarchy by establishing only two levels of GAAP, authoritative and nonauthoritative accounting
literature. Effective July 2009, the FASB ASC, also known collectively as the Codification, is
considered the single source of authoritative U.S. accounting and reporting standards, except for
additional authoritative rules and interpretive releases issued by the SEC. This guidance is
effective for financial statements issued for reporting periods that end after September 15, 2009.
Where possible, FASB references have been replaced with ASC references.
7
As of January 1, 2009, the Company implemented the transition guidance related to FASB Staff
Position (FSP) Emerging Issues Task Force (EITF) 03-6-1, Determining Whether Instruments Granted
in Share-Based Payment Transactions Are Participating Securities, which is included in the
codification in ASC 260-10, Earnings Per Share (ASC 260-10). ASC 260-10 requires the Company to
treat unvested deferred stock units as participating securities in accordance with the two-class
method in the calculation of both basic and diluted earnings per share. ASC 260-10 must be applied
retrospectively. The effect of the retrospective application of ASC 260-10 was not material to the
Companys earnings per share in 2008, 2007 or 2006.
The Company has adopted FASB ASC 820-10, Fair Value Measurements and Disclosures (ASC 820-10)
with respect to its financial assets and liabilities. In February 2008, the FASB issued updated
guidance related to fair value measurements, which is included in the Codification in ASC 820-10,
Fair Value Measurements and Disclosures. The updated guidance provided a one year deferral of the
effective date of ASC 820-10 for non-financial assets and non-financial liabilities, except those
that are recognized or disclosed in the financial statements at fair value at least annually. The
implementation of the non-financial items measured on a non-recurring basis did not have a material
impact on the Companys financial statements.
In April 2008, the FASB issued ASC 350, Intangibles-Goodwill and Other (ASC 350). ASC 350 amends
the factors that should be considered in developing renewal or extension assumptions used to
determine the useful life of a recognized intangible asset. ASC 350 is effective for calendar-year
companies beginning January 1, 2009. The requirement for determining useful lives must be applied
prospectively to intangible assets acquired after the effective date and the disclosure
requirements must be applied prospectively to all intangible assets recognized as of, and
subsequent to, the effective date. The implementation of this standard did not have a material
impact on the Companys financial statements.
In May 2009, the FASB issued guidance which is included in the Codification in ASC 855, Subsequent
Events (ASC 855). This guidance establishes the accounting and disclosure of events that occur
after the balance sheet date but before financial statements are issued or are available to be
issued. It requires the disclosure of the date through which an entity has evaluated subsequent
events and the basis for that date. This guidance is effective for interim or annual financial
periods ending after June 15, 2009, and as such, became effective for the Company on June 30, 2009.
We evaluated subsequent events through the date and time the financial statements were issued on
November 9, 2009.
6. RECENT ACCOUNTING PRONOUNCEMENTS
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R)
(SFAS 167), which has not yet been codified in the ASC. SFAS 167 amends certain requirements of
FASB Interpretation No. 46 (revised December 2003), Consolidation of Variable Interest Entities, to
improve financial reporting by enterprises involved with variable interest entities and to provide
more relevant and reliable information to users of financial statements. This Statement is
effective as of the beginning of each reporting entitys first annual reporting period that begins
after November 15, 2009, for interim periods within that first annual reporting period, and for
interim and annual reporting periods thereafter. Earlier application is prohibited. The Company is
currently assessing the impact of the adoption of SFAS 167.
In August 2009, the FASB issued Accounting Standards Update (ASU) No. 2009-05, Fair Value
Measurements and Disclosures (Topic 820) (ASU 2009-05). ASU 2009-05 provided amendments to ASC
820-10, Fair Value Measurements and Disclosures Overall, for the fair value measurement of
liabilities. ASU 2009-05 provides clarification that in circumstances in which a quoted price in an
active market for the identical liability is not available, a reporting entity is required to
measure fair value using certain techniques. ASU 2009-05 also clarifies that when estimating the
fair value of a liability, a reporting entity is not required to include a separate input or
adjustment to other inputs relating to the existence of a restriction that prevents the transfer of
a liability. ASU 2009-05 also clarifies that both a quoted price in an active market for the
identical liability at the measurement date and the quoted price for the identical liability when
traded as an asset in an active market when no adjustments to the quoted price of the asset are
required are Level 1 fair value measurements. The new guidance is effective for interim and
8
annual periods beginning after August 27, 2009, and applies to all fair-value measurements of liabilities
required by GAAP. The Company is currently assessing the impact of the adoption of ASU 2009-05.
In October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue Arrangements,
(amendments to FASB ASC Topic 605, Revenue Recognition ) (ASU 2009-13). ASU 2009-13 requires
entities to allocate revenue in an arrangement using estimated selling prices of the delivered
goods and services based on a selling price hierarchy. The amendments eliminate the residual method
of revenue allocation and require revenue to be allocated using the relative selling price method.
ASU 2009-13 should be applied on a prospective basis for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010, with early adoption
permitted. The Company is currently assessing the impact of the adoption of ASU 2009-13.
7. NET LOSS PER COMMON SHARE
Net loss per common share is presented in accordance with the provisions of FASB ASC 260, Earnings
Per Share (EPS). Basic EPS excludes dilution for potentially dilutive securities and is computed
by dividing net loss attributable to common stockholders by the weighted average number of common
shares outstanding during the period. Diluted EPS gives effect to dilutive options, warrants and
other potential common shares outstanding during the period. Diluted net loss per common share is
equal to the basic net loss per common share since all potentially dilutive securities are
anti-dilutive for each of the periods presented. Potential common stock equivalents excluded
consist of stock options and warrants which are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
2009 |
|
2008 |
Common stock options |
|
|
2,038,073 |
|
|
|
1,949,616 |
|
Warrants |
|
|
1,297,985 |
|
|
|
1,124,544 |
|
|
|
|
|
|
|
|
|
|
Total |
|
|
3,336,058 |
|
|
|
3,074,160 |
|
|
|
|
|
|
|
|
|
|
8. STOCK-BASED COMPENSATION
The Company has one stock-based compensation plan which allows the Board of Directors to grant
incentives to employees, consultants, directors, officers and collaborating scientists in the form
of incentive stock options, non-qualified stock options and restricted stock awards. The Company
also has two other stock-based compensation plans pursuant to which stock options are outstanding
but from which no new grants may be made.
Stock awards under the Companys stock option plans have been granted at prices which are no less
than the closing price of the stock on the date of the grant. Options granted under the 2005 Stock
Incentive Plan (2005 Plan), are generally time-based or performance-based and vesting varies
accordingly. Options under this Plan expire in up to a maximum of ten years from the date of
grant. Since the Company adopted the 2005 Plan, awards may not be granted under the Companys
previous stock option plans.
The compensation expense recognized in the Statement of Operations in the third quarter of 2009 and
2008 for stock options amounted to $185 (of which $25 relates to performance milestones) and $69
(of which $20 relates to performance milestones), respectively. For the nine months ended
September 30, 2009 and 2008, compensation expense for stock options amounted to $411 (of which $38
relates to performance milestones) and $248 (of which $73 relates to performance milestones),
respectively. Cash received from options and warrants exercised under all share-based payment
arrangements for the three months ended September 30, 2009 and 2008 was $158 and $21, respectively,
and for the nine month periods ended September 30, 2009 and 2008, was $289 and $45, respectively.
9
The fair value of each option award granted is estimated on the date of grant using the
Black-Scholes option valuation model and assumptions as noted in the following table:
|
|
|
|
|
|
|
|
|
|
|
For the Nine Months |
|
For the Nine Months |
|
|
Ended September 30, 2009 |
|
Ended September 30, 2008 |
Expected life |
|
5 years |
|
5 years |
Expected volatility |
|
60-65% |
|
60% |
Risk-free interest rate |
|
1.69-2.67% |
|
2.95-3.72% |
Dividend yield |
|
0% |
|
0% |
The expected life of the options is based on the observed and expected time to post-vesting,
forfeiture and exercise. Groups of employees that have similar historical exercise behavior are
considered separately for valuation purposes. Starting with the three months ended September 30,
2009, the expected volatility percentage is stated as calculated rather than as implied. The
expected volatility assumptions were determined based upon the historical volatility of the
Companys daily closing stock price. The calculated expected volatility approximates implied
volatility from other publicly-traded stock that was established at the time of our IPO. The
risk-free interest rate is based on the continuous rates provided by the U.S. Treasury with a term
equal to the expected life of the option. The expected dividend yield is zero as the Company has
never paid dividends and does not currently anticipate paying any in the foreseeable future.
At September 30, 2009, stock options to purchase 2,038,073 shares of common stock at exercise
prices ranging from $0.46 to $8.32 per share were outstanding and exercisable at various dates
through 2018.
During the three and nine months ended September 30, 2009, the weighted average fair value of
options granted, estimated as of the grant date using the Black-Scholes option valuation model, was
$4.01 and $3.80, respectively. For the three and nine month periods ended September 30, 2008, the
weighted average fair value of options granted was $5.57 and $3.87, respectively.
The status of the Companys stock option plans at September 30, 2009 is summarized in the following
table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
|
|
|
|
|
|
|
Exercise |
|
Contractual |
|
Aggregate |
|
|
Number of |
|
Price per |
|
Term in |
|
Intrinsic |
|
|
Shares |
|
Share |
|
Years |
|
Value |
Outstanding at December 31, 2008 |
|
|
2,069,080 |
|
|
$ |
4.39 |
|
|
|
5.8 |
|
|
|
|
|
Granted |
|
|
112,600 |
|
|
|
6.88 |
|
|
|
4.7 |
|
|
|
|
|
Exercised |
|
|
(83,607 |
) |
|
|
2.01 |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(60,000 |
) |
|
|
4.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2009 |
|
|
2,038,073 |
|
|
$ |
4.62 |
|
|
|
5.3 |
|
|
$ |
10,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at September 30, 2009 |
|
|
798,210 |
|
|
$ |
4.65 |
|
|
|
3.4 |
|
|
$ |
3,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
Options Exercisable |
|
|
|
|
|
|
Average |
|
Weighted |
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Remaining |
|
Average |
|
|
|
|
|
Average |
|
|
Number |
|
Contractual |
|
Exercise |
|
Number |
|
Exercise |
Range of Exercise Prices |
|
Outstanding |
|
Life |
|
Price |
|
Exercisable |
|
Price |
$.01-$.46 |
|
|
90,000 |
|
|
0.2 years |
|
$ |
.46 |
|
|
|
65,000 |
|
|
$ |
.46 |
|
$.47-$1.00 |
|
|
65,971 |
|
|
2.6 years |
|
$ |
1.00 |
|
|
|
65,971 |
|
|
$ |
1.00 |
|
$1.01-$8.32 |
|
|
1,882,102 |
|
|
5.6 years |
|
$ |
4.95 |
|
|
|
667,239 |
|
|
$ |
5.42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$.01-$8.32 |
|
|
2,038,073 |
|
|
5.3 years |
|
$ |
4.62 |
|
|
|
798,210 |
|
|
$ |
4.65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three and nine months ended September 30, 2009, the total intrinsic value of options
exercised was $300 and $428, respectively. For the three and nine months ended September 30, 2008,
the total intrinsic value of options exercised was $266 and $384, respectively.
10
As of September 30, 2009, of the total 2,038,073 options outstanding, 1,239,863 have not vested. Of
this total unvested amount, 905,263 will vest upon the attainment of certain milestones, and the
balance will vest over the requisite service period. The weighted average vesting period for the
non-milestone, non-vested awards not yet recognized is 2.1 years.
As of September 30, 2009, of the $3,195 of total unrecognized compensation cost related to unvested
options to be recognized, $2,715 is to be recognized over a period to be determined by
performance-based milestones, and $480 is to be recognized over the requisite service period
through 2013.
As of September 30, 2009, there were 1,315,051 shares available for future grants under the
Companys 2005 Plan.
9. COMMITMENTS AND CONTINGENCIES
The Company is party to a non-cancelable operating lease for office space expiring in January 2011.
The lease is subject to escalations for increases in operating expenses. A second lease for
office and laboratory space that expired on September 30, 2009 has been continued on a
month-to-month basis.
On July 14, 2009, the Company entered into a seven year lease agreement for 19,957 square feet of
office and laboratory space in Irvington, NY replacing the 10,300 square feet of space currently
occupied by the Company. The Company will continue to occupy space under the building leases in
effect as of September 2009 until the new space is ready for occupancy. The approximate aggregate
minimum future payments under the existing leases and this new lease, which will be effective no
later than January 1, 2010, are due as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2010 |
|
2011 |
|
2012 |
|
2013 |
|
2014-16 |
$85 |
|
$ |
356 |
|
|
$ |
384 |
|
|
$ |
412 |
|
|
$ |
441 |
|
|
$ |
1,329 |
|
In January 2006, the Company entered into an agreement with ASKION GmbH (ASKION) to produce and
test commercial-grade MelaFind® hand-held imaging device systems. The
Company expects to maintain a relationship, which has evolved into a month-to-month agreement, with
ASKION and continue with production and development activities throughout 2009 and into 2010.
In August of 2006, the Company engaged Carl Zeiss Jena GmbH on usual commercial terms to build the
lenses and assemblies, as well as provide certain technical consulting services for the
MelaFind® units. The Company expects Carl Zeiss Jena GmbH to continue to
supply lenses and assemblies through ASKION for commercialization units throughout 2009 and into
2010.
The Company has an employment agreement with its President and Chief Executive Officer, Dr. Gulfo,
which provides for an annual base salary, stock options and discretionary performance bonuses. The
agreement, which provides for automatic one-year renewal terms, currently runs through the end of
2009. In July 2009, and effective March 1, 2009, the Board of Directors increased Dr. Gulfos
annual base salary to $313.6 and awarded him a bonus of $150.
The Company is not currently subject to any material legal proceedings, nor to managements
knowledge is any material legal proceeding threatened against the Company.
10. STOCKHOLDERS EQUITY
On October 31, 2006, the Company entered into securities purchase agreements and a registration
rights agreement with certain accredited investors for the private placement of 2,312,384 shares of
the Companys common stock and warrants to purchase up to 346,857 shares of the Companys common
stock for aggregate gross proceeds of approximately $13.2 million and net proceeds of approximately
$12.5 million. Pursuant to the securities purchase agreements, for a purchase price of $5.70 each
investor received one share of the Companys common stock and a warrant to purchase 0.15 of a share
of the Companys common stock. The warrants are five-year warrants with an exercise price of $6.70
per share.
11
On July 31, 2007, the Company entered into a securities purchase agreement and a registration
rights agreement with certain accredited investors for the private placement of 2,000,178 shares of
the Companys common stock and warrants to purchase up to 500,041 shares of the Companys common
stock for aggregate gross proceeds of approximately $11.5 million and net proceeds of approximately
$10.7 million. The private placement closed August 3, 2007. Pursuant to the securities purchase
agreement, for a purchase price of $5.75 each investor received one share of the Companys common
stock and a warrant to purchase 0.25 of a share of common stock. The warrants are five-year
warrants with an exercise price of $8.00 per share.
Both of these private placements were completed pursuant to an exemption from registration provided
by Section 4(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder.
Pursuant to the terms of the registration rights agreements, the Company filed resale registration
statements covering the shares issued in both private placements, including the shares issuable
upon exercise of the warrants, with the SEC. In the event that the Company fails to maintain the
effectiveness of these registration statements for the periods described in the registration rights
agreements, the holders would be entitled to certain monetary damages. However, in no event is the
Company obligated to make payments in excess of 10% of the aggregate purchase price of the common
shares. The Company has concluded that it is unlikely that the Company would be required to remit
any payments to its investors for failing to maintain its effectiveness. The Companys resale
registration statements on Forms S-3 were declared effective by the SEC (file #333-139056 and file
#333-145740) on February 12, 2007 and September 11, 2007, respectively.
On June 26, 2008, the Company filed a Form S-3 shelf registration statement for an indeterminate
number of shares of common stock, warrants to purchase shares of common stock and units consisting
of a combination thereof having an aggregate initial offering price not to exceed $40 million. The
SEC declared the registration statement effective on July 7, 2008. Management utilized this shelf
registration statement to raise additional equity capital by completing a registered direct
offering of 2,088,451 shares of the Companys common stock for aggregate gross proceeds of
approximately $11.9 million (approximately $11 million net proceeds) to the Company at a per share
offering price of $5.68. The offering closed August 8, 2008.
On July 16, 2009, the Company utilized the shelf registration to complete a registered direct
offering of 2,400,000 shares of the Companys common stock with a select group of institutional
investors. The aggregate gross proceeds from the offering were $15 million (approximately $13.75
million of net proceeds). The offering closed on July 22, 2009 for a purchase price of $6.25 per
share of the Companys common stock. Approximately $13.1 million remains available for sale under
the shelf registration statement as of September 30, 2009
On May 7, 2009, the Company entered into a committed equity financing facility (CEFF) with
Kingsbridge Capital Limited, pursuant to which Kingsbridge committed to purchase from time to time
at the Companys sole discretion, up to the lesser of $45 million or 3,327,000 shares of the
Companys common stock, prior to May 7, 2012 subject to various conditions for individual sales,
including dollar, timing, and trading volume limitations, a minimum market per share price, and
other contractual and regulatory requirements. There is no assurance that the Company will satisfy
all the various conditions for individual sales enabling it to use all of the CEFF. In connection
with this CEFF, the Company issued a 5 year warrant, exercisable as of November 7, 2009, to
Kingsbridge to purchase up to 200,000 shares of our common stock at an exercise price of $11.35 per
share.
Under the CEFF, during August and September of 2009, the Company sold 862,201 shares of common
stock to Kingsbridge Capital Limited, at an average per share price of approximately $9.25, for
gross proceeds of $7.977 million. A proportionate share of the CEFF originating expenses was
allocated to this sale from deferred offering costs. Net of expenses, proceeds from this sale were
approximately $7.928 million. As of September 30, 2009, legal, accounting, and other costs
associated with this agreement approximating $140 have been deferred and will be charged to equity
as a reduction of proceeds from the CEFF or operations should management decide to abandon the
CEFF.
12
Subsequent to September 30, 2009 and through November 5, 2009, also under the CEFF, the Company
sold 962,740 shares of common stock to Kingsbridge Capital Limited, at an average per share price
of approximately $9.23, for gross proceeds of $8.886 million. A proportionate share of the CEFF
originating expenses was allocated to this sale from deferred offering costs. Net of expenses,
proceeds from this sale were approximately $8.831 million (see also Note 14). Following this sale,
legal, accounting, and other costs associated with this agreement approximating $86 have been
deferred and will be charged to equity as a reduction of proceeds from the CEFF or operations
should management decide to abandon the CEFF.
As of September 30, 2009, the Company had 10,000,000 shares of $0.10 par value preferred stock
authorized with no shares issued and outstanding.
11. WARRANTS
Warrants outstanding at September 30, 2009 include a 5-year warrant to purchase 75,000 shares of
the Companys common stock at an exercise price of $7.00 per share issued to one of the Companys
consultants in 2004, which expires in November of 2009. Also outstanding at September 30, 2009,
are 5-year warrants to purchase an aggregate of 47,962 shares of the Companys common stock at an
exercise price of $4.52 per share, which expire in November of 2009.
In connection with the Companys IPO which closed on November 2, 2005, the Company issued 150,000
warrants to the underwriters to purchase shares of the Companys common stock at $6.25 per share,
which became exercisable on October 28, 2006, and expire November of 2010. At September 30, 2009,
143,125 of these warrants remain outstanding.
Additionally, as previously discussed, in connection with the Companys two private placement
financings the following warrants have been granted and remain outstanding as of September 30,
2009: (also see Note 14.)
Financing that closed November 3, 2006: warrants to purchase up to 346,857 shares of the
Companys common stock were issued. At September 30, 2009, 331,857 of these warrants remain
outstanding. These warrants are five-year warrants with an exercise price of $6.70 per share,
Financing that closed August 3, 2007: warrants to purchase up to 500,041 shares of the
Companys common stock were issued. At September 30, 2009, 500,041 of these warrants remain
outstanding. The warrants are five-year warrants with an exercise price of $8.00 per share.
In connection with the May 7, 2009 CEFF with Kingsbridge, the Company issued a 5 year warrant,
exercisable as of November 7, 2009, to Kingsbridge to purchase up to 200,000 shares of our common
stock at an exercise price of $11.35 per share, with a Black Scholes Fair Value of $678.
Cash received for warrants exercised during the three and nine months ended September 30, 2009 was
$21 and $122 respectively. Cash received for warrants exercised during the three and nine months
ended September 30, 2008 was $11 and $11 respectively.
12. RELATED PARTY CONSULTING AGREEMENTS
The Company has in place the following consulting agreements with related parties:
13
Consulting Agreement with Breaux Castleman
In June 2003, the Company entered into a consulting agreement with Breaux Castleman, the Chairman
of the Companys Board of Directors, for consulting services related to the FDA approval of
MelaFind®, and the Companys business and financial strategy. Under this
agreement, Mr. Castleman receives compensation for each month of services rendered. The Company
made payments, pursuant to this consulting agreement, of $6 in each of the three month periods
ended September 30, 2009 and 2008 and $18 in each of the nine month periods ended September 30,
2009 and 2008. This consulting agreement is terminable by either party by providing thirty days
prior written notice.
Consulting Agreement with Marek Elbaum, Ph.D.
Effective as of May 31, 2005, the Company retained Marek Elbaum, Ph.D., the Companys founder and
former President and Chief Science and Technology Officer, as the Companys Chief Scientist. In
consideration of the services to be provided, the Company agreed to pay Dr. Elbaum a monthly fee of
$15.
In May of 2007 and effective June 1, 2007, Dr. Elbaum and the Company entered into an amended
agreement. Under the terms of the amended agreement, Dr. Elbaum was paid a monthly fee of $9
through January 2009 when the contract terminated.
Consulting Agreement with Robert Friedman, M.D.
The Company has retained the services of Robert Friedman, M.D. as a consultant, medical advisor to
the Companys Board of Directors, and in connection with the clinical testing of
MelaFind®. In consideration for these services, Dr. Friedman is being paid at
a rate of $5 for each day of service.
This consulting agreement continues to automatically renew for successive one-year terms unless
either party terminates the agreement at least 30 days prior to its expiration. The Company made no
payments to Dr. Friedman for the three month period ending September 30, 2009, and $40 for the nine
month period ending September 30, 2009. The Company made payments to Dr. Friedman totaling $33 for
the three month period ending September 30, 2008, and $60 for the nine month period ending
September 30, 2008.
Consulting Agreement with Gerald Wagner, Ph.D.
Effective April 1, 2006, the Company entered into an amended and restated consulting agreement with
Gerald Wagner, Ph.D., a member of the Companys Board of Directors and its former Acting Chief
Operating Officer. Under this amended consulting agreement, the Company agreed to pay Dr. Wagner
the annual amount of $180 payable monthly over the term of the agreement. In addition, in
connection with his ongoing engagement as a consultant, Dr. Wagner received a stock option grant of
50,000 shares of the Companys common stock which vested upon commencement of the pivotal trial for
MelaFind® in January 2007. In addition, on March 24, 2006, Dr Wagner received
another stock option grant of 49,500 shares of the Companys common stock which vested immediately.
With the start of the Companys pivotal clinical trial in January 2007, Dr. Wagner transitioned out
of his role as the Companys acting Chief Operating Officer and entered into an amended and
restated consulting contract with the Company. Under the terms of the amended contract, Dr. Wagner
is paid a monthly retainer of $2.5 and will be paid $2.5 for each additional consulting day. This
amended agreement will end at the option of Dr. Wagner or the Company at any time, by providing
fifteen days prior written notice, or immediately upon the mutual agreement of the Company and Dr.
Wagner. The Company incurred consulting costs pursuant to this agreement of $7.5 in the three month
period and $22.5 in the nine month period ended September 30, 2009. The Company incurred
consulting costs pursuant to this agreement of $38 in the three month period and $60 in the nine
month period ended September 30, 2008.
14
Consulting Agreement with Anne Egger
In March 2009, the Company entered into a consulting agreement with Anne Egger for certain
consulting services primarily focusing on physician advocacy. The agreement was for an initial
term of three months, has subsequently been extended to run through October 2010, and may be
terminated by either party with 30 days notice. Under the terms of the agreement, Ms. Egger is
entitled to receive a consulting fee of $1.6 per day. Ms. Egger was appointed to the Companys
Board of Directors as of June 10, 2009. During the three and nine month periods ended September
30, 2009, Ms. Egger was paid $31 and $50, respectively, under this agreement.
13. OTHER INCOME
During March 2007, the Company entered into an agreement with LOreal to study and assess the
feasibility of using EOS novel multi-spectral imaging technology for the evaluation and
differentiation of pigmented skin lesions of cosmetic importance. EOS has granted LOreal an option
to take an exclusive license to use EOS technology in the field covered by the research, on terms
to be mutually agreed. The option expired June 30, 2009. On December 16, 2008, LOreal and the
Company agreed on a second amendment to the agreement, for a new three month study. The laboratory
and clinical research is being funded by LOreal. Pursuant to the agreement, LOreal is responsible
for all costs and expenses incurred in connection with the feasibility program, and will reimburse
EOS for expenses incurred by EOS with respect to the feasibility program. The work to be carried
out under the agreement has been completed. During the three and nine month periods ended
September 30, 2009, the Company did not earn other income from LOreal under the feasibility
program. During the three and nine month periods ended September 30, 2008, the Company earned
other income of $45 and $98, respectively.
During April 2005, the Company discontinued all operations associated with its
DIFOTI® product in order to focus its resources and attention on the
development and commercialization of MelaFind®. During December 2006, the
Company entered into a sale and exclusive licensing agreement with KaVo Dental GmbH (KaVo), a
leading dental equipment manufacturer, which provides for KaVo to further develop and commercialize
DIFOTI®. Beginning in July 2008, KaVo is required to pay to the Company a
royalty stream based upon the worldwide aggregate net sales of the licensed product, as defined in
the license agreement, or a set minimum. During the year ended December 31, 2008, the Company
earned $10 as the pro rated portion of the minimum royalty. For the three and nine month periods
ended September 30, 2009, the Company accrued royalty income of $5 and $15, respectively.
14. SUBSEQUENT EVENTS
The following are subsequent events of the Company during the period of October 1, 2009 through the
date and time the financial statements were issued on November 9, 2009:
Under the May 7, 2009 CEFF with Kingsbridge Capital Limited, subsequent to September 30, 2009 and
through November 5, 2009, the Company has sold 962,740 shares of Company common stock at an average
per share price of approximately $9.23, for gross proceeds of $8.886 million. A proportionate
share of the CEFF originating expenses was allocated to this sale from deferred offering costs.
Net of expenses, proceeds from this sale were approximately $8.831 million.
To date, the Company has sold 1,824,941 shares under the CEFF leaving 1,502,059 shares available
for sale under the CEFF, exclusive of the 200,000 outstanding warrants held by Kingsbridge.
On October 20, 2009, warrants to purchase 67,581 shares of the Companys common stock, issued in
connection with the private placement financing that closed in November 2006, were exercised. The
exercise of these warrants at $6.70 per common share, resulted in approximately $453 of proceeds to
the Company.
15
Also on October 20, 2009, warrants to purchase 37,050 shares of the Companys common stock, issued
in connection with the private placement financing that closed in August 2007, were exercised.
The exercise of these warrants at $8.00 per common share, resulted in approximately $296 of
proceeds to the Company.
On October 22, 2009, warrants to purchase 90,313 shares of the Companys common stock, issued in
connection with the private placement financing that closed in November 2006, were exercised. The
exercise of these warrants at $6.70 per common share, resulted in approximately $605 of proceeds to
the Company.
Also on October 22, 2009, warrants to purchase 50,450 shares of the Companys common stock, issued
in connection with the private placement financing that closed in August 2007, were exercised.
The exercise of these warrants at $8.00 per common share, resulted in approximately $404 of
proceeds to the Company.
16
ITEM 2.
ELECTRO-OPTICAL SCIENCES, INC.
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This managements discussion and analysis of financial condition and results of operations is
intended to provide information to help you better understand and evaluate our financial condition
and results of operations. We recommend that you read this section in conjunction with our
unaudited condensed financial statements and accompanying notes included under Part I, Item 1 of
this Quarterly Report and our audited financial statements and accompanying notes in our Annual
Report on Form 10-K for the year ended December 31, 2008.
This quarterly report on Form 10-Q, including the following discussion and analysis of financial
condition and results of operations, contains forward-looking statements that you should read in
conjunction with the financial statements and notes to financial statements that we have included
elsewhere in this report. These statements are based on our current expectations, assumptions,
estimates and projections about our business and our industry, and involve known and unknown risks,
uncertainties, and other factors that may cause our or our industrys results, levels of activity,
performance or achievements to be materially different from any future results, levels of activity,
performance or achievements expressed or implied in, or contemplated by, the forward-looking
statements. Words such as believe, anticipate, expect, intend, plan, will, may,
should, estimate, predict, potential, continue, or the negative of such terms or other
similar expressions, identify forward-looking statements. Our actual results and the timing of
events may differ significantly from the results discussed in the forward-looking statements, and
you should not place undue reliance on these statements. Factors that might cause such a difference
include those discussed below under the heading Risk Factors, as well as those discussed
elsewhere in this quarterly report on Form 10-Q. We disclaim any intent or obligation to update any
forward-looking statements as a result of developments occurring after the period covered by this
report or otherwise.
Overview
We are a medical device company focused on the design and development of a non-invasive,
point-of-care instrument to assist in the early diagnosis of melanoma. Our flagship product,
MelaFind®, features a hand-held imaging device that emits multiple wavelengths
of light to capture images of suspicious pigmented skin lesions and extract data. The data are then
analyzed utilizing image processing classification algorithms, trained on our proprietary
database of melanomas and benign lesions, to provide information to assist in the management of the
patient, including information useful in the decision of whether to biopsy the lesion. We currently
do not have any commercialized products or any significant source of revenue.
We commenced operations in December 1989 as a New York corporation and re-incorporated as a
Delaware corporation in September 1997. Since our inception, we have generated significant losses.
As of September 30, 2009, we had an accumulated deficit of $73.6 million. We expect to continue to
spend significant amounts on the development and commercialization of
MelaFind®.
Our revenue for the foreseeable future will depend on the approval and commercialization of
MelaFind® and may vary substantially from year to year and quarter to
quarter. Our operating expenses may also vary substantially from year to year and quarter to
quarter based on the timing of activities and approvals.
On February 13, 2009, the Company announced that a third-party, independent bio-statistician had
provided positive top line results from the MelaFind® pivotal clinical trial.
This blinded study was conducted at seven clinical sites and included 1,831 pigmented skin lesions
from 1,383 patients.
On June 3, 2009, the Company submitted the MelaFind® Pre-market Approval Application
(PMA) to the U.S. Food and Drug Administration (FDA), which the FDA has previously indicated
will receive expedited review. Expedited review means that upon filing the PMA application, the
FDA will conduct a team review, prioritize the application, and allocate sufficient resources
toward a 180 day review period.
17
While the expedited review could shorten the MelaFind® FDA approval process, the Company
can provide no assurances that this will be the case.
The Company was notified by the FDA, pursuant to the submission of the MelaFind®
Pre-Market Approval Application on June 3, 2009, that the application was suitable for filing, and
the official filing date is June 9, 2009. The MelaFind® PMA is under review at the FDA,
and the Company is actively working with the FDA during this process. The date for an anticipated
FDA Advisory Panel to review the MelaFind® PMA has not been established, therefore, we
expect the review of the MelaFind® PMA to continue into 2010.
We believe that period-to-period comparisons of our results of operations may not be meaningful and
should not be relied on as indicative of our future performance.
Liquidity and Capital Resources
On July 31, 2007, the Company entered into a securities purchase agreement and a registration
rights agreement with certain accredited investors for the private placement of 2,000,178 shares of
the Companys common stock and warrants to purchase up to 500,041 shares of the Companys common
stock for aggregate gross proceeds of approximately $11.5 million and net proceeds of approximately
$10.7 million. This transaction closed August 3, 2007.
On June 26, 2008, the Company filed a Form S-3 shelf registration statement for an indeterminate
number of shares of common stock, warrants to purchase shares of common stock and units consisting
of a combination thereof having an aggregate initial offering price not to exceed $40 million. The
SEC declared the registration statement effective on July 7, 2008. Management utilized this shelf
registration statement to raise additional equity capital by completing a registered direct
offering of 2,088,451 shares of the Companys common stock for aggregate gross proceeds of
approximately $11.9 million (approximately $11 million net proceeds) to the Company at a per share
offering price of $5.68. The offering closed August 8, 2008.
On May 7, 2009, the Company entered into a committed equity financing facility (CEFF), with
Kingsbridge Capital Limited, pursuant to which Kingsbridge committed to purchase, subject to
certain conditions, up to the lesser of $45 million or 3,327,000 shares of the Companys common
stock. In connection with this CEFF, the Company issued a 5 year warrant, exercisable as of
November 7, 2009, to Kingsbridge to purchase up to 200,000 shares of our common stock at an
exercise price of $11.35 per share (refer to Note 10 for further details). The Company registered
for resale on Form S-3 3,527,000 of its common shares under this financing arrangement. The
registration statement was declared effective by the SEC on May 22, 2009.
On July 16, 2009, the Company completed, pursuant to the Companys shelf registration statement on
Form S-3, a registered direct offering of 2,400,000 shares of the Companys common stock with a
select group of institutional investors. The aggregate gross proceeds from the offering were $15
million (with net proceeds of approximately $13.75 million). The offering closed on July 22, 2009
for a purchase price of $6.25 per share of the Companys common stock. Approximately $13.1 million
remains available for sale under the Companys shelf registration statement as of September 30,
2009.
Under the CEFF, during August and September of 2009, the Company sold 862,201 shares of common
stock to Kingsbridge Capital Limited, at an average per share price of approximately $9.25, for
gross proceeds of $7.977 million. A proportionate share of the CEFF originating expenses was
allocated to this sale from deferred offering costs. Net of expenses, proceeds from this sale were
approximately $7.928 million.
Subsequent to September 30, 2009 and through November 5, 2009, also under the CEFF, the Company
sold 962,740 shares of common stock to Kingsbridge Capital Limited, at an average per share price
of approximately $9.23, for gross proceeds of $8.886 million. A proportionate share of the CEFF
originating expenses was allocated to this sale from deferred offering costs. Net of expenses,
proceeds from this sale were approximately $8.831 million (see also Note 14).
18
Most of our expenditures to date have been for research and development activities and general and
administrative expenses. Research and development expenses represent costs incurred for product
development, clinical trials, activities related to regulatory filings, and manufacturing
development efforts. We expense all of our research and development costs as they are incurred.
To date, we have not borrowed (other than by issuing convertible notes, all of which have been
converted into equity) or financed our operations through equipment leases, financing loans or
other debt instruments.
As of September 30, 2009, the Companys total of cash, cash equivalents was $24.8 million. The
existing cash balances and the availability of the Kingsbridge CEFF, will allow the Company to fund
anticipated levels of operations for at least the next twelve months. However, there can be no
assurances that the Company will be able to raise funds as needed from time to time, whether under
the CEFF or by other types of financing. Funds that become available may not be on acceptable
terms, and there can be no assurance that any additional funding that the Company does obtain will
be sufficient to meet the Companys needs in the long term.
Our cash and cash equivalents at September 30, 2009 are liquid investments in money market accounts
and deposits with commercial banks, which are held in amounts that substantially exceed FDIC
limits.
Cash Flows from Operating Activities (in thousands)
Net cash used in operations was $12,271, for the nine months ended September 30, 2009. For the
corresponding period in 2008, net cash used in operations was $12,069. In both periods, cash used
in operations was attributable to net losses, after an adjustment for non-cash charges related to
depreciation/amortization and share-based compensation, and other changes in operating assets and
liabilities.
Cash Flows from Investing Activities
For the nine months ended September 30, 2009, there was $152 net cash provided by our investing
activities. For the corresponding period in 2008, net cash provided by our investing activities
was $636. In 2009, cash provided was related to the redemption of marketable securities offset by
leasehold improvements, the purchase of information technology equipment, and the purchase of
manufacturing related equipment in support of MelaFind®. In 2008, cash
provided was related to the redemption of marketable securities offset by the purchase of
information technology and manufacturing related equipment.
Cash Flows from Financing Activities
For the nine months ended September 30, 2009, net cash provided by financing activities was
$21,827. Cash was provided by net proceeds received from the sale of common stock under the
Companys July 2009 registered direct offering ($13.75 million), from the exercise of options and
warrants ($289), and from the sale of common stock under the CEFF with Kingsbridge Capital ($7.977
million) offset by $190 of deferred offering costs related to the CEFF transaction. For the nine
months ended September 30, 2008, net cash provided by financing activities was $11,013,
representing the exercise of options and warrants ($45) and the net proceeds of the June 2008
registered direct offering ($10,968).
Operating Capital and Capital Expenditure Requirements
We face certain risks and uncertainties, which are present in many emerging medical device
companies. At September 30, 2009, we had an accumulated deficit of $73.6 million. To date, we have
not commercialized our principal product, MelaFind®. We anticipate that we
will continue to incur net losses for the foreseeable future as we pursue regulatory approvals for
MelaFind®, continue to develop the MelaFind® system,
expand our corporate infrastructure, and prepare for the potential commercial launch of
MelaFind®.
19
We do not expect to generate significant product revenue until we successfully obtain PMA approval
for and begin selling MelaFind®.
If additional funds are raised through the issuance of debt securities or preferred stock, these
securities could have rights senior to those associated with our common stock and could contain
covenants that would restrict our operations. If we are unable to obtain additional financing, we
may be required to reduce the scope of, delay or eliminate some or all of planned product research
and development and commercialization activities, which could harm our business.
Because of the numerous risks and uncertainties associated with the development of medical devices
such as MelaFind®, we are unable to estimate the exact amounts of capital
outlays and operating expenditures associated with our current and anticipated clinical trials. Our
future funding requirements will depend on many factors, including, but not limited to:
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The schedule, costs, and results of our clinical trials; |
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The success of our research and development efforts; |
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The costs and timing of regulatory approval; |
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Reimbursement amounts for the use of MelaFind®
that we are able to obtain from Medicare and third party
payers, or the amount of direct payments we are able to obtain from
patients and/or physicians utilizing MelaFind®; |
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The cost of commercialization activities, including product marketing
and building a domestic direct sales force; |
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The emergence of competing or complementary technological developments; |
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The costs of filing, prosecuting, defending and enforcing any patent
claims and other rights, including litigation costs and the results of
such litigation; |
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The costs involved in defending any patent infringement actions
brought against us by third parties; and |
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Our ability to establish and maintain any collaborative, licensing or
other arrangements, and the terms and timing of any such arrangements. |
Contractual Obligations (in thousands)
The Company is party to a non-cancelable operating lease for 2,800 and 2,500 square feet of office
space expiring in January 2011. The lease is subject to escalations for increases in operating
expenses. A second lease for 5,000 square feet of office and laboratory space, that expired on
June 30, 2009, has been continued on a month-to-month basis.
On July 14, 2009, the Company entered into a new lease agreement for 19,957 square feet of office
and laboratory space. The following table summarizes our outstanding contractual obligations as of
September 30, 2009, adjusted to give effect to the July 14, 2009 lease agreement.
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Less than |
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More than |
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Total |
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1 year |
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1-3 years |
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4-5 years |
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5 years |
Operating leases |
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$ |
3,008 |
|
|
$ |
351 |
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$ |
782 |
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$ |
888 |
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$ |
987 |
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20
Results of Operations (in thousands)
Through the first nine months of 2009, the Company announced positive top line results from the
pivotal clinical trial, submitted the MelaFind® PMA to the FDA, continued the
development of processes and equipment to allow for the efficient manufacturing of
MelaFind®, and focused on increasing corporate capabilities to meet the needs of product
launch.
The Company was notified by the FDA, pursuant to the submission of the MelaFind®
Pre-Market Approval Application on June 3, 2009, that the application was suitable for filing, and
the official filing date is June 9, 2009. The MelaFind® PMA is under review at the FDA,
and the Company is actively working with the FDA during this process. The date for an anticipated
FDA Advisory Panel to review the MelaFind® PMA has not been established, therefore, we
expect the review of the MelaFind® PMA to continue into 2010.
Three Months Ended September 30, 2009 Compared to Three Months Ended September 30, 2008
Research and Development Expense
Research and development expense overall decreased 16% for the three month period ended September
30, 2009 compared to the same period ended September 30, 2008. The R&D costs were refocused from
clinical to regulatory principally attributable to:
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clinical studies costs in the third quarter of 2009 the pivotal trial study sites were
shut down leaving only ongoing data acquisition sites. In the third quarter of 2008, all
sites of the pivotal clinical trial data acquisition phase were fully engaged. Clinical
studies costs decreased $343. |
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quality and regulatory costs were increased in the third quarter of 2009 with activities
in support of the review of our PMA , making extensive use of consultants to assist in this
process. Quality and regulatory costs increased $48 period to period. |
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development activities in the third quarter of 2009, we experienced a significant decrease
in design and process development costs for MelaFind® as the product had become
defined and finalized. There were more extensive development efforts of 2008. Development
costs decreased $229 from the prior year. |
General and Administrative Expense
General and administrative expenses consist primarily of salaries and related expenses of general
corporate activities, certain costs associated with our efforts to obtain PMA approval for
MelaFind® and development of a commercial infrastructure to market and
sell MelaFind® when approved.
General and Administrative expense for the three months ended September 30, 2009 increased 117% as
compared to the same period ended September 30, 2008. This increase is reflective of:
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pre-marketing activities intensified during the third quarter of 2009 following the
submission of the MelaFind® PMA. in June. There were limited
pre-marketing efforts during the nine month period ended September 30, 2008 while the data
acquisition phase of the pivotal clinical trial continued. Pre-marketing expenses in 2009
increased $492 over the same period in 2008. |
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in the third quarter of 2009 there were increased legal activities relating to regulatory
requirements and patent activities associated with protecting MelaFind®
intellectual property. Legal and patent expense increased $108 over the same period a year
earlier. |
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information technology department upgrades and other one-time staffing related employee
costs increased general and administrative related costs $466 in the three months ending
September 30, 2009 over the same period a year earlier. For the quarter, non-cash expenses of
depreciation and share-based compensation were $94 higher in 2009 than in 2008. |
21
Nine Months Ended September 30, 2009 Compared to Nine Months Ended September 30, 2008
Research and Development Expense
Research and development expense overall decreased 24% for the nine month period ended September
30, 2009 compared to the same period ended September 30, 2008. The R&D costs were refocused from
clinical to regulatory principally attributable to:
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clinical studies costs in the first nine months of 2009 we closed down the pivotal
clinical trial study sites which, in the same period in 2008,` were fully engaged. Clinical
studies costs decreased $1,958 from the prior period. |
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quality and regulatory the nine month cost level was increased in 2009 as we intensified
activities in support of the PMA submission and review, making extensive use of consultants
to assist in this process. In the first nine months of 2008, we were not yet in the position
to be preparing the PMA. Quality and regulatory costs increased $701 over the prior period. |
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development activities in the first nine months of 2009, we experienced a significant
decrease in design costs and process development for MelaFind® as the product had
become defined and finalized through the more extensive development efforts of 2008.
Development costs decreased $1,101 from the prior period. |
General and Administrative Expense
General and administrative expenses consist primarily of salaries and related expenses of general
corporate activities, certain costs associated with our efforts to obtain PMA approval for
MelaFind® and development of a commercial infrastructure to market and
sell MelaFind®.
General and Administrative expense for the nine months ended September 30, 2009 increased 35% as
compared to the same period ended September 30, 2008. This increase is reflective of:
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pre-marketing activities accelerated throughout the first nine months of 2009 following
announcement of positive top-line results from the pivotal clinical trial and particularly in
the third quarter, following the submission of the MelaFind® PMA.
There were limited pre-marketing efforts during the nine month period ended September 30,
2008, while the data acquisition phase of the pivotal clinical trial continued. Pre-marketing
expenses increased $603 over the prior period. |
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in 2009 there has been increased legal and investor relations activities involving required
disclosures and investor notification; such as the release of top-line results from our
pivotal clinical trial and the submission of our PMA. Patent expenses have increased
associated with protecting MelaFind® intellectual property. Legal, patent
and investor relations expenses increased $188 over the same period in 2008. |
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information technology department upgrades and other one-time staffing related employee costs
increased general and administrative related costs $358 in the first nine months over the same
period a year earlier. Non-cash expenses of depreciation and share-based compensation were
$234 higher in 2009 than in 2008 through nine months. |
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations is
based on our financial statements, which have been prepared in accordance with GAAP. The
preparation of these financial statements requires us to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and
liabilities at the date of the financial statements as well as the reported revenues and expenses
during the reporting periods. On an ongoing basis, we evaluate our judgments related to accounting
estimates. We base our estimates on historical experience and on various other factors that we
believe are reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not readily
22
apparent from other sources. Actual results may differ from these estimates under different
assumptions or conditions.
We believe that the following accounting policies and significant judgments and estimates relating
to revenue recognition, stock-based compensation charges, and accrued expenses are most critical to
aid you in fully understanding and evaluating our reported financial results.
Revenue Recognition
We currently do not have any commercialized products or any source of revenue.
Stock-Based Compensation
We record compensation expense associated with stock options and other forms of equity compensation
in accordance with FASB ASC-718, Stock Compensation (FASB 718), as interpreted by SEC Staff
Accounting Bulletins No. 107 and No.110. A compensation charge is recorded when it is probable
that performance conditions will be satisfied. The probability of vesting is updated at each
reporting period and compensation is adjusted via a cumulative catch-up adjustment or prospectively
depending on the nature of the change.
We have also granted to certain employees stock options that vest with the attainment of
development milestones not under the Companys control. Upon the attainment of the relevant
development milestones, there will be a significant compensation charge based on the fair value of
such options on the date granted.
Options or warrants issued to non-employees for goods or services are recorded at fair value and
accounted for in accordance with FASB ASC 505, Equity-based payments to non-employees.
Accrued Expenses
As part of the process of preparing financial statements, we are required to estimate accrued
expenses. This process involves identifying services that have been performed on our behalf and
estimating the level of service performed and the associated cost incurred for such service where
we have not been invoiced or otherwise notified of the actual cost. Examples of estimated accrued
expenses include:
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professional service fees; |
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contract clinical service fees; |
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fees paid to contract manufacturers in conjunction with
the production of clinical components or materials; and |
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fees paid to third party data collection organizations and
investigators in conjunction with the clinical trials. |
In connection with such service fees, our estimates are most affected by our projections of the
timing of services provided relative to the actual level of services incurred by such service
providers. The majority of our service providers invoice us monthly in arrears for services
performed. In the event that we do not identify certain costs that have begun to be incurred or we
are under or over our estimate of the level of services performed or the costs of such services,
our actual expenses could differ from such estimates. The date on which certain services commence,
the level of services performed on or before a given date, and the cost of such services are often
subjective determinations. We make these judgments based upon the facts and circumstances known to
us in accordance with GAAP. This is done as of each balance sheet date in our financial statements.
23
Off-Balance Sheet Arrangements
We do not currently have, nor have we ever had, any relationships with unconsolidated entities or
financial partnerships, such as entities often referred to as structured finance or special purpose
entities, which would have been established for the purpose of facilitating off-balance sheet
arrangements or other contractually narrow or limited purposes. In addition, we do not engage in
trading activities involving non-exchange traded contracts. As such, we are not materially exposed
to any financing, liquidity, market or credit risk that could arise if we had engaged in these
relationships.
Recently Adopted Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (FASB) issued guidance which is included in
the Codification in FASB Accounting Standards Codification (ASC) 105, Generally Accepted
Accounting Principles. This guidance modifies the Generally Accepted Accounting Principles (GAAP)
hierarchy by establishing only two levels of GAAP, authoritative and nonauthoritative accounting
literature. Effective July 2009, the FASB ASC, also known collectively as the Codification, is
considered the single source of authoritative U.S. accounting and reporting standards, except for
additional authoritative rules and interpretive releases issued by the SEC. This guidance is
effective for financial statements issued for reporting periods that end after September 15, 2009.
Where possible, FASB references have been replaced with ASC references.
As of January 1, 2009, the Company implemented the transition guidance related to FASB Staff
Position (FSP) Emerging Issues Task Force (EITF) 03-6-1, Determining Whether Instruments Granted
in Share-Based Payment Transactions Are Participating Securities, which is included in the
codification in ASC 260-10, Earnings Per Share (ASC 260-10). ASC 260-10 requires the Company to
treat unvested deferred stock units as participating securities in accordance with the two-class
method in the calculation of both basic and diluted earnings per share. ASC 260-10 must be applied
retrospectively. The effect of the retrospective application of ASC 260-10 was not material to the
Companys earnings per share in 2008, 2007 or 2006.
The Company has adopted FASB ASC 820-10, Fair Value Measurements and Disclosures (ASC 820-10)
with respect to its financial assets and liabilities. In February 2008, the FASB issued updated
guidance related to fair value measurements, which is included in the Codification in ASC 820-10,
Fair Value Measurements and Disclosures. The updated guidance provided a one year deferral of the
effective date of ASC 820-10 for non-financial assets and non-financial liabilities, except those
that are recognized or disclosed in the financial statements at fair value at least annually. The
implementation of the non-financial items measured on a non-recurring basis did not have a material
impact on the Companys financial statements.
In April 2008, the FASB issued ASC 350, Intangibles-Goodwill and Other (ASC 350). ASC 350 amends
the factors that should be considered in developing renewal or extension assumptions used to
determine the useful life of a recognized intangible asset. ASC 350 is effective for calendar-year
companies beginning January 1, 2009. The requirement for determining useful lives must be applied
prospectively to intangible assets acquired after the effective date and the disclosure
requirements must be applied prospectively to all intangible assets recognized as of, and
subsequent to, the effective date. The implementation of this standard did not have a material
impact on the Companys financial statements.
In May 2009, the FASB issued guidance which is included in the Codification in ASC 855, Subsequent
Events (ASC 855). This guidance establishes the accounting and disclosure of events that occur
after the balance sheet date but before financial statements are issued or are available to be
issued. It requires the disclosure of the date through which an entity has evaluated subsequent
events and the basis for that date. This guidance is effective for interim or annual financial
periods ending after June 15, 2009, and as such, became effective for the Company on June 30, 2009.
We evaluated subsequent events through the date and time the financial statements were issued on
November 9, 2009.
24
Recent Accounting Pronouncements
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R)
(SFAS 167), which has not yet been codified in the ASC. SFAS 167 amends certain requirements of
FASB Interpretation No. 46 (revised December 2003), Consolidation of Variable Interest Entities, to
improve financial reporting by enterprises involved with variable interest entities and to provide
more relevant and reliable information to users of financial statements. This Statement is
effective as of the beginning of each reporting entitys first annual reporting period that begins
after November 15, 2009, for interim periods within that first annual reporting period, and for
interim and annual reporting periods thereafter. Earlier application is prohibited. The Company is
currently assessing the impact of the adoption of SFAS 167.
In August 2009, the FASB issued Accounting Standards Update (ASU) No. 2009-05, Fair Value
Measurements and Disclosures (Topic 820) (ASU 2009-05). ASU 2009-05 provided amendments to ASC
820-10, Fair Value Measurements and Disclosures Overall, for the fair value measurement of
liabilities. ASU 2009-05 provides clarification that in circumstances in which a quoted price in an
active market for the identical liability is not available, a reporting entity is required to
measure fair value using certain techniques. ASU 2009-05 also clarifies that when estimating the
fair value of a liability, a reporting entity is not required to include a separate input or
adjustment to other inputs relating to the existence of a restriction that prevents the transfer of
a liability. ASU 2009-05 also clarifies that both a quoted price in an active market for the
identical liability at the measurement date and the quoted price for the identical liability when
traded as an asset in an active market when no adjustments to the quoted price of the asset are
required are Level 1 fair value measurements. The new guidance is effective for interim and annual
periods beginning after August 27, 2009, and applies to all fair-value measurements of liabilities
required by GAAP. The Company is currently assessing the impact of the adoption of ASU 2009-05.
In October 2009, the FASB issued ASU 2009-13, Multiple-Deliverable Revenue Arrangements,
(amendments to FASB ASC Topic 605, Revenue Recognition ) (ASU 2009-13). ASU 2009-13 requires
entities to allocate revenue in an arrangement using estimated selling prices of the delivered
goods and services based on a selling price hierarchy. The amendments eliminate the residual method
of revenue allocation and require revenue to be allocated using the relative selling price method.
ASU 2009-13 should be applied on a prospective basis for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15, 2010, with early adoption
permitted. The Company is currently assessing the impact of the adoption of ASU 2009-13.
ITEM 3.
Quantitative and Qualitative Disclosures about Market Risk
Our exposure to market risk is confined to our cash, cash equivalents, and short-term investments.
We invest in high-quality financial instruments, primarily money market funds, with the average
effective duration of the portfolio within one year which we believe are subject to limited credit
risk. We currently do not hedge interest rate exposure. Due to the short-term nature of our
investments, we do not believe that we have any material exposure to interest rate risk arising
from our investments. The Company is exposed to credit risks in the event of default by the
financial institutions or issuers of investments in excess of FDIC insured limits. The Company
performs periodic evaluations of the relative credit standing of these financial institutions and
limits the amount of credit exposure with any institution.
25
ITEM 4.
Controls and Procedures
Evaluation of disclosure controls and procedures
Based on their evaluation as of September 30, 2009, our Chief Executive Officer and Chief Financial
Officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e)
and 15d-15(e) of the Securities Exchange Act of 1934, as amended, were effective to ensure that the
information required to be disclosed by us in this Quarterly Report on Form 10-Q was recorded,
processed, summarized and reported within the time periods specified in the SECs rules and Form
l0-Q, and that such information was accumulated and communicated to management, including the Chief
Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding
required disclosure.
Change in internal control over financial reporting
There were no changes in our internal control over financial reporting during the quarter ended
September 30, 2009 that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Limitations on the effectiveness of controls
Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance
that the objectives of our disclosure control system are met. Because of inherent limitations in
all control systems, no evaluation of controls can provide absolute assurance that all control
issues, if any, within a company have been detected.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Not Applicable.
Item 1A. Risk Factors
Our business and operations entail a variety of serious risks and uncertainties, including those
described in Item 1A of our Form 10-K for the year ended December 31, 2008. In addition, the
following risk factors have materially changed during the nine months ended September 30, 2009:
We have incurred losses for a number of years, and anticipate that we will incur continued losses
for the foreseeable future.
We began operations in December 1989. At that time, we provided research services, mostly to US
government agencies, on classified projects. We have financed our operations since 1999 primarily
through the sale of our equity securities and have devoted substantially all of our resources to
research and development relating to MelaFind®. Our net loss for the three and
nine months ended September 30, 2009 was approximately $5 million and $12.9 million, respectively,
and as of September 30, 2009, we had an accumulated deficit of approximately $73.6 million. Our
research and development expenses may increase in connection with our clinical trials and other
development activities related to MelaFind®. If we receive PMA approval for
MelaFind® from the FDA, we expect to incur significant sales and
marketing expenses, which will require additional funding, and manufacturing expenses. As a result,
we expect to continue to incur significant and increasing operating losses for the foreseeable
future. These losses, among other things, have had and will continue to have an adverse effect on
our stockholders equity.
26
We may be unable to complete the development and commence commercialization of
MelaFind® or other products without additional funding, and we will not be
able to achieve significant commercialization without additional funding.
As of September 30, 2009, we had $24.8 million in cash and cash equivalents. Our operations have
consumed substantial amounts of cash for each of the last eight years. The Company will require
additional funds to pursue regulatory approvals and to achieve significant commercialization of
MelaFind®. There can be no assurances that the Company will be able to raise
financing as needed from time to time, whether under the CEFF or by other types of securities
offerings.
Additional funds may not become available on acceptable terms, and there can be no assurance that
any additional funding that the Company does obtain will be sufficient to meet the Companys needs
in the long term. Any additional financing may be dilutive to stockholders, or may require us to
grant a lender a security interest in our assets. The amount of funding we will need will depend on
many factors, including:
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the schedule, costs, and results of our clinical trials; |
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the success of our research and development efforts; |
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the costs and timing of regulatory approval; |
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reimbursement amounts for the use of MelaFind®
that we are able to obtain from Medicare and third-party payers, or
the amount of direct payments we are able to obtain from patients
and/or physicians utilizing MelaFind®; |
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the cost of commercialization activities, including product marketing
and building a domestic direct sales force; |
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the emergence of competing or complementary technological developments; |
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the costs of filing, prosecuting, defending and enforcing any patent
claims and other rights, including litigation costs and the results of
such litigation; |
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the costs involved in defending any patent infringement actions
brought against us by third parties; and |
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our ability to establish and maintain any collaborative, licensing or
other arrangements, and the terms and timing of any such arrangements. |
If we are unable to obtain adequate financing on a timely basis, we may be required to
significantly curtail or cease one or more of our development and marketing programs. We could be
required to seek funds through arrangements with collaborators or others that may require us to
relinquish rights to some of our technologies, product candidates or products that we would
otherwise pursue on our own. We also may have to reduce marketing, customer support and other
resources devoted to our products. If we raise additional funds by issuing equity securities, our
then-existing stockholders will experience ownership dilution, could experience declines in our
share price and the terms of any new equity securities may have preferences over our common stock.
27
Our stock price is likely to be volatile, meaning purchasers of our common stock could incur
substantial losses.
Our stock price is likely to be volatile. Between October 28, 2005 (the date of our initial public
offering) and September 30, 2009, our stock price has ranged from $2.29 to $10.95 per share. The
stock market in general and the market for medical technology companies in particular have
experienced extreme volatility that has often been unrelated to the operating performance of
particular companies. The following factors, in addition to other risk factors described in this
section and general market and economic conditions, may have a significant impact on the market
price of our common stock:
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results of our research and development efforts and our clinical trials; |
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the timing of regulatory approval for our products; |
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failure of any of our products, if approved, to achieve commercial success; |
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the announcement of new products or product enhancements by us or our competitors; |
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regulatory developments in the US and foreign countries; |
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ability to manufacture our products to commercial standards; |
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developments concerning our clinical collaborators, suppliers or marketing partners; |
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changes in financial estimates or recommendations by securities analysts; |
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public concern over our products; |
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developments or disputes concerning patents or other intellectual property rights; |
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product liability claims and litigation against us or our competitors; |
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the departure of key personnel; |
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the strength of our balance sheet; |
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variations in our financial results or those of companies that are perceived to be similar to us; |
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changes in the structure of and third-party reimbursement in the US and other countries; |
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changes in accounting principles or practices; |
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general economic, industry and market conditions; and |
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future sales of our common stock. |
A decline in the market price of our common stock could cause you to lose some or all of your
investment and may adversely impact our ability to attract and retain employees and raise capital.
In addition, stockholders may initiate securities class action lawsuits if the market price of our
stock drops significantly. Whether or not meritorious, litigation brought against us could result
in substantial costs and could divert the time and attention of our management. Our insurance to
cover claims of this sort, if brought, may not be adequate, or in certain circumstances, not
provide coverage.
28
Results could be impacted by the effects of, and changes in, world-wide economic and capital market
conditions
The Companys business may be adversely affected by factors in the United States and other
countries that are beyond its control, such as disruptions in the financial markets or downturns in
economic activity. The current world-wide economic conditions could have an adverse impact on the
availability and cost of capital, interest rates, tax rates, or regulations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On May 7, 2009, the Company entered into a Committed Equity Financing Facility arrangement, or
CEFF, with Kingsbridge Capital Limited (Kingsbridge) in which Kingsbridge has committed to
purchase, subject to certain conditions and at the Companys sole discretion, up to the lesser of
$45 million or 3,327,000 shares of common stock, through May 7, 2012.
Under the CEFF, during August and September of 2009, the Company sold 862,201 shares of common
stock to Kingsbridge Capital Limited, at an average per share price of approximately $9.25, for
gross proceeds of $7.977 million.
Subsequent to September 30, 2009 and through November 5, 2009, also under the CEFF, the Company
sold 962,740 shares of common stock to Kingsbridge Capital Limited, at an average per share price
of approximately $9.23, for gross proceeds of $8.886 million. These shares were issued in reliance
upon the exemption from registration provided by Section 4(2) of the Securities Act of 1933, as
amended, for transactions by an issuer not involving a public offering.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders.
Not applicable.
Item 5. Other Information
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(a) |
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Not applicable |
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(b) |
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Not applicable |
29
Item 6. Exhibits
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Exhibit |
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Number |
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Exhibit Title |
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31.1#
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Certification of Chief Executive Officer Pursuant to Rule
13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act
of 1934, as amended. |
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31.2#
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Certification of Chief Financial Officer Pursuant to Rule
13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act
of 1934, as amended. |
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32.1#
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Certification of Chief Executive Officer and Chief Financial
Officer Pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
30
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ELECTRO-OPTICAL SCIENCES, INC.
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By: |
/s/ Richard I. Steinhart
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Richard I. Steinhart |
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Vice President and Chief Financial Officer
(Principal Accounting and Financial Officer) |
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Date: November 9, 2009
31
EXHIBIT INDEX
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Exhibit No. |
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Description |
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31.1
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Certification by the Chief Executive Officer pursuant to
Rule 13a-14(a) or Rule 15d-14(a) under the Securities
Exchange Act of 1934, as amended. |
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31.2
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Certification by the Chief Financial Officer pursuant to
Rule 13a-14(a) or Rule 15d-14(a) under the Securities
Exchange Act of 1934, as amended. |
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32.1
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Certification Pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act
of 2002. |
32
exv31w1
Exhibit 31.1
CERTIFICATION BY THE CHIEF EXECUTIVE OFFICER PURSUANT TO RULE 13A-14(A) or
RULE 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Joseph V. Gulfo, certify that:
1. |
|
I have reviewed this report on Form 10-Q of Electro-Optical Sciences, Inc.; |
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a
material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report; |
|
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for,
the periods presented in this report; |
|
4. |
|
The registrants other certifying officer and I are responsible for establishing
and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and
have: |
|
a) |
|
designed such disclosure controls and
procedures, or caused such disclosure
controls and procedures to be
designed under our supervision, to
ensure that material information
relating to the registrant, including
its consolidated subsidiaries, is
made known to us by others within
those entities, particularly during
the period in which this report is
being prepared; |
|
|
b) |
|
designed such internal control over
financial reporting, or caused such
internal control over financial
reporting to be designed under our
supervision, to provide reasonable
assurance regarding the reliability
of financial reporting and the
preparation of the financial
statements for external purposes in
accordance with generally accepted
accounting principles; |
|
|
c) |
|
evaluated the effectiveness of the
registrants disclosure controls and
procedures and presented in this
report our conclusions about the
effectiveness of the disclosure
controls and procedures, as of the
end of the period covered by this
report based on such evaluation; and |
|
|
d) |
|
disclosed in this report any change
in the registrants internal control
over financial reporting that
occurred during the registrants most
recent fiscal quarter that has
materially affected, or is reasonably
likely to materially affect, the
registrants internal control over
financial reporting; and |
5. |
|
The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the
registrants auditors and the audit committee of the registrants Board of
Directors (or persons performing the equivalent functions): |
|
a) |
|
all significant deficiencies and
material weaknesses in the design or
operations of internal control over
financial reporting which are
reasonably likely to adversely affect
the registrants ability to record,
process, summarize and report
financial information; and |
|
|
b) |
|
any fraud whether or not material,
that involves management or other
employees who have a significant role
in the registrants internal control
over financial reporting. |
Date: November 9, 2009
/s/ Joseph V. Gulfo, M.D.
Joseph V. Gulfo, M.D.
President and Chief Executive Officer
(Principal Executive Officer)
33
exv31w2
Exhibit 31.2
CERTIFICATION BY THE CHIEF FINANCIAL OFFICER PURSUANT TO RULE 13A-14(A) or
RULE 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
I, Richard I. Steinhart, certify that:
1. |
|
I have reviewed this report on Form 10-Q of Electro-Optical Sciences, Inc.; |
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light
of the circumstances under which such statements were made, not misleading with
respect to the period covered by this report; |
|
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the
periods presented in this report; |
|
4. |
|
The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
|
designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material
information relating to the registrant, including its
consolidated subsidiaries, is made known to us by
others within those entities, particularly during the
period in which this report is being prepared; |
|
|
b) |
|
designed such internal control over financial
reporting, or caused such internal control over
financial reporting to be designed under our
supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the
preparation of the financial statements for external
purposes in accordance with generally accepted
accounting principles; |
|
|
c) |
|
evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in
this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end
of the period covered by this report based on such
evaluation; and |
|
|
d) |
|
disclosed in this report any change in the registrants
internal control over financial reporting that occurred
during the registrants most recent fiscal quarter that
has materially affected, or is reasonably likely to
materially affect, the registrants internal control
over financial reporting; and |
5. |
|
The registrants other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the registrants
auditors and the audit committee of the registrants Board of Directors (or persons
performing the equivalent functions): |
|
a) |
|
all significant deficiencies and material weaknesses in
the design or operations of internal control over
financial reporting which are reasonably likely to
adversely affect the registrants ability to record,
process, summarize and report financial information;
and |
|
|
b) |
|
any fraud whether or not material, that involves
management or other employees who have a significant
role in the registrants internal control over
financial reporting. |
Date: November 9, 2009
/s/ Richard I. Steinhart
Richard I. Steinhart
Vice President and Chief Financial Officer
(Principal Accounting and Financial Officer)
34
exv32w1
Exhibit 32.1
ELECTRO-OPTICAL SCIENCES, INC.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Each of the undersigned officers of Electro-Optical Sciences, Inc. (the Company) hereby
certifies to his knowledge that the Companys quarterly report on Form 10-Q for the period ended
September 30, 2009 (the Report), as filed with the Securities and Exchange Commission on the date
hereof, fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the
Securities Exchange Act of 1934, as amended, and that the information contained in the Report
fairly presents, in all material respects, the financial condition and results of operations of the
Company.
/s/ Joseph V. Gulfo
Joseph V. Gulfo
President and Chief Executive Officer
(Principal Executive Officer)
November 9, 2009
/s/ Richard I. Steinhart
Richard I. Steinhart
Vice President & Chief Financial Officer
(Principal Accounting and Financial Officer)
November 9, 2009
|
|
|
* |
|
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley
Act of 2002 has been provided to Electro-Optical Sciences, Inc. and will be retained by
Electro-Optical Sciences, Inc. and furnished to the Securities and Exchange Commission or its
staff upon request. This written statement accompanies the Form 10-Q to which it relates, is
not deemed filed with the Securities and Exchange Commission, and will not be incorporated by
reference into any filing of Electro-Optical Sciences, Inc. under the Securities Act of 1933
or the Securities Exchange Act of 1934, irrespective of any general incorporation language
contained in such filing. |
35