þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware | 31-1080091 | |
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
425 Metro Place North, Suite 300, Dublin, Ohio | 43017-1367 | |
(Address of principal executive offices) | (Zip Code) |
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
2
September 30, | ||||||||
2008 | December 31, | |||||||
(unaudited) | 2007 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash |
$ | 2,599,816 | $ | 1,540,220 | ||||
Accounts receivable, net |
1,315,937 | 1,621,910 | ||||||
Inventory |
786,140 | 1,237,403 | ||||||
Prepaid expenses and other |
205,990 | 247,035 | ||||||
Total current assets |
4,907,883 | 4,646,568 | ||||||
Property and equipment |
2,028,569 | 1,918,343 | ||||||
Less accumulated depreciation and amortization |
1,654,604 | 1,630,740 | ||||||
373,965 | 287,603 | |||||||
Patents and trademarks |
3,030,399 | 3,016,783 | ||||||
Acquired technology |
237,271 | 237,271 | ||||||
3,267,670 | 3,254,054 | |||||||
Less accumulated amortization |
1,823,202 | 1,652,912 | ||||||
1,444,468 | 1,601,142 | |||||||
Other assets |
623,140 | 527,634 | ||||||
Total assets |
$ | 7,349,456 | $ | 7,062,947 | ||||
3
September 30, | ||||||||
2008 | December 31, | |||||||
(unaudited) | 2007 | |||||||
LIABILITIES AND STOCKHOLDERS DEFICIT |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 698,615 | $ | 778,085 | ||||
Accrued liabilities and other |
912,645 | 801,949 | ||||||
Capital lease obligations, current portion |
12,207 | 14,592 | ||||||
Deferred revenue, current portion |
491,742 | 451,512 | ||||||
Notes payable to finance companies |
| 124,770 | ||||||
Total current liabilities |
2,115,209 | 2,170,908 | ||||||
Capital lease obligations, net of current portion |
12,813 | 2,422 | ||||||
Deferred revenue, net of current portion |
501,772 | 623,640 | ||||||
Notes payable to CEO, net of discounts of $81,407
and $95,786, respectively |
918,593 | 904,214 | ||||||
Notes payable to investors, net of discounts of $5,158,353
and $2,600,392, respectively |
4,841,647 | 4,399,608 | ||||||
Derivative liabilities |
627,223 | 2,853,476 | ||||||
Other liabilities |
47,352 | 52,273 | ||||||
Total liabilities |
9,064,609 | 11,006,541 | ||||||
Commitments and contingencies |
||||||||
Stockholders deficit: |
||||||||
Preferred stock; $.001 par value; 5,000,000 shares
authorized at September 30, 2008 and December 31, 2008;
none issued and outstanding |
| | ||||||
Common stock; $.001 par value; 150,000,000 shares
authorized; 69,787,540 and 67,240,030 shares issued and
outstanding at September 30, 2008 and December 31, 2007,
respectively |
69,787 | 67,240 | ||||||
Additional paid-in capital |
142,927,031 | 136,765,697 | ||||||
Accumulated deficit |
(144,711,971 | ) | (140,776,531 | ) | ||||
Total stockholders deficit |
(1,715,153 | ) | (3,943,594 | ) | ||||
Total liabilities and stockholders deficit |
$ | 7,349,456 | $ | 7,062,947 | ||||
4
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Net sales |
$ | 1,800,266 | $ | 1,985,049 | $ | 5,838,083 | $ | 5,245,799 | ||||||||
Cost of goods sold |
692,817 | 836,436 | 2,259,494 | 2,325,772 | ||||||||||||
Gross profit |
1,107,449 | 1,148,613 | 3,578,589 | 2,920,027 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
1,810,929 | 548,455 | 3,273,344 | 2,287,600 | ||||||||||||
Selling, general and administrative |
812,752 | 690,206 | 2,592,044 | 2,123,075 | ||||||||||||
Total operating expenses |
2,623,681 | 1,238,661 | 5,865,388 | 4,410,675 | ||||||||||||
Loss from operations |
(1,516,232 | ) | (90,048 | ) | (2,286,799 | ) | (1,490,648 | ) | ||||||||
Other income (expenses): |
||||||||||||||||
Interest income |
18,843 | 12,601 | 47,933 | 56,858 | ||||||||||||
Interest expense |
(456,686 | ) | (862,762 | ) | (1,258,500 | ) | (1,749,609 | ) | ||||||||
Change in derivative liabilities |
59,415 | | (440,773 | ) | | |||||||||||
Other |
4,070 | (1,569 | ) | 2,699 | (3,918 | ) | ||||||||||
Total other expenses, net |
(374,358 | ) | (851,730 | ) | (1,648,641 | ) | (1,696,669 | ) | ||||||||
Net loss |
$ | (1,890,590 | ) | $ | (941,778 | ) | $ | (3,935,440 | ) | $ | (3,187,317 | ) | ||||
Net loss per common share: |
||||||||||||||||
Basic |
$ | (0.03 | ) | $ | (0.01 | ) | $ | (0.06 | ) | $ | (0.05 | ) | ||||
Diluted |
$ | (0.03 | ) | $ | (0.01 | ) | $ | (0.06 | ) | $ | (0.05 | ) | ||||
Weighted average shares outstanding: |
||||||||||||||||
Basic |
68,758,281 | 63,756,043 | 68,191,889 | 61,687,077 | ||||||||||||
Diluted |
68,758,281 | 63,756,043 | 68,191,889 | 61,687,077 |
5
Additional | ||||||||||||||||||||
Common Stock | Paid-in | Accumulated | ||||||||||||||||||
Shares | Amount | Capital | Deficit | Total | ||||||||||||||||
Balance, December 31, 2007 |
67,240,030 | $ | 67,240 | $ | 136,765,697 | $ | (140,776,531 | ) | $ | (3,943,594 | ) | |||||||||
Issued restricted stock to
employees |
450,000 | 450 | | | 450 | |||||||||||||||
Issued stock to investor
advisory services firms |
52,500 | 52 | 34,348 | | 34,400 | |||||||||||||||
Issued stock to 401(k) plan
at $0.28 |
114,921 | 115 | 29,916 | | 30,031 | |||||||||||||||
Issued stock upon exercise
of warrants |
1,745,089 | 1,745 | 168,061 | | 169,806 | |||||||||||||||
Issued stock upon exercise
of options |
185,000 | 185 | 61,715 | | 61,900 | |||||||||||||||
Paid common stock
issuance costs |
| | (900 | ) | | (900 | ) | |||||||||||||
Issued warrants to
purchase common stock |
| | 1,342,458 | | 1,342,458 | |||||||||||||||
Effect of beneficial conversion
feature of convertible
promissory note |
| | 1,443,845 | | 1,443,845 | |||||||||||||||
Reclassified derivative
liabilities |
| | 2,924,994 | | 2,924,994 | |||||||||||||||
Stock compensation expense |
| | 156,897 | | 156,897 | |||||||||||||||
Net loss |
| | | (3,935,440 | ) | (3,935,440 | ) | |||||||||||||
Balance, September 30, 2008 |
69,787,540 | $ | 69,787 | $ | 142,927,031 | $ | (144,711,971 | ) | $ | (1,715,153 | ) | |||||||||
6
Nine Months Ended | ||||||||
September 30, | ||||||||
2008 | 2007 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (3,935,440 | ) | $ | (3,187,317 | ) | ||
Adjustments to reconcile net loss to net cash
used in operating activities: |
||||||||
Depreciation and amortization |
302,904 | 306,143 | ||||||
Amortization of debt discount and debt offering costs |
515,056 | 1,077,365 | ||||||
Provision for bad debts |
699 | 962 | ||||||
Stock compensation expense |
156,897 | 77,608 | ||||||
Change in derivative liabilities |
440,773 | | ||||||
Other |
111,295 | 34,020 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
305,274 | (142,326 | ) | |||||
Inventory |
323,957 | 53,896 | ||||||
Prepaid expenses and other assets |
111,229 | 154,489 | ||||||
Accounts payable |
(79,470 | ) | 112,662 | |||||
Accrued liabilities and other liabilities |
105,775 | 339,099 | ||||||
Deferred revenue |
(81,638 | ) | (54,825 | ) | ||||
Net cash used in operating activities |
(1,722,689 | ) | (1,228,224 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchases of available-for-sale securities |
(196,000 | ) | | |||||
Maturities of available-for-sale securities |
196,000 | | ||||||
Purchases of property and equipment |
(97,673 | ) | (36,872 | ) | ||||
Proceeds from sales of property and equipment |
120 | | ||||||
Patent and trademark costs |
(13,616 | ) | (5,889 | ) | ||||
Net cash used in investing activities |
(111,169 | ) | (42,761 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from issuance of common stock |
232,156 | 1,300,000 | ||||||
Payment of stock offering costs |
(900 | ) | (21,510 | ) | ||||
Proceeds from notes payable |
3,000,000 | 1,000,000 | ||||||
Payment of debt issuance costs |
(200,154 | ) | (67,833 | ) | ||||
Payment of notes payable |
(124,770 | ) | (2,211,926 | ) | ||||
Payments under capital leases |
(12,878 | ) | (11,300 | ) | ||||
Net cash provided by (used in) financing activities |
2,893,454 | (12,569 | ) | |||||
Net increase (decrease) in cash |
1,059,596 | (1,283,554 | ) | |||||
Cash, beginning of period |
1,540,220 | 2,502,655 | ||||||
Cash, end of period |
$ | 2,599,816 | $ | 1,219,101 | ||||
7
1. | Summary of Significant Accounting Policies |
a. | Basis of Presentation: The information presented as of September 30, 2008 and for the three-month and nine-month periods ended September 30, 2008 and September 30, 2007 is unaudited, but includes all adjustments (which consist only of normal recurring adjustments) that the management of Neoprobe Corporation (Neoprobe, the Company, or we) believes to be necessary for the fair presentation of results for the periods presented. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. The results for the interim periods are not necessarily indicative of results to be expected for the year. The consolidated financial statements should be read in conjunction with Neoprobes audited consolidated financial statements for the year ended December 31, 2007, which were included as part of our Annual Report on Form 10-K. | ||
Our consolidated financial statements include the accounts of Neoprobe, our wholly-owned subsidiary, Cardiosonix Ltd. (Cardiosonix), and our 90%-owned subsidiary, Cira Biosciences, Inc. (Cira Bio). All significant inter-company accounts were eliminated in consolidation. | |||
b. | Financial Instruments and Fair Value: We adopted Statement of Financial Accounting Standards (SFAS) No. 157, Fair Value Measurements, for financial assets and liabilities as of January 1, 2008. SFAS No. 157 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under SFAS No. 157 are described below: |
A financial instruments level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In determining the appropriate levels, we perform a detailed analysis of the assets and liabilities that are subject to SFAS No. 157. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. In estimating the fair value of our derivative liabilities, we used the Black-Scholes option pricing model and, where necessary, other macroeconomic, industry and Company-specific conditions. |
8
2. | Fair Value Hierarchy | |
The following tables set forth by level financial liabilities measured at fair value on a recurring basis. |
Quoted Prices | ||||||||||||||||
in Active | ||||||||||||||||
Markets for | Significant | |||||||||||||||
Identical | Other | Significant | ||||||||||||||
Assets and | Observable | Unobservable | Balance as of | |||||||||||||
Liabilities | Inputs | Inputs | September 30, | |||||||||||||
Description | (Level 1) | (Level 2) | (Level 3) | 2008 | ||||||||||||
Liabilities: |
||||||||||||||||
Derivative liabilities
related to warrants |
$ | | $ | | $ | | $ | | ||||||||
Derivative liabilities
related to conversion
and put options |
| | 627,223 | 627,223 | ||||||||||||
Total derivative liabilities |
$ | | $ | | $ | 627,223 | $ | 627,223 | ||||||||
Quoted Prices | ||||||||||||||||
in Active | ||||||||||||||||
Markets for | Significant | |||||||||||||||
Identical | Other | Significant | ||||||||||||||
Assets and | Observable | Unobservable | Balance as of | |||||||||||||
Liabilities | Inputs | Inputs | December 31, | |||||||||||||
Description | (Level 1) | (Level 2) | (Level 3) | 2007 | ||||||||||||
Liabilities: |
||||||||||||||||
Derivative liabilities
related to warrants |
$ | | $ | 1,254,404 | $ | | $ | 1,254,404 | ||||||||
Derivative liabilities
related to conversion
and put options |
| | 1,599,072 | 1,599,072 | ||||||||||||
Total derivative liabilities |
$ | | $ | 1,254,404 | $ | 1,599,072 | $ | 2,853,476 | ||||||||
9
The following table sets forth a summary of changes in the fair value of our Level 3 liabilities for the three-month period ended September 30, 2008: |
Purchases, | ||||||||||||||||||||
Balance at | Issuances | Transfers In | Balance at | |||||||||||||||||
June 30, | Unrealized | and | and/or (Out) | September 30, | ||||||||||||||||
Description | 2008 | Gains | Settlements | (See Note 9) | 2008 | |||||||||||||||
Derivative liabilities
related to conversion
and put options |
$ | 686,638 | $ | (59,415 | ) | $ | | $ | | $ | 627,223 | |||||||||
Total derivative liabilities |
$ | 686,638 | $ | (59,415 | ) | $ | | $ | | $ | 627,223 | |||||||||
The following table sets forth a summary of changes in the fair value of our Level 2 and Level 3 liabilities for the nine-month period ended September 30, 2008: |
Purchases, | ||||||||||||||||||||
Balance at | Issuances | Transfers In | Balance at | |||||||||||||||||
December 31, | Unrealized | and | and/or (Out) | September 30, | ||||||||||||||||
Description | 2007 | Losses | Settlements | (See Note 9) | 2008 | |||||||||||||||
Derivative liabilities
related to warrants |
$ | 1,254,404 | $ | 270,654 | $ | | $ | (1,525,058 | ) | $ | | |||||||||
Derivative liabilities
related to conversion
and put options |
1,599,072 | 170,119 | 257,968 | (1,399,936 | ) | 627,223 | ||||||||||||||
Total derivative liabilities |
$ | 2,853,476 | $ | 440,773 | $ | 257,968 | $ | (2,924,994 | ) | $ | 627,223 | |||||||||
Nonfinancial Assets and Liabilities Subject to FSP FAS 157-2 Deferral Provisions | ||
We will apply the fair value measurement and disclosure provisions of SFAS No. 157 effective January 1, 2009 to nonfinancial assets and liabilities measured on a nonrecurring basis. We measure the fair value of (1) long-lived assets and (2) intangible assets on a nonrecurring basis. |
3. | Stock-Based Compensation | |
At September 30, 2008, we have three stock-based compensation plans. Under the Amended and Restated Stock Option and Restricted Stock Purchase Plan (the Amended Plan), the 1996 Stock Incentive Plan (the 1996 Plan), and the Second Amended and Restated 2002 Stock Incentive Plan (the 2002 Plan), we may grant incentive stock options, nonqualified stock options, and restricted stock awards to full-time employees, and nonqualified stock options and restricted awards may be granted to our consultants and agents. Total shares authorized under each plan are 2 million shares, 1.5 million shares and 7 million shares, respectively. Although options are still outstanding under the Amended Plan and the 1996 Plan, these plans are considered expired and no new grants may be made from them. Under all three plans, the exercise price of each option is greater than or equal to the closing market price of our common stock on the date of the grant. | ||
Options granted under the Amended Plan, the 1996 Plan and the 2002 Plan generally vest on an annual basis over one to three years. Outstanding options under the plans, if not exercised, generally expire ten years from their date of grant or 90 days from the date of an optionees separation from employment with the Company. | ||
Compensation cost arising from stock-based awards is recognized as expense using the straight-line method over the vesting period. As of September 30, 2008, there was approximately $231,000 of total unrecognized compensation cost related to unvested stock-based awards, which we expect to recognize over remaining weighted average vesting terms of 0.7 years. For the three-month periods ended September 30, 2008 and 2007, our total stock-based compensation expense was approximately $63,000 and $10,000, respectively. For the nine-month periods ended September 30, 2008 and 2007, our total stock-based compensation expense was approximately $157,000 and $78,000, respectively. We have not recorded any income tax benefit related to stock-based |
10
compensation in any of the three-month and nine-month periods ended September 30, 2008 and 2007. | ||
The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model to value share-based payments. Expected volatilities are based on the Companys historical volatility, which management believes represents the most accurate basis for estimating expected volatility under the current circumstances. Neoprobe uses historical data to estimate forfeiture rates. The expected term of options granted is based on the vesting period and the contractual life of the options. The risk-free rate is based on the U.S. Treasury yield in effect at the time of the grant. | ||
A summary of stock option activity under our stock option plans as of September 30, 2008, and changes during the nine-month period then ended is presented below: |
Nine Months Ended September 30, 2008 | ||||||||||||||||
Weighted | ||||||||||||||||
Weighted | Average | |||||||||||||||
Average | Remaining | Aggregate | ||||||||||||||
Number of | Exercise | Contractual | Intrinsic | |||||||||||||
Options | Price | Life | Value | |||||||||||||
Outstanding at beginning
of period |
5,495,473 | $ | 0.42 | |||||||||||||
Granted |
576,000 | $ | 0.42 | |||||||||||||
Exercised |
(185,000 | ) | $ | 0.33 | ||||||||||||
Forfeited |
| | ||||||||||||||
Expired |
(266,973 | ) | $ | 1.02 | ||||||||||||
Outstanding at end of period |
5,619,500 | $ | 0.40 | 5.6 years | | |||||||||||
Exercisable at end of period |
4,730,167 | $ | 0.40 | 5.0 years | | |||||||||||
A summary of the status of our restricted stock as of September 30, 2008, and changes during the nine-month period then ended is presented below: |
Nine Months Ended | ||||||||
September 30, 2008 | ||||||||
Weighted | ||||||||
Average | ||||||||
Number of | Grant-Date | |||||||
Shares | Fair Value | |||||||
Outstanding at beginning of period |
| | ||||||
Granted |
450,000 | $ | 0.36 | |||||
Vested |
| | ||||||
Forfeited |
| | ||||||
Expired |
| | ||||||
Outstanding at end of period |
450,000 | $ | 0.36 | |||||
11
4. | Comprehensive Loss | |
We had no accumulated other comprehensive loss activity during the three-month and nine-month periods ended September 30, 2008 or 2007. | ||
5. | Earnings Per Share | |
Basic earnings (loss) per share is calculated using the weighted average number of common shares outstanding during the periods, adjusted for unvested restricted stock. Diluted earnings (loss) per share is calculated using the weighted average number of common shares outstanding during the periods, adjusted for the effects of convertible securities, restricted shares, options and warrants determined using the treasury stock method, if dilutive. |
Three Months Ended | Three Months Ended | |||||||||||||||
September 30, 2008 | September 30, 2007 | |||||||||||||||
Basic | Diluted | Basic | Diluted | |||||||||||||
Earnings | Earnings | Earnings | Earnings | |||||||||||||
Per Share | Per Share | Per Share | Per Share | |||||||||||||
Outstanding shares |
69,787,540 | 69,787,540 | 65,084,134 | 65,084,134 | ||||||||||||
Effect of weighting changes
in outstanding shares |
(579,259 | ) | (579,259 | ) | (1,328,091 | ) | (1,328,091 | ) | ||||||||
Contingently issuable shares |
(450,000 | ) | (450,000 | ) | | | ||||||||||
Adjusted shares |
68,758,281 | 68,758,281 | 63,756,043 | 63,756,043 | ||||||||||||
Nine Months Ended | Nine Months Ended | |||||||||||||||
September 30, 2008 | September 30, 2007 | |||||||||||||||
Basic | Diluted | Basic | Diluted | |||||||||||||
Earnings | Earnings | Earnings | Earnings | |||||||||||||
Per Share | Per Share | Per Share | Per Share | |||||||||||||
Outstanding shares |
69,787,540 | 69,787,540 | 65,084,134 | 65,084,134 | ||||||||||||
Effect of weighting changes
in outstanding shares |
(1,145,651 | ) | (1,145,651 | ) | (3,397,057 | ) | (3,397,057 | ) | ||||||||
Contingently issuable shares |
(450,000 | ) | (450,000 | ) | | | ||||||||||
Adjusted shares |
68,191,889 | 68,191,889 | 61,687,077 | 61,687,077 | ||||||||||||
There is no difference in basic and diluted loss per share related to the three-month and nine-month periods ended September 30, 2008 and 2007. The net loss per common share for these periods excludes the effects of 49,799,546 and 40,354,155 common share equivalents, respectively, since such inclusion would be anti-dilutive. The excluded shares consist of restricted stock and common shares issuable upon exercise of outstanding stock options and warrants, or upon the conversion of convertible debt. | ||
6. | Inventory | |
From time to time, we capitalize certain inventory costs associated with our Lymphoseek® product prior to regulatory approval and product launch based on managements judgment of probable future commercial use and net realizable value of the inventory. We could be required to permanently write down previously capitalized costs related to pre-approval or pre-launch inventory upon a change in such judgment, due to a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential factors. Conversely, our gross margins may be favorably |
12
impacted if some or all of the inventory previously written down becomes available for commercial use and is used for commercial sale. During the nine-month period ended September 30 2007, we capitalized $150,000 associated with our Lymphoseek product. During the nine-month period ended September 30, 2008, we wrote off $153,000 of previously capitalized Lymphoseek inventory due to changes in our projections of the probability of future commercial use for the specific units previously capitalized. | ||
The components of inventory are as follows: |
September 30, | ||||||||
2008 | December 31, | |||||||
(unaudited) | 2007 | |||||||
Materials and component parts |
$ | 385,914 | $ | 471,753 | ||||
Work-in-process |
| 151,741 | ||||||
Finished goods |
400,226 | 613,909 | ||||||
Total |
$ | 786,140 | $ | 1,237,403 | ||||
7. | Intangible Assets | |
The major classes of intangible assets are as follows: |
September 30, 2008 | December 31, 2007 | |||||||||||||||||||
Wtd | Gross | Gross | Accumulated | |||||||||||||||||
Avg | Carrying | Accumulated | Carrying | Amortization | ||||||||||||||||
Life | Amount | Amortization | Amount | |||||||||||||||||
Patents and trademarks |
8.1 yrs | $ | 3,030,399 | $ | 1,594,358 | $ | 3,016,783 | $ | 1,449,350 | |||||||||||
Acquired technology |
0.3 yrs | 237,271 | 228,844 | 237,271 | 203,562 | |||||||||||||||
Total |
$ | 3,267,670 | $ | 1,823,202 | $ | 3,254,054 | $ | 1,652,912 | ||||||||||||
The estimated amortization expense for the next five fiscal years is as follows: |
Estimated | ||||
Amortization | ||||
Expense | ||||
For the year ended 12/31/2008 |
$ | 212,148 | ||
For the year ended 12/31/2009 |
170,136 | |||
For the year ended 12/31/2010 |
169,414 | |||
For the year ended 12/31/2011 |
168,310 | |||
For the year ended 12/31/2012 |
168,267 |
8. | Product Warranty | |
We warrant our products against defects in design, materials, and workmanship generally for a period of one year from the date of sale to the end customer, except in cases where the product has a limited use as designed. Our accrual for warranty expenses is adjusted periodically to reflect actual experience and is included in accrued liabilities on the consolidated balance sheets. Our primary marketing partner, Ethicon Endo-Surgery, Inc. (EES), a Johnson & Johnson company, also reimburses us for a portion of warranty expense incurred based on end customer sales they make during a given fiscal year. Payments charged against the reserve are disclosed net of EES estimated reimbursement. |
13
The activity in the warranty reserve account for the three-month and nine-month periods ended September 30, 2008 and 2007 is as follows: |
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||
Warranty reserve at
beginning of period |
$ | 87,679 | $ | 90,176 | $ | 115,395 | $ | 44,858 | ||||||||
Provision for warranty claims and
changes in reserve for warranties |
3,932 | 39,911 | 13,894 | 111,817 | ||||||||||||
Payments charged against the
reserve |
(18,816 | ) | (12,791 | ) | (56,494 | ) | (39,379 | ) | ||||||||
Warranty reserve at end of period |
$ | 72,795 | $ | 117,296 | $ | 72,795 | $ | 117,296 | ||||||||
9. | Notes Payable | |
In December 2004, we completed a private placement of four-year convertible promissory notes in an aggregate principal amount of $8.1 million under a Securities Purchase Agreement with Biomedical Value Fund, L.P., Biomedical Offshore Value Fund, Ltd. and David C. Bupp, our President and CEO. Biomedical Value Fund, L.P. and Biomedical Offshore Value Fund, Ltd. are funds managed by Great Point Partners, LLC (collectively, the Great Point Funds). The notes originally bore interest at 8% per annum and were due on December 13, 2008. As part of the original transaction with the Great Point Funds, we issued the investors 10,125,000 Series T warrants to purchase our common stock at an exercise price of $0.46 per share, expiring in December 2009. The fair value of the warrants issued to the investors and the value of the beneficial conversion feature were recorded as discounts on the note and were being amortized over the term of the notes using the effective interest method. In November 2006, we amended the Agreement and modified several of the key terms in the related notes, including the interest rate which was increased to 12% per annum, and modified the maturity of the notes to provide for a series of scheduled payments due on approximately six month intervals through January 7, 2009. We were also required to make additional mandatory repayments of principal to the Great Point Funds under certain circumstances. During 2007, we made scheduled principal payments and mandatory repayments totaling $2.4 million. | ||
In exchange for the increased interest rate and accelerated principal repayment schedule, the note holders eliminated the financial covenants under the original notes and eliminated certain conversion price adjustments from the original notes related to sales of equity securities by Neoprobe. We treated the amendment to the Agreement as a modification for accounting purposes, and the amortization of debt discount and issuance costs using the effective interest method was revised accordingly. During the third quarter of 2007, management determined that we had, from the date of the modification of the notes payable on November 30, 2006, through June 30, 2007, incorrectly applied the effective interest method in calculating the amortization of the debt discount and issuance costs related to the notes. As a result of the error in calculation, we recorded a total adjustment of $286,000 in non-cash interest expense related to the seven months ended June 30, 2007 in our results of operations for the third quarter of 2007. We determined that the net effect of this adjustment was not material, either quantitatively or qualitatively, to our results of operations and would not have resulted in changes to net loss per share, as reported, for the year ended December 31, 2006 or for the quarters ended March 31, 2007 and June 30, 2007. Recording the adjustment did not require amendment of the previously filed reports for the periods affected. | ||
In July 2007, David C. Bupp, our President and CEO, and certain members of his family (the Bupp Investors) purchased a $1.0 million convertible note (the Bupp Note) and warrants. The note bears interest at 10% per annum, had an original term of one year and is repayable in whole or in part with no penalty. The note is convertible, at the option of the Bupp Investors, into shares of our common stock at a price of $0.31 per share, a 25% premium to the average closing market price of our common stock for the 5 days preceding the closing of the transaction. As part of this transaction, we |
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issued the Bupp Investors 500,000 Series V warrants to purchase our common stock at an exercise price of $0.31 per share, expiring in July 2012. The fair value of the warrants issued to the investors was approximately $80,000 on the date of issuance and was determined using the Black-Scholes option pricing model with the following assumptions: an average risk-free interest rate of 4.95%, volatility of 105% and no expected dividend rate. The value of the beneficial conversion feature of the note was estimated at $86,000 based on the effective conversion price at the date of issuance. The fair value of the warrants issued to the investors and the value of the beneficial conversion feature were recorded as discounts on the note. We incurred $43,000 of costs related to completing the Bupp financing, which were recorded in other assets. The discounts and the deferred debt issuance costs were being amortized over the term of the note using the effective interest method. | ||
In December 2007, we executed a Securities Purchase Agreement (the Montaur Purchase Agreement) with Platinum Montaur Life Sciences, LLC (Montaur), pursuant to which we issued Montaur: (1) a 10% Series A Convertible Senior Secured Promissory Note in the principal amount of $7,000,000, due December 26, 2011 (the Series A Note); and (2) 6,000,000 Series W warrants to purchase our common stock at an exercise price of $0.32 per share, expiring in December 2012 (the Series W warrants). Additionally, pursuant to the terms of the Montaur Purchase Agreement: (1) upon commencement of the Phase 3 clinical studies of Lymphoseek, we agreed to issue to Montaur a 10% Series B Convertible Senior Secured Promissory Note, due December 26, 2011 (the Series B Note, and hereinafter referred to collectively with the Series A Note as the Montaur Notes), and five-year warrants to purchase an amount of common stock equal to the number of shares into which Montaur may convert the Series B Note, at an exercise price of 115% of the conversion price of the Series B Note (the Series X warrants), for an aggregate purchase price of $3,000,000; and (2) upon completion of enrollment of 200 patients in the Phase 3 clinical studies of Lymphoseek, we agreed to issue to Montaur 3,000 shares of our 8% Series A Cumulative Convertible Preferred Stock (the Preferred Stock) and five-year warrants to purchase an amount of common stock equal to the number of shares into which Montaur may convert the Preferred Stock, at an exercise price of 115% of the conversion price of the Preferred Stock (the Series Y warrants, and hereinafter referred to collectively with the Series W warrants and Series X warrants as the Montaur warrants), also for an aggregate purchase price of $3,000,000. | ||
The Series A Note bears interest at 10% per annum and is partially convertible at the option of Montaur into common stock at a price of $0.26 per share. Interest is payable monthly, in arrears, beginning February 2008 until the earlier of the maturity date or the date of conversion. At our discretion, we may pay the monthly interest payments in cash, common stock, or a combination of cash and common stock, subject to certain limitations set forth in the Series A Note. According to the provisions of the Certificate of Designations, Voting Powers, Preferences, Limitations, Restrictions, and Relative Rights of Series A 8% Cumulative Convertible Preferred Stock (the Certificate of Designations), Montaur may convert all or any portion of the shares of Preferred Stock into a number of shares of common stock equal to the quotient of: (1) the Liquidation Preference Amount of the shares of Preferred Stock by (2) the Conversion Price then in effect for the Preferred Stock. Per the Certificate of Designations, the Liquidation Preference Amount is equal to $1,000 per share of Preferred Stock, and the Conversion Price is equal to the lesser of $0.50 or the closing price of the common stock on the issuance date of the Preferred Stock, subject to adjustment as described in the Certificate of Designations. | ||
Under the terms of the original Registration Rights Agreement, dated December 26, 2007, we agreed to file a registration statement with the Commission registering the shares of common stock underlying the Notes, the Preferred Stock and the Warrants issued to Montaur pursuant to the Montaur Purchase Agreement. On April 16, 2008, we entered into the Second Amendment to Registration Rights Agreement (the Second Amendment), pursuant to which Montaur agreed to limit our registration obligations to (a) the shares of common stock issuable upon conversion of the Series B Note; (b) the shares of common stock issuable upon exercise of the Series W and X Warrants; and (c) 3,500,000 shares of common stock issuable as interest on the Montaur Notes. On July 10, 2008, we entered into a Third Amendment to Registration Rights Agreement (the Third Amendment), pursuant to which Montaur agreed to further limit our registration obligations to: (a) the |
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shares of common stock issuable upon conversion of the Series B Note; (b) the shares of common stock issuable upon exercise of the Series X Warrants; and (c) 3,500,000 shares of common stock issuable as interest on the Montaur Notes. Additionally, pursuant to the terms of the Registration Rights Agreement, as amended by the Second Amendment and Third Amendment, we agreed that: (a) within thirty-five (35) days following the Third Closing Date (as that term is defined in the Montaur Purchase Agreement) we will prepare and file with the Commission an additional resale registration statement providing for the resale of (in the following order of priority): (i) the shares of common stock issuable upon the conversion of the Preferred Shares; (ii) the shares of common stock issuable upon exercise of the Series Y Warrant; and (iii) shares of common stock issuable as dividends on the Preferred Shares, for an offering to be made on a continuous basis pursuant to Rule 415, and (b) within thirty-five (35) days of a receipt by the written request of the Holder therefore, we will prepare and file with the Commission an additional resale Registration Statement providing for the resale of the shares of common stock issuable upon the conversion of the Series A Note, and the shares of common stock issuable upon the exercise of the Series W Warrant. | ||
In accordance with SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, the conversion option and two put options were considered derivative instruments and were required to be bifurcated from the Series A Note and accounted for separately. In addition, in accordance with SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, the Series W warrants were accounted for as a liability due to the existence of certain provisions in the instrument. As a result, we recorded a total aggregate derivative liability of $2.6 million on the date of issuance of the Series A Note and Series W warrants. The fair value of the bifurcated conversion option and put options was approximately $1.45 million on the date of issuance. The fair value of the Series W warrants was approximately $1.15 million on the date of issuance and was determined using the Black-Scholes option pricing model with the following assumptions: an average risk-free interest rate of 3.7%, volatility of 94% and no expected dividend rate. Changes in the fair value of the derivative liabilities are recorded in the consolidated statement of operations. As of December 31, 2007, the derivative liabilities had estimated fair values of $1.60 million and $1.25 million for the conversion and put options and the warrants, respectively. | ||
On March 14, 2008, Neoprobe and Montaur executed amendments to the Series A Note and the Series W warrants. The amendments eliminated certain minor cash-based penalty provisions in the Series A Note and Series W warrants which entitled the holders to different compensation than our common shareholders under certain circumstances and qualifying Triggering Events. The provisions that were eliminated and/or modified were the provisions that led to the derivative accounting treatment for the embedded conversion option in the Series A Note and the Series W warrants. Because the value of our stock increased between December 31, 2007, our year end, and March 14, 2008, the effect of marking the conversion option and warrant liabilities to market at March 14, 2008 resulted in an increase in the estimated fair value of the conversion option and warrant liabilities of $381,000 which was recorded as non-cash expense during the first quarter of 2008. The estimated fair value of the conversion option and warrant liabilities of $2.9 million was reclassified to additional paid-in capital during the first quarter of 2008 as a result of the amendments. The effect of marking the put option liabilities related to the Series A Note to market at March 31, June 30, and September 30, 2008 resulted in a net increase in the estimated fair value of the put option liabilities of $43,000 which was recorded as non-cash expense during the first nine months of 2008. The estimated fair value of the put option liabilities related to the Series A Note of $353,000 remained classified as derivative liabilities as of September 30, 2008. | ||
The initial aggregate fair value of the conversion option and the put options related to the Series A Note and the fair value of the Series W warrants of $2.6 million were recorded as a discount on the note and are being amortized over the term of the note using the effective interest method. During the first nine months of 2008, we recorded interest expense of $403,000 related to the amortization of the debt discount. We incurred $510,000 of costs related to completing the initial Montaur financing, which were recorded in other assets on the consolidated balance sheet. The deferred financing costs are being amortized using the effective interest method over the term of the note. During the first nine months of 2008, we recorded interest expense of $79,000 related to the amortization of the deferred financing costs. |
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In April 2008, we completed the second closing under the December 2007 Montaur Purchase Agreement, as amended, pursuant to which we issued Montaur a 10% Series B Convertible Senior Secured Promissory Note in the principal amount of $3,000,000, due December 26, 2011; and 8,333,333 Series X warrants to purchase our common stock at an exercise price of $0.46 per share, expiring in April 2013. The Series B Note bears interest at 10% per annum and is fully convertible at the option of Montaur into common stock at a price of $0.36 per share. Interest is payable monthly, in arrears, beginning in April 2008 until the earlier of the maturity date or the date of conversion. At our discretion, we may pay the monthly interest payments in cash, common stock, or a combination of cash and common stock, subject to certain limitations set forth in the Series B Note. | ||
The fair value of the Series X warrants was approximately $1.28 million on the date of issuance and was determined using the Black-Scholes option pricing model with the following assumptions: an average risk-free interest rate of 2.6%, volatility of 95% and no expected dividend rate. The value of the beneficial conversion feature of the Series B Note was estimated at $1.44 million based on the effective conversion price at the date of issuance. The fair value of the warrants issued to the investors and the value of the beneficial conversion feature were recorded as discounts on the notes and are being amortized over the term of the notes using the effective interest method. The two put options were considered derivative instruments and were required to be bifurcated from the Series B Note and accounted for separately. The fair value of the bifurcated put options was approximately $258,000 on the date of issuance. Changes in the fair value of the derivative liabilities are recorded in the consolidated statement of operations. The effect of marking the put option liabilities related to the Series B Note to market at June 30 and September 30, 2008 resulted in a net increase in the estimated fair value of the put option liabilities of $16,000 which was recorded as non-cash expense during the first nine months of 2008. The estimated fair value of the put option liabilities related to the Series B Note of $274,000 remained classified as derivative liabilities as of September 30, 2008. | ||
The initial aggregate fair value of the beneficial conversion feature and put options related to the Series B Note, and the fair value of the Series X warrants of $2.98 million were recorded as a discount on the note and are being amortized over the term of the note using the effective interest method. During the second and third quarters of 2008, we recorded interest expense of $18,000 related to the amortization of the debt discount. We incurred $188,000 of costs related to completing the second Montaur financing, which were recorded in other assets on the consolidated balance sheet. The deferred financing costs are being amortized using the effective interest method over the term of the note. During the second and third quarters of 2008, we recorded interest expense of $1,000 related to the amortization of the deferred financing costs. | ||
In connection with the second closing, we also amended the Montaur Purchase Agreement with respect to the milestone that would trigger the third closing for an additional $3 million investment from Montaur. The milestone was revised from the accrual of 200 patients in a Phase 3 trial for Lymphoseek to obtaining 135 vital blue dye lymph nodes from patients with breast cancer or melanoma who have completed surgery with the injection of the drug in a Phase 3 clinical trial of Lymphoseek. | ||
In connection with the Montaur Purchase Agreement, Montaur requested that the term of the $1.0 million Bupp Note be extended until at least one day following the maturity date of the Montaur Notes. In consideration for the Bupp Investors agreement to extend the term of the Bupp Note pursuant to an Amendment to the Bupp Purchase Agreement, dated December 26, 2007, we agreed to provide security for the obligations evidenced by the Amended 10% Convertible Note in the principal amount of $1,000,000, due December 31, 2011, executed by Neoprobe in favor of the Bupp Investors (the Amended Bupp Note), under the terms of a Security Agreement, dated December 26, 2007, by and between Neoprobe and the Bupp Investors (the Bupp Security Agreement). As further consideration for extending the term of the Bupp Note, we issued the Bupp Investors 500,000 Series V warrants to purchase our common stock at an exercise price of $0.32 per share, expiring in December 2012. The |
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fair value of the warrants issued to the Bupp Investors was approximately $96,000 on the date of issuance and was determined using the Black-Scholes option pricing model with the following assumptions: an average risk-free interest rate of 3.72%, volatility of 94% and no expected dividend rate. The fair value of the warrants was recorded as a discount on the note and is being amortized over the term of the note using the effective interest method. We treated the amendment to the Bupp Note as an extinguishment of debt for accounting purposes. As such, the remaining discount resulting from the fair value of the warrants and the value of the beneficial conversion feature and the remaining unamortized deferred financing costs associated with the original note were written off as a loss on extinguishment of debt in December 2007. | ||
We applied $5,725,000 from the proceeds of our issuance of the Series A Note and Series W warrants to the complete and total satisfaction of our outstanding obligations under the Replacement Series A Convertible Promissory Notes issued to the Great Point Funds and David C. Bupp as of November 30, 2006, pursuant to the Securities Purchase Agreement, dated as of December 13, 2004, by and among Neoprobe, the Great Point Funds and Mr. Bupp, as amended by the Amendment dated as of November 30, 2006 (the Amended GPP Purchase Agreement). We treated the early repayment of the notes as an extinguishment of debt for accounting purposes. As such, the remaining discount resulting from the fair value of the warrants and the value of the beneficial conversion feature associated with the original notes was written off as a loss on extinguishment of debt in December 2007. We applied an additional $675,000 from the proceeds of our issuance of the Series A Note and Series W warrants to the redemption of 10,000,000 Series T warrants to purchase our common stock at an exercise price of $0.46 per share, issued to the Great Point Funds pursuant to the Amended GPP Purchase Agreement. In connection with the consummation of the Montaur Purchase Agreement and amendment of the Bupp Purchase Agreement, Mr. Bupp agreed to the cancellation of 125,000 Series T warrants to purchase our common stock at an exercise price of $0.46 per share, originally issued to Mr. Bupp pursuant to the Amended GPP Purchase Agreement. The combined events retired all of the Series T warrants issued to the Great Point Funds and Mr. Bupp. | ||
10. | Stock Warrants | |
During the first nine months of 2008, David C. Bupp, our President and CEO, exercised 375,000 Series Q warrants in exchange for issuance of 375,000 shares of our common stock, resulting in gross proceeds of $48,750. In addition, an outside investor exercised 500,000 Series Q warrants in exchange for issuance of 500,000 shares of our common stock, resulting in gross proceeds of $65,000. Also during the first nine months of 2008, another outside investor exercised a total of 200,200 Series R warrants in exchange for issuance of 200,200 shares of our common stock, resulting in gross proceeds of $56,056. In addition, certain outside investors exercised a total of 1,354,349 Series R warrants and 644,565 Series S warrants on a cashless basis in exchange for issuance of 669,889 shares of our common stock. | ||
At September 30, 2008, there are 19.2 million warrants outstanding to purchase our common stock. The warrants are exercisable at prices ranging from $0.28 to $0.50 per share with a weighted average exercise price of $0.39 per share. |
11. | Income Taxes | |
Effective January 1, 2007, we adopted Financial Interpretation (FIN) No. 48, Accounting for Uncertainty in Income Taxes an Interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in the financial statements in accordance with SFAS No. 109, Accounting for Income Taxes. FIN 48 also prescribes a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. No adjustment was made to the beginning retained earnings balance as the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result, no liability for uncertain tax |
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positions was recorded as of September 30, 2008. Should we need to accrue interest or penalties on uncertain tax positions, we would recognize the interest as interest expense and the penalties as a selling, general and administrative expense. | ||
12. | Segment and Subsidiary Information | |
We report information about our operating segments using the management approach in accordance with SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information. This information is based on the way management organizes and reports the segments within the enterprise for making operating decisions and assessing performance. Our reportable segments are identified based on differences in products, services and markets served. There were no inter-segment sales. We own or have rights to intellectual property involving two primary types of medical device products, including oncology instruments currently used primarily in the application of sentinel lymph node biopsy, and blood flow measurement devices. We also own or have rights to intellectual property related to several drug and therapy products. |
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The information in the following table is derived directly from each reportable segments financial reporting. |
Blood | Drug and | |||||||||||||||||||
($ amounts in thousands) | Oncology | Flow | Therapy | |||||||||||||||||
Three Months Ended September 30, 2008 | Devices | Devices | Products | Corporate | Total | |||||||||||||||
Net sales: |
||||||||||||||||||||
United States1 |
$ | 1,630 | $ | 26 | $ | | $ | | $ | 1,656 | ||||||||||
International |
85 | 59 | | | 144 | |||||||||||||||
Research and development expenses |
272 | 65 | 1,474 | | 1,811 | |||||||||||||||
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
7 | 44 | | 658 | 709 | |||||||||||||||
Depreciation and amortization |
32 | 59 | 1 | 12 | 104 | |||||||||||||||
Income (loss) from operations3 |
763 | (134 | ) | (1,475 | ) | (670 | ) | (1,516 | ) | |||||||||||
Other income (expenses)4 |
| | | (374 | ) | (374 | ) | |||||||||||||
Total assets, net of depreciation
and amortization: |
||||||||||||||||||||
United States operations |
1,796 | 584 | 26 | 3,534 | 5,940 | |||||||||||||||
Israeli operations (Cardiosonix Ltd.) |
| 1,409 | | | 1,409 | |||||||||||||||
Capital expenditures |
2 | | | 51 | 53 |
Blood | Drug and | |||||||||||||||||||
($ amounts in thousands) | Oncology | Flow | Therapy | |||||||||||||||||
Three Months Ended September 30, 2007 | Devices | Devices | Products | Corporate | Total | |||||||||||||||
Net sales: |
||||||||||||||||||||
United States1 |
$ | 1,935 | $ | | $ | | $ | | $ | 1,935 | ||||||||||
International |
12 | 38 | | | 50 | |||||||||||||||
Research and development expenses |
152 | 86 | 310 | | 548 | |||||||||||||||
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
| | | 592 | 592 | |||||||||||||||
Depreciation and amortization |
23 | 65 | | 10 | 98 | |||||||||||||||
Income (loss) from operations3 |
955 | (133 | ) | (310 | ) | (602 | ) | (90 | ) | |||||||||||
Other income (expenses)4 |
| | | (852 | ) | (852 | ) | |||||||||||||
Total assets, net of depreciation
and amortization: |
||||||||||||||||||||
United States operations |
1,916 | 667 | 187 | 1,662 | 4,432 | |||||||||||||||
Israeli operations (Cardiosonix Ltd.) |
| 1,620 | | | 1,620 | |||||||||||||||
Capital expenditures |
| | | 1 | 1 |
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Blood | Drug and | |||||||||||||||||||
($ amounts in thousands) | Oncology | Flow | Therapy | |||||||||||||||||
Nine Months Ended September 30, 2008 | Devices | Devices | Products | Corporate | Total | |||||||||||||||
Net sales: |
||||||||||||||||||||
United States1 |
$ | 5,513 | $ | 32 | $ | | $ | | $ | 5,545 | ||||||||||
International |
117 | 176 | | | 293 | |||||||||||||||
Research and development expenses |
718 | 189 | 2,366 | | 3,273 | |||||||||||||||
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
8 | 152 | | 2,130 | 2,289 | |||||||||||||||
Depreciation and amortization |
86 | 184 | 1 | 32 | 303 | |||||||||||||||
Income (loss) from operations3 |
2,694 | (452 | ) | (2,367 | ) | (2,161 | ) | (2,287 | ) | |||||||||||
Other income (expenses)4 |
| | | (1,649 | ) | (1,649 | ) | |||||||||||||
Total assets, net of depreciation
and amortization: |
||||||||||||||||||||
United States operations |
1,796 | 584 | 26 | 3,534 | 5,940 | |||||||||||||||
Israeli operations (Cardiosonix Ltd.) |
| 1,409 | | | 1,409 | |||||||||||||||
Capital expenditures |
4 | | 18 | 76 | 98 |
Blood | Drug and | |||||||||||||||||||
($ amounts in thousands) | Oncology | Flow | Therapy | |||||||||||||||||
Nine Months Ended September 30, 2007 | Devices | Devices | Products | Corporate | Total | |||||||||||||||
Net sales: |
||||||||||||||||||||
United States1 |
$ | 4,825 | $ | 160 | $ | | $ | | $ | 4,985 | ||||||||||
International |
136 | 125 | | | 261 | |||||||||||||||
Research and development expenses |
532 | 291 | 1,465 | | 2,288 | |||||||||||||||
Selling, general and administrative
expenses, excluding depreciation
and amortization2 |
| | | 1,817 | 1,817 | |||||||||||||||
Depreciation and amortization |
74 | 197 | | 35 | 306 | |||||||||||||||
Income (loss) from operations3 |
2,206 | (380 | ) | (1,465 | ) | (1,852 | ) | (1,491 | ) | |||||||||||
Other income (expenses)4 |
| | | (1,697 | ) | (1,697 | ) | |||||||||||||
Total assets, net of depreciation
and amortization: |
||||||||||||||||||||
United States operations |
1,916 | 667 | 187 | 1,662 | 4,432 | |||||||||||||||
Israeli operations (Cardiosonix Ltd.) |
| 1,620 | | | 1,620 | |||||||||||||||
Capital expenditures |
16 | 9 | | 12 | 37 |
1 | All sales to EES are made in the United States. EES distributes the product globally through its international affiliates. | |
2 | Selling, general and administrative expenses, excluding depreciation and amortization, represent expenses that relate to the general administration of the Company and as such are not currently allocated to our individual reportable segments. | |
3 | Income (loss) from operations does not reflect the allocation of selling, general and administrative expenses, excluding depreciation and amortization, to the operating segments. | |
4 | Amounts consist primarily of interest income and interest expense which are not currently allocated to our individual reportable segments. |
13. | Supplemental Disclosure for Statements of Cash Flows | |
During the nine-month periods ended September 30, 2008 and 2007, we paid interest aggregating $753,000 and $457,000, respectively. During the nine-month periods ended September 30, 2008 and 2007, we transferred $127,000 and $76,000, respectively, of inventory to fixed assets related to the creation and maintenance of a pool of service loaner equipment. During the nine-month period ended September 30, 2008, we purchased equipment under a capital lease totaling $20,000. During the nine-month periods ended September 30, 2008 and 2007, we issued 114,921 and 107,313 shares of common stock, respectively, as matching contributions to our 401(k) Plan. |
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| Obtained clearance from FDA to commence patient enrollment in a Phase 3 clinical study to evaluate the efficacy of Lymphoseek in patients with breast cancer or melanoma. | ||
| Submitted a protocol design for a second Phase 3 clinical study to evaluate the efficacy of Lymphoseek as a sentinel lymph node tracing agent in patients with head and neck squamous cell carcinoma. | ||
| Completed a $3 million investment from Montaur. The closing represents the second tranche received from Montaur bringing their investment to $10 million of the total $13 million commitment made in December of last year. | ||
| Initiated the formalized scientific advice review process for Lymphoseek in the European Union (EU). | ||
| Commenced a Phase 3 multi-center clinical trial for Lymphoseek in patients with breast cancer and melanoma. | ||
| Introduced the neoprobe GDS enhanced gamma detection system. | ||
| Introduced a wireless version of our laparoscopic gamma detection probe based on Bluetooth® technology. | ||
| Received a positive response on a regulatory pathway and a Phase 3 clinical trial design for RIGScan® CR with regulatory authorities in the EU under the scientific review process. |
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| Stock-Based Compensation. We account for stock-based compensation in accordance with SFAS No. 123(R), Share-Based Payment, which is a revision of SFAS No. 123, Accounting for Stock-Based Compensation. SFAS No. 123(R) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the income statement based on their estimated fair values. Compensation cost arising from stock-based awards is recognized as expense using the straight-line method over the vesting period. We use the Black-Scholes option pricing model to value share-based payments. The valuation assumptions used have not changed from those used under SFAS No. 123. | ||
| Inventory Valuation. We value our inventory at the lower of cost (first-in, first-out method) or market. Our valuation reflects our estimates of excess, slow moving and obsolete inventory as well as inventory with a carrying value in excess of its net realizable value. Write-offs are recorded when product is removed from saleable inventory. We review inventory on hand at least quarterly and record provisions for excess and obsolete inventory based on several factors, including current assessment of future product demand, anticipated release of new products into the market, historical experience and product expiration. Our industry is characterized by rapid product development and frequent new product introductions. Uncertain timing of product approvals, variability in product launch strategies, product recalls and variation in product utilization all impact the estimates related to excess and obsolete inventory. |
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| Impairment or Disposal of Long-Lived Assets. We account for long-lived assets in accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets. This Statement requires that long-lived assets and certain identifiable intangibles be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net undiscounted cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. As of September 30, 2008, the most significant long-lived assets on our balance sheet relate to assets recorded in connection with the acquisition of Cardiosonix. The recoverability of these assets is based on the financial projections and models related to the future sales success of Cardiosonix products. As such, these assets could be subject to significant adjustment should the Cardiosonix technology not be successfully commercialized or the sales amounts in our current projections not be realized. | ||
| Product Warranty. We warrant our products against defects in design, materials, and workmanship generally for a period of one year from the date of sale to the end customer. Our accrual for warranty expenses is adjusted periodically to reflect actual experience. EES also reimburses us for a portion of warranty expense incurred based on end customer sales they make during a given fiscal year. | ||
| Fair Value of Derivative Liabilities. We account for derivatives in accordance with SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities, which provides accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities. Derivative instruments embedded in contracts, to the extent not already a free-standing contract, are required to be bifurcated from the debt instrument and accounted for separately. All derivatives are recorded on the consolidated balance sheet at fair value. In accordance with SFAS No. 133, the conversion option and two put options embedded in the Series A Note issued in December 2007 were considered derivative instruments and were required to be bifurcated from the debt instrument and accounted for separately. In addition, in accordance with SFAS No. 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, the Series W warrants issued in connection with the Series A Note were accounted for as a liability due to the existence of certain provisions in the instrument. As a result, we recorded a total aggregate derivative liability of $2.6 million on the date of issuance of the note. The fair value of the Series W warrants was determined using the Black-Scholes option pricing model. Changes in the fair value of the derivative liabilities are recorded in the consolidated statement of operations. As of December 31, 2007, the derivative liabilities had a fair value of $1.60 million and $1.25 million for the conversion and put options and the warrants, respectively. | ||
On March 14, 2008, Neoprobe and Montaur executed amendments to the Series A Note and the Series W warrants. The amendments eliminated certain minor cash-based penalty provisions in the Series A Note and Series W warrants which entitled the holders to different compensation than our common shareholders under certain circumstances and qualifying Triggering Events. The provisions that were eliminated and/or modified were the provisions that led to the derivative accounting treatment for the embedded conversion option in the Series A Note and the Series W warrants. Because the value of our stock increased between December 31, 2007, our year end, and March 14, 2008, the effect of marking the conversion option and warrant liabilities to market at March 14, 2008 resulted in an increase in the estimated fair value of the conversion option and warrant liabilities of $381,000 which was recorded as non-cash expense during the first quarter of 2008. The estimated fair value of the conversion option and warrant liabilities of $2.9 million was reclassified to additional paid-in capital during the first quarter of 2008. The effect of marking the put option liabilities related to the Series A Note to market at March 31, June 30, and September 30, 2008 resulted in a net increase in the estimated fair value of the put option liabilities of |
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$43,000 which was recorded as non-cash expense during the first nine months of 2008. The estimated fair value of the put option liabilities related to the Series A Note of $353,000 remained classified as derivative liabilities as of September 30, 2008. | |||
The two put options embedded in the Series B Note issued in April 2008 were also considered derivative instruments and were required to be bifurcated from the debt instrument and accounted for separately. The fair value of the bifurcated put options was approximately $258,000 on the date of issuance. Changes in the fair value of the derivative liabilities are recorded in the consolidated statement of operations. The effect of marking the put option liabilities related to the Series B Note to market at June 30 and September 30, 2008 resulted in a net increase in the estimated fair value of the put option liabilities of $16,000 which was recorded as non-cash expense during the first nine months of 2008. The estimated fair value of the put option liabilities related to the Series B Note of $274,000 remained classified as derivative liabilities as of September 30, 2008. |
| pertain to the maintenance of records that, in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company; | ||
| provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles and that receipts and expenditures of the Company are being made only in accordance with authorization of management and directors of the Company; and | ||
| provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Companys assets that could have a material effect on the financial statements. |
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(a) | During the three-month period ended September 30, 2008, a placement agent who received warrants to purchase our common stock in connection with a November 2003 financing exercised a total of 391,304 warrants with an exercise price of $0.28 per share on a cashless basis in exchange for issuance of 234,782 shares of our common stock. In addition, an investor who received warrants to purchase our common stock in connection with the November 2003 financing exercised a total of 200,200 warrants with an exercise price of $0.28 per share in exchange for issuance of 200,200 shares of our common stock, and we realized gross proceeds of $56,000. The issuances of the shares and warrants to the placement agents and investors were exempt from registration under Sections 4(2) and 4(6) of the Securities Act and Regulation D. | ||
(b) | During the three-month period ended September 30, 2008, we issued 52,500 shares of our common stock pursuant to agreements with two investor advisory services firms as partial payment for their services under the agreements. The issuance of these shares was exempt from registration under Sections 4(2) and 4(6) of the Securities Act and Regulation D. |
31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* | ||
31.2 | Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* | ||
32.1 | Certification of Chief Executive Officer of Periodic Financial Reports pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350.* | ||
32.2 | Certification of Chief Financial Officer of Periodic Financial Reports pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350.* |
* | Filed herewith. |
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NEOPROBE CORPORATION | ||||||
(the Company) | ||||||
Dated: November 14, 2008 | ||||||
By: | /s/ David C. Bupp | |||||
David C. Bupp | ||||||
President and Chief Executive Officer | ||||||
(duly authorized officer; principal executive officer) | ||||||
By: | /s/ Brent L. Larson | |||||
Brent L. Larson | ||||||
Vice President, Finance and Chief Financial Officer | ||||||
(principal financial and accounting officer) |
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