UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-QSB
(Mark One)
[X] QUARTERLY REPORT UNDER SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED: JUNE 30, 2002
OR
TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE
EXCHANGE ACT
FOR THE TRANSITION PERIOD FROM _______TO________
COMMISSION FILE NUMBER: 0-26520
NEOPROBE CORPORATION
(Exact name of small business issuer as specified in its charter)
DELAWARE 31-1080091
(State or other jurisdiction of (I.R.S. employer identification no.)
incorporation or organization)
425 METRO PLACE NORTH, SUITE 300, DUBLIN, OHIO 43017
(Address of principal executive offices)
614.793.7500
(Issuer's telephone number)
36,503,183 SHARES OF COMMON STOCK, PAR VALUE $.001 PER SHARE
(Number of shares of issuer's common equity outstanding as of the
close of business on August 1, 2002)
Transitional Small Business Disclosure Format (check one) Yes [ ] No [X]
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
NEOPROBE CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
ASSETS JUNE 30, DECEMBER 31,
2002 2001
(UNAUDITED)
------------------- ------------------
Current assets:
Cash and cash equivalents $1,003,535 $ 4,287,101
Available-for-sale securities 2,243,765 -
Accounts receivable, net 468,143 561,129
Inventory 1,528,170 1,430,908
Prepaid expenses and other 286,751 268,445
------------------- ------------------
Total current assets 5,530,364 6,547,583
------------------- ------------------
Property and equipment 2,372,498 2,171,788
Less accumulated depreciation and amortization 1,716,251 1,502,676
------------------- ------------------
656,247 669,112
------------------- ------------------
Patents and trademarks 3,196,659 3,183,639
Non-compete agreements 603,880 603,880
Acquired technology 245,131 245,131
------------------- ------------------
4,045,670 4,032,650
Less accumulated amortization 364,030 122,697
------------------- ------------------
3,681,640 3,909,953
------------------- ------------------
Other assets 82,308 202,258
------------------- ------------------
Total assets $9,950,559 $11,328,906
=================== ==================
2
NEOPROBE CORPORATION AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS, CONTINUED
LIABILITIES AND STOCKHOLDERS' EQUITY JUNE 30, DECEMBER 31,
2002 2001
(UNAUDITED)
------------------ ------------------
Current liabilities:
Line of credit $1,000,000 $ -
Notes payable to finance company 27,953 161,865
Capital lease obligations, current 13,770 12,914
Accrued liabilities 971,440 1,011,495
Accounts payable 328,137 489,688
Deferred license revenue, current 800,000 800,000
------------------ ------------------
Total current liabilities 3,141,300 2,475,962
------------------ ------------------
Capital lease obligations 12,905 20,011
Deferred license revenue 1,000,000 1,400,000
Contingent consideration for acquisition 429,574 453,602
Other liabilities 146,831 75,493
------------------ ------------------
Total liabilities 4,730,610 4,425,068
------------------ ------------------
Commitments and contingencies
Stockholders' equity:
Preferred stock; $.001 par value; 5,000,000 shares authorized at June 30,
2002 and December 31, 2001; none issued and outstanding (500,000 shares
designated as Series A, $.001 par value, at June 30, 2002 and
and December 31, 2001; none outstanding) - -
Common stock; $.001 par value; 50,000,000 shares
authorized; 36,502,183 shares issued and
outstanding at June 30, 2002; 36,449,067 shares issued
and outstanding at December 31, 2001 36,502 36,449
Additional paid-in capital 124,600,682 124,581,800
Accumulated deficit (119,430,696) (117,714,411)
Unrealized gain on available-for-sale securities 13,461 -
------------------ ------------------
Total stockholders' equity 5,219,949 6,903,838
------------------ ------------------
Total liabilities and stockholders' equity $9,950,559 $11,328,906
================== ==================
See accompanying notes to the financial statements
3
NEOPROBE CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
------------------------------------ -------------------------------------
2002 2001 2002 2001
---------------- --------------- ----------------- ----------------
Revenues:
Net sales $ 905,941 $2,079,619 $ 1,641,245 $3,475,288
License revenue and other 359,442 325,000 684,442 675,000
---------------- --------------- ----------------- ----------------
Total revenues 1,265,383 2,404,619 2,325,687 4,150,288
---------------- --------------- ----------------- ----------------
Cost of goods sold 706,186 1,442,281 1,199,696 2,391,111
---------------- --------------- ----------------- ----------------
Gross profit 559,197 962,338 1,125,991 1,759,177
---------------- --------------- ----------------- ----------------
Operating expenses:
Research and development 697,431 223,162 1,237,187 422,953
Selling, general and administrative 745,589 593,449 1,620,396 1,163,558
---------------- --------------- ----------------- ----------------
Total operating expenses 1,443,020 816,611 2,857,583 1,586,511
---------------- --------------- ----------------- ----------------
(Loss) income from operations (883,823) 145,727 (1,731,592) 172,666
---------------- --------------- ----------------- ----------------
Other income (expense):
Interest income 20,386 32,838 37,338 82,993
Interest expense (5,217) (3,541) (8,052) (6,675)
Other (2,506) 2,360 (13,979) 9,488
---------------- --------------- ----------------- ----------------
Total other income 12,663 31,657 15,307 85,806
---------------- --------------- ----------------- ----------------
Net (loss) income $(871,160) $ 177,384 $ (1,716,285) $ 258,472
================ =============== ================= ================
(Loss) income per common share:
Basic $ (0.02) $ 0.01 $ (0.05) $ 0.01
Diluted $ (0.02) $ 0.01 $ (0.05) $ 0.01
Weighted average shares:
Basic 36,023,659 25,895,770 36,016,403 25,895,365
Diluted 36,023,659 26,111,063 36,016,403 26,122,631
See accompanying notes to the financial statements
4
NEOPROBE CORPORATION AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
SIX MONTHS ENDED
JUNE 30,
-----------------------------------------
2002 2001
------------------- ------------------
Cash flows from operating activities:
Net (loss) income $(1,716,285) $ 258,472
Adjustments to reconcile net (loss) income to
net cash used in operating activities:
Depreciation and amortization 456,743 200,565
Change in operating assets and liabilities:
Accounts receivable 108,252 228,796
Inventory (111,681) (213,813)
Accounts payable (185,331) (116,313)
Deferred license revenue (400,000) (400,000)
Other assets and liabilities 183,154 9,923
------------------- ------------------
Net cash used in operating activities (1,665,148) (32,370)
------------------- ------------------
Cash flows from investing activities:
Purchases of available-for-sale securities (2,491,361)
Maturities of available-for-sale securities 250,000 -
Purchases of property and equipment (165,216) (42,133)
Proceeds from sales of property and equipment - 2,175
Patent and trademark costs (13,020) (9,492)
Subsidiary acquisition costs (24,028) -
------------------- ------------------
Net cash used in investing activities (2,443,625) (49,450)
------------------- ------------------
Cash flows from financing activities:
Proceeds from issuance of common stock, net - 834
Payment of offering costs (34,631) -
Proceeds from notes payable 1,000,000 -
Payment of notes payable (133,912) (89,996)
Payments under capital leases (6,250) (5,497)
------------------- ------------------
Net cash provided by (used in) financing activities 825,207 (94,659)
------------------- ------------------
Net decrease in cash and cash equivalents (3,283,566) (176,479)
Cash and cash equivalents, beginning of period 4,287,101 4,643,347
------------------- ------------------
Cash and cash equivalents, end of period $ 1,003,535 $4,466,868
=================== ==================
See accompanying notes to the financial statements
5
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
1. BASIS OF PRESENTATION
The information presented for June 30, 2002 and 2001, and for the periods
then ended is unaudited, but includes all adjustments (which consist only
of normal recurring adjustments) that the management of Neoprobe
Corporation (Neoprobe, we or the Company) 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 generally accepted accounting principles have been
condensed or omitted pursuant to the rules and regulations of the U.S.
Securities and Exchange Commission. The results for the interim period are
not necessarily indicative of results to be expected for the year. The
financial statements should be read in conjunction with the Company's
audited financial statements for the year ended December 31, 2001, which
were included as part of the Company's Annual Report on Form 10-KSB.
Certain 2001 amounts have been reclassified to conform with the 2002
presentation (see Note 10).
The consolidated financial statements of the Company include the accounts
of the Company and its wholly-owned subsidiary, Cardiosonix Ltd.
(Cardiosonix) beginning December 31, 2001 (see also Note 10). All
significant inter-company accounts were eliminated in consolidation.
2. COMPREHENSIVE INCOME (LOSS)
Due to the Company's net operating loss position, there are no income tax
effects on comprehensive (loss) components for the three-month and
six-month periods ended June 30, 2002.
THREE MONTHS SIX MONTHS
ENDED ENDED
JUNE 30, 2002 JUNE 30, 2002
------------------ ------------------
Net loss $ (871,160) $ (1,716,285)
Unrealized gains on securities 19,829 13,461
---------------- ------------------
Other comprehensive loss $ (851,331) $ (1,702,824)
================ ==================
The Company had no accumulated other comprehensive income (loss) activity
during the three-month and six-month periods ended June 30, 2002.
3. EARNINGS PER SHARE
Basic earnings per share is calculated using the weighted average number of
common shares outstanding during the periods. Diluted earnings per share is
calculated using the weighted average number of common shares outstanding
during the periods, adjusted for the effects of convertible securities,
options and warrants, if dilutive.
THREE MONTHS ENDED THREE MONTHS ENDED
JUNE 30, 2002 JUNE 30, 2001
---------------------------------- ---------------------------------
BASIC DILUTED BASIC DILUTED
EARNINGS EARNINGS EARNINGS EARNINGS
PER SHARE PER SHARE PER SHARE PER SHARE
--------------- --------------- -------------- ---------------
Outstanding shares 36,502,183 36,502,183 26,265,770 26,265,770
Effect of weighting changes
in outstanding shares (38,524) (38,524) - -
Contingently issuable shares (440,000) (440,000) (370,000) (370,000)
Stock options - - - 215,293
--------------- --------------- -------------- ---------------
Adjusted shares 36,023,659 36,023,659 25,895,770 26,111,063
=============== =============== ============== ===============
6
SIX MONTHS ENDED SIX MONTHS ENDED
JUNE 30, 2002 JUNE 30, 2001
---------------------------------- =---------------------------------
BASIC DILUTED BASIC DILUTED
EARNINGS EARNINGS EARNINGS EARNINGS
PER SHARE PER SHARE PER SHARE PER SHARE
--------------- --------------- -------------- ---------------
Outstanding shares 36,502,183 36,502,183 26,265,770 26,265,770
Effect of weighting changes
in outstanding shares (45,780) (45,780) (405) (405)
Contingently issuable shares (440,000) (440,000) (370,000) (370,000)
Stock options - - - 227,266
--------------- --------------- -------------- ---------------
Adjusted shares 36,016,403 36,016,403 25,895,365 26,122,631
=============== =============== ============== ===============
The following table summarizes options to purchase common stock of the
Company which were outstanding during the three-month and six-month periods
ended June 30, 2001, but which were not included in the computation of
diluted income per share because their effect was anti-dilutive.
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, 2001 JUNE 30, 2001
------------------------------------------------- -----------------------------------------------
EXERCISE OPTIONS EXERCISE OPTIONS
PRICE OUTSTANDING PRICE OUTSTANDING
-------------------------- ------------------- ---------------------- ---------------------
$0.60 - $1.25 407,000 $0.60 - $ 1.25 405,494
$1.50 - $2.50 227,373 $1.50 - $2.50 227,446
$3.25 - $6.00 269,700 $3.25 - $6.00 269,700
$13.38 - $15.75 92,500 $13.38 - $15.75 92,500
------------------- ---------------------
996,573 995,140
=================== =====================
There is no difference in basic and diluted earnings per share for the
Company related to the three-month and six-month periods ended June 30,
2002. The net loss per common share for this period excludes the number of
common shares issuable upon exercise of outstanding stock options and
warrants into the Company's common stock since such inclusion would be
anti-dilutive.
4. INVENTORY
The components of inventory are as follows:
JUNE 30, DECEMBER 31,
2002 2001
---------------- ---------------
Materials and component parts $ 818,440 $ 807,393
Work in process 25,178 -
Finished goods 684,552 623,515
---------------- ---------------
$ 1,528,170 $ 1,430,908
================ ===============
5. LINE OF CREDIT
During February 2002, the Company entered into a line of credit facility
with an investment management company. The facility provides for a maximum
line of credit of $2.0 million and is fully collateralized by pledged cash
and investments on deposit with the investment management company.
Availability under the facility is based on advance rates varying from 80%
to 92% of the underlying available collateral. Outstanding amounts under
the facility bear interest at LIBOR plus
7
175 basis points. The facility expires in February 2007. There was $1.0
million outstanding under the line of credit as of June 30, 2002.
6. INCOME TAXES
For the six months ended June 30, 2001, the reversal of certain temporary
differences related to accrued expenses and deferred revenue resulted in
the generation of a loss for income tax purposes. As a result, no income
tax expense is reflected in the statement of operations for the six months
ended June 30, 2001. All of the Company's net deferred tax assets have been
fully offset by a valuation allowance.
7. STOCK OPTIONS
During the first half of 2002, the Board of Directors granted options to
employees and certain directors of the Company to purchase 905,000 shares
of common stock, exercisable at an average price of $0.42 per share,
vesting over three years. As of June 30, 2002, the Company has 2.8 million
options outstanding under three stock option plans. Of the outstanding
options, 1.1 million options have vested as of June 30, 2002, at an average
exercise price of $0.87 per share.
8. AGREEMENTS
During January 2002, the Company completed a license agreement with the
University of California, San Diego (UCSD) for a proprietary compound that
the Company believes could be used as a lymph node locating agent in
intraoperative lymphatic mapping (ILM) procedures. The license agreement is
effective until the later of the expiration date of the longest-lived
underlying patent or January 30, 2023. Under the terms of the license
agreement, UCSD has granted the Company the exclusive rights to make, use,
sell, offer for sale and import Licensed Products as defined in the
agreement and to practice the defined Licensed Methods during the term of
the agreement. The Company may also sublicense the Patent Rights, subject
to the approval of certain sublicense terms by UCSD. In consideration for
the license rights, the Company agreed to pay UCSD a license issue fee of
$25,000 and license maintenance fees of $25,000 per year. The Company also
agreed to pay UCSD milestone payments related to successful regulatory
clearance for marketing of the Licensed Products, a royalty on Net Sales of
Licensed Products subject to a $25,000 minimum annual royalty, fifty
percent of all sublicense fees and fifty percent of sublicense royalties.
The Company also agreed to reimburse UCSD for all patent-related costs.
UCSD also has the right to terminate the agreement or change the nature of
the agreement to a non-exclusive agreement if the Company is determined not
to have been diligent in developing and commercializing the covered
products, not marketing the products within six months of receiving
regulatory approval, reasonably filling market demand or obtaining all the
necessary government approvals.
9. SEGMENT AND SUBSIDIARY INFORMATION
The Company owns or has rights to intellectual property involving two
primary types of medical diagnostic products, including gamma detection
instruments currently used primarily in the application of ILM, and blood
flow measurement devices.
8
The information in the following table is derived directly from the
segment's internal financial reporting used for corporate management
purposes. Selling, general and administrative costs, including
amortization, interest and other costs that relate primarily to corporate
activity, are not currently allocated to the operating segments.
($ AMOUNTS IN THOUSANDS) GAMMA BLOOD
THREE MONTHS ENDED JUNE 30, 2002 DETECTION FLOW UNALLOCATED TOTAL
----------------------------------------------- ------------ ----------- --------------- -----------
Net sales:
United States(1) $ 905 $ - $ - $ 905
International 1 - - 1
License revenue and other 359 - - 359
Research and development expenses 212 485 - 697
Selling, general and administrative expenses - - 746 746
Income (loss) from operations(2) 347 (485) (746) (884)
Other income - - 13 13
THREE MONTHS ENDED JUNE 30, 2001
-----------------------------------------------
Net sales:
United States(1) $ 2,080 $ - $ - $ 2,080
International - - - -
License revenue and other 325 - - 325
Research and development expenses 223 - - 223
Selling, general and administrative expenses - - 593 593
Income (loss) from operations(2) 739 - (593) 146
Other income - - 32 32
($ AMOUNTS IN THOUSANDS) GAMMA BLOOD
SIX MONTHS ENDED JUNE 30, 2002 DETECTION FLOW UNALLOCATED TOTAL
----------------------------------------------- ------------ ----------- --------------- -----------
Net sales:
United States(1) $ 1,581 $ - $ - $ 1,581
International 60 - - 60
License revenue and other 684 - - 684
Research and development expenses 495 742 - 1,237
Selling, general and administrative expenses - - 1,620 1,620
Income (loss) from operations(2) 630 (742) (1,620) (1,732)
Other income - - 15 15
SIX MONTHS ENDED JUNE 30, 2001
-----------------------------------------------
Net sales:
United States(1) $ 3,407 $ - $ - $ 3,407
International 68 - - 68
License revenue and other 675 - - 675
Research and development expenses 423 - - 423
Selling, general and administrative expenses - - 1,164 1,164
Income (loss) from operations(2) 1,337 - (1,164) 173
Other income - - 86 86
(1) All sales to Ethicon are made in the United States. Ethicon
distributes the product globally through its international affiliates.
(2) Income (loss) from operations does not reflect the allocation of
selling, general and administrative costs to the operating segments.
9
10. NEW ACCOUNTING PRONOUNCEMENTS
In July 2001, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards (SFAS) No. 141, Business
Combinations, and SFAS No. 142, Goodwill and Other Intangible Assets. Under
SFAS 141, any business combination initiated after June 30, 2001 must be
accounted for as a purchase. For purchase business combinations that are
consummated after June 30, 2001, goodwill and identifiable intangibles
should be recorded and amortized in accordance with SFAS 142, i.e.,
goodwill and intangible assets with indefinite lives are not amortized and
other identified intangibles are amortized. For any purchase business
combination consummated on or before June 30, 2001, the accounting under
APB 16 and APB 17 still applies. Goodwill and separately identifiable
intangibles should be recorded and amortized until adopting SFAS 142, which
is required for fiscal years beginning after December 15, 2001. A calendar
year-end company would continue to amortize goodwill and all separately
identifiable intangibles through December 31, 2001. Upon adoption of SFAS
142, a company would cease amortizing goodwill and separately identifiable
intangibles with indefinite lives and amortize other identifiable
intangibles in accordance with the guidelines set forth in the standard.
The Company adopted SFAS 141 and SFAS 142 as of December 31, 2001 related
to its acquisition of Cardiosonix. The adoption of these pronouncements
resulted in recording $3.5 million of acquired intangible assets with a
weighted average useful life of approximately 13 years. During the first
half of 2002, the Company recorded $180,000 in amortization expense that is
included in selling, general and administrative expenses, and recorded a
purchase price adjustment of $24,000 to the contingent consideration
liability related to net acquisition costs in excess of initial estimates.
In October 2001, the FASB issued SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, which supersedes both SFAS
121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived
Assets to Be Disposed Of and the accounting and reporting provisions of APB
Opinion No. 30, Reporting the Results of Operations--Reporting the Effects
of Disposal of a Segment of a Business, and Extraordinary, Unusual and
Infrequently Occurring Events and Transactions, for the disposal of a
segment of a business (as previously defined in that Opinion). SFAS 144
retains the fundamental provisions in SFAS 121 for recognizing and
measuring impairment losses on long-lived assets held for use and
long-lived assets to be disposed of by sale, while also resolving
significant implementation issues associated with SFAS 121. For example,
SFAS 144 provides guidance on how a long-lived asset that is used as part
of a group should be evaluated for impairment, establishes criteria for
when a long-lived asset is held for sale, and prescribes the accounting for
a long-lived asset that will be disposed of other than by sale. SFAS 144
retains the basic provisions of APB 30 on how to present discontinued
operations in the income statement but broadens that presentation to
include a component of an entity (rather than a segment of a business).
Unlike SFAS 121, an impairment assessment under SFAS 144 will never result
in a write-down of goodwill. Rather, goodwill is evaluated for impairment
under SFAS 142, Goodwill and Other Intangible Assets.
The Company adopted the provisions of SFAS 144 as of January 31, 2002. The
impairment assessment for long-lived assets held for use under SFAS 144 is
largely unchanged from SFAS 121. The provisions of SFAS 144 for assets held
for sale or other disposal generally are required to be applied
prospectively after the adoption date to newly initiated disposal
activities. The adoption of SFAS 144 did not have a material effect on the
Company's financial statements for the first half of 2002.
In November 2001, the Emerging Issues Task Force of the FASB issued Topic
D-103, Income Statement Characterization of Reimbursements Received for
Out-of-Pocket Expenses Incurred. The FASB is requiring Topic D-103 be
applied in financial reporting periods beginning after December 15, 2001.
Topic D-103 requires companies to characterize reimbursements received for
out-of-pocket expenses as revenue. The adoption of Topic D-103 requirements
resulted in the reclassification of the $125,000 per quarter reimbursement
by Ethicon of certain research and development charges from research and
development expenses to license revenue and other for all periods
presented.
10
In July 2002, the FASB issued SFAS No. 146, Accounting for Costs Associated with
Exit or Disposal Activities. SFAS 146 will require the Company to disclose
information about its exit and disposal activities, the related costs, and
changes in those costs in the notes to the interim and annual financial
statements that include the period in which an exit or disposal activity is
initiated. SFAS 146 will require the Company to disclose, for each reportable
segment, the exit or disposal activity costs incurred in the period and the
cumulative amount incurred, net of any changes in the liability, with an
explanation of the reasons for the changes. SFAS 146 will also require the
Company to disclose the total amount of costs expected to be incurred in
connection with the exit or disposal activity. The new requirements are
effective prospectively for exit and disposal activities initiated after
December 31, 2002. We do not anticipate that adoption of SFAS 146 will have a
material impact on our financial condition or results of operations.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
RESULTS OF OPERATIONS
Revenue for the first half of 2002 decreased $1.8 million to $2.3 million from
$4.2 million for the same period in 2001. Research and development expenses
during the first half of 2002 were $1.2 million or 43% of operating expenses for
the period. Selling, general and administrative expenses were $1.6 million or
57% of operating expenses for the period. Overall, operating expenses for the
first half of 2002 increased $1.3 million or 80% over the same period in 2001.
The Company anticipates that total operating expenses for the remaining half of
2002 will be consistent with first half 2002 levels, except for research and
development expenses that are expected to increase as a result of efforts to
bring the first of the blood flow measurement devices to market.
Three months ended June 30, 2002 and 2001
Net Sales and Margins. Net product sales decreased $1.2 million or 56% to
$906,000 during the second quarter of 2002 from $2.1 million during the same
period in 2001. Gross margins on product sales decreased to 22% of net sales for
the second quarter of 2002 compared to 31% of net sales for the same period in
2001.
The decline in net product sales was the result of lower overall demand for
gamma detection devices during the second quarter of 2002 as compared to the
same period in 2001. End customer (i.e., hospital) demand for the Company's
neo2000(R) gamma detection devices appears to be slowing. In addition, BlueTipTM
probes do not appear to be achieving the end customer acceptance originally
anticipated when initial stocking orders for Ethicon Endo-Surgery, Inc.
(Ethicon) were delivered in the first and second quarters of 2001. The decline
in demand below Ethicon's original expectations for neo2000 systems and BlueTip
probes, coupled with purchases they were required to make under the terms of the
Distribution Agreement, has resulted in an overstock position for probes and
control units at Ethicon. Ethicon began to take steps to decrease the overstock
position in the first quarter of 2002. These steps have resulted in a combined
decrease in sales of BlueTip probes and 14mm probes of over 70% during the
second quarter of 2002 as compared to the prior year. While control units are
also affected by the decline in end customer demand, the timing of scheduled
deliveries in the second quarters of 2001 and 2002 resulted in a net increase of
30% in control unit sales over the two periods. The decline in gross margins on
product sales was due to changes in the product sales mix as noted above with
decreased sales volumes of higher-margin products more than offsetting the
increase in sales volumes of lower-margin products during the quarter.
License Revenue and Other. License revenue and other in the second quarters of
2002 and 2001 included $200,000 from the pro-rata recognition of license fees
related to the distribution agreement with Ethicon, and $159,000 and $125,000,
respectively, from the reimbursement by Ethicon of certain product development
costs.
Research and Development Expenses. Research and development expenses increased
$474,000 or 213% to $697,000 during the second quarter of 2002 from $223,000
during the same period in 2001. The
11
increase is primarily due to the product development support efforts of
Cardiosonix and $21,000 in gamma detection drug development costs.
Selling, General and Administrative Expenses. Selling, general and
administrative expenses increased $152,000 or 26% to $746,000 during the second
quarter of 2002 from $593,000 during the same period in 2001. The increase was
primarily a result of the general and administrative costs incurred in the
operation and support of Cardiosonix, $90,000 in amortization of intangible
assets related to the acquisition of Cardiosonix, and the transfer of
manufacturing of certain components of the neo2000 gamma detection system to a
new contract manufacturer, offset by decreases in certain overhead costs, such
as bad debts and warranty expense.
Other Income. Other income decreased $19,000 or 60% to $13,000 during the second
quarter of 2002 from $32,000 during the same period in 2001. Other income during
the second quarters of 2002 and 2001 consisted primarily of interest income. The
Company's interest income decreased because the Company received a lower
interest rate on its cash and investments during the second quarter of 2002 as
compared to the same period in 2001, consistent with marketplace activity over
the two periods.
Six months ended June 30, 2002 and 2001
Net Sales and Margins. Net product sales decreased $1.8 million or 53% to $1.6
million during the first half of 2002 from $3.5 million during the same period
in 2001. Gross margins on product sales decreased to 27% of net sales for the
first half of 2002 compared to 31% of net sales for the same period in 2001.
The decline in net product sales was the result of lower overall demand for
gamma detection devices during the first half of 2002 as compared to the same
period in 2001. End customer (i.e., hospital) demand for the Company's neo2000
gamma detection devices appears to be slowing. In addition, BlueTip probes do
not appear to be achieving the end customer acceptance originally anticipated
when Ethicon's initial stocking orders were delivered in the first half of 2001.
The decline in demand below Ethicon's original expectations for neo2000 systems
and BlueTip probes, coupled with purchases they were required to make under the
terms of the Distribution Agreement, has resulted in an overstock position for
probes and control units at Ethicon. In connection with delays in the transfer
of manufacturing of the neo2000 systems to a new contract manufacturer during
the first quarter of 2002, the Company began working with Ethicon during the
first quarter to decrease their overstock position. The steps taken have
resulted in a combined decrease in sales of BlueTip probes and 14mm probes of
over 60% during the first half of 2002 as compared to the prior year. While
control units are also affected by the decline in demand, the timing of
scheduled deliveries in the first halves of 2001 and 2002 resulted in a net
increase of 20% in control unit sales over the two periods. The decline in gross
margins on product sales was due to changes in the product sales mix as noted
above with decreased sales volumes of higher-margin products more than
offsetting the increase in lower-margin products during the first half of 2002.
The Company believes, based on Ethicon's current purchase commitments and
forecasts, that sales volumes for the second half of 2002 will be more
consistent with first quarter 2002 levels and that Ethicon will meet its minimum
purchase obligations by the end of 2002. Despite the declines in demand, the
Company believes, again based primarily on Ethicon's current forecasts, that
Ethicon's overstock position for 14mm probes and control units will be
substantially, if not completely, eliminated by the end of 2002 and that sales
of 14mm probes and control units to Ethicon should begin to increase in 2003
once the overstock position has been eliminated. The Company does not expect
that the overstock situation with respect to BlueTip probes will show the same
degree of improvement in the near term. The Company expects gross margins on
product sales for the second half of 2002 to be consistent with margins
experienced during the first half of 2002.
License Revenue and Other. License revenue and other in the first half of 2002
and 2001 included $400,000 from the pro-rata recognition of license fees related
to the distribution agreement with Ethicon and $284,000 and $250,000,
respectively, from the reimbursement by Ethicon of certain product development
costs. License revenue and other in the first half of 2001 also included $25,500
from the
12
recognition of milestone fees related to an option agreement to license certain
of the Company's RIGS(R) technology.
Research and Development Expenses. Research and development expenses increased
$814,000 or 193% to $1.2 million during the first half of 2002 from $423,000
during the same period in 2001. The increase is primarily due to the product
development efforts related to the Cardiosonix line of blood flow products
coupled with $55,000 in gamma detection drug development costs.
Selling, General and Administrative Expenses. Selling, general and
administrative expenses increased $457,000 or 39% to $1.6 million during the
first half of 2002 from $1.2 million during the same period in 2001. The
increase was primarily a result of the general and administrative costs incurred
in the operation and support of Cardiosonix, $180,000 in amortization of
intangible assets related to the acquisition of Cardiosonix, increased
professional services incurred by the Company related to Cardiosonix, the
transfer of manufacturing of certain components of the neo2000 gamma detection
system to a new contract manufacturer, and $45,000 in impairment of intellectual
property that the Company did not believe had ongoing value to the business.
These increases were offset by decreases in certain overhead costs, such as bad
debts and warranty expense.
Other Income. Other income decreased $70,000 or 82% to $15,000 during the first
half quarter of 2002 from $86,000 during the same period in 2001. Other income
during the first half of 2002 and 2001 consisted primarily of interest income.
The Company's interest income decreased because the Company received a lower
interest rate on its cash and investments during the first quarter of 2002 as
compared to the same period in 2001, consistent with marketplace activity over
the two periods. In addition, the Company recorded $14,000 of currency exchange
losses during the first half of 2002 related to operations at Cardiosonix.
LIQUIDITY AND CAPITAL RESOURCES
Operating Activities. Cash used in operations increased $1.6 million to $1.7
million during the first half of 2002 from $32,000 during the same period in
2001. Working capital decreased $1.7 million to $2.4 million at June 30, 2002 as
compared to $4.1 million at December 31, 2001. The current ratio decreased to
1.8 at June 30, 2002 from 2.6 at December 31, 2001. The decrease in working
capital was primarily related to cash used to fund development activities.
Cash and investment balances decreased to $3.2 million at June 30, 2002 from
$4.3 million at December 31, 2001, primarily due to the requirements of
supporting the operations of Cardiosonix and the decrease in net sales during
the first half of 2002.
Accounts receivable decreased to $468,000 at June 30, 2002 from $561,000 at
December 31, 2001. The Company expects receivable levels to fluctuate in 2002
depending on the timing of purchases and payments by Ethicon.
Inventory levels increased to $1.5 million at June 30, 2002 as compared to $1.4
million at December 31, 2001 as we began to replenish our control unit safety
stock following a manufacturing transfer in the first quarter and began to
acquire materials in preparation for production of blood flow products. During
the remainder of 2002, we will continue to work through our carryover stock of
certain long-lead gamma device components that were built up during 2001 as a
result of quantity price breaks. We expect inventory levels to increase slightly
in the third quarter as the use of these long-lead components is offset by the
re-establishment of our control unit safety stock and we start to build
inventory of blood flow products in preparation for commercial launch.
The Company had previously indicated it would spend a net amount of $3.5 million
during 2002, primarily in support of development of its blood flow product line.
We believe this goal is still achievable despite the declines in revenue from
our original expectations, and to that end, we made certain organizational
changes early in the third quarter in the resources that support our gamma
detection product line in order to keep our cash needs for the remainder of 2002
in line with our original expectations.
13
Investing Activities. Cash used in investing activities increased to $2.4
million during the first half of 2002 from $49,000 during the same period in
2001. During the first half of 2002, the Company invested in $2.5 million of
available-for-sale securities. Capital expenditures in the first half of 2002
were primarily for purchases of production tools and equipment, product
development equipment, and technology infrastructure. Capital expenditures in
the first half of 2001 were split between purchases of production tools and
equipment and technology infrastructure. Capital needs for the remainder of 2002
are expected to increase over 2001 to support instrument development and
manufacturing activities, although it is our intent to outsource manufacturing
of blood flow products in the long-term as is currently done for our gamma
detection devices.
Financing Activities. Financing activities provided $825,000 in cash in the
first half of 2002 versus $95,000 used during the same period in 2001. During
the second quarter of 2002, the Company drew $1.0 million under a line of credit
primarily to fund the development activities of Cardiosonix. Payments of notes
payable were 50% higher during the first half of 2002 as compared to the same
period in 2001, due to the increased cost of financed insurance.
On November 19, 2001, the Company entered into a common stock purchase agreement
with an investment fund, Fusion Capital Fund II, LLC (Fusion) for the issuance
and purchase of Neoprobe common stock. Under the stock purchase agreement,
Fusion committed to purchase up to $10 million of Neoprobe common stock over a
forty-month period that commenced in May 2002. A registration statement
registering for resale of up to 5 million shares of Neoprobe common stock was
declared effective on April 15, 2002. The Company will be able to request daily
draw downs, subject to a daily base amount, currently set at $12,500. The number
of shares the Company is to issue to Fusion in return for that money will be
based on the lower of (a) the closing sale price for Neoprobe common stock on
the day of the draw request or (b) the average of the three lowest closing sales
prices during a twelve day period prior to the draw request. No shares may be
sold to Fusion at lower than a floor price currently set at $0.30, but in no
case below $0.20 without Fusion's prior consent. Upon execution of the common
stock purchase agreement, the Company issued 449,438 shares of Neoprobe common
stock to Fusion as a commitment fee. Market conditions (i.e., share price) have
effectively prohibited the Company from drawing funds under the Fusion facility
during the first half of 2002, and in the absence of a change in those
conditions, the Fusion facility is unlikely to be drawn on in the foreseeable
future.
During February 2002, the Company entered into a line of credit facility with an
investment management company. The facility provides for a maximum line of
credit of $2.0 million and is fully collateralized by pledged cash and
investments on deposit with the investment management company. Availability
under the facility is based on advance rates varying from 80% to 92% of the
underlying available collateral. Outstanding amounts under the facility bear
interest at LIBOR plus 175 basis points. The facility expires in February 2007.
There was $1.0 million outstanding under the line of credit as of June 30, 2002.
The Company believes its current cash, available-for-sale securities, and cash
expected to be provided through sales of its gamma detection products are
adequate to sustain the Company's planned development and operations through the
fourth quarter of 2002. However, the Company's ability to execute its plans into
2003 significantly depends on its ability to raise additional funds from sources
other than operations. The Company's future liquidity and capital requirements
will depend on a number of factors, including its ability to raise additional
capital in a timely manner through additional investment, expanded market
acceptance of its current products, its ability to commercialize new products
such as its blood flow product line, its ability to monetize its investment in
non-core technologies, its ability to obtain milestone or development funds from
potential development and distribution partners, regulatory actions by the FDA
and other international regulatory bodies, and intellectual property protection.
There can be no assurance that the additional capital the Company may require to
finance operations beyond 2002 will be available on acceptable terms, if at all.
Any failure to secure additional financing will force the Company to modify its
business plan. There can be no assurance that the Company will be able to
achieve significant product revenues from its current or potential new products.
In addition, there can be no assurance that the Company will achieve
profitability again in the future.
14
FORWARD-LOOKING STATEMENTS
Our company and its representatives may from time to time make written or verbal
forward-looking statements, including statements contained in this report and
other Company filings with the Securities and Exchange Commission and in our
reports to shareholders. Statements that relate to other than strictly
historical facts, such as statements about our plans and strategies,
expectations for future financial performance, new and existing products and
technologies, and markets for our products are forward-looking statements.
Generally, the words "believe," "expect," "intend," "estimate," "anticipate,"
"will" and other similar expressions identify forward-looking statements. The
forward-looking statements are and will be based on our management's
then-current views and assumptions regarding future events and operating
performance, and speak only as of their dates. Investors are cautioned that such
statements involve risks and uncertainties that could cause actual results to
differ materially from historical or anticipated results due to many factors
including, but not limited to, our company's limited revenues, accumulated
deficit, future capital needs, uncertainty of capital funding, dependence on
limited product line and exclusive distributor, uncertainty of market
acceptance, competition, limited marketing and manufacturing experience, and
other risks detailed in our company's most recent Annual Report on Form 10-KSB
and other Securities and Exchange Commission filings. We undertake no obligation
to publicly update or revise any forward-looking statements.
15
PART II - OTHER INFORMATION
ITEM 4. Submission of Matters to a Vote of Security Holders.
(a) Neoprobe Corporation held its Annual Meeting of Stockholders on June
20, 2002, for the purpose of electing two directors, approving and
adopting the Company's 2002 Stock Incentive Plan, and increasing the
authorized number of shares of the Company's stock.
(b) At the Annual Meeting of Stockholders, all directors nominated were
elected.
(c) The table shows the voting tabulation for each matter voted upon at the
Annual Meeting of Stockholders.
ACTION FOR WITHHELD
------ --- --------
Election of Directors
Nancy E. Katz 21,828,980 442,561
Fred B. Miller 21,873,852 397,689
ACTION FOR AGAINST ABSTAIN
------ --- ------- -------
Adoption of the Company's 2002
Stock Incentive Plan 14,250,179 1,203,240 86,610
ACTION FOR AGAINST ABSTAIN
------ --- ------- -------
Increase the authorized number of shares of the
Company from 55,000,000 to 80,000,000, consisting of
75,000,000 shares of common stock, $.001 par value,
and 5,000,000 shares of preferred stock, $.001 par
value 14,740,257 2,018,830 72,500
ITEM 6. Exhibits and Reports on Form 8-K
(a) LIST OF EXHIBITS
99. ADDITIONAL EXHIBITS
Exhibit 99.1 Certification Under Section 906 of Sarbanes-Oxley Act
of 2002
Exhibit 99.2 Certification Under Section 906 of Sarbanes-Oxley Act
of 2002
(b) REPORTS ON FORM 8-K
None.
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
NEOPROBE CORPORATION
(the Company)
Dated: August 13, 2002
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)
17