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U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
[X] Quarterly Report pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
For the quarterly period ended September 30, 2000
[ ] Transition Report Under Section 13 or 15(d) of the Securities
Exchange Act of 1934
For the transition period from To
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Commission File Number: 0-17119
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A-Fem Medical Corporation
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(exact name of small business issuer as specified in its charter)
Nevada 33-0202574
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(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
10180 SW Nimbus Ave., Suite J5
Portland, OR 97223
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(Address of principal executive offices)
(503) 968-8800
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(Issuer's telephone number)
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes [X] No [ ]
As of October 31, 2000, the issuer had outstanding 9,596,558 shares of its $.01
par value Common Stock.
Transitional Small Business Disclosure Format: (Check one) Yes [ ] No [X]
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PART I - FINANCIAL INFORMATION
See "Basis of Presentation."
ITEM 1. FINANCIAL STATEMENTS
A-Fem Medical Corporation
BALANCE SHEETS
<TABLE>
<CAPTION>
As of
September 30, December 31,
2000 1999
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ASSETS (unaudited)
<S> <C> <C>
CURRENT ASSETS:
Cash and cash equivalents $ 290,914 $ 428,845
Accounts receivable 5,022 6,622
Inventory 49,882 65,581
Prepaids and other 69,316 86,649
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Total current assets 415,134 587,697
EQUIPMENT, FURNITURE and LEASEHOLDS, at cost 1,044,932 1,286,012
Less: accumulated depreciation (658,144) (640,331)
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386,788 645,681
PATENTS and LICENSES, net 83,999 54,700
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Total assets $ 885,921 $ 1,288,078
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LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 59,953 $ 64,101
Current portion of capital lease 6,510 31,664
Current portion of note payable 400,000 50,000
Accrued expenses 74,658 83,796
Accrued salaries and related liabilities 88,898 84,857
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Total current liabilities 630,019 314,418
LONG-TERM LIABILITIES
Long-term portion of capital lease obligation 0 4,660
Long-term note payable 0 400,000
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Total long-term liabilities 0 404,660
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Total Liabilities 630,019 719,078
STOCKHOLDERS' EQUITY:
Series A Convertible Preferred Stock, $0.01 par value; authorized
9,750,000 shares; issued 7,492,135 and 6,971,305 shares at
September 30, 2000 and December 31, 1999 74,921 69,713
Common Stock, $0.01 par value; authorized 33,000,000 shares;
issued 9,596,558 and 9,563,225 shares at September 30, 2000
and December 31, 1999 95,965 95,632
Warrants issued for Series A Convertible Preferred Stock 1,893,316 1,152,148
Warrants issued for common stock 76,491 76,491
Additional paid-in capital 18,391,083 18,093,143
Loan receivable-officers and directors (68,287) (65,675)
Accumulated deficit (20,207,587) (18,852,452)
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Total stockholders' equity 255,902 569,000
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Total liabilities and stockholders' equity $ 885,921 $ 1,288,078
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</TABLE>
The accompanying notes are an integral part of these balance sheets.
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A-Fem Medical Corporation
STATEMENTS OF OPERATIONS
(unaudited)
<TABLE>
<CAPTION>
FOR THE THREE MONTHS FOR THE NINE MONTHS
ENDED SEPTEMBER 30, ENDED SEPTEMBER 30,
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2000 1999 2000 1999
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<S> <C> <C> <C> <C>
Sales, net $ 6,309 $ 13,740 $ 24,706 $ 57,278
Cost of sales 49,301 76,190 167,222 204,455
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Gross Margin (42,992) (62,450) (142,516) (147,177)
Operating expenses:
Research and development 222,250 302,183 630,942 812,080
Marketing and selling 7,999 32,452 30,206 273,322
General and administrative 209,674 223,182 628,575 715,253
----------- ----------- ----------- -----------
Total operating expenses 439,923 557,817 1,289,723 1,800,655
----------- ----------- ----------- -----------
Net operating loss (482,915) (620,267) (1,432,239) (1,947,832)
----------- ----------- ----------- -----------
Other income (expense) (3,502) (1,405) 77,104 (23,201)
----------- ----------- ----------- -----------
Net loss (486,417) (621,672) (1,355,135) (1,971,033)
=========== =========== =========== ===========
Basic and diluted net loss per share $ (0.05) $ (0.07) $ (0.14) $ (0.21)
=========== =========== =========== ===========
Weighted average shares
outstanding 9,596,558 9,546,717 9,579,892 9,505,888
=========== =========== =========== ===========
</TABLE>
The accompanying notes are an integral part of these statements.
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A-Fem Medical Corporation
STATEMENTS OF CASH FLOWS
Increase (Decrease) in Cash
(unaudited)
<TABLE>
<CAPTION>
For The Nine Months
Ended September 30,
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2000 1999
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<S> <C> <C>
Cash Flows From Operating Activities:
Net loss $(1,355,135) $(1,971,033)
Adjustments to reconcile net loss to net cash used in operating
activities:
Depreciation and amortization 73,074 95,696
(Gain) loss on disposal of assets (8,060) 4,782
Other non-cash expenses 11,264 24,491
Other non-cash income (2,612) (2,612)
Changes in working capital:
Accounts receivable 1,600 36,179
Inventory 15,699 (481)
Prepaid expenses and other 6,069 102,607
Accounts payable (4,148) (178,795)
Accrued expenses (9,138) 8,348
Accrued salaries and related liabilities 4,041 30,589
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Net cash used in operating activities (1,267,346) (1,911,407)
Cash Flows From Investing Activities:
Purchases of equipment, furniture and leaseholds (9,394) (29,166)
Net proceeds from sale of equipment 204,456 --
Other assets (30,482) --
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Net cash provided by (used in) investing activities 164,580 (29,166)
Cash Flows From Financing Activities:
Net repayments of lease obligations (29,814) (152,109)
Net repayments of note payable (50,000) --
Net proceeds from sale of common and preferred stock, exercise of
options and warrants, net of expenses 1,044,649 1,919,002
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Net cash provided by financing activities 964,835 1,766,893
Net Decrease in Cash and Cash Equivalents (137,931) (173,680)
Cash and Cash Equivalents, beginning of period 428,845 668,369
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Cash and Cash Equivalents, end of period $ 290,914 $ 494,689
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</TABLE>
The accompanying notes are an integral part of these statements.
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A-Fem Medical Corporation
NOTES TO FINANCIAL STATEMENTS
September 30, 2000
ORGANIZATION OF THE COMPANY AND SIGNIFICANT ACCOUNTING POLICIES
ORGANIZATION
A-Fem Medical Corporation (the Company or A-Fem) is a medical technology
company with multiple product platforms targeting women's health needs. A-Fem
has developed three proprietary technology platforms: one based on its inSYNC(R)
miniform interlabial pad, another based on its RAPID-SENSE(R) diagnostic tests
and the third based on its PADKIT(R) SAMPLE COLLECTION SYSTEM. A-Fem currently
markets the inINSYNC miniform as an alternative to tampons, pads and liners for
light flow, or in combination for heavier flow protection. The PADKIT, currently
in clinical trials, utilizes a miniform as a noninvasive sample collection
method for use in testing for certain cancers and sexually transmitted and
infectious diseases. A-Fem has also entered into several joint relationships to
develop point-of-care diagnostic products that use its proprietary RAPID-SENSE
technology.
Basis of Presentation
The interim financial data are unaudited; however, in the opinion of
management, the interim data include all adjustments, consisting only of normal
recurring adjustments, necessary for a fair statement of the results for the
interim periods. The financial statements included herein have been prepared by
A-Fem pursuant to the rules and regulations of the Securities and Exchange
Commission. 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 such rules and
regulations, although A-Fem believes that the disclosures included herein are
adequate to make the information presented not misleading. Operating results for
the periods presented are not necessarily indicative of future results. These
financial statements should be read in conjunction with the financial statements
and notes to financial statements included in A-Fem's Annual Report on Form
10-KSB for the year ended December 31, 1999.
Net Loss Per Share
Basic and diluted loss per share are required to be computed using the
methods prescribed by Statement of Financial Accounting Standards No. 128,
"Earnings per Share" (SFAS 128). Basic loss per share is calculated using the
weighted average number of common shares outstanding for the period and diluted
loss per share is computed using the weighted average number of common shares
and dilutive common equivalent shares outstanding. A net loss was reported in
each of the quarters ended September 30, 2000 and 1999. Stock options for the
purchase of 3,409,484 and 3,552,489 shares at September 30, 2000 and 1999,
respectively, and warrants for the purchase of 1,592,939 and 2,428,656 shares at
September 30, 2000 and 1999, respectively, were not included in loss per share
calculations, because to do so would have been
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anti-dilutive. In addition, shares of A-Fem's convertible preferred stock and
warrants covering shares of A-Fem's convertible preferred stock outstanding at
September 30, 2000 were not included in loss per share calculations because to
do so would have been anti-dilutive.
Recent Accounting Pronouncements
In June 1998, the Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards No. 133, "Accounting for Derivative
Instruments and Hedging Activities" (SFAS 133). This statement establishes
accounting and reporting standards requiring that every derivative instrument be
recorded in the balance sheet as either an asset or liability measured at its
fair value. SFAS 133 also requires that changes in the derivative instrument's
fair value be recognized currently in results of operations unless specific
hedge accounting criteria are met. In June 1999, the FASB issued Statement of
Financial Accounting Standards No. 137 (SFAS 137) which deferred the effective
date of SFAS 133. SFAS 133 is now effective for fiscal years beginning after
June 15, 2000. The Company expects that adoption of SFAS 133 will not have a
material impact on the Company's financial condition or results of operations.
Reclassifications
Certain amounts have been reclassified in the prior year financial
statement presentation to conform to the current year presentation.
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION OR PLAN OF
OPERATION
OVERVIEW
A-Fem Medical Corporation is a medical technology company with multiple
product platforms targeting women's health needs. A-Fem has developed three
proprietary technology platforms: one based on its inSYNC(R) miniform
interlabial pad, another based on its RAPID-SENSE(R) diagnostic tests, and the
third based on its PADKIT(R) SAMPLE COLLECTION SYSTEM. A-Fem currently markets
the inSYNC miniform as an alternative to tampons, pads and liners for light
flow, or in combination for heavier flow protection. The PADKIT, currently in
clinical trials, utilizes a miniform as a non-invasive sample collection method
for use in testing for certain cancers and sexually transmitted and infectious
diseases. A-Fem has also entered into several joint relationships to develop
point-of-care diagnostic products that use its proprietary RAPID-SENSE
technology.
During the first half of 2000, A-Fem shifted the emphasis of its
technology development efforts to focus on the PADKIT, and will continue
RAPID-SENSE technology development solely for third-party development contracts.
A-Fem is in the process of evaluating alternative product strategies for the
PADKIT that will affect the magnitude of PADKIT clinical studies to be
undertaken. Results from initial clinical trials revealed additional product
claims were possible for the PADKIT, and larger and more complex clinical
studies would be required to support such claims. In addition to seeking funding
to support additional clinical studies, A-Fem will seek strategic partnerships
for the PADKIT.
RESULTS OF OPERATIONS
Net sales for the quarter ended September 30, 2000, were approximately
$6,000, as compared to approximately $14,000 for the quarter ended September 30,
1999. For the nine-month period ended September 30, 2000, net sales were
approximately $25,000, as compared to approximately $57,000 for the same period
in 1999. This decrease was the result of decreased levels of promotional support
for the inSYNC miniform as compared to the levels maintained during the prior
year.
Marketing and selling expense for the third quarter of 2000 was
approximately $8,000, as compared to approximately $32,000 for the quarter ended
September 30, 1999. For the nine-month period ended September 30, 2000,
marketing and selling expense was approximately $30,000, as compared to
approximately $273,000 for the same period in 1999. The change in marketing and
selling expense resulted from decreased advertising and promotional support in
2000 as compared to the expenditures required to support the inSYNC roll-out in
1999.
Research and development expense for the quarter ended September 30,
2000, was approximately $222,000, as compared to approximately $302,000 for the
same quarter of the prior year. For the nine-month period ended September 30,
2000, research and development
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expense was approximately $631,000, as compared to approximately $812,000 for
the same period in 1999. This decrease resulted from a reduction in headcount as
research and development efforts focused on PADKIT clinical studies that utilize
contract resources. We anticipate an increase in research and development
expense in the year 2001 as additional PADKIT clinical studies are initiated.
General and administrative expense was approximately $210,000 for the
quarter ended September 30, 2000, as compared to approximately $223,000 for the
same period in the prior year. For the nine-month period ended September 30,
2000, general and administrative expense was approximately $629,000, as compared
to $715,000 for the same period in 1999. This decrease resulted from decreased
payroll expense due to a reduction in the number of employees, and a decrease in
travel expense and banking fees.
A-Fem's operating loss for the quarter ended September 30, 2000, was
approximately $483,000 as compared to approximately $620,000 for the same
quarter of the prior year. For the nine-month period ended September 30, 2000,
the operating loss was approximately $1,432,000, as compared to a loss of
approximately $1,948,000 in the comparable period of the prior year. This
decrease resulted from lower expenses in all operating departments in 2000 as
compared to the expenses in 1999.
A-Fem's other income (expense) is composed primarily of income from
development contracts, interest income and interest expense. For the quarter
ended September 30, 2000 other expense was approximately $4,000, as compared to
other expense of approximately $1,000 for the same period in the prior year. For
the nine-month period ended September 30, 2000 other income was approximately
$77,000, as compared to other expense of approximately $23,000 for the same
period in the prior year. The period-to-period fluctuations for the quarter and
nine month period reflect the receipt of $80,000 related to a development
contract for a RAPID-SENSE diagnostic test and a reduction of interest expense
on capital leases.
A-Fem's net loss for the quarter ended September 30, 2000, was
approximately $486,000, as compared to approximately $622,000 for the same
period in the prior year. For the nine-month period ended September 30, 2000,
the Company's net loss was approximately $1,355,000, as compared to a net loss
of $1,971,000 for the same period in the prior year. These decreases reflect the
receipt of payments related to a development contract for a RAPID-SENSE
diagnostic test, offset by a reduction in interest expense for the first nine
months of 2000 as compared to the comparable period in 1999.
LIQUIDITY AND CAPITAL RESOURCES
As of September 30, 2000, A-Fem had cash and cash equivalents of
$290,914. A-Fem's net cash position decreased by $137,931 between December 31,
1999 and September 30, 2000, as a result of normal operating expenses.
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A-Fem continued to experience operating losses during the year ended
December 31, 1999, and in the first nine months of 2000, and has never generated
sufficient revenues from operations to offset expenses. A-Fem expects to
continue to incur losses through 2000 and 2001, because the costs of development
are expected to continue to exceed income from product sales. A-Fem incurs
approximately $160,000 per month of operating expenses and expects that
significant ongoing expenditures will be necessary to successfully implement its
business plan and develop, manufacture and market its products. These
circumstances raise substantial doubt about A-Fem's ability to continue as a
going concern. Execution of A-Fem's plans and its ability to continue as a going
concern depend upon its acquiring substantial additional financing. Management's
plans include efforts to obtain additional capital, through the sale of equity
securities and by licensing its RAPID-SENSE technology, and to seek partnering
opportunities for the INSYNC miniform. A-Fem does not expect significant amounts
of debt financing to be available to it in the near term, and therefore expects
that it will have to issue additional equity. A-Fem cannot predict on what terms
any such financing might be available, but any such financing could involve
issuance of equity below current market prices and result in significant
dilution of existing stockholders.
A-Fem has raised operating funds in the past by selling shares of its
common and preferred stock for consideration totaling approximately $2.4 million
during 1999 and $1.1 million during the first nine months of 2000. Since the
third quarter of 1998, substantially all such sales have been made to clients of
a single investment advisor. A-Fem anticipates that no further funds will be
available from this source and that A-Fem will have to find alternative sources
for its additional financing. A-Fem has engaged an investment banker to pursue
alternative sources of additional funding. A-Fem may not be able to raise
additional funding or enter into a strategic alliance. If A-Fem is unable to
obtain adequate additional financing, enter into such strategic alliance or
generate sufficient sales revenues, management may be required to curtail
A-Fem's product development, marketing activities and other operations, and
A-Fem may be forced to cease operations.
In order to carry out its development plans for the PADKIT, A-Fem
estimates it will need to raise approximately $3 to 6 million in addition to the
funds needed for its monthly operating expenses. The funds required to carry out
such development plans will vary based on the size or number of clinical studies
undertaken, which will be determined by the potential number of applications of,
or claims that can be made for, the PadKit. If A-Fem were able to raise the
entire $3 to 6 million at once, it would take approximately 18 to 24 months to
complete A-Fem's development plans and receive US approval to market for the
PADKIT for the initial set of claims.
FACTORS AFFECTING FORWARD-LOOKING STATEMENTS
The statements contained in this report that are not statements of
historical fact may include forward-looking statements (as defined in Section
27A of the Securities Act of 1933, as amended) that involve a number of risks
and uncertainties. Moreover, from time to time A-Fem may issue other
forward-looking statements. The following factors are among those that could
cause actual results to differ materially from the forward-looking statements
and should be
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considered in evaluating any forward-looking statements: need for additional
financing; uncertainty associated with need to find new sources of financing;
results of financing efforts; uncertainty associated with need for regulatory
approvals; continuing operating losses; lack of revenues from products; market
acceptance risks; uncertainty associated with product development; the impact of
competitive products and pricing; the effect of economic conditions generally
and within the medical technology industry; and the additional factors listed
from time to time in the Company's SEC reports, including but not limited to,
the Company's report on Form 10-KSB for the fiscal year ended December 31, 1999.
PART II - OTHER INFORMATION
ITEM 2. RECENT SALES OF UNREGISTERED SECURITIES
On August 21, 2000, and again on September 21, 2000, the Company issued
86,805 shares of Series A Preferred Stock (173,610 shares in the aggregate) and
warrants to purchase an additional 79,861 shares of Series A Preferred Stock
(159,722 shares in the aggregate) at an exercise price of $.01 per share to one
entity, Capital Consultants, LLC (formerly Capital Consultants, Inc.), acting as
an agent for individual investors, for cash consideration of approximately
$166,666 ($333,332 in the aggregate). The warrants become exercisable two years
after the date issued and expire 10 years after the date issued. Shares of
Series A Preferred Stock are convertible into shares of the Company's Common
Stock on a one-for-one basis, subject to adjustment under certain circumstances
to prevent dilution. Capital Consultants, LLC, represented that such entity and
each individual represented by such entity was an "accredited investor" within
the meaning of Rule 501(a) of the Securities Act. Jeffrey L. Grayson, the
chairman and chief executive officer of Capital Consultants LLC, shares voting
and dispositive power with such entity with respect to the shares it owns as
agent. In issuing these securities, the Company relied upon an exemption from
registration pursuant to Section 4(2) of the Securities Act.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
a) Exhibits
See Exhibit Index.
b) Reports on Form 8-K
None
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SIGNATURES
In accordance with the requirements of the Exchange Act, the Company caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
A-FEM MEDICAL CORPORATION
Date: November 9, 2000
/s/ Steven T. Frankel
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Steven T. Frankel
President and Chief Executive Officer
/s/ Martin Harvey
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Martin Harvey
Controller
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EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION
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<S> <C>
3.1 Articles of Incorporation, as amended(1)
3.2 Amended and Restated Bylaws(2)
11.1 Statement re: computation of per share earnings
27.1 Financial Data Schedule
</TABLE>
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(1) Incorporated by reference to A-Fem's quarterly report on Form 10-QSB for the
quarter ended June 30, 2000.
(2) Incorporated by reference to the exhibits to A-Fem's annual report on Form
10-KSB for the year ended December 31, 1998, as amended.
