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U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB/A
(AMENDMENT NO. 1)
[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 November 30, 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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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
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
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prior year. For the nine-month period ended September 30, 2000, research and
development 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. In addition,
A-Fem's outstanding note payable obligation of $400,000 will be due in April
2001. If A-Fem is not able to raise additional financing to repay this
obligation, A-Fem plans to renegotiate the obligation to extend the period for
repayment. If A-Fem is not able to timely repay or renegotiate this obligation,
A-Fem will be in default on this obligation. 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.
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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 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.
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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: December 13, 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
