UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-KSB
[ X ] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2000
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES ACT OF 1934
For the transition period from_________ to___________
Commission File Number: 0-17119
A-Fem Medical Corporation (Name of small business issuer in its charter) Nevada 33-0202574 (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 10180 SW Nimbus Ave., Suite J-5 Portland, OR 97223 (Address of principal executive offices) Issuer's telephone number, including area code: (503) 968-8800 |
Securities registered under Section 12(b) of the Exchange Act:
(Title of each class (Name of each exchange on which registered)
None None
Securities registered under Section 12(g) of the Exchange Act:
(Title of Class)
Common Stock, par value $0.01 per share
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 ----- ----- Check if there is no disclosure of delinquent filers in response to |
Issuer's revenues for the fiscal year ended December 31, 2000: $ 29,611
As of March 28, 2001 the aggregate market value of $.01 par value Common Stock held by non-affiliates of the issuer was $3,381,772.
As of March 28, 2001, the issuer had outstanding 9,596,558 shares of its $.01 par value Common Stock.
PART I
When used in this Annual Report, the words "believes," "anticipates" and "intends" and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those protected. See "Factors Affecting Forward-Looking Statements." Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. A-Fem undertakes no obligation to publicly release any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are urged, however, to review the factors set forth in reports A-Fem files from time to time with the Securities and Exchange Commission.
Item 1: Business
Description of Business
A-Fem Medical Corporation is a development stage medical technology company with multiple product platforms targeting women's health needs that has never generated a profit from its operations. See "Management's Discussion and Analysis of Results of Operations." A-Fem has developed three proprietary technology platforms: one based on its inSync(R) miniform interlabial pad, another based on its RapidoSense(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 RapidoSense technology.
During 2000, A-Fem shifted the emphasis of its technology development efforts to focus on the PadKit, and will continue RapidoSense 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.
A-Fem was incorporated in Nevada on December 9, 1986, as Xtramedics, Inc. In June 1994, it changed its name to ATHENA Medical Corporation, and in July 1997, to A-Fem Medical Corporation.
Principal Products
A-Fem's inSync miniform is the first generation of a product that introduces an entirely new segment within the feminine protection market. The miniform is a small, convenient absorbent pad worn lengthwise between the labia where a woman's body naturally and comfortably holds it in place. The miniform provides dependable protection on light menstrual flow days and additional protection against leakage on heavy menstrual flow days. In addition, the miniform may be used as protection for slight
urine loss (stress incontinence), vaginal discharge, mid-cycle spotting and to provide a general feeling of freshness.
A-Fem anticipates that its RapidoSense point-of-use diagnostic technology will enable consumers and healthcare providers to obtain quantifiable test results quickly, conveniently and inexpensively. Currently, there are only two alternatives for diagnostic testing: point-of-use tests that produce qualitative (yes/no) results and laboratory tests that provide quantitative results. While current point-of-use diagnostic tests are convenient and cost-effective, they do not provide quantitative results and are limited to applications that have a clear positive or negative response. Laboratory testing, on the other hand, produces more information but requires sophisticated instruments, more time and greater cost. The key to A-Fem's RapidoSense technology is that it combines the convenience and low cost of a point-of-use test with the type of semi-quantitative results previously only available when using an instrument to interpret the results. The RapidoSense technology enables visual quantification of a desired substance, such as a hormone, disease marker or analyte of infection, in a sample of blood, saliva or urine.
A-Fem expects to continue to seek strategic partners to assist in the manufacturing, marketing and distribution of specific applications of its RapidoSense technology. To date, A-Fem has entered into three such strategic arrangements, two of which have been completed. The third strategic arrangement involves a long-term license of A-Fem's RapidoSense technology for use in tests to detect drugs of abuse in a sample of saliva.
A-Fem's PadKit Sample Collection System integrates A-Fem's miniform technology with its diagnostic expertise to create a unique sample collection system that provides a novel approach to diagnostic testing. The PadKit allows women to collect a menstrual or cervical-vaginal fluid sample at home, using an interlabial pad, such as the miniform. The sample collected with the interlabial pad is mailed to a laboratory that processes the sample and provides test results to the physician prior to the patient's routine gynecological examination. Thus, one self-collected and laboratory-processed PadKit sample has the potential to be used by a physician to screen for cervical and other cancers, Human Papilloma virus (a precursor to cervical cancer), and sexually transmitted and other infectious diseases, before the patient visit. Clinical and laboratory testing has demonstrated the PadKit's effectiveness as a sample collection system that may be processed in a laboratory to detect cervical and other cancers, the Human Papilloma virus, and sexually transmitted and other diseases. In March 1998, A-Fem was issued its first PadKit patent that covers methods of collection and diagnosis of vaginal fluid, including menses, which form the technological basis for the PadKit. Additional US and International patents were issued in 1999 and 2000 further expanding the PadKit patent portfolio.
A-Fem is completing clinical studies for its PadKit to demonstrate the effectiveness of this sample collection system as an alternative to the cervical scrape. An estimated 50 million cervical scrapes are performed annually in the United States alone to collect samples to use in the Pap smear test for cervical cancer. Although significant improvements have been made in the area of Pap smear test sample reading and sample preparation, no improved sample collection method has been developed. A-Fem believes the PadKit will provide a superior cellular sample as well as a simpler, more comfortable and convenient procedure for collecting the cells. The Company expects to demonstrate the significant market advantages, cost effectiveness, improved disease specificity, and patient preference for the self-collected PadKit sampling system.
Marketing and Distribution
A-Fem launched a marketing rollout of its inSync miniform in grocery, drug and mass retailers in Oregon and Washington in January 1998. In July 1998, the product's area of distribution was expanded to include Colorado, Arizona, Utah, New Mexico, Nevada, Montana and Idaho. In 1999, the Company added several e-tailing and catalog outlets to its distribution network. During 2000 the total number of retail outlets was significantly reduced as A-Fem reduced its marketing programs, although the inSync miniform remained available for purchase in selected retail grocery chains, drugstores and mass merchandisers. In addition, the inSync miniform is available through catalog and on-line, web-based (Internet) retailers, such as PlanetRx, Transitions for Health and CVS, and directly from inSync miniform.com. Direct sales of the inSync miniform have increased as the number of retail outlets has decreased. The inSync miniform competes within the $1.8 billion United States feminine protection market. The miniform represents a new category of products that both competes with and complements existing feminine protection products, including tampons, pads, and pantiliners. A-Fem is seeking a strategic partner to assist in the continued national rollout of the miniform.
In order to focus on research and product development opportunities and increase the speed to market for our products, A-Fem is seeking alliances with strategic marketing partners. For the miniform and RapidoSense products, A-Fem will seek strategic partners with proven experience in consumer and diagnostics marketing. A-Fem has no such alliance at present.
In April 1997, A-Fem and the Proctor & Gamble Company entered into a license agreement that granted to the Proctor & Gamble Company certain non-exclusive rights to use A-Fem's miniform technology and certain trademarks. That agreement expired October 28, 1999 and the product technology has reverted to A-Fem. The Proctor & Gamble Company retained certain rights to trademarks not used by A-Fem. In early 2000, the Proctor & Gamble Company launched its first interlabial pad product, the Envive(R) miniform, in a single test market in Eau Clair, Wisconsin.
Competition
The inSync miniform represents a new segment of the feminine protection market and provides benefits not offered by competitive products. Four major consumer products companies currently dominate the United States feminine protection market: the Procter & Gamble Company, Johnson & Johnson, Kimberly-Clark and Playtex. Features of the inSync miniform that distinguish it competitively are its versatility, convenience, comfort and safety. The Company believes these competitors are evaluating the interlabial pad and market, and will eventually enter it. This entry is expected to rapidly expand market acceptance for the interlabial pad and enhance the value of the inSync miniform. The Proctor & Gamble Company is currently test marketing its first interlabial pad product.
A-Fem believes that the semi-quantifiable test results provided by point-of-use tests that incorporate A-Fem's RapidoSense technology will address market needs that prior technology could not meet, provide significant end-user cost savings over older technology and move various laboratory tests to the point-of-use markets. These factors will increase early patient intervention to improve healthcare in general. Competition for A-Fem's RapidoSense products is likely to come primarily from larger, well-established diagnostics companies, and/or smaller innovative companies.
The first application of the PadKit will be an alternative to the cervical scrape as a sample collection process for the Pap smear test, the standard diagnostic procedure for cervical cancer detection. While improvements have been made in the area of Pap test sample preparation and interpretation by such companies as Cytyc, and TriPath Imaging, the PadKit represents the first improvement in the method of sample collection by introducing a non-invasive, user-friendly sample collection method.
A-Fem's current products and products under development will compete with products from other companies that have an established market, more employees and substantially greater research, financial and marketing resources than A-Fem.
Materials and Manufacturing
A-Fem's current manufacturing facility in Portland, Oregon, was completed in 1996 and upgraded in 1997. This facility provides miniforms for both the inSync product and the PadKit. The present operation requires minimal overhead and direct labor and is capable of producing more than $1,000,000 wholesale value of miniforms monthly, which capacity is sufficient to meet A-Fem's forecasted demand for the foreseeable future within current area of distribution. A-Fem's miniform manufacturing facility encompasses 3,700 square feet and has been inspected by the United States Food and Drug Administration and found to be without reportable deficiencies. A-Fem will need additional space and equipment to manufacture sufficient quantities of the miniform to support a national marketing rollout. A-Fem is not currently manufacturing any RapidoSense products.
Raw materials used for production of the inSync miniform and A-Fem's diagnostic products are produced in the United States. A-Fem has located a satisfactory source of the raw materials needed to manufacture the miniform, but has not entered into an agreement with such supplier. A-Fem's suppliers are meeting A-Fem's current manufacturing needs, and A-Fem believes that it will be able to obtain raw materials in sufficient quantity when needed, although an uninterrupted flow of raw materials cannot be guaranteed.
Patents and Trademarks
A-Fem owns United States patents and additional foreign patents in Canada and Japan relating to the miniform. These patents cover manufacturing apparatus and methods for making both the current miniform and a 100% biodegradable absorbent miniform. In 1998, 1999 and 2000 A-Fem was granted broad patents for the technology that is the basis for the PadKit collection system. Additionally, A-Fem has patents pending for its RapidoSense and miniform technology.
The issued United States patents currently owned, assigned or licensed to A-Fem and the pending patent applications are as follows:
------------------- ----------------------- ------------------------------------ US Patent or Serial Number Date of Issue or Filing Title ------------------- ----------------------- ------------------------------------ Miniform 4,995,150 02/26/91 Method and Apparatus for Making Feminine Protection Pads 6,183,455 06/25/96 Biodegradable Absorbent Pads 5,575,0471 11/19/96 Method for Making Biodegradable Absorbent Pads 09/548,219 03/10/00 Anal Hygienic Pad and Method for Use 09/644,472 02/16/01 Administration of therapeutic or diagnostic agents using an Interlabial Pad ------------------- ----------------------- ------------------------------------ PadKit 5,725,4811 03/10/98 Method and Apparatus for Collecting Vaginal Fluid and Exfoliated Vaginal Cells for Diagnostic Purposes 6,007,4981 12/28/99 Method and Apparatus for Collecting Vaginal Fluid and Exfoliated Vaginal Cells for Diagnostic Purposes 09/699,061 10/26/00 Method and Apparatus for Collecting Vaginal Fluid and Exfoliated Vaginal Cells for Diagnostic Purposes 6,174,293 01/16/01 GB2,329,843 10/18/00 Method and Apparatus for Collecting Vaginal Fluid and Exfoliated Vaginal Cells for Diagnostic Purposes GB2,349,573 12/27/00 ------------------- ----------------------- ------------------------------------ RapidoSense 60/092,1912 06/05/97 Single or Multiple Analyte Semi- Quantitative, Quantitative Rapid Diagnostic Lateral Flow Test System for Large Molecules 09/417,9572 10/13/99 Covalent bonding of Molecules to an Activated Solid Phase Material, and Devices Made Using the Material 09/501,339 02/9/00 Collection Device for Lateral-Flow Chromatography 60/197,365 04/14/00 Positive Detection Lateral-Flow Apparatus and Method for Small and Large Analytes 60/203,696 05/11/00 ------------------- ----------------------- ------------------------------------ ----------- |
1Also applied for in Germany, Japan, England, France, Italy, Sweden, and Canada. 2Patent pending.
The term for patents issued on applications filed on or after June 8, 1995, is 20 years from the date of the application or, if the application contains a specific reference to an earlier filed application under 35 USC ss.ss. 120, 121 or 365(c), 20 years from the date on which the earliest such application was filed. The term for patents issued on applications filed before June 8, 1995, is the greater of the 20-year term described above or 17 years from grant, depending on the amount of time between application and issuance.
A-Fem holds United States trademarks for all its current products, including for the PadKit, RapidoSense and its related design, and for inSync and its related design. In addition to these
applications, A-Fem has also applied for international trademarks on RapidoSense and inSync and its related design. A-Fem also relies on trade secrets and other unpatented proprietary information.
Regulatory Requirements
The production and marketing of A-Fem's products are subject to regulation by the United States Food and Drug Administration. Before a medical product may be marketed for use by humans, laboratory and clinical trials must be performed to validate the safety and effectiveness of the product. A-Fem's miniform product required FDA approval before being marketed to the public, and such clearance was obtained in 1997. A-Fem's RapidoSense products sold to the industrial and environmental testing markets do not require FDA clearance. However, when A-Fem's RapidoSense technology is applied to the human diagnostic market, such products will require FDA clearance.
A-Fem is completing clinical trials for its PadKit, and is in the process of conducting additional studies in order to receive FDA clearance. A-Fem anticipates that this product will be ready for commercial production in late 2001. A-Fem has assembled a team to obtain marketing clearance from the FDA for its planned products. This team includes senior management, personnel with regulatory expertise, personnel with scientific skills for clinical field trials and a Medical Advisory Board, consisting of scientific Ph.D.s and M.D.s, to contribute to the scientific and medical validity of its clinical trials.
Research and Development
A-Fem invested approximately $788,000 on research and development in the year ended December 31, 2000, primarily with respect to ongoing PadKit clinical trials and continued patent applications. A-Fem spent approximately $1,074,000 on research and development in the year ended December 31, 1999, primarily with respect to development of the PadKit diagnostic technology.
Employees
As of December 31, 2000, A-Fem had 7 full-time employees. Since December 31, 2000, A-Fem has reduced its full-time staff to 4 employees pending receipt of additional financing. A-Fem believes that its relations with its employees are good.
Item 2. Description of Property
A-Fem's corporate office and product development facilities are located in 7,100 square feet of leased space in Portland, Oregon. A-Fem also leases 3,700 square feet of manufacturing and warehouse space in proximity to its corporate office. The term for the leases for these spaces expired in February 2001 according to their terms and A-Fem continues to occupy these spaces on a month-to-month basis.
Item 3. Legal Proceedings
None.
Item 4. Submission of Matters to a Vote of Security Holders
A Special Meeting of Stockholders in lieu of A-Fem's annual meeting of stockholders was held March 8, 2001, and adjourned to March 16, 2001. At the special meeting, stockholders elected the persons identified below as directors for the terms set forth below by the votes set forth opposite their names.
Votes For Votes Against or Broker Withheld Abstained Non-Votes Class I Directors Common Preferred Common Preferred Common Preferred Common Preferred ------------------ ------ --------- ------ --------- ------ --------- ------ --------- Merry Disney 6,292,898 0 202,003 0 0 7,492,135 0 0 James E. Reinmuth 6,292,898 0 202,003 0 0 7,492,135 0 0 RoseAnna Sevcik 6,292,898 0 202,003 0 0 7,492,135 0 0 Class II Directors ------------------ Steven T. Frankel 6,292,898 0 202,003 0 0 7,492,135 0 0 William H. Fleming 6,292,898 0 202,003 0 0 7,492,135 0 0 Carol A. Scott 6,292,898 0 202,003 0 0 7,492,135 0 0 James R. Wilson 6,292,898 0 202,003 0 0 7,492,135 0 0 |
Stockholders were also asked to vote on the following matters, which received the votes indicated below:
Votes Against or Votes For Withheld --------- -------- Common Preferred Common Preferred ------ --------- ------ --------- An amendment to A-Fem's Articles of Incorporation to increase the number of authorized shares of common stock and preferred stock 6,228,445 7,492,135 229,736 0 Amend A-Fem's 1994 Incentive and Nonqualified Plan to increase the number of shares reserved for issuance 6,136,948 7,492,135 320,733 0 Ratification of the appointment of Arthur Andersen LLP as independent public accountants for the fiscal year ending December 31, 2001 6,334,331 7,492,135 126,975 0 |
PART II
Item 5. Market for Common Equity and Related Stockholder Matters
(a) A-Fem's common stock low and high bid prices are reported on the OTC Bulletin Board. The following table sets forth the range of high and low bids for A-Fem's common stock as reported on the OTC Bulletin Board for the periods indicated.
High Low 1st Quarter 1999 $ 2.34 $ 1.31 2nd Quarter 1999 2.69 1.25 3rd Quarter 1999 2.06 .94 4th Quarter 1999 1.22 .69 1st Quarter 2000 2.38 .75 2nd Quarter 2000 2.09 .88 3rd Quarter 2000 2.06 1.13 4th Quarter 2000 1.38 .59 |
The foregoing prices reflect inter-dealer prices, without retail markup, markdown or commission, and may not represent actual transactions.
(b) On December 31, 2000, there were approximately 267 holders of record of A-Fem's common stock.
(c) A-Fem has paid no dividends and does not expect to pay any dividends in the foreseeable future because A-Fem intends to retain earnings, if any, to finance growth of its operations. A-Fem is under contractual restriction as to its present or future ability to pay dividends. The holders of A-Fem's preferred stock have the right to receive dividends in preference to the holders of A-Fem's common stock.
Item 6. Management's Discussion and Analysis of Results of Operations
Overview
A-Fem continued to experience operating losses during the years ended December 31, 2000 and 1999. Further, A-Fem has continued to incur losses into the first quarter of 2001 and has never generated significant revenues from operations. A-Fem expects that significant ongoing expenditures will be necessary to successfully implement its business plan and develop, manufacture and market its products. 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 RapidoSense technology, and to seek partnering opportunities for the inSync miniform . A-Fem has raised operating funds in the past by selling shares of its common and preferred stock for consideration totaling approximately $1.1 million during 2000 and $2.4 million during 1999.
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 will likely be required to further curtail A-Fem's product development, marketing activities and other operations, and A-Fem will likely cease operations.
Results of Operations
For the year ended December 31, 2000, A-Fem generated net sales of approximately $30,000 as compared to net sales of approximately $67,000 for the year ended December 31, 1999. This decrease in net sales was the result of lower levels of promotional support for the inSync miniform as compared to the levels maintained during the previous year. The cost of goods sold for the year ended December 31, 2000, was approximately $227,000, as compared to approximately $274,000 in the year ended December 31, 1999. This decrease was the result of a reduced quantity of goods sold in 2000 as compared to 1999. A-Fem's operating loss for the year ended December 31, 2000 was approximately $1,887,000, compared to an operating loss of approximately $2,499,000 for the previous year. The decrease in operating loss was caused by the decrease in operating expenses.
Gross margin for the year ended December 31, 2000 was approximately $(197,000) (-665.1% of net sales) as compared to $(207,000) (-311.2% of net sales) for the year ended December 31, 1999. The change in the gross margin resulted primarily from the decrease in net sales as compared to our minimum fixed manufacturing costs.
Marketing and selling expenses were approximately $37,000 for the year ended December 31, 2000, as compared to approximately $298,000 for the prior year. This decrease resulted from reductions in consumer advertising and promotional support for inSync miniform.
Research and development expenses for the year ended December 31, 2000, totaled approximately $788,000, as compared to approximately $1,074,000 for the year ended December 31, 1999. This decrease is primarily attributable to a decrease in development costs related to RapidoSense.
General and administrative expenses for the year ended December 31, 2000, totaled approximately $865,000, compared to approximately $919,000 for the year ended December 31, 1999. The decrease in these expenses is attributable primarily to decreased bank fees, note payable discount, and reduced travel expense.
A-Fem's other income (expense) is composed primarily of income from development contracts and licenses, interest income and interest expense. For the year ended December 31, 2000, other income was approximately $71,000, as compared to other income of approximately $4,000 for the prior year. These amounts reflect receipt of $80,000 in 2000 related to a development contract for a RapidoSense diagnostic test and $27,379 in reduction of interest expense from 1999.
A-Fem's net loss for the year ended December 31, 2000, decreased to approximately $1,816,000 from $2,494,000 for the year ended December 31, 1999. The decrease in the net loss reflects the reduction in all categories of operating expenses, primarily as a result of the lack of available operating funds.
Liquidity and Capital Resources
At December 31, 2000, A-Fem had cash and cash equivalents of approximately $5,600 as compared to approximately $429,000 at December 31, 1999. A-Fem's net cash position decreased as a result of normal operating expenses and because A-Fem has not continued to receive financing to fund its operations at prior year levels.
A-Fem continued to experience operating losses during the year ended December 31, 2000, and has never generated sufficient revenues from operations to offset expenses. A-Fem expects to continue to incur losses through 2001 because the costs of development are expected to continue to exceed income from product sales. A-Fem incurs approximately $150,000 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. Since January 1, 2001, A-Fem has deferred payment of compensation accrued for its remaining 4 full-time employees pending receipt of additional financing. 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 RapidoSense 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.
Since December 31, 2000 A-Fem has financed its operations through bridge loans while it seeks additional equity financing. 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 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 $8 million in addition to the funds needed for its monthly operating expenses. This estimate has been increased due to the probability that larger and more complex clinical studies may be needed to support additional product claims for the PadKit that were revealed by earlier clinical trials. 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 $8 million at once, it would take
approximately 18 to 24 months to complete A-Fem's development plans and receive US approval to market the PadKit for the initial set of claims.
Factors Affecting Forward-Looking Statements
You should carefully consider the following factors regarding forward-looking statements and other information included in this Annual Report. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not currently known to us or that we currently deem immaterial also may impair our business operations. If any of the following risks actually occur, our business, financial condition and operating results could be materially adversely affected.
If A-Fem Is Not Able to Obtain Additional Financing, A-Fem Will Likely Cease Operations
During the fiscal year ended December 31, 2000, A-Fem incurred net losses of approximately $1.8 million. Further, A-Fem has not generated significant revenues from operations. A-Fem expects to continue to incur losses as the costs of developing, manufacturing and marketing our products continue to exceed income from product sales.
In order to carry out our development and marketing plans for the PadKit product, we will need to raise significant additional capital. If we are unable to obtain sufficient financing, it would have a material adverse effect on our financial condition.
A-Fem expects that significant, ongoing expenditures will be necessary to successfully implement our business plan and develop, manufacture and market our products. These circumstances raise substantial doubt about A-Fem's ability to continue as a going concern. If A-Fem is unable to obtain adequate additional financing, enter into a strategic partnership, or generate sufficient profitable sales revenues, we may be required to curtail our product development, marketing activities and other operations, and we may be forced to cease operations.
If A-Fem Is Not Able to Attract a Strategic Partner, A-Fem May Be Unable to Execute Our Marketing and Distribution Plans for Our Products
In order to carry out our marketing plans, we will need to find one or more partners to assist in marketing and distributing our miniform and RapidoSense products. To date we have been unable to attract such a partner. If we are not able to attract one or more partners, we may be unable to carry out our marketing plans for these products, which could have a material adverse effect on our financial condition and results of operations.
A-Fem Is Unlikely to Earn Significant Revenues From Our Products in the Near Term Because Most of A-Fem's Products Are in the Early Stages of Product Development or Marketing
A-Fem's products, the inSync miniform, PadKit, and RapidoSense diagnostic products, are in the early stages of development or marketing. There have been no significant revenues from the inSync miniform, and there have been no sales revenues at all from the PadKit or RapidoSense diagnostic products. A-Fem has concluded that we cannot raise sufficient funds to market the inSync miniform nationally through retail outlets. A-Fem cannot estimate the potential market for our products.
You should be aware that A-Fem may encounter problems because our products are in an early stage of development or marketing, including the following risks:
o A-Fem may encounter unanticipated developmental, testing, regulatory compliance and marketing costs;
o The new products that A-Fem is developing may not be successfully developed;
o A-Fem's new products, once developed, may not be successfully manufactured, advertised and marketed;
o Any of A-Fem's products may become obsolete within a short time after its development; and
o Costs of research and development and clinical trials for A-Fem's new products may substantially exceed A-Fem's expectations and financial resources.
A-Fem's Products May Not Achieve Market Acceptance
A-Fem's only product in commercial production, the inSync miniform, is a new product form that addresses women's concerns with current feminine protection products. Because the inSync miniform is worn interlabially, unlike any other existing feminine protection products, women may not purchase this product or our other products in commercially viable quantities. If our products do not achieve adequate market acceptance, such failure may have a material adverse effect on our financial condition and results of operations.
A-Fem's Products May Not Be Able to Compete Successfully With Existing or Future Products Produced by A-Fem's Competitors
A-Fem's current product and products in development will compete with products from other companies that have an established market, more employees and substantially greater research, financial and marketing resources than A-Fem. With respect to our miniform products, these competitors include the Procter & Gamble Company, Johnson & Johnson, Kimberly-Clark and Playtex. In 2000, the Proctor & Gamble Company introduced its first miniform product in a single test market in Eau Clair, Wisconsin. A-Fem's research, financial and marketing resources may not be adequate to create and market products that will compete successfully with existing or future products created and marketed by such competitors.
Holders of A-Fem's Common Stock May Experience Dilution If We Fulfill Our Financing Needs by Issuing Additional Shares of Stock
In order to carry out our development, marketing and distribution plans for our products, we will need to raise significant funds through equity and/or debt financing. We do not expect significant amounts of debt financing to be available in the near term, and expect that we will have to issue additional equity to meet our financing needs. Such equity financing may not be available or may not be available on terms favorable to A-Fem or our shareholders. If we issue additional equity in the future to raise funds, this could have a dilutive effect on holders or purchasers of shares of our common stock.
A-Fem's Patent and Other Intellectual Property Protection May Not Be Adequate
A-Fem has received patents with respect to the PadKit that cover the method and apparatus for collection and use of vaginal fluid for diagnostic purposes. A-Fem has received a patent with respect to the inSync miniform that covers the manufacturing methods and manufacturing materials. A-Fem has filed patent applications for our first generation RapidoSense technology. The term for these patents is or will be 20 years from the date of the application.
The issuance of patents to A-Fem is not conclusive as to validity or as to the enforceable scope of claims. The validity and enforceability of a patent can be challenged by litigation after its issuance, and, if the outcome of litigation is adverse to the owner of the patent, the owner's rights could be diminished or eliminated. The issuance of patents covering any of A-Fem's products may be insufficient to prevent competitors from essentially duplicating the product by designing around the patented aspects. The patent laws of other countries may differ from those of the United States as to the patentability of A-Fem's products and processes, and the degree of protection afforded by foreign patents may be different from that in the United States.
The technologies used by A-Fem may infringe patents or proprietary technology of others. The cost of enforcing A-Fem's patent rights in lawsuits that A-Fem may bring against infringers or defending itself against infringement charges by other patent holders may be high and could adversely affect A-Fem.
Trade secrets and confidential know-how are important to A-Fem's scientific and commercial success. Although A-Fem seeks to protect our proprietary information through confidentiality agreements and appropriate contractual provisions, others may develop independently the same or similar information or gain access to proprietary information of A-Fem.
A-Fem May Be Adversely Affected by Certain Government Regulations
Many of A-Fem's activities are subject to regulation by various local, state and federal regulatory authorities in the United States.
Before a medical product may be marketed for use by humans, laboratory and clinical trials must be performed to validate the safety and effectiveness of the product. The PadKit is still in the development stage and will require FDA approval before being marketed to the public. Obtaining such approval may be a lengthy and expensive proceeding and may involve extensive testing and clinical trials to demonstrate safety, reliability and efficacy.
In addition, regulations may change, resulting in unexpected costs and uncertainty. A-Fem may not be able to comply with the applicable requirements, and necessary approvals may not be granted. We cannot predict the extent and impact of future governmental regulations. If we fail to comply with the applicable regulatory requirements, we may be subject to fines, injunctions, civil penalties, recall or product seizure, among other penalties.
A-Fem Depends on Our Management and Consultants to Successfully Implement Our Business Plan
A-Fem depends to a large extent upon the abilities and continued participation of its executive officers, consultants and current directors. The loss of any of these people could have a serious adverse
effect upon our business. We may not be able to attract and retain key personnel with the skills and expertise necessary to manage our business. We do not have key-man life insurance on the lives of any of our personnel. Because competition for management and scientific staff in the biotechnology, biomedical and healthcare fields is intense, we may not be able to continue to employ personnel and consultants with sufficient expertise to satisfy our needs. We do not have employment contracts with any personnel other than Steven T. Frankel and James R. Wilson.
A-Fem's Product Liability Insurance Coverage For Claims Is Limited and Does Not Cover Claims Arising From Toxic Shock Syndrome
A-Fem could be subject to claims for personal injuries or other damages resulting from its products. We carry general liability insurance, including products liability insurance in the amount of $5,000,000. If any claims for amounts exceeding our insurance coverage were successful, it would have a material adverse effect on A-Fem. A-Fem's insurance may not adequately protect A-Fem against all such liabilities.
A-Fem May Issue Additional Shares of Preferred Stock, Which Could Dilute the Interests of Holders of Our Common Stock
A-Fem is authorized to issue up to 10,000,000 shares of preferred stock and A-Fem's Board of Directors has the authority to fix the rights, preferences, privileges and restrictions of such shares without any further vote or action by A-Fem's shareholders.
Through December 2000, A-Fem issued shares of Series A Convertible Preferred Stock and warrants to purchase additional shares of Series A Convertible Preferred Stock to Capital Consultants, LLC (formerly Capital Consultants, Inc.) as follows:
o 4,316,405 shares of Series A Convertible Preferred Stock issued in exchange for 4,316,405 shares of A-Fem's common stock;
o 3,175,730 shares of Series A Convertible Preferred Stock and warrants to purchase an additional 1,204,012 shares of Series A Convertible Preferred Stock (at a weighted average exercise price of $0.39 per share) in exchange for aggregate consideration consisting of approximately $6.1 million and warrants to purchase 50,000 shares of A-Fem's common stock.
These issuances of Series A Preferred Stock and any future issuance of preferred stock may:
o have the effect of delaying, deferring or preventing a change in control of A-Fem;
o discourage bids for the common stock at a premium over the market price of the common stock; or
o adversely affect the market price and the voting and other rights of the holders of common stock.
Holders of A-Fem's Series A Preferred Stock Could Delay or Prevent A-Fem From Taking Certain Actions
A-Fem's Series A Preferred Stock has protective provisions that require
A-Fem to get the vote or consent of the holders of a majority of the outstanding
shares of Series A Preferred Stock before taking certain actions, which could
delay or prevent A-Fem from taking such actions. Such actions include:
authorizing or issuing securities with rights equal to or superior to the Series
A Preferred Stock, incurring debt, or issuing derivative securities.
Certain Mergers or Takeover Attempts Could Be Delayed or Prevented by the Anti- Takeover Effect of Nevada Law
Nevada law contains "business combination" provisions that could make it more difficult to consummate a merger or tender offer involving A-Fem, even if such event could be beneficial to the interests of the stockholders.
The Nevada business combination law prohibits certain transactions between a corporation and any interested stockholder for three years after the interested stockholder first becomes an interested stockholder, unless the corporation's Board of Directors approves in advance. An interested stockholder is one who owns 10% or more of a corporation's voting shares, or who is an affiliate of a corporation.
The types of transactions prohibited include:
o a merger;
o a sale, lease or other disposition of a material amount of a corporation's assets;
o a transaction that results in the issuance of 5% or more of a corporation's equity stock to the interested stockholder; or
o the liquidation or dissolution of a corporation.
However, these prohibitions do not apply if the Board of Directors of a corporation approves the share acquisition or business combination transaction before the stockholder acquired 10% or more of such corporation's outstanding voting stock.
The provisions of Nevada law described above give A-Fem's Board of Directors the ability to determine whether or not to allow any of the transactions of the type described above by limiting the ability of an interested stockholder to act without first obtaining the approval of the Board of Directors. If A-Fem's Board of Directors chose not to approve a share acquisition, this would discourage such acquisition and any subsequent business combination transactions with the interested stockholder. The fact that A-Fem's Board of Directors has the power to do this would also discourage tender offers not conducted in cooperation with such Board of Directors. These consequences could result even if the business combination transaction or tender offer would be beneficial to the interests of A-Fem's stockholders.
The Thin Public Market for A-Fem's Common Stock May Cause Volatility in Our Stock Price
A-Fem's common stock is quoted on the OTC Bulletin Board and is thinly traded.
The market price of our common stock has experienced significant volatility. During 2000, the price of our common stock ranged from $0.59 per share to $2.38 per share. The market price of the common stock could be subject to significant variation due to:
o the degree of success A-Fem achieves in implementing its business strategy, changes in business or economic conditions affecting A-Fem, its customers or its competitors;
o fluctuations in A-Fem's operating results, changes in or actual results varying from earnings or other estimates made by securities analysts;
o announcements by A-Fem or our competitors concerning product developments, patents or proprietary rights; and
o other factors both within and outside our control.
In addition, the stock market may experience volatility that affects the market prices of companies in ways unrelated to the operating performance of such companies, and such volatility may adversely affect the market price of our common stock.
There has been significant volatility in the market price of securities of other early stage companies, technology companies in general and biotechnology companies in particular.
A-Fem's Common Stock is Quoted on The OTC Bulletin Board
Our stock is quoted on the OTC Bulletin Board. As a result, our shareholders may find it more difficult to dispose of, or to obtain accurate quotations as to the market value of, our common stock, and the market price for our common stock may decline.
Trading in our common stock is subject to the requirements of Rule 15g-9 promulgated under the Securities Exchange Act of 1934. Under this rule, broker/dealers who recommend low-priced securities to persons other than established customers and accredited investors must satisfy special sales practice requirements, including a requirement that they make an individualized written suitability determination for the purchaser and receive the purchaser's written consent prior to the transaction.
The Securities Enforcement Remedies and Penny Stock Reform Act of 1990 also requires additional disclosure in connection with any trades involving a stock defined as a penny stock (generally any equity security not traded on an exchange or quoted on Nasdaq that has a market price of less than $5.00 per share, subject to certain exceptions), including the delivery, prior to any penny stock transaction, of a disclosure schedule explaining the penny stock market and the risks associated with the penny stock market. These requirements could severely limit the market liquidity of our common stock and the ability of our shareholders to dispose of their shares, particularly in a declining market.
A-Fem May Not Be Able to Successfully Manufacture Our Products
A-Fem currently manufactures the inSync miniform. As a manufacturer, A-Fem faces the following risks:
o A-Fem may not be able to maintain sufficient numbers of employees, or may have to pay increased wages.
o A-Fem may not be able to obtain sufficient raw materials, including the fiber used to manufacture the miniform, when needed or at reasonable prices.
o A-Fem may have to expend additional funds to purchase additional capital equipment to be able to increase the quantity of miniforms we manufacture or to remedy plant or equipment obsolescence.
o A-Fem may not be able to adequately maintain the quality of the miniforms we manufacture.
o If the demand for miniforms is significantly greater or lower than we predict, we may experience excess or inadequate manufacturing capacity.
Any of the risks listed above, or any other disruption in A-Fem's production, could have a material adverse effect on A-Fem's results of operations and financial condition.
A-Fem May Experience an Adverse Impact From Future Sales of Our Stock
As of December 31, 2000, 3,725,923 shares of common stock were subject to outstanding stock options under A-Fem's stock option plans at a weighted average exercise price of approximately $2.28 per share. As of December 31, 2000, 1,592,939 shares were issuable upon exercise of outstanding warrants at a weighted average exercise price of $2.81 per share.
We have filed a registration statement on Form S-8 under the Securities Act to register for resale a total of 5 million shares of common stock reserved for issuance under A-Fem's stock option plans. Sales of substantial amounts of A-Fem's common stock in the public market by existing shareholders or holders of options or warrants could cause the price of the common stock to go down.
A-Fem has approximately 9.6 million shares of common stock outstanding as of December 31, 2000. Approximately 1.9 million of these shares of common stock are registered under the Securities Act (including approximately 0.9 million shares of common stock issuable upon exercise of warrants), approximately 1.2 million shares are freely tradable under the federal securities laws subject to volume limitations under Rule 144, and approximately 7.4 million additional shares are freely tradable under the federal securities laws to the extent they are not held by our affiliates or are not subject to certain contractual volume restrictions.
In general, under Rule 144 as currently in effect, any person (or persons whose shares are aggregated) who has beneficially owned restricted securities for at least one year is entitled to sell, within any three-month period, a number of shares that does not exceed the greater of:
o 1% of the then outstanding shares of the issuer's common stock, and
o the average weekly trading volume during the four calendar weeks preceding such sale
provided that certain public information about the issuer as required by Rule 144 is then available and the seller complies with certain other requirements.
A person who:
o is not an affiliate,
o has not been an affiliate within three months prior to sale, and
o has beneficially owned the restricted securities for at least two years
is entitled to sell such shares under Rule 144(k) without regard to any of the limitations described above.
Item 7. Financial Statements
Financial Statements begin on page F-1.
Item 8. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.
PART III
Item 9. Directors, Executive Officers and Key Employees
A-Fem's executive officers, directors and key employees are:
Directors and Executive Officers Age Position -------------------------------- --- -------- James E. Reinmuth, Ph.D. 60 Chairman and Director Steven T. Frankel 58 Chief Executive Officer, President and Director William H. Fleming, Ph.D. 54 Vice Chairman-Diagnostics, Secretary and Director Carol A. Scott, Ph.D. 51 Director RoseAnna Sevcik 37 Director James Wilson 51 Treasurer, Director of Business Development and Director Merry L. Disney 54 Director Key Employees ------------- Martin Harvey 59 Controller Paul Mueggler, Ph.D. 50 Vice President, Clinical and Regulatory Affairs |
Directors and Executive Officers
James E. Reinmuth, Ph.D. has served as Chairman of A-Fem since September 1996, and has been a Director of A-Fem since May 1995. From September 1996 to April 1998, Dr. Reinmuth served as Chief Executive Officer of A-Fem. From May 1995 to September 1996, Dr. Reinmuth served as Treasurer of A-Fem. Since July 1994, Dr. Reinmuth has served as the Charles H. Lundquist Distinguished Professor of Business at the University of Oregon. From June 1976 until July 1994, Dr. Reinmuth served as Dean of the College of Business at the University of Oregon. Since 1988, Dr. Reinmuth has also served in several administrative positions within the University of Oregon.
Steven T. Frankel has served as Chief Executive Officer and a Director of A-Fem since April 1998, and as President of A-Fem since November 1998. From May 1992 to March 1998, Mr. Frankel was president and chief executive officer of Quidel Corporation, a manufacturer of physicians' office diagnostic test kits. From January 1983 to May 1992, Mr. Frankel was president of various international and domestic divisions of Becton, Dickinson and Company, a diagnostic and medical device manufacturer. From 1979 to 1983, Mr. Frankel was vice president and general manager of the Becton Dickinson Home Health Care unit. Mr. Frankel also serves as a director of HIDA Educational Foundation, Washington, D.C.
William H. Fleming, Ph.D., has served as Vice Chairman-Diagnostics of A-Fem since August of 1997, and as a Director and Secretary of A-Fem since February 1994. From February 1994 through
August 1997, Dr. Fleming served as President and Chief Operating Officer of A-Fem. He was president, chief operating officer and a director of ProFem from July 1993 until its merger with A-Fem in June 1994. From April 1992 until July 1993, Dr. Fleming served as an associate with Sovereign Ventures, a healthcare consulting firm; concurrently he served as director of corporate development of Antivirals, Inc., a biotechnology company involved in antisense technology. Dr. Fleming is a director of ERC, a non-profit company.
Carol A. Scott, Ph.D., has served as a Director of A-Fem since February 1995. Dr. Scott is a professor of marketing and the chairman of the marketing faculty at The John E. Anderson Graduate School of Management at the University of California, Los Angeles. Dr. Scott has been on the faculty at UCLA since 1977, and served the school in a variety of administrative positions from 1986 through 1994, including as chairman of the faculty and associate dean for academic affairs. She was also a visiting associate professor at the Harvard Business School in 1985, and was on the faculty at Ohio State University for three years prior to joining UCLA in 1977. Dr. Scott is a frequent author and lecturer and has served on the Editorial Board of the Journal of Consumer Research since 1980. Dr. Scott also serves on the board of directors of Sizzler International.
RoseAnna Sevcik has served as a Director of A-Fem since May 1995. Ms. Sevcik has been serving as director of mortgage backed securities for SunAmerica Investments since July of 1999. From March 1996 to May 1999, Ms. Sevcik served as vice president/senior portfolio manager of Penn Mutual. From February 1993 to March 1996, Ms. Sevcik was vice president/senior portfolio manager and served as a director on the pension plans board of the Life Insurance Company of the Southwest. From February 1990 to February 1993, Ms. Sevcik was senior portfolio manager/securities analyst at Securities Management and Research, an investment management services company.
James R. Wilson has served as Treasurer and a Director of A-Fem since September 1996 and as Director of Business Development since July 1997. In addition, since August 1995 Mr. Wilson has been a private financial consultant to firms in both manufacturing and service industries. From August 1992 to August 1995, Mr. Wilson was a sales manager for Advanced Equipment Systems, Inc. From January 1985 to August 1992, Mr. Wilson was treasurer and director of marketing in various divisions of Production Technologies, Inc. Mr. Wilson also serves as a director of Design Pacific/Oregon Dome, Inc.
Merry L. Disney has been president and chief executive officer of Disney West operations since 1985. From 1986 to 1988, she was president of Bridaldale Development Corporation and served as a director from 1979 to 1986. Ms. Disney worked as an Academic Instructor of Children with Reading Disabilities from 1982 until 1991 and currently is active in major real estate developments and acquisitions.
Key Employees
Martin Harvey has served as the Company's Controller since June 1998. From 1993 to 1998, Mr. Harvey held several other controller positions with a variety of manufacturing companies. From August 1987 to June 1993, Mr. Harvey was division controller for Spacelabs Medical, Inc., a manufacturer of critical care medical monitors. From January 1980 to August 1987, Mr. Harvey was division controller for the Medical Systems Division of Control Data, Inc.
Paul Mueggler, Ph.D. has served as Vice President, Clinical and Regulatory Affairs of the Company since July 2000. Prior to this date, Dr. Mueggler served as Director of Clinical Affairs for the Company since April of 1997. From August 1989 to January 1994, Dr. Mueggler served as director of clinical and technical operations for OXIS Corporation, a diagnostic company. From April 1984 to August 1989, he served as assistant professor and chief, toxicology section for the Department of Clinical Pathology of the School of Medicine at Oregon Health Sciences University.
A-Fem's directors hold office until the next annual meeting of stockholders or until their successors are duly elected and qualified; officers hold office at the discretion of the Board. Directors are reimbursed for expenses incurred in attending meetings of the Board of Directors. Non-employee directors receive options or warrants to purchase shares of A-Fem's common stock in consideration for their services.
In March 1997, A-Fem formed a Medical Advisory Panel. This panel currently consists of seven members, two of whom are employees of A-Fem. The outside members are all prominent Ph.D.s and M.D.s specializing in public and/or women's health. The Medical Advisory Board is expected to provide guidance to A-Fem on clinical validations for its planned products.
Item 10. Executive Compensation
Compensation Summary
The following table sets forth certain information regarding the compensation paid to the Chief Executive Officer and any other corporate officers who received in excess of $100,000 in compensation (the "Named Executive Officers") for each of the fiscal years ended December 31, 1999, 1998 and 1997.
Summary Compensation Table Long-Term Annual Compensation Compensation ------------------------ -------------------- Other Annual Securities Underlying Name and Principal Salary Compensation Options/Warrants Position Year ($) ($) (#) ----------------------------- ---- --------- -------------- -------------------- James E. Reinmuth (1) 2000 30,000 - - Chairman and Director 1999 30,000 - - Chief Executive Officer, 1998 45,025 - 150,000 Steven T. Frankel (2) 2000 240,000 - 50,000 Chief Executive Officer, 1999 300,769 - - President and Director 1998 103,863 - 1,700,000 William H. Fleming 2000 115,000 - 50,000 Vice Chairman-Diagnostics, 1999 115,000 - - Secretary and Director 1998 119,449 - 150,000 |
(1) James E. Reinmuth served as Chief Executive Officer of A-Fem until April 1998.
(2) Steven T. Frankel became Chief Executive Officer of A-Fem in April 1998 and President of A-Fem in November 1998. Mr. Frankel's 1999 salary reflects $60,769 in deferred salary from 1998.
Option Grants
The following table sets forth certain information regarding options granted to Named Executive Officers during the fiscal year ended December 31, 2000.
Individual Grants ------------------------------------------------------------- Percent of Number of Total Options Securities Granted to Underlying Employees Exercise Options in Price Expiration Name Granted Fiscal Year ($/Share) Date ------------------ ---------- ----------- --------- ------------ Steven T. Frankel 50,000(1) 13.8% $0.78 Dec 19, 2010 William H. Fleming 50,000(1) 13.8% $0.78 Dec 19, 2010 -------------- |
(1) These options vest on December 19, 2001.
Exercise of Stock Options and Year-End Option/Warrant Values
No Named Executive Officers exercised options or warrants during the year ended December 31, 2000. The following table sets forth certain information regarding options and warrants of the Named Executive Officers as of December 31, 2000.
2000 Year-End Options/Warrant Values Number of Securities Value of Unexercised Underlying Unexercised In-the-Money Options/Warrants at Options/Warrants at December 31, 2000 December 31, 2000 (2) -------------------------- -------------------------- Name Exercisable Unexercisable Exercisable Unexercisable ------------------ ----------- ------------- ----------- ------------- James E. Reinmuth 476,667 150,000(1) -0- -0- Steven T. Frankel 487,500 1,262,500(1) -0- -0- William H. Fleming 376,667 200,000(1) -0- -0- |
(1) These options are subject to performance-based conditions.
(2) Based on a fair market value of $.75 per share, the price per share of A-Fem's common stock on December 31, 2000.
Compensation of Directors
Directors of A-Fem who are also employed by A-Fem do not receive additional compensation for their services as directors. Non-employee directors of A-Fem receive compensation in the form of options to purchase A-Fem's common stock. Directors who serve on the committee that administers A-Fem's 1994 Incentive and Non-Qualified Stock Option Plan receive options pursuant to paragraph 13 of the Plan.
Employment Agreements
A-Fem entered into a consulting agreement with James E. Reinmuth dated effective December 1, 1998 (the "Reinmuth Consulting Agreement"), with respect to Mr. Reinmuth's services as Chairman of the Board. The Reinmuth Consulting Agreement provides for a fee of $2,500 per month. Either party may terminate the Reinmuth Consulting Agreement on 30 days' prior notice.
A-Fem entered into an employment agreement with James R. Wilson dated effective May 1, 1997 (the "Wilson Employment Agreement"), with respect to Mr. Wilson's services as A-Fem's Treasurer. The Wilson Employment Agreement provides for a salary of $5,000 per month. Either party may terminate the Wilson Employment Agreement on 30 days' prior notice.
A-Fem entered into an employment agreement with Steven T. Frankel dated effective April 25, 1998 (the "Frankel Employment Agreement"), with respect to Mr. Frankel's services as A-Fem's Chief Executive Officer. The Frankel Employment Agreement provides for a salary of $20,000 per month. Either party may terminate the Frankel Employment Agreement on 30 days' prior notice.
Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Securities Exchange Act of 1934, as amended, requires that A-Fem's officers, directors and persons who own more than 10% of A-Fem's common stock file with the Securities and Exchange Commission initial reports of beneficial ownership on Form 3 and reports of changes in beneficial ownership of common stock and other equity securities of A-Fem on Form 4. Officers, directors and greater than 10% stockholders of A-Fem are required by SEC regulations to furnish to A-Fem copies of all Section 16(a) reports that they file. To A-Fem's knowledge, based solely on reviews of such reports furnished to A-Fem and written representations that no other reports are required, all Section 16(a) filing requirements applicable to its officers, directors and greater than 10% beneficial owners were complied with during the fiscal year ended December 31, 2000, except that William H. Fleming reported on his Form 4 filed for June 2000 three transactions not previously reported that should have been reported on a Form 5 for the year ended December 31, 1999 that Mr. Fleming failed to file.
Item 11. Security Ownership of Certain Beneficial Owners and Management
The following table sets forth certain information regarding the beneficial ownership as of December 31, 2000, of A-Fem's common stock $0.01 par value of (i) each beneficial owner of more than 5% of the common stock, (ii) the Named Executive Officers, (iii) each director of A-Fem and (iv) all directors and executive officers as a group. Each person named in the table has sole investment and voting power with respect to the shares set forth opposite his name or her name, except as otherwise noted.
Name and Address of Amount and Nature of Percent of Class Beneficial Owner Beneficial Ownership (1) Outstanding ----------------------------------- ------------------------ ----------------- Capital Consultants, LLC 7,976,335 (2) 45.4% 2300 SW First Avenue, Suite 200 Portland, OR 97201 Merry Disney 10,000 (3) * c/o Pacific Group 100 Atlantic Avenue, Suite 409 Long Beach, CA 90802 Director William H. Fleming 791,367 (4) 8.1% 10180 SW Nimbus Ave., Suite J-5 Portland, OR 97223 Vice-Chairman, Secretary and Director |
Steven T. Frankel 487,500 (5) 4.8% Suite J-5 10180 SW Nimbus Avenue Portland, OR 97223-4341 Chief Executive Officer, President and Director James E. Reinmuth 540,667 (6) 5.5% 5171 Solar Heights Drive Eugene, OR 97405 Chairman and Director Richard T. Schroeder 539,000 (7) 5.5% 3840 SW 75th Ave. Portland, OR 97225 Carol A. Scott 60,000 (8) * 1834 Park Blvd. Palo Alto, CA 94306 Director RoseAnna Sevcik 60,000 (9) * 3843 Cottonwood Grove Terrace Calabasas, CA 91301 Director James R. Wilson 410,095 (10) 4.2% 2968 Matt Drive Eugene, OR 97408 Treasurer and Director All directors and officers 2,359,629 (11) 21.8% as a group (8 persons) ---------- |
* Less than 1%.
(1) "Beneficial Ownership" is defined pursuant to Rule 13d-3 of the Exchange Act, and generally means any person who directly or indirectly has or shares voting or investment power with respect to a security. A person shall be deemed to be the beneficial owner of a security if that person has the right to acquire beneficial ownership of such security within 60 days, including, but not limited to, any right to acquire such security through the exercise of any option or warrant or through the conversion of a security. Any securities not outstanding that are subject to such options or warrants shall be deemed to be outstanding for the purpose of computing the percentage of outstanding securities of the class owned by such person, but shall not be deemed to be outstanding for the purpose of computing the percentage of the class owned by any other person.
(2) Includes 7,492,155 shares issuable upon conversion of shares of Series A Stock, and an additional 484,200 shares issuable upon conversion of shares issuable upon exercise of warrants to purchase Series A Stock.
Capital Consultants, Inc. acts as an
agent for individual investors with respect to all shares beneficially owned by it. Capital Consultants, Inc. is an investment advisor registered under Section 203 of the Investment Advisors Act of 1940 and has, on behalf of certain of its clients, sole voting power and sole investment power with respect to certain of these shares. In September 2000 Mr. Thomas F. Lennon was appointed receiver of Capital Consultants and its related entities by the U.S. District Court for the District of Oregon.
(3) Consists of 10,000 shares issuable upon exercise of options to purchase Common Stock.
(4) Includes 176,667 shares issuable upon the exercise of options to purchase Common Stock.
(5) Consists of 487,500 shares issuable upon the exercise of options to purchase Common Stock.
(6) Includes 23,000 shares of common stock held by the Reinmuth Family Trust, 23,000 shares held by Terry A. Reinmuth, 4,000 shares held by Hilary J. Reinmuth, 4,000 shares held by Jennifer C. Reinmuth, 250,000 shares issuable upon exercise of a warrant to purchase Common Stock and 76,667 shares issuable upon exercise of options to purchase Common Stock.
(7) Includes 200,000 shares issuable upon the exercise of warrants to purchase Common Stock, 30,000 shares held by Mr. Schroeder's spouse, and 29,000 shares held by their children. Mr. Schroeder disclaims beneficial ownership of the 29,000 shares held by his children.
(8) Includes 60,000 shares issuable upon the exercise of options to purchase Common Stock.
(9) Includes 60,000 shares issuable upon the exercise of options to purchase Common Stock.
(10) Includes 160,000 shares of Common Stock held jointly with Mr. Wilson's spouse, with whom Mr. Wilson shares voting power with respect to an additional 153,428 shares, and 96,667 shares issuable upon the exercise of options to purchase Common Stock.
(11) Includes 967,501 shares issuable upon the exercise of options to purchase Common Stock and 250,000 shares issuable upon exercises of warrants to purchase Common Stock.
Item 12. Certain Relationships and Related Transactions
As of December 31, 2000, William H. Fleming, A-Fem's Vice-Chairman of the Board and Secretary, had an outstanding balance of approximately $69,000 on a loan from A-Fem. This loan was made on November 18, 1994, and the original principal balance was $52,000. Interest accrues at a rate of 6.24% and is capitalized. Mr. Fleming used the proceeds from this loan to purchase shares of A-Fem's common stock upon exercise of a stock option. Mr. Fleming and A-Fem have agreed that the outstanding balance on this loan shall become due and payable on July 1, 2001, and that Mr. Fleming may make such repayment by tendering shares of A-Fem's common stock that he owns with a value equal to such outstanding balance on the date of repayment.
Item 13. Exhibits and Reports on Form 8-K
See Exhibit Index.
None.
In accordance with Section 13 or 15(d) of the Exchange Act, the Registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
A-FEM MEDICAL CORPORATION
By:/s/ Steven T. Frankel ------------------------------------- Steven T. Frankel Chief Executive Officer and President Date: April 16, 2001 |
In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:
Signature Title Date
/s/ Steven T. Frankel Chief Executive Officer, April 16, 2001 ---------------------- President and Director Steven T. Frankel (principal executive officer) /s/ James E. Reinmuth Chairman and Director April 16, 2001 ---------------------- James E. Reinmuth /s/ William H. Fleming Vice Chair-Diagnostics, April 16, 2001 ---------------------- William H. Fleming Secretary and Director /s/ James R. Wilson Treasurer and Director April 16, 2001 ---------------------- James R. Wilson /s/ Martin Harvey Controller April 16, 2001 ---------------------- (principal financial and accounting Martin Harvey officer) /s/ Carol A. Scott Director April 16, 2001 ---------------------- Carol A. Scott /s/ RoseAnna Sevcik Director April 16, 2001 ---------------------- RoseAnna Sevcik /s/ Merry Disney Director April 16, 2001 ---------------------- Merry Disney |
EXHIBIT INDEX
Exhibit No. Description ------- ----------- 3.1 Articles of Incorporation, as amended 3.2(1) Bylaws, as amended 4.1(2) Form of Stock Purchase Warrant 4.2(2) Form of Series A Preferred Stock Certificate *10.1(3) Employment Agreement between A-Fem Medical Corporation and Steven T. Frankel, dated effective April 25, 1998 10.2(4) Business Park Lease between A-Fem Medical Corporation, Petula Associates, Ltd. and Koll Portland Associates, dated March 1, 1996 10.3(5) Scholls Business Center First Amendment to Lease between A-Fem Medical Corporation, Petula Associates, Ltd. and Equity FC, Ltd. 10.4(6) Form of Registration Rights Agreement used for Mr. Waller, Esler, Stephens & Buckley and Lane, Powell, Spears and Lubersky 10.5(7) Form of Registration Rights Agreement 10.6(7) ATHENA Medical Corporation's 1994 Incentive and Non-Qualified Stock Option Plan, dated as of June 7, 1994 *10.7(7) Form of Incentive Stock Option Agreement *10.8(7) Form of Non-Statutory Stock Option Agreement 10.9(7) Form of Purchase Warrant Certificate 10.12(8) Agreement dated effective as of April 28, 1997, between The Proctor & Gamble Company and A-Fem Medical Corporation *10.13(9) Employment Agreement between A-Fem Medical Corporation and James R. Wilson, dated as of May 1, 1997 10.14(10) Form of Capital Lease between A-Fem Medical Corporation and First Portland Leasing Corp. 23.1 Consent of Arthur Andersen LLP, Independent Public Accountants |
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(1) Incorporated by reference to the exhibits to A-Fem's annual report on Form 10-KSB/A to the year ended December 31, 1998.
(2) Incorporated by reference to the exhibits to A-Fem's quarterly report on Form 10-QSB for the quarter ended September 30, 1998.
(3) Incorporated by reference to the exhibits to A-Fem's quarterly report on Form 10-QSB for the quarter ended June 30, 1998.
(4) Incorporated by reference to the exhibits to A-Fem's Registration Statement on Form S-2 (file no. 333-2053), filed with the SEC on March 29, 1996.
(5) Incorporated by reference to the exhibits to A-Fem's Registration Statement on Form S-2 (file no. 333-2053), filed with the SEC on January 21, 1999.
(6) Incorporated by reference to the exhibits to A-Fem's Registration Statement on Form S-2 (file no. 33-88230), filed with the SEC on January 5, 1995.
(7) Incorporated by reference to the exhibits to A-Fem's Annual Report on Form 10-KSB for the year ended December 31, 1996.
(8) Incorporated by reference to exhibit number 10.1 to A-Fem's Current Report on Form 8-K (file no. 0-17119) filed with the SEC on May 16, 1997.
(9) Incorporated by reference to the exhibits to A-Fem's quarterly report on Form 10-QSB for the quarter ended June 30, 1997.
(10) Incorporated by reference to the exhibits to A-Fem's Annual Report on Form 10-KSB for the year ended December 31, 1997.
* Indicates management contract or compensation plan.
Report of Independent Public Accountants
To the Board of Directors and Stockholders of A-Fem Medical Corporation:
We have audited the accompanying balance sheets of A-Fem Medical Corporation (a Nevada corporation) as of December 31, 2000 and 1999, and the related statements of operations, changes in stockholders' equity (deficit) and cash flows for each of the two years in the period ended December 31, 2000. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with auditing standards generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of A-Fem Medical Corporation as of December 31, 2000 and 1999, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2000, in conformity with accounting principles generally accepted in the United States.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations and has a net working capital deficiency that raises substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern.
/s/Arthur Andersen LLP ---------------------- ARTHUR ANDERSEN LLP Portland, Oregon April 6, 2001 |
A-Fem Medical Corporation Balance Sheets As of December 31, 2000 and 1999 ASSETS 2000 1999 ------------- ------------- CURRENT ASSETS: Cash and cash equivalents $ 5,644 $ 428,845 Accounts receivable 10,990 6,622 Other receivables 17,158 13,675 Inventories 41,496 65,581 Prepaid expenses 65,162 86,649 ------------- ------------- Total current assets 140,450 601,372 PROPERTY, EQUIPMENT AND LEASEHOLD IMPROVEMENTS 1,044,932 1,286,012 Less- Accumulated depreciation and amortization (681,392) (640,331) ------------- ------------- Total property, equipment and leasehold improvements 363,540 645,681 PATENTS, net 83,605 54,700 ------------- ------------- Total assets $ 587,595 $ 1,301,753 ============= ============= (Continued) F-2 |
A-Fem Medical Corporation Balance Sheets (Continued) As of December 31, 2000 and 1999 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) 2000 1999 ------------- ------------- CURRENT LIABILITIES: Accounts payable $ 146,763 $ 64,101 Current portion - capital lease obligations 4,590 31,664 Accrued expenses 98,084 83,796 Accrued salaries and benefits 96,584 84,857 Deferred income 30,000 - Note payable - related party 400,000 - ------------- ------------- Total current liabilities 776,021 264,418 LONG-TERM LIABILITIES: Long-term portion - capital lease obligations - 4,660 Long-term note payable - related party - 450,000 ------------- ------------- Total long-term liabilities - 454,660 ------------- ------------- Total liabilities 776,021 719,078 COMMITMENTS (NOTE 7) STOCKHOLDERS' EQUITY (DEFICIT): Series A Convertible Preferred Stock, $.01 par value; authorized 8,200,000 shares; issued 7,492,135 shares and 6,971,305 shares at December 31, 2000 and 1999, respectively 74,921 69,713 Common stock, $.01 par value; authorized 33,000,000 shares; issued 9,596,558 shares and 9,563,225 shares at December 31, 2000 and 1999, respectively 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 Note receivable (52,000) (52,000) Accumulated deficit (20,668,202) (18,852,452) ------------- ------------- Total stockholders' equity (deficit) (188,426) 582,675 ------------- ------------- Total liabilities and stockholders' equity (deficit) $ 587,595 $ 1,301,753 ============= ============= |
The accompanying notes are an integral part of these balance sheets.
A-Fem Medical Corporation
Statements of Operations
For the Years Ended December 31, 2000 and 1999
2000 1999 REVENUES: Sales, net of discounts $ 29,611 $ 66,534 -------------- -------------- Net sales 29,611 66,534 COST OF SALES: Cost of goods sold 226,536 273,589 -------------- -------------- Gross margin (196,925) (207,055) OPERATING EXPENSES: Selling and marketing 36,825 297,822 General and administrative 865,235 919,355 Research and development 788,074 1,074,346 -------------- -------------- Operating loss (1,887,059) (2,498,578) -------------- -------------- OTHER INCOME (EXPENSE): Interest income 22,271 13,611 Interest expense (42,182) (69,561) Licensing income 80,000 35,000 Other income 11,220 25,361 -------------- -------------- 71,309 4,411 -------------- -------------- Net loss $ (1,815,750) $ (2,494,167) ============== ============== NET LOSS PER SHARE, basic and diluted $ (.19) $ (.26) ============== ============== WEIGHTED AVERAGE COMMON SHARES OUTSTANDING 9,584,138 9,520,249 ============== ============== |
The accompanying notes are an integral part of these statements.
A-Fem Medical Corporation Statements of Changes in Stockholders' Equity (Deficit) For the Years Ended December 31, 2000 and 1999 (Page 1 of 2) Preferred Stock Common Stock Shares Amount Warrants Shares Amount --------- --------- ------------- --------- ----------- BALANCE, December 31, 1998 5,773,405 $ 57,734 $ 761,882 9,471,875 $ 94,719 Common stock issued for cash $1.50 per share, net of financing costs - - - 25,000 250 Common stock issued for cash $1.49 per share, net of financing costs - - - 33,333 333 Common stock issued for cash $1.52 per share, net of financing costs - - - 33,017 330 Preferred stock issued for cash $1.92 per share, net of financing costs 1,197,900 11,979 - - - Warrants issued in connection with issuance of preferred stock - - 390,266 - - Net loss - - - - - --------- --------- ------------- --------- ----------- BALANCE, December 31, 1999 6,971,305 69,713 1,152,148 9,563,225 95,632 Common stock issued for exercise of warrants - - - 33,333 333 Preferred stock issued for cash $1.92 per share, net of financing costs 520,830 5,208 - - - Warrants issued in connection with issuance of preferred stock - - 741,168 - - Net loss - - - - - --------- --------- ------------- --------- ----------- BALANCE, December 31, 2000 7,492,135 $ 74,921 $ 1,893,316 9,596,558 $ 95,965 ========= ========= ============= ========= ========== |
The accompanying notes are an integral part of these statements.
F-5a
A-Fem Medical Corporation Statements of Changes in Stockholders' Equity (Deficit) - continued For the Years Ended December 31, 2000 and 1999 (Page 2 of 2) Total Additional Shareholders' Paid-In Note Accumulated Equity Warrants Capital Receivable Deficit (Deficit) -------- ----------- ---------- ------------ ------------ BALANCE, December 31, 1998 $76,491 $16,081,044 $(52,000) $(16,358,285) $ 661,585 Common stock issued for cash $1.50 per share, net of financing costs - 37,250 - - 37,500 Common stock issued for cash $1.49 per share, net of financing costs - 49,167 - - 49,500 Common stock issued for cash $1.52 per share, net of financing costs - 49,695 - - 50,025 Preferred stock issued for cash $1.92 per share, net of financing costs - 2,266,253 - 2,278,232 Warrants issued in connection with issuance of preferred stock - (390,266) - - - Net loss - - - (2,494,167) (2,494,167) ------- ----------- -------- ------------ ------------ BALANCE, December 31, 1999 76,491 18,093,143 (52,000) (18,852,452) 582,675 Common stock issued for exercise of warrants - 49,667 - - 50,000 Preferred stock issued for cash $1.92 per share, net of financing costs - 989,441 - - 994,649 Warrants issued in connection with issuance of preferred stock - (741,168) - - - Net loss - - - (1,815,750) (1,815,750) ------- ----------- -------- ------------ ------------ BALANCE, December 31, 2000 $76,491 $18,391,083 $(52,000) $(20,668,202) $ (188,426) ======= =========== ======== ============ ============ |
The accompanying notes are an integral part of these statements.
F-5b
A-Fem Medical Corporation Statements of Cash Flows For the Years Ended December 31, 2000 and 1999 2000 1999 ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(1,815,750) $(2,494,167) Adjustments to reconcile net loss to net cash flows used in operating activities- Depreciation and amortization 96,716 126,581 Loss (gain) on disposal of assets (8,060) 362 Other noncash income (3,483) (3,482) Other noncash expense 4,388 32,655 Changes in operating assets and liabilities: Accounts receivable (4,368) 31,613 Inventories 24,085 5,274 Prepaid expenses 6,126 170,954 Accounts payable 82,662 (235,370) Accrued expenses 14,288 9,721 Accrued salaries and benefits 11,727 (53,537) Deferred income 30,000 - ----------- ----------- Net cash used in operating activities (1,561,669) (2,409,396) ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of property, equipment and leasehold improvements (9,393) (61,183) Net proceeds from sale of equipment 199,546 825 Other assets (30,482) 3,595 ----------- ----------- Net cash provided by (used in) investing activities 159,671 (56,763) ----------- ----------- CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from sale of common stock 50,000 137,025 Net proceeds from sale of preferred stock, net of offering costs 994,649 2,278,232 Repayments on capital lease obligations (15,852) (188,622) Payments on note payable (50,000) - ----------- ----------- Net cash provided by financing activities 978,797 2,226,635 ----------- ----------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (423,201) (239,524) CASH AND CASH EQUIVALENTS, beginning of period 428,845 668,369 ----------- ----------- CASH AND CASH EQUIVALENTS, end of period $ 5,644 $ 428,845 =========== =========== SUPPLEMENTAL DISCLOSURE OF NONCASH ACTIVITY: Settlement of lease obligation and prepaid expenses $ 10,973 - SUPPLEMENTAL CASH FLOW DISCLOSURE: Total cash paid for interest $ 42,182 $ 69,561 |
The accompanying notes are an integral part of these statements.
A-Fem Medical Corporation
Notes to Financial Statements
December 31, 2000 and 1999
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 RapidoSense(R) diagnostic tests and the third based on its Padkit(R) Sample Collection System. A-Fem currently markets the inSync(R) miniform as an alternative to tampons, pads and liners for light flow, or in combination for heavier flow protection. The Padkit(R), 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 provide quantified results using its proprietary RapidoSense(R) technology.
Going Concern Uncertainty
The Company has experienced significant operating losses during the years ended December 31, 2000 and 1999 and has continued to incur losses into the first quarter of 2001. Further, the Company has not generated significant revenues. The Company 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 the Company's ability to continue as a going concern. Execution of the Company'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 and to evaluate potential partnering opportunities. The Company has demonstrated the ability to raise operating funds in the past by securing investment commitments in its preferred and common stock of approximately $1.0 million and $2.4 million during 2000 and 1999, respectively, net of issuance expenses. However, there can be no assurance that the Company's efforts to raise additional funding or enter into a strategic alliance will be successful. If the company is unable to obtain adequate additional financing, enter into such strategic alliance or generate sufficient profitable sales revenues, management may be required to curtail the Company's product development, marketing activities and other operations and the Company may be forced to cease operations.
Fair Value
The carrying value of financial instruments approximates fair value, unless otherwise disclosed.
Cash and Cash Equivalents
The Company considers all instruments with maturities of three months or less when purchased to be cash equivalents.
Concentration of Risk
The Company currently purchases certain raw materials from a single supplier. Management believes that other suppliers could supply these products, but there is no assurance that such a change in suppliers would not adversely impact the terms currently received by the Company.
The Company performs periodic credit evaluations of its customers' financial condition and generally does not require collateral. For the year ended December 31, 2000, sales to four customers accounted for all of the Company's total sales. For the year ended December 31, 1999, sales to one customer amounted to approximately 18 percent of total sales.
Inventories
Inventories are valued at the lower of cost or market with cost determined on a
first-in, first-out basis and market based on the lower of replacement cost or
estimated net realizable value.
Property, Equipment and Leasehold Improvements
Property, equipment and leasehold improvements are recorded at cost and depreciated on a straight-line basis over useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the lives of the related leases. Maintenance and repair costs are expensed as incurred; renewals and betterments are capitalized.
Long-Lived Assets
In accordance with Statement of Financial Accounting Standards No. 121, long-lived assets held and used by the Company are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. For purposes of evaluating the recoverability of long-lived assets, the recoverability test is performed using undiscounted net cash flows of the asset.
Patents
Patent costs are capitalized and amortized by the straight-line method over a 17-year period beginning with the date the patent is granted. Total accumulated amortization for these patents was $23,629 and $22,052 as of December 31, 2000 and 1999, respectively.
Income Taxes
The Company accounts for income taxes in accordance with Statement of Financial Accounting Standards No. 109, "Accounting for Income Taxes" (SFAS 109). Under SFAS 109, deferred tax assets and liabilities are recorded based on the tax effected difference between the tax bases of assets and liabilities and their carrying amount for financial reporting purposes, referred to as "temporary differences," using enacted marginal income tax rates.
Advertising Costs
Advertising costs, which are included in sales and marketing expense, are expensed when the advertising first takes place. Advertising expense was zero and $41,934 in 2000 and 1999, respectively.
Net Loss Per Share
Basic earnings per share (EPS) and diluted EPS are required to be computed using the methods prescribed by Statement of Financial Accounting Standards No. 128, "Earnings per Share" (SFAS 128). Basic EPS is calculated using the weighted average number of common shares outstanding for the period and diluted EPS is computed using the weighted average number of common shares and dilutive common equivalent shares outstanding. Following is a reconciliation of basic EPS and diluted EPS for the years ended December 31:
2000 1999 ------------------------------- --------------------------------- Per Per Share Share Income Shares Amount Income Shares Amount ----------- --------- ----- ----------- --------- ----- Basic EPS: Loss available to Common Shareholders $(1,815,750) 9,584,138 $(.19) $(2,494,167) 9,520,249 $(.26) Effect of dilutive securities: Stock options - - - - - - ----------- --------- ----- ----------- --------- ----- Diluted EPS: Loss available to Common Shareholders $(1,815,750) 9,584,138 $(.19) $(2,494,167) 9,520,249 $(.26) =========== ========= ====== =========== ========= ===== |
At December 31, 2000 and 1999, the Company had options and warrants outstanding covering 5,318,862 and 5,906,144, respectively, of the Company's common stock not included in the above calculations since they would have been antidilutive. In addition, at December 31, 2000 and 1999, the Company had 7,492,135 and 6,971,305 shares, respectively, issuable pursuant to the Company's convertible preferred stock and warrants outstanding covering 1,204,012 and 790,064 shares, respectively, of the Company's convertible preferred stock that were not included as they would have been antidilutive.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities, if any, at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
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), which established accounting and reporting standards for all derivative instuments. SFAS 133 will require the Company's derivative financial instruments to be recorded at fair value and reflected in income unless they are effective as hedges. In June 1999, the FASB issued Statement of Financial Accounting Standards No. 137, "Accounting for Derivative Instruments and Hedging Activities - Deferral of the Effective Date of FASB Statement No. 133," which delays the Company's adoption of SFAS 133 until 2001. In June 2000, the FASB issued SFAS No. 138, which amended certain guidance within SFAS No. 133. The adoption of SFAS 133 in 2001 is not expected to have a material effect on the Company's fiancial position or results of operations.
Reclassifications
Certain reclassifications have been made to prior year amounts to conform to the current year presentation.
Prepaid expenses consisted of the following components at December 31:
2000 1999 --------- --------- Deposits refundable $ 44,913 $ 56,177 Prepaid rent 11,124 16,852 Other prepaid expenses 9,125 13,620 --------- --------- $ 65,162 $ 86,649 ========= ========= |
Inventories consisted of the following components at December 31:
2000 1999 --------- --------- Raw materials $ 39,727 $ 40,629 Work-in-process - - Finished goods 1,769 24,952 --------- --------- $ 41,496 $ 65,581 ========= ========= |
4. Property, Equipment and Leasehold Improvements ---------------------------------------------- 2000 1999 ---------- ---------- Property $ 37,099 $ 37,099 Equipment 890,682 1,131,762 Leasehold improvements 117,151 117,151 ---------- ---------- 1,044,932 1,286,012 Less- Accumulated depreciation and amortization (681,392) (640,331) ---------- ---------- Net property, equipment and leasehold improvements $ 363,540 $ 645,681 ========== ========== |
Included in the above table are amounts relating to assets utilized under capital leases which had a net book value of $34,348 and $228,100 at December 31, 2000 and 1999, respectively.
Accrued expenses consisted of the following components at December 31:
2000 1999 --------- --------- Loan fee $ 50,000 $ 50,000 Professional fees 48,084 27,859 Other - 5,937 --------- --------- $ 98,084 $ 83,796 ========= ========= 6. Financing Arrangements ---------------------- |
Note Payable
During 1998, A-Fem entered into a note payable with an investor in the amount of $450,000 (the Agreement). The Agreement was collateralized by a one-half security interest in a licensing agreement between a major manufacturer and the Company (Note 10). The Agreement is now unsecured. The Agreement requires monthly interest payments, at a fixed interest rate of 9.5 percent. The balance, plus a $50,000 loan fee, was payable one year from the date of the agreement, April 13, 1999. The loan fee was accrued over the original term of the Agreement. In March 2000, the investor agreed to extend the due date of the Agreement by one year. The total interest expense on this note for 2000 and 1999 was $42,182 and $69,561, respectively, including zero and $16,667, respectively, for accrual of the loan fee.
Capital Leases
Certain collateralized equipment is leased by the Company, which obligations are reflected by the secured leases as noted below. This equipment is used for research and development of new products and for manufacturing and production of the miniform.
Future minimum lease payments under capital leases as of December 31 are as follows:
2001 total minimum lease payments $ 4,778 Less: amount representing interest (188) --------- Present value of minimum lease payments $ 4,590 ========= |
Preferred Stock
During the year ended December 31, 1998, the Company amended its Articles of Incorporation in order to authorize 10,000,000 shares of preferred stock having a par value of $.01 per share. The Company authorized the first series for up to 8,200,000 of the total authorized shares, of which 7,492,135 shares have been issued. These shares, designated as Series A Convertible Preferred Stock (the Preferred Stock), are nonredeemable, voting shares. The Preferred Stock is convertible at any time into shares of common stock on a one-for-one basis. The Preferred Stock has priority over other classes of capital stock with respect to dividends and upon liquidation.
During 1998, the Company entered into an agreement with an investor to exchange all of the investor's holdings of the Company's common stock into shares of the Company's Preferred Stock on a one-for-one basis in addition to additional Preferred Stock investment for cash. Additionally, this investor also exchanged 50,000 warrants to purchase common stock for 50,000 warrants to purchase Preferred Stock.
Common Stock
Holders of Common Stock are entitled to one vote per share on all matters requiring shareholder vote. Holders of Common Stock are entitled to receive dividends when and as declared by the Board of Directors out of any funds lawfully available therefor, and, in the event of liquidation or distribution of assets, are entitled to participate ratably in the distribution of such assets remaining after payment of liabilities, in each case subject to any preferential rights granted to any series of Preferred Stock that may then be outstanding.
Common Stock Options
On April 21, 1998, the Company granted nonstatutory stock options to the new Chief Executive Officer of the Company exercisable for 1,700,000 shares of the Company's common stock at an exercise price of $2.06 per share. At December 31, 2000, 487,500 of the granted options were exercisable with the remaining options vesting over the next seven years. The options expire ten years from the date of grant. Additionally, at December 31, 2000 the Company has options outstanding exercisable for 495,833 shares of the Company's common stock. The options are fully vested and expire on 2002 to 2004.
In addition, the Company has an Incentive and Non-Qualified Stock Option Plan (the Incentive Plan), under which 3,300,000 shares of Common Stock are reserved for issuance under qualified options, nonqualified options, stock appreciation rights and other awards as set forth in the Incentive Plan. The Incentive Plan provides for administration by a Committee comprised of not less than two members of the Company's Board of Directors. Such Committee (or the Board of Directors in its absence) determines the number of shares, option price, duration and other terms of the options granted under the Incentive Plan. Qualified options are available for issuance to employees of the Company. Nonqualified options are available for issuance to consultants, advisors and others having a relationship with the Company, on terms as determined by the Committee. Under the Incentive Plan, the exercise price of a qualified option cannot be less than the fair market value on the date of grant and the exercise price of a nonqualified option is determined by the Committee on the date of grant. Options granted under the Incentive Plan generally vest three to five years from the date of grant and generally expire ten years from the date of grant.
Activity under the Incentive Plan as well as other issuances is summarized as follows:
Weighted Average Shares Subject Exercise Price to Options Per Share -------------- -------------- Balance at December 31, 1998 3,738,611 $2.66 Options granted 570,833 2.77 Options canceled (831,956) 2.81 --------- ----- Balance at December 31, 1999 3,477,488 2.55 Options granted 402,500 0.85 Options canceled (154,065) 2.91 --------- ----- Balance at December 31, 2000 3,725,923 $2.54 ========= ===== |
Of the outstanding options at December 31, 2000 and 1999, 1,247,340 and 963,905, respectively, were qualified stock options and 282,750 and 242,750, respectively, were nonqualified stock options. The options are exercisable for shares of the Company's Common Stock. Outstanding options and rights expire on various dates through November 2008. The number of shares available for grant under the Incentive Plan were 522,130 and 660,643 at December 31, 2000 and 1999, respectively.
The following table summarizes information about stock options outstanding at December 31, 2000:
Options Outstanding Options Exercisable ----------------------------------------------------------------- ------------------------------ Weighted Number of Number Average Weighted Shares Weighted Range of Outstanding at Remaining Average Exercisable at Average Exercise December 31, Contractual Exercise December 31, Exercise Prices 2000 Life - Years Price 2000 Price ------------ ------------- ------------ -------- -------------- --------- $0.78 - 1.00 392,500 9.89 $0.80 10,000 $1.00 1.75 - 2.88 2,572,955 5.15 2.18 877,854 2.00 3.00 - 4.69 610,468 5.10 3.42 610,468 3.27 5.13 150,000 3.84 5.13 150,000 5.13 ------------ --------- ---- ----- --------- ----- $0.78 - 5.13 3,725,923 4.21 $2.54 1,648,322 $2.75 ============ ========= ==== ===== ========= ===== |
At December 31, 1999, 1,614,222 options were exercisable at a weighted average exercise price of $2.81 per share.
Common Stock Warrants
As of December 31, 2000, warrants for a total of 1,592,939 shares of Common Stock had been awarded. The warrants may be exercised for shares of the Company's Common Stock. The following summarizes outstanding warrants for shares of the Company's Common Stock:
Shares Weighted Average Subject to Exercise Price Warrants Per Share Balance at December 31, 1998 2,520,006 $2.34 Warrants granted - - Warrants canceled - - Warrants exercised (91,350) 1.50 --------- ------ Balance at December 31, 1999 2,428,656 2.37 Warrants granted - - Warrants canceled (802,384) 1.54 Warrants exercised (33,333) 1.50 --------- ----- Balance at December 31, 2000 1,592,939 $2.81 ========= ===== Number exercisable at December 31, 2000 1,592,939 $2.81 |
During the years ended December 31, 2000 and 1999, the Company extended the exercise date of warrants for 33,333 and 141,350 shares, respectively, of the Company's Common Stock previously granted to various investors in the Company. The warrants are exercisable at a price of $1.50 per share and expire in 2005 and 2004, respectively, five years from the date of the extension.
Preferred Stock Warrants
During 2000, the Company awarded warrants for a total of 413,948 shares of the Company's Preferred Stock. During 1999, the Company awarded warrants for a total of 305,864 shares of the Company's Preferred Stock. The warrants may be exercised for shares of the Company's Preferred Stock. As of December 31, 2000, warrants for 1,204,012 preferred shares were granted and outstanding with a weighted average exercise price of $.39 per share. The warrants vest two years from the date of issuance.
Statement of Financial Accounting Standards No. 123
During 1995, the FASB issued Statement of Financial Accounting Standards No. 123, "Accounting for Stock-Based Compensation" (SFAS 123), which defines a fair value based method of accounting for an employee stock option and similar equity instruments and encourages all entities to adopt that method of accounting for all of their employee stock compensation plans. However, it also allows an entity to continue to measure compensation cost for those plans using the method of accounting prescribed by APB 25. Entities electing to remain with the accounting in APB 25 must make pro forma disclosures of net income or loss and, if presented, earnings or loss per share, as if the fair value based method of accounting defined in SFAS 123 had been adopted.
The Company has elected to account for its stock-based compensation plan under APB 25; however, the Company has computed, for pro forma disclosure purposes, the value of all options granted during 2000 and 1999 using the Black-Scholes option pricing model as prescribed by SFAS 123 using the following weighted average assumptions for grants:
For the Year Ended December 31, 2000 1999 -------- -------- Average risk-free interest rate 5.22% 5.85% Expected dividend yield - - Expected lives 6 years 6 years Expected volatility 125.00% 108.80% |
Using the Black-Scholes methodology, the total value of options and warrants granted during 2000 and 1999 was $331,121 and $1,120,818, respectively, which would be amortized on a pro forma basis over the vesting period of the options (typically four years). The weighted average fair value of options granted during 2000 and 1999 was $0.76 and $1.57 per share, respectively. If the Company had accounted for its stock-based compensation plan in accordance with SFAS 123, the Company's net loss and net loss per share would approximate the pro forma disclosures below:
2000 1999 ------------------------ ------------------------ As Reported Pro Forma As Reported Pro Forma Net loss $(1,815,750) $(3,400,415) $(2,494,167) $(4,329,973) Net loss per share (.19) (.35) (.26) (.45) |
While additional awards are anticipated in future years, the effects of applying SFAS 123 in this pro forma disclosure are not indicative of future amounts.
As of December 31, 2000, the Company had federal net operating loss (NOL) carryforwards of approximately $23 million. If not applied against future taxable income, the federal NOL carryforwards will expire in the years 2002 through 2020. Changes in the Company's ownership may cause an annual limitation on the amount of carryforwards that can be utilized. As of December 31, 2000 and 1999, the Company had net deferred tax assets of approximately $9.3 million and $8.4 million, respectively, primarily resulting from NOL carryforwards. In accordance with SFAS 109, at December 31, 2000 and 1999 a valuation allowance was recorded to reduce the net deferred tax assets to zero.
The significant components of the Company's deferred tax assets and liabilities as of December 31, 2000 and 1999 are as follows:
2000 1999 ----------- ----------- Components of deferred tax assets- Accrued salaries and benefits $ 34,287 $ 25,852 Accrued expenses 27,940 22,196 Deferred income 11,490 - Net operating loss and other tax credit carryforwards 9,197,293 8,440,058 ----------- ----------- Total deferred tax assets 9,271,010 8,488,106 Components of deferred tax liability: Fixed assets (93,118) (80,024) Valuation allowance (9,177,892) (8,408,082) ----------- ----------- Net asset $ - $ - =========== =========== |
The reconciliation between the effective tax rate and the statutory federal tax rate on net loss as a percentage is as follows for the years ending December 31:
2000 1999 ------ ------ Statutory federal income tax rate 34.0 34.0 State taxes, net of federal tax benefit 4.3 4.3 Effect of change in valuation allowance (38.3) (38.3) ------ ------ - - ====== ====== 9. Related Party Transactions |
As of December 31, 2000, the Company's Vice-Chairman of the Board and Secretary, had an outstanding balance of approximately $69,000 on a loan from the Company. This loan was made on November 18, 1994, and the original principal balance was $52,000. Interest accrues at a rate of 6.24 percent and is capitalized. The proceeds from this loan were used to purchase shares of the Company's common stock upon exercise of a stock option and is recorded as a reduction of stockholders' equity in the accompanying balance sheet. The difference between the outstanding and original principal balance which represents interest receivable on the loan, is recorded as other receivable in the accompanying balance sheet.
10. Commitments
Licensing Agreements
On April 28, 1997, the Company entered into a license agreement with a major manufacturer and distributor of consumer products to make, use and sell the Company's interlabial products and to use certain of the Company's trademarks. The Company received $2 million upon signing this agreement, with an additional $2 million to be received over the term of the agreement if certain milestones were achieved. The manufacturer opted not to continue with the contract.
In October 2000, the Company entered into an agreement with a medical laboratory for the sale of certain equipment. The Company received $30,000 through December 31, 2000, of a total amount of $50,000 to be paid. Per the agreement, title to the equipment does not transfer until all payments have been made. Accordingly, the $30,000 received in 2000 has been recorded as deferred income on the accompanying balance sheets as of December 31, 2000.
Operating Leases
The Company has operating leases for its corporate office, warehouse, product development and manufacturing facilities, and some office equipment. The following is a schedule by years of the Company's future minimum rental payments required under these operating leases that have lease terms in excess of one year as of December 31, 2000:
2001 $ 28,659 2002 4,491 2003 4,392 2004 4,392 2005 732 --------- Total minimum payments required $ 42,666 ========= |
Rent expense for the Company's operating leases was $127,259 and $134,968 for 2000 and 1999, respectively.
11. Subsequent Event
Subsequent to yearend, the Company held a meeting of its shareholders. At that meeting, the shareholders approved an amendment to the Articles of Incorporation increasing the number of authorized shares of preferred and common stock to 25,000,000 and 75,000,000, respectively. Additionally, the shareholders approved an amendment to the Incentive Plan, authorizing an additional 1,800,000 shares of common stock to be reserved for issuance pursuant to the Incentive Plan.
Exhibit 3.1
AMENDED AND RESTATED
ARTICLES OF INCORPORATION
OF
A-FEM MEDICAL CORPORATION
ARTICLE 1. NAME
The name of the Corporation is A-FEM MEDICAL CORPORATION.
ARTICLE 2. PRINCIPAL OFFICE AND REGISTERED AGENT
Its principal office in the State of Nevada is located at 502 East John Street, Room E, Carson City, Carson County, Nevada 89706. The name and address of its resident agent is CSC Services of Nevada, Inc. 502 East John Street, Room E, Carson City, Carson County, Nevada 89706.
ARTICLE 3. PURPOSE
The nature of the business, or objects or purposes to be transacted, promoted or carried on by the corporation are:
To engage in any lawful activity and to manufacture, purchase or otherwise acquire, invest in, own, mortgage, pledge, sell, assign and transfer or otherwise dispose of, trade, deal in and deal with goods, wares and merchandise and personal property of every class and description.
To perform research and development services and to manufacture and market health care devices, products and services.
To hold, purchase and convey real and personal estate and to mortgage or lease any such real or personal estate with its franchises and to take the same by devise or bequest.
To acquire, and pay for in cash, stock or bonds of this corporation or otherwise, the goodwill, rights, assets and property, and to undertake or assume the whole or any part of the obligations or liabilities of any person, firm, association or corporation.
To acquire, hold, use, sell, assign, lease, grant licenses in respect of, mortgage, or otherwise dispose of letters patent of the United States or any foreign country, patent rights, licenses and privileges, inventions, improvements and processes, copyrights, trademarks and trade names, relating to or useful in connection with any business of this corporation.
To guarantee, purchase, hold, sell, assign, transfer, mortgage, pledge or otherwise dispose of the shares of the capital stock of or any bonds, securities or evidences of the indebtedness created by any other corporation or corporations of this state, or any other state or government, and, while owner of such stock, bonds, securities or evidence of indebtedness, to exercise all the rights, powers and privileges of ownership, including the right to vote, if any.
To borrow money and contract debts when necessary for the transaction of its business, or for the exercise of its corporate rights, privileges or franchises, or for any other lawful purpose of its incorporation; to issue bonds, promissory notes, bills of exchange, debentures, and other obligations and evidences of indebtedness, payable at specified time or times, or payable upon the happening of a specified event or events, whether secured by mortgage, pledge or otherwise, or unsecured, for money borrowed, or in payment for property purchased, or acquired, or for any other lawful objects.
To purchase, hold, sell and transfer shares of its own capital stock, and use therefor its capital, capital surplus, surplus, or other property or funds; provided it shall not use its funds or property for the purchase of its own shares of capital stock when such use would cause any impairment of its capital; and provided further, that shares of its own capital stock belonging to it shall not be voted upon, directly or indirectly, nor counted as outstanding, for the purpose of computing any stockholders' quorum or vote.
To conduct business, have one or more offices, and hold, purchase, mortgage and convey real and personal property in this state, and in any of the several states, territories, possessions and dependencies of the United States, the District of Columbia, and in any foreign countries.
To do all and everything necessary and proper for the accomplishment of the objects hereinbefore enumerated or necessary or incidental to the protection and benefit of the corporation, and, in general, to carry on any lawful business necessary or incidental to the attainment of the objects of the corporation, whether or not such business is similar in nature to the objects hereinbefore set forth.
The objects and purposes specified in the foregoing clauses will, except where otherwise expressed, be in nowise limited or restricted by reference to, or inference from, the terms of any other clause in these articles of incorporation, but the objects and purposes specified in each of the foregoing clauses of this article shall be regarded as independent objects and purposes.
ARTICLE 4. SHARES
4.1 Authorized Capital
The corporation is authorized to issue two classes of stock to be designated, respectively, "Common Stock" and "Preferred Stock." The total number of shares of stock which the corporation shall have authority to issue shall be 100,000,000, consisting of 75,000,000 shares of Common Stock with a par value of $.01 per share, and 25,000,000 shares of Preferred Stock with a par value of $.01 per share.
4.2 Common Stock
Subject to any preferential or other rights granted to any series of Preferred Stock, the holders of shares of the Common Stock shall be entitled to receive dividends out of funds of the corporation legally available therefor, at the rate and at the time or times as may be provided by the Board of Directors and shall be entitled to receive distributions legally payable to stockholders on the liquidation of the corporation. The holders of shares of Common Stock, on the basis of one vote per share, shall have the right to vote for the election of members of the Board of Directors of the corporation and the right to vote on all other matters, except where a separate class or series of the corporation's stockholders vote by class or series. Holders of Common Stock shall not be entitled to cumulate their votes for the election of directors.
4.3 Preferred Stock
Shares of Preferred Stock may be issued from time to time in one or more series, in any manner permitted by law, as determined from time to time by the Board of Directors and stated in the resolution or resolutions providing the issuance thereof, prior to the issuance of any shares thereof. The Board of Directors shall have the authority to fix and determine the rights and preferences of the shares of any series so established.
4.3.1 Designation and Number of Shares
4.3.1.1 Designation
The initial series of Preferred Stock shall be designated "Series A Convertible Preferred Stock." The term "Series A Stock" as used herein refers to the Series A Convertible Preferred Stock.
4.3.1.2 Number of Shares
The number of shares constituting the Series A Stock shall be 9,750,000 shares.
4.3.2 Dividends and Distributions; Liquidation Rights
4.3.2.1 Dividends
The holders of shares of Series A Stock shall be entitled to receive dividends, when, as and if declared by the Board of Directors of the Corporation, out of any assets legally available therefor prior and in preference to any declaration or payment of any dividend on the Common Stock and no such dividend or distribution may be declared or paid on the Common Stock unless at the same time an equivalent dividend or distribution is declared or paid on all outstanding shares of Series A Stock. The dividend or distribution on shares of Series A Stock shall be payable based upon the number of shares of Common Stock which the holder of shares of Series A Stock would have held if such holder had converted such shares of Series A Stock into Common Stock immediately prior to the record date of such dividend or distribution.
4.3.2.2 Liquidation Preference
In the event of any liquidation, dissolution or winding up of the Corporation, either voluntary or involuntary, the holders of the Series A Stock shall be entitled to receive, prior and in preference to any distribution of any of the assets of the Corporation to the holders of the Common Stock, an amount per share appropriately adjusted for any stock dividend, split, combination or similar recapitalization of such gives Series A Stock equal to $2.00, plus a further amount equal to any declared but unpaid dividends thereon before any payment shall be made or any assets distributed to the holders of Common Stock. If upon such liquidation, dissolution or winding up of the Corporation, the assets thus distributed among the holders of the Series A Stock shall be insufficient to permit the payment in full of the aforesaid preferential amounts, the entire assets of the Corporation to be distributed shall be distributed among the holders of the Series A Stock so that the holder of each share of Series A Stock shall receive the same percentage of the stated liquidation preferences of such share as is received by every other holder of Series A Stock.
Following the completion of the distribution of the stated liquidation preferences to be paid to the holders of the Series A Stock, any remaining assets shall be distributed to the holders of the Common Stock of the Corporation; provided, however, if no shares of Common Stock are outstanding at the time of such distribution, the holders of the Series A Stock shall be entitled to receive, ratably (assuming conversion of all shares of Series A Stock to Common Stock), all assets of the Corporation remaining after the payment of the stated liquidation preferences of the Series A Stock as set forth herein.
A consolidation or merger of the Corporation with or into another corporation or other entity or person or any other corporate reorganization or other transaction or series of related transactions by the Corporation, in any such case, in which more than 50 percent of
the voting power of the Corporation is transferred or a sale, conveyance, or disposition of all or substantially all of the assets of the Corporation, shall be deemed to be a liquidation, dissolution or winding up within the meaning of this Section 4.3.2.2.
Whenever a distribution of assets provided for in this Section 4.3.2.2 shall be payable in property other than cash, the value of such distribution shall be the fair market value of such property as determined in good faith by the Board of Directors of the Corporation.
4.3.3 Conversion
4.3.3.1 Conversion Rights
A holder of shares of Series A Stock shall be entitled, at any time, to cause any or all of such shares to be converted into shares of Common Stock.
4.3.3.1.1 Conversion Rate
The conversion rate for Series A Stock in effect at any time (the "Conversion Rate") shall equal $1.92 divided by the Conversion Price, calculated as provided in Section 4.3.3.1.2.
4.3.3.1.2 Conversion Price
The conversion price for the Series A Stock in effect from time to time, except as adjusted in accordance with Section 4.3.3.2.2, shall be $1.92 (the "Conversion Price").
4.3.3.2 Conversion Procedure; Anti-Dilution Adjustments
4.3.3.2.1 Conversion Procedure
Before a holder of the Series A Stock shall be entitled to convert the same into shares of Common Stock, such holder shall surrender the certificate or certificates therefor, duly endorsed in blank or accompanied by proper instruments of transfer, at the office of the Corporation or of any transfer agent for the shares of the Series A Stock, and shall give written notice to the Corporation at such office that such holder elects to convert the same and shall state in writing therein the name or names in which such holder wishes the certificate or certificates for shares of Common Stock to be issued. The Corporation shall, as soon as practicable thereafter, issue and deliver at the address of the holder of the Series A Stock, or to the holder's nominee or nominees, certificates for the number of full shares of Common Stock to which the holder shall be entitled. Such conversion shall be deemed to have been made as of the date of such surrender of the shares of the Series A Stock to be converted, and the person or persons entitled to receive the shares of Common
Stock issuable upon such conversion shall be treated for all purposes as the record holder or holders of such shares of Common Stock on said date.
4.3.3.2.2 Adjustments to Applicable Conversion Price
(a) Extraordinary Common Stock Event. Upon the happening of an Extraordinary Common Stock Event (as defined below) after the date of the initial issuance of any shares of Series A Stock, the Conversion Price shall, simultaneously with the happening of such Extraordinary Common Stock Event, be adjusted by multiplying the then effective Conversion Price, by a fraction, the numerator of which shall be the number of shares of Common Stock outstanding immediately prior to such Extraordinary Common Stock Event and the denominator of which shall be the number of shares of Common Stock outstanding immediately after such Extraordinary Common Stock Event (with the number of shares issuable with respect to Common Stock Equivalents (as defined below) determined in the manner provided for deemed issuances in Section 4.3.3.2.2(b)(v)), and the product so obtained shall thereafter be the Conversion Price. The Conversion Price, as so adjusted, shall be readjusted in the same manner upon the happening of any successive Extraordinary Common Stock Event or Events.
"Extraordinary Common Stock Event" shall mean (i) the issuance of additional shares of Common Stock, as a dividend or other distribution on outstanding Common Stock of the Corporation, or other securities or rights convertible into, or entitling the holder thereof to receive directly or indirectly, additional shares of Common Stock ("Common Stock Equivalents"), (ii) a split or subdivision of outstanding shares of Common Stock into a greater number of shares of Common Stock, or (iii) a combination of outstanding shares of Common Stock into a smaller number of shares of Common Stock.
(b) Sale of Shares Below Applicable Conversion Price.
(i) If the Corporation shall issue any Additional Stock (as defined below) without consideration or for a consideration per share less than the Conversion Price in effect immediately prior to the issuance of such Additional Stock, the Conversion Price in effect immediately prior to issuance of such Additional Stock (except as otherwise provided in this Section 4.3.3.2.2(b)) shall be adjusted down to a price equal to the quotient obtained by dividing the total computed under clause (A) below by the total computed under clause (B) below as follows:
(A) an amount equal to the sum of (1) the result obtained by multiplying the number of shares of Common Stock deemed outstanding immediately prior to such issuance (which shall include the actual number of shares outstanding plus all shares issuable upon the conversion or exercise of all outstanding convertible securities, warrants and options other than shares excluded
from the definition of Additional Stock by Section 4.3.3.2.2(c)) by the Conversion Price then in effect, and (2) the aggregate consideration, if any, received by the Corporation upon the issuance of such Additional Stock;
(B) the number of shares of Common Stock of the Corporation outstanding immediately after such issuance (including the shares deemed outstanding as provided in clause (A) above).
(ii) No adjustment of the Conversion Price shall be made in an amount less than one cent per share, provided, that any adjustments which are not required to be made by reason of this sentence shall be carried forward and shall be taken into account in any subsequent adjustment made to the Conversion Price. Except as provided in Sections 4.3.3.2.2(b)(v)(C) and (D) below, no adjustment of the Conversion Price shall have the effect of increasing the Conversion Price above the Conversion Price in effect immediately prior to such adjustment.
(iii) In the case of the issuance of Common Stock for cash, the consideration shall be deemed to be the net amount of cash received by the Corporation after deducting any discounts, commissions or other expenses allowed, paid or incurred by the corporation for any underwriting or placement in connection with the issuance and sale thereof.
(iv) In the case of the issuance of Common Stock for a consideration in whole or in part other than cash, the consideration other than cash shall be deemed to be the fair value thereof as determined in good faith by the Board of Directors irrespective of any accounting treatment.
(v) In the case of the issuance of options or warrants to purchase or rights to subscribe for Common Stock, securities by their terms convertible into or exchangeable for Common Stock, or options or warrants to purchase or rights to subscribe for such convertible or exchangeable securities, the following provisions shall apply:
(A) the aggregate maximum number of shares of Common Stock deliverable upon exercise of such options or warrants to purchase or rights to subscribe for Common Stock shall be deemed to have been issued at the time such options, warrants, or rights were issued for a consideration equal to the consideration (determined in the manner provided in Sections 4.3.3.2.2(b)(iii) and (iv) above), if any, received by the Corporation upon the issuance of such options, warrants or rights plus the minimum purchase price provided in such options, warrants or rights for the Common Stock covered thereby, but no further adjustment to the Conversion Price shall be made for the actual issuance of Common Stock upon the exercise of such options, warrants or rights in accordance with their terms;
(B) the aggregate maximum number of shares of Common Stock deliverable upon conversion of or in exchange for any such convertible or exchangeable securities or upon the exercise of options or warrants to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversion or exchange thereof shall be deemed to have been issued at the time such securities were issued or such options, warrants or rights were issued for a consideration equal to the consideration received, if any, by the Corporation for any such securities and any related options, warrants or rights, plus the minimum additional consideration, if any, to be received by the Corporation upon the conversion or exchange of such securities or the exercise of any related options, warrants or rights (the consideration in each case to be determined in the manner provided in Sections 4.3.3.2.2(b)(iii) and (iv) above), but no further adjustment to the Conversion Price shall be made for the actual issuance of Common Stock upon the conversion or exchange of such securities in accordance with their terms;
(C) if such options, warrants, rights or convertible or exchangeable securities by their terms provide, with the passage of time or otherwise, for any change in the consideration payable to the Corporation or in the number of shares of Common Stock issuable upon the exercise, conversion or exchange thereof, including, without limitation, a change resulting from the antidilution provisions thereof, the Conversion Price computed upon the original issue thereof, and any subsequent adjustments based thereon, shall, upon such change becoming effective, be recomputed to reflect such change, but no further adjustment to the Conversion Price shall be made for the actual issuance of Common Stock upon the exercise of any such options, warrants or rights or the conversion or exchange of such securities in accordance with their terms; and
(D) upon the expiration of any such options, warrants or rights, the termination of any such rights to convert or exchange or the expiration of any options, warrants or rights related to such convertible or exchangeable securities, the Conversion Price shall forthwith be readjusted to such Conversion Price as would have been obtained had the adjustment which was made upon the issuance of such options, warrants, rights or securities or options, warrants or rights related to such securities been made upon the basis of the issuance of only the number of shares of Common Stock (and convertible or exchangeable securities which remain in effect) actually issued upon the exercise of such options, warrants or rights, upon the conversion or exchange of such securities or upon the exercise of the options, warrants or rights related to such securities.
(c) "Additional Stock" shall mean any shares of Common Stock or securities convertible into or exchangeable or exercisable for shares of Common Stock issued (or deemed to have been issued pursuant to Section 4.3.3.2.2(b)(v) above) by the Corporation after the date of initial issuance of any Series A Stock other than:
(i) Common Stock issued in connection with an Extraordinary Common Stock Event; and
(ii) Common Stock issued or issuable upon conversion of Series A Stock.
4.3.3.2.3 Adjustment for Reclassification, Exchange or Substitution
If the Common Stock issuable upon the conversion of the Series A Stock shall be changed into the same or different number of shares of any class or classes of stock, by capital reorganization, involving exchange, substitution, reclassification or otherwise (other than a subdivision or combination of shares or stock dividend provided for above, or a reorganization, merger, consolidation or sale of assets provided for below), then the holders of the shares of Series A Stock shall have the right thereafter to convert each such share into the same kind and amount of shares of stock and other securities and property receivable upon such exchange, reclassification or other change, as a holder of the number of shares of Common Stock into which such shares of Series A Stock might have been converted immediately prior to such substitution, reclassification or other change, all subject to further adjustment as provided herein.
4.3.3.2.4 Reorganization, Merger, Consolidation or Sale of Assets
If at any time there shall be a capital reorganization of the Common Stock (other than a subdivision, combination, reclassification or exchange of shares provided for elsewhere in this Section 4.3.3.2) or a merger or consolidation of the Corporation with or into another corporation, or the sale of all or substantially all of the Corporation's properties and assets to any other person, then, as a part of such reorganization, merger, consolidation or sale, provision shall be made so that the holders of the Series A Stock shall thereafter be entitled to receive upon conversion of such Series A Stock, the number of shares of stock or other securities or property of the Corporation, or of the successor corporation resulting from such reorganization, merger, consolidation or sale, to which a holder of Common Stock deliverable upon conversion would have been entitled upon such capital reorganization, merger, consolidation or sale, all subject to adjustment as provided herein.
4.3.3.2.5 Certificate of Adjustment
Upon the occurrence of each adjustment or readjustment of the Conversion Rate of the Series A Stock pursuant to this Section 4.3.3.2, the Corporation shall promptly compute such adjustment or readjustment in accordance with the terms hereof and prepare and furnish to the holders of the Series A Stock, as applicable, a certificate, signed by the
Chairman of the Board, the President or the Chief Financial Officer, setting forth such adjustment or readjustment and showing in detail the facts upon which such adjustment or readjustment is based. If there has been an adjustment, the Corporation shall, upon the written request at any time of any holder of Series A Stock, furnish or cause to be furnished to such holder a certificate setting forth: (A) such adjustments and readjustments; (B) the Conversion Price at the time in effect; and (C) the number of shares of Common Stock and the amount, if any, of other property which at the time would be received upon the conversion of a share of Series A Stock.
4.3.3.2.6 Fractional Shares
The Corporation shall not be obligated to deliver to holders of Series A Stock any fractional share or shares of Common Stock issuable upon conversion of such shares of Series A Stock, and the number of shares of Common Stock to be issued shall be rounded up or down, as the case may be, to the nearest whole share, determined on the basis of the total number of shares of Series A Stock the holder is at the time converting into Common Stock and the number of shares of Common Stock issuable upon such aggregate conversion.
4.3.3.2.7 Reservation of Stock Issuable Upon Conversion
The Corporation shall at all times reserve and keep available, out of its authorized but unissued Common Stock, solely for the purpose of effecting the conversion of the Series A Stock, the full number of shares of Common Stock deliverable upon the conversion of all shares of the Series A Stock from time to time outstanding. The Corporation shall from time to time, in accordance with the laws of the State of Nevada, use its best efforts to increase the authorized amount of its Common Stock if at any time the authorized number of shares of Common Stock remaining unissued shall not be sufficient to permit the conversion of all of the shares of the Series A Stock at the time outstanding.
4.3.3.2.8 No Impairment
The Corporation will not, by any voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Corporation, but will at all time in good faith assist in the carrying out of all the provisions of this Section 4.3.3.2 and in the taking of all such actions as may be necessary or appropriate in order to protect the conversion rights of the holders of Series A Stock against impairment.
4.3.3.2.9 Issue Taxes
The Corporation shall pay any and all issue and other taxes attributable to the issuance or delivery of shares of Common Stock upon conversion of shares of Series A
Stock; provided that the Corporation shall not be required to pay any taxes which may be payable in respect of any transfer involved in the issuance or delivery of any certificate for such shares in a name other than that of the holder of the shares of Series A Stock in respect of which shares are being issued.
4.3.4 Voting Rights
4.3.4.1 Voting Rights of Series A Stock
4.3.4.1.1 Voting with Common Stock
The holders of Series A Stock shall be entitled to vote on all matters submitted to a vote of the holders of Common Stock of the corporation, voting together with the holders of Common Stock as one class except as otherwise provided in this Section 4.3.4. Each share of the Series A Stock shall be entitled to the number of votes equal to the number of shares of Common Stock into which such share of Series A Stock could be converted on the record date for determining the shareholders entitled to vote with any fractional share determined on an aggregate conversion basis rounded up or down, as the case may be, to the nearest whole share. The holders of Series A Stock shall be entitled to the notice of any shareholders' meeting in accordance with the bylaws of the Corporation.
4.3.4.1.2 Voting as a Separate Voting Group
The holders of Series A Stock shall be entitled to vote as a separate voting group with respect to (i) any of the transactions listed in Section 4.3.4.2 hereto, (ii) the creation of any senior or pari passu security, (iii) any transaction constituting a deemed dividend under federal tax law or (iv) as otherwise provided by law.
4.3.4.2 Protective Provisions of Series A Stock
So long as 400,000 shares or more of the Series A Stock are outstanding , the Corporation shall not, without the vote or written consent, of the holders of a majority of the Series A Stock, do any of the following:
(a) authorize or issue any shares of stock with rights, including liquidation preferences, superior to the Common Stock;
(b) effect any sale, lease, assignment, transfer, or other conveyance of all or substantially all of the assets of the Corporation or the sale, transfer or license of intellectual property other than in the ordinary course of business;
(c) effect any consolidation or merger involving the Corporation;
(d) effect any voluntary dissolution, liquidation, recapitalization, reclassification or reorganization of the Corporation;
(e) repurchase or redeem any equity securities, or pay any dividends or other distributions on equity securities;
(f) engage in any business other than the business currently conducted;
(g) authorize or issue warrants, options or rights to purchase additional equity;
(h) authorize or issue any equity securities to employees, consultants or directors;
(i) amend the Articles of Incorporation or Bylaws;
(j) acquire the assets, business or control of any other corporations or business entity, through merger, consolidation or otherwise or make any other form of investment in any corporation or business entity where the cost to the Corporation would exceed $100,000, whether effected in a single transaction or in a series of related transactions, other than assets acquired in the ordinary course of business;
(k) incur any indebtedness for borrowed money or enter into any capital lease obligations which aggregate in excess of $25,000.
4.3.4.3 Status of Converted Stock
In case any shares of Series A Stock shall be converted pursuant to
Section 4.3.3.2 hereof, the shares so converted shall assume the status of
authorized but undesignated and unissued shares of Series A Stock.
4.3.4.4 Notices
Any notice required herein except as otherwise specifically provided herein, to be given to a holder of the Series A Stock shall be in writing and may be delivered by personal service, sent by overnight professional courier service, sent by telegraph or cable or sent by United States registered or certified mail, return receipt requested, with postage thereon fully prepaid. All such communications shall be addressed to such holder of record at its address appearing on the books of the Corporation. If sent by telegraph or cable, a confirmed copy of such telegraphic or cabled notice shall promptly be sent by mail (in the manner provided above) to the holders. Service of any such communication made only by mail shall be deemed complete on the date of actual delivery as shown by
the addressee's registry or certification receipt or at the expiration of the third business day after the date of mailing, whichever is earlier in time.
4.3.4.5 Severability
If any right, preference or limitation of the Series A Stock as set forth herein (as so amended) is invalid, unlawful or incapable of being enforced by reason of any rule or law or public policy, all other rights, preferences and limitation set forth herein (as so amended) which can be given effect without the invalid, unlawful or unenforceable right, preference or limitation shall, nevertheless, remain in full force and effect, and no right, preference or limitation herein set forth shall be deemed dependent upon any other such right, preference or limitation unless so expressed herein.
4.4 No Preemptive Rights
Stockholders of the corporation do not have preemptive rights.
ARTICLE 5. BOARD OF DIRECTORS
The governing board of the corporation will be known as directors, and the number of directors may from time to time be increased or decreased in such manner as shall be provided by the bylaws of the corporation, provided that the number of directors will not be reduced to less than three (3), except that in cases where all the shares of the corporation are owned beneficially and of record by either one or two stockholders, the number of directors may be less than three (3) but not less than the number of stockholders.
ARTICLE 6. STOCKHOLDER LIABILITY
The capital stock, after the amount of the subscription price or par value has been paid in, will not be subject to assessment to pay the debts of the corporation.
ARTICLE 7. INCORPORATORS
(Omitted pursuant to NRS 78.403).
ARTICLE 8. DURATION
The corporation is to have perpetual existence.
ARTICLE 9. AUTHORITY OF THE BOARD OF DIRECTORS
In furtherance, and not in limitation of the powers conferred by statute, the board of directors is expressly authorized:
Subject to the bylaws, if any adopted by the stockholders, to make, alter, or amend the bylaws of the corporation.
To fix the amount to be reserved as working capital over and above its capital stock paid in, to authorize and cause to be executed mortgages and liens upon the real and personal property of the corporation.
By resolution passed by a majority of the whole board, to designate one
(1) or more committees, each committee to consist of one (1) or more of the
directors of the corporation, which, to the extent provided in the resolution or
in the bylaws of the corporation, will have and may exercise the powers of the
board of directors in the management of the business and affairs of the
corporation, and may authorized the seal of the corporation to be affixed to all
papers that may require it. Such committee or committees will have such name or
names as may be stated in the bylaws of the corporation or as may be determined
from time to time by resolution adopted by the board of directors.
When and as authorized by the affirmative vote of stockholders holding stock entitling them to exercise at least a majority of the voting power given at a stockholders' meeting called for that purpose, or when authorized by the written consent of the holders of at least a majority of the voting stock issued and outstanding, the board of directors will have power and authority at any meeting to sell, lease, or exchange all of the property and assets of the corporation, including its good will and its corporate franchises, upon such terms and conditions as its board of directors deem expedient and for the best interests of the corporation.
ARTICLE 10. LOCATION OF MEETINGS AND BOOKS
Meetings of the stockholders may be held outside the State of Nevada, if the bylaws so provide. The books of the corporation may be kept (subject to any provision contained in the statutes) outside the State of Nevada at such place or places as may be designated from time to time by the board of directors or in the bylaws of the corporation.
ARTICLE 11. AMENDMENTS
The corporation reserves the right to amend, alter, change, or repeal any provision contained in these articles of incorporation, in the manner now or hereafter prescribed by statute, or by these articles of incorporation, and all rights conferred upon stockholders herein are granted subject to this reservation.
ARTICLE 12. INDEMNIFICATION
The Bylaws of the corporation shall provide for the indemnification of the corporation's directors, officers, employees and agents for expenses incurred in connection
with the defense of actions, suits or proceedings to the fullest extent permitted by Nevada law.
ARTICLE 13. LIMITATION OF DIRECTOR AND OFFICER LIABILITY
No director or officer of the corporation shall be liable to the corporation or to the stockholders for damages for any breach of fiduciary duty; provided, however, that a director or officer shall be liable for damages which result from any of the following:
(a) Acts or omissions which involve intentional misconduct, fraud or a knowing violation of law;
(b) The willful or grossly negligent payment of any improper dividend or distribution; or
(c) Acts or omissions which occurred prior to March 18, 1987.
The amendments included in these Amended and Restated Articles of Incorporation were adopted by the Board of Directors on January 11, 2001 and by the stockholders at a meeting on March 8, 2001, adjourned to March 16, 2001, by the following vote: out of the 9,596,558 shares of common stock and 7,492,135 shares of preferred stock outstanding, 6,228,445 shares of common stock and 7,492,135 shares of preferred stock voted for the amendment, and 229,736 shares of common stock and no shares of preferred stock voted against the amendment.
The Board of Directors authorized its President and Secretary to execute these Amended and Restated Articles of Incorporation by resolutions adopted by the Board of Directors on January 11, 2001, and these Amended and Restated Articles of Incorporation correctly set forth the text of the Articles of Incorporation as amended to the date hereof.
[Signature pages follow]
IN WITNESS WHEREOF, A-Fem Medical Corporation has caused these Amended and Restated Articles of Incorporation to be signed by its President and Secretary this 13th day of April 2001.
A-FEM MEDICAL CORPORATION
By /s/ Steven T. Frankel -------------------------------------- Steven T. Frankel, President |
By -------------------------------------- William H. Fleming, Secretary STATE OF CALIFORNIA ) ) ss: COUNTY OF SAN DIEGO ) |
The foregoing instrument was acknowledged before me, a Notary Public, on this 13th day of April 2001, by Steven T. Frankel of A-Fem Medical Corporation.
/s/ L. A. Carrillo ----------------------------------------- Notary Public My commission expires April 11, 2002 ------------------- |
[Notary Stamp or Seal]
/stamp/
/seal/
IN WITNESS WHEREOF, A-Fem Medical Corporation has caused these Amended and Restated Articles of Incorporation to be signed by its President and Secretary this 13th day of April 2001.
A-FEM MEDICAL CORPORATION
By /s/ William H. Fleming -------------------------------------- William H. Fleming, Secretary |
STATE OF OREGON ) ) ss: COUNTY OF WASHINGTON ) |
The foregoing instrument was acknowledged before me, a Notary Public, on this 13th day of April 2001, by William H. Fleming of A-Fem Medical Corporation.
/s/ Amy L. Davenport ----------------------------------------- Notary Public for My commission expires October 4, 2004 ------------------- |
[Notary Stamp or Seal]
/stamp/
Exhibit 23.1
CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS
As independent public accountants, we hereby consent to the incorporation by reference of our report dated April 6, 2001, included in this Form 10-KSB, into the Company's previously filed Registration Statement No. 333-36664 on Form S-8.
/s/ Arthur Andersen LLP ARTHUR ANDERSEN LLP Portland, Oregon April 16, 2001 |