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As filed with the Securities and Exchange Commission on November 9, 1999
Registration No. 333-________
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM S-3 REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ACCUMED INTERNATIONAL, INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 36-4054899
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification no.)
920 N. FRANKLIN STREET, SUITE 402
CHICAGO, ILLINOIS 60610
(312) 642-9200
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(Address, including zip code, and telephone number,
including area code, of registrant's
principal executive offices)
PAUL F. LAVALLEE
Chief Executive Officer
AccuMed International, Inc.
920 N. Franklin Street, Suite 402
Chicago, Illinois 60610
(312) 642-9200
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(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER,
INCLUDING AREA CODE, OF AGENT FOR SERVICE)
Copy to:
JOYCE L. WALLACH, ESQ.
AccuMed International, Inc.
920 N. Franklin Street, Suite 402
Chicago, Illinois 60610
(312) 642-9200
Telecopy (312) 642-2985
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Approximate date of commencement of proposed sale to the public: from
time to time after the effective date of this Registration Statement.
If only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. [ ]
If any of the securities being registered on this Form are to be offered
on a delayed or continuous basis pursuant to Rule 415 under the Securities Act
of 1933, check the following box. [x]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule
434, please check the following box. [ ]
The Registrant hereby amends this Registration Statement on such date or
dates as may be necessary to delay its effective date until the Registrant shall
file a further amendment which specifically states that the Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until the Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
CALCULATION OF REGISTRATION FEE
PROPOSED PROPOSED
MAXIMUM MAXIMUM
TITLE OF AGGREGATE AGGREGATE
SECURITIES TO BE AMOUNT TO BE PRICE OFFERING REGISTRATION
REGISTERED REGISTERED PER SHARE(1) PRICE FEE
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Common Stock
Underlying
Convertible Note 250,000 shares $1.75 $437,500 $122
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TOTAL 250,000 shares $1.75 $437,500 $122
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(1) Estimated solely for the purpose of calculating the amount of the
registration fee in accordance
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with Rule 457(c) under the Securities Act of 1933, as amended, based on
$1.75 per share, the average of the high and low sales prices reported
for the Common Stock on November 4, 1999.
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PROSPECTUS
250,000 SHARES
ACCUMED INTERNATIONAL, INC.
COMMON STOCK
This Prospectus relates to 250,000 shares (the "Shares") of Common
Stock, par value $0.01 per share (the "Common Stock"), of AccuMed International,
Inc., a Delaware corporation (the "Company" or "AccuMed") all of which are
underlying a Floating Rate Convertible Note (the "Convertible Note"). The
Company will not receive any of the proceeds from any sales of the Shares. If
the holder fully converts the Convertible Note into the Shares, the Company will
be relieved of the obligations to repay to the holder the CND$500,000 principal
amount of the Convertible Note. The Registration Statement of which this
Prospectus forms a part has been filed pursuant to the terms of the Convertible
Note made by the Company in favor of the holder (the "Selling Securityholder.")
See "Selling Securityholder."
The Common Stock is quoted on the National Association of Securities
Dealers Automated Quotation System ("Nasdaq") SmallCap Market under the trading
symbol "ACMI." The Selling Securityholder may, from time to time, sell the
Shares at market prices prevailing on Nasdaq at the time of the sale or at
negotiated prices (this "Offering") under the terms described under the caption
"Plan of Distribution." See "Risk Factors," "Selling Securityholder" and "Plan
of Distribution."
The last reported sale price for the Common Stock on November 4, 1999,
as reported on the Nasdaq SmallCap Market, was $1.75 per share.
THE SECURITIES OFFERED HEREBY INVOLVE A HIGH DEGREE OF RISK AND SHOULD
BE CONSIDERED ONLY BY PERSONS WHO CAN AFFORD THE LOSS OF THEIR ENTIRE
INVESTMENT. SEE "RISK FACTORS" BEGINNING AT PAGE 13.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
AND EXCHANGE COMMISSION NOR HAS THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION PASSED UPON THE ACCURACY OR
ADEQUACY OF THIS PROSPECTUS. ANY
REPRESENTATION TO THE CONTRARY
IS A CRIMINAL OFFENSE.
No underwriting commissions or discounts will be paid by the Company in
connection with this Offering. Estimated expenses payable by the Company in
connection with this Offering are approximately $18,000.
This date of this Prospectus is _____________________, 1999.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements contained in this Prospectus constitute
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 (the "Reform Act"). Such forward-looking
statements involve known and unknown risks, uncertainties and other factors
which may cause the actual results, performance or achievements of the Company,
or industry results, to be materially different from any future results,
performance or achievements expressed or implied by such forward-looking
statements. Such factors include, among other things, the following: the
Company's history of losses and uncertainty of profitability; the uncertainty of
market acceptance of the Company's products; the Company's limited sales,
marketing and distribution experience and dependence on distributors; the
Company's highly competitive industry and rapid technological change within such
industry; the Company's ability to obtain rights to technology and obtain and
enforce patents and other proprietary rights; the Company's ability to
commercialize and manufacture products; the results of clinical studies; the
results of the Company's research and development activities; the business
abilities and judgment of the Company's personnel; the availability of qualified
personnel; changes in, or failure to comply with, governmental regulations; the
ability to obtain adequate financing in the future; general and business
conditions; and other factors referenced in this Prospectus. See "Risk Factors."
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and in
accordance therewith files reports, proxy statements and other information with
the Securities and Exchange Commission (the "Commission"). Such reports, proxy
statements and other information filed by the Company may be inspected and
copied at the public reference facilities maintained by the Commission at 450
Fifth Street, N.W., Room 1024, Washington, D.C. 20549, and at the following
regional offices: New York Regional Office, 7 World Trade Center, Room 1400, New
York, New York 10048 and Chicago Regional Office, 500 West Madison Street, Suite
1400, Chicago, Illinois 60661. Copies of such material may also be obtained from
the Public Reference Section of the Commission at 450 Fifth Street, N.W.,
Washington, D.C. 20549, at prescribed rates. The Commission maintains a Web site
that contains reports, proxy and information statements and other information
regarding issuers that file electronically with the Commission, including the
Company, at http://www.sec.gov. The Common Stock is quoted on the Nasdaq
SmallCap Market and reports and other information regarding the Company may be
inspected at the National Association of Securities Dealers, Inc. at 1735 K
Street, N.W., Washington, D.C. 20006.
ADDITIONAL INFORMATION
Additional information regarding the Company and the securities offered
hereby is contained in Registration Statement on Form S-3 (Registration No.
333-_______) of which this Prospectus forms a part, and the exhibits thereto
filed with the Commission under the Securities Act of 1933, as amended (the
"Securities Act"). For further information pertaining to the Company and the
securities offered hereby, reference is made to the Registration Statement and
the exhibits thereto, which may be inspected without charge at, and copies of
which may be obtained at prescribed rates from, the office of the
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Commission at 450 Fifth Street, N.W., Washington, D.C. 20549.
The Company furnishes stockholders with annual reports containing audited
financial statements and other periodic reports as the Company may deem to be
appropriate or as required by law or the rules of the National Association of
Securities Dealers, Inc.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents which have heretofore been filed by the Company
with the Commission pursuant to the Exchange Act are incorporated by reference
herein and shall be deemed to be a part hereof:
(1) The Company's Annual Report on Form 10-K for the year ended December 31,
1998.
(2) The Company's Quarterly Report on Form 10-Q for the quarter ended March
31, 1999.
(3) The Company's Quarterly Report on Form 10-Q for the quarter ended June
30, 1999.
(4) The description of the Common Stock contained in the Company's Amendment
No. 1 to Registration Statement on Form 8-A/A filed with the Commission
on January 2, 1996.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14
or 15(d) of the Exchange Act after the date of this Prospectus and prior to the
termination of this Offering shall be deemed to be incorporated by reference in
this Prospectus and to be a part hereof from the date of filing of such
documents. Any statement incorporated by reference herein shall be deemed to be
modified or superseded for purposes of this Prospectus to the extent that a
statement contained herein or in any other subsequently filed document which
also is or is deemed to be incorporated by reference herein modifies or
supersedes such statement. Any statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part of this
Prospectus.
The Company will provide without charge to each person to whom this
Prospectus is delivered, upon written or oral request, a copy of any or all of
the documents incorporated by reference in this Prospectus (not including
exhibits and other information that is incorporated by reference unless the
exhibits are themselves specifically incorporated by reference). Requests for
such documents should be directed to AccuMed International, Inc., located at 920
North Franklin Street, Suite 402, Chicago, Illinois 60610, Attn: Chief Financial
Officer, telephone (312) 642-9200.
The following are trade names and common law trademarks or registered
trademarks of the Company: the "ACCUMED" logo and name, "ACCELL," "TRACCELL,"
"ACCUTECH, "ACCELL-SAVANT," "ONCOMETRICS," "SPECIFIND," "MACCELL,"
"MACROVISION," "RELATIONAL CYTOPATHOLOGY REVIEW GUIDE," "IMPROVING CYTOLOGY
PROCESSES," and "AND YOU THOUGHT YOU'D SEEN IT ALL."
The Company's address is 920 North Franklin Street, Suite 402, Chicago,
Illinois 60610, and its
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telephone number is (312) 642-9200.
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PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the more detailed
information appearing elsewhere in this Prospectus, including information under
"Risk Factors," and the financial statements incorporated be reference herein.
Special Note: Certain statements set forth below constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995. See "Special Note Regarding Forward-Looking Statements" on page 2 for
additional factors relating to such statements.
THE COMPANY
BACKGROUND
AccuMed International, Inc. was incorporated in California in June 1988
under the name Alamar Biosciences, Inc. Prior to December 29, 1995, the Company
was engaged in developing, manufacturing and marketing microbiology products,
including alamarBlue(TM) and certain diagnostic test kits under the name Alamar.
AccuMed, Inc., an Illinois corporation, was formed in February 1994 and was
engaged in researching and developing cytopathology products. Effective January
1995, AccuMed, Inc. acquired the Sensititre microbiology business by purchasing
certain assets of a division of Radiometer America, Inc. and purchasing from
Radiometer (UK) Limited all of the shares of Sensititre Limited, an English
registry company (renamed AccuMed International Limited, "AccuMed UK," and
collectively, such businesses are referred to as "AccuMed, Inc."). On December
29, 1995, AccuMed, Inc. merged with and into the Company (the "Alamar Merger").
The Company then changed its name to AccuMed International, Inc., reincorporated
under Delaware law and changed its fiscal year end from September 30 to December
31.
On October 15, 1996, the Company acquired a two-thirds interest in
Oncometrics Imaging Corp., a company continuing under the laws of the Yukon
Territory, Canada ("Oncometrics"). Oncometrics was formed in 1995 as a
wholly-owned subsidiary of the Selling Securityholder, Xillix Technologies
Corp., to complete the development of an automated instrument designed to be
used in the detection, diagnosis and prognosis of early-stage cancer by
measuring the DNA in cells on microscope slides. See "Certain Relationships and
Transactions."
On October 15, 1996, the Company acquired all the outstanding shares of
common stock (the "RADCO Stock") not already owned by the Company of RADCO
Ventures, Inc., a Delaware corporation ("RADCO"), at which time RADCO became a
wholly-owned subsidiary of the Company. RADCO was formed in March 1996, for the
purpose of developing a diagnostic microbiology test panel and automated reading
instrument known as FluoreTone(TM). RADCO was merged with and into the Company
effective November 15, 1996, at which time RADCO ceased to exist as a separate
corporate entity.
On March 3, 1997, the Company acquired the ESP(TM) Culture System II
product line (the "ESP Product Line") for a total purchase price of $6,000,000
in cash. This acquisition consisted of accounts receivable, inventories,
production equipment and a portfolio of rental instruments used to detect
microorganisms in blood cultures. The purchase price was ultimately funded by an
$8,500,000 private
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placement of convertible debt and warrants to purchase 850,000 shares of Common
Stock.
On March 5, 1998, the Company announced that the Board of Directors has
authorized management to seek buyers for the Company's microbiology business.
On May 19, 1998, stockholders approved an amendment to the Company's
Certificate of Incorporation to effect a one-for-six reverse stock split on the
Common Stock. Such reverse stock split became effective at the opening of
trading on May 21, 1998.
On June 26, 1998, the Company paid a purchase price of CND$500,000 in
cash and the Convertible Note in to acquire from the Selling Securityholder the
remaining one-third interest in Oncometrics. At such time, Oncometrics became a
wholly-owned subsidiary of the Company. See "Certain Relationships and
Transactions."
On January 29, 1999, the Company completed the sale of substantially all
the assets and certain liabilities related to the Company's microbiology
division, including the Company's formerly wholly-owned subsidiary AccuMed UK
(such assets and liabilities are collectively referred to as the "Microbiology
Business"). The Microbiology Business was sold to Trek Diagnostic Systems, Inc.
("Trek") for a purchase price of $15,150,000 in cash (subject to post-closing
adjustments). A portion of the proceeds totaling $9,415,000 was used to retire a
revolving line of credit, secured notes payable, unsecured notes payable,
accrued interest thereon, and expenses related to the transaction.
The Company and Microsulis Corporation, a Florida corporation
("Microsulis"), have entered into a Letter of Intent dated October 6, 1999, as
amended (the "Letter of Intent"), pursuant to which Microsulis would be merged
(the "Microsulis Merger") with and into the Company or a wholly-owned subsidiary
of the Company, and the Company would continue as a corporate entity (the
"Surviving Corporation"). The Letter of Intent provides that the Company's
current stockholders would retain an aggregate of approximately 37.5% of the
outstanding Common Stock and Microsulis stockholders would receive an aggregate
of approximately 62.5% of the Common Stock in the Surviving Corporation. The
Common Stock would remain unchanged. Pursuant to a license agreement with
Microsulis PLC of the United Kingdom ("Microsulis PLC"), Microsulis has
exclusive marketing and distribution rights, and the potential option of
manufacturing rights, in the Western Hemisphere for Microwave Endometrial
Ablation ("MEA(TM)") systems and related applicators developed and manufactured
by Microsulis PLC. Consummation of the Microsulis Merger is subject to the
following conditions, among others, (i) satisfaction with the results of a due
diligence investigation by each corporation with respect to the other, (ii)
negotiation, board approval, and execution and delivery of a definitive merger
agreement containing representations, warranties, covenants and conditions
customary in such transactions, (iii) effectiveness of a registration statement
registering the shares of Common Stock to be issued to Microsulis stockholders
and clearance by the Commission of the Company's proxy materials for use in
connection with a special meeting of stockholders, and (iv) approval of the
Microsulis Merger by the stockholders of the Company and Microsulis. Terms of
the Microsulis Merger as set forth in the definitive merger agreement, if any,
could be materially different from those of the Letter of Intent as described
herein. There can be no assurances that the Microsulis Merger will be
consummated. See "Recent Developments."
THE BUSINESS
The Company is engaged in the development and commercialization of
products, using patented and proprietary technology, that support the review and
analysis of cytology and histology preparations in the diagnostic laboratory
healthcare market. The Company's primary focus is on the development of cytology
and histology
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products that improve the quality of cell-based specimen analyses and increase
productivity in the clinical diagnostic laboratory. The initial products
developed were designed for review and analysis of both cervical and
non-cervical conventional Pap smears and liquid-based preparations. The Company
has made significant expenditures on research and development, patent
applications, and regulatory approvals to bring these products to a marketable
position.
The Company commenced sales of its initial cytopathology product, the
AcCell(TM) Cytopathology System, an automated slide handling, data management
system and microscopy workstation, at the end of the first quarter of 1996. The
TracCell(TM) 2000 Slide Mapping System (the "TracCell 2000") is a slide mapping
system that automatically creates a computerized map that excludes empty space
and certain non-clinically relevant portions of the specimen to permit a more
efficient analysis of the slide. A human screener then reviews the mapped
specimen through an AcCell microscopy workstation. In August 1997, the United
States Food and Drug Administration (the "FDA") granted the Company clearance to
market the TracCell 2000 in the United States pursuant to a pre-market
notification under Section 510(k) under the United States Food, Drug and
Cosmetic Act (the "FD&C Act").
The Company believes it is the only company competing in the
computer-aided cytology screening cytodiagnostic market with a modular,
expandable product (the "AcCell(TM)" cytopathology workstations and systems)
that allows customers to upgrade to more fully automated versions and with a
product line that support both gynecological and non-gynecological specimen
analysis using both conventional Pap smears as well as liquid-based
preparations.
Although the cervical Pap test is the largest volume diagnostic cytology
test, the cytopathology laboratory routinely conducts other tests based on
samples from numerous organs and areas of the body, all of which require
precision optical microscopy and careful error-free management of data to be
implemented effectively. The Company is currently developing products for these
applications by combining its AcCell technology with other proprietary
technology developed by the Company for use in connection with the analysis of
these tests in a manner similar to that of qualitative and quantitative Pap
tests. The tests and methods rely, in part, on computer-aided microscopy,
electronic imaging, image cytometry, digital image processing and analysis,
cytochemistry, and medical informatics technologies.
The Company and Ampersand Medical Corp. ("Ampersand") entered into a
Patent and Technology License Agreement on September 4, 1998, pursuant to which
the Company granted to Ampersand an exclusive license in certain patents and
other intellectual property for use in products that relate to in vitro
cytological and/or histological specimen and/or sample fixation and analysis.
Pursuant to the agreement, the Company received an initial license fee and is
entitled to receive certain minimum guaranteed royalty payments during the
minimum five-year term of the agreement. Ampersand is in default on payment
obligations aggregating $600,000 due September 7, 1999, and has been given
notice of a cure period ending November 21, 1999. There can be no assurance that
Ampersand will perform its payment obligations under the agreement.
Early Lung Cancer Screening. The Company has also developed and
assembled technologies and systems that could lead to a much more effective,
sensitive, reliable, and commercially viable early lung cancer testing program
to identify individuals with early more curable lung cancer.
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The Company believes a screening program for early lung cancer detection
and diagnosis is possible. It must rely upon identifying and recruiting
high-risk patient populations into non-invasive screening programs before they
become symptomatic. A screening program for high-risk individuals has the
potential to not only save lives, but also be a highly cost-effective healthcare
program by significantly reducing overall healthcare costs due to earlier
detection and treatment.
To achieve this goal, the Company is developing a cell and sample
analysis instrument platform, the AcCell-Savant. The AcCell-Savant, a
quantitative microscopy analytical instrument, incorporates features and
benefits derived from the AccuMed proprietary AcCell workstations and TracCell
slide mapping systems. It relies on several core technologies including
cytochemistry, computer-aided microscopy, electronic imaging, digital image
processing and analysis, and medical informatics. This cell analysis platform
facilitates the direct measurement of cellular changes (e.g., "MAC" or
Malignancy-Associated Changes) associated with early disease development and
progression. The Company believes such cellular assays could be performed, with
the AcCell-Savant, more sensitively, accurately, and reproducibly than is
possible by the human eye-brain combination alone. The instrument's
photodetectors, electro-mechanical precision, ability to focus selectively
cell-by-cell and nucleus-by-nucleus on the most informative cell populations,
image processing and analysis algorithms, and statistical calibration and
classification methods gives the cytotechnologist, cytopathologist, and
cytologist-in-general the ability to analyze multiple lung cancer markers and
probes simultaneously for improved sensitivity, specificity and positive
predictive value. The human-machine interface allows the pathologist to
consider, in suspicious cases, the objective, visual and subvisual AcCell-Savant
data in their patient diagnostic reports.
The Company's subsidiary Oncometrics conducted a field study in
conjunction with the British Columbia Cancer Agency and a consortium of
hospitals. The two-year field study and analysis approximately 1,000 patient
cases qualified to be at high-risk for early lung cancer took place in five
countries on three continents. Results from that study show that conventional
sputum cytopathology has a reduced sensitivity for early stage lung cancer
detection. Most significantly, this study also demonstrated that the
AcCell-Savant approach improves, over conventional methods, the detection of the
early, most curable, lung cancers by up to several-fold. Further significant
performance improvements are anticipated based upon current research and
development activities in enhanced and innovative methods of specimen
collection; sample deposition, fixation, and staining; panel test design with
multiple probes; image analysis algorithms; and computer-aided pattern
recognition and classification methods.
The Company has set the following major near-term (i.e., 18-month)
milestones in this lung cancer screening business development program: (1)
completion of comprehensive system requirements and specifications from specimen
collection and preparation through cellular analysis, diagnosis and reporting,
(2) development of the clinical instrument ("intended use" apparatus), (3)
submission of appropriate supplemental patent protection, (4) completion of a
pre-clinical trial (i.e., pilot run) with adequate screening test sensitivity
and specificity, (5) demonstration of revenues from research instrument sales,
and (6) demonstration of revenues from per-test usage fees at Alpha and Beta
sites.
Markets and Products. The Company's products and equipment are sold to
customers that operate principally in the clinical laboratory segments of the
healthcare market. Currently, marketing
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of the AcCell systems and TracCell is conducted through one employee and is
focused primarily in the research and development markets. Modest sales of the
AcCell-Savant have been made to academic and research laboratories through
licensing agreements which provide the Company a right of first refusal to
commercialization rights of any intellectual property related to applications
related to use of the AcCell-Savant developed by such laboratories. The Company
presently has no third-party distributor arrangements. Other than for research
use and clinical use with restrictions, sales of AcCell-Savant in the United
States may not be made without FDA clearance of a pre-market approval
application of the intended use apparatus under the FD&C Act. See "Risk
Factors--Government Regulation."
The Company is exploring joint ventures with partners to combine Savant
and/or AcCell proprietary technology with a partner's intellectual property and
the Company would sell its platforms for use in combination with the partner's
intellectual property. The Company is also exploring alliance relationships with
partners that may further speed the commercialization of the early lung cancer
screening test by bringing additional technology (e.g., lung cancer probes for
panel assays), prospective customers (e.g., clinical trial sites and end-users),
distribution channels (e.g., pharmaceutical industry), and programmatic funding.
For additional information regarding the Company's products, competition
and intellectual property, see "Risk Factors--Uncertainty of Market Acceptance
and Initial Investment in Cytopathology Products;" "--Technological Change and
Competition; "--Delayed or Unsuccessful Product Development"; "--Government
Regulation;" and "--Protection of Intellectual Property."
The Company's principal executive offices are located at 920 North
Franklin Street, Suite 402, Chicago, Illinois 60610, and its telephone number is
(312) 642-9200.
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THE OFFERING
Securities offered .......... 250,000 shares of Common Stock offered by the
Selling Securityholder.
Common Stock outstanding
after the Offering(1) ..... 5,741,901 shares (which assumes the conversion
of the Convertible Note to acquire an aggregate
of 250,000 Shares to be sold in this Offering).
Use of Proceeds ............. The Company will not receive any proceeds from
the sale of the Common Stock by the Selling
Securityholder. If the holder fully converts the
Convertible Note into the Shares, the Company
will be relieved of the obligations to repay to
the holder the CND$500,000 principal amount of
the Convertible Note. Any such resulting savings
will be used by the Company for general
corporate purposes, including research and
development, and working capital.
Nasdaq SmallCap
Market Symbol ............... ACMI
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(1) Based upon shares outstanding at November 4, 1999. Excludes: (i) an
aggregate of 2,229,784 shares reserved for issuance upon exercise of
warrants outstanding at November 4, 1999; (ii) an aggregate of 629,620
shares reserved for issuance upon the conversion of the shares of Series
A Convertible Preferred Stock outstanding at November 4, 1999; (iii) an
aggregate of 675,437 shares reserved for issuance upon the exercise of
stock options outstanding at November 4, 1999; and (iv) an aggregate of
88,650 shares reserved for issuance upon exercise of options available
for future grant under the Company's stock option plans. On May 23,
1997, the Company's stockholders approved an amendment to the Company's
Certificate of Incorporation increasing the authorized Common Stock from
30,000,000 shares to 50,000,000 shares. On May 19, 1998, the Company's
stockholders approved an amendment to the Company's Certificate of
Incorporation effecting a one-for-six reverse stock split on the Common
Stock which became effective at the opening of trading on May 21, 1998.
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RISK FACTORS
AN INVESTMENT IN THE SHARES OF COMMON STOCK OFFERED HEREBY INVOLVES A
HIGH DEGREE OF RISK. PROSPECTIVE INVESTORS SHOULD CAREFULLY CONSIDER THE
FOLLOWING RISK FACTORS, IN ADDITION TO THE OTHER INFORMATION IN THIS PROSPECTUS.
SPECIAL NOTE: CERTAIN STATEMENTS SET FORTH BELOW CONSTITUTE "FORWARD-LOOKING
STATEMENTS" WITHIN THE MEANING OF THE REFORM ACT. SEE "SPECIAL NOTE REGARDING
FORWARD-LOOKING STATEMENTS" ON PAGE 2 FOR ADDITIONAL FACTORS RELATING TO SUCH
STATEMENTS.
SIGNIFICANT CAPITAL REQUIREMENTS; NEED FOR ADDITIONAL CAPITAL. The
Company has expended substantial funds for research and product development, and
other working capital and general corporate purposes. Management believes that
the Company's existing capital resources and anticipated internally generated
revenues will not provide sufficient capital to meet the Company's current and
projected requirements over the next 12 months. Additional financing will be
required to fund the Company's proposed operations during the next 12-month
period. The Company may seek to raise such additional funds through public or
private financings, collaborative relationships or other arrangements. The
Company currently has no commitments with respect to sources of additional
financing, and there can be no assurance that any such financing sources will be
available to the Company or that adequate funds for the Company's operations,
whether from the Company's revenues, financial markets, collaborative or other
arrangements with corporate partners or from other sources, will be available
when needed or on terms satisfactory to the Company. The failure of the Company
to obtain adequate additional financing may require the Company to delay,
curtail or scale back some or all of its research and development programs,
sales and marketing efforts, manufacturing operations or out-sourcing, clinical
studies and regulatory activities and, potentially, to cease its operations. Any
additional equity financing may involve substantial dilution to the Company's
then-existing stockholders.
The Company's future liquidity and capital requirements will depend upon
numerous factors including the costs, timing and success of the Company's
product development efforts, the ability to cost effectively contract with a
third party manufacturer or the costs and timing of expansion of manufacturing
capacity, the costs and timing of potential acquisitions, including the
Microsulis Merger, and joint ventures, the extent to which the Company's
existing and new products gain market acceptance, competing technological and
market developments, the progress of commercialization efforts by the Company
and its future distributors (if any), the costs involved in preparing, filing,
prosecuting, maintaining, enforcing and defending patent claims and other
intellectual property rights, developments related to regulatory and third party
reimbursement matters, and other factors.
LIMITED RELEVANT OPERATING HISTORY; SIGNIFICANT OPERATING LOSSES;
ACCUMULATED DEFICIT; CHARGES ARISING FROM AMORTIZATION OF GOODWILL AND
IN-PROCESS RESEARCH AND DEVELOPMENT, ISSUANCE OF CONVERTIBLE NOTES; UNCERTAINTY
OF PROFITABILITY. The Company was formed in 1988 under the name Alamar
Biosciences, Inc. and was engaged primarily in research and development of
microbiology products based on the alamarBlue technology. Prior to the Alamar
Merger, the Company never realized any significant revenues from product sales.
AccuMed, Inc. was incorporated in February 1994 and, effective January 1995,
acquired the Sensititre microbiology business. Until such acquisition, AccuMed,
Inc. had no revenues and operations consisted of a limited amount of
cytopathology research and
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development. Accordingly, although the Sensititre business had a significant
operating history and revenues from sales, AccuMed, Inc., as a separate entity,
had very limited operating history prior to the Alamar Merger. Upon consummation
of the Alamar Merger, the operations of the Company and AccuMed, Inc. were
combined, and the Company began to develop, manufacture and sell both the
alamarBlue and the Sensititre microbiology products and recently (in 1996 and
1997) began to commercialize certain cytopathology products. In March 1997, the
Company acquired the ESP Product Line from Difco. The Company has been advised
that Difco, and its affiliates Difco Laboratories Incorporated, a Michigan
corporation, and Difco Laboratories Incorporated, a Wisconsin corporation, had
been engaged in the production of the ESP Product Line since 1992. Accordingly,
there was a limited relevant operating history with respect to the ESP Product
Line upon which an evaluation of its prospects could be made. Difco was not able
to conduct the ESP Business in a profitable manner and the Company conducted the
ESP Business in a profitable manner for only a limited time before selling the
Microbiology Business to Trek in January 1999. The Company acquired a two-thirds
interest in Oncometrics in October 1996 and in June 1998 acquired sole ownership
of Oncometrics, which was formed in 1995. The Company is in the development and
initial testing stages of a cell and sample analysis instrument platform, the
AcCell-Savant, incorporating the Oncometric's technology. Thus, the Company has
a limited relevant operating history upon which an evaluation of its prospects
can be made. Such prospects must be considered in light of the risks, expenses
and difficulties frequently encountered in establishing a new business in a
continually evolving industry with an increasing number of market entrants and
intense competition as well as the risks, expenses and difficulties encountered
in the shift from development to commercialization of new products based on
innovative technology.
The Company has incurred significant net operating losses in each fiscal
quarter since its inception. For the fiscal year ended December 31, 1998, and
for the six-month period ended June 30, 1999, the Company's net operating losses
from continuing operations were approximately $10,359,755 million and $2,721,855
million, respectively. As of June 30, 1999, the Company had an accumulated
deficit of approximately $54,427,921 million. Losses are expected to continue
for the foreseeable future until such time, if ever, as the Company is able to
attain sales levels sufficient to support its operations. There can be no
assurance that the Company will be able to implement successfully its operating
strategy, generate increased revenues or ever achieve profitable operations. See
"--Uncertainty of Market Acceptance and Initial Investment in Cytopathology
Products."
During the first quarter of 1997, certain contingencies were satisfied
with respect to 940,955 shares of Common Stock and warrants to purchase 63,472
shares of Common Stock issued in connection with the Alamar Merger. As a result,
approximately $3.6 million, the fair market value of such securities at the date
on which such contingencies were satisfied were recorded as goodwill associated
with the Alamar Merger and charged off in its entirety to operations during the
three months ended March 31, 1997 as an impaired asset.
The Company's acquisition of a two-thirds equity interest in Oncometrics
was accounted for under the purchase method of accounting, resulting in
approximately $1.6 million of acquired in-process research and development and
approximately $1.1 million of purchased technology. The $1.1 million of
purchased technology will be amortized over its useful life of seven years and
the $1.6 million of acquired in-process research and development was written off
as a charge to earnings in the last quarter
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of 1996.
The Company's acquisition of all of the outstanding shares of Common
Stock not previously owned by the Company of RADCO for an aggregate cost to the
Company of $1.4 million also included approximately $800,000 of acquired
in-process research and development. Amounts recorded as acquired in-process
research and development for the RADCO acquisition were written off as a charge
to earnings in the last quarter of 1996.
Issuance of Convertible Notes in the aggregate principal amount of $8.5
million during the first quarter of 1997 at a conversion rate of $0.50 less than
the market price at the time of issuance resulted in recognition of a discount
of $1.9 million recorded against such notes at the date of issuance. Such notes
were first convertible during the second quarter of 1997, which resulted in such
$1.9 million being written off as a non-cash charge against earnings during such
quarter. The Company extinguished debt with a carrying value of $4,818,800
through the issuance of Series A Convertible Preferred Stock and warrants to
purchase Common Stock with a fair value of $5,986,880 including transaction
fees, resulting in an extraordinary loss of $1,168,000 in February 1998.
CONVERTIBLE PREFERRED RANK SENIOR TO COMMON STOCK. If the Company were
to liquidate, proceeds from the sale of assets would be applied first to satisfy
the Company's outstanding indebtedness of the Company, including trade debt. At
November 4, 1999, the Company's only indebtedness other than trade debt is the
Convertible Note in the principal amount of CND$500,000 which would be required
to be converted, at least in part, by the Selling Securityholder if it is to
sell Shares in this Offering. Any proceeds remaining after full satisfaction of
all indebtedness of the Company would be applied to satisfy the liquidation
preference of the Series A Convertible Preferred (the "Convertible Preferred")
and other preferred stock of the Company, if any is then outstanding, which has
parity as to liquidation preference with the Convertible Preferred (on a pro
rata basis if such remaining proceeds were insufficient to satisfy fully such
liquidation preferences). The aggregate liquidation preference of the
Convertible Preferred outstanding at November 4, 1999 is $4,249,735. There can
be no assurances that any proceeds would remain for distribution to holders of
Common Stock following satisfaction of such indebtedness and liquidation
preferences.
UNCERTAINTY OF MARKET ACCEPTANCE AND INITIAL INVESTMENT IN CYTOPATHOLOGY
PRODUCTS. The Company has generated limited revenues from the sale of its
cytopathology products to date. The Company's success, growth and profitability
will depend primarily successful development, and market acceptance of the
AcCell-Savant in the cytology or genetic market, and will depend to a lesser
extent on market acceptance of the AcCell System 2000 and 2001 and the TracCell
2000 for use in connection with cervical cancer screening by cytopathology
laboratories, or the Company's ability to acquire marketable technologies and
products through acquisitions, such as the Microsulis Merger, or the ability of
the Company to enter into joint ventures which include operational financing
from a partner.
The Company currently markets the AcCell cytopathology products directly
and on a limited basis in order to collect, analyze and document performance
data of the products in several primary clinical cytology laboratory market
segments. The AcCell/Savant(TM) DNA image cytometer, the Company's next
generation product, is currently in development and prototyping. Marketing
efforts for the
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AcCell/Savant began in the latter half of 1999. Such marketing has resulted in
only modest sales of the AcCell/Savant to academic and research laboratories
through licensing agreements which provide the Company a right of first refusal
to commercialization rights of any intellectual property related to applications
related to use of the AcCell/Savant developed by such laboratories. See "--
Technological Change and Competition."
LIMITED SALES, MARKETING AND DISTRIBUTION EXPERIENCE; LACK OF
THIRD-PARTY DISTRIBUTORS. In order for the Company to increase revenues and
achieve profitability, the Company's current and proposed products must achieve
a significant degree of market acceptance. The Company has only limited
experience marketing and selling its cytopathology products. The Company
currently distributes its products directly through one internal sales employee.
The Company currently has no arrangements with third-party distributors. The
Company intends to continue to distribute its products as it is presently, and
if demand and opportunity warrant, the Company may expand its internal sales and
marketing efforts and/or enter into arrangements with third-party distributors.
In 1996, the Company entered into its initial distribution arrangement
and commenced direct sales efforts with respect to cytopathology products. In
August 1998, the Company and Leica Microscopy and Systems GmbH ("Leica")
terminated a distribution agreement (commenced in May 1997) which had granted
Leica exclusive third-party distribution rights outside the Western Hemisphere
for the AcCell Systems and has a right of first negotiation with respect to
TracCell 2000 and other future cytopathology products. While the agreement was
in effect, Leica sold very few AcCell Systems to end-users. In September 1997,
the Company and Olympus terminated the distribution agreement entered into in
May 1996 which had granted Olympus exclusive distribution rights for the AcCell
Systems in the Western Hemisphere. While the agreement was in effect, Olympus
sold very few AcCell Systems to end-users. Furthermore, as required by the
agreement, the Company has repurchased the AcCell Systems that were in Olympus'
inventory.
The Company and Sunquest Information Systems, Inc. entered into a
five-year Finders Agreement on April 30, 1998. Pursuant to the Finders
Agreement, Sunquest has the right to market, in collaboration with the Company,
licenses for the Company's AcCell, TracCell, SpeciFind and Data Management
System (DMS)/network software products to Sunquest software endusers in the
United States and Canada. On October 23, 1998, the Company advised Sunquest that
it refrain from any making efforts pursuant to the agreement until further
notice. No sales or licenses were made under such agreement.
The Company will be required to enter into successful distribution
arrangements in order to achieve broad distribution of its products. There can
be no assurance that the Company will be able to enter into and maintain such
arrangements with distributors on acceptable terms, or on a timely basis, if
ever. If the Company is able to enter into such arrangements, it will be
dependent upon such distributors to assist it in promoting market acceptance of
and demand for its products. In addition, because the Company intends to rely on
a limited number of distributors, sales to these distributors could account for
a significant portion of the Company's revenues. There can be no assurance that
these distributors will devote the resources necessary to provide effective
sales and marketing support to the Company. In addition, the Company's
distributors may give higher priority to the products of other medical suppliers
or their own products, thus reducing their efforts to sell the Company's
products. If
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any of the Company's distributors becomes unwilling or unable to promote, market
and sell its products, the Company's business, financial condition and results
of operations would be materially adversely affected.
UNCERTAINTY OF PROFITABLE CYTOPATHOLOGY MANUFACTURING. The Company has
developed the system for assembling the AcCell Systems. Presently, the Company
has a significant inventory of AcCell Systems and a limited number of TracCells
which would be available to fill sale orders for such products. If product
demand were to increase beyond that which could be filled through such
inventory, the Company intends to out-source assembly of such products. There
can be no assurance that the Company will be able to enter into a cost-effective
arrangement for assembly of the AcCell Systems or the TracCell 2000 on a timely
basis, if at all. Furthermore, there can be no assurance that the Company will
continue to be able to obtain the component parts to the AcCell 2000 products
which have previously been supplied by a variety of vendors. The Company also
faces the possibility that defects in designs or manufacture of its products
could result in product recall.
PROTECTION OF INTELLECTUAL PROPERTY. The Company relies on a combination
of patents, licensing arrangements, trade names, trademarks, trade secrets,
know-how and proprietary technology and policies and procedures for maintaining
the secrecy of trade secrets, know-how and proprietary technology in order to
secure and protect its intellectual property rights.
As of the date of this Prospectus, the Company owns 18 issued patents,
including 12 United States patents, four United Kingdom patents, one German
patent, and one Canadian patent. In addition, the Company has 35 patent
applications pending throughout the world, including 11 United States patent
applications, eight Canadian patent applications, five German patent
applications, five international patent applications, three European patent
applications, one United Kingdom patent application, one Australian patent
application, and one Japanese patent application. The Company is continuing to
prepare additional patent applications.
Since patent applications in the United States are maintained in secrecy
until patents issue, and since publications of discoveries in the scientific or
patent literature tend to lag behind actual discoveries by several months, the
Company cannot be certain that the Company or another relevant patent applicant
was the first creator of inventions covered by pending patent applications or
that such persons were the first to file patent applications for such
inventions. Protections relating to portions of such technology may be
challenged or circumvented by competitors and other portions may be in the
public domain or protectable only under state trade secret laws. There also can
be no assurance that any patents, patent applications and patent licenses will
adequately cover the Company's technologies.
The Company owns a Canadian trademark registration for the mark
"ONCOMETRICS." In addition, the Company has eight pending U.S. trademark
applications for the marks "TRACCELL," "ACCELL-SAVANT," "ONCOMETRICS,"
"SPECIFIND," "MACCELL," "MACROVISION," "RELATIONAL CYTOPATHOLOGY REVIEW GUIDE,"
and "IMPROVING CYTOLOGY PROCESSES." The Company may file additional U.S. and
foreign trademark applications in the future. However, no additional trademark
registrations have yet been granted to the Company, and there can be no
assurance that any such registrations will be granted. In addition, there can be
no assurance that third
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parties have not or will not adopt or register marks that are the same or
substantially similar to those of the Company, or that such third parties will
not be entitled to use such marks to the exclusion of the Company. Selecting new
trademarks to resolve such situations could involve significant costs, including
the loss of goodwill already gained by the marks previously used.
The Company relies for protection of its trade secrets, know-how and
proprietary technology on nondisclosure and confidentiality agreements with its
employees, consultants, distributors, suppliers, researchers and advisors. There
can be no assurance that such agreements will provide meaningful protection for
the Company's trade secrets, know-how or proprietary technology in the event of
any unauthorized use or disclosure of such information. In addition, others may
obtain access to, or independently develop, technologies or know-how similar to
that of the Company.
There can be no assurance that the Company's patents, patent
applications, patent licenses, trademarks and trade secret protections will
adequately protect the Company from potential infringement or misappropriation
by third parties. Historically, the Company has been required to undertake
costly litigation to enforce its intellectual property rights. Although the
Company is not currently aware of any potential infringement, future litigation
by the Company may be necessary to enforce its patent rights, as well as to
protect its trade secrets, know-how and proprietary technology, or to determine
the scope and validity of the proprietary rights of others. Any such litigation
could result in substantial cost to and diversion of effort by the Company.
The Company's success will also depend on its ability to avoid
infringement of patent or other proprietary rights of others. The Company is not
aware that it is infringing any such rights of a third party, nor is it aware of
proprietary rights of others for which it will be required to obtain a license
in order to develop its products.
There can be no assurance that the Company is not infringing the
proprietary rights of others, or that the Company will not be required to defend
itself against claimed infringement of the rights of others. Adverse
determinations in any such litigation could subject the Company to significant
liability to third parties, could require the Company to seek licenses from
third parties and could prevent the Company from manufacturing, selling or using
certain of its products or technologies, any of which could have a material
adverse effect on the Company.
TECHNOLOGICAL CHANGE AND COMPETITION. The Company's AcCell System and
TracCell 2000 face competition from companies that have developed or may be
developing competing systems. The Company believes that many of the Company's
existing and potential competitors possess substantially greater financial,
marketing, sales, distribution and technical resources than the Company, and
more experience in research and development, clinical trials, regulatory
matters, manufacturing and marketing. The Company is aware of a company that
currently markets imaging systems to re-examine or rescreen conventional Pap
smear specimens previously diagnosed as negative as well as two companies that
are developing devices for the preparation and analysis of Pap smear slides. The
Company is aware that at least one such company has submitted an imaging system
for use as a primary means of screening Pap smear slides under a pre-market
approval application (a "PMA") to the FDA under the United States Food, Drug and
Cosmetic Act (the "FD&C Act"). Another company markets a manual rescreening test
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claimed to detect the presence of cervical cancer using reagents to detect
certain hybrid cells. If any company currently marketing rescreening products
receives FDA clearance or approval for use of its product as a primary screening
system to replace or work in conjunction with conventional Pap smear screening
or if automated analysis systems are developed and receive FDA clearance or
approval, the use of conventional Pap smear screening could be substantially
affected and the Company's business, financial condition and results of
operations could be materially adversely affected.
The medical diagnostics industry is characterized by rapid product
development and technological advances. There can be no assurance that other
technologies or products that are functionally similar to those of the Company
are not currently available or under development, or that other companies with
expertise and resources that would encourage them to attempt to develop and
market competitive products will not develop new products that compete directly
with the Company's products. The Company's products could be rendered obsolete
or uneconomical by the introduction and market acceptance of competing products,
technological advances of the Company's current or potential competitors, or by
other approaches. There can be no assurance that the Company will be able to
compete successfully against current or future competitors or that competition,
including the development and commercialization of new products and technology,
will not have a material adverse effect on the Company's business, financial
condition and results of operations.
DELAYED OR UNSUCCESSFUL PRODUCT DEVELOPMENT. The Company's growth and
profitability will depend, in part, upon its ability to complete development of
and successfully introduce new products. The Company will likely be required to
undertake time-consuming and costly development activities and seek regulatory
approval for new products. There can be no assurance that the Company will not
experience difficulties that could delay or prevent the successful development,
introduction and marketing of new products, that regulatory clearance or
approval of these or any new products will be granted on a timely basis, if
ever, or that the new products will adequately meet the requirements of the
applicable market or achieve market acceptance. The completion of the
development of any of the Company's products under development remains subject
to all the risks associated with the commercialization of new products based on
innovative technologies, including unanticipated technical or other problems,
manufacturing difficulties and the possible insufficiency of the funds allocated
for the completion of such development, which could result in a change in the
design, delay in the development or the abandonment of such products.
Consequently, there can be no assurance that any of the Company's products under
development will be successfully developed or manufactured or, if developed and
manufactured, that such products will meet price or performance objectives, be
developed on a timely basis or prove to be as effective as competing products.
The inability to successfully complete development of a product or application,
or a determination by the Company, for financial, technical or other reasons,
not to complete development of any product or application, particularly in
instances in which the Company has made significant capital expenditures, could
have a material adverse effect on the Company's business, financial condition
and results of operations and could cause the Company to reassess its business
strategy. Such reassessment could lead to changes in the Company's overall
business plan, including the relative emphasis on current, as well as future,
products. See "- Government Regulation."
GOVERNMENT REGULATION. The Company's products and manufacturing
processes are regulated by state and federal authorities, including the FDA and
comparable authorities in certain states and other
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countries. Failure to comply with the FD&C Act and any applicable regulatory
requirements can result in, among other things, civil and criminal fines,
product recalls, detentions, seizures, injunctions and criminal prosecutions.
United States regulatory requirements promulgated under the FD&C Act
provide that the TracCell and certain of the Company's products in development
may not be shipped in interstate commerce without prior authorization from the
FDA. Such authorization is based on a review by the FDA of the product's safety
and effectiveness for its intended uses. Medical devices may be authorized by
the FDA for marketing in the United States either pursuant to a 510(k)
Notification or a PMA. The process of obtaining marketing clearance from the FDA
and other applicable regulatory authorities can be expensive, uncertain and time
consuming, frequently requiring several years from the commencement of clinical
trials or submission of data to the receipt of regulatory approval.
A 510(k) Notification, among other things, requires an applicant to show
that its products are "substantially equivalent" in terms of safety and
effectiveness to existing products that are currently permitted to be marketed.
An applicant is permitted to begin marketing a product as to which it has
submitted a 510(k) Notification at such time as the FDA issues a written finding
of substantial equivalence. Requests for additional information may delay the
market introduction of certain of an applicant's products and, in practice,
initial clearance of products often takes substantially longer than the FDA
pre-market notification review period of 90 days.
A PMA consists of the submission to the FDA of information sufficient to
establish independently that a device is safe and effective for its intended
use. A PMA must be supported by extensive data, including preclinical and
clinical trial data, as well as extensive literature to prove the safety and
effectiveness of the device. By statute, the FDA is required to respond to a PMA
within 180 days from the date of its submission; however, the approval process
usually takes substantially longer, often as long as several years. During the
review period, the FDA may conduct extensive reviews of the Company's
facilities, deliver multiple requests for additional information and
clarifications and convene advisory panels to assist in its determination.
FDA marketing clearances, if granted, may include significant
limitations on the intended uses for which a product may be marketed. FDA
enforcement policy strictly prohibits the promotion of cleared or approved
medical devices for non-approved or "off-label" uses. In addition, product
clearances or approvals may be withdrawn for failure to comply with regulatory
standards or the occurrence of unforeseen problems following initial marketing.
Under current interpretation of FDA regulations, marketing of the AcCell
2000 in the United States does not require FDA marketing clearance. Marketing of
the TracCell 2000 in the United States, however, does require pre-marketing
clearance by the FDA, which clearance was granted to the Company in August 1997.
Marketing in the United States of the Company's products under
development may require additional FDA clearances. For example, the
AcCell-Savant DNA image cytometer, the Company's next generation product
currently in development and prototyping, may not be sold (other than for
research
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use and clinical use with restrictions) in the United States without FDA
clearance of a pre-market approval application of the intended use apparatus
under the FD&C Act.
not be sold in the United States unless and until the Company has obtained FDA
marketing clearance, either through a 510(k) Notification or a PMA. The Company
is currently conducting research and development with respect to the
AcCell-Savant and has not yet begun clinical trials. There can be no assurance
that any such products will be developed or, if developed, that such products
will be cleared for marketing by the FDA or other applicable regulatory
authorities or, if such clearance is received, that such marketing clearance
will not be withdrawn.
Sales of medical devices outside of the United States are subject to
foreign regulatory requirements that vary from country to country. The time
required to obtain clearance by a foreign country may be longer or shorter than
that required for FDA clearance, and the requirements may differ. Export sales
of certain devices that have not received FDA marketing clearance generally are
subject to both FDA certificate for product for export regulations and, in some
cases, general U.S. export regulations. In order to obtain a FDA export permit,
the Company may be required to provide the FDA with documentation from the
medical device regulatory authority of the country in which the purchaser is
located. No assurance can be given that foreign regulatory clearances will be
granted on a timely basis, if ever, or that the Company will not be required to
incur significant costs in obtaining or maintaining its foreign regulatory
clearances.
Underwriters Laboratories Inc. (UL) is an independent, not-for-profit
product safety testing and certification organization. The UL Listing Mark on a
product indicates that UL has found that samples of this product met UL's safety
requirements. These requirements are primarily based on UL's own published
Standards for Safety. The AcCell 2000 Series has been tested and found to comply
with UL's safety requirements and carries the UL Listing Mark. However, there
can be no assurance that the Company will obtain the UL Listing Mark for any
proposed products or that any product that the Company may develop or
commercialize will obtain the UL Listing Mark.
The CE mark is recognized by countries that are members of the European
Union and the European Free Trade Association and is required to be affixed to
all medical devices sold in the European Union. The AcCell Series is certified
as complying with CE mark requirements. However, no assurance can be given that
the Company will obtain the CE mark for any proposed products or that any
product that the Company may develop or commercialize will obtain the CE mark or
will obtain any other required regulatory clearance or approval on a timely
basis, if ever.
In addition to the regulations directly pertaining to the Company and
its products, many of the Company's existing and potential customers are subject
to extensive regulation and governmental oversight. Regulatory changes in the
healthcare industry that adversely affect the business of the Company's
customers could have a material adverse effect on the Company's business,
financial condition and results of operations.
There can be no assurance that the Company will be able to obtain
necessary regulatory clearances in the United States or internationally on a
timely basis, if ever. Delays in the receipt of, or
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failure to receive, such clearances, the loss of previously received listings or
clearances, or failure to comply with existing or future regulatory requirements
would have a material adverse effect on the Company's business, financial
condition and results of operations.
DEPENDENCE ON KEY EMPLOYEES. The Company believes that its success will
depend to a significant extent upon the efforts and abilities of a small group
of executive, scientific and marketing personnel. The loss of the services of
one or more of these key personnel could have a material adverse effect on the
Company's business, financial condition and results of operations. In addition,
the Company's future success will depend upon its ability to continue to attract
and retain qualified scientific and management personnel who are in great
demand. There can be no assurance that the Company will be successful in
attracting and retaining such personnel.
POTENTIAL FLUCTUATIONS IN FUTURE QUARTERLY RESULTS. The Company expects
that its operating results will fluctuate significantly from quarter to quarter
in the future and will depend on various factors, many of which are outside the
Company's control. These factors include the success of the marketing efforts of
the Company and its future distribution partners (if any), the likelihood,
timing and costs associated with obtaining necessary regulatory clearances or
approvals, the timing and level of expenditures associated with expansion of
sales and marketing activities and overall operations, the Company's ability to
cost effectively contract to out-source assembly of its products, the timing of
establishment of strategic distribution arrangements and the success of the
activities conducted under such arrangements, changes in demand for the
Company's products, order cancellations, competition, changes in government
regulation and other factors, the timing of significant orders from and
shipments to customers, and general economic conditions. These factors are
difficult to forecast, and these or other factors could have a material adverse
effect on the Company's business, financial condition and results of operations.
Fluctuations in quarterly demand for products may adversely affect the
continuity of the Company's operations, increase uncertainty in operational
planning, disrupt cash flow from operations and increase the volatility of the
Company's stock price. The Company's expenditures are based in part on the
Company's expectations as to future revenue levels and to a large extent are
fixed in the short term. If revenues do not meet expectations, the Company's
business, financial condition and results of operations could be materially
adversely affected. The Company believes that period to period comparisons of
its operating results are not necessarily meaningful and should not be relied
upon as indications of future performance. As a result of the foregoing factors,
it is likely that in some future quarter the Company's revenue or operating
results will be below the expectations of public market analysts and investors.
In such event, the price of the Company's Common Stock could be materially
adversely affected.
TEMPORARY EXEMPTION ON NASDAQ SMALLCAP LISTING; RISKS RELATING TO
LOW-PRICE STOCKS. From October 1996 until February 19, 1998, the Common Stock
traded on The Nasdaq National Market under the symbol "ACMI." Due to the
Company's failure to meet the continued listing requirements of the Nasdaq
National Market, Nasdaq moved trading of the Common Stock to The Nasdaq SmallCap
Market under the symbol "AMCIC" on February 19, 1998, pursuant to a temporary
exemption from the initial listing requirements.
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On February 17, 1998, Nasdaq notified the Company that in order to
continue listing of the Common Stock on the Nasdaq SmallCap Market the Company
must (i) file an application for listing the Common Stock on the Nasdaq SmallCap
Market by February 28, 1998, and (ii) file with the Commission on or prior to
March 20, 1998, a pro forma balance sheet dated February 28, 1998 showing net
tangible assets of a minimum of $7,000,000 and compliance with all criteria for
continued listing on the Nasdaq SmallCap Market. The Company filed the required
listing application within the prescribed period. On March 20, 1998, the Company
filed with the Commission a Current Report on Form 8-K evidencing compliance
with the $7,000,000 minimum net tangible assets requirement and all criteria for
continued listing, except that, from February 19, 1998 through March 23, 1998
and then again on April 2, 1998, the bid price for the Common Stock dropped
below the $1.00 minimum bid price for continued listing.
On March 17, 1998, Nasdaq granted the Company's request for an extension
of the deadline for achieving compliance with the minimum $1.00 price per share
of Common Stock to allow time to complete a reverse stock split as a possible
means to increase the bid price of the Common Stock. An amendment to the
Company's Certificate of Incorporation to effect a one-for-six reverse stock
split on the Common Stock was approved by stockholders on May 19, 1998 and
became effective at the opening of trading on May 21, 1998 (at which time the
new temporary symbol for the Common Stock became "ACMCD"). Nasdaq has required
that the bid price remain over $1.00 per share during the ten consecutive
trading days (through June 5, 1998) following the effectiveness of the reverse
stock split. The Company achieved this requirement.
In order to maintain listing on The Nasdaq SmallCap Market, the Company
will have to maintain certain minimum financial and corporate governance
requirements which generally requires either (x) (i) net tangible assets of
$2,000,000, (ii) a public float of 500,000 shares with a market value of
$1,000,000, (iii) a $1.00 minimum bid price, (iv) 300 round lot stockholders and
(v) two market makers. There can be no assurances that the Company will be able
to maintain compliance for continued listing.
If the Common Stock is not listed on Nasdaq, trading, if any, in the
Common Stock would thereafter be conducted in the non-Nasdaq over-the-counter
market in the so-called "pink sheets" or the NASD's "Electronic Bulletin Board."
Consequently, the liquidity of the Company's securities could be impaired, not
only in the number of shares of Common Stock that would be bought and sold, but
also through delays in the timing of transactions, reduction in security analyst
coverage of the Company and lower prices for the Common Stock than might
otherwise be attained. Consequently, investors could find it more difficult to
dispose of, or to obtain accurate quotations as to the market value of the
Company's Common Stock. In addition, delisting could result, in certain
circumstances, in the Common Stock becoming characterized as a low-priced or
"penny" stock. In such event, the market liquidity for the Company's securities
could be severely affected as the Common Stock would be subject to compliance
with The Securities Enforcement and Penny Stock Reform Act of 1990. The
regulations governing low-priced, so-called "penny" stocks could limit the
ability of broker-dealers to sell the Company's Common Stock and, in turn, the
ability of stockholders to sell their Common Stock.
VOLATILITY OF STOCK PRICE. The market price of the shares of the
Company's Common Stock, like that of the common stock of many other medical
products and high technology companies, has in the past been, and is likely in
the future to continue to be, highly volatile. Factors such as fluctuations in
the
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Company's operating results, announcements of technological innovations or new
commercial products by the Company or competitors, government regulation,
changes in the current structure of the health care financing and payment
systems, developments in or disputes regarding patent or other proprietary
rights, economic and other external factors and general market conditions may
have a significant effect on the market price of the Common Stock. Moreover, the
stock market has from time to time experienced extreme price and volume
fluctuations which have particularly affected the market prices for medical
products and high technology companies and which have often been unrelated to
the operating performance of such companies. These broad market fluctuations, as
well as general economic, political and market conditions, may adversely affect
the market price of the Company's Common Stock. In the past, following periods
of volatility in the market price of a company's common stock, securities class
action litigations have occurred against the issuing company. There can be no
assurance that such litigation will not occur in the future with respect to the
Company. Such litigation could result in substantial costs and diversion of
management's attention and resources, which could have a material adverse effect
on the Company's business, financial condition and results of operations. Any
adverse determination in such litigation could also subject the Company to
significant liabilities.
NEED TO MANAGE EXPANDING OPERATIONS. The Company will be required to
expand its operations, particularly in the areas of sales and marketing. Such
expansion will likely result in new and increased responsibilities for
management personnel and place significant strain upon the Company's management,
operating and financial systems and resources. To accommodate any such growth
and compete effectively, the Company may be required to implement and/or improve
its information systems, procedures and controls, and to expand, train, motivate
and manage its work force. The Company's future success will depend to a
significant extent on the ability of its current and future management personnel
to operate effectively, both independently and as a group. There can be no
assurance that the Company's personnel, systems, procedures and controls will be
adequate to support the Company's future operations. Any failure to implement
and improve the Company's operational, financial and management systems or to
expand, train, motivate or manage employees as required by future growth, if
any, could have a material adverse effect on the Company's business, financial
condition and results of operations.
RISK OF LITIGATION; RISK OF PRODUCT RECALLS; POTENTIAL UNAVAILABILITY OF
INSURANCE. Commercial screening of Pap smear tests has been characterized by
significant malpractice litigation. The Company faces a risk of exposure to
product liability, errors and omissions or other claims if the use of its AcCell
System 2000 or any future potential products, including the TracCell 2000, is
alleged to have contributed to or resulted in a false negative diagnosis. While
neither the AcCell System 2000 nor the TracCell 2000 is purported to offer any
clinical diagnosis, there can be no assurance that the Company will avoid
significant litigation. The Company also faces the possibility that defects in
designs or manufacture of its products could result in product recall.
The Company currently maintains a product liability insurance policy
providing maximum coverage of $10.0 million and per occurrence coverage of $10.0
million. The medical device industry in general has experienced increasing
difficulty in obtaining and maintaining reasonable product liability coverage,
and substantial increases in insurance premium costs in many cases have rendered
coverage economically impractical. There can be no assurance that the Company's
existing product liability
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insurance will be adequate or continue to be available, or that additional
product liability insurance will be available to the Company when needed or at a
reasonable cost. An inability to maintain insurance at acceptable costs or
otherwise protect against potential product liability could prevent or inhibit
the continued commercialization of the Company's products. In addition, a
product liability claim in excess of relevant insurance coverage or a product
recall could have a material adverse effect on the Company's business, financial
condition and results of operations.
IMPACT OF MEDICARE, MEDICAID AND OTHER THIRD-PARTY REIMBURSEMENT. In the
United States, some Pap smear screenings are currently paid for by the patient
directly, and the level of reimbursement by third party payers that do provide
reimbursement varies considerably. Third party payers (Medicare/Medicaid,
private health insurance, health administration authorities in foreign countries
and other organizations) may affect the demand, pricing or relative
attractiveness of the Company's products and services by regulating the
frequency and maximum amount of reimbursement for Pap smear screening provided
by such payers or by not providing any reimbursement at all. Restrictions on
reimbursement for Pap smear screening may limit the price that the Company can
charge for its products or reduce the demand for them. In addition, if the level
of reimbursement provided by Medicare and Medicaid is significantly below the
amount laboratories and hospitals charge patients to perform Pap smear
screening, the size of the potential market available to the Company may be
reduced. There can be no assurance that the level of reimbursement for Pap smear
screening will achieve, or be maintained at, levels necessary to permit the
Company to generate substantial revenues or be profitable.
In the international market, reimbursement by private third party
medical insurance providers, including governmental insurers and providers,
varies from country to country. In certain countries, the Company's ability to
achieve significant market penetration may depend upon the availability of third
party or governmental reimbursement.
UNCERTAINTY AND POSSIBLE NEGATIVE EFFECTS OF HEALTH CARE REFORM. The
health care industry is undergoing fundamental changes that are the result of
political, economic and regulatory influences. In the United States,
comprehensive programs have been proposed that seek to control the escalation of
health care expenditures within the economy. Reforms that have been, and may be,
considered include controls on health care spending through limitations on the
increase in private health insurance premiums and Medicare and Medicaid
spending, the creation of large insurance purchasing groups and other
fundamental changes to the health care delivery system. Health care reform
could, for example, result in a reduction in the recommended frequency of Pap
smear screening or limitations on reimbursement which would likely reduce the
demand for the Company's cytopathology products. The Company anticipates that
Congress and state legislatures will continue to review and assess cost
containment measures, alternative health care delivery systems and methods of
payment, and that public debate of these issues will likely continue. Due to
uncertainties regarding the outcome of health care reform initiatives and their
enactment and implementation, the Company cannot predict what reforms will be
proposed or adopted or the effect that such proposals or their adoption may have
on the Company. There can be no assurance that future health care legislation or
other changes in the administration or interpretation of government health care
or third party reimbursement programs will not have a material adverse effect on
the Company's business, financial condition and results of operations.
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LACK OF DIVIDENDS. The Company has never paid cash or other dividends on
its Common Stock and does not anticipate paying any cash dividends on its Common
Stock in the foreseeable future.
AUTHORIZATION AND POTENTIAL ISSUANCE OF ADDITIONAL PREFERRED STOCK;
DELAWARE ANTI-TAKEOVER LAW. The Company's Certificate of Incorporation
authorizes the issuance of Preferred Stock with such designations, rights and
preferences as may be determined from time to time by the Board of Directors.
Accordingly, the Board of Directors is empowered, without stockholder approval,
to issue Preferred Stock with dividend, liquidation, conversion, voting or other
rights which could adversely affect the voting power or other rights of the
holders of the Company's Common Stock. The Company currently has outstanding
944,383 shares of Series A Convertible Preferred Stock. Although the Company
does not currently intend to issue any other shares of its Preferred Stock, in
the event of issuance, such shares could be utilized, under certain
circumstances, as a method of discouraging, delaying or preventing a change in
control of the Company. There can be no assurance that the Company will not,
under certain circumstances, issue shares of its Preferred Stock. Furthermore,
the Company may in the future adopt other measures that may have the effect of
delaying, deferring or preventing a change in control of the Company. Certain of
such measures may be adopted without any further vote or action by the
stockholders, although the Company has no present plans to adopt any such
measures. The Company is also afforded the protections of Section 203 of the
Delaware General Corporation Law, which could delay or prevent a change in
control of the Company, impede a merger, consolidation or other business
combination involving the Company or discourage a potential acquirer from making
a tender offer or otherwise attempting to obtain control of the Company.
SHARES ELIGIBLE FOR FUTURE SALE. Sales of substantial amounts of Common
Stock in the public market, or the possibility of such sales occurring, could
adversely affect prevailing market prices for the Common Stock or the future
ability of the Company to raise capital through an offering of equity
securities. As of November 4, 1999, the Company has outstanding 5,491,901 shares
of Common Stock, warrants to purchase 2,229,784 shares of Common Stock, and
options to purchase 675,437 shares of Common Stock. As of November 4, 1999,
approximately 5,438,126 shares have been sold or are available for immediate
sale in the public market pursuant to effective registration statements or
exemptions from registration under the Securities Act of 1933, as amended (the
"Securities Act"), subject in the case of certain holders to the limitations
applicable to affiliates pursuant to Rule 144 under the Securities Act. The
Company has registered the issuance of approximately 20,700 shares of Common
Stock issuable upon the exercise of options outstanding pursuant to certain of
the Company's stock option plans. Such shares are available for immediate sale
in the public market upon exercise of options. In addition to the resale of the
250,000 Shares to be registered hereby, the resale of approximately 2,794,195
shares of Common Stock underlying immediately exercisable warrants or
immediately convertible Series A Convertible Preferred Stock has been registered
pursuant to currently effective registration statements. The Company also
intends to register the resale of approximately 269,400 shares issuable upon
exercise of options granted under the 1997 Stock Option Plan approved by
stockholders in May 1998.
YEAR 2000 COMPLIANCE. The inability of computers, software and other
equipment utilizing microprocessors to recognize and properly process data files
containing a two-digit year is commonly referred to as the Year 2000 compliance
issue. As the Year 2000 approaches, such systems may be
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unable to accurately process certain date-based information. The Company and
third parties with which it does business rely on numerous computer programs in
their day-to-day operations.
The Company's Year 2000 compliance plan provided for and resulted in the
conversion of non- compliant information technology systems in the third quarter
of 1999. The conversion project involved three phases: selection and
installation of hardware and software, loading the financial database into the
new system, and testing. Conversion to Year 2000 compliant information
technology systems was completed in the third quarter of 1999.
The Company has reviewed its non-information technology systems and has
determined that any required repair of replacement of imbedded technology should
not have a significant impact on the Company's operations. The Company has
received representations from its vendors of non-financial network servers and
software that these products are Year 2000 compliant. All of the Company's
products, including software sold in products to customers, have been developed
with consideration for the millennium change, and have undergone specific Year
2000 date testing to verify and validate compliance.
The Company has made inquiry of its bank and has received
representations that the devices and software it uses is Year 2000 compliant.
RECENT DEVELOPMENTS
The Company and Microsulis Corporation, a Florida corporation
("Microsulis"), have entered into a Letter of Intent dated October 6, 1999, as
amended (the "Letter of Intent"), pursuant to which Microsulis would be merged
(the "Microsulis Merger") with and into the Company or a wholly-owned subsidiary
of the Company which would continue to exist as a corporate entity (the
"Surviving Corporation"). The Letter of Intent provides that the Company's
current stockholders would retain an aggregate of approximately 37.5% of the
outstanding Common Stock and Microsulis stockholders would receive an aggregate
of approximately 62.5% of the Common Stock in the Surviving Corporation (based
on shares of Common Stock. The Common Stock would remain unchanged.
Microsulis markets, distributes and may manufacture a Microwave
Endometrial Ablation system ("MEA system") for the treatment of menorrhagia, a
condition of excessive menstrual blood loss in women. MEA is a minimally
invasive day-patient or out-patient procedure for the treatment of menorrhagia
which can be performed in approximately three to five minutes under local
anesthesia. The typical at-home recovery period is approximately two to three
days. Unlike other procedures currently on the market, the MEA system employs
microwave frequency radiation, which allows for deeper penetration into the
endometrium in a much shorter time period than other current procedures. During
the procedure, a surgeon inserts an applicator (the "MEA Applicator") into the
uterus and moves the MEA Applicator from side to side until the therapeutic
temperature is reached and the entire uterine cavity is covered.
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Microsulis has the exclusive right to distribute the MEA system in the
United States, Canada and Central and South America pursuant to a 20-year
license agreement with Microsulis PLC, a company organized under the laws of the
United Kingdom. Microsulis is presently marketing the MEA system for sale in
Canada through its wholly-owned subsidiary, Microsulis (Canada) Inc., with the
assistance of a distributor, Minogue Medical, Inc.
Consummation of the Microsulis Merger is subject to the following
conditions, among others, (i) satisfaction with the results of a due diligence
investigation by each corporation with respect to the other, (ii) negotiation,
board approval, and execution and delivery of a definitive merger agreement
containing representations, warranties, covenants and conditions customary in
such transactions, (iii) effectiveness of a registration statement registering
the shares of Common Stock to be issued to Microsulis stockholders and clearance
by the Commission of the Company's proxy materials for use in connection with a
special meeting of stockholders, and (iv) approval of the Microsulis Merger by
the stockholders of the Company and Microsulis. Terms of the Microsulis Merger
as set forth in the definitive merger agreement, if any, could be materially
different from those of the Letter of Intent as described herein. There can be
no assurances that the Microsulis Merger will be consummated.
USE OF PROCEEDS
The Company will not receive any proceeds from the sale of the Shares of
Common Stock by the Selling Securityholder. If the holder fully converts the
Convertible Note into the Shares, the Company will be relieved of the
obligations to repay to the holder the CND$500,000 principal amount of the
Convertible Note. Any such resulting savings will be used by the Company for
general corporate purposes, including research and development, and working
capital. The Company has agreed to pay certain expenses in connection with this
Offering, currently estimated to be approximately $18,000.
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PRICE RANGE OF COMMON STOCK
The Company's Common Stock is quoted on the Nasdaq SmallCap Market under
the trading symbol "ACMI." On November 4, 1999, the last reported sale price of
the Common Stock on the Nasdaq SmallCap Market was $1.75 per share. Effective
May 21, 1998, the Company effected a one-for-six reverse stock split on the
Common Stock. The tables below sets forth, for the periods indicated, the range
of high and low sales prices for the Common Stock on the Nasdaq SmallCap Market
on a post-reverse stock split basis. At November 4, 1999, there were
approximately 5,500 beneficial owners of Common Stock.
High Low
----- -----
1997 FISCAL YEAR
First Quarter 26.63 14.44
Second Quarter 24.75 18.00
Third Quarter 22.88 13.50
Fourth Quarter 18.00 5.63
1998 FISCAL YEAR
First Quarter 13.88 3.75
Second Quarter 8.63 1.31
Third Quarter 2.06 0.56
Fourth Quarter 2.75 0.31
1999 FISCAL YEAR
First Quarter 1.91 0.59
Second Quarter 1.31 0.72
Third Quarter 1.22 0.47
Fourth Quarter (through
November 4, 1999) 2.06 0.56
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SELLING SECURITYHOLDER
The following table sets forth information as of November 4, 1999 (the
"Reference Date") with respect to the beneficial ownership of shares of Common
Stock by the Selling Securityholder. At the Reference Date there were
approximately 5,491,901 shares of Common Stock outstanding (subject to further
adjustment to reflect issuance of one additional whole share of Common Stock in
lieu of a fractional share otherwise issuable in the one-for-six reverse stock
split effective May 21, 1998).
Shares to
Shares Beneficially Owned be Sold in Shares Beneficially Owned
Prior to Offering(1) Offering After Offering(1)
------------------------- ----------- -------------------------
NAME Number Percent Number Percent
- ---- ------ ------- ------ -------
250,000 4.4 0 *
- -----------------------
* Represents less than 1%.
(1) The Company believes that the person named in the table has sole voting
and investment power with respect to all shares of Common Stock listed
as beneficially owned by them. A person is deemed to be the beneficial
holder of securities that can be acquired by such person within 60 days
from the Reference Date upon the exercise of warrants and other
securities convertible into Common Stock. The beneficial owner's
percentage ownership is determined by including shares underlying
securities which are exercisable or convertible into Common Stock by
such person currently or within 60 days following the Reference Date,
and excluding shares underlying securities held by any other person. The
percentage of shares owned after the Offering is calculated assuming
that 5,741,901 shares of Common Stock will be outstanding, which
includes the 5,491,901 shares outstanding on the Reference Date and an
additional 250,000 Shares underlying the Convertible Note which would
have to be converted in order to sell the Shares.
(2) Shares listed as held by Xillix Technologies Corp. include 250,000
Shares underlying the Convertible Note that is convertible currently or
within 60 days following the Reference Date.
The Company has agreed to indemnify the Selling Securityholder and the
Selling Securityholder has agreed to indemnify the Company against certain civil
liabilities, including liabilities under the Securities Act.
Except as noted under the caption "Certain Relationships and
Transactions" below, the Selling Securityholder has held any office or
maintained any material relationship with the Company or any of its affiliates
during the past three years.
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CERTAIN RELATIONSHIPS AND TRANSACTIONS
Set forth below is certain information regarding certain relationships
and transactions between the Selling Securityholder and the Company and
Oncometrics during the past three years.
On October 15, 1996, the Company acquired a two-thirds equity interest
in Oncometrics for aggregate consideration of $4.0 million in cash. Of the
consideration, $2.0 million was paid to the Selling Securityholder and former
parent corporation of Oncometrics for 1,000,000 shares of previously outstanding
common stock of Oncometrics ("Oncometrics Stock") pursuant to a Share Purchase
Agreement between the Company and the Selling Securityholder dated as of August
16, 1996. The remaining $2.0 million was paid to Oncometrics in consideration
for 1,000,0000 newly issued shares of Oncometrics Stock pursuant to Subscription
Agreement.
Between October 15, 1996 and June 25, 1998, a Shareholders Agreement was
in effect between the Company and the Selling Securityholder pertaining to,
among other things, capital contributions and corporate governance of
Oncometrics, and restrictions and procedures for transfer of Oncometrics Stock.
Pursuant to the Shareholders Agreement, the Selling Securityholder was entitled
to nominate one member of the Oncometrics Board of Directors. Pierre Leduc,
President and Chief Executive Officer of the Selling Securityholder, served as a
director and Secretary of Oncometrics during the term of such agreement.
On June 25, 1998 the Company paid a purchase price of CND$500,000 in
cash and the Convertible Note in to acquire from the Selling Securityholder the
remaining one-third interest in Oncometrics. At such time, Oncometrics became a
wholly-owned subsidiary of the Company. The Convertible Note bears interest a
the rate of the Prime Rate (as defined therein) plus 2% (or a default rate of
prime plus 6%) payable quarterly in arrears. The Convertible Note is convertible
in whole or part any time on or after June 25, 1999 at a current conversion rate
of US$1.43 per share (subject to adjustment).
PLAN OF DISTRIBUTION
The Selling Securityholder may sell the Shares of Common Stock (i) in an
underwritten offering or offerings, (ii) through brokers and dealers, (iii) "at
the market" to or through a market maker or in an existing trading market, on an
exchange or otherwise, for such Shares, (iv) in other ways not involving market
makers or established trading markets, including direct sales to purchasers and
(v) to the extent not prohibited by applicable securities law, in ways other
than pursuant to the distribution plan presented in this Prospectus.
The distribution of Shares of Common Stock may be effected from time to
time in one or more underwritten transactions at a fixed price or prices, which
may be changed, or at market prices prevailing at the time of sale, at prices
related to such prevailing
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market prices or at negotiated prices. Any such underwritten offering may be on
a "best efforts" or a "firm commitment" basis.
In connection with any such underwritten offering, underwriters or
agents may receive compensation from the Selling Securityholder for whom they
may act as agents in the form of discounts, concessions or compensation in the
form of discount, concessions or commissions from the underwriters and/or
commissions from the purchasers for whom they may act as agents.
At any time a particular offer of Shares of Common Stock is made, if
required, a Prospectus Supplement will be distributed that will set forth the
names of the Selling Securityholder(s) offering such Shares of Common Stock, the
aggregate amount of such Shares of Common Stock being offered and the terms of
the offering, including the names or names of any underwriters, dealers or
agents, any discounts, commissions and other items constituting compensation
from the Selling Securityholder and any discounts, commissions or concessions
allowed or reallowed or paid to dealers. Such Prospectus Supplement and, if
necessary, a post-effective amendments to the tea Registration Statement of
which this Prospectus forms as part, will be filed with the Commission to
reflect the disclosure of additional information with respect to the
distribution of such Shares of Common Stock.
The Selling Securityholder and any underwriters, dealers or agents that
participate in the distribution of Shares of Common Stock may be deemed to be
underwriters, and any profit on the sale of Shares of Common Stock by the
Selling Securityholder and any discount, commissions or concessions received by
any such underwriters, dealers or agents might be deemed to be underwriting
discounts and commissions under the Securities Act.
Under an agreement that may be entered into by the Company,
underwriters, dealers, and agents who participate in the distribution of Shares
of Common stock may be entitled to indemnification by the Company against
certain liabilities, including liabilities under the Securities Act, or to
contribution with respect to payments which such underwriters, dealers or agents
may be required to make in respect thereof.
The sale of Shares of Common Stock by Selling Securityholder may also be
effect from time to time by Selling Securityholder directly to purchasers or to
or through certain broker-dealers. In connection with any such sale, any such
broker-dealer, acting as agent or s principal, may be made pursuant to any of
the methods described below. Such sales may be made on the Nasdaq or other
exchanges on which the Common Stock is then traded, in the over-the-counter
market, in negotiated transactions or otherwise at prices and at terms then
prevailing or at prices related to the then-current market prices or at prices
otherwise negotiated.
The Shares of Common Stock may also be sold in one or more of the
following transactions: (i) a block transactions (which may involve crosses) in
which a broker-dealer may sell all or a portion of such shares as agent but may
position and resell all or a portion of the block as principal to facilitate the
transaction; (ii) purchases by any such broker-dealer as principal and resale by
such broker-dealer for its own account pursuant to this Prospectus which forms a
part of the Registration Statement; (iii) a special offering, an exchange
distribution or a secondary distribution in accordance with applicable stock
exchange rules; and (iv) ordinary brokerage transactions and transactions in
which any such broker-dealer solicits purchasers. In effecting sales,
broker-dealers engaged by the Selling Securityholder may arrange for to the
broker-dealers to participate. Broker-dealers will receive commissions or other
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compensation from the Selling Securityholder in amounts to be negotiated
immediately prior to the sale that will not exceed the customary in the type of
transactions involved. Broker-dealers may also receive compensation from
purchasers of the Shares which is not expected to exceed that customary in the
types of transactions involved.
Such brokers or dealers and any other participating brokers or dealers
may be deemed to be "underwriters" within the meaning of the Securities Act in
connection with such sales. In addition, any securities covered by this
Prospectus that qualify for sale pursuant to Rule 144 under the Securities Act
might be sold under Rule 144 rather than pursuant to this Prospectus.
LEGAL MATTERS
The legality of the securities offered by this Prospectus will be passed
upon for the Company by its General Counsel, Joyce L. Wallach, Esq.
EXPERTS
The consolidated financial statements and schedules of AccuMed
International, Inc. and subsidiaries as of December 31, 1998 and 1997, and for
each of the years and the three-year period ended December 31, 1998 have been
incorporated by reference herein and in the registration statement in reliance
upon the report of KPMG, L.L.P., independent certified public accountants,
incorporated by reference herein, and upon the authority of said firm as experts
in accounting and auditing.
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=================================== ====================================
No dealer, salesperson or any
other person has been authorized to
give any information or to make any 250,000 Shares
representations other than those
contained in this Prospectus and, ACCUMED INTERNATIONAL,
if given or made, such information
or representations must not be INC.
relied upon as having been
authorized by the Company or any Common Stock
selling securityholder. This
Prospectus does not constitute an --------------
offer to sell, or a solicitation of
any offer to buy any security other
than the shares of Common Stock
offered by this Prospectus, nor PROSPECTUS
does it constitute an offer to sell
or a solicitation of any offer to ---------------
buy the shares of Common Stock by
anyone in any jurisdiction in which
such offer or solicitation is not
authorized, or in which the person
making such offer or solicitation
is not qualified to do, or to any
person to whom it is unlawful to
make such offer or solicitation.
Neither the delivery of this
Prospectus nor any sale made
hereunder shall, under any
circumstances, create any
implication information contained
herein is correct as of any time
subsequent to the date hereof.
----------------------
TABLE OF CONTENTS
Page
----
Special Note Regarding Forward
Looking Statements ...............
Available Information.............
Additional Information............
Incorporation of Certain
Documents by Reference ...........
Prospectus Summary................
The Company.......................
Risk Factors .....................
Use of Proceeds...................
Selling Securityholder............
Certain Relationships and
Transactions...........
Plan of Distribution..............
Legal Matters.....................
Experts ..........................
=================================== ===================================
36
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses, other than
underwriting discounts and commissions, payable by the Company in connection
with the issuance and distribution of the securities being registered hereunder.
All of the amounts shown are estimates (except for the SEC registration fee).
SEC registration fee $ 122
Printing and engraving expenses $ 3,000
Accounting fees and expenses $10,000
Legal fees and expenses $ 4,000
Blue Sky fees and expenses $ 500
Miscellaneous $ 378
- ----------------------------------------------------
TOTAL $18,000
None of these expenses will be paid by the Selling Securityholder
pursuant to the terms of the agreement under which the shares of Common Stock to
be sold hereby will be issued.
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Company has provisions in its Certificate of Incorporation which
eliminate the liability of the Company's directors to the Company and its
stockholders for monetary damages to the fullest extent permissible under
Delaware law and provisions which authorize the Company to indemnify its
directors and agents by bylaws, agreements or otherwise, to the fullest extent
permitted by law. Such limitation of liability does not affect the availability
of equitable remedies such as injunctive relief or rescission.
The Company's Bylaws provide that the Company shall indemnify its
directors and officers to the fullest extent permitted by Delaware law.
The Company's officers and directors are covered by a director's and
officer's liability insurance policy maintained by the Company. Under the
insurance policy, the Company is entitled to be reimbursed for indemnity
payments that it is required or permitted to make to its directors and officers.
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37
ITEM 16. EXHIBITS
The following exhibits are filed herewith:
EXHIBIT
NUMBER DESCRIPTION
------ -----------
4.1 Certificate of Incorporation of the Registrant.(1)
4.2 Certificate of Amendment to Certificate of Incorporation of the
Registrant increasing authorized Common Stock.(2)
4.5 Certificate of Amendment to Certificate of Incorporation of the
Registrant effecting reverse stock split.(3)
4.6 Specimen Certificate for Common Stock.(1)
4.7 Bylaws of the Registrant.(1)
4.8 Amendment No. 1 to Bylaws of the Registrant.(4)
4.9 Floating Rate Convertible Promissory Note dated June 26, 1998
made by the Registrant in favor of Xillix Technologies Corp. in
the original principal amount of CND$500,000.
5.1 Opinion of Joyce L. Wallach, Esq., counsel to the Registrant,
regarding the legality of the securities offered hereby.
23.1 Consent of Joyce L. Wallach, Esq., counsel to the Registrant,
(contained in Exhibit 5.1).
23.2 Consent of KPMG LLP.
24.1 Powers of Attorney (contained in the signature page).
- ------------------------
(1) Incorporated by reference to the Registrant's Transition Report of Form
10-KSB for the transition period ended December 31, 1995.
(2) Incorporated by reference to the Registration Statement on Form S-3
(Regis. No. 333-28125) filed with the Commission on May 30, 1997.
(3) Incorporated by reference to the Registration Statement on Form S-3
(Regis. No. 333-56393) filed with the Commission on June 9, 1998.
(4) Incorporated by reference to the Annual Report on Form 10-K for the year
ended December 31, 1997.
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ITEM 17. UNDERTAKINGS
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made,
a post-effective amendment to this registration statement to include any
additional or changed material information with respect to the plan of
distribution.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the termination of
the offering.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 (the Act") may be permitted to directors, officers and controlling
persons of the Company pursuant to the foregoing provisions, or otherwise, the
Company has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the Company of expenses
incurred or paid by a director, officer or controlling person of the Company in
the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the Company will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
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1
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-3 and has duly caused this Registration
Statement on Form S-3 to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Chicago, State of Illinois on November 9, 1999.
ACCUMED INTERNATIONAL, INC.
By:/s/Paul F. Lavallee,
-------------------------------------
Chairman, Chief Executive Officer
and Principal Accounting Officer
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement on Form S-3 has been signed by the following persons in
the capacities and on the dates indicated.
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Paul F. Lavallee attorney-in-fact for the
undersigned, with the power of substitution, for the undersigned in any and all
capacities, to sign any and all amendments to this Registration Statement
(including post-effective amendments), and to file the same, with all exhibits
thereto, and other documents inc connection therewith, with the Securities and
Exchange Commission, hereby certifying and confirming all that each of said
attorneys-in-fact or his substitute or substitutes may lawfully do or causes to
be done by virtue hereof.
Signature Title Date
- --------- ----- ----
/s/ Paul F. Lavallee Chairman of the Board, November 9, 1999
- --------------------------------- and Chief Executive Officer, and
(Paul F. Lavallee) Principal Accounting Officer (Principal
Executive Officer and Principal
Accounting Officer)
/s/ Mark Banister Director November 9, 1999
- ---------------------------------
(Mark Banister)
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Signature Title Date
- --------- ----- ----
/s/ Jack H. Halperin Director November 9, 1999
- ---------------------------------
(Jack H. Halperin)
/s/ Robert L. Priddy Director November 9, 1999
- ---------------------------------
(Robert L. Priddy)
/s/ Leonard M. Schiller Director November 9, 1999
- ---------------------------------
(Leonard M. Schiller)
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INDEX TO EXHIBITS
EXHIBIT
NUMBER DESCRIPTION
------ -----------
4.1 Certificate of Incorporation of the Registrant.(1)
4.2 Certificate of Amendment to Certificate of Incorporation of the
Registrant increasing authorized Common Stock.(2)
4.5 Certificate of Amendment to Certificate of Incorporation of the
Registrant effecting reverse stock split.(3)
4.6 Specimen Certificate for Common Stock.(1)
4.7 Bylaws of the Registrant.(1)
4.8 Amendment No. 1 to Bylaws of the Registrant.(4)
4.9 Floating Rate Convertible Promissory Note dated June 26, 1998
made by the Registrant in favor of Xillix Technologies Corp. in
the original principal amount of CND$500,000.
5.1 Opinion of Joyce L. Wallach, Esq., counsel to the Registrant,
regarding the legality of the securities offered hereby.
23.1 Consent of Joyce L. Wallach, Esq., counsel to the Registrant,
(contained in Exhibit 5.1).
23.2 Consent of KPMG LLP.
24.1 Powers of Attorney (contained in the signature page).
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(1) Incorporated by reference to the Registrant's Transition Report of Form
10-KSB for the transition period ended December 31, 1995.
(2) Incorporated by reference to the Registration Statement on Form S-3
(Regis. No. 333-28125) filed with the Commission on May 30, 1997.
(3) Incorporated by reference to the Registration Statement on Form S-3
(Regis. No. 333-56393) filed with the Commission on June 9, 1998.
(4) Incorporated by reference to the Annual Report on Form 10-K for the year
ended December 31, 1997.
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