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AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 22, 2000
REGISTRATION NO. 333-94379
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------------------
PRE-EFFECTIVE AMENDMENT NO. 4
TO
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
-------------------------------------
BOSTON BIOMEDICA, INC.
(Exact Name of Registrant as Specified in Its Charter)
MASSACHUSETTS 04-2652826
(STATE OR OTHER JURISDICTION OF (IRS EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NUMBER)
375 WEST STREET
WEST BRIDGEWATER, MASSACHUSETTS 02379
(508) 580-1900
(Address, Including Zip Code, and Telephone Number, Including Area Code, of
Registrant's Principal Executive Offices)
-----------------------------------
RICHARD T. SCHUMACHER
BOSTON BIOMEDICA, INC.
375 WEST STREET
WEST BRIDGEWATER, MA 02379
(508) 580-1900
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code,
of Agent for Service)
----------------------------------
COPIES TO:
STEVEN R. LONDON, ESQUIRE
BROWN, RUDNICK, FREED & GESMER
ONE FINANCIAL CENTER
BOSTON, MASSACHUSETTS 02111
TEL: (617) 856-8200
FAX: (617) 856-8201
----------------------------------
Approximate date of commencement of proposed sale to the public: From time to
time after the effective date of this Registration Statement.
If the 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 Securities Act of 1933,
other than securities offered only in connection with dividend or interest
reinvestment plans, 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 THIS
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.
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PROSPECTUS (SUBJECT TO COMPLETION)
THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE
HAVE FILED A REGISTRATION STATEMENT RELATING TO THE COMMON STOCK WITH THE
UNITED STATES SECURITIES AND EXCHANGE COMMISSION. WE MAY NOT SELL THE COMMON
STOCK UNTIL THE SEC DECLARES THAT THE REGISTRATION STATEMENT IS EFFECTIVE.
THIS PROSPECTUS IS NOT AN OFFER TO SELL THE COMMON STOCK AND IT IS NOT
SOLICITING AN OFFER TO BUY THE COMMON STOCK IN ANY STATE WHERE THE OFFER OR
SALE IS NOT PERMITTED.
BOSTON BIOMEDICA, INC.
Up to 633,306 Shares of Common Stock
The shareholders named on page 13 are offering for sale up to 633,306
shares of our common stock under this prospectus.
Our common stock is traded on the Nasdaq National Market under the
symbol "BBII." On November 17, 2000, the last reported sale price of our
common stock was $2.94 per share.
AN INVESTMENT IN THE COMMON STOCK OFFERED UNDER THIS PROSPECTUS INVOLVES A
HIGH DEGREE OF RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 4.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF
THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY
IS A CRIMINAL OFFENSE.
The date of this prospectus is _______, 2000
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TABLE OF CONTENTS
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SUMMARY......................................................................3
RISK FACTORS.................................................................4
WARNINGS REGARDING FORWARD-LOOKING STATEMENTS...............................13
USE OF PROCEEDS.............................................................13
SELLING SHAREHOLDERS........................................................15
PLAN OF DISTRIBUTION........................................................16
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES..............................17
LEGAL MATTERS...............................................................18
EXPERTS.....................................................................18
WHERE YOU CAN FIND MORE INFORMATION.........................................18
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SUMMARY
ABOUT BOSTON BIOMEDICA
Boston Biomedica provides products and services for the detection
and treatment of infectious diseases such as AIDS, lyme disease, and viral
Hepatitis. We currently operate four business units:
(1) BBI Diagnostics, a manufacturer and seller of quality control
and diagnostic products that increase the accuracy of
diagnostic tests that are performed IN VITRO, in a test tube
or other laboratory equipment;
(2) BBI Clinical Laboratories, a leading infectious disease
testing laboratory that specializes in testing blood for the
presence or absence of nucleic acids in pathogens, testing for
tick borne diseases and follow-up testing for blood banks
after an initial test shows questionable or positive results;
(3) BBI Biotech Research Laboratories, our research and
development arm, which provides research and development
support for our other business units and contract research
services and specimen storage services for other parties,
including various agencies of the National Institutes of
Health; and,
(4) BBI Source Scientific, a manufacturer and seller of laboratory
and medical instruments.
In addition, we are also conducting research in a technology that
repeatedly applies and releases pressure on pathogens present in blood or
plasma in an effort to destroy them, with the goal of introducing new
solutions for improving blood plasma safety, for improving specimen
preparation in the testing of blood for the presence or absence of nucleic
acids in pathogens and for improving the treatment of infectious diseases.
We were organized in Massachusetts in 1978 and commenced significant
operations in 1986. Our principal executive offices are located at 375 West
Street, West Bridgewater, Massachusetts 02379. Our telephone number is (508)
580-1900.
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RISK FACTORS
BEFORE YOU BUY SHARES OF OUR COMMON STOCK, YOU SHOULD BE AWARE THAT THERE ARE
VARIOUS RISKS ASSOCIATED WITH THAT PURCHASE, INCLUDING THOSE DESCRIBED BELOW.
YOU SHOULD CONSIDER CAREFULLY THESE RISK FACTORS, TOGETHER WITH ALL OF THE
OTHER INFORMATION IN THIS PROSPECTUS AND THE DOCUMENTS WE HAVE INCORPORATED
BY REFERENCE IN THE SECTION "WHERE YOU CAN FIND MORE INFORMATION" BEFORE YOU
DECIDE TO PURCHASE SHARES OF OUR COMMON STOCK.
WE RELY ON PURCHASE ORDERS AND CONTRACTS FROM A SMALL NUMBER OF CUSTOMERS FOR
A LARGE PORTION OF OUR REVENUES; THE LOSS OF BUSINESS FROM THESE CUSTOMERS
COULD MATERIALLY REDUCE OUR REVENUES AND INCOME.
Purchase orders account for the majority of our orders; none of our
customers have contractually committed to make future product purchases from
us. In 1999, our three largest customers, Hoffman-La Roche, Inc., Medilabs,
Inc. and Ortho-Diagnostics, Inc., together accounted for approximately 16% of
our revenues. In addition, the various agencies of the National Institutes of
Health, including the National Institutes of Allergies and Infectious
Disease, the National Cancer Institute and the National Heart Lung and Blood
Institute, in the aggregate accounted for approximately 15% of our revenues
in 1999. Each agency within the National Institutes of Health, however, makes
independent purchasing decisions. The loss of any major customer, including
any agency within the National Institutes of Health, or a material reduction
in any major customer's purchases would materially reduce our revenues and
our operating results.
IF WE ARE UNABLE TO INCREASE OUR SALES OF QUALITY CONTROL PRODUCTS TO
END-USERS OF INFECTIOUS DISEASE TEST KITS, THEN OUR FUTURE REVENUES COULD BE
LESS THAN WE HAVE PROJECTED.
Currently, we sell most of our quality control products for
infectious disease test kits to test kit manufacturers and regulators, which
is a relatively small market. However, we also sell our quality control
products to end-users of infectious disease test kits, including hospital
laboratories, blood donor testing centers, public health laboratories and
commercial laboratories. This end-user market is a larger market which has
not yet become accustomed to using quality control products to monitor test
results, but which we believe is a growing market. Currently, we expect an
increase in both the frequency of use and the number of products used by our
current end-user customers. However, these end-users of infectious
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disease test kits may not increase their use of our products. Further, large
manufacturers and distributors of quality control products that have
historically sold to the non-infectious disease market and that have greater
financial, manufacturing and marketing resources than we have could begin
selling their products to the end-users of infectious disease test kits. If
the end-user market for quality control products for infectious disease
testing does not develop further, or if we are unable to increase sales of
our products to this market, our future revenues could be substantially less
than we have projected.
IF OUR BBI BIOSEQ, INC. AND BBI SOURCE SCIENTIFIC, INC. SUBSIDIARIES CONTINUE
TO HAVE SUBSTANTIAL OPERATING LOSSES, THEN WE MAY NOT BE ABLE TO REALIZE THE
BOOK VALUE OF THEIR ASSETS.
Our BBI BioSeq subsidiary has incurred operating losses of
approximately $2,160,000, since its acquisition in September 1998, through
September 30, 2000. This subsidiary may not be successful in developing its
in-process technology, and its technology may never achieve commercial
viability. If we cannot successfully commercially develop its technology, our
BBI BioSeq subsidiary may never become profitable and we may need to write
off some or all of the current net book value of its intangible assets
related to its patents, which was approximately $681,000 as of September 30,
2000.
As a result of our July 1997 acquisition of Source Scientific, Inc.,
we recorded approximately $2,200,000 of goodwill. Since this acquisition, our
BBI Source Scientific subsidiary has incurred cumulative operating losses of
approximately $2,975,000, not including the write down of goodwill, as of
September 30, 2000. As of September 30, 2000, the net book value of goodwill
from the BBI Source Scientific acquisition of approximately $1,718,000 was
written down by approximately $1,464,000 to a balance of $254,000. That
subsidiary may continue to have operating losses and may never become
profitable. If operating losses continue, some or all of the remaining
goodwill associated with BBI Source Scientific may be written down or written
off entirely.
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IF WE ARE UNABLE TO OBTAIN BOTH THE NECESSARY REGULATORY APPROVALS AND
SUBSTANTIAL FUNDS FOR OUR BBI BIOSEQ SUBSIDIARY'S PRODUCTS, OUR FUTURE
REVENUES AND INCOME WILL BE LESS THAN WE HAVE PROJECTED.
Our BBI BioSeq subsidiary is currently developing products that will
require significant additional development, preclinical and clinical testing,
regulatory approvals and investment of substantial funds prior to their
commercialization. Our BBI BioSeq subsidiary is developing laboratory
instruments that will use pressure cycling technology, a technology that
repeatedly applies and releases pressure on pathogens present in blood or
plasma in an effort to destroy them. Our BBI BioSeq subsidiary is also
developing its pressure cycling process to refine an existing laboratory
instrument prototype. Both the development of the laboratory instruments and
the pressure cycling process will require substantial capital and development
activities to ready the existing prototype for commercial use. The process of
obtaining required regulatory approvals can be costly and time-consuming, and
we may not be able to successfully develop our future products, prove them to
be safe and effective in clinical trials or receive applicable regulatory
approvals. If we are not able to obtain substantial funds, develop adequate
technology and receive regulatory approvals for products being developed by
our BBI BioSeq subsidiary, our future revenues and income will be less than
we have projected.
IF THE FDA REQUIRES CLEARANCE OR APPROVAL FOR EITHER OUR PRODUCTS THAT ARE
DESIGNATED ONLY FOR RESEARCH AND NOT FOR DIAGNOSTIC PROCEDURES OR OUR
PRODUCTS THAT WE BELIEVE ARE EXEMPT FROM FDA CLEARANCE AND INITIATES
ENFORCEMENT ACTION FOR OUR FAILURE TO DO SO, WE WILL LIKELY EXPEND
SIGNIFICANT RESOURCES TO RESOLVE THE MATTER.
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In the United States, the Food, Drug, and Cosmetic Act prohibits the
marketing of most IN VITRO diagnostic products until the Food and Drug
Administration either clears or approves the products through processes that
are time-consuming, expensive and uncertain. Some IN VITRO diagnostic
products may be exempt from FDA clearance or approval if they have undergone
validation studies. As of July 31, 2000, 31 of our Accurun 1-Registered
Trademark- and Accurun-Registered Trademark- products had received FDA
clearance, and we believe that 17 are exempt from FDA clearance. During 1999,
our Accurun-Registered Trademark- products accounted for approximately 11.55%
of our revenue. Although it has not done so in the past, the FDA may not
agree that some of these products are entitled to an exemption and may adopt
a different interpretation of the Food, Drug, and Cosmetic Act or other laws
it administers. We believe that products which are used only for research and
not in diagnostic procedures are not subject to FDA clearance or approval. We
currently label some of our products "for research use only" because they are
not intended for use in diagnostic procedures, and have not been cleared or
approved by the FDA. It is possible, however, that some purchasers of these
products may use them for diagnostic purposes rather than for research,
despite our labeling. Under any of these circumstances, the FDA could allege
that some or all of these products should have been cleared or approved, or
otherwise validated prior to marketing, and could initiate enforcement action
against us. If the FDA initiates enforcement action against us, we will
likely expend a large amount of time, money, resources and management
attention to resolve the matter. In addition, if we cannot obtain or are
delayed in obtaining FDA clearances or approvals for our products, we may
encounter delays or be unable to ever sell those products.
IF WE FAIL TO COMPLY WITH GOOD MANUFACTURING PRACTICES IN CONNECTION WITH THE
MANUFACTURE OF OUR MEDICAL DEVICE PRODUCTS, WE MAY NOT BE ABLE TO DISTRIBUTE
OUR PRODUCTS AND MAY NOT GENERATE PRODUCT REVENUES.
We are also subject to strict FDA good manufacturing practice
regulations which govern testing, control and documentation practices, and
other post-marketing restrictions on the manufacture of our medical device
products. Our IN VITRO diagnostic products and our laboratory instrumentation
products are considered "medical device products," as defined by the FDA.
Regulatory authorities monitor our ongoing compliance with good manufacturing
practices and other applicable regulatory requirements through periodic
inspections. If we fail to comply with good manufacturing practices or other
regulatory requirements, we may not be able to obtain future pre-market
clearances or approvals, or the FDA or other regulatory agencies may impose
corrective action requirements, including total or partial suspension of
product distribution, injunctions, civil penalties, recall or seizure of
products, and criminal prosecution.
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Any of these events would lead to increased costs and a drain on resources
and could reduce our revenues and operating results.
BECAUSE WE CONDUCT OUR BUSINESS WORLDWIDE, CHANGES IN INTERNATIONAL
REGULATORY REQUIREMENTS MAY MATERIALLY REDUCE OUR TOTAL REVENUES.
Our international sales accounted for approximately 13.7% of our
total revenues for the year ended December 31, 1999. Several
Accurun-Registered Trademark- products are subject to international
regulatory approvals in Germany and France. These approval processes are
similar to the FDA clearance process. Changes in international regulatory
requirements and policies, including both changes in existing restrictions
and future restrictions on importation of blood and blood derivatives, could
result in reduced international sales, which may materially reduce our total
revenues and income.
IF WE ARE UNABLE TO OBTAIN A STEADY AND ADEQUATE SUPPLY OF RARE SPECIMENS OF
PLASMA AND SERUM, THEN WE MAY BE UNABLE TO PRODUCE OUR QUALITY CONTROL PANEL
PRODUCTS AND OUR ACCURUN-Registered Trademark- RUN CONTROLS PRODUCTS.
We manufacture our diagnostic products, including our quality control
panel products and Accurun-Registered Trademark- run controls products, from
human plasma and serum which we obtain from nonprofit and commercial blood
centers in the United States and from similar sources throughout the world.
Our BBI Diagnostics business unit, which manufactures and sells these
diagnostic products, accounts for approximately 40% of our revenues. Our
quality control panel products and Accurun-Registered Trademark- run control
products contain unique and rare plasma specimens that we collect from
individuals who have been infected with particular diseases. The specimens
are unique and rare because we can collect them only during the brief period
of time when the markers for a particular disease in an infected individual
are converting from negative to positive. It is difficult to identify such
infected individuals and to collect specimens from them during the brief
period of time when the markers for a particular disease are converting from
negative to positive. As a result, quantities of these specimens are limited.
As we sell our quality control panel products and run control products, we
must find replacement specimens that are equally unique and rare. We may also
face competition to obtain these specimens which could further limit our
ability to obtain the specimens and to produce our quality control panel
products and run control products. A limit in our ability to produce our
products would reduce our future revenues and operating results.
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IF WE ARE NOT ABLE TO REACT QUICKLY TO TECHNOLOGICAL CHANGE, WE MAY NOT BE
ABLE TO COMPETE EFFECTIVELY.
The infectious disease test kit industry is characterized by rapid
and significant technological change, and changes in customer requirements.
As a result, our ability to continue to compete effectively in this industry
depends upon our ability to enhance our existing products and to develop or
acquire, and introduce in a timely manner, new products that take advantage
of technological advances and respond to customer requirements. We may not be
successful in developing and marketing such new products or enhancements to
our existing products on a timely basis, if at all, and such products may not
adequately address the changing needs of the marketplace. Furthermore, rapid
technological development may result in our products or services becoming
obsolete or noncompetitive before we recover our investment in research,
development and commercialization.
IF WE CANNOT PROTECT OUR INTELLECTUAL PROPERTY, WE MAY BE UNABLE TO COMPETE
EFFECTIVELY.
Our ability to compete effectively with other companies depends in
part on our ability to maintain the proprietary nature of our technologies
and products. We rely primarily on a combination of trade secrets and
non-disclosure and confidentiality agreements to establish and protect our
proprietary rights in our technology and products. We have 15 patents pending
related to the pressure cycling technology that our BBI BioSeq subsidiary is
developing. If we have not adequately protected our technology, or if our
competitors misappropriate our intellectual property, we could lose market
share and our future revenues and operating income could be significantly
less than projected.
IF WE ARE UNABLE TO ATTRACT AND RETAIN HIGHLY QUALIFIED SCIENTIFIC AND
MANAGEMENT PERSONNEL, THEN WE MAY NOT BE ABLE TO DEVELOP AND REFINE OUR
PRODUCTS AND SERVICES.
Our products and services are highly technical and our key personnel
must have specialized training or advanced degrees in order to develop and
refine these products and services. There are a limited number of qualified
scientific and management personnel who possess the technical background
necessary to adequately understand and improve our products and services. We
compete for these personnel with other companies, academic institutions,
government entities and other organizations
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engaged in research and development of quality control products. If we are
unable to attract and retain scientific and management personnel with the
appropriate credentials who are capable of developing and refining our
products and services, then our products and services could become inaccurate
or unreliable, or could fail to obtain FDA approval and we may be unable to
deliver new products.
PENDING LITIGATION COULD RESULT IN SUBSTANTIAL COSTS AND MAY DIVERT
MANAGEMENT'S ATTENTION AND RESOURCES.
On August 18, 2000, we received a summons and complaint from
Paradigm Group, LLC, naming us as a defendant. Paradigm Group, LLC is a
selling shareholder in this registration statement. The suit, filed in the
Circuit Court of Cook County, Illinois, alleges breach of contract claims and
fraud against us in connection with the sale by us to them of warrants to
purchase our shares of common stock, the exercise of those warrants by
Paradigm Group, LLC, and a delay in the registration of those shares in this
registration statement. Paradigm Group, LLC, seeks several remedies,
including $3 million in damages or unspecified monetary damages, return of
the $42,500 purchase price for the warrants and rescission of its exercise of
the warrants, and unspecified punitive damages. We have announced that we
intend to vigorously defend this matter. This lawsuit could result in
substantial costs and may divert management's attention and resources. Any
adverse determination in this case could also subject us to significant
liabilities.
INSIDERS CONTROL A SIGNIFICANT PERCENTAGE OF VOTING POWER AND MAY EXERCISE
THEIR VOTING POWER IN A MANNER ADVERSE TO OTHER SHAREHOLDERS' INTERESTS.
Our chief executive officer, Richard T. Schumacher, his relatives,
and our other existing officers and directors collectively have voting
control over approximately 35% of the outstanding shares of our common stock.
Accordingly, these shareholders, should they choose to act in concert, are in
a position to exercise a significant degree of control and to significantly
influence shareholder votes on the election of directors, increasing the
authorized capital stock, and authorizing mergers and sales of assets. These
shareholders may act in a manner that is adverse to your personal interests.
PROVISIONS IN OUR CHARTER AND BY-LAWS MAY DISCOURAGE OR FRUSTRATE
SHAREHOLDERS' ATTEMPTS TO REMOVE OR REPLACE OUR CURRENT MANAGEMENT.
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Our amended and restated articles of organization and restated
bylaws contain provisions that may make more difficult or discourage changes
in our management that our shareholders may consider to be favorable. These
provisions include:
- a classified board of directors;
- advance notice to the board of directors of shareholder proposals
and shareholder nominees for the board of directors;
- limitations on the ability of shareholders to remove directors and
call shareholders meetings; and
- a provision that allows a majority of the directors to fill
vacancies on the board of directors.
These provisions could prevent or frustrate shareholders' attempts
to make changes in our management that our shareholders consider to be
beneficial.
THE CONVERSION OF OUR OUTSTANDING 3% SENIOR SUBORDINATED CONVERTIBLE
DEBENTURES AND/OR THE EXERCISE OF OUTSTANDING WARRANTS TO PURCHASE OUR COMMON
STOCK WILL HAVE A DILUTIVE IMPACT ON OUR SECURITY HOLDERS AND MAY PLACE
DOWNWARD PRESSURE ON THE PRICE OF OUR COMMON STOCK.
The number of shares of common stock that may ultimately be issued
upon conversion of the outstanding debentures is presently undeterminable
because the conversion price of the debentures is the lower of: (i) $3.36 a
share or (ii) 90% of the average of the five (5) lowest volume weighted
average sales prices of our common stock as reported by Bloomberg, L.P.
during the 25 business days immediately preceding the date on which any
debenture holder notifies us that it will convert all or a part of their
debenture into common stock. Assuming a conversion price of $3.36 a share,
conversion of all our outstanding debentures would result in the issuance of
967,262 shares of common stock. This represents about 17.2% of our
outstanding common stock based on the number of shares outstanding as of
September 19, 2000. In addition, the number of shares issuable upon
conversion of the debentures will increase if the price of our common stock
drops below $3.36 a share. For example, if the average of the five (5) lowest
volume weighted average sales prices of our common stock as reported by
Bloomberg, L.P. during the 25 business days immediately preceding the date on
which any debenture holder elects to convert all or a part of their debenture
into common stock is equal to $2.00 a share, and assuming all the debentures
were converted, we would issue approximately 1,625,000 shares of our common
stock, which represents approximately 28.8% of our issued and outstanding
common stock based on the number of
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shares outstanding as of September 19, 2000. A downward spiral in the price
of our common stock could result in the loss of a significant portion of your
investment, and the conversion of our outstanding debentures could place
downward pressure on the price of our common stock. The terms of the
debenture entitle us to redeem any of the outstanding debenture(s) at a
redemption price equal to (x) the number of shares of common stock into which
said debenture(s) is then convertible times (y) the average closing bid price
as reported by Bloomberg L.P. for the five (5) trading days immediately prior
to the date that the debenture(s) is called for redemption, plus accrued and
unpaid interest. We may not have sufficient funds to redeem the debentures at
such time as we determine it is most appropriate to redeem the debenture(s).
In addition, we have outstanding warrants, with various strike
prices, which are exercisable for a total of 494,709 shares of our common
stock (warrants for 135,556 of which were issued to the selling shareholders
named on page 15). This represents approximately 8.8% of our issued and
outstanding common stock based on the number of shares issued and outstanding
as of September 19, 2000. The exercise of our outstanding warrants could
place downward pressure on the price of our common stock.
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WARNINGS REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements contained in this prospectus under "Summary"
and "Risk Factors," and in the documents incorporated by reference, are
forward-looking statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. In essence, forward-looking
statements are predictions of future events. Although we would not make
forward-looking statements unless we believe we have a reasonable basis for
doing so, we cannot guarantee their accuracy, and actual results may differ
materially from those we anticipated due to a number of uncertainties, many
of which we are not aware. We urge you to consider the risks and
uncertainties discussed under "Risk Factors" and in the other documents filed
with the SEC that we have referred you to in evaluating our forward-looking
statements.
You should also understand that we have no plans to update our
forward-looking statements. Our forward-looking statements speak only as of
the date of this prospectus, or in the case of forward-looking statements in
documents incorporated by reference, as of the date of those documents.
We generally identify forward-looking statements with the words "plan,"
"expect," "anticipate," "believe," "intend," "estimate," "continue," "will,"
"may," "should" and similar expressions. Examples of our forward-looking
statements may include statements related to:
- our plans, objectives, expectations and intentions;
- the timing, availability, cost of development and functionality of
products under development or recently introduced; and
- the anticipated markets for our products and the success of our
products in those markets.
USE OF PROCEEDS
The selling shareholders are selling all of the shares covered by
this prospectus for their own account. Accordingly, we will not receive any
proceeds from the resale of the shares.
However, the 633,306 shares of our common stock that we are
registering under this prospectus include shares that may be issued to
selling shareholders upon the conversion of outstanding stock purchase
warrants.
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Paradigm Group, L.L.C. obtained its shares upon the exercise of
stock purchase warrants that it received in connection with its investment in
Boston Biomedica. The total purchase price for the warrants was $50,000.
David Kavrell, Brian Friedman, Craig Gould, Steven Rothstein and Robert
Daskal obtained their shares upon the exercise of stock purchase warrants
that they received by transfer from Paradigm Group. These shareholders and
Paradigm Group have agreed to pay us a total of $2,225,000, as payment of the
aggregate exercise price of their warrants, on the business day after the SEC
declares our registration statement relating to these shares effective.
National Securities received stock purchase warrants as a fee for
services rendered in connection with Paradigm Group's investment in Boston
Biomedica. National Securities may exercise warrants to purchase up to 40,000
shares of our common stock at an exercise price of $4.25 per share and
warrants to purchase up to 25,000 shares of our common stock at an exercise
price of $8.00 per share in connection with Paradigm Group's exercise of its
warrants. This transaction is the subject of the litigation described under
"Risk Factors" beginning on page 4. In addition, National Securities may
exercise warrants to purchase up to 10,000 shares of our common stock at an
exercise price of $5.25 per share. National Securities' warrants expire on
August 15, 2001.
MdBio, Inc., received 29,153 stock units in connection with its
award of $175,000 to Boston Biomedica under a manufacturing incentive program
that MdBio instituted. Each stock unit consists of one share of our common
stock and a warrant to purchase one additional share of our common stock at
an exercise price of $10.00 per share. MdBio's warrants expire on September
29, 2003.
We will use any proceeds which we will receive from the exercise of
these stock purchase warrants for working capital purposes.
We prepared this prospectus to satisfy our obligations to the
selling shareholders to register their shares. We will bear the expenses
relating to this registration, other than selling discounts and commissions,
which will be paid by the selling shareholders.
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SELLING SHAREHOLDERS
The selling shareholders named below are offering for sale up to
633,306 shares of our common stock under this prospectus. We will not receive
any proceeds from those sales. The 633,306 shares of our common stock that we
are registering under this prospectus include shares that may be issued to
selling shareholders upon the conversion of outstanding stock purchase
warrants.
The following table sets forth information regarding the beneficial
ownership of our common stock by the selling shareholders as of November 15,
2000 and as adjusted to reflect the sale or transfer by the selling
shareholders of the shares of our common stock being registered under this
prospectus, including the sale or transfer of shares of our common stock
underlying warrants held by selling shareholders. This information is based
upon information received from or on behalf of the selling shareholders.
<TABLE>
<CAPTION>
SHARES BENEFICIALLY NUMBER OF SHARES BENEFICIALLY
OWNED SHARES BEING OWNED AFTER
PRIOR TO OFFERING OFFERED OFFERING
-------------------- ------------ -------------------
NAME OF SECURITYHOLDER NUMBER PERCENT NUMBER NUMBER PERCENT
---------------------- ------ ------- ------ ------ -------
<S> <C> <C> <C> <C> <C>
Paradigm Group, L.L.C.(1) 425,000 7.76% 425,000 0 *
David Kavrell 15,000 * 15,000 0 *
Brian Friedman 10,000 * 10,000 0 *
Craig Gould 20,000 * 20,000 0 *
Steven Rothstein 20,000 * 20,000 0 *
Robert Daskal 10,000 * 10,000 0 *
National Securities 75,000 (2) 1.37% 75,000 0 *
MdBio, Inc. 58,306 (3) 1.06% 58,306 0 *
</TABLE>
------------------
* Less than 1%.
(1) Paradigm Group, L.L.C. is controlled by Sheldon Drobny.
(2) Consists of warrants to purchase an aggregate of 75,000 shares of our
common stock.
(3) Consists of stock units comprised of 29,153 shares of our common stock
and warrants to purchase an additional 29,153 shares of our common stock.
15
<PAGE>
PLAN OF DISTRIBUTION
The selling shareholders and their pledgees, donees, transferees and
other non-sale transferees may offer their shares at various times in one or
more of the following transactions:
- in the Nasdaq National Market;
- in the over-the-counter market; or
- in privately negotiated transactions
at prevailing market prices at the time of sale, at prices related to those
prevailing market prices, at negotiated prices or at fixed prices.
The selling shareholders may also sell the shares under Rule 144
instead of under this prospectus, if Rule 144 is available for those sales.
We will not receive any proceeds from the sale of our common stock
by the selling shareholders.
The transactions in the shares covered by this prospectus may be
carried out by one or more of the following methods:
- ordinary brokerage transactions and transactions in which the broker
solicits purchasers;
- purchases by a broker or dealer as principal, and the resale by that
broker or dealer for its account as part of the distribution under
this prospectus, including resale to another broker or dealer;
- block trades in which the broker or dealer will attempt to sell the
shares as agent but may position and resell a portion of the block
as principal in order to facilitate the transaction; or
- negotiated transactions between selling shareholders and purchasers,
with or without a broker or dealer.
As of the date of this prospectus, we are not aware of any
agreement, arrangement or understanding between any broker or dealer and any
of the selling shareholders with respect to the offer or sale of the shares
under this prospectus.
We have advised the selling shareholders that, during the time each
is engaged in distributing shares covered by this prospectus, each must
comply with the requirements of the Securities Act and the Exchange Act,
including Rule 10b-5 and Regulation M. Under those rules and regulations,
they:
- may not engage in any stabilization activity in connection with our
securities;
16
<PAGE>
- must furnish each broker that offers common stock covered by this
prospectus with the number of copies of this prospectus that are
required by each broker; and
- may not bid for or purchase any of our securities or attempt to
induce any person to purchase any of our securities other than as
permitted under the Exchange Act.
Under the terms of each of the warrants, we have agreed to indemnify
and hold harmless each selling shareholder against liabilities under the
Securities Act, which may be based upon, among other things, any untrue
statement or alleged untrue statement of a material fact or any omission or
alleged omission of a material fact, unless made or omitted in reliance upon
written information provided to us by that selling shareholder for use in
this prospectus. We have agreed to bear the expenses incident to the
registration of the shares, other than selling discounts and commissions.
INDEMNIFICATION FOR SECURITIES ACT LIABILITIES
Our Amended and Restated Articles of Organization eliminate, subject
to certain exceptions, the personal liability of our directors for monetary
damages for breaches of fiduciary duties as directors. Our Restated Articles
do not provide for the elimination of, or any limitation on, the personal
liability of a director for (i) any breach of the director's duty of loyalty
to Boston Biomedica and our shareholders; (ii) acts or omissions not in good
faith or which involve intentional misconduct or a knowing violation of law;
(iii) certain unauthorized dividends, redemptions or distributions as
provided under Section 61 of the Massachusetts Business Corporation Law; (iv)
certain loans of company assets to any of our officers or directors as
provided under Section 62 of the Massachusetts Business Corporation Law; or
(v) any transaction from which the director derived an improper personal
benefit. This provision of our Amended and Restated Articles of Organization
will limit the remedies available to you in the event of breaches of any
director's duties to Boston Biomedica and our shareholders. Our Amended and
Restated Articles of Organization provide that we may, either in our by-laws
or by contract, provide for the indemnification of directors, officers,
employees and agents, by whomever elected or appointed, to the full extent
permitted by law.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to our directors, officers or
controlling persons pursuant to the foregoing provisions, or otherwise, we
have been informed that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the
Securities Act and is, therefore, unenforceable.
17
<PAGE>
LEGAL MATTERS
For the purpose of this offering, Brown, Rudnick, Freed & Gesmer,
Boston, Massachusetts, will pass upon the validity of the shares of common
stock covered under this prospectus.
EXPERTS
The financial statements incorporated in this prospectus by
reference to the Annual Report on Form 10-K for the year ended December 31,
1999 have been so incorporated in reliance on the report of
PricewaterhouseCoopers LLP, independent accountants, given on the authority
of said firm as experts in auditing and accounting. The valuation information
incorporated in this prospectus by reference to the Annual Report on Form
10-K for the year ended December 31, 1999 has been so incorporated in
reliance on the valuation report of The Michel/Shaked Group, a division of
Back Bay Management Corporation, given on the authority of said firm as
experts in asset valuation.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file at
the SEC's public reference rooms at 450 Fifth Street, N.W., Washington, D.C.,
20549, in Chicago, Illinois and in New York, New York. Please call the SEC at
1-800-SEC-0330 for further information on the public reference rooms. Our SEC
filings are also available to the public over the Internet on the SEC's
website at http://www.sec.gov.
We have filed with the SEC a registration statement on Form S-3
under the Securities Act of 1933, as amended, with respect to the common
stock offered in connection with this prospectus. This prospectus does not
contain all of the information set forth in the registration statement. We
have omitted parts of the registration statement in accordance with the rules
and regulations of the SEC. For further information with respect to us and
our common stock, you should refer to the registration statement and to the
exhibits and schedules filed as part of the registration statement, as well
as the documents discussed below. Statements contained in this prospectus as
to the contents of any contract or other document are not necessarily
complete and, in each instance, you should refer to the copy of the contract
or document filed as an exhibit to or incorporated by reference in the
registration statement. Each statement as to the contents of any contract or
document is qualified in all respects by reference to the contract or
document
18
<PAGE>
itself. You may obtain copies of the registration statement from the SEC's
principal office in Washington, D.C. upon payment of the fees prescribed by
the SEC, or you may examine the registration statement without charge at the
offices of the SEC described above.
The SEC allows us to "incorporate by reference" the information that
we file with it, which means that we can disclose important information to
you by referring you to those documents. The information incorporated by
reference is considered to be part of this prospectus, and information that
we file later with the SEC will automatically update and supersede this
information. We incorporate by reference the following documents:
- Our Annual Report on Form 10-K for the fiscal year ended December
31, 1999, as amended;
- Our Quarterly Report on Form 10-Q for the fiscal quarter ended March
31, 2000, as amended;
- Our Quarterly Report on Form 10-Q for the fiscal quarter ended June
30, 2000, as amended;
- Our Quarterly Report on Form 10-Q for the fiscal quarter ended
September 30, 2000, as amended;
- Our Definitive Proxy Statement on Schedule 14A and proxy materials
filed on May 1, 2000;
- Our Current Report on Form 8-K filed on September 8, 2000; and
- The description of our common stock contained in our registration
statement on Form 8-A dated October 25, 1996.
We also incorporate by reference any future filings made with the SEC under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as
amended, prior to the termination of the offering to which this prospectus
relates.
You may request a copy of any or all of these filings, at no cost,
by writing or telephoning us at the following address:
Boston Biomedica, Inc.
375 West Street
West Bridgewater, MA 02379
(508) 580-1900
Attn: Investor Relations
19
<PAGE>
THIS PROSPECTUS IS PART OF A REGISTRATION
STATEMENT WE FILED WITH THE SEC. YOU
SHOULD RELY ONLY ON THE INFORMATION OR
REPRESENTATIONS PROVIDED IN THIS PROSPECTUS.
WE HAVE NOT AUTHORIZED ANYONE TO PROVIDE YOU BOSTON BIOMEDICA, INC.
WITH ANY INFORMATION THAT IS NOT CONTAINED
IN THIS PROSPECTUS. THE SELLING SHAREHOLDERS
DESCRIBED IN THIS PROSPECTUS ARE NOT MAKING
AN OFFER TO SELL OR SOLICITING AN OFFER TO Up to 633,306 Shares
BUY ANY SHARES IN ANY JURISDICTION WHERE THE of Common Stock
OFFER OR SALE IS NOT PERMITTED. YOU SHOULD NOT
ASSUME THAT THE INFORMATION IN THIS PROSPECTUS
IS ACCURATE AS OF ANY DATE OTHER THAN THE DATE PROSPECTUS
OF THIS PROSPECTUS. (Subject to Completion)
-------------------
TABLE OF CONTENTS
-------------------
<TABLE>
<S> <C>
Summary 3
Risk Factors 4
Warnings Regarding Forward-Looking Statements 12
Use of Proceeds 12
Selling Shareholders 14
Plan of Distribution 15
Indemnification for Securities Act Liabilities 16
Legal Matters 17
Experts 17
Where You Can Find More Information 17
</TABLE>
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the various expenses payable by us in
connection with the sale and distribution of the securities registered
hereby. All amounts are estimated except the SEC and Nasdaq fees. We will
bear all of the costs of issuance and distribution as follows:
<TABLE>
<S> <C>
SEC Registration Fee................................................... $ 481
Nasdaq Filing Fee...................................................... $ 17,500
Accounting Fees and Expenses........................................... $ 50,000
Legal Fees and Expenses................................................ $ 50,000
Costs of Printing and Engraving $ 5,000
Miscellaneous.......................................................... $ 519
=========
Total......................................................... $ 124,500
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Our amended and restated by-laws include provisions to permit the
indemnification of our officers and directors for damages arising out of the
performance of their duties unless such damages arise out of the officer's or
director's failure to exercise his duties and to discharge the duties of his
office in good faith and in the reasonable belief that his action was in, or
not opposed to, the best interest of Boston Biomedica, and with respect to
any criminal action or proceeding, do not have reasonable cause to believe
that his conduct was unlawful.
ITEM 16. EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER
-------
<S> <C> <C>
4.1 Description of certificate for shares of Boston Biomedica common stock *
4.2 Form of Warrant Certificate **
5.1 Legal Opinion of Brown, Rudnick, Freed & Gesmer, P.C. previously filed
23.1 Consent of PricewaterhouseCoopers LLP filed herewith
23.2 Consent of The Michel/Shaked Group, a division of Back Bay Management filed herewith
Corporation
23.3 Consent of Brown, Rudnick, Freed & Gesmer, P.C. (included in Exhibit 5.1) previously filed
24.1 Power of Attorney previously filed
</TABLE>
----------
*The above exhibit was previously filed as an exhibit of the same number to
our registration statement on Form S-1 (registration no. 333-10759), as
amended, filed on August 23, 1996 and is incorporated herein by reference.
**The above exhibit was previously filed as exhibit number 4.3 to our
quarterly report on Form 10-Q for the period ended September 30, 1999, and is
incorporated herein by reference.
II-1
<PAGE>
ITEM 17. UNDERTAKINGS
(a) 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
material information with respect to the plan of distribution not previously
disclosed in the registration statement or any material change to such
information in the registration statement;
(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; and
(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.
(b) The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of
the registrant's annual report pursuant to Section 13(a) or Section 15(d) of
the Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement 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.
(c) Not applicable.
(d) Not applicable.
(e) Not applicable.
(f) Not applicable.
(g) Not applicable.
(h) Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing provisions,
or otherwise, the registrant has been advised that in the opinion of the SEC
such indemnification is against public policy as expressed in the Securities
Act of 1933 and is, therefore, unenforceable. In the event that a claim for
indemnification against such liabilities (other than the payment by the
registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant 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 registrant 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 of
whether such indemnification by it is against public policy as expressed in
the Securities Act of 1933 and will be governed by the final adjudication of
such issue.
(i) Not applicable.
(j) Not applicable.
II-2
<PAGE>
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 the
requirements for filing on Form S-3 and has duly caused this pre-effective
amendment number 4 to the registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the Town of West
Bridgewater, Commonwealth of Massachusetts, on November 22, 2000.
BOSTON BIOMEDICA, INC.
By: /s/ RICHARD T. SCHUMACHER
---------------------------
Richard T. Schumacher,
Chief Executive Officer
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS
PRE-EFFECTIVE AMENDMENT NUMBER 4 TO THE REGISTRATION STATEMENT HAS BEEN
SIGNED BY THE FOLLOWING PERSONS IN THE CAPACITIES AND ON THE DATES INDICATED.
<TABLE>
<CAPTION>
SIGNATURE TITLE DATE
--------- ----- ----
<S> <C> <C>
/s/ Richard T. Schumacher Director and Principal Executive November 22, 2000
-------------------------------------------- Officer
Richard T. Schumacher
/s/ Kevin W. Quinlan Director and Principal Financial and November 22, 2000
-------------------------------------------- Accounting Officer
Kevin W. Quinlan
* Director November 22, 2000
--------------------------------------------
Francis E. Capitanio
* Director November 22, 2000
--------------------------------------------
Calvin A. Saravis, Ph.D.
* Director and Treasurer November 22, 2000
--------------------------------------------
William R. Prather, R.Ph., M.D.
</TABLE>
* By: /s/ RICHARD T. SCHUMACHER
-----------------------------
Richard T. Schumacher,
Attorney-in-Fact
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT
NUMBER
-------
<S> <C> <C>
4.1 Description of certificate for shares of Boston Biomedica common stock *
4.2 Form of Warrant Certificate **
5.1 Legal Opinion of Brown, Rudnick, Freed & Gesmer, P.C. previously filed
23.1 Consent of PricewaterhouseCoopers LLP filed herewith
23.2 Consent of The Michel/Shaked Group, a division of Back Bay Management Corporation filed herewith
23.3 Consent of Brown, Rudnick, Freed & Gesmer, P.C. (included in Exhibit 5.1) previously filed
24.1 Power of Attorney previously filed
</TABLE>
----------
*The above exhibit was previously filed as an exhibit of the same number to
our registration statement on Form S-1 (registration no. 333-10759), as
amended, filed on August 23, 1996 and is incorporated herein by reference.
**The above exhibit was previously filed as exhibit number 4.3 to our
quarterly report on Form 10-Q for the period ended September 30, 1999, and is
incorporated herein by reference.
E-1
