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Rule 424(b)(3)
Registration No. 333-92353
PROSPECTUS
4,658,973 SHARES
BIGMAR, INC.
COMMON STOCK
-------------------------
We are registering 4,658,973 shares of our common stock for resale by the
sellers identified in "Selling Stockholders."
Our common stock is quoted on the Nasdaq SmallCap Marketsm under the symbol
"BGMR." On June 6, 2000, the closing price of our stock as quoted on the Nasdaq
SmallCap Market was $2.31 per share.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK FACTORS"
BEGINNING ON PAGE 3.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR PASSED UPON THE
ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY
IS A CRIMINAL OFFENSE.
---------------------------
JUNE 8, 2000
<PAGE>
BIGMAR, INC.
TABLE OF CONTENTS
<TABLE>
<S> <C>
Bigmar, Inc.............................................. 3
Risk Factors............................................. 3
Forward-Looking Information.............................. 9
Selling Stockholders..................................... 9
Plan of Distribution..................................... 11
Validity of Stock.........................................12
Experts...................................................12
Available Information.....................................13
Information Incorporated by Reference.....................13
</TABLE>
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BIGMAR, INC.
We manufacture generic pharmaceutical oncology products and intravenous
infusion solutions through our subsidiaries located in Switzerland. We market
these products in Europe, the United States and other countries primarily
through pharmaceutical company partners. Currently, we have the necessary
approvals to manufacture and sell more than 20 generic oncology products
and 18 intravenous infusion solutions and related products.
Our corporate headquarters, including a research and development
laboratory, are located at:
9711 Sportsman Club Road
Johnstown, Ohio 43031-9141
(740) 966-5800
RISK FACTORS
OUR HISTORY OF CONTINUING LOSSES AND LIMITED CAPITAL RESERVES CREATES
UNCERTAINTY ABOUT OUR ABILITY TO CONTINUE IN BUSINESS.
The independent auditor's report on our financial statements for the
fiscal year ended December 31, 1999 indicates that there is substantial doubt
about Bigmar's ability to continue as a going concern. From our inception in
1995 through March 31, 2000 we have incurred net losses totaling approximately
$23.5 million. To achieve profitable operations, we must alone or with others
successfully develop, manufacture, obtain regulatory approvals for, and market
existing and additional products.
WE WILL REQUIRE ADDITIONAL FUNDING TO CONTINUE OPERATIONS AND FACILITATE GROWTH.
Over the next 12 months, we will need to raise substantial
additional funds to continue to pay for operating expenses and our expansion
strategy. Without more funding, we may not be able to continue manufacturing
and marketing our products, and may have to sell, suspend or terminate
operations.
DUE TO AN EXCLUSIVE AGREEMENT, WE MUST RELY ON ANOTHER COMPANY TO MARKET KEY
PRODUCTS.
We have given American Pharmaceutical Partners the exclusive right
for five years, which ends in 2004, to market and distribute, in the United
States and Canada, three of our oncological products in various dosages.
Those products are Methotrexate for Injection - 1 gr, Calcium Leucovirin for
Injection - 200 mg and 500 mg, and Daunorubicin Hydrochloride for Injection -
20 mg. As a result, Bigmar:
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- Cannot independently market these products;
- Does not have control of marketing abilities or strategies;
and
- Cannot make other strategic alliances or collaborative
arrangements regarding these products.
Revenues from this arrangement in 1999 comprised about 60% of total
company sales of oncological products, nearly all of the company's U.S. sales
and 13% of total company revenues. The acceptance of the products in the
marketplace is dependent upon APP's ability to demonstrate the benefits of
our products to the health care community and to sell commercial quantities
of our products at acceptable costs.
POTENTIAL INABILITY TO OBTAIN ESSENTIAL RAW MATERIALS MAY HARM OUR BUSINESS.
There are currently three suppliers from which we purchase the raw
materials needed to make our oncological products. These suppliers are Orion
Corporation which supplies Methotrexate, Indena S.p.A which supplies
Paclitaxel, and Heraeus GmBh which supplies Leucovirin Calcium. Most of our
raw materials are generally not readily available and must be purchased from
limited sources. Any disruption in one or more of these sources poses
potential risks, including:
- Inability to obtain an adequate supply of raw materials;
- Increased raw material or packaging component costs; and
- Problems with quality or timely delivery.
Any interruption in the supply of raw materials can hinder us from
manufacturing and selling our products. In addition, obtaining raw materials
from a new source may require regulatory approval. Further, we may not be
able to do business with all potential alternative suppliers as some of them
may have exclusive relationships with our competitors.
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WE RELY HEAVILY UPON AN AGREEMENT WITH PLM, A PHARMACEUTICAL CONTAINER
MANUFACTURER, IN OUR INTRAVENOUS SOLUTIONS BUSINESS.
We acquired the exclusive right through 2005 to purchase intravenous
solution containers from PLM Langeskov A/S and to package and distribute
intravenous infusion solutions in those containers in Switzerland and
Liechtenstein. PLM can cancel our exclusive right to these containers if,
among other things, we does not purchase about $894,500 each year. PLM is
believed to be the sole supplier of this particular type of IV container, and
termination of this favorable arrangement would harm our IV solutions
business. The IV solutions business accounted for approximately 78% of our
total revenues in 1999, and sales of IV solutions in the PLM-supplied
containers accounted for 93% of our IV solutions business in 1999.
LARGER COMPETITORS HAVE THE RESOURCES TO SUPPORT MANY SIMULTANEOUS REGULATORY
APPLICATIONS, IMPROVING THEIR CHANCES TO RECEIVE REGULATORY APPROVAL AND MARKET
GENERIC PRODUCTS FIRST.
We compete in the highly competitive generic injectable drug
industry. Our competitors in the oncology market include companies such as
Bedford Laboratories, Bristol-Myers Squibb Co., Pharmachemle BV, Pharmacia
& Upjohn and Gensia-Sicor and our competitors in the intravenous infusion
market include Braun and Fresenius.
Each of these competitors has substantially greater experience and
financial and other resources than us. Although a company with greater
resources will not necessarily receive regulatory approval for a particular
generic drug before its smaller competitors, it does have the resources to
support many simultaneous regulatory applications, improving its chances at
being the first to receive approval. We also face competition from other drug
companies who introduce generic versions of their own products just before
the patents for their products expire.
EXTENSIVE GOVERNMENTAL REGULATIONS COULD INCREASE COSTS AND HINDER OUR ABILITY
TO DEVELOP, MANUFACTURE AND MARKET OUR PRODUCTS.
The development, manufacturing and marketing of our products are
subject to extensive and rigorous governmental regulations in the U.S. and other
countries. The process of obtaining and maintaining required regulatory
approvals is lengthy, expensive and uncertain. Since our products are primarily
sold in Switzerland and Germany, we are subject to regulation by these countries
and the European Medicines Evaluation Agency of the European Union. In the U.S.,
the FDA regulates the development, testing, labeling, manufacturing,
registration, notification, clearance or approval, marketing, distribution,
record-keeping and reporting requirements for drugs. Delays in the approval
process or our inability to obtain regulatory approvals for any of our
proposed products would adversely affect Bigmar's ability to market these
products and to recoup our research and development costs for these products.
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OUR OPERATIONS MAY BE RESTRICTED IF WE FAIL TO COMPLY WITH ENVIRONMENTAL LAWS
AND REGULATIONS IN SWITZERLAND.
Our Swiss facilities are subject to comprehensive environmental laws
and regulations governing air emissions, waste water discharge and solid and
hazardous waste disposal. While we anticipate expenditures in connection with
environmental matters from time to time, we cannot predict the extent or timing
of these expenses. Future administrative actions or liabilities arising from
environmental matters could restrict operations and impede profitability.
WE ARE SUBJECT TO FOREIGN CURRENCY EXCHANGE FLUCTUATIONS IN OUR
BUSINESS.
Our operations are conducted primarily from Switzerland. All of our
revenues for fiscal years through December 31, 1998 and 87% of our revenues for
1999 were derived from sales outside of the U.S. As a result, we are exposed to
adverse fluctuation in foreign currency exchange rates, particularly
fluctuations in the value of the U.S. dollar against the Swiss franc. For
example, although we realized a $332,000 gain on foreign currency transactions
in 1998, we incurred a loss of $837,000 on foreign currency transactions in
1999. The Swiss franc has declined by more than 11% against the U.S. dollar
during 1999. These fluctuations have affected, and will continue to affect, our
financial condition and results. We do not have any programs in place to control
these risks.
OUR BUSINESS HAS A SUBSTANTIAL RISK OF PRODUCT LIABILITY CLAIMS, AND INSURANCE
MAY BE EXPENSIVE OR UNAVAILABLE.
The testing, clinical trials, manufacturing and marketing of our
products involve inherent risks of product liability claims by consumers and
other third parties. Although we currently maintain product liability insurance
coverage which we believe is adequate, the risk of such liability exposure
cannot be eliminated. While we have successfully renewed our
policies in the past, but may not be able to do so in the future. Product
liability insurance varies in cost, is difficult to obtain and may not be
available in the future on terms acceptable to us. A successful product
liability claim or other judgment against us in excess of our insurance coverage
could have a material adverse effect on us. In some of our agreements with other
companies, we have indemnification provisions with respect to product liability
claims concerning products covered by the agreements. Under such agreements, we
may be required to make payments which in some cases could be substantial.
THE MARKET FOR OUR PRODUCTS MAY DIMINISH DUE TO REIMBURSEMENT CHANGES OR
HEALTHCARE REFORM.
In the United States and other countries, sales of our products depend
in part upon the availability of reimbursement from third-party payors, which
include government health administration authorities, managed care providers,
and private health insurers. There are continuing efforts by governmental and
third-party payors to contain or reduce the costs of medical products and
services. Adoption of new legislation and regulations could further limit
reimbursement for our products. If third-party payors fail to provide adequate
coverage and reimbursement rates for our products, we may have difficulty
selling our products at attractive prices.
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SWISS REQUIREMENTS ON RETAINED EARNINGS MAY LIMIT CASH FLOW.
Bigmar is a Delaware corporation which owns 100% of the capital stock
of two Swiss corporations. According to the Swiss Federal Code of Obligation, at
least 5% of a Swiss company's net income each year must be appropriated to a
legal reserve until the reserve equals 20% of the company's paid-in share
capital. Additionally, 10% of any distribution made by a company in excess of a
5% dividend must also be appropriated to the company's legal reserve. The
reserve of up to 50% of the share capital is not available to stockholders.
While these requirements have been met, they may adversely impact the amount of
dividends to be obtained by Bigmar through its subsidiaries and may limit cash
flow.
IF KEY PERSONNEL LEAVE, WE COULD FAIL TO ACHIEVE OUR OBJECTIVES.
We are highly dependent on our small management team, including
manufacturing, marketing and corporate management personnel. The loss of key
personnel might significantly delay or prevent the achievement of our growth and
profitability objectives.
SINCE OUR DIRECTORS AND EXECUTIVE OFFICERS BENEFICIALLY OWN IN EXCESS OF
TWO-THIRDS OF OUR COMMON STOCK, THEY CAN CONTROL THE OPERATION OF OUR BUSINESS.
These directors and officers are in a position to control the management and
policies of Bigmar in general. They can also determine the outcome of many
corporate transactions or matters submitted to stockholders for approval.
IF WE DO NOT MEET THE MAINTENANCE CRITERIA OF NASDAQ, OUR STOCK MAY BE DELISTED
RESULTING IN A MORE LIMITED MARKET.
Bigmar's common stock is quoted on the Nasdaq SmallCap Marketsm,
although it is thinly traded. Failure to meet the continuing maintenance
criteria in the future may result in our common stock not being listed on
Nasdaq. In such an event, investors may find it more difficult to sell or to
obtain accurate quotations as to the market value of the common stock. We
also would face additional difficulties in raising capital.
7
<PAGE>
THERE ARE A SUBSTANTIAL NUMBER OF SHARES ELIGIBLE FOR FUTURE SALE, AND
THE SALE OF THESE SHARES MAY DEPRESS OUR STOCK PRICE.
Sales of a substantial amount of our common stock in the public
market could adversely affect prevailing market prices for our stock and our
ability to raise capital in the future. As of the date of this prospectus, we
have outstanding 9,493,973 shares of our common stock, and 8,993,973 of those
shares are freely tradeable in the public market, unless owned by our
affiliates, or are "restricted securities" but nonetheless eligible for
immediate sale in the public market pursuant to Rule 144 under the Securities
Act of 1933, subject to volume and manner of sale restrictions. A total of
6,143,605 shares are owned by affiliates. Under Rule 144, any registered
shares owned by an affiliate and any restricted securities which have been
owned by an affiliate or non-affiliate for at least one year may be sold in
the public market, so long as the number of shares sold by the person during
a three-month period does not exceed the greater of 1% of the total
outstanding shares or the average weekly trading volume during the previous
four weeks. Under Rule 144(k), restricted securities owned by non-affiliates
for at least two years are freely tradeable.
THERE MAY BE A DILUTIVE EFFECT ON OUR COMMON STOCK FROM THE CONVERSION OR
EXERCISE OF OTHER OUTSTANDING SECURITIES.
We have 3,529,905 shares of common stock reserved for issuance in
connection with outstanding stock options, warrants and convertible notes.
These options, warrants and convertible notes have different exercise or
conversion prices, expiration dates and other terms, but all are immediately
exercisable or convertible into common stock. The exercise or conversion
prices range from $2.5625 to $9.75 per share, with a weighted average of
about $4.33 per share. The market price for the Bigmar common stock at June
6, 2000 was $2.31 per share. The sale, or availability for sale, in the
public market of the common stock underlying these options, warrants and
convertible notes could adversely affect the market price of our stock.
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WE DO NOT EXPECT TO PAY DIVIDENDS IN THE FORESEEABLE FUTURE.
We have never paid any dividends on our common stock. We do not
anticipate paying any cash dividends in the foreseeable future because:
- we have experienced losses since inception;
- we have significant capital requirements in the future; and
- we presently intend to retain future earnings, if any, to
finance the expansion of our business.
OTHER ISSUANCES OF PREFERRED STOCK COULD AFFECT THE INTERESTS OF EXISTING
STOCKHOLDERS
Bigmar's governing documents authorize the issuance of up to 5,000,000
shares of preferred stock with designations, rights and preferences as
determined from time to time by the board of directors. The board can issue,
without stockholder approval, preferred stock with dividend, liquidation,
conversion, voting or other rights that could adversely affect the voting power
or other rights of common stockholders. The issuance of preferred stock could:
- Discourage, delay or prevent a change in control of Bigmar.
- Dilute the rights of common stockholders.
- Dilute the market price of the stock.
FORWARD-LOOKING INFORMATION
This prospectus contains forward-looking statements concerning future
events or performance of our company. You should not rely excessively on these
forward-looking statements, because they are only predictions based on our
current expectations and assumptions. Forward-looking statements often contain
words like "estimate," "anticipate," "believe" or "expect." Many known and
unknown risks and uncertainties could cause our actual results to differ
materially from those indicated in these forward-looking statements. You should
review carefully the risks and uncertainties identified in this prospectus,
including those explained above and in our other SEC filings such as our Form
10-KSB for the fiscal year ended December 31, 1999. We have no obligation to
update or announce revisions to any forward-looking statements to reflect actual
events or developments.
SELLING STOCKHOLDERS
The table below lists the selling stockholders and other information
regarding the beneficial ownership of shares of common stock. Except as
otherwise disclosed in this prospectus, the selling stockholders neither have
nor within the past three years had any position, office or other material
relationship with our company or any of its predecessors or affiliates. The
selling stockholders may offer all or a portion of the shares of common stock
registered by this prospectus.
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Beneficial ownership is determined in accordance with SEC rules and
generally includes voting or investment power with respect to securities.
<TABLE>
<CAPTION>
NUMBER OF SHARES MAXIMUM NUMBER OF NUMBER OF SHARES PERCENT
BENEFICIALLY OWNED PERCENT OF SHARES BENEFICIALLY OWNED OF
SELLING STOCKHOLDER PRIOR TO OFFERING OUTSTANDING OFFERED AFTER OFFERING OUTSTANDING
<S> <C> <C> <C> <C> <C>
Jericho II, L.L.C. (1) 6,607,805 (2) 50.7% 3,692,308 2,915,497 22.4%
Patrick G. Wolgast 10,000 * 10,000 0 ---
GRQ, LLC (3) 184,266 1.4% 166,666 17,600 *
Tietje Bros. (4) 54,000 * 40,000 14,000 *
John A. Horner 20,000 * 20,000 0 ---
JJS Wolf Realty, LLC (5) 10,000 * 10,000 0 ---
Leif H. Perkhild 250,000 1.9% 250,000 0 ---
John S. Hodgson 43,333 * 33,333 10,000 *
Banca del Gottardo 2,247,605(6) 17.3% 70,000 2,177,605 16.7%
Robert Goldstein (7) & 78,333(8) * 33,333 45,000 *
Judy Goldstein
Janet A. Baldauf (9) 333,333 2.6% 333,333 0 ---
</TABLE>
* Less than one percent (1%).
(1) Jericho is a privately-owned company involved in investment
activities. Cynthia R. May, a Director of the Company, is the managing
member of Jericho with sole voting and investment power with respect to
the shares of common stock held thereby. John G. Tramontana, Chairman
and Chief Executive Officer of Bigmar, is also a member of Jericho,
which is Bigmar's largest stockholder.
(2) Includes (i) 500,000 shares of common stock issuable upon exercise
of warrants, (ii) 1,000,000 shares of common stock issuable upon
exercise and conversion of Preferred Stock warrants, and (iii) 184,266
shares owned by GRQ, LLC (see Note (3)).
(3) GRQ, LLC is a privately-owned company involved in investment
activities. Cynthia R. May is also the managing member of GRQ, LLC with
sole voting and investment power with respect to the shares of common
stock held thereby.
(4) The principals of Tietje Bros. with voting and investment power
with respect to the shares of common stock held thereby are Dennis
Tietje and Erwin Tietje.
(5) The principal of JJS Wolf Realty, LLC with voting and investment
power with respect to the shares of common stock held thereby is John
Wolf.
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(6) Includes (i) 761,905 shares of common stock issuable upon
conversion of convertible notes issued in August 1997, (ii) 528,000
shares of common stock issuable upon conversion of convertible notes
issued in November 1999, and (iii) 150,000 shares of common stock
issuable upon exercise of warrants.
(7) Mr. Goldstein is a principal of The Equity Group Inc., which has
been engaged by Bigmar since 1996 to provide public relations and
investor relations services.
(8) Includes 45,000 shares issuable upon exercise of warrants held by
The Equity Group, Inc.
(9) Ms Baldauf is the mother of Cynthia R. May. Ms. May disclaims
beneficial ownership of the shares of common stock held by Ms. Baldauf.
PLAN OF DISTRIBUTION
The selling stockholders have advised us that they may offer the shares
of common stock registered under this prospectus to purchasers from time to
time:
- in transactions in the Nasdaq SmallCap Market, in negotiated
transactions, or by a combination of these methods;
- at fixed prices that may be changed; at market prices
prevailing at the time of the resale;
- at prices related to such market prices; or
- at negotiated prices
At the date of this prospectus, the selling stockholders have not
entered into any underwriting arrangements. The selling stockholders may sell
the shares registered under this prospectus through:
- ordinary brokers' transactions;
- transactions involving cross or block trades or otherwise on
the Nasdaq SmallCap Market;
- purchases by brokers, dealers or underwriters who may receive
compensation in the form of discounts or commissions from the
selling stockholders or the purchasers of these shares, for
whom the broker-dealers may act as agent or principal, or
both;
- any combination of the foregoing.
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In effecting sales, the brokers or dealers which the selling
stockholders have engaged may arrange for other brokers or dealers to
participate. Brokers and dealers will receive commissions or discounts from the
selling stockholders in amounts negotiated prior to the sale. The selling
stockholders and any brokers or dealers participating in the distribution of the
shares may be deemed "underwriters" in connection with these sales. Any
commissions or profits they receive may be seen as underwriting discounts or
commissions under the Securities Act.
The selling stockholders may agree to protect these broker-dealers from
liability, with respect to these shares being offered. Any underwriters,
brokers, dealers and agents who participate in any sale may also be our
customers, engage in transactions with us, or perform services for us or our
selling stockholders.
We will pay substantially all of the expenses relating to the
registration, offer and sale of the shares of common stock registered under
this prospectus to the public other than commissions or discounts of
underwriters, broker-dealers or agents. We also have agreed to indemnify the
selling stockholders and certain related persons against any losses, claims,
damages or liabilities under the Securities Act or otherwise that arise out
of, or are based upon, any untrue or alleged untrue statement of a material
fact or the omission or alleged omission instating a material fact under this
registration.
To the extent that indemnification for liabilities arising under the
Securities Act may be permitted to our directors, officers and controlling
persons, we have been advised that, in the opinion of the SEC, this
indemnification is against public policy as expressed in the Securities Act and
is therefore unenforceable.
VALIDITY OF STOCK
The validity of the shares offered hereby have been passed upon for our
company by Bricker & Eckler LLP, Columbus, Ohio.
EXPERTS
The consolidated financial statements of Bigmar, Inc. as of December
31, 1999 and 1998, and for each of the years in the three-year period ended
December 31, 1999, have been incorporated by reference herein and in the
registration statement in reliance upon the report of KPMG LLP, independent
certified public accountants, incorporated by reference herein, and upon the
authority of said firm as experts in accounting and auditing. The report of
KPMG LLP states we have suffered recurring losses from operations, and
anticipates we will require additional financing in order to fund continuing
operations. These factors raise substantial doubt about Bigmar's ability to
continue as a going concern. The consolidated financial statements do not
include any adjustments that might result from the outcome of that
uncertainty.
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AVAILABLE INFORMATION
We are subject to the reporting requirements of the Securities Exchange
Act of 1934, and file reports, proxy statements and other information with the
SEC. Such information may be inspected and copied at the public reference
facilities maintained by the SEC at Room 1024, 450 Fifth Street, N.W.,
Washington, D.C. 20549 and at the Regional Offices of the SEC at Seven World
Trade Center, Suite 1300, New York, New York and at Suite 1400, 500 West Madison
Street, Chicago, Illinois. Copies of such information can be obtained at
prescribed rates from the Public Reference Section of the SEC at 450 Fifth
Street, N.W., Washington, D.C. 20549. Additional information regarding the
operation of the public reference facilities may be obtained by calling the SEC
at 1-800-SEC-0330. Access to such information is also available from the SEC's
website (http://www.sec.gov).
Reports and other information concerning Bigmar can also be inspected
at The Nasdaq Stock Market, Inc., 1735 K Street, Washington, D.C. 20006.
We have filed with the SEC a Registration Statement on Form S-3 under
the Securities Act with respect to the shares offered by this prospectus. In
accordance with the rules and regulations of the SEC, this prospectus omits
certain of the information contained in the registration statement. Statements
made in this prospectus concerning the provisions of any document are not
necessarily complete and, in each instance, reference is made to the copy of
such document filed as an exhibit to the registration statement or otherwise
filed with the SEC. Each such statement is qualified in its entirety by such
reference.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to "incorporate by reference" the information we file
with them, 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 documents listed below and any future filings we
will make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the
Securities Exchange Act of 1934 until this offering is finished.
1. Our Quarterly Report on Form 10-QSB for the fiscal quarter ended
March 31, 2000;
2. Our Annual Report on Form 10-KSB for the fiscal year ended December
31, 1999, and Amendment No. 1 thereto; and
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3. The description of our common stock contained in our registration
statement on Form S-1, declared effective June 19, 1996.
We will provide complimentary copies of these documents upon request.
To request a copy, please contact:
Investor Relations
Bigmar, Inc.
9711 Sportsman Club Road
Johnstown, Ohio 43031-9141
(740) 966-5800
This prospectus is part of a registration statement we filed with the
SEC. You should rely only on the information provided in this prospectus or to
which we have referred you. We have not authorized anyone to provide you with
different information. The common stock will not be offered in any state where
an offer is not permitted. You should not assume that the information in this
prospectus is accurate as of any date other than the date on the cover of this
prospectus.
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