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FORM S-8
REGISTRATION STATEMENT
UNDER THE
SECURITIES ACT OF 1933
BIOPURE CORPORATION
(Exact name of Registrant as specified in its charter)
DELAWARE 04-2836871
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification No.)
11 Hurley Street
Cambridge, Massachusetts 02141
(Address of Principal Executive Offices)
1988 STOCK OPTION PLAN
1998 STOCK OPTION PLAN
1999 OMNIBUS SECURITIES AND INCENTIVE PLAN
(Full title of the plans)
JANE KOBER
SENIOR VICE PRESIDENT
Biopure Corporation
11 Hurley Street
Cambridge, Massachusetts
(Name and address of agent for service)
(617) 234-6500
(Telephone number, including area code, of agent for service)
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CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
=============================================================================================================================
Title of Proposed Maximum Amount of
Securities To Amount To Be Aggregate Registration
Be Registered Registered(1) Offering Price(2) Fee
- -----------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C>
Class A 2,470,490 $39,945,132 $10,546
Common Stock
=============================================================================================================================
</TABLE>
(1) The number of shares of Class A common stock, par value $.01 per share
("Common Stock"), stated above consists of the aggregate number of
shares which may be sold upon the exercise of options granted or which
hereafter may be granted under the plans identified above (the "Plans")
and 9,681 shares for resale which were issued under the Plans.
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(2) This calculation is made solely for the purpose of
determining the registration fee pursuant to the provisions
of Rule 457(h) under the Securities Act of 1933, as amended
(the "Securities Act") as follows: the fee for the shares
available for options not yet granted and the fee for the
9,681 shares being registered for resale are calculated
pursuant to Rule 457(c) under the Securities Act on the
basis of the average of the high and low sale prices per
share of the Common Stock on the Nasdaq National Market
("Nasdaq") as of a date within 5 business days prior to
filing this Registration Statement; the fee for options to
purchase 2,000,873 shares is based on the option exercise
prices.
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PART I
INFORMATION REQUIRED IN SECTION 10(a) PROSPECTUS
This Registration Statement includes two forms of Prospectus. The
documents constituting the prospectus under Part I of this Registration
Statement (the "Plan Prospectus") will be sent or given to participants in the
1988 Stock Option Plan, the 1998 Stock Option Plan and the 1999 Omnibus
Securities and Incentive Plan (the "Plans") as specified by Rule 428(b)(1) under
the Securities Act. The second prospectus (the "Resale Prospectus") may be used
in connection with reoffers and resales of shares of the class A common stock of
Biopure Corporation (the "Company") acquired pursuant to the Plans prior to the
date of this Registration Statement. The Plan Prospectus has been omitted from
this Registration Statement as permitted by Part I of Form S-8. The Resale
Prospectus is filed as part of this Registration Statement as required by Form
S-8.
Upon written or oral request, the Company will provide, without charge,
the documents incorporated by reference in Item 3 of Part II of this
Registration Statement. The documents are incorporated by reference in both the
Plan Prospectus and the Resale Prospectus. The Company will also provide,
without charge, upon written or oral request, other documents required to be
delivered to employees pursuant to Rule 428(b). Requests for the above-mentioned
information should be directed to the Company, 11 Hurley Street, Cambridge, MA
02141, (617) 234-6500.
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PROSPECTUS
BIOPURE CORPORATION
9,681 Shares
Class A Common Stock
The selling stockholders referred to in this prospectus may sell up to
9,681 shares of our class A common stock that have been issued to them upon the
exercise of certain stock options. We are not selling any shares of our class A
common stock under this prospectus and will not receive any of the proceeds from
the sale of shares by the selling stockholders.
The selling stockholders may sell the shares of class A common stock
described in this prospectus in a number of different ways and at varying
prices. We provide more information in "Plan of Distribution."
Our class A common stock is listed on the NASDAQ National Market under
the symbol "BPUR." On January 31, 2000, the closing sale price of our class A
common stock, as reported on the NASDAQ National Market, was $27.63.
INVESTING IN OUR CLASS A COMMON STOCK INVOLVES A HIGH DEGREE
OF RISK. SEE "RISK FACTORS".
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE
ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
No underwriter is being utilized in connection with this offering. We
will bear the costs of registering the shares to be sold by the selling
stockholders under the Securities Act.
The information in this prospectus is not complete and may change. The
selling stockholders may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is effective. This
prospectus is not an offer to sell these securities and it is not soliciting an
offer to buy these securities in any state where the offer or sale is not
permitted.
The date of this prospectus is February 3, 2000.
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TABLE OF CONTENTS
Page
Prospectus Summary....................................... 3
Risk Factors............................................. 5
Selling Stockholders..................................... 12
Plan of Distribution..................................... 13
Where You Can Get More Information....................... 15
Experts.................................................. 16
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PROSPECTUS SUMMARY
The following is a summary of our business. You should carefully read
the section entitled "Risk Factors" in this prospectus and our Annual Report on
Form 10-K for the year ended October 31, 1999 for more information on our
business and the risks involved in investing in our stock.
BIOPURE
Biopure is a leading developer, manufacturer and marketer of oxygen
therapeutics. Our oxygen therapeutics are pharmaceuticals administered
intravenously into the circulatory system to increase oxygen delivery to the
body's tissues. We have developed and manufacture two hemoglobin-based oxygen
therapeutic products -- Hemopure, for human use, and Oxyglobin, for veterinary
use. Hemopure is currently in a pivotal Phase III clinical trial in the United
States. Oxyglobin, the only hemoglobin-based oxygen carrier approved by the U.S.
Food and Drug Administration, or the FDA, has been commercially available in the
United States since March 1998 for the treatment of anemia in dogs, regardless
of cause. Oxyglobin was approved for sale in the European Union in December
1999.
Acute blood loss and other medical conditions can disrupt the delivery
of oxygen to the body's tissues. A red blood cell transfusion is the standard
therapy for blood loss. Hemopure compares favorably to transfused red blood
cells in that it:
- is highly purified by proprietary and patented processes to
remove possible infectious agents;
- has a two-year shelf life as compared to blood's 42-day
shelf life;
- does not require refrigeration;
- maintains full oxygen-releasing capability during storage;
- does not require blood typing or other tests for
compatibility; and
- has an abundant, low-cost raw material source -- bovine red
blood cells.
We believe that Hemopure also has potential for use in the treatment of
other critical care conditions such as trauma, ischemic conditions, including
stroke and heart attack, and malignant hypoxic, or oxygen deficient, tumors.
Hemopure:
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- is significantly smaller in molecular size than red blood cells,
so it can flow around partial blockages and through constricted
vessels;
- is less viscous than red blood cells and, therefore,
possesses better flow characteristics;
- is chemically designed to release more oxygen than the
hemoglobin contained in red blood cells; and
- facilitates the release of oxygen from red blood cells.
We have infused Hemopure into 421 humans in 19 completed clinical
trials at doses of up to 244 grams of hemoglobin contained in approximately two
liters, or eight units, of Hemopure. We believe Hemopure is a safe, effective
alternative to red blood cell transfusion after blood loss from surgery. Our
trials demonstrate Hemopure's efficacy as measured by the elimination of a
significant percentage of red blood cell transfusions. Biopure has filed for
Hemopure marketing approval as an alternative to red blood cell transfusions for
specified surgical procedures in South Africa in July 1999 and expects to file
in the United States in 2000.
Oxyglobin is identical to Hemopure except for its molecular size
distribution. Veterinarians report successful use of Oxyglobin in critical care
situations involving blood loss, destruction of red blood cells and ineffective
production of red blood cells in dogs.
Biopure operates a large-scale manufacturing facility with adequate
capacity to produce both Oxyglobin for commercial sale and Hemopure for clinical
trials and market introduction following FDA approval. Biopure believes that its
manufacturing facilities comply with current Good Manufacturing Practices
established by the FDA.
Biopure's incorporation occurred in 1984 in Delaware. Our address is 11
Hurley Street, Cambridge, Massachusetts 02141 and our telephone number is (617)
234-6500.
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RISK FACTORS
You should carefully consider each of the risks and uncertainties
described below and all of the other information contained in this prospectus
before deciding to invest in shares of our class A common stock. The trading
price of our class A common stock could decline if any of the following risks
and uncertainties develop into actual events, and you may lose all or part of
the money you paid to buy our class A common stock.
COMPANY RISKS
IF WE CANNOT GENERATE ADEQUATE, PROFITABLE SALES OF HEMOPURE, WE WILL NOT BE
SUCCESSFUL
In order to succeed as a company, we must develop Hemopure commercially
and sell adequate quantities of Hemopure at a high enough price to generate a
profit. We may not accomplish either of these objectives.
Even if we succeed in developing Hemopure commercially, a
number of factors may affect future sales of our product. These
factors include:
- whether physicians, patients and clinicians accept Hemopure as a
cost-effective and therapeutic alternative to other products,
including donated human blood;
- whether reimbursement for the cost of Hemopure is
available; and
- whether the public accepts the use of a natural protein product
extracted from bovine red blood cells in transfusions,
particularly in light of public perceptions in Europe and
elsewhere about the risk of "mad cow disease".
IF WE FAIL TO OBTAIN FDA APPROVAL, WE CANNOT MARKET HEMOPURE IN THE UNITED
STATES
We will not be able to market Hemopure in the United States until we
receive FDA approval. Obtaining FDA approval generally takes years and consumes
substantial capital resources with no assurance of ultimate success. We cannot
apply for FDA approval to market Hemopure until the product successfully
completes an ongoing U.S. pivotal Phase III clinical trial. Several factors may
prevent successful completion of this clinical trial, including an inability to
enroll the required number of patients and insufficient demonstration that
Hemopure is safe and effective for
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use in humans. If safety problems develop, the FDA could stop our trial before
its completion. Recent publicity about enrollment abuses in the pharmaceutical
industry and regulatory actions taken with respect to some major research
institutes engaged in the clinical testing of pharmaceutical products could
affect the ability of Biopure to enroll patients in its clinical studies.
Even if we complete the trial, we are not certain that we will be able
to obtain FDA approval of Hemopure. We believe that our ongoing U.S. pivotal
Phase III clinical trial is consistent with the FDA's most recent guidance on
the design and efficacy and safety endpoints required for approval of products
such as Hemopure. However, the FDA could change its view or require a change in
study design, additional data or even further clinical trials prior to approval
of Hemopure. If we fail to complete our ongoing U.S. pivotal Phase III clinical
trial and obtain FDA approval, we cannot market Hemopure in the United States.
OUR FAILURE TO OBTAIN REGULATORY APPROVALS IN FOREIGN JURISDICTIONS WILL PREVENT
US FROM MARKETING HEMOPURE ABROAD
We also intend to market our products in international markets,
including the European Union and South Africa. We must obtain separate
regulatory approvals in order to market our products in the European Union,
South Africa and many other foreign jurisdictions. The regulatory approval
processes may differ among these jurisdictions. Approval in any one jurisdiction
does not ensure approvals in a different jurisdiction. As a result, obtaining
foreign approvals may require additional trials and additional expenses.
WE CANNOT EXPAND INDICATIONS FOR OUR PRODUCTS UNLESS WE RECEIVE FDA APPROVAL FOR
EACH PROPOSED INDICATION
The FDA requires a separate approval for each proposed indication for
the use of Hemopure. We expect that our first indication for Hemopure will only
involve its use in elective orthopedic surgery. Subsequently, we expect to
expand Hemopure's indications. In order to do so, we will have to design
additional clinical trials, submit the trial designs to the FDA for review and
complete those trials successfully. We cannot guarantee that the FDA will
approve Hemopure for any indication. We can only promote Hemopure for
indications which have been approved by the FDA. Moreover, it is possible that
the FDA may require a label cautioning against Hemopure's use for any or all
other indications.
The FDA has approved the use of our veterinary product, Oxyglobin, for
the treatment of anemia in dogs, regardless of cause. Supplemental approvals are
required to market Oxyglobin for
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any new indications or additional species. We cannot guarantee that we will
receive such approvals.
IF WE CANNOT FIND APPROPRIATE MARKETING PARTNERS, WE MAY NOT BE ABLE TO MARKET
AND DISTRIBUTE HEMOPURE EFFECTIVELY
Our success depends, in part, on our ability to market and distribute
Hemopure effectively. We have no experience in the sale or marketing of medical
products for humans. In the past, we entered into agreements with two
established pharmaceutical companies to market our products upon successful
completion of clinical development. These arrangements ended in 1996 and 1997.
In the event that we obtain FDA approval of Hemopure, we may require the
assistance of one or more experienced pharmaceutical companies to market and
distribute Hemopure effectively.
If we seek an alliance with an experienced pharmaceutical company:
- we may be unable to find a collaborative partner, enter into an
alliance on favorable terms or enter into an alliance that will be
successful;
- any partner to an alliance might, at its discretion, limit
the amount and timing of resources it devotes to marketing
Hemopure; and
- any marketing partner or licensee may terminate its agreement with
us and abandon our products at any time for any reason without
significant payments.
If we do not enter into an alliance with a pharmaceutical company to
market and distribute our products, we may not be successful in entering into
alternative arrangements, whether engaging independent distributors or
recruiting, training and retaining a marketing staff and sales force of our own.
FAILURE TO INCREASE MANUFACTURING CAPACITY MAY IMPAIR HEMOPURE'S MARKET
ACCEPTANCE
We will need to construct additional manufacturing facilities to meet
annual demand in excess of 120,000 units of Hemopure. If Hemopure receives rapid
market acceptance, we may experience difficulty manufacturing enough of the
product to meet demand. If we cannot fill orders for Hemopure, customers might
turn to alternative products and choose not to use Hemopure even after we have
addressed our capacity shortage.
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FAILURE TO RAISE ADDITIONAL FUNDS IN THE FUTURE MAY AFFECT THE DEVELOPMENT,
MANUFACTURE AND SALE OF OUR PRODUCTS
We require substantial working capital to properly develop, manufacture
and sell our products. We expect to use a significant portion of the net
proceeds of this offering to fund our working capital requirements. Additional
manufacturing facilities will require additional financing. If such financing is
not available when needed or is not available on acceptable terms, we may
experience a delay in developing products, building manufacturing capacity or
fulfilling other important goals.
OUR LACK OF OPERATING HISTORY MAKES EVALUATING OUR BUSINESS DIFFICULT
Licensing fees, payments to us from investors and payments to fund our
research and development activities comprise almost all of our funding to date.
We have no operating history upon which to base an evaluation of our business
and our prospects. We must successfully develop our products and product
enhancements, achieve market acceptance of our products and respond to
competition. We cannot guarantee that we will be successful in doing so, that we
will ever be profitable or, if we are, that we will remain profitable on a
quarterly or annual basis.
WE HAVE A HISTORY OF LOSSES AND EXPECT FUTURE LOSSES
We have had annual losses from operations since our inception in 1984.
We expect to continue to incur losses from operations until we are able to
develop Hemopure commercially and generate a profit. As of October 31, 1999, we
had accumulated a deficit of $250.4 million. Our 1999 auditors' report stated
that our recurring losses from operations raise substantial doubt about our
ability to continue as a going concern.
IF WE ARE NOT ABLE TO PROTECT OUR INTELLECTUAL PROPERTY, COMPETITION COULD FORCE
US TO LOWER OUR PRICES, WHICH MIGHT REDUCE PROFITABILITY
We believe that our patents, trademarks and other intellectual property
rights, including our proprietary know-how, will be important to our success.
Our business position will depend, in part, upon our ability to defend our
existing patents and engage in our business free of claims of infringement by
third parties. We will need to obtain additional patents for our products, the
processes utilized to make our products and our product uses. We cannot
guarantee that additional products or processes will achieve patent protection.
In addition, third parties may successfully challenge our patents. Oppositions
to one of our European patents have already led to a narrowing of this patent in
Europe and, since
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some oppositions are still pending, may lead to further narrowing or even a loss
of this European patent.
We have not filed patent applications in every country of the world. In
certain countries, obtaining patents for our products, processes and uses may be
difficult or impossible. Patents issued in countries other than the United
States and in regions other than Europe may be harder to enforce than, and may
not provide the same protection as, patents obtained in the United States and
Europe.
OUR PROFITABILITY WILL BE AFFECTED IF WE INCUR PRODUCT LIABILITY CLAIMS IN
EXCESS OF OUR INSURANCE COVERAGE
The testing and marketing of medical products, even after FDA approval,
have an inherent risk of product liability. We maintain limited product
liability insurance coverage in the total amount of $10.0 million. Our
profitability will be affected by a successful product liability claim in excess
of our insurance coverage. We cannot guarantee that product liability insurance
will be available in the future or be available on reasonable terms.
REPLACING OUR SOLE SOURCE SUPPLIERS FOR KEY MATERIALS COULD RESULT IN UNEXPECTED
DELAYS AND EXPENSES
We obtain some key materials, including membranes and chemicals, from
sole source suppliers. If such materials were no longer available at a
reasonable cost from our existing suppliers, we would need to obtain supply
contracts with new suppliers for substitute materials. If we need to locate a
new supplier, the substitute or replacement materials will most likely be tested
for equivalency. Such evaluations could delay development of a product, limit
commercial sales of an FDA-approved product and cause us to incur significant
additional expense. In addition, the time expended for such tests could delay
the marketing of an FDA-approved product.
CONCENTRATION OF STOCK OWNERSHIP AND PROVISIONS OF OUR RESTATED CERTIFICATE OF
INCORPORATION COULD DISCOURAGE TAKEOVER TRANSACTIONS THAT A STOCKHOLDER MIGHT
CONSIDER TO BE IN ITS BEST INTEREST
Carl W. Rausch, one of our co-founders and our current Chairman and
Chief Executive Officer, beneficially owns 24.7% of our outstanding class A
common stock. As a result, Mr. Rausch has significant influence over the outcome
of all matters requiring stockholder approval, including the election and
removal of directors and a merger or consolidation of Biopure or sale of all or
substantially all of our assets. Mr. Rausch's influence could discourage others
from initiating a potential merger, takeover or other change of control
transaction, including a potential transaction at a premium over market price
that a stockholder might
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consider to be in its best interest. In addition, certain provisions of our
Restated Certificate of Incorporation and by-laws, as well as the adoption of a
proposed stockholders' rights plan, could discourage these transactions.
INDUSTRY RISKS
INTENSE COMPETITION COULD HARM OUR FINANCIAL PERFORMANCE
The biotechnology and pharmaceutical industries are highly competitive.
There are a number of companies, universities and research organizations
actively engaged in research and development of products that may be similar to
Hemopure. Increased competition could diminish our ability to become profitable
or affect our profitability in the future. Our existing and potential
competitors:
- are also conducting clinical trials of their products;
- may have substantially greater resources than we do and may
be better equipped to develop, manufacture and market their
products;
- may have their products approved for marketing prior to
Hemopure; and
- may develop superior technologies or products rendering our
technology and products non-competitive or obsolete.
STRINGENT, ONGOING GOVERNMENT REGULATION AND INSPECTION OF OUR PRODUCTS COULD
LEAD TO DELAYS IN THE MANUFACTURE, MARKETING AND SALE OF OUR PRODUCTS
The FDA continues to review products even after they receive FDA
approval. If and when the FDA approves Hemopure, its manufacture and marketing
will be subject to ongoing regulation, including compliance with current Good
Manufacturing Practices, adverse event reporting requirements and the FDA's
general prohibitions against promoting products for unapproved or "off- label"
uses. We are also subject to inspection and market surveillance by the FDA for
compliance with these and other requirements. Any enforcement action resulting
from failure to comply with these requirements could affect the manufacture and
marketing of Hemopure. In addition, the FDA could withdraw a previously approved
product from the market upon receipt of newly discovered information.
We will be subject to a variety of regulations governing clinical
trials and sales of our products outside the United States. Whether or not FDA
approval has been obtained, we must
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secure approval of a product by the comparable non-U.S. regulatory authorities
prior to the commencement of marketing of the product in a country. The approval
process varies from country to country and the time needed to secure additional
approvals may be longer than that required for FDA approval. These applications
may require the completion of preclinical and clinical studies and disclosure of
information relating to manufacturing and controls. Unanticipated changes in
existing regulations or the adoption of new regulations could affect the
manufacture and marketing of our products.
HEALTH CARE REFORM AND CONTROLS ON HEALTH CARE SPENDING MAY LIMIT THE PRICE WE
CHARGE FOR HEMOPURE AND THE AMOUNT WE CAN SELL
The federal government and private insurers have considered ways to
change, and have changed, the manner in which health care services are provided
in the United States. Potential approaches and changes in recent years include
controls on health care spending and the creation of large purchasing groups. In
the future, it is possible that the government may institute price controls and
limits on Medicare and Medicaid spending. These controls and limits might affect
the payments we collect from sales of our products. Assuming we succeed in
bringing Hemopure to market, uncertainties regarding future health care reform
and private market practices could impact our ability to sell Hemopure in large
quantities at profitable pricing.
UNCERTAINTY OF THIRD-PARTY REIMBURSEMENT COULD AFFECT OUR PROFITABILITY
Sales of medical products largely depend on the reimbursement of
patients' medical expenses by governmental health care programs and private
health insurers. There is no guarantee that governmental health care programs or
private health insurers will reimburse our sales of Hemopure, or permit us to
sell our products at high enough prices to generate a profit.
This prospectus also contains forward-looking statements that involve
risks and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of certain factors,
including the risks faced by us described above and elsewhere in this
prospectus. We assume no obligation to update any forward-looking statements or
reason why actual results might differ.
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SELLING STOCKHOLDERS
The following table sets forth certain information regarding the
beneficial ownership of the class A common stock, as of January 31, 2000, by one
of the selling stockholders. Beneficial ownership is determined in accordance
with Rule 13d-3(d) promulgated by the Commission under the Securities Exchange
Act of 1934.
Number of Shares
Number of Shares Beneficially
Beneficially Shares Owned After
Selling Owned Prior to Being Completion of
Stockholder this Offering Offered this Offering
John Mossop 8,000 8,000 8,000
Certain unnamed selling stockholders who are non-affiliates of Biopure
may use this prospectus to sell up to 1000 shares of class A common stock.
Because the selling stockholders may sell all or some portion of the shares of
class A common stock beneficially owned by them, we cannot estimate with any
certainty the number of shares of class A common stock that will be beneficially
owned by the selling stockholders after this offering. In addition, the selling
stockholders may have sold, transferred or otherwise disposed of, or may sell,
transfer or otherwise dispose of, at any time or from time to time since the
date on which they provided the information regarding the shares of class A
common stock beneficially owned by them, all or a portion of the shares of class
A common stock beneficially owned by them in transactions exempt from the
registration requirements of the Securities Act.
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PLAN OF DISTRIBUTION
The shares of class A common stock may be sold from time to time by the
selling stockholders in one or more transactions at fixed prices, at market
prices at the time of sale, at varying prices determined at the time of sale or
at negotiated prices. As used in this prospectus, "selling stockholders"
includes donees, pledgees, transferees and other successors in interest selling
shares received from a selling stockholder after the date of this prospectus as
a gift, pledge, partnership distribution or other non-sale transfer. The selling
stockholders may offer their shares of class A common stock in one or more of
the following transactions:
- on the NASDAQ National Market or any national securities exchange
or quotation service on which our class A common stock is listed
or quoted at the time of sale;
- in the over-the-counter market;
- in private transactions;
- through options;
- by pledge to secure debts and other obligations; or
- a combination of any of the above transactions.
The shares of class A common stock described in this prospectus may be
sold from time to time directly by the selling stockholders. Alternatively, the
selling stockholders may from time to time offer shares of class A common stock
to or through underwriters, broker/dealers or agents. The selling stockholders
and any underwriters, broker/dealers or agents that participate in the
distribution of the shares of class A common stock may be deemed to be
"underwriters" within the meaning of the Securities Act of 1933. Any profits on
the resale of shares of class A common stock and any compensation received by
any underwriter, broker/dealer or agent may be deemed to be underwriting
discounts and commissions under the Securities Act of 1933. The selling
stockholders may agree to indemnify any agent, dealer or broker-dealer that
participates in the sale of shares of class A common stock described in this
prospectus against certain liabilities, including liabilities arising under the
Securities Act of 1933.
Any shares covered by this prospectus that qualify for sale pursuant to
Rule 144 under the Securities Act of 1933 may be sold under Rule 144 rather than
pursuant to this prospectus. The
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selling stockholders may transfer, devise or gift shares by other means not
described in this prospectus.
To comply with the securities laws of certain jurisdictions, the class
A common stock must be offered or sold only through registered or licensed
brokers or dealers. In addition, in certain jurisdictions, the shares of class A
common stock may not be offered or sold unless they have been registered or
qualified for sale or an exemption is available and complied with.
Under the Securities Exchange Act of 1934, any person engaged in a
distribution of the class A common stock may not simultaneously engage in
market-making activities with respect to the class A common stock for five
business days prior to the start of the distribution. In addition, each selling
stockholder and any other person participating in a distribution will be subject
to the Securities Exchange Act of 1934, which may limit the timing of purchases
and sales of class A common stock by the selling stockholders or any such other
person. These factors may affect the marketability of the class A common stock
and the ability of brokers or dealers to engage in market-making activities.
All expenses of this registration, estimated at approximately $15,000
will be paid by us. These expenses include the SEC's filing fees.
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WHERE YOU CAN GET MORE INFORMATION
We are a reporting company and are required to file annual, quarterly
and current reports, proxy statements and other information with the SEC. You
may read and copy these reports, proxy statements and other information at the
SEC's public reference rooms at Room 1024, 450 Fifth Street, N.W., Washington,
D.C., as well as at the SEC's regional offices at 500 West Madison Street, Suite
1400, Chicago, Illinois 60661 and 7 World Trade Center, Suite 1300, New York, NY
10048. You can request copies of these documents by writing to the SEC and
paying a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for
more information about the operation of the public reference rooms. Our SEC
filings are also available at the SEC's web site at "http://www.sec.gov." In
addition, you can read and copy our SEC filings at the office of the National
Association of Securities Dealers, Inc. at 1735 "K" Street, Washington, D.C.
20006.
The SEC allows us to "incorporate by reference" information that 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
an important 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 Section 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act
of 1934:
- Annual Report on Form 10-K for the year ended October 31,
1999; and
- Description of class A common stock contained in the Registration
Statement on Form 8-A filed on July 26, 1999 under the Securities
Exchange Act of 1934.
You may request a copy of these filings at no cost, by writing or
telephoning us at the following address:
Biopure Corporation
11 Hurley Street
Cambridge, MA 02141
(617) 234-6500
This prospectus is part of a registration statement we filed with the
SEC. You should rely only on the information incorporated by reference or
provided in this prospectus and the registration statement. We have authorized
no one to provide you with different information. You should not assume that the
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information in this prospectus is accurate as of any date other than the date on
the front of the document.
EXPERTS
The consolidated financial statements of Biopure Corporation appearing
in Biopure Corporation's Annual Report on Form 10-K for the year ended October
31, 1999 have been audited by Ernst & Young LLP, independent auditors, as set
forth in their report thereon (which contains an explanatory paragraph
describing conditions that raise substantial doubt about the company's ability
to continue as a going concern as described in Note 2 to the consolidated
financial statements) included therein and incorporated herein by reference.
Such consolidated financial statements are incorporated herein by reference in
reliance upon such report given on the authority of such firm as experts in
accounting and auditing.
16
<PAGE> 20
PART II
INFORMATION REQUIRED IN THE REGISTRATION STATEMENT
ITEM 3. INCORPORATION OF DOCUMENTS BY REFERENCE:
The following documents filed by the Registrant with the Commission are
incorporated herein by reference.
(a) the Company's Annual Report on Form 10-K for the year ended October 31,
1999.
(b) The description of the Common Stock contained in the Registrant's
Registration Statement on Form 8-A (File No. 0-001- 15167), filed under the
Securities Exchange Act of 1934, including any amendment or report filed for the
purpose of updating such description.
All reports and other documents filed by the Registrant after the date
hereof pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Securities
Exchange Act of 1934 prior to the filing of a post-effective amendment which
indicates that all securities offered hereby have been sold or which deregisters
all securities then remaining unsold, shall be deemed to be incorporated by
reference herein and to be part hereof from the date of filing of such reports
and documents.
ITEM 4. DESCRIPTION OF SECURITIES.
Not applicable.
ITEM 5. INTERESTS OF NAMED EXPERTS AND COUNSEL
Jane Kober, Esq., the Company's counsel, is Senior Vice President, General
Counsel and Secretary of the Company. As of January 23, 2000 Ms. Kober held
4,000 shares of Common Stock, options under the 1998 Stock Option Plan to
purchase 33,333 shares of Common Stock and options under the 1999 Omnibus
Securities and Incentive Plan to purchase 133,333 shares of Common Stock.
ITEM 6. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Incorporated herein by reference from Registration Statement on Form S-1,
No. 333-78829
ITEM 7. EXEMPTION FROM REGISTRATION CLAIMED
The securities being resold pursuant to the resale prospectus contained in
this Registration Statement were issued
II-1
<PAGE> 21
in reliance on the exemption from registration under Rule 701 of the Securities
Act. Biopure's employees, directors and officers who exercised stock options
represented their intentions to acquire the securities for investment purposes
only and not with a view for distribution thereof, and appropriate restrictive
legends were affixed to the shares of class A common stock issued pursuant to
the exercise of stock options.
ITEM 8. EXHIBITS.
5. Opinion of Jane Kober, Esq., as to the legality of shares
being registered.
23.1 Consent of Jane Kober (included in opinion of counsel filed as
Exhibit 5).
23.2 Consent of Ernst & Young LLP.
24. Power of Attorney to file future amendments (set forth on the
signature page of this Registration Statement).
ITEM 9. 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:
(i) To include any prospectus required by Section 10(a)(3) of
the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising
after the effective date of the Registration Statement (or the
most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental
change in the information set forth in the Registration
Statement. Notwithstanding the foregoing, any increase or
decrease in volume of securities offered (if the total dollar
value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form
of prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price
represent no more than a 20% change in the maximum aggregate
offering price set forth in the "Calculation of Registration
Fee" table in the effective Registration Statement.
(iii) To include any material information with respect to the
plan of distribution not previously disclosed in
II-2
<PAGE> 22
the Registration Statement or any material change to such
information in the Registration Statement.
Provided, however, that paragraphs (a)(1)(i) and
(a)(1)(ii) do not apply if the Registration Statement is on
Form S-3, Form S-8 or Form F-3, and the information required
to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or
furnished to the Commission by the Registrant pursuant to
Section 13 or Section 15(d) of the Securities Exchange Act of
1934 that are incorporated by reference in this 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.
(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 that is
incorporated by reference in this 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) 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 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 Registrant of
expenses incurred or paid by a director, officer or
controlling person of the Registrant in the successful
II-3
<PAGE> 23
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 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.
II-4
<PAGE> 24
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that is has reasonable grounds to believe that it meets all
of the requirements for filing on Form S-8 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the city of Cambridge, state of Massachusetts, on this 1st day of
February, 2000.
BIOPURE CORPORATION
By: /s/ Francis H. Murphy
---------------------------------
Francis H. Murphy
Chief Financial Officer
Each person whose signature appears below constitutes and appoints
Francis H. Murphy and Jane Kober, or either of them, his true and lawful
attorney-in-fact and agent, with full power of substitution and resubstitution,
for him and in his name, place and stead, and in any and all capacities, to sign
any and all amendments (including post-effective amendments) to this
Registration Statement on Form S-8 of Biopure Corporation and to file the same,
with all exhibits thereto and other documents in connection therewith, with the
Securities and Exchange Commission, granting unto said attorney-in-fact and
agent, full power and authority to do and perform each and every act and thing
requisite or necessary to be done in or about the premises, as full to all
intents and purposes as he might or could do in person, hereby ratifying and
confirming all that said attorney-in-fact and agents or any of them or their or
his substitute or substitutes may lawfully do or cause to be done by virtue
hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
SIGNATURE TITLE DATE
--------- ----- ----
By: /s/ Carl W. Rausch Chairman of the February 1, 2000
------------------------------ Board, Chief
Carl W. Rausch Executive
Officer
(principal
executive
officer)
II-5
<PAGE> 25
By: /s/ Paul A. Looney Director, February 1, 2000
------------------------------ President
Paul A. Looney (principal
operating
officer)
By: /s/ Francis H. Murphy Chief Financial February 1, 2000
------------------------------ Officer
Francis H. Murphy (principal
financial and
accounting
officer)
By: /s/ David N. Judelson Director February 1, 2000
------------------------------
David N. Judelson
By: /s/ Daniel P. Harrington Director February 1, 2000
------------------------------
Daniel P. Harrington
By:
------------------------------ Director February 1, 2000
C. Everett Koop
By: Director February 1, 2000
------------------------------
Charles A. Sanders,M.D.
By: Director February 1, 2000
------------------------------
Stephen A. Kaplan
II-6
<PAGE> 26
INDEX TO EXHIBITS
NUMBER DESCRIPTION OF EXHIBIT PAGE
- ------ ---------------------- ----
5 - Opinion of Jane Kober
23.1 - Consent of Jane Kober (contained in Exhibit 5) __
23.2 - Consent of Ernst & Young LLP __
24 - Power of Attorney (see "Power of Attorney" in the
Registration Statement) __
<PAGE> 1
[BIOPURE LETTERHEAD]
Exhibit 5
February 1, 2000
Biopure Corporation
11 Hurley Street
Cambridge, MA 02141
Re: Biopure Corporation Registration on Statement Form S-8
------------------------------------------------------
Ladies and Gentlemen:
This opinion is being delivered by me as General Counsel of Biopure
Corporation, a Delaware corporation (the "Company"), in connection with the
registration of up to 2,470,490 shares of Class A Common Stock, par value $.01
per share (the "Shares"), on a registration statement on Form S-8 (the
"Registration Statement"), being filed with the Securities and Exchange
Commission pursuant to the Securities Act of 1933 (the "Securities Act"). These
shares are to be purchased from the Company by holders of options granted under
employee stock option plans, or to be reoffered for sale to the public by
holders of shares acquired upon exercise of options granted to them under the
Company's stock options plan.
For the purpose of the opinion set forth below, I have examined originals
or copies, certified or otherwise identified to my satisfaction, of such
documents and corporate and public records as I have deemed necessary as a
basis for the opinion hereafter expressed. In my examination, I have assumed
the genuineness of all signatures, the authenticity of all documents presented
to me as originals and the conformity to the originals of all documents
presented to me as copies. In rendering my opinion, I have relied as to factual
matters upon certificates and representations of officers of the Company and
certificates of public officials.
Based upon the foregoing, I am of the opinion that the Shares, when issued
and sold as contemplated in the Registration Statement, will be validly issued,
fully paid and nonassessable.
I do not express any opinion herein concerning any law other than the
Delaware General Corporation law.
I hereby consent to the use of this opinion as Exhibit 5 to the
Registration Statement and to the use of my name under the caption "Interests
of Named Experts and Counsel" contained in the Registration Statement.
Very truly yours,
/s/ Jane Kober
Jane Kober
Senior Vice President,
General Counsel
<PAGE> 1
Exhibit 23.2
CONSENT OF INDEPENDENT AUDITORS
We consent to the reference to our firm under the caption "Experts"
in the Registration Statement (Form S-8) pertaining to the Biopure Corporation
1988 Stock Option Plan, the 1998 Stock Option Plan and the 1999 Omnibus
Securities and Incentive Plan and to the incorporation by reference therein of
our report dated December 10, 1999 with respect to the consolidated financial
statements of Biopure Corporation included in its Annual Report (Form 10-K) for
the year ended October 31, 1999, filed with the Securities and Exchange
Commission.
Boston, MA /s/ ERNST & YOUNG LLP
January 28, 2000
