<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 18, 2000
REGISTRATION NO. 333-
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U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
------------------------
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
------------------------------
GENZYME CORPORATION
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C>
MASSACHUSETTS 06-1047163
(State or other jurisdiction (I.R.S. Employer
incorporation or organization) Identification Number)
</TABLE>
ONE KENDALL SQUARE, CAMBRIDGE, MASSACHUSETTS 02139
(617) 252-7500
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
------------------------------
PETER WIRTH, ESQ.
EXECUTIVE VICE PRESIDENT AND CHIEF LEGAL OFFICER
GENZYME CORPORATION
ONE KENDALL SQUARE
CAMBRIDGE, MASSACHUSETTS 02139
(617) 252-7500
(Name and address, including zip code, of agent for service)
WITH COPIES TO:
PAUL M. KINSELLA, ESQ.
PALMER & DODGE LLP
ONE BEACON STREET
BOSTON, MASSACHUSETTS 02108
(617) 573-0100
------------------------------
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 the 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. / /
------------------------------
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
PROPOSED MAXIMUM PROPOSED MAXIMUM
TITLE OF EACH CLASS AMOUNT TO BE OFFERING PRICES PER AGGREGATE OFFERING AMOUNT OF
OF SECURITIES TO BE REGISTERED REGISTERED SHARE PRICE REGISTRATION FEE
<S> <C> <C> <C> <C>
Genzyme Biosurgery Division Common Stock,
$0.01 par value per share 48,076 shares(1) $31.63(2) $924,662.25(3) $245.00(4)
</TABLE>
(1) Represents the estimated maximum number of shares of Genzyme Biosurgery
Division common stock of the Registrant ("Biosurgery Stock") to be issued
upon the exercise of options by former employees and directors of
Biomatrix, Inc. ("Biomatrix) following the completion of the merger of
Biomatrix with and into a wholly-owned subsidiary of the Registrant (the
"Merger") based on the issuance of one share of Biosurgery Stock for each
share of common stock of Biomatrix that the options were exercisable for
immediately before the completion of the Merger. Shares of Biosurgery Stock
include associated purchase rights which shall be evidenced by certificates
for shares of Biosurgery Stock and will automatically trade with such
shares.
(2) Following the Merger, each holder of an option may purchase shares of
Biosurgery Stock pursuant to the terms of its option agreement. The proposed
maximum offering price per share reflects what will be the highest exercise
price per share of Biosurgery Stock represented by the terms of the option
agreements following the Merger.
(3) Since the shares of Biosurgery Stock issuable upon the exercise of the
options following the Merger will have exercise prices ranging from
approximately $18.07 to $31.63 per share of Biosurgery Stock, the proposed
maximum aggregate offering price constitutes the maximum amount of proceeds
receivable by the Registrant.
(4) Calculated pursuant to Rule 457(g) under the Securities Ac t of 1933, as
amended.
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.
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
<PAGE>
>THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. WE MAY
NOT SELL THESE SECURITIES UNTIL THE SECURITIES AND EXCHANGE COMMISSION DECLARES
OUR REGISTRATION STATEMENT 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.
<PAGE>
SUBJECT TO COMPLETION, DATED DECEMBER 18, 2000
GENZYME
48,076 SHARES
GENZYME BIOSURGERY DIVISION COMMON STOCK
We are registering a total of 48,076 shares of Genzyme Biosurgery Division
common stock that are issuable upon the exercise of certain options that we
assumed as part of our acquisition of Biomatrix, Inc. The exercise prices of the
options we have assumed range from approximately $18.07 to $31.63 per share of
Genzyme Biosurgery Division common stock. If all of these options are exercised
in full, we will receive total cash proceeds of approximately $924,662.
Genzyme Biosurgery Division common stock is one of Genzyme Corporation's
three tracking stocks. It is quoted on the Nasdaq National Market under the
trading symbol "GZBX," and on December , 2000 its closing price was $ per
share.
------------------------
INVESTING IN SHARES OF GENZYME BIOSURGERY DIVISION COMMON STOCK INVOLVES A
HIGH DEGREE OF RISK. YOU SHOULD CAREFULLY READ AND CONSIDER THE "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.
------------------------
You should rely only on the information included in this prospectus. We have
not authorized anyone to provide you with different information. You should not
assume that the information in this prospectus is accurate as of any date other
than date below.
THE DATE OF THIS PROSPECTUS IS DECEMBER , 2000.
Genzyme Corporation - One Kendall Square, Cambridge, Massachusetts 02139 -
(617) 252-7500
<PAGE>
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE
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<S> <C>
Genzyme Corporation......................................... 2
Where You Can Find More Information......................... 2
Risk Factors................................................ 4
Special Note Regarding Forward-Looking Statements........... 20
Plan of Distribution........................................ 21
Use of Proceeds............................................. 21
Legal Matters............................................... 21
Experts..................................................... 21
</TABLE>
NOTE REGARDING TRADEMARKS
Genzyme-Registered Trademark-, Cerezyme-Registered Trademark-,
Ceredase-Registered Trademark-, Sepra Film-Registered Trademark- and
Carticel-Registered Trademark- are registered trademarks of Genzyme Corporation.
Fabrazyme-TM- is a trademark of Genzyme Corporation.
Genzyme-Registered Trademark- is a registered service mark of Genzyme
Corporation.
AVONEX-Registered Trademark- is a registered trademark of Biogen, Inc.
Renagel-Registered Trademark- is a registered trademark of GelTex
Pharmaceuticals, Inc.
Synvisc-Registered Trademark- and Hylaform-Registered Trademark- are registered
trademarks of Genzyme Biosurgery Corporation.
NOTE REGARDING REFERENCES TO GENZYME DIVISIONS AND SERIES OF STOCK.
Throughout this prospectus, the words "we," "us," "our" and "Genzyme" refer
to Genzyme Corporation and all of its operating divisions taken as a whole, and
"our board of directors" refers to the board of directors of Genzyme
Corporation. In addition, we refer to our three operating divisions as follows:
- Genzyme General Division = "Genzyme General;"
- Genzyme Molecular Oncology Division = "Genzyme Molecular Oncology;" and
- Genzyme Biosurgery Division = "Genzyme Biosurgery."
We currently have three designated series of common stock. Each of these
series is intended to reflect the value and track the performance of one of our
divisions. We refer to each series of common stock as follows:
- Genzyme General Division Common Stock = "Genzyme General Stock;"
- Genzyme Molecular Oncology Division Common Stock = "Molecular Oncology
Stock;" and
- Genzyme Biosurgery Division Common Stock = "Biosurgery Stock."
<PAGE>
GENZYME CORPORATION
We are a biotechnology company that develops innovative products and
services for major unmet medical needs. We were founded in 1981 and became a
Massachusetts corporation in 1991. We currently have three operating divisions.
We also have three series of common stock--or "tracking" stock--which are
designed to reflect the value and track the financial performance of our
operating divisions. Our three operating divisions are:
- Genzyme General, which develops and markets therapeutic products and
diagnostic products and services, with an emphasis on therapies for
genetic diseases;
- Genzyme Molecular Oncology, which develops cancer products, with a focus
on cancer vaccines and angiogenisis inhibitors. It is shaping these new
therapies through the integration of its genomics, gene discovery, cell
therapy, gene therapy, small molecule drug discovery and protein
therapeutic efforts; and
- Genzyme Biosurgery, which develops and markets devices, biomaterials,
biotherapeutics and other products for the orthopedic market and the
cardiovascular, general and plastic surgery markets.
We allocate all of our products, services, programs, assets and liabilities
among our divisions for purposes of financial statement presentation; however,
Genzyme, the corporation, continues to own all of the assets and is responsible
for all of the liabilities allocated to each of the divisions.
WHERE YOU CAN FIND MORE INFORMATION
You may read and copy any reports, statements or other information that we
file with the SEC at the SEC's public reference rooms at the following
locations:
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<S> <C> <C>
Public Reference Room New York Regional Office Chicago Regional Office
450 Fifth Street, N.W. 7 World Trade Center Citicorp Center
Room 1024 Suite 1300 500 West Madison Street
Washington, D.C. 20549 New York, NY 10048 Suite 1400
Chicago, IL 60661-2511
</TABLE>
Please call the SEC at 1-800-SEC-0330 for further information on the public
reference rooms. These SEC filings are also available to the public from
commercial document retrieval services and at the Internet world wide web site
maintained by the SEC at "http://www.sec.gov." Reports, proxy statements and
other information concerning us may also be inspected at the offices of The
Nasdaq Stock Market, which is located at 1735 K Street, N.W., Washington, D.C.
20006.
The SEC allows us to "incorporate by reference" information into this
prospectus, which means that we can disclose important information to you by
referring you to other documents filed separately with the SEC. The information
incorporated by reference is considered part of this prospectus, except for any
information superseded by information contained directly in this prospectus or
in later-filed documents incorporated by reference in this prospectus.
This prospectus incorporates by reference the documents set forth below that
we have previously filed with the SEC. These documents contain important
business and financial information about Genzyme that is not included in or
delivered with this prospectus.
1. Annual Report on Form 10-K for the year ended December 31, 1999, as amended
by amendments on Form 10-K/A filed with the SEC on June 28, 2000 and
October 17, 2000;
2. Quarterly Reports on Form 10-Q for the quarters ended March 31, 2000, as
amended on Form 10-Q/A filed with the SEC on October 17, 2000, June 30,
2000, as amended on Form 10-Q/A filed with the SEC on October 17, 2000 and
September 30, 2000;
2
<PAGE>
3. Current Reports on Form 8-K filed with the SEC on January 10, 2000,
March 15, 2000, March 23, 2000, June 30, 2000, July 14, 2000, July 19, 2000,
September 12, 2000, September 13, 2000, November 20, 2000 and December [19],
2000;
4. The description of Genzyme Biosurgery Division Common Stock contained in our
Registration Statement on Form 8-A/A filed with the SEC on December [19],
2000]; and
5. The description of Genzyme Biosurgery Stock purchase rights contained in our
Registration Statement on Form 8-A/A filed with the SEC on December [19],
2000.
We also incorporate by reference additional documents that we may file with
the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act between the
date of this prospectus and the date that we terminate this offering. These
include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports
on Form 10-Q and Current Reports on Form 8-K, as well as proxy statements.
You may request a copy of these filings and future filings, at no cost, by
writing or telephoning us at the following address or number:
Shareholder Services
Genzyme Corporation
One Kendall Square
Cambridge, Massachusetts 02139
(617) 252-7526.
3
<PAGE>
RISK FACTORS
IF YOU PURCHASE SHARES OF BIOSURGERY STOCK, YOU WILL TAKE ON FINANCIAL RISK.
IN DECIDING WHETHER TO INVEST, YOU SHOULD CAREFULLY CONSIDER THE FOLLOWING RISK
FACTORS IN ADDITION TO THE OTHER INFORMATION INCLUDED AND INCORPORATED IN THIS
PROSPECTUS.
RISKS RELATING TO GENZYME TRACKING STOCKS
The following are risks related to owning shares of our tracking stock. You
should consider carefully these risk factors before deciding whether to invest
in our stock.
THE HOLDERS OF OUR TRACKING STOCK ARE STOCKHOLDERS OF A SINGLE COMPANY AND
UNFAVORABLE FINANCIAL TRENDS AFFECTING ONE DIVISION COULD NEGATIVELY AFFECT
OTHER GENZYME DIVISIONS.
None of our divisions are separate legal entities. Holders of Biosurgery
Stock, together with holders of our other series of tracking stock, are
stockholders of a single company and face all of the risks of an investment in
Genzyme.
For purposes of financial presentation, we allocate programs, products,
assets and liabilities among our operating divisions. Genzyme Corporation,
however, continues to own all of the assets and is responsible for all of the
liabilities of each division. A holder of Biosurgery Stock, for example, does
not have any specific rights to the assets allocated to Biosurgery in our
financial statements. Furthermore, if we are unable to satisfy one division's
liabilities out of the assets we allocate to that division, we may be required
to satisfy those liabilities with assets we have allocated to another division.
We encourage you to review our consolidated financial statements and the
financial statements of Genzyme Biosurgery included in the reports that we file
with the SEC.
OUR BOARD OF DIRECTORS MAY TAKE ACTIONS THAT HAVE AN UNEQUAL AND ADVERSE
EFFECT ON ONE OR MORE SERIES OF OUR TRACKING STOCK.
At times, the interests of the holders of the different series of our
tracking stock may diverge or appear to diverge from each other. We are not
aware of any legal precedent interpreting the fiduciary duties of the directors
of a Massachusetts corporation in that situation. Recent cases in Delaware have
established that a Delaware court will afford considerable deference to business
decisions that are made in good faith by a disinterested and adequately informed
board of directors even when those decisions involve disparate treatment of
different series of tracking stock. These Delaware cases rely upon the premise
that the board of directors owes its fiduciary duties to the corporation and all
of its stockholders and does not owe separate duties to each class or series of
stockholders. We do not know to what extent a Massachusetts court would be
influenced by these Delaware decisions. If a Massachusetts court were to follow
the reasoning in these Delaware cases, a Genzyme stockholder may not be able to
successfully challenge an action by the board of directors that has a
disadvantageous effect on a particular series of our tracking stock.
MEMBERS OF OUR BOARD OF DIRECTORS MAY FAVOR ONE SERIES OF TRACKING STOCK
OVER ANOTHER IF THEY OWN A DISPROPORTIONATE AMOUNT OF THAT SERIES.
A member of our board of directors may own a disproportionate amount of
tracking stock in a particular series, or the value of his or her holdings of a
particular series of stock may be different from the value of his or her
holdings in another series. This disparate stock ownership may cause the board
member to favor one series of stock over another. Nevertheless, we believe that
a member of our board of directors could properly perform his or her fiduciary
responsibilities to all of our stockholders even if his or her interests in
shares of different series are disproportionate or of unequal values. Our board
members may create committees to review matters that raise conflict-of-interest
issues. If a committee is formed, it would report to the full board of
directors.
4
<PAGE>
HOLDERS OF OUR TRACKING STOCK HAVE LIMITED DECISION-MAKING POWER BECAUSE
THEY HAVE LIMITED SEPARATE VOTING RIGHTS.
Holders of all series of our tracking stock generally vote together as a
single class on all matters requiring common stockholder approval, including the
election of directors. Holders of one series of tracking stock do not have the
right to vote on matters separately from the other series except in limited
circumstances. These circumstances are dictated by Massachusetts law, our
charter and the management and accounting policies adopted by our board of
directors. Therefore, stockholders of one series of tracking stock generally
could not make a proposal that would require approval only of the holders of
that series. Instead, they would have to obtain approval from all common
stockholders.
THE VOTES PER SHARE OF OUR TRACKING STOCKS ARE ADJUSTED EVERY TWO YEARS.
Under our charter, Genzyme General Stock is entitled to one vote per share,
which is never adjusted. However, the votes per share of our other tracking
stocks are adjusted every two years. Specifically, on January 1, 2001 and every
second anniversary thereafter, the vote per share to which each outstanding
tracking stock is entitled will be recalculated based on its fair market value
divided by the fair market value of a share of Genzyme General Stock, with "fair
market value" meaning the average closing price over the 20 consecutive trading
days beginning the 30th trading day preceding the January 1st adjustment date.
At the time of an adjustment, the per share voting power of any Genzyme tracking
stock relative to the other series of tracking stock could decrease materially.
Additionally, during the intervening period between adjustments, the per share
voting power of each tracking stock will remain the same even though its market
price will fluctuate relative to, and could become materially greater than, the
market prices of the other tracking stocks.
THE LIQUIDATION RIGHTS FOR EACH SERIES OF TRACKING STOCK ARE NOT ADJUSTED TO
REFLECT CHANGES IN THE MARKET VALUE OF THAT SERIES.
If we dissolve, liquidate or wind up our affairs, other than as part of a
merger, business combination or sale of substantially all of our assets, our
stockholders would receive any remaining assets according to the percentage of
total liquidation units that they hold. The number of liquidation units per
share for each series of our tracking stock is as follows:
- each share of Genzyme General Stock has 100 liquidation units;
- each share of Molecular Oncology Stock has 25 liquidation units; and
- each share of Biosurgery Stock has 50 liquidation units.
Although we adjust liquidation units to prevent dilution in the event of
some subdivisions, combinations or distributions of common stock, we do not
adjust them to reflect changes in the relative market value or performance of
the divisions. Therefore, at the time of a dissolution, liquidation or winding
up, the relative liquidation units attributable to each series of tracking stock
may not correspond to the value of the underlying assets allocated to that
division.
OUR BOARD OF DIRECTORS MAY CHANGE ITS MANAGEMENT AND ACCOUNTING POLICIES TO
THE DETRIMENT OF ONE SERIES OF TRACKING STOCK WITHOUT STOCKHOLDER APPROVAL.
Our board of directors has adopted management and accounting policies that
are used to govern our business and to prepare our financial statements. These
policies cover the allocation of corporate expenses, assets and liabilities and
other accounting matters, and the reallocation of assets between divisions and
other matters. Our board of directors generally may modify or rescind these
policies or adopt new ones without stockholder approval. Any revised policies
could have different effects on each series of our tracking stock and could be
detrimental to one series as compared to another. The discretion of our board of
directors to make changes is limited only by the policies themselves and the
board's fiduciary duty to all of our stockholders. We encourage you to review
the full text of our management and accounting policies, a copy of which is
attached as Exhibit to our Current Report on Form 8-K that we filed with the
SEC on December [19], 2000.
5
<PAGE>
WE MAY ELIMINATE TRACKING STOCK IF A CORPORATE LEVEL TAX IS IMPOSED ON THE
ISSUANCE OF TRACKING STOCK.
In 1999, the Clinton Administration proposed tax legislation that would have
imposed a corporate level tax on issuances of tracking stock. In 2000, the
Clinton Administration proposed legislation that would tax stockholders upon the
receipt of tracking stock from the issuing corporation as a distribution or in a
tracking stock exchange. Congress has not enacted either of these proposals into
law. If these or similar proposals are enacted into law or effected through
Treasury regulations, we could be taxed on an amount up to the gain realized in
future financings in which we sell tracking stock, including Biosurgery Stock.
Also, any use of our tracking stock to acquire other companies could result in a
tax to us, the stockholders of the target company, or both. We also may be taxed
if we distribute to stockholders "designated" shares of tracking stock, which
are shares designated by the tracked division as issuable at the option of our
board of directors for Genzyme General's benefit. In addition, stockholders
could be taxed if they receive a distribution of designated shares of tracking
stock or if they receive shares of tracking stock in exchange for other Genzyme
stock. These or similarly adverse tax consequences could cause us to eliminate
tracking stock from our capital structure. We cannot predict, however, whether
Congress will enact legislation, or whether the Treasury Department will issue
regulations effecting these or similar proposals.
WE CANNOT ASSURE THAT OUR TRACKING STOCKS WILL "TRACK" THE PERFORMANCE OF
THE CORRESPONDING DIVISION.
Although we have attempted to design our tracking stocks to "track" the
performance of their corresponding divisions, we cannot assure that the market
prices of these stocks will indeed reflect that performance. The market may
assign values to a tracking stock that are based on factors other than a
corresponding division's reported financial performance. For instance, we cannot
be certain what, if any, valuation the market might place on the mandatory and
optional exchange features or the differing voting rights and liquidation units
of the tracking stocks. In addition, as discussed above under the subheading
"--THE HOLDERS OF OUR TRACKING STOCK ARE STOCKHOLDERS OF A SINGLE COMPANY AND
UNFAVORABLE FINANCIAL TRENDS AFFECTING ONE DIVISION COULD NEGATIVELY AFFECT
OTHER GENZYME DIVISIONS," financial developments in one division, particularly
if significant and/or adverse, may affect other divisions.
RISKS RELATED TO GENZYME BIOSURGERY
Biosurgery Stock is intended to track the value and reflect the performance
of Genzyme Biosurgery. Accordingly, you should carefully consider the following
factors affecting the business of Genzyme Biosurgery.
A FAILURE TO INCREASE SALES OF SYNVISC COULD HAVE A NEGATIVE EFFECT ON THE
PRICE OF BIOSURGERY STOCK.
Genzyme Biosurgery will generate a substantial portion of its product
revenues from sales of Synvisc, a product for treatment of osteoarthritis of the
knee. Genzyme Biosurgery began marketing Synvisc in 1993. Net product sales of
Synvisc totaled $68.3 million for the year ended December 31, 1999, which
represented approximately [32]% of Genzyme Biosurgery's total revenues for 1999.
Failure to achieve sales growth for Synvisc may cause the value of
Biosurgery Stock to decline. Revenues from Synvisc could be impacted negatively
if competitive treatments for osteoarthritis of the knee are deemed more
efficacious or cost effective. Some companies are developing competitive
products, and other companies may do so in the future.
The commercial success of Synvisc also will depend on many other factors,
including the following:
- THE AVAILABILITY OF THIRD PARTY REIMBURSEMENT.
Many third party payers in the United States and abroad cover Synvisc.
Genzyme Biosurgery will continue to discuss reimbursement for Synvisc with
European government agencies. We cannot guarantee that any third party
payers will continue to cover Synvisc or that additional third party
payers will begin to provide reimbursement.
6
<PAGE>
- CONTINUED RELATIONS WITH MARKETING PARTNERS.
Genzyme Biosurgery has entered into several distribution agreements for
marketing and distributing Synvisc. Genzyme Biosurgery has in the past and
may in the future periodically reacquire distribution rights in some
territories if partners cease to perform under agreements relating to
these territories. Genzyme Biosurgery may not be able to maintain or
replace these marketing partners. In this event, there may be disruptions
in sales associated with restructuring Genzyme Biosurgery's distribution
arrangements.
THE COMMERCIAL SUCCESS OF GENZYME BIOSURGERY'S PRODUCT, CARTICEL
CHONDROCYTES, IS UNCERTAIN.
Carticel cartilage repair is a service used to treat knee cartilage damage.
This service involves a proprietary process for growing autologous chondrocytes
(a patient's own cartilage cells) to replace those that are damaged or lost.
Revenues from Carticel chondrocytes accounted for approximately [7.0]% of
Genzyme Biosurgery's total revenue during 1999. The commercial success of
Carticel chondrocytes will depend on many factors, including the following:
- POSITIVE RESULTS FROM POST-MARKETING STUDIES.
We have agreed with the FDA to conduct two post-marketing studies to
confirm the effectiveness of Carticel chondrocytes. The first study
compares clinical outcomes of patients in Genzyme Biosurgery's registry
who did not respond to treatment before being implanted with Carticel
chondrocytes. This study will measure outcomes before and after
implantation with Carticel chondrocytes. The second study compares the
long-term clinical effects of treatment with Carticel chondrocytes to
other available treatments. If these studies demonstrate that treatment
with Carticel chondrocytes is not superior to the alternatives studied,
the FDA may suspend or withdraw its approval of Carticel chondrocytes. If
Genzyme Biosurgery cannot market Carticel chondrocytes in the U.S., its
financial results may be negatively impacted.
- FDA APPROVAL OF RELATED DEVICE.
Genzyme Biosurgery has developed a device to improve the procedure for
implanting Carticel chondrocytes and plans to file for marketing approval
with the FDA. We believe Genzyme Biosurgery will begin marketing this
device in [2000]. However, we cannot guarantee that the FDA will approve
this device, that this device will improve the procedure for implanting
Carticel chondrocytes, or that this device will gain commercial
acceptance.
- THE AVAILABILITY OF THIRD PARTY REIMBURSEMENT.
Since the FDA approved Carticel chondrocytes, we have seen a substantial
increase in the number of third party payers who cover it. Some third
party payers, however, do not cover Carticel chondrocytes. We cannot
guarantee that any third party payers will continue to cover it or that
additional third party payers will begin to provide reimbursement.
Although FDA approval is a crucial factor in insurance plans deciding to
cover new treatments, a number of major insurance plans also base such
decisions on their own or third party evaluations of treatments. One
independent association that conducts evaluations is the Blue Cross Blue
Shield Association. The Blue Cross Blue Shield Association has determined
that its Technology Assessment Committee does not believe that Carticel
chondrocytes meets all of its published criteria for new treatments. We
believe that Carticel chondrocytes does in fact meet all of these criteria
and are discussing the evaluation with the Blue Cross Blue Shield
Association. While individual Blue Cross Blue Shield plans representing
more than 50% of Blue Cross Blue Shield policyholders have provided policy
coverage for Carticel chondrocytes without a favorable evaluation by the
Blue Cross Blue Shield Association, many Blue Cross Blue Shield plans have
delayed approving Carticel chondrocytes from coverage under their policies
as a direct result of this unfavorable ruling. Since these remaining plans
represent a significant percentage of insured lives in the U.S., this
ruling has restricted our access to a substantial portion of the market
for Carticel chondrocytes.
7
<PAGE>
- THE SUCCESS OF COMPETITIVE PRODUCTS.
The process we use to grow a patient's cartilage cells is not patentable,
and we do not yet have significant patent protection covering the other
processes used in providing Carticel chondrocytes. Consequently, we cannot
prevent a competitor from developing the ability to grow cartilage cells
and from offering a product or service that is similar or superior to
Carticel chondrocytes. If a competitor were to develop such ability and
obtain FDA approval for a competitive product or service, Genzyme
Biosurgery's results of operations would be negatively impacted. We are
aware of at least two other companies that are growing autologous
cartilage cells for cartilage repair in the European market. Also, several
pharmaceutical and biotechnology companies are developing alternative
treatments for knee cartilage damage. One or more of these companies may
develop products or services superior to the Carticel chondrocytes.
- MARKET ACCEPTANCE BY ORTHOPEDIC SURGEONS.
We are marketing Carticel chondrocytes to orthopedic surgeons. We cannot
guarantee that we will train enough surgeons who incorporate Carticel
chondrocytes into their practice to make it commercially successful.
- FLUCTUATING REVENUES DUE TO SEASONAL FACTORS.
We expect that the revenues from the sale of the Carticel chondrocytes
will fluctuate based on Genzyme Biosurgery's success in penetrating the
market, the availability of competitive procedures and the availability of
third party reimbursement. We cannot predict the timing or magnitude of
these fluctuations. Furthermore, we expect that revenues from Carticel
chondrocytes will be lower in the summer months because fewer operations
are typically performed during those months.
- RELIANCE ON KEY COLLABORATORS.
Carticel chondrocytes were developed based on the work of a group of
Swedish physicians. Genzyme Biosurgery had consulting agreements with the
two leaders of that group. These agreements, however, expired in 1998, and
Genzyme Biosurgery is currently negotiating renewals of these agreements.
Pending these negotiations, these physicians are continuing to advise
Genzyme Biosurgery on the commercialization and further development of
Carticel chondrocytes. We cannot guarantee that the two physicians will
sign a new contract or continue to advise Genzyme Biosurgery.
In addition, individuals who are familiar with the know-how underlying
Carticel chondrocytes through their association with these physicians may
disclose the information to our competitors. This event could have an adverse
effect on Genzyme Biosurgery's results of operations.
Genzyme Biosurgery [will have] a sponsored research agreement with the
University of Gothenburg in Sweden and certain physicians, including the two
physicians who lead the group that developed Carticel chondrocytes. The purpose
of the agreement is to conduct additional research on Carticel chondrocytes. The
agreement [will prohibit] members of the research team from disclosing any
information relating to Genzyme Biosurgery or its business that they acquire in
connection with their work under the agreement. The agreement also [will state]
that all inventions that the members conceive or reduce to practice during the
course of the research program will be Genzyme Biosurgery's property, with
royalties payable to the inventing member. We cannot guarantee that these
members will honor their obligations under the sponsored research agreement.
GENZYME BIOSURGERY WILL DEVOTE SIGNIFICANT RESOURCES TO DEVELOP NOVEL
PRODUCTS AND TREATMENTS THAT MAY NOT BE COMMERCIALLY SUCCESSFUL.
Genzyme Biosurgery has devoted a significant amount of money to developing
products that will represent alternatives to traditional surgical procedures or
treatments. These products will likely require
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several years of aggressive and costly marketing before they might become widely
accepted by the surgical community. Genzyme Biosurgery expects to develop
products that are designed to enable surgeons to perform minimally invasive
cardiovascular surgery. The medical conditions that can be treated with
minimally invasive cardiovascular surgery are currently being treated with
widely accepted surgical procedures such as coronary artery bypass grafting and
catheter-based treatments, including balloon angioplasty, atherectomy and
coronary stenting. To date, minimally invasive cardiovascular surgery has been
performed on a limited basis and its further adoption by the surgical community
will partly depend on Genzyme Biosurgery's ability to educate cardiothoracic
surgeons about its effectiveness and to facilitate the training of
cardiothoracic surgeons in minimally invasive cardiovascular surgery techniques.
Similarly, until recently surgeons have not used products designed to reduce
the incidence and extent of postoperative adhesions. Since 1996, when Sepra Film
bioresorbable membrane was introduced, market acceptance of anti-adhesion
products has been slow. To increase sales of the Sepra products, Genzyme
Biosurgery has had to educate surgeons and hospital administrators about the
problems of, and costs associated with, adhesions and the benefits of preventing
adhesions. Genzyme Biosurgery also has had to, and continues to have to, train
surgeons on the proper handling and use of these products.
We cannot guarantee that either Genzyme Biosurgery's efforts in educating
and training the surgical community will result in the widespread adoption of
minimally invasive cardiovascular surgery and anti-adhesion products or that
surgeons adopting these procedures and products will use Genzyme Biosurgery's
products.
ADVERSE EVENTS IN THE FIELD OF GENE THERAPY MAY NEGATIVELY AFFECT REGULATORY
APPROVAL OR PUBLIC PERCEPTION OF GENZYME BIOSURGERY'S GENE THERAPY PRODUCTS.
The recent death of a patient undergoing gene therapy using an adenoviral
vector to deliver a therapeutic gene has been widely publicized. This death and
any other adverse events in the field of gene therapy that may occur in the
future may result in greater governmental regulation and potential regulatory
delays relating to the testing or approval of Genzyme Biosurgery's gene therapy
products. As a result of the death, the U.S. Senate has commenced hearings to
determine whether additional legislation is required to protect volunteers and
patients who participate in gene therapy clinical trials. Additionally, the
Recombinant DNA Advisory Committee, which acts as an advisory body to the
National Institutes of Health, has extensively discussed the use of adenoviral
vectors in gene therapy clinical trials and recently issued a draft report on
the safety of adenoviral vectors. While this draft report recommends that
clinical trials using adenoviral vectors should continue with caution, it also
suggested a number of changes in the way gene therapy clinical trials are
conducted.
The commercial success of any gene therapy products that Genzyme Biosurgery
develops will depend in part on public acceptance of the use of gene therapies
for the prevention or treatment of human diseases. Public attitudes may be
influenced by claims that gene therapy is unsafe, and gene therapy may not gain
the acceptance of the public or the medical community. Negative public reaction
to gene therapy could result in greater government regulation and stricter
clinical trial oversight and commercial product labeling requirements of gene
therapies and could cause a decrease in the demand for any gene therapy product
that Genzyme Biosurgery may develop.
BECAUSE GENZYME BIOSURGERY WILL HAVE SIGNIFICANT FIXED PAYMENTS, IT MAY NEED
TO DEVOTE A SUBSTANTIAL PORTION OF ITS CASH FLOW TO MAKE THE PAYMENTS AND
MAY NEED TO BORROW MONEY IN THE FUTURE TO MAKE DEBT PAYMENTS AND OPERATE ITS
BUSINESS.
We have incurred approximately $[200] million in long-term debt to finance
the cash costs of our acquisition of Biomatrix. Although we have allocated this
debt to Genzyme Biosurgery, it will remain a liability of the corporation as a
whole. Genzyme Biosurgery will use a large part of its cash flow from operations
to make principal and interest payments on this debt. If Genzyme Biosurgery's
cash flow from operations is insufficient to meet these obligations, we may need
to allocate additional borrowings
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to Genzyme Biosurgery to make these payments. We cannot guarantee that such
additional financing will be available or available on favorable terms.
In addition to amounts that were borrowed to finance the acquisition of
Biomatrix, our significant cash obligations allocated to Genzyme Biosurgery
include the following:
- PURCHASE OF LIMITED PARTNERSHIP INTERESTS.
In 1989, we organized Genzyme Development Partners, L.P., a special
purpose research and development entity. We transferred to the partnership
technology and commercial rights to the Sepra products and entered into a
joint venture with the partnership to develop and commercialize the Sepra
products in the U.S. and Canada. During November 2000, Genzyme Biosurgery
exercised its option to purchase the Class A limited partnership interests
in the partnership for an advance payment of approximately $26 million in
cash, payable during January 2001, plus continuing royalties based on
certain sales of the Sepra products.
- CONTINGENT PAYMENT TO GENZYME GENERAL.
In 1999, Genzyme Biosurgery received $25 million in cash from Genzyme
General in connection with the transfer to Genzyme General of our interest
in Genzyme Biosurgery's joint venture with Diacrin, Inc. If the joint
venture does not initiate a Phase III clinical trial of NeuroCell-PD by
June 30, 2001, Genzyme Biosurgery will be required to repay Genzyme
General $20 million plus accrued interest at 13.5% per year. Genzyme
Biosurgery, may repay this amount in cash, Biosurgery designated shares,
or a combination of both, at its option. If these milestones are not
achieved, and Genzyme Biosurgery elects to repay Genzyme General in cash,
Genzyme Biosurgery's cash reserves will be diminished. If Genzyme
Biosurgery elects to repay Genzyme General in shares of Biosurgery
designated shares, this would dilute the rights of the holders of
Biosurgery Stock and could adversely affect the market price of Biosurgery
Stock.
- CONVERTIBLE NOTE.
As part of our acquisition of Biomatrix, Genzyme Biosurgery assumed the
outstanding 6.9% Convertible Subordinated Note due May 14, 2003 in favor
of UBS Warburg LLC. At September 30, 2000, $10 million of the principal
amount of this note remained outstanding. Genzyme Biosurgery will use a
part of its cash flow to satisfy debt service on this note. If all or a
portion of the note is not converted at the option of the holder into
Biosurgery Stock, at maturity Genzyme Biosurgery's cash reserves will be
diminished by the amount necessary to repay the outstanding principal of
the note.
GENZYME BIOSURGERY ANTICIPATES FUTURE LOSSES AND MAY NEVER BECOME PROFITABLE.
Genzyme Biosurgery was formed in December 2000 from the combination of two
of our prior operating divisions, Genzyme Surgical Products and Genzyme Tissue
Repair, and Biomatrix. Neither Genzyme Surgical Products nor Genzyme Tissue
Repair had ever operated profitably during their existence. Genzyme Biosurgery
expects to have operating losses before amortization of intangibles and goodwill
through at least the second quarter of 2001 as it combines the operations of
Genzyme Surgical Products, Genzyme Tissue Repair and Biomatrix, and as it
continues to spend substantial amounts of money on, among other things,
conducting research, development, regulatory and commercialization activities to
support its expanded product lines. This strategy involves risks, which include
supporting higher levels of operating expenses, attracting and retaining
employees, and dealing with other management difficulties that arise from rapid
growth. If Genzyme Biosurgery cannot manage growth effectively, it may not
become profitable.
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IF GENZYME BIOSURGERY FAILS TO OBTAIN CAPITAL NECESSARY TO FUND ITS
OPERATIONS, IT WILL BE UNABLE TO FUND DEVELOPMENT PROGRAMS AND COMPLETE
CLINICAL TRIALS.
We anticipate that Genzyme Biosurgery's current cash resources, together
with revenues generated from products sales, will be sufficient to fund its
operations through at least 2001.
Genzyme Biosurgery's cash needs may differ from those planned because of
many factors, including the:
- ability to become profitable;
- results of research and development efforts and clinical testing;
- ability to establish strategic alliances and licensing arrangements for
research and development programs;
- achievement of milestones under strategic alliances;
- ability to establish and maintain additional distribution arrangements;
- cost of protecting its intellectual property rights;
- market's acceptance of novel approaches and therapies;
- development of competing products; and
- ability to satisfy regulatory requirements of the FDA and other government
authorities.
Genzyme Biosurgery may require significant additional financing to continue
operations at anticipated levels. We cannot guarantee that Genzyme Biosurgery
will be able to obtain additional financing or find it on favorable terms. If
Genzyme Biosurgery has insufficient funds or is unable to raise additional
funds, it may have to delay, reduce or eliminate some of its programs. Genzyme
Biosurgery may also have to give third parties rights to attempt to
commercialize technologies or products that it would otherwise have sought to
commercialize itself. See the discussion above under the subheading "--BECAUSE
GENZYME BIOSURGERY WILL HAVE SIGNIFICANT FIXED PAYMENTS, IT MAY NEED TO DEVOTE A
SUBSTANTIAL PORTION OF ITS CASH FLOW TO MAKE THE PAYMENTS AND MAY NEED TO BORROW
MONEY IN THE FUTURE TO MAKE DEBT PAYMENTS AND OPERATE ITS BUSINESS" above.
CHANGES IN GENZYME BIOSURGERY'S MANUFACTURING CAPABILITIES COULD
SIGNIFICANTLY REDUCE ITS ABILITY TO DELIVER ITS PRODUCTS.
Genzyme Biosurgery produces a wide variety of products and services and its
manufacturing processes are highly complex and are regulated by the government.
Genzyme Biosurgery is seeking to achieve synergies among the manufacturing
capabilities that it acquired from Genzyme Tissue Repair, Genzyme Surgical
Products and Biomatrix when it was formed in December 2000. It is possible that
Genzyme Biosurgery will have problems maintaining or expanding its facilities in
the future and achieving these synergies. These problems could cause delays in
production or delivery. Any significant disruption in Genzyme Biosurgery's
manufacturing operations or in its ability to manufacture products cost
effectively could have an adverse effect on its business, results of operations,
and financial condition.
COMPETITION FROM OTHER MEDICAL DEVICE AND TECHNOLOGY COMPANIES COULD HURT
GENZYME BIOSURGERY'S PERFORMANCE.
The human health care products and services industry is extremely
competitive. Major medical device and technology companies compete or may
compete with Genzyme Biosurgery. These include such companies as:
- Atrium Medical Corporation and Sherwood-Davis & Geck, a division of Tyco
International, Ltd., in the cardiovascular chest drainage and fluid
management market;
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- The Ethicon division of Johnson & Johnson Ltd. and U.S. Surgical
Corporation, a division of Tyco, in the cardiovascular closure market;
- CardioThoracic Systems, Inc., Medtronic, Inc., U.S. Surgical, Guidant
Corporation, Baxter Healthcare Corporation and Ethicon in the minimally
invasive cardiovascular surgery market;
- Ethicon, Lifecore Biomedical, Inc., Life Medical Sciences, Inc. and
Gliatech, Inc. in the anti-adhesion market;
- Karl Storz Endoscopy America, Inc., Scanlan International, Inc., Pilling
Weck Surgical Instruments and the Codman division of Johnson &
Johnson Ltd. in the reusable instruments market; and
- Fidia S.p.A., Sanofi and OrthoLogic Corp., Anika Therapeutics, Inc. and
Zimmer, Inc., and Seikagiku Corporation and Smith & Nephew in the
viscosupplementation products market.
These competitors may have superior research and development, marketing and
production capabilities. Some competitors also may have greater financial
resources than Genzyme Biosurgery. The division is likely to incur significant
costs developing and marketing new products without any guarantee that they will
be competitively successful in one or more markets. The future success of
Genzyme Biosurgery will depend on its ability to effectively develop and market
its products against those of its competitors.
THE TREND TOWARD CONSOLIDATION IN THE SURGICAL DEVICES INDUSTRY MAY
ADVERSELY AFFECT GENZYME BIOSURGERY'S ABILITY TO MARKET SUCCESSFULLY ITS
PRODUCTS TO SOME SIGNIFICANT PURCHASERS.
The current trend among hospitals and other significant consumers of
surgical devices is to combine into larger purchasing groups to increase their
purchasing power and thus reduce their purchase price for surgical devices.
Partly in response to this development, surgical device manufacturers have been
consolidating to be able to offer a more comprehensive product line to these
larger purchasing groups. In order to market successfully its products to larger
purchasing groups, Genzyme Biosurgery may have to expand its product lines or
enter into joint marketing or distribution agreements with other manufacturers
of surgical devices. We cannot guarantee that Genzyme Biosurgery will be able to
employ either of these initiatives or that, when employed, these initiatives
will increase the marketability of Genzyme Biosurgery's products.
IF GENZYME BIOSURGERY CANNOT MAINTAIN OR REPLACE ITS EXISTING MARKETING
PARTNERS, THERE MAY BE DISRUPTIONS IN SALES ASSOCIATED WITH RESTRUCTURING
ITS DISTRIBUTION ARRANGEMENTS.
Genzyme Biosurgery has entered into several distribution agreements for
marketing and distributing some of its products, including Synvisc and Hylaform.
As a result, Genzyme Biosurgery will depend on these marketing partners for
sales of its products in countries in which it will have marketing and
distribution agreements. It is possible that Genzyme Biosurgery will not be able
to maintain or replace these marketing partners or replace them following
termination of the related agreements. If this happens, there may be disruptions
in sales associated with restructuring Genzyme Biosurgery's distribution
arrangements.
GENZYME BIOSURGERY FACES LITIGATION THAT COULD HAVE A MATERIAL ADVERSE
EFFECT ON BUSINESS, FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
On July 21 and August 7, 15, and 30, 2000, class action lawsuits requesting
unspecified damages were filed in the United States District Court for the
District of New Jersey against Biomatrix and two of its officers and directors,
Endre A. Balazs and Rory B. Riggs. In these actions, the plaintiffs seek to
certify a class of all persons or entities who purchased or otherwise acquired
Biomatrix common stock during the period between July 20, 1999 and April 25,
2000. The plaintiffs allege, among other things, that the defendants failed to
accurately disclose information related to Synvisc during the period between
July 20, 1999 and April 25, 2000, and assert causes of action under the Exchange
Act and Rule 10b-5 promulgated under that Act. As part of our acquisition of
Biomatrix, Genzyme Biosurgery
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succeeded to these lawsuits. We disagree with the claims brought in these
lawsuits and believe that information related to Synvisc was properly disclosed.
We intend to defend these actions vigorously. However, we can give no assurance
as to the outcome of the matters. It is possible that we may be required to pay
substantial damages or settlement costs to the extent that those damages or
settlement costs are not covered by insurance. Regardless of the outcome of the
actions, these actions may cause a diversion of Genzyme Biosurgery's management
time and attention. Under Biomatrix' charter, officers and directors of
Biomatrix were entitled to indemnification for these types of claims from
Biomatrix to the full extent permitted by Delaware law, and as part of our
acquisition of Biomatrix, Genzyme Biosurgery agreed to honor these
indemnification obligations of Biomatrix.
RISKS RELATING TO GENZYME
The following risk factors relate to us generally and affect all of our
divisions, including Genzyme Biosurgery. Holders of Biosurgery Stock are
stockholders of Genzyme and are, therefore, subject to all of our risks and
uncertainties, not just those of Genzyme Biosurgery. Liabilities or
contingencies of our divisions other than Genzyme Biosurgery that affect our
resources or financial condition could affect the financial condition or results
of operations of Genzyme Biosurgery. Therefore, you should consider carefully
these risk factors before investing in our stock.
GOVERNMENT REGULATION IMPOSES SIGNIFICANT COSTS AND RESTRICTIONS ON THE
DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCTS AND SERVICES.
Our success will depend on our ability to satisfy regulatory requirements.
We may not receive the required regulatory approvals on a timely basis or at
all. Government agencies heavily regulate the production and sale of healthcare
products and the provision of healthcare services. In particular, the FDA and
comparable agencies in foreign countries must approve human therapeutic and
diagnostic products before they are marketed. This approval process can involve
lengthy and detailed laboratory and clinical testing, sampling activities and
other costly and time-consuming procedures. This regulation may delay the time
at which a company like us can first sell a product or may limit how a consumer
may use a product or service or may adversely impact third-party reimbursement.
A company's failure to comply with applicable regulatory approval requirements
may lead regulatory authorities to take action against the company, including:
- issuing warning letters;
- issuing fines and other civil penalties;
- suspending regulatory approvals;
- refusing approval of pending applications or supplements to approved
applications;
- suspending product sales in the United States and/or exports from the
United States;
- recalling products; and
- seizing products.
Furthermore, therapies that have received regulatory approval for commercial
sale may continue to face regulatory difficulties. The FDA and comparable
foreign regulatory agencies, for example, may require post-marketing clinical
trials or patient outcome studies. In addition, regulatory agencies subject a
marketed therapy, its manufacturer and the manufacturer's facilities to
continual review and periodic inspections. The discovery of previously unknown
problems with a therapy, the therapy's manufacturer or the facility used to
produce the therapy could prompt a regulatory authority to impose restrictions
on the therapy, manufacturer or facility, including withdrawal of the therapy
from the market.
LEGISLATIVE CHANGES MAY ADVERSELY IMPACT OUR BUSINESS.
The FDA has designated some of our products, including Cerezyme enzyme, as
orphan drugs under the Orphan Drug Act. The Orphan Drug Act provides incentives
to manufacturers to develop
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and market drugs for rare diseases, generally by entitling the first developer
that receives FDA marketing approval for an orphan drug to a seven-year
exclusive marketing period in the United States for that product. In recent
years Congress has considered legislation to change the Orphan Drug Act to
shorten the period of automatic market exclusivity and to grant marketing rights
to simultaneous developers of the drug. If the Orphan Drug Act is amended in
this manner, Cerezyme enzyme, as well as any other drugs for which we have been
granted exclusive marketing rights under the Orphan Drug Act, will face
increased competition which may decrease the amount of revenue we receive from
these products.
In addition, the U.S. government has shown significant interest in pursuing
healthcare reform. Any government-adopted reform measures could adversely
affect:
- the pricing of therapeutic products and medical devices in the United
States or internationally; and
- the amount of reimbursement available from governmental agencies or other
third-party payers.
If the U.S. government significantly reduces the amount we may charge for
our products, or the amount of reimbursement available for purchases of our
products declines, our future revenues may decline and we may need to revise our
research and development programs.
THE DEVELOPMENT OF OUR PRODUCTS INVOLVES A LENGTHY AND COMPLEX PROCESS, AND
WE MAY BE UNABLE TO COMMERCIALIZE ANY OF THE PRODUCTS WE ARE CURRENTLY
DEVELOPING.
Before we can commercialize our development-stage products, we will need to:
- conduct substantial research and development;
- undertake preclinical and clinical testing; and
- pursue regulatory approvals.
This process involves a high degree of risk and takes several years. Our
product development efforts may fail for many reasons, including:
- failure of the product in preclinical studies;
- clinical trial data that is insufficient to support the safety or
effectiveness of the product; or
- our failure to obtain the required regulatory approvals.
For these reasons, and others, we may not successfully commercialize any of
the products we are currently developing.
ANY MARKETABLE PRODUCTS THAT WE DEVELOP MAY NOT BE COMMERCIALLY SUCCESSFUL.
Even if we obtain regulatory approval for any of our development-stage
products, those products may not be accepted by the market, or approved for
reimbursement by third-party payers. A number of factors may affect the rate and
level of market acceptance of these products, including:
- regulation by the FDA and other government authorities;
- market acceptance by doctors and hospital administrators;
- the effectiveness of our sales force;
- the effectiveness of our production and marketing capabilities;
- the success of competitive products; and
- the availability and extent of reimbursement from third-party payers.
If our products fail to achieve market acceptance, our profitability and
financial condition will suffer.
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WE WILL REQUIRE SIGNIFICANT ADDITIONAL FINANCING WHICH MAY NOT BE AVAILABLE
ON FAVORABLE TERMS, IF AT ALL.
As of September 30, 2000, we had approximately $808.3 million in cash, cash
equivalents and short- and long-term investments, excluding investments in
equity securities.
Although we currently have substantial cash resources and positive cash
flow, we intend to use substantial portions of our available cash for:
- product development and marketing;
- expanding facilities and staff;
- working capital; and
- strategic business initiatives.
In addition, we expect to pay:
- approximately $245.0 million in cash to stockholders of Biomatrix in
connection with our acquisition of that company during December 2000;
- approximately $509.4 million in cash to stockholders of GelTex
Pharmaceuticals in connection with our acquisition of that company during
December 2000; and
- approximately $26.0 million in cash to the limited partners of Genzyme
Development Partners, L.P. in connection with our acquisition of the
limited partnership interests in that partnership.
We will further reduce available cash reserves to pay principal and interest
on the following debt:
- In May 1998, we issued $250.0 million in convertible notes, the entire
principal amount of which is allocated to Genzyme General. These
convertible notes bear interest at an annual rate of 5 1/4% and mature on
June 1, 2005. However, the holders of these notes may exchange principal
on the notes for shares of Genzyme General Stock, Molecular Oncology Stock
and Biosurgery Stock.
- [As of December , 2000, we owed approximately $ million under a
revolving credit facility with a group of commercial banks. We have
allocated to Genzyme General $ million of this amount, which
represents additional funds borrowed to finance a portion of the cash
consideration for our acquisition of GelTex Pharmaceuticals and we have
allocated to Genzyme Biosurgery $ million of this amount, which
represents $18.0 million originally allocated to Genzyme Tissue Repair and
$ million which represents additional funds borrowed to finance a portion
of the cash consideration for our acquisition of Biomatrix. Amounts
borrowed under this revolving credit facility bear interest at . We
must repay all borrowings under this facility by .]
- In August 1998, we issued $21.2 million in convertible debentures, the
entire principal amount of which is allocated to Genzyme General. These
convertible debentures bear interest at an annual rate of 5% and mature on
August 29, 2003, but the holders of these convertible debentures may
exchange principal, and under some circumstances interest, on the
convertible debentures for shares of Genzyme General Stock.
If we use cash to pay or redeem all or a portion of this debt, including the
principal and interest due on it, our cash reserves will be diminished. To
satisfy these and other commitments, we will have to obtain additional
financing. We may be unable to obtain any additional financing, extend any
existing financing arrangement, or obtain either on terms that we consider
favorable.
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WE MAY FAIL TO PROTECT ADEQUATELY OUR PROPRIETARY TECHNOLOGY, WHICH WOULD
ALLOW COMPETITORS TO TAKE ADVANTAGE OF OUR RESEARCH AND DEVELOPMENT EFFORTS.
Our long-term success largely depends on our ability to market
technologically competitive products. If we fail to obtain or maintain these
protections we may not be able to prevent third parties from using our
proprietary rights.
Our currently pending or future patent applications may not result in issued
patents. In the United States, patent applications are confidential until
patents issue, and because third parties may have filed patent applications for
technology covered by our pending patent applications without us being aware of
those applications, our patent applications may not have priority over any
patent applications of others. In addition, our issued patents may not contain
claims sufficiently broad to protect us against third parties with similar
technologies or products or provide us with any competitive advantage. If a
third party initiates litigation regarding our patents, our collaborators'
patents, or those patents for which we have license rights, and is successful, a
court could revoke our patents or limit the scope of coverage for those patents.
The U.S. Patent and Trademark Office, commonly referred to as the USPTO, and
the courts have not consistently treated the breadth of claims allowed in
biotechnology patents. If the USPTO or the courts begin to allow broader claims,
the incidence and cost of patent interference proceedings and the risk of
infringement litigation will likely increase. On the other hand, if the USPTO or
the courts begin to allow narrower claims, the value of our proprietary rights
may be limited. Any changes in, or unexpected interpretations of, the patent
laws may adversely affect our ability to enforce our patent position.
We also rely upon trade secrets, proprietary know-how and continuing
technological innovation to remain competitive. We protect this information with
reasonable security measures, including the use of confidentiality agreements
with our employees, consultants and corporate collaborators. It is possible that
these individuals will breach these agreements and that any remedies for a
breach will be insufficient to allow us to recover our costs. Furthermore, our
trade secrets, know-how and other technology may otherwise become known or be
independently discovered by our competitors.
WE MAY BE REQUIRED TO LICENSE TECHNOLOGY FROM COMPETITORS IN ORDER TO DEVELOP
AND COMMERCIALIZE SOME OF OUR PRODUCTS AND SERVICES, AND IT IS UNCERTAIN
WHETHER THESE LICENSES WILL BE AVAILABLE.
Third-party patent rights may cover some of the products that we or our
strategic partners are developing or testing. As a result, we or our strategic
collaborators may be required to obtain licenses from the holders of these
patents in order to use, manufacture or sell these products and services, and
payments under these licenses may reduce our revenue from these products.
Furthermore, we may not be able to obtain these licenses on acceptable terms or
at all. If we fail to obtain a required license or are unable to alter the
design of our technology to fall outside of a patent, we may be unable to
effectively market some of our technology and services, which could limit our
profitability.
WE MAY INCUR SUBSTANTIAL COSTS AS A RESULT OF LITIGATION OR OTHER PROCEEDINGS
RELATING TO PATENT AND OTHER INTELLECTUAL PROPERTY RIGHTS.
A third party may sue us or one of our strategic collaborators for
infringing the third-party's patent rights. Likewise, we or one of our strategic
collaborators may need to resort to litigation to enforce our patent rights or
to determine the scope and validity of third-party proprietary rights. For
example, we filed a lawsuit on July 25, 2000 seeking injunctive relief and
damages against Transkaryotic Therapies, Inc. in the U.S. District Court in
Wilmington, Delaware for patent infringement resulting from Transkaryotic
Therapies' manufacture and use of Replagal, its replacement therapy for Fabry
disease. The suit alleges infringement of U.S. Patent No. 5,356,804, which we
exclusively licensed from Mount Sinai School of Medicine. The patent is directed
to methods of making alpha-galactosidase in mammalian cells, as well as the
genetically-engineered cells themselves. On September 19, 2000, Transkaryotic
Therapies filed a lawsuit against us and Mount Sinai School of Medicine in the
U.S. District Court in Boston, Massachusetts seeking declaratory judgments that
the manufacture, use and
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sale of Replagal does not infringe the patent we license from Mount Sinai and
that the Mount Sinai patent is invalid.
The cost to us of any litigation or other proceeding relating to
intellectual property rights, even if resolved in our favor, could be
substantial, and the litigation would divert our management's efforts. Some of
our competitors may be able to sustain the costs of complex patent litigation
more effectively than we can because they have substantially greater resources.
If we do not prevail, we or our strategic collaborators may be required to:
- pay monetary damages;
- stop commercial activities relating to the affected products or services;
- obtain a license in order to continue manufacturing or marketing the
affected products or services; or
- compete in the market with a substantially similar product.
Uncertainties resulting from the initiation and continuation of any
litigation could limit our ability to continue our operations. In addition, a
court may require us to pay expenses or damages and litigation could disrupt our
commercial activities.
WE MAY BE LIABLE FOR PRODUCT LIABILITY CLAIMS NOT COVERED BY INSURANCE.
Individuals who use our products or services, including those we acquire in
business combinations, may bring product liability claims against us or our
subsidiaries. While we have taken, and continue to take, what we believe are
appropriate precautions, we may be unable to avoid significant liability
exposure. We have only limited amounts of product liability insurance, which may
not provide sufficient coverage against any product liability claims. We may be
unable to obtain additional insurance in the future, or we may be unable to do
so on acceptable terms. Any additional insurance we do obtain may not provide
adequate coverage against any asserted claims. In addition, regardless of merit
or eventual outcome, product liability claims may result in:
- diversion of management's time and attention;
- expenditure of large amounts of cash on legal fees, expenses and payment
of damages;
- decreased demand for our products and services; and
- injury to our reputation.
OUR COMPETITORS IN THE BIOTECHNOLOGY AND PHARMACEUTICAL INDUSTRIES MAY HAVE
SUPERIOR PRODUCTS, MANUFACTURING CAPABILITIES OR MARKETING POSITION.
The human healthcare products and services industry is extremely
competitive. Our competitors include major pharmaceutical companies and other
biotechnology companies. Some of these competitors may have more extensive
research and development, marketing and production capabilities. Some
competitors also may have greater financial resources than we do.
Our future success will depend on our ability to develop and market
effectively our products against those of our competitors. For instance, we are
seeking orphan drug designation for some of our products that are still in
development or are currently being reviewed by the FDA for marketing approval,
including Fabrazyme enzyme for the treatment of Fabry disease. We are aware of
other companies developing products for the treatment of Fabry disease.
Transkaryotic Therapies Inc., for example, submitted its application for
marketing approval for its product to the FDA approximately one week before we
submitted our application for Fabrazyme enzyme. If Transkaryotic Therapies or
any other company receives FDA approval for a Fabry disease therapy with orphan
drug designation before we receive FDA approval for Fabrazyme enzyme, the Orphan
Drug Act may preclude us from selling Fabrazyme enzyme in the United States for
up to seven years. If our products receive marketing
17
<PAGE>
approval but cannot compete effectively in the marketplace, our profitability
and financial position will suffer.
IF WE ARE UNABLE TO KEEP UP WITH RAPID TECHNOLOGICAL CHANGES, OUR PRODUCTS OR
SERVICES MAY BECOME OBSOLETE.
The field of biotechnology is characterized by significant and rapid
technological change. Although we attempt to expand our technological
capabilities in order to remain competitive, research and discoveries by others
may make our products or services obsolete. For example, some of our competitors
may develop a product to treat Gaucher disease that is more effective or less
expensive than Cerezyme enzyme. If we cannot compete effectively in the
marketplace, our profitability and financial position will suffer.
IF WE FAIL TO OBTAIN ADEQUATE LEVELS OF REIMBURSEMENT FOR OUR PRODUCTS FROM
THIRD-PARTY PAYERS, THE COMMERCIAL POTENTIAL OF OUR PRODUCTS WILL BE
SIGNIFICANTLY LIMITED.
A substantial portion of our revenue comes from payments by third-party
payers, including government health administration authorities and private
health insurers. As a result of the trend toward managed healthcare in the
United States, as well as legislative proposals to reduce payments under
government insurance programs, third-party payers are increasingly attempting to
contain healthcare costs by:
- challenging the prices charged for healthcare products and services;
- limiting both coverage and the amount of reimbursement for new therapeutic
products;
- denying or limiting coverage for products that are approved by the FDA,
but are considered experimental or investigational by third-party payers;
and
- refusing in some cases to provide coverage when an approved product is
used for disease indications in a way that has not received FDA marketing
approval.
Government and other third-party payers may not provide adequate insurance
coverage or reimbursement for our products and services, which could impair our
financial results.
In addition, third-party payers may not reimburse patients for newly
approved healthcare products, which could decrease demand for our products.
Furthermore, Congress occasionally has discussed implementing broad-based
measures to contain healthcare costs. It is possible that Congress will enact
legislation specifically designed to contain healthcare costs. If third-party
reimbursement is inadequate to allow us to recover our costs or if Congress
passes legislation to contain healthcare costs, our profitability and financial
condition will suffer.
CHANGES IN THE ECONOMIC, POLITICAL, LEGAL AND BUSINESS ENVIRONMENTS IN THE
FOREIGN COUNTRIES IN WHICH WE DO BUSINESS COULD CAUSE OUR INTERNATIONAL SALES
AND OPERATIONS, WHICH ACCOUNT FOR A SIGNIFICANT PERCENTAGE OF OUR
CONSOLIDATED NET SALES, TO BE LIMITED OR DISRUPTED.
Our international operations accounted for 41% of our consolidated revenues
for each of the years ended December 31, 1999 and 1998 and 37% of our
consolidated revenues in 1997, and we expect that international sales will
continue to account for a significant percentage of our revenues for the
foreseeable future. In addition, we have direct investments in a number of
subsidiaries outside of the United States, primarily in Europe and Japan. Our
international sales and operations could be limited or disrupted, and the value
of our direct investments may be diminished, by any of the following:
- fluctuations in currency exchange rates;
- the imposition of governmental controls;
- less favorable intellectual property or other applicable laws;
- the inability to obtain any necessary foreign regulatory approvals of
products in a timely manner;
18
<PAGE>
- import and export license requirements;
- political instability;
- trade restrictions;
- changes in tariffs;
- difficulties in staffing and managing international operations; and
- longer payment cycles.
A significant portion of our business is conducted in currencies other than
our reporting currency, the U.S. dollar. We recognize foreign currency gains or
losses arising from our operations in the period in which we incur those gains
or losses. As a result, currency fluctuations among the U.S. dollar and the
currencies in which we do business have caused foreign currency transaction
gains and losses in the past and will likely do so in the future. Because of the
number of currencies involved, the variability of currency exposures and the
potential volatility of currency exchange rates, we may suffer significant
foreign currency transaction losses in the future due to the effect of exchange
rate fluctuations on our future operating results.
SEVERAL ANTI-TAKEOVER PROVISIONS MAY DEPRIVE OUR STOCKHOLDERS OF THE
OPPORTUNITY TO RECEIVE A PREMIUM FOR THEIR SHARES UPON A CHANGE IN CONTROL.
Provisions of Massachusetts law and our charter, by-laws and shareholder
rights plan could delay or prevent a change in control of Genzyme or a change in
our management. Our tracking stock structure may also deprive our stockholders
of the opportunity to receive a premium for their shares upon a change in
control because, in order to obtain control of a particular division, an
acquiror would have to obtain control of the entire corporation.
In addition, our board of directors may, in its sole discretion:
- exchange shares of Molecular Oncology Stock or Biosurgery Stock, for
Genzyme General Stock at a 30% premium over the market value of the
exchanged shares; and
- issue shares of undesignated preferred stock from time to time in one or
more series.
Either of these board actions could increase the cost of an acquisition of
Genzyme and thus discourage a takeover attempt.
CONTRACT MANUFACTURERS, SUPPLIERS AND LICENSORS MAY TERMINATE THEIR
ARRANGEMENTS WITH GELTEX PHARMACEUTICALS, INC. OR DEMAND NEW ARRANGEMENTS AS
A RESULT OF OUR ACQUISITION OF GELTEX PHARMACEUTICALS, INC.
On December 14, 2000, we completed our acquisition of GelTex
Pharmaceuticals, Inc. GelTex Pharmaceuticals is now a wholly-owned subsidiary of
ours and GelTex Pharmaceuticals' contract manufacturers, suppliers and licensors
are indirectly our contract manufacturers, suppliers and licensors. For
competitive or other reasons, some of these entities may choose to terminate
their arrangements with GelTex Pharmaceuticals rather than conduct business with
us. Alternatively, they may demand new arrangements with us. If we are unable to
maintain relationships on favorable terms with some or all of these contract
manufacturers, suppliers or licensors, our future results may be negatively
impacted.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements about our financial
condition, results of operations, business strategies, operating efficiencies,
competitive positions, growth opportunities for existing products, future
success of development-stage products, plans and objectives of management and
other matters. These forward-looking statements involve a number of risks and
uncertainties that could cause actual results to differ materially from those
suggested by the forward-looking statements. Forward-looking statements,
therefore, should be considered in light of all of the information included or
referred to in this prospectus, including the information set forth under the
heading "RISK FACTORS" beginning on page 4.
Words such as "estimate," "project," "plan," "intend," "expect," "believe,"
"anticipate," "should," "may," "will" and similar expressions are intended to
identify forward-looking statements. These forward-looking statements are found
at various places throughout this prospectus and the documents incorporated by
reference.
You are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this prospectus.
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<PAGE>
PLAN OF DISTRIBUTION
In connection with our acquisition of Biomatrix, Inc., and pursuant to the
Agreement and Plan of Merger by and among us, Biomatrix and Seagull Merger
Corporation, a wholly-owned subsidiary of ours, dated as of March 6, 2000, as
amended, we have agreed to assume the outstanding options of Biomatrix,
including options granted to former employees of Biomatrix pursuant to stock
option plans maintained by Biomatrix.
On December [18], 2000, our acquisition of Biomatrix became effective, with
Biomatrix becoming a wholly-owned subsidiary of ours, renamed Genzyme Biosurgery
Corporation, and each outstanding option of Biomatrix was converted into the
right to purchase shares of Biosurgery Stock. This prospectus covers the shares
of Biosurgery Stock that are issuable upon exercise of options granted to former
employees of Biomatrix pursuant to stock option plans maintained by Biomatrix.
We are offering these shares of Biosurgery Stock directly to the holders of
these options according to the terms of their option agreements. We are not
using an underwriter in connection with this offering. These shares will be
listed for trading on the Nasdaq National Market.
In order to facilitate the exercise of the options, we will furnish, at our
expense, such reasonable number of copies of this prospectus to each
recordholder of options as the holder may request, together with instructions
that such copies be delivered to the beneficial owners of these options.
The exercise price and other terms of the options assumed were determined by
the board of directors or a committee of the board of directors of Biomatrix.
These options shall continue to have, and be subject to, the same terms and
conditions that were in effect immediately before our acquisition of Biomatrix
became effective, except that these options are now exercisable for shares of
Biosurgery Stock. Accordingly, these terms and conditions may not necessarily
bear any relationship to our assets or results of operations.
This prospectus forms a part of a registration statement that we have filed
with the Securities and Exchange Commission. We will bear the expenses of
preparing and filing the registration statement and currently estimate that the
total amount of these expenses will be approximately $4,500.
USE OF PROCEEDS
The exercise prices of the options granted to former employees of Biomatrix
range from approximately $18.07 to $31.63 per share of Biosurgery Stock. If all
of these options were exercised in full, we would issue approximately 48,076
shares of Biosurgery Stock for total cash proceeds of approximately $924,662. We
currently intend to use the net proceeds from any exercises of these options for
working capital and general corporate purposes.
LEGAL MATTERS
The validity of the shares offered by this prospectus will be pass upon by
Palmer & Dodge LLP, Boston, Massachusetts.
EXPERTS
[Language to provided by amendment.]
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PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The expenses to be borne by Genzyme in connection with the registration of
the Genzyme Biosurgery Division Common Stock are estimated as follows:
<TABLE>
<S> <C>
SEC Registration Fee........................................ $ 245
Printing and engraving expenses............................. $ 1,000
Accounting fees and expenses................................ $ 1,000
Legal fees and expenses..................................... $ 2,000
Miscellaneous expenses...................................... $ 255
-------
Total................................................... $ 4,500
=======
</TABLE>
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 67 of chapter 156B of the Massachusetts Business Corporation Law
grants Genzyme the power to indemnify any director, officer, employee or agent
to whatever extent permitted by Genzyme's amended and restated articles of
organization, by-laws or a vote adopted by the holders of a majority of the
shares entitled to vote thereon, unless the proposed indemnitee has been
adjudicated in any proceeding not to have acted in good faith in the reasonable
belief that his or her actions were in the best interests of Genzyme or, to the
extent that the matter for which indemnification is sought relates to service
with respect to an employee benefit plan, in the best interests of the
participants or beneficiaries of such employee benefit plan. Such
indemnification may include payment by Genzyme of expenses incurred in defending
a civil or criminal action or proceeding in advance of the final disposition of
such action or proceeding, upon receipt of an undertaking by the person
indemnified to repay such payment if he or she shall be adjudicated to be not
entitled to indemnification under the statute.
Article VI of Genzyme's by-laws provides that Genzyme shall, to the extent
legally permissible, indemnify each person who may serve or who has served at
any time as a director or officer of the corporation or of any of its
subsidiaries, or who at the request of the corporation may serve or at any time
has served as a director, officer or trustee of, or in a similar capacity with,
another organization or an employee benefit plan, against all expenses and
liabilities (including counsel fees, judgments, fines, excise taxes, penalties
and amounts payable in settlements) reasonably incurred by or imposed upon such
person in connection with any threatened, pending or completed action, suit or
other proceeding, whether civil, criminal, administrative or investigative, in
which he or she may become involved by reason of his or her serving or having
served in such capacity (other than a proceeding voluntarily initiated by such
person unless he or she is successful on the merits, the proceeding was
authorized by the corporation or the proceeding seeks a declaratory judgment
regarding his or her own conduct); PROVIDED that no indemnification shall be
provided for any such person with respect to any matter as to which he or she
shall have been finally adjudicated in any proceeding not to have acted in good
faith in the reasonable belief that his or her action was in the best interests
of Genzyme or, to the extent such matter relates to service with respect to any
employee benefit plan, in the best interests of the participants or
beneficiaries of such employee benefit plan; and PROVIDED, FURTHER, that as to
any matter disposed of by a compromise payment by such person, pursuant to a
consent decree or otherwise, the payment and indemnification thereof have been
approved by Genzyme, which approval shall not unreasonably be withheld, or by a
court of competent jurisdiction. Such indemnification shall include payment by
Genzyme of expenses incurred in defending a civil or criminal action or
proceeding
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in advance of the final disposition of such action or proceeding, upon receipt
of an undertaking by the person indemnified to repay such payment if he or she
shall be adjudicated to be not entitled to indemnification under Article VI,
which undertaking may be accepted without regard to the financial ability of
such person to make repayment.
The indemnification provided for in Article VI is a contract right inuring
to the benefit of the directors, officers and others entitled to
indemnification. In addition, the indemnification is expressly not exclusive of
any other rights to which such director, officer or other person may be entitled
by contract or otherwise under law, and inures to the benefit of the heirs,
executors and administrators of such a person.
Genzyme also has in place agreements with its officers and directors which
affirm Genzyme's obligation to indemnify them to the fullest extent permitted by
law and contain various procedural and other provisions which expand the
protection afforded by Genzyme's by-laws.
Section 13(b)(1 1/2) of chapter 156B of the Massachusetts Business
Corporation Law provides that a corporation may, in its articles of
organization, eliminate a director's personal liability to the corporation and
its stockholders for monetary damages for breaches of fiduciary duty, except in
circumstances involving (i) a breach of the director's duty of loyalty to the
corporation or its stockholders, (ii) acts or omissions not in good faith or
which involve intentional misconduct or a knowing violation of law,
(iii) unauthorized distributions and loans to insiders, and (iv) transactions
from which the director derived an improper personal benefit. Article VI.C.5. of
Genzyme's Amended and Restated Articles of Organization provides that no
director shall be personally liable to Genzyme or its stockholders for monetary
damages for any breach of fiduciary duty as a director, except to the extent
that such exculpation is not permitted under the Massachusetts Business
Corporation Law as in effect when such liability is determined.
ITEM 16. EXHIBITS
See Exhibit Index immediately following the signature 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:
(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 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 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
information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed by
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<PAGE>
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 herein, 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 provisions referred to in Item 15 hereof, 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 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.
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant
certifies that it has reasonable grounds to believe that it meets all of the
requirements of filing on Form S-3 and has duly caused this Registration
Statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Cambridge, Commonwealth of Massachusetts, as of
December 18, 2000.
<TABLE>
<S> <C> <C>
GENZYME CORPORATION
By: /s/ MICHAEL S. WYZGA
-----------------------------------------
Michael S. Wyzga
SENIOR VICE PRESIDENT AND
CHIEF FINANCIAL OFFICER
</TABLE>
POWER OF ATTORNEY
We, the undersigned officers and directors of Genzyme Corporation, hereby
severally constitute and appoint Henri A. Termeer, Michael S. Wyzga, Evan M.
Lebson and Peter Wirth, and each of them singly, our true and lawful
attorneys-in-fact, with full power to them in any and all capacities, to sign
any and all amendments to this registration statement on Form S-3 (including any
pre-and post-effective amendments thereto), and any related Rule 462(b)
registration statement or amendment thereto, and to file the same, with exhibits
thereto and other documents in connection therewith, with the Securities and
Exchange Commission, hereby ratifying and confirming all that each of said
attorneys-in-fact may 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 below by the following persons in the
capacities and as of the dates indicated.
<TABLE>
<CAPTION>
NAME TITLE DATE
---- ----- ----
<C> <S> <C>
/s/ HENRI A. TERMEER
------------------------------------------- Principal Executive Officer December 18, 2000
Henri A. Termeer and Director
/s/ MICHAEL S. WYZGA
------------------------------------------- Principal Financial and December 18, 2000
Michael S. Wyzga Accounting Officer
/s/ CONSTANTINE E. ANAGNOSTOPOULOS
------------------------------------------- Director December 18, 2000
Constantine E. Anagnostopoulos
/s/ DOUGLAS A. BERTHIAUME
------------------------------------------- Director December 18, 2000
Douglas A. Berthiaume
/s/ HENRY E. BLAIR
------------------------------------------- Director December 18, 2000
Henry E. Blair
/s/ ROBERT J. CARPENTER
------------------------------------------- Director December 18, 2000
Robert J. Carpenter
</TABLE>
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<PAGE>
<TABLE>
<CAPTION>
NAME TITLE DATE
---- ----- ----
<C> <S> <C>
/s/ CHARLES L. COONEY
------------------------------------------- Director December 18, 2000
Charles L. Cooney
/s/ VICTOR J. DZAU
------------------------------------------- Director December 18, 2000
Victor J. Dzau
</TABLE>
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EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT
NO. DESCRIPTION
------- -----------
<C> <S>
4.1 Amended and Restated Articles of Organization of Genzyme, as
amended. Filed as Exhibit 1 to Genzyme's Current Report on
Form 8-K filed with the Commission on June 30, 2000, and
incorporated herein by reference.
4.2 By-laws of Genzyme, as amended. Filed as Exhibit 3.2 to
Genzyme's Quarterly Report on Form 10-Q for the quarter
ended September 30, 1999, and incorporated herein by
reference.
4.3 Indenture, dated as of May 22, 1998, between Genzyme and
State Street Bank and Trust Company, as Trustee, including
the form of Note. Filed as Exhibit 4.3 to Genzyme's
Registration Statement on Form S-3 (File No. 333-59513)
and incorporated herein by reference.
4.4 Registration Rights Agreement, dated as of May 19, 1998,
among Genzyme, Credit Suisse First Boston Corporation,
Goldman, Sachs & Co. and Cowen & Company. Filed as Exhibit
4.4 to Genzyme's Registration Statement on Form S-3 (File
No. 333-59513) and incorporated herein by reference.
4.5 Purchase Agreement, dated as of May 19, 1998, among Genzyme,
Credit Suisse First Boston Corporation, Goldman, Sachs &
Co. and Cowen & Company. Filed as Exhibit 4.5 to Genzyme's
Registration Statement on Form S-3 (File No. 333-59513)
and incorporated herein by reference.
4.6 Amended and Restated Renewed Rights Agreement dated as of
June 10, 1999 between Genzyme and American Stock Transfer
and Trust Company. Filed as Exhibit 4 to Amendment No. 1
to Genzyme's Registration Statement on Form 8-A dated June
11, 1999, and incorporated herein by reference.
4.7 Warrant issued to Richard Warren, Ph.D. Filed as Exhibit 4
to the Current Report on Form 8-K of IG Laboratories, Inc.
dated October 11, 1990 (File No. 0-18439), and
incorporated herein by reference.
4.8 Form of Genzyme General Division Convertible Debenture dated
August 29, 1998, including a schedule with respect thereto
filed pursuant to Instruction 2 to Item 601 of Regulation
S-K. Filed as Exhibit 4.15 to Genzyme's Registration
Statement on Form S-3 (File No. 333-64901) and
incorporated herein by reference.
4.9 Registration Rights Agreement dated as of August 29, 1997 by
and among Genzyme and the entities listed on the signature
pages thereto. Filed as Exhibit 10.8 to Genzyme's
Quarterly Report on Form 10-Q for the quarter ended
September 30, 1997, and incorporated herein by reference.
4.10 Warrant Agreement between Genzyme and Comdisco, Inc. Filed
as Exhibit 10.22 to a General Form for Registration on
Form 10 of PharmaGenics, Inc. (File No. 0-20138), and
incorporated herein by reference.
5 Opinion of Palmer & Dodge LLP. To be filed by amendment.
23.1 Consent of PricewaterhouseCoopers LLP, independent
accountants to Genzyme. To be filed by amendment.
23.2 Consent of Palmer & Dodge LLP (contained in Exhibit 5
hereto).
24 Power of Attorney (included on signature page).
</TABLE>
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