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As filed with the Securities and Exchange Commission on July 16, 1998.
REGISTRATION NO. 333-______
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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
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GENZYME TRANSGENICS CORPORATION
(Exact name of registrant as specified in its charter)
Massachusetts 04-3186494
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification Number)
Five Mountain Road, Framingham, Massachusetts, 01701 (508) 620-9700
(Address, including zip code, and telephone number, including area code, of
registrant's principal executive offices)
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SANDRA NUSINOFF LEHRMAN
President and Chief Executive Officer
Genzyme Transgenics Corporation
Five Mountain Road
Framingham, Massachusetts 01701
(508) 620-9700
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
with copies to:
LYNNETTE C. FALLON, ESQUIRE
Palmer & Dodge LLP
One Beacon Street
Boston, Massachusetts 02108
(617) 573-0100
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Approximate date of commencement of proposed sale to the public:
From time to time after the effective date of this Registration Statement.
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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
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<CAPTION>
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Proposed maximum Proposed maximum
Title of each class of securities to be Amount to be offering price per aggregate offering Amount of
registered registered share(1) price registration fee
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<S> <C> <C> <C> <C>
Common Stock, $0.01 par value 48,284 shares $7.25 $350,059.00 $103.27
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(1) Estimated solely for the purpose of determining the registration fee
and computed pursuant to Rule 457(c), based upon the average of the
high and low sale prices on July 15, 1998, as reported by the Nasdaq
National Market.
<PAGE>
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>
PROSPECTUS
48,284 SHARES
GENZYME TRANSGENICS CORPORATION
COMMON STOCK, PAR VALUE $0.01 PER SHARE
This Prospectus relates to the offer and sale of up to 48,284 shares
(the "Shares") of Common Stock, $0.01 par value (the "Common Stock") of
Genzyme Transgenics Corporation ("GTC" or the "Company") by an existing
stockholder of the Company (the "Selling Stockholder"). The Shares may be
offered and sold by the Selling Stockholder from time to time in open market
or privately-negotiated transactions, at market prices prevailing at the time
of sale, at prices related to such prevailing market prices or at negotiated
prices. The Selling Stockholder may effect such transactions by selling the
Shares to or through broker-dealers and such broker-dealers may receive
compensation in the form of discounts, concessions or commissions from the
Selling Stockholder or the purchasers of the Shares for whom such
broker-dealers may act as agent or to whom they sell as principal or both
(which compensation to a particular broker-dealer might be in excess of
customary commissions). See "Selling Stockholder" and "Plan of Distribution."
None of the proceeds from the sale of the Shares by the Selling
Stockholder will be received by the Company.
The Common Stock of the Company is listed for quotation on the Nasdaq
National Market under the symbol GZTC. On July 14, 1998, the closing sale
price of the Common Stock, as reported by Nasdaq, was $7.375 per share.
-----------------
AN INVESTMENT IN THE SECURITIES REGISTERED HEREBY INVOLVES
A HIGH DEGREE OF RISK. SEE "RISK FACTORS"
-----------------
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION; NOR HAS THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED
UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
No person is authorized, in connection with the offering made hereby, to
give any information or to make any representation other than as contained in
this Prospectus, and, if given or made, such information or representations
must not be relied upon as having been authorized by the Company. This
Prospectus is not an offer to sell, or a solicitation of an offer to buy, by
any person in any jurisdiction in which it is unlawful for such person to
make such an offer or solicitation.
The date of this Prospectus is July ___, 1998
<PAGE>
TABLE OF CONTENTS
<TABLE>
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Page
<S> <C>
AVAILABLE INFORMATION................................................................................................... 3
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE......................................................................... 3
RISK FACTORS............................................................................................................ 4
THE COMPANY............................................................................................................. 9
SELLING STOCKHOLDER..................................................................................................... 9
PLAN OF DISTRIBUTION.................................................................................................... 9
LEGALITY OF COMMON STOCK............................................................................................... 10
EXPERTS................................................................................................................ 10
</TABLE>
2
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AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and in
accordance therewith, files reports, proxy statements and other information
with the Securities and Exchange Commission (the "Commission"). Reports,
proxy and information statements and other information filed by the Company
can be inspected and copied at the public reference facilities of the
Commission, Room 1024, Judiciary Plaza, 450 Fifth Street, N.W., Washington,
D.C. 20549 and at the Commission's regional offices located at 7 World Trade
Center, 13th Floor, New York, New York 10048 and Northwestern Atrium Center,
500 West Madison Street, Suite 1400, Chicago, Illinois 60661. Copies of such
materials can be obtained from the Public Reference Section of the Commission
at 450 Fifth Street, N.W., Washington, D.C. 20549 at prescribed rates. Such
reports and other information can also be reviewed through the Commission's
web site on the Internet (http://www.sec.gov). The Common Stock of the
Company is quoted on the Nasdaq National Market. Reports and other
information concerning the Company may be inspected at the National
Association of Securities Dealers, Inc., 1735 K Street, N.W., Washington,
D.C. 20006-1506.
---------------------------
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents filed with the Commission (File No. 0-21794),
pursuant to the Exchange Act, are incorporated herein by reference:
(a) The Company's Annual Report on Form 10-K for the fiscal year ended
December 28, 1997, filed with the Commission March 27, 1998.
(b) All other reports, if any, filed by the Company pursuant to Section
13(a) or 15(d) of the Exchange Act since the Annual Report referred
to in paragraph (a) above.
(c) The description of the Common Stock of the Company contained in the
Company's Registration Statement on Form 8-A, filed on May 19,
1993, including any amendment or reports filed for the purpose of
updating such description.
All documents filed by the Company pursuant to Sections 13(a), 13(c), 14
or 15(d) of the Exchange Act subsequent to the date of this Prospectus and
prior to the termination of the offering of the securities offered hereby
shall be deemed incorporated by reference into this Prospectus and to be a
part hereof from the date of filing such documents. Any statement contained
in any document incorporated or deemed to be incorporated by reference herein
shall be deemed to be modified or superseded, for purposes of this
Prospectus, to the extent that a statement contained herein (or in any other
subsequently filed document which also is or is deemed to be incorporated by
reference herein) modifies or supersedes such statement. Any such statement
so modified or superseded shall not be deemed, except as so modified or
superseded, to constitute a part of this Prospectus.
The Company will provide, without charge, to each person to whom a copy
of this Prospectus is delivered, upon written or oral request of such person,
a copy of any or all of the documents which are incorporated herein by
reference, except for certain exhibits to such documents. Requests should be
directed to the Company, Five Mountain Road, Framingham, Massachusetts 01701,
Attention: John B. Green, telephone: (508) 620-9700.
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RISK FACTORS
An investment in the shares of Common Stock being offered hereby
involves a high degree of risk. Prospective investors should carefully
consider the following risk factors, in addition to the other information
contained in this Prospectus, before purchasing the shares of Common Stock
offered hereby.
History of Operating Losses; Need for Additional Funds. GTC has had
operating losses since its inception and expects such losses to continue for
the next several years. For the period from its inception in 1993 to December
28, 1997, the Company incurred cumulative losses of approximately $27.3
million. GTC's losses have resulted principally from costs incurred in
connection with research activities and from expenses in excess of revenues
from the Company's contract research organization ("CRO") services. GTC's
sources of revenues to date have consisted primarily of research and
development contracts and CRO services. Such revenues to date have not been
sufficient to generate profits. The Company expects to continue to incur
significant operating losses until such time as product sales and CRO service
revenues are sufficient to fund its operations. No assurance can be given
that the Company will become profitable.
The Company currently believes that existing cash resources and
available financing will be sufficient to meet its operating cash flow needs
and capital requirements at least through the end of 1998. The development of
transgenic products by the Company will require the commitment of substantial
resources to conduct costly and time-consuming research, preclinical testing
and clinical trials necessary to bring such products to market. If GTC's
businesses do not achieve profitable operations at or prior to the time such
existing resources are exhausted, the Company will need to obtain additional
financing, through public or private financings, including debt or equity
financings, or through collaborative or other arrangements with corporate
partners, as appropriate. Adequate funds for the Company's operations from
such sources may not be available when needed or on terms acceptable to the
Company. If additional financing cannot be obtained when needed or on
acceptable terms, GTC could be forced to delay, scale back or eliminate
certain of its research and development programs or to license to other
parties rights to commercialize products or technologies that the Company
would otherwise seek to develop internally as well as delaying or foregoing
timely expansion, improvement or investment in the Company's contract
research services.
The foregoing forward-looking statements regarding the Company's
expectations of the need for additional funds are subject to risks and
uncertainties. The Company's cash requirements may vary materially from those
now planned, depending upon the results of existing businesses, the terms of
future collaborations, results of research and development, competitive and
technological advances, regulatory requirements and other factors.
Early Stage of Transgenic Technology. Development of products based on
transgenic technology is subject to a number of significant technological
risks and the time period required for any such development is both lengthy
and uncertain. Neither GTC nor, to GTC's knowledge, any other entity has
completed human clinical trials of any protein produced in the milk of
transgenic animals, and there can be no assurance that GTC will be able to do
so successfully. There can be no assurance that any transgenically produced
protein will be safe or effective. All of the proteins that GTC is developing
will require significant additional research, development and testing and
will require the expenditure of substantial additional capital prior to their
commercialization. In addition, there can be no assurance that research and
discoveries by others will not render GTC's technology obsolete or
noncompetitive.
No Assurance of Commercial Success of Transgenic Products. The
successful commercialization of any transgenic protein product by the Company
will depend on many factors, including the successful completion of clinical
testing, the response of medical professionals to the data from clinical
trials, the Company's ability to create or access a sales force able to
market such transgenic products, the Company's ability to supply a sufficient
amount of product to meet market demand, the degree to which third-party
reimbursement for use of such product is available and the number and
relative efficacy of competitive products that may subsequently enter the
market, as well as, with respect to transgenic products designed to replace
or supplement products currently being marketed, the relative
cost-effectiveness of the transgenic products. There can be no assurance that
the Company or its collaborative partners will be successful in efforts to
develop and implement a commercialization strategy for any such products.
4
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GTC does not currently have a sales force to market any transgenic
products it may develop. The Company anticipates that, for products it
develops independently, it will enter into marketing arrangements with larger
pharmaceutical or biotechnology companies which have established sales forces
that are able to market such products. There can be no assurance that any
marketing or distribution arrangements will be available on acceptable terms
or that, in the alternative, GTC will be able to establish its own sales
force successfully. Unforeseen delays in this process may have an adverse
effect on the commercialization of any of the Company's products.
Third-party payors are increasingly attempting to contain health care
costs by limiting both coverage and the level of reimbursement for new
therapeutic products. The successful commercialization of any products
developed by the Company may depend on obtaining coverage and reimbursement
for the use of these products from third-party payors.
In addition, the successful commercialization of the Company's products
will require that medical professionals become convinced of the efficacy of
the products in treating a particular condition and incorporate such products
as standard practice in relevant therapeutic protocols. There can be no
assurance that any transgenic product developed by GTC will be accepted by
the medical profession.
Government Regulation. Transgenic products will require approval by the
U.S. Food and Drug Administration ("FDA") prior to marketing in the United
States. In addition, the manufacturing and marketing of such products, and
certain areas of research related to them, are subject to regulations by
other U.S. governmental authorities including the United States Department of
Agriculture (the "USDA") and the Environmental Protection Agency (the "EPA").
Comparable authorities are involved in other countries.
In cases where the Company expects to obtain revenue from the sale of
transgenic products, whether through direct sales, marketing relationships
with others or royalty arrangements, the Company will incur the risk of such
product failing to satisfy applicable regulatory requirements prior to
marketing. The approval process involves two parts, governing first the
approval of an individual pharmaceutical product as safe and effective and
second the approval of the manufacturing process as complying with applicable
FDA current good manufacturing practices regulations ("GMPs"). In 1995, the
FDA and comparable European regulatory authorities issued guidelines
regarding the production of therapeutic proteins in transgenic animals. While
the FDA's guidelines, known as Points to Consider guidelines ("Points to
Consider"), cover issues specific to transgenic production, the basic
regulatory framework for FDA approval will also apply to transgenic
therapeutic products submitted for approval. To GTC's knowledge, no protein
produced in the milk of a transgenic animal has been submitted for regulatory
approval in the United States or elsewhere.
The FDA and comparable agencies in foreign countries impose substantial
requirements upon the introduction of therapeutic pharmaceutical products
through lengthy and detailed laboratory and clinical testing procedures,
sampling activities and other costly and time-consuming procedures.
Satisfaction of these requirements typically takes several years or more and
can vary substantially based upon the type, complexity and novelty of the
product. With respect to therapeutic products, the standard FDA approval
process includes preclinical laboratory and animal testing, submission of an
IND to the FDA, appropriate human clinical trials to establish safety and
effectiveness and submission of either a Biologics License Application or a
New Drug Application ("NDA") prior to market introduction. With respect to
obtaining approval for the production facilities to be used in producing a
therapeutic product, the Company expects to be subject to both the
requirements for establishment license applications and the Points to
Consider issued with respect to transgenic recombinant products.
The effect of government regulation may be to delay marketing of the
Company's products for a considerable or indefinite period of time, impose
costly procedural requirements upon the Company's activities and may furnish
a competitive advantage to larger companies or companies more experienced in
regulatory affairs. There can be no assurance that the FDA or other
regulatory approvals for any products developed by the Company will be
granted on a timely basis or at all. Any delay in obtaining or any failure to
obtain such approvals could adversely affect the Company's ability to
generate revenue. Even if initial regulatory approvals for the Company's
product candidates are obtained, the Company, its products and its transgenic
manufacturing processes would be subject to continual review and periodic
inspection. There can be no assurance that the FDA will permit the marketing
of any transgenic product for any particular indication, if at all.
5
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The Company's operations are also subject to federal, state and local
laws, rules, regulations and policies governing the use, generation,
manufacture, storage, air emission, effluent discharge, handling and disposal
of certain materials and waste, including but not limited to animal waste and
waste water.
Dependence of Testing Services on Current Government Regulatory
Requirements. The market for GTC's preclinical testing services is dependent
upon the maintenance of strict standards for the conduct of laboratory and
clinical tests and related procedures which are promulgated by governmental
entities responsible for public health and welfare, including the FDA, and by
regulatory authorities in foreign countries. The process of obtaining these
approvals varies according to the nature and use of the product and routinely
involves lengthy and detailed laboratory and clinical testing and other
costly and time-consuming procedures. The Company offers the customers of its
preclinical testing and development services the necessary expertise to
comply with these complex regulations. If the regulatory structure were to
change in a way which reduced the need for such services, the Company could
be materially adversely affected.
Dependence on Genzyme. GTC has entered into a number of contractual
agreements with Genzyme regarding technology and product development and
other matters, as discussed below:
Under a research and development agreement, Genzyme is obligated to use
commercially reasonable efforts to perform purification services for GTC. GTC
does not currently have personnel capable of undertaking such purification
services. Until such time, if ever, as GTC develops its own capabilities in
this regard, there can be no assurance that Genzyme will be able to provide
such services when and as required by GTC or that GTC would be able to obtain
comparable services elsewhere.
Under a collaboration agreement, Genzyme has agreed to provide funding
for transgenic AT-III development in exchange for co-marketing rights to
AT-III in all territories other than Asia. The term of the agreement is
perpetual, except that either party may terminate the agreement for certain
material breaches, failure to make payments, and either upon the grant, or
certain absences of a grant, by the FDA of a license to market an AT-III
product. There can be no assurance, should the agreement terminate before
completion of the development of an AT-III product, that Genzyme and GTC
could reach an agreement to extend Genzyme's development funding, that the
Company would be able to fund such program on its own or that the Company
would be able to obtain such funding from a third party on acceptable terms,
if at all.
Under a services agreement, GTC pays Genzyme a fixed monthly fee for
basic laboratory and administrative support services provided by Genzyme. The
monthly fee is adjusted annually, based on the services to be provided and
changes in Genzyme's cost of providing the services. The services agreement
is self-renewing annually and may be terminated upon 90 days notice by either
party to the other party. There can be no assurance, should the agreement
terminate, that GTC would be able to renegotiate a new agreement or obtain
the provision of substitute services from a third party on acceptable terms,
if at all.
In 1995, GTC obtained a credit line and a term loan with a commercial
bank, each secured by Genzyme's guaranty of the Company's obligations
thereunder. GTC has agreed to reimburse Genzyme for any liability Genzyme may
incur under such guaranty and has granted Genzyme a first lien on all of
GTC's assets to secure such obligation. The various loan documents provide
that if GTC or Genzyme breach certain financial covenants, the bank may
refuse to extend further credit as well as accelerate outstanding
indebtedness. There can be no assurance, in the event Genzyme or GTC breaches
such financial covenants, that GTC will be able to meet any repayment demands
upon acceleration or to make new arrangements with the bank, Genzyme and/or
any third parties to provide for a replacement extension of credit on
acceptable terms, if at all.
In March 1996, GTC entered into the Genzyme Credit Line Agreement with
Genzyme (the "Genzyme Credit Line") under which Genzyme agreed to provide a
revolving line of credit in the amount of $10 million. During 1996,
$1,673,000 of debt was converted into 219,565 shares of common stock, leaving
$8,327,000 available on the revolving line of credit. In September 1997, GTC
and Genzyme amended the terms of the $8.3 million Genzyme Credit Line. The
expiration date of the revolving credit line was extended to March 31, 2000,
with an option, at that date, for GTC to convert the outstanding
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balance to a three-year term loan. As a result of the issuance of the
Preferred Stock in the private placement of March 1998, the amount of the
credit line was reduced by approximately $1.9 million. There can be no
assurance, upon the termination of the credit line, that GTC will be able to
negotiate an extension or replacement of the line of credit, if necessary,
with Genzyme or a third party on acceptable terms, if at all.
Potential Conflicts of Interest with Genzyme. Genzyme is the largest
single stockholder of GTC. Assuming exercise of a currently exercisable
warrant for 145,000 shares of Common Stock, Genzyme beneficially owns
approximately 44% of the outstanding Common Stock of GTC. Genzyme's ownership
interest gives it significant influence over any election of directors and
any other action requiring approval by the holders of a majority of the
Common Stock. Three members of GTC's Board of Directors also serve as
directors and/or executive officers of Genzyme. The interests of Genzyme on
the one hand and GTC on the other hand may, from time to time, differ.
Dependence on Collaborators. The success of GTC's transgenic protein
production business will depend, in large part, on GTC's ability to enter
into arrangements with biotechnology and pharmaceutical companies for the
transgenic production of proteins to which such companies have proprietary
rights or to fund the development of transgenic proteins which are in the
public domain or the subject of expiring patents. To date, the scope of these
agreements has generally been limited to demonstrating the feasibility of
transgenic production of targeted proteins in particular animal species.
There can be no assurance that these feasibility studies will be successful
or lead to agreements for the commercial production of any proteins.
Depending upon the terms of any future collaborations, the Company's role in
such collaborations may be limited to the production aspects of the proteins
under development. As a result, GTC may also be dependent on collaborators
for other aspects of the development, preclinical and clinical testing,
regulatory approval and commercialization of any transgenic product.
Uncertainty Regarding Patents and Proprietary Technology. GTC has relied
upon trade secrets, proprietary know-how and continuing technological
innovation to develop and maintain its competitive position and to protect
its proprietary technology. In part, these legal rights are protected by
contracts with employees, consultants and business partners. There can be no
assurance that trade secrets possessed by GTC will be maintained, that
secrecy obligations will be honored or that others will not independently
develop similar or superior technology. There is no assurance that patent
applications filed by GTC will result in patents being issued or that any
patents issued to or licensed by GTC will be held valid. The Company may also
be subject to claims that result in the revocation of patent rights
previously licensed to GTC as a result of which the Company may be required
to obtain licenses from others to continue to develop, test or commercialize
its products. There can be no assurance that GTC will be able to obtain such
licenses on acceptable terms, if at all. In addition, there may be pending or
issued patents held by parties not affiliated with GTC that relate to the
technology utilized by GTC. As a result, GTC may need to acquire licenses to,
or contest the validity of, such patents or any other similar patents which
may be issued. GTC could incur substantial costs in defending itself against
challenges to patent or infringement claims made by third parties or in
enforcing any patent rights of its own. The loss or exposure of trade secrets
possessed by GTC could also adversely affect its business.
Competition. The industries in which GTC operates are highly competitive
and may become even more competitive. It will be necessary for GTC to
continue to devote substantial efforts and expense to research, development,
sales and marketing in order to maintain a competitive position. There can be
no assurance that developments by others will not render GTC's current and
proposed services, products or technologies obsolete. In addition, GTC may
encounter significant competition for protein development and production
contracts from other companies. Transgenic products may face significant
competition from biological products manufactured in cell culture or derived
from human serum or tissue or animal serum or tissue. GTC's business will
compete both against other companies whose business is dedicated to offering
transgenic production or preclinical testing and development as a service and
with prospective customers or collaborators who decide to pursue such
transgenic production or preclinical testing and development internally.
Risk of Service or Product Liability. GTC's business exposes it to
potential product and professional liability risks which are inherent in the
testing, production, marketing and sale of human therapeutic products. While
GTC has obtained product and professional liability insurance under an
insurance policy arrangement with Genzyme and Genzyme's affiliates, there can
7
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be no assurance that such insurance will be sufficient to cover any claim.
Uninsured product or service liability could have a material adverse effect
on the financial results of GTC. In addition, there can be no assurance that
any insurance will provide GTC with adequate protection against potential
liabilities. Potential liability also may arise from the handling by GTC of
clinical samples containing human blood and tissues, which may contain human
pathogens; liability may also arise from handling animal blood and tissue
which may contain zoonotic pathogens. Although such products are used only in
the laboratory, inadvertent human contact may occur.
Retention of Key Personnel. Although GTC believes that the size and
qualifications of its current staff are adequate for its current business,
the Company must continue to attract and retain qualified scientific,
technical, marketing and management personnel as its business expands. There
is intense competition for qualified personnel in the areas of the Company's
activities, and there can be no assurance that GTC will be able to continue
to attract and retain the qualified personnel necessary for the development
of its business. Loss of the services of, or failure to recruit, key
scientific and technical personnel could have a material adverse effect on
GTC's business.
Public Concerns. Certain of GTC's activities involve animal testing and
genetic engineering in animals. Such activities have been the subject of
controversy and adverse publicity. Animal rights groups and various other
organizations and individuals have attempted to stop animal testing and
genetic engineering activities by pressing for legislation and regulation in
these areas. To the extent the activities of such groups are successful,
GTC's business may be adversely affected.
Shares Eligible for Future Sale. Sales of substantial amounts of Common
Stock in the public market, or the perception that such sales may occur,
could adversely affect the prevailing market price of the Common Stock. As of
July 1, 1998, there were 18,474,249 shares of Common Stock outstanding. As of
July 1, 1998, options to purchase an aggregate of 2,129,732 shares of
Common Stock at varying exercise prices were outstanding; of such total,
options for 1,494,484 shares were immediately exercisable and such shares
could be immediately resold into the public market. All of the 7,428,365
shares held by Genzyme could be sold into the public markets upon compliance
with Rule 144. The 145,000 shares issuable to Genzyme upon exercise of an
outstanding warrant are entitled to registration rights, which could expedite
the resale of such shares into the public market. Another 210,600 shares of
Common Stock are reserved for issuance upon exercise of outstanding warrants,
all of which are currently exercisable. Furthermore, in connection with a
private placement in March 1998, 3,599,138 shares of Common Stock are
reserved for issuance, and have been registered for resale, upon (i) exercise
of currently exercisable warrants for 450,000 shares of Common Stock and (ii)
conversion of 20,000 shares of Preferred Stock, currently convertible into
1,374,569 shares of Common Stock. Approximately twice the number of shares
currently issuable upon conversion of the securities issued in the March 1998
private placement were registered because on and after December 21, 1998 the
conversion price per share of the preferred stock shall become the lower of
(i) $14.55 and (ii) the average closing price of the Company's Common Stock
as quoted by the Nasdaq National Market for any five trading days, selected
by the holder, during the twenty trading days immediately preceding the date
of conversion. As a result, the number of shares of Common Stock issuable
upon conversion of the preferred stock may increase above, but will not
decrease below, 1,374,569 shares. Lastly, an indeterminate amount of shares
are registered for issuance and sale by the Company on a continuous basis at
a maximum aggregate offering price of $12,000,000, of which, to date, 603,300
shares have been sold at an aggregate purchase price of $6,515,640.
Possible Volatility of Stock Price; Absence of Dividends. There has been
a history of significant volatility in the market prices of publicly-traded
common stock of companies engaged in applications of biotechnology, including
the Company, and the market price of the Common Stock has been and may
continue to be highly volatile. Announcements of technological innovations or
new products by GTC or others, developments or disputes concerning patents or
proprietary rights, publicity regarding actual or potential medical results
relating to products under development by GTC or its competitors, regulatory
developments, period-to-period fluctuations in GTC's financial results and
general economic and market conditions, among other things, may have a
significant impact on the market price of the Common Stock. GTC has not paid
any dividends since its inception and does not intend to pay any dividends in
the foreseeable future.
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Change in Control. Certain provisions of Massachusetts law and of GTC's
charter documents could have the effect of discouraging others from
attempting hostile takeovers of GTC. Such provisions may also have the effect
of preventing changes in the management of GTC. It is possible that such
provisions could make it more difficult to accomplish transactions which
stockholders may deem to be in their best interests.
THE COMPANY
GTC is engaged in the application of transgenic technology to the
development and production of recombinant proteins for therapeutic and
diagnostic uses. GTC produces such proteins by inserting a gene that directs
the production of a desired protein into the genetic material of an animal
such that the target protein is secreted in the milk of female offspring. GTC
believes that transgenic production offers significant economic and
technological advantages relative to traditional protein production systems.
GTC intends to develop and produce a broad range of proteins, both in
collaboration with pharmaceutical and biotechnology companies and
independently.
Through a wholly-owned subsidiary, Primedica Corporation, GTC also
provides preclinical testing services to pharmaceutical, biotechnology,
medical device and chemical companies. Such services help Primedica's
customers reduce the time and cost of bringing their products to market.
GTC's principal executive offices are located at Five Mountain Road,
Framingham, Massachusetts 01701, and its telephone number at that location is
(508) 620-9700.
SELLING STOCKHOLDER
All 48,284 shares offered hereby are held of record by the Putnam
Fiduciary Trust Company, as trustee of the Plan. Prior to this offering, the
Selling Stockholder is the owner of record of 214,576 shares of the Company's
Common Stock.
PLAN OF DISTRIBUTION
The Company has filed with the Commission a Registration Statement on
Form S-3 (the "Registration Statement") under the Securities Act of 1933, as
amended (the "Securities Act"), of which this Prospectus forms a part, with
respect to the resale of the Shares from time to time by the Selling
Stockholder in open-market or privately-negotiated transactions. The Company
has agreed to keep the Registration Statement effective until the earlier of
(i) the date on which the Selling Stockholder no longer holds any of the
shares of Common Stock offered hereby and (ii) the first anniversary of the
effective date of the Registration Statement.
The Company has been advised that the Selling Stockholder may sell the
Shares at market prices prevailing at the time of sale, at prices related to
such prevailing market prices or at negotiated prices. The Selling
Stockholder may effect such transactions by selling the Shares to or through
broker-dealers and such broker-dealers may receive compensation in the form
of discounts, concessions or commissions from the Selling Stockholder or the
purchasers of the Shares for whom such broker-dealers may act as agent or to
whom they sell as principal, or both (which compensation to a particular
broker-dealer might be in excess of customary commissions). The Selling
Stockholder will be responsible for all brokerage commissions and other
amounts payable with respect to any sale of Shares with respect to the
Selling Stockholder.
The Selling Stockholder and any broker-dealers who act in connection
with the sale of Shares hereunder may be deemed to be "underwriters," as such
term is defined in the Securities Act, and any commissions received by them
or profit on any resale of the Shares as principal might be deemed to be
underwriting discounts and commissions under the Securities Act.
9
<PAGE>
LEGALITY OF COMMON STOCK
The validity of the securities offered hereby will be passed upon for
the Company by Palmer & Dodge LLP, Boston, Massachusetts. Lynnette C. Fallon,
a partner of Palmer & Dodge LLP, is the Clerk of the Company.
EXPERTS
The consolidated balance sheets of the Company as of December 28, 1997
and December 29, 1996 and the related consolidated statements of operations,
cash flows and changes in shareholders' equity for each of the three fiscal
years in the period ended December 28, 1997 appearing in the Company's Annual
Report on Form 10-K for the year ended December 28, 1997 have been audited by
PricewaterhouseCoopers LLP, independent accountants, as set forth in their
report included therein and incorporated herein by reference. Such
consolidated financial statements of the Company are referred to above and
incorporated herein by reference in reliance upon such reports given upon the
authority of that firm as experts in accounting and auditing.
10
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The expenses to be borne by the Company in connection with the securities
being registered are as follows:
<TABLE>
<CAPTION>
<S> <C>
SEC registration fee........................ $ 105
Nasdaq listing fee.......................... 2,000
Accounting fees and expenses................ 2,500
Legal fees and expenses..................... 2,500
Printing and photocopying expenses.......... 500
Miscellaneous expenses...................... 500
------
Total.................................. $8,105
------
------
</TABLE>
All of the above figures, except the SEC registration and Nasdaq listing
fees, are estimates.
Item 15. Indemnification of Directors and Officers
Section 67 of chapter 156B of the Massachusetts Business Corporation Law
grants the Company the power to indemnify any director, officer, employee or
agent to whatever extent permitted by the Company's Restated Articles of
Organization, Bylaws or a vote adopted by the holders of a majority of the
shares entitled to vote thereon, unless such 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 the corporation 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 the Company 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 the Company's Bylaws provides that the Company 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 Company, 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). Such indemnification shall include payment by the Company 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 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.
II-1
<PAGE>
Item 16. Exhibits
See the Exhibit Index immediately following the signature page.
Item 17. Undertakings
(a) The undersigned registrant hereby undertakes as follows:
(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;
(ii) to reflect in the prospectus any facts or events arising
after the effective date of this Registration Statement (or the most recent
post-effective amendment hereof) which, individually or in the aggregate,
represent a fundamental change in the information set forth in this
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 this Registration Statement;
provided, however, that no filing will be made pursuant to
paragraph (a)(1)(i) or (a)(1)(ii) if the information required to be included
in a post-effective amendment by those paragraphs is contained in periodic
reports filed by the Registrant pursuant to Section 13 or 15(d) of the
Exchange Act that are incorporated by reference in this Registration
Statement.
(2) That, for the purpose of determining any liability under the
Securities Act, 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 this offering.
(b) The undersigned hereby undertakes that, for purposes of determining
any liability under the Securities Act, each filing of the registrant's
annual report pursuant to section 13(a) or section 15(d) of the Exchange Act
that is incorporated by reference in this Registration Statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to
be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the
Securities Act may be permitted to directors, officers or controlling persons
of the registrant pursuant to the foregoing provisions, or otherwise, the
registrant has been advised that in the opinion of the 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.
II-2
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended,
the registrant certifies that it has reasonable grounds to believe that it
meets all of the requirements for filing on Form S-3 and has duly caused this
registration statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in the Town of Framingham, Commonwealth of
Massachusetts, on July 16, 1998.
GENZYME TRANSGENICS CORPORATION
By: /s/ Sandra Nusinoff Lehrman
-------------------------------------
Dr. Sandra Nusinoff Lehrman
President and Chief Executive Officer
POWER OF ATTORNEY
We, the undersigned officers and directors of Genzyme Transgenics
Corporation, hereby severally constitute and appoint Sandra Nusinoff Lehrman,
John B. Green and Lynnette C. Fallon, 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 amendments to this Registration Statement on Form S-3 (including
any post-effective amendments 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.
Witness our hands and common seal on the dates set forth below.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this registration statement has been signed below by the following persons in
the capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ Sandra Nusinoff Lehrman
- -------------------------------------------- President and Chief Executive Officer July 16, 1998
Sandra Nusinoff Lehrman (Principal Executive Officer)
/s/ John B. Green
- -------------------------------------------- Vice President, Chief Financial Officer July 16, 1998
John B. Green and Treasurer
(Principal Financial Officer
and Principal Accounting Officer)
- -------------------------------------------- Chairman of the Board July 16, 1998
James A. Geraghty
</TABLE>
II-3
<PAGE>
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
/s/ Robert W. Baldridge
- -------------------------------------- Director July 16, 1998
Robert W. Baldridge
/s/ Henry E. Blair
- -------------------------------------- Director July 16, 1998
Henry E. Blair
/s/ Francis J. Bullock
- -------------------------------------- Director July 16, 1998
Francis J. Bullock
/s/ Alan E. Smith
- -------------------------------------- Director July 16, 1998
Alan E. Smith
/s/ Henri A. Termeer
- -------------------------------------- Director July 16, 1998
Henri A. Termeer
/s/ Alan W. Tuck
- -------------------------------------- Director July 16, 1998
Alan W. Tuck
</TABLE>
II-4
<PAGE>
Exhibit Index
-------------
<TABLE>
<CAPTION>
Number Description
- ------ -----------
<S> <C>
4.1.1 Restated Articles of Organization of the Company, filed with the
Secretary of the Commonwealth of Massachusetts on December 27, 1993.
Filed as Exhibit 3.1 to the Company's Annual Report on Form 10-K for
the year ended December 31, 1993 and incorporated herein by
reference.
4.1.2 Articles of Amendment to the Restated Articles of Organization filed
with the Secretary of the Commonwealth of Massachusetts on October
3, 1994. Filed as Exhibit 3.1.2 to the Company's Annual Report on
Form 10-K for the year ended December 28, 1997 and incorporated
herein by reference.
4.1.3 Articles of Amendment to the Restated Articles of Organization of
the Company filed with the Secretary of the Commonwealth of
Massachusetts on June 26, 1997. Filed as Exhibit 3 to the Company's
Quarterly Report on Form 10-Q for the quarter ended June 29, 1997
and incorporated herein by reference.
4.1.4 Certificate of Vote of Directors Establishing a Series of a Class of
Stock (Series A Convertible Preferred Stock). Filed as Exhibit 3.1.4
to the Company's Annual Report on Form 10-K for the year ended
December 28, 1997 and incorporated herein by reference.
4.2 By-Laws of the Company, as amended. Filed as Exhibit 3.2 to the
Company's Registration Statement on Form S-1, File No. 33-62782, and
incorporated herein by reference.
4.3 Specimen Common Stock Certificate. Filed as Exhibit 4.1 to the
Company's Registration Statement on Form S-1, File No. 33-62782, and
incorporated herein by reference.
4.4 Specimen Series A Convertible Preferred Stock Certificate. Filed as
Exhibit 4.2 to the Company's Annual Report on Form 10-K for the year
ended December 28, 1997 and incorporated herein by reference.
4.5.1 TSI Specimen Warrant Certificate. Filed as Exhibit 4.8 to TSI
Corporation's Registration Statement on Form S-3,
File No. 33-48107, and incorporated herein by reference.
4.5.2 Form of Notice of Assumption by GTC of the TSI warrants to which
Exhibit 4.2.1 to this Report relate. Filed as Exhibit 4.2.2 to the
original filing of the Company's Annual Report on Form 10-K for the
year ended December 31, 1994 and incorporated herein by reference.
4.6.1 TSI Common Stock Purchase Warrant No. F-1 issued to The First
National Bank of Boston ("FNBB") on October 28, 1993. Filed as
Exhibit 4.6 to the Company's Registration Statement on Form S-4,
File No. 33-80924, and incorporated herein by reference.
4.6.2 TSI Common Stock Purchase Warrant No. G-1, dated September 27, 1994,
issued to Financing for Science International, Inc. ("FSI"). Filed
as Exhibit 4.4 to the original filing of the Company's Annual Report
on Form 10-K for the year ended December 31, 1994 and incorporated
herein by reference.
4.6.3 Form of Notice of Assumption by GTC of the TSI Common Stock Purchase
Warrants Nos. F-1 and G-1. Filed as Exhibit 4.5 to the original
filing of the Company's Annual Report on Form 10-K for the year
ended December 31, 1994 and incorporated herein by reference.
4.7 Common Stock Purchase Warrant, dated June 30, 1995, issued to FSI.
Filed as Exhibit 10.9 to the Company's Quarterly Report on Form 10-Q
for the period ended July 2, 1995 and incorporated herein by
reference.
</TABLE>
II-5
<PAGE>
<TABLE>
<CAPTION>
Number Description
- ------ -----------
<S> <C>
4.8 Common Stock Purchase Warrant, dated July 3, 1995, issued to
Genzyme. Filed as Exhibit 10.5 to the Company's Quarterly Report on
Form 10-Q for the period ended July 2, 1995 and incorporated herein
by reference.
4.9 Common Stock Purchase Warrant, dated March 13, 1996, issued to FSI.
Filed as Exhibit 4.8 to the Company's Quarterly Report on Form 10-K
for the year ended December 31, 1995 and incorporated herein by
reference.
4.10 Common Stock Purchase Warrant, dated as of June 26, 1997, issued to
Government Land Bank d/b/a The MassDevelopment. Filed as Exhibit 4
to the Company's Quarterly Report on Form 10-Q for the quarter ended
June 29, 1997 and incorporated herein by reference.
4.11 Form of Common Stock Purchase Warrant issued to the Purchasers of
Series A Convertible Preferred Stock, dated as of March 20, 1998,
together with a schedule of holders. Filed as Exhibit 4.9 to the
Company's Annual Report on Form 10-K for the year ended December 28,
1997 and incorporated herein by reference.
4.12 Form of Common Stock Purchase Warrant issued to Shoreline Pacific
Institutional Finance and affiliates, dated as of March 20, 1998.
Filed as Exhibit 4.10 to the Company's Annual Report on Form 10-K
for the year ended December 28, 1997 and incorporated herein by
reference.
4.13 Registration Rights Agreement between the Company and certain
Stockholders named therein. Filed as Exhibit 10.53 to the Company's
Annual Report on Form 10-K for the year ended December 28, 1997 and
incorporated herein by reference.
4.14 Securities Purchase Agreement, dated as of March 20, 1998, between
the Company and certain purchasers named therein. Filed as Exhibit
10.54 to the Company's Annual Report on Form 10-K for the year ended
December 28, 1997 and incorporated herein by reference.
5 Opinion of Palmer & Dodge LLP. Filed herewith.
23.1 Consent of counsel (contained in opinion of Palmer & Dodge LLP filed
as Exhibit 5).
23.2 Consent of PricewaterhouseCoopers LLP. Filed herewith.
24 Power of Attorney. Included on signature page to this Registration
Statement.
</TABLE>
II-6
<PAGE>
EXHIBIT 5
PALMER & DODGE LLP
One Beacon Street
Boston, Massachusetts 02108
Telephone: (617) 573-0100 Facsimile: (617) 227-4420
July 16, 1998
Genzyme Transgenics Corporation
Five Mountain Road
Framingham, Massachusetts 01701
We are rendering this opinion in connection with the Registration
Statement on Form S-3 (the "Registration Statement") filed by Genzyme
Transgenics Corporation (the "Company") with the Securities and Exchange
Commission under the Securities Act of 1933, as amended, on or about the date
hereof. The Registration Statement relates to the registration of 48,284
shares of the Company's Common Stock, $0.01 par value (the "Shares"). We
understand that the Shares are to be offered and sold in the manner described
in the Registration Statement.
We have acted as your counsel in connection with the preparation of
the Registration Statement and are familiar with the proceedings taken by the
Company in connection with the authorization and issuance of the Shares. We
have examined such documents as we consider necessary to render this opinion.
Based upon the foregoing, we are of the opinion that the Shares have
been duly authorized and are validly issued, fully paid and nonassessable.
We hereby consent to the use of our name under the caption "Legal
Opinions" in the Registration Statement and to the filing of this opinion as
an exhibit to the Registration Statement.
Very truly yours,
/s/ Palmer & Dodge LLP
----------------------
Palmer & Dodge LLP
<PAGE>
EXHIBIT 23.2
CONSENT OF INDEPENDENT ACCOUNTANTS
We consent to the incorporation by reference in this registration
statement of Genzyme Transgenics Corporation on Form S-3 to register 48,284
shares of the Company's common stock of our report dated February 25, 1998,
except as to the information presented in Note 13, for which the date is
March 20, 1998, on our audits of the consolidated financial statements of
Genzyme Transgenics Corporation as of December 28, 1997 and December 29, 1996
and for each of the three fiscal years in the period ended December 28, 1997,
which report is included in the Company's 1997 Annual Report on Form 10-K. We
also consent to the reference to our firm under the caption "Experts."
/s/ PricewaterhouseCoopers LLP
----------------------------
PricewaterhouseCoopers LLP
Boston, Massachusetts
July 16, 1998
