|
Previous: SANGSTAT MEDICAL CORP, S-3, EX-23.1, 2000-09-25 |
Next: SANGSTAT MEDICAL CORP, S-3, EX-4.4, 2000-09-25 |
As filed with the Securities and Exchange Commission on September 25, 2000
Registration No. 333-________
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
under
THE SECURITIES ACT OF 1933
SANGSTAT MEDICAL CORPORATION
(Exact name of Registrant as specified in its Charter)
Delaware
94-3076-069
__________________________
6300 Dumbarton Circle
Fremont, California 94555
(510) 789-4300
(Address and telephone number of
Registrant's principal executive offices)
Carole L. Nuechterlein, Esq.
SangStat Medical Corporation
6300 Dumbarton Circle
Fremont, California 94555
(510) 789-4300
___________________________
Copy to:
Edwin D. Williamson, Esq.
Sullivan & Cromwell
1701 Pennsylvania Avenue, N.W.
Washington, D.C. 20006
(202) 956-7500
Approximate date of commencement of proposed sale to the public: As soon as practicable 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, 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
Title Of Shares To Be Registered |
Amount To Be Registered |
Proposed Maximum Offering Price Per Share(1) |
Proposed Maximum Aggregate Offering Price(1) |
Amount Of Registration Fee |
Common Shares, par value $.001, of SangStat Medical Corporation |
500,773 |
$15.1125 |
$7,567,931.96 |
$1,998 |
(1) Estimated solely for the purpose of computing the amount of the
registration fee pursuant to Rule 457(c) under the Securities Act of 1933 based
on the average bid and asked price of our common stock on the Nasdaq National
Market as of September 22, 2000.
We hereby amend this
registration statement on such date or dates as may be necessary to delay its
effective date until we 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 SEC, acting pursuant to
said Section 8(a), may determine. SUBJECT TO COMPLETION, DATED SEPTEMBER 25, 2000 PROSPECTUS SANGSTAT MEDICAL CORPORATION 500,773 COMMON SHARES This prospectus relates to 500,773 shares of the common stock, par value
$.001 of SangStat Medical Corporation, a Delaware corporation, that may from
time to time be sold by UBS AG, London Branch. We will not receive any of the
proceeds from the sale of the shares. We have agreed to bear all expenses (other
than selling commissions and fees and expenses of counsel and other advisors to
the selling stockholder) in connection with the registration and sale of the
shares being offered by the selling stockholder. See "Selling Stockholder" and
"Plan of Distribution". The shares may be sold from time to time by the selling stockholder. Such
sales may be made in the over-the-counter market, or on the Nasdaq National
Market (the "Nasdaq") or on other exchanges if the shares are listed for trading
thereon, or otherwise at prices and at terms then prevailing, at prices related
to the then current market price or at negotiated prices. The shares may be sold
by any one or more of the following methods: (a) a block trade in which the
broker or dealer so engaged will attempt to sell the shares as agent but may
position and resell a portion of the block as principal to facilitate the
transaction; (b) purchases by a broker or dealer as principal and resale by such
broker or dealer for its account; (c) ordinary brokerage transactions and
transactions in which the broker solicits purchasers; (d) option transactions
and (e) privately negotiated transactions. In addition, any shares that qualify
for sale pursuant to Rule 144 may be sold under Rule 144 rather than pursuant to
this prospectus. The shares covered by this prospectus were acquired by the selling
stockholder after the conversion of our 6.5% Convertible Note due March 30, 2004
in the principal amount of $10,000,000. The selling stockholder acquired the
Note in a private placement exempt from registration under the Securities Act of
1933 pursuant to Section 4(2) of the Securities Act. The selling stockholder and any broker-dealers, agents or underwriters
that participate with the selling stockholder in the distribution of the shares
may be deemed to be "underwriters" within the meaning of the Securities Act and
any commission received by such broker-dealers, agents or underwriters and any
profit on the resale of the shares purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act. Our common shares are traded on the Nasdaq under the symbol "SANG". On
September 22, 2000, the closing sale price per share, as reported by the Nasdaq,
was $15.4375. INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU
SHOULD CONSIDER CAREFULLY THE RISK FACTORS BEGINNING ON PAGE 5 OF THIS
PROSPECTUS BEFORE MAKING A DECISION TO PURCHASE OUR STOCK. Neither the SEC nor any state securities commission has approved
or disapproved of these securities or passed upon the adequacy or accuracy of
this prospectus. Any representation to the contrary is a criminal offense. The Date of this Prospectus is September 25, 2000.
The information contained in this prospectus is not complete and may be changed. A
registration statement relating to these securities has been filed with the Securities and
Exchange Commission. These securities may not be sold nor may offers to buy these securities
be accepted prior to the time the registration statement becomes 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.
AVAILABLE INFORMATION We are subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith file reports and other information with the Securities and Exchange
Commission or SEC. Such reports and other information (which are not
incorporated by reference herein and do not form a part hereof except as stated
below under "Incorporation of Certain Information by Reference") filed with the
SEC are available to the public over the Internet at the SEC's web site at
http://www.sec.gov and may be read and copied at
the SEC's Public Reference Room located at 450 Fifth Street, N.W., Washington,
D.C., or at the SEC's regional offices in New York, New York and Chicago,
Illinois. Please call the SEC at 1-800-SEC-0330 or visit the SEC's website for
more information about the SEC's public reference facilities. You also may find
information about us at our website, http://www.sangstat.com. We have filed a registration statement on Form S-3 with the SEC under the
Securities Act with respect to the shares offered hereby. This prospectus, which
constitutes a part of the registration statement, does not contain all the
information set forth in the registration statement. Certain items are contained
in exhibits to the registration statement as permitted by the rules and
regulations of the SEC. Statements made in this prospectus as to the content of
any contract, agreement or other document are not necessarily complete. With
respect to each such contract, agreement or other document filed as an exhibit
to the registration statement, reference is made to the exhibit for a more
complete description of the matter involved, and each such statement shall be
deemed qualified in its entirety by such reference. INCORPORATION OF CERTAIN INFORMATION BY REFERENCE We are incorporating by reference into this prospectus the following
documents that we have previously filed with the SEC: In addition, all additional documents we file with the SEC pursuant to
Section 13(a), 14 or 15(d) of the Exchange Act before all of the shares are sold
shall be deemed to be incorporated in this prospectus any statement in, or
incorporated in, this prospectus reference and be a part of this prospectus from
the dates of filing of those documents. Any statement contained in this
prospectus or in a document incorporated or deemed to be incorporated in this
prospectus any statement in, or incorporated in, this prospectus by reference
shall be deemed to be modified or superseded for purposes of this prospectus to
the extent that a statement contained in this prospectus any statement in, or
incorporated in, this prospectus or in any other subsequently filed document
which also is, or is deemed to be, incorporated by reference in this prospectus
any statement in, or incorporated in, this prospectus modifies or supersedes in
this prospectus any statement in, or incorporated in, this prospectus. Any
modified or superseded statement will not be deemed, except as modified or
superseded, to constitute a part of this prospectus. We will furnish without charge to each person to whom this prospectus is
delivered, upon that person's written or oral request a copy of any or all of
the documents incorporated in this prospectus any statement in, or incorporated
in, this prospectus by reference (other than the exhibits to those documents
unless those exhibits are specifically incorporated by reference). Written or
telephone requests should be directed to: SangStat Medical Corporation, 6300
Dumbarton Circle, Fremont, CA 94555 (telephone number (510) 789-4300),
Attention: Carole L. Nuechterlein, Vice President and General Counsel. THE ISSUER SangStat,
The Transplant Company® is a global bio-pharmaceutical company applying a
disease management approach to improving the outcome of organ, bone marrow, and
stem cell transplantation. Since 1988, we have built a family of products and
services to address the pre-transplant, acute care and chronic phases of
transplant in the worldwide market. Our business is currently organized into two
segments: Transplantation Products and Transplantation Services. The
Transplantation Products segment consists of five marketed products, three
principal product candidates and additional product candidates in various stages
of research and development. The Transplantation Services segment consists of
the Transplant Pharmacyâ , which provides mail order
distribution of drugs and transplant patient management services, and Transplant
Rx.com™, the first online pharmacy dedicated to organ transplantation. We
are headquartered in Fremont, California and our principal executive offices are
located at 6300 Dumbarton Circle, Fremont, California 94555. Our telephone
number is (510) 789-4300. RISK
FACTORS You should carefully consider
the following risk factors before purchasing our common stock. The risks and
uncertainties described below are not the only ones we face. There may be
additional risks and uncertainties that are not known to us or that we do not
consider to be material at this time. If the events described in these risks
occur, our business, financial condition and results of operations would likely
suffer. This prospectus contains forward-looking statements which involve risks
and uncertainties. SangStat's actual results may differ significantly from the
results discussed in the forward-looking statements. This section discusses some
of the factors that might cause those differences. We have a history of operating losses and our future
profitability is uncertain. We were incorporated in 1988 and have
experienced significant operating losses since that date. As of June 30,
2000, our accumulated deficit was $161,284,000. Our operating expenses have
increased from approximately $31.0 million to $60.9 million to $89.9 million
over the three year period ended December 31, 1999, and were approximately $63.6
million for the six months ended June 30, 2000. Total revenues increased from
approximately $4.5 million to $19.7 million to $58.2 million, and were
approximately $36.2 million for the six months ended June 30, 2000, while losses
from operations increased from approximately $26.5 million to $41.3 million and
decreased to $31.7 million over the three year period ended December 31, 1999,
and were approximately $27.4 million for the six months ended June 30, 2000. We
cannot guarantee that we will ever achieve significant revenues from product
sales or that we will achieve profitable operations. To date, our product
revenues have been primarily derived from sales of Thymoglobulin,
Lymphoglobuline, and Gengraf. We may elect to raise additional funds within the next 12 months.
Within the next twelve months, we may need to raise additional funds through
financings and collaborative research and development arrangements with
corporate partners. We may not be able to raise funds on favorable terms, if at
all, and our discussions with potential collaborative partners may not result in
any agreements. If adequate funds are not available, we may be required to
delay, scale back or eliminate one or more of our development programs or obtain
funds through arrangements with collaborative partners or others that may
require us to relinquish rights to certain technologies, product candidates or
products that we would not otherwise relinquish. To raise funds, we may also be
required to sell shares of our common stock, which may be at prices below the
price at which you may have purchased shares. Such sales would also constitute a
dilution of your percent ownership of SangStat. Our future growth depends on sales of key products. We expect to
derive most of our future revenues from sales of Gengraf (cyclosporine capsule,
USP, MODIFIED), a cyclosporine capsule product, and Thymoglobulin. We have
limited experience selling our products. Our sales of Thymoglobulin began in the
U.S. in 1999. We began distributing Gengraf in May 2000. We are marketing
Gengraf in the United States under a co-promotion agreement with Abbott
Laboratories ("Abbott"). We cannot guarantee that Abbott will be able to
effectively market Gengraf pursuant to the agreement, and its failure to do so
may impact sales of these products. Any factor adversely affecting the regulatory approval of our
cyclosporine capsule product or sale of Gengraf or Thymoglobulin, individually
or together, would harm our business and results of operations. Sales of these
products could be adversely affected by the following: In particular, with respect to Gengraf, sales may be affected by the
following: Failure of sales to meet forecasts may also cause excessive inventory
build- up, which, if not sold prior to lot expiration, may be required to be
taken as a charge against earnings. Our recent recall of SangCya Oral Solution in the U.S. could result in an
FDA investigation and negative marketing by our competitors. We recalled all
lots of SangCya Oral Solution from the US wholesalers in July 2000
and at the same time announced its withdrawal from the U.S. market. In addition
to anticipated SangCya Oral Solution revenues being lost, the FDA may conduct an
investigation into the circumstances that led to the SangCya recall. Responding
to an FDA investigation could be costly, time consuming, and may distract senior
management from other tasks. Negative marketing may reduce sales of Gengraf or
Thymoglobulin as competitors attempt to use the recall in marketing against us
and our products. The FDA or other regulatory authorities may review our future
drug approval applications more carefully, which may result in slower approval
times. If approvals are delayed, revenues from these products would also be
delayed. Our business exposes us to the risk of product liability claims for which
we may not be adequately insured. We face an inherent business risk of
exposure to product liability claims in the event that the use of our products
results in adverse effects during research, clinical development or commercial
use. We cannot guarantee we will avoid significant product liability exposure.
Our product liability insurance coverage is currently limited to $10 million,
which may not be adequate to cover potential liability exposures. Moreover, we
cannot assure you adequate insurance coverage will be available at acceptable
cost, if at all, or that a product liability claim would not harm our results of
operations. Our litigation with Novartis may be resolved adversely and will be a drain
on time and resources. While we have settled the patent litigation with
Novartis regarding SangCya Oral Solution, we are involved in litigation with
Novartis in the U.S. and the U.K., which could potentially harm sales of SangCya
Oral Solution and our cyclosporine capsule product candidates in Europe. See
"Part II, Item 2 - Legal Proceedings" of our Quarterly Report on Form 10-Q filed
with the SEC on August 14, 2000. The course of litigation is inherently
uncertain and we may not achieve a favorable outcome. The litigation, whether or
not resolved favorably to us, is likely to be expensive, lengthy and time
consuming, and divert management's attention. Novartis' patent lawsuit against Abbott with respect to Gengraf may be
resolved adversely. Novartis has sued Abbott claiming that Gengraf, the
product we jointly market with Abbott, infringes certain Novartis patents.
Novartis is seeking both a preliminary injunction and a permanent injunction to
prevent the sale of Gengraf in the United States. Abbott informs us it believes
that the lawsuit is without merit and that it intends to defend the lawsuit
vigorously. We have not been named a defendant in this lawsuit, and under our
agreement with Abbott, Abbott is obligated to indemnify us against such suits.
The course of litigation is inherently uncertain, however; Novartis may choose
to name us in this suit, Abbott may not prevail, or Abbott may choose to settle
on terms adverse to our interests. Should we be named in this suit, we may incur
expenses prior to reimbursement (if any) by Abbott pursuant to its indemnity
obligation. Should Novartis succeed in obtaining a preliminary or permanent
injunction, Gengraf may be temporarily or permanently removed from the market.
If we or Abbott were forced to remove Gengraf from the market prior to the
expiration of our co-promotion agreement with Abbott (December 31, 2004), our
revenues would be materially adversely affected. A change in marketing strategy and a delay in product approval have
created excess perishable inventories. We have significant amounts of bulk
cyclosporine active ingredient inventory that we are not using to manufacture
finished product in the amount anticipated. This inventory was originally
purchased for use in cyclosporine finished products to be sold in the United
States and Europe. However, since we are now distributing Gengraf in the United
States and we have withdrawn SangCya from the United States market, we are
dependent on the European market to use this inventory. Although we plan to
obtain marketing approval for a cyclosporine capsule product in Europe, the
inherent uncertainty of the approval process makes it very difficult to forecast
a launch date for this product. We currently expect approval of a cyclosporine
capsule product in the UK at the end of 2001 at the earliest. If the approval
and product launch are delayed, we may not be able to convert all the inventory
into finished product and sell it before its expiration date. As a result, we
could write off portions of our bulk active ingredient in the future, which
could significantly reduce the gross margin reported for that future period. If we do not develop and market new products, our business will be
harmed. To achieve profitable operations, we must successfully develop,
obtain regulatory approval for, manufacture, introduce and market products and
product candidates. We cannot guarantee that we will successfully do this. Our
product candidates will require extensive development and testing, as well as
regulatory approval prior to commercialization. Our cyclosporine capsule product
candidate in Europe has been delayed and we do not anticipate having approval of
a cyclosporine capsule product in Europe until late 2001 at the earliest. In
addition, cost overruns and product approval delays could occur due to the
following: These events would prevent or substantially slow down the development
effort and ultimately would harm our business. Furthermore, there can be no
assurance that any product candidate under development will be safe, effective
or capable of being manufactured in commercial quantities at an economical cost,
or that any product will not infringe the proprietary rights of others or will
achieve market acceptance. We may not be able to manufacture or obtain sufficient quantities of
our products. We have contracted for commercial scale production of
cyclosporine bulk material, the active ingredient of cyclosporine, for SangCya
Oral Solution (to be sold outside the U.S.) and our cyclosporine capsule product
candidates from Gensia Sicor and Abbott. We have also contracted with Eli Lilly
and Company for the manufacture of SangCya Oral Solution and our cyclosporine
capsule product candidates. We cannot control these suppliers, and they may fail
to timely deliver adequate supplies of a sufficiently high quality product, and
any such failure may delay product launch, impair our ability to deliver
our products on a timely basis, or otherwise impair our competitive position,
which would harm our business and results of operations. Thymoglobulin is also difficult to manufacture and there can be no assurance
that we will be able to manufacture commercial quantities at an economical cost.
We acquired the IMTIX division of Aventis in 1998, including certain
manufacturing capabilities with respect to Thymoglobulin. From time to time
prior to the acquisition, certain batches of Thymoglobulin did not meet
manufacturing specifications, resulting in a shortage of Thymoglobulin for
commercial sale. We still rely on Aventis for certain important manufacturing
services, including quality assurance, quality control, and lyophilization. We
cannot guarantee that Aventis will continue to effectively and continuously
provide us these critical manufacturing services. We cannot guarantee we will
not experience manufacturing difficulties with respect to Thymoglobulin in the
future which may impair our ability to deliver products on a timely basis, or
otherwise impair our competitive position, which would harm our business. We rely on third parties for manufacturing. We generally rely on third
parties to manufacture compounds (other than Thymoglobulin and Lymphoglobuline)
and devices for commercial sales and clinical trials. We cannot guarantee
manufacturers will meet FDA standards governing Good Manufacturing Practices or
other regulatory guidelines, that any Biologics License Applications, or BLA,
required for manufacturing will be filed, reviewed and approved, or that any
third-party manufacturer will pass a pre-approval inspection. We cannot
guarantee we will be able to enter into additional commercial scale
manufacturing contracts or that any other third-party arrangements can be
established on a timely or commercially reasonable basis, or at all. We will
depend on all such third parties to perform their obligations effectively and on
a timely basis. We cannot guarantee that such parties will perform and any
failures by third parties may delay clinical development or submission of
products for regulatory approval, or otherwise impair our competitive position,
which could harm our business. In addition, the manufacturing of drug candidates
involves a number of technical steps and requires meeting stringent quality
control specifications imposed by regulatory authorities and by us.
Additionally, such products can only be manufactured in facilities approved by
the applicable regulatory authorities. Because of these and other factors, we
may not be able to replace our manufacturing capacity quickly or efficiently in
the event that our manufacturers are unable to manufacture their products at one
or more of their facilities. For certain of our potential products, we will need
to develop our production technologies further for use on a larger scale in
order to conduct human clinical trials and produce such products for commercial
scale at an acceptable cost. Failure of the market to adopt our products will harm our business.
Whether or not our products receive regulatory approval, the market may not
accept them. We cannot guarantee patients, physicians, pharmacists, or third-
party payers will accept our products. Accordingly, we cannot guarantee our
products and product candidates will obtain significant market share. Factors
that may affect the willingness of patients, physicians, pharmacists and third-
party payers to convert to SangStat products, if approved, include price,
perception of bioequivalence, perceived clinical benefits and risks, ease of
use, other product features and brand loyalty. In addition, other factors may
limit the market acceptance of products we develop, including the timing of
regulatory approval and market entry relative to competitive products, the
availability of alternative therapies, the price of our products relative to
alternative therapies, the availability of third-party reimbursement and the
extent of our or third party distributor's or agents' marketing efforts. In
particular, with respect to SangCya Oral Solution (outside the U.S.) and our
cyclosporine capsule product candidates, we cannot guarantee we will be
successful in taking significant market share away from Novartis, even if
product approval is granted. We may have a charge against earnings if we lose a breach of contract
lawsuit. In August 2000, two affiliated suppliers sued our French
subsidiary, IMTIX-SangStat SAS, for breach of contract because we ordered lower
quantities than were anticipated by the agreements. The suppliers are asking for
damages of $5 million for lost profits and reimbursement of capital
expenditures. While we believe that this lawsuit is without merit, the course of
litigation is inherently uncertain and we may not achieve a favorable outcome.
If the judge finds in the suppliers' favor, we would suffer a one-time charge
against earnings, which could be material if these parties are awarded the full
amount requested. We have other suppliers who could supply us with sufficient
product if these agreements are terminated or if these suppliers refuse to
supply us with further product. Fluctuations in quarterly and annual operating results may adversely
affect our stock price. Our quarterly and annual operating results may
fluctuate due to a variety of factors. We therefore believe that quarter-to-
quarter comparisons of our operating results may not be a good indication of our
future performance, and you should not rely on them to predict our future
performance or the future performance of our stock. Our operating losses have
been substantial each year since inception. We also expect losses to continue in
the near future as a result of a number of factors, including: Our operating results may also fluctuate significantly as a result of
other factors, including: Fluctuations in our operating results have affected our stock price in
the past and are likely to continue to do so in the future. In particular, the
realization of any of the risks described in this prospectus could have a
significant and adverse impact on the market price for our stock. Our stock price as well as the stock prices for competitors in our
industry have historically been volatile. The market prices for securities
of pharmaceutical and biotechnology companies, including ours, are highly
volatile. The stock market has from time to time experienced significant price
and volume fluctuations that may be unrelated to the operating performance of
particular companies. The market price for our common stock may fluctuate as a
result of factors such as: Our future success depends on our ability to successfully manage
growth. We continue to expand our operations, which places a strain upon our
management, systems and resources. Our ability to compete effectively and to
manage future growth, if any, will require us to continue to, on a timely basis,
improve our financial and management controls, reporting systems and procedures
and expand, train and manage an increasing number of employees. Our failure to
do so would harm our results of operations. Failure to protect our intellectual property would adversely affect our
business. Our success depends in part on our ability to obtain and enforce
patent protection for our products and to preserve our trade secrets. We hold
patents and pending patent applications in the United States and abroad. Some of
our patents involve specific claims and thus do not provide broad coverage.
There can be no assurance that our patent applications or any claims of these
patent applications will be allowed, or found to be valid or enforceable, that
any patents or any claims of these patents will provide us with competitive
advantages for our products or that such issued patents and any patents issued
under pending patent applications will not be successfully challenged or
circumvented by our competitors. We have not conducted extensive patent and
prior art searches with respect to our product candidates and technologies, and
we cannot guarantee that third-party patents or patent applications do not exist
or could not be filed in the United States, Europe or other countries which
would have an adverse effect on our ability to market our products. We cannot
guarantee claims in our patent applications would be allowed, or found to be
valid or enforceable, or that any of our products would not infringe on others'
patents or proprietary rights in the United States or abroad. We also have
patent licenses from third parties whose patents and patent applications are
subject to the same risks as ours. We cannot guarantee we will be able to manufacture, or that we have
manufactured, formulated or commercialized our cyclosporine capsule product
candidates without infringing patent or other proprietary rights of Novartis or
other third parties. Patent applications in the United States are maintained in secrecy until
patents issue. Since publication of discoveries in the scientific or patent
literature tends to lag behind actual discoveries by several months, we cannot
be certain that we were the first to discover compositions covered by our
pending patent applications or the first to file patent applications on such
compositions. Our pending patent applications may not result in issued patents
and any of our issued patents may not afford protection against a
competitor. We also rely on trade secrets and proprietary know-how that we seek to
protect, in part, by confidentiality agreements with our employees and
consultants. We cannot guarantee these agreements will not be breached, that we
would have adequate remedies for any such breach or that our trade secrets will
not otherwise become known or independently developed by competitors. We have registered or applied for trademark registration of the names of all
of our marketed products and plan to register the names of our products under
development once a name has been selected for the product candidate. We have
registered or applied for trademark registration of the names of most of our
products under development or commercialized for research and development use.
However, these trademark registrations may not be granted to us or may be
challenged by competitors. We face substantial competition. The drugs we develop compete with
existing and new drugs being created by pharmaceutical, biopharmaceutical,
biotechnology and diagnostics companies and universities. Many of these entities
have significantly greater research and development capabilities, as well as
substantial marketing, manufacturing, financial and managerial resources and
represent significant competition. The principal factors upon which our products
compete are product utility, therapeutic benefits, ease of use, effectiveness,
marketing, distribution and price. With respect to Thymoglobulin, Gengraf,
SangCya Oral Solution and cyclosporine capsules, we are competing against large
companies that have significantly greater financial resources and established
marketing and distribution channels for competing products. For example,
Novartis currently controls virtually 100% of the worldwide cyclosporine markets
and has significantly greater resources than we do. We cannot guarantee we will
be able to compete successfully against Novartis. To date, we have a limited
number of contracts with managed care providers and group purchasing
organizations. Our future sales will be dependent on our ability to enter into
contracts with these entities. The drug industry is characterized by intense
price competition and we expect we will face this and other forms of
competition. We cannot guarantee that developments by others will not render our
products or technologies obsolete or noncompetitive, or that we will be able to
keep pace with technological developments. Many of our competitors have
developed or are in the process of developing technologies that are, or in the
future may be, the basis for products that compete with our own. Some of these
products may have an entirely different approach or means of accomplishing the
desired therapeutic effect than our products and may be more effective and less
costly. In addition, many of these competitors have significantly greater
experience than we do in undertaking preclinical testing and human clinical
trials of pharmaceutical products and obtaining regulatory approvals of such
products. Accordingly, our competitors may succeed in commercializing products
more rapidly than we can. For example, we believe that the degree of market
penetration of a cyclosporine capsule is dependent in part on whether we are the
first company to market a bioequivalent formulation of cyclosporine. We believe
that other companies may be developing cyclosporine formulations that may be
marketed as generic equivalents. Were these competitors to develop their
products more rapidly and complete the regulatory process sooner, that would
harm our business. Other treatments for the problems associated with transplantation that our
products seek to address are currently available and under development. To the
extent these therapeutics or monitoring products address the problems associated
with transplantation on which we have focused, they may represent significant
competition. The Transplant Pharmacy may not become a viable distributor.
Establishing The Transplant Pharmacy as a viable distributor of
pharmaceutical products and services entails a number of risks, including our
ability to enter into agreements with transplant centers to utilize The
Transplant Pharmacy's services, compliance with state regulations regarding
pharmacy licensing and compliance with federal and state laws regulating
payments for referrals for health care services. On November 11, 1998, the
Office of the Inspector General, or OIG, of the Department of Health & Human
Services issued an Advisory Opinion which stated that the placement by a
pharmacy of a licensed pharmacist at a hospital transplant center might
constitute prohibited remuneration under the anti-kickback statute section of
the Social Security Act. This Advisory Opinion was not addressed at us, and the
Advisory Opinion only applies to the party to whom it was addressed. We believe
the Advisory Opinion does not apply to an operation like The Transplant Pharmacy
and our operation does not make prohibited remuneration. We cannot guarantee
that the OIG will agree with this analysis, in which case we may reorganize The
Transplant Pharmacy so that it would no longer include an on-site pharmacist at
transplant centers. We cannot guarantee that we will be successful in
establishing The Transplant Pharmacy as a viable distributor of pharmaceutical
products and services. If our products do not receive regulatory approvals, or if we do not
otherwise comply with government regulations, our business would be harmed.
Our research, preclinical development, clinical trials, manufacturing, marketing
and distribution of our products in the United States and other countries are
subject to extensive regulation by numerous governmental authorities including,
but not limited to, the FDA. In order to obtain regulatory approval of a drug
product, we must demonstrate to the satisfaction of the applicable regulatory
agency, among other things, that such product is safe and effective for its
intended uses and that the manufacturing facilities are in compliance with GMP
requirements. We must also demonstrate the approvability of a BLA for our
biological products. The approval of our generic product candidates is dependent
on demonstrating bioequivalence with reference products in addition to assurance
of compliance with GMP regulations. The process of obtaining FDA and other required regulatory approvals is
lengthy and will require the expenditure of substantial resources, and we cannot
guarantee that we will be able to obtain the necessary approvals. Moreover, if
and when such approval is obtained, the marketing, distribution and manufacture
of our products would remain subject to extensive regulatory requirements
administered by the FDA and other regulatory bodies. Failure to comply with
applicable regulatory requirements can result in, among other things, warning
letters, fines, injunctions, civil penalties, recall or seizure of products,
total or partial suspension of production, refusal of the government to grant
pre-market clearance or pre-market approval, withdrawal of approvals and
criminal prosecution of SangStat and our employees. Our therapeutic products are subject to foreign regulatory requirements
governing the conduct of clinical trials, product licensing, pricing and
reimbursement, which vary from country to country. The process of obtaining
foreign regulatory approvals can be lengthy and require the expenditure of
substantial resources, and we cannot guarantee we will be able to obtain the
necessary approvals or the approvals for the proposed indications. We depend on collaborative relationships. We have a number of
strategic relationships for the development and distribution of our products. In
particular, we have entered into a multi- year co-promotion, distribution and
research agreement for Gengraf in the U.S. with Abbott. We are dependent upon
Abbott for certain regulatory, manufacturing, marketing, and sales activities
under the agreement. Abbott may not perform satisfactorily and any such failure
may delay regulatory approval, product launch, impair our ability to deliver
products on a timely basis, or otherwise impair our competitive position, which
would harm our business. We may enter into additional collaborative
relationships with corporate and other partners to develop and commercialize
certain of our potential products. We cannot assure you that we will be able to
negotiate acceptable collaborative arrangements in the future, that such
collaborations will be available to us on acceptable terms or that any such
relationships, if established, will be scientifically or commercially
successful. We depend upon key personnel. Our ability to develop our business
depends in part upon our attracting and retaining qualified management and
scientific personnel. As the number of qualified personnel is limited,
competition for such personnel is intense. We cannot assure you that we will be
able to continue to attract or retain such people. The loss of our key personnel
or the failure to recruit additional key personnel could significantly impede
attainment of our objectives and harm our financial condition and results of
operations. Our planned activities will require the addition of new personnel,
including management, and the development of additional expertise by existing
management personnel, in areas such as research, product development,
preclinical testing, clinical trial management, regulatory affairs, finance,
manufacturing, pharmacy affairs and marketing and sales. The inability to
acquire such services or to develop such expertise could harm our
business. Pharmaceutical pricing and reimbursement is uncertain. Our ability to
commercialize our products may depend in part on the extent to which
reimbursement for the cost of such products and related treatment will be
available from government health administration authorities, private health
coverage insurers and other organizations. The pricing, availability of
distribution channels and reimbursement status of newly approved healthcare
products is highly uncertain and we cannot assure you that adequate third-party
coverage will be available for us to maintain price levels sufficient for
realization of an appropriate return on our investment in product development.
In certain foreign markets, pricing or profitability of healthcare products is
subject to government control. In the United States, there have been, and we
expect that there will continue to be, a number of federal and state proposals
to implement similar governmental control. In addition, an increasing emphasis
on managed care in the United States has and will continue to increase the
pressure on pharmaceutical pricing. While we cannot predict whether any such
legislative or regulatory proposals will be adopted or the effect such proposals
or managed care efforts may have on our business, the announcement of such
proposals or efforts could harm our ability to raise capital, and the adoption
of such proposals or efforts could harm our results of operations. Further, to
the extent that such proposals or efforts harm other pharmaceutical companies
that are our prospective corporate partners, our ability to establish corporate
collaborations may be adversely affected. In addition, third-party payers are
increasingly challenging the prices charged for medical products and services.
We cannot guarantee that our products and product candidates, if approved, will
be considered cost effective or that reimbursement to the consumer will be
available or will be sufficient to allow us to sell our products on a
competitive basis. We deal with hazardous materials. In connection with our research and
development activities and operations, we are 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, biological specimens and wastes. We cannot assure you that we
will not incur significant costs to comply with environmental and health and
safety regulations. Our research and development involves the controlled use of
hazardous materials, including but not limited to certain hazardous chemicals
and infectious biological specimens. Although we believe that our safety
procedures for handling and disposing of such materials comply with the
standards prescribed by state and federal regulations, the risk of accidental
contamination or injury from these materials cannot be eliminated. In the event
of such an accident, we could be held liable for any damages that result and any
such liability could exceed our ability to pay. Our charter documents, stockholder rights plan and Delaware law may
serve to deter a takeover. Certain provisions of our Certificate of
Incorporation and our recently amended Bylaws could delay or make more difficult
a merger, tender offer or proxy contest, which could adversely affect the market
price of our common stock. Our board of directors has the authority to issue up
to 5 million shares of preferred stock and to determine the price, rights
preferences, privileges and restrictions, including voting rights, of those
shares without any further vote or action by the stockholders. The rights of the
holders of common stock will be subject to, and may be adversely affected by,
the rights of the holders of any preferred stock that may be issued in the
future. The issuance of preferred stock could have the effect of making it more
difficult for a third party to acquire a majority of our outstanding voting
stock. Further, we have adopted a stockholder rights plan. The plan allows for
the issuance of a dividend to stockholders of rights to acquire our shares or,
under certain circumstances, an acquiring corporation, at less than half their
fair market value. The plan could have the effect of delaying, deferring or
preventing a change in control. In addition, we are subject to the antitakeover
provisions of Section 203 of the Delaware General Corporation Law, which will
prohibit us from engaging in a "business combination" with an "interested
stockholder" for a period of three years after the date of the transaction in
which the person became an interested stockholder, unless the business
combination is approved in a prescribed manner. The application of Section 203
also could have the effect of delaying or preventing a change of control. USE OF PROCEEDS We will not receive any proceeds from sales of the shares by the
selling stockholder. The selling stockholder will receive all of the proceeds of
the sale of the shares. However, we will pay all costs and expenses incurred in
connection with the registration of the shares under the Securities Act and the
offering made hereby, other than any brokerage fees and commissions, fees and
disbursements of legal counsel of the selling stockholder and stock transfer and
other taxes attributable to the sale of the shares, which will be paid by the
selling stockholder. SELLING STOCKHOLDER This prospectus relates to the sale by the selling stockholder from
time to time of up to 500,773 shares of our common stock, par value $.001.
However, the selling stockholder is not obligated to, and there is no assurance
that the selling stockholder will, sell any or all of the shares. The shares were acquired by the selling stockholder after exercising its
rights to convert our 6.5% Convertible Note due March 30, 2004 $10,000,000 into
shares of our common stock at a rate of 50.0773 shares for each $1,000 of
principal amount of Convertible Note. PLAN OF DISTRIBUTION The selling stockholder may sell shares to or through one or more
underwriters or dealers and also may sell shares directly to purchasers or
through agents. The distribution of shares may be effected from time to time in
one or more transactions at a fixed price or prices, which may be changed, 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 sell its shares by one or more of the
following methods: In connection with the sale of shares, underwriters may receive
compensation from the relevant selling stockholder or from purchasers of shares
for whom they may act as agents in the form of discounts, concessions or
commissions. Underwriters, dealers and agents that participate in the
distribution of shares may be deemed to be underwriters and any discounts or
commissions received by them from the relevant selling stockholder and any
profit on the resale of shares by them may be deemed to be underwriting
discounts and commissions under the Securities Act. At such time that the
selling stockholder elects to make an offer of shares, a prospectus supplement,
if required, will be distributed that will identify any underwriters, dealers or
agents and any discounts, commissions and other terms constituting compensation
from such selling stockholder and any other required information. Under agreements which may be entered into by the selling stockholder,
underwriters, dealers and agents who participate in the distribution of shares
may be entitled to indemnification by the selling stockholder against certain
liabilities, including liabilities under the Securities Act. We have also agreed
to indemnify in certain circumstances the selling stockholder and any
underwriter and certain control and other persons related to the foregoing
person against certain liabilities, including liabilities under the Securities
Act. The selling stockholder has agreed to indemnify us in certain
circumstances, as well as certain related persons, against certain liabilities,
including liabilities under the Securities Act. Certain of the underwriters or agents and their associates may be
customers of, engage in transactions with and perform services for us in the
ordinary course of business. The selling stockholder is not obligated to, and there is no assurance
that the selling stockholder will, sell any or all of the shares. We will pay expenses, if any other than underwriting discounts and
commissioned legal fees of counsel to the selling stockholder, incurred in
connection with the offering and sale to the public of the shares by the selling
stockholder, including, without limitation, all registration and filing fees and
the fees and disbursements of our outside counsel and independent
accountants. We agreed with the selling stockholder to keep the registration statement
of which this prospectus constitutes a part effective until the earlier of: VALIDITY OF SHARES Carole L. Nuechterlein, our Vice President and General Counsel, will
give a legal opinion concerning the validity of the shares. EXPERTS The annual consolidated financial statements and the related consolidated
financial statement schedule incorporated in this prospectus by reference from
our Annual Report on Form 10-K have been audited by Deloitte & Touche LLP,
independent auditors, as stated in their report, which is incorporated herein by
reference, and have been so incorporated in reliance upon the report of such
firm given upon their authority as experts in accounting and auditing. TABLE OF CONTENTS Prospectus
Page
Available Information
4
Incorporation of Certain Information by Reference
4
The Issuer
5
Risk Factors
5
Use of Proceeds
13
Selling Stockholder
13
Plan of Distribution
14
Validity of Shares
15
Experts
15
PART II INFORMATION NOT REQUIRED IN THE PROSPECTUS Item 14. Other Expenses of Issuance and Distribution The following are the estimated expenses to be incurred in connection
with the issuance and distribution of the shares registered under this
registration statement:
Securities and Exchange Commission Registration Fee
$ 1,998
Legal Fees and Expenses
7,500
Accounting Fees and Expenses
5,000
Miscellaneous
1,000
Total
15,498
We will pay all such expenses. All amounts are estimated except the SEC
registration fee. Item 15. Indemnification of Directors and Officers Section 145 of the Delaware General Corporation Law authorizes a
court to award, or a corporation's board of directors to grant, indemnity to
directors and officers in terms sufficiently broad to permit such
indemnification under certain circumstances for liabilities (including
reimbursement for expenses incurred) arising under the Securities Act. The
Registrant's Certificate of Incorporation and By-laws provide for
indemnification of its directors, officers, employees and other agents to the
maximum extent permitted by the Delaware General Corporation Law. In addition,
the Registrant has entered into Indemnification Agreements with its directors.
The Registrant also has purchased and maintained insurance for its officers,
directors, employees or agents against liabilities which an officer, a director,
an employee or an agent may incur in his capacity as such. Item 16. Exhibits Exhibit
Number Description of
Exhibit 4.1 Provisions of the Company's Restated Certificate of
Incorporation, dated as of June 2, 1995, that define the rights of
securityholders (incorporated by reference to the Company's registration
statement on Form 8-B filed with the SEC on December 4, 1995, to which these
provisions were attached as an exhibit). 4.2 Provisions of the Company's Certificate of Designation for the
Series A Junior Participating Preferred Stock, filed with the Delaware Secretary
of State on August 16, 1995 (incorporated by reference to the Company's current
report on Form 8-K filed with the SEC on August 14, 1995, to which these
provisions were attached as an exhibit). 4.3 Provisions of the Company's Restated Bylaws that define the
rights of securityholders (incorporated by reference to Exhibit 3.5 to
SangStat's Quarterly Report on Form 10-Q for the quarter ended March 31,
2000). 4.4 Registration Rights Agreement,
dated as of March 19, 1999, by and between the Company and 5 Opinion of Carole L.
Nuechterlein regarding the validity of the shares. 23.1 Independent Auditors' Consent. 23.2 Consent of Carole L.
Nuechterlein. (Included in 5) 24 Powers of Attorney (included on
signature page herein). Item 17. Undertakings 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 and of the
estimated maximum offering range may be reflected in the form of prospectus
filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in
volume and price represent no more than 20 percent 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 (1)(i) and (1)(ii) do not
apply if the registration statement is on Form S-3, Form S-8 or Form F-3, and
the information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or furnished to the SEC
by the registrant pursuant to Sections 13 or 15(d) of the Securities Exchange
Act of 1934 that are incorporated by reference in the registration
statement. (2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed to be
a new registration statement relating to the securities offered therein, and the
offering of such securities at that time shall be deemed to be the initial
bona fide offering thereof. (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. The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 (and, where applicable, each filing of an
employee benefit plan's annual report pursuant to Section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering
thereof. 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 described in Item 15 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. SIGNATURES Pursuant to the requirements of the Securities Act of 1933, SangStat
Medical Corporation 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 City of Fremont, California, on September 25, 2000.
SangStat Medical Corporation
By:
/s/ Jean-Jacques Bienaimé
Name: Jean-Jacques Bienaimé
Title: Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Jean-Jacques Bienaimé and Stephen G. Dance, and each of them individually (with full power to each of them to act alone), as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to do any and all things and execute any and all instruments that such attorney may deem necessary or advisable under the Securities Act of 1933, and any rules, regulations and requirements of the Securities and Exchange Commission in connection with the registration of these securities of the registrant, including to sign this registration statement and any and all amendments (including post-effective amendments) thereto, and to file such registration statement and any and all such amendments or supplements, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing necessary or advisable to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or their or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons, in the capacities indicated, as of September 25, 2000.
Signature |
Title |
|
/s/ Philippe Pouletty Philippe Pouletty, M.D. |
Chairman of the Board of Directors |
|
/s/ Jean-Jacques Bienaimé Jean-Jacques Bienaimé |
Chief Executive Officer, Director |
|
/s/ Stephen G. Dance Stephen G. Dance, CPA, FCA |
Senior Vice President, Finance (Principal Accounting Officer) |
|
/s/ Fredric J. Feldman Fredric J. Feldman, Ph.D. |
Director |
|
/s/ Elizabeth Greetham Elizabeth Greetham |
Director |
|
../s/ Richard D. Murdock Richard D. Murdock |
Director |
|
/s/ Andrew Perlman Andrew Perlman, M.D., Ph.D. |
Director |
|
/s/ Vincent Worms Vincent Worms |
Director |
INDEX TO EXHIBITS
Exhibit Number |
Description of Exhibit |
Page Number |
4.1 |
Provisions of the Company's Restated Certificate of Incorporation, dated as of June 2, 1995, that define the rights of securityholders (incorporated by reference to the Company's registration statement on Form 8-B filed with the SEC on December 4, 1995, to which these provisions were attached as an exhibit). |
|
4.2 |
Provisions of the Company's Certificate of Designation for the Series A Junior Participating Preferred Stock, filed with the Delaware Secretary of State on August 16, 1995 (incorporated by reference to the Company's current report on Form 8-K filed with the SEC on August 14, 1995, to which these provisions were attached as an exhibit). |
|
4.3 |
Provisions of the Company's Restated Bylaws that define the rights of securityholders (incorporated by reference to Exhibit 3.5 to the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2000). |
|
4.4 |
Registration Rights Agreement, dated as of March 19, 1999, by and between the Company and Warburg Dillon Read LLC. |
|
5 |
Opinion of Carole L. Nuechterlein regarding the validity of the shares. |
|
23.1 |
Independent Auditors' Consent. |
|
23.2 |
Consent of Carole L. Nuechterlein. (Included in 5) |
|
24 |
Powers of Attorney (included on signature page herein). |
|
|