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For Immediate Release
SANGSTAT TO REFOCUS ITS STRATEGY FOR FUTURE GROWTH
The Company Will Capitalize On Its Success With Thymoglobulin
And The Potential Offered By Its Early Stage Products In Order To Maximize
Shareholder Value
Fremont, California - October 16, 2000 - SangStat,
(Nasdaq: SANG) today announced the implementation of a strategy to
refocus the company to enhance shareholder value. This announcement is made in
conjunction with a separate release issued today by the company announcing that
Jean-Jacques Bienaimé has been elected as the new Chairman of the
SangStat Board of Directors. SangStat plans to redirect resources to capitalize
on its proven strengths in the marketing and development of high value
therapeutics in niche markets. The impact of this strategy will be to position
the company to continue to improve its EPS (earnings per share) and move toward
profitability while furthering the development of new products.
SangStat plans to build on the foundation in transplantation,
which has characterized the first part of its development, to grow its core
business in high value therapeutics. SangStat was initially solely focused on
solid organ transplantation, with a particular focus on the cyclosporine market;
however, recent events have required the company to reexamine this focus. First,
the success of Thymoglobulin and its potential in areas beyond solid organ
transplantation has provided the opportunity for the company to take advantage
of markets beyond solid organ transplantation. Second, the changing nature of
the cyclosporine market, including another generic entrant and the increased use
of other chronic immunosuppressants, has reduced the overall potential of this
market for SangStat. In order to aggressively pursue other opportunities for
Thymoglobulin as well as its earlier stage product candidates (ABX-CBL and
RDP58), SangStat has re-evaluated all of its programs.
To this end, all clinical development programs for SangCya
Oral Solution, CycloTech and diagnostic or monitoring products have been
terminated. The company will reduce direct marketing expenses behind its
cyclosporine products if the generic cyclosporine market becomes increasingly
price-driven. This strategic plan also includes overall expense control and may
include head count reduction in those areas not critical to the company's
growth. SangStat also plans to sell The Transplant Pharmacy, a specialty mail
order pharmacy with revenues annualizing to approximately $20M. SangStat has
decided to divest this business because it is outside its core business with
considerably lower margins than those enjoyed by therapeutics. In addition, the
company believes that the capital investment required to expand this business
would be better spent on the development of its other products.
These changes will allow the company to focus clinical and
marketing support on Thymoglobulin, ABX-CBL and RDP58 and give it the
flexibility to take advantage of other collaboration opportunities in the
broader therapeutic areas of inflammation, hematology and oncology.
"The success of Thymoglobulin with Q3 sales in North America
of $7.3M is evidence of our strong commercial sales and marketing capability in
the specialty high value therapeutic category. We will refocus our resources to
capitalize on Thymoglobulin's success through expansion into new therapeutic
areas, continue to develop our pipeline products and enhance our current product
offerings by co-promotions or product/technology acquisitions," said Jean-
Jacques Bienaimé, President, CEO and Chairman. "Sometimes changes in
particular markets offer an opportunity for companies to re-examine their focus
and direction. SangStat was originally almost exclusively focused on the
cyclosporine market and with the recent changes to the nature of this market we
now have the opportunity to strategically re-position the organization to
capitalize on its strengths. With gross margins greater than 75% in North
America, Thymoglobulin is the product that we believe will bring SangStat to
profitability."
The strategy for the expansion of applications for
Thymoglobulin is well underway and includes growth in a number of therapeutic
areas. In addition to the focus on solid organ transplantation with the ongoing
induction trial comparing Thymoglobulin to Simulect and the DGF (Delayed Graft
Function) trial initiated with the NIH, SangStat recently announced that it had
received Orphan Drug Designation for MDS (myelodysplastic syndrome, also known
as pre-leukemia). This is a key event for the company as it validates SangStat's
decision to move beyond transplantation into oncology. Use of the product in
these additional therapeutic areas, if approved by the FDA, has the potential to
double the current sales of Thymoglobulin in the US. SangStat expects to file
for the MDS indication in 2002.
The shift beyond transplantation was also the impetus for
SangStat's recent collaboration with Abgenix for ABX-CBL, a product in Phase
II/III clinical trials for the treatment of steroid resistant GVHD (graft versus
host disease), a disease associated with bone marrow transplantation. This
agreement offers a number of advantages for SangStat including the expansion of
its portfolio with a product that has tremendous synergies with Thymoglobulin
and the opportunity to become further involved in the hematology/oncology
area.
RDP58 is a concrete example of the company's natural
progression from a singular focus on transplantation to a broader immunology
focus. This product originated from research in organ rejection, but after
further study it was discovered that this product had potential in IBD
(inflammatory bowel disease) and is now scheduled to enter human clinical trials
for this indication in the early part of 2001.
As part of this refocusing, SangStat is taking the
opportunity to reset expectations. Previously expectations for the company were
built almost exclusively around its cyclosporine products and as a result, with
uncertainty in the cyclosporine market, the company's share price has suffered.
In order to mitigate the impact of another potential generic entrant into the
cyclosporine market as well as the extent to which aggressive pricing will
affect this market SangStat is reducing its estimates for Gengraf to $20M for
2001. This figure represents a 10% market share at a 50% discount and is
intended to be set at a level which removes this item as a risk to the company's
financials and addresses the uncertainty in the cyclosporine market. According
to the September 29, 2000 weekly IMS prescription report, Gengraf's share of the
US cyclosporine capsule market is 7% of total prescriptions. The most recent
monthly IMS report (August 2000) showed that Gengraf is ahead of Eon in both
unit and dollar sales and is now the leading cyclosporine generic in the US. The
company's expectations for North American Thymoglobulin sales in 2001 range from
$38M to $42M. The company further expects 2001 sales to range from $23M to $25M
in Europe. Even with this conservative cyclosporine sales forecast, by
implementing its cost containment program the company expects to move more
aggressively towards profitability with a goal that fiscal year 2002 will be
profitable.
SangStat will report its third quarter earnings on October
31st and expects to report a loss per share of $0.58 to $0.62, which includes
approximately $0.22 loss per share associated with the Abgenix agreement, on net
revenues of $20.5 to $21.5 million. SangStat expects a loss per share of $0.30
to $0.35 for the fourth quarter, which includes potential expenses or a possible
restructuring charge relating to the implementation of the new strategic plan
and is based on net revenues of $22 to $24 million.
SangStat, Inc.
As part of this new direction, SangStat Medical
Corporation will be changing its name to SangStat, Inc., will phase out using
the logo "The Transplant Company" and will be using the following new
company description.
"SangStat is a global biotechnology company building on its
foundation in transplantation to discover, develop and market high value
therapeutic products in the transplantation, immunology and hematology/oncology
areas. Since 1988, SangStat has been dedicated to improving the outcome of organ
and bone marrow transplantation through the development and marketing of
products to address all phases of transplantation in the worldwide market.
SangStat's US headquarters are in Fremont California. SangStat also maintains a
strong European presence, including direct sales and marketing forces in France,
Germany, Italy, Spain, and the U.K., and distributors throughout the rest of the
world. SangStat's stock is traded on the Nasdaq under the symbol "SANG." The
company's web site is located at www.sangstat.com."
This press release contains forward-looking statements
that involve risks and uncertainties, including statements regarding the
company's (1) commitments, intents and goals, (2) product development and
potential future sales, (3) expected utilization of resources; (4) opportunities
for future growth and development of new markets; (5) potential reductions in
expenses; (6) potential divestiture of The Transplant Pharmacy; and (7) expected
financial results including future revenues, expenses, charges, and
earnings/losses per share. Forward-looking statements reflect SangStat's current
views with respect to future events. Actual results may vary materially and
adversely from those anticipated, believed, estimated, or otherwise
indicated. This press release relies on IMS
data. There can be no assurances that IMS data is accurate and reflects actual
sales, or that Gengraf will continue to sell at the same levels described in
this press release. There can be no assurance that Thymoglobulin will be
effective for, or receive regulatory approval in, induction, DGF, or treatment
for MDS or any other indications, will achieve market acceptance with these
indications, or that SangStat will be able to manufacture sufficient quantities
to supply the market. There can be no assurance that any product candidate under
development will be safe, effective, receive regulatory approval, or if
approved, will be capable of being manufactured in commercial quantities at an
economical cost, will not infringe the proprietary rights of others or will
achieve market acceptance. There can be no assurance that the company will be
able to fulfill its commitments or meet its goals, effectively utilize its
resources, take advantage of opportunities for growth in new or existing
markets, reduce expenses, divest itself of The Transplant Pharmacy in a timely
fashion or at all, or meet its financial goals, including revenues, expenses,
and earnings/losses per share. Other factors that could cause actual results to
differ materially include, without limitation, unforeseen market developments
such as new competitors or increased sales by current competitors, reduction of
margins on key products, reduction in demand or failure of demand to reach
anticipated levels, the inability to reduce expenses due to fixed costs,
delays in clinical trial enrollment which could delay regulatory filings and
approvals, loss of critical employees and other issues of employee retention,
and changes in reimbursement for products. For a discussion of these and other
factors that might result in different outcomes, see "Risk Factors" in
SangStat's 1999 Annual Report on Form 10-K, its 2000 quarterly reports on Form
10-Q and other documents (including registration statements on Form S-3) filed
with the Securities and Exchange Commission.
# # #
SangStat will hold a conference call at 4:30pm Eastern
Time on Monday, October 16, 2000. To access the call dial 888-323-5255; the call
leader is Jean-Jacques Bienaimé; confirmation number is 9588414. A replay
will be available until Wednesday, October 18 at 4:30pm EST (800-385-2540).
You can find full copies of our latest press releases on the
web at www.sangstat.com.
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